By Lisa M. Campbell and Heather F. Collins, M.S.
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text. EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit. Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.” EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.” The final rule will become effective on July 2, 2019.
By Lisa M. Campbell and James V. Aidala
On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. Comments are due by July 8, 2019.
The draft profile includes a chapter on glyphosate’s potential for human exposure, which states the following in the overview:
- “Glyphosate has not been identified in any of the 1,832 hazardous waste sites that have been proposed for inclusion on the [U.S. Environmental Protection Agency (EPA)] National Priorities List (NPL) (ATSDR 2015). However, the number of sites evaluated for glyphosate is not known.”
- “Occupational and residential exposure is a result of glyphosate’s use in agricultural, nonagricultural, industrial, and residential settings. The highest potential for dermal, inhalation, and ocular exposure is expected for pesticide applicators, farm workers, and home gardeners who use herbicides containing glyphosate.”
- “The general population is exposed to glyphosate via ingestion of crops, plants, and foods with residues of this chemical. Residential exposure may occur via inhalation, dermal contact, and/or ocular contact during mixing or application of consumer products containing glyphosate or by coming into contact with crops, soils, or water to which glyphosate-containing products have been applied.”
- “Occupational exposure to glyphosate may occur via inhalation, dermal contact, and/or ocular contact during manufacture, transport, mixing, loading, application, and disposal processes. Accidental oral exposure may occur via unintentional ingestion. Dermal contact appears to be the major route of exposure to glyphosate for individuals involved in its application.”
- “Glyphosate mainly enters the environment as a direct result of its herbicidal use. Fate of this chemical in the environment includes degradation, transport, and partitioning processes, which are governed by its physicochemical properties and by abiotic or biotic degradation under certain environmental conditions. Glyphosate is a nonvolatile, highly polar, non-residual herbicide that has low potential for environmental persistence and is unlikely to bioaccumulate.”
ATSDR’s draft profile and the peer review which will follow can be expected to become part of the larger debate about the potential risks of glyphosate. Meanwhile, EPA continues its work on the registration review of the herbicide. In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments. See our December 19, 2017, blog item EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment for more information. After the public comment period for the draft human health and ecological risk assessments ended in April 2018, EPA officials have stated they hope to complete the registration review sometime this year.
By Lisa R. Burchi
On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate. One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI). The second decision (Hautala et al. v. EFSA, Case T-329/17) related to a request from Members of the European Parliament for access to parts (i.e., “material, experimental conditions and methods” and “results and discussions”) of 12 unpublished carcinogenicity studies, described as the “‘most crucial’ studies for the peer review and [EFSA’s] conclusion that glyphosate is unlikely to pose carcinogenic hazard to humans.” Partial access to those studies (i.e., raw data and findings aggregated in tables and figures) had been granted in an earlier 2016 decision.
A prior November 21, 2018, case related to glyphosate (Stichting Greenpeace Nederland and Pesticide Action Network Europe v. European Commission, Case T-545/11 RENV) and the General Court/Fourth Chamber’s judgment to prevent applicants from receiving access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities is discussed here. In contrast to the Stichting decision, where access was denied, the court in the March 7, 2019, decisions annulled prior decisions dated October 16, 2017 and March 14, 2017, that refused access to the requested information.
Article 4(2) of Regulation No. 1049/2001 (regarding public access to European Parliament, Council and Commission documents) provides that access to documents should be refused where disclosure would undermine, in part, commercial interests of a natural or legal person, including intellectual property, unless “there is an overriding public interest in disclosure.”
Article 6(1) of Regulation No. 1367/2006 (regarding the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies) provides that, with regard to Regulation No. 1049/2001 Article 4(2), “an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment.” Recital 15 of Regulation No. 1367/2006 also provides: “The grounds for refusal as regards access to environmental information should be interpreted in a restrictive way, taking into account the public interest served by disclosure and whether the information requested relates to emissions in the environment.”
Taken together, the court stated: “that means that an EU institution, hearing a request for access to a document, cannot justify its refusal to divulge it on the basis of the exception relating to the protection of the commercial interests of a particular natural or legal person for the purposes of Article 4(2), first indent, of Regulation No 1049/2001, where the information contained in that document constitutes information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.”
The General Court/Fourth Chamber thus addressed whether the information contained in the applicants’ requests constituted information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation 1367/2006.
