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Pesticide Program Dialogue Committee
Meeting Summary

November 12 and 13, 1996
Hyatt Regency Crystal City
Arlington, Virginia

OPENING REMARKS

Jim Aidala for Lynn Goldman

Jim briefly welcomed the Pesticide Program Dialogue Committee (PPDC) members to their second formal meeting.

OVERVIEW OF AGENDA AND MEETING OBJECTIVES

Dan Barolo

Dan welcomed the PPDC members. He looks forward to using this forum to discuss evolving public policy issues. There was enough to discuss before the new Food Quality Protection Act (FQPA), but now the Committee's input is especially needed and welcomed.

Besides adjusting to the new law, the Office of Pesticide Programs (OPP) also is going through a realignment and is "flattening" -- from 100+ down to 50+ supervisors. Changes consistent with the general direction of the new law include the creation of a new Antimicrobials Division. Frank Sanders is the acting Director of this new interdisciplinary division, which will bring scientists and regulatory managers under the same umbrella. We hope this change will enable OPP to deliver a more efficient and effective antimicrobial program. The second major organizational change involves integrating the policy shop with field operations into a new Field and External Affairs Division. Anne Lindsay is the designated Director of this new division. We hope to have both new divisions in place and working in early 1997.

On top of flattening and adjusting to new responsibilities under the FQPA, OPP now is getting new sidewalks (the good news is that drilling takes place only between 9 a.m. and 5 p.m.), and elevator and carpet upgrades. We are coping as best we can with these additional organizational and practical issues.

OPP also is dealing with budget changes. Twelve months ago, we were in a shut down mode. Some staff were deemed "essential," and then "custodial"... Now, a supplemental budget is bringing OPP funds in the $16 million range. This will give us the authority to hire additional people -- good news in terms of delivering the mandates in the new statute. It will take time to hire and train new staff, of course. 1997 is a transition year, giving us the opportunity to sort things out organizationally and to meaningfully address the provisions of the new law.

We've had a couple of new Division Directors announced whom I will introduce as they arrive. Tomorrow morning, there will be 3 small break-out sessions for PPDC members only. We hope to get a sense of the most important areas of interest to you, to start forming subcommittees and to help structure future meetings.

The Food Safety Advisory Committee also is meeting later this week. The two committee meetings are scheduled back-to-back so you can attend both meetings, if you wish, and can get copies of the prepared materials. Questions we are most frequently asked include, "What are you doing to formally implement the provisions of the new law?" and, "When will you be able to start making decisions again, and what decision logic will you use?" For answers, see the materials, especially the paper on our proposed tolerance reassessment program. Give us your thoughts and recommendations.

Two or three other pieces include a flow chart showing how the new risk characterization factors (aggregate risk, common mode of action, additional safety factors for children, etc.) are going to be folded into the regulatory decision process. Also, there's an overview of some broad decision logic for aggregate risk and common mode of action; for example, reserving some of the "risk cup" for consumption of drinking water, etc. None of us have the answers at this point, but we're going to propose an approach because we have to begin to apply these factors to regulatory actions within our program. We need your advice and counsel on these key documents. At the next PPDC meeting, we'll ask for your assistance in helping refine how we apply our decision logic and criteria. PPDC will be the agent for bringing these issues through our program during the next few years.

Regarding science issues, we've recently asked the Scientific Advisory Panel (SAP) to review the 10 x factor and the in utero testing guidelines. We'll continue to use them for input on major science policy issues.

The PPDC has access to any and all information being generated for these other groups, and we look forward to your advice and counsel. Tomorrow, Committee members will get an advance copy of our 1996 Annual Report. This may provide a better overview of the depth and breadth of OPP during 1996 -- to say the least, a very trying year.

FOOD QUALITY PROTECTION ACT OVERVIEW

Anne Lindsay, Part 1 (See copies of overheads)

I'm here to present the context or background -- the environment in which we have to implement the FQPA. OPP had identified three broad priorities prior to the new law, and it gave us tools, responsibilities, and challenges in each area:

Please keep these priorities in mind, to help us identify where we want to do future work.

Jim Aidala, Part 2

[Comments and questions by Committee members are in bullets.]

The FQPA -- no one thought about what the acronym would sound like, so we refer to it as the "F. Q. P. A." -- was signed into law on August 3 and went into effect immediately, creating some implementation questions and issues for the Agency.

This is a simplistic overview/executive summary of the new amendments. "We must update or modernize the Delaney Clause" provided much of the impetus. Also, it was important to capture NAS's recommendations, and enhance consumer confidence in our food supply.

The Senate debate lasted 28 seconds; the House debate a little bit longer. Once agreement was reached, the Bill was unanimously passed in days. This is a remarkable achievement, but a few "grooming issues" remain in the law.

