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On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia. 84 Fed. Reg. 16486. The Federal Register notice states that the agenda is not yet available but that this meeting will provide advice and recommendations to EPA’s Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The draft agenda will be available on or before May 5, 2019, on the PPDC webpage. The meeting is open to the public and no advance registration is required.
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:
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.
EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. Comments on the draft guidance are due by May 28, 2019.
EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants (PBS) to regulation under FIFRA as plant regulators. While EPA has not yet promulgated a regulatory definition for a PBS, the draft guidance describes a PBS as “a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.” EPA is seeking comment on the draft guidance itself, as well as on whether it should develop a definition for PBSs. EPA states that there is currently no statutory definition for PBSs under FIFRA and that development of a definition for PBSs would require rulemaking. The guidance also notes that the 2018 Farm Bill, enacted on December 20, 2018, does provide a statutory definition for PBSs, which is: “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.”
In developing the draft guidance, EPA states that it “considered whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide” and that “a key consideration is what claims are being made on product labels.” Further, as FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition, “many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.”
The draft guidance provides several examples of both product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims. The examples are described in the Tables below.
On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was updating its Residual Time to 25% Bee Mortality (RT25) Data Table with information it has collected since the table was first published in 2014. EPA states that the “RT25 data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies the agency has analyzed as part of [its] routine pesticide regulatory activities.” One example that EPA provides regarding how this new data will work is that farmers can now “choose pesticides that quickly lose their toxicity to bees,” and that applying the products in the evening “helps ensure that by morning the pests have been dealt with and blooming crops are safe for bees.”
EPA states that RT25 values are a function of a number of factors including application rate, physical-chemical properties, dissipation, crop, and pesticide formulation. The values provided were compiled from registrant-submitted data submitted to fulfill the data requirement for Honey Bee (Apis mellifera) Toxicity of Residues on Foliage study (OCSPP Guideline 850.3030). EPA states that the honey bee toxicity of residues on foliage study “is a laboratory test designed to determine the length of time over which field weathered foliar residues remain toxic to honey bees, or other species of terrestrial insects” and, depending on the chemical tested, “either the technical grade active ingredient or a specific formulation was tested using either the honey bee, alfalfa leaf cutting bee, or alkali bee.” The data table lists the test material, the species tested, and the plant species on which residues were aged.
EPA plans to update the table annually as it collects additional data going forward. More information on EPA’s actions intended to protect pollinators is available on EPA’s website.
In addition to providing the residual toxicity values, the table also illustrates the wide range of toxicity values among the various pesticides. RT25 times for the different active ingredients can range between a few and over 500 hours to reach the RT25 threshold. Even different formulations using the same active ingredient can have a significant difference in toxicity values. This illustrates the importance of reading the specific label instructions for a pesticide, even one that might be generally familiar to the user.
EPA’s publication of this information online also imposes a duty for EPA to continually update the table, especially to capture any changes in the information appearing in an earlier listing of the data. If, upon further review or later data submissions there are changes to the table for a product, EPA will need to alert users to potentially important changes in the information. Again, this illustrates the need for reading the label for each pesticide at the time of application, since some important information may have changed.
European Court Annuls Prior Judgments to Protect Testing Information Related to Glyphosate Authorization
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:
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:”
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.
On March 8, 2019, President Trump signed S. 483, the “Pesticide Registration Improvement Extension Act of 2018,” which reauthorizes the Pesticide Registration Improvement Extension Act (PRIA 4) through fiscal year 2023, updates the fee collection provisions and authorities available under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and addresses worker protection matters. The text is available at Congress.gov, which has not yet been updated to confirm that the bill has been signed (but this appears to be the final amended text of the bill).
On February 14, 2019, the Senate approved S. 483 to reauthorize the Pesticide Registration Improvement Extension Act (PRIA 4) and the House of Representatives approved it on February 25, 2019. Further amendments were made and the Senate approved the amended text on February 28, 2019. More information on the PRIA 4 legislation is available on our blog under key word PRIA.
On February 14, 2019, the Senate approved S. 483 to reauthorize the Pesticide Registration Improvement Extension Act (PRIA 4). The Senate bill did not have the specific categories and timelines of earlier reauthorization language, referring instead to more general legislative language that the Senate approved during the Farm Bill authorization in 2018. Legislation in this new session of Congress was necessary since PRIA was not reauthorized as part of the appropriations language approved by Congress to end the government shutdown. More information on the Senate bill is available in our blog item “PRIA Not Extended in Appropriations Bill; PRIA 4 Bill Passed by Senate.”
When, on February 25, 2019, the House of Representatives also approved S. 483, the legislation included the specific timelines and PRIA categories which appeared in the original PRIA 4 proposal. This meant that either the different language in the legislation would need a House-Senate conference, or, the Senate could simply vote again and approve the House version of S. 483. That is the course of action taken by the Senate, which then approved the amended text (the House approved language) of S. 483 on February 28, 2019.
The legislation now awaits signature by the President, and then PRIA 4 will become law. It extends PRIA through fiscal year (FY) 2023. The legislation raises the industry registration fees and refines some of the categories of actions from PRIA 3 (specific legislative text is available here).
This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides: past, present, and future.
In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it. Listen to the full episode and subscribe here.
On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.
