Bergeson & Campbell, P.C.’s (B&C®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as they discussed key OPP developments and priorities.
With year one of the Biden Administration’s term in the history books, EPA OPP is focusing on long-standing challenges, especially EPA-wide efforts to implement Environmental Justice (EJ) work and determining how best to meet core pesticide registration review obligations in 2022. During this webinar, Messina spoke about the recently released Endangered Species Act (ESA) Workplan, chlorpyrifos and dicamba developments, pesticide product performance data requirements, and per- and polyfluoroalkyl substances (PFAS) issues, as Aidala followed up with questions informed by his many years of experience in senior positions at EPA.
We encourage you to view the webinar, subscribe to B&C’s informative FIFRAblog™ and pesticide newsletter, and access more pesticide development news directly from OPP on its website.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include:
- Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon toxicity data generated from laboratory test species for the protection of wildlife in the environment. Typically, ecological risk assessments integrate safety factors to account for interspecies variability. According to EPA, the SeqAPASS tool is a more informed way to extrapolate knowledge from model species to other species that does not require the use of animals in toxicity testing and instead uses existing protein sequence knowledge. LaLone will describe EPA’s SeqAPASS tool and its applications for cross-species extrapolation relative to understanding conservation of biology and predicting chemical susceptibility.
- Michael Lowit, Ph.D., EPA Office of Pesticide Programs (OPP), on “Exploring Potential Reductions in Fish Testing in a Regulatory Context.” According to EPA, as part of its commitment to reducing animal testing, OPP is conducting retrospective analyses of existing data to evaluate critically which EPA guideline studies form the basis of regulatory decisions. EPA states that the results from these analyses can inform if reductions can be made to the number of animals used without reducing the quality of ecological risk assessments. EPA is currently conducting a retrospective analysis for fish acute toxicity tests, which are used by OPP to assess potential risk to fish species from pesticides. For each pesticide, EPA typically requires in vivo testing of three different fish species. Lowit will focus on the relative sensitivity among species subjected to in vivo fish acute toxicity studies. The results of this analysis will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions.
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers. Registration is now open.
Wednesday, April 20, 2022
12:00 p.m. - 1:00 p.m. (EDT)
Register now to join Bergeson & Campbell, P.C. (B&C®) for “FIFRA Hot Topics,” a complimentary webinar covering key Office of Pesticide Programs (OPP) priorities and what companies should know to avoid market delays.
With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts. EPA OPP is focusing on long-standing challenges, especially a renewed effort to meet Endangered Species Act (ESA) consultation requirements and determining how best to meet core pesticide registration review obligations in 2022. These program priorities must reflect special considerations for environmental justice and climate change, advance critical science and policy issues, develop a fifth Pesticide Registration Improvement Act (PRIA) implementation framework, and display a renewed commitment to working collaboratively with state partners and other stakeholders to implement the program.
- OPP and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues and Priorities
- Climate Change and Environmental Justice
- Trade and Import Issues
- Recent Developments in EPA Efforts to Better Coordinate FIFRA Efforts and ESA Requirements
- Reauthorization of PRIA
- Additional Review of Chlorpyrifos and Dicamba
- Per- and Polyfluoroalkyl Substances (PFAS) in Pesticide Containers
By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced it has issued a response denying the objections filed against its final rule revoking all chlorpyrifos tolerances (Response). EPA issued the August 18, 2021, final rule in response to the Ninth Circuit Court’s Order directing EPA to issue a final rule in response to Pesticide Action Network North America and Natural Resources Defense Council’s 2007 petition, which requested EPA to revoke all chlorpyrifos tolerances.
After issuing the August 2021 final rule, and consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA provided an opportunity for any interested party to file an objection to any aspect of the final rule and request a hearing on those objections. Several objections were filed, with concerns ranging from the scope of the revocation of tolerances, the economic and environmental impacts of the revocation, and the implementation timeframe. EPA stated that after careful consideration, it denied all objections, hearing requests, and requests to stay the final rule filed during the period for submitting responses to the final rule.
In addition to its Response, EPA issued letters to the registrants of chlorpyrifos products with food uses confirming revocation of the tolerances and providing options for cancellation and label amendments. In particular, these options include the ability for registrants to submit registration amendments to remove food uses from product labels or submit a voluntary cancellation for products where all uses are subject to the tolerance revocation. For registrations not voluntarily cancelled, EPA stated it intends to issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. A copy of its Response and the accompanying order in the chlorpyrifos final rule docket is available at EPA-HQ-OPP-2021-0523.
EPA states that this action will be incorporated into the ongoing registration review of chlorpyrifos and it will continue to review the comments submitted on the chlorpyrifos Proposed Interim Decision, draft Revised Human Health Risk Assessment, and draft Ecological Risk Assessment. These documents are available in the chlorpyrifos registration review docket at EPA-HQ-OPP-2008-0850. After considering public comments, EPA will proceed with registration review for the remaining non-food uses.