If you get rid of the Delaney Clause, what do you replace it with? FQPA provides a single health-based standard for raw and processed food: "reasonable certainty of no harm." It requires consideration of aggregate exposure (from drinking water and other potential sources). It requires consideration of other pesticides with a similar mode of action in making decisions. And FQPA contains a number of provisions to protect children including an explicit determination that tolerances are safe for children, and an additional 10-fold safety factor for children.

Congress wrestled with another thorny issue: the role of benefits. Tolerances had never been set based on benefits considerations. But risk/benefit considerations were a big concern of the Congress. As a result, the new law states that benefits may apply only to nonthreshold effects, i.e. carcinogenic risks, and not to threshold risks like neurotoxicity. It notes when benefits analysis may be appropriate, and sets risk "backstops" or limits. In no case may benefits exceed the safety standard for children. Tolerances set with benefits considered are called "eligible tolerances" or "benefit-based tolerances."

The amendments require EPA to review all tolerances on the books over the next 10 years to make sure they meet the new safety standard (review 33% in 3 years, 66% in 6 years, etc.). In one year, EPA must issue its plan to do this, giving priority to pesticides presenting the greatest risk to public health.

Response by Dan Barolo: "Very significantly." We are not going to be able to deliver the list of active ingredients (AI's) that were in the queue for 1997. However, we want to use the reregistration process to deal with reassessment of tolerances. Our approach will be to look at broad classes of chemicals, like organophosphates (OP's), carbamates, or others. They will trigger the AI's that will be reviewed in a particular year. We will bring the post-'84 tolerances into this process.

A number of factors must be considered in evaluating or setting new tolerances. The law captures several things that seem to be a smarter way of doing business, including Endocrine Disruptors. The FQPA picks up language that was developed under the Safe Drinking Water Act. We must establish a screening program within 2 years, implement the program within 3 years, and report to Congress the year after that.

Right-to-know is another important provision. Annually, we must publish a pamphlet discussing the risks and benefits of pesticides and ways to reduce exposure, and explicitly listing benefit-based tolerances. This provision was a compromise with interest groups that wanted pesticide-treated foods to be labeled. The pamphlet must be updated each year, and offered for display in grocery stores. FQPA also recognizes states' rights to use a warning that food has been treated with a pesticide.

Response: Yes, Dan is going to drive a truck to the grocery stores... He notes that the details have not been worked out. If anyone can provide advice and counsel on practical ways to accomplish what's needed -- how best to write the pamphlet in plain English, design it, and distribute it -- let us know. We will be requesting input from HHS and USDA.

Another controversial issue is the ability of states to impose residue limits on foods marketed within their boundaries. FFDCA allowed states to have any tolerance they thought wise. This was a concern to food producers and processors. Under FQPA, a State may not set a tolerance different from the national level. But a state can petition EPA for a different, lower tolerance.

Response: It's not clear, but EPA makes the initial decision.

Response: Yes, it's probably envisioned for this purpose, too.

Regarding enforcement provisions, there are no changes. But FQPA gives FDA (which is responsible for monitoring the food supply for compliance with tolerances) authority to impose civil penalties, instead of just seizing and destroying food that's over tolerance levels.

Funding is an issue for all three agencies and others affected by this new law. You can't pass a law and say, "Now go do it with less."

Response: FDA is still working out how this new provision will be applied and enforced.

Amendments to FIFRA -- Most were worked out during the summer of 1995, pre-shut downs, etc. The House Agriculture Committee did a lot of the work on these amendments, which include:

Reregistration - Maintenance fees are continued -- we say "thank you" to Congress for this. It's an important achievement to have this program maintained.

Registration - Every 15 years, starting in the year 2000, every pesticide must be reviewed, guaranteeing that we don't put registered pesticides aside and not look at them again.

Minor Use - Extensive new provisions include minor use programs at EPA and USDA. A USDA revolving grant program supports development of minor uses. A number of procedural enhancements provide flexibility in processing minor uses, and incentives may supplement the current universe of minor uses.

Response: The minor use problem is not a new one and the statute contains many provisions that will help, including measures to support public health uses. Dan says, also, we want to find ways to give all types of users a voice in the decisions that are being made about risk.

Response: It's important to be developing exposure data for these uses, and to be looking at new pest control alternatives.

Response: We collectively need to do more in terms of communicating with growers and users. Dan notes, again, see the tolerance reassessment document, which sets out time frames for dealing with different classes of chemicals. It gives users forewarning that decisions on these pesticides are coming. It also sets out the decision logic and criteria we will use to define "residential," for example. Nothing is a given -- give us input. The big fear on all sides is that it will take us forever to make decisions on these chemicals, or, on the other hand, that the day after tomorrow, all uses will be canceled. Obviously the program will walk somewhere down the middle of that road.

