By Lisa R. Burchi and Barbara A. Christianson

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise. According to EPA, the purpose of the comment period and virtual public meeting is to obtain feedback from stakeholders on ideas for modernizing EPA’s and FDA’s approach to product oversight.

EPA also has opened a docket for the agencies to receive comments on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. EPA posted to the docket, and is requesting comments on, a document entitled, “WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight,” (Whitepaper) which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products. The Whitepaper is available at EPA-HQ-OPP-2023-0103, and comments on the Whitepaper are due on or before April 24, 2023.

In the Whitepaper, EPA focuses on two particular product types:

• Products administered topically to animals (e.g., flea and tick collars): EPA states that the “agencies have historically determined oversight for products topically administered to animals to treat fleas and ticks based on whether the chemical is systemically absorbed into the bloodstream (FDA oversight) or remains on the skin (EPA oversight).” Based on new understandings that many of these topically administered products regulated by EPA are systemically absorbed into the bloodstream as well as agreement by the agencies that FDA is better equipped to evaluate and monitor products topically administered to animals, the agencies are considering the transfer of approximately 600 topically administered products for external parasites on animals currently regulated by EPA to FDA.
• Genetically engineered pest animals (e.g., mosquitoes genetically engineered to control the mosquito population in the environment): EPA states a new approach can “provide the agencies with more flexibility to update and align their regulatory oversight of relevant products consistent with each agency’s mission and expertise.” No specific proposal is offered, although EPA notes that it “may need resources to expand its existing biotechnology program for products to control populations of pest animals and clarify the program’s approach to meet the needs of this growing industry.”

EPA announced that registration for the virtual public meeting is available and closes at 11:59 p.m. (EDT) on March 15, 2023. Requests for oral presentations must be made by March 15, 2023. Comments can be submitted in regulations.gov under docket EPA-HQ-OPP-2023-0103 until April 24, 2023. To register to attend the public meeting, visit https://www.eventbrite.com/e/547810324427.

Additional information is available at:

• Virtual Public Meeting: FDA and EPA Product Oversight
• Federal Register Notice
• Whitepaper: A Modern Approach to EPA and FDA Product Oversight

Commentary

Stakeholders are urged to review the information EPA has made available and consider commenting upon these proposed changes and potentially other EPA-FDA jurisdictional issues. The current focus on products administered topically to animals may seem narrow, but there are broader implications both for this category and for other EPA-FDA jurisdictional issues. It is unclear, for example, if the agencies have sufficiently considered EPA’s expertise in evaluating risks to the environment that may be at issue for many products administered topically to animals, as these products are not limited to flea and tick collars as described in the Whitepaper. Besides this one proposal to transfer jurisdiction for these products from FDA to EPA, there are few concrete details or proposals, leaving open the possibility to submit comments to the agencies regarding other areas where industry has struggled to determine which agency has authority over certain products, components, and devices.

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By Lisa R. Burchi and Barbara A. Christianson

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s expertise, thereby improving protection of human, animal, and environmental health.

EPA and FDA will hold a joint virtual public meeting on March 22, 2023, to provide information and receive public comment on the agencies’ current approaches for the oversight of various products regulated as either pesticides or new animal drugs. EPA and FDA state that members of the public will have the opportunity to comment during the meeting, and a docket will be available for the submission of written comments.

As background, EPA and FDA currently determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Since that time, pesticide and animal drug technologies, and both agencies’ understanding of these technologies, have evolved. Examples provided include the following:

• Parasite treatment products applied topically to animals are regulated by EPA if they remain on the skin to control only external parasites (e.g., fleas, ticks) and by FDA if they are absorbed systemically into the bloodstream to control internal parasites (e.g., intestinal worms). The agencies state they now understand that many of the topically administered products currently regulated by EPA may not remain on the skin and are instead absorbed into the bloodstream. EPA and FDA are thus questioning the current approach and potentially different safety concerns.