In the March 7, 2019, decisions, the General Court/Fourth Chamber held that EFSA cannot argue that the requested studies do not concern actual emissions or the effects of actual emissions because “an active substance contained in plant protection products, such as glyphosate, in the course of normal use, is intended to be discharged into the environment by virtue of its function, and its foreseeable emissions cannot, therefore, be regarded as purely hypothetical.” The court further held: “It is apparent from that case-law that the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 is not limited to information which makes it possible to assess the emissions as such, but also covers information relating to the effects of those emissions.” The Court further stated that the “concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 must be interpreted as covering not only information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions, but also data concerning the medium to long-term consequences of those emissions on the environment.”
The court also found that EFSA’s “argument that the conditions in which the requested studies were carried out are not linked to emissions is irrelevant. What matters is not the conditions in which the requested studies were carried out, but their purpose.” In these cases, the purpose to define a no observed adverse effect level (NOAEL) from which the ADI was calculated, or to determine the carcinogenic effects of exposing humans to glyphosate, “must be regarded as constituting information which ‘relates to emissions into the environment; for the purposes of Article 6(1) of Regulation No. 1367/2006.”
In sum, the court in Tweedale concluded:
- It follows from the foregoing that the exception relating to the protection of commercial interests, provided for in Article 4(2), first indent, of Regulation No 1049/2001, cannot be relied upon in order to object to the disclosure of the requested studies which are regarded as information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.
The court in Hautala further stated that “an overriding public interest in disclosing the studies is deemed to exist, and EFSA could not refuse to disclose them on the ground that that would have an adverse effect on the protection of the commercial interests of the owners of the requested studies for the purposes of Article 4(2), first indent, of Regulation No 1049/2001.”
These decisions support transparency but also may add confusion regarding any limitations placed on the scope of what is to be considered “information on emissions into the environment.” The prior 2018 Stichting decision refused access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities, finding that such information is excluded from the concept of “information relating to emissions into the environment:”
- Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment.
These decisions may expand the scope of information that relates to emissions into the environment, including, for example, “data concerning the medium to long-term consequences of those emissions on the environment.” For information that is determined to constitute information that “relates to emissions into the environment,” the decisions appear to create a presumption for disclosure that cannot be countered based on the exception relating to the protection of the commercial interests of a particular natural or legal person.
Companies should continue to monitor these decisions closely, as guidance continues to evolve regarding the scope of disclosure.
More information on glyphosate issues is available on our blog.
By Jason E. Johnston, M.S.
On May 23, 2018, the U.S. Environmental Protection Agency (EPA) held an “Environmental Modeling Public Meeting” (EMPM). As stated in the April 12, 2018, Federal Register notice announcing the meeting, the “EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.” The overall theme of the EMPM was the quantitative use of surface water monitoring data.
The morning session featured a series of presentations by representatives from EPA, the U.S. Geological Survey (USGS), and the Washington State Department of Agriculture concerning the development of a framework to use surface water monitoring data quantitatively in pesticide risk assessments. A major focus of the presentations was the exploration and evaluation of the capabilities of the USGS recently-developed model SEAWAVE-QEX to improve the robustness of surface water monitoring datasets so that they might be used in pesticide risk assessments. Further public presentations on the evaluation and development of the framework are scheduled at the American Chemical Society meeting to be held on August 19-23, 2018, in Boston, Massachusetts. There are plans to hold a Scientific Advisory Panel meeting on the framework in 2019, but no exact date has been set.
The afternoon session consisted of presentations by representatives of the registrant community. Topics addressed included developments in the use of surface water monitoring data in quantitative risk assessment, a statistical analysis of non-targeted monitoring data at the watershed scale, the creation of a curated database of water and sediment monitoring data for synthetic pyrethroids, the use of high-resolution spatial and temporal monitoring data to parameterize watershed scale drift exposure predictions, and an evaluation of model predictability using monitoring data and refined pesticide use at the watershed level.
Presentations from the May 23, 2018, EMPM will soon be posted to Docket No. EPA-HQ-OPP-2009-0879, accessible at www.regulations.gov.
Registrants should monitor these activities, as this effort at EPA represents a potential shift away from the current reliance exclusively on estimated water concentrations in quantitative human health and ecological risk assessments.