The Ninth Circuit’s order granting the Respondent’s petition that the case be re-heard en banc does not provide an explanation for its decision. The Ninth Circuit evidently found the arguments offered by Respondents and other interested parties that filed amicus curiae briefs more persuasive than Petitioners’ brief (including the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC)), who argued against submission of certain amicus curiae briefs and also that, with limited exception, Respondent’s petition for rehearing lacked merit and should be denied.
The en banc oral argument will be held March 26, 2019, at 2:30 p.m. (PST).
Arguments for Rehearing
Prior to the February 6, 2019, order, on October 15, 2018, three amicus curiae briefs were filed in support of EPA’s petition by CropLife America (CLA), Agribusiness Council of Indiana (Agribusiness), and Dow Agrosciences LLC (DAS). Despite Petitioners’ objection to the motions of Agribusiness and CLA for leave to file amicus curiae briefs in support of Respondent’s petition for rehearing, on November 13, 2018, the Ninth Circuit granted the motions for leave to file amicus curiae briefs.
EPA’s petition for rehearing made multiple arguments as to why an en banc and panel rehearing should be granted, including the Panel’s lack of jurisdiction, the Panel’s order conflicting with applicable Supreme Court precedent, and specific modifications to be addressed to the order to comply with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements. More information regarding EPA’s petition is available in our blog item “EPA Petitions for En Banc and Panel Rehearing in Ninth Circuit Chlorpyrifos Case.”
The amicus curiae briefs supported EPA’s arguments and also made arguments supporting rehearing in addition to those previously set forth by EPA. CLA’s brief focused on the fact that the Panel’s decision disregarded FIFRA’s cancellation process, stating: “if EPA ultimately were to determine that any chlorpyrifos registration would need to be cancelled, such an action could not be accomplished in the way the panel majority prescribed: by circumventing the procedures Congress required to ensure that pesticide cancellation decisions are not made unless and until these harms and the best science available are properly vetted.” DAS’ brief addressed in detail the Panel’s violation of administrative law in dictating how EPA must act (i.e., cancel the chlorpyrifos registrations) and the potential violation of FIFRA by EPA if forced to comply with the Panel’s order regarding the timing for cancelling such registrations. The amicus curiae briefs also sought to provide information on the practical consequences that chlorpyrifos registrants and users would face if the panel opinion is not revised. For example, DAS discussed its proprietary interest in protecting its registrations and defending its product, while Agribusiness in its brief provided some background on the use and benefits of chlorpyrifos, the lack of viable alternatives, and the ramifications of the order on insect pest resistance and the ability to combat new invasive pests.
Petitioners’ response to the petition for rehearing and rehearing en banc argued that there was no basis for rehearing. Petitioners noted that en banc review is “disfavored” and appropriate in limited “extraordinary circumstances” and in the face of “an irreconcilable conflict between the holdings of controlling prior decisions of this court.” Petitioners argued that the Panel decision was in accord with precedent and that a request for rehearing “would only result in further delay.” Petitioners did concede on two points: (1) modifying the order to direct EPA to cancel the registrations under the FIFRA cancellation process, which necessitates more time than the 60 days set forth in the order; and (2) clarifying that the order is limited to cancelling registrations that can result in residues on food.
EPA, chlorpyrifos registrants and users, and industry generally should be encouraged by the decision to grant an en banc rehearing in this case, but the outcome is far from certain. Given the issues at stake, registrants should monitor this hearing closely.
FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Combination Sunscreen-Insect Repellent Products
The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Under the proposed rule, products that combine sunscreens with insect repellents would not be GRASE. Publication of the proposed rule in the Federal Register will begin a 90-day comment period.
Sunscreen-insect repellent products are jointly regulated by FDA as sunscreen drugs and by the U.S. Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). On February 22, 2007, FDA and EPA both issued advance notices of proposed rulemaking (ANPR) requesting comment on the appropriate regulatory status of these products. FDA published a notice seeking information to formulate a regulatory position on insect repellent products that contain OTC sunscreen ingredients. 72 Fed. Reg. 7941. EPA published a similar notice announcing that it was also seeking information to determine how insect repellent-sunscreen combination products should be regulated to complete the reregistration review described in the Reregistration Eligibility Decision document for the insect repellent N,N-diethyl-meta-toluamide (DEET). 72 Fed. Reg. 7979.
In the proposed rule, FDA states that it reviewed comments submitted in response to the 2007 ANPRs, as well as pertinent scientific literature and publicly available EPA regulatory documents. Based on that review, FDA has tentatively concluded that sunscreen-insect repellent combination products, as a class, are not GRASE and are misbranded because conflicting labeling requirements for the sunscreen and insect repellent components cannot be reconciled to create labeling that will sufficiently ensure the safe and effective use of the sunscreen component, as well as adequate directions for use as a sunscreen. FDA states that even if it did not have this labeling concern, it would still tentatively determine that available data regarding the safety and effectiveness of these products for their use as sunscreens are insufficient to classify these sunscreen products as GRASE for such use. Specifically, according to FDA, evidence suggests that interactions between some sunscreen active ingredients and insect repellents may decrease safety by increasing systemic absorption of one or both components, and potential synergistic effects on the efficacy of sunscreen active ingredients apparently have not been studied.
The proposed rule states that FDA tentatively determines that sunscreen-insect repellent combination products are not GRASE for nonprescription sunscreen use. FDA seeks comment on this tentative determination. Publication of the proposed rule in the Federal Register on February 26, 2019, will begin a 90-day comment period. More information on the proposed rule is available in our memorandum, "FDA Will Publish Proposed Rule for OTC Sunscreen Drug Products."