• Genetically engineered (GE) pest animals, which are gaining interest as a pest control tool, were not envisioned 50 years ago when the original regulatory approach was developed. As agreed in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products, EPA and FDA have considered how to update their respective responsibilities with the goal of developing an efficient, transparent, and predictable approach for overseeing GE insects and other pest animals. Recently, Executive Order 14081, issued September 12, 2022, further directed the agencies to improve the clarity and efficiency of the regulatory process for biotechnology products, underscoring the need for continued coordination between the agencies on biotechnology.

In its notice, EPA acknowledges that the current approach to determining whether EPA or FDA is the appropriate regulator of certain products “does not effectively reflect or accommodate scientific advancement, and it has become clear in some cases that the current approach has resulted in misalignment between product characteristics and the agency better equipped to regulate the product.” EPA states further that “[a] modernized approach would ensure that the oversight of these products better aligns with each agency’s expertise, accounts for scientific advancement, avoids redundancy, better protects animal health and safety, and improves regulatory clarity for regulated entities, animal owners, veterinarians, and other stakeholders.”

Additional information about how to participate in the public meeting, including more detailed information describing challenges with the current approach, and how to submit public comments, will be posted on both FDA’s and EPA’s websites.

Commentary

The MOU at issue is outdated and presents considerable challenges for companies trying to determine the legal and regulatory construct for certain products. This notice thus is a significant development and potential opportunity to address numerous issues with the current jurisdictional divide between EPA and FDA. EPA has provided some clear examples where updated policies and approaches will be beneficial, but there are many more products to be considered. There also are other jurisdictional questions between EPA and FDA for other products that do not appear to be part of the current initiative, including antimicrobial products and medical/pesticide devices. The process being initiated now has the potential to provide much needed clarity for certain products and potentially pave the way for the agencies to consider further public input beyond the scope of the current notice.

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Please check out Bergeson & Campbell, P.C.'s (B&C®) new podcast "Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn" on its All Things Chemical™ webpage.  In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn. 

As Assistant Administrator Dunn has spent just over five months in office, she and Lynn sit down and talked about what it’s been like to take over OCSPP at this crucial time when the amended Toxic Substances Control Act (TSCA), post-Lautenberg, is just coming into its maturity.  They discuss the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far.  

This is a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months.  

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By Lisa R. Burchi and Lisa M. Campbell

On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use.  These short-term pesticide use approvals are called emergency exemptions.”  OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.”  OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.”

OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:

1. EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
2. OPP does not consistently communicate emergency exemption information with its stakeholders.  OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process.  OPP has not sent this letter since 2015, however.
3. There were significant deficiencies in the OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget.

The eight OIG recommendations in the report for the Assistant Administrator (AA) for the Office of Chemical Safety and Pollution Prevention’s (OCSPP) consideration, and OCSPP’s response to those recommendations, are as follows:   

Recommendation 1:  Develop and implement applicable outcome-based performance measures to demonstrate the human health and environmental effects of the EPA’s emergency exemption decisions.

• OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that development of an outcome-based performance measure for the Section 18 emergency exemption process was neither appropriate nor feasible.  No proposed corrective actions were proposed and this issue remains unresolved. 

Recommendation 2:  Determine which application review performance target for emergency exemption applications the OPP plans to meet, and make that target consistent between its Annual Performance Goal and its internal controls governing the emergency exemption process.

• OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless provided a corrective action “to avoid future confusion” and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 3:  Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 4:  Develop formal emergency exemption application review procedures that detail specific data collection, management and reporting control steps, and procedures that require specific management controls for accurately and consistently updating the OPP’s Section 18 database.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided acceptable planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 5:  Develop concise emergency exemption application guidance that specifies the minimum requirements of an application submission and is available on the OPP’s Section 18 website.

• OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless proposed to:  (1) evaluate how its web resources can be enhanced to respond to this recommendation; and (2) if it determines that enhancements to the Section 18 website are necessary, implement any needed web updates by December 2019.  OIG does not believe the proposed corrective action for this recommendation is sufficient to meet the intent of the recommendation and states this recommendation remains unresolved.

Recommendation 6:  Provide clear guidance to state lead agencies on how and when they can use efficacy data from other state lead agencies to satisfy the emergency exemption application criteria.

• OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that the only example provided by OIG to support this recommendation represents an extremely rare situation.  No corrective actions were proposed and this issue remains unresolved. 

