By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom
On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S. Environmental Protection Agency (EPA) and its Administrator Gina McCarthy regarding a 2014 decision by EPA not to proceed with a rulemaking to require disclosure of hazardous inert ingredients on pesticide product labels under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This decision was characterized by EPA as a denial of a petition previously filed by the Plaintiffs.
Specifically, Plaintiffs and others previously petitioned EPA in 2006 to require label disclosure of some 370 substances used as inert ingredients in pesticide products that Plaintiffs claim are known to be hazardous to human health and the environment. In 2009, EPA decided to partially grant the 2006 petition and issued an advance notice of proposed rulemaking to require disclosure of hazardous inert ingredients on pesticide labels. When EPA did not pursue the rulemaking, the Plaintiffs filed a suit on March 5, 2014, alleging unreasonable delay. On May 22, 2014, EPA issued a letter explaining that EPA had decided not to proceed with a proposed rule and stating that “this amended response constitutes a denial of the  petitions.”
In the May 22, 2014, letter, EPA cited some legal arguments by registrants in opposition to the proposed rule, including a contention that inert ingredients are entitled to confidential treatment as a class, and that EPA cannot compel disclosure of inert ingredients based solely on hazard without considering exposure. In the letter, EPA stated that it has concluded that it “can achieve greater reduction in the risks from use of pesticides containing potentially hazardous inert ingredients through a series of non-rule actions designed to reduce the presence of hazardous inert ingredients in specific pesticide products.” EPA also set forth its plan to prioritize pesticide inert ingredients for increased scrutiny, as well as a list of voluntary and regulatory actions that could be used, as appropriate, to address potential risks from inert ingredients.
In the Complaint, Plaintiffs request that the court: (1) declare that EPA’s May 22, 2014, decision violates FIFRA and is arbitrary, capricious, and runs counter to the evidence in the record; (2) remand the case to EPA with instructions to consider the evidence weighing in favor of disclosure of inert pesticide ingredients, including the abundance of documentation regarding toxicity and potential risks of exposure to inert pesticide ingredients; (3) retain jurisdiction over this matter until such time as EPA complies with its duties to control unreasonable risk as set forth under FIFRA, including the risks posed by hazardous inert ingredients, and completes its rulemaking to increase disclosure of inert ingredients contained in pesticide products; and (4) award Plaintiffs their costs of litigation.
By Lisa M. Campbell and Lisa R. Burchi
On July 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice extending the public comment period regarding its proposed Antimicrobial Pesticides Use Site Index (USI) from July 31, 2015 to August 31, 2015. The initial Federal Register notice announcing the availability of EPA’s guidance on the USI was issued on July 1, 2015.
By way of background, in 2014, EPA issued a final rule on Data Requirements for Antimicrobial Pesticides amending the regulations setting forth the data requirements that support an application to register a pesticide product. The final rule contains the data requirements specifically applicable to antimicrobial pesticides that were codified in 40 C.F.R. Part 158, subpart W. The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201. The data requirements applicable to a pesticide product depend in part on the product’s use pattern. The general use patterns are broad designations, and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.
EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and to assist EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product. EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.
The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit.
In addition to extending the comments, EPA also published in the docket a Question and Answer document on the USI Webinar for questions submitted to EPA prior to the July 14, 2015, webinar. Additional information regarding the USI is available in EPA Docket EPA-HQ-OPP-2015-0302.
By Lisa M. Campbell and Margaret R. Graham
On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ''Pesticides; Revisions to Minimum Risk Exemption.'' This notice states that the draft final rule will not be available to the public until after it has been signed and made available to EPA. Sections 25(a)(2)(B) and 21(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the EPA Administrator to provide to the Secretary of USDA and the Secretary of HHS a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register; EPA must only provide any draft final rules pertaining to public health pesticides, however, to HHS.
The Spring 2015 Regulatory Agenda stated that EPA is developing the final rule related to revisions it proposed in December 2012: "Specifically, EPA proposed to more clearly describe the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. These lists would be reorganized by adding specific chemical identifiers that would make it clearer which ingredients are permitted in minimum risk pesticide products. No ingredients would be added or removed from the exemption. The label requirements in the exemption would also be modified to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. These changes are intended to maintain the availability of minimum risk pesticide products while providing more consistent information for consumers, clearer regulations for producers, and easier identification by states, tribes and EPA as to whether a product is in compliance with the exemption." Further information regarding the proposed rule is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.
