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PPDC AZM Transition Issues Workgroup - March 6, 2007 Meeting Summary


Co-chairs: Rick Keigwin, Director, Biological and Economic Analysis Division (BEAD), Office of Pesticide Programs (OPP), EPA
Al Jennings, Director, Office of Pest Management Policy (OPMP), USDA

Designated Federal Official:  Linda “Pineapple” Murray, EPA/OPP/BEAD
Members of the AZM Transition Issues Workgroup

Rick Keigwin and Al Jennings started the meeting with introductions of the workgroup members present in Potomac Yard and on the phone.  Linda Murray gave an overview of the FACA requirements for this workgroup.  She informed the group that the meeting summary will be docketed.

Rick Keigwin noted that the meeting summary will be posted to OPP’s PPDC website and the meeting summary and attendance list will be posted to AZM docket [located at http://www.regulations.gov under docket number EPA-HQ-OPP-2005-0061].

Rick Keigwin also noted that litigation on the AZM decision has been reinstated.  He informed the group that the purpose of the meeting was not to discuss the merits of the decision or the lawsuit.  The purpose of the meeting is to come together to work on transition.  The workgroup will discuss new products, trade issues, Codex, and ways to ensure that there are MRLs in key export markets, as well as to discuss technical barriers to an effective transition.  EPA is in the process of doing a chemical / crop matrix for the workgroup.

Discussion on the purpose of the meeting was opened by Larry Elworth of the Center for Agricultural Partnerships.  He said that the purpose should be to transition to something that works, not necessarily away from AZM.  He said that the transition should be to a specific destination, and that we should have a picture in mind of what the destination will look like.  

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Co-chair of the committee, Al Jennings of USDA/OPMP asked, “How do you rebuild ag systems that were built on AZM?  What are the alternative systems?  This is not a situation of losing chemical A, and substituting chemical B.” 

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Margaret Rice of EPA/OPP Special Review and Reregistration Division (SRRD) gave the group an overview of the AZM Final Decision document that was published on November 16, 2006.  She noted that most of what she was to say is information also available in the AZM Fact Sheet, which is available on the EPA website.  AZM has a long regulatory history.  The 2001 AZM Interim Reregistration Eligibility Decision (IRED) divided AZM uses into three different groups.  The first two groups were comprised of uses that were phased out by 2006.  The uses in the other group, group 3, were to be revisited.  These were uses that posed high risk, and had high benefits to their use.  EPA issued a proposed decision for these uses in June, and issued a final decision in November.  Listening sessions were held with key members of the AZM team, including OPPTS Assistant Administrator Jim Gulliford, and growers and other stakeholders.  There were some key comments that contributed to the risk management decision such as comments received on exposure to residents, workers, and their families living in or near orchards, particularly in the northwest.  Also, new information from the United States Geological Society (USGS) showed continuing AZM detections in surface water at levels exceeding the EPA Level of Concern (LOC) for aquatic life. 

Benefits - some chemicals that had been in the pipeline as alternatives to AZM had been registered by 2005.  However, even with these new registrations, the percent crop treated with AZM hadn’t changed much between 2001 and 2006.  This showed that growers had not been moving to alternatives.  Comments from USDA and other stakeholders noted that Maximum Residue Levels (MRLs) had not been established for alternatives in key markets.  Historically, it has taken 6 years or longer to establish MRLs.  There is a need to establish MRLs more quickly.  Several commenters on the AZM decisions noted that the new alternatives need to be applied on a more specific time frame than the older, broad-spectrum pesticides and growers needed time to learn the techniques associated with these new alternatives.

The AZM decision allows for a graduated phase-out.  Nursery stock and Brussels sprouts will be phased out by September 2007.  Almonds, pistachios, and walnuts will be phased out by October 2009.  Apples, cherries, pears, blueberries, and parsley will be phased out by September 2012.  The group to be phased out in 2012 is further restricted by a graduated reduction in annual maximum application rates.  The crop specific limitations were established to ensure that the phase out is truly a phase out.  Growers told the Agency that they preferred a limit on maximum annual application rates instead of maximum single application rates, and the Agency was able to honor this preference.  In addition, the AZM Decision called for larger buffer zones around water bodies, buffers around houses and occupied structures, further restriction on aerial applications, and a stewardship program to help workers and their families reduce their exposure to AZM and other pesticides.  New AZM labels will be in place for the 2008 use season.