Antimicrobial provisions speak to a longstanding issue. Over 5,000 decisions were made in OPP last year, including many on antimicrobials. These are an important part of our work. The new law continues our reform of the antimicrobial review and handling processes. Liquid chemical sterilants (gluteraldehydes) go to FDA.

Outreach and Communications - We need to continue to do a better job. Improve our ability to get information out and available. The law establishes an advisory committee, as well as right-to-know provisions. (See handout on how to obtain information from OPP.)

Who's Going to Do It - (see overhead) - EPA has set up a number of internal teams to address implementing different parts of the new law.

FOOD QUALITY PROTECTION ACT OVERVIEW (CONTINUED)AND UPDATE ON STATUS OF IMPLEMENTATION

Dan Barolo

Six Fundamental Areas of Redirection for OPP as a Result of the FQPA:

1) Fundamentally redirects reregistration by making tolerance reassessment the framework for examining and making decisions on existing or "old" active ingredients.

2) Substantially raises the threshold for meeting health standards. This has huge policy implications for tolerance assessment in the future.

3) Registration renewal program fundamentally shifts how we do business. The obligation to revisit our registration decisions within a given time frame (15 years) changes the philosophy and culture of the program.

4) Places emphasis on 3 areas: minor use, antimicrobials, and reduced risk or "safer" program.

5) Forces coalitions among people in organizations that traditionally have not communicated with each other in the past, like registrants and users, OPP and consumers, and others.

6) Right-to-Know aspect of the new law will force ways to make the information we have available. How can we make better use of the information we have to meet multiple needs?

Broad accountability (GPRA) also is important. This management oversight responsibility transcends these 6 areas.

Which of these areas are most important to the Committee members, and which would they like to focus on?

Comments by Committee Members:

Response by Dan: The reregistration decision-making process for non-food uses is ongoing and is still a priority.

Response by Dan: The Certification and Training (C&T) program, a pillar for training in the past, has been semi-ravaged in the budget process. We all need to inform Congress about the value of this program. Hopefully the new law will force coalitions to support C&T.

Response: EPA assumes there will be few benefits-based tolerances, but we don't know for sure, yet. We need more exposure information to factor in with risk information, and we need time to develop this data.

Response: The statute directs a screening program. What happens when the data is positive is less clear. If there's a huge ecological impact, what should we do? We assume we should do what we can under FIFRA to protect wildlife and ecosystems.

Response: EPA will share its decision logic, as it develops, to help people see what's needed where.

Response: There is no magic date, but our plans and approaches on common mode, etc., will become firmer over the next few months. Our decision logic will be finalized within the next 30 days. Materials for meetings will become fuller and meatier starting around January, after the FQPA Implementation Plan is completed. By the next PPDC meeting (in February), members will be receiving more detailed information and we'll start asking you for more concrete types of input.

PUBLIC COMMENTS, November 12, 1996

1) John Impson, USDA Cooperative State Resource Education Extension Service

There's a real need beyond right-to-know as discussed here today. Their pesticide coordinators touch several hundred thousand private and commercial applicators in all 50 states. Consider partnering an FQPA presentation (with slides or overheads) and use their network to disseminate this information. He is getting more and more requests for information on the new law. Integrating an FQPA presentation into their training sessions would be a big help to the agricultural community.

2) Paula Paul, Agrevo

Don't neglect new registrations. It's important to have alternatives with different modes of action to replace some existing compounds. Keep new products rolling onto the market as they will aid EPA's decision making and help the growers, as well.

REPORTS FROM BREAK-OUT SESSIONS

The PPDC members met in three small groups to discuss which aspects of the FQPA, or areas of change, are of most interest and should be the focus for future involvement.

Group 1 - What does EPA intend PPDC's responsibilities to be regarding the items on this list? EPA needs to clarify PPDC's role in relation to these 6 items. Item #2, raised health standards, is most critical. Benefits considerations is not on the list and should be reflected somewhere, as should IPM. Pollution prevention should be added under #4. Regarding food monitoring and FDA's role, more funding is needed so the law can be better enforced, and we need better public communication. Import tolerances should be included. Generic tolerances, as in Canada, should be considered (determine a trivial residue level at which FDA would not enforce). Dan says that EPA's cross-contamination policy, coming out soon, should help. CODEX MRLs should be considered. Under #5, force FDA-USDA interaction.

Group 2 - Refined the 6 key areas, and voted on how the PPDC could be most helpful. Recommendations:

The most important items are the first two.

Dan notes that EPA will refine the items as suggested and get back to the Committee. Consider which of the items the PPDC can best help OPP with in implementing FQPA, and which areas you personally are interested in, so that as subcommittees are formed, we can invite you to participate.

