July 9 & 10, 1996
Hyatt Regency Crystal City
Arlington, VA

WELCOME AND INTRODUCTION

Lynn R. Goldman, Assistant Administrator for Prevention, Pesticides and Toxic Substances, EPA

Welcome, Committee members and others. Pleased that the Pesticide Program Dialogue Committee (PPDC) represents a balance of interests and points of view including public interest, industry, users, public health, legal, Congress, and the general public.

Many expressed interest in participating on the PPDC, and new members will start rotating into the Committee starting in September 1997.

Until now, EPA talked separately to different types of interest groups. Now, through the PPDC, the Agency can have the benefit of dialogue with many at once. Committee members also will benefit from hearing and carrying back a diverse range of points of view expressed.

During the dialogue to follow, it's OK to bring forth differing points of view. All members must feel free to participate on an equal basis to give us the advice we need.

Pesticides touch every sector of society. EPA has an enormous responsibility in balancing their risks and benefits. Until now, the Office of Pesticide Programs may have seemed like a "black box"--information goes in and decisions come out, but you may have wondered how those decisions are made. This forum will help bring the process out into the open.

PESTICIDE PROGRAM UPDATES

PESTICIDE PROGRAM ORGANIZATION AND BUDGET ISSUES

Daniel M. Barolo, Director, Office of Pesticide Programs

The PPDC gives us an opportunity to educate a broader audience to what OPP is and isn't. We take our responsibilities seriously.

NUMBERS - These numbers, taken together, help illustrate the size and scope of our responsibilities and annual workload:

1. 620 Active Ingredients
2. 20,000 Products
3. 9,000 Tolerances
4. 6,000 Regulatory Decisions
5. 1,900 FOIA Requests (the most in the Agency)
6. 21,000 calls to NPTN hotline
7. 1,500,000 Certified Applicators
8. 3,500,000 Farm Workers
9. 400,000 Publications Distributed
10. $9 Billion in Sales
11. 1 Billion Pounds Used in the U.S.
12. 740 OPP Employees (fewer than in 1980, while our responsibilities have increased)

PROGRESS - Recent progress includes:

1. Realignment - The interdisciplinary Biopesticides and Pollution Prevention Division (BPPD) has been established, and a new Antimicrobials Division will begin its pilot stage by the end of this calendar year.

2. Reinvention - Certain pesticides that are naturally-occurring and/or foods, flavorings, etc. (like cedarwood blocks and garlic) have been deregulated. A dedicated Labeling Unit has been established in the Registration Division.

3. Management Changes in OPP - Those that have occurred so far are bringing new opportunities, and the flattening process now in the works will bring more.

4. Public Access - Many of our publications and regulatory documents (like REDs) are now on the Internet. The NPTN hotline provides information and answers on request, but cannot keep up with the public demand.

5. PESP - OPP's major investment in pollution prevention and IPM. We have 37 partners so far, and others are invited to join the program.

6. International - We are actively involved in CUSTA, NAFTA (most recently), California (exchanging science reviews), OECD, and other harmonization activities.

7. Science - OPP is at the forefront of evolving science issues.

MILES TO GO - Our major goals include:

1. Finish the Reregistration Program - Completing the process is in everyone's interest.

2. Register New, Safer Products - Over half of the new active ingredients registered last year were in this category.

3. Stabilize the Program - Get beyond the impacts of this year's budget crises, furloughs, etc.

4. Increase Public Education to Gain Greater Credibility - An agenda item today: How can we improve understanding, respect, credibility?

5. Provide Access to Information Bases - We lead the galaxy in the amount of data that we have. How can we best package and disseminate this information?

6. GPRA/Accountability - Emphasis is on planning and setting goals, to show outcomes and outputs achieved. We have an obligation to put this together, and will bring the topic to this Committee for input in the future.

7. Public Input - Issue to consider is how to provide information to the public while protecting the confidentiality of data/information?

8. Work Smart/Work Share - These concepts are necessary for us to stay effective and efficient into the future.

REREGISTRATION PROGRAM

Lois Rossi, Director, Special Review and Reregistration Division, OPP

See Also: Overheads/Handout on Reregistration Program

Reregistration is a comprehensive assessment of the risks posed by a pesticide. In reregistration, unlike registration or Special Review, we look at all uses and endpoints of the pesticide at once. We consider all routes of exposure and all possible populations exposed. Issues put aside earlier have to be dealt with during reregistration.

Each Reregistration Eligibility Decision (RED) has brought about some risk reduction measures and changes. (See table in handout.)

