By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On July 6, 2022, the U.S. Environmental Protection Agency (EPA) released a proposed consent decree intended to resolve the case, Center for Food Safety, et al. v. U.S. Environmental Protection Agency (3:21-cv-09640-JSC), brought against EPA in the United States District Court for the Northern District of California alleging that EPA has unreasonably delayed responding to a petition for rulemaking relating to the regulatory exemption of pesticide treated seed. 87 Fed. Reg. 40233.
In accordance with EPA’s March 18, 2022, memorandum entitled “Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency,” EPA issued a Federal Register notice providing the proposed consent decree to resolve Center for Food Safety, et al. v. U.S. Environmental Protection Agency and providing a comment period. Comments on the proposed consent decree from persons who are not named as parties to the litigation in question are due on or before August 5, 2022. The public can submit comments at www.regulations.gov in Docket ID Number EPA-HQ-OGC-2022-0511.
This case was filed in connection with a petition (Petition) from the Center for Food Safety on or around April 26, 2017, requesting that EPA amend 40 C.F.R. Section 152.25(a) to exclude seeds for planting coated with systemic pesticides intended to kill pests of the plant, or, in the alternative, publish a formal agency interpretation in the Federal Register stating that 40 C.F.R. Section 152.25(a) does not apply to seeds for planting coated with systemic pesticides intended to kill pests of the plant, and enforce the numerous pesticide registration and labeling requirements for each separate crop seed product that is coated with a neonicotinoid or other systemic insecticidal chemical (2017 Petition Requests). EPA requested public comment on the 2017 Petition and received approximately 100 substantive comments. On December 14, 2021, Plaintiffs filed a Complaint alleging that EPA's failure to respond to the Petition constitutes an unreasonable delay under Section 706(1) of the Administrative Procedure Act (APA), 5 U.S.C. 706(1).
Under the proposed consent decree, EPA would, no later than September 30, 2022, either grant, deny, or grant in part and deny in part each of the Petition Requests. Court approval of this proposed consent decree would resolve all claims in this case except for the claim for the costs of litigation, including reasonable attorneys’ fees. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the APA or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unless EPA or the Department of Justice determines that consent should be withdrawn, the terms of the proposed consent decree will be affirmed and entered with the court.
The treated article exemption under FIFRA, as EPA has applied it over the years, has been relevant mostly to uncontroversial products such as shower curtains (the pesticide applied to such a product is intended to preserve the shower curtain and not considered using a pesticide when one uses the shower curtain). Meanwhile, the practice of coating seeds with pesticides became more controversial in recent years about possible impacts on honeybees from fugitive dust from neonicotinoid-treated crop seeds. The concern is whether such non-target movement of pesticide residues (the dust) might be partly responsible for the apparent decline in honeybee populations. Critics view EPA’s policy about treated articles as not incorporating a sufficiently robust assessment of the impacts of this pesticide use pattern -- that is, the dust from the treated seeds and the systemic nature of neonicotinoid products used this way have impacts that EPA “ignores” due to the treated article exemption.
Interestingly, any residues remaining in the food produced using such products still must meet the Food Quality Protection Act (FQPA) safety standard of “reasonable certainty of no harm” from consuming the food -- but critics view the neonicotinoid products as causing unreasonable environmental impacts -- even if the finished food product is safe. In this view, critics of the current treated article exemption definition argue that the environmental impacts of neonicotinoid pesticides are left insufficiently regulated. One problem EPA faces, however, is that the treated article exemption applies to a much larger universe of pesticide applications than seed treatments, so changes to better evaluate the environmental impact of neonicotinoids could impact other products currently not viewed as controversial. This partly explains why EPA has delayed its response to the Petition as it considers how to respond. Changes to the current policy could result in many more products or applications needing EPA review, which would expand the pesticide registration universe at a time when EPA struggles to meet evaluation deadlines for currently registered products. EPA now will have to decide how to move forward on this issue, which will likely have more complex implications for products beyond neonicotinoid pesticides.
By Lisa R. Burchi and Barbara A. Christianson
On July 1, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2019 (2019 Report). 87 Fed. Reg. 39517. Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2019 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2019 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before August 30, 2022.
EPA’s completed product reregistration actions totaled 161, short of EPA’s goal of 400 actions. The table below details the actions completed in FY 2019.
Table 1. Product Reregistration Actions Completed in FY 2019
(as of January 22, 2022)
|Product reregistration actions
|Product amendment actions
|Product cancellation actions
|Product suspension actions
EPA also states that 4,081 products had product reregistration decisions pending at the end of FY 2019, compared to 4,193 products with product reregistration decisions pending at the end of FY 2018, and 4,370 products with product reregistration decisions pending at the end of FY 2017. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has dropped slightly in 2019, with 2,574, 2,303, and 1,739 in 2017, 2018, and 2019, respectively.
The latest episode of Bergeson & Campbell, P.C.’s (B&C®) All Things Chemical® podcast, “Balancing Wildlife Protection and Responsible Pesticide Use -- A Conversation with Jake Li,” features a conversation with Jake Li, Deputy Assistant Administrator for Pesticide Programs, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Conversation topics include what the Administration is doing to balance wildlife protection and responsible pesticide use and how the Endangered Species Act (ESA) Workplan is helping EPA’s Pesticide Program meet its ESA obligations.