OPP'S PLANNED INITIATIVES FOR ECOLOGICAL PROTECTION

Joe Merenda, Denise Keehner, and Paul Mastradone

Introduction - Joe Merenda

Historically, ecological concerns are not alien to the public. However, over the last 25 years, as risk assessment and risk management advanced, risk management policies moved ahead more rapidly in the human health area than for ecological effects. Today we will discuss some of EPA's efforts to reinvigorate ecological effects risk assessment.

Background - Denise Keehner

When she arrived in OPP, Denise immediately heard three people's views regarding what was right and wrong with EPA's ecological risk assessments. First, a scientist said, "It doesn't matter how good our analysis is, the risk managers never believe us and never find that ecological risks outweigh the benefits." The second person was a risk manager who said that if only the scientists had more confidence in their decisions, the risk managers would act on the scientists' input. The third person was a senior level manager who said that OPP's goal was to move forward in a directionally correct way, implying that cancellations based on ecological risks were rare, and were not reflective of an appropriate balancing of ecological risks and benefits.

To what extent do the ecological risk assessments that OPP's scientists provide its risk managers do a good job in accurately predicting what will happen in the environment as a result of the use of a pesticide? And, to what extent are OPP scientists communicating with risk managers about ecological risks?

Ecological risk assessment consists of a screening process, through which we identify pesticides that are not likely to pose significant ecological risks. But in cases where pesticides fail the screen and may pose significant risks, we need to do a better job in communicating this to risk managers in the Agency. Partly this involves improving our methods and tools, as the SAP provided advice on earlier this year.

Another fundamental area we need to address is "the values thing" -- how people value ecological protection, and how they weigh environmental impacts v.s. benefits in deciding whether more aggressive action is needed to protect ecological resources. The values thing is what makes people think that directionally correct is enough. OPP should try to get a better handle on whether our risk management decisions in the ecological arena are reflective of mainstream American values.

The FIFRA Scientific Advisory Panel (SAP) Recommendations - Paul Mastradone

In May, EPA presented two case studies to the SAP, on carbofuran and the corn cluster (four organophosphate pesticides used to control corn rootworm). We asked the SAP to comment on methodologies used in making the risk assessments. The SAP suggested that OPP could improve its ecological risk assessments in four areas:

In response to these suggestions, EPA proposed the following short- and long-term strategies:

"The Values Thing" -Denise Keehner

Are we reflecting mainstream American values in assessing ecological risk? Some possible ways to determine this include:

Questions/Issues for PPDC Input - Denise Keehner

OPP asked the PPDC members in advance to consider these four questions/issues:

Comments by Committee Members:

The measurement of ecological effects is very difficult and it changes on a regular basis. Data has tremendous variability and imprecision. Don't spend too much time worrying about risk assessment; the best course may be to fine tune the data.

Five things: 1) OPP needs to have a clearer vision of where we want to be when all of this is done, to help guide the effort; 2) Time frames are missing -- our proposals are too open-ended; 3) Re: the values thing, people bring different sets of risk preferences to the discussion -- people's tolerances for risks vary; 4) Don't rely on any one group and get outside the D.C. area interest groups for input; 5) Do pilots in different areas using different approaches, and don't bet the farm on any one approach.

Like politics, all ecological risk management is local. Local involvement is essential. Go back to models put together previously by some of the state groups for the endangered species program. These involved all stakeholders at the local level. We recognized early on that private land management can be more effective than public land management in ensuring the continued diversity of habitats and availability of some species. Go out to the states and local stakeholders (wildlife groups, agencies, etc.) for input. Don't draw a box around the D.C. area -- move this out to as local a level as you feel comfortable doing.

The most compelling part is developing the models and making sure they work. Also, it's not clear how values fit into this part of the program as opposed to the rest -- values are no more relevant here than in assessing human health. It's also important to see if a species poses a public health threat.

Think about what the endpoint is -- then see what we need to do to get there. Also, re: values v.s. assessment, the first is a policy question, the other is a science question. If you mix the two, you will end up with bad policy and bad science. Keep good science as the uppermost consideration. Also, be cautious about field studies -- past experience in doing these hasn't been too good because it's difficult to define a set of conditions that turn themselves into reliable results. Be sure studies, like mesocosm studies, are validated in some way.

The sublethal issue is extremely important in protecting wildlife and also in predicting human health problems. Incident monitoring data gaps may be a problem, but there also is a huge amount of raw data out there that we are not using. Some generalities and assumptions probably could be drawn based on what is known (for example, only a teeny percent of the dead birds in a field are actually found). Re: terrestrial organisms, it's important from the standpoint of beneficals vital to the functioning of IPM programs to promote technologies that depend less on pesticides over time. About values, it's important for EPA to be concerned about more than what mainstream America is thinking. EPA could use the Migratory Bird Treaty in a more severe way for enforcement purposes; this would raise the public's awareness about ecological risks. Do a visioning exercise --use ecological risk assessment as a means of driving pesticide use reduction and IPM.

