 |
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated. |
|
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated. |
ATTENDANCE LIST
John Ehrmann, Project Director, Meridian Institute
Peter Robertson, Acting Deputy Administrator, EPA
Richard Rominger, Deputy Secretary, USDA
Daniel Botts, Director, Environmental and Pest Management Florida Fruit and
Vegetable Association
Jim Czub, National Corn Growers Association
Wally Ewart, Northwest Horticultural Council
William Lovelady Chairman, National Cotton Council
Brad Luckey, Owner-Operator Luckey Farms
Jose Amador, Texas Agriculture Research & Extension Center in Weslaco,
Texas
Greg Krissek, Assistant Secretary of the Kansas Department of Agriculture
Steve Balling, Del Monte Food
Mark Greenwood, Ropes and Gray.
Kay Holcombe, Policy Directions
Jon Jessen, President, Gowan Company
Tobi Jones, California Department of Pesticide Regulation
Robert Keifer, Chemical Specialties Manufacturers Association
Mike Kashtak, Center for Food Safety and Applied Nutrition, FDA
Mike Linker, North Carolina State University
Charles Mellinger, Glades Crop Care, Florida
Elin Miller, Global Vice President, Dow Chemical Company
Mark Miller, American Academy of Pediatrics
Nancy Rachman, Director, Global Regulatory Affairs, American Cyanamid
Bill Spencer, Citrus Farmer, President, Associated Citrus Packers American
Farm Bureau Federation
Robin Spitko, Plant Pathologist, New England Fruit Consultants
Mark Trostle, Texas Department of Agriculture, Representing the Association
of American Pest Control Officials
Jay Vroom, President, American Crop Protection Association
Mark Whalon, Pesticide Research Center Michigan State University
Dave Whitacre, Novartis
George Wichterman, Lee County Mosquito Control District
Margaret Wittenberg, National Communications Team Leader Whole Food Market
Anne Lindsay, Office of Pesticide Programs
Marcia Mulkey, Office of Pesticide Programs
Stephen Johnson, Acting Deputy Assistant Administrator, EPA
Jim Aidala, Associate Assistant Administrator, OPP, EPA
Susan Wayland, Acting Assistant Administrator Preventative Pesticides and
Toxic Substances, EPA
Keith Pitts, Special Assistant to the Deputy Secretary, USDA
Al Jennings, Office of Pest Management, USDA
Lois Rossi, Director, Special Review and Reregistation Division, OPP, EPA
Jack Housinger, EPA
Ed Zager, Associate Director of the Health Effects Division, EPA
Margaret Stasikowski, EPA
Margie Fehrenbach, Executive Assistant to Director, Office of Pesticide Programs,
EPA
Susan Hazen, Deputy Director, Office of Pesticide Programs, EPA
Mike Metzger, Chemist Branch Chief, EPA
Felicia Fort, EPA
Catherine Eiden, Health Effects Division, Office of Pesticide Programs, EPA
Jack Arthur, Health Effects Division, Office of Pesticide Programs
Jess Rowland, Toxicologist, Health Effects Division, OPP
Barry O'Keefe, Special Review and Re-registration Division, Chemical Review
Manager for Azinphos-Methyl
Therese Murtaugh, USDA
Wilfred Burr, Entomologist, USDA, Office of Pest Management Policy
Suzanne Deatheridge, USDA, Office of Pest Management Policy
Lora Lee Schroeder, Representative, Region Four
Richard Avcoin, Pest Management Regulatory Agency of Health Canada
Teung Chin, USDA, Office of Pest Management Policy
Sarah Walen, Meridian
Steve Galfon, Director of the Office of Science Coordination and Policy,
EPA
Bill Jordan, Office of Pesticide Programs
Kevin Keaney, Worker Protection and Applicator Certification Training, EPA
Antonio Bravo, Special Assistant to Pesticides, EPA
Jeff Kempter, EPA
Carol Peterson, Policy and Regulatory Services Branch
Brad Shurdit, House Agricultural Committee
Terri Nintemann, Senate Agricultural Committee
Neysa Call, Congressman George Brown's Office
Kathy Monk, Branch Chief, Special Review and Registration
Dave Jones, Environmental Fate and Effects Division
Neil Anderson, Biologist, Biological and Economic Analysis Division, EPA
Tom Kiely, Economist, Biological and Economic Analysis Division, EPA
Rich Dumas, Special Review and Registration, EPA
John Cady, President, National Food Processors Association
Linda Abbott, Office of Risk Assessment and Cost Benefit Analysis
Bob Epstein, Secretary Science Advisor
PROCEEDINGS
MR. EHRMANN: Welcome to the -- what I believe is the sixth meeting of the Tolerance Reassessment Advisory Committee of EPA and USDA, which is a subcommittee of the NASEP committee at EPA.
And what I want to do first is go around and have folks introduce themselves. And we have a lot of people at the table, as well as at the back tables.
And I want to take the time also to introduce the folks at the back tables, because you're going to be hearing from a number of them throughout the course of this agenda as -- and in presentations and also they're here as resource folks, so I think it's important to recognize everyone.
And we also have some -- some friends from the Hill here, I want to make sure they get a chance to introduce themselves. So we'll go first around the inner table and then around the two outer tables.
And then I will turn it over to our co-chairs for some opening comments. And let me start the introductions with Dr. Amador and we'll work our way around.
MR. AMADOR: Good morning. My name is Jose Amador and the Director with Texas A & M Research and Extension Center at Weslaco.
MR. BALLING: Steve Balling, Del Monte Food.
MR. BOTTS: Dan Botts, Florida Fruit and Vegetable Association.
MR. CZUB: Jim Czub, National Corn Growers Association, a grower from upstate New York.
MR. KRISSEK: I apologize for the alphabetical order. I was Allie Devine. I am Greg Krissek, I'm the assistant secretary of the Kansas Department of Agricultural for Allie.
MR. EHRMANN: Welcome.
MR. EWART: I'm Wally Ewart with the Northwest Horticultural Council.
MR. GREENWOOD: Mark Greenwood, Ropes and Gray.
MS. HOLCOMBE: Kay Holcombe, Policy Directions.
MR. JESSEN: Jon Jessen, Gowan Company.
MS. JONES: Tobi Jones, California Department of Pesticide Regulation.
MR. KEIFER: Robert Keifer, Chemical Specialties Manufacturers Association.
MR. KASHTAK: Mike Kashtak, Center for Food Safety and Applied Nutrition, FDA.
MR. LINKER: Mike Linker, North Carolina State University.
MR. LOVELADY: Bill Lovelady, I'm a cotton grower from Texas and I represent the National Cotton Counsel.
MR. LUCKEY: Good morning. Brad Luckey, I'm a farmer from the Imperial Valley in southeastern California.
MR. MELLINGER: Charles Mellinger, Glades Crop Care, Florida.
MS. MILLER: Elin Miller, the Dow Chemical Company.
MR. MILLER: Mark Miller, American Academy of Pediatrics.
MS. RACHMAN: Nancy Rachman, American Cyanamid.
MR. SPENCER: Bill Spencer, I'm a citrus grower from Yuma, Arizona and I represent American Farm Bureau Federation.
MS. SPITKO: Robin Spitko, I'm an independent crop consultant from New England, representing the National Alliance of Independent Crop Consultants.
MR. TROSTLE: I'm Mark Trostle with the Texas Department of Agriculture, representing the Association of American Pest Control Officials, which is all the state lead agencies.
MR. VROOM: I'm Jay Vroom, President of the American Crop Protection Association.
MR. WHALON: Mark Whalon, Michigan State University.
MR. WHITACRE: Dave Whitacre, Novartis.
MR. WICHTERMAN: George Wichterman with the Lee County Mosquito Control District in Fort Myers, Florida.
MS. WITTENBERG: Margaret Wittenberg, Whole Food Market.
MS. LINDSAY: Anne Lindsay, Office of Pesticide Programs.
MS. MULKEY: Marcia Mulkey, Office of Pesticide Programs.
MR. JOHNSON: Steve Johnson, EPA.
MR. AIDALA: Jim Aidala, EPA.
MS. WAYLAND: Susan Wayland, I am the Acting Assistant Administer for Preventative Pesticides and Toxic Substances at EPA.
MR. ROBERTSON: I'm Peter Robertson, Acting Deputy Administrator at EPA.
MR. EHRMANN: I'm John Ehrmann, Meridian Institute.
MR. ROMINGER: Rich Rominger, Deputy Secretary, USDA.
MR. PITTS: Keith Pitts, USDA.
MR. JENNINGS: Al Jennings, USDA.
MS. ROSSI: Lois Rossi, EPA.
MR. HOUSINGER: Jack Housinger (phonetic,) EPA.
MR. ZAGER: Ed Zager, EPA.
MS. STASIKOWSKI: Margaret Stasikowski, EPA.
MR. EHRMANN: Margie, why don't we start with you.
MS. FEHRENBACH: Margie Fehrenbach.
MS. HAZEN: Susan Hazen, EPA.
MR. METZGER: Mike Metzger, EPA.
MS. FORT: Felicia Fort, EPA.
MR. EHRMANN: It would be helpful if the EPA folks could tell us -- just give us a sense of what part of EPA you work in, just so people can get a --
MS. EIDEN: Catherine Eiden, the Health Effects Division in the Office of Pesticide Programs at EPA.
MR. ARTHUR: Jack Arthur (phonetic,) Health Effects Division, Office of Pesticide Programs.
MR. ROWLAND: Jess Rowland, Toxicologist, Health Effects Division, OPP.
MR. O'KEEFE: Barry O'Keefe, Special Review and Reregistration Division, Chemical Review Manager for azinphos-methyl.
MS. MURTAUGH: Therese Murtaugh, USDA.
MR. BURR: Wilfred Burr (phonetic,) USDA, Office of Pest Management Policy.
MS. DEATHERIDGE: Same office. Suzanne Deatheridge, USDA.
MS. SCHROEDER: Lora Lee Schroeder, representing region four and former TRAC member.
MR. AVCOIN: I'm Richard Avcoin with the Pest Management Regulatory Agency of Health Canada.
MR. CHIN: Teung Chin, USDA Office of Pest Management Policy.
MS. WALEN: Sarah Walen, Meridian.
MR. GALSON: Steve Galson, I'm the Director of the Office of Science Coordination and Policy at EPA.
MR. JORDAN: I'm Bill Jordan, I work on science policies in the Office of Pesticide Programs.
MR. KEANEY: Kevin Keaney, with Worker Protection and Applicator Certification Training at EPA.
MR. BRAVO: Antonio Bravo (phonetic,) Special Assistant to Pesticides, EPA.
MR. KEMPTER: Jeff Kempter, I work on science policy issues, EPA.
MS. PETERSON: Carol Peterson (phonetic,) Policy and Regulatory Services Branch.
MR. SHURDIT: Brad Shurdit, House Agricultural Committee.
MS. NINTEMANN: Terri Nintemann, Senate Agricultural Committee.
MS. CALL: Neysa Call, Congressman George Brown's Office.
MR. EHRMANN: Great. Did we miss anybody? Let me turn it over to Mr. Rominger with some opening comments.
MR. ROMINGER: Thank you, John. Well, good morning everyone. And I want to thank all of you for coming to our sixth TRAC meeting.
And we look forward to updating you on the Administration's ongoing efforts to implement the Food Quality Protection Act.
I also look forward to hearing your thoughts on the progress that we've made to date, as well as your guidance on future actions being considered by USDA and EPA as we shift into the risk management phase for some of the organophosphate chemicals currently in the final stages of interagency review.
Peter, I also want to welcome you onboard as the esteemed co-chair of the TRAC. As a long-termer here, I was initially planning to regale you with tales about how Fred and I struggled through our first TRAC meeting and how fortunate you were to inherit a -- the mantel of co-chair under some relatively calm circumstances.
But unfortunately, some recent events have resulted in some refinements to my own preliminary risk assessment under the assessment of TRAC.
In all seriousness though, I do welcome you aboard, and want to emphasize to the Advisory Committee how much I value the working relationship that you and I have developed over the past several months.
For me, that sense of value and respect extends to each person that we've asked to contribute to this committee.
Each of us has an important perspective to offer to the TRAC, and ultimately to the larger effort, to ensure that the Food Quality Protection Act is fully and appropriately implemented. And that suffers in the absence of any one segment or even any individual.
The decision of the environmental and public health community members to resign from the TRAC is very disappointing to Peter and to me and to our agencies.
USDA and EPA are fully committed to getting the most out of this process, to better inform and shape our implementation of the FQPA.
We also want to make it abundantly clear that our responsibilities in implementing this law extend beyond the TRAC, and that -- and that USDA and EPA will make every possible effort to solicit a broad range of advice to fully inform our decisions.
In turn, each of you should know that your views and voices are not limited to your participation on the TRAC.
Peter and I both look forward to working with each of you today, tomorrow and well into the future through this forum and others.
Recently in Chicago, we had a gathering of our Land Grant University partners, the pesticide coordinators from those universities. And I think there were about 90 of them there, is that right, Al?
We got together to talk about the work that -- that they are doing in helping us on the crop profiles, and on the risk assessments, and the increasing involvement they'll have as we develop mitigation and risk management strategies.
So we had a good three-day session with all of them there, going through some examples of what we've accomplished so far and -- and how we expect to be partnering with them in getting the additional information and activities as we move to continue to implement FQPA.
So we wanted to make sure that our Land Grant partners were full engaged, and I think they are, and will be of tremendous value as we move forward with implementation.
Before we go any further with the meeting, I want to make some brief observations about where I think we are in the organophosphate review process.
First, EPA has to date formally delivered 10 organophosphate risk assessments through USDA. We've completed our review of four, and have returned them to EPA.
And within the next few days, we'll complete two additional reviews and submit our formal comments to the Agency, bringing our total to six completed reviews.
The two agencies recently met on a seventh chemical, azinphos-methyl, and we've collectively agreed to work intensively over the next few weeks to bring that interagency review to closure.
Some lessons learned on my part from this subset of the organophosphate class of chemicals are number one, that these risk assessments are quite complex and in some instances daunting.
USDA has truly gained a greater appreciation for the very difficult work that many people at EPA undertake on a daily basis.
EPA and USDA are jointly making every effort to ensure that risk assessments are made on the best available data.
USDA is confident that the data that we're collecting is being used by the Agency, and that USDA data is generally being collected in a manner and format that is useful to EPA.
Number three, the refined data have had a significant impact in changing the preliminary risk assessments for dietary exposure on individual chemicals.
And four, many agricultural uses appear to contribute little or nothing to the individual risk cup. Conversely, major contributions to the risk cup for some chemicals seems to concentrate on a few commodities.
And number five, even in the event that an individual chemical falls within its reference dose, the cumulative risk assessment will have an impact on some commodities.
So recognizing this, USDA and EPA want to engage some selected commodities on mitigation and transition strategies now, in order to avoid any risk of future market disruption.
And finally number six, worker risks are a consistent issue across the entire class of organophosphates, and will provide some interesting challenges to all the impacted parties.
USDA's gained a lot of knowledge and insight from our new working relationship with EPA. And on the basis of this information, we're now in a better position to understand and even anticipate the needs of both EPA and the grower community.
So USDA is accepting its new role in this process and is making long-term budgetary and immediate resource allocation decisions to support the implementation of FQPA, particularly as risk mitigation needs arise from the regulatory process.
So I look forward to hearing your thoughts about how the Department can continue to be an effective partner in this evolving process. Thank you. Peter?
MR. ROBERTSON: Rich, thank you very much. And good morning to all of you. I'm very grateful for you continued willingness to commit to this process, and for just showing up. I didn't know how much a measure of success just showing up would be until this morning.
Rich, let me say to you how grateful I am, both for your warm welcome and for your willingness to -- to work with me, counsel me and tutor me over these last several months.
I've appreciated your personal help and the help of everyone at USDA, as I've tried to come up this steep learning curve over the last several months.
This is a critical time for EPA, for USDA, and for the agricultural community as we move into the implementation of the Food Quality Protection Act.
We've got a full agenda ahead of us. We've gotten to this point because of the commitment of everyone around this table and around this room. But we'll need your continued full support if we're going to move ahead in this process.
FQPA, the enactment of FQPA, and now the implementation of FQPA, is one of the most significant accomplishments of the Clinton Administration.
EPA and USDA are working extremely hard together to ensure that the statute is fully implemented in a timely manner to achieve greater food safety for U.S. consumers, particularly infants and children.
As I said, I very much enjoyed my working relationship with Deputy Secretary Rominger and everyone at the Department of Agriculture. I think we have a closer relationship between our two agencies than has ever existed before, certainly in this arena.
As you know, we've had some resignations -- or I guess we'll experience some resignations from the TRAC this morning, stemming from differences over an acceptable time frame for regulatory or transitional issues.
I deeply regret these resignations, because I'm certain that they do not help our shared goal of protecting the health of the American people.
TRAC is charged with ensuring that EPA's implementation of FQPA be transparent, inclusive, based on sound science, and that it provide a reasonable transition for agriculture. These charges are easy enough to enumerate, but they are by no means easy to carry out.
Nonetheless, the Clinton Administration is absolutely committed to implementing FQPA's important protections on schedule as the law requires.
Making sure that EPA's risk reduction actions are based on sound science, is the most important step that all of us can take to guarantee that FQPA's promise of protection for our children and the American public is actually fulfilled.
Let me clarify a few things about the differences in opinion that led to the resignations, specifically some things about which there were no difference of opinion.
There was no disagreement about the fact that organophosphates pose health risks. There was no disagreement that significant reductions in use will be required.
EPA also wishes that this process could move faster. But let there be no mistake, we're on schedule for assessing risks and for taking risk reduction actions beginning in August as the law prescribes.
In the meantime, we're calling on the manufacturers of OPs to work with us to reduce the significant risks these compounds pose in a sensible manner.
We also will continue to work with the farm community to ensure that it is able to provide the American public with an abundant, affordable, healthy and safe food supply.
I think the accomplishments of TRAC so far have been truly outstanding, and that's one of the reasons that I'm so disappointed by the resignations that we witnessed this morning.
We've made a fundamental change in the way that this Agency approaches pesticide regulation. The goals of transparency and inclusiveness have never been better annunciated or accomplished than they have been in this process.
The presence of all of you who are here today, I think signals the progress that we've made. We've really changed the way that pesticide decisions are made in our Agency.
We have, for what is for all practical purposes, a new process for review of the organophosphates. I think that new process -- we hope to talk with you further over these last TRAC meetings about ways we can improve that process. But we hope that it will continue to serve us as we reassess other groups of chemicals.
Another goal was to ensure the use of sound science. We forged a strong partnership with USDA, which will help us to ensure the use of the best available agricultural data.
Cooperative efforts with the Land Grant universities has increased the quality of our information.
Working with all of the stakeholders, we're continuing to improve the database that we're using in making our decisions.
We have enormous challenges yet before us, and we need your help in facing and meeting those challenges. We need to build on the progress we've made so far on the difficult issues of organophosphates.
We need to work to ensure continued protection for public health and stability for U.S. agriculture. We want to work to improve our transparency.
We've made enormous success so far in that arena, I believe. But in particular areas, for example, worker protection, I think our efforts could continue to improve transparency.
Finally, we will at all times and under all circumstances work as hard as we can to support and encourage extensive stakeholder involvement by all parties.
We will continue to work for a reasonable transition for agriculture, as we continue the tolerance reassessment and risk mitigation efforts.
We will work hard with our partners at the Department of Agriculture and with all of you to reduce the risks that the American public faces, and we will minimize disruptions for growers while providing these strong protections.
It is my hope that during these final TRAC meetings, we can focus primarily on formulating ways to gain everyone's input on practical, feasible and affordable risk mitigation measures.
Again, my thanks to all of you for your continued willingness to help us do our job of protecting public health in the environment, while continuing to provide a strong agricultural community for our County. Thank you.
MR. EHRMANN: Thanks both of you very much. And let me just say a few words about the agenda for today, and then we'll get at it.
The -- this morning we're going to, after a very brief summary of what took place at the work group a few weeks ago, hear a report on the current status of the organophosphate pilot process.
And this will be an update of exactly where the various organophosphates are in the process, the various time lines for public review, comment, et cetera. And there will be an opportunity for questions and answers about that.
This afternoon we're going to have an opportunity to hear from a number of you with some initial presentations on some thoughts that folks have collected about that pilot process. So I want to keep the discussion this morning to be more of a clarification kind of discussion.
When we get to that afternoon part of the agenda at 1:30, where we'll hear from various perspectives, will be more of the time where we can have a qualitative kind of evaluative discussion about the pilot process.
And specifically get your recommendations about how you would like to see that process going forward that -- that Peter and Rich referred to in their comments.
So that will be -- the 10:30 item will be the update and status of the pilot process. After a break then we'll hear a prototype briefing on azinphos-methyl.
For those who were at the work group meeting a few weeks ago, this briefing will include a review of the current dietary risk assessment which will have some updated numbers from what you saw a few weeks ago.
Plus there will be briefing, as the agenda indicates, on other aspects of that assessment of azinphos related to drinking water, worker risk, eco risk, et cetera. So it will be a -- a fuller presentation than what we reviewed at the worker meeting a couple of weeks ago.
Then as I mentioned, after lunch we'll have the opportunity for an interactive discussion about the current status of the pilot process in the azinphos review.
And again, looking for advice and guidance to the Department and the Agency for how you believe they should go forward as it relates to that kind of process.
After an afternoon break, we're going to hear a -- a discussion on worker-risk issues. This will be a -- basically a generic presentation.
So not focusing on any particular organophosphate, but what is the approach and methodologies that are being used to evaluate worker risk.
This is an issue that the TRAC has not spent any indepth time on, but obviously it's come up throughout the course of these discussions. And that will be the -- an opportunity to hear from the Agency and the Department about their work in that arena and discuss those issues.
Then at 4:30, for members of the public who are here, we will have a public comment period between 4:30 and 5:00.
And I would encourage you -- request that you sign up outside if you're interested in making public comments, so that we can calibrate our timing. And I'll make sure we allow adequate time for those folks who do wish to make public comment in that period.
Tomorrow's agenda will start with a brief overview of the nine science policies, which again will be updated from the information you received at the briefings a few months ago.
Mark Whalon has kindly agreed to make a presentation regarding various transition activities in Michigan.
This kind of complements a couple of presentations that we had at the work group meeting, one by Sarah Lynch from World Wildlife Fund one by Jan Relford from Gerber on their transition work.
And Mark unfortunately wasn't able to be at that meeting, so he's kind enough to make this presentation tomorrow morning. And I know that will be very helpful.
And then we'll go into a more general discussion of transition strategies led by USDA right before we adjourn tomorrow.
And we will end the session with a discussion and any advice you have to the Department or the Agency about the -- the next TRAC meeting in terms of both content and timing. And again, there will be an opportunity for public comment tomorrow in that session.
So we will, as I indicated, work through the agenda as we have in previous meetings, trying to keep as close as we can to these time lines, but be flexible if we need to adjust things. And I'll try to keep you posted on how I see the timing affecting the overall flow of the agenda.
Also, as always, we have a lot of people here. I'd ask that you use your name teats on end, or give me a clear signal when you want to speak.
I'll try to blend together the desire of people to follow each other's comments, as well as keep everybody in the que, which is a balancing act.
But I think sometimes it's helpful to be able to let folks kind of cut in line and respond to somebody else.
But I also want to make sure everybody gets their chance to comment, so I'll do my best to blend those priorities together as we go through the agenda.
Let me just say a word about the work group meeting that was held on April 8th and 9th, and a number of you did attend that meeting. Which was I think a very helpful opportunity to kind of get warmed up on some of these issues, since there hadn't been any organized TRAC meetings for a while.
And I'm not going to go into detail on what was covered in that work group meeting, because we're going to hear some of that at this meeting, in addition to the new information that I commented on a few minutes ago.
But for those who weren't there, that meeting -- basically we did hear a -- a status update at that point about the organophosphate pilot process and the numbers of reviews and where pieces were. And again, we'll hear an update on that presentation today.
We did have a -- a dietary risk assessment presentation on azinphos-methyl. But again, it didn't include the other parts of that assessment, which we will hear today.
But I think it was of -- I think widely seen by folks who were at that meeting as -- as the best and clearest presentation of the risk assessment process that the TRAC had had.
And I know that the staff both appreciated that feedback, and has tried to incorporate that in the presentations that you're going to hear today. So I think that was a very helpful run through on that overview.
And it also, I think, gave, as Rich and Peter mentioned, a sense of the kind of refinements that are taking place as these risk assessments move forward and the coordination between USDA and EPA.
In the afternoon of that work group meeting, we had a dry run, technical briefing on bensalane. Which again I think was a very clear and helpful presentation, and gave the group a sense of the way that these technical briefings are going to be structured.
Again, just to remind everybody, at the end of the risk assessment refinement process the plan is to have a technical briefing which would invite stakeholders to participate.
Where the Agency and the Department would present their -- their review in that final form, to allow an opportunity for everybody to get the same information at the same time as the process moves into the risk management side of the overall process that the TRAC has -- has helped the Department and the Agency lay out.
So that was a -- kind of prototype of that technical briefing. And I think some very helpful feedback came back in terms of the way that briefing was structured, and how those might be done going forward.
Then as I mentioned, we had a presentation from -- from Jan Relford from Gerber and Sarah Lynch from World Wildlife on the work that they've been doing in the area of transition.
And we'll try to reprise some of that and summarize some of that for you in the context, along with Mark's presentation tomorrow, so we can use that as input to that overall transition discussion that we'll have tomorrow. But those presentations were very helpful.
We had a brief update on the science policies, and then we had a very good discussion about the organophosphate and initial discussion on the pilot process. And that's really what I think seeded our request to have some of the folks at this meeting give us a more indepth feedback on the pilot process.
So that the Department and the Agency can really move forward in making the decisions they need to make about how that process is going to operate in the future in terms of stakeholder involvement, transparency, public review, et cetera.
So I think the work group meeting gave us a good opportunity to determine what would best be on the agenda for this meeting, and appreciate those who attended and participated in that context.
Are there any questions about either that meeting or the agenda for the next day and a half before we move to the first agenda item on today's schedule?
Okay. Then let me turn it over to Lois and Al, who are going to provide the update on the status of the pilot process.
MS. ROSSI: I'm going to discuss the pilot process, and then Al is going to finish the presentation with some points on the pilot process that USDA is directly involved with.
What we're going to do this morning is present the six stages of the pilot process and some comments that hopefully will be the source of your discussion this afternoon.
What you have in your packet is a paper related to this presentation called, "Organophosphate Pilot Process Discussion." There's a cover page.
This paper actually takes a couple of papers that have been developed for this TRAC as we've developed phases one through three and then four through six, and it presents them all in one. So this -- this is basically the TRAC pilot process all in one paper.
And the second sheet of paper gives you on both sides the status of the OPs that are being considered in the pilot process and which phase they're in.
So starting with phase one, which is considered -- or called the registrant "error only" review phase.
What it is designed to do is give registrants an opportunity to identify errors in the preliminary health -- human health and ecological risk assessment for a given OP. EPA has also shared this preliminary risk assessment with USDA.
The Agency has received the comment that 30 days is too short a time to review some of the lengthy risk assessments. However, this is just one of several comment periods in the whole process that people do have a chance to comment on.
The Agency has received more than just error comments during this phase, sometimes we receive data. We've also received analysis of the assessments.
We have been able to review the comments that are directed to errors that are error comments -- truly error comments.
And have been able to make those corrections, or note in the assessment that's put in the docket. We've noted any changes we've made or addressed these changes.
So we have been able in this phase one, we have been able to deal with the comments received and move the process along to the next phase.
And we are -- we are only actually aware of one instance where the preliminary assessments have had any impact -- real-world impact.
Phase two is an EPA phase. We've also started thinking of these phases as -- is -- as registrant activity, EPA activity, intergovernmental activity.
Phase two, again, is the EPA phase. And as I said, that we -- that it is the 30-day phase. We have been able to stick to that schedule for the most part, and have been able to address the comments.
Again, I'd like to note that this phase, as well as phase three, has resulted in the generation and submission of a lot of data on a fairly rapid time frame. So it has been valuable in that the Agency has received quite a bit of data.
Phase three is a public comment period, the -- the first public comment period in the process. And it is a second opportunity actually for registrant involvement, and it is the first opportunity for the public.
At that time, EPA releases the preliminary risk assessments for the public review and comment and opens a docket and places them in the docket, as well as the Internet.
I think docket and internet have almost become synonymous these days. But we have been posting them on the internet, and they are available in a public docket.
The majority of comments that we have received in this 60-day comment period have been from the manufacturers of the chemicals, the registrants.
Comments from other stakeholders or general pubic, have in some cases been generic to all the OPs, and a few are chemical specific.
We have addressed this phase and as we go into the next public comment phase, we will be addressing the comments.
MR. EHRMANN: Thank you.
MS. ROSSI: We will -- we will be addressing the generic comments as well as the chemical-specific comments as we go into phase five.
Okay. The next phase, phase four, which is the one most of our chemicals are in right now, we have 27 chemicals that we're currently working on phase four.
It begins at the close of the 60-day public comment period, and it gives the Agency up to 90 days to revise the risk assessments based on the public comments.
In drafting the revised assessments, the Agency, together with USDA, has discussed and implemented several revisions to the risk assessments.
I'd like to just briefly touch on those. They were presented to the work group, and some of them were presented at the TRAC update. Many of them were presented to the TRAC work group meeting three weeks ago.
But I'd like to just highlight some of these changes that we've made in revising the risk assessments.
First of all, we developed a methodology to use composite PDP data to estimate single servings in probabilistic risk assessments.
We've used the best data available to get the most realistic exposure estimates to predict risk. We are determining the risk contributors of these assessments.
These have been referred to as drivers, risk contributors. The analysis has been referred to as sensitivity analysis.
When anyone hears these words, they all refer to looking at the risk assessments to see what is going on in them.
You can look at -- you look at the underlying assumptions and you can see if a risk is being driven by a particular commodity, or even a food form within that commodity. Is it the consumption data, is it -- are the residue levels driving the risk, contributing to the risk.
We've tried various runs with our model, with our dietary probabilistic assessment model to see if we used zeros instead of non-detects, what the impact of that would be. We've also run these assessments at various level -- levels, percentiles, 99, 99.5, 99.9.
Those are many of the refinements that we've made to our thinking process and our analysis as we're going through these revised risk assessments -- going through the process of revising these risk assessments.
With regard to worker risk, we've received some data and we are continuing to get data from the Agricultural Reentry Task Force, which was formed in response to a DCI, the Agency issued to get worker -- better worker reentry data.
Back in 1995 we issued that DCI. And these are being used in the assessment as they are received by the Agency.
In an effort to make clear to the public the data and the assumptions used in the risk assessment, we have developed standard formats, overviews, and an even briefer summary cover sheet. Those were presented to the work group when we did our dry run of the bensulide last time.
The assumptions that go into the assessment are laid out, including the risk and the data and other factors that have impacted the assessment of risk.
Again, the purpose of the overview was to help communicate to the public how we develop the risk assessments, and the Agency's findings in a shorter, more easily understood way.
As referred to this morning, these assessments are very complex and very lengthy. And these overviews and summaries are an attempt by the Agency and the Department to make clearer what goes into these assessments, to allow for a better public comment and understanding of public comment, and ultimately to aid in the risk management process and decision.
Once the revised assessment and overview are completed, EPA then sends the entire package to USDA for intergovernmental review.
And as was said this morning, there are 10 currently that the Department has received at this time and that we are working. We have 17 more yet to deliver.
USDA will focus their assessment on the assessments, utilization of use and usage data, the assumptions used, as well as possible strategies and options for managing the risk.
Their review team will include their Land Grant University employees, and I was going to tell a little more about that in a minute.
We will also consult with the Department of Health and Human Services when an OP has public health uses. And their role will be similar to USDA's.
We have sent -- one OP currently is with DHHS. And we have actually received comments on that OP since the work group meeting.
USDA and DHHS need time to do a proper review of the OP documents. And originally when this process was designed, that time was not provided for. The intergovernmental review does take time beyond the 90 days.
Let me just say at this point that the 90 days that was allotted to this phase, in some cases the Agency has found this time is adequate.
And in other cases, it's found that it's needed more than the 90 days, particularly when a lot of the comments have been new data being submitted.
So while we have aggressively worked with this 90-day time period and in most cases have been able to get the majority of the revised risk assessment completed in the 90 days, it -- it does become a little difficult depending upon new data and the extent of the comments received, but mostly the new data.
We -- with USDA, we have agreed upon another amendment to the time frame of this process. We have allowed -- we need to allow USDA and HHS time to review these documents.
And if it generally takes us 90 days -- while we turn over the revised assessment to the Department or the -- or HHS as soon as we complete it, if it does take us 90 days, then USDA -- we have come to an agreement with them that depending upon the complexity, which mostly is a function of the number of uses that are -- that a chemical is registered for, we would determine whether a two-week, a four-week or a six-week time period would be adequate for the Department.
So if it's -- in the case of -- of a fairly straight forward chemical with one use and -- and we have had one like that, the Department has turned that around very rapidly. And that was like less than two weeks. Some of the more complicated ones are more like four weeks and six weeks.
So we can look at this phase as going from 90 days to a minimum of like 120, because the Agency would need some time to look at the Department's comments, address them, and agree with the Department on how we are going to address the comments, to possibly 180 days in the case of where you have six weeks of USDA review time.
By the end of the review process, USDA will then send their comments to the Agency and we will incorporate these comments and discuss them with USDA. And we've had many discussions just on the ones that we've sent over so far.
At the last TRAC work group meeting we announced a slight amendment to the -- even that delivery, in that we directly hand over to Al and his team the assessments once the Agency is ready to send them. And we meet and sort of do a debriefing.
Because by the time the Agency has finished with these assessments, we've certainly spent a lot of time and Al thought it would be a good use of our time and his time to share that information with him.
And we have done that since the last work group meeting. We've already done that once and probably will do it again in the next two weeks.
The next step in the process would be after the USDA, HHS review. EPA would announce the date of a public meeting, and we call that a technical briefing.
We will post a -- a notice in the Federal Register to publicize the meeting, as well as other traditional ways that the Agency has used to announce meetings. And we'll give it a two-week announcement.
At the work group it was suggested that at the time we post the announcement that we also post the summary, so that -- in that it would be a good way for people to decide if they need to come to the technical briefing or not. Because the two-page summary just briefly summarizes the uses and highlights concerns, and that was suggested.
Again, the purpose of this briefing would be yet another opportunity to go through the risk assessment and explain the assumptions behind the assessment.
It would give interested stakeholders an opportunity to become more informed about the major points in the assessment, such as the risk contributors and drivers and the data that was used, and describe how public comment has affected the assessment. In addition, USDA could bring to this meeting ideas on possible risk management strategies and options.
The public would be given an opportunity at that point in time to ask clarifying questions about the refined risk assessment.
And again, all meeting minutes, as the case with all meetings in this process, would be placed in the public docket.
It was also suggested at the work group meeting that -- the focus of these technical briefings. Because some of them, if you go through every aspect of the assessment that's presented in these documents, it could be a fairly long presentation.
And the -- and the work group suggested that we focus on the areas of concern, that is the areas that are most likely to need risk management.
(END OF TAPE)
After the technical briefing, we would open a public docket and post on the internet the risk assessment for a 60-day public participation period, in which the -- the public and -- and stakeholders would be invited to submit risk management proposals on the risks that have been identified in the assessment as needing management and mitigation.
During this time we also view it as a time where we would be conducting meetings with registrants, with growers, both USDA and EPA.
And again, all these meetings would be docketed. And it would be a time to discuss strategy for the risk management of the chemical.
And -- and then the last phase, which is phase six of the process. Phase six, which we have not had experience with at this point.
We're getting ready to have experience with phase five on four of our chemicals, which would be the first step in the formal regulatory decision process, and that would be an EPA with USDA phase.
That pretty much concludes my thoughts. We -- we are hoping that the discussion this afternoon will comment on the various phases as we determine to move this process out of the pilot into just a process for the review of chemicals in the tolerance reassessment program. So with that, I'll turn it over to Allen.
MR. JENNINGS: Well, as usual, we've divided up the work here so that Lois has to do most of it. You can find in your package, staff paper 36, which is just a one-pager, kind of outlining the -- the USDA review process in short bullet form. But I will talk a little bit about that and expand some of the bullets.
So far the experience I think has been very positive. We've had a good exchange of thoughts and data on the first 10 -- actually, we've only probably gotten our teeth into about eight of them.
But of the first ones that have come over, I think we've learned a lot from each other, lessons that will apply to the future risk assessments as they come through the door, how to do it better.
I think as Lois mentioned, we're -- recently experimented with getting a detailed briefing from Lois and her people, and that helped a great deal to get us oriented and will save time down the road as we go through the review process.
I guess the other thing to focus on with -- with our review process is that we are not engaging heavily in toxicology.
The USDA review is directed more towards the exposure part of the equation, looking at the data generated by USDA, pesticide-data-program-type data, the consumption survey information, as well as the ag statistics pesticide-use information, to ensure ourselves that the risk assessment accurately captures our information, and the analysis is something we can agree with, and finding any additions or corrections or gaps that -- that may be there.
It's also caused us to think about those data programs in the planning mode, what do we need to do in the future.
As we're seeing how they're applied in risk assessments, it helps us look forward and ask what we can do to gather information that will be of more value to EPA in the future.
So as I said, we're learning a lot in this process. And I think some of it will help, again, in the future as we get better at doing this process.
Well, once the risk assessment arrives in my office, we create our team. And our team really is a combination of USDA headquarters, as well as our Land Grant partners, the state -- out in the states, the state universities.
Within headquarters, I've already mentioned a couple of those, The National Ag Statistical Service. Our Office of Risk Assessment and Cost Benefit Analysis, who have expertise in Monte Carlo analysis are part of the team.
The Ag Marketing Service, these are the people who collect the -- the data in the pesticide data program.
The Ag Research Service, I already mentioned them, for the food consumption. But we also have scientific crop production experts, both at Beltsville, which is in the area, as well as research facilities across the country. So we identify those.
Animal Plant Health Inspection Service, Teung Chin, who is on detail from my office, represents APHIS. And they are particularly useful in looking at public health issues, as well as other invasive species-type control -- use patterns for these chemicals.
So I've probably missed somebody. But I think the message is that the USDA headquarters' team really is broad based and incorporates the -- the agencies within the Department to -- who have expertise in a role in pest management.
Our outside team at the Land Grant depends on our review internally. The use pattern is where is the chemical used, where is it important, what are the risk drivers.
So we will then contact -- through out network of pesticide impact assessment people, contact the appropriate expert, get them to agree to do the review in a reasonable time, ship it out and ask them for a response by a date certain.
As with most things, there's still some kinks in that process. These are not directly under our control, they are our partners, and they, like everyone else, have too much to do. So we are imposing on them to do something extra. And the timing isn't always something that is not as good as we'd like, but we're working on that.
Again, as I mentioned, the Land Grant review -- reviewers work with my team. Once their comments are in, we assemble everything in -- in my office. Therese Murtaugh does the bulk of that work. And then we will then ship our comments over to EPA.
Now, during this process, when we find issues, questions, concerns, we don't wait until everything is in. We will sit down with Lois and her folks and go over any issues that we've identified.
So again, we're trying to be more proactive, rather than looking at this as a huge block of time in which we're not communicating.
Any issues that are identified, we do communicate. And that I think is helping accelerate the process.
I think that's primarily what I wanted to cover. I guess the other thing -- the important feature of the team that we're putting together -- this is not a team that is here just for review and then it goes away and never looks at the chemical again.
I'm looking at this as building a group of expertise to engage later on in the risk mitigation or the risk management phase, as well as when needed to lead the transition strategy process when we do need to move to alternative pest management strategies.
The team we're putting together now and the depth of expertise that they're gaining from familiarity with the risk assessments, will help down the road in -- in both of those processes. And I think those are the main points. So both Lois and I will entertain questions.
MR. EHRMANN: And again, let's keep the questions in this portion to clarification or, you know, initial observations.
And this afternoon, we'll come back and have a more indepth conversation about how you might want to advise modifying this process for future work. Bill Lovelady?
MR. LOVELADY: Thank you, John. I have a question for Lois, and also one for Al. But before I do, I -- I had the opportunity to attend the hearing -- the oversight hearing last week.
And -- and I was hoping I could say this and get the floor before Jim came back in, because I certainly wouldn't want him to get a big head. But he -- he received some very, very good comments.
And I'm not saying this for EP or -- EPA or USDA's benefit, but for the benefit of the other members of this TRAC who were not there.
But Charlie Stenholm (phonetic) was extremely complimentary about the progress that had been made in the TRAC.
And I think it's important that everybody understand that there are members of Congress who are very happy with progress that is being made.
And -- and I say that because -- because we all know that there are people who have walked out of this committee because they say no progress is being made or not sufficient progress is being made.
So I just want everyone to know that -- that there are some who think that -- that good, positive progress has been made.
So now to -- after editorializing, I will get to my two questions. Lois, I just would like a clarification.
You said during the errors-only corrections that you received comments beyond just error correction. Could you kind of clarify how those comments are handled?
MS. ROSSI: Those comments are handled when we do the revised -- when we take the comments from phase two, I guess -- three.
They were -- they are just looked at with -- with the other comments that we get during the 60-day public comment period, if they're not --
MR. LOVELADY: So they --
MS. ROSSI: -- if they're not errors. If they're --
MR. LOVELADY: You don't -- you don't note it or anything? You just kind of roll them over into the next --
MS. ROSSI: Right.
MR. LOVELADY: -- phase?
MS. ROSSI: Right. I mean, we start start looking at them and they --
MR. LOVELADY: Okay.
MS. ROSSI: -- they give you a head start on what you might receive in phase three. Because lots of times they're submitted again in phase three. But we don't -- we don't respond at that time.
FEMALE SPEAKER: You do put them in the docket?
MS. ROSSI: We do put them into --
FEMALE SPEAKER: They do go into --
MS. ROSSI: -- the docket.
FEMALE SPEAKER: -- the docket?
MS. ROSSI: Yes.
MR. LOVELADY: Okay. And -- and -- and Al, now that you have had a chance to -- to see some of these and you have returned, what, four of them I believe you said, is -- is the time adequate to do -- in view of the complexity of -- of some of this data, is -- is the time adequate for USDA to do that?
And does the information come in a format that's usable? And do you have any suggestions of how things should change after having done four of them?
MR. JENNINGS: As Lois mentioned, the time is somewhat variable. We try to shoot for two weeks on the easy ones.
And those are generally just a headquarters' review, where we feel we don't really need to involve the Land Grants.
And it can go out to six weeks on the more complicated ones. So, yes, I think it is adequate and I'm sure we can negotiate longer if we really needed.
The one area we have had a lot of trouble with is in worker risk assessments, and that's partly I think because we haven't had this long history of the TRAC process with a lot of papers and a lot of discussion. Our Land Grant reviewers have been very puzzled by some of them.
And I think Lois and I have talked about the need to do a workshop with our Land Grant partners, or at least some of them, to go through the process and get a better understanding of how that works and what data are used in that process. So that's been I think our major concern.
MR. EHRMANN: Okay. Brad?
MR. LUCKEY: I think my comments are kind of the same as -- as Bill's. Looking at specifically phase four and then phase six.
And you allow yourselves 90 days, and I'm assuming those are calendar days, which equate back to only 60 work days.
And I'm wondering -- and Lois you did mention that sometimes you do get into a time crunch. Since this is a pilot process, how -- how concrete are these time lines? Can you extend them in order to be more comfortable with the information as you're collecting it?
And I guess Allen it would be the same question to you, in that you're looking at -- at -- at 60 calendar days, which is only 40 work days. Is that enough time and -- or is it too big a burden on the staff to try and get through this? And do we need to allow more time?
MS. ROSSI: The phase four where we revise the risk assessments. Well, at the work group I answered this question also.
I think it's a -- I think 90 days is probably a good target to shoot for. It -- it really depends on what your -- it really depends on the new data.
If you get new data that we are trying to review and that will make a difference in the risk assessment, that is what ends up taking the more time.
For the most part, I think the Agency has been able to get the bulk of the work done within the 90 days. So I think it's a reasonable time length to shoot for.
And what I think has taken a little longer, but I do think we're getting much better at this, is understanding what the risk assessment says after it's been completed, and looking at the drivers and looking at the sensitivity.
And again on these early ones, we've been developing process, developing thinking, developing methodology, as well as doing production.
And any time you're trying to do all of those three things with production, it's difficult and it takes a long -- a long time.
A lot of that routine thinking that we've -- the routine questions that we've been asking along with USDA in the assessments, we're getting pretty good at asking these questions and figuring out what it is. And so I think it will go smoother.
Again, also, I think some of the preliminary assessments that you'll see in these ones -- these 10 remaining ones where we have an issue of preliminary assessments, I think they will be of a higher quality than the earlier preliminary assessments, which again affects how much of a revised assessment you have to do in phase four.
So I think 90 days is a good one to shoot for. And I think it will be attainable as we continue to go through the process. But it has been -- it has been difficult in some of these early ones.
MR. EHRMANN: Al?
MR. JENNINGS: Brad, as I understand your question, it's near the same -- same as Bill's, is the time enough? Or did I miss that?
MR. LUCKEY: Basically, yes. Is there enough time?
MR. JENNINGS: Again, I think so. I'm counting on learning a lot. I'm also hoping on some increased resources.
I think as this process has gone on, you've seen new faces back here. I am bringing in people like Teung Chin on detail from other agencies to help with the process.
And again, Lois and I talk fairly routinely. And if we're having a problem, I'm sure we can get a few extra days to get our work finished.
These deadlines are things that we are shooting for. We recognize a need to bring reviews to conclusion, but they're not drop dead dates.