By Lynn L. Bergeson and Carla N. Hutton
In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (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. The Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture, is short, but clear as to timetable and deliverables.
Last updated in 1992, and first rolled out in 1986, the Coordinated Framework is the blueprint for federal regulatory policy for ensuring the safety of products of biotechnology. The Coordinated Framework is of significant interest to the agribusiness community as USDA and EPA regulate genetically modified crops and plant pests. According to the New York Times, more than 90 percent of the corn, soybeans, and cotton grown in the U.S. have foreign genes inserted into the DNA to make the crops resistant to herbicides, insects, or both. While acknowledging the Coordinated Framework is working as intended in ensuring the safety of biotechnology products, the OSTP was quick to note in their blog item “Improving Transparency and Ensuring Continued Safety in Biotechnology,” that “the complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.”
The goal of the update effort, according to the memorandum, is to ensure public confidence in the regulatory system, improve transparency, predictability, coordination, and efficiency in the regulatory system, and encourage and support innovation in the area of biotechnology and products of biotechnology. According to the OSTP blog item:
- “First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
- Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
- Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.”
According to the memorandum, the following elements will support the process to achieve these objectives:
- Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee: The Biotechnology Working Group will include representatives from the Executive Office of the President, EPA, FDA, and USDA.
- Mission and Function of the Biotechnology Working Group: Within one year of the date of the memorandum, the Biotechnology Working Group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology. The Working Group will:
- Update the Coordinated Framework to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public; and
- Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.
- Independent Assessment: EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment, and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood. The review will help inform future policy making. Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.
- Budgeting for Efficiency: EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in agency fiscal year (FY) 2017 budget requests and, as appropriate, in future budget submissions.
- Annual Reporting: For at least five years, starting one year after the release of the strategy described above, the Biotechnology Working Group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products. This report will be made available to the public by the Executive Office of the President.
A number of reports have .issued in the recent past calling for exactly what the Administration announced on July 2. Last year, the Venter Institute issued a landmark analysis of the domestic biotechnology regulatory system in which it highlighted the critical need for modernizing the Coordinated Framework. J. Craig Venter Institute. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (May 2014).
More recently, the National Research Council of the National Academies issued, on March 13, 2015, Industrialization of Biology: A Roadmap to Accelerate the Advance Manufacturing of Chemicals. The report, prepared by the Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, identified the challenges and opportunities posed by the current regulatory system relating to biotechnology and synthetic biology.
The Woodrow Wilson International Center for Scholars Synthetic Biology Project issued a statement praising the Administration’s decision: “The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology.” The statement goes on to say: “We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology.”
A forthcoming report from the Synthetic Biology Project examines the regulatory pathways of new applications that are close to entering the market. That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions which statutes apply to the applications. Earlier this year, the Project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.
The memorandum is welcome news as the Coordinated Framework needs updating for all the reasons outlined in the reports noted above. Despite the Framework’s inherent elasticity and nimbleness, the pace of innovation and complexity of new biotechnology products require a modernized, forward-focused framework.
By Lisa R. Burchi and Lisa M. Campbell
On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA.
The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level. PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives.
The court held as a matter of law that “to give effect to CEQA’s current policy goals as developed since 1979 in the Public Resources Code, in the CEQA Guidelines and in case law, that the court must read the DPR’s regulations as requiring that the DPR apply current CEQA analysis in deciding whether to register pesticides.” That does not, however, require DPR to comply with all of CEQA’s documentation requirements; instead, DPR’s environmental documentation is required to “address only those significant adverse environmental effects that can reasonably be expected to occur, directly or indirectly, from implementing the proposal.”
With regard to the standard of review, the court found that DPR’s decision is in the nature of an EIR, which required the court to review the adequacy of the decision for substantial evidence, and not, as PANNA had argued, the functional equivalent of a negative declaration that would have triggered a “fair argument” review standard. The court then found there was substantial evidence in the administrative record supporting DPR’s decision that the proposed mitigation measures will eliminate any significant environmental impact. The court held that the record supported DPR’s assertion that the product labels provide necessary environmental protections, noting, for example, that EPA’s conclusion that the federal labeling is adequate to protect bees is substantial evidence to support DPR’s “identical conclusion.” The court further held that DPR was not required to consider the feasibility of alternatives.
