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.
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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.


 
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By Lisa M. Campbell and Timothy D. Backstrom

On February 10, 2016, the U.S. Environmental Protection Agency (EPA) announced it was initiating an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products.  The products in question are hard surface copper-containing surface products such as door handles, light switch panels, and bed rails, which are utilized for their antimicrobial characteristics.  EPA states that “the testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims.”  Numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process, and product characterization.  Following completion of the review, EPA states that it will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  EPA indicates that antimicrobial efficacy testing of copper-containing surface products poses challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces, and the wide variation in potential product forms and use patterns.  EPA states the following regarding the protocols and how they will affect the test results:

  • This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed;
  • The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms -- Staphylococcus aureus and Pseudomonas aeruginosa; and
  • The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.

More information is available on EPA’s Antimicrobial Pesticide Registration website.  Information regarding other antimicrobial pesticide issues is available in our blog items EPA Posts Revised Antimicrobial Pesticides Use Site Index and EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

Commentary

Products that are intended to have pesticidal efficacy over a protracted period require testing that differs materially from those pesticides that are only effective for a transient period and, thus, must be used repeatedly.  Some believe copper-containing surfaces have great promise as antimicrobial sanitizers, particularly in health care environments where limiting patient exposure to potential pathogens has become a critical institutional concern.  EPA’s enhanced test protocols are intended to address questions EPA and others have raised concerning the continued efficacy of a copper-containing surface over a prolonged life span, and the potential impact of cleaning and disinfecting agents.


 
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By Lisa M. Campbell and Timothy D. Backstrom

Significant issues concerning the scope of the U.S. Environmental Protection Agency’s (EPA) authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by BayerCrop Science LP (Bayer) under the trade name Belt.  Bayer announced on February 5, 2016, that it will not comply with EPA’s request that Bayer “voluntarily” cancel its registered flubendiamide products.  In a January 29, 2016, letter, EPA stated that flubendiamide and a  degradate compound are “mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates.”  Based primarily on EPA’s ecological risk assessment, EPA has determined “that the continued use of the currently registered flubendiamide products will result in unreasonable adverse effects on the environment.”  Bayer disagrees strongly with the EPA risk assessment, because Bayer believes it is based on overly conservative modeling estimates that cannot be reconciled with actual monitoring and environmental fate data for this pesticide.

Conditional registrations for pesticides containing flubendiamide were first granted by EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) in 2008.  As one condition of registration, EPA required Bayer to conduct specific environmental fate studies, which have now been submitted and reviewed.  EPA also adopted an initial expiration date for all registrations of flubendiamide products of July 31, 2013, which EPA later agreed to extend several times to allow time for further review and discussion of the submitted data.  The current dispute with Bayer involves a specific condition that EPA included in its preliminary acceptance letter for this active ingredient, which EPA contends obligates Bayer to request voluntary cancellation of the registrations now that EPA has made a finding of unreasonable adverse effects.  Bayer characterizes the condition in question as “unlawful,” and argues that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) before the registrations can be cancelled.

Commentary

Because Bayer has not submitted the “voluntary” cancellation requests demanded by EPA, EPA has stated that it will initiate the cancellation process for conditional registrations established by FIFRA Section 6(e).  Although this process affords Bayer an opportunity for an administrative hearing, the issues in a conditional registration hearing under FIFRA Section 6(e) are limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks.  Bayer argues that the condition as it was originally imposed by EPA was improper and denies statutory due process rights, and that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) rather than the limited hearing provided under FIFRA Section 6(e).

This dispute presents a variety of important legal questions, including what authority EPA has under FIFRA to impose time limitations or expiration dates for pesticide registrations, the rights a registrant has when it applies to amend or to renew a time-limited registration, and the nature of the conditions that EPA may lawfully impose for a conditional registration under FIFRA Section 3(c)(7).  The entire pesticide industry will be watching this matter with great interest.


 
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By Susan M. Kirsch

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides in the Federal Register, which applies to discharges of pesticides to waters of the United States.  EPA is requesting comments on the draft permit by March 11, 2016.  This draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP, which will expire on October 31, 2016.  EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs.  Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year.

