Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

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.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to FIFRA Blog readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. For the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), 2021 was a full year of working from home while addressing ongoing priorities; continuing the march toward meeting the 2022 deadline for registration review of pesticides registered before 2006; attempting to comply with the requirements of the Endangered Species Act (ESA); and meeting Pesticide Registration Improvement Act (PRIA) deadlines for registration applications. OPP is expected to focus on long-standing challenges, especially a renewed effort to meet ESA consultation requirements and to meet core pesticide registration review obligations. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
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B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022.
 
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product approval process is protracted, and often challenging, for any given product. Further complicating matters are the ensuing -- often expensive -- data, recordkeeping, and advocacy requirements associated with obtaining FIFRA product approvals. These courses are intended to provide on-demand knowledge to assist with the strategic planning that is critical to global product development. The subtleties of FIFRA are presented in a clear and business-focused context.
 
FIFRA Tutor online training courses include video lessons and detailed handout materials, including copies of all presentations and relevant course materials from the U.S. Environmental Protection Agency (EPA) and other sources. The newly-released modules cover:

  • F101 -- An Overview of FIFRA
  • F102 -- Import and Export of Pesticides
  • F109 -- Defining Tolerances and Their Regulation
  • F110 -- Adverse Effects Reporting Requirements

Additional modules in the FIFRA Tutor curriculum will be released throughout 2022.

FIFRA Tutor courses are developed and presented by members of B&C’s renowned FIFRA practice group, which includes former EPA officials, an extensive scientific staff, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of FIFRA law, regulation, policy, compliance, and litigation.

Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.FIFRAtutor.com to view sample course segments and purchase modules.

Watch a preview of TSCA Tutor and FIFRA Tutor courses: T101 – TSCA Inventory Overview, T202 – TSCA Section 5 (Part 1) TSCA Chemical Inventory, Exemptions, and F109 – Defining Tolerances and Their Regulation.

Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.


 

By James V. Aidala

In early July 1996, I was returning on a flight from Amman, Jordan, wondering what kind of negotiation we in the Clinton Administration faced in completing the legislative text of what became the Food Quality Protection Act (FQPA). (I had been asked to go to Jordan to visit the Jordanian pesticide regulatory program by a friend who was a senior official at the State Department. The result of my visit may have played a very, very small role in the Middle East peace process -- but that is another story for another time).

Some weeks earlier, I had been approached by Congressional staff members whom I knew from my previous job at the Congressional Research Service (CRS) as the subject area expert on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and pesticide regulation. I joined the Clinton Administration as a political deputy in the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS, now renamed as the Office of Chemical Safety and Pollution Prevention (OCSPP)). Dr. Lynn Goldman was the Assistant Administrator who had recruited me to join the efforts to reform, that is, modernize, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FFDCA). Over the years since it was enacted in 1958, risk assessment methods and our understanding of possible cancer risks had changed greatly.

Setting the Context

In 1989, the National Academy of Sciences issued a report on “The Delaney Paradox,” examining how the Delaney Clause ironically prevented safer new pesticides from entering the market. After an important court decision (Les v. Riley), EPA was told that even if it was undesirable public policy, the law can only be changed by Congress. As EPA went along with its work, many feared that numerous pesticides might be forced off the market even if, using modern evaluation policies, they presented little risk or were in fact safer than the alternatives.

During this time, advocacy groups were concerned that the then-current law was not protective enough of the possible risks to children’s diets. A simple way to say this is, for purposes of risk assessment: “Children are not little adults,” and supporters emphasized that dietary risk assessments by EPA should pay special attention to possible children’s risk given differences in metabolism, growth stages, and other important physiological characteristics.

This led to another National Academy of Sciences report in 1994 on “Pesticides in the Diets of Infants and Children,” which recommended that pesticide regulation include particular attention and possibly greater regulation of estimated dietary risks from pesticides. Given that the new Assistant Administrator of OPPTS was Dr. Lynn Goldman, a pediatrician, this concern was a priority for the Clinton Administration.

“The Gingrich Revolution”

A less noticed irony, but also important to the history of FQPA, is the change in party control of the House of Representatives, led by Representative Newt Gingrich (R-GA) and the “Contract with America” during the 1994 elections. Unexpectedly, the Republicans had the majority in the House for the first time in 40 years, and they elected Representative Gingrich Speaker of the House.

Much longer stories have been and will be written, but shortly after taking power in the House in January 1995, the Republicans were viewed as letting lobbyists run amok -- even suggesting amendments to environmental laws while lobbyists were sitting on the dais of Committee meetings. By the end of 1995 and going into an election year in 1996, “word was” the leadership, at least on the House Energy and Commerce Committee -- chaired by Representative Thomas Bliley (R-VA) -- was looking for a “green vote” to offset the image of an anti-environment House majority. Led by staff from the office of Chair Bliley and Representative John Dingell (D-MI), who was the senior Democrat on the Committee, a draft of a compromise bill was floated and made its way to my office at EPA.