By Lisa M. Campbell and Lisa R. Burchi
On February 12, 2018, the U.S. Environmental Protection Agency (EPA) announced it has reached an agreement with Syngenta Seeds, LLC (Syngenta), a pesticide company in Hawaii, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) at its farm in Kekaha, Kauai. The settlement includes two penalty components: a $400,000 Supplemental Environmental Project (SEP) for worker protection standard (WPS) training; and $150,000 as a civil penalty.
The Consent Agreement and Final Order (CAFO), issued on February 7, 2018, states the parties are resolving alleged violations under FIFRA Section 12(a)(2)(G) from the use of the registered restricted-use pesticide Lorsban Advanced on an agricultural establishment in Kekaha, Hawaii, “in manners inconsistent with its labeling by not complying with applicable Worker Protection Standard regulations.” Syngenta neither admitted nor denied the allegations but consented to the assessment of the civil penalty and to the other conditions in the CAFO.
EPA’s Press Release states that under the settlement, Syngenta “will spend $400,000 on eleven worker protection training sessions for growers in Hawaii, Guam, and the Northern Mariana Islands.” Specifically, the SEP states it “is intended to assist and provide compliance tools to small-scale growers of agricultural plants that face compliance challenges based on cultural, literacy, or language considerations, and/or geographic isolation.” Further, Syngenta will “also develop compliance kits for use at these trainings and for wider distribution in the agricultural community in English and four other languages commonly spoken by growers and farmworkers in the training locations -- Mandarin, Korean, Tagalog, and Ilocano.” These compliance kits will include the following practical resources, among others:
- Summary documents with corresponding videos addressing the major compliance topic areas within the WPS;
- Worker training resources including, but not limited to, training outlines with materials, tailgate training toolkits, and sign-in sheets; and
- Sample WPS company policies and procedures.
This CAFO and in particular the SEP will be interesting to monitor considering EPA’s recent WPS revisions that became effective on January 2, 2017, and the additional proposed revisions for which comments are expected to be solicited.
More information on FIFRA enforcement issues is available on our blog under key word enforcement. Information on Syngenta’s 2016 CAFO regarding label violations is available in our blog item Syngenta Settles with EPA on Alleged Label Violations.
By Lisa R. Burchi and Lisa M. Campbell
On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.
DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.
Scope of Notice 2018-1
DPR is currently reevaluating certain pesticide products containing the following active ingredients:
- Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
- Diazinon; and
- Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).
This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.
Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:
- A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
- Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
- New or modified uses (e.g., new crops, pests, or use sites);
- New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
- Significant formulation changes (unless prompted by the reevaluation);
- Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
- Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.
This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation. As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.
DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”
DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact. It is an initiative that many in industry are monitoring closely.
More information on other California DPR-related issues is available on our blog under key phrase California DPR.
By Lisa M. Campbell and Timothy D. Backstrom
On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court’s order includes actions concerning two pending motions. The court has denied a motion by the U.S. Environmental Protection Agency (EPA) and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.”
In support of their August 21, 2017, motion to dismiss the case for lack of jurisdiction, Respondents argued that the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Petitioners to exhaust their administrative remedies by submitting formal objections to the order denying their request to revoke the tolerances for chlorpyrifos and then waiting for EPA to issue a final order before they may seek judicial review. The Petitioners argued in response that requiring exhaustion in this instance would be “futile,” and that the court should also consider reviewing the EPA order under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), because EPA has declined to cancel the registrations for chlorpyrifos. In response, Respondents argued that Petitioners have not shown that requiring exhaustion of administrative remedies would be futile, and that 21 U.S.C. § 346a(h)(5) explicitly prohibits judicial review of any order concerning pesticide tolerances under any other statute, including FIFRA.
After the motion to dismiss was fully briefed, the court summarily denied it, but also characterized that denial as “without prejudice to renewing the arguments in the answering brief.” The court also denied a motion by the Petitioners for oral argument concerning the pending motion to dismiss. These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits.
The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. Petitioners submitted this motion to expedite because they contend that the refusal of EPA to revoke the tolerances and cancel the registrations for chlorpyrifos is causing ongoing harm even though EPA “did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.”
