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 Lisa R. Burchi

On February 2, 2016, the Executive Board of the North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) released details of its proposed strategic framework the next five years.  The environmental regulatory authorities in the U.S., Canada, and Mexico comprise the TWG and developed the strategy.  They are the U.S. Environmental Protection Agency (EPA), Health Canada’s Pest Management Regulatory Agency (PMRA), and Mexico’s Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA) and its Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT) .

The message from the Executive Board states that the main goal is to “align the North American registration systems for pesticides and products treated with pesticides and make work-sharing a way of doing business.”  There are three strategic objectives listed in the message, as described below.  Information regarding some of these strategic objectives is discussed in our blog.

Objective 1: Identify trade barriers and approaches to promote equal access and simultaneous introduction for pest management tools, which includes:

  • MRL Alignment:  This objective includes the alignment of maximum residue limits (MRL) to encourage registrants to consider potential export markets of agricultural commodities intended for treatment with proposed new pesticides or new uses as a way to reduce the number of use expansion submissions and reduce potential trade barriers.
  • Expansion, Development and Harmonization of Crop Groups with Specified Representative Crops for Field Crop Residues Studies:  The TWG plans to continue ongoing work, through the International Crop Grouping Consulting Committee (ICGCC) for harmonizing crops, on the process for developing new/additional crop groups and to revise the existing guidance document as new scientific information becomes available.

Objective 2: Encourage cooperation on joint reviews of new pesticides and uses, and the reevaluation/re-registration review of pesticides to increase efficiency and quality of decision making, which includes:

  • Increasing Simultaneous Registration of Biopesticides:  The TWG will seek opportunities with biopesticide manufacturers for their simultaneous submission of registration applications to NAFTA countries to provide opportunities for joint review.
  • Minor Use Joint Reviews:  The TWG will continue the focus on pesticide registration for minor uses, and will work with the minor crop grower communities, the U.S. IR-4 program, and the Canadian Pest Management Centre program to: identify pest control gaps; follow the established minor use joint review procedures to enable joint submissions of registration applications in U.S. and Canada; and make simultaneous regulatory decisions in both countries within a 10-month timeframe.
  • Coordination of Registration Review and Re-evaluation:  The TWG will continue to identify opportunities for countries to work-share on pesticides; work shares that are currently ongoing include the glyphosate and neonicotinoid pesticides.

Objective 3:  Work cooperatively on priority science and regulatory issues and practices including data requirements, science approaches and policies for data interpretation, and risk assessment and communications of regulatory decisions, which includes:

  • Pollinator Protection:  The TWG will share information on policies, risk assessments, initiatives, and actions to improve the countries’ protection of pollinators, and EPA and PMRA will provide training to SAGARPA and SEMARNAT on the process for conducting pollinator risk assessments.
  • Alignment of Data Requirements/Science Policies:  The TWG will facilitate a common approach and efficiencies in joint reviews and worksharing among the EPA, PMRA, and Mexico; all countries will continue to consider the alignment of data requirements and science policies. This will include developing and completing guidance for the review and interpretation of specific data and guidance related to risk assessment methodologies (e.g., cumulative exposure) and novel technologies such as RNAi (Ribonucleic acid Interference).
  • Integrated Approaches to Testing and Assessment (IATA):  EPA and PMRA will continue to work on initiatives related to Chemical Testing in the 21st Century, e.g., a bilateral effort by EPA and PMRA to develop an OECD Guidance Document that builds upon the existing EPA and PMRA guidelines on waiving/bridging acute toxicity studies, and a continuation of their joint efforts to work with stakeholders on alternative approaches for the acute toxicity studies.

The objectives and specific focus areas are ambitious.  To achieve some of these objectives will require addressing some controversial issues, for example, the confidential treatment of data that underlie these programs (e.g., MRLs, residue studies, biopesticide registrations).

More information on the strategy is available on Health Canada’s website.


 

NAFTA TWG on Pesticides Meeting

By Lisa M. Campbell and Margaret R. Graham

On November 3-5, 2015, the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides, established in 1997 to streamline certain pesticide shipments between Canada (CN), Mexico (MX), and the United States (U.S.), held a meeting hosted by the U.S. Environmental Protection Agency in Durham, North Carolina.  NAFTA TWG states that its primary objective “is to develop relevant and cost-effective pesticide regulation and trade among the three countries and meet the environmental, ecological, and human health objectives of NAFTA.”  Further, TWG partners address trade issues, national regulatory and scientific capacity, governmental review burden, and coordination of regulatory decision making and industry burden reduction.

The topics discussed at its November meeting, a government-stakeholder meeting with the Executive Board, regulatory officials, and interested stakeholders such as growers, industry, and public interest groups, were:

     Five-Year Strategic Plan and NAFTA Industry Working Group (IWG) Updates.  The presentation was as follows:

      Science and Policy Initiatives:

  • Updates on Pollinator Protection in the U.S., CN, and MX.  The presentations were as follows:

          “Update on Pollinator Protection Activities in the U.S.” (Lead: U.S. - Rick Keigwin);

          “Pollinator Protection in Canada” (CN - Scott Kirby);

          MX’s input regarding “US EPA Guidance for Assessing Pesticide Risks to Bees” (Lead: MX -

          SEMARNAT or SENASICA);

          “Update on Mexican Project: Preliminary Study on Some Factors That Influence on Bee Colony

          Loss in Different Regions of Apicultural Importance in Mexico” (Lead: MX - Nelly Peña); and

          “Pollinator Update: US, CN, and MX” - Presentation on Behalf of IWG on Pesticides (Lead: CN -

          Maria Trainer, CropLife Canada).

  • Re-evaluation of Neonicotinoid Pesticides Update in the U.S. and Canada.  The presentation was as follows:

          “Update on Re-evaluation of Neonicotinoid Pesticides in the U.S. and CN” (Leads: U.S. -

          Don Brady and CN - Margherita Conti).

  • Minor Use Program Developments. The presentations were as follows:

          “Joint Minor Use Updates” (Leads: U.S. - Susan Lewis and CN - Margherita Conti); and

          “IR-4: Update on Local Minor Uses” (Leads: U.S. IR-4 - Dan Kunkel and MX - 

          Alma Liliana Tovar Diaz).

  • Maximum Residue Limits (MRL)/Codex.  The presentations were as follows:

          “MRL Alignment Activities Update” (Leads: U.S. - Susan Lewis and CN - Yadvinder Bhuller);

          “Benefits of Harmonized MRLs” (Lead: CN - Gordon Kurbis, Pulse Canada); and

          “Inadvertent Residues” (Lead: CN - Craig Hunter, Ontario Fruit and Vegetable Growers’

          Association).

    Stakeholder Presentations and Discussions:

  • Stakeholders’ Lessons Learned on Joint Reviews including Industry’s Experiences and Prospectives of Joint Reviews. The presentations were as follows:

          Lead:  CN - Tanya Tocheva, Syngenta Crop Protection Canada;

          Lead:  CN - Gordon Kurbis, Pulse Canada; and

          Lead:  MX - Hector Guillén, Avocado Growers Association, APAMEX.

  • Progress of the TWG’s joint action plan and receipt of input on the next phase of activities.
  • Discussion on Future Collaboration Regarding Joint Review.

The presentations, many of which address issues of significant controversy and debate, are of interest to many in industry and to other stakeholders.