The public can influence EPA's scheduling of pesticides for REDs during the next several years by commenting on our Federal Register notice on RED candidate chemicals.

QUESTIONS:

Q. The reregistration process is impressive. Why does EPA feel that a "reduced use" policy is still necessary?

A. Pesticide labels often allow for broad scale use. We've found that in many cases the amount used can be reduced by as much as 50% without reducing effectiveness. We're trying to bring amounts allowed and used down to what's really needed.

REGISTRATION PROGRAM

Stephen L. Johnson, Director, Registration Division, OPP

See Also: Overheads/Handout on Registration of Pesticides

Steve notes that his goals are the same as Lois', however, unlike reregistration, OPP will never complete registration! He discussed the scope and primary activities of the registration program, the volume of decisions made annually, streamlining and reinvention activities, progress in registration (decision times and cycles are faster and more efficient), and some new ways that the program is doing business.

QUESTIONS:

Q1. Compared to registration, how much resources does EPA put into reviewing tolerances, and on harmonization?

A1. EPA puts a proportional amount of resources into reviewing tolerances. The Agency also is an active participant in Codex and other international organizations, and is trying to achieve uniform tolerances.

Q2. What about the interactive effects of multiple chemicals (such as synergy, additivity, etc.)?

A2. EPA hasn't had the resources to study or review such effects among pesticides and other chemicals. The new cancer assessment guidelines, however, begin to address multiple exposures.

Comment 3. A committee member suggests that EPA encourage "efficient, targeted use" of pesticides rather than "safer" or "reduced use," and cautions the Agency to beware of the potential pitfalls of bean counting.

Comment 4. Another committee member would like to see "reliance on pesticides" addressed. As policy evolves, what does EPA do when a new science effect is discovered? Address the setting of reasonable goals--these should include reduced risk and reduced reliance.

Q5. How is EPA enforcing the threshold requirement in the Section 18 emergency exemption for cotton, and is this a concept the Agency would use for a full Section 3 registration?

A5. OPP worked closely with the States and growers in considering this Section 18. All agreed that there was an identifiable threshold level. The States presented the concept to us, and proposed ways in which they would administer the program (each State is handling it a little differently). The program seems to be working out, and "yes," this is a concept OPP would consider using in the future for a full Section 3 registration.

Comment 6. The USDA representative highlighted the need for more and better communication and public information about the status of pesticides and pesticide issues.

Q7. Which changes are the biggest?

A7. Lynn Goldman answered that the biggest changes include the program switch to looking at exposures to children. This has driven tolerance levels down in some cases as we reassess tolerances during reregistration. Also, the models we use for cancer risk assessment have changed. Now industry is bringing forth biological data where we have concerns. Another area of change is exposure assessment. In some cases we are finding less and in other cases more exposure than we expected. Some improvements may come after reregistration, like spray drift management practices based on new exposure data recently received. We are becoming more sophisticated in assessing ecological risks but are not as advanced in this area as we are with human health risks.

PUBLIC EDUCATION AND COMMUNICATIONS NEEDS

William Jordan, Acting Director, Field Operations Division, OPP

Presenters: Mary Frances Lowe and Scott Schwenk, FOD/OPP

See Also: White Paper on Public Education/Communications Needs;

Handout: Pesticide Information on The Internet

OPP places a high value on communicating with the public and wishes to improve this effort. The program's communications goals include increasing safety, informing the public, and serving as an information resource.

At this session, the Committee members were asked to provide their input and views in three areas: expanding electronic distribution of information, expanding the service of the National Pesticide Telecommunications Network (NPTN), and improving OPP's educational materials.

1) ELECTRONIC INFORMATION DISSEMINATION

Scott Schwenk provided a demonstration of OPP's new home page on the Internet, and noted that the program's goal is to make our information available to anyone who wants it, anytime. He asked the Committee members what they thought of this new technology, whether it is something they would use, what would be their priorities for posting additional information materials, and if they had comments on the organization or presentation of information on our home page.

DISCUSSION

The States need access to information that OPP has in its files, and think it's great that the program is putting more information on the Internet. States other than California want to rely on EPA's registration and reregistration data bases--they need good, reliable data from OPP.

Committee members also would like access to information that permits rapid response regarding a chemical problem or hot topic.

Some would like OPP's home page to become a universal gateway, linking users with other pesticide-related data bases developed by industry, academia, the international community, and others.

They would like to see standard pesticide references and summaries of EPA's regulatory documents available electronically for downloading.