Be very careful about the values issue. What is the question, and what answers are you looking for? Use the discussion to learn about the public's awareness -- to find out what the public believes about levels of ecological risk -- and tailor educational programs accordingly. On the science side, there's a need for better understanding of environmental fate (how long a pesticide persists, its metabolites, etc.). Be selective. This can lead to cooperation with other EPA offices and programs.

Dan asks that if one or two committee members are interested in working on these issues further with us, please let us know.

REMARKS BY THE ASSISTANT ADMINISTRATOR

Lynn Goldman

Regarding ecological risk, we actually are responsible for protecting ecosystems under three laws--FIFRA, the Endangered Species Act, and the Migratory Bird Protection Act. We take very seriously our responsibilities under these three laws. And we have had some successes, especially in protecting bird populations. We have had legal disputes over some of the actions we've taken, and we have done well in court. We also have had some successes in protecting fish. But earlier remarks about sublethal effects and our ability to quantify them and to take regulatory action to prevent those effects are well taken.

Given the risk/benefit balancing provisions of FIFRA, we have the ability to take action to protect ecological resources. To do this, we need to be able to assign value to ecological resources. But this isn't easy to do. This may be an area where we need to go to outside experts like the National Academy of Sciences, in the long run.

We need to do much more to utilize information that is available about ecological impacts as they actually occur. The regulatory actions that we have taken so far, particularly for avian species, have been based on actual incidents of pesticide misuse, rather than on field data and quantitative assessments. If you know of ways to make better use of data that's available because of incidents happening in the real world, please work with us on this.

Next you will hear about the Government Performance and Results Act, which says we should base our activities on performance. This is a very important effort for the Agency as a whole and especially for the Pesticide Program. Too often, we have measured our performance based on the number of standards, registrations, label changes, etc. that we've been able to process. We have to look beyond the number of actions we've processed and consider our goals in protecting health and the environment. This is an area where your input is extremely important.

The issue of labeling also is very important to us. Right-to-know has been a very important issue to this administration. With pesticides, it's also a matter of making sure all our customers have the information they need in order to use products safely--products that when misused or not used according to label directions can be extremely hazardous. This is an area where we are making progress, but need input to make sure we are on the right course.

The comment about having longer term goals for the program is a good point. The Report on Sustainable Agriculture from the President's Council on Sustainable Development is one we should get to all of you. It provides a broader overview, and a context for the last presentation. All our efforts in protecting ecosystems have to do with a commitment to move to a system of sustainable agriculture in the U.S.. This concept has broad support from industry, public interest groups, and others. It may help provide a broader perspective on the work we are doing.

The new legislation is an opportunity and a challenge for EPA and for all concerned about pesticides. We have the ability to move forward with a tougher standard for the pesticides on our food, to make sure we are protecting children, and to look at chemicals not just one at a time but also within their chemical classes. This is going to be very challenging for the Agency to do, but it is something we think ought to be done.

The other opportunity is to change the public's perception about the safety of pesticides in our food supply, by having more realistic risk assessments for pesticides on our food, and by having explicit safety findings that children are protected when we set a tolerance. This will do much to enhance the credibility of the process. It will provide assurance the public needs to have that when they see the EPA label on a product, it means the product is safe. We want to have that credibility.

In terms of risks, there are many. Certainly, 1997 will be a transition year in terms of how we interpret the statutory language, how we move forward, whether we are able to make the transition smoothly and reorient our program to meet the challenges of the new law, or whether we bog down in disagreements or even litigation.

Another challenge has to do with our being able to continue to address other risk issues besides food safety; that is, to continue to protect the environment, to provide an environment for species other than humans, and to protect ecological diversity. That will be a challenge given the resource demands of the new law.

Another issue that's been raised is that we move forward in protecting workers and that we not neglect our responsibilities to farm workers. I'm seriously considering adding more worker protection expertise to this Committee so we can obtain stronger advice in this area. Farm workers and worker protection issues are going to continue to be a priority even though they are not specifically addressed by the new legislation.

Resources are going to be an issue. We enjoy a strong level of support from the Administration in making sure the new law is implemented in a responsible fashion and that we have adequate resources to implement it. We are working through basic budget issues, even this afternoon.