The draft 2016 PGP retains coverage of the previous pesticide use patterns (mosquito/flying insect; weed and algae; animal pest; and forest canopy), and leaves unchanged the reliance on technology-based effluent limitations (TBELs) to satisfy permit requirements, which require proper maintenance and calibration of equipment along with visual inspections to minimize discharges and meet water quality standards and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements.  The draft 2016 PGP also retains the distinctions in compliance requirements of “For-hire Applicators” and “Decision Makers,” and includes the same requirements for recordkeeping and reporting of adverse incidents.  The draft permit now mandates electronic reporting, which will make Notice of Intent (NOI) and Annual Report submissions public on EPA’s e-reporting website.  The draft permit retains the “joint and several liability” provision that would extend potential legal risks to all parties involved in decision-making and application of pesticides.  In spite of the lack of new or altered provisions, there are some aspects of the draft 2016 PGP that could signal an EPA policy change going forward, and could potentially appear in the final version of the permit.  These areas include:

  • Absence of a definition for “Waters of the U.S.,” which could create confusion as to the scope of jurisdiction;
  • An ongoing Endangered Species Act (ESA) consultation, which could expand the list of requirements included in the final permit;
  • Request for comments on whether water quality-based effluent limitations (WQBELs), such as water quality monitoring and fish tissue testing (i.e., laboratory studies), should be included in the final permit;
  • Request for comments on whether additional information should be included in NOI submissions, including whether the treatment area includes a source water for public drinking water supplies;  and
  • An expanded discussion of required compliance with all other applicable state and federal laws, including FIFRA storage and handling requirements, which could be perceived to attach Clean Water Act liability to a PGP permittee’s violations of FIFRA and other laws.

EPA’s webpage for pesticide NPDES permitting includes links to the draft permit, fact sheet, and Federal Register docket.


 
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By Lynn L. Bergeson and Margaret R. Graham

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products."  The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas.  The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California.  Additional details on meeting times, agendas, and how to participate will be announced in a forthcoming Federal Register notice. 

The July 2, 2015, memorandum was jointly issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality, and directs EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework).  The memorandum also directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products.  Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology and describes the federal regulatory policy intended to ensure the safety of biotechnology products. 

The first public engagement session took place on October 30, 2015, at the FDA’s White Oak Campus in Silver Spring, Maryland.  Opening remarks were given by John Holdren, Ph.D., Assistant to the President for Science and Technology and Director of OSTP.  Roberto Barbero, Ph.D., Assistant Director for Biological Innovation at OSTP, gave an overview on what OSTP is doing and how, as well as the principles that have led up to OSTP’s current efforts.  Representatives from USDA’s Animal and Plant Health Inspection Service, EPA, and FDA also delivered statements on the federal regulation of biotechnology products.  Interested parties in attendance included a number of non-governmental organizations that spoke out against the use of biotechnology, academic institutions that were supportive of continued research, and industry participants that were supportive of reasonable risk-based regulation to oversee biotechnology’s continued growth.  A transcript from the meeting is available online.

More information regarding the Coordinated Framework is available in our October 6, 2015, memorandum OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and in our July 6, 2015, memorandum White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.


 
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By Lisa M. Campbell and James V. Aidala

On February 1, 2016, the U.S. Environmental Protection Agency (EPA) announced that Yu-Ting Guilaran has been selected as the new Director of the Pesticide Re-Evaluation Division (PRD) within the Office of Pesticide Programs (OPP), effective February 7, 2016.  Yu-Ting has been the Biological and Economic Analysis Division (BEAD) Director since 2013, and with the agency for nearly 25 years.  She has worked in EPA’s Office of Water, Office of International and Tribal Affairs, and Region 10’s Superfund program prior to joining OPP.  Yu-Ting holds a BS and a MS Degree in Civil Engineering with emphasis in environmental engineering from the University of Washington in Seattle.  Wynne Miller will serve as acting Director for BEAD until that position is filled.  


