EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.

/in , ,

Last week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.

The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.

EPA agrees to clarify data requirement rule for antimicrobial pesticides.

/in , ,

EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.

Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:

  • Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
  • Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
  • Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.

In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”

EPA updates Endocrine Disruptor Screening Program plan.

/in , ,

Today, the EPA announced the update of its Endocrine Disruptor Screening Program (EDSP) Comprehensive Management Plan. The EDSP was established by EPA in 1998 under the authority of 1996 amendments to the Federal Food, Drug and Cosmetic Act and Safe Drinking Water Act with the mission to screen chemicals in pesticides, commercial chemicals, and environmental contaminants for potential adverse effects on estrogen, androgen, and thyroid hormone systems. Generally, the EDSP provides for a two-tiered screening and testing program based on prioritized lists of chemicals.

The updated plan [PDF] outlines the critical activities for the program over the next five years, as well as strategic guidance for the agency. According to the EPA’s announcement email, a focus of the program’s activities will be “using informational technology to enhance data interpretation and applying computational methods to more efficiently prioritize and screen the universe of EDSP chemicals for potential effects on the endocrine system.”

The EDSP plan – which is non-binding – applies to fiscal year 2014 through fiscal year 2019, and will be evaluated on an annual basis for revisions. In fiscal year 2013, the program underwent four external scientific peer reviews on the critical science of the program; EPA will be considering the recommendations made by the reviewers in revising the plan moving forward, while undergoing further reviews on computational models and methods in the next few years. Other activities planned in 2014 include:

  • Completion of List 1, Tier 1 scientific review, data evaluation records, and weight of evidence decisions for 52 pesticide chemicals;
  • Completion of Tier 2 Test Methods Validation, development of test guidelines, guidance documents and standard evaluation procedures;
  • Issuance of List 1 Chemicals, Tier 2 test orders and review of other scientifically relevant information;
  • Develop various IT solutions to increase efficiency through electronic submission, tracking, and systematic data reviews; and
  • Issuance of List 2 Chemicals, Tier 1 test orders and review of other scientifically relevant information; test orders will be issued incrementally over three years.

The plan envisions completing all testing and scientific reviews, data evaluation records, and weight of evidence decisions by 2021-2023. More information on the EDSP is available on the program’s website.

USDA and EPA Report: Honey Bee Decline Caused By Multiple Factors

/in

Earlier this month, the EPA and USDA, along with beekeepers and academic researchers, released a report attributing the recent sharp decline in U.S. honey bee colonies to multiple factors, including pesticides, parasites, viruses and malnutrition. The report, summarizing the proceedings of the National Honey Bee Health Stakeholder Conference held in October 2012, stated that commercial honey bee colonies lost 31 percent of their population last winter, more than double the historical rate of loss (about 10 to 15 percent), and in line with rates documented since the start of Colony Collapse Disorder (CCD) in 2006. Because many agricultural crops depend on pollination by bees, CCD threatens crop yields and thus, food prices and food security. The report synthesizes the current state of knowledge of CCD and factors affecting honey bee health for the purpose of better developing research priorities and best management practices for beekeepers and the agricultural community.

The report identified pesticide effects on honey bees as “a primary concern,” and called for further research on the risks to honey bee decline associated with pesticide exposure. Based on current research, it is “not clear” whether pesticide exposure is a major factor in the deterioration of honey bee health, or if it specifically affects honey production or pollination. On the other hand, the report states that it is clear “that in some instances honey bee colonies can be severely harmed by exposure to high doses of insecticides” used on crops. Studies have also shown that sublethal doses of pesticides can increase susceptibility to a gut pathogen.

Overall, the report emphasizes that there is no “single silver bullet” to alleviating CCD and instead recommended a mix of strategies including habit enhancement, better-targeted pesticide use, and breeding bees for disease- and pest-resistance.

The report was released just days after the European Union voted to partially ban neonicotinoids, following a European Food Safety Authority finding that the pesticides posed an “acute risk” to honey bees. EPA stated that it has accelerated the registration review process for neonicotinoid insecticides, citing concerns over the pesticides’ potential effects on bees, and would require the completion of new field studies on oral toxicity, contact exposure, and toxicity to larvae.

EPA’s Acting Administrator Bob Perciasepe said the agency’s guidance document for improving “bee kill” investigations will be released this month. The preparers of the report, the National Honey Bee Health Stakeholder Conference Steering Committee, will next prepare an Action Plan in late 2013 or early 2014.

Fourth Circuit overturns use restrictions on pesticides.

/in

Last week, the Fourth Circuit Court of Appeals handed down a unanimous decision vacating a 2008 Biological Opinion by the National Marine Fisheries Service (“NMFS”) that supported use restrictions on certain pesticides near the habitat of endangered Pacific salmon. In Dow AgroSciences v. National Marine Fisheries Service [PDF], the Fourth Circuit held that the Biological Opinion was arbitrary and capricious under the Administrative Procedure Act. The Biological Opinion, which concluded that the application of chlorpyrifos, diazinon, and malathion would jeopardize endangered and threatened salmonids, failed to adequately explain certain critical assumptions. The Fourth Circuit directed that the Biological Opinion be remanded to NMFS for further analysis and revision.

This decision may have sweeping effects on other pesticides subject to use restrictions recommended by NMFS Biological Opinions. The overturned Biological Opinion was the first issued as part of a 2008 settlement requiring the EPA to consult with NMFS on 37 pesticides, with eight more Biological Opinions forthcoming. NMFS may have to reevaluate their procedures in developing Biological Opinions, which would only worsen EPA’s backlog of pesticide consultations. This reversal exemplifies the overburdening of the NMFS (and Fish and Wildlife Service) under the Endangered Species Act’s protracted consultation process.