Meantime, during the previous Congress (103rd Congress, 1993 - 1994), a team of EPA staff, led by Jim Jones (a later even more famous name in EPA pesticide regulation) of the Assistant Administrator’s office, along with staff from the Office of Pesticide Programs (OPP) and the Office of General Counsel (OGC), and staff from the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) (it takes a village), had developed a Clinton Administration bill that did not gather much support during 1994. The legislation did have the core concepts of “fixing Delaney” and including the “reasonable certainty of no harm” standard, and it incorporated strong protections about possible risks from residues in the diets of infants and children.

In the new Congress (the 104th), there was some action during 1995 in the House Agriculture Committee on FIFRA issues related to antimicrobial products, minor uses of pesticides, and ways to prod the registration process to become more predictable and timely (this was before the Pesticide Registration Improvement Act (PRIA)). The FIFRA amendments were not viewed as controversial and were successfully discussed between both sides of the aisle (the Agriculture Committees were much more bipartisan in those days). By itself, that package was not likely to make it through the legislative gauntlet, given the shift in political power on the Hill.

Also in 1995, Carol Browner (the EPA Administrator) cautioned us that successful bipartisan legislation was unlikely, so not much effort should be invested, given other priorities.

The key event came in the late spring of 1996, when we first saw a draft of the legislation floated by the staff of Representatives Bliley and Dingell. It was far from perfect, but it included the core elements of what the Administration had proposed in the previous Congress. Since that earlier bill had been drafted with the coordination of EPA, FDA, and USDA, if it had the essential ingredients, we thought it might be a viable vehicle for further discussion. We also sought comment from some of the influential environmental groups that had been disappointed in the Administration’s legislation in the previous Congress. Suffice it to say, inclusion of the core elements of a tough standard (reasonable certainty of no harm) and special protections regarding children’s diets made the proposals a “possible” vehicle for further discussion.

We also started to have discussions with the staff of Representative Waxman (D-CA) in the House and Senator Kennedy (D-MA). Representative Waxman was the ranking Democrat on the Energy and Commerce Subcommittee, and Senator Kennedy was the ranking Democrat on the Labor Committee, which had jurisdiction over the FFDCA.

Back to July 1996

To shorten the story, we had intense, long meetings with the various interested parties -- pesticide registrants; environmental groups; trade associations; agency staff at EPA, FDA, and USDA; Congressional staff from the authorizing Committees; and Administration leaders within the agencies and the White House. In an amazingly short time, we came to agreement over the text, which is now FQPA. Representatives Waxman and Roberts (R-KS -- Chair of the House Agriculture Committee) held a press event about the historic compromise -- even more historic since the two Representatives rarely agreed on significant legislation. Their joint endorsement and statement of support signaled to members of both parties on both sides of Capitol Hill that this was an unusual, and important, compromise. The Congressional staff then recognized the next hurdle: the August recess was approaching fast, and if not enacted into law by then, the delay could be fatal, or at least make matters more complicated, as the multitude of interest groups would likely pick apart and want further changes to the agreement that had been reached. So the rush was on to get the “green vote” to the floor of the House and Senate.

Some last-moment hiccups took a little more time. Senator Lugar (R-IN), the Senate Agriculture Committee Chair, wanted a hearing to at least review the legislation. This was not a huge hurdle, but finding time on the floor was a race against the clock before the August recess. The House was the first to vote on July 23, 1996. The bill was approved with a surprising unanimous roll call vote in the majority Republican House (the vote was 417-0 with 16 not voting). Unanimous bipartisan support! -- imagine that in today’s world.

Then, with a sprinkling of clarifying (that is, reassuring) pieces of correspondence, the Senate agreed to the House legislation under unanimous consent. (In fact, for any trivia nuts out there, if you watch the C-SPAN video of how long the Senate deliberation lasted at the end of the day on July 24, 1996 -- the request for unanimous consent and agreement clocks in under 30 seconds.)

So with unanimous support in both the House and the Senate, FQPA was approved.

One Last Step

One very important last step was needed before FQPA became law -- the President needed to sign the legislation. That happened at the White House when H.R. 1627 was signed by President Clinton on August 3, 1996.

Tags: FIFRA, FQPA, FFDCA

 

By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson

On August 13, 2021, the U.S. Environmental Protection Agency (EPA) announced that it appointed two new members, Cheryl A. Murphy, Ph.D., Professor, Director of Center for PFAS Research, Michigan State University, and Veronica J. Berrocal, Ph.D., Associate Professor, Department of Statistics, University of California, to serve on the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). The Chair and one other existing member also were reappointed. These appointments, effective July 30, 2021, were made by the EPA Administrator following nominations provided by the National Institutes of Health (NIH) and the National Science Foundation (NSF).