 
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By Lisa M. Campbell and Margaret R. Graham

On January 28, 2016, in docket EPA–HQ–OPP–2015–0302, the U.S. Environmental Protection Agency (EPA) posted its revised Antimicrobial Pesticides Use Site Index (USI).  In the USI, EPA states that it “has developed [the USI] to provide guidance about the antimicrobial pesticide use sites associated with these antimicrobial pesticide use patterns,” and it “is a guidance document to assist applicants in identifying the data that are necessary to support registration of products and to determine if labeled uses necessitate establishment of a tolerance or exemption from the requirement of a tolerance.”  EPA also posted a Response to Public Comments which stated that there have been a number of changes based on comments received, specifically from the American Chemistry Council’s Biocides Panel (ACC or Panel) and the Consumer Specialty Products Association (CSPA).  These changes include:

  • Clarifying that the USI is a guidance document and that the sites in the USI are not intended for use in labeling;
  • Simplifying the USI by organizing example use sites into broader groups;
  • Using a tabular format to provide examples of use sites organized by food use description (i.e., direct food use, indirect food use, and nonfood use) within each major use pattern category to make it easier to follow;
  • Clarifying that “food” is defined under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 321(f), and that definition applies, as appropriate, to all food use descriptions;
  • Revising the description of “nonfood use” to provide better clarity;
  • Deleting from the USI some example use sites that were ambiguous, too vague, too specific, or incorrectly categorized regarding major use pattern category or food use description; and
  • Incorporating many of ACC’s suggestions of specific use sites to include in the materials preservatives and wood preservatives general use pattern categories.

More information regarding the draft USI is available in our blog post EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

 

 


 
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By Lisa R. Burchi and Lisa M. Campbell

On January 22, 2016, Ontario released for consultation a draft Health Action Plan (Plan) to reduce losses of honeybees and other pollinators caused by several “stressors” stated in the Plan to include: (1) reduced habitat and poor nutrition; (2) diseases, pests, and genetics; (3) exposure to pesticides; and (4) extreme weather and climate change.  This action plan is part of a broader strategy to protect pollinators, with Ontario’s aim, in part, to reach an 80 percent reduction in the number of acres planted with neonicotinoid-treated corn and soybean seeds by 2017.   Other actions taken by Ontario related to pollinators and the regulation of corn and soybean seeds treated with neonicotinoids are discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule

Comments can be submitted through the Environmental Registry until March 7, 2016.

The Plan “identifies potential actions that have been informed through an ongoing consultation process with key stakeholders and the broader public.”  For each of the four stressors identified as a cause of the pollinator decline, the Plan summarizes what information Ontario has gathered, what potential actions it is considering, and what potential additional action areas exist.  With regard to the exposure to pesticides, the Plan states the following regarding potential actions for Ontario to take and additional measures under consideration.

Potential Actions by the Province:

  • Increase education and outreach activities to stakeholder groups on Best Management Practices (BMP) and integrated pest management to support the implementation of Ontario Regulation 63/09 under the Pesticides Act;
  • Support integrated pest management training for growers;
  • Enhance sector outreach to support beekeeper education around the use of appropriate pest treatments in-hive;
  • Continue to work with industry to support agricultural production and land stewardship practices that reduce pollinator pesticides exposure;
  • Explore opportunities to facilitate completion and launch of an e-tool to alert pesticide applicators of nearby beehives for the purpose of reducing bee exposures;
  • Provide financial support for producers to acquire dust deflectors for planting equipment through the Great Lakes Agricultural Stewardship Initiative;
  • Enhance provincial monitoring efforts to track changes in agricultural practices stemming from the implementation of Ontario Regulation 63/09; and
  • Monitor neonicotinoid concentrations in the environment.

Potential Additional Action Areas:                        

  • Profile and highlight BMPs for pesticide use in agriculture;
  • Improve beekeeper education on the effectiveness of honey bee pest treatments; and
  • Support research in selective breeding strategies for honey bees resistant to pests and diseases.

The Plan also discusses Ontario’s research and monitoring efforts, including its intent to align and leverage existing research programs and its consideration to launch a special “Call for Proposals” to “fund new pollinator health research projects to fill knowledge gaps for example, understanding how varroa infestations interact with other stressors, studying implications of climate change for Ontario’s pollinators and assessing the effectiveness of various land management practices.”

In addition to submitting comments on the Plan, Ontario also developed an online survey for input on what priorities should be the focus to improve pollinator health and what steps should be taken to improve pollinator health.


 
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By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On January 25, 2016, in a significant development in the case involving the continued registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo product, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur of the Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration.  DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.”  DowAgro did oppose EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the normal cancellation process by having the court vacate the registration.  The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place.  The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.”  After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo.

The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand.  DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.”  DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief.  This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA.