Since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts a state from imposing label requirements that are different from the U.S. Environmental Protection Agency (EPA)-approved label, the court noted that DPR’s decision was either to register the products consistent with EPA’s approved labels or not register the products for use in California. Although DPR’s failure to conduct a risk-benefit analysis was not argued before the court, the decision, by way of dicta, noted that the “record suggests that the DPR conducted a de facto risk-benefit analysis and did not actually conclude that the labeling on the Insecticides would mitigate all adverse affect on bees.” Instead, the court suggests DPR’s risk-benefit analysis was based on the fact that under FIFRA, the only alternative would be to deny the registrations and that would be infeasible considering economic, social, or other considerations.
The decision is a significant judgment regarding DPR’s ability to make decisions regarding label amendments and the court’s ability to review such decisions. It appears likely an appeal will be filed. It is also important to note that DPR’s reevaluation of neonicotinoids is still pending -- DPR is required under AB 1789 (codified at Food and Agricultural Code Section 12838(a)) to issue a determination before July 1, 2018, regarding the neonicotinoid registrations and to adopt any control measures determined to be necessary to protect pollinator health.
By Lisa M. Campbell
On July 01, 2015, the U.S. Environmental Protection Agency (EPA) issued a notice announcing the availability of and requesting public comment on a proposed guidance document called the Antimicrobial Pesticide Use Site Index (USI).
In 2014, EPA issued a final rule amending the regulations setting forth the data requirements that support an application to register a pesticide product. The final rule contains the data requirements specifically applicable to antimicrobial pesticides, which were codified in 40 C.F.R. Part 158, subpart W. The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201. The data requirements applicable to a pesticide product depend in part on the product’s use pattern. The general use patterns are broad designations and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.
EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product. EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.
The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit. Comments are due by July 31, 2015.
By Lara A. Hall, Lisa M. Campbell, and Jane S. Vergnes, Ph.D.
The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant bench-mark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential interactions of the remaining 52 chemicals with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system. EPA evaluated the data from 11 screening assays (five in vitro and six in vivo), along with other scientifically relevant information (OSRI) comprised of existing toxicology studies and peer reviewed published literature, and drew preliminary conclusions about the potential of these 52 chemicals to disrupt endocrine functions. Importantly, EPA noted on the EDSP webpage that “a result indicating potential should not be construed as meaning that EPA has concluded that the chemical is an endocrine disruptor.”
The individually published weight-of-evidence (WoE) assessments and anticipated data evaluation records (DER) can be accessed online for the 52 chemicals involved in the Tier 1 screening assessment. EPA summarized its conclusions from EPA’s Tier 1 WoE assessments as follows:
- No evidence of potential interaction with any of the endocrine pathways was identified for 20 chemicals.
- Fourteen chemicals showed potential interaction with one or more pathways, but based on the available information, do not pose a risk for endocrine disruption.
- Eighteen chemicals showed potential interaction with the thyroid pathway, 17 of which also showed potential interaction with the androgen pathway, and 14 of which showed potential interaction with the estrogen pathway.
To explore further any potential adverse effects on the endocrine system that may be caused by the 18 chemicals that EPA categorized in the third group noted above, EPA has recommended the following Tier 2, multigenerational studies across various species for them:
- A comparative thyroid assay for four chemicals that EPA found to have potential interaction with the thyroid pathway in mammals;
- The Medaka Extended One Generation Reproduction Test, MEOGRT (Draft Test Guideline OCSPP 890.2200), for 13 chemicals that EPA found to have potential interaction with the estrogen or androgen pathways in wildlife; and
- The Larval Amphibian Growth and Development Assay, LAGDA (Draft Test Guideline OCSPP 890.2300), for five chemicals that EPA found to have potential interaction with the thyroid pathway in wildlife.
EPA has not yet issued its final Tier 2 non-mammalian Office of Chemical Safety and Pollution Prevention (OCSPP) test guidelines (890 Series). Public comment on the proposed guidelines closed on March 31, 2015. It is expected that the release of these remaining guidelines will signal the approach of the Tier 2 test orders, which EPA is likely to issue in 2016. Although a formal public comment period is not expected to be opened for the Tier 1 assessments, affected registrants should have the opportunity to respond directly to EPA regarding WoE assessments and forthcoming DERs.