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Companies requested the opportunity to provide final comment on the ecological risk assessment, and an internal meeting on the human health hazard assessment.  The terms and conditions of the AZM label amendments provided for at least one meeting prior to July 2011 to discuss whether or not the necessary pieces are in place to ensure successful phase out, including MRLs in key export markets.

Carol Dansereau asked Margaret Rice to comment more on the buffer zone specifics.  Margaret Rice noted that the buffers around housing and other occupied dwellings is 60 feet and will go into effect in 2008.  Shelley Davis asked if the Agency placed value on impact on endangered species and their habitat.  Margaret Rice noted that impact on endangered species was not considered for the most recent AZM decision, but that there is an endangered species assessment going on now for litigation in the Pacific Northwest and elsewhere.  Shelley Davis mentioned that it may take 6 years or more for MRLs to be established, and asked how this was balanced in the decision.  She also asked what EPA considered when balancing human health risks with benefits.  Margaret Rice said that in the short term, EPA believed that benefits outweighed risks, and this is explained in the decision document.  Margaret Rice said that the purpose of this meeting is to ensure that phase out occurs.  Shelley Davis said that some of the margins of exposure (MOEs) for AZM are below 10, so there are specific examples of acute neurotoxicity.  She asked what the criteria were for concluding that the benefits outweighed the risks (for allowing continued use of AZM) for the early stages of the phase-out.  Rick Keigwin indicated that Shelley Davis had not heard the ground rules for the workgroup meeting.  The group had discussed that they would not delve into rationale for the Agency’s decision, but focus on transition.  Jim Cranney asked about the meaning of an MOE in the low tens.  Margaret Rice responded that it means there is approximately a 10 fold margin between expected exposure and the no effect level.

Al Jennings suggested that the group brainstorm ideas for paths forward for the workgroup. Jay Brunner of Washington State University asked for structure during the brainstorming, and suggested that the group brainstorm by category.  It was decided that the group would first brainstorm for categories.  

The group brainstormed many categories.  Barbara VanTil suggested that one category should be the infrastructure to support growers- scouting, training, etc. 

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Jeff Zellers said that the definition of alternative was key.  Many of the alternatives researched include other OP’s or other chemicals with risk.  He said that the group should define alternatives as “viable” alternatives.  He also said that the group should look at infrastructure – what does the group have to do to “elevate” research to make sure they are identifying viable alternatives (in terms of efficacy, MRLs, economics of use, etc.).  Paula Paul said that the ability of alternatives to manage resistance should be considered.  She also suggested that the Agency’s MRL spreadsheet should be expanded to include the pest to be controlled.  She said that the groups should identify which MRLs are in place and what the time frame is for achieving MRLs.  Rick Keigwin indicated that EPA is working on the pest matrix and will incorporate Paula’s suggestions.  He also told the group that Lois Rossi, Director of the Registration Division in EPA’s Office of Pesticide Programs asked him to tell the group that CODEX is looking for candidates for MRLs.  This workgroup can identify chemicals for prioritization within the CODEX MRL setting process. 

Rebeckah Adcock asked, “What is the Plan B?” What happens if problems such as resistance occur, or if MRLs are not established?  She asked about a scenario in which AZM is the only tool left and the transition is not successful. 

Steve Balling of Del Monte Foods said that Codex is not always used as a default for export markets.  Many countries have abandoned Codex in favor of establishing their own residue limits.  He said that infrastructure and research are eroding at the same time we are asking growers to adopt products that are assumed to be less risky.  Sustainability issues (water, air quality, biodiversity) are weighing heavily on food processors and growers and they need to consider sustainability while they are transitioning and remaining competitive in the global marketplace.  Steve Balling would like to see metrics to measure success or failure of the transition.  He said that we often institute change and then never look back.  Barbara VanTil agreed that metrics are important.  Shelley Davis suggested that the group explore whether mitigation efforts are really protecting workers and their families.  Biomonitoring and incident reporting could be measures of this.  She also asked about the viability of moving to organic production and measuring the number of producers that are growing organically.  Larry Elworth said that the economics component of the transition needs to be broad in scope – is the cost of alternatives too high?  He also agreed that the transition should distinguish between pests.  The transition should look at secondary pests as well because they become more important as AZM is replaced.  Just having something registered is different than knowing if it works.  Experimental Use Permits (EUPs) are important for determining efficacy.