More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.


 
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By Lisa R. Burchi and Lisa M. Campbell

On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union.  The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a “fair, transparent, and non-discriminatory manner” associated with the sharing and joint submission of information and also the costs relating to a registrant’s obligation to share information in accordance with REACH. 

Many of the requirements set forth in the Regulation may be already in place in existing Substance Information Exchange Forums’ (SIEF) data-sharing agreements. Nevertheless, the Commission found based on information collected following the 2010 and 2013 REACH registration deadlines that “data sharing and joint submission have not been used to their full potential, their implementation falling short of expectations.”  The Commission found that these problems were “especially prejudicial to small and medium size enterprises.”  The requirements set forth apply prospectively as well as retroactively, meaning that all companies that are parties to REACH data-sharing agreements are affected by this new Regulation. 

Discussion

The Regulation seeks to “promote good management practices” and “ensure the efficient functioning of agreements” related to data sharing.  The requirements set forth in the Regulation are intended to further the OSOR principle, ensure transparency and fairness in data-sharing agreements, and end excessive charges.  The Regulation furthers its goals of promoting transparency and fairness by ensuring that a cost-sharing model and reimbursement mechanism are in place when future registrants provide additional compensation and by eliminating concerns that potential registrants pay for studies that are not required of them under REACH. 

The Regulation will enter into force on January 26, 2016.  All agreements to be executed after this date must be in compliance with these new requirements. More information can be found in The Acta Group’s (Acta®) memo REACH:  EU Publishes Regulation Regarding REACH Joint Submission of Data and Data Sharing.


 
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By Lisa M. Campbell and Timothy D. Backstrom

On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners).  The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products”  because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be “treated articles” exempt from registration under 40 C.F.R. § 152.25(a).  Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the “treated article” exemption and was in effect an unlawful rule issued without prior notice and comment.

According to Petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the “treated article” exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves.  Based on this analysis, Petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA.  Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered.

The Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption.  Petitioners also request that the District Court enjoin EPA from:  (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself.

Commentary

The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the “treated article” exemption by including seeds coated with neonicotinoid insecticides are of significant concern.  Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use.  EPA could seek dismissal of some or all of the Petitioner’s claims on jurisdictional grounds, arguing that the risks and benefits of seed treatment were considered at the time each neonicotinoid insecticide was registered for such use, and that the Petitioners should have sought prior review of those registration decisions in the Court of Appeals within the applicable 60-day window.  EPA may also object to the apparent failure of the Petitioners to exhaust their administrative remedies before challenging the policy embodied in the purported “rule,” and also to the Petitioners’ extensive reliance on extra-record evidence.


 
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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.  


 
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By Lisa M. Campbell and Lisa R. Burchi

The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015.  The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption.  Labeling requirements for minimum risk pesticides are also revised to require manufacturers to list ingredients on product labels with a designated label display name and to provide the producer’s contact information on the products’ labels.  EPA states that the revisions are intended to “clarify the terms of the original exemption and to provide additional clarity and transparency concerning the ingredients that are currently used in exempted products.”  Information regarding the proposed rule that was issued on December 31, 2012, is available in our memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.

The final rule will become effective on February 26, 2016.  The compliance date for the new label requirements is February 26, 2019

Under the revised regulations, the minimum risk exemption requirements are as follows:

  • Condition 1:  The product's active ingredients must be only those that are listed in 40 C.F.R. Section 152.25(f)(1).  Previously, the regulations included only the names of the active ingredients.  Under the newly revised reguations, the new Table 1 includes the “Label Display Name,” the “Chemical Name,” any “Specifications,” and the Chemical Abstracts Services Registry Number (CAS No.). 
    • In response to comments, EPA restored two active ingredients inadvertently omitted from the proposed rule (sodium chloride and ground sesame plant) and clarified how “mint and mint oils” are listed.  EPA also has changed the name of one active ingredient from cedar oil to cedarwood oil and clarified its chemical names and CAS Nos.
    • EPA removed United States Pharmacopeia (USP) specifications for 19 active ingredients because such specifications would have removed technical grade active ingredients that are currently eligible but do not meet USP specifications, and EPA states that it did not intend with this rule to add or remove substances from the ingredients list.  The USP specification for castor oil remains since that was part of the original active ingredient list.