MR. LUCKEY: Thank you.
MR. EHRMANN: Steve Balling?
MR. BALLING: Lois, I'm curious about the sensitivity analysis for risk drivers. Any general conclusions from those? What -- is it the zeros? Is it specific high-risk crops?
MS. ROSSI: It -- it really varies. I mean, it -- depending upon the chemical, it -- it varies. Whether it's -- whether it's a crop, whether it's -- whether the zeros make a difference.
We've -- we've seen in each of the chemicals that we've done so far -- I mean, we've seen different things affect each one of them, residue values.
We look at the consumption data. We haven't really seen outrageous consumption, you know, like eating -- some commodity, you know, eight -- eight or 10 helpings of something. We haven't really seen that.
In some cases the endpoint might be the driver if the exposure and the residue levels are -- so we've seen various things.
It's -- it's not always the same commodity. And it also differs what's driving the risk, depending upon what subpopulation you're looking at.
So -- and it's even gotten into the food form of the commodity, which we're able to do.
You're actually able to go in and look at the -- at what food form it is. And in the case -- in some cases it's the food form, it's not the rock commodity.
MR. BALLING: Well, the reason I ask is in -- in the context of trying to be most efficient in collection of data, if --
MS. ROSSI: Um-hum.
MR. BALLING: -- if we go through what EPA has asked for over the last two and a half years, it's pretty much the kitchen sink. That data is very difficult to get, it's very expensive.
And in the context of trying to refine -- and as we go through these pilot processes, that seems the most appropriate thing. In the process of trying to refine that, how can we better provide what you really need?
MS. ROSSI: Ed, do you want to --
MR. ZAGER: Yeah. The USDA's Pesticide Data Program has been focusing on the top consumption foods -- top consumption foods mostly for children, and we found the data extremely useful.
And we've been able also to translate the data from those commodities to other commodities. So if you -- if you work in coordination with USDA, that's going to be very helpful.
Not to duplicate what USDA is doing. USDA is mostly focusing on rock commodities, but maybe to fill some gaps.
MR. BALLING: Just to follow up. Al, have you found these crop assessments that USDA's been developing with the Land Grants valuable?
MR. JENNINGS: The crop profiles, yeah. They are, in my mind, not tools for risk assessments. So much as tools for risk mitigation, risk management and probably transition strategies down the line.
But they have been very helpful in identifying which Land Grants need to be involved in the process, helping to identify the risk drivers, and have had many other uses that are not directly related to the review process.
So they are a wealth of information. But in my mind, they are a starting point on a lot of other things yet to come.
MR. EHRMANN: Okay. Jay?
MR. VROOM: My question goes to the volume of public comment input, and I guess that it would come in phases two, three -- I'm sorry, three, four and five, with opportunity for written comments in three and five. And some public input in the technical briefings during phase four.
And I've heard some grower groups in particular indicate that they feel real frustrated at that earliest public comment point.
That because of -- of the inaccuracies and the fact that they know that their comments will be more applicable and targeted nearer the end.
Have you seen a difference in the volume and -- and applicability relevance and robustness of the public comment?
And is there anything that we can learn from the -- the variations across those three points of public comment input that could help sharpen this process, both what you've experienced so far in the pilot, and then maybe can you compare it to other public comment experiences that predated FQPA even?
MS. ROSSI: Well, we've only -- first of all, we've only had experience with phase three. I mean, we haven't -- we haven't put a -- a revised assessment in the docket. I mean, that will happen very soon, but we've only -- we've only had that experience.
One thing, you know, that could be raised is for these preliminary assessments where we don't do overviews and summaries, which we have done in preparation for the phase five, is something that could be considered.
Again, I think that the quality of the preliminary risk assessments that you'll begin to see for these ones that will be entering phase three over the course of the next few months, will be much better.
Because they're incorporating, you know, a lot of the thinking and a lot of the practices that we're doing for the revised assessments.
We're incorporating them into these ones that are preliminary, we don't have a separate set of directions for the preliminary and -- and the revised.
So I think you'll start seeing that the preliminary will be better. And -- and the complexity I think may be an overview, and a summary might -- might help there.
MR. EHRMANN: Let me suggest we take the cards that are up. And then we'll -- we'll move toward our break. Bill?
MR. SPENCER: Until I got involved in the TRAC process, first meeting last May, I thought Monte Carlo was the third riskiest place in the world to gamble with your money after number one being my citrus farm and number two Las Vegas.
But I noticed with a little bit of interest when Lois was talking about risk assessments, I believe you said, Lois, that you were running the Monte Carlo -- Monte Carlo analysis at 99, 99.5 and 99.9.
MS. ROSSI: Um-hum.
MR. SPENCER: And I think when we went to the work group two meeting on the 7th and 8th, you had just that day released science policy paper number 11 where you -- where you are starting to at least put it out for public comment, choosing a percentile of acute dietary exposure as a threshold of regulatory concern.
And I guess my question is, if the Agency is already doing something other than 99.9, in the form of 99 and 99.5, are you also running these risk assessments at 95, which is the way that you used to do them, and 97.5, which was the way that our friends across the ocean do them?
MS. ROSSI: You can -- I mean, I mentioned 99. I mean, you can run them at -- at just about any percentile.
The printout will give you 95, 97, 99, so you can look and see what happens as you -- as you go through the different percentiles. So you don't have to just run it for 99.9, you get -- get all those percentiles --
MR. SPENCER: So --
MS. ROSSI: -- in a run.
MR. SPENCER: As a follow-up, is the Agency using that data?
MS. ROSSI: Well, we're using it to -- in -- in sort of sensitivity analysis to see what -- what is happening as you go from 97.5 to 98 to 99 to 99.9.
And it -- what it -- what it -- what it directs your attention is -- is it -- once you see what's going on, it directs your attention to go into the data and see what's going on.
What -- what residue levels are causing the change from -- in this percentile or this small increment in going from 97.5 to 98, or 99 to 99.5.
It directs your questions, it directs -- peeling back what's behind this.
Then you've got to look at the consumption and see if there is a routine or -- or a reasonable consumption or a very high consumption.
And -- so that's how it's used in -- in -- in your thinking. And ultimately that leads to the points that would have to be risk managed. Do you want to say anything about that?
MR. EHRMANN: Any more on that, Al?
MR. JENNINGS: As I mentioned at the work group, I think it's a question of how do you interpret the output of the model, and 99.9 and other points are -- are just one.
Lois, I think, mentioned that other sensitivity analyses are going on. For example, does it matter whether you have zeros or the limit of detection or the limit of quantification. In those cases where it doesn't matter, that's one less thing to worry about.
So I think the sensitivity analyses that are going on try to narrow down to the real risk and risk management issues we have to spend our time and effort on.
MR. EHRMANN; Okay, Bill. Robert?
MR. KEIFER: At the last work group meeting we -- there was some discussion on public health uses. And you mentioned out of the 10 chemicals in the intergovernmental review, that one of them is currently public health use at HHS.
And I wanted to know if you can give a little bit more information on that use, and also how the process with Health and Human Services is going?
MR. EHRMANN: Lois?
MS. ROSSI: There -- actually, there were two. It was -- and the two specific chemicals were temephos and fenthion. And they're both -- the use is mosquito control. That -- that's being looked at.
We have talked to the HHS people, and we are planning in the near future to also have a meeting.
The problem with them is they're in -- they're down in Atlanta, so we need to do a little bit more creative coordination than just hopping a cab over to the Department.
They have provided comments on fenthion, which we're currently looking at. And once we look at them, we -- that's when we'd like to go down and talk to them about that.
And fenthion, I don't think we received that --we have -- we received them on both. So we're in the process of looking at them. And we really need to engage them in a dialogue like we have with -- with USDA.
MR. EHRMANN: Okay. Tobi?
MS. JONES: Lois, I know you've received funding to develop a National Residue Database. But I don't see -- and I'll just say in the fenthion draft risk assessment -- risk assessment group, I don't see any indication that any of the state data from residue monitoring programs managed by the state has incorporated that.
Do you see some time in the future when you'll work through some of the issues on -- and most of those samples are composite samples, when you will be able to use some of those data in the future, in addition to PDP and other -- I'm sorry --
MS. ROSSI: PDP?
MS. JONES: -- PPD and other sources?
MS. ROSSI: PDP. I mean, as far as the composite, the answer is yes. I mean, we do have a methodology that we presented in considerable detail at the work group meeting on how we can use the composite data to estimate single serving. Ed, the role of the state?
MR. ZAGER: Yeah. For acute analysis, we'll have to look at the numbers and the quality of the data received from various states.
And the way I understand it, the plan is to incorporate over state and to the National Pesticide Residue Database, and I think that's being done.
MR. EHRMANN: Okay. Dan?
MR. BOTTS: At the risk of getting in a fairly lengthy discussion, which knowing it's break time, we'll save most of the discussion until after lunch.
Lois, I appreciate the fact that there's been a major change in the numbers relative to the risk assessment.
But just in your general impression, how much of that change in the risk assessment has been the result of -- of new information versus changes in the process and the model and the way you look at things and utilizing existing information that was already at the Agency, prior to publication of even the first preliminary risk assessment?
I mean, looking at -- and the reason I ask, just looking at the first one that we've had a discussion on, a lot of the base information that was used to refine the risk numbers already existed, either through PDP or some place else. The problem was the process wasn't in place, the issues weren't there.
And having said that, is it going to be reflected in the new preliminary risk assessments that we will have a much more focused document to respond to, as compared to the first ones out of the box back in August and September, which is really the model that we've looked at as far as how to respond, at least in this process? And the next question's for Al. But I'd like to get some kind of --
MS. ROSSI: You've got a --
MR. BOTTS: -- response to that first.
MS. ROSSI: -- few comments in your question -- in your -- or a few questions in your comments, or something like that.
The answer to the last part of your -- your comment, yeah. Like -- like I said, we are not going -- we don't have two sets of directions, oh, we do this thing for preliminary and we do this for revised.
I mean, as we make these changes in the revised as far as the process goes and use the PDP and whatever, we're going to incorporate those in the preliminary.
So I do think you'll see in these remaining 10, as well as other assessments that currently are for non-OPs that aren't in this process, you'll see that kind of process being used in those. So I do think the preliminaries will be better. You had another question about the data?
MR. BOTTS: Well, a big point has been made of all the new data that was submitted --
MS. ROSSI: Right.
MR. BOTTS: -- that had to be looked at as a result of preliminary risk assessment. That's -- and that's just not my impression of --
MS. ROSSI: Right.
MR. BOTTS: -- what's actually happened.
MS. ROSSI: Right.
MR. BOTTS: There's been a new way of looking at data that may have already been there, rather than absolutely new information that's been submitted. And it's just a feeling for --
MS. ROSSI: Yeah.
MR. BOTTS: -- for how --
MS. ROSSI: I think --
MR. BOTTS: -- the relationship --
MS. ROSSI: I --
MR. BOTTS: -- between those two points.
MS. ROSSI: I think the difference is that new -- the new data has mostly related to the toxicology side of the whole equation.
Whereas, utilizing the data on hand and -- and just looking at it differently and developing methods to use it the best way has mostly happened on the exposure side. So that's kind of how the mix has played out. I mean --
MR. BOTTS: Yeah. I think your answer drives to the reason I asked the question. Because the exposure side is the stuff that we in the user --
MS. ROSSI: Right.
MR. BOTTS: -- community --
MS. ROSSI: Right.
MR. BOTTS: -- can deal with.
MS. ROSSI: Right.
MR. BOTTS: If it's a tox side, that's not something that we in the user community are really going to be --
MS. ROSSI: Right.
MR. BOTTS: -- the experts on. And would hope that there would be a lot of dialogue with the registrants or other people who have expertise with their own chemistry to drive that toxicology question.
The other question that's for Al, and listening to the discussion from this point forward, especially in the technical briefings that come forward, it's -- this is a little bit of change from some discussion that we had before that it was -- at one it was USDA bringing risk mitigation proposals together.
And what you just said, it was probably going to be USDA at that technical briefing that comes forward with risk mitigation.
What are the plans within USDA to open up that process to make the mitigation process development as transparent as how the Agency's done with the exposure and some of the other information processes?
MR. EHRMANN: Let me ask Al to -- let's have a brief response here. I think that's really in a way the topic for tomorrow's discussion on transition, more than evaluating the pilot process.
But let's -- let's -- let him respond here, and then I think we'll get more time on it when we get to that part of the agenda. We can do it either place, but just in respecting the time. But go ahead, Al.
MR. JENNINGS: Well, then I'll brief that. I think it's a joint effort with EPA, and the briefings I think are the starting point.
And I envision some follow-up -- I would say a lot of follow-up in some cases, involving all stakeholders. And we can talk more about it tomorrow.
One of the things we are thinking about is some kind of a list server page where we can get into transition and mitigation and -- so we don't have to have meetings in Washington back to back for the next five years. But a way of dealing with this that will involve you and the internet hopefully.
MR. EHRMANN: Let's make sure we come back again to that either this afternoon or --
MR. BOTTS: We'll talk a little bit about it this afternoon --
MR. EHRMANN: Yeah.
MR. BOTTS: -- I'm sure.
MR. EHRMANN: Yeah. But if I remember right, you'll have a shot at another bite at the apple, so to speak, this afternoon.
MR. BOTTS: That is right.
MR. EHRMANN: Let's go ahead and take a 15-minute break and we'll come back and pick up with the discussion on azinphos.
(BRIEF RECESS)
MR. EHRMANN: Briefing on azinphos-methyl. And again, at the work group meeting a few weeks ago we had a first run through this just on the dietary portion.
What you're about to hear is going to be some additional information on the dietary side, as well as the current state of affairs as it relates to other aspects of the overall assessment.
So this is some -- some new information, and I want to turn to -- to Lois to initiate this part of the agenda. Lois?
MS. ROSSI: Okay. We're going to describe and explain the complete risk assessment for azinphos this morning, and illustrate how the assessment has changed and evolved through the various phases of the TRAC pilot public participation process.
We're going to try to show how this particular chemical went through the different phases.
Before I get into the specifics, for those of you who were at the work group meeting, this might be a repeat.
But for everyone here, I would like to introduce the azinphos team that's been working on this chemical for the last X number of -- of months. They're mostly sitting behind me, so I'm going to get up here.
Starting with -- Barry O'Keefe is with the Special Review and Registration Division. He is the chemical review manager for azinphos. He has coordinated the entire review of this chemical, the first line of contact for all questions and issues, and will be responsible for leading the risk management phase of the chemical.
Jess Rowland from the Health Effects Division, the toxicologist on the chemical. Kathy Monk, with Special Review and Registration, the branch chief on the chemical.
Dave Jones from EFED, Environmental Fate and Effects Division, the agronomist and risk assessor for the water part.
And Mike Metzger, who presented at the work group meeting the probabilistic assessment and methodology, a chemist branch chief on the project.
At the table -- and first of all, over by the slides, Felicia Fort, who is going to do the slides for us this morning.
But who -- whose role in the assessment has been -- Felicia has done all the probabilistic runs on the deem model for us, and has done many, many, many, many runs for us.
Jack -- presenting today on the -- on -- will be Jack Arthur, he will present the worker risks. He's with the Health Effects Division.
Catherine Eiden is also with the Health Effects Division, she's the risk assessment coordinator for azinphos.
And lastly but not least, Rich Dumas is with Special Review and Registration, and he's going to present the -- he's a team leader on azinphos, and he's going to present the use profile.
Oh, I forgot two very important people. The use people from our -- our Biological and Economic Analysis Division, Neil Anderson, the biologist on the chemical. Stand up. And Tom Kiely, the economist.
I just wanted everyone in the TRAC to see who the team is behind -- the actual people behind all the paper and the assessments that we've done here today.
Okay. We're going to expand on the acute dietary case study that was done for the work group session two weeks ago, in that we're including a discussion of all the risks that we consider in a comprehensive assessment.
This assessment, I'd like to point out, is not just one that's being done for the OPs or for azinphos, but it's the one that we do normally in the registration review of every single chemical.
The assessment will -- will consider worker risk, ecological risk, as well as the dietary risk from food and drinking water.
For azinphos, we will not be representing the residential risk assessment because it doesn't have residential uses. If it did, we would.
We're again using azinphos as an example to build on the case study already presented to the work group, because azinphos illustrates many of the complex methodology and policy issues related to the OPs that we are going to face.
We happen to be facing it -- facing some of these issues with azinphos. But it is not alone, in that we will be facing many of these issue with the other OPs.
Also, azinphos is relatively far along in the pilot process. It was among the first group of OPs that are nearing the completion of phase four. It -- it started actually phase one back in last August.
Today's presentation is intended to be an example or prototype for the technical briefings that conclude phase four of the pilot process for the OPs.
The technical briefings will be public meetings jointly hosted by EPA and USDA or HHS, and are intended to share the refined risk assessment and initiate the discussion of risk management options.
As with the previous acute dietary case study, our goal is to show advances in methodologies and the many revisions that have been incorporated into these assessments.
We'll try to clarify where assumptions are used, where actual data are used and the sources of those data, and the uncertainties associated with these assessments.
Finally, we intend to focus the discussion on risks that appeared to be of concern, since these will be the focus of the next phase that azinphos will enter, phase five and phase six of the pilot process.
The azinphos-methyl -- the azinphos-methyl risk assessments considered both human health effects and ecological effects.
Among the potential effects on humans, we look at dietary exposure from food and drinking water on both an acute and chronic basis.
We also consider risk to agricultural workers before, during and after pesticide applications. Azinphos has no residential or public health uses, so those risk assessments were not performed.
It's important to note that exposure bystanders, including children, is possible from secondary exposure to azinphos, such as drift into residential areas and from clothing brought home by agricultural workers.
We currently do not have a method for quantifying these types of exposures, and they're not reflected in this assessment today.
In the ecological effects assessment we consider potential effects of pesticide use on birds, mammals, fish and other aquatic species. As well as the possible impacts on water resources, specifically drinking water.
Where is this chemical in the pilot process and how did it get to where it is today? That -- by the way, you have a copy of these slides in your packet to follow along. That slide presents the phases one through six. And it presents for the health effects and the ecological assessment, the dates which various completions in the review go.
You can see first of all that the health effects assessment is slightly ahead of the ecological assessment, and we'll -- and that will become obvious when we talk about the ecological assessment.
But it went through phase one, the health assessment, last July it was placed. The docket was the -- it went through the error/comment period.
The docket was opened in August. There were really no substantive errors identified in either assessment. The -- the ecological one entered phase one in -- in November, so there -- there is that lag.
The minor corrections to the ecological assessment included correcting typo's, clarifying a model input value, and reconciling a table to match the text. It was out of since there. There were no major changes made prior to the opening of the public docket in phase two.
The preliminary health assessment that was placed in the docket in August showed acute dietary risks of concern. And that assessment was based on a non-probabilistic model, referred to as the DRES system, D-R-E-S.
Use of mostly tolerance-level residues, except for blended commodities where we used field trial data; 100 percent crop treated, which was necessitated by the use of the non-probabilistic model to estimate acute dietary risk; and USDA consumption data from 1977 and 1978, which is the consumption data in that DRES model which was used at the time.
The preliminary human health assessment also indicated a concern for workers based mostly on surrogate data, and some chemical-specific data.
The preliminary ecological effects assessment indicated risk of concern for both aquatic species and terrestrial species. The concern for aquatic species is in part based on many incidents resulting from azinphos use.
During phase three, comments on the human health assessment were received from the registrant, public interest groups and growers. We received 31 comments, about half addressed azinphos specifically.
We also received a number of comments that dealt with issues that relate to all of the OPs, such as the nine policy issues and consistency among the assessments.
The registrant's major concern was that the Agency should incorporate data that is currently in development before moving forward. This outstanding data will be discussed further after the presentation on the risk assessments.
Growers commented on the importance of azinphos in agricultural, specifically in the integrated pest management programs and for crop/pest combinations for which there are few, if any, good alternatives, such as control of the codling moth in cherries, several pests in apples, and the import quarantine use for almonds.
Public interest groups question the removal of the 10X FQPA safety factor, and called for action based on the preliminary dietary assessment.
Along with comments, both growers, registrants provided additional data. Growers provided information on use practices that enabled us to verify percent crop treated, actual use practices, application rates and other use perimeters.
Registrants provided a Monte Carlo analysis, along with the residue data files that enabled us to do multiple runs with different inputs and assumptions.
The registrants also provided dermal exposure studies for cotton and apples. These are so-called, and we'll get into this term.
And hopefully by the end of the day we'll all be familiar with dislodgeable foliar residue data, which basically tells you how much of a chemical comes off a plant and gets on your skin as you're walking through treated areas.
That provide actual measurements of the amount of residue that workers could contact in the field during the course of harvesting and other post-application activities.
(END OF TAPE)
Even though some of these data were submitted after the close of the comment period, we have taken them into consideration and reviewed them and are -- they are accounted for in our revised assessment that we'll talk about today.
Phase four revisions to the assessment. The most dramatic changes to the preliminary reassessment -- or assessment resulted from refinements to the acute dietary risk assessment.
This was possible because the Monte Carlo submission with residue files that allowed us to do multiple runs, and sensitivity analysis projecting what-if scenarios.
However, it should be mentioned that EPA's development of the methodology for being able to use monitoring data from USDA's pesticide data program, PDP, in acute assessments, also had a big impact on the assessment.
For the worker assessment, the dermal exposure data that were submitted did not greatly change risk estimates for post-application exposure to azinphos.
However, azinphos specific data gathered under actual use conditions increased the level of confidence in these post-application risk assessments.
No changes were made to the chronic dietary risk assessment, the drinking water or some of the mixer/loader/applicator scenarios for the worker assessment.
In summary, we've made many changes to the preliminary assessment, which are reflected in the revised assessment, and which will affect other assessments.
As well in -- specifically developing a method for using the monitoring data for acute dietary assessments, developing the in-house Monte Carlo capabilities, our ability to perform sensitivity analysis to see which factor most influences the risk assessment or which piece of data, and incorporating new data as it comes in, particularly from the agricultural reentry task force.
The work that remains to be done focuses mainly on the ecological assessment, which is currently still in phase four, and we are working on that. The comment period didn't close that long ago.
So now it's getting into the specifics of azinphos, I've tried to show you how it's gone through phases one through four, and is about ready for phase five.
A little bit of regulatory history, in that we have been working on azinphos -- different aspects of the azinphos review for some time.
But the whole comprehensive one came up in the que, and the reregistration red review que about a year and a half ago.
A registration standard actually was issued for azinphos back in September of 1986. And then it is subject to the FIFRA-88 requirement, so it was in -- in the reregistration program once again.
We also worked with the State of Louisiana on -- with regard to their use of azinphos on sugarcane back in 1993, based on some large fish-kill incidents in Louisiana. And we worked with the registrant, the state, and the use of -- of azinphos on sugarcane became a prescriptive use only.
And it was -- and we increased buffer zones and -- on incidents monitoring program and this use we said would be definitely dealt with when -- at the time of reregistration.
Azinphos also was looked at along with the other OPs, a total of 28 chemicals, OPs and carbamates, and an acute worker risk strategy that we undertook in 1992, which was an analysis based largely on incident data from California, as well as from Poison Control Center data.
And recently over the last year, we've worked with the State of California on emergency regulations that they've undertaken regarding worker exposure, and particularly the post-application exposure involving extending the reentry intervals. And we'll get into that a little more in the presentation.
We've had a series of label changes on azinphos, in part because the California regulations, and in part because of the Agency's work with the registrants to implement some interim mitigation.
Which included some additional personal protective equipment and closed cabs, and the use of the closed mixing/loading systems for products.
The REI, the reentry intervals for various commodities have been extended to 14 in 30 days and 21 days, depending upon the commodity. And we'll talk a little bit about that later.
Right now, we -- I'd like to get started with the presentation with Rich Dumas, who'll go briefly through the use -- the uses that we're considering in the review.
Catherine Eiden will talk about the actual human health assessment, the dietary portion. And Jack Arthur will discuss the worker risk assessment. And then it will come back to me for the rest.
MR. DUMAS: Okay. Azinphos-methyl was first registered for food use in 1959. It is currently registered on about 50 foods.
The Agency typically gets its use information from USDA and some other sources. In some cases, we actually get registrant and grower-group information.
When we get this type of information, what we normally do is we compare it with our other information. Oftentimes it corresponds with the information. In fact, it even comes from the same sources.
However, when we do find inconsistencies, we look -- delve into it further to reconcile those differences.
In the case of azinphos-methyl, the comments that we receive were -- or the data that we receive were primarily from USDA.
For more information on sources -- sources of use data, how estimates are developed, and how the Agency uses these estimates in risk assessment, the Agency recently completed a draft paper on use information that will be available for public comment in the near future.
On average, 2,000,000 pounds of azinphos are used per year. Of that amount, over half is used on fruit trees, about 15 percent on nut crops, and about 20 percent on cotton.
Foods for which a high percent of the crop is treated include apples, pears, cherries, with at least 50 percent of the crop treated.
And in addition, blueberries, almonds, pistachios and cranberries have at least 25 percent of the crop treated.
Azinphos is used throughout the U.S., but is most widely used in California and the Pacific Northwest on tree crops and in the Delta States and in Texas on tree and cotton.
As you'll hear in our discussions this morning and this afternoon, use practices, that is application rates, application method and reentry, play an important role in our risk assessment.
To illustrate this type of information, I refer you to the table either in your handout or on the screen. What the table shows is the Agency's most current use information that can be incorporated into our risk assessments.
The crops that are used were primarily there, not to pick on any one crop, but it was just to show ones that were important for some reason, such as high-percent corp treated or a large volume of use.
Just to sort of look at the table, you'll see, like, percent crop treated. I think most of you are aware from how important that can be in our risk assessment.
The application rate and the number of applications actually -- as you'll see more in -- today, are important not only in our dietary risk assessment, but also in our occupational and ecological assessments.
And the reentry intervals in particular, you'll see when Jack talks about occupational risk, are very important.
And final point on this table is you'll notice a few NS's, and just -- we didn't put a footnote unfortunately on that. What that means is it's not specified on the label.
And sometimes instead of putting a maximum application rate and the maximum number of applications, we'll put a cap on the maximum that can be used per year.
And that affords a -- a grower community a little bit more flexibility on how they can use this to control their own pest problems.
To give you more information on how the Agency's azinphos assessment was done, I'll turn the presentation over to Cathy Eiden for the dietary and aggregate risk assessment, who will be followed by Jack Arthur on the occupation assessment.
MS. EIDEN: Good morning. It's a pleasure to be here. Is this on?
MS. ROSSI: Yeah.
MS. EIDEN: Okay. The human health risk assessment consists of several components. And I will be describing the dietary inclusive of food and drinking water, and then briefly the aggregate assessment.
Next slide, please? Some of you may be familiar with this particular equation, it's the risk equation, basically hazard times exposure, where exposure is a product of consumption times residue.
In this sense, we're talking about the consumption of food items, how much you eat of a particular item, how often you eat it. And then the residues of -- in this case, talking about azinphos-methyl, that may be on those food items.
Two basic dietary assessments were conducted for azinphos, an acute assessment which is meant to reflect one-day dietary exposures to azinphos-methyl and a chronic dietary assessment that is meant to reflect lifetime exposures to azinphos-methyl in a diet.
Let me just say one thing here on the chronic side, that assessment was completed fairly early in the process and the risk estimates based on that assessment were not of concern to us.
So most of my presentation will be focused on the acute dietary, which is also a reflection of the effort and time that we put into the acute dietary assessment for azinphos-methyl.
The next few slides will basically go over the toxic endpoints that were selected for azinphos that were used in this assessment.
I want to point out that these toxic endpoints are basically how we measure the hazard associated with the chemical, and these toxic endpoints are the fundamental basis of these risk assessments.
For the acute toxicity of azinphos-methyl, we used an acute neurotoxicity study in rats, and the endpoint or toxic effect selected as the basis of the risk assessment was cholinesterase inhibition in red blood cells, plasma and brain tissue.
Significant effects were seen at one milligram per kilogram body weight per day, and this was the lowest dose tested in this particular study, and for that reason, we established that -- that level, that dose as the lowest observed adverse effect level, the LOAEL.
Because the lowest dose tested had significant effects, we could not establish or determine a no-observed adverse effect level from this study.
And this particular endpoint then most accurately reflects what we would believe could be toxic effects experienced from exposure to azinphos in the diet over a one-day period.
Next slide? This slide captures the same information used in the chronic dietary assessment for azinphos-methyl. Some of you saw the acute assessment previously.
For the chronic assessment, we used the results of a one-year chronic feeding study in dogs. The toxic effect or endpoint selected was also cholinesterase inhibition, but in the red -- red blood cell only.
The level at which the cholinesterase inhibition was seen, was point seven milligram per kilogram body weight per day. This was established as the -- the LOAEL, the lowest observed adverse effect level.
And in this study, the next lowest dose tested, 0.15 milligram per kilogram body weight per day was established as the no observed adverse effect level, as we did not see any effects at that particular dose.
And again, this endpoint reflects what we believe would be potential toxic effect seen from long-term, lifetime-type exposures to azinphos-methyl in the diet.
Once we select the endpoints based on the toxicity data, we make a determination as to the uncertainty associated with those results.
And in the particular case for azinphos-methyl, we applied the following uncertainty factors. A 10X factor for interspecies variability, that has to do with extrapolating from the test species which was rats to humans.
A 10X factor for the interspecies variability, which has to do with sensitivity differences within individuals within a species, be it rats, dogs or humans.
And we applied an additional 3X factor to the acute dietary assessment only, to account for the lack of a NOAEL, no observed adverse effect level. We removed the FQPA safety factor for special sensitivity in infants and children.
The total uncertainty factor then applied to the acute dietary assessment for azinphos was 300X, and the total uncertainty factor applied to the chronic dietary assessment was 100X.
And this is a typical type of uncertainty analysis that's conducted on a daily basis in the Office of Pesticide Programs.
This information on endpoints and uncertainty factors is then used to basically calculate the reference doses for chemicals.
In the case of azinphos-methyl, the LOAEL value divided by the uncertainty factor results in the acute reference dose used as the basis of the acute dietary risk assessment, point zero, zero, three milligrams (.003) per kilogram body weight per day.
And the following equation shows you the -- how the chronic reference dose was calculated for the chronic dietary assessment, point zero, zero, one, five milligram (.0015) per kilogram body weight per day.
And these -- the reference dose then is used in a percentage form as a measure of risk. You can think of the reference dose as the exposure or dose which we do not want to exceed.
And we compare exposure calculated to that reference dose to develop our risk measure in the form of a percent of the reference dose.
An analysis was done regarding special sensitivity to infants and children for azinphos-methyl. The database was complete and of good quality, and a comprehensive review was made of that database. As well as a search of the open literature from 1969, looking for any articles that might be present from 1969 to the present that might describe any sensitive effects. And the basic conclusion of that effort was that for comparative cholinesterase inhibition between adults and their fetuses or offspring, there was no evidence of that.
And on that basis and some of the other points up there on the slide, the decision was made to remove the 10X factor.
There was also a determination not to require a developmental neurotoxicity study at this point for azinphos-methyl.
However, the Agency is considering a broader requirement for a DNT study for a broader class of compounds of which AZM would be included.
The other side of that risk assessment equation is exposure. And exposure is a function of consumption, foods you eat, how much you eat, and residues, in this case of AZM that might be present on those foods.
To include consumption in our assessments -- as you've heard, we use the USDA's continuing survey of food intake by individuals.
These particular assessments for azinphos-methyl used the most current data we had at the time that had been validated, that was the 1989 to 1991 data. And as soon as the 1994 to 1996 data are updated, we will be using that.
USDA will also be providing us some supplemental information on children's foods, and we expect that information in December of 1999.
Okay. If you're looking at your handout, this is slide 29, it's a -- out of sequence. The other part of the exposure equation then is the residues present.
We have several sources of data that we can go to, to use in our assessments on residue data. We can -- at a tier-one assessment, which is a preliminary assessment, very unrefined, almost really a screening-level-type of assessment, we use tolerance level residues, these are worst-case residues not expected at the point of consumption.
At the tier-two level, we can use field trial residues. These are high-end residue values, also not expected at the point of consumption, and more reflective of residues on the food item or crop at the farm gate.
At tier three when we're moving into our probabilistic assessment, we're turning to monitoring data and leaning heavily on USDA's pesticide data program data, as well as FDA's surveillance marketing data. And when we have it available, Market Basket data for specific food items.
And the point of this slide is that as we move through these tiered level of residue information, we're refining our risk estimates based on data that closer approximates actual residues at the point of consumption.
As I said earlier that our chronic dietary risk assessment's at a fairly unrefined level of analysis, using field trial level residues, resulted in risk estimates that were below our levels of concern.
Because of that, we stopped our analysis at that point. Any further refinement would have provided us with lower risk estimates, and we focused our attention on acute dietary assessments for azinphos.
But the results of the chronic dietary are presented on the next slide, for four subpopulations of interest.
The risk estimates are given as a percentage then of the chronic reference dose that was described earlier and the most exposed subgroup on this particular assessment was children one through six, where -- basically what that is telling you is that residues of azinphos-methyl in the diet were taking up 33 percent of the available exposure or dose -- chronic reference dose.
At this point I'd like to turn your attention back to the acute dietary assessment, because we did spend an awful lot of time on this.
The acute dietary assessment -- the first phase was a tier-one assessment using tolerance level residues, it was non-probabilistic, and we assumed that every crop on which azinphos is registered had a tolerance level residue.
The tier-three assessment that was a probabilistic assessment, then used monitoring data, and we incorporated information -- specific information on the percentage of a particular corp treated with AZM.
The monitoring data used again was USDA's PDP, that is statistically designed for these types of dietary assessment. It has important children's and infant's foods included in it. We also used FDA surveillance monitoring data when we did not have USDA's PDP data for a specific crop.
Visually, you can think of these two types of dietary risk assessments. The slide up there now is showing you the non-probabilistic assessment.
In that assessment, we use a range or distribution of consumption values taken from the CSFII, and we assume that a high end, in the case of azinphos, a tolerance-level residue is present on each piece of food eaten.
That results in a range of exposures -- dietary exposures that are very high end and unrealistic of what you might actually expect at the point of consumption.
The next slide shows you visually or graphically the probabilistic type of assessment. In this case we use the same distribution or range of values related to consumption; however, we use that along with a range or distribution of values on residues of AZM, and again, taken from our various sources of monitoring data.
The result of this assessment is a range of exposures to azinphos-methyl in the diet that -- are reflective of what you would actually expect at the point of consumption.
Not to beat this to death, but again, the types of residue data that we use relied extremely heavily on USDA's PDP program. We were able to use data for approximately 80 percent of the foods consumed in the assessment.
We also supplemented that PDP data with FDA surveillance monitoring data. Although I must say PDP data are the data of first choice when they are available.
As a third choice, in the absence of either FDA or USDA data, we will use field trial data. But acknowledging that they are high-end residues and less reflective of residues at the point of consumption.
We use processing data related to foods that are blended and processed, that might be cooking factors, saucing factors, dilution factors or concentration factors.
There is, I think, something in your handout that goes through the specific foods and how they were handled in the analysis as far as the data used for each of the different crops, and you can refer to that for specifics on that.
The results: Okay. For the acute dietary, this slide provides risk estimates as a percentage of the acute reference dose for four subpopulations of interest. And in the first column there under the 95th percentile, those were the results from our tier-one analysis, the screening level analysis with tolerance level residues, and assuming that 100 percent of the crop was treated with azinphos-methyl. And you can see why we moved to the tier-three assessment.
At the 99.9th percentile of exposure under a probabilistic assessment, the risk estimates change fairly remarkably.
And in the middle column there, that was the results of the assessment that we sent to the U.S. Department of Agriculture.
In the column to the far right then are the risk estimates at the 99.9th percentile of exposure based on a very refined risk assessment, using the most current information that we had. The most highly exposured subgroup as you can see, is children one through six.
I want to make one comment here that the results of these assessments are very sensitive to the toxic endpoint used.
In the case of the previous -- or the acute assessment, if we had used a chronic reference dose that was not rounded down to one significant figure, the risk estimate for that most exposed group, children one through six, would probably have been around 120 percent.
And I just point that out, again, to let you have some indication of how sensitive these dietary assessments are to the toxic endpoint selected and used. Did I say -- what did I say? It was the acute reference dose. All right.
This side is a continuation of the results that we've seen previously. However, it provides you with a look at the risk estimates, again, as a percentage of the acute reference dose at two different percentiles of exposure, the 99.9th on the far left and the 99th in the middle column.
The far right column is probably the most interesting. It shows you the percentile of exposure at which we reach 100 percent of the acute RfD, which would be -- you can think of as the -- as far as we might want to go.
At the 99.89th percentile of exposure, you're at 100 percent of the acute RfD for infants less than one year.
And at the 99.83 percentile of exposure, you are at 100 percent of the acute reference dose for children one through six.
The main differences between the assessment sent to USDA and the most recent assessment or the current assessment, are shown on this slide.
New percent crop treated data, use of single serving data on pears, and we used canning or saucing factor for canned fruits and the acute dietary assessment.
We also did an analysis to determine the -- the critical or the -- the major contributors to these risk estimates, specific crops.
And in the case of azinphos-methyl, the major contributors to the risk estimates were peaches, apples, pears and cherries.
Some of the minor crops, that is those crops that had very little affect on the risk estimates, included tomatoes, grapes, almonds, citrus and beans.
We also did an analysis to determine the effect of basically substituting zeros into the residue distribution for all samples for which non-detectable residues were reported, and that had very little -- significant impact on the results of the risk estimates.
And finally we're looking at percent crop treated data and how much of an effect those types of data have on the risk assessments.
Okay. So in summary then on the acute dietary assessment, we've developed methodology that allows us to use PDP and FDA data in our acute dietary risk assessments.
And this then included monitoring data in this assessment for approximately 80 percent of the foods included in the assessment, most -- included most or if not all of the major contributors to the risk estimates.
We used most current crop treated information, and we conducted the -- again, as I said, the sensitivity analysis to look at the different crops that would be driving the risk as -- as Lois referred to these crops before.
The sensitivity analysis is going on to look at the tail of the exposure distribution to see if there are any outliers as in people that eat 10 pounds of apples a day, or unusual amounts of food, or maybe very high-end residues that would be suspect.
At this point, I'd like to turn your attention away from food and talk about the drinking water assessment.
As you've heard, azinphos-methyl is widely used on a number of crops based on its use pattern and some of its environmental fate characteristics.
We determined that we needed to conduct drinking water assessment for azinphos-methyl, and the environmental fate data indicated it could get into the surface water and potentially into some limited sources of ground water.
Our available monitoring data do show that AZM gets into surface water. And we have had some sporadic results, detects, also in ground water.
We, however, relied on model estimates for the drinking water assessment. And we do expect some exposure to AZM in drinking water, and therefore some contribution to the risk. Concerns raised by this very preliminary assessment indicated the need for additional monitoring.
I don't know if you all are familiar with TRAC's science policy paper number five, but it does lay out how we estimate drinking water exposure for inclusion into the dietary risk assessments.
And as per that paper, generally we determine the exposure to food first and then concentrate on the drinking water.
In the case of azinphos-methyl, I will use the chronic assessment as an example. For the children's group one through six, remember the chronic percent of the RfD that was taken up was 33 percent. This is basically telling us that we have a 67 percent of that chronic reference dose left over.
And our drinking water assessment then included an estimate of the drinking water exposures based on model estimates that was determined to be less than the remaining 67 percent of the chronic RfD.
And based on this, again, screening level preliminary assessment, we determined that drinking water concerns -- the chronic exposure to azinphos-methyl in drinking water was not of concern.
And we base this conclusion on the health-protective nature of the model estimates used to estimate the drinking water exposure.
That is, we don't expect concentrations of AZM in actual drinking water to be as high as the estimates from our models.
Last slide is -- or last two slides, basic summary. The aggregate risk assessment is something as you know that we now conduct under FQPA.
We consider exposures not only through food, but in drinking water. And if there are any nonoccupational exposures such as lawns or golf courses or home uses, we consider that as well.
But azinphos-methyl having no nonoccupational registered uses, we only consider food and drinking water in the aggregate risk assessment for AZM.
And in the case of the acute assessment, we did not conduct an aggregate acute risk assessment because of the results of our risk estimates for acute exposure to AZM on the dietary side.
We did, however, as I have shown previously, do a preliminary screening-level-type assessment aggregate chronic risk assessment for AZM.
And that assessment indicated that the combined exposures to AZM in food based on a very refined assessment using monitoring data and exposures in drinking water based on model estimates, were not of concern.
At this point, I will turn the presentation over to Jack Arthur, and he will tell you about the occupational risk assessment.
MR. ARTHUR: Thank you very much. I'm pleased to discuss with you this morning the worker risk assessment.
This first -- this first slide simply shows you that there are actually a couple of different worker populations that we're covering in our assessment.
One of them are the handlers, and these are the professional applicators and farmers and growers who mix, load and apply pesticides.
And then the other group are the post-application workers, and these are the people who conduct activities in the field following pesticide application.
We assessed these two groups separately, because the kinds of data that we have for them and the approach that we use in assessing their -- their risks are different.
The next slide -- there are a number of factors that form the basis for our risk assessment for pesticide workers, and I've listed them here.
I'll briefly go through them, and remind you that later this afternoon there will be a discussion of our approach in general.
But the first factor I've listed is that formulation and application equipment have an impact on the exposure potential.
It makes a difference whether you're using liquid versus wetable powder, or using an airblast sprayer versus a groundboom sprayer.
And because of this fact, we assess all the different relevant combinations of formulation and application equipment for azinphos-methyl.
The next factor is unit exposure. It's an indicator of exposure potential in milligrams of active ingredient per pound of active ingredient handled. And this varies according to formulation and application equipment type.
The rate of application in pounds AI per acre, that's the normal one we have, is -- I guess the affect of that on exposure potential is pretty obvious.
And areas treated per day -- acres per day is the normal one we work with. And these values primarily vary, depending on the capabilities of the application equipment and formulation that you're using.
The toxicity endpoint is a toxic effect of primary concern for our pesticide assessment. And it's expressed as a dose to the test animal where this effect is actually not seen, and that's expressed as a no-observed adverse affect level in our assessment.
And the last factor I have listed are levels of protection. These include the use of protective clothing or PP -- PPE, personal protective equipment, which refers mostly to respirators and engineering controls which covers a variety actually of controls.
And we assess each exposure scenario with -- at a baseline, and then with varying levels of mitigation. So that in the end, we can see the effect and the need for these mitigation measures.
The next slide is where we bring all of these factors together in our handler-risk calculation. We're just talking about the handlers now, and I'll talk about the post-application workers in a moment.
The dose -- exposure dose is the unit exposure times the application rate times the acres per day times the dermal absorption factor if you need one.
For the acute effects for azinphos-methyl, we did not use one because we had a 21-day dermal toxicity test -- animal toxicity test that we use directly in our calculation. And those factors are divided by body weight to give a milligram per kilogram per day exposure dose.
Now, our risk expression is known as the margin of exposure, which is the ratio of the no-observed adverse effect level in the animal study to the potential human exposure dosage.
We do this calculation for each of the exposure scenarios that we identify for the azinphos-methyl handlers, and we usually want this to be at least 100 or above.
Next slide? Now, for the next two or three slides I've simply listed the 14 exposure scenarios that we came up with for azinphos-methyl. You can see that they're organized by mixing and loading liquids first, and then mixing and loading wetable powders. And then under each of these, we've listed the type of application equipment that matched with this formulation. And in the italics below each major grouping are the maximum mitigation measures that we figured in our assessment. We also did these, as I indicated before, at the baseline exposure and with just personal protective equipment and clothing.
Also you'll notice that we -- for each of these scenarios, we've chosen a couple of important representative crops. And we used their application rates in the exposure calculations for each of those -- for each scenario.
The next slide is just more of the 14 scenarios that we've identified. And then the next slide is likewise.
Getting right to the results of our assessment. The results for our short and intermediate term handler risks.
Out of the 14 handler scenarios, one has an MOE above 100 when considering the short and intermediate term exposure.
I'd like to move on now to the post-application worker population. There are a couple of major factors that -- upon which we base our risk assessment for post-application workers. One is the dislodgeable folia residues, which have been mentioned a couple of times earlier on today.
And simply put -- I think it was put simply before, I'll do it again. It's the amount of the residue on foliage that workers can contact.
And then the transfer coefficient is an indicator of the amount of the pesticide residue that workers actually contact. It's a bit more complicated than that, but -- simply put, that gives you an understanding.
And these factors come together in the formula that you see below, to give us a dose again for the workers. It's a dislodgeable foliar residue number times the transfer coefficient times an eight-hour day divided by the body weight.
And then we again use the -- we use the acute NOEL -- acute affect NOEL divided by that dose to give us our MOE.
And by looking at MOEs on various days' post-application, we can determine what reentry interval there should be.
And in your note there you see that the reentry interval is that period of time during -- following application, during which the worker cannot enter the field.
The next slide we've included to show that -- for this assessment for azinphos, we were fortunate because the registrants had supplied data on dislodgeable foliar residues.
And also we had real data for transfer coefficients, at least for the orchard crops and citrus crops.
And many times we don't have this data and we have to rely entirely on our standard default assumptions.
Some of those were included in this assessment. But for -- for orchard crops and citrus crops, we had some good transfer coefficients.
And now the next slide shows the results of the post-application risk assessment. And using our data and methodology, we found that the risk assessments for reentry workers for azinphos post some concerns, especially based on the current application rates and REIs that are on the labels.
Many of those reentry intervals have been established at two days, except for the stone and pome fruits and nut crops, which are at 14 days, and grapes are at 21 days, and citrus are at 30 days.