Lynn L. Bergeson, Managing Partner, B&C, and James V. Aidala, Senior Government Affairs Consultant, B&C, and former Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances, join Mr. Li for a wide-ranging discussion of OCSPP obligations and priorities related to wildlife protection and ESA.
Enacted almost 50 years ago, ESA is intended to preserve and protect imperiled species. Implementing ESA while balancing the need for pesticide use has proven to be challenging for decades. Jake Li and Jim Aidala both have significant experience in senior policy positions in this space at EPA, with a keen understanding of the legal, policy, and commercial implications of ESA. This discussion will be of keen interest to growers, pesticide suppliers, policy makers, and anyone with an interest in balancing the protection of wildlife and the responsible use of pesticides to protect the food supply and human health.
“Balancing Wildlife Protection and Responsible Pesticide Use -- A Conversation with Jake Li” is available now on B&C’s website and on Apple Podcasts, Google Podcasts, and Stitcher.
By Lisa M. Campbell, James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On May 6, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and requesting comments on, data related to aquatic toxicity of chitosan salts. 87 Fed. Reg. 27059. Specifically, EPA is seeking comments on the following two aquatic toxicity reports submitted by Tidal Vision Products, LLC (Tidal Vision), the company that submitted a petition to EPA on October 10, 2018, requesting that EPA add chitosan to the list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b):
- Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4345. Report Date: June 17, 2019. EPA Master Record Identification (MRID) 51861901.
- Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4421. Report Date: August 28, 2019. EPA Master Record Identification (MRID) 51861902.
EPA is seeking input on how these reports may be used by EPA in its assessment of aquatic toxicity of chitosan and its salts. EPA states “chitosan may form as a salt (e.g., acetate, lactate, hydrochloride, and salicylate) when it is solubilized in acids for end use product formulation and subsequently applied in the environment” and the new information submitted by Tidal Vision pertains to these salts. Comments on the aquatic toxicity reports are due on or before June 6, 2022, in Docket EPA-HQ-OPP-2019-0701.
As background, EPA on August 20, 2020, announced that it was seeking to add chitosan to the list of active ingredients allowed in minimum risk pesticides that are exempt from pesticide registration requirements and was providing to the United States Department of Agriculture (USDA) for review a draft regulatory document titled ‘‘Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.” A minimum risk product must meet six specific conditions to be exempt from pesticide registration. One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA. If EPA adds chitosan to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions also are satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims).
On November 2, 2020, EPA requested comments on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In the May 6, 2022, Notice, EPA states that comments received on the proposed rule expressed concerns regarding derivatives of chitosan that are likely to be produced when chitosan is mixed with certain acids and on the potential hazard for aquatic organisms exposed to chitosan salts. Because of the concerns raised, EPA now is requesting comments on the two aquatic toxicity reports that pertain to these salts.
EPA continues to remain focused on listing this specific substance rather than address other issues related to minimum risk pesticides that have been raised by industry to EPA over many years. There is, for example, a petition filed in 2006 by the Consumer Specialty Products Association (CSPA) requesting that EPA modify the minimum risk pesticide regulations to exclude products claiming to control public health pests from the Section 25(b) exemption. Comments submitted in response to the November 2, 2020, proposed rule raise additional concerns, including but not limited to the fact that the vast majority of states now require registration of minimum risk pesticides, thus shifting the burden away from EPA with costly and potential inconsistent results.
Though this EPA list is called “minimum risk,” it more accurately could be described as -- “so safe no one could, or at least should, have any concern about toxicity.” There is long-standing reluctance for EPA to call any pesticide whatsoever as “safe” for various reasons, even to the point of an outright prohibition on using the word “safe” on registered labels. (This is the clever distinction that “minimum risk” pesticides do meet the FIFRA definition of a pesticide, but the Section 25(b) designation allows that the label not be subject to EPA review and registration of the label.)
This issue of possible risks from adding chitosan to the Section 25(b) list in light of the studies EPA seeks comment on appears to allow EPA to back away from its intended designation as minimum risk or to have the public comment reaffirm EPA’s assessment that chitosan’s safety profile is sufficiently beyond reproach to align with the other members of this category. There are many other pesticides considered of very low risk but not so low as to have made the Section 25(b) list until now. That there is a hint of debate about possible toxicity could signal that future additions to the list are being contemplated to encourage more “minimum risk” product development. Or more simply, it may signal EPA’s reaction to the comments received has triggered some reconsideration of how “minimum” any minimum risk needs to be to qualify for the Section 25(b) list.
Wednesday, May 18, 2022
12:00 p.m. - 1:00 p.m. (EDT)
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.”
- Achieving sustainability and the promise of the circular economy
- Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act
- Federal policy and Toxic Substances Control Act (TSCA) regulatory shifts intended to support sustainability and circularity
- Transitioning chemicals from research and development (R&D) platforms into the market
- Changes to TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that affect chemical innovation
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.
Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.
Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University
Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.
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.
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 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.