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Mike Shaw of Dow AgroSciences said that trade is a necessary category.  It is more complex than MRLs; getting a Codex MRL is not as useful as it used to be.  Japan does not accept as many MRLs.  How can MRLs be established for new or existing chemicals in a timely way?  He would like to see a framework developed with USDA-Foreign Ag Service (FAS) to do this.  Regarding organics, Steve Shaw said that international organic standards differ.  A US organic label does not mean that something can be sent to Japan or Europe as organic.  Mike Willett said that in the markets where MRLs are not recognized, commodities might actually be able to get into those markets faster than the six years it takes to get an MRL.  Al Jennings indicated that USDA Deputy Secretary Conner has laid out some goals for advancing specialty crop trade in the upcoming Farm Bill.  Michael Fry said that funding for regional efficacy and IPM studies is important.  He asked if there are any anticipated changes in the standards for Section 18’s or 24C’s?  How cumbersome are the regulatory constraints for Section 18’s and 24C’s?  Ephi Gur of MANA said that some alternatives might not be registered in all U.S. states.  Ann Pingitore mentioned that aflatoxin contamination could increase in pistachios if alternatives do not adequately control worm pests. 

Larry Elworth asked about the registration status of AZM in Canada.  Andrew Beyak of Canada’s Pest Management Regulatory Agency (PMRA) told the group that AZM is registered on apples, crabapples, apricots, blackberries, cherries, cranberry, grapes, pear, peaches, plums, prunes, and raspberries.  Of those, apples, cherries, and pears are the most important uses.  Some phase-outs are scheduled for 2007.  Alfalfa, clover, rye, Brussels sprouts, and nursery plants, and some other uses are already phased out.  Andrew Beyak said that one way to find information on Canadian MRLs is to search for AZM MRL on the PMRA web site.  Larry Elworth asked about the status of AZM in Mexico.  Jerry Baron asked Andrew Beyak if there are still MRLs for parsley and blueberries in Canada.  David Trinka said that economics is important, and that application methods of AZM and alternatives are important.  Michigan blueberries need aerial application for some pests.  IR-4 needs to be funded to ensure that alternatives are available for smaller crops.  Bob Elliot of the California DPR spoke to the group about California’s experiences with transition grants and on infrastructure and field testing.  He talked about smart sprayer technology and said that there is a lot of interest in California for this technology.  Rick Keigwin asked Bob Elliot to send him a fact sheet about their grant programs for the workgroup.

Larry Elworth suggested that the group consolidate categories.  Mike Shaw suggested some major categories – trade, pest management systems (efficacy, alternatives, economics, strategy shifts), transition metrics, and a generic category (registration, etc.), and said that there may be other categories.  Mike Willet suggested four different categories that would include all of the brainstormed items: (1) Research and efficacy; (2) International MRL efforts; (3) Grower impact assessment and tracking changes; and (4) Registration of alternatives and risk profile of alternatives.

Lori Berger noted her interest in discussing the definition of alternative.  Rick Keigwin noted that it is important to know what a working definition of alternative is.  Barbara VanTil volunteered to work with a smaller group to facilitate the consolidation of the brainstorm list.  Larry Elworth suggested that EPA look for a previous definition of alternative as developed by a TRAC committee.  Shelley Davis suggested that the group not obsess over the word alternative.  Al Jennings reminded the group that its purpose is to provide USDA and EPA advice.  Lori Berger restated that it is important for this group to establish definitions.  Rebeckah Adcock said that there may not be a consensus by the workgroup on the definition of alternative, but she would like a clear understanding of what EPA means by alternatives.  Mr. Keigwin indicated that there are Canadian MRLs for AZM for blueberries (2 ppm), cranberry (1 ppm), and strawberry (1 ppm). 

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During lunch a smaller group of the AZM Transition team worked to consolidate the brainstorming ideas into a workable list to break down the transition process.

The smaller group reported back to the full workgroup.  The categories decided upon include:

  1. Trade
  2. Regulatory Issues
  3. Impact Assessment
  4. Research and Implementation

A question was brought up about how to capture resistance management issues.  Another question was brought up how performance will be measured.

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Mike Shaw noted that the workgroup had identified categories and will work on the definition of what a successful transition would be.  He said that the group should look at where we are now and identify where there are gaps to getting to the goal of transition.  Then the group should determine what is needed to get to the goal, and what it will take to get from here to there.  Larry Elworth said that the group should not only have a goal in mind, but have a check list of what it needs to do to get there.  Shelley Davis noted that not only do we need a check list of what needs to be done, but we need to list out who will do these things.  What is it that the workgroup will do?  Rick Keigwin said that the work group will help pull a framework for transition together, and will also keep the Agency up-to-date on how the transition is going. 