Recommendation 7:  Expand the data presented in the OPP’s Section 18 database by considering additional data points, such as application acreage requested, actual acreage applied, and registration status of each exempted pesticide.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “consider additional data points, such as application acreage requested, decision documents, and registration status of each exempted pesticide, as OCSPP explores ways to improve the website database and its overall content.”  OCSPP proposed that by December 2019 recommendations would be made to the OPP Director for enhancing the Section 18 database and a memorandum would be provided to the OCSPP AA with a plan for updating the Section 18 database addressing these recommendations.  OIG states that OCSPP did not commit to expanding the data presented in the Section 18 database and, thus, this issue remains unresolved.

Recommendation 8:  Provide an annual update and information summary to state lead agencies to better inform them about any changes to the emergency exemption application-and-review process.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “explore how to provide periodic and useful program updates to applicants.”  OCSPP proposed by that December 2019 it would “work with State Lead Agencies to identify the types of information they may find helpful for periodic updates” and “develop a strategy which details the activities that might be conducted to provide periodic and useful program updates to applicants.”  OIG states that OCSPP found the term “periodic” unclear and stated the issue remains unresolved.

Although several of these recommendations and EPA’s proposals remain unresolved, registrants should monitor for actions to be taken by EPA in response to the OIG Report. 

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By Heather F. Collins, M.S. and Margaret R. Graham

On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines.  The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests.  83 Fed. Reg. 8666.  The three final guidelines are:

• OCSPP 810.2000 -- General Considerations for Testing Public Health Antimicrobial Pesticides -- Guidance for Efficacy Testing;
• OCSPP 810.2100 -- Sterilants, Sporicides, and Decontaminants -- Guidance for Efficacy Testing; and
• OCSPP 810.2200 -- Disinfectants for Use on Environmental Surfaces -- Guidance for Efficacy Testing.

EPA states these “test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions.”

EPA issued draft guidelines in June 2015 and solicited comments.  EPA states that some comments received on those draft guidelines have been incorporated into the final versions.  EPA states that the revision “is more user friendly and clarifies topics such as confirmatory data, repeat testing, hard water formulation, wetness determination testing for towelettes, and internal toilet testing … [and] also includes information on supplemental testing policies such as lower certified limits, revision of the AOAC Use Dilution Method performance standards and clarified technical details for efficacy testing.”

Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov, in Docket No. EPA-HQ-OPP-2015-0276.  More information on test guidelines is available on our blog.

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By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

• Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
• Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
• The addition of a limit test option to several acute invertebrate toxicity tests;
• Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
• Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing as a matter of federal policy.  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.

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By Sheryl L. Dolan and Henry M. Jacoby, M.S.

On June 17, 2015, the Environmental Protection Agency (EPA) published a notice announcing the availability for comment of three draft revised 810 series test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP).  These test guidelines will provide updated guidance on antimicrobial efficacy testing to the regulated community.

EPA states that when these guidelines were published in final in 2012, they drew criticism as confusing and inaccurate.  EPA states that the guidelines have been reformatted, corrected and updated to reflect policy and technical changes during the intervening three years.  The draft revised guidelines include expanded upfront summaries and appear more accessible with bolded titles for sections and subsections.  Recent policy and technical changes that are incorporated into the draft revised test guideline include the following:  a requirement that certain product efficacy testing must be conducted at the active ingredient’s (AI) lower certified limit (LCL) concentration; and the updated test methodology for Clostridium difficile (C. diff).  In 2013, EPA specified in separate guidance that specific efficacy testing must be conducted on products with the AI at the LCL concentration.  In 2014, EPA announced the revised C. diff test methodology.  The substance of these two guidance documents is now incorporated into the draft revised test guideline. 

EPA is inviting public comment on the three draft revised 810 Series test guidelines, available at the below links:

• OCSPP Test Guideline 810.2000:  General Considerations for Testing Antimicrobial Agents;
• OCSPP Test Guideline 810.2100:  Sterilants & Sporicides Recommendations for Efficacy Testing; and
• OCSPP Test Guideline 810.2200:  Disinfectants for Use on Hard Surfaces --Efficacy Data Recommendations.

Comments must be received on or before August 17, 2015.

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