Additional information on chlorpyrifos is available on our blog and on EPA’s website.
It is not surprising that EPA denied all objections to its tolerance revocation decision. Since the earlier decision in 2009 to revoke the tolerances for the insecticide carbofuran, EPA, along with advocates of greater restrictions on pesticide exposures, have found a pathway for terminating pesticide uses while avoiding the significant procedural requirements of FIFRA’s cancellation provisions. The elaborate legal niceties of either approach will likely not quiet those grower groups and others who challenged EPA’s decision in this case.
Of note, in its lengthy Response (51 pages in the Federal Register, 87 Fed. Reg. 11222 (Feb. 28, 2022)), EPA again admits that some uses of chlorpyrifos on certain crops in certain areas are “high benefit” uses that can meet the required safety standards even when using EPA’s most conservative assumptions. Those eleven crop uses were among the many additional uses of the insecticide, and here EPA is explaining its case that as part of its decision, all of the uses on the current label are to be assessed together. At the point in time when EPA most recently assessed chlorpyrifos uses (the 2020 registration review Pesticide Interim Decision), some uses may have been able to meet the standard, but as explained in this notice: “In the final rule, EPA assessed aggregate exposure based on all currently registered uses of chlorpyrifos as required by the FFDCA and consistent with its guidance.”
This will likely be of little satisfaction to growers who produce those crops identified by EPA as meeting the standard.
To affected growers, the revocation of tolerances for the identified crop uses that nonetheless could meet the standard, along with the long-winded denial of objections citing the fine points of the legal procedures, amount -- to them -- as what Justice Scalia once described as “pure applesauce.” (Ironically, according to EPA’s 2020 assessment, applesauce sourced from New York and Michigan apples would have met the required standards according to EPA’s 2020 risk assessment.) Those groups may decide to continue the legal back-and-forth process for further review of the original decision and now the objection denials.
But the larger question for all registrants and pesticide users, not just chlorpyrifos, is what longer term issues are raised by EPA’s approach.
Bergeson & Campbell, P.C.’s (B&C®) January 26, 2022, webinar “What to Expect in Chemicals in 2022” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/864194569862780944. During the 1-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C offered their best informed judgment as to the trends and key developments chemical industry stakeholders should expect to see from the U.S. Environmental Protection Agency (EPA) in 2022.
Momentous changes initiated in 2021 will continue to influence policy development and rulemakings in 2022. For EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), emphasis on science integrity, reviewing decisions made by the Trump Administration in both the pesticide and industrial chemicals programs, meeting statutory deadlines looming over the work of both programs, and dealing with the constant problem of EPA-wide competing priorities will drive the OCSPP program budget and regulatory priorities. We encourage you to view the webinar and read our comprehensive Forecast for U.S. Federal and International Chemical Regulatory Policy 2022 to learn more about these competing priorities for which companies should now prepare.
By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) announced it is extending supply-chain flexibilities for registrants of certain conventional and biopesticide products to alleviate a supply-chain issue facing the pesticide industry.
This is an extension of EPA’s July 2, 2021, action when EPA implemented supply-chain flexibilities that allowed registrants to substitute a combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide (PO) feedstocks. This was intended to address the limited supply of PO feedstocks due to weather events that occurred in the U.S. Gulf Coast in February 2021. This action was originally set to expire on December 31, 2021, but EPA has extended these supply-chain flexibilities until December 31, 2022, due to continued disruptions to production.
EPA emphasized in its initial July 2021 action that this relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.
The pre-approved alternates for propylene glycol, a derivative of PO feedstocks, include:
- glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5);
- diethylene glycol (CAS RN 111-46-6);
- ethylene glycol (CAS RN 107-21-1); and/or
- 1,3-propanediol (CAS RN 504-63-2).
These substitutions can be added to a product formulation or a brand name mixture.
Registrants must self-certify that the substitute inert ingredients will:
- Serve the same function in the product as propylene glycol;
- Maintain the validity of product-specific data submitted in support of the registration;
- Maintain the product’s acute toxicity category and physical/chemical characteristics such that no label modifications are required; and
- Maintain the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, and any other factor.
EPA states that any registrants that wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.
Supply-chain issues have become a national concern whether one is shopping for furniture or manufacturing pesticides. The Biden Administration across government agencies and programs has sought ways to ease difficulties as part of a national response to economic disruptions caused by the COVID-19 pandemic. Pesticide ingredients may not be subject to as much media coverage as consumer products, but in the end, could have impacts affecting availability of disinfectants and other pesticide products. In the broader economy, supply-chain issues have been identified as a factor affecting the availability of pesticides used to help meet the food and fiber production needs of the nation, along with concerns about freight capacity limiting the normal distribution of crop inputs and ultimately affecting the movement of finished crops.