Jay Brunner said that the group needs a framework, and that the framework would contain the implementation plan.  He hopes that the workgroup will talk about the framework.  He suggested that the group make recommendations on priorities, the reallocation of funding, etc.  Rick Keigwin asked how folks wanted to proceed from here.  It was suggested to pick a category and proceed.  Rebeckah Adcock asked if the group was going to break into smaller groups.  She said that she works with growers in the field.  Farming is already complicated.  Transitioning at the grower level is difficult.  The ultimate matrices are if we will have any agriculture left.  She has seen that by the time changes in regulations come down to growers, they often don’t apply to the growers situations. 

            The workgroup divided into two groups.  One break-out group addressed what would fall under research and implementation and the other break-out group addressed what would fall under trade and regulatory issues.  The workgroup came back together to ‘report out’ on the break-out discussions.


Regulatory Issues

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The group questioned the trade and regulatory break out group.  Jay Brunner asked about the prioritization of crops by IR-4.  Are there experimental use permits (EUPs) for large-scale testing before registration?  Larry Elworth said that it would take a significant change to use EUPs like this because the information, cost, and time needed to obtain an EUP currently prevents EUPs from being a viable option.  Jerry Baron said that IR-4 would give high priority to AZM alternatives.  We would need to know if a chemical is likely to serve as an AZM alternative in the necessary time frame.  Jim Cranney said that the first couple years of use for new chemicals are part of the experimentation process for growers.  This is when growers determine whether the new materials are solving problems or whether they are not.  Rebeckah Adcock asked, “What is the market reality of having a product available for use as a Section 18?  Is it a real option as a plan B?”  She said that crops with a small percentage of crop treated will be in this position.  Pat Cimino of EPA/OPP said that tart cherries would be a crop in that position.  Zero tolerance is the standard for some of these pests.  Could the group talk to USDA about these standards?

Larry Elworth commented that for an alternative to be viable in 2012 it really needs to be in the queue now.  Jerry Baron said that a project started by IR-4 in 2007 would be submitted to the Agency in 2009.  Then the project would have to wait for PRIA timeframes.  So there is a two year minimum between residue trials and submission to EPA.  Barbara VanTil said that grower and crop level impacts would need to be assessed, as would resistance management.  The group should realize that some crops are already on Plan B.  The group will need to decide what impacts will be risked?  Worker risk or ecological risk?  Will we impact systems – water and air quality?  She also asked, “When will this be done and who is going to do it?  Need to establish baselines, what is the time table?
What are some methods that have worked for transitions in the past?

Research and Implementation
            Aspects of research and implementation identified by the break out group are described below:

Impact Assessment

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Jay Brunner commented that alternatives come along and are assumed “safe.”  If there is information that becomes available from non-traditional sources, it should be included in the registration process.  Jeff Zellers asked if something “drops out” of the matrix, i.e. doesn’t meet all of the criteria for a real alternative, what is Plan B?  Rick Keigwin said that the workgroup exists to help find the answer to this question.  Shelley Davis said that it would be a good first step to find out what is in pipeline.  She also suggested to talk to people that have already switched and see if it is a workable system for people who need to transition.  Larry Elworth said that we know what time frame is available, and should be able to lay the steps out.  Al Jennings said that the USDA has PMSPs, and that some have been done and not published.  That may be a good starting point.  Larry Elworth said that the PMSP is a good starting place, but we will need to narrow down focus by specific pests. 

            Mike Shaw said that there is not a secret list of products that are in pipeline.  He also said that the IR 4 list of alternatives may be longer.  Jerry Baron of IR 4 said that there are some alternatives in the pipeline in IR 4. 

            Lori Berger suggested that there be a case study for how the transition will look.  She suggested parsley.  Shelley Davis requested to look at apples first because it is the majority of the use.  Barbara VanTil said that two case studies may make sense – apple and parsley.  Mike Willett asked how we would assess whether sufficient progress is being made as we go through the transition.  The case studies should identify what is working and not working during transition.  Jim Cranney said that regional issues need to be considered.  Barbara VanTil will work with Jeff Zellers on a parsley case study.

            It was decided that Mike Willett, Jay Brunner, and Shelley Davis will meet with Al Jennings on the apple case study.  Al Jennings said that he would set up a meeting with the apple case study group within two weeks of the meeting. 

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