2) NPTN

OPP funds the NPTN, a national toll-free telephone service currently operated out of Oregon State University. NPTN handles approximately 21,000 telephone calls each year and provides factual, impartial information about pesticides. Although most callers are very satisfied with this toll-free service, NPTN is no longer staffed 24 hours a day, seven days a week, due to budget constraints. In 1995, thousands of callers each month (17,000 callers in one month) received a busy signal. This indicates a huge unmet need for timely pesticide information. Committee members were asked for their comments and ideas on improving service and garnering additional resources for NPTN.

DISCUSSION

Committee members generally expressed support for NPTN. They encouraged OPP to publicize it more widely, and seek alternative funding solutions including public-private partnership arrangements. OPP noted that one reason why the Agency had not publicized the service more widely was because it was having difficulty keeping up with current demand, as reflected by the number of "busy signals" reported. To deal with the overload problem, one member suggested that OPP narrow the types of information that the Agency wants NPTN to handle. Another suggested that the Agency use NPTN to determine what types of information people seek most often; then plan and coordinate accordingly.

One member asked if there were any checks on the validity of the information that NPTN disseminates, and asked how they handle the tough questions. OPP agreed that periodically auditing NPTN's responses was a good suggestion.

Members asked for cost comparisons between NPTN and the Internet. OPP responded that NPTN costs $450K per year while the Internet costs very little. However, both are important as they are used by different audiences. Committee members agreed that live phone contact is important since callers don't always know exactly what information they want, and getting incident-specific advice via Internet may not be feasible for all callers.

Committee members noted that other pesticide-related hotlines exist, operated by companies who market pesticide products, for example. Often they duplicate efforts and try to cover too much ground, sacrificing quality as a result. Committee members and OPP agreed that it would be desirable to find a way to build a more comprehensive, better coordinated, high quality system of hotlines/information lines across the U.S..

Several Committee members asked if there are important audiences not being served by NPTN. They believe the Agency should seek out "people who don't know, and don't know that they don't know." EPA's role in part is to educate people about their rights to information and where to obtain it. It requires a "conscious humility" to identify communities that have a right to know and reach out to them with appropriate information resources.

3) EDUCATIONAL MATERIALS

OPP sent the Committee members packages in advance containing samples of the program's general educational materials, status reports, and pesticide-specific documents. The Committee was asked to comment on the usefulness of these materials and to offer suggestions for improvement.

DISCUSSION

Committee members believe that OPP's information materials generally are good, however...

Some think these information materials are too "scary"--that is, they provide too much information, or information that is too technical for the public to easily understand. (Others disagree.)

Several Committee members find most of OPP's pesticide documents and labels "hopelessly technical in nature," and likened them to OSHA's Material Safety Data Sheets (MSDS'). They cautioned that if the information OPP issues in publications or on pesticide labels is overly complex, people won't read, understand, or pay attention to it. (Dan Barolo asked that the Committee steer away from labeling issues per se, as these could be the topic of a future meeting.)

A Committee member suggested that OPP routinely subject its documents to a "readability test" using a word processing tool similar to spell-check. This would alert the program to use of jargon, technical terminology, etc.

Some Committee members feel that in communicating with the public, EPA should try to influence people's choice of which pesticides to use, and should steer them toward use of safer pesticides. Other members feel that people should be provided objective information and left to make their own choices. The public should be able to trust that they are "in good hands" and that EPA is "doing the right thing"--i.e., that any registered pesticide they choose can be used safely.

Other suggestions include adding Congressional testimony to the Internet, and adding an e-mail mailing list to our home page Internet site.

SUMMARY

• Information is important. It allows people to make choices and it influences their behavior. Access to sound, impartial information is of interest to everyone. All see information availability as an important responsibility of EPA.

• OPP deals with many audiences and needs to use a full range of ways and means to make information available to them. The Agency can either guide people's decisions, or make information available "as is" and let people make their own decisions.

• There is a huge unmet demand/need for the information and services that NPTN provides. OPP should try to coordinate with other hotlines and information centers to meet these needs and demands, and reach out to under served populations.

• OPP should conduct audits/surveys to ensure the quality and consistency of NPTN's responses.

• OPP should make use of "readability" software to ensure that program documents and educational materials are free of jargon, are not overly technical, and can be readily understood by the public.

• OPP thanked the Committee for the discussion, and encouraged members to submit any additional thoughts about public education and communication needs at any time in the future.