This release of the Tier 1 WoE assessments, the anticipated release of Tier 2 test guidelines, along with EPA’s commitment to further the development of high-throughput (HTP) assays and computational tools will significantly influence the prioritization of List 2 chemicals in the EDSP and the timing of the List 2 test orders. The revised List 2 includes 109 chemicals for Tier 1 screening. As with List 1, List 2 candidates reportedly were selected based on EPA’s review concerning their possible presence in public drinking water and/or registration review status within EPA, and not because of their potential to interfere with the endocrine systems of humans or other species.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides. These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.
The new rules create a new class of pesticides, known as “Class 12 pesticides.” This class applies to corn seed grown for grain or silage, and soybean seeds treated with the following neonicotinoid insecticides: imidacloprid; thiamethoxam; and clothianidin. The new regulations will not apply to popping corn, sweet corn, corn used for the production of seed, or soybean seeds planted for the purpose of producing a soybean seed crop of certified status.
The new system established by these regulations will take effect on July 1, 2015, and be phased in over time. The elements include but are not limited to the following:
- Integrated Pest Management Training: The regulations will require farmers to complete training on integrated pest management methods. To encourage participation, training will be offered for free until September 1, 2016; after that time, training will be provided at a cost. After August 31, 2016, any person (e.g., farmer) who purchases neonicotinoid-treated seeds will be required to have completed the integrated pest management training course and received a certification number, which will be valid for five years.
- Pest Assessment Reports: Farmers wanting to buy and plant neonicotinoid-treated seed on more than 50 percent of the total area of their corn and soybean crop will need to complete a pest assessment report and provide it to the sales representative or seed vendor from which they purchase the seeds.
- Requirements for Vendor Licenses for the Sale of Neonicotinoid-Treated Seeds: The regulations will require companies selling neonicotinoid-treated seeds to obtain a treated seed vendor’s license, notify purchasers that the seed is a neonicotinoid-treated seed, and offer untreated seed for purchase, among other requirements. Growers will only be able to buy and use neonicotinoid-treated seeds that vendors have put on the "Class 12 Pesticides List," a list updated by August of each year.
- Tracking of the Sale of Neonicotinoid-Treated Seeds: The regulations will require the annual submission of the sales of treated seeds “to ensure an open and transparent system to track progress.” The Ministry of the Environment will publicly report amalgamated sales and seed treatment data for neonicotinoid-treated corn and soybean seed.
The regulations do not include requirements for the transport and storage of Class 12 pesticides.
Further information is available at the below links:
It is important to consider these new requirements in conjunction with those being developed in the U.S. EPA’s approach to date in considering additional restrictions to neonicotinoid pesticides to protect pollinators appears to focus not as much on reducing the use of products, but instead on controlling and preventing unwanted exposure of pollinators to these products.
In recent weeks, the U.S. government issued a “National Strategy to Promote the Health of Honey Bees and Other Pollinators” on May 19, and on May 28, EPA released for comment: “EPA’s Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products.”
By Lisa R. Burchi
On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15). The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated by the parties in the midst of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) arbitration proceeding, and continued its refusal to pay after the Task Force successfully moved the arbitrator to issue an award enforcing the settlement agreement. The Court determined it has jurisdiction because FIFRA “confers jurisdiction on the judiciary to enforce [such] arbitration awards” in federal court and Tagros’ participation in the arbitration allowed the court to exercise jurisdiction over Tagros. The Court found that the arbitration award must be confirmed in full absent evidence of fraud, misrepresentation, or other misconduct by one of the parties, and no such allegations were put forth. The Court also granted the Task Force’s motion seeking permission to register this judgment in other district courts based on information that Tagros’ assets were not in the District of Columbia and evidence of assets in other jurisdictions.
This decision adds to a growing number of recent cases where companies have sought judicial enforcement of a FIFRA arbitration award. Judicial judgments enforcing arbitration awards, in addition to judicial authority to register such judgments in districts where assets are available, are tools data owners are increasingly using to obtain the compensation owed.