The current actions of the court should be viewed in the context of the prior decision by this same court to issue a writ of mandamus that required EPA to take action on pending petitions to cancel the registrations and revoke the tolerances for chlorpyrifos after what Petitioners claimed was a quite protracted administrative delay, and the subsequent decision by EPA under Administrator Pruitt to defer final action on chlorpyrifos, after the prior Administration had proposed to take the actions sought by the Petitioners. By granting the motion to expedite, and also by deferring the ultimate disposition of the jurisdictional issues raised by EPA, the court appears to have given the Petitioners a prompt and full opportunity to explain why judicial intervention at this stage of the administrative process is warranted. Nevertheless, because the jurisdictional arguments made by EPA are supported by substantial precedent, it could prove difficult for the Petitioners ultimately to overcome these arguments.
More information on the chlorpyrifos litigation and related matters is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document. These documents were signed by EPA scientists on December 29, 2016, prior to the new Administration, but were placed in the docket only last month, under the new Administration. The documents attempt to rebut the various criticisms of EPA’s assessment of the epidemiology studies for chlorpyrifos and the original FQPA safety factor determination for OP pesticides, and they reaffirm the policy embodied in the original Literature Review. Because these new documents were signed in the last days of the Obama Administration, they may be viewed by some industry stakeholders as an effort by some at EPA to “lock in” the prior policy concerning OP pesticides.
The public release of the “updated” Literature Review and response to comments must be considered in the context of the ongoing chlorpyrifos battles that have received significant public attention. During the five months between the date that these “update” documents were signed and the date that EPA placed them in the public docket, EPA Administrator Pruitt issued a decision on March 29, 2017, to deny the petition filed by the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos products. See EPA Denies Petition to Ban Chlorpyrifos. In his denial decision, Administrator Pruitt concluded it would be appropriate for EPA to defer determining whether chlorpyrifos is likely to cause neurodevelopmental effects at exposure levels below the levels that cause acetylcholinesterase (AChE) inhibition until the completion of the registration review process for chlorpyrifos. Administrator Pruitt based his decision on the premise that “the science addressing neurodevelopmental effects remains unresolved” and that “significant uncertainty … exists regarding the potential for chlorpyrifos to cause adverse neurodevelopmental effects.”
Some industry stakeholders may argue that the decision by the EPA scientists who prepared the “updated” Literature Review which concluded that EPA should retain the 10X FQPA uncertainty factor for OP pesticides can be reconciled with Administrator Pruitt’s subsequent denial decision, because the “updated” FQPA safety factor determination does not preclude further scientific discussion concerning the potential for neurodevelopmental effects from OP pesticide exposures. On the other hand, other industry stakeholders may be concerned about the immediate adverse impact of this “updated” FQPA determination on the risk assessments prepared by EPA for OP pesticides and the measures that will be demanded by EPA to mitigate purported risks.
On April 5, 2017, PANNA and NRDC responded to Administrator Pruitt’s March 29, 2017, decision to deny their petition to revoke the tolerances and cancel the registrations for chlorpyrifos by submitting to the Ninth Circuit Court of Appeals a Motion for Further Mandamus Relief. That motion was substantially based on the premise that EPA does not “suggest that it has reconsidered its finding that chlorpyrifos is unsafe.” The briefing on the new mandamus motion was completed on May 5, 2017, several weeks before EPA disclosed the documents concerning the “updated” FQPA determination. Nevertheless, petitioners could try to argue that these documents constitute further evidence supporting their key premise that EPA has not actually revisited its prior determination that chlorpyrifos exposures are unsafe.
The legal and policy issues posed by EPA’s evaluation of the epidemiological data for chlorpyrifos and by EPA’s determination that these data create sufficient uncertainty to warrant retention of the FQPA 10X safety factor for all OP pesticides will be a continued source of controversy, and will be watched with interest by all stakeholders.
More information and updates on chlorpyrifos, the epidemiological data, and their surrounding legal issues is available on our blog item under keyword chlorpyrifos.
By Lynn L. Bergeson, Karin F. Baron, and Margaret R. Graham
On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.”
For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instruction for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria.
The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of EPA risk approaches and GHS fundamentals. Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications.
Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions.
This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ Strategic Vision for Adopting 21st Century Science Methodologies. More information on these initiatives can be found on our Pesticide Law and Policy blog under key phrase “toxicity testing.”
By Lisa M. Campbell and Timothy D. Backstrom
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.” Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred. EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise. In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects. EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources. The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”
The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.” While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.
More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.