FEES FOR SERVICES FOR PESTICIDE REGISTRATION Stephen L. Johnson, Director, Registration Division, OPP

Presenters: Peter Caulkins and Jeff Kempter, RD/OPP

See Also: White Paper on Fees for Service for Pesticide Registration;

Overheads/Handout: Fees for Services

During the past two years, OPP has improved its productivity and efficiency, completing a record number of registration decisions faster. While these streamlining and reinvention gains have been impressive, they will not be sufficient to keep the registration program on target in the future due to decreasing resources, increasing backlogs, and unavoidable rework cycles. EPA needs an additional $20 million to sustain the registration program, and at the pesticide industry's suggestion has developed a Fee for Services proposal that would cover 50% of the cost.

Under the Fees for Services concept, EPA would charge fees for all registration actions (except for minor food uses, Section 18's and 24(c)'s, and new inerts). For every type of decision, there's a target completion time or "clock" to run against. If EPA doesn't make its target timeframes, the Agency must pay money back (rebates) to registrants. However, if EPA completed decisions in less than target times, the Agency would collect bonuses. Registrants also would pay time and dollar penalties for incomplete applications.

Issues surrounding Fees for Services include perception (that registrants are "buying" decisions), accountability to the public and to registrants, and sunset provisions. OPP asked Committee members in advance to prepare their comments, questions, and suggestions regarding ways to address these issues.

DISCUSSION

The Committee suggested that fee amounts and time periods should be subject to revision and adjusted in the future, based on experience (not on entitlements). OPP agrees.

The FDA representative indicated that that agency's program under the new Prescription Drug User Fee Act has been a big success. FDA's integrity has not been compromised, accountability has increased, and the program has straightened itself out and become the fastest and most efficient in the world.

Some members of the Committee cautioned OPP that implementing a Fee for Service program could put EPA on a "slippery slope." Where would the Agency ultimately draw the line in receiving fees for decisions? Which decisions are inherently governmental and should not be associated with fees? In whose interest are good decisions made, and who should pay? Other members say not to worry, it will always be EPA's job to make the decisions and make them well. Congress will understand. This efficiency measure needs to happen.

To maintain public confidence if OPP adopts a Fee for Service program, the States want to see complete data bases, not negotiated agreements supporting conditional registrations. Audits should be built into the program, and a short sunset provision might further increase public confidence.

Committee members asked how the amounts of fees would be determined, how they would be collected, and what the "prudent reserve" consists of. OPP explained that the Agency is working with Congress to determine the total cost to do each job, and to decide how to collect funds. It's important that EPA not make more money than we need to do this work. However, the Agency also needs "insurance" to cover us in the slow years, so a prudent reserve makes sense.

A Committee member suggested that a FIFRA citizen supervision provision could be added. EPA responded that this was proposed in an earlier bill, but States with agricultural departments administering their pesticide laws objected.

Another Committee member pointed out that this provision really shouldn't change anything. OPP should go forward and do what can be done to improve efficiency and speed, anyway, with or without Fees for Services. OPP agrees.

Since two Congressional committees would have oversight over OPP's activities if Fees for Services were implemented, a Committee member asked what will happen if both Congressional committees start adding new responsibilities and the Agency can no longer meet the short time frames. OPP responded that the Agency has enough flexibility built into the system so that it could readjust timeframes and fees based on performance to date. We also hope to bring efficiencies to the program so we can reduce the unit costs of producing some decisions.

A Committee member noted that we have a very open process in the U.S. compared to Canada, and the important thing will be to keep the lines of communication open so that minor uses stay in the picture and are not forgotten.

Commercial applicators won't care how this comes out as long as EPA keeps doing its job and doing it well. Price structures could become an issue if some types of registrations were no longer available to them, however.

Another Committee member noted that there is an accountability issue to consider, and that good tracking systems will help ensure accountability overall.

SUMMARY

• While Fees for Service is still a proposal at EPA, FDA's experience to date has been good. The integrity of their program was not compromised, while speed and efficiency increased.

• The "slippery slope" is something to consider. Who benefits most/should pay for sound, timely decisions? What functions are inherently governmental?

• Accountability will continue to be an issue. OPP should look at quantifiable measures to track the program and should operate in the open to address this concern.

• Other ways to increase public confidence include audits and oversight provisions, citizen suit provisions, and the mill tax issue in California.

• EPA should review the program after several years based on experience, and should consider a sunset provision.

• EPA must consider price issues and be sensitive to the impact that these could have on minor uses and small businesses.