Members of the FIFRA SAP serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to human health and ecological risk assessment of pesticides. Members also have background and experiences that typically contribute to the diversity of scientific viewpoints on the Panel.

The FIFRA SAP serves as a primary scientific peer review mechanism of EPA’s Office of Pesticide Programs and is structured to provide independent scientific advice and recommendations to EPA on health and safety issues related to pesticides.

The FIFRA SAP is composed of the following scientists:

  • Robert E. Chapin, Ph.D., Chair
    • Affiliation:  Former Senior Research Fellow (Retired), Pfizer Global Research and Development, Groton, Connecticut
    • Expertise: In vitro predictive toxicology; pre-conception reproductive toxicology
    • Education: Ph.D., Pharmacology, University of North Carolina, Chapel Hill; B.A., Biology, Earlham College
  • Veronica, J. Berrocal, Ph.D., Member
    • Affiliation: Associate Professor, Department of Statistics, University of California, Irvine, California
    • Expertise: Statistics; spatial and spatio-temporal statistics; statistical methods for environmental exposure assessment; spatial and environmental epidemiology
    • Education: Ph.D. Statistics, University of Washington, Seattle, Washington; M.Sc. Statistics, Michigan State University, East Lansing, Michigan; Laurea in Mathematics, Universita’ “La Sapienza,” Roma, Italy; and Degree of Etudes Approfondis (DEA) en Mathematiques, Universite’ “Joseph Fourier,” now part of Universite’ Grenoble Alpes, Grenoble, France
  • Jeffrey R. Bloomquist, Ph.D., Member
    • Affiliation: Professor of Entomology, Entomology and Nematology Department, Emerging Pathogens Institute, University of Florida, Gainesville, Florida
    • Expertise: Chemistry, human and insect neurophysiology, neurochemistry, insecticide toxicology, mode of action, and resistance; including studies of comparative neurotoxicology and environmental Parkinsonism
    • Education: Ph.D. Entomology, University of California, Riverside, California; M.S. Entomology, Mississippi State University, Mississippi; B.S. Entomology, Purdue University, Indiana; and Postdoctoral appointment in Insecticide Toxicology, Cornell University, New York
  • Gaylia Jean Harry, Ph.D., Member
    • Affiliation: Group Leader, Neurotoxicology Laboratory, National Toxicology Program, National Institute of Environmental Health Sciences (NTP/NIEHS), Research Triangle Park, North Carolina
    • Expertise: Mode of action of environmental agents on the nervous system with focused interest on the developing nervous system, neurotoxicology, neuropathology, behavioral assessments, neuroinflammation, and developmental processes using in vivo and in vitro models
    • Education: Ph.D. Experimental Psychology, Virginia Commonwealth University; M.S. Psychology, Virginia Commonwealth University; and B.S. Psychology, Virginia Commonwealth University, Richmond, Virginia
  • Cheryl A. Murphy, Ph.D., Member
    • Affiliation: Professor, Director of Center for PFAS Research, Michigan State University, East Lansing, Michigan
    • Expertise: Ecological Toxicology, Adverse Outcome Pathways, Fish Physiology, Behavior
    • Education: Ph.D. Department of Oceanography and Coastal Sciences, Louisiana State University, Baton Rouge, Louisiana; M.S. Physiology and Cell Biology, University of Alberta, Edmonton, Alberta; and BSc (Honors) Marine Biology, Dalhousie University, Halifax Regional Municipality, Nova Scotia
  • Rebecca L Smith, D.V.M., Ph.D., Member
    • Affiliation: Assistant Professor, Department of Pathobiology, College of Veterinary Medicine, University of Illinois, Urbana-Champaign, Illinois
    • Expertise: Epidemiologic research on longitudinal data analysis and mathematical modeling of diseases for purposes of prediction and control, with a focus on One Health
    • Education: Ph.D. Epidemiology, Cornell University; M.S. Biosecurity and Risk Analysis, Kansas State University. D.V.M. Cornell University; B.A. Biology, Gustavus Adolphus College
  • Clifford P. Weisel, Ph.D., Member
    • Affiliation: Professor, Rutgers University, Piscataway, New Jersey
    • Expertise: Exposures to chemical agents; multi-route exposures to environmental contaminants; the association between exposure and adverse health effects; utilization of sensors for continuous exposure measurement; and development and application of biomarkers of exposure
    • Education: Ph.D. Chemical Oceanography, University of Rhode Island; M.S. Analytical Chemical, University of Rhode Island; and B.S. Chemistry, State University of New York at Stony Brook

Additional biographical details on the current members is available here.