 

  • Condition 2:  Prior to these revisions, EPA’s regulations stated that a product's inert ingredients may be only those that have been classified by EPA as:  (1) List 4A “Inert Ingredients of Minimal Concern”; (2) commonly consumed food commodities, animal feed items, and edible fats and oils as described in 40 C.F.R. Sections 180.950(a), (b), and (c); and (3) certain chemical substances listed under 40 C.F.R. Section 180.950(e).  The final rule codifies, at 40 C.F.R. Section 152.25(f)(2)(iv), a list of inert ingredients permitted in minimum risk pesticide products.  The codified list at Table 2 includes the “Label Display Name,” the “Chemical Name,” and the Chemical Abstract Services Registry Number (CAS No.). 
    • In response to comments, EPA removed from the “Label Display Name” certain bracketed language intended to provide clarifying language, for example, “safety limitations on certain inert ingredients such as vinegar (maximum 8% acetic acid in solutions) to chemical formulas for inert ingredients such as calcite (Ca(CO3)).”  This bracketed language remains in the Chemical Name column to assist manufacturers in correctly identifying inert ingredients eligible for the exemption.
    • As it did with respect to active ingredients, EPA states that this rule is not intended to add or remove any inert ingredients.  EPA states that it is considering developing guidance to describe the petition process and types of information EPA would need to add or delete an inert ingredient from this list.

 

  • Condition 3:  Previously, EPA required that all of the ingredients (both active and inert) be listed on the label, with active ingredient(s) listed by name and percentage by weight and each inert ingredient listed by name only.  Under the provisions of the newly promulgated rule, the label must include the following:  (1) the “Label Display Name” for each active ingredient with its percentage by weight; (2) the “Label Display Name” for each inert ingredient; (3) “prominent” display of the name of the producer or the company for whom the product was produced; and (4) “prominent” display of contact information (i.e., street address including zip code and telephone number) for the producer/company listed.

 

  • Condition 4:  The label cannot include any false or misleading statements.  The final rule does not propose any explicit changes to this condition, but some new changes may affect the requirements necessary to meet this condition.  For example, under the newly promulgated revisions, while all active and inert ingredients may be used in non-food use products, “food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter.”  Regarding requirement, EPA states:
    • EPA is not attempting to enforce adherence to the labels of minimum risk pesticides, which as noted cannot be done for pesticides subject to 40 CFR 152.25(f).  Rather, the Agency is assisting minimum risk pesticide producers in ensuring that the use directions on the product do not cause the label to be false or misleading.  An exemption from FIFRA requirements under section 25(b) of the statute, including the minimum risk exemption at 40 CFR 152.25(f), cannot exempt pesticides from the requirements of a tolerance or tolerance exemption under FFDCA.  Under FFDCA, any pesticide chemical residue to be used in or on foods in commerce in the United States must have either an established tolerance or tolerance exemption.  When a minimum risk product explicitly states on its label that it can be used in or on food or food-use sites in commerce, but one or more of the ingredients does not have an established tolerance or tolerance exemption, the label is indicating that the product may be used in a way that would violate Federal law.  Such a label is therefore false or misleading.

 

  • Condition 5:  The product must not bear claims either to control or mitigate organisms that pose a threat to human health, or to control insects or rodents carrying specific diseases.  The final rule does not change this condition.

EPA states that it intends the newly promulgated revisions to assist manufacturers, the public, and federal, state, and tribal inspectors in determining whether a chemical substance can be used in a minimum risk product (i.e., is eligible for the exemption) as well as to provide improved clarity and transparency for consumers who want more information about the ingredients used in a product.  EPA also hopes that requiring company contact information on labels will provide further transparency and accountability should an adverse event occur during the use of a minimum risk pesticide product.

EPA has determined that the total cost for industry to comply with the labeling requirements of this rulemaking is approximately $800,000, under a three-year implementation period.  The three-year implementation period was extended from the two-year proposed implementation plan in response to comments that “[s]ince most companies update their labels every three years…a rule implementation period of three years will allow most companies to meet the labeling requirements of the rule as part of their normal labeling practices and will therefore keep industry costs to a minimum.” 