• EPA must continue to operate in the open to keep the minor use community informed and to maintain the confidence of both the public and registrants.

RESISTANCE MANAGEMENT

Dr. Janet L. Andersen, Acting Director, Biopesticides and Pollution Prevention Division, OPP

Presenter: Sharlene Matten, EFED/OPP

See Also: White Paper on Pesticide Resistance Management;

Overheads/Handout: Pesticide Resistance Management

Pests can develop resistance to pesticides resulting in a loss of pesticide efficacy. Hundreds of pests already are known to have developed resistance to a variety of pesticides. Pesticide resistance can lead to increases in the frequency and rate of application of pesticides, thus increasing risks to humans, wildlife, and the environment. However, successful resistance management strategies can result in significant pollution prevention, cost savings, and extended market life of pesticides.

EPA currently considers pest resistance and resistance management in making decisions on Section 18 emergency exemption requests, Special Reviews, and proposed new pesticides and new uses (but has no formal policy for the latter). The Agency has studied, pesticide resistance and resistance management, identified elements needed in a resistance management plan, and discussed these topics with the FIFRA Scientific Advisory Panel and SFIREG. OPP also has developed an internal interdisciplinary workgroup to further analyze the problem, identify options, review plans, and propose labeling to address concerns.

OPP asked the Committee in advance for their views on the best approach for the Agency to take in addressing the problem of pest resistance; the need for a new active ingredient screening process; whether OPP should address the problem of pest resistance to already registered pesticides; and whether resistance management recommendations should be required on pesticide labeling.

DISCUSSION

1) Best Approach for EPA to Take?

A Committee member that EPA should give growers the tools needed to manage resistance. Growers are down to single pesticides for some minor crop/pest combinations, at present. This is a major problem.

Another member stated that EPA should be careful about what it is trying to "manage" -- a company's product or the public good. Protecting the efficacy of Bt, for example, is a public good. A mandatory resistance management program for Bt is appropriate.

Cross-resistance between chemicals is a difficult problem, a Committee member pointed out. EPA should serve as a liaison between companies in these cases.

Dan Barolo asked if distinctions could be made to define those cases in which resistance management is in the "public good." The Committee found it difficult to define "public good" parameters.

One Committee member expressed the view that while EPA could provide some guidance, resistance management has to be a voluntary program. He asked that the Agency be consistent and flexible in administering any resistance management program, and get involved where there's a public need, not in protecting products (which is the pesticide industry's job).

Dan Barolo asked if, like efficacy, resistance should simply be dealt with in the marketplace. Should EPA have a role at all, and if so, what should it be?

A Committee member noted that resistance is a more serious and difficult problem than efficacy, and feels that EPA should play a role since resistance can spread worldwide. The Agency should include resistance management considerations in its registration program as well as its global agenda.

Another Committee member disagreed, noting that it's in the manufacturer's best interest to develop and maintain products that continue to be effective over the long term. This is part of any pesticide stewardship program. Regarding questions of the public good, he feels that EPA should participate selectively (as with Bt). It is inevitable that EPA will be involved in resistance management. The key is for the Agency to be consistent and flexible.

A Committee member noted that he has been dealing with resistance in tropical minor crops since 1979 or '81. For every new product coming on the market, he believes, resistance is considered by industry. Companies will walk away from a chemical with resistance on the horizon. He suggested that EPA work with registrants to develop enforceable label language, but defer to experts at the local and State level in developing effective resistance management programs. Again, "Be flexible."

Another Committee member observed that resistance doesn't develop overnight. National monitoring programs can identify where resistance is occurring. When EPA sees it arising, he thinks the Agency should start working with companies to address the problem and should play an oversight, monitoring role. When only one chemical is left that works, it's too late. EPA should do the surveillance needed to spot these cases coming up.

A Committee member cautioned EPA, with limited resources, to focus on protecting safer pesticides like Bt. Don't spend public resources to support pesticides that some would consider "public bads."

Other Committee members expressed the following views.

EPA should consider and communicate to others the target pests already identified as resistant.

EPA should define what the "public good" is on a case-by-case basis. Let the industry worry about their (big) products. They study this, and see when resistance is starting to occur.

Resistance will continue to be a problem; it's just not EPA's problem to manage the gene pool of every pest.

2) Is a New Active Ingredient Screening Process Needed?

A Committee member asked about USDA's role in resistance management. That agency focuses on specific pests, and seeks to understand resistance management and communicate findings at the local level.