The table below shows you some of the results. We didn't take it all the way out as far as it would go. But we show for the major crops that we had assessed, what the MOEs were at the day that -- the day indicates when the dislodgeable foliar residue amount was recorded, and then at what application rate.
And then finally we do have some incidents information available from the California Pesticide Illness Surveillance Program and the American Association of Poison Control Centers.
That information showed cases of illnesses among mixers, loaders, applicators, reentry workers and from spray drift. The effects that were seen were systemic skin, eye and respiratory effects.
I would like to say that these results had not driven our risk assessment, but they served to inform and reinforce some of our concerns. That ends my presentation.
MS. ROSSI: Okay. In conclusion about the worker risk, it -- it should be pointed out that worker risks are regulated under FIFRA. As opposed to the tolerance and dietary, which is under and FQPA. And so the worker risk would require a -- a FIFRA risk benefit balance.
And -- and it's just important to keep that in mind as we're going through these assessments that now I'm not only -- crossed lots of endpoints and lots of roots, but now they're also across two different laws.
In wrapping up this assessment, I want to spend a couple of minutes on the ecological assessment, and then conclude with some of the outstanding issues the -- the issues the Agency is facing with this particular chemical.
But some of them are going to be for all the chemicals, as well as any additional data that we know of that's out there that possibly could impact the assessment.
With regard to the ecological assessment, this is preliminary. We're currently in the midst of phase four for the ecological assessment. As I pointed out earlier, it's -- it's lagging now.
So I'm just going to really touch on the highlights of what we know is kind of going on. But it is by no means a revised risk assessment at this point.
Comment period closed in March. We received comments from registrants and grower groups. And the registrants' comments focused mainly on fate and water issues. Grower groups focused on the application methods considered.
The aquatic risks seem to be of greatest concern at this point. The concern is -- is based mainly on runoff and drift, and is supported by incidents.
There have been many reported incidents relative to other chemicals for azinphos. They have involved large numbers of fish.
And approximately 50 percent of the incidents in OPP's database for ecological incidents are associated with azinphos.
It should be noted that many of the reported incidents were associated with the sugarcane use, which we have worked with the states on.
And initially many of the incidents were related to the initiation of the boll weevil eradication program, which also has been modified.
So you need to keep those in mind and we need to keep those in mind as we're -- as we're reviewing these incidents.
Estimated risk to birds and small mammals appear to be high. And there are some incident reports that support those conclusions.
(END OF TAPE)
I think the next slide -- but the overall status of our risk assessments -- once again, at this point, we do not have a -- we do not have a concern with the chronic dietary risk.
For the acute dietary risks, there are some subpopulations of concern at the 99.9 percentile, even with use of PDP and FDA monitoring data.
Also, the acute dietary risk does not include the contribution from drinking water. And under FQPA, we would have to take that into consideration in the aggregate.
It is based on a probabilistic model. And we have used methodology to be able to use PDP with regard to the occupational and handler risk assessment. For most handler exposure scenarios considered, we do not have margins of exposure approaching 100, even with the maximum personal protective clothing and engineering controls. When we combined mixer, loaders and applicators, all scenarios have margins of exposure below 100.
With regard to the occupational post-application exposure, again, for the currently labeled reentry intervals, we do have MOEs that are less than 100.
We have used recently submitted data from the Agricultural Reentry Task Force. We have basically used the best data that we have currently -- that currently is with the Agency.
While the eco is preliminary, it does begin to show, you know, risks that we will have to address for particularly aquatic and to some extent terrestrial.
With regard to additional data, we are aware of additional data being generated out there. And we have incorporated a couple of the things even since -- within the last month, refinements to the percent crop treated that we received from USDA and working with their sources and growers.
We used in our dietary assessment the USDA PDP single serving data for pears, which helped in the modeling of using the PDP composite data.
We are aware of various studies that are being done on process commodities, such as applesauce that is being done by the Apple Processing Association. That's schedule for completion next year.
Although they are providing quarterly updates to the registrant, who is then sharing that with EPA. An apple processing study being conducted by the registrant, which is soon to arrive in June.
There's a cherry processing study that's also being completed. And we also have a PDP single-serving data on apples that's expected later this year.
And there, of course, is also the single-serving Market Basket survey that's being conducted by seven registrants.
There are some other field trial studies going on in apples and pears, using lower application rates that were previously tested.
As you can see, there is a list of new data that's in the pipeline that either we've already taken into consideration or that's planned in the near future.
And it should be noted, however, that because of the fact that we have used monitoring data in the assessment so far, either PDP or FDA, some of the data that is underway and being generated would not be expected to necessarily change the risk estimates that much. So you need to look at some of this data.
And the Agency is looking at the data that's being generated to determine what impact it could possibly have, how sensitive is the analysis, how would the analysis react to new information.
With regard to the toxicology data, we have received a human oral study in the end of March which is currently being reviewed.
With regard to the worker exposure part of the assessment, we have received a number of label changes in the last year that we have been working, as I mentioned earlier, in conjunction with California's regulations regarding the REIs. The ones that Jack presented are currently on the label for major crops.
And there's currently a study that is being proposed to evaluate how the closed system -- a closed mixing and loading system on -- that's on the current labels would impact exposure estimates, particularly for mixers and loaders.
Outstanding issues. Obviously this is one of the first comprehensive assessments that we've done using a lot of the newly developed methodology.
We've been meeting regularly with USDA, and on mostly determining what a lot of these results that we're getting out of this analysis mean and how to interpret them.
For example, we are looking at the use of the maximum percent crop treated, as opposed to using a weighted average percent crop treated, our method of calculating that.
That whole concept is the topic of a policy paper, one of the so-called science policy papers, which explains how we do these calculations and what sources of data we use in going through that. And we look to that method to get comment and developed our policy with regard to that.
In addition, we have this new method that allows us to decomposite the samples in PDP, and that methodology will go to the SAP in May.
We are continuing to look at the impacts of this methodology and the numbers that it generates as we go through our sensitivity analysis.
We are also -- as I said earlier, we are also looking again to look at values in the consumption database, as well as residues that are actually from PDP or that are a result of the decompositing model, to see if they're reasonable, to see what they look like. We look at observations that are in this database to see what the characteristics of the consumption and the residues are in the different percentiles that we're looking at.
Again, with regard to the worker, we currently do have concerns for the handlers, the mixer/loader/applicators. As well as for the post-application workers with the increased reentry intervals, or with the current reentry intervals. And these are obviously going to be the topic of our risk management strategies. These are where we are. This is the results to date based on the data that we have.
We've -- we've given you a presentation today of what a technical briefing would be like as we have it currently planned.
The objective and the thinking behind doing this technical briefing, is to allow another opportunity to present the risk assessment and what went into the risk assessment and the assumptions.
As you can see today, azinphos is fairly difficult. It did take us over an hour to go through this.
And it was very difficult even to decide which information to pull out of the assessment to present and to provide the adequate level of understanding, which we all believe is necessary to go into the next phase of risk management.
A common understanding of what the risk is, what it's based on and what is driving it, seems to be and is a critical step towards a common risk management strategy. We'd like to discuss that this afternoon. Thank you.
MR. EHRMANN: Thank you all very much. Let's just take a couple -- if there are any just questions of clarification, let's take a few of those.
And then, you know, we'll come back and pick up on this after lunch, as well as have the presentations. It looks like we have a few questions. Mr. Rominger, do you want --
MR. ROMINGER: John, can we do --
MR. EHRMANN: -- to comment?
MR. ROMINGER: -- one thing?
MR. EHRMANN: Sure.
MR. ROMINGER: I just wanted to give you an idea of some of the people from our side who have been working -- who have been working on this risk assessment. Al, would you do that?
MR. JENNINGS: Sure. And again, if you're here, you might want to stand up. But we did not bring a lot of these --
MR. EHRMANN: Right here.
MR. JENNINGS: -- folks in. If you're not here, don't stand up. That's all right. Thank you, John. The National Ag Statistical Service, NAS, as we call them, full of statisticians and data, Doug Kloeno (phonetic) and Norm Bennett (phonetic) have been doing a lot of the work, as has Jim Smith.
They also have a -- what we call a mathematical statistician who gets involved in many, many of our issues, his name is Phil Cott (phonetic.) I know Phil isn't here.
ORACBA or -- also known as the Office of Risk Assessment and Cost Benefit Analysis, Linda Abbott. I know she was here earlier. Yes, there's Linda. She is a Monte Carlo expert, among other things.
The Pesticide Data Program, that was formerly run by Bob Epstein, who is here and is now the secretary's science advisor.
And one of Bob's functions there has been taken over by Martha LaMont (phonetic,) formerly of USDA and then formerly of EPA.
So Martha has bounced back and forth between EPA and USDA a couple of times now, and we're glad to have her back.
In terms of azinphos and our review process, Mark Whalon -- actually we're relying on him to do a lot with pulling our Land Grant efforts together. He should be a familiar face here.
In terms of experts who will be involved, Jay Brunner of Washington State. He's a tree fruit entomologist there. And our kind of lead out in the northwest is Katherine Daniels at Washington State.
Bob Kreiger at University of California, Riverside, has been our lead expert on worker exposure issues in many of the first organophosphates that we've seen.
And of course one of the threads holding all this together is Wilfred Burr, who is here. Wilfred is my OPMP entomologist.
Let's see, I guess I need to mention Ag Research Service. The survey folks are headed by Alana Moeshfay. And her statistician is Joe Goldman, who has been involved in many of these issues. And Therese, have I missed anybody?
MS. MURTAUGH: That's it.
MR. ROMINGER: I've probably missed somebody. But anyhow, that's kind of the crowd that has been doing most of the work for USDA. Thank you.
MR. EHRMANN: Very good. Dave?
MR. WHITACRE: I think hearing -- having heard the azinphos-methyl review twice now, it's -- it's made a big impression in the following way.
Clearly there's a lot that goes into these things. And I don't know whether you've counted the manhours or the manweeks, but it's a big number.
And it raises one small question in my mind, and here's the question. To the extent that you have data that would allow a higher-tier analysis to be made, what is the value to doing the earlier tier analyses, because they take time?
MS. ROSSI: The value of doing the earlier tiers is because they may save time actually, because they're very easy to do.
And if you don't have a risk concern, you stop there. And that's what we did, like, for chronic, we stopped.
The tier one doesn't take a whole lot of time. The -- the tier four takes a lot of time, you have to feed in individual residues into these models.
And the last time, we said there are 45,000,000 data points and all that. I mean, we don't feed in 45,000,000 values, but it's much difficult.
MR. WHITACRE: And absolutely clear. And I -- and that's right, I understand that. But I also have another -- another side question that comes to mind.
Bill Spencer brought it up a couple of times at the last -- at the work group two meeting. And in the short term it's faster and easier and you'll get to maybe stop points early. But eventually we've got to come back to the cumulative risk, and it raises the question all over again. And there's another cycle, and you don't really know where you stand in the -- in the later cycle if you stop too early.
So what -- I guess it's -- it's something that's going to come back and we'll have to deal with it later again?
MS. ROSSI: Yeah. I mean, we acknowledge that, like, for example, in the dry run that we did at the work group on bensulide where it wasn't -- the risk wasn't -- it was at a higher tier -- a lower tier, rather, it was a tier one, tier two. We acknowledge that when we do cumulative we have to go back and -- and do more refined.
The only thing those -- the only thing you can say is that the cup is like -- I mean, whatever contribution that particular chemical makes to the cumulative is less than what it's showing individually at a higher tier.
But we will have to go back. I mean, we know that, we're planning for that. When we do eventually arrive at cumulative, planning to go back to these ones where we've used higher tier.
And, you know, we'll probably even be better at doing the probabilistic by the time we go back to those simpler ones.
MR. EHRMANN: Okay. Mark Miller?
MR. MILLER: Mark Miller, with American Academy of Pediatrics. One thing -- you know, I was slightly distressed this morning as we went around and we're introducing ourselves.
And -- and found myself sitting with primarily and industry group here, and so I -- I might need to be a little more vocal than I would otherwise. I'm a pediatrician, not a -- not research scientist.
A few questions came up, one is the adequacy of the children's consumption data that this is based on. You did allude to that there was further data that would be coming out.
When we met in -- in February, there was a presentation around the issue of glossing over certain crops because they weren't consumed.
And flax seed was -- was put out as a -- an illustration of that, that consume -- you know, consuming study of 30,000 people, nobody ate flax seed.
And, you know, that -- that hit home, since the day before I had noticed a loaf of bread in my house that my wife had bought that had flax seed in it.
So if we're eating flax seed sometimes, somebody loves the stuff and must be eating it every day. So if -- so that's the children's consumption study.
Then -- then a question came up about we use these tolerances as though that's the maximal amount, how often our tolerance is actually exceeded on the crops. I mean, I know they're not supposed to be, but that's a fact.
And then the -- the question came up about there's -- there's -- you said, well, we have these neurodevelopmental toxicity studies which may be run in the future. You know, what -- what is really the adequacy of the testing?
We didn't go in depth in that. But to say the effect on children is negligible -- you know, is our testing adequate? And is the neurodevelopmental studies, are those required?
And if so, you know, how do we drop the tenfold factor for children if consumption data is not full and testing data is not -- I mean, the default should be to retain that until we're absolutely satisfied about the data.
And one other question was about the LOEL to NOEL, how -- how do we come up with a threefold factor instead of a tenfold factor there? Thank you.
MR. EHRMANN: That's a lot.
MS. ROSSI: Okay. Well, I think there's --
MR. EHRMANN: One at a time.
MS. ROSSI: -- four questions.
MR. MILLER: Yeah.
MS. ROSSI: The first one is the adequacy of the consumption for children. Al, do you want to talk about the consumption data that is expected later this year and how it might differ from the ones we're currently using?
MR. JENNINGS: The consumption data are based on a statistical sample, and they are representative of the U.S. and various subpopulations.
We are, at EPA's request -- because when you get out on some of the extreme consumption levels you have very, very few samples, so there's a huge uncertainty.
So that's why we are doing -- have done the supplemental survey which collects an additional 5,000 children's data points, which should make the analysis much, much more robust. I don't know how much at this point.
The data have been collected, they're being -- what's the right word? Verified or validated and put in a database, and will be available to EPA in early December.
You're right, there are limitations, which is why we worry about what the Monte Carlo analysis is telling us when we're out on the tail of the curve. Because the huge uncertainties, with very few samples.
MR. MILLER: Right. It's a short -- my assumption would be short of that kind of data, we would say we'll drop the tenfold factor for children.
But in fact, we would retain the tenfold factor, because the data isn't here yet. And maybe in the future we would have enough data to be able to say with some confidence that this is safe. That would be where my assumption is that we should be coming from, baseline.
MR. EHRMANN: Lois, you want to come in on the other questions, including that issue?
MS. ROSSI: Yeah. Well, you also mentioned about the -- where you heard the meeting on -- in February about the flax seed possibly not being something that people eat a lot of.
And I think that -- that whole concept and that whole paper the Agency is currently looking at and thinking in terms of those questions, that you're raising.
And when that policy surfaces, then that will be a full discussion of those issues, including your viewpoint.
Currently, I mean, currently we're considering everything that's a food stuff is being eaten by somebody.
The second question was with regard to tolerances and being exceeded on crops. I think you specifically mentioned about it being exceeded on crops.
MR. ZAGER: I can answer that.
MS. ROSSI: Ed --
MR. JENNINGS: Ed, do you want to.
MS. ROSSI: Yeah, go ahead.
MR. ZAGER: The method that we are currently using -- as a matter of fact, we've been criticized because it generates numbers on single serving -- servings higher than the tolerance.
And these numbers, in the extreme of a distribution, are being included in our risk estimates. So that's one answer to one of your questions.
And as a matter of fact, we are looking at the ways to put some constraints on that method on the numbers that are being generated.
And we are consulting with statisticians outside of the Agency, and we are taking the method to the Scientific Advisory Panel for additional input.
You also had a question about the developmental and neurotox study. And that issue is being considered by the Agency, as was discussed before, for a whole class of chemicals that are being used on foods, or some subclasses of those chemicals.
In this particular case, the existing toxicity studies that we've received, did not indicate any need for requiring such a study. Nevertheless, the issue is still being considered.
MS. ROSSI: All right. And the tenfold and the -- the no-effects versus the LOEL?
MR. ZAGER: Oh.
MS. ROSSI: Why is it --
MR. ZAGER: Historically we've been using a 3X factor in the -- in the absence of NOAEL. And that has been born out by the studies that we received.
In other words, the NOAEL in general has not been lower -- more than three times lower than the LOAEL.
MS. ROSSI: There is a 10X policy paper -- your 10X policy paper.
MR. ZAGER: Excuse me?
MS. ROSSI: 10X policy paper.
MR. ZAGER: Oh. The science policy paper on 10X is also being presented -- is going to the SAP --
MS. ROSSI: So --
MR. ZAGER: -- in the --
MR. MILLER: What was the factor difference on the chronic study there? It was -- it was at least around three --
MR. ZAGER: Oh. On the chronic study?
MR. MILLER: On the -- on the one that was presented here for methane --
MS. ROSSI: The --
MR. ZAGER: In --
MS. ROSSI: The 3X factor was --
MR. ZAGER: In the absence of --
MS. ROSSI: That wasn't part of the FQPA 10X. That's an --
MR. ZAGER: In addition?
MS. ROSSI: -- an additional factor that we would apply on a normal uncertainty analysis, specifically --
MR. MILLER: Okay.
MS. ROSSI: -- for the case where you do not identify a NOAEL.
MR. MILLER: I'm -- but I'm just saying that you had a LOAEL and a NOAEL --
MS. ROSSI: For -- in the case --
MR. MILLER: -- for -- for the chronic --
MS. ROSSI: -- of the chronic we did have a NOAEL, and that additional 3X factor was not applied. And that was --
MR. MILLER: I know. But --
MS. ROSSI: -- the difference.
MR. MILLER: But you didn't have to. But you actually had the data?
MS. ROSSI: Yes.
MR. MILLER: And -- and it was about how many fold?
FEMALE SPEAKER: The levels.
MS. ROSSI: Oh. The LOAEL? NOAEL? About three to four.
MR. MILLER: Yeah. So that's pretty shaky on whether or not threefold is -- is actually adequate on your own study for the same chemical on a chronic basis.
MR. EHRMANN: Okay. Did we respond to all of the issues? I think. Let me suggest, just given the time, let's keep your cards up.
Let's go ahead and take an hour lunch break, and then we'll come back and start with the folks who already have asked to be recognized and on the same topic.
And there are a lot of restaurants up and down Wilson Boulevard here. There's a list out on the registration table if you want specific suggestions.
(BREAK FOR LUNCH)
AFTERNOON SESSION
(1:30 p.m.)
MR. EHRMANN: We want to start by providing an opportunity for some of the folks who had asked to be recognized before the lunch break to make their remarks related to any questions of clarification or follow-up on the azinphos assessment that we heard about before lunch.
And then we'll move to the comments about the pilot process that we've asked some folks to kick off for us, specifically Dan Botts from the grower perspective and Jay from the registrant community, given who is here today.
But then that again, we'll open that up for any other perspectives or thoughts you have about -- and advice you have for the Department and the Agency about how to move forward on this pilot process and review process. So let me first go to Mark Greenwood and follow-up on the presentation we had before lunch. Mark?
MR. GREENWOOD: Okay. I'm not sure my question survived lunch, but maybe I can try it. The question I had really grew out of as I was listening to the analysis, trying to figure out what criteria the Agency's using when it decides when it does a sensitivity analysis.
The example I -- I give is that I understand you had said that you were not going to do a drinking water assessment because you felt that the dietary risk for azinphos, it essentially sucked up all of the risk cup.
But as I went back and looked at that slide 34, which shows that depending on which percentile you pick, you have plenty of room in the risk cup, depending on what you pick there.
And I guess the question I have, at what point would you look at a chart like that and say, you know, this is close enough to the line that maybe we should go ahead and do the drinking water assessment just to see how it came out?
And I realized at that point I don't really know what the criteria are that you use when you're going to do a sensitivity analysis and when you're not. I just wondered if you have any ground rules you use there?
MR. EHRMANN: Lois?
MS. ROSSI: Well, when you say sensitivity analysis, I mean, we do a sensitivity analysis because that's basically the foundation for deciding what you're going to do with risk management. So --
MR. GREENWOOD: Yeah. Well, let me --
MS. ROSSI: But --
MR. GREENWOOD: -- let me --
MS. ROSSI: But wait, you're -- but what you're --
MR. GREENWOOD: Yeah.
MS. ROSSI: -- but what you're referring to is when do you -- when do -- with the whole drinking water decision, right?
MR. GREENWOOD: Yeah. I mean, at some point you can look at this and say and say, ah-ha --
MS. ROSSI: Yeah.
MR. GREENWOOD: -- 99.9, I stop there, I don't go beyond it ever. And therefore since the risk cup is all filled, I'm not going to go any further.
But as we've talked about here, this is a very sensitive point about which percentile you pick. And as you look at that chart, you can see there, very small differences make a lot of difference.
And I would think at some point you might look at that and say, well, maybe we should go ahead and do the drinking water analysis to see how it comes out.
MS. ROSSI: Yeah.
MR. GREENWOOD: And I just realized --
MS. ROSSI: I mean --
MR. GREENWOOD: -- I don't know --
MS. ROSSI: -- the thinking --
MR. GREENWOOD: -- how you do that.
MS. ROSSI: -- the thinking is, is that we know that drinking water is a component based on the chemical -- physical and chemical and fate characteristics of the chemical.
So I know at some point we have to allow some -- some room in the risk cup for that. At this particular point in the process we stopped.
Also, we have been revising this risk assessment based on PDP, based on all these things that we've been explaining.
So, you know, at this point these are the results we have, and we're right there. And we were presenting at the same time we're doing this, so it's also a time factor.
The -- the second point is the way we do the drinking water. And do -- do you want to Katherine and Ed, do you want to just explain how we kind of do -- not come up with a number as we presented in the policy paper number five, I guess it is, but we -- we come up with a level of concern and then we see how much there is in the cup to see if that level of concern is exceeded. So it's a combination of things.
I think if we had issued the final risk assessment, put it -- you know, and put it to bed and said we're not going to calculate it, I think your comments about stopping at this point would be a little bit more appropriate.
But I -- I think it's -- we're still trying to figure out the dietary. We are still doing that at this point. But do you want to explain? Or does that answer your question, or --
MR. GREENWOOD: Well, it sounds like it's still up in the air. But I --
MS. ROSSI: Yeah. I mean, it --
MR. GREENWOOD: -- I think that's the answer.
MS. ROSSI: -- it is somewhat up in the air.
MR. GREENWOOD: All right.
MR. EHRMANN: Okay. Mark Whalon?
MR. WHALON: Thanks. I had two general areas that I wanted to ask questions on. One is about the refinement process beyond here.
It strikes me that at least where cherries are concerned, there's considerable need for refinement.
I know that -- that you listed on one of your slides that the Cherry Marketing Institute was going to have more input, and I'm really concerned about that. It kind of mystifies me how we're coming up with cherries as a risk driver.
And in preparation for this meeting, I -- I called Phil Course (phonetic) and I asked him for -- he's the director of the CMI, the Cherry Marketing Institute.
I asked him for the production figures because they relate very much to I think the exposure and risk assessment. And maybe Cathy or somebody can address this.
But I think it's four-to-one process to fresh, something like 410,000 tons of -- of processed cherries an 110,000 fresh.
And of the fresh -- of those fresh, another -- that's 110,000 are actually consumed. But there's another 90,000 that are processed.
So essentially, the ratio of processed to fresh is about four to one. And the residues are very low to nonexistent on processed cherries.
And the other factor that I asked him about was what kind of data did he have on consumption relative to cherries.
And cherries are one of the more expensive kind of fruits, and they tend not to be the kinds of things that you feed in mass to -- to one to six year olds.
And what kind of consumption data that they had, and they -- they felt that less than two percent of the cherries are actually consumed by that age group.
So I'm wondering, you know, how cherries came up so high as a risk driver, given the kind of data that's out there?
And then the second point I -- I'd raise is as I look at the REI issues. I think for us in Michigan, in some cases particularly as it relates to fruit fly control on tree fruits and on some small fruits, a longer REI is essentially a de facto cancellation because we wouldn't be able to use it.
And I'm wondering in transition if there aren't alternatives, will there be some other alternative approaches that we can take, or some other things that we can do to do that.
Cherries are a good example. They're all mechanically harvested in Michigan, except for a few sweets. So the reentry interval as it relates to harvesters isn't an issue.
But it's very significant where it relates to IPM and monitoring and how we run scouts in or pest management field assistants or consultants. And how that all plays out are big concerns for me, and so maybe you could help me think about that.
I think that it's -- and another part of that question on REIs is the whole issue of what's it going to cost to -- to reeducate people about how to use these things?
And I know USDA -- this is maybe a plug for USDA's 13.1 or $3,000,000 headed into extension. But those dollars are desperately needed as we go down through this kind of thing to get people to -- to use these compounds again in a different way and a more complex way.
So overall, I want to complement the Agency on its analysis and the process it went through. I know it's an incredible amount of work to get through that.
But I still have these questions about refining exposure and what are we going to do to get around the REI thing so that we can actually -- get around's a wrong term. So that we can actually use these things where we have no alternatives right now.
MR. EHRMANN: Comments?
MR. JENNINGS: Let me share some comments on --
MS. ROSSI: Well, let's -- let's take --
MR. JENNINGS: Do you want to take --
MS. ROSSI: Let's do the REI thing that -- first, and then we'll -- we'll talk about the -- the cherries and the risk driver.
I mean, all the things you said, Mark, would be exactly the type -- I mean, part of presenting this is where the Agency is on its analysis.
I mean, this is what we're faced with. These are the databases we have to evaluate this. Some of it is being generated by a task force that's -- that was set up to -- designed to do this.
This is where we are. This is what it is. We haven't peeled back exactly as much as what the most sensitive factor in that equation is.
But it's not defaults, it's not made up assumptions. It is data that's generated for that purpose. So I think we're trying to present this is where we are.
The suggestions you made about the mechanical harvesting and stuff like that, I mean, that would all come in the risk management strategies, and that's I think where that would be discussed. Did you want to say something on that before we talk about cherries?
MR. JENNINGS: Well, just on -- I think, as Lois says, part of the process we're going to go through when we meet and talk about risk drivers, we need to get into discussions about REIs and what is actually going on.
I think what you'll learn later on this afternoon is that a number of the worker risk assessments are based on certain activities. Which if they don't apply, we need to find that out during the process.
MS. ROSSI: Now, with regard to the cherries. I mean, what you need to do to answer your question is look into exactly what percentage of the -- and this comes out -- this is part of our dissecting process of -- of how much we assume is processed, what factor we used for processing, what's fresh and -- and all that.
And Felicia Fort, who actually has been doing these runs, would like to -- Felicia, do you want to just --
MS. FORT: Certainly.
MS. ROSSI: -- address cherries to the best -- whatever?
MS. FORT: For the analysis for azinphos-methyl we didn't have any monitoring data for cherries, so we had to use field trial data. And generally that would be higher -- it would -- would cause the residues to be higher.
But we did consider sweet and tart in our analysis. We had percent crop treated information for both sweet and tart. And so we did consider sweet and tart.
And also, we considered processing factors and -- and data. There are several food forms, baked, cooked, different types of uses of cherries, and we adjusted the data by the different types of food forms.
MR. WHALON: Well, just to come back. I hope that you will use the data that's available, the Michigan Market Basket data, for example, other forms of data. We have some new data coming in right now.
Because I think when you look at that, processing cherries -- I don't know if you realize this or not, but when they're harvested, they're harvested by machines and they're loaded into about a half-ton container. And that half-ton contained is put on a cooling pad and it sits.
Because the biggest problem with tart cherries and sweets is cracking and brown rot as a result. So those things are put in a cooling thing and water runs over them for hours.
We have a hard time getting any residues out of processed cherries. So it's a mystery how that -- they're --
MS. FORT: Any -- any additional information that you could give us, we would definitely --
MS. ROSSI: Yeah.
MS. FORT: -- use in our analysis.
MS. ROSSI: Do we have the -- the Michigan Market Basket, Mark?
MR. WHALON: I actually submitted all that stuff back when I submitted all the residue data out of Michigan before TRAC started, I think, to Susan Hummel and I'm not sure. I might have put it in the wrong place.
MR. EHRMANN: All right. I want to -- I want to move to some other -- other points, because the --
MR. WHALON: I can redo it. Give it back to --
MR. EHRMANN: Yeah, that --
MS. ROSSI: Well, let's talk about it.
MR. EHRMANN: -- would be great.
MS. ROSSI: Let's talk about it.
MR. EHRMANN: Yeah, that would be great. Jim, did you want to make a comment?
MR. SMITH: Yeah, just sort of to put it in context to Mark and others here. I mean, two things, one is to draw your attention to this paper called 38B, which I'm sure you've all memorized.
But it is a very specific recitation of what the data are that we're using in the assessment.
And so for example, as Felicia says, and we did not have the PDP data, we did not have the sort of specific monitoring data.
And it says right there, "We used field trial data." That's one reason why, Mark, if you want to call it that, it's a likely overestimate or whatever characterization you might want to make.
I mean, that's -- that's -- the shortest answer is we didn't have this more specific data. This calculation's based on the field trial data.
When the folks would then bring that up to the decision makers, we would then ask the following question: Again, how much of the analysis is based on, you know, the PDP data, other sources of data, the most realistic estimates, the best available data, all the other kinds of works we've used around in a long time, and what may be based a lot or a little on field trial data or some other kind of estimating algorithm that's contained in the analysis?
You then capture that when you're doing a decision about, okay, what does this mean? We really need to do blank on, you know, this commodity, that commodity, et cetera.
Are cherries a driver?, which is I think your simplest first sort of general question. I think the answer is given this analysis, fully knowing all the stuff we went through for a long time this morning and the chart.
And as you might imagine, in government there's a whole lot more where this came from. And -- and that's what you would then ask, okay, is it -- now what?
I mean -- you know, and so what? And what other information? Let's talk to the Michigan folks. Did we get that data?
There's more places -- believe it or not, I'm sure you know there's more places than Michigan that grow cherries. Although the Michigan guys don't want to admit that sometimes.
But, you know, that kind of realistic real time decision-making is what we would then take this and ask those other questions of the staff when they bring this analysis up and say what else do we need to do. Or does it imply that we're in a -- in a position to take some kind of action, make some pronouncement, make a recommendation. I'm not trying to get in the, you know, real specific end game there, but just -- that's the kind of real time decision-making we would face.
As in some of these commodities we've got very solid data from PDP, other ones we don't. Other ones whether or not we're using percent crop treated above a couple -- right above cherries is celery seed, where fully 13 percent of the crop is treated, and so on and so forth.
But again, as a not-large component of the diet, we have something in the system, but probably it's not likely going to sway the analysis.
So again, it's -- sort of try and remember the real-time context of when we have this information, bringing it up to the decision-makers.
Those are the kind of questions we will ask. We have asked in the programs notes, you know, to be expected to have some answer about.
MR. WHALON: You know, there's -- maybe this brings up another issue. And the data here is not only insufficient, it's really air-prone in the sense that it identifies cherries as a risk driver, and that's going to cost that industry whatever.
I mean, they've been in the front page of some newspaper as a result. Cherries are a big risk driver, et cetera.
So that kind of treatment is pretty significant to people who are producing it and people who are processing, et cetera.
So maybe there ought to be some sort of air-checking mechanism through USDA or something before that kind of risk driver language is released.
MR. EHRMANN: Keith?
MR. PITTS: Mark, I just want to point out that's -- that is what we're doing with the Land Grant partners. Is before this risk assessment and any others are finalized, we are sending these out to people we recognize as experts in those particular crops and making sure that we are squared away.
The vetting we're doing is not just happening here in Washington. We are going out through the system. And I'm fairly certain that you've probably got this risk assessment sitting on your desk when you get back to your office.
MR. EHRMANN: Congratulations.
MR. PITTS: So that --
MR. EHRMANN: Okay. Let's --
MR. PITTS: -- that information will certainly be useful.
MR. WHALON: I guess my point is, it might be a little late.
MR. EHRMANN: Okay.
MR. WHALON: I mean -- I mean from the risk driver perspective.
MR. EHRMANN: All right. Wally?
MR. EWART: I guess I'll follow-up on cherries first, since we were talking about cherries. And I had several questions, Mark covered some of those. But one of them was -- Lois had said that -- that the LOQ situation didn't really make a lot of difference in this case.
But for cherries, I guess I would anticipate that to be more important in this case than for the crops you had the PDP on. Now, maybe I'm wrong, but that's -- one of the questions I had was LOQ.
Then the other was do you use percent crop treated? I assume you would, which you have that -- you have that data at least I know. So would that have been used in this --
MS. ROSSI: Yeah.
MR. EWART: -- analysis?
MS. ROSSI: Yeah. Again, I guess referring to this paper that --
MR. EWART: Right.
MS. ROSSi: -- you know, this chart shows the percent crop treated that was used.
The LOQ thing where I said we tried zeros through -- that was the impact on the total risk cup. So we didn't really go and look to see what it would do to drivers and whatever.
MR. EWART: Yeah.
MS. ROSSI: It was just like a total run where you looked at the total risk cup. So -- I mean, another analysis we could do is see what something like that does to an individual commodity.
MR. EWART: I think in these commodities where you don't have that robust data with residues, it's probably a good idea, like Mark says --
MS. ROSSI: Yeah.
MR. EWART: -- before you identify them that way, to try what you can in the system --
MS. ROSSI: Yeah, I see. Yeah.
MR. EWART: -- to make sure that --
MS. ROSSI: That's a --
MR. EWART: -- you know, that isn't happening.
MS. ROSSI: -- good idea.
MR. EWART: The other thing I was wondering about is on single serving. Knowing that we have single-serving data coming in for apples and pears and peaches, three of my crops, you're going to have one year of that, and the Market Basket survey and perhaps PDP.
And my question I guess is when you have that data, and that should be a big data set, are you still going to have to average in prior years and do the decompositing, or are you going to be able to use that sort of straight across because it is current and it's robust and we -- we assume at least that it really reflects what's out there?
MS. ROSSI: Ed?
MR. ZAGER: I think we would compare the single-serving data to the already existing pear data. We expect data from a number of sources.
We expect additional data from PDP on apples and expect data from the next Market Basket survey from a task -- industry task force.
We would compare the data. I don't think that we would average in the results gotten from the compositing method.
But still we would certainly compare it to see how, you know, how robust the method is, how -- how well the method predicts reality also.
MR. EHRMANN: Okay.
MR. EWART: The last question gets back to cherries. Since you've identified it as a major contributor, which is your term, I just wondered if you had taken that and separated that out, you know, and seen what it did to the rest of the risk cup when you take cherries out.
Because I understand that that's sort of a tricky business when you're at really low contributions. But with cherries, is that one that you actually can separate out and actually know that by taking it out it makes a difference?
MS. ROSSI: I think a little bit of clarification on these risk contributors -- I mean, there were three major ones, and then the next one was cherries. And maybe we didn't do a good job in clarifying how much of a contributor cherries is.
I mean, the major contributors are the crops we had up there, apples, peaches and pears.
And then like the next one -- and I think maybe we failed to say how much of a drop off there was between those three and the next one, first of all. And then didn't we take cherries out?
FEMALE SPEAKER: Yeah.
MALE SPEAKER: Yeah.
(END OF TAPE)
MS. FORT: We excluded cherries from the analysis. And we didn't see a large change in the children and infant groups.
But there was a significant change on -- I don't want to use the word significant. But there was some change --
MALE SPEAKER: Comparable to the others.
MS. FORT: -- comparable to the others.
MR. EWART: Well, I think --
MS. FORT: For the U.S. --
MR. EWART: -- that gets back --
MS. FORT: -- population.
MR. EWART: Thanks. Because that gets back to what Mark said. I think we really feel very sensitive about a crop being identified based on a small database.
And then if you do what you can do to look at that and see if it really is still significant, I think it's important. It will make a lot of difference to us.
MR. EHRMANN: Okay.
MR. ZAGER: Simply because -- Wally, simply because we are using field study data rather than monitoring data on this particular analysis, it would be one of -- you know, it would move up on the scale of drivers. So really what we need to do is look at that monitoring data -- good data.
MR. EHRMANN: Brad?
MR. LUCKEY: A couple of questions. If you look at your table number 43, it's talking about the occupational assessment.
The fourth bullet down says, "Areas treated per day." I'm wondering if you've made a distinction in the method of application.
Say you took a 70-acre field and compared the exposure in minutes and/or hours. And aerial applicator would apply that chemical in about 15 to 20 minutes, where a ground application would take three, maybe four hours.
And I'm wondering if there's a way that you can add in that difference of application -- aerial application being much, much less exposure than ground, and I don't know that -- that you've considered that.
Also, on the next slide -- or on number 45 it says, "Handler scenarios." It says, "Includes representative crops, comma, and maximum mitigation measures assessed."
Looking at the bottom of that on the left side and it -- and it lists, "Closed mixing system, single layer of clothing, chemical resistant gloves." And we're talking about guthion.
I'm from California, and if that's maximum mitigation, this closed system, single air, clothing and chemical, I've got to wear more than that just to wash my truck.
You know, I've been around herbicides and insecticides most of my life, mixing them and applying them.
Maybe I come from an over-regulatory state. But even to use Roundup, which is pretty benign, we have to wear gloves, coveralls, rubber boots and you have to have eye protection.
And I'm wondering, did you look at the label on guthion and see what the PPE requirements were before you made up this table?
MS. ROSSI: Not federally.
MR. LUCKEY: Because very limited PPE requirements, especially for mixing and loading of wetable powders, you don't have any PPEs listed at all.
There's no splash-proof aprons, there's no rubber gloves, no rubber boots, and no eye protection. And would that make a difference in your exposure scenario if you'd considered possibly what's on the label for -- if it's necessary and minimum equipment to protect these mixers and loaders?
MS. ROSSI: Yeah. Let's take your first question first, and then do the second one on the labels.
With regard to the acres treated and whether they considered different application, Jack, do you want to address that question?
MR. ARTHUR: Well, if I understand it right, you're saying that because you can apply to the -- you can apply it faster with an airplane that there -- did we take that into account.
I think if I can answer this properly, our whole assessment is based on the pounds AI and the unit exposure, which is pounds AI per pound AI handled.
And so we factor that into -- it doesn't have to do with the time element, but more the amount of pesticide that's being applied. And I may be off base on the --
MR. LUCKEY: Well, you mentioned -- it says, "Area treated per day," and I'm assuming that that's a measure of exposure. And I'm wondering if it's better to use time as a reference --
MS. ROSSI: Oh, I see.
MR. LUCKEY: -- rather than acres.
MS. ROSSI: -- what you're saying.
MR. JENNINGS: Brad, perhaps as not the ones doing this every day, asking some of the same questions, maybe I can respond to it a little bit.
As I understand it, the whole notion is even though someone may only be able to apply a certain amount over a groundboom because it's going slower than an airplane, at the same time the airplane may cover more ground over a total day.
So it's -- it's more you have to worry about an aerial applicator potential risk, and then also a groundboom applicator potential risk.
And it's -- it attempts to capture all the things that I think you're trying to get at in terms of is it -- you know, there is a difference between aerial application and the rate should be able -- the amount of ground you'll be able to cover, as well as the rate you'll be applying, compared to applying it in another way. I think that's the shorter and more direct version of --
MR. LUCKEY: You know, it would be very difficult to try and -- you know, and quantify that. I understand. I just want to make sure that there -- you know, there is an acknowledgment of different application measures --
MR. JENNINGS: There are --
MR. LUCKEY: -- that may reduce exposure levels.
MR. JENNINGS: There is that acknowledgment, I believe. And then also this originally was built in consultation with the industry at the time. I mean, that's how a lot of these assumptions went in, asking those kind of questions.
Obviously it's different if you're doing a backpack sprayer, the amount of ground you would cover, compared to groundboom, compared to an airplane.
MR. LUCKEY: Okay. And what about --
MR. EHRMANN: And also there will be another chance too just to build on what you're saying this afternoon. Later when we talk about the worker generic approach some of these issues will come up again.
MR. LUCKEY: Okay. What about the PPE requirements, were those considered?
MR. EHRMANN: In this particular one, yeah.
MS. ROSSI: I mean, we go what's on the Federal label, that's part of it. But also the scenarios and the protective clothing are based on a part of the database
-- the Pesticide Handler Database. The -- Jack, do you want to --
MR. ARTHUR: Right. We -- you know, we use the data from the Pesticide Handler's Exposure Database, and those studies -- and we have protection factors for certain layers of PPE.
We don't have, for instance, a protection factor for eye protection. So if that's on the label, we don't have a protection factor to -- we can't quantitate that -- the contribution to that protection factor.
MS. ROSSI: So I mean, what we would do -- we quantitate as much as we can, as much as we have data for, as much as supported by the databases.
But if, for example, we expanded the protective clothing as part of a risk management thing, we would have to make some judgment as to what we think this contributes to the reduction of risk.
Now, there are studies that are going on with the closed systems, the lock and load, and those will help. Because those factors the risk reduction from those kinds of methods we don't really have any data on.
Common sense will tell you that it does reduce risk at exposure, but we don't have that.
I mean, that would be part of risk management, where we have to make some kind of judgement as to whether we think adding these measures are reducing the risk.
MALE SPEAKER: We also, as sort of a policy, don't normally add full PPE with closed mix -- with what we're calling engineering controls, if that adds anything to -- if that answers part of your question.
MR. LUCKEY: Well, it should be considered if it's on the label as required equipment. To me it should be.
MR. EHRMANN: Do you have another question, Brad, or --
MR. LUCKEY: Just one. Number 48, it says, "Out of the 14 handler scenarios, only one has an MOE above 100." I was wondering which one that was, which -- which --
MR. EHRMANN: Which one?
MR. LUCKEY: -- which handler risk was it?
MALE SPEAKER: It's actually the flagger risk that makes it all the way through.
MR. EHRMANN: Flag? Which number is that?
MALE SPEAKER: Ten.
MR. EHRMANN: Number 10.
MR. LUCKEY: Thank you.
MR. EHRMANN: Yeah. Let me take Nancy, Elin and Tobi. And then we'll move to our folks who are going to make the comments about the pilot process, et cetera. Nancy?
MS. RACHMAN: Just continuing along this same line that Brad started, I was going to ask whether or not you do a sensitivity analysis on the worker risk assessment?
And I guess I'd like to suggest it would be a good idea to try and do the reality check with the label, and to just highlight which parts of the equation might be driving that risk. For example, the assumption about the number of acres treated in a day, because that's something that could differ significantly in different parts of the country for different crops.
So in an effort to be transparent, it probably would be good to do that sort of analysis and lay it all out.
I also wanted to ask whether this handout would be the prototype for a technical briefing document, and whether it would also include the complete listing of all the residue inputs that were used in the analysis. Is that the plan?
MS. ROSSI: 38B.
MS. RACHMAN: Sorry?
MS. ROSSI: The handout you're referring to is the paper -- the table with all the crops?
MS. RACHMAN: Yes. Would that be part of the information package that's released to the docket at the technical briefing?
MS. ROSSI: Well, that is something we raised at the work group. Personally I think this table is very helpful to me. But I think that's, you know, something we're seeking input.
If this type of table makes the dietary risk assessment more transparent so that you can see what we used and whatever, then, yes.
MS. RACHMAN: I think it would be critical. And I would also suggest that you might want to carry forward some of the information.
For example, the discussion about cherries that we just had, that should be carried forward to the more abbreviated summary document. So that folks know that if you've identified a driver, here's why it's a driver.
MS. ROSSI: Um-hum.
MS. RACHMAN: You're using field trial data to estimate exposure to a commodity that's processed, that's an important thing for somebody to know.
Just one other quick point. And that is when Mark Miller asked the questions before lunch about the developmental data, it reminded me of some questions that Routt Reigart had raised at an earlier TRAC meeting.
And Routt told me in a conversation off-line, that he had written a letter to Lynn Goldman asking those questions. And he was at that point, which is some months ago now, waiting for a response.
I understand that the Agency has prepared that response, and I'd like to suggest that it be shared with the TRAC members. I think Mark needs to see that information so that his questions can be answered.
MR. EHRMANN: Several good suggestions. Thank you, Nancy. Can we do that?
MALE SPEAKER: Sure.
MR. EHRMANN: Okay. Elin?
MS. MILLER: I'd just like to say for one who at previous TRAC meetings was very interested in really understanding the risk assessment process as it evolved, and taking a snapshot in time of now versus where we were, I think you all did an excellent job.
I think some of us have been trying to explain what we thought was going on and couldn't quite get there, maybe because we couldn't put it in terms the people could understand, so appreciate that.
And I think we've come a long way on the dietary side. But maybe some of these questions can be focused when we deal with worker safety later, but I'll lay it on the table.
One of the things that, you know, as we have seen in evolution as data provided and as you develop models and you look at new information on dietary and the kind of shift that occurs from where we thought the risk was to where we think it is now and that evolves. On the worker side, I think we're going to have as much and even more of a challenge.
And I'd just like to get an idea of a snapshot in time. I had dealt with PHED in my past. I never thought I'd deal with PHED again, but I guess today I am.
Where are we really on let's say the difference between true actual data from either field work or handler whatever, compared to -- to PHED in a general assumption?
I mean, what kind of a delta is there? How comfortable we are with that model? And not a negative TPA, maybe we just haven't gotten more exposure data
into it over time. But what's the delta here? What kind of --
MS. ROSSI: Well --
MS. MILLER: -- assumption --
MS. ROSSI: -- first --
MR. EHRMANN: Can I -- can we hold that one until we talk about the worker stuff after a little bit later?
