Study Finds Roundup Cancer Risk Isn’t from Active Ingredient Glyphosate

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A newly released study has found that glyphosate, the active ingredient in Roundup, may not be directly responsible for the increased risk of cancer that has been associated with the weedkiller. The study was conducted by a team of federal and private sector researchers who tested glyphosate and herbicide mixtures using glyphosate on human B-lymphoblastoid TK6 cells. The researchers concluded that neither glyphosate nor its metabolite forms damaged DNA, causing cancer. Instead, they found that some other ingredient in weedkillers containing glyphosate may be responsible for the DNA damage attributed to glyphosate. This finding contradicts the 2015 World Health Organization (“WHO”) conclusion that glyphosate was “probably carcinogenic to humans” and genotoxic (meaning it damages DNA). WHO’s conclusion has led to numerous lawsuits against Bayer AG and Monsanto Co., as well as lawsuits against the Environmental Protection Agency for concluding that the herbicide would not cause cancer.

Although the study indicates that DNA damage was caused by other components of the formulations, not glyphosate, it did not rule out the possibility that exposure to glyphosate might cause cancer through other mechanisms, according to the National Toxicology Program. Bayer AG has long maintained that glyphosate does not cause cancer and is not genotoxic, and the company released a statement in response to the study, stating that “the extensive body of research on glyphosate-based herbicides and findings of leading health regulators worldwide support the conclusion that glyphosate does not cause cancer and is not genotoxic.”

EPA Revokes Interim Approval of Glyphosate

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EPA recently withdrew its 2020 Interim Approval of glyphosate, often referred to by its trade name Roundup. Interim approvals are part of a conditional registration process used by the Agency to allow new active ingredients to enter the market for an unspecified period of time while the registrant generates missing data required by the Agency for the formal registration process.  Although the Interim Approval was revoked, EPA maintains that the chemical is not carcinogenic, and the product will remain on the market as the Agency completes its periodic review as required by law. In its registration review of glyphosate, the Agency will attempt to elaborate on its evaluation of the carcinogenic potential of glyphosate. EPA will also consider whether a better explanation is needed for its findings on other aspects of the human health analysis. EPA expects to complete the review of glyphosate in 2026.

The 2020 Interim Approval was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners made two main allegations, first that EPA’s analysis of human health, particularly related to cancer analysis, was faulty. Second, the Agency violated the Endangered Species Act (ESA) which requires the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures.

In June 2022, the Court vacated the human health portion of the glyphosate interim review decision and held that EPA’s registration review decision under FIFRA triggered ESA obligations. It also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the interim registration review decision but imposed a deadline for EPA to issue a new ecological potion.

While the EPA has made this withdrawal decision, it is unable to finalize the new ecological portion in a registration review decision as mandated by the Court decision. The Agency states the delay is necessary to appropriately address the issues EPA sought to remedy in the ecological potion and satisfy the ESA requirements. EPA is currently working on a consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Services. Any proposed decisions will require a 60-day comment period and an assessment of comments received. You can read EPA’s full release on its withdrawal decision here.

EPA Advances Early Pesticides Protections for Endangered Species

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On November 16, 2022, the Environmental Protection Agency (EPA) released an update to its Endangered Species Act (ESA) Workplan that outlines steps to increase protections for wildlife while also providing regulatory certainty for pesticide users. The update, which follows the EPA’s April 2022 ESA Workplan, aims to address the complexity of meeting the Agency’s obligations under the ESA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). When registering or reevaluating a pesticide, EPA has an obligation under FIFRA to determine whether the pesticide presents unreasonable adverse effects on human health or the environment.   EPA is also obligated under the ESA to ensure pesticide registrations do not imperil the continued existence of ESA-listed species or adversely impact their respective critical habitats.

To better fulfill the Agency’s obligations under the ESA, the Workplan update stresses the need for pesticide registration review and other FIFRA actions to provide protections for nontarget species, including endangered and threatened species, earlier in the review process. As well as resulting in better ESA compliance, these changes could provide farmers with more predictable access to pesticides.

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for future conventional and biological pesticide registration and registration review actions to protect non-target species
  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture..
  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The FIFRA Interim Ecological Mitigation measures will focus on reducing pesticide spray drift and runoff. and will be applied on a case-by-case basis, depending on the level of risk that a particular pesticide presents to species and the exposure route. This approach is intended to more efficiently protect nontarget species, including listed species, and to standardize protections across similar pesticides, rather than addressing risks on a pesticide or species-specific basis as the EPA has done in the past.

Additionally, the Agency plans to work with registrants of pesticides to add language to pesticide labels that direct users to reference Bulletins Live! Two, a website containing endangered species protection bulletins. These bulletins contain use limitations to protect threatened and endangered species and their designated critical habitat in specific geographic areas. The EPA expects that adding the reference to Bulletins Live! Two, to pesticide labels in advance of consultation with the US Fish and Wildlife Service and the National Marine Fisheries Service, will save time and resources by reducing the number of amendments to labels. It further plans to add language on pesticide incident reporting and advisory language to protect insect pollinators to protect listed and other non-target species better.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their companies’ websites as well as on Amazon. The product’s labeling contained public health claims that EPA found to differ substantially from statements approved by the Agency in its review of the product label. The approved label allows only for statements regarding the product’s effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae.  EPA did not approve the use of the product as a disinfectant or sanitizer or make any public health claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

EPA Issues Stop Sale, Use, or Removal Orders to Amazon

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In February 2021, EPA announced that the Agency issued a “stop sale” order to Amazon in relation to unregistered pesticides and disinfectants.  This is the third stop sale order Amazon has been issued by EPA and brings the list of products in the stop sale order from 30 to 70.  The first stop sale order for unregistered pesticide products was on August 12, 2015.  The second stop sale order for unregistered pesticide products was on January 29, 2016.  For the current stop sale order, a majority of the products at issue make antimicrobial, antibacterial, or antiviral claims.  A few examples include Antimicrobial Pure Copper Therapy Ring, Replaceable Wipes Made of Sterile Non-Woven Fabric, and Antibacterial Sanitizing Disinfecting Alcohol Wipes.  EPA states that consumers wishing to purchase products to kill the coronavirus SARS-CoV-2 (COVID-19) should refer to the Agency’s list of disinfectants, instead of purchasing unregistered pesticides, because unregistered pesticides have not been evaluated for safety and efficacy by EPA.

In its announcement, EPA reminded the public that unregistered pesticides pose health risks to consumers, children, pets, and others who are exposed to the products.  Additionally, EPA advised consumers to dispose of the unregistered pesticides and disinfectants in accordance with local, state, and federal laws.  The announcement noted that pesticides and disinfectants intended for sale in the U.S. must be evaluated by EPA and have approved labeling with an EPA registration number according the requirements of the Federal Insecticide Fungicide and Rodenticide Act.

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

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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.

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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.

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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

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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.

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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.