Lynn Goldman sees too many requests for Section 18's because of resistance problems. Companies are doing R & D, but new products just trickle out. Solutions?

One Committee member responded that the pipeline is starting to refill, new products are coming on the market, and many of them are much safer.

Another solution to the Section 18's problem, noted another Committee member, is use of IPM. EPA could promote greater use of IPM. The government dedicates only paltry resources to IPM, though the PESP is good.

3) Should EPA Address Problems of Pest Resistance to Already-Registered Pesticides?

Some Committee members answer, "If in the public good, yes; otherwise, no." Other members believe that EPA should be in the business of protecting the efficacy of (all) pesticides, particularly those that are in the public good. But there still is no consensus on how to define which pesticides are in the "public good." The Committee had no clear answer regarding where to draw the line between acting in the public interest, which EPA should do, and becoming too involved in marketplace decisions.

A Committee member suggested that acting in the "public good" may involve protecting the efficacy of pesticides used for public health purposes, such as mosquito control.

Another member suggested that EPA could do an empirical analysis of the behavior of the market (which is not necessarily logical). The Agency could identify circumstances where a market failure has occurred, and step in. He suggested that EPA should be in the business of protecting the efficacy of the product.

A member suggested that since this is a decentralized problem, EPA could gather and transfer information on trends, like CDC does.

4) Should pest resistance management recommendations be required on pesticide labeling?

[The Committee had insufficient time to discuss this issue.]

SUMMARY

• EPA must make sure that sufficient pest control tools are available, particularly for minor crops, so growers can manage pest resistance.

• In addressing the problem of pest resistance, EPA should act in the "public good" to protect the efficacy of certain pesticide products that are safer or provide unique public health or other societal benefits.

• Some Committee members believe that EPA should play a major role in protecting the efficacy of pesticide products.

• Other Committee members believe that pesticide producers have primary responsibility for managing their products' pest resistance, as part of industry's stewardship role, and that EPA should focus on providing guidance and coordination.

• EPA probably should play some role in pest resistance management. This may involve providing education and guidance, serving as a liaison between companies, or disseminating information on trends.

• EPA should not make resistance management mandatory in all cases.

• EPA should look for and approve Section 18's/unregistered pesticides that fulfill a "public good" compared to existing Section 3 registrations.

• There is disagreement on EPA's exact role in pest resistance management, and on how to define what constitutes a "public good."

ENDOCRINE DISRUPTERS

Denise M. Keehner, Acting Director, and Tony Maciorowski, Environmental Fate and Effects Division, OPP

Presenters:Les Touart and Mary Powell, EFED/OPP

See Also: White Paper on Endocrine Disrupters

Overheads/Handout: Endocrine Disrupting Chemicals

A growing body of scientific research indicates that a number of man-made industrial chemicals and pesticides may interfere with the normal functioning of human and wildlife endocrine systems. These endocrine or "hormone" disrupters may cause a variety of problems with development, behavior, and reproduction. The implications for wildlife and human populations and, in particular, for unborn children, who may be at greatest risk from exposure to these chemicals, are serious and warrant priority attention by EPA. The Agency is investing significant resources into learning how and to what extent chemicals may be adversely affecting human health and wildlife through endocrine disruption.

Although many pesticides have undergone extensive toxicological testing, a key issue is the extent to which this testing has been adequate to detect these types of impacts, and if it is inadequate, what additional testing is needed for EPA to assess and characterize risk. OPPTS is taking the lead for the Agency on these issues, and is interested in the views of the PPDC on its planned approach.

Committee members were asked in advance to consider the following discussion points. Does the PPDC support development of a screening and testing strategy now? Are there other key issues that OPPTS should be considering? What's the PPDC's reaction to the approach of holding some preliminary non-FACA discussions, and moving to linkage with an existing FACA? Would the PPDC recommend one FACA versus another?

INTRODUCTORY REMARKS

Lynn Goldman presented opening remarks noting that this is an area where the science has been moving rapidly in recent years. Studies are showing effects in wildlife at levels much lower than anticipated. EPA is funding increased research, and is updating test procedures and protocols. It seems clear that endocrine disruption is a mechanism that can lead to reproductive effects. We hope that new assays will help predict which pesticides may cause these effects. In the SDWA, Congress has inserted requirements for screening and testing pesticides in drinking water for endocrine effects. EPA is deciding how broadly to interpret this mandate, and will be working hard to meet the deadlines in the SDWA.