How this Committee will work with EPA is very important to us. We now have a Food Quality Protection Act Advisory Committee to help us make the transition to the new law in the short term. That committee will be sunsetting in December. In January, hopefully, we will publish a Federal Register notice setting forth a schedule for implementation of the new law -- a blueprint of how we're going to move forward. From that point on, the advice we get will come from you. It's going to be critical for us to get feedback from you on what are the priority areas, where do you want to be engaged, and how intensively do you want to be engaged. I want to encourage as much of that engagement as possible because the decisions we will be making over the next year are going to be difficult decisions, and I frankly need the support from you. The no-brainers were decided in the context of the statute -- truly difficult decisions are left for the processes that can involve dialogue and the time and analysis you need to make them. So stick with us, it's going to be an exciting time. We have the privilege of putting in place policies that will make a difference for this country for years to come.

GOVERNMENT PERFORMANCE RESULTS ACT (GPRA)

Al Jennings, Iantha Gilmore, Janet Andersen, and Jack Housenger

Overview - Al Jennings and Iantha Gilmore

GPRA was signed into law about three years ago and, unlike FQPA, we got some time to figure out how to implement it before its provisions went into effect. The idea of GPRA is to move all federal agencies into measuring their results and progress in terms of outcomes instead of the usual, more traditional beans and widgets, inputs and outputs. Instead, we are to consider our goals, and whether we are achieving them or not.

EPA's ultimate measure of success is improved human and environmental health. We obviously have more than a few problems coming up with outcome-based measures. We really don't have the tools to go out and measure whether we've achieved these goals or not. Nevertheless, we are trying to get closer to measuring those real results. The law requires consultation with stakeholders, and that is the process we want to begin here today with this Committee. You are our stakeholders.

We are undertaking two pilots in 1997: the Pesticide Environmental Stewardship Program (PESP) and the tolerance reassessment program, which we will discuss more in a minute. First, think about the concept of risk indices. This is something we've been working on as a means of measuring real results. How do we come up with an index of risk, and then use measures of pesticides applied along with the index to find out whether we are doing a better job or not -- i.e., using fewer pounds per acre or fewer tons per year?

The GPRA requires a few things including a strategic plan on September 30, 1997, an annual performance plan beginning in fiscal year 1999, and in March 2000, a performance progress report. These reports will show our plans and whether we are achieving them or not. This gets to the issue of accountability, which is really the overall driving force.

About the pilots for 1997, in the Pesticide Environmental Stewardship Program we are looking at performance goals and getting the Partners' strategies approved and implemented. We're emphasizing protection of infants and children through those partnerships, focusing on the top 20 foods eaten by infants and children. We are looking at registering new and safer products including biopesticides, and increasing the use of safer pesticides by Partners.

On tolerance assessment and reassessment, this is a no-brainer looking at what FQPA tells us to do. The first step is an implementation plan by the end of the first quarter of FY '97. In the future, we'll look at how many tolerances we have reassessed in any of the performance years. This is getting back into bean counting, but we don't know any other way to approach it. We will also take a look at how many tolerance actions are revocations, reductions, etc., as a measure of how well we're doing.

Turning to the concept of risk indices, how can we couple our pesticide usage data with measures of chemical risk or hazard and come up with a way, maybe by commodity, to see if we are moving toward safer, less risky pest management practices? We have a reasonably good data set over seven to eight years of pesticide use on major commodities. The question is, what endpoints should we look at? Using ecological endpoints, this approach seems to have some promise. Can we look at similar things for human health and, over time, couple use patterns with commodities and these risk indices?

Comments and Questions by Committee Members:

Response: PESP has grown faster than we had anticipated, but we're very pleased with the number of Partners and Supporters we have. The most important thing for us to do now is to bring the commitment into reality, and focus on implementing the strategies in place. Several major commodity groups are about to sign on, which will bring more of the agricultural acreage of the U.S. under the program. We are pleased with the way the program is going. For '97, rather than add more Partners, our focus is to see the existing Partners get their strategies done. We've challenged each one of them to come up with their own measures of success.

Dan responds: Good point. The GPRA's focus on accountability and outcomes coupled with the new law is a golden opportunity to come up with some measurement indicators of progress toward some public goals. We need to decide which parts of the program can benefit most from developing these measurement indicators and focus on making sure they occur.

Response: Their Economic Research Service is trying to figure out how to measure these accomplishments and determine what percent of the nation currently is using IPM. We are working cooperatively with USDA toward achieving this goal.

Response: Dan is hopeful that we can take sub-pieces of these areas of discussion and develop subcommittees to develop ideas further. EPA has to put out the strategic plan by next fall, but needs input now to get a draft done sooner. If anyone is interested, let us know. Lynn adds that the pilots should help.

Response: We would be delighted to have more state participation in the PESP program. However, the PESP partners write the strategies. We agree that local involvement is important and are trying to get more local projects by including people in our Regional offices as liaisons, etc.