By Lisa M. Campbell and Lisa R. Burchi
On June 10, 2015, and June 15, 2015, the U.S. Environmental Protection Agency (EPA) held a webinar entitled “eDisclosure: EPA's Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.” During the webinar, EPA set forth its plans to release in fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations (Audit Policy) and Small Business Compliance Policy. EPA stated that it is developing eDisclosure in an effort to continue to promote the benefits of self-disclosures, while also saving time and resources by modernizing and streamlining the disclosure procedure.
Companies with potential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations that can satisfy all nine conditions of self-disclosure under the Audit Policy (i.e., systematic discovery; voluntary discovery; prompt disclosure; independent discovery and disclosure; correction and remediation; prevent recurrence; repeat violations are ineligible; certain types of violations are ineligible; and cooperation) are eligible for 100 percent penalty mitigation, while companies that satisfy conditions 2-9 (i.e., all except systematic discovery) are eligible for 75 percent penalty mitigation. A related policy for small businesses (those with 100 or fewer employees) modifies the conditions as further incentives (e.g., 100 percent penalty mitigation even if the discovery is not systematic, with longer compliance timeframes).
FIFRA self-disclosures will fall into Tier 2, under which the eDisclosure system will automatically issue an electronic Acknowledgement Letter (AL) confirming EPA’s receipt of the disclosure, and promising that EPA will make a determination as to eligibility for penalty mitigation if and when it considers taking an enforcement action for environmental violations. There are timeframes set for the submission, and/or potential extension, of compliance reports certifying violations have been corrected.
If an extension is sought for more than 60 days (or within 90 days of submitting an online Small Business Compliance Policy disclosure) past the date of discovery of such violation(s), EPA states that eDisclosure will automatically grant the request, but that EPA could later determine, if and when it considers taking an enforcement action, that the correction was not made promptly and thus this Audit Policy condition is not satisfied.
Companies with potential FIFRA violations can benefit from EPA’s development of eDisclosure, as this is a positive step indicating EPA’s support for and interest in encouraging continued use of its Audit Policy There are several issues that companies will need to review carefully, including Central Data Exchange (CDX) registration, protection of confidential business information, special issues for “new” owners disclosing violations of recently acquired companies, and changing EPA policies regarding its potential disclosure of settled and unsettled Audit Policy cases.
EPA will issue in fall 2015 a Federal Register notice simultaneously with its launch of e-Disclosure to describe the new portal and how EPA plans to implement the Audit Policy and Small Business Compliance Policy. Although there is no formal comment period, stakeholders should consider providing input now while EPA is in the midst of developing eDisclosure.
By Lisa M. Campbell and Jane S. Vergnes, Ph.D.
On June 19, 2015, the U.S. Environmental Protection Agency (EPA) announced a plan for incorporating validated high throughput assays and a computational model into the Endocrine Disruptor Screening Program (EDSP) to screen chemicals for their ability to interact with the endocrine system. These proposed new methods would serve as an alternative for three of the eleven current assays in the EDSP Tier 1 screening battery, specifically the estrogen receptor binding (ER), estrogen receptor transactivation (ERTA), and uterotrophic assays.
These computational high-throughput (HTP) tools will have the potential to impact significantly the prioritization for testing and will have a significant impact on List 2 test orders. EPA states that use of these alternative methods will accelerate the pace of screening, decrease costs, and reduce animal testing. In addition, this approach advances the goal of providing sensitive, specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment. EPA has stated its commitment to the development of HTP and computational tools to improve regulatory science, as recommended in the 2007 National Research Council report, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” and to meet its statutory obligations in the face of challenging budget constraints.
Comments are due by August 18, 2015. EPA specifically seeks comment on the following issues, which are related to its stated intention to use the scientific tools discussed as alternatives to some of the current EDSP Tier 1 screening assays:
- The use of the ToxCastTM “ER Model” for bioactivity as an alternative method for the current ER binding and ERTA Tier 1 screening assays.
- The use of the ToxCastTM “ER Model” for bioactivity as an alternative method for the current uterotrophic Tier 1 screening assay.
- The use of results from the ToxCastTM “ER Model” for bioactivity on over 1800 chemicals as partial screening for the estrogen receptor pathway.