Commentary

The FIFRA SAP has been an important element of EPA’s pesticide program scientific review procedures. The pesticide program has been able to use the FIFRA SAP as an outside review element to add credibility to its key scientific policies over the decades since it was created as part of the FIFRA legislative amendments in the 1970s. (In fact, the FIFRA SAP was created before the EPA-wide Science Advisory Board (SAB).) Also important is the statutory provision, added as part of the Food Quality Protection Act in 1996, to establish a Science Review Board made up of 60 scientists “who shall be available to the Scientific Advisory Panel to assist in reviews conducted by the Panel.” Together, the goal is to have a range of scientific discipline expertise available to offer outside peer review of the wide range of science questions that confront EPA when evaluating pesticide registration issues.


 

By Lisa M. Campbell and Lisa R. Burchi

On April 8, 2021, the U.S. Environmental Protection Agency (EPA) issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit information on the current pesticide exemption provision process.  86 Fed. Reg. 18232.  EPA announced its intent to issue this ANPR on January 19, 2021, as discussed here.  The issuance of the ANPR was paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies.

EPA states that it is soliciting comments and suggestions to determine whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPR are due before July 7, 2021.  Discussed below are the issues raised in the ANPR for stakeholder consideration and changes made since the ANPR was first announced in January 2021.

The ANPR is generally the same as what was first announced in January 2021, in which EPA states it is seeking public input for two main categories:

  • Whether EPA should be streamlining the petition process and revisions to how EPA evaluates the potential minimum risk active and inert substances, factors used in classes of exemptions, state implementation of the minimum risk program, and the need for any future exemptions or modifications to current exemptions; and
  • Whether EPA should consider amending existing exemptions or adding any new classes of pesticidal substances for exemption.

One important difference is that the April 2021 ANPR now includes a discussion of environmental justice.  EPA states that Executive Order 12989 directed agencies, “to the greatest extent practicable and permitted by law, to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of its actions on minority and low-income populations.”  EPA states in the ANPR that it has not identified any such disproportionate effects, since this ANPR is soliciting comments and is not proposing any specific actions or regulatory changes.

Specific questions posed that relate to environmental justice include the following:

  1. Given the identified minimum risk characteristics of these products and anticipated low impacts on communities, are current approaches effective for seeking input from the public and stakeholders, including state, local, tribal, and territorial officials, scientists, labor unions, environmental advocates, and environmental justice organizations?  Are there particular approaches that are more or less effective?
  2. Are there other policies that EPA should consider in determining whether a substance should be exempt from FIFRA regulation via the Minimum Risk Pesticide Listing Program?  For example, should EPA consider additional environmental justice and pollution prevention policies?
  3. When considering products that are a “minimum risk” to public health and the environment, should the product also be considered to be of low impact to all communities, including low-income and minority populations?  Please explain why or why not.
  4. When considering whether a category or class of products are a “minimum risk” to public health and the environment, should the category or class of products also be considered as being of low impact to all communities, including low-income and minority populations?  Are there other factors that EPA should consider?

Other questions posed that have not changed substantively since the 2021 ANPR include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  3. Are there other pesticidal substances or systems (e.g., peat) that EPA should consider adding as new classes at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?  How do these other pesticidal substances or systems meet the existing factors?
  4. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  5. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and labeling changes, made it easier for manufacturers, the public, and federal, state, and tribal inspectors to identify specific chemicals used in minimum risk pesticide products?
  6. Are there state challenges to implementing the minimum risk program?  Can EPA address those challenges with changes to its program?  Do states have suggestions for improvements to the program?

Commentary

Given the change in Administrations and the “pause” that was imposed and further review that was required before this proposed rulemaking could be issued, it was unclear whether EPA would issue this proposal.

Now that EPA has issued the ANPR, it is important for stakeholders to review these issues carefully and consider submitting comments to identify challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  EPA also notes that with regard to environmental justice, it is seeking public input on the consideration of environmental justice concerns in the context of the issues raised in the ANPR, and that “if and when the Agency proposes regulatory options regarding exemptions under FIFRA or the related procedures, EPA will seek additional input from the public, as appropriate.”


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

  • Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
  • Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
  4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
  6. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
  8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.


 

By Heather F. Collins, M.S.

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 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, as the majority of EPA staff are still working remotely and may not be on site to receive mailed reports.

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 M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307.

The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption.  EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA).  EPA states that no comments were submitted on that notice by USDA or any other person.  EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.”  On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.

EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.”  According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan.  Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.

Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701.   EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.

Additional information on chitosan is available on our blog.


 
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