By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.
Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.
EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.
If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.
EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.
This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.
This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.
Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.
In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.
For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.
By Heather F. Collins, M.S. and Barbara A. Christianson
On January 10, 2022, the U.S. Environmental Protection Agency (EPA) announced it is opening a 60-day comment period requesting public comments on the sixth proposed rule in an ongoing series of revisions to the pesticide crop grouping regulations.
EPA states it is proposing revisions to its pesticide tolerance crop grouping regulations, which allow the establishment of tolerances for multiple related crops based on data from a representative set of crops. EPA proposes to amend the following crop groups:
- Crop Group 6: Legume Vegetables;
- Crop Group 7: Foliage of Legume Vegetables;
- Crop Group 15: Cereal Grains; and
- Crop Group 16: Forage, Fodder, and Straw of Cereal Grains.
The proposed rule includes changes to the terminology in the names of Crop Groups 6, 7, and 16 and the addition of commodities and modifications that increase efficiencies in assessing the risks of pesticides used on crops grown in and outside of the United States. The crop groups will now include certain minor or specialty crops, many of which have become more popular since the crop groups were first established.
EPA sets the maximum amount of a pesticide allowed to remain in or on a food (tolerances) as part of the process of regulating pesticides that may leave residues in food. Crop groups are established when residue data for certain representative crops are used to establish pesticide tolerances for a group of crops that are botanically or taxonomically related. Representative crops of a crop group or subgroup are those crops whose residue data can be used to establish a tolerance for the entire group or subgroup.
According to EPA, these revisions will:
- Enhance EPA’s ability to conduct food safety evaluations for tolerance-setting purposes;
- Promote global harmonization of food safety standards;
- Reduce regulatory burden; and
- Ensure food safety for agricultural goods.
Comments on the proposed rule are due on or before March 11, 2022, in docket EPA-HQ-OPP-2006-0766 at www.regulations.gov.
By Heather F. Collins, M.S.
The March 1, 2022, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2021 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”
Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.
EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.
Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.
Further information is available on EPA’s website.
By Lisa R. Burchi and Barbara A. Christianson
On December 30, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule rescinding the March 2, 2020, final rule (2020 inspection rule) regarding EPA’s procedures for conducting on-site civil inspections. This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA.
This rule is effective immediately, as EPA states this rulemaking is procedural rather than substantive.
The 2020 inspection rule was promulgated to implement Executive Order (EO) 13892, “Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication” (84 Fed. Reg. 55239). The 2020 inspection rule, codified at 40 C.F.R. Part 31, set forth the elements of the process to conduct on-site civil inspections (e.g., timing of inspections, opening and closing conferences, document review) and guidance regarding each element.
EPA states it is rescinding the 2020 inspection rule in accordance with EO 13992, “Revocation of Certain Executive Orders Concerning Federal Regulation,” issued by President Biden on January 20, 2021 (86 Fed. Reg. 7049). Specifically, EO 13992 revokes EO 13892, stating that it is the policy of the Biden Administration “to use available tools to confront the urgent challenges facing the Nation, including the coronavirus disease 2019 (COVID-19) pandemic, economic recovery, racial justice, and climate change. To tackle these challenges effectively, executive departments and agencies (agencies) must be equipped with the flexibility to use robust regulatory action to address national priorities. This order revokes harmful policies and directives that threaten to frustrate the Federal Government's ability to confront these problems, and empowers agencies to use appropriate regulatory tools to achieve these goals.”
According to EPA, the 2020 inspection rule being rescinded converted a subset of what had been long-standing civil inspection practices, guided by applicable Agency policies, into “rules” of EPA procedure by which “all” civil inspections “shall be conducted.” 40 C.F.R. Part 31.1(a). EPA states:
Although not altering the rights of parties outside of EPA, the change from an Agency practice to a rule of procedure reduces the flexibility that is inherent in implementing agency policies in a case-by-case manner. The procedures for inspections must be adaptable to the site-specific conditions that the Agency faces in conducting its investigations. By rescinding the 2020 inspection rule, EPA is restoring the flexibility needed when carrying out civil inspections under a myriad of circumstances.
EPA notes that it will continue to employ its policies and methods for public transparency of Agency procedures for conducting on-site civil inspections. For example, EPA notes procedures described in this rule already exist in inspection guidance documents and manuals, which are accessible to the public through EPA’s website. Additionally, EPA states it has met and will meet all statutory obligations pertaining to posting documents for public accessibility. To the extent that concerns arise regarding Agency guidance, a person may -- consistent with the Administrative Procedure Act -- petition EPA, including a request to issue, amend, or repeal EPA guidance, by contacting the EPA program office or regional office that is responsible for administering the area of stakeholder interest.