MS. MILLER: Okay.
MR. EHRMANN: Just because I think that's kind of the guts of the kind of thing we're going to be talking about later this afternoon.
MS. MILLER: Okay.
MR. EHRMANN: Did you have any other follow-ups?
MS. MILLER: No.
MR. EHRMANN: Okay. We'll make sure we start with that in that part. Tobi?
MS. JONES: I just need clarification, since it sounds like you're wrapping up the azinphos-methyl risk assessment very shortly.
If in fact state data -- and I know it sounds like Mark Whalon's data's stuck in the same pot. If state data that were submitted as part of the National Residue Database aren't current being considered, do I need to go back and round up all of the California residue data that was submitted to that to get to you straight away for azinphos-methyl?
Because I think some of the commodities for which you have no data, we may have residue data on. I'm not going to make any judgment about whether or not the quality of the data meets your needs, but I think Mark's and my question are the same. If you need that data now for consideration on this final draft, let me know.
MS. ROSSI: I think we'd probably like to follow-up with you on that. But I think we'd also like to just check and make sure what we have and what form it's in. But I think we'd like to follow-up with --
MS. JONES: Well, apparently --
MS. ROSSI: -- doing that.
MS. JONES: -- we were working through an FDA contractors. And I don't know if other state residue monitoring programs were doing the same --
MS. ROSSI: Um-hum.
MS. JONES: -- but there was an FDS contractor who was compiling state data for submission. And we've had -- our chemistry lab has had some contact with Susan Hummel, we have not.
MR. ZAGER: We need to talk. We may very well have some of the data, if not all of the data. But we need to follow-up.
MS. JONES: Okay.
MR. EHRMANN: Okay. Thanks. John, did you have a quick one? Go ahead.
MR. CADY: Yeah. I had a couple of -- I wanted to urge you people to -- when you feel pressed on time -- I know that this is a big issue with people saying that you're not moving fast enough.
But we're hitting some things now that look like there are transparency issues and maybe even a sound science issue that we question, and it will take time to work them through.
We have a situation where I feel a transparency thing where an endpoint was changed by EPA after the public comment period.
And we're kind of caught flat-footed with not being able to use a couple of studies that have been accepted a couple of times before EPA.
We had no idea this was coming, and kind of straight-armed. And we want to go through it and try to understand, talk it through and figure it out.
Another issue where a 10X safety factor that we felt should be removed is not being moved at all.
And I've heard that argument that sound science doesn't mean that the registrant gets what he wants all the time, I know that.
But this -- to use a metaphor that I used one previous TRAC is, this is not a deal where -- where we were going 63 miles an hour and you thought we were going 68.
We think we're going 40 miles an hour. And we think any sound science would recognize it if he heard our case.
So I hope that this thing doesn't move so fast and you feel you're pressed by -- by events to get on past things, that you don't have time to work through these issues that you're working on.
MR. EHRMANN: Peter, do you want to --
MR. ROBERTSON: John, we appreciate the comment. I think you heard both Lois and Al say today that they felt the time that we had was appropriate to the task involved.
And, you know, we'll continue to try to -- you know, if -- if the enviros were here, they would tell you that this was a process that was far too deliberate.
I think it's a deliberate process, but appropriately so. And we'll try to, you know, ensure that we have the time necessary to ensure that sound science is used in every case. We are trying to set reasonable time frames and stick to those time frames as much as we can.
MR. CADY: Well -- and, you know, I say go as fast as you can. Except some of these things do take time to work through.
And then of course this transparency thing is part of the fact that there's not been -- that some of these things appear to be happening that there's -- no policy's been announced or no policy's even being changed would maybe without our registration people being made aware of the fact that this is occurring.
So anyway, we'll need to -- and maybe all it takes is talking through a couple of these things. And one of the two of us will come away saying we see what they're talking about, or maybe we'll both come through that way.
But that's -- from the standpoint of the registrant, neither the transparency nor the sound science is coming through loud and clear yet.
It's better -- it's better. We're taking a lot more time than I think was intended to take when this whole TRAC deal started a year and a half ago.
But you -- from our standpoint -- and we had a huge number of these early products where our little company had them.
But we're running into problems that don't look -- it looks to us like those two principals are being violated.
MR. EHRMANN: Okay. Let's turn then to a couple of folks who we asked in advance of the meeting to give some thought to the reflection on the pilot process, the way it's worked, suggestions for improving going down the road, as well as any thoughts they have on this presentation we just had.
Again, as an example of a technical briefing, what kind of insights and comments might be helpful. And again, Dan and Jay are going to do this from the perspective of their interest.
But I just want that to kind of kickoff obviously a discussion where everyone should add your thoughts as well. And let me start with Dan.
MR. BOTTS: Thank you, John. And having received this phone call and draft agenda the day I got back from Michigan, talking about FQPA to the Michigan folks about where I thought the process was going, let me just say right up front that this -- most of my comments are going to be colored by the discussion we had at the work group meeting two weeks ago, rather than the presentation we had this morning with a little bit of twist on the end of that. And I'm going to focus on process, not on the specific risk analysis that we've gone through in detail. Except to possibly use that as an example of some of the things that I think are critically important for people to recognize. At least from the perspective of someone who has to represent commodity growers in Florida across the board, everything from sugarcane and sod and ornamentals to the infamous kumquat and limes and litchi nuts and some of the other things that most people have never heard of.
Just take it from the top. The process when it was announced, I think everybody recognized going in that the numbers were very preliminary, and the Agency did a fairly good job of stressing that at every point in the process.
But the magnitude of issues that seem to accrue at that point when you had levels of exposure that hit the press at 10,000, 4,000, 10,000, based on the various breakdowns of subpopulations, there was a tremendous concern in the industry of how to deal with that.
I think as you look toward the refined analysis that comes forward, especially with the error correction and whatever that meant, as the very first step.
And then especially the involvement by both EPA and USDA to refine those numbers as best we can to get to the point that we are today, I think it illustrates something that most of us in the grower community thought since day one in this process.
If you've got real risk numbers rather than screening tier analysis, you'd see at least from the dietary side of the equation we're not out there creating problems from a dietary exposure standpoint.
And I would suggest even though unfortunately we chose the term risk driver for some of these commodities up front that contribute to the risk, I like risk contributor a lot better as a term of art.
But I would also suggest that even though they are listed as risk contributors or major risk contributors, that none of those individual commodities in and of themselves at this point under the analysis that we've done represent a risk that would trigger direct regulatory action as a result of FQPA as a single, stand-alone food item.
And from that standpoint, some of the concerns that have been expressed by Mark and others in the commodity groups that are sitting around this table -- because when that term of art, whether it's risk driver or risk contributor, gets out there, it implies something that may or may not be true.
And I would encourage the Agency at every point in the process, that these numbers are close to real and you believe in them and to stress that issue.
Because recognizing there's other issues down the road we're going to have to deal with from a collective standpoint, we're not there yet.
And the science isn't there to drive, to be able to make a determination or make even an allegation that any of these commodities represent a risk in and of themselves at the grower level.
From that standpoint, how do we get from the process that we have in place to something that's going to work long term? And that's what I thought my charge to look at how the process has worked to date and how to go forward would be.
Quite frankly, the preliminary risk assessments as initially released, and I've said this a thousand times, are almost incomprehensible at the grower level to be able to deal with.
The refined risk analysis and the supporting documentation, and especially the summary documents that were provided at the work group meeting, both on bensulide and the staff paper 38B, which I think are the minimum things that need to accompany a description even of the refined risk analysis, are absolutely necessary to focus the user side of the input into refining any risk analysis or any individual commodity's potential response to being identified as a risk contributor.
And listening to the conversation this morning, a couple of things jumped out. And maybe I misunderstood. And if I did, correct me.
It was my understanding that the refined risk analysis opened a comment period to allow a discussion of the type that has centered on cherries and some other issues today to further refine that risk analysis to most accurately reflect what would be real risk from the use of those products in American agriculture.
What I heard this morning was that when that refinement comes out, essentially EPA has made their final decision of where the risk is. It's been sent to USDA at that point for them to refine it. And then we would be talking strictly risk mitigation.
I would suggest that that's probably not the appropriate schedule or framework. We at least need the opportunity to further refine the use information.
And just looking at section 38B in the infamous celery seeds number, it probably doesn't amount to a hill of beans in the overall risk cup of azinphos-methyl.
But if you look at the percent crop treated, it's the same as the percent crop treated for celery juice and the same percent crop treated for celery as a raw product.
And I would suggest that if you grow celery for seed, it's a different crop than if you grow fresh market celery.
And from that standpoint, percent crop acreage treated. For those, it is probably not going to drive the overall risk number below 105, or 135, or whatever the number comes out to be.
But those are the kind of things that commodity groups can sink their teeth in and give you real information on to further refine those risk analysis numbers.
I would also suggest that -- especially looking at the numbers in the table on the handout we got today of page 33, rather than waiting until EPA's absolutely certain that they're absolutely comfortable with the numbers and then sending it to USDA, it would probably be more appropriate as we refine this process to move USDA involvement back earlier in the process so that you don't end up having to do multiple analyses of the same data to end up getting to a point where you reach the refinement that you have.
And I'm sure that as we work through the process beyond the first couple that have been done, all parties are going to get more comfortable with each other's contributions and ability to perform relative to that issue. And I would suggest that that's not necessarily the most efficient utilization of time in the process to absolutely think you've got a finished document before you send it over there.
It would be nice to start that process a lot earlier, so we don't have to go through multiple iterations.
I guess one of the biggest issues I've got is where we go forward from here. We haven't followed the pilot process all the way through to completion on any individual compound. I think some of the biggest concerns that we have in the user community is once we get to the point of identifying in an overall risk scenario things that have to be done, how we mitigate those risks, or what the role of the user community is. And not only coming up with the options to most effectively deal with those, but also how to test them to ensure that they do meet the goals of both EPA and the user community.
I mean, we can sit here and tell horror stories all day of risk mitigation actions that have been taken in the past, that because of use patterns didn't represent real risk mitigation at any point in the process. And I would hope that that's not a closed system, that it would be as open and as transparent as the risk analysis process as being built today.
John, I don't know if that's what you wanted, but that's thoughts off the top of my head. And I would suggest that there has been a tremendous amount of work that's been done. To go into just this one analysis, I have some very serious concerns as somebody who would like to see some other actions be taken by the Agency over the long term that all of the resources don't get eaten up in this black hole of doing this analysis process just on the dietary side.
We'd like to see some new products get registered some time in the future as well. And recognizing there's a tremendous amount of work associated with this, there are other places resources need to go.
MR. EHRMANN: Okay. Thanks, Dan. Thanks for preparing. That was, I think,
exactly the kind of feedback the Department and the Agency are looking for
in terms of moving the process forward. Jay has a handout with his
presentation.
MR. VROOM: Thank you.
MR. EHRMANN: Jay Vroom.
MR. VROOM: While Ray McAlister's turning the overhead projector on, I'll pass around copies. I've got seven overhead slides that I'd like to move quickly through.
And as Ray's turning the projector on, let me just remind everyone of something that our friends from Bayer asked me to mention.
And that is that the azinphos-methyl example has been offered I think in the spirit of understanding process, and that there are many more stages of refinement and analyses and data to come in.
And that many of us expect the risk estimates and projections to go down. There may be data that will push some places upward. And it's not a final document, and is a work in progress.
Just quickly -- I'll skip over very quickly two of the slides. But the second slide I would like to go to observes that since this pilot process was initiated by Fred Hansen at the July TRAC meeting with Mr. Rominger's involvement and input from the Department, I would quickly say that we've tried to canvas the registrants that I've been able to talk to since I learned that we'd be invited to make this preliminary assessment of the preliminary pilot assessment process.
First of all, I think we generally acknowledge that the pilot response to a fundamental public right to know about these kinds of issues and the process as well as the facts, it attempts as -- the pilot attempts to allow EPA greater management control, if you will, of information that otherwise would be accessible through the Freedom of Information Act. And we acknowledge that that is an important fundamental benefit of the pilot.
We acknowledge that the pilot was developed on the go in the midst of a great deal of other FQPA time and resource demand pressures on the Agency and the Department.
And that the pilot has enabled many constituent stakeholders, not the least of which are registrants one to another, to gain a practical understanding of the risk assessment process and how it's being applied uniformly or otherwise on various chemicals, especially in utilization of the new standards being brought forward and -- and implemented through the science policies from FQPA.
The next slide makes four observations about how we all have fared through this process. First of all, the registrants I think could be commended for going the extra mile in cooperating on the pilot process, plus a few of them having stepped up and provided the TRAC presentation walk-throughs.
I'm sorry that Ken isn't here to criticize that. But if he were here, he would probably refer to Jack Kennedy and PT-109.
The next point is EPA and USDA staffs should be commended for working to adopt an approach to earlier public release in the pilot and implementing it simultaneously with proper caveats that have been appended.
And I think a good job has been done on that and lessons have been learned. New words have been invented and substituted appropriately. And that's a work in progress as Mark has reminded us here just this afternoon.
Growers in the food companies I think could be commended for keeping the marketplace informed and relatively calm as the pilot information has been released and disseminated.
And lastly, I'd commend the environmental and consumer groups for avoiding distortion of information that has come from the pilot process.
The next two slides really have already been covered by Lois and Al in the earlier presentation, and I don't think need any further elaboration. So let me skip ahead then to the last two slides on the pilot path forward.
The most fundamental question that occurred to us is one of a legal nature, and that is where is the Freedom of Information Act bright line been drawn? And I assume that that is a decision that's been made by the Office of General Counsel at EPA.
And we're then in turn raising the question, is that line, if it is defined as to where it is drawn, at the appropriate point?
And we'd like to come back to that question in -- particularly in the case of the example of azinphos-methyl, where we've seen such a dramatic change in refinement numbers. Is it the public's right to be misinformed by information that is so preliminary as to be potentially very misleading? And is that a function of where that FOIA bright line is drawn, which initiates the process where the pilot has started?
Is the -- next question is, is the bright line for FOIA being fairly and uniformly applied? And we'd like to know more about that. I asked the next question earlier. And I think we'd like to continue to keep an eye on this as the pilot further unfolds and becomes something more permanent, and that is what benefit is coming to the process for regulatory action by the Agency and the Department from the volume, quality and the robustness of public comment. And is that being enhanced by way of the stages and phases that are currently in place.
And again, I'd commend the Agency and the Department for the great deal of additional detail that I think you've unveiled in the staff papers that have been reviewed this morning by the leadership teams from Al and Lois' presentations.
Lastly, we wonder about the ability to enlarge and/or clarify the definition of error correction up there in phase one.
And then, John, lastly, I would like to commit ACPA to the notion of bringing forward to the TRAC and the Department and Agency, specific written recommendations with regard to these and some other questions we'd like some more time to think about ahead of the next TRAC meeting.
MR. EHRMANN: Thank you, Jay and Dan very much for -- again, for preparing those thoughts. I think it's very helpful to kind of see this discussion and give us a set of issues to focus on, as well as others. Let me go to Bill Lovelady's comments next.
MR. LOVELADY: I thought perhaps I should have asked this earlier before lunch. But then since it's basically the same questions that Jay had just asked, maybe it is better that it's in this session.
I want to ask two questions. And the first question is not a baiting question, but it does have to do with the second question.
First of all -- and I noticed that he had it up there too about the type of comments. I would be interested to know what kinds of public comments the 10,000 percent of the RfD elicited from the public.
And I'm not asking that to bait, but it does have a bearing on my second question. So I don't know if you want the second -- both questions first, or what?
MR. EHRMANN: Why don't you ask the second one, too.
MR. LOVELADY: Okay. Well, the second question is -- I mean -- well, maybe -- maybe I will tell you why I'm asking about the first question.
I would be real interested to find out if there was a lot of response when they put out the 10,000 percent of the RfD.
I would think that if anybody were looking, that that would have elicited a lot of response. Because that sounds -- I mean, that sounds just -- I think every mother in the world would want to know why are you bombarding our children with something like this.
Well, we all know that when you further refine this data -- and I'm sure that the Agency and the Department knew before they put out a 10,000 percent figure, that further refinement was going to dramatically reduce that. Is that not correct?
And so I have to ask the question without trying to -- without trying to point fingers, what is the purpose of putting out what would appear to me, and correct me if I'm wrong, but it would appear to me that a 10,000 percent figure would be inflammatory. What would be the point of putting out intentionally inflammatory information out -- over on the internet?
I know that it's preliminary, but I would just be interested in further knowing why it's important for the public to know something inflammatory and which I am sure everyone knew was going to be reduced dramatically when you further refined it.
So that's what I want to know. What kind of response did you get? What kind of response did this elicit? And then what is the purpose of giving this kind of information when we know that -- that further refinement will -- will drastically reduce it?
MR. EHRMANN: Jim?
MR. AIDALA: Okay. Let me have Lois or whoever respond to the comments that we received on this particular one, but -- and the specifics of that.
But before that, Bill, I think that a couple of things in terms of the general question on the purpose of the preliminaries and whatever level of transparency that's associated with releasing them either under FOIA on the internet or otherwise.
First of all, I think it's part of what Jay was just talking about in his last bullet on one of the slides where even in absentia, the environmental and consumer groups will be commended for not distorting this information.
I don't think there has been, and certainly it is not our intention, of calling them intentionally inflammatory.
Basically they are the analyses that are the analyses at that point in the assessment. Let me contrast it in one way.
If after we do this preliminary analysis there are no problems, and in fact many of the ones -- and in fact the first dry run we did at the working group had the dietary assessment as such that there is no exceedance of the risk cup by 105 percent, 10,000 -- 1,000 percent or 10,000 percent or any other number.
Basically you can't have a system I don't think and call it transparent if you do it in some cases but not all, or at least within broad parameters.
There may be some reasons because we know we're getting other information, it's subject to radical change, et cetera.
But the bottom line is that the -- the algorithms are there in order to tell us what we need to go focus on further.
In a couple of cases the numbers are very large, that tells us a couple of things. That first of all helps us set priorities, and secondly it helps to inform you that again there's probably more as a grower to be worried about in -- in the use of this material versus bensulide, where there isn't -- azinphos versus bensulide just as an example, not trying to get into particulars. Because on the bensulide example there's no dietary concern.
It was mentioned earlier that the reason we use some of these modeling procedures in estimates, is it helps us determine what we don't need to do further.
Given all those crops and things that this material is used on, do you really need all the information, a Market Basket survey on each one of the components, and the answer is generally no.
That's one further reason why we try and see what the major contributors are. And further identifying, again, whether it's based on, quote, PDP data, field trial data, or whatever.
And -- and basically attempting to lay out -- and again, inflammatory I think is something I take a little issue with, lay out the proper caveats.
One of the things we'd like to get response of the group here is to the extent that we properly footnoted, caveated, explained, communicated, all those kinds of words, to the public when we've released these reports, that is again, I think, part of what Jay's getting in his last bullet. I mean, he didn't include us in there. But again, I think we've done an okay job at properly putting them in context, fully advising the world that these are subject to change, will be changed.
And if pressed at all, we say they are sometimes likely to change radically, I mean, to the orders of magnitude that you saw on this one particular example.
There are others, for example, that would also want us not -- you know, let the chips fall where they may is in part a very short summary. Some of the environmental -- our environmental friends may want us not to put out an assessment that shows that at -- you know, at 99.89, instead of at 99.9, this might be an acceptable risk cup.
We don't control a priority what the answers are going to be, that's a problem sometimes. No matter what -- you know, no matter what we'd like to think of it, that's part of transparency and openness is to put out those assessments.
So again, I think the underlying issue for us that we especially are wanting to hear about is did we do a good job of communicating. I think we are committed to again, as part of that transparency that we talked to with all the TRAC members in earlier sessions, we are going to put out those assessments. I think there are some valid questions about again, if we put them in proper context. I think Jay's last questions are talking about some of the -- one of the rationales to, if this is a public document because it's subject to FOIA, what would be the reason to not put them out any sort of less formally.
In other words, if you can get it by FOIA, why would we not put it out if someone just sort of asked for it or as a matter of routine basis.
Those are I think the underlying issues, Jay, that you raise. And we may want to have some discussion about that.
But again, it cuts both ways. The numbers may be large in some cases and do we properly caveat them. On the other hand, when we put -- put in all those caveats and when we do those other refinements, other people may not want us to make it public that in fact the risks are not -- either not exceeded or -- or not large.
MR. EHRMANN: Well --
MR. SMITH: Did I sort of generally response do some of the issues you raised, Bill?
MR. LOVELADY: You responded.
MS. EHRMANN: Lois, any reflection on the specific --
MR. SMITH: I'm sorry, on the particular -- yeah, what we got --
MS. ROSSI: Yeah.
MR. SMITH: -- specifically.
MS. ROSSI: We received 31 comments on azinphos. And about half addressed the chemical specifically, the other half were just general comments that were made on all the rest of the OPs that started the process at the same time. We mostly got comments from registrants and growers. We received comments from two environmental groups.
Registrants mostly focused on -- or one of the things that the registrants brought to our attention was data that was being developed or submitted data. Growers commented on the importance of the role of the chemical in agricultural.
MR. EHRMANN: Let me just add one comment too from -- that relates to the TRAC itself. I think in isolation of this kind of process, it's hard to tell what would have happened if information like that had, you know, gone out and different groups had looked at it and interpreted it without some of the context that I think has been provided by these discussions. And as Jay, I think, did a very good job going through each group and kind of commenting on what groups have done. It's interesting to note that even given those numbers as -- as he indicated, folks, you know, who sometimes have taken those kinds of reports or numbers and said certain things which would be of concern to growers, didn't happen in this case. And I think it's partly because you all talked about that explicitly in the context of giving advice to the Agency and the Department about launching the pilot process in the first place.
So, you know, as Jim said, I think it -- you've got -- it kind of goes both ways. And I appreciate Jay taking the time to -- to list out there kind of some of the ways some of the groups around this table have responded to the process.
Because it probably has not lived up or down, depending on how you look at it, to some expectations in terms of going forward.
(END OF TAPE)
MR. SMITH: From this first pilot is that what you have called your preliminary assessments, really weren't a document that was really ready for comment as a decision-making tool. I mean, it really wasn't an analysis that you were going to base a regulatory decision on.
So it sort of struck me that you could have done some of your transparency goals by simply opening up a docket, making sure the documents you had were available so people could look at them, and they could comment on them as they wanted to. And then at a later point, develop a document that was really what you wanted to use to make a decision -- a regulatory decision.
And that does not mean then you have to have multiple rounds of comment every time you have an open docket. And I think those are distinctions you should think about as you kind of refine this process.
MR. EHRMANN: That's helpful. We also -- we've also heard -- and Lois, correct me if I'm wrong about this, but the assessments that are going to be coming out now going forward, are going to probably be in a format and a structure that's more in the shape of the final assessments, except the numbers will get changed. But the way it's presented is going to be more consistent going forward, which I think will also help the -- I mean, the point you're making, Marty. Steve?
MR. BALLING: Well, actually to that specific point, I think one of the things that folks I've heard so far are hoping for, is that they also are further refined before they come out, and I think Lois and had expressed that that's one of the goals that they will shoot for.
One question, one comment. In terms of the process, this gets back to some questions I think that were asked a long time ago. What about market shares, market share changes due to your regulatory actions?
Sort of the Heisenberg Principal, that as you make changes, that what you're trying to -- to measure changes. So you're looking at -- at changing the way in which azinphos-methyl might be used. At the same time, you're doing a risk assessment on Imidan (phonetic) or on methylparathion and the -- the availability of azinphos will impact the use of those crop treated -- or percent crop treated changes constantly. Is this like an annual event that you're going to have to redo these assessments based on last year's market share?
MS. ROSSI: I hope not. Well, first of all, FIFRA does ask you to look at percent crop treated over so many years. But -- I mean, not FIFRA, FQPA.
I think the question you're asking, although I'm not familiar with the Heisen whatever principal --
MR. BALLING: Heisenberg.
MALE SPEAKER: It's part of physics.
MALE SPEAKER: Mark will know what it is.
MALE SPEAKER: It's an uncertainty principal, yes.
MALE SPEAKER: It's practical physics.
MS. ROSSI: Okay.
MALE SPEAKER: My niece has explained it to me.
MS. ROSSI: What? Okay. I think the question you're asking is, is the one about making a decision on one of them without looking at what's happening to the other ones. And that isn't -- that is a question that's I think been asked all along.
And I think in the risk management strategies as we go through these, that's going to be part of any decision that you make is what's going to happen.
As far as the market share of percent crop treated that sort of actually comes into play whether you use maximum and weighted average and what you actually use.
So I think the answer is, I don't think we can determine a final risk management strategy on any one of these without looking to see what will happen if. And that's normally part of our risk management thinking anyway. Al, did you want to --
MR. JENNINGS: Yes. I think your arguments are just those that we went through in deciding.
We probably needed to look at the crop and start working on transition strategies that dealt with a category, a class of chemicals, rather than trying to respond and react to each individual chemical as it rolled off the assembly line.
MR. BALLING: Um-hum.
MR. JENNINGS: It just makes sense for us to step back and take a bigger picture.
MR. BALLING: Good. And then just a comment. It seems like when we first started looking at risk assessment and the whole FQPA process, our analogy was the risk cup.
I thought this was a great presentation, the technical briefing. And I think it really goes along way to what we're wanting to try to accomplish. But you might want to bring the risk cup back in again, because I think it really is valuable. Even though you've been criticized I'm sure by lots of people, I think it still keeps it fairly simple. And the analogy reaches back to where and when we first began discussing it.
MR. EHRMANN: Okay. Margaret then Henry.
MS. WITTENBERG: Well, I was wondering, and I think I got this document the last -- the work group two meeting.
MS. ROSSI: Um-hum.
MS. WITTENBERG: But this choosing of percentile of acute dietary exposures, the threshold of regulatory concerns. I got it then, right? Is there an update on that at this point?
MR. JENNINGS: It's at comment --
MS. WITTENBERG: It's for comment right now?
MR. JENNINGS: Yeah.
MS. WITTENBERG: Okay.
MR. JENNINGS: But that's why the paper's mentioned in the list. I believe it's -- April 7th it was issued for public comment. Due to be revised towards -- and I think it says the end of the year, September or -- let's see -- anyway. yeah, it's --
MS. WITTENBERG: It's on that list?
MR. JENNINGS: Right.
MS. WITTENBERG: Well, anyway, it's a terrific document. I think one thing that I really got a lot out of it because we've been in this process for so long. And I think you can get so into details you forget the whole big perspective. And I think this document gets back to what we're really here for. As well as all what EPA and USDA has done to really work towards this process, making it dynamic and also exploring all the different areas that they have decided really makes sense to make this a scientific process. It was sound science.
So I don't know how many people have not seen this, if they were not at the work group two meeting. But if they haven't, I'd encourage you to send this out to --
MR. JENNINGS: It's out. It's on the internet.
MS. WITTENBERG: It is on the internet? Okay. It's really well done. And the other thing is -- also tells about perspective.
I think there's a lot of successes that we've had with the process. I think all those have not been looked at. First of all, some real -- very real questions have been asked here. If we didn't have the FQPA, if we didn't have the TRAC, we may not have asked all these questions about how we can look at pesticides, what -- should we be changing how we're applying some, should we be doing some mitigation schedules or procedures.
I think all of that is something that we've really accomplished here, it just -- even starting to ask the real questions.
Challenges are being made. And I know some of the companies are starting to look at that, even in the mitigation process itself, and I think that's a real success. Gerber gave their presentation at the work group two meeting. So I think there are some successes. Obviously we want to keep this moving along. And the consumers do want to see where there is some progress made where they're feeling more comfortable if pesticides are going to be used, that it is going to be more comfortable in their application. But again, I think we sometimes forget about the real successes that we have had done here also.
MR. EHRMANN: All right. Henry?
MR. ANDERSON: Yeah. I just wanted to say -- you know, add my two cents to saying I think the process has worked quite well. I think it has been slow. And hopefully as we move forward now that you kind of have the format together here, that will be very helpful. It's been very descriptive. What is sort of missing is -- is reading between the lines as well, how important is this to the Agency or not, or where the decision process is going to go next. So I think the following steps are important.
And I would just add as -- because there are some of these variables that some of us aren't as familiar with and that do seem to have a significant impact.
Just looking at that table 33 where you see based on apparently just changing the percent of crop treated, the infants -- you reduce that by a factor of three.
And I think the critical factor to have in the discussion here is how are you going to actually stabilize that particular figure so that it doesn't reflect a single point in time, when it can be quite different.
While we have Monte Carlo to simulate diet versus, you know, concentrations in the various products, I think we need to think about how are we going to use a similar stabilization for some of these others. Because as was just pointed out, it does vary over time.
You have a dry season or a wet season, Michigan's cherry crop fails and Wisconsin does real well and vice versa, that can have a major change if you're doing a point in time survey and basing a regulatory decision. Especially if some of these are very close.
I guess what we really need to know is -- you know, the next step is where it's going to happen and what's going to trigger some kind of action.
I think I'd also caution when you went through the chronic and basically saying we're not concerned about the chronic. To then perhaps turn around and say when you deal with cumulative risk, oh, yes, but it would maybe be important there. I think you need to clearly up front say that we're setting cumulative risk aside, these are issues that may be addressed at that point in time. But it's somewhat misleading to say, you know, we're not concerned about that, when basically a third of the chronic risk is taken up by a single agent. And in fact, that may be revised down if you spend more effort on the assessment.
So I think that would be just one thing I would try to anticipate, what's coming down the line. And lay that out up front, so that people are not then -- say, oh, don't need to worry about chronic.
And then low and behold it comes back in a next revision, and we're all back into generating new data and concerns.
MR. EHRMANN: Thanks. Nancy?
MS. RACHMAN: Steve's question about changes in percent crop treated, and also some of Henry's remarks takes me back to the PDP data.
I mean, we have there an outstanding tool that integrates, if you will, all the sources of variability in the production of crops and the use of pesticides over time. Because of the way that study is designed, it takes all of this into account.
And it occurs to me that maybe going forward, we might want to think about expanding PDP, making it more comprehensive and using it as the sort of ongoing way to have confidence that the EPA's risk assessment is still a valid representation of risk.
I mean, that's the tool. That is a premiere tool. The more I learn about it, the more impressed I continue to be with it.
So maybe we could just put that on the table for future TRAC recommendations or discussions or whatever. But that's definitely the answer to the year-to-year changes.
MR. EHRMANN: Keith, do you want to comment?
MR. PITTS: Why don't I just -- I want to acknowledge it's something that we have in discussion that -- you know, one thing that we -- has come up time and time again in our -- and actually with EPA. But also with what we're hearing from some of you out there is can we not turn the -- I'm scared of these things.
MR. EHRMANN: Yeah, really. There's no water in there. It's not going to squirt at you or anything.
MR. PITTS: When we start looking at just long-term monitoring efforts. As well as when we get into transition, how can we confirm we're meeting targets? What is an appropriate method to use there?
And I think we are looking at PDP and perhaps filling that gap. And also looking at a way to better integrate NAS and PDP, so we can have a more complete picture there as well.
So those are some things that we want to keep on the table and develop further. Obviously it's going to come with some budget requirements.
So PDP's already an expensive program and we'd have to be able to justify whatever track we took on that. It's something we do want to consider.
MR. EHRMANN: Okay. Jim, you want to make some comments this time and talk to some of the --
MR. AIDALA: Well, just -- just on some of the other feedback from the work group for the full TRAC members, not everybody was there.
Obviously there were -- there's a bit of a longer discussion in some ways. But also just to make some of the observations and conversations we've had with some of our environmental and consumer group friends.
Again, that's certainly representing them per se. But just to report back out, the transparency issue is one where, of course, that was applauded. That in fact it is useful and a significant change, a milestone, compared to some of the earlier practices of the Agency real or imagined.
Again, I'll try not editorialize too much. But basically that in fact the general transparency ethic is one that, you know, is -- is A, a good thing, and B, just have more of it.
At the same time in terms of some of the sort of formalized process, the phase one through X kind of -- the process that we've laid out, obviously there's some concern for an opportunity for delay in general.
Just again from a point of view of at what point does the Agency have enough information to act, inseparable from an argument about when do you have a duty to act.
Obviously there's always a concern for -- additional data will always improve things, I think we can all say that. And again, that was stated even in that setting.
But the sort of dribbling in of data leads to delay, and at some point can become there's a concern for a never-ending process, a never-ending mystery of -- of an additional dual loop to going on and on and on, always getting more data.
And again, bottom line being at some point, you know, when does the Agency have enough information to make an informed decision.
And again, have enough information to make a decision, then also has a duty under various interpretations of the Act that they have to make a decision.
That's a very gross summary of again, some other points of view. I don't -- again, not trying to characterize it myself per se. Anything else?
MALE SPEAKER: No, that's good.
MR. EHRMANN: Any other -- any other comments on the pilot process, advice. Again, this is an open opportunity to -- to provide some feedback.
I think the -- the Agency and the Department are in the process of trying to, you know, determine what the next steps are going to be here. So any other thoughts you have as we go through this agenda today or tomorrow would be very helpful.
And as Jay indicated, you know, if you want to make written comments after you've talked to other folks and from your interest group perspective or constituency, that's always helpful as well. So I'm sure that would be welcome.
And if there are any specific time lines around when decisions are going to be made, we'll share those so that you know what time frame you've got to work within for that particular feedback on this part of the process.
Let's go ahead and take our afternoon 15-minute break. And we'll come back and pick up on the worker issues and starting with Elin's question.
(BRIEF RECESS)
MR. EHRMANN: For the remaining agenda this afternoon, first we're going to have a presentation on worker risk assessment process kind of generically, not associated directly with any one chemical.
But the --we have not previously had a walk-through on kind of how the worker assessment part of the process functions. And as you could see from the presentation we had on azinphos, there are going to be a number of issues associated with this. So we thought it would be useful to have an overall discussion on the worker issues, so that will be first.
And then we will have an opportunity for public comment at the end of the day. And again, I'd ask members of the public who want to make a comment to please sign up outside to do that.
We have a couple of folks signed up. If there are others, please do that in the next few minutes so we can calibrate our time accordingly.
And that's the plan for this afternoon. We will start tomorrow morning at 9:00, as the agenda indicates, with the update on the science policies and then Mark Whalon's presentations.
Let me first turn to Bill Spencer, who wanted to make a quick comment following up on our earlier discussion before the break, and then we'll go to the worker discussion. Bill?
MR. SPENCER: Thanks. I just wanted to make a comment and reply to --I guess it was just a word that -- that Jim used in talking about where we are and where we're going in this process. And I think he used the word delay, but he used it in a positive term.
And at the last working group two meeting, and unfortunately Shelley's not here with us today, but -- but Shelley made a point several times during the work group meeting to grab the mike and very slowly tell us sooner better than later, sooner better than later, sooner better than later.
The president of the organization that I represent, almost 5,000,000 members strong, is in St. Louis. Same day -- I suspect the same two days that this TRAC is meeting, meeting in a farm economic summit in -- in St. Louis.
And over that two days, what they're going to try and address -- describe and address and maybe try and figure out some solutions to the severe economic crisis in agriculture in America today.
We've got farmers hanging on by their fingernails trying to survive. And always coming to one of these meetings, I have the opportunity to talk to a lot of people who represent a lot of farmers across this country from New York to California, from Oregon to Florida, down to Texas and up to Wisconsin.
And I can tell you that agriculture in America today is definitely suffering. They are probably in some of the worst shape that we've been in since the great depression.
And so in reference to the word delay, I -- I think what I just wanted to add my two cents worth as far as the process is concerned, is that we need to be deliberative. We need to be very, very deliberative. And because we have agriculture, again, I think you've heard me say this, as we know it today, you know, sort of standing out there waiting to see what kind of decisions, you know, we're going to make as a -- as TRAC.
And in our working group meeting that we held last July, we had a number of farmers stand up, again, representing farmers from all over the United States, and they said a lot of the things that I've heard some of us farmers say.
And not only that, but I've heard some people, who again, you know, didn't choose to show up today, and that is as a farmer, I don't want to use anything on my crops that's going to harm any consumer, whether that consumer is a baby or just another person.
And as far as the people that work for me, I've got people that work for me -- I'm going to be 51 years old the end of this week, and they worked for my family for at least that long. And in some cases, they worked for them longer. And the last thing I want to do is use anything that's going to harm those workers that I consider part of -- part of my family. But at the same time, you know, we're sitting here talking about the crop protectant tools that we use as farmers. And the loss of some of those tools, or the potential loss of some of those tools because we don't do this process very deliberately -- very deliberately and very carefully, could put a whole lot of farmers out of business.
And there aren't many of us left out there that are producing the safe, affordable and abundant food supply that we enjoy and that, you know, we provide to the rest of the world.
So I just wanted to make that little comment in reference to Jim's remark. And again, his positive remark as it related to delay. Thanks.
MR. EHRMANN: Thanks, Bill. Any other comments before we move to the worker discussion? Okay. Who's leading this one off? Jack? Lois?
MR. ARTHUR: Yeah, I am.
MR. EHRMANN: Jack?
MR. ARTHUR: Just put the next -- earlier today we described the various components that went into the occupational or worker risk assessment for azinphos-methyl.
This presentation will provide a general overview of how the Agency conducts a worker risk assessment, including the basic methodologies we use, discussion of the issues we are seeing from the OP assessments conducted so far, and ideas on how to address them.
We evaluate worker risk for all registration and reregistration decisions we make. The assessments conducted for the OPs are done in the same way we conduct worker risk assessments for any other pesticides. We haven't done anything different, because the pesticide happens to be an organophosphate.
Unlike dietary risk assessments, which are governed by FQPA, which is a health-based standard, worker risk, like ecological risks, are governed by FIFRA, which requires that we consider the benefits of the use of a pesticide when taking regulatory action.
In the past we have taken action to address high rates of incidents observed in workers exposed to pesticides.
Specifically in 1991 we negotiated for the cancellation of most uses, that is the uses which pose the greatest potential for risk, of ethylparathion. Additionally for the nine uses that were allowed to remain, stringent restrictions were put in place.
Also in 1991, we began a project called the acute worker risk strategy, which looked at incidents across all pesticides to determine which pesticides posed the greatest risk to agricultural workers.
As a direct result of that project, all uses of mevinphos were voluntarily canceled after negotiations with the registrant.
For virtually every registration decision we have made to date, some worker mitigation measures have been included to reduce exposures.
Ed Zager, who's the associate director of the Health Effects Division, will now explain how worker risk assessment is conducted.
MR. ZAGER: I'm going to describe to you today how the Agency estimates the risk from the occupational use of pesticides. Some of which you will hear, you already heard this morning in connection with AZM.
My presentation is rather basic. And I have with me, Jack Arthur and Jeff Dawson, who spent a lot of time preparing for this meeting. And I just want to thank them. They will be here to help in answering questions.
Next slide? I will describe under what circumstances farm workers, applicators can be exposed. I will discuss the factors that need to be considered to estimate magnitude of exposure from the activities connected with the application of pesticides. Mixing and loading pesticides, applying pesticides and working in a treated area, field or orchard or greenhouse, following the application of pesticides. I will then describe risk assessment approaches and present some examples of calculations used to estimate the exposure.
Pesticides can be used in a variety of settings. One billion pounds of pesticides was applied in 1995, of which 80 percent was used in agriculture.
Pesticides can also be used in industrial and commercial settings. For example, fly control and food handling establishments. As well as in public places, for example, turf management, all pest control operators applying termiticides. Pesticides can be used for public health purposes, such as mosquito control.
In order to be able to estimate exposure from the use of pesticides, we must examine a number of factors connected with each use.
Each of these factors can significantly impact the exposure and the associated risk. Exposure is dependent on use pattern, that is application rates, and intervals between applications, types of exposures, that is short or long term, hazard aspects, toxicity of a chemical and possible exposure route, chemical properties, for example, persistence of a chemical, and job function. Is someone a harvester or a handler, that is someone who makes this and loads the pesticide, and the equipment and formulation used.
Now I'm going to discuss these individually. Go back. Okay. In examining the use patterns, we look at the label, we determine how much is applied, how often, what equipment is used. We also consider what crop is being treated. The potential for exposure is different when applying to a tree crop than to a field of lettuce. The frequency of application of course is also going to affect the exposure.
The label may contain certain restrictions, for example, only spot treatments are allowed. This, in effect, will reduce the acreage treated.
The actual use and usage data are obtained from a variety of sources. We obtain much of our information concerning ag uses of pesticides directly from USDA.
We also get information from such groups as American Mosquito Control Association, National Pest Control Association, Agricultural Reentry Task Force and the Chemical Specialty Manufacturer's Association.
The use information allows the Agency to determine the frequency and typical rates of application. The frequency of application information helps us to determine whether the exposure will be short or long term in duration, and determines the type of risk assessment needed.
For example, if a grower used a chemical at planting only, we would calculate short term exposure and the associated risk, but not long term exposure.
Okay. Types of exposure. For the purposes of our risk assessments, we grouped the kinds of exposures that occur into these three categories: short term, that is one to seven days, for example single early season application of a herbicide, one week, two months; intermediate exposure, for example, application of a fungicide to growing vegetables; and long term exposure, and an example would be fungicide used in flora culture.
Next slide? This is the hazard toxicity aspects that we considered in estimating the exposure and the consequent risk.
In order to select a toxicity endpoint for risk assessment, we must consider how the worker's actually exposed and the duration of exposure. We matched the duration of a toxicity study to the length of time a worker is likely to be exposed.
The biggest concern is dermal exposure. We know that in a vast majority of cases, that's how the predominant exposure occurs, absorption of a chemical through he skin. For handlers or applicators, another significant exposure route may be inhalation. The Agency relies on animal toxicity studies, these are usually oral, and require consequently route-to-route extrapolation.
Of course the Agency prefers route-specific studies. For example a dermal administration toxicity study would be preferable to assess the risks for dermal exposures.
We examine chemical properties of the chemical. Volatility, water solubility, sensitivity to light and persistence determine how quickly a chemical dissipates, and are considered in evaluating the potential exposure.
If a chemical is volatile, this would lead to quicker dissipation of a chemical. But on the other hand, in greenhouses could lead to inhalation concerns.
We examine the metabolism of the pesticide, look at the metabolites, look whether it's photo sensitive, does it break down in water, does it break down because of microbial activity.
For occupation risk assessment, we also collect a series of data called dislodgeable foliar residues. The definition of it, you heard it I think already twice this morning, is simply the amount of a chemical on leaf surface that could rub off on the skin when the person comes in contact with a treated plant.
This is the amount that could rub off, not necessarily is going to rub off. We also need information on the transfer coefficients, and I will discuss those further.
In addition to the nature of a chemical of a factor such as growing and climatic conditions could effect the amount of pesticide remaining on these surfaces.
For example, growing citrus in Florida, California, residues may be on the surface and may be quite different. All applications of the pesticides may be different.
Next one? People's exposures depend on the kind of work they are doing. The main issue we consider is whether or not they are involved in the application, or they get exposed because they have to work in an area that has been previously treated.
Handlers are the people involved in the application, these include mixers, loaders and applicators.
Mixers are those individuals who prepare the spray solutions for applications. They might mix a whole truckload of a herbicide and carry it to a sprayer out in the field.
Loaders are those people who fill up planters or other devises with solid products, such as granules. They also might transfer large volumes of spray solution to a sprayer in the field.
Applicators are those people that drive a sprayer during an application. And flaggers are those people that help direct aerial applications from the ground.
Other people that can be exposed to pesticides may be exposed because they work in the areas that -- areas that have been previously treated.
We refer to them as post-application workers. These people are engaged in many types of activities through which they can be exposed.
Harvesters get exposed because they are having a lot of contact with the treated foliage as they remove the fruit or vegetable from the field.
People's exposures of course differ depending on the type of a crop they are harvesting. For example, someone picking beans is not likely to come in contact with as much treated foliage as someone picking fruits from a tree.
Other post-application workers include maintenance workers. For example, workers who tend to a growing crop, such as tying tomatoes or trellising grapes. And again, exposures may greatly vary for these groups.
Next? Formulations and application methods. The level of exposure will be different for different formulation types. Formulations can be liquids or solids.
The most common liquid is emulsifiable concentrate. Solids can be a variety of types, including wetable powders, a talc-like material, granulars or dusts.
Exposure levels can be directly related to the type of product or formulation used. For example, dermal exposures for liquids and granulars are very different. Likewise, inhalation exposures for handlers from granulars and wetable powders are very different.
Because of a talc-like nature of the wetable powder, it would be expected to result in a higher inhalation exposure. The exposure of the applicator will be different, depending on the application equipment used. For example, groundboom application, groundboom is usually pulled behind a tractor, results in lower exposure than applications from airblast equipment, which is in closer proximity to the applicator.
Exposure also increases with the duration of the activity, acres treated, and the amount of pesticide applied.
Label may include protective measures. And the use of protective measures to reduce exposures is a common approach in occupational risk management. The protective measures that are usually included on the label include clothing, chemical-resistant gloves, respirators. Other measures include engineering controls, such as water-soluble packets, closed loading systems and closed cabs. All these reduce exposure and are considered in estimating risk.
Next? I just described a number of factors that can affect exposure. I will talk a little about the sources of variables that are used in the exposure calculations.
For handlers, that is mixer, loaders and applicators exposure calculation, we use chemical-specific exposure data to estimate the unit exposures. When these are lacking, we use Pesticide Handler's Exposures Database.
For post-application exposure, we use chemical-specific exposure data, such as dislodgeable residues, combined with transfer coefficients to estimate exposure. In the absence of chemical-specific data, we use standard factors derived from public and industry sources.
Next, please? For the chemical-specific data, always preferred, but these are often limited. And the data that we are receiving through various data call-ins from some specific manufacturers, generally support values in our PHED database.