EPA concludes that the ToxCastTM “ER Model” meets the criteria for use as “other scientifically relevant information” to satisfy Tier 1 for the ER, ERTA, and uterotrophic assays. EPA’s conclusion is based upon the findings of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) peer review held in December, 2014 that endorsed the ToxCastTM “ER Model” as a replacement for the ER and ERTA assays, and additional data developed by EPA to address the SAP’s concerns regarding the uterotrophic assay. Recipients of EDSP Tier 1 test orders would have three options for addressing the Tier 1 requirements with respect to the three EDSP Tier 1 endpoints that EPA considers validated:
- Cite existing ToxCastTM “ER Model” data, if it is applicable.
- Generate new data using the 18 ER HTP assays and the ToxCastTM “ER Model.”
- Generate Tier 1 data using the validated methods for the ER, ERTA, and uterotrophic endpoints in the traditional EDSP Tier 1.
EPA is careful to note that activity in the ToxCastTM “ER Model” is not a determination that a chemical causes endocrine disruption, only that is has the potential to do so, and that further testing (Tier 2) would be needed to make a determination regarding the ability to cause “adverse effects in an intact organism or its progeny, or subpopulations,” as stated in the World Health Organization International Programme on Chemical Safety definition.
More detailed information on the Endocrine Disruptor Screening Program and its use of computational tools is available at: http://www.epa.gov/endo/ or http://www.epa.gov/endo/pubs/pivot.htm.
By Timothy D. Backstrom
On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA). The plaintiffs in the Ellis case are individual beekeepers and non-governmental organizations, and two out of the six claims in their complaint allege a failure by EPA to consult under the ESA before registering or adding new registered uses for products containing two neonicotinoid pesticides, clothianidin and thiamethoxam. Judge Chesney’s order was issued in response to separate motions by EPA and by industry intervenors Bayer Crop Science, Syngenta Crop Protection, and Croplife America to preclude the plaintiffs from utilizing extra record material to support their ESA claims.
Although EPA and the intervenors argued that the Court’s review of the ESA claims should be confined to the administrative record based on the Administrative Procedure Act (APA), Judge Chesney determined that extra record material may be used to support an allegation that an administrative agency failed to consult with the FWS as required by ESA Section 7. The Judge based this holding on two cases decided in the Ninth Circuit, Washington Toxics Coalition v. EPA and Western Watersheds Project v. Kraayenbrink, which each held that extra record material may be properly considered in determining whether an agency improperly failed to consult under ESA Section 7. The Judge rejected the contention by EPA and the intervenors that these two decisions were supplanted by Karup Tribe v. U.S. Forest Service, concluding that the “arbitrary and capricious” standard of review established by the APA is utilized to review the ESA claims, but the scope of review for these claims is not constrained by the APA.
The effect of this decision will be to allow the plaintiffs to present expert opinion and evidence concerning the claimed adverse effects of the two neonicotinoid pesticides on endangered and threatened species, including but not limited to pollinator species, that was not expressly considered by EPA when it decided to register these pesticides. The plaintiffs will argue that such extra record material establishes that there was a sufficient basis to conclude that these pesticides “may affect” endangered or threatened species for EPA’s failure to consult FWS under the ESA to be arbitrary and capricious. This preliminary ruling could materially affect review of the ESA counts because there is a substantial division of expert scientific opinion concerning the alleged adverse effects of neonicotinoid pesticides, and the Court may conclude that EPA did not afford adequate weight to some of this opinion.
By Sheryl L. Dolan and Henry M. Jacoby, M.S.
On June 17, 2015, the Environmental Protection Agency (EPA) published a notice announcing the availability for comment of three draft revised 810 series test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP). These test guidelines will provide updated guidance on antimicrobial efficacy testing to the regulated community.
EPA states that when these guidelines were published in final in 2012, they drew criticism as confusing and inaccurate. EPA states that the guidelines have been reformatted, corrected and updated to reflect policy and technical changes during the intervening three years. The draft revised guidelines include expanded upfront summaries and appear more accessible with bolded titles for sections and subsections. Recent policy and technical changes that are incorporated into the draft revised test guideline include the following: a requirement that certain product efficacy testing must be conducted at the active ingredient’s (AI) lower certified limit (LCL) concentration; and the updated test methodology for Clostridium difficile (C. diff). In 2013, EPA specified in separate guidance that specific efficacy testing must be conducted on products with the AI at the LCL concentration. In 2014, EPA announced the revised C. diff test methodology. The substance of these two guidance documents is now incorporated into the draft revised test guideline.