Asked what kinds of regulatory decisions the new data will produce, Dr. Goldman responded that, as always, there are a range of ways in which EPA can regulate pesticides. We'll focus on ways to reduce exposure, based on learning more about doses that cause these effects. She agreed that the timing aspect also must be considered, and will make these decisions quite complicated. The effects can be acute, not chronic, and may occur as a result of exposure on a particular day of gestation, for example. Synergistic effects also may occur, as some data now show. If in vitro assays work, this would be a big advantage to the Agency.

A Committee member noted that while the media suggests that this problem is brand new and EPA knows nothing about it, this is not true. EPA has received lots of data regarding the chronic effects of pesticides. Dr. Goldman agrees that EPA has looked for effects of pesticides, but notes that the Agency has not examined how these effects occurred.

Asked about interagency coordination, Dr. Goldman noted that much is underway, led by the President's Office of Science and Technology Policy, and including work by the National Academy of Sciences, NIEHS, FDA, CPSC, and others.

DISCUSSION

1) Should EPA develop a screening and testing strategy now? and,

2) Are there other key issues that EPA should be considering?

One Committee member says, "yes," develop a strategy now. Move ahead while on the front edge of the curve. The key is to look at information already in-house, but in a new way. Start to define the limits and parameters of endocrine disrupters.

Another Committee member recognizes that the public is alarmed and agrees that EPA should be concerned. However, from the standpoint of the data, is a big, fast response by EPA warranted scientifically? Or is the Agency's response more politically driven? EPA indicates that the data the Agency has seen are compelling, but the information available is spotty so we need to look further. We have little data on thresholds, for example, and need more.

A Committee member asked how the multi-stakeholder process will do the initial screening that's needed. EPA indicated that by developing a strategy, the group will design how to attack the problem, will set criteria, define stages of testing, etc. EPA will lead the effort to implement the resulting strategy, with industry paying for any testing required.

The USDA Committee member asked about resources: The NAS kids study three years ago produced interest among agencies in doing lots of follow-up work, yet we never received resources to do this work. Why rush to the next priority issue when we have insufficient resources?

Dan Barolo answered that it's a prioritizing issue, and a challenge. The stakeholders must help EPA set priorities for reviewing studies. In the reregistration process, OPP already is reviewing lots of studies for many pesticides. He will ask the stakeholders to recommend how the endocrine disrupters should work into the queue of pesticides awaiting review for reregistration. He agrees that the worst thing to do is to raise false hopes and expectations. Unless the weight of evidence indicates that the endocrine disrupters should be our highest priority, OPP can't arbitrarily put them up front.

A Committee member noted that there's richness in the data submitted to EPA already, and urged the Agency to look at the data we have before rushing off to develop new methodologies for more studies. EPA agreed that the Agency has a fair amount of data, even wildlife studies, that can tell us a certain amount. However, OPP has few of the types of studies we need most for endocrine disrupters, that is, behavioral studies (such as nesting studies), reproduction studies, and studies of effects on immune systems in wildlife. OPP might have to add to the array of tests already required, at least for certain pesticides.

Another Committee member noted that while concern and attention must now be paid to endocrine disrupters, this is not a new issue. What's new is that the Agency is looking at reproductive effects more broadly, in wildlife. It's a huge task and EPA is being pressured to act, but the Agency should not look for quick "yes" and "no" indications. Instead, look at the whole data base. It's worthwhile to look for a screening mechanism, and to change the endpoints in some existing studies. EPA should look very hard at data we already have and know.

A Committee member noted that the Lake Apopka of the human world is the workplace, where exposure levels are highest. EPA should look at workplace exposures to pesticides to learn more about endocrine disrupter effects.

3 & 4) Should the group link with a full FACA committee, and if so, which one?

The long range success and credibility of the endocrine disrupter program requires a FACA-type committee umbrella. However, the Committee encouraged EPA to get started sooner, in a non-FACA setting if necessary, and develop a sound strategy. The strategy is important to ensure that the tests EPA will require will tell the Agency something useful.

Which committee? -- EPA probably has a better idea than the PPDC members which FACA committee charter would best accommodate the endocrine disrupter group, Committee members responded. The composition of the new committee probably is more important than its charter, anyway.

It's most important that the subcommittee selected to look at the endocrine disrupter issue be composed of really well qualified scientists who understand the effects and have a handle on the existing data base.

SUMMARY

• There is a need for EPA and other stakeholders to work on developing a screening methodology for endocrine disrupters.

• In addressing the endocrine disrupter issue, it's important that EPA look at existing pesticide data already in the Agency's files before requiring new studies.