Next slide, please? Pesticide Handler's Exposure Database. And most of you have heard about it, it's a tool for calculating exposures to those involved in pesticide application. It's a product of a task force formed of the U.S. EPA, Health Canada, California Department of Pesticide Regulations and by industry. Some European countries have also provided input. The approach has been extensively peer reviewed, including science advisory panels on numerous occasions.
The premise of a database is that it's an active ingredient -- that the exposure's active ingredient independent, but it depends on how and how much of a chemical is applied. Basically what it is, it's a library of actual exposure monitoring data.
Next slide, please? PHED allows the Agency and the regulated industry to sort the data by formulation type, by application method. The database also includes protective clothing information.
PHED allows us to calculate the exposure by finding the best match of an application in question to the existing database.
In this particular case, we are using PHED to determine the unit exposure volume from application of a liquid via groundboom, and we're estimating unit exposure for an applicator who's wearing shirt and pants. That volume then is used in our exposure calculations.
Next slide? In addition to the unit exposure that I just described, other factors used in exposure calculations include number of acres treated, body weight, which is 70 kilograms for an average worker, duration of work, typically an eight-hour day.
The standard reference and data sources that we use is the Exposure Factors' Handbook, an EPA publication, survey data and equipment manuals.
Next slide? This is an example of exposure calculation. This is an equation estimating exposure for someone applying a pesticide.
You can see the daily exposure depends on the unit exposure, increases with the acres treated per day. The question was asked early in the day. It depends on the rate of -- application rate of a chemical, and it's expressed per kilogram of a person handling the chemical. This may be applicator, mixer, loader and so on.
Now, another definition. The margin of exposure is simply the ratio of a no-observable adverse effect level from a toxicity study, to the exposure calculated above.
We generally consider an MOE of 100 to be adequate. The 100 is derived from an inter and intraspecies extrapolation, same as in dietary, 10X and 10X.
If it is determined that the margin of exposure needs to be increased, certain steps can be taken, which include imposition of protective measures, such as requiring gloves, protective clothing, changes in application equipment, rates possibly, or changes in formulation. For example, requiring water soluble packaging.
Next, please? Thank you. I just discussed the exposure calculation for handlers, mixers, loaders and applicators exposed during the application of a pesticide.
Now I'm going to talk a little about post-application -- exposure from post-application activities. Some more definitions. Transfer coefficient represents the level of contact with treated foliage while performing an activity.
Again, we prefer chemical-specific and scenario-specific data. In the absence of such data, we estimate exposures based on standard factors.
In 1995, Jack already talked about it, an extensive data call-in was issued. An industry task force is working closely with Canada, California DPR and the U.S. EPA.
One of the results of this data call-in will be an extensive transfer coefficient library. And the data call-in will also provide product-specific data on dislodgeable residues.
Okay. Some more equations. This is exposure calculations for a post-application worker. The first equation is used to calculate how much exposure a person present in a treated field can receive per day.
Okay. And again, this -- this is dependent on dislodgeable foliar residues, that is the amount present on the leaves.
The transfer coefficient, or what is the amount of contact of a person performing certain activity with a treated plant. Again, eight-hour working day, and this is expressed in per kilogram of body weight.
In a second equation, we compare the dose calculated, the exposure, to the no-observable adverse effect level.
And if the margin of exposure, again, is judged to be unacceptable, certain steps can be taken to reduce it.
For example, in this particular case, what we would do is we would require a longer reentry interval before a worker can enter a treated field.
Okay. Now, I described to you our approaches to estimating exposure to pesticides in occupation settings. I described how we estimate and evaluate exposure to people connected with pesticide applications, and to the workers involved in maintaining and harvesting treated crops.
I also discussed some measures that can be taken to reduce the exposure. Now I will turn it back to Jack, who will discuss it further.
MR. ARTHUR: They put us on at the end of the day, because they knew the energy level would be high in the room, so just bear with me.
(END OF TAPE)
I'd like to talk a little bit about the issues that we've seen to date. Only six of those included an assessment of the worker risk. One was for cadusaphos (phonetic,) which was an import tolerance for bananas only, so we didn't conduct a worker assessment.
Virtually all of the assessments have indicated concerns for workers, either mixers, loaders, applicators, or persons entering a treated field, or both.
For handlers, concerns are solved easily. For some, by requiring that an additional layer of clothing or chemical-resistant gloves be worn. Others require the use of engineering controls, such as closed mixing/loading systems or the use of enclosed cabs. While others still have inadequate MOEs, regardless of the most stringent measures.
For post-application risk, a slight increase in the reentry interval may solve risk concerns for some. While others would require such a lengthy interval, that it would be tantamount to cancellation.
Next slide? As you can tell from this morning's presentation on azinphos-methyl and Ed's presentation on how we conduct worker risk assessments in general, these assessments are complex and not easily understood. USDA has raised concerns about the difficulty in interpreting our assessments, as have some of the people who have commented on the preliminary OP assessments released so far for public comment.
We have taken great lengths to make the dietary assessments transparent, and now must find ways to have worker assessments more understandable.
As discussed earlier, a large data call-in was issued in 1995, which required registrants to develop data on exposures to individuals entering treated fields to perform such tasks as harvesting and hoeing.
Some of these data have already been submitted to the Agency and have been used to evaluate worker exposures, such as in the case of azinphos-methyl.
Other data will be submitted shortly and will be incorporated into the assessments when received. However, it will not be until 2001 until all of these data required in the call-in are actually received.
The most refined worker risk assessments will not be able to be performed for some of OP uses until that time.
Finally, since worker risks are regulated under FIFRA, which requires a risk benefit balancing, a benefits assessment may be necessary when risk concerns would indicate the need for regulatory action.
Given the number of OPs and the number of uses of each, the amount of time and resources involved with such an effort would be substantial. It is important that we explore alternative ways to accomplish this goal, such as addressing up front the question of what level of benefits offsets a low margin of exposure and by more actively involving USDA in conducting the benefits assessment.
Next slide? I'd like to talk a little bit about incident data and how it plays a role. When we evaluate worker risk, it is useful to consider incident data that are available to look at any effects from the exposure of pesticides in the field.
I spoke earlier about previous actions which have been taken against ethylparathion and mevinphos based on high incidents. It is important when evaluating incidents, to take into account the amount of the pesticide used. For example, for equally toxic pesticides it would be reasonable to assume that you would see double the number of incidents for one if twice as much of it were used as the other, all other things being equal. However, they both pose the same potential risk of causing an incident. It is therefore important to normalize the incident data so it can be compared across pesticides. It is also important to evaluate the severity of the incident. Greater concern is given to a pesticide if the majority of its incidents results in hospitalization, rather than merely producing clinical effects.
It is important to keep in mind that regardless of the database, it can be expected that incidents are under-reported, with only the worst events being the ones that are captured.
Next slide? There are a number of sources available with varying levels of information upon which to draw conclusions about whether the incident actually occurred from the pesticide in question, how the pesticide exposure occurred, if use was made in accordance with the label, or if it was a misuse, et cetera.
The best source of information available is from California Department of Pesticide Regulation. California has a mandatory reporting system by physicians of all illnesses suspected of being related to exposure to a pesticide. Data have been collected by California since 1992, and incidents are classified as definite, probable or possible. As you can see, there are a number of sources -- other sources which are available with little -- either little information, to little to draw conclusions on how or why an incident occurred, or have just recently been initiated.
The next slide presents some of the results in two of the sources of incidents that we have available to us. The first one, the Poison Control Center for the years 1993 through 1996. And the second one, the California Department of Pesticide Regulation for the years 1991 and 1995.
As you can see, the Poison Control Center data indicates that OPs represented not only the greatest percentage of illnesses, but also the most severe. California data show a large number of illnesses. The majority of which were systemic, resulting from exposure to OPs.
Next slide? When we conducted the acute worker risk strategy, it was evident from the incident data alone that for the more toxic pesticides such as the organophosphates and the carbamates, that the production provided for on the current labels was not providing enough.
As we conduct worker risk assessments for the OPs today, that conclusion is confirmed from the low margins of exposure that are calculated.
While we have routinely encountered risk concerns for pesticides going through reregistration, the measures required to fix these concerns have generally been easy to deal with, requiring only additional protective clothing or some times closed systems.
However, the OPs pose a more challenging fix. Whereas risk concerns from other pesticides can be corrected by further reducing exposure, the risk from the OPs tend to be endpoint driven. That is the toxicity endpoint or the no-observed adverse effect level is so small, even minuscule exposures result in inadequate margins of exposure.
In order to address risk to workers immediately and across the board, it may be useful to increase the baseline protection for all OPs, and possibly the carbamates as well.
For instance, an additional layer of clothing or the use of chemical resistant gloves could be required. Or for the most toxic OPs, engineering controls such as closed mixing/loading systems or enclosed cabs for applicators. To address risks to persons entering treated fields, reentry intervals could be increased until data from the ag reentry task force are submitted, evaluated, and a more refined assessment occurs. Other baseline protection that could be considered includes an outreach or general education program aimed at better informing individuals of the risks associated with exposure to the OPs.
Finally, we have been discussing with USDA the possibility of a worker workshop to help people better understand how worker risk assessments are conducted. This will allow individuals to make more informed comments on our worker risk assessments.
And the last secret slide, which you don't have a copy of in your packet, this slide shows some of the ways to accomplish some of the baseline generic measures for the OPs and/or the carbamates. Basically, there's two ways to do it. One way, which is the easiest, the quickest, the way that I love, is to have registrants voluntarily agree to amend their labels. Once a set of measures are agreed to, registrants would send in label amendments, which the Agency would approve.
Voluntary risk mitigation has been relied on increasingly more and more by the Agency in order to achieve the quickest mitigation using the least amount of resources.
The alternative means is thorough regulatory action. This would require the Agency to develop a notice of intent to cancel, which would go into effect. That is the registration would be canceled, unless the registrant made the changes sought through the notice.
There are various time frames and options associated with implementing baseline exposure mitigation measures.
Obviously, measures obtained voluntarily are quicker to implement than those requiring regulatory action. Consequently, these measures could be in place as early as next growing season. There could also be a phased approach, depending on how easily the measure is implemented. For instance, if it required that closed mixing/loading systems are -- are required and the product is a wetable powder, it could take some time to develop the packing, such as a water soluble packet in order to accomplish this.
We look forward to any suggestions or advice the TRAC may have in how to approach the issue surrounding worker risk for the OPs. And that concludes my presentation. I'm sure that Ed will be happy to answer any of your questions.
MR. EHRMANN: Thank you guys very much. Brad, question, comment?
MR. LUCKEY: I think this is going to go back to my comments earlier. Looking on your chart on page 17/18 at the bottom -- or maybe let me preface this a little bit. If you look at the -- on 17/18, the top one, it says, "Other factors, standard values used for some exposure factors," "Acres a day," which we discussed earlier, "Body weight, duration and skin surface areas."
And yet when you go down and you look at your equation for daily exposure, which is expressed in milligrams of active ingredient per kilogram of body weight per day, I'm assuming what that -- that duration means, or that -- that -- that formula is for daily exposure, is that correct?
MR. ZAGER: Um-hum. Yes, um-hum.
MR. LUCKEY: Is milligrams of active ingredient per kilogram of body weight per day?
MR. ZAGER: Correct.
MR. LUCKEY: Okay. And you look at the steps that it takes to make that equation work. One is unit exposure, which is milligrams per pound of active ingredient, is that correct? Times the acres per day, times the rate, which is expressed in pounds of active ingredient per acre over the body weight, is that correct? When you're talking about risk mitigation involving increasing the use of personal protective equipment, where would that reduction in exposure be applicable to this equation?
MR. ZAGER: In -- that would occur in the unit exposure part. That would be reflective in the PHED database. You would -- you would simply match all this protective -- whatever protective equipment to monitoring value in a PHED. And that would drop if you added additional protective equipment.
MR. LUCKEY: Well, Ed, where is that in this equation? I don't see that.
MS. ROSSI: It -- it would be factored into the unit exposure.
MR. ZAGER: It's in the unit --
MS. ROSSI: -- that you would get --
MR. ZAGER: -- exposure.
MS. ROSSI: -- from PHED.
MR. LUCKEY: Well, unit exposure here is defined as milligrams per pound --
MR. ZAGER: No, that's the --
MR. LUCKEY: -- of active ingredient.
MR. ZAGER: -- units of the unit exposure. Unit exposure's actual number.
MR. ARTHUR: It varies.
MR. ZAGER: It varies --
MR. ARTHUR: For example --
MR. ZAGER: -- and it's -- it varies and you get that number from the PHED. Look on --
MR. ARTHUR: There would be one value if you did not have gloves on. If it was material where up to now you don't have any gloves being used. And then if you have protective gloves, that value will change.
MR. LUCKEY: Okay. So I can be assured that as risk mitigation comes into this, because worker exposure scares me to death as a way to eliminate the usage of some of these pesticides, that if we start mandatory requirements of respirators, face shields, splash-proof aprons, rubber gloves and boots to eliminate the exposure, that we're not -- we're not going to see these numbers -- I mean, we are going to see these numbers decrease, right --
MR. ARTHUR: The numbers will change --
MR. LUCKEY: -- as we increase --
MR. ARTHUR: -- as a result of it, right. I mean, again, staff can talk about what's -- I think this morning they're saying there's not a number that's modeled for your face shield --
MR. LUCKEY: Good.
MR. ARTHUR: -- or something.
MR. LUCKEY: The reason I say that --
MR. ARTHUR: The numbers will go down.
MR. LUCKEY: All right. The reason I say that is in California, we have very stringent regulations as far as -- as training our applicators of pesticides, and Tobi can attest to this.
And that's the one thing when I train my employees, and I am on them every single time that they use these chemicals, is they better have their gloves, they better have their goggles, they better have their coveralls and their rubber boots. Because I've been touting that it reduces their exposure.
MR. ARTHUR: Right.
MR. LUCKEY: And I want to make sure that we do see that reduction in the level of exposure through the use of these PPEs. I just didn't --
MR. ZAGER: You know --
MR. LUCKEY: Ed, I didn't see that in this equation.
MR. ZAGER: -- I think what -- what we need to do here is we dissected the dietary exposure. I think we all need to look at the individual calculations for a specific scenario, and look at the actual numbers to see what adding additional protective measures would give you, how much the unit exposure would drop, and whether it would increase the margin of exposure.
MR. LUCKEY: Right. That also goes back to an aerial versus a ground application.
MR. JOHNSON: Brad, it may be helpful if you turned to page -- or everyone turned to page 15/16, the previous page, and the lower chart that tries to describe -- this is a very small snapshot of the Pesticide Handler Exposure Database. Those nine cells that you see there?
MR. LUCKEY: Right.
MR. JOHNSON: There's actually -- Jeff, how many cells are there in the Desticide Handler Exposure Database?
MR. DAWSON: We could really make 160 cells --
MR. JOHNSON: So --
MR. DAWSON: -- if we wanted to.
MR. JOHNSON: So what there is, really is about 160 cells, which represent the method of application and the personal protective equipment that may be applied or may be used with that, and so a variety of variations of that theme. For example, airblast, shirts, pants; airblast, coveralls and gloves; airblast, closed cab.
And so when -- when we get a label that says it's going to be an application via groundboom and they specific some personal protective equipment on that, then that links to one of those 100-plus cells.
Which then the data are there that then spits out what the unit exposure is, that's then used in this calculation.
MS. MULKEY: Let me see if I can help Ed. One very simplifying fact that maybe not everybody got. These data are measured data with these various application approaches and equipment on. So what you're doing is going into the data set to find the actual data with that scenario --
MS. MULKEY: -- that use pattern. And that's why you don't see a multiplier to show the impact of the protective equipment. Because what you do is, is go into the database and pull out the data that measured exposure given that kind of application and protective equipment.
So that's why you don't see a multiplier to move from one to the other. You go in and get a different set of the data, the ones that measured the other scenario. Maybe that helps to --
MR. ZAGER: Yeah. That's correct, Marcia. If
-- if you looked at those -- see what the arrow points to, groundboom, shirt, pants? If you go down this column, the unit exposure would drop by a -- by a certain factor.
I don't know exactly what factor, but probably something on the order of 50 percent when you go to coveralls and for everyone when you go further down the column. So the unit exposure would get smaller and smaller.
MR. LUCKEY: Maybe that should be part of the chart.
MS. ROSSI: Yeah.
MR. EHRMANN: Yeah. I think --
MR. LUCKEY: To show me if -- if you show me that first, then I maybe wouldn't have had my concerns.
MR. EHRMANN: Yeah. I think it could be demonstrated more clearly in terms of how that's presented. But that's the relationship between those two pieces.
MR. LUCKEY: Thank you for the explanation.
MR. JOHNSON: Well, actually if you go -- if you go to any of the risk assessments -- the preliminary risk assessments, we usually run it baseline, which is long sleeved shirt, long pants, and then add an extra layer of clothing, and then go to engineering control.
So you can see the differences in the exposures in -- in a particular assessment of -- of an individual OP.
MR. LUCKEY: Do you do those exposures with less than label requirements on PPEs?
MR. JOHNSON: We evaluate them on the basis of PHED, and then match that to a label. So a lot of times -- in other words, if -- I think it was for bensulide, in fact, the label said long -- long sleeved shirt, long pants and gloves, and -- and like --
MR. LUCKEY: So that's your minimum --
MR. JOHNSON: So --
MR. LUCKEY: -- starting point?
MR. JOHNSON: So -- well, but -- but PHED would look at long sleeve pants,
long shirt. And then the next one up would have coveralls on and -- and gloves
on it.
So you'd have to add some protection factor to account for the gloves. It's not always a perfect match, it's using the data that are available.
MR. EHRMANN: Okay. Elin, let's go to you since you were kind enough to defer earlier. Go ahead and ask your question again.
MS. MILLER: And going through the presentation, I think a statement was made -- and I've got one on the exposure side, as well as one on the hazard side I'll get to in a second.
But on the exposure side, getting back to PHED
-- and I do think delving in a little bit more into PHED might be helpful for everybody to understand. But the statement was made that basically the data generally supports values from PHED when compared to data that's being submitted, and I didn't know that was necessarily the case.
And I don't know, we'd had one example this morning with -- a compound into that compare, or were there some deltas? And what I was worried about, is there a need for better generations of studies?
We're looking at ag reentry certainly. But if you've got still some either old stuff or default stuff in PHED and that is a key driver for these decisions when you say most of the OPs are for handlers or, you know, in trouble, you know, how comfortable do we really feel with that PHED database?
I know where we were a little while ago, and that wasn't very comfortable. So that's the first question.
MR. EHRMANN: Okay.
MS. MILLER: Maybe particularly for azinphos or -- or whatever we've just talked about.
MR. EHRMANN: Comments? Jeff, go ahead.
MR. DAWSON: I think I can respond to that. We would always prefer that we have scenario and chemical-specific data to work with.
And then basically if the scenarios are the same, if we have a set of data from a study that's exactly the same, given the same formulation, the same equipment types, those kind of things, the exposures would be comparable.
Keeping in mind that PHED is actual monitoring events from -- from similar things, it's all how you use the data and -- and cull it down to represent your specific scenario.
There are obvious exceptions. For example, some of the new granular materials that are not as friable as the old -- or breakup into smaller components of dust are really not represented in PHED, so that wouldn't be a good correlation. So -- but generally, it is the case. They do -- they do match up pretty well.
MS. MILLER: What about airblast?
MR. DAWSON: Well, the airblast data set we actually have in the database is one of our richer data sets, and it actually has pretty good quality assurance and quality control associated with it.
And it's a higher number of replicates if you know how the system works. So it all looks pretty consistent.
And there's, you know, several studies, and they are representing that scenario, and they seem to compare pretty well.
MS. MILLER: Okay. Because you had said, if my numbers are correct, 100 different studies representing 160 different cells, which I assume each cell is a scenario.
So did you then extrapolate to get to -- I guess it's -- you know, I'm -- if -- if every single cell is based on data and we have 100 studies --
MR. EHRMANN: Well --
MR. DAWSON: Every single cell is -- is probably based on some data. There are some components of the data where we typically may have to extrapolate. For example, we may have a scenario where they didn't use gloves or a respirator.
For example, and we would use standard protection factors to extrapolate. And that's very consistent, and with all kinds of occupational risk assessments.
For example, the standard protection factors we use for respirators, they're derived -- or we derive them directly from NIASH, they publish that kind of information.
And then the factors we use for clothing and those kind of things, are consistent with the data that we have from the database.
MS. MILLER: Okay. But there are standard factors. That if we wanted to delve into this some more, it's maybe what -- the word default's taken on a -- kind of a life of its own.
But there are standard factors if you don't have the data that you plug in, basically is what you're saying?
MR. ZAGER: You're correct, yeah.
MS. MILLER: Okay. On -- on the hazard side -- and this even maybe gets back into the question on dietary, since we're focused on OPs in particular.
And I think, Jack, when you were explaining, you know, one of the -- the biggest drivers here is really endpoint driven.
If we take a look at organophosphates in particular, compared to maybe some other compounds with different endpoints and I'm still having difficulty when you'd get to that risk management situation, even on the FQPA side let alone on the FIFRA side, that you treat the same -- two different effects the same way with the same assumptions.
If you say plasma cholinesterase depression, which some of us may argue is an indicator of exposure versus any kind of a clinical sign or effect, with maybe in another study another kind of compound elision that would occur, we're treating those things the same way in the assumptions.
And if that's the case, you know, we're seeing OPs. And this being such a driver on the worker safety -- that's what I say, even on the FQPA side on the food safety side, you know, it's -- I'm not sure -- you know, as we evolve with risk assessment, as we evolve with more knowledge, if that's really the right kind of assumption for equality on how we look at hazard identification. And just if that's such a driver, that's something we need to really look at here.
MR. EHRMANN: Okay. Let me just take a time check. We have three folks who want to make public comments, so I need to hold about seven or eight minutes for that.
So we've got about 20 minutes left for discussion. So let me encourage the folks who have your cards up to --
MR. ROMINGER: Two and a half minutes apiece.
MR. EHRMANN: Yeah, my co-chair says two and a half minutes apiece. So we can get everybody in as we go through these comments. Nancy, you're next.
MS. RACHMAN: No problem. I think I can do it in 30 seconds.
MR. EHRMANN: Oh. Hey.
MS. RACHMAN: This transfer factor has to do, in the case of dermal exposure, with the transfer of residues to the skin, does it not? Where does the dermal absorption come in? And in the absence of chemical-specific data, what's your default assumption for the amount that gets absorbed from the surface of the skin?
MR. ZAGER: It's 100 -- it's -- it's 100 percent if we don't have a dermal absorption study.
MS. RACHMAN: One hundred percent?
MR. ZAGER: Right.
MS. RACHMAN: Can you just comment a little bit on how that compares with the chemical-specific data where you have it for some OPs? You must have it.
MR. ZAGER: I don't --
MS. ROSSI: Wait a minute.
MR. EHRMANN: Lois?
MS. ROSSI: Yeah. Let me say a couple of things here first. If we assume 100 percent dermal absorption if we -- if we don't have dermal absorption data, if we're using an oral study.
If we're using a 21-day dermal study as the endpoint, then we don't take into account a different factor. Okay.
MS. RACHMAN: Yeah.
MS. ROSSI: And then -- does that answer your -- what was your second question?
MS. RACHMAN: Well, that --
MS. ROSSI: That answers it? Okay.
MS. RACHMAN: That clarifies it. But I think there -- there's some hidden conservatism here -- some hidden safety factors here that I think could be brought out --
MS. ROSSI: Right.
MS. RACHMAN: -- especially if you're going to go into a little more detail. Which I think was a great suggestion, Ed, about what's in the PHED database.
It would be good to shed a little light on those built-in conservative approaches that are already in the assessment.
MS. MULKEY: Ed, do you have somebody here who can answer her other question, which is sort of the range of dermal absorption that we've seen in these. I know I've asked that question and --
MS. ROSSI: It's all over the place.
MS. MULKEY: -- I can tell you what I think I heard. But it would be better if somebody has a feel for what that is.
MS. ROSSI: It varies, there's really no -- it's all over the place. But we did --
MS. RACHMAN: But is it --
MS. ROSSI: -- we did though actually tell -- we did -- a few years ago we -- we talked to OP registrants. And those that didn't have 21-day dermal studies or did not have a dermal absorption study, we -- we advised them that that would be a smart thing to do. So we do have a fair number of those studies in, the 21-day dermal and a dermal absorption.
MS. MULKEY: My impression is I was told that some are, in fact, quite high and approach 100, or at least, you know, are up in the upper range. Others obviously are not. But that was what I -- I thought maybe somebody had a more precise answer to that.
MR. ARTHUR: Marcia, can I say something really quick? It's -- when you say 100 percent dermal absorption, it doesn't mean 100 percent of what gets on the skin gets in.
It means that you assume the same absorption dermally as what you're seeing orally, which is very different.
MR. EHRMANN: When they don't have the dermal study, right.
MS. MULKEY: Right.
MR. ARTHUR: When we don't, right.
MR. EHRMANN: Okay.
MALE SPEAKER: The other thing -- Nancy, we will have in the overviews for the individual assessments is an explicit -- as part of the worker risk discussion is have it explicitly there stated.
For example, is it based on, you know, a -- the 100 percent dermal absorption assumption, or is it -- you know, we have a 21-day study, or whatever it is, as part of the sort of transparency, if you will, on the summaries alone, as well as obviously being in the document --
MS. ROSSI: Right.
MALE SPEAKER: -- in the assessment document itself, it will be all laid out.
MS. RACHMAN: It's been my experience that this is an area that many people find confusing. I still get confused about it at times.
And so I would just encourage you to explain a little bit about the relationship between, you know, using the dermal study -- the dermal tox study versus the oral tox study and how that makes a difference.
MR. EHRMANN: Okay. George?
MR. WICHTERMAN: Thank you. I've got two questions for Ed on slide number seven, in reference to the use and usage data that you alluded to about the surveys that had been voluntarily undertaken.
It's been my understanding that in phase four of the pilot process there are three public health pesticides that are currently in there, phenthion, nayled (phonetic) and temophos.
And please correct me if I'm wrong. But it's my understanding that the results of our survey that were voluntarily undertaken by the American Mosquito Control Association had not been factored into the revised risk assessment. And if that's correct, please let me know.
And if not, how would you plan to redress the issue as it relates to those three OPs, going back to the survey to defer to the different frequencies that were enumerated in there?
MR. ZAGER: I'm not sure whether we have or not. I'll check on it.
MR. EHRMANN: We'll get back to you --
MR. WICHTERMAN: Okay.
MR. EHRMANN: -- if I find out about that.
MR. ZAGER: That's all I can do.
MR. EHRMANN: Did you have a second question?
MR. WICHTERMAN: Yes, one other question. Has EPA worked out or developed a process to assess the benefits versus the risks issue as it relates to public health pesticide issues?
MS. ROSSI: No, I don't think we can say we've worked out a process yet.
MR. WICHTERMAN: Okay.
MS. ROSSI: I think that's an area that still needs a lot of work and discussion.
MR. WICHTERMAN: Okay.
MS. ROSSI: Yeah.
MR. WICHTERMAN: Thank you.
MR. EHRMANN: Bill Spencer?
MR. SPENCER: On slide 25/26 up there at the top, looking at PCC. Mainly looking at California, because I -- as the way you explained it, they've had a law on the books since 1982 where they have to report these incidents.
Do you know whether these incidents are, you know, caused from farm workers being exposed to legal label rates and, you know, the correct reentry intervals, or, you know, just do -- I mean, do you have that information?
MR. ARTHUR: Well, I think that information will be available for California, but not the Poison Control Centers.
MR. SPENCER: So you -- you could break down that 775 illnesses in California over that five-year period of time?
MR. ARTHUR: Yeah. Like I said, those are broken down into probable, definite and possible, and there's a good information database for those.
So that there is a lot of information about how the exposure occurred and the illness occurred.
MR. SPENCER: How I keep hearing the term robust being used. So I ask you how robust do you think your conclusions are as it relates to worker exposure generally, and worker exposure specifically as far as azinphos-methyl?
Because, you know, I look on the back on your slide number 51, and I see an MOE on apples, for instance, at point nine, and it's supposed to be 100 or better.
And shouldn't -- in places like California and Michigan and Washington and upstate New York and places like that, shouldn't we have farm workers dropping like flies --
MR. ARTHUR: Well, remember --
MR. SPENCER: -- for all the --
MR. ARTHUR: Remember that --
MR. SPENCER: -- for all of that that we use?
MR. ARTHUR: Yeah. Our MOEs are calculated on cholinesterase inhibition, not on clinical signs, okay. So you -- if you went -- if you calculated an MOE based on clinical signs, you'd have to base it on a new NOEL, or new no adverse effect level. Yeah, it's a different endpoint.
MR. DAWSON: Can I say -- when your MOE is near one, what that means is that you're at the level at which you're not seeing any effects.
So you -- you wouldn't expect to see people dropping like flies. You're at the NOEL, you're right near the level where you wouldn't expect --
MR. ARTHUR: And the NOEL is based on cholinesterase inhibition, not --
MR. DAWSON: Right.
MR. ARTHUR: -- illnesses.
MR. EHRMANN: Okay. Jon Jessen?
MR. JESSEN: I've no idea -- first of all, I have no idea why -- why our friends
walked out this morning, because it looks to -- if Jack gets done what he's
setting out to do, they've won beyond their wildest expectations.
I would have thought they would have stayed here and enjoyed this. But anyway,
I want to say that I think that --
MALE SPEAKER: You probably said it.
MR. JESSEN: I think that -- that this worker safety thing has got to be handled very carefully, because it's talking about killing this whole class of products. They can be attributed to death just as easily as they can be just killed with a single stroke.
And it looks like by adding these worker reentry periods much beyond where some of them are now makes a product unusable. There's things that have to go on in those fields.
And to say that workers are not allowed to enter for a very long period, and -- and many of these crops should just as well grasp the nettle and say the products can't be used on it any more.
And I think that this is -- it looks like this whole thing has evolved to the point that this is probably a worse -- a worse threat to agricultural certainly than the -- look -- maybe -- as this thing -- as this whole process unfolds, it looks like Everett Coop was right 10 years ago when he said America's food supply's safe.
But -- and we're -- I think that's starting to be demonstrated as the -- as the numbers come out and as people will start working through the process.
But this worker safety thing has been sprung on us quite -- almost surprisingly here much faster. And the time hasn't been given to develop the data that's needed to -- to demonstrate safety.
Some of these products -- we have one, for instance, Prefar (phonetic) that to my knowledge has never had a worker incident in the -- in the 35 years of history.
And yet to say that you're going to raise the baseline for a product like this, Jack, just seems ridiculous to me. You take the whole class and you're throwing out the baby with the bath water.
MR. ARTHUR: I don't -- I don't think I've -- I've put ideas on the table that could be used to deal with some of the risk concerns that we've seen.
In -- in terms of -- you have to remember that we've been doing worker risk assessments now for 180 some rads.
And until this point in time, no one's really questioned how they've been done. Because they haven't indicated that great of a level of concern as we're seeing with the organophosphates.
So it's not something new and it's not something we're doing differently than we have in the past, it's just yielding results that raises people's eyebrows somewhat.
MR. JESSEN: Okay. This is an aside, but -- and not the main point. But, you know, I've lived out there in and around and worked in and around and had people working for me and worked in the pesticides pretty much all my life, and I believe that the incidents might not be that far from right.
You say they're under reported. From what I've seen, many, many of the things that are termed as incidents were not really incidents at all.
Many times a guy has a hangover and he tells you that it's pesticides, we know that. And those of us, like Bill and I, that have lived in there, realize this is just something that goes on. So we know that some things are under reported.
But we also know there's quite a bit of over reporting. And the doctors that mark it down, really don't go to a lot of lengths on some of those things to take cholinesterase tests or anything else. So that's just an aside. But there's two sides to that under reporting thing.
MR. ARTHUR: I do think though that if you look at incidents, and there's more for one pesticide than another, it does give you some indication that something may be going on.
So I think if you look at it like that and not just an exact number, it -- it can tell you something.
MR. EHRMANN: Henry?
MR. JESSEN: And finally --
MR. EHRMANN: Oh, I'm sorry. Go ahead. Henry just want to make a --
MR. ANDERSON: Go ahead. I'll -- I'll answer your questions in a minute.
MR. JESSEN: Finally, I wanted to point that if you an exaggerated worker safety protocols in the United States and we accept these things and adopt them, that is more than food tolerances is going to put the American farmer at an unfair disadvantage.
Because certainly if they've been using a product in Mexico, for instance, for 20 years, say Imidan in citrus, for instance, which we don't carry it on the label up here anymore, but it still was on it when it came in.
And if they've used it for 20 years and had no incidents, and I think you moved our reentry period on the preliminary risk assessment from one day to 365 days, the Mexicans will see something like this and they'll say, this is ridiculous.
And the Americans, should we -- which we're not still registered on citrus. But if you were, the Americans would be denied the use of this product. And the Mexicans would know what was safe, and they would use it in a sensible fashion. And so the American producers are going to be denied a tool, and many tools in these cases -- many cheap and effective tools that are going to be available. And there's no way of really checking it at the border when it comes in, a tolerance you can.
But these worker safety things, if you push this beyond the level of reason, you're just going to deny the American farmer a tool that's going to be used by his competitors in the rest of this global agricultural system.
MR. EHRMANN: Henry?
MR. ANDERSON: Yeah. Jon, I'm glad you're not a physician and you're not an epidemiologist or anybody involved with surveillance. Because your impressions and your understanding is completely wrong.
You certainly must realize that agricultural workers have the highest fatality rates, the highest injury rates of all occupational groups in this country.
MR. JESSEN: And I worked right in there with them. I've been a field checker for 20 years. And I've been --
MR. ANDERSON: Let me --
MR. JESSEN: I've --
MR. ANDERSON: Let me speak --
MR. JESSEN: I've done that.
MR. EHRMANN: Gentlemen, let's --
MR. ANDERSON: I didn't --
MR. EHRMANN: -- conduct ourselves in the --
MR. ANDERSON: I didn't --
MR. EHRMANN: -- appropriate manner, please.
MR. ANDERSON: -- break in on yours. I just want to say that as a occupational health physician who deals with these issues, somebody who's made a living of doing surveillance, there is no pesticide surveillance to speak of in this country.
So to say that you have a product that's never been shown to be poison, you don't have -- your company does not do surveillance, you don't go out and test workers, you haven't done any surveillance --
MR. JESSEN: Right.
MR. ANDERSON: -- on your product. And the reality is if we look at what's done, we spend a great deal more dollars on testing foods. When in fact we have biomonitoring that can be done.
You do all of these risk assessments, and you can go out and get urine from a worker and you can actually measure what they've been exposed to.
And in fact, that's what can be done. But there's no resource to go out and spend the same amount as we do testing the food on addressing worker health issues.
MR. JESSEN: We should --
MR. ANDERSON: The reality is, it's not done, the companies aren't doing it,. And we have individuals being poisoned and children being poisoned, and that's a critical issue that has to be addressed.
And to say that these are underestimates -- just knowing the ability of physicians, they're not adequately trained to recognize these and they do sort through these things, that it's just not there. And to say that people aren't being exposed and injured --
MR. JESSEN: That's why I think they should -- they should have money spent to see what the poison is. But I think you'll find out that the poisons are --
MR. ANDERSON: Who should do that?
MR. JESSEN: -- maybe about where they are right now. Because many of what's termed as poisonings are not poisonings.
MR. EHRMANN: Okay. Let --
MR. ANDERSON: Just --
MR. EHRMANN: Wait a minute.
MR. ANDERSON: -- a second --
MR. EHRMANN: Wait a minute. Wait a minute.
MR. ANDERSON: -- I got another point.
MR. EHRMANN: Let's make sure that -- for the time remaining here, that folks express your view about the issues that have been presented. If you two want to continue your conversation --
(END OF TAPE)
MR. ANDERSON: One thing one can always do is you can do enforcement. I think the issue of are the individuals who are poisoned, are those cases that are following the current guidelines before you change guidelines.
You move in that direction, but you have to go out. And the way you enforce laws is to go out and inspect and see -- and actually get out to see what's going on. And one of those issues would be to look at biomonitoring as a tool which you could go out and -- and actually check to see what people are doing and are they following the label restrictions. And then do -- worker education I think is a -- a critical issue.
So I would clearly say you need to look at enforcing what you've already got, do the investigations to see how many of these cases are under current activities that are approved, and then use that information to move forward.
So I think clearly there's things that can be done with existing rules already on the books, to be sure that those are done and enforced more aggressively.
MR. EHRMANN: Thanks. Steve, did you want to make a comment? And then I'll take the other --
MR. JOHNSON: A general -- some general comments. Obviously we've been doing worker risk assessments for all the pesticides since the beginning of time.
In 1992, with the development of the Pesticide Handler Exposure Database -- you know, again, many countries, industry, ourselves, our state partner, California, it was a quantum leap forward. Actual data -- I mean, actually studies, actual data driving decisions.
And as Jack has said, we have now since then made literally hundreds and hundreds of decisions. And so that's the point of reference you need to understand.
The other point of reference you need to understand is that as we have begun to march through the organophosphates, we're seeing numbers that we have never seen before. And we're seeing them across the entire class of compounds.
And so that gives us obviously great pause for concern, and in fact we want to share. This is a very difficult issue that collectively we have to face. And so we were looking at trying to share both -- here's our history, here's where we're at now with the organophosphates. And one of the questions is, where do we go from here.
Clearly, our regulatory authority is chemical by chemical, company by company. But does it make sense -- and that's what Jack was trying to -- trying to say, does it make sense that we're seeing this for the entire class. And are there some things that we can do to help protect workers without putting a grower out of business, is there some way to do that? And is there some way to do that across the class? And so that is the concept. We recognize that when we move toward a regulatory approach, it triggers FIFRA, which is a risk benefit statute. And so we will be very much into evaluating the risks and benefits.
But as was pointed out, our experience is if we can get the key players around the table, we can make progress a whole lot faster. And in fact, deal with some of these issues. And if we can do it in such a way that it's not chemical-by-crop at a time over time, we can actually have a more level playing field.
So we're really looking for your ideas and suggestions. You know, we didn't really intend to want to get into the Pesticide Handler Exposure Database, that's been peer reviewed ad nauseum over the years. We can certainly do that so people will understand. People need to understand the worker assessment or risk assessment, and we know that that right now is for many still black box. And so we need to -- to open that up, and we can go forward in doing that.
But then lastly, given what we're seeing, and we're, you know, trying to share with you what we're seeing so far, are there some innovative approaches for dealing with the workers issues, rather than the traditional chemical-by-chemical, company-by-company approach.
And so that was really the message we want to share. This is really difficult, and it's not something that we have seen before. And it's not something we've seen as a class as we have here before.
And since you are our advisory committee, or at least most of our advisory committee, we'd certainly like to hear from you any thoughts and ideas given this difficult situation.
MR. EHRMANN: Thanks, Steve. I want to try to get all the folks in who have their cards up. So again, let me ask you to be concise. Robin and then Mark.
MS. SPITKO: Steve, your comments fit perfectly in what I was going to suggest. What about some sort of a cost share program, and incentive program for growers that are trying to do risk mitigation for worker exposure, or for -- what about -- you know, in the past, growers have felt if the Federal Government is willing to support their programs, even if it's a small percentage of the actual cost to the grower, that it makes it a more valid program.
I mean, it's the old put your money where your mouth is kind of thing. And what if -- if we could come up with programs? What if they were going to purchase spray-safe cabs for airblast?
I mean, we as consultants, we beg our people to have spray-safe cabs, because it makes all the difference in the world. But they're expensive.
I mean, what if there was some that -- I mean, we love to spend the Federal Government's money in agriculture.
You know, I think as -- as we move down the road and we're dealing with these worker exposure issues, which I'm feeling are going to be a very major part or this, what about offering them some help with the economic burden? I mean, would that be something we could consider? I mean, just a suggestion. But --
MR. EHRMANN: Okay.
MS. SPITKO: -- I know it would soften the blow a lot and it would certainly -- you know, incentive is always better than punitive. Just an idea for someone working with the growers. So thanks.
MR. EHRMANN: Okay. Thanks. Mark?
MR. TROSTLE: Yes. I'm dealing with the issue of being part of the family that Marcia brings up. And I won't -- in difference to my colleague from Texas, I won't mention redheaded stepchildren.
But there is lots of data, Jack, out there that you can look at from the state lead agencies on enforcement issues, incidents that we investigate. All the state lead agencies have a grant agreement with EPA. And we are gathering reams of data about enforcement use and -- and incidents that happened, human exposures. So I think there's an untapped database there that may be that we haven't thought about. But I'd like to suggest that we look at it for is some incidents that are occurring. Because we are documenting all of those. Anyone that calls in, as we say BR549, can report an incident, anonymously or whatever. Many of the states have that -- that process in place.
Texas is very unique in the fact that we have a right-to-know law for our ag people, or anyone, actually. But there is a law that's going on. So I kind of take exception sometimes, Tobi, to the -- California being the God savior to the world.
MR. EHRMANN: Even though it is.
MR. TROSTLE: But, you know, Texas doesn't toot the horn a whole lot, we just do our thing.
MR. EHRMANN: Out there doing the real work.
MR. TROSTLE: Out there in the middle of nowhere, you know. But I just want to let you know there is a lot of data being gathered by -- by the state lead agencies. There is a lot of data that -- we're under grant agreement with EPA. We are collecting a lot of enforcement data.
We in Texas have taken enforcement actions of PPE and WPS violations, so there are things happening out there.
And the gentleman across the table, there is extensive training going on in WPS and worker handling, extensive.
By extension, the state government and private industries, so -- and monitoring of that. So I would stress that there is a lot of that, that does happen, in case you were not familiar with that.
So -- but I would like to suggest as a positive aspect, that there is a good database I think for enforcement incidents --
MR. EHRMANN: Okay.
MR. TROSTLE: -- and what's happening, human exposure, et cetera.
MR. EHRMANN: Good. Nancy?
MS. RACHMAN: Some other information that maybe isn't being used. It's my recollection that virtually everywhere organophosphates are used, there's a requirement that workers using these compounds have their blood tested on a regular basis.
And there are regulations that require when cholinesterase drops to a certain point, that worker is taken off -- you know, out of work until he recovers and can be put back on the job.
What we have here is actually a safety net that is preventing exposures from reaching the levels that your models may be predicting.
I mean, I'm -- it's obvious that -- PHED measured data predict certain kinds of exposures. The question is whether those are ever really occurring out in the field.
These requirements are actually in place worldwide. And there are programs worldwide to keep workers from handling these compounds when cholinesterase falls below acceptable levels, is that not relevant here?
MR. EHRMANN: Steve?
MR. JOHNSON: Nancy, are you referring to industrial manufacturing workers?
MS. RACHMAN: No, agricultural workers.
MR. JOHNSON: Does this -- well, let's -- I don't believe so. I didn't think so.
MR. ROMINGER: Speak up, Tobi.
MR. JOHNSON: Let's ask Texas. We have a couple of states here.
MR. ROMINGER: Well, talk to Tobi.
MS. JONES: I don't -- I don't -- Mark can comment on Texas. California has that system. I don't know of any other state that has it. But Mark -- and Michigan? I see Mark Whalon --
MR. EHRMANN: Good. Michigan.
MS. ROSSI: There are some states --
MR. WHALON: That's what I was going to --
MS. ROSSI: -- at least --
MR. WHALON: -- comment on, is -- is that we've done studies since the '80s. The Michigan Department of Health does both phlebotomy studies and also they have a prick test for measuring acetacholinesterase deprivation, depression.
And we -- we -- we do those on all of our university scouts, pest management field assistants, as part of the regular process. And that was done all the way through --
MR. TROSTLE: Is it required for farm workers to be done?
MR. WHALON: It's been done. Different surveys have been done on --
MR. TROSTLE: It's surveys?
MR. WHALON: Right.
MR. TROSTLE: It's surveys?
MR. WHALON: Yeah.
MR. TROSTLE: Okay.
MR. WHALON: But it's not a required process all the time. And it -- it's continuing today.
MR. EHRMANN: Okay. And Brad?
MR. LUCKEY: I was going to ask Tobi to -- to tell you about -- then Mark said something about California and you hurt my feelings.
California -- all of the applicators, be they pilots or the drivers of ground rigs, any time they have a license for -- what it is, category one, they're tested every 30 days on their cholinesterase. It's state law and it has been, what, the last five years, I believe, maybe a little bit longer.
MS. ROSSI: It's much longer.
MR. LUCKEY: There should be a tremendous database there for you to look at. And that was my comment. I thought that's where Nancy was heading, that --
MS. RACHMAN: I'm real bad on details, you know. I'm real good at the big picture stuff.
MALE SPEAKER: And look what you got started, Nancy.
MR. LUCKEY: But --
MS. RACHMAN: But the California database would give you a way to validate --
MR. LUCKEY: Yeah. I don't know if you've --
MS. RACHMAN: -- some of the --
MR. LUCKEY: -- every seen it --
MS. RACHMAN: -- predictions from PHED.
MR. LUCKEY: -- but all of our applicators are tested on any time -- if they have a category one license to apply.
So one other quick comment, and I guess I direct it -- direct it to Jack. Back -- and I'm real cautious on these PPEs. If all the PPEs we know of were used, how close to zero on unit exposure could we get?
MR. ARTHUR: I'm sorry?
MR. LUCKEY: On the daily exposure, or our unit exposure from your chart, using all available PPEs, respirators, gloves, goggles, boots, everything, how close to zero can we get?
MR. ARTHUR: I think I'm going to answer this one. With some of the studies we've seen with the use of PPE and -- and engineering controls and things, you see very low levels as you would expect.