EPA is inviting public comment on the three draft revised 810 Series test guidelines, available at the below links:
Comments must be received on or before August 17, 2015.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow pace of review by the U.S. Environmental Protection Agency (EPA). The petitioners previously sought such a writ in 2012, and the Court denied that request without prejudice in 2013. EPA took action in 2012 that addressed seven out of the ten issues originally raised by the petitioners, and the Court found in 2013 that the time taken by EPA to address the petition was “not unreasonable in light of the complexity of the issue.” On March 26, 2015, EPA wrote to the petitioners stating that it intends to deny their petition to cancel registrations and revoke tolerances for chlorpyrifos. EPA bases this anticipated decision on a new human health risk assessment incorporating a physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) model that allows EPA to estimate human risk directly rather than extrapolating from animal data. Based on this model, EPA determined that label changes are needed to mitigate certain occupational exposures and localized drinking water exposure, and has requested comment on these findings.
EPA counsel represented during oral argument in the case that EPA could complete its review of the comments and take action on the petition by mid-September 2015. In response, the Court has issued an order directing EPA either to submit a status report by June 30, 2015, stating whether EPA intends to finalize its preliminary denial, or whether EPA has decided instead to grant the petition in whole or in part. If the petition will be denied, EPA must issue the final denial decision by September 15, 2015.
The schedule imposed by the Court order is demanding, but it is likely that EPA will make every effort to meet it. The Court did not require EPA to respond to all of the comments on the risk assessment, or to determine what mitigation measures will ultimately be required, by the September deadline. Although EPA would normally prefer to complete all related tasks and to compile a comprehensive administrative record before issuing the final decision denying the petition to cancel chlorpyrifos, that would be very challenging to do in this instance. The comment period for the current risk assessment closed on April 30, 2015, and EPA must evaluate and respond to detailed comments on a complex assessment, one which has some important issues subject to serious dispute by the affected registrants. For example, Dow Agrosciences LLC submitted a 130 page set of comments on April 29, 2015, in addition to comments received from the general public, users of the pesticide, and other interested parties. If EPA determines it will proceed with its stated intent to deny the petition to cancel, this action may precede the mitigation measures that EPA imposes based on the chlorpyrifos risk assessment and the comments on that assessment. Nevertheless, because the petitioners are likely to challenge the denial decision as well, EPA will need to prepare an adequate explanation of the reasons for the denial and to expedite the related administrative actions to the extent that is practicable.
By Lisa M. Campbell and Lisa R. Burchi
On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential.
The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information be treated as confidential, and not included in the EFSA’s peer reviewed draft assessment report on potassium phosphonate. The European Commission agreed with EFSA. EFSA stated that under the Plant Protection Product Regulation No. 1107/2009 (and Article 14 of its predecessor Directive 91/414) and European Union (EU) Regulation No. 199/2011 setting forth procedures for reviewing certain active substances including EFSA’s peer review of draft assessment reports, confidential status cannot be extended to: information on the composition of the substance at issue; the analysis method for that substance; the analysis methods for residues; the scientific information on the basis for the evaluation and risk assessments performed; and information already in the public domain. After EFSA refused the confidentiality request, Luxembourg sought reconsideration by the European Commission, who found that the sanitization principles applied by EFSA “reflect a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.”
In its decision, the Court dismissed the lawsuit because Luxembourg brought the case against the European Commission when the appropriate party was EFSA. The Court agreed with the Commission that the decision at issue was an act of and attributable to EFSA, stating that while the Commission “indicated to EFSA the legislation and principles applicable to the requests for confidentiality at issue, the fact remains that the Commission did not apply that legislation and those principles in order to determine those claims itself.” The Court stated that Article 7(2) of Regulation No. 188/2011 grants EFSA to make confidentiality determinations “in its own right” and that Articles 12(1) and 60 of Regulation No. 1107/2009 show that EFSA is “competent to adopt a decision on a request for confidentiality.”
While this decision does not provide certainty or guidance to industry regarding the type of information that can be claimed, and accepted, as confidential, it does add to a growing pool of cases addressing complex issues regarding the confidential treatment of information related to agrochemicals. This includes, but is not limited to, the ongoing case following the European Court of Justice’s October 8, 2013, ruling that the European Commission erred by refusing access to documentation about the pesticide glyphosate.