Response: We can set two broad goals, public health protection and environmental protection. To what extent do we set more specific goals for different aspects of the program? The issue is, how can we minimize the bureaucracy and find goals that are meaningful for all of us in OPP, showing that we made progress but going deeper than the usual bean counting?

Dan's Closing Thoughts:

The new law is huge and its implications are profound. It's a unique opportunity for public health and environmental protection, and advancement of the program's objectives as a whole. I view 1997 as a major transition year. The new law on one hand is a license to get rid of all pesticides, or to bring OPP to a halt. On the other hand, it's a new-found obligation to process new registrations in 35 seconds. Given flattening and the transition to FQPA, it's a critical transition year. There will be less output and more time spent on organization, policy development, measurement indicators, etc., maybe in the interest of all our long-term objectives.

It's critical that we find ways to get advice and input from real people out there. The next step is for us to identify areas where input will be most helpful. This is a commercial -- we need your input. Hang on a little bit longer until we find ways for more aggressive participation by all of you.

PESTICIDE PRODUCT LABELING

Jim Jones, Registration Division, OPP

Bob Harness and Dennis Ward, Monsanto

Steve Balling, Del Monte

Paul Orum, Working Group on Community Right-to-Know

OPP Perspective - Jim Jones

EPA's pesticide labeling program, which is administered by the Labeling Unit in the Registration Division of OPP, serves multiple customers including users, the states (which enforce labeling), and pesticide manufacturers (who communicate with users through labeling). Labeling also serves multiple uses. "The label is the law"; i.e., it serves as an enforceable tool. Labeling also is intended to protect public health and the environment.

The Labeling Unit conducts a number of specialized label improvement activities. For example, they have worked on labeling issues that resulted in revised labeling directing airlines not to spray passengers; improving safety instructions on pet care products; and enabling homeowners to protect themselves from termiticide applications.

The Labeling Unit currently is considering reduced risk and environmental claims, and is deciding which ones the Agency will allow on pesticide labels. They also are working on household storage and disposal statements on labels. These are an issue because one flat statement doesn't work everywhere in the U.S. The Unit also has accomplished a number of coordination and standardization activities, such as completing the Label Review Manual.

The Consumer Labeling Initiative (CLI) is a high priority effort to make consumer labeling more readable, understandable, and meaningful.

A Food Industry Perspective on Labeling Issues

Steve Balling, DelMonte Foods (Also see paper)

DelMonte contracts with 3,000 growers. The company gives each grower a list of approved pesticides, with information on use that is critical to safety and/or to residues remaining on food. There is much disagreement about the intent of pesticide labeling, and many problems arise in interpreting labels.

Three areas are of major concern:

1) IPM Labeling - IPM directions now are being included in section 18 emergency exemption and section 24(c) special local need labeling. Don't start including IPM directions on labels of products registered under section 3, too! IPM can't be defined on a national scale; growers want to make decisions for themselves (once IPM is mandated by labeling, growers will reject it); and it's unenforceable.

2) Users' Right to Know - IPM is a decision tree, and users try to find the least risky options. In order to do this successfully, they need more information on potential environmental effects, acute toxicity of the end use product, cancer risk, etc., either on labeling or in some other way (such as in a guide for users).

3) Label Interpretation - Pesticide labels are not user friendly. Some of the herbicide labels with many crop and other uses (Roundup, for example) are the worst. He encourages standardized label format; use of tabular form rather than text; standardized location and content of descriptive information; and streamlined EPA approval of label changes.

The electrostatic sprayer has great potential for allowing low volume use, but growers can't use it because this use pattern is not covered by labeling.

The Pesticide Industry Perspective on Labeling Issues, Part 1

Bob Harness, Monsanto

There's actually a lot of agreement here today about pesticide labeling. The purpose of the label is to give users clear instructions on how to use the product safely (protecting themselves, others, and the environment), effectively, and efficiently.

Three examples of labels I've encountered recently are the labeling for a camera, a prescription drug, and a desk. The camera labeling had about 40 illustrations followed by the text, so you had to constantly flip back and forth between the two. The prescription drug is one I've taken for 25 years. It comes with a booklet which is beyond my comprehension. It's written for a different audience. The third example is the computer desk I bought for my college-bound daughter. This desk had about a zillion parts, but it had the best labeling or assembly instructions I've ever seen. Every piece had a picture with instructions right next to it, all the parts were identified, and it was an easy thing to put together.

So what does this say about labeling? Labels ought to be written with the user in mind, they ought to be easy to "do," and they ought to have content appropriate for the purpose that needs to be served. I don't think we're able to do this in every case for pesticide labeling.

In defense of the Roundup label, this product is registered for use on over 150 crops. Every crop and every type of application from pre-plant to pre-harvest has to be there on the label. If we rewrote the label, it would be a monumental task from a writing standpoint, and even more so from a review standpoint. Labels are built in an evolutionary way, and it would be difficult to recreate one.