And it's kind of -- when you get to that level we're basically talking about an issue similar to the LOQ, LOD issue with the residue chemistry. It's driven by, you know, how low can you go in your analytical method.
But we do see what you're discussing in the empirical data. When people are doing well-designed studies using specific mitigation measures, they typically act as you would expect them to act and reduce the exposure proportionately.
MR. LUCKEY: But how close to zero can we get?
MR. ARTHUR: Again, it's analogous to how low you can go as far as screening.
It's very low levels and it's chemical dependent about what you can look at in the analytical chemistry aspects of the data.
MR. LUCKEY: All right. From a handler perspective, if I dressed up in a space suit, could I then get my exposure to zero?
MR. ARTHUR: To answer your question, I don't think you can ever get zero.
MS. ROSSI: This is the Heisenberg Uncertainty --
MR. ARTHUR: Right.
MS. ROSSI: -- Principal we're talking --
MR. ARTHUR: Exactly.
MS. ROSSI: -- about here?
MR. EHRMANN: Okay.
MR. ARTHUR: Thank you.
MR. EHRMANN: Mark, did you have a --
MR. TROSTLE: Yeah. Will this type of data if we have it in our state be good?
MS. MULKEY: Yeah, I want to ask a couple of questions about California. But obviously if there are available to us databases that involve measured cholinesterase levels in urine or blood or whatever, that would be very useful.
But in California, I understand that the -- is there in fact a centralized database, or are these data in -- just held at -- at users or whatever?
MS. JONES: Well, Marcia, it -- thank you for asking the question, because I'll check on this. But it's my assumption that physicians who are identified -- and Brad, you're probably in a better position to answer this question than I am.
MR. LUCKEY: Okay.
MS. JONES: But the physicians who --
MR. LUCKEY: That's a scary thought.
MS. JONES: -- farmers contract with collect the data on workers, don't necessarily have to file that data with the state.
MS. ROSSI: Right.
MS. JONES: But that is something that I can -- I can check with.
MS. MULKEY: I mean, the point I was trying to make. Rather than trying for us to sort out here exactly what data are -- I just want to correct -- I was afraid we had left with the impression there was a magic database somewhere we could all go tap into and sort through.
Obviously, any viable useful data we are eager to identify, and will pursue whether there's something coming out of the California requirements or any other state's requirements relating to this that we can use. But it does appear that as -- seems to be the case with everything relating to pesticides, nothing is ever easy.
And there probably is not an easy single available database of the sort that I'm sure Nancy and Tobi and I all wish there were.
MR. EHRMANN: Okay. Thank you all. This is clearly an important issue. And as I noted at the outset and others have, it's an issue the TRAC has not spent much time on. And I think clearly needs more time for discussion, either in this forum or other similar processes. So I think it's clear that there's a number of issues here to dig into. And appreciate the staff laying out the process as it currently sits to help stimulate this discussion.
I want to go now to the three folks who have signed up for public comment. I'd ask them each to keep their remarks to two minutes or less.
There's a standing microphone over here on this side of the room. Mr. Keating, you're going to be first. So let me just say I've got Mark Keating, Ed Gray and Jim Kuntzman, if I'm reading that right.
So if the other two folks, Mr. Gray and Mr. Kuntzman could get cued up, you'll follow Mark in your comments. Take it away.
MR. KEATING: Thank you. I'm Mark Keating, I work here in Washington with the Henry Wallace Institute for Alternative Agricultural.
We are submitting much more extensive comments to the record. And I have copies of those available if anybody would care for a more indepth representation of our point of view.
But I do want to say that we are very supportive of the progress that the EPA has made over the past six to eight months in terms of their implementation methodology.
I think it's very evident -- it's evident to me that the people at the head of the table that I'm facing, are -- are clearly talking the same language now when it comes to the techniques and the principals and the methodology behind at least the single chemical risk assessment and increasingly the risk mitigation policies behind FQPA. And a lot of the questions that six and eight months ago were being answered by a turn to the left and then a turn to the right, are now being articulated very clearly. So I consider that to be excellent progress.
I think bringing USDA into the process to the extent that -- that EPA has, has been a very important part of that success. Clearly the statutory responsibility rests with EPA. But clearly USDA has established a very, very significant role in bringing this progress forward.
That being said, I just want to articulate that we at the Wallace Institute are very supportive of the FQPA, we believe the methodology's coming together. But we also feel that it's necessary to view the next step in this process as the transition. And it's very important, I think something Mr. Spencer alluded to earlier, the crisis currently in agriculture in the United States, difficulty of domestic production.
We really see the FQPA as a transition to the next stage, reduced risk compounds, new chemistries that represent something that is a genuine replacement for the technologies we're dependent upon now.
I think that we clearly have some major hurdles ahead of us in terms of the cumulative work that needs to be done.
The worker issues are also something -- that clearly is something that is -- we're lower on the learning curve now than -- but we're just finding out where we are on that learning curve.
We've come a long way on some of the single compound issues. We will continue to be supportive of the process.
And we do want to compliment the Agency and the Department for what they've succeeded in so far. Thank you.
MR. EHRMANN: Thank you very much. Mr. Gray?
MR. GRAY: Hi. I'm Ed Gray from Jellinek, Schwartz and Connelly. And in comparison to the last talk, I have something much, much simpler to talk about.
I was very interested in the handout, 38B. And it occurred to me as I was looking at it, that it would be relatively easy, it seems to me, to generalize this -- this chart to cover all OPs and all the crops that any of the OPs are registered for and put that information on the internet. I realize that some of the information in here, much of it is the product of a lot of massaging and examination by the chemists. But it seems to me that this kind of stuff could be very helpful at a -- as an early a stage as possible for certainly registrants and growers both, and maybe others too if they want to participate in the process, to look at, to try to figure out.
So that when the time comes to say, well, what are we going to do about the analysis, they will be better prepared and have a better understanding. And it just seems to me like it would be a great idea to get this stuff out as soon as possible, rather than waiting to lay it on us at the -- almost at the end of the process. Thank you.
MR. EHRMANN: Thanks, Ed.
MR. KUNTZMAN: Good afternoon. My name is Jim Kuntzman, registrations manager for Bayer Corporation, the primary registrant for azinphos.
Many people have asked me in the last couple of days whether I felt like I had a target on my back, and it's true that I don't have one. But --
MR. EHRMANN: It's on your front. No.
MR. KUNTZMAN: Yeah. I don't think it would surprise too many people in the room if I'd say that Bayer wasn't totally excited to have azinphos-methyl selected as a candidate chemical for this poster child session.
I'll give you an example chemical before I explain the risk assessment process. And this lack of excitement is not because of a lack of enthusiasm for the chemical, or a lack of enthusiasm for the process. But mainly because it put azinphos-methyl in the spotlight of scrutiny probably more than any agricultural chemical that's on the market today.
But I was pleased to see the progress that the agencies collectively made in showing that when the appropriate data that was required by FQPA was generated and utilized in the risk assessment process, for the most part showed that the risk of using azinphos-methyl as a valuable crop protection tool are not unacceptable or at manageable levels.
This of course validates what we as the primary registrant of azinphos-methyl have stood behind since it was first developed, registered and used over the past 40 years. But as you saw, there are still a few questions remaining to be completely answered.
My big concern, therefore, comes from hearing that regulatory decisions and possible additional risk mitigation discussions may be coming up in the next few months for this chemical, at a time when it's clear that number one there are still significant additional data coming in, in the near future that may significantly affect the decision process.
Two, that these decisions will be prior to formalizing decisions on many of the important policy decisions yet to be made.
And three, that these decisions will occur prior to performing comparable risk assessments on alternative chemicals or technologies available to growers for the uses which may be affected by real or perceived risks were created in the risk assessment process. Once again, Bayer stands behind its support of azinphos-methyl as a valuable crop protection tool.
To touch briefly on what Jack mentioned earlier, relative to voluntary implementation of risk mitigation measures, I think Bayer has taken quite a few steps forward in the last couple years in proposing voluntarily risk mitigation measures on our label, use of closed systems voluntarily starting this year, which doesn't always help us on a competitive basis with other chemicals. But nevertheless, it's the right thing to do. The Agency may want to consider ways to encourage incentives or recognize registrants to do this.
We remain eager to work with the EPA, USDA and grower organizations to evaluate the continued use of this chemical. Thank you.
MR. EHRMANN: Thank you. Jay, comment?
MR. VROOM: I just was thinking ahead to tomorrow morning. And that we will have the opportunity to look back at a new cycle today, which gives us the experience of right-sizing the TRAC. And I wondered if our co-chairs will be planning to be present tomorrow for any further clarifications or questions about where we go forward. Great. Thanks.
MR. EHRMANN: Yes. Yeah, that will part of the agenda. Okay. Any final comments for today? You can leave your papers here.
Don't leave, you know, valuable here, obviously. But if you want to leave your papers here, they're -- that's fine. They're not going to take the room apart and put it back together or anything.
And we'll keep everything alphabetical so you can find our seat tomorrow. So have a good evening. We'll see you at 9:00.
(The meeting was adjourned.)
DAY TWO - APRIL 28, 1999
MR. EHRMANN: Let's -- yeah, be like Keith -- let me review the agenda for this morning, and then we'll get at it. The first item will be to have a brief update on the nine science policies from Bill Jordan, and then Mark Whalon will be providing us with a presentation about various transition activities in Michigan. And you should have in front of you several handouts and some materials that we distributed this morning for Mark in preparation for that presentation.
Then after a short break, we'll come back and pick up with discussion on transition issues that will build on some discussion we had at the Work Group II meeting a few weeks ago led by USDA. Then we want to spend some time talking about the final TRAC meeting agenda items planning other issues of concern and interest to people about the process. We'll have public comment for those of you in the public. Please sign up outside if you wish to make a public comment so we can gauge that time appropriately. And then we will adjourn no later than 1:00.
Any questions, comments, issues we ought to touch on this morning relative to the agenda or anything else before we get started?
Okay. Let's start with Bill Jordan. Bill Jordan.
MR. JORDAN: Thanks, John. There are two papers in the package of materials that was made available to you -- Staff Papers 37A and 37B, which contain a lot of detailed information about the TRAC science policy papers -- their status, their content, schedules, and so forth.
I'm not going to go through them in detail. I'm sure those of you who were at the update got your fill of that, and much of the material has remained the same.
But I do want to take a couple of minutes and talk a little bit about the broad context of the TRAC science policy papers -- where we've come from, what we've accomplished, and what remains to be done.
About seven months ago, the last TRAC meeting, things looked considerably different. There was a sense of confusion about some aspects of what EPA was doing in the science policy arena. There was a sense among some that EPA wasn't doing the right thing. There was a sense that if only we would listen better, we would understand better and do the right thing.
And I think those motivations led to the recommendations in the TRAC that EPA engaged in a process that involved public comment on nine broad science policy issues. EPA and USDA said that had a lot of merit, and we agreed to do that.
And since then, we have made a lot of progress, I think, in doing it. We had issued a paper in October laying out the nine broad science policy issue areas and 19 specific papers that we would make available for public comment.
We also identified a number of companion activities, such as review by the scientific advisory panel of work being done by ILSI or other industry task forces, or other related efforts that would help to inform and, perhaps, shape our science policy decisions.
Since October, of the 19 papers that we said we would put out for public comment over the course of the next 12 months after that, we have issued 11. There are some that have actually gone all the way through the public comment process, and we have reviewed the public comments and revised one of those 11 papers.
The Staff Paper 37B gives you a quick reference as to which papers those are and where we are with regard to the issuance dates for them.
We are still actively working on a number of the other science policy issue papers, but so far, we have issued at least one paper for seven of the nine areas that were identified as major or critical to the decision-making about organophosphates.
Generally speaking, we are on schedule with regard to the dates that were in the October framework notice. Some of the individual papers have slipped by in some weeks. But in broad strokes, I think we've come very, very close to keeping the schedules that were in the October framework notice.
Getting papers out on time, however, is only part of the story. It really is also important, in our view, in EPA and at USDA, that the papers be a worthwhile exercise -- that the papers really contribute to and improve the quality of the debate. And I think in that regard, we can also feel as though we've had some measure of success. And I will say that listening on the sidelines to the TRAC policy debates that have gone on in this meeting and in previous meetings, I can tell that the science policy documents that have come out have helped to inform people, and have helped to make the discussions more focused, and have helped to sharpen the discussion about the areas which are genuinely in disagreement or conflict.
So that it has succeeded, I believe, in the first goal, which was to make it clear what EPA is doing in these science policy areas. The second thing it has succeeded in doing is to sharpen the focus. And I believe that the discussion, for example, of 999 issue, which happened yesterday, is an example of that. And the third thing that I think these papers have done -- although it's probably not so obvious to you, yet -- is that they have served to get genuinely helpful information into the Agency and to, in some cases, actually change our policy in ways that we think will make it clearer, better, more scientifically defensible.
For example, in the science policy paper that we put out about estimating the distribution of residues in specific values in non-detects, we identified one statistical method called the Cohen's Method.
Public comments that we've received identified several other statistical techniques that are also recognized in the academic literature, and we have begun identifying them and using them or accepting them as alternative approaches.
So, there are -- that's just one small example, and I think that some of the comment process that has gone on -- both internally at EPA and with our sister agencies -- the Department of Agriculture and the Food and Drug Administration -- have also served to sharpen and improve the quality of our decision-making.
To the extent that this has been a success, I want to say that the list of people who have contributed is very, very long. Lois Rossi introduced the people who have worked on particular organophosphate risk assessments.
The list that I could go down would be many times longer than that, and so I'll just identify the organizations that have played major roles.
Obviously, the Health Effects Division in Office of Pesticide Programs has been critical and worked really, really hard to help get these papers in shape and out on time.
But a number of other parts of the Office of Pesticide Programs, the Environmental FATE and Effects Division, and the Field and External Affairs Division, the Biological and Economic Analysis Division, as well as our colleagues in the Registration Division and Special Review Divisions have also made real contributions.
But we have been working not just within the Office of Pesticide Programs. We've also had a lot of help -- as I mentioned -- from the Department of Agriculture and the Food and Drug Administration.
We've worked with our colleagues in the Office of Research and Development, the Office of Water, the Office of Children's Health Protection, Pollution Prevention and Toxics, Science Coordination and Policy, Office of the General Counsel. In short, this has really been a collective effort by a lot of very, very thoughtful and hard-working folks. And to the extent that you think that this has been a success, please recognize that it has been a team effort that -- and a lot of people really deserve credit for it.
One of the reasons why I am fairly optimistic and confident in saying publicly that I think it has been successful is that when you do a good job, you get more work. And already -- it's not just that the top brass at EPA and USDA are saying, hey, you ought to write another paper. But actually, staff people in Office of Pesticide Programs are coming to Jeff Kempter -- without whom I couldn't -- we couldn't get this work done -- Jeff is my colleague on this -- coming to Jeff and me and saying, you know, this process that you're going through is something that we would like to put this paper that we're working on, or would it be okay to develop a policy paper?
Now, without -- I don't want to commit ourselves and them to more schedules than we need to, but I will tell you that you may look for some unadvertised shoppers' specials coming up in the next several months of additional science policy papers that we think would be useful to get public comment on. And we found this process to be particularly helpful.
With that as a sort of teaser, let me just talk a little bit about where we are with regard to specific papers and what you might expect to see in the next several weeks or months.
In the short term -- in the very short term, there are a group of papers relating to the 10X provision of FQPA. I've discussed them before, and I won't go into too much detail about them, but there are four papers that EPA is writing, which will be discussed at the Scientific Advisory Panel at the end of May.
And it is our intention before the Scientific Advisory Panel meeting to make them available to the public and to start the public comment process. Before papers are a guidance paper saying how we in the Office of Pesticide Programs implement that particular provision, a standard operating procedure that elaborates on and describes sort of procedurally what information we collect and who makes decisions and when.
The third and fourth papers were developed by a task force of agency scientists who had been looking at working on the 10X implementation questions and looking at sort of scientifically what we know in this area. Those four papers should be hitting the streets pretty soon.
The other paper that is going to the Scientific Advisory Panel is one which discusses the statistical manipulations or methodology by which EPA has been using data on composite samples of particular foods in estimating the amount of residue that might be present in a serving of that food that is a smaller size and more likely to be consumed by an individual.
Put another way, it's how to figure out what residue might be found on a single peach or a single apple when the only information we have is the average residue present on a composite of 15 or 20 peaches or apples.
This decompositing paper will be discussed at the Scientific Advisory Panel and put out for public comment, also, some time first half of the month. Close behind it are a paper on how EPA uses information about the application rates -- typical application rates, percentage crop treated, pre-harvest intervals, and so on -- or usage information as it's sometimes called -- in our -- both our risk assessment processes and our risk management processes. That also should be out some time pretty early in May.
We're working on a paper relating to early assessments, and that one is pretty close to being finished in terms of working through where we want to come out on that. Not too far behind those four in line are papers relating to our aggregate risk assessment policies. This is a revision and a refinement to the paper that we presented to the Scientific Advisory Panel in February and builds on that paper. It takes the comments from the SAP into account and fills in some of the details that the review process has brought to light.
We are revising the paper we put out on how we interpret data relating to cholinesterase inhibition in light of public comments.
We are also revising, updating, expanding, clarifying the paper that explains in general terms how we do dietary risk assessment.
Finally, we're working on the paper that we've made available for comment on the new policy approach called, Threshold of Regulation. Those last four -- Aggregate, Cholinesterase Inhibition, The Framework for Dietary Exposure, and Threshold of Regulation are going to be toward the end of the month -- at least as the current schedule stands.
I want to say again that the process has been valuable for us, and we really appreciate the efforts that the public has made working through organizations to present comments from a group of organizations in one form in one single submission.
That is something that continues to make our task of understanding the issues of focusing in on what really matters a lot easier. And I think, in fact, that the groups working together has actually tended to bring different points of view to bear. And the comments that we're getting are of genuinely helpful, thoughtful, and high quality nature, and we appreciate that.
So, that's a quick summary of where we are on the science policies, and we'll keep working on it. John.
MR. EHRMANN: Okay, comments, questions. Yes, Robert.
ROBERT: Bill, I don't know if you can answer this -- or somebody else from the Office of Pesticide Programs -- but in a related area, we still have an incomplete and draft version of the Series 875 Group B Post-Application Exposure Monitoring Test Guidelines. Registrants -- especially for residential and, you know, non-dietary risk -- basically don't have a complete test guidelines to be able to do any testing right now for these types of products.
And I wanted to know what is the status of the Series 875 completion -- of that, you know, having it a final document, and also, any, quote, revisions to 40 CFR Part 158, that will also clearly demonstrate what the requirements will be to registrants.
MR. JORDAN: I don't have any information on the 875 guidelines. The residential standard operating procedures, which are related to at least some aspects of those guidelines, are scheduled for revision and work over the spring and early summer and are scheduled to come out in a revised form according to the schedule here.
We've gotten a fair number of comments, both from the Scientific Advisory Panel and from the public. And so, it looks to us like there is a good deal of work to do. And I don't think we have our arms all the way around that issue yet.
Those two probably need to be looked at together. I don't know whether anybody from the Health Effects Division is prepared to add anything on that.
MR. EHRMANN: Ed, you want to, you know --
ED: For residential SOPs, they're going to the Science Advisory Panel. We're planning to take them sometime in July, I think. I'll get back to you on 875. UNIDENTIFIED MALE: Yeah, because we've put a lot of time into guidance documents and into default conservative assumptions, and models, and this and that, but where we actually have to begin generating data -- many of the methods that were in the draft version of the Series 875, they still require validation, peer review.
And the registrants really don't have clear guidance to start doing some of this testing. And so, that would be very helpful if we can, you know, move along on that lines, too.
UNIDENTIFIED MALE: We'll get back to you.
MR. EHRMANN: Another -- yeah, Dave.
UNIDENTIFIED FEMALE: That's okay. I was just going to say something -- (inaudible).
MR. WHITACRE: Thanks, John. Yesterday, Dr. Anderson brought up a point near the end of the day, which I think is a good one -- which is that biomonitoring data can be a very useful and, perhaps, one of the most direct tools in determining whether or not there are individuals that are contacting products through occupational pursuits -- what the actual risk or probable risk is to such people.
I wanted to make a comment and ask a question of Bill or anyone else that's prepared to respond.
The comment is that such undertakings with biomonitoring do require -- in order if they're to be valuable -- do require a modicum of human pharmacokinetic data. You have to know what the relationship is between the contact and the amount that can show up in body fluids, primarily urine.
And then the question has to do with whether there's any additional information since the Work Group II meeting on progress being made on a human testing policy.
MS. MULKEY: Let me take a crack at that. First a narrow and then a broader answer. The primary focus of both of the SAB -- SAP meeting and our policy regarding human testing has not been on the kind of testing that would give you basic pharmacokinetic information; but, rather, on testing to establish toxic endpoints.
With that sort of caveat -- in other words, though there are certainly issues regarding human testing for pharmacokinetics, I don't think they are the sort of heart of the difficult, ethical, or scientific issues relating to human testing.
As you know, the SAP and SAB met and had an extremely significant meeting -- a lot of dialogue -- in December. We continue to await the report of the advisory committee. We have not yet received it.
We had said that we expected to move as expeditiously as we can to establish a policy regarding ethical acceptability of human -- especially human toxicity testing.
As soon as we get the benefit of that advice -- we have continued to work toward such a policy, but we continue to await the report, which we believe is close -- but imminent might be a little too strong.
Okay. You think it -- we think it's a couple of weeks? Okay?
UNIDENTIFIED MALE: Thank you, ma'am.
MR. EHRMANN: Any other comments or questions on the science policies? Nancy.
MS. RACHMAN: I would just like to compliment the Agency on the policy paper on 99.9. I believe I said this at the Work Group meeting, and I think it's worth repeating.
That's an outstanding job, and the issues are much more clearly framed. I think we've all developed a much better understanding of the statistical underpinnings of the issues. And I look forward to providing some comments.
MR. EHRMANN: All right. Anything else on this? Okay. Very good. Let's go then to Mark Whalon's presentation on transition activities in Michigan. Go Blue. No, no -- Blue, Blue, Blue. That's the other school in Michigan. That's right. But it's the right state. He's not contagious, honest.
UNIDENTIFIED MALE: It's the hot air.
MR. EHRMANN: Yeah. You're a brave man, Volling, you're hanging in there.
MR. WHALON: I just want to say to start that I'm going to emphasize four or five points over and over again.
The first one is, is that what we've accomplished in Michigan relates a lot to partnerships. Building partnerships at the federal level, the state level with registrants, with commodities, with the University, and with our other constituents in the state, including the environmental community and the organic community.
So, partnerships, I think, are key to anything in these areas. And that's a really important point that I'll stress over and over again.
Secondly, I think another area that's key in this whole thing is systems thinking. I don't think that you can address agriculture as an agri-eco system without taking a system science view of agriculture and trying to put together a systems -- an integrated systems program.
And that's what I'm going to try to show you today -- that the thinking that we put into this is a systems integration approach.
Thirdly, we really do stress integration. We won't solve pest problems or develop productive agricultural systems that are sustainable in the long-run if we're not integrating broadly across biological systems as well as natural products and conventional chemicals for management of pests in agriculture.
Another area that I'm going to stress is, is that we really are a land grant university at Michigan State University unlike Michigan, which doesn't have a real responsibility to the people -- the State of Michigan.
So, we feel a real service thrust -- a real -- I'm glad you came back, John -- a real service thrust. And so, the center that I'm going to be talking about -- its primary focus is service in applied science and in extension.
So, just a little familiarity with Michigan's production system -- all kinds of rating systems, but we have 10.5 million acres. This doesn't include turf. We have about 3.5 million acres of managed turf in golf courses. There are 54 crops -- and the top 10 of which most of those are food crops -- 65 specialty crops in total, not counting ornamentals and bedding plants.
Cash receipts just in the food area is 1.3 billion annually, and FQPA is definitely going to impact many, many of those.
In 1993-'94, I was part of the USDA Leadership Training Program and for the Michigan Ag Experiment Station, I was an intern through that period of time before I became an assistant director in the Ag Experiment Station. And my assignment through that Leadership Training Program was to, basically, take a systems view of the pesticide issues in the state.
And so, what came out of that study -- and a couple of short-term and long-term goals. First was understanding forces driving change and monitor those factors. And then to develop information on decision practices and other types of information that we needed to help make pesticides loss factors and commodity at risk factors and put those all together into a system that we could use to award or to give scarce resources to the most needy commodity pesticide crop combinations.
In order to do that, I think you have to understand something about information. First of all, there's all kinds of information out there. I did a study on biotechnology -- on the word biotechnology. And if you look at citations of biotechnology in the last -- since 1989 -- first cited in 1989 -- it's a geometric increase.
We're well over in abstracts and scientific journal articles in biotechnology -- we're well over about 7,000 references a year now. Who can keep up with that? Tremendous.
So, information is useless unless it's managed. It has to be managed, and packaged, and targeted. And part of the issue that was going on yesterday on cherries is exactly that issue. You got to put the information in the right place at the right time, and it needs to be managed in an appropriate way for the information to be useful.
So, we wanted to do that. And then we wanted to, basically, take a look at our crops and triage or try to award resources where they were most appropriate. And we also developed a political thrust in the state, largely through our commodities called GREEEN -- Generating Research and Extension to meet Economic and Environmental Needs. It's a little bit of a southern taste for the word green.
And also developed some long-term, five-year-or-out thrust and goals. One was proactive planning. We wanted to take an ag-systems management program -- and I'll show you that more specifically in a moment -- but we also wanted to develop incentives in the state for producers to adopt integrated pest management, integrated crop management, sustainable agriculture, and biologically intense management systems.
And we knew back then that we were going to have to pioneer many alternatives to conventional pesticides. All of agriculture surely must have its head in the sand if it doesn't see that coming -- and didn't see it coming for a long time.
And so, we wanted to be prepared. This is our ag-systems management approach to the center in managing pesticide issues in the state. And, basically, it has three databasing features in it. A pesticides-at-risk feature, a pesticide alternative feature, and a commodities-at-risk feature. It also has two different delivery mechanisms. One was our evaluation trials at the Ag Experiment Station -- 17 outlying agriculture experiment stations in the state -- and on-farm trials putting alternatives in the hands of growers on-farm. And then we also have a very large value-added portion of this project or this system that we put together that's trying to develop new products, new ingredients from Michigan ag systems.
We also involved a whole series of stakeholders -- outlined here in green -- who are involved in this process and producers. Of course, we were targeting producers, but they were involved all across the system. And one pundit said a while ago that, well, producers have problems, universities have departments. And to a certain extent, it's true.
I mean, we create in the university system for organizational reasons and for resource allocation reasons vertical structures. But problems in agriculture and society are not vertical, they're horizontal. They integrate across all kinds of disciplines.
So, we needed some sort of system that cut across all of those different departments in agriculture and the other parts of the University -- including sociology and political science, et cetera -- to solve problems for agriculture. And what we came up with then was a center -- this isn't a new concept to have a center, but I think this is a unique formulation of a center because this center concept is integrated around the concepts of agro-ecology. And it's based on the biophysical processes that go on in the soil and soil health. So, it embraces a lot of the concepts of sustainability and organic production. And, in fact, what we're after is best practice without an ideological commitment anywhere. We want best practice in the field.
And so, we can embrace anything, basically, in this center and evaluate it. We recognize two principal feeding systems -- two leaves in the system. One is the whole social system, and the policy integration into this system, and taking advantage and paying attention to that process -- but also looking at productivity. And out of that agro-ecology focus for the center comes a series of delivery mechanisms. One is obvious -- integrated pest management. We also wanted to have plant stress management -- how flooding, cold, irrigation, other production practices integrate into the system in a truly integrated crop kind of philosophy.
Phyto-sanitation, import, export -- the whole idea of the legal ramifications associated with marketing crops and growing them is a key part.
The soil fertility and management -- and we set up a system of trying to move towards diagnostic capabilities of assessing what is a truly healthy soil. How do you do that? It's a very integrated kind of challenge. It's a five, ten-year project as we see it to be able to accomplish that.
And we also wanted to use that agro-ecology again to accomplish that, and Dick Harwood, who's the MOTT endowed chair at Michigan State University -- sustainable agriculture chair -- is responsible for that.
Then we integrated throughout the University to bring people together, and you have a handout with you with all these programs and their directors. And basically, these people are team leaders. They go into the University, recruit people to address different areas, and even integrate across different organizations, or different programs within the center to accomplish tasks.
The structure of the center is pretty straightforward, but it's quite different from a department. The structure looks like this, where the director of the center answers to the Ag Experiment Station director and to the Extension director independent of the department structure in the University.
We also have two advisory groups. One is an internal advisory group made up of the program leaders from the different programs in the center. The second is an external advisory committee, which initially started out through the Integrated Pest Management Coalition, which was part of the political process starting in the late 70s and building through the 80s that delivered GREEEN to the University -- about $6.5 million a year for operating this center and other things in the University.
It took a long time to do that politically in the state and get it done. The people who drove that system were the people that we trained through the University Extension and IPM in the early 80s. Anyway, this advisory committee is not just composed of commodity people, processors. It's composed also of organic and environmental people. So that after the last presentation I made at TRAC, some calls came out of the people that were around the table back to Michigan saying, there's a guy out there who's after organic, and the person they called was on my board.
She came and talked to me and said, golly, we're really worried about what's going on and what you said -- let me see what you said. So, I laid it out before her, and she says, yeah, that's right on.
So, it isn't like we're trying to run an end-run or anything on sustainable agriculture or organics. We're inclusive and working hard to be inclusive and take best practice out of that process.
The next thing I wanted to do was just talk about this pesticides-at-risk database -- how it works, and what we're about there because it relates very directly to how the state can prepare for FQPA impacts in the state.
First of all, to understand this thing, I would like to lay out, kind of, what its goals and objectives are. It identifies risks and impact factors. It tries to identify indicators or data sources that will help us look at the horizon out there and determine where we will lose pesticides and for what reasons in the future. And therefore, how we would have to backfill or have to build a systems kind of program to deal with that.
And for those factors without consistent data or where data isn't available, we would have to develop our own survey systems and carry those out in the state.
We also wanted -- through a committee process, through a team process -- to develop a logic for how to combine those loss factors and make decisions.
We ranked these in a ranking system that's quantifiable and publishable in the state that anybody can see. It's very much like the kind of thing that EPA is doing on 19 science issues -- or 9 science issues and the papers that have been releasing.
And then we went through a peer review process to verify this. We've done this since 1995 now, and the logic looks something like this. We've been able to capture an array of different published data sources, including all kinds of use data, risk of loss for pesticides, et cetera. We have 13 categories in that pesticide loss category, including industry withdrawal, avian toxicity, worker protection -- and I'll show you in a moment how we're handling FQPA.
All of this system goes into a committee. This committee is in your -- I won't show it on an overhead, but it's in that handout I gave you -- the representatives that are there -- into a database and that decision logic to come out with a pesticide crop ranking system.
And based on that ranking system then, we would award grants through the Ag Experiment Station Extension Service to deal with problems in the state.
We release that to the decision makers who set policy and impact the agricultural production systems. And that's how the pesticides-at-risk system works. And basically, this is part of the '98 schedule, where we have what crops had -- are likely to have the biggest problems, what chemistry was involved, what type of chemistry it is -- the trade name -- the rank in the state, the pesticide priority index, which is a culmination of the whole thing.
A loss indices based on those 13 criteria that I mentioned. An alternative index if there are no indices -- if there are no alternatives readily available, it gets a one and down from there as the quality of the alternatives change. This thing goes out to about 300, so this is just the first 25.
An economic index and an impact index based on ecological factors -- environmental factors. It's a modified COVAT (phonetic) system based on World Wildlife's update of that.
And then in 1996, along came FQPA. Well, how did we respond? Initially, our response was pretty straightforward. We just tried to take a systems approach to understanding the pesticide loss factors associated with FQPA.
And we worked through this thing, and we've updated this process over and over. It includes a whole series of things that you would all recognize -- on track, whether or not a chemical is included for -- has uses in both agriculture and human health, whether it's a minor use or a major use, whether it has non-occupational exposure issues, whether it's used in the 20 foods that are common in kids' diets, whether the residue data is available on it.
If residue data is available, are they commonly detected? We were doing this in 1996, '97. This particular one has been updated such that if there is residue, is there a mitigation plan in hand? Can we step forward and put a mitigation plan in hand?
If yes, what are the proposed alternatives that go along with that? And then, are those alternatives viable in Michigan? Have we tested them? How far along are we in their adoption?
And we've used that system pretty effectively, I think, to line up our industries to focus on how FQPA is going to affect these 64 different specialty crops that we grow in the state.
I want for the rest of the presentation to use this as kind of my outline of what I want to address because this is the real meat of how we're dealing with FQPA in the state.
First of all, I talked about pesticides-at-risk. I want to just touch for a moment on what we call MIPMAT -- the Michigan Pest or Pesticide Management Action Team. It's kind of a serendipitous process that we got into this organization. It was a response to FQPA -- came in late 1996.
We started meeting for breakfast with some farm bureau representatives, with some commodity representatives, Michigan Department of Agriculture representatives -- 7:00 a.m. Friday mornings, every Friday morning, at the Kellogg Center on campus. And after a while, this thing became a fairly large meeting where we would have up to sometimes 40, 50 people. Representatives from our state legislator (sic) were there -- even various growers. We've had various registrants appear for these meetings. We've discussed a whole array of things. And out of that meeting process that we structured, now we're meeting monthly. We went to a two-week thing in 1998. But that meeting MIPMAT system has continued. And I put up an E-mail list-serve on that, we've put out updates on TRAC, and updates on FQPA, and other issues that are pertinent across the state and the other people outside the state who participate in that.
In addition, we did get GREEEN funded -- there's an overhead in there that tells you about GREEEN a little bit. And we had broad buy-in from MSU, from Michigan Department of Agriculture, from various commodities, from Michigan Farm Bureau.
And I want to focus on this pesticide alternatives very briefly and tell you what we're up to there from a databasing point of view. Remember, that way back in '94, '95, we had said in our Ag Systems Management program that pesticide alternatives were going to be a key part. And we wanted to started databasing and managing information such that we could make key decisions.
So, we already had a structure to deal with alternatives before FQPA. And basically, what we said through the team that focuses on this is that we need biologically based technologies. In other words, biologically intensive IPM.
We need to fill the pesticide gaps that are coming. We know that those biologically intense systems would have many advantages -- which you can read there in red -- but they may suffer from some of the same drawbacks that conventional pesticides have today. In other words, once you have an alternative -- and just because it's biologically intense, it doesn't mean it's going to last forever, or that it will even be integratable. It takes a lot of work to get from conception to delivery and uptake by producers. So, it has to fit into the system. And if it's a single-tactic approach, if there's opportunities for resistance, or if you have to do multiple treatments, you may not be any better off than you are currently because the ecological, and economic, and environmental impacts may be more severe in some cases. And I have an example of that in just a moment.
But basically, our structure for that pesticide alternatives database looks like this -- where we knew that we had our pesticides-at-risk system, and it was functioning to give us priorities of where to look. But we needed to develop a database that would encompass what was coming in industry -- a so-called pipeline database. And we worked with IR-4 and with EPA and with industry to try to put that pipeline database together. It's a pretty robust database at this point.
We also know that there is a lot of biological control agents out there. What are they? How good are they? What's quality control of those things? How can we integrate them? We needed to bring that information in, and parse it, and put some sort of logic to it. And then what I call para-biological control. These are all the natural products -- the IGRs -- other things like that fit into that category, and I'll show you more on that in just a minute. But we wanted to put that into an alternatives research and delivery system. This was a systems view -- a production systems view that we would put on the landscape. And that handout on Clarksville is an example of one in apples that have been going since '95. And I'll come back and talk about that just briefly in a moment.
We needed on-farm research as well as our 17 outlying experiment stations engaged in this process. And we needed elaborate evaluation so we involved sociologists and political scientists, actually, right from day one in this process so that we could assess how well we were doing in these systems and how effective they might be and feed back into the system and reiterate that loop over and over again as we went toward --
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-- with APHIS, for example, who was going to close down the Niles (phonetic) Lab, which is in southern Michigan.
We've been effective in getting resources out of the state government, and out of the University, and out of USDA to foster the development of that Niles Lab for more specific issues in minor crops in the state.
So, we've gone a long ways there, and there's a handout on biological control that is out on your desk that represents an alert that comes out monthly in the state on different cropping systems.
So, there's cropping systems, like row crop systems, fruit tree systems, vegetable systems -- they're all mixed in out there, so whatever you got is one representative of one of those.
Parabiological controls -- this is our list of parabiological controls that we include in this whole process. Many of the new chemistries in the pipeline fit into these categories. And we've been working extensively with these, trying to bring them online and cooperating with registrants as well as with state and national organizations to accomplish that.
But in the end, you have to evaluate these things. What are the feasibility criteria for alternatives? What makes a real alternative that can be plugged in -- if it could ever be plugged in?
While we put together a series of biological, economic, legal, cultural, environmental, and operational as well as social sustainability, equity, and labor issues in that evaluation are part of our logic and in part of our filter as we go through that.
And so, this is the kind of output we get. In some cases, you don't have quantifiable data, and you have to take an expert's guess. And that's what these pluses represent in this kind of chart.
So, we would have a series of alternatives here, and this represents just the ecological characterization of each of these alternatives in terms of what it is, what its common name is, the kind of ecological effects it might have in terms of how long it lives in the environment, what the non-target impacts it might have.
Some people got really mad at me at the last TRAC presentation for talking about oils. Well, it turns out if you look at oils, oils have as much impact quantifiably as nerve toxins -- OPs -- in production systems. And there's pretty good data on that.
So, because it's -- because it happens to be thought of as a benign target -- ecologically, it may be very devastating.
And we also did a selectivity index on parasites and predators because they're different, and you've got to pay attention to that if you want something that's sustainable over time that you can put out into the field.
Here's another example of one of the evaluation systems -- this is operational characteristics -- often overlooked. How difficult is it to get something in the landscape? How difficult is it to get the growers to uptake a technology?
Well, this is an estimate of doing that and working through ease of adoption, pest spectrum covered -- how does it fit into our IPM systems? Are there regulatory issues involved? What about resistance? What about toxicity to non-targets?
Anyway, when we look at our alternative
system -- I'm going to show you some data that comes from the peach project that Gerber helped sustain and that you -- those of you in Work Group II heard about at the last work group meeting -- but this data comes from 1996.
What we were doing in terms of mating disruption in the field for Oriental Fruit Moth in the field with six different growers. On-farm research, comparing conventional to mating disruption -- essentially developing an indicator of what kind of savings we could get with OPs, primarily, in peach production.
That kind of approach and that kind of investment from the early 90s on is really what led to what Jan Relford presented at that workshop. And that was, basically, taking OPs out of peach production in Michigan for about 78 to 80 percent of the acreage in the state.
The way we did that is we started a long time ago doing biology of the pest and working through that process to the point where we could take and try and experiment in cooperation with the processor who would accept increased damage -- significant increased damage in the system -- such that we could take OPs right out of the system.
When we did that, we took a concomitant increase in price. Now, that has changed somewhat with economies of scale, and we're getting that down. Our biological control that we ran side-by-side in the system may not be doable in peaches. It's very expensive to do on a per-acre basis, and it is not profitable at this point.
That kind of information is hard to come by today in terms of a systems production kind of view. The apple example I throw up -- and you have that handout that I mentioned -- and this is what I'm talking about when I talk about this system.
In the past when we've done pipeline chemistry, it cost the University somewhere between 1,000 and 6,000 a year for a single chemical in one of its outlying experiment stations. And that's heavily subsidized by the public and private sector, and the output of that system is very simple. It's a spray calendar, and that's what we were doing in the 70s and early 80s.
It is very much changed today. And when we move out into a systems integrated project like you have in front of you in that little brochure, we're talking about huge increase in cost to get this done, and it's mostly borne by the public sector.
Where do those resources come from? Good question. Maybe we ought to fund USDA. Public sector support is starting to grow now, and private sector support is starting to grow. We get good support now from a couple of registrants, and we also get very good support from our processor community in the state to get down this road to be able to do this.
But at the bottom line, it's very high risk research, and it's very informationally intensive. It's very complex recommendations. In fact, I kind of -- overviewed these what it costs and what we've learned -- and one of the things that we've learned from this system is that diversity is not the panacea.
You can't just make an agricultural system diverse in arthropods, and in bacteria, and in other microorganisms and expect that system to be sustainable.
What we've done is, we've taken diverse systems, and we've lowered economic entry levels and the diversity in those systems using broad spectrum inputs into the system. And what we're doing now in alternative agriculture is we're coming out of that. We're trying to push up our thresholds -- our quality thresholds a little bit -- trying to use conventional systems to stabilize around that new equilibrium place.
You need the correct diversity in the system for it to be stable. And if you don't understand those diversity systems in a systems kind of view of that agricultural production system, things can go out of whack.
And here's a good example of that. In Michigan in our tree fruit industry and blueberry industry, our late season or OP applications are all dictated by this pest. These are the ragaleedes (phonetic) fruit flies that occur in the eastern part of the U.S. and in very low densities in some parts of the west.
But these things drive OP application late in the season. This is what puts residues on fruit. We have a very elaborate monitoring system that we've been working on since the late 70s to growers -- growers to use monitoring tools such that they could go in and spray only when they were required to.
And in most years -- one out of three years -- growers only put on border sprays for these pests. But every third year or so, we have to go in and eradicate, if you will, inside a tree fruit orchard so that we reduce that population below economic levels or detection levels with our monitoring system, and then go back to a border spray strategy.
If we lose the ability of OPs to go in on this system, we lose our industries associated with this pest. Well, unbeknown to us, we had this monitoring system in place from the early 80s. I did a lot of research on it when I first went to Michigan State. APHIS has been releasing a spotted napweed biological control.
And we have huge spotted napweed populations in the northern part of our state, and our monitoring system picks these flies up as well. And they're virtually indistinguishable to the untrained eye -- same size, same wing pattern, basically.
Guess what? Our OP application started climbing up in some of these fruit-producing areas that were using this monitoring system. And what were they detecting? A biological control agent.
So, we had to go into a huge education program to get this thing done and get it done right. And now growers are wondering if they actually can identify them all the time because when you catch one of these flies on a sticky trap, it crinkles the wings, and it's hard to identify. You got to pull them off and get stickum -- that's how I lost all my hair, I got some stickum. Well, if you believe that.
So, one of the other things we've learned about trying to do this is looking at where we were at with conventional, where we need to go with alternatives, and the bottom line -- and you can sort through all of those and see how I rate those things. But the complexity index is going to go up 10 to 20X just to accomplish this stuff in a lot of these specialty crops.
It looks like this -- operation and biological complexity over time with biointensive IPM is going up. Producers bear that cost. Universities, land grant systems deliver that information. Who pays for it?
If we don't get more funding into extension, we don't do a better job of taking care of the people who deliver this information, we could never get it in the landscape. Private sector -- will private sector do it? Yeah, they are much more today than they have in the past.
All right. I'm going to get off pesticide alternatives and talk just a little bit about our IPM-ICM program. Michigan State University has struggled with its IPM program over the years.
Right now, it came back in the 90s because of growers. IPM Alliance Group led -- and we have a structure something like this. The key point I wanted to make here is that we're laying on integrators right now. And the way we're doing that is we're taking half the resources it cost for one of these persons, providing that out of public funds -- out of GREEEN funds.
The other half comes from the commodity area that wants one of those integrators. So, that person belongs to them, in a sense.
They're administered out of the University. They're trained, they're part of an overall team, but their -- half of their salary is the Vegetable Council or is CMI -- Cherry Marketing Institute -- or is the apple group in the state.
Those integrators are key to getting this complexity out there. They are the living history, if you will, of agriculture and pest management today.
We buy into this continuum of change -- incremental continuum of change in IPM-ICM. And what we would like to see is we would like to take some sustainable principles and close some of the input cycles in our agricultural system so that they're more sustainable over time.
If they're not profitable -- like we heard yesterday -- we're not going to be in the business. Boy, we've got to keep our eye on that, and we're trying to, and that's one of our goals.
We need environmentally friendly systems, and we're working that way -- ecologically diverse, but the right diversity that I mentioned a moment ago. They need to be biologically intense in my view, but that has some costs associated with it -- significant costs.
They need to be user friendly, or they're never going to be adopted. If you don't pay attention to the adoption -- sociological dynamics of adoption -- it's not going to happen.
And finally -- I mentioned before -- best practice. That's where it's at. We're not into ideologies in any particular direction. We want best practice in the field, and we want to put science behind it.
Our IPM program has done a very good job of involving NGOs, and we're seeing more partnerships. And I'm glad to see, Larry, that you showed up today. I don't know -- where are you now? You missed a really good session yesterday, let me tell you about it -- no.
Anyway, PEW Charitable Trust has pitched in to our apple situation in Michigan and is funding an implementation program it's moving out through the state.
And we also have Kellogg Foundation, the Michigan Environmental Council, who also have a representative on my advisory board. Michigan Ag Stewardship Association, which is a sustainable movement. The Mott Foundation, as I mentioned before, is involved in helping fund some of these things in the field.
I want to turn for a moment and just go to pesticide education because one of the things that's often overlooked is, if you make a label change, and you think that that mitigation has done the job, think again. Education is key in that process.
And we have an excellent pesticide educator and education program at Michigan State University. In fact, on FQPA issues, these really high quality brochures have gone out all over the U.S. and are used by many extension services around. Chris Defonzo (phonetic) should get a lot of credit for her efforts in that area. That comes through pesticide education program.
We're also partnering with IR-4 in that program, and we're going to try to do some national level extension of IR-4 pipeline chemistry kinds of thing through our pesticide education coordinator.