• EPA should consider factors such as occupational exposure in setting priorities and screening pesticides for endocrine disrupter effects.

• The group addressing this issue should become linked to whichever FACA committee is most appropriate. It's most important that the subcommittee examining the endocrine disrupter issue be technically oriented and scientifically well qualified.

OPEN DISCUSSION

Short Statements by Non-PPDC Members

Tuesday, July 9 --

1) John McCarthy, American Crop Protection Association

2) George Wichterman, American Mosquito Control Association and Lee County Mosquito Control District

3) Rick Kocurek, Texas Pest Management Association

4) Amy Brown, University of Maryland

Wednesday, July 10 --

1) John McCarthy, American Crop Protection Association

2) Tim McCarthy, Technical Assessment Systems (TAS)

3) Norm Goldenberg, Servicemaster

4) Elliott Gordon, Makhteshim-AGAN, PBI Gordon

5) Ed Gray, Jellinek, Schwartz and Connolly

6) Sandra Marquart, Consumers Union

DISCUSSION OF FUTURE TOPICS AND WRAP-UP

Led by Dan Barolo

1) How can we improve future PPDC meetings and make them more valuable?

• Increase opportunities for informal dialogue among PPDC members, and between Committee members and EPA staff/other participants. Have lunch together. Hold meetings outside the immediate Washington, D.C. area so fewer people are torn away to take care of other pressing business.

• Adjust the format of meetings to include more opportunity for dialogue and discussion of issues, and less "show and tell." (Background materials and brief presentations opening each of the issue discussions would still be helpful, however.) Allow Committee members to discuss one or two issues to the point of reaching conclusions and making recommendations.

• For part of the meeting, divide the Committee members into smaller groups to stimulate more formal and informal discussion.

• Schedule some presentations by Committee members, and have them lead the discussion at times.

2) Should the composition of the Committee be changed, and how?

• We need "fewer Bobs" and more women.

• Grower interests should be more heavily represented. Add a "real" grower?

• More grass roots representation would be beneficial. Add a real grower using IPM? Or a worker group representative?

• Keep the size of the Committee relatively small.

3) What issues would members like the Committee to address in the future?

• Labeling (many concerns fall under this umbrella topic);

• Education for the urban/homeowner population as well as the C&T population;

• Public access to information;

• Reduced use policy and promotion of IPM;

• Section 3 registrations and Section 18's requiring IPM;

• Responsible use as opposed to reduced use;

• Definitional questions (such as "public good," "of concern," etc.)

• Tolerance issues, such as residues in foods without tolerances;

• Risk, how EPA deals with risk, risk communication;

• Ground water State Management Plans;

• Inerts;

• Internal EPA management, processes, and bean counting;

• GPRA;

• Infants and children issue update;

• C & T program;

• Exposure from aerial application, even when use is correct;

• International arena;

• Interagency research and coordination;

• Efficacy;

• Devices;

• Indoor applications;

• User group involvement in EPA decisions;

• Resistance management, following up on the earlier discussion;

• Field communications;

• Worker health surveillance.

• Chemical interaction (synergistic/additive effects)

• Agency cancer policy

• Information data needs

MEMBER OBLIGATIONS/OPPORTUNITIES

1) Preparation - Review materials in advance and come prepared to comment.

2) Attendance - It's essential that everyone make an extra effort to attend these meetings.

3) Represent - Act as an extension agent and reach out to others in your constituency. Bring a sense of their viewpoints to these meetings.

4) Participation - is encouraged both during and outside of sessions. It's OK to have different viewpoints.

5) Accountability - is due on both sides. Be both participatory and responsive.

Dan wants to change two things about OPP: its Pace (make more timely decisions) and Place (increase understanding of the program's mission, goals, and interests and advance these). He looks to the PPDC members for assistance in bringing about changes in these two areas.

OPP is committed to making the PPDC a success. Looking for opportunities for successes. He mentioned that FIFRA will be 50 years old in 1997. Any ideas on ways to commemorate this event? (National workshop? Special publication?) Let us know.

FOLLOW-UP

Within the next few weeks, OPP will send the PPDC members a summary of this meeting and a proposed list of about 10 issues for discussion at future meetings, drawn from the Committee members' suggestions, above. An OPP Docket is being opened where documents pertaining to this meeting will be filed and made available for pubic review.

NEXT PPDC MEETING: Is tentatively scheduled for November 12 and 13, 1996.

THANKS TO ALL!

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