I would like to offer a few suggestions:

1) EPA should continue its labeling initiative. Focus on the consumer, but also focus on the agricultural user.

2) Standardize label format.

3) Look for ways to make the label more user friendly.

4) Regarding "green labeling," making claims, etc., personally I think this is the direction we have to head. We have to give users information they need to make choices. We must figure out ways to incorporate into the label the things people need in order to choose.

5) An education program also is needed. The information is there on the label, although it may be difficult to find. We should help users find their way through labeling.

The Pesticide Industry Perspective on Labeling Issues, Part 2

Dennis Ward, The Solaris Group, Monsanto Company (Also see paper)

Label improvement is an important issue for our industry. A lot more can be done to generate user-friendly labels that promote responsible use. We have a way to go at Solaris--some of our labels haven't been rewritten in 10 years. But we're working on it. If you can generate a user-friendly label, you're going to have greater customer satisfaction.

In our experience, incidents involving non-performance of a product are almost always due to the fact that people don't read the labels, don't understand them, or can't find the information they need. When products are not used, stored, or disposed of properly, you increase the risks to children and pets. More can be done to improve these key parts of pesticide labels.

We have to acknowledge that pesticides are an extremely complex category of products. Few other consumer products require you to read a 10 page booklet, measure correctly, dilute properly , use special application devices, consider the weather, etc. In days past, consumers used to be able to depend on experts in hardware stores and other retail outlets for advice. That is no longer the case. Today, the label is the only source of information for most consumers.

So, how do we get to a user-friendly label? Go out to consumers and ask what works for them. The CLI is a step in this direction as it's reaching out to users, surveying them, and getting their reactions to current labels. We are finding that with labels, less is more. The shorter a label is, the more likely it is that consumers will read it. Also, a distinction among different types of users has to be made in deciding what types of information you put on labels, and how you enforce labels.

Regarding "green" label claims, if you want to maximize risk reduction, you have to provide users the information they need to select lower risk alternatives.

The first phase of the CLI is completed. Some feedback from consumer surveys indicates:

EPA deserves credit for the progress that's been made through the CLI so far, and the Agency should continue this initiative.

Toxics in Pesticides: Honoring the Public's Right-to-Know

Paul Orum, Working Group on Community Right-to-Know (Also see paper)

The Working Group on Community Right-to-Know responded last year along with about 70 other organizations to EPA's CLI, focusing on right-to-know. We proposed full disclosure on pesticide labels of chemicals and their hazards. These elements work together.

Honor consumers' right-to-know. List all ingredients, their common names, and their CAS numbers, so people can know what they are buying.

By itself, the chemical name is not very helpful. Also identify health and environmental hazards, and put this information together in a simple matrix.

We also recommend that labels provide phone numbers for reporting incidents and obtaining general information on pesticides and their hazards.

The main point is honoring consumers' right to know -- letting people know what chemicals they are exposed to and what these chemicals can do. This is the basic floor of information that is needed.

General Discussion on Pesticide Labeling

Jim Jones, Moderator

What we are hearing so far suggests that there is general support for providing consumers more health and environmental information on pesticide labels, and for standardizing label formats. All seem to agree on these points.

Comments by Committee Members:

Response: Industry does this to an extent already. Big products are packaged and marketed differently for agricultural and consumer use.

Response: TRI does not present risk information in any particular way. However, EPA had a contractor develop a matrix approach that would be helpful. It uses chemical names and the CAS number, and then indicates whether each chemical is a carcinogen, teratogen, etc., and indicates where there is no information available.

Response: Most electronic information will only be accessed by middle class and upper middle class educated people, so it is not a way to reach all pesticide users.

Response: This seems like a good idea, except we must remember that we still are linked to the label -- product-specific use and safety information still must go on the label.

Dan's Summary

Here are a few things that might help:

CLOSING COMMENTS

Dan Barolo

He understands many PPDC members' frustration that they cannot yet discuss issues to the point of making recommendations. He encourages the Committee members to sign up for in-depth work on the subcommittees mentioned these last two days. Hopefully, the next PPDC meeting will be a working meeting by subcommittees, offering solutions. That way, all will have something concrete to point to, contributing to meaningful change.

Results from both this PPDC meeting and the Food Safety Advisory Committee meeting later this week will contribute to the agenda of the next meeting of this Committee, in February 1997. Consider meeting outside the Washington, D.C. area next time -- suggestions?

PUBLIC COMMENT, November 13, 1996

John Gray, ISK Biosciences

Labeling of agricultural products with home uses has been cleaned up, to a great extent. Regarding use of the Internet, EPA should check with the Universities, which are doing a lot in this area, before investing a lot of its own resources.

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