I want to turn to use and usage data because the QUA and QUA Plus System were key to setting up for use and usage way back when when we first started doing some of this stuff in '94-'95.
Our intent in Michigan was to develop a system to collect unaggregated data and to put that in the databases that were public and up on the Web. After my presentation last time to TRAC, somebody said we're going to FOIA for that data. I said, don't bother, it's on the Web. It's a great tool. I know EPA is doing the same thing. It works great.
We wanted to review the accuracy of the data, and we have an ongoing reviewing process -- trying to check for errors. That's a huge job -- it may be an endless job.
We also need to assess where are the holes for this use and usage data in the field? What crops are next in line, and we have a process for doing that that's committee-based. And we're trying to fill that data through a cooperative data gathering system, which I'll show you in a moment.
And we're trying to prioritize that gathering system across the state, and we're moving out regionally now -- cooperating with Cornell, for example, in some of our vegetable surveys.
In terms of data collection efforts, it looks like this -- and you got a record of it there. We've invested across, we've tried to capture information for this data process, and we borrowed heavily on states like California, and Washington, Oregon, because of our commodities -- and the New York system.
So, our data collection system looks like this. It focuses primarily on our area of expertise teams and extension. There would be a tree fruit area of expertise team, and they have responsibility and linkage right down through to growers.
So, we set up a structure involving them in a process and involving the MIPMAT crew in collecting that information. And if you want more information on that, you can get it off our website.
The next thing I'm going to report on is hot off the press. This is some of the cooperation that we've tried to forge with NASS to get a vegetable survey done that would add critical new data in our state; but hopefully nationally, that would be appropriate for doing the kind of risk assessments that EPA has to do.
So, this is -- this new veg-chem survey system that we ran in Michigan Enterprise System is delivering data on applications rates -- actual rates of application. When a pound is on the label, we're finding that a lot of celery growers, for example, on azinphos-methyl are not using that -- that high a rate. And, in fact, are cutting rates all the time -- something that we've maintained to EPA from the beginning.
We also have data now on pre-harvest interval. When was the last application put on? The legal application is seven days, but most of the people are out at twenty-eight days. What kind of impact does that distribution have on risk assessment? Pretty significant, I think, in time.
We're also capturing data on target pests now in this survey. This is very important because it links up into the crop profile information that USDA OPMP is doing and will give us a lot of information on how our extension programs and information delivery programs are actually impacting growers from a state and a national basis -- critical.
A good thing to point out here is that more than 50 percent of the Guthion or azinphos-methyl that's used in celery production in Michigan is targeting leaf-hoppers. Somebody might scratch their head and say, well, what's so big about leaf-hoppers?
Actually, leaf-hoppers don't do any cosmetic damage to celery, but they transmit astrayellows (phonetic), which can devastate the crop -- make it unsalable. So, they're trying to prevent transmission of a microplasmo-like organism or a phytophasma to the celery plant.
Here's the key -- the knockdown feature of a nerve toxin like OP is key to that process because if you excite those leaf-hoppers and you move them from plant to plant with a new chemistry that may be effective in 24 hours, but not in minutes, you'll actually exacerbate it -- transmission of the disease and cause a disaster in the crop.
Pretty important information to have. You could say, oh yeah, that's an alternative. Well, it causes disease transmission to jump up. It's really not an alternative. It causes financial devastation of the crop. It's not a true alternative.
So, I want to transition away from use and usage and go to crop profiles. Michigan State University is participating in that. Typically, we've put together a team, and here's a report on where we're at. There are two of those completed. There are eight near completion, and a whole series of additional ones are underway. We hope to have all of those caught up by the end of this fiscal year.
The last thing I'm going to talk about is bridging data and our residue mitigation efforts in various crops. And this is -- represents true integration, true partnership, true reaching across the regional and national resources to accomplish this.
First of all, I want to report to you where we're at on OP residue mitigation in terms of our apple production systems. We've actually done work on this since the late 80s -- looking ahead to what we would need to do as we lost some of these compounds and as the issues of residue are coming on.
Right now, we have no viable alternatives for two pests in apples in Michigan -- plumcurculio and apple maggot. And what we've done is, is that we've been able to target half-sprays of organophosphates to control those pests. What we wanted to do was, what are the consequences of that in terms of residue?
Well, we've got the residue as a result of washing, we've got it what happens in storage, what happens in different slice concentration juice. Basically, we can mitigate that residue down to about 10 parts per billion, and in some cases, undetectable levels.
And the way we're doing that is, is that we're not only doing it in processing, but we're also doing it in the field using half-rate applications, using alternate row applications, using border sprays as I mentioned before, extending PHIs, and paying attention to post-harvest washes.
Our processors are picking this up, and even some of the processors have now invested beyond Gerber -- invested in G.C. Masbeck (phonetic) to do some of this cooperatively.
Our bridging data cooperative project involving Region 5, Michigan Department of Agriculture, Michigan Farm Bureau, commodities, various other stakeholders -- we set out a series of goals to accomplish this. This project was about a quarter-of-a-million dollars that came out of Region 5 into our state to accomplish this.
We wanted to develop real world bridging data. That is, when applications are put in the field, what are the consequences downstream at harvest, in the processing, clear to consumption?
And we wanted to develop a methodology that would be useful to other states. I think we've done that, and we're starting to get buy-in from in the Midwest in what we call Comprehensive Residue Management Program. It's really a Hassett (phonetic) program.
And this program has got buy-ins from Michigan Department of Agriculture now, various commodities. Michigan State University has committed one technical position. MDA has committed part of their lab to do this as a service function to industry through this transition period of FQPA impacts.
Last year, we did these crops. We're going to try to continue this system. There's more information in there on it. I just want to say that we've developed standard operating procedures. Some of these are very important. For example, the chain-of-custody issues are huge here because growers needs to be anonymous in this process, or you won't get their data.
So, if you hook up a regulatory organization with a grower who is submitting information, and he's -- and that operation may get nailed because they put that information in when their goal is to reduce residues, et cetera, it could backfire on you really quickly.
So, this sample submission process is a ticklish deal. And Michigan State University has been very effective, I think, in working with growers and assuring an anonymous nature to this data collection and providing that.
We've developed these protocols and have those available for other states, and we're seeing broader buy-in. We're hoping that we can sustain some national funding in the future so that we can get down the road faster.
I just want to give you one example. You have a handout there that summarizes in bullet form all of those crops. I just want to use grapes -- some statistics on grapes. Michigan ranks fourth. We have about 12,500 acres, 61,000 tons -- about 95 percent of it is juice. It's where Welch's grape juice comes from -- Michigan.
Five percent goes into wine -- ever-growing percent as producers get diversified. This is what our sample system looked like. We had 20 growers who volunteered to participate in this. We also had five research plots on outlying experiment stations on grapes where we were looking at a target pest -- grape berry moth -- where we were comparing conventional OP versus a sprayable pheromone.
Kept the fungicide program the same across the system. Took samples through that system, and this is kind of what it looks like -- some of the data.
Focusing again on OPs and B2s, this is the maximum legal amount that could be used. This is the PHI that was legal, and this is what we found. These were the use rates the growers were actually using in the program, and these were the PHIs that they had.
Would that information be useful in doing risk assessments? I think so. So, development of this kind of real bridging data, I think, is key to the future of the life of these kinds of compounds and their use in Michigan production systems.
This is the actual detected residue levels that we found in the system. Looking at our LOQs -- or limit of quantification -- what number of positive samples we had, what kind of tolerances are legal, and what our actual levels of -- our detection levels were.
In some cases, these mitigation measures that we incorporated are very significant in reducing residues. So, we think that this kind of study has broad over-arching significance to what's happening with FQPA today.
It could be incorporated in the use -- in the lifeline model. It could be real-life scientific information that's replicated and statistically valid for doing a risk assessment. And we have a chain of custody all the way from when the pesticide was applied right through the raw and processed system. And we're planning on extending that in the future.
It also gives really good data on
alternatives -- what they actually do, and how they actually impact the system, what PHIs were involved, how important IPM is, and what role processors can play.
We're getting more and more processor buy-in as we move down this. In fact, we formed a task force to address this area. I hope that we'll have a similar program to 1998 this year in the field.
Still iffy because it takes very substantial resources and a tremendous commitment on the part of our Michigan Department of Agriculture to carry a program like this off as well as our regional partners in EPA.
We're adding processors all the time. As I mentioned before, we're trying to stay abreast of EPA, track FQPA changes so that we can build these programs so that they're very timely and address the major issues.
We are incorporating biologicals. We're trying to build bridges where it's appropriate, and we're targeting high-profile commodities -- so called risk-drivers -- or whatever language you want to use.
We're trying to support the crop profile projects with this kind of data, and obviously, resources are the key. The program will only be as good as the resources that we have to do it.
I would just like to summarize or leave you with these thoughts as I finish up. I think there are critical questions that remain. Certainly, the worker protection issues that we developed yesterday. They're not really FQPA, but FIFRA questions. They haven't gone away. They have always been there. We need to address those in a broader way -- not always, but since FIFRA.
But there is also something else out there. What about the endocrine disrupter effects? What about pipeline chemistry? Are alternatives going to be true alternatives given our new high through-put testing for endocrine disrupters? I don't know.
We're going to have to take that into consideration. Cumulative -- Michigan is going to go ahead and do a cumulative analysis for the state as limited as it's going to be using our database system. We're going to try to do that so that we can be proactive. So that we stop burying our head in the sand, and we look at what's coming, and we try to line up and do the right thing for our producers.
So, we're going to go ahead and do that even though it's quite controversial. And we're still trying to get at the true use and usage patterns, especially as we develop alternatives because the pesticide issue, I don't think, is going to go away. I think it's going to be with us even beyond where we're at with OPs and B2s.
I think we're going to be facing similar kinds of things with synthetic pyrethroids and even with some of the new pipeline chemistries which have long residue issues associated with them.
This issue of real alternatives -- I think we need real science when we approach real alternatives, and that's what we're trying to do at Michigan.
So, that's what I've got for my presentation. Thanks for your time. It's a real golden opportunity to tell you what we're doing.
MR. EHRMANN: Are there any questions -- just quick questions of clarification, et cetera? We'll come back and integrate some of this into our overall discussion on the transition.
Also, let me note that -- as I mentioned yesterday -- at the Work Group II meeting, we had a presentation from Jan Relford at Gerber, where he explained their approach, and Mark referenced that in terms of the peach production in Michigan this year.
And we also had a presentation from Sarah Lynch from World Wildlife about the potato -- collaborative effort on potato -- (inaudible) -- in Wisconsin that she has been involved in. And she had given that presentation at an earlier meeting as well, but I think we wanted to do that, and Mark was able to give this presentation here.
So, I think between the three of those, it
gives some examples of the kinds of activities that are out there as it relates to transition issues. Jay, comment?
JAY: Three points. One, I think that the most important message I got, Mark, was an integrated approach -- both in terms of practical field application and the growers' alertness, and education, and thoughtfulness about what they're doing.
And second is integrating the expert disciplines that you're working with across the state. And I think that that's the model, as I understand it, that USDA has been applying in the work that Keith has been leading over the last year or so that -- to really get USDA sort of approaching this in that way. Is that correct in our other states -- doing things similar to what you're doing?
Second point is, you kind of -- I think you probably have -- maybe unintentionally -- glossed over where's the worker protection component in everything you're doing? And maybe you could speak to that a little bit.
And then the third question is, how are you finding ability to handle what we classically -- from the registrant community -- would call crop loss damage liability at less than label rate? Who's assuming the liability, if and when there is crop loss, when less than labeled rate is used?
And I think that universally you'll find registrants unable to be a legal party to that kind of activity because of the crop loss liability questions that we have a lot of practical experience with.
MR. WHALON: Well, other states -- many of the other states have similar integrative pest management programs -- many of them more robust than Michigan State University's program. In terms of an overall systems approach, I think we're unique in that. I could be corrected, however.
I think the issue of partnerships is strong in the land grant university tradition, and the issue of service is very strong. I think that FQPA did something that nobody could have anticipated. I do have a slide on this, and I didn't put it in because it's a little controversial.
But the idea is, is that agriculture has been very disparate and going in different directions. And many minor crops are especially in this form. And to get those people together in the same room is like herding calves. I mean, it's very difficult.
FQPA put them all in the same room and gave them a mantra to go on and a place to go. And so, what we've been able to do in Michigan, I think, is that we were just timely. We were lucky in a sense that we had been building towards this, and then FQPA hit, and all at once, the grower says, yeah, that's the direction we got to go.
So, there's serendipity involved, too, in where we're going. And I think it's -- for agriculture, FQPA actually is a tremendous opportunity to get some things done. And I've been implementing IPM long enough -- and, Mike, you could comment on this, too -- is that you have to be ready with the system when the opportunity for implementation is there because there's a lot of resistance to change.
If things are working, and they're profitable, people are not going to necessarily just helter skelter develop change. So, you got to be ready with a system that they can see, and believe in, and grab ahold of, and test. It's got to be trialable, it's got to be implementable. Those criteria have to meet, and that's what we're trying to do.
In terms of worker protection, I did gloss over it, and the reason was is that I didn't think that right now in this presentation would be appropriate because I was asked to do the FQPA part.
Michigan has done a lot on worker protection. We're -- well, I mean, we're a manufacturing state, and we got big unions, and ag-labor's unionized. And so, I mean, we talked about ACH acetyl cholinesterase testing, depression yesterday. We've done a lot of that, and it has been forced on the state in some forms.
But a lot of that was abandoned in the 80s because they couldn't find much depression. You know, I mean, so, I don't know. We probably need to go back and visit that and dig up that data.
We were forced to do all -- do that routinely for all of our field scouts. I know Robin doesn't like the term, field scouts, so I say pest management field assistants in the field.
In terms of crop loss and damage liability, the University -- like many institutions has a bunch of legal eagles that they have, and this question has come up repeatedly. And not to poke fun at Texas, but I was down in Texas one time doing an IPM conference, and at the very end of the conference before anybody got out of there, all the Extension guys were there.
And I was sitting up on the podium, and they introduced this legal person from their office. And, basically, what the message was, is if you didn't implement this and recommend this program exactly as we've outlined it, you're outside the system, and if you get sued, you're on your own.
That hasn't happened in Michigan. We've not been on our own. And although we don't come out and recommend half-rates, or quarter-rates, or anything like that, growers are doing experiments all the time. Growers are trying this all the time, and they talk.
And so, when I first came to Michigan, they used this term, we're cheating, we're mining our pesticide bill. And look at this, oh, and they're going on, and communicating that way.
So, whenever you have a grower panel, it's always a lively discussion. And a lot of that information is not transmitted by Extension, but by the grower community itself. So, so far, we've avoided the litigation issue and the liability issue. It's a big one, and we're cognizant of it, and we educate about it. MR. EHRMANN: Okay. Let me go to Nancy and Margaret, and then we'll take a break. Nancy?
MS. RACHMAN: Mark, I'm curious about your process for identifying pesticides-at-risk, especially the regulatory component, and how you deal with this sort of evolving landscape of risk assessment methods and science policies, where, you know, the answer is continually changing.
MR. WHALON: Yeah, a really good question, Nancy. The way we're doing that -- the nice thing about databasing is once you have a flat file in a bunch of categories, you can change your weighting factors, you can change your analysis pretty directly.
And, in fact, most database shells today -- we use Access and Oracle -- but most database shells today allow you to do almost changes on-the-fly. And so, for example, I would make runs during the hot political days in the state of trying to get GREEEN funded.
I would sometimes be called on to give an updated run in 20 minutes, and we could deliver from our databases. We would just change a weighting factor, or we would -- the vice provost would call me and say, what if? And I would grab my database guy, and I would say, what if? And half an hour later, here it was, and we would just pass it through the system and kind of analyze it.
The big issue in all this changing landscape is, is that information, properly formatted, can be manipulated in many different ways and delivered in useful packets and byte sizes. The key is to get it into that useful format. So, that's what we've tried to do.
MR. EHRMANN: Margaret?
MS. WITTENBERG: Well, since I'm the only consumer-oriented rep left, I just wanted to say a few things. I do want to underscore what Mark said about FQPA being an opportunity. And I think what he suggested as far as what they're -- Michigan is doing, I think we need to use that to communicate out to the consumers about how successful -- I'm going to say again from yesterday -- how successful this whole process really is in getting the people to the table that really haven't talked together before.
And I want to also underscore that we need to make sure that the message is that we know there are risks with pesticides. Denying it is one of the worst things you can do for a consumer because then they know -- they aren't going to listen at all.
They need to know, yes, there are risks, but there are, perhaps, ways to mitigate it. What Mark is doing, what Gerber has done, World Wildlife, you know, Steve Pavich with Organic -- these are all options. And the consumers need to know that, again, the questions are being asked. We're looking at it. This is the best information we know at this time. We're continuing to look.
The communication between the groups is going to continue. We're looking at all the stakeholders, and what is important to them in trying to come to some -- not consensus so much as just an understanding that sometimes we're going to agree to disagree, but here is some areas that we can agree on.
But, again, we need to let consumers know that the communication is going on, the questions are being asked, and some programs are really being explored rather than just saying, pesticides are just fine. This is a bunch of ridiculous talk.
So, whatever we can do in the transition phase to get this communication out there, I truly support.
MR. EHRMANN: Jim, you had a question?
JIM: Yeah, two real quick questions, sort of very, very specific ones. One is, do we -- either on the Web or do you have what would be kind of full-page slides -- these are kind of hard to read -- some of them -- and you can kind of ran through them. I would hate to be in the class that was trying to take notes from you.
I did ask Peter if any of this was going to be on a final, but -- number one, so, just if we can get a copy -- and other members of TRAC may want that, too, I think, because there are certainly some things that I want to see to speak -- (inaudible).
MR. WHALON: All the slides I used today and about 300 others are up on the Web. If you have Powerpoint, you can pull them off. And on the bottom of every page on the handout, is a website.
JIM: I got you, okay, great.
UNIDENTIFIED MALE: This is normal size for Extension slides.
UNIDENTIFIED MALE: And secondly, because Jim wasn't here yesterday, but it's good to have him back.
JIM: Just a real quick -- well, that's one opinion. Specifically, too, if, you know, starting at some baseline point -- like, I don't know -- pick three years -- you know, before FQPA, per se, or something, and you walked in, and you and/or Mike were asked, you know, gee, this is a really great thing. Are we doing this in my state -- whatever that state is.
How much money would it take? I mean, obviously, there's already a lot of resources -- land grants exist, and all that -- but what is sort of the increment in ballpark kind of numbers or a range?
MR. WHALON: For the pesticide-at-risk program, actually, we funded the pesticides-at-risk program out of Ag Experiment Station money. And we funded it, initially, at 25,000 a year.
It runs right now about 35,000. The grants program was 1.8 million last year. The commodity buy-in -- commodities in the state buy-in to the University to foster this was about 3.2 million to get down the road in research.
MDA's buy-in we don't have good figures on because what it mostly was, was time -- payment-in-kind, really. So, it was technical assistance and access to their residue lab.
Since 1991, Michigan has done market basket surveys, and this was part of their market basket survey program. We just expanded it, so there was buy-in there.
In terms of the pesticide alternative database, it's kind of a black hole because there's three levels of information. There's real hard science reference journal information out there, and right now we have about 5,000 articles on pesticide alternatives in our system.
There's pretty good information, especially from IR-4 on pipeline that we're -- for minor crops that we're using, and that's pretty straightforward. It didn't cost us anything to get it, but it cost us some to set it up.
And then there's this soft literature that's in the popular press that comes out in grower magazines, that comes out in newsletters, et cetera.
JIM: Let me just interrupt a second. For example, I mean, obviously again, there's a lot of established infrastructure and, obviously, every state will probably want to have some grower contributions and all that, but is there a round number even within a range of what the, quote, new governmental resources are made available that could help do this in all or in part?
I mean, you know, I'm doing a real quick math what you just said -- a million bucks, five million bucks, half-million bucks -- what kind of numbers are we talking about?
MR. WHALON: I think it's -- I think without the research part of it -- just an infrastructure part -- we're talking a half-a-million to three-quarters of a million per state to do a similar kind of thing to what we've done.
MR. EHRMANN: Good, good. Thank you very much, Mark, for the presentation -- very helpful. Let's go ahead and take a 15-minute break, and then we'll come back and pick up with the USDA transition discussion.
(Brief pause.)
(END OF TAPE)
MR. EHRMANN: -- have some discussion of transition issues. Again, I would encourage folks to, kind of, reflect on the presentations we've had, both for those who were able to hear the Work Group presentations -- either get them in here or shut the door.
Heard the presentations from Gerber and World Wildlife at the last meeting, and, of course, Mark's presentation this morning related to transition issues. And think about some of the approaches and issues that were raised in those presentations in the context of what Al's going to review for us in terms of some of the work that USDA has had underway and will be continuing, obviously, as we move into the latter phases of the overall decision-making process on the OPs.
After that discussion, then we'll have an opportunity for some discussion about the TRAC itself -- future meeting, et cetera, take public comment and, again, we'll adjourn by 1:00.
So with that, let me turn it over to Al Jennings to lead this discussion.
MR. JENNINGS: Okay, thanks, John. It's always difficult to follow Mark, but I'll give it a shot here. I think probably one of the things you obviously picked up from Mark is that change in pest management crop production is difficult, it's expensive. I think the positive side, though, is there's a lot of work that's already underway -- not just in Michigan, but in a number of the land grants. And I think some of the issues that we have to deal with at USDA amount to how do we package the work that's already underway? How do we promote it in other areas? How do we establish some priorities?
And maybe most importantly for the Department, is how do we feed all of the good work that's already underway and that we'll be producing more of? How do we feed this into EPA's risk management process so that we can come out with sound regulatory decisions and a roadmap for the future?
So, think of a lot of what we're talking about here as work-in-progress. In some ways, it has never been done before. But in other ways, it consists of a lot of familiar steps. And they are familiar because, in my mind, we are characterizing the past. What has agriculture done in the past in response to a regulatory action that limits, restricts, cancels a particular pest management tool?
We have gone through this before, and I think, again, there are familiar steps. What is new is to try to do the upfront thinking and planning. I think we're moving into an era where we can't afford to try to react to each individual chemical decision. But as I said yesterday, we do have to look at crop production and categories of chemicals.
Let's see -- let's look at the first area here, and these are thoughts, ideas -- and if you will, perhaps, an outline ultimately of a transition strategy on a national basis. We clearly have to establish priorities and think about which crops we can and should do first.
Right now, our plans are to come up with three or four high priority prototypes, run it through the system, and see how it works. Obviously, one needs to think about high consumption patterns as an obvious target. Again, no surprises here.
Through our PDP data programs as well as other residue monitoring programs, we should probably look at high frequency or high levels of residue in those crops -- essentially the exposure side of the equation.
One of the key items in my mind is that we do need a well organized grower group or, certainly, as Jan pointed out, an interested processor. I don't think the transition strategy process will work very well if we do not have grower buy-in that will be -- I think, again, as Mark emphasized -- partnerships are important. And the growers are clearly not only a partner, but in many ways, leaders in this process.
Well, secondarily, we should think about the chemical or chemicals. As I said, we have -- agriculture has in the past reacted one chemical at a time. EPA risk assessments have indicated the need for change, and agriculture has done that.
In this era of FQPA and organophosphates, though, we do need to think much broader, and the obvious second choice would be an entire class of chemicals. We've all spend a lot of time here talking and thinking about the organophosphates. That's a logical choice, and we probably will be pursuing that.
But at the same time, we can't afford to ignore, probably, the next group of chemicals down the line -- the carbamates. And part of our transition process has got to be thinking ahead, not just, again, reacting to a group of chemicals. Maybe that's doable, maybe not. But certainly for now, organophosphates with keeping carbamates in mind for the future.
And quite possibly some combination of events here. Mark threw us all a curve when he said don't forget about the endocrine disrupters, and how successfully we can incorporate that at this point, I don't know.
Just in my mind, again, an important part of any transition strategy would be a clear statement of goals. And along with that, how do we measure progress as we are moving from one variety of pest management to another?
Certainly, again, reflecting back on the which crops first, we probably need to keep in mind frequency and magnitude of residue detection. Well, how do we do that?
Certainly, the pesticide data program has done an admirable job of helping identify which foods have which residues, but it's very expensive. And the program has tended to take a one, two, or three-year snapshot of what residues exist on a particular crop and then move on to another food.
The idea is we need to gather as much information as possible on a very large number of foods that are produced in the United States. We need to think about focusing, perhaps, a continuing monitoring program on some of these crops.
In my mind again, it would be different to routinely monitor than the current program. We could possibly get by with fewer numbers of samples. Currently, we shoot for about 700 samples a year for each crop. I think the question is could we get by with 70 or some smaller number as an ongoing monitoring program? Again, it would be a slightly different twist on where we are with the PDP program.
An alternative, or maybe an adjunct, would be thinking about how to use our national ag statistical service use surveys. Is it adequate just to monitor what pesticides are applied as a surrogate or an option for looking at the actual residues? It's cheaper. The information will be gathered anyhow. The information is not focused just on organophosphates. It would be on all pesticides used for a particular crop that's in the NASS surveys.
As I should mention here at the same time, we are talking about expanding the NASS program. Again, using Mark's presentation to its fullest, he did talk about some of the new work that we explored with Michigan, and we're certainly interested in expanding that level of -- extra level of detail -- collecting pre-harvest interval and information as well as target pest information in other states and expanding it to a much broader selection of minor crops. We think that was a success, and we'll be trying to expand upon that.
So, a transition strategy -- again, statement of goals and measurement of progress requires a lot of thought and possibly some redirection of some programs.
Then again, building on Mark's presentation, we really need to understand current chemical uses. A critical part of this process is what pests are driving the current chemical use patterns. That tells us what pests need to be controlled with alternatives. We need to look -- essentially, interim steps, if you will. Are there tactics that we can use to eliminate chemical residues, reduce chemical use? In other words, can we make progress on the overall risk picture while preserving some of the important niche uses of the organophosphates?
Along these lines, while we're looking at pests, we do have to understand the integrative pest management programs that are out there and in place. Many of these have been developed, as you all know, over many years with a lot of money and a lot of effort.
And we have to understand, I guess, the impact of modifying the pest management tool mix -- not only integrated pest management but resistance management programs depend heavily on the organophosphates.
So, looking at the pests and the control strategies that are out there -- again, a critical piece of any transition strategy -- which that, of course, leads us into what are the alternative pest management tools?
The obvious question is, well, what's registered for that particular pest and crop combination, and are there nonchemical approaches? Most likely, we're looking at some kind of a combination. Of course, going back to IPM and resistance management, if we do have to sort out how the alternatives might fit into those programs and look at research that would, essentially, rebuild integrated pest management resistance management programs. What are the barriers to adoption? The more we look at the pipeline database, we find there are lots of alternatives registered -- particularly if you look at the biologicals. EPA has done a good job of accelerating the registration of safer chemicals and biologicals over the last few years, but we tend to see products that are registered for all possible combinations -- all crops, all places, all pests. And growers have a difficult time adopting those new products because frequently they lack efficacy information. They lack the kind of field trial and research farm information that, again, Mark mentioned, that's a critical piece of being able to assure growers these products actually work and fit into IPM resistance management. How do you use these new products?
There are, I think, technical barriers to adoption of some. In other cases, there are economic barriers. Many of them are just not economically feasible at this point. And certainly, again, as Mark mentioned, there are probably social barriers to adopting alternatives that are out there.
So, because something is registered, that does not mean we can plug it into the current system. It means we need to look carefully at those options and do the research required to figure out how to put them in the system. Do they fit or not, and what modifications need to be made to make that fit?
Future options -- again, Mark mentioned the pipeline. We have -- we will, hopefully soon -- measured in weeks -- have the pipeline database up on the Web at our website. This draws heavily on the Michigan State system as well as the IR-4 system and adds to that the products that are in the queue at EPA.
We have gathered information on recent emergency exemptions that have been granted by EPA. You know, what we're looking for here is a strong indication that the product works and has been used. I think the emergency exemptions under Section 18 are a good indication that a product has those attributes, and it could be a registered alternative in the near future.
So, the pipeline is a fairly near-at-hand option that we're looking at and promising alternatives -- what's out there.
I guess research and education is part of a successful transition strategy. I don't think we can achieve all of the goals that we're looking for with existing technology -- possibly some of them, and hopefully, some positive interim steps at risk mitigation and risk reduction. But certainly, we need to ask the questions about research needs. And when I talk research here, I mean both basic as well as applied. We also need to think about grower education and training. Again, it's difficult to follow Mark in many ways, but it's also easy because he laid the groundwork for all these concepts.
The new technology that I mentioned before often cannot be adopted without a rigorous structured -- and in some cases -- costly grower education program. How do you use the new pheromones and other tools?
We probably should be thinking as well about incentive programs. What incentives can we offer? As it has already been mentioned several times, that growers will not joyfully jump into new, unproven technology. There's always some risk there. Is there a safety net that we can provide growers to adopt new pest management systems, and technologies, and incentives to move in that direction?
The successful transition strategy is going to have a long to-do list, and there will be lots of people who have a piece of the to-do list. USDA clearly is one of those. And I've already mentioned the crop profiles, the pipeline database -- those are underway.
The crop profiles are up on the Web, and we have a continuing effort to complete that project. And then looking down the road, we do need to think about how to keep them updated, accurate. In my mind, the profiles are growing a living document, if you will.
Certainly, we need to continue our support for the land grant institutions, and Michigan State and a number of others are pretty well out front. We need to think about how to bring some other land grants up to that level in the near future.
Agriculture research service and cooperative state research extension services are key research organizations. We need to make sure they're adequately funded. And perhaps more importantly, establish the research priorities -- perhaps with a bit more clarity in those areas.
The IR-4 program -- Bob Holm, who I was hopeful could be here today, but had a conflict -- is the new executive director of the IR-4 program and has done a great job, I think, at looking ahead at the regulatory picture, particularly organophosphates and reorienting the IR-4 priorities towards the newer chemistry. He has a very aggressive program of working with registrants to bring in new products online that feature the new chemistry for the minor crops.
I'm not going to read all this to you, but certainly, at EPA we think they have a to-do list. Clearly, one of the keys to moving away from the old technology is to get the new technology online.
And again, we have ongoing discussions about what new technology is there in the pipeline, and some discussions about how to juggle priorities from time-to-time. And I think that's an important feature for both USDA and EPA is to continue to watch that evolution and do what we can to accelerate it.
Again, in the incentives area, the Environmental Stewardship Program at EPA I think has done an incredibly good job at bringing a number of grower organizations into the process -- certainly into the regulatory process. And we need to see about leveraging some of those relationships that already exist and factoring those groups into the transition strategy process.
Let's just take a look at a couple of others. Grower organizations, as I've already mentioned, are key in this process and in some ways must be the leaders. They have the technical expertise as well as the personnel to support the process.
They -- because of their connection with their member growers -- are obviously key in the training and education programs.
Land grants, we've already talked a lot about. We don't need to discuss those any more. But public interest groups, I see having a role in this process.
I did not put on the slide -- and probably should mention -- the professional societies such as Wheat Sciences and the Entomologists. Again, these are the people who have the hands-on expertise in working with the pests and with the newer chemistries, though. I certainly see a role for those organizations.
Okay, now do not think of this as a hit list. It's not a hit list. This should not surprise anybody, but as we start looking at where to start on transition strategies, this list, and variations thereof, certainly come to mind. These are just the high kid-consumption items with some pruning.
And just thoughts here -- if we look at apples, we do have to keep in mind that there are multiple production regions. Mark's apple problems are much different from apples in the northwest.
So, if we talk about doing an apple strategy, I think we have to keep in mind we're talking at least two -- and maybe three or four different apple strategies.
If we are looking at peaches, again, there's probably not one peach crop. There are really two. There's a fresh and a processed market. So, we need to think about those. Steve is staring at me -- (inaudible) -- pears.
Okay, anyhow, again, this is not a hit list. This is just the -- look, folks, we all know that these are popular kids' items and certainly we've seen PDP data indicating residue hits on some of these products, so it's a starting point. And the question really is, well, where do we go from here? So, you know, a draft commodity list and then we have to go back to the beginning, which talks about, well, which crops first? We're working on that.
Then again, our thoughts right now are to try to get three or four of these crops started right now and, hopefully, have draft transition strategies in the next few months. Again, we'll be talking with grower organizations and trying to get them to work with us in this process.
At that -- let me throw it open for any questions and comments.
MR. EHRMANN: Thanks, Al. Bill Spencer.
MR. SPENCER: Under alternative pest tools and future options, the question, are there registered alternatives, and also, under future options, promising alternatives?
And, Al, I know you mentioned it in your comments, but back in the hotel that we met at where we had to stop talking like they do at the baseball field close to New York while the airplanes go over -- I think in this case it was jackhammers -- I think we agreed that -- the fact is we came up with a rather long definition of alternative -- but one of the very important parts of that definition of alternative was the word, economical.
And I know you used that, but again, as a grower, when I'm reading down the laundry list and taking something home with me to share with other people, I sure would prefer that, you know, when you put something like this together, you should -- or could say, are there registered economic alternatives and promising economic alternatives because that's one of the most critical points of an alternative.
Certainly, it would be an oxymoron to say that something is an alternative if it doesn't have the right efficacy, or interrupts your IPM program, or something. But again, with agriculture sort of hanging on by its fingernails, you know, I think we all agree that economical was one of the major concerns when we go to looking at alternative pest tools that are either currently registered or tools that might be in the pipeline.
And the other comment that I have, too, I don't see anything in here -- I don't see any question about what I think could be called unintended consequences. In other words, if we go to alternative pest tools, are we, in fact, instead of decreasing the amount of pesticides -- excuse me, crop protectant materials that us farmers are using, you know, on our farms, are we, in fact, going to increase the amount of crop protectant materials that we're going to be using on our farms because we've lost, you know, more effective tools that we had been using over the years?
So, I think you really have to take that into consideration. You know, you could definitely see the possibility of seeing the amount of pesticides that we use on an annual basis go up as we lose some of the effective tools that we've had the last, you know, 35 or 40 years. So, I think that has to be part of your strategy considerations. Thank you.
MR. JENNINES: Okay, thanks, Bill. A couple of very good points, and we do want to make sure we're not going in the wrong direction. And certainly the economics are something we can stress. Nancy.
MS. RACHMAN: This may not be exactly the right place to raise this point, so I'll just throw it out for consideration. It's something that has been troubling me throughout the process, but we haven't really laid it on the table yet.
Information I've seen is that in any given time of year -- considering many different commodities -- some 30 percent of the food supply in the U.S. comes from imports. And yet, that doesn't seem to figure either in the risk assessment process -- in the law, the way it was written, certainly -- in the risk assessment process at EPA or in the transition strategy of USDA.
And I think because FQPA has obviously got a public health focus, we need to put that issue on the table and figure out what it means and what we're going to do about it.
If the transition strategy is going to cause further shifts in the U.S. food supply, that's a significant thing that needs to be discussed.
MR. EHRMANN: Comment on that? No?
MR. JENNINGS: Maybe EPA should comment on that, but certainly the imports will be required to meet the same standards as the domestic production, with the exception of the worker protection issues.
MR. AIDALA: Al's right. I mean, I think the biggest underlying issue, and one that was -- that we've struggled with and we've talked about, I think, in past TRAC sessions is, to meet the safety standard if it's a non-detect, it sort of gets quickly balled up in the non-detect, and how do we value those, which is one reason we do the sensitivity analysis. We're more than aware of it. And, in fact, I think it's one of the things that we want to -- and I imagine even if we don't want to, we'll get comment on in terms of the non-detect policy. I mean, that's the underlying issue for all of us in terms of maintaining production, and the viability of the farm sector, and other kinds of broader issues even beyond EPA or USDA, per se.
It's just something that I think speculating about when they wrote FQPA, they were explicitly thinking about, I don't think so. But obviously, it's something that we are all worried about collectively. And I don't even -- in that, even other interest groups are not really, you know, sort of pushing it one way or the other.
If we're even getting into, sort of, secondary effects even though strictly as Al points out, if imported produce, then to what extent are we -- if we're aware of worker concerns? Are we just shifting those risks to other people? And what even just outside the law, you know, what do we think about that, and how would we consider that?
In terms of risk assessments and things, obviously, again, the standards, as Al says, are the same. And obviously, we are also not putting our head in the sand in terms of, well, if the official analysis says X, but we know something else goes on, that's something that we would consider.
Another issue unrelated in terms of FDA, is the FDA's ability to monitor and enforce. And the resources there are, I think, a legitimate issue, too, because all of us need to make sure that we're -- regardless of what you think the rules are, are the rules being enforced? Is it a level playing field and all that, too?
So, those are all issues that are very valid, Nancy, and we would agree with that.
MR. EHRMANN: Okay, Brad. Oh, I'm sorry. Keith, you want to make a comment?
MR. PITTS: Can I -- I just wanted to add -- reiterate that we haven't gone into it in a lot of detail with this group, but we have touched upon it. And I think it's while we developed a lot of the issue papers and policy papers on what are we doing non-detectables, and also this early assessment category.
And also, I think as we're going through these individual risk assessments, we are trying to make that assessment now of telling certain commodities, you don't have an issue -- as an example, with azinphos-methyl -- certainly at this time. And we want to be able to be clear with commodities on that as we move through this process.
And a third issue that Jim mentioned a little bit, is we do recognize those vulnerabilities even if we do get a good, no-detect policy in place, and an early assessment policy in place that we can't always control what's happening overseas, particularly on a worker perspective.
And one thing that the administration has put forward is some legislation to give FDA the authority to actually go overseas and take the authority one step further. And if we see a use that's inconsistent with U.S. laws, that we can also either halt those imports entirely or certainly put some sort of sanctions in place.
So, we do realize that's a vulnerability with our current food safety system. It's something that we are trying to fix.
MR. EHRMANN: Okay. Brad.
MR. LUCKEY: Good luck, Keith.
MR. PITTS: Yeah.
MR. LUCKEY: You know, we can eliminate the usage here, but you're never going to control what happens in a foreign country. I just don't see that happening. I think you're going to start a trade war that will be to the detriment of everyone.
Allen, I like your list under your action items. One thing on USDA on the third page, next to the last, you have grower outreach. Being a stubborn, independent farmer, I think we better move that up to the top of the list because that's going to take much longer than anything else you've got on that list to accomplish.
I think it's something we need to look at immediately. The farmers that I know that I work with on a daily basis and talk to -- most of them don't believe this process is even happening, and it's going to hit them like a ton of bricks when it does.
And I go and talk to people all the time and try and explain to them why I'm involved in the process. And they just look at me like, why do you even bother?
I think, you know, we all need to -- wherever you go and whoever you talk to -- is explain why this is happening. And it is, you know, a lot of it is for the protection of our kids.
One other thing that we looked at on your list -- draft commodity list -- I don't know why you're specific to apples being multiple production region when I think that applies to every crop you've got on the list. And the cultural practices vary from one county to the next -- not just across states or regions.
So, I think you could take that out and just, you know, broad-brush it. That, you know, there's differences in cultural practices for all these crops across the country. And are you sure you want to put bananas -- where do we grow bananas in the United States? MR. JENNINGS: As I said, this was a list of kid consumption, not of targets.
MR. LUCKEY: Okay.
MR. JENNINGS: In Puerto Rico, actually, we grow bananas.
MR. LUCKEY: Well, I always remember the comment that Bob Lake made when he was asked how much of the food entering this country do we check? And he said it's less than two percent. So, I think, you know, there's going to have to be an acknowledgement that some resources will have to be dedicated to make sure that the food coming in doesn't bypass what we're trying to do here in this room with FQPA.
It seems to me that, you know, shifting our dependence on fresh fruits and vegetables to a foreign country makes no sense when we can't guarantee that these pesticides haven't been used in the production of those crops even though they don't show up at the border.
You know, we can sit -- like Mark said -- take cherries, sit them and cool them for two or three hours in a cold water bath -- there won't be any residues. But it doesn't mean that that chemical wasn't used in the production of that crop.
But I think, you know, it's a little far-fetched that -- to extend the authority to go to a foreign country and start telling them how to grow it. I think we're stretching it a little bit there. I think that, you know, we can all think that, but from a practical standpoint, I don't know how far we'll -- we're going to get with that type of a policy. Because then we'll just get into tit-for-tat like has happened many, many times in the past.
MR. EHRMANN: Thanks. Wally.
MR. EWART: One area I looked at was in terms of future options and promising alternatives. You were talking about a database being put together. And as I listened to it, one question I had was, I assume that does not include new active ingredients for which there isn't currently a tolerance.
MR. JENNINGS: I'm sorry, Wally, I didn't --
MR. EWART: In the pipeline, you were going to put together a database?
MR. JENNINGS: Yeah. Right.
MR. EWART: That will not include new active ingredients for which there is not existing tolerance at this time. Is that right?
MR. JENNINGS: No. The idea is to put in things that could look like they should work that are not yet registered with the idea that part of EPA's to-do list would be to give that a higher priority.
MR. EWART: But that would include both a new tolerance plus active ingredients that have no tolerances at all. Is that correct?
MR. JENNINGS: Right. Right.
MR. EWART: Okay.
UNIDENTIFIED MALE: (Inaudible) -- I think, Wally.
MR. EWART: Beg pardon?
MR. AIDALA: New AIs, and then new uses, too, like expansion lists of already registered -- as I understand it, Al.
MR. EWART: Okay. And when will that be available to us?
MR. JENNINGS: Yeah, it will be up on the Web in a couple weeks, I hope.
MR. EWART: Okay.
MR. PITTS: Can I just -- Wally, you're more aware of our forum -- what we're doing right now than anybody else, but they actually are working with companies to identify products that they don't even have in registration right now. And that sort of information would also be in these pipeline databases.
MR. JENNINGS: Part of our pipeline is the IR-4 database. We're just going to work with them to get it up on the Web.
MR. EHRMANN: Okay. Elin?
MS. MILLER: Yeah, a couple questions. Al, what kind of feedback have you received on the quality of the crop profiles, and what kind of quality assurance do you have in place for them and their continued update?
MR. JENNINGS: Generally, positive feedback, although, obviously, there is variation in the quality from crop-to-crop, state-to-state right now. But generally good and useful information.
MS. MILLER: But do you have, like, a way to formally look at some quality assurance -- and especially, too, as things change over time, and we've talked about that.
MR. JENNINGS: Oh, and the QA that goes into it? Again, we're relying on the land grants to do this, and they all have adopted a peer review process that has, in fact, delayed getting vast numbers up on the Web as improved quality. So, these are basically all peer reviewed at the state land grant level.
MS. MILLER: Okay. The other question is, for integration into EPA's risk assessment process, certainly I assume some of this information is very valuable. Could we just explain a few highlights of the incorporation of the crop profile into EPA's risk assessment?
MR. JENNINGS: I would let EPA talk about that. But in my mind, while it may be useful for risk assessment, I think it's much more useful as we get into risk management and transition strategies. There are probably some usage information gems in there that have been useful in risk assessment. And I, again, don't view that as the main use of the tool.
MR. EHRMANN: Marcia, you want to comment on that?
MS. MULKEY: I think that's essentially correct. Because the crop profiles are focused on states and don't give you, sort of, national level information in a lot of instances.
Our use of them is primarily focused on risk management understanding and a qualitative -- although very valuable way -- the use of a sort of detailed -- at the detailed level -- the use patterns.
We might draw information from them to help us to think about what worker scenarios to run and that kind of thing. But they are sort of by their nature not designed to give you national quantitative values for such things as percent of crop treated, and so forth.
You know, about the matrices, which is also a collaboration between us and USDA, which is an effort to give them more --
MS. MILLER: -- a more of an aggregate --
MS. MULKEY: -- snapshot.
UNIDENTIFIED FEMALE: Okay.
MS. MULKEY: And the crop profiles provide a cross-check, if you will, to that information.
MS. MILLER: Well, that's -- it's kind of like a resource deployment, and how much time do we spend on looking at developing the crop profiles in detail versus some of these other tools to get you the right information through the right -- you know, in the right place at the right time.
And I think we're weighing a lot on crop profiles initially, but what I guess I'm hearing is it's not going to be much for the risk assessment, but later on when you're dealing with mitigation measures.
MR. JENNINGS: Correct.
MS. MILLER: Okay. And the other thing is, is I looked at Page 3, and of all the different stakeholders with input, I saw the absence of registrants. And
just -- I do think that, you know, there is some technical expertise at a minimum, let alone, hopefully, our whole research efforts and product focus for the future that kind of gets put into where the future is headed. And if we don't bet right, we're not in business. So, hopefully, we can --
MR. JENNINGS: Good point, Elin. I was not trying to exclude anyone. It was not a totally exhaustive list. You're clearly part of the process.
MR. EHRMANN: Okay. Mike Linker.
MR. LINKER: Al, it seems to me what you all are trying to do -- and I realize your office is new and you guys are new at this -- is develop a process. You know, you'll get a chemical in after EPA is done with their thing on it, you'll be the next people to know whether a chemical is in trouble or not -- at least an assessment.
And it seems to me, you're trying to set up a process by which you'll react to that, and handle it, and have a program to handle as these chemicals come out.
And I think a lot of people out there -- and especially if land grants are going to be interested in how you go through this thought process because what you have now is a list of sort of -- what I call thinking out loud things that, you know, you should think about and so on. But they're not weighted against each other and that sort of thing.
And eventually, as you start -- get into this and start allocating your resources, and then USDA starts sort of shifting around grants programs, which they have already started to do, people are going to start asking, why is this so important, and this not important, and that sort of thing.
So, you're going to get some hard questions down the line about this. So, I guess what I'm urging -- and especially since the TRAC people are already hearing together -- is to start solidifying your thinking some and put it in sort of process form the way we've seen some of the EPA stuff, so you can sort of look at it a little bit and think about, you know, of how your thinking is going and so on.