EPA’s recently updated minimum risk pesticides webpage includes guidance on pesticide tolerances for minimum risk ingredients and provides alternative formats of the active and inert ingredient lists that may be more suitable for some users.  EPA states that it intends to include additional guidance, as needed, such as labeling guidance for minimum risk pesticides and how to request additional ingredients to be added or removed from the minimum risk exemption shortly after the final rule becomes effective.  


 
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By Lisa M. Campbell and Lisa R. Burchi

The U.S. Environmental Protection Agency (EPA) recently launched a new Pesticide Worker Protection Dashboard (Dashboard).  EPA states this Dashboard is “focused on the universe of agricultural operations regulated and farm workers and pesticide handlers covered by the Worker Protection Standard.”  EPA states that the Dashboard provides charts and graphs presenting certain key enforcement and compliance information related to the Worker Protection Standard (WPS) program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Specifically, the Dashboard has screens which show the number of WPS inspections conducted, the number of violations found during inspections, the types of violations found, and the types and numbers of enforcement actions taken.  Since the Dashboard is interactive, users can find answers to questions such as:

  • How many facilities in the United States employ workers or handlers covered by the WPS;
  • How many inspections are reported; and
  • How many violations have been found, and what enforcement actions have been taken by states, tribes and/or EPA.

EPA states that Dashboard information from states and tribes is compiled from data on state and tribal inspections and regulatory actions submitted annually (Form: 5700-33H) to EPA.  This form provides information regarding the number of WPS inspections conducted, the types and numbers of violations found, and the number and types of regulatory actions taken during the year.  EPA inspection data is obtained from EPA’s Integrated Compliance Information System (ICIS) database.  Other information is compiled from data from the U.S. Department of Agriculture’s National Agricultural Statistics Service’s Agricultural Statistics, 2007 and 2012 Census of Agriculture database. 

EPA makes several caveats to the data presented, including:  (1) EPA does not require regional offices to enter all regulatory actions into ICIS, so many “informal” actions are not recorded; (2) the data included in the Dashboard do not reflect all compliance monitoring/inspections or enforcement activities, nor the full extent of enforcement activity within a state or tribe; and (3) tribal inspections and enforcement actions conducted under sovereign tribal authority and regulations are not EPA reviewed or reported, and are not included in the Dashboard.

The Dashboard shows data from 2010 to 2014 to provide context at the national level, or within a state or tribe.  EPA plans to update the information annually when new data are available (e.g., after annual state and tribal reporting forms are submitted to EPA).

The Dashboard provides interesting information and should be monitored, as many groups will likely use it in support of their unique interests.  

More information on the WPS is available in our blog item EPA Publishes Worker Protection Standard Final Rule.


 
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By Lisa M. Campbell and Timothy D. Backstrom

On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), the U.S. Environmental Protection Agency (EPA) filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor DowAgroSciences LLC (DowAgro) for Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  DowAgro responded to the motion by agreeing that remand is appropriate but opposing vacatur as an effort to circumvent the normal cancellation process, while the petitioners Center for Food Safety, et al. (CFS) filed a response supporting the motion for vacatur.  More information on the DowAgro and CFS responses is available in our blog entry DowAgro and Center for Food Safety File Responses to EPA’s Motion for Voluntary Vacatur and Remand.

In its reply, EPA rejects the argument by DowAgro that it is trying to “short-circuit” the normal cancellation procedures under FIFRA.  Citing recent Ninth Circuit precedent on vacatur, EPA argues that “vacatur would be more protective of the environment during the time in which EPA evaluates the new information, and Dow has failed to demonstrate any disruptive consequences of vacatur.” 

EPA also takes issue with certain statements by CFS that it characterizes as “erroneous or irrelevant.”  EPA contradicts assertions by CFS that EPA overlooked important evidence concerning the synergistic effects of Enlist Duo’s principal ingredients, that EPA determined that Enlist Duo will not protect endangered non-target plants, that EPA has violated the ESA, and that EPA is approaching synergistic effects as a new issue.  EPA also objects to the efforts of CFS to introduce an extra-record newspaper article.

This case will continue to be watched closely, as there is widespread industry concern about EPA’s effort to use a judicial process in lieu of normal adjudicatory procedures and about EPA’s substantive approach to evaluating synergistic efficacy data.  In this regard, it is noteworthy that the issue of potential synergistic effects is relatively narrow and does not appear to be among the purported deficiencies in the EPA decision originally cited by the petitioners. 


 
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