Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Heather F. Collins, M.S.

On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C.  The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada.  Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation. 

During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration.  The U.S. and Canadian agencies are working together to:

  • Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
  • Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
  • Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
  • Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
  • Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.

Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.  

Specific times for this and other breakout sessions, as well as more detail, will be made available online.  The Stakeholder Forum is open to the public, with advance registration.  Space is limited and registrations will be accepted on a first-come-first-served basis.  Registration is available online.


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced. 

In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treatment uses.”  EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.”  EPA’s announcement states that “the analysis showed that the data required to support registration could be substantially reduced and still be protective of human health.”

EPA developed two decision trees detailing the process for determining the residue chemistry field trial data requirements for seed-treatment uses:  one for potato seed-piece (PSP) treatments only and another one for all remaining crops.  EPA states that this case study demonstrates that application of the guidance set forth in these decision trees can, for both manufacturers and the agency, “potentially save considerable resources in terms of conducting, submitting, and reviewing the studies while still obtaining the data necessary to support seed-treatment pesticide registrations.”

The outlined procedure and memo document will supersede EPA’s previous guidance issued on October 28, 1999, entitled “Classification of Seed Treatments as Food or Nonfood Uses.”

More information is available on EPA’s Determining the Number of Field Trials Required to Register Seed-Treatment Uses webpage.

Commentary

This announcement of improved review procedures allows EPA to cite both greater coordination across national borders (working with Canada), and reduce unnecessary data requirements.  This would fit with the current Administration’s emphasis on reducing regulatory burdens and fostering greater innovation in regulated arenas.  It also might be seen as general “good government,” as it updates guidance which is now almost twenty years old.  Since seed treatment technology and associated policy issues have both evolved over the years, such a review and revision would seem timely regardless of any larger political directive.


 

By Lisa M. Campbell and Sheryl L. Dolan

On June 2, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA) released harmonized product chemistry templates for use by registrants when submitting pesticide registration packages

These templates were developed by EPA and PMRA under the United States -- Canada Regulatory Cooperation Council (RCC) workplan.  EPA stated that the templates are based on the Organization for Economic Cooperation and Development’s (OECD) Harmonized Templates for Reporting Chemical Test Summaries’ format, “but have been streamlined to address a single product/application and will facilitate the review of product chemistry data for global and joint registrations, as well as other actions.”  EPA and PMRA are encouraging applicants to begin using these templates to organize and summarize the product chemistry data for each product and/or registration package that is submitted to EPA and PMRA.

More information on these templates is available in the RCC’s Work Planning Format document.  


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment).  In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators. 

EPA coordinated efforts with Canada’s Pest Management Regulatory Agency (PRMA).  PMRA simultaneously released the overview and science evaluation of its imidacloprid pollinator-only assessment, which reaches the same preliminary conclusions as set forth in EPA’s Assessment.  PMRA plans to release the complete assessment with appendices as a revised version on January 18, 2016, and to accept written comments until March 18, 2016.

EPA’s Preliminary Risk Assessment will be subject to a 60-day comment period commencing on the announcement of the Assessment in the Federal Register.  EPA did not indicate how long it will be before the Federal Register notice is issued. 

This Assessment is the first of four such assessments that will be prepared in 2016 under President Obama’s National Pollinator Strategy.  The other three assessments, for neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, are scheduled to be released for public comment in December 2016.  EPA also states that following the receipt of public comments on this Assessment by December 2016, it plans to issue a revised Preliminary Ecological Risk Assessment that will: “(i) consider any comments or information submitted in response to this bee-only preliminary risk assessment; (ii) incorporate additional data EPA anticipates to receive that is relevant to bees; and, (iii) assess the potential risks of all registered uses of imidacloprid to all taxa.”

EPA’s Preliminary Risk Assessment describes how EPA conducted a screening level assessment (Tier I) for the various uses of imidacloprid, with a stepwise, tiered risk assessment approach evaluating risks to individual bees first and, if needed, risks to the colony.  EPA has divided its risk findings for honey bees for the registered use patterns of imidacloprid into three categories:  (1) Crop Groups/Use Patterns that Present Low On-Field Risk; (2) Crop Groups/Use Patterns with Uncertainty in Colony (Tier II) Assessment; and (3) Crop Groups/Use Patterns with Colony (Tier II) Risk Indicated, with this last category including “Citrus Fruits (Oranges)” and “Oilseed (Cotton).”  EPA further states:  “Based on a tri-agency analysis of the statistical and biological considerations of the data, a NOAEC and LOAEC of 25 and 50 μg a.i./L in nectar were determined based on reductions of the number of adult workers, numbers of pupae, pollen stores and honey stores which persisted across much of the study duration.  The level of imidacloprid in nectar at or below which no effects would be expected to the colony is determined to be 25 μg a.i./L.”

Additional information regarding EPA’s actions regarding neonicotinoid insecticides and the National Pollinator Strategy can be found on our blog.  EPA stated its intent to hold a webinar regarding the imidacloprid Preliminary Risk Assessment in early February 2016.  More information can be found on EPA’s website.

Commentary

EPA’s statements about the assessment have indicated that imidacloprid uses on citrus and cotton are of greatest concern.  Not included in this assessment is what, if any, specific regulatory actions might be needed to reduce any risks to an acceptable level.  Regardless, the registrants, along with other stakeholders, will almost certainly comment on the assessment (likely to say that the risks are both overestimated, according to the registrants, and underestimated, according to environmental groups).

What may be of less notice is what EPA appears to conclude about the other uses of the pesticide.  Not long ago, many claimed that significant honeybee decline was due to planting crops, especially corn, with neonicotinoid seed treatments such as imidacloprid.  This assessment appears to contradict that assertion (along with other improvements that have been made in reducing fugitive dust exposures during application).  And, even if EPA is correct in its assessment that the citrus and cotton uses are of concern, there are many other uses of imidacloprid currently suspended from the market in the European Union (EU) -- where cotton and citrus are not widely produced.  This EPA assessment might become part of the debate about the rationale behind the current EU policies.  

The documents released today are long (the assessment is 305 pages with an appendix of 212 pages).  That EPA plans to complete its assessment within this calendar year indicates that current EPA leaders want any decision to be issued (or at least be framed) before the arrival of any new Administration.  That alone will cause some to question the degree to which any actions are based more on “science and data” or on the “politics” of pollinator protection.