Because right now, as far as I can tell, every one of these have equal priority and so on. So, it would be nice to start, you know, just sort of getting that conversation going a little bit and to, you know, I think it would be very helpful to you, and I know it would be for me to know how that's going to work because a lot of people are real interested about your role in this whole thing and how that's going to work.
So, the sooner we can, you know, hear what you're thinking about, the better I think it will be.
MR. JENNINGS: Okay. Good point. We will try to fill in the many blanks. We appreciate any suggestions you would have.
MR. PITTS: Again, I think part of what we're going to be engaging in the next couple of months is actually working on a couple of commodities, and we're going to gain a lot of experience as we work through that process. It's a new territory for all of us as well. And I think as we engage on it, we're going to have something more clear and deliberative laid out at the time.
MR. EHRMANN: Tobi.
MS. JONES: Al, I think on your action item commitment and schedules -- kind of to paraphrase Elin's comment -- there's just another stakeholder that needs to be listed, and it's your state lead agencies that manage pesticide use at the state level.
And particularly in regard to using 24C in Section 18, since the states are involved in working collaboratively with EPA on those issues, and states try to use the existing guidance on Section 18 and 24C.
And I think in, you know, looking at issues of alternatives, eagerly pursuing those venues under FIFRA (phonetic) may cause EPA to re-look at the guidance, and communication with states is very necessary.
MR. JENNINGS: Good point.
MR. EHRMANN: And I've got Henry, Michael, and Bill at this point. Henry.
MR. ANDERSON: Yeah, I just wanted to ask a question as to -- it seems to me that this is pretty much a list and an approach we talked about a year ago. And I guess the question is, what in the intervening year now, what has changed on this? And where do you see the, you know, greater focus?
This, to me, is pretty much of a shotgun -- again, the first listing here, and it's clear that there's going to need to be a great deal of focus.
And I guess the question -- the second question is, well, when are we going to expect to see which of those commodities are you going to focus on as a strategy to be -- start with the children's issues as identified in FQPA?
And what is the information that's going to help you narrow this down, and what information has come in the last year to get us -- we're already, at least in the northern tier -- to a new growing season.
So, making any alterations for this summer period is pretty much gone. So, last April we started, and now we're, you know, a year beyond that.
MR. JENNINGS: Well -- and my hope is get three or four started and finished by the end of summer. What's new and what has changed, certainly, I've gained a much greater focus on what's driving the risk assessments.
I think until that process worked through a little bit further, we were all guessing about what might be driving it -- what use patterns, what crops, what chemicals. I think we just have to let that process mature a little bit to get the kind of focus I feel we now have to move ahead.
MR. PITTS: Let me just -- there's a process issue here I want to try and clarify. We've got a couple things going on. One is with individual chemicals. We've got a responsibility to work with EPA to make sure that the individual chemicals fall within their individual risk cups, and that's something that will be an iterative process that happens within the timelines we've set up with Phases I through VI.
So, that's something that we're going to be doing as we finalize these risk assessments. What we're talking about here with the three to four commodities -- and I think the obvious list to look at would be what you saw with azinphos is that what we're going to do is sit down and work on a, basically, cumulative assessment on those commodities and kind of sort through a process.
Now, we're at the end of the day, we've got a strategy in place that covers, you know, the regulatory needs that EPA has got to meet at the end of the day. But also, we've got something that we're confident that a grower group is not going to get caught flat-footed and not have pest management tools available.
And we've always viewed the incentive to bring people into this process with -- (inaudible) -- being up in the airs that basically those that come to us now -- EPA and USDA have -- are going to make the commitment to share our resources towards getting the situation resolved sooner rather than later.
And, obviously, the Department's not going to be able to do transition strategy on 100 commodities and guarantee resources so those commodities either coming to us or those that we're going to and asking for help now. And we have been doing that and pulling the data together. They're going to get our full attention in this process.
MR. EHRMANN: Okay. Thank you. Michael.
MR. KASHTAK: I'm Mike Kashtak from FDA Center for Food Safety and Applied Nutrition. Obviously, FDA enforces the pesticide tolerances. And the question was raised with respect to imports -- as the tolerances change, how much can we rely on checks at the border?
And I would point out that we have a major initiative with respect to reducing microbial contamination in produce. Last year we published a major guidance document. And the international side of that issue is one that we're giving a lot of attention to.
We involve the international agricultural community in the development of that guidance and continued outreach to the international agricultural community with respect, again, to pathogens is a major part of what we're doing as we're implementing our good agricultural practices.
We're continuing to work with foreign agricultural interests, and we're going to farms abroad and trying as much as possible --
(END OF TAPE)
-- road when perhaps the same kinds of circumstances apply to changes in our pesticide tolerances that call for interaction with the foreign agricultural community will have to be engaged in.
And the more that we can succeed in communicating our requirements to be carried out at the source, the less we will have to rely solely on checking at the border.
MR. EHRMANN: Okay. Thank you. Bill?
BILL: First of all, I would like to compliment the Department on the role that they have played in the risk assessment, and we appreciate that role that you've played, and I know EPA probably appreciates it, too.
And we recognize the fact, though, that your probably greatest role is still to come in transition and mitigation in the role that you can help there.
I would just like to offer -- and I know that you know this -- but I just would like to offer the tremendous resources that we have with our grower education programs. And we're willing to help in any way that we can with that transition process.
MR. JENNINGS: Thank you, appreciate that.
MR. EHRMANN: Good. Jay?
JAY: Just one general thought, and that is that I think it bears repeating that agriculture is a biological system and has always been in transition. And so, what FQPA impacts is a small part of that in the larger continuum but is very important.
And I believe that it is intended still to indicate that both USDA and EPA are thinking about this in the context of not if, but when, we get to the point of having to make changes.
And obviously, everybody expects changes. It's a matter of what those changes are, and the magnitude of changes in terms of use of the chemicals that will be affected and also future chemical registrations that have been referenced here a few times. But new products and new uses also are critically important in this overall transition equation.
Second point is, just for clarification, is it now given, and understood, and written in black-and-white somewhere that the land grant inputs that would come either directly or through USDA will be docketed into the individual pesticide risk assessment decisions that EPA undertakes -- is undertaking and will continue to undertake?
MR. JENNINGS: I think the easy answer is, I don't know. We've sent comments over. Maybe Marcia --
MR. ROSSI: I think that -- I didn't quite understand what --
MR. JENNINGS: Comments and, you know -- would be data -- land grant data and also interpretation -- land grant interpretation of the data that they would submit, either directly to the Agency on individual --
UNIDENTIFIED FEMALE: Yeah, we're responding to them, so they could all be part of the --
MS. MULKEY: Right. We have so far been treating that as an intergovernmental -- but not public process.
MR. JENNINGS: Yeah.
MS. MULKEY: And I think it would be useful to know what is the sense of different stakeholders about whether that ought to be -- the -- without going to -- the advantages of keeping it at intergovernmental is that you have a very high free flow of information. You encourage openness and so forth.
It's probably subject to FOIA at some point anyway. There are stages, you know, about deliberative process, and there's some of it that might not be.
But by the same token, there are advantages to openness even within the government. But we have, so far, been treating that more like an internal dialogue just as we wouldn't show you the comments from our various divisions on risk assessments. We've been treating this as an NA within the government dialogue.
But I think -- my impression is that we're open on that. But our current plan is not to docket that.
MS. JENNINGS: It might be helpful at the next TRAC meeting for us to have a little more discussion about what are the pros and cons, and, you know, where would that bright line be crossed. And, obviously, it's a work in progress.
We don't -- probably none of us at the TRAC member level know enough to comment on it right now, but if you could key it up a little bit more for us at the next meeting, that would be helpful.
MR. EHRMANN: Okay. Steve?
MR. BALLING: Al, I was looking at this commodity list, and I was wondering if you might have an extra office there at USDA for me to take over? I feel like I'm going to be spending a lot of time there.
MR. JENNINGS: Sure. Sure. Any time, Steve.
MR. BALLING: Is there any appeal process to get on this list?
MR. JENNINGS: Remember, this is kind of the NASS, you know, statistics, but anyhow, the list of things kids eat, so --
MR. AIDALA: What are Del Monte's leading commodities you want to put on -- spinach and --
MR. JENNINGS: Which one are you volunteering?
MR. BALLING: Most of them are already on it, so I don't think we have to worry. Well, we could argue about certain ones, but these are actually just based on foods children eat and not on residues, or lack of residues.
MR. JENNINGS: Right, right. This is not a hit list. Do not interpret it as -- someone will.
MR. PITTS: But, obviously, where we're going to be focusing our attention over time is what we're seeing coming up as risk contributors for specific chemicals. Even if we're getting something within the referent studies, the Department's just trying to get in the position of being proactive and anticipating that when the day comes that we do get to cumulative, there are some commodities that we're going to have to deal with.
And we would like to get a lot of the basic work done on that now. And even if we can -- you know, ideally, if we can solve the problem now, we would like to do that as well. So, that's the kind of position we're trying to get ourselves into.
UNIDENTIFIED MALE: Give me a call.
UNIDENTIFIED MALE: Should we add canned spinach?
MR. EHRMANN: Rich, you want to make a comment in terms of the overall discussion?
MR. ROMINGER: Yes, I would. I just wanted to say that this discussion is helpful for us, and I agree with what Bill said a few minutes ago. I'm sorry he's gone, but that we do see our role in what we're going to be doing from here on in the transition mitigation as important, and we'll be more and more involved in more and more activity at USDA in this area.
But we're not going to be able to do it by ourselves certainly. And Mark talked about all the partnerships that are going to be necessary. So, we are going to have to have the cooperation of Del Monte and the grower groups. And we appreciate all the help that has been offered in the educational process.
I was hoping Larry Elworth would talk about some of the education work that he has been doing with growers, but that's the kind of activity that's going to be required in order to make sure that we do have some reasonable, sensible, economic transition strategies as we move forward here.
On the import issue, that is one that we have been working on, thinking about. It's an area where we have had some experience in a different setting in meat and poultry inspection.
Because countries import meat and poultry to the U.S., we -- USDA -- go to those slaughtering and processing plants in those countries and make sure that their system is equal to the system that we have in the U.S.
And that as we heard, the FDA is looking at how they can do more of that in this area of foods and especially fruits and vegetables. So, I think we can build on that experience. Actually, we're doing it in some of the fruits and vegetables that are coming into the U.S. now from other countries where we are going to those countries and looking at their production systems, their processing, their packaging systems.
And other countries are coming to the U.S. and looking at our systems as well as we have more and more trade. So, we can build the experience we have there. So, we are going to continue to focus on the imports because our job is to protect the consumers of this country and the agriculture of this country. So, we're going to need help from everybody at the table in making this transition process work to the benefit of everyone. So, thank you for all the help you're going to give us.
MR. EHRMANN: Advance payment. Larry?
MR. ELWORTH: Let me just briefly respond to the Deputy's points there. At least from our experience that, if in fact, what you want to do is make it possible for growers to use different practices that keep them in business, then I think the point of a number of people is that you have to start with growers in this process -- that the federal government has a role in providing resources, adding expertise, helping to coordinate.
But, by and large, it has got to be done by growers. And as all of us know, the growers have to deal with a lot of things -- not just pest management. They need to make sure the economics are there. They need to make sure they're going to be able to sell their products. And they're going to need to have a system that's stable, especially if you're running a processing plant if you want to have a stable supply of a crop that you think you can market once you put it in a can or a container.
So, it really does take the cooperative effort of an awful lot of people here. If you are interested in implementation, though, you really have to work -- not just with the growers and their organizations. Those people have to provide the leadership along with the companies in an industry with the registrants -- in some cases, with the suppliers.
But you've got to have some fairly clear objectives, and it involves an awful -- the tools that we're going to be using in the future are much more complicated to use. They're harder. There's a real good chance that they're not going to be as effective in the same ways as the materials we may move away from.
Growers -- if you talk about incentives with growers to move away from one set of technology to another, it's going to involve economics. It's going to have to work. You look at whether a grower group thinks that FQPA poses a problem, it's partly what Brad is saying in terms of understanding of what might happen. But if you're a grower group that has a significant pest, you've got basically one alternative you're treating a large percentage of your crop with, and it turns out that that chemical may come under regulatory scrutiny, you don't need, you know, you don't need Crayolas to write this on the wall. Grower groups are going to face a problem in the future.
So, I think that's really the starting place for all this. One thing I would add to this, though -- my experience is that actually achieving results in the field for farmers -- which should be the ultimate goal of what we're trying to do -- is not an easy thing. We don't have a command and control program set up here. It's labor intensive, and it really requires managing our resources and our programs in a way that demands a whole lot more skill than we've been bringing to the table so far.
So, I would hope that whatever process we commit to not only commits to the understanding and the involvement of growers upfront -- it commits to a process to bring them in to make any decisions about how transition will take place. And really provides the resources -- not just for the technical side of it, but for the organizational investment it's going to take to make it possible for growers to understand and use these tools to document their use and be able to use it in the future.
And I think that's something that the private sector, by and large, is going to be in a better situation and position to do than simply the public sector.
MR. EHRMANN: Thanks. Any other comments on
the transition issue -- the presentation, et cetera? Robin?
MS. SPITKO: Just a very, very quick one.
MR. EHRMANN: Yeah.
MS. SPITKO: The University of Florida, as Charlie Mellinger knows, now has a doctor of plant medicine program. It's a Ph.D. level practitioner of independent plant medicine in the field. And I just -- in the list, I wasn't going to mention us because I didn't want to sound self-serving. But that is another tremendous resource for --
UNIDENTIFIED MALE: I was going to say, go ahead, everyone else did, but --
MS. SPITKO: Well, I figured everyone else did, so it's okay. But also that, you know, independent people working in the field one-on-one is a really effective way to make a transition.
And the thing is, it doesn't cost anything because the growers pay our fees. They're basically paying us for a weekly visit by a qualified person to sit down, present them with options, and help them with the transition strategies.
So, it's a really cost effective way. And now it is being recognized in the land grant system, and we've been asking for probably 10, 15 years for a Ph.D. -- like equivalency of a veterinary medicine degree for practitioners. And it is happening, so thanks for that.
And also, I think that that same kind of support for independent work with growers -- with certified, you know, educated people can be also a really effective tool in itself.
MR. PITTS: And of right now, we're kind of focused on the immediate of how we get through these individual and chemicals and cumulative.
But one thing that we are also working on is beyond our budget and the new grants programs we're trying to move forward through, which I think are very compatible with what we're trying to do with this OP pilot process.
We have put a lot of work in some discussions into the issue of regional centers, both with EPA and with the PPDC, and some of you with the TRAC are aware of it. And that is something that we want to move forward with is, you know, how can we regionalize our research agenda and not only have USDA resources going into the centers, but EPA expertise and resources as well -- and also pulling the industry in at that point. And having the work and the priority setting happening out there in what we envision being 12 crop production regions. And that means pulling the crop consultants in, and I think if you get that -- if you get that kind of group together -- consumer groups -- sort of a Michigan model -- I think we're going to make a lot of headway. And it's not something that we're going to just turn on next year, but I just want to make people aware it is something that we're working on. And that there is some interest up there on the Hill. Unfortunately, we didn't get this concept worked into this last budget process, so we're going to be working on it in the upcoming one and actually talking about doing a joint budget with EPA on this concept.
So, I think as we start thinking about our last TRAC meeting, there's a couple of things that Al and I feel like will be deliverable. And that is, transition strategies, obviously, having something done on a couple of chemicals as far as the review process we're going through with EPA. But then also, I would like to have a little bit more discussion about this regional center concept and what people see in that, and if it's something that we could get some support for from this group.
And I'm thinking out-of-the-box things -- you brought the issue of cost-sharing. We do have an equipped program over at NRCS. Pest management is one of the criteria for that. Cost-share money should be available.
I think the issue we run into there is that as priorities are set on a state-by-state basis. And I think that commodity groups that weren't aware of that program need to come us and get aware of it. And it's basically something that you have to work on at a state level. It's just how the program is set up and how Congress appropriated the money. But there is funding there to do those sort of things down the road, so --
MS. SPITKO: So, does that mean you're going to buy us all tractors with enclosed cabs?
UNIDENTIFIED MALE: Well, people are -- (inaudible) -- with them and things like that, so I do think that there is funding available there. It's just a matter of bringing the interest to bear on it. And I think a regional center type of approach could maybe help be a catalyst for that.
MR. EHRMANN: Just listening to this discussion -- and obviously others about transition, there really is this tension -- for lack of a better word -- creative tension, but tension between -- and Mike talked about this, and Larry, and a couple other people -- about the need for a process. How do the elements that Al laid out link together? What's going to happen first, second, third? What are the priorities in getting people -- as several folks -- as many people have said, and I think everyone agrees -- having the grower community and the other communities that are on that list engaged -- and at the same time not by reaching out and trying to create that process and solicit that engagement -- try to pre-guess and hence, you know, overly concern unnecessarily folks about the results of the risk assessment process, which is still underway. And how do you kind of do those things at the same time? And that's really, I think, a tension again that the TRAC has been kind of tip-toeing up to for quite a while.
There isn't any easy answer to it. I think everyone has through this process come to recognize, kind of, that push-pull. People are frustrated because there's not more answers; yet, you don't want to pre -- you know, go out and say to somebody, hey, you got a big problem, when they may not. But somehow -- and I think the work that Al described and Mr. Rominger emphasized that the Department is engaging here is trying to figure out what those elements are, invite people to come forward. As Keith said, those who come forward -- whether or not it's totally clear what the dynamics of the situation are going to be right now relative to the materials that they're using -- are going to get the opportunity to get engaged and be part of the process. And there needs to be a way to try to do that without at the same time saying, we've already concluded something before we have all the answers. And that's a tough back-and-forth. And then you lay over top of that the issues that Bill and others raised about, obviously, the economic context and the other realities that the agricultural community is facing. It's a complex matrix. But I think the Department is, basically, inviting folks to work with them on how to start unweaving that puzzle. And obviously, the Agency is doing whatever it can to assist on that end of the process as well. So, it's not, in some ways, going to lend itself to the same kind of process and structure that the scientific assessment process does because of the number of players, but it's similarly complicated. And I think we've seen that now reflected in a number of discussions in the TRAC. And I'm going to use that in addition to Keith's comment as our segue into thinking about the future agenda and process for this body. And I think the Department and the Agency are interested in your thoughts about that.
I'm going to ask Jay to make some comments first because he and his folks have given some thought to that issue and a couple others that I think set some context. So, let me ask him to do that, and then open it up for others to lay out your thoughts as it relates to the final meeting of this group, timing of that, potential agenda items, and other -- any other issues that are relevant to how the TRAC should operate down the road. Jay.
JAY: Thank you, John. I shared earlier with Peter and Rich a copy of the memo that I've had copied and sending around the table right now that addresses three thoughts -- three points.
The first is the April 27 TRAC resignation. I commend the Department and the Agency for the way you've handled this. I appreciate the fact that you didn't allow a small group of us to kind of fire the rest of us from this job. And I think that your perseverance and commitment to keeping the process open and allowing discussion and keeping the door open to those who made statements yesterday, I would recommend that we all welcome them back if they wanted to come back and reconsider their positions.
So, that's that. In regard to one of the points that Peter made in opening remarks yesterday -- and I noticed it was captured in the third sentence of the third paragraph of the letter that she sent to them -- I wondered if you might be able to clarify that for us and the public, Peter.
My suspicion is that you maybe didn't mean what exactly the words say in that sentence. But if you did, I think we ought to know that and know what that means. And I understand because I've got to correct myself in the second paragraph of this note that I -- in the blurriness of writing this on my wife's computer this morning -- didn't say what I intended to say.
So, if you could respond to that point. The second point I made is FQPA safety factors. I think we have come a long way. We've seen evidence of that. One of the points, though, that has come up that I didn't mention yesterday in my remarks about the pilot process is that it seems that there's a real chance that registrants and products that are going to come through the pilot and its permanent successor later will be not penalized, but actually advantaged because of the fact that the process is getting better, and we're learning. That's obviously a phenomenon that needs to be anticipated, but how do we make sure that that playing field across -- especially a class of chemistry like the OPs gets leveled out before, you know, final steps are taken? And I would just offer that as a suggestion.
Then lastly, on worker safety issues, while that's not, per se, the purview of the TRAC, I think that we have to as an advisory group recognize that it would have been addressed even if FQPA had not been passed. It was an issue that was getting more focused thanks to the rollout of the new worker protection standards that have been in place since early in the first term of the Clinton administration.
And that there's a lot more progress that has been achieved than might have been left as an impression or a perception after the discussions yesterday -- partly because I guess that we as registrants -- and I suspect the growers and the state representatives -- just weren't prepared yesterday. And so, my suggestion here is that you consider convening a meeting of the pesticide program dialogue committee sometime before the next TRAC meeting to focus on the worker protection safety issues and allow us a little more advanced running time to present some case studies of what is going on -- the investments that are made out there, and the databases that are out there that are viable -- some of which need to be updated, as Mark referenced earlier.
But it's not a total void as Dr. Anderson suggested yesterday after hearing the presentations. We do have information about worker exposures and the health effects. And we also acknowledge as registrants that there's lots of improvement that yet can be made.
But my suggestion in kicking this to the PPDC also would have a political advantage, which would be to invite friends back to that table since they're still on the PPDC and haven't resigned there yet -- some ideas.
MR. EHRMANN: Peter, do you want to respond at least to the issue around the clarification on the letter and any other comments you want to make?
MR. ROBERTSON: Sure. Thank you, John and Jay. I'm happy to try to clarify some. I will say that I don't think there's much different there than has been said since the very first TRAC meeting when we indicated that there was -- the two co-chairs at the time indicated that there was cause for concern about the class of organophosphates.
And I think it was Fred Hanson who said, you know, don't misunderstand, we're not about to get rid of the class of organophosphates, either. And that's certainly not what this letter suggests or is intended to suggest.
If you -- while it was included in my response to the environmentalists, I wouldn't suggest that it's not in some way sort of a call-to-action for this group in its entirety. You know, what we're seeing, I think, with azinphos and bensulide, and the worker concerns, and some of the other OPs that we have, you know, in Phase IV with the Department of Agriculture do suggest that we're going to have to take action.
And we can do these things, you know, sort of seriatim -- one-at-a-time. It makes a lot more sense to me to, you know, to work on them in the approach that Keith and others at the Department of Agriculture have been working so hard, and I think, so far, successfully from what we're hearing in a more comprehensive approach.
So, that's -- I hope that addresses some of your concerns, at least, with the first one, Jay.
The -- I'll also say -- just to jump to Number 3 about the -- I think your suggestion about the PPDC is a good idea. I, you know, we'll talk some more about the TRAC process yet to come. I expect to have one more TRAC meeting, and that doesn't mean, obviously, the end of dialogue. We have a lot of opportunities, and the PPDC is one of the main opportunities for that.
And you're right, the environmental community has suggested to us that they're going to continue with us. I hope they might, frankly, be a part of any last TRAC meeting that we have. But as I said in my opening comments, I think the worker safety issue was one of the issues where we could make some improvements in our efforts at transparency. And what I heard during the course of this last day-and-a-half, I've certainly confirmed that thought for me. And I think your suggestion is a good one. There may be others that we can carry out as well. I'll stop there.
MR. EHRMANN: Okay. Good. John?
MR. ROBERTSON: I was just going to ask Rich if he had anything to add.
MR. EHRMANN: Yeah, yeah. Rich, anything to add on that issue? Okay. Jon Jessen.
MR. JESSEN: Yeah, I wanted to the attention on worker safety here. I wanted to clarify that yesterday I was not trivializing the issues of pesticide toxicity of workers.
I agree that exposure issues need analysis, and I do think that we need good records and a good evaluation of the problem.
I don't see it the same as some of you people in the room. There are statisticians, perhaps, or people that work with numbers because, I guess, to get them coming out from a different experience.
And in our case, I have over 300 people that work full-time handling pesticides in either formulation or application. And it has been through good training and investment -- it has been several years since we had any incident at all -- any incident at all of pesticide toxicity. And those are, incidentally, records -- good records are kept, and they're open for anybody to look at that cares to.
So, I think it's worth understanding in this group that the tools we have in agriculture now can be handled safely. We do handle them safely. Our records are open for everyone to come and look at that would like to. And I just think that that's a point I wanted to make before we left -- that it's not -- it's not just a good old boy saying it's a bad -- there's nothing going on here. I'm not trivializing it, and I think that in my company, our actions speak louder than words. That we take it seriously, and we have solved the problems with the tools that we have at hand right now.
MR. EHRMANN: Thanks, Jon. Henry.
MR. ANDERSON: Yeah, I just wanted to say I greatly welcome all privately maintained data. And as you know, some of the other data systems that we heard about, in fact, are proprietary information -- and certainly any health data. My comments were, there isn't a national public surveillance system that has any kind of credibility to it that would give you a good estimate of is disease occurring or not? It may be at the private growers, but mostly the information is maintained by an individual grower.
And if people will come forward with data, that would be greatly useful to those of us in public health because it's very difficult, if not possible at this point, to get ahold of that type of information.
MR. EHRMANN: Okay. Let me just -- as we take additional comments -- just share some of the thoughts about the final TRAC meeting that the folks up here have been discussing. And that is, timing that would be -- rather than June, which I think, you know, was an initial thought -- given the amount of work to be done and the materials that are currently in the process and some of the issues that Keith and others have laid out that would potentially be on the agenda -- probably looking at more of a September-kind-of-time frame for that.
And some of that's related just to scheduling, too, it's tough to do things in August. So, it will probably end up being September.
So, that's some initial thinking. Nothing is nailed down. No dates have been -- you know, firm dates have been set or anything else. But I just wanted to give you that as context, so if you have a view different than that or want to reinforce that, or have other thoughts, let's share those, too, in the discussion we're having right now. Larry.
LARRY: Well, I missed the discussion of worker safety issues yesterday. I was funding an occupational exposure experiment in my crawlspace.
UNIDENTIFIED MALE: Eradicating his carpenter ants.
LARRY: I really do think that Jay -- I appreciated what Jay said about the PPDC here. I think that's a really appropriate place to deal with this. I think that a number of people over the last -- over this meeting and other meetings -- the Work Group meeting a couple, three weeks ago -- really pointed out that an out-come of this process has been a much more clearly articulated risk assessment process from the Agency. And it has been -- I think it has been really helpful and well done. I would hope that we could do something similar to that on worker safety issues through PPDC, which is I think is a much more appropriate forum. And I -- as a PPDC member -- I would like us to focus and really work on something that is not only useful to the public, but ends up really useful to the program in the same way that the tolerance reassessment process has been.
I would actually be interested at some point in hearing from the Agency on where they think the TRAC process -- or what -- I mean, at some point, we're going to be looking at some agendas that you all prepare based on whatever input you get. And I would be interested in what things USDA as the agency would like to get from a TRAC meeting in terms of either participation, in terms of presentations, or things like that. And if you're not at that point now, that's fine, but I would be real interested.
MR. EHRMANN: Any comments at this juncture on that? Okay. They will talk about that some in their closing remarks, if that's okay. Mark?
MARK MILLER: I would like to encourage the agencies to work -- not just to say that the environmental groups are welcome back, but to continue your communication with them and really, you know, encourage them to be here at the table. I think it's a great loss for the credibility of this panel to have them not here.
Secondly, I think it would be helpful to consider having a science panel look at some of the product of your reviews. So, take, like maybe -- you know, not every chemical, but one, or two, or three, and have them -- have the decision process looked at by a science group, which is obviously quite different than the group we have here today. You know, there's so many points at which decisions are made. For example, deciding to take a three-fold factor for a LOEL to a NOEL as opposed to a ten-fold factor.
But, you know, you know that there's a lot of different -- that's the art of the risk assessment there. And I think that just for your own feedback it would be helpful to hear from that sort of a group.
And thirdly, you know, I come to this as a pediatrician and thinking about children's health. And I think that in future presentations when you review the decision process, like we did yesterday, around the thinking about a particular pesticide, that it's really important to maintain the focus that was really a major issue of the Food Quality Protection Act -- and walk through in real detail how children's health has been addressed and considered.
You got to talk about the specifics. You have to demonstrate that the data is actually there to say that an extra factor for child protection is not needed. And that includes, you know, all the areas. We have to have the science basis and good data on food consumption. And you can't say, well, it's not there, it's coming in the future, or something. If it's not there, then it's incumbent to use the child protective factor.
MR. EHRMANN: Okay, thanks. Let's see, Nancy?
MS. RACHMAN: I would like to go back to the worker protection issue for just a minute. And this is more in the nature of, sort of, a long-range suggestion. We are clearly talking about a transition in American agriculture. I don't think anybody here can deny that at this point. Regardless of what happens with FQPA, there are some changes that have already started to be made.
Presentations like Mark's, like Jan Relford's, like Sarah Lynch's already indicate that the train has left the station in a way.
When I think back over how we've been assessing and regulating worker risks, it seems to me that the system that we have doesn't recognize or encourage the creativity, the inventiveness, the diversity of practices that we're trying to push out there when we talk about transition.
And what I'm wondering is, if it's even feasible anymore to do a sort of centralized national command-and-control worker risk assessment and regulation of worker safety. And maybe what we need to talk about at some point is setting some sort of, you know, performance standards -- acceptable exposure levels, and then letting the regional people or the states figure out the specific practices for the crops grown in their regions, and how the exposures really are occurring, and what they need to do to manage them.
MR. EHRMANN: Okay. Bill Spencer and then Dave.
MR. SPENCER: As a grower having been involved in this process from the beginning, you know, I have to say once again to both the Agency and Department how much I appreciate all the work that they have done in, basically, educating me and educating a whole lot of other growers out there on FQPA and the implementation of FQPA.
But I look at the agenda item, you know, that says, planning for final TRAC meeting, and I feel a little bit about -- a little bit like the person sitting in the movie, High Noon -- my favorite western with Gary Cooper. And, you know, we're just getting ready to the big gunfight scene, and the film breaks. And we don't get to see the rest of movie, guys.
Transition is going to be critically important for agriculture. Absolutely. And I echo some of the statements that I've heard around the table that, like Nancy said, obviously, the train has left the table here -- or left the station, and we're going to have to, you know, seriously consider transition for a lot of uses that right now us farmers are using as crop protectant materials.
But we've got that big thing called cumulative hanging out there, and I just can't believe that we're going to not allow somebody to break -- not allow somebody to repair the break in the film, and start the film, and let us go to the end of the process here because we don't know what the big C is going to do.
We don't know what's going to be left out there. And until that happens, we don't know how much more help this particular body is going to be able to give you based on what you're going to find out.
And so my two-cents worth is I hate to see this being called the final TRAC meeting when, obviously, there's no discussion at all from that part of the table to even talk about that part. And until we get to that part, you know, we really haven't come full circle.
MR. EHRMANN: Thanks, Bill. Dave?
MR. WHITACRE: I put my card up before Bill spoke, so there may be a similarity of message. But let me start off by saying I may be running through an open door, but the -- at the September meeting, or whenever we hold this meeting that you mentioned, John, that the prime topic ought to be cumulative risk assessment.
It is a topic that we've long talked about. It has been somewhat obscure, partly because of the size of the topic. When I say it should be included -- not only talk about the progress that has been made -- the process that we may be using -- that EPA and USDA may be using, but also the tools that we may be relying on to help sort out what is going to be appropriate to retain, and maybe what isn't, and what we're going to do about that, and how that ties into transition.
Okay, full stop. So, cumulative risk assessment needs to be on that agenda. And we said that last September, so it's not a surprise.
But let me just make one, maybe, appeal, too, that if this has been tried before -- regulating a class or groups and classes of substances under a cumulative rubric, and it hasn't been -- no one has been called to do it quite in the way that EPA is being called to do it under FQPA.
No one knows how to do it. It has never been tried in this way before. It is a big task. In one way, everything we've talked about in the last year, and everything EPA has been doing, and USDA has been doing has been practice for what is coming up next.
The leverage is tremendous against agriculture -- or perhaps for it -- depending on how we do this. The leverage against some of these chemicals under this new rubric could be great for or against -- depending on how it's employed.
So, the slope is going to get slipperier. And it's -- and the angle of incline is going to get higher, and it's going to be very complex. So, let's give it full play.
And I guess I'll just add one other comment to what Bill has already said. I cannot believe that given the complexity of the topic -- cumulative risk assessment and how difficult it's going to be to manage -- that we're not going to be in some appropriate forum -- and you can call it TRAC or you can call it something else.
I think you're going to need additional input and maybe through more than one mechanism. But I don't think it can end in August, or September, or October because it's going to get more difficult, more complex -- not easier.
MR. EHRMANN: Thanks. Mark? Oh, I'm sorry, Robert was next, then Mark.
ROBERT: Yes. I wanted to echo some of the same concerns and comments that were made over here about the continuation of the TRAC. Obviously, we've made a lot of good progress from where we started, but we're not quite there yet.
Obviously, August is a critical time period where we're going to have the first one-third of the food tolerances completed. We're about halfway through many of the science policy papers at this point.
Many of the reviews -- or some of the reviews are as far as Phase IV right now in that progress. So, Mr. Ralph Engle couldn't make this meeting this week because we have our mid-year meeting going on, but he did want me to express the desire to either continue the TRAC group in this process or some other forum that can provide input and advice to the agencies as we continue moving along and -- and because this has been a very valuable process.
And also, John, from the last Work Group meeting, we did a brainstorming session on several different agenda items. And I think you've got some good subjects there, and I realize we had a very short time period from that Work Group meeting to this to actually put something together on some of them. But we've heard the issue of cumulative risk -- I would agree that that's probably a topic to discuss. We talked about some data needs and maybe doing an inventory or review of various data collection activities -- both by industry task groups, grower user groups, ORD within the agency -- some of the work that they're doing, that would be very helpful as well.
And also, you know, we have a vested interest in some of the public health issues that -- and the work going on with the Health and Human Services, and the risk benefit issue related to many of these chemicals as well as the non-dietary residential risk assessment.
I think the azinphos-methyl portfolio or briefing that we got yesterday was very good. Obviously, that's not one of the chemicals that has the residential component to it. And obviously, that's going to play a part in some of the aggregate risk assessments, and we would be very interested in that aspect as well.
(END OF TAPE)
MARK: Back to the azinphos-methyl briefing on Slide 38 about drinking water -- I was visiting this morning early with our water person in Texas. And of all the required monitoring chemicals that are through the EPA guidelines that we monitor drinking water for, he found it interesting to note that azinphos-methyl was not on the list, and it had been determined by EPA to be a chemical of no concern. So, you might want to talk to your water folks and kind of get unified on that issue because we need to be monitoring for it, then we need to put it in our drinking water issues there.
So, just a little FYI. You might want to check both sides.
UNIDENTIFIED MALE: (Inaudible) -- by comparing the MCLs, but you didn't ask that. Go ahead.
MR. EHRMANN: Thanks, Mark. George?
MR. WICHTERMAN: Thank you, John. Once again, I would like to appeal to the agenda makers for the next TRAC meeting, or perhaps, final TRAC meeting, to have the now elusive point person at the Department of Health and Human Services to make a presentation.
And they have disappeared or evaporated from Washington, so it's down in Atlanta right now being kicked around. Where it's going to go, I don't know, but at least we could see what they're going to be doing because they're conspicuously absent at this particular meeting.
But I would also like to thank the folks at EPA and USDA for all of their help on the public health pesticide issue. And I have great admiration for what they have been doing for us and speak mostly in positive veins about that issue. And if we could get someone from HHS, we would appreciate it.
MR. EHRMANN: Great. Thanks, George. Any other comments before -- what I want to do is take -- we have one public comment. I want to go ahead and take that public comment, and then turn to the co-chairs for their closing remarks. Any other advice? I've got a good list of issues here.
Again, as was noted, there was, obviously, a very short time between the Work Group II meeting and this meeting. And some of the topics that were suggested at the Work Group II meeting have -- certainly have been kept in mind. It just wasn't possible to get new things on the agenda with that short turnaround, but there are a number of issues -- cumulative, public health, and a number of the others that were mentioned have certainly been duly noted.
And as we work on the agenda for the next TRAC meeting, we'll be -- we'll have a lot more time frame here to vet those ideas with you and put that agenda together, if we're going to be operating in the time frames that we were talking about.
But I appreciate all those very good suggestions. Let me ask Vern -- Highley, is it -- to kind of tell us where -- what organization you're with and make your comment please?
MR. HIGHLEY: Yes, I'm Vern Highley. I represent the National Watermelon Association and about a half-a-dozen other groups whose combined memberships are about 40,000 producers.
And on behalf of those 40,000 producers, I would like to ask you what kind of a forum we're going to have if we terminate TRAC for us to be able to continue to partnerize and seek collective answers to this tremendous question that is going to have a lot to do with the greatness of our country and whether or not we're going to have a viable and productive agricultural system here.
I think we've been making progress of late. We've had some real good commentaries in the last two or three TRAC meetings. So, I want to encourage you two -- Peter and Richard -- to extend TRAC indefinitely because at the House Ag Committee last week, at the oversight hearing -- Jim Aidala lauded what TRAC is doing. And we've heard it many other times, and it is doing something good.
It's regrettable that the environmental nation has decided to pull out, but I agree with the good doctor that they should -- we should encourage them to come back. And I hope the good doctor would also say that if for some reason, the four farmers here on TRAC could not be here, that they should be encouraged to come back, also. Because in our pluralistic society here, we've got to all work together on this critical question.
Just quickly, I want to say that without TRAC, we would not have known -- for example, the presentation that Mark Whalon has made -- I want to tell you, this is where we're going in agriculture. I want to see a national model like this. And I'm going to be working on that with all my heart and soul to get a national model for everybody -- all farmers to be able to plug into some kind of a system that says, hey, if you use this kind of a concept -- whether it be parabiologicals, or chemicals, or whatever, you know, this can be the result.
Also, I want to say that this afternoon, I understand that Congressman Richard Pombo will be introducing a legislative enhancement to FQPA. And as I understand it, that enhancement is saying that EPA needs to have more data, more scientific data, more information with which to deal.
So, I think what Congressman Palmbo and others who are going to join with him -- and hopefully, this legislation can get passed -- what they're saying is that we want to arm or give the opportunity for EPA to have new kinds of information. And I think what the past few TRAC meetings we've had, it has been evidenced that the more you massage something, the more you use these models and search and dig beneath the surface for answers, maybe we can find some things.
And anyway, those are the brunt of my comments. One final one -- Peter said yesterday that FQPA is one of the Clinton administration's most significant accomplishments.
I just want to say that I think TRAC is one of the Clinton administration's most important consultant committees. And it's showing good progress, and you're going to hearing from me and, I think, some other farmers who will encourage you to keep TRAC on track indefinitely. Thank you.
MR. EHRMANN: Thank you. Let me now turn to Peter and Rich for closing thoughts. Peter.
MR. ROBERTSON: Thank you, John. First, thanks to all of you. And let me say how impressed I have been with the meeting over the last day-and-a-half. It increases my disappointment at the resignation of the environmental members of this body because, you know, not for any public relations reason, but because the process suffered by them not being here.
We very much encourage them to come back and hope they will come back for a final TRAC meeting. And let me address that. I think there should be one more TRAC meeting, but my sense is only one more TRAC meeting. When the issue came up at the last TRAC meeting before this one as to whether there ought to be additional meetings, Fred Hanson and Rich decided that two additional meetings were appropriate. And Fred stated very unequivocally that the last two TRAC meetings would have to involve less vigorous participation -- and maybe, if you will -- expensive participation by EPA staff because it has been consuming enormous resources of EPA staff to do these meetings.
That obviously has been one of the complaints of the environmental community -- that we're too busy doing TRAC and not implementing FQPA. We obviously don't agree with that. At great personal cost to them and budgetary costs to us, we're able to do both, but we can't continue that indefinitely. And these -- this meeting hasn't been any less expensive if you saw all of the EPA staff that were here yesterday. I began to wonder whether there was anybody left in Crystal Mall, Susan, because I think they were all over here with us.
So, I think it's entirely appropriate to have one last TRAC meeting. And that's not to say that that's the end of our consultative process. The, you know, the four principles of sound science, and transparency, and consultation, and a reasonable transition for agriculture weren't processes for the TRAC. They are processes for implementation of FQPA generally.
And if the TRAC ends, those principles are not going to end. USDA and EPA have been charged by the vice president with continuing to carry out those principles while we implement FQPA. And I think I can safely speak for Deputy Secretary Rominger on this and say, we fully intend to do that.
We will find the processes. The PPDC is, you know, is one good process, and there may be others. I think we need to look at a lot of things about how we carry out those future processes -- the involvement of Deputy Secretary Rominger and myself.
And let me say that I remain fully committed to continuing to participate actively and vigorously in helping guide FQPA implementation in my Agency because Administrator Browner expects me to, whether we're continuing with a TRAC process or not.
As regards the subjects for discussion of that last TRAC meeting, Larry, I think it deserves more thought than I've been able to give it so far. But certainly the issue of cumulative risk, I think, would be an excellent one.
This isn't an entirely science-based body, obviously. It's much more policy-based body, and that needs to be recognized. But that doesn't mean that we can't have useful conversations about the cumulative risk.
And as Keith pointed out earlier in his comments, you know, what USDA and EPA may be doing soon as a sort of mini-cumulative analysis on several commodities. So, I think it's entirely appropriate to look at discussing cumulative risk at the next TRAC meeting.
I think, obviously, transition -- and assuming we have a meeting in the September time frame -- we'll have a lot more by way of concrete things to talk about regarding transition. So, I think that's going to be an important subject. I hope it will be an important subject for discussion as well.
The OP pilot process -- we've heard a number of comments -- a number of good comments from you all over the last day-and-a-half about how you think that process is working. We'll obviously be looking to institutionalize that regarding the rest of the work that we have to do on OPs, but also for other classes of chemicals. So, your continued suggestions and comments about how we ought to go about doing that will obviously very much be appreciated.
Worker risk issues continue to be, obviously, something of great concern. I mentioned my desire to continue the process of providing additional transparency in that area because I think it's extremely important. We want to continue to work with all of our stakeholders in addressing these issues whether it's sort of through the traditional chemical-by-chemical approach or other approaches that may allow us to work across the board or to address chemicals in a group-by-group fashion, if you will.
And I think that's sort of all by way of closing comments that I have, other than to again express my appreciation to all of you -- but my particular appreciation to everyone at USDA, all my colleagues at EPA who have worked so hard to help support me and help support this group. But most especially to Rich Rominger. Rich, for your friendship and guidance to me over this past six months -- I'm very grateful for it.
And I look forward to continuing to work with all of you through a final TRAC meeting -- but through our continuing processes to ensure that you all help us do our job of protecting public health and the environment and assuring a safe and stable food supply for our country in the most common sense and cost effective ways that we can possibly do that.
MR. EHRMANN: Thanks, Peter. Richard.
MR. ROMINGER: Okay. Well, this has been a good day-and-a-half. And we've continued to learn from this process as a result of your input.
A number of people have talked about that agriculture is in transition -- that the train has already left the station. Jay said we have been doing this since the beginning, and I agree.
As a farmer most of my life, it seems to me like ever since we started using chemicals for crop protection, there has been a continuous transition with new chemicals coming on and old chemicals disappearing -- new techniques that are non-chemical as well. So, that FQPA has certainly put more focus on the transition and bringing some of these things to a head. And we're going to be bringing a lot more resources to bear on how we make these transitions, taking into account what the major problems are that are driving this transition. So, I think the next TRAC meeting, certainly one of the agenda items will be the progress that we're making on transition because we should have something to talk about by September.
So, this could be the last TRAC meeting in September, but it's as Peter said, it will not be the end of consultation and involvement for you. We're going to continue to need that in one way or another.
PPDC has been mentioned -- that we should have another meeting of that before the next TRAC meeting. I think that's a good idea. I think the second part of that suggestion, Jay, that the members of this committee be invited to that group is important so that we get the whole range of suggestions, and discussion, and learning at that next meeting.
I think if we should, perhaps, choose that forum to continue, that group may need some formal augmentation to make sure that we have all interests well represented there.
But whatever forum, we are going to need your continued consultation and participation as we move forward. We're certainly not going to be done in September, by any means, with transition, or with addressing the cumulative issues.
But I think what all this does point out is that transition changes the words in Peter's letters and significant reductions -- I think what, you know, what we're -- when we look at what the drivers are, some of the commodities, some of the chemicals, it, you know, it will mean significant changes for some specific materials and some specific crops. But we're certainly not saying, as Peter reiterated, that there's going to be wholesale changes in elimination of organophosphates.
So -- but we do need to work through all of those. And certainly Mark pointed out in his presentation the niche needs for many of our IPM programs and other control programs.
So, it's going to take a lot of work by all of us, and we want to have your continuing participation. We will look forward to the next TRAC meeting in September, I think, probably, looks the most logical to me right now from what we're trying to get accomplished prior to that TRAC meeting.
So, we'll look forward to your insight and help again then and continuing on after that in some form or another. And so, I would just end by saying that I think we do have a good working system and process with EPA and that Peter has certainly picked up the reins that Fred Hanson had held, and has done a good job -- a great job in bringing EPA and USDA together and continuing that dialogue and that working relationship.
And Peter and I get together, and whenever that we sense that there are any bugs in the process, in smoothing out the way things are going, and what needs to have more focus. So, that has been a good relationship, continues to be, and we're going to continue to build on that.
We look forward to your continued participation and your continued help, and thank you all for being here for this meeting.
MR. EHRMANN: All right. Any other final comments? If not, thank you all for participating. Travel safely and see you later.
(The meeting was concluded).
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updated September 24, 1999