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 James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On August 18, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will stop the use of the pesticide chlorpyrifos on all food. In the pre-publication of the Federal Register notice released on August 19, 2021, EPA revoked all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. EPA has stated the cancellation order will follow in approximately six months after the tolerance revocations.

EPA’s announcement responds to the Ninth Circuit’s order, issued on April 29, 2021, that vacated EPA orders issued in 2017 and 2019 denying a 2007 petition filed by Pesticide Action Network North America and Natural Resources Defense Council. That petition requested that EPA revoke all chlorpyrifos tolerances, or the maximum allowed residue levels in food, because those tolerances were not safe, in part due to the potential for neurodevelopmental effects in children. The 2017 and 2019 orders denying the 2007 petition were challenged in the Ninth Circuit by a coalition of farmworker, health, environmental, and other groups.

In its order, the Ninth Circuit found that “...EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act (FFDCA) ...” to “conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm.” After vacating the 2017 and 2019 orders, the court remanded the matter to EPA with instructions to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA ‘has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information,’ including for ‘infants and children’; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”

In its announcement, EPA states that it has determined that the current aggregate exposures from the use of chlorpyrifos do not meet the legally required safety standard that there is a reasonable certainty that no harm will result from such exposures. Chlorpyrifos is an organophosphate insecticide used for a large variety of agricultural uses and has been continually reviewed with regard to potential adverse effects, including possible neurological effects in children, which has been the subject of considerable controversy for many years. EPA’s announcement notes that a number of other countries, including the European Union and Canada, and some states, including California, Hawaii, New York, Maryland, and Oregon, have taken similar action to restrict the use of this pesticide on food.

EPA states its action also will be incorporated into the ongoing registration review for chlorpyrifos. EPA is continuing 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 EPA-HQ-OPP-2008-0850 at www.regulations.gov and a discussion of these issues is available on our blog here.

After considering public comments, EPA will proceed with its registration review of the remaining non-food uses of chlorpyrifos by issuing the interim decision, which may consider additional measures to reduce human health and ecological risks.

Commentary

Separate from any issues of science, evidence, or interpretation, the FFDCA’s channels of trade provision is designed to address what happens if EPA cancels a pesticide product for not meeting Food Quality Protection Act (FQPA) standards and then revokes the tolerance. EPA’s initial description of its decision was unclear on this important point regarding the status of food already in the channels of trade that may contain chlorpyrifos residues.

EPA statements at an August 18, 2021, phone briefing with agricultural stakeholders appeared to present a position that the tolerance revocations would be in effect immediately upon publication in the Federal Register. This implied that there may be an immediate revocation of the tolerances before any parallel action to cancel the associated pesticide registrations. The pre-publication version of the notice clarified that the revocation of chlorpyrifos tolerances would not become effective until six months after the publication of the notice in the Federal Register.  As of August 24, 2021, the notice has not been published in the Federal Register.

This revocation delay of six months aligns with the statement also made by EPA to cancel the registration of chlorpyrifos food use products six months after the revocation notice. EPA may face questions from some of the groups that have been advocating for this type of EPA action concerning why, if these tolerances need to be revoked, the use of the pesticide will continue in effect for the remainder of this growing season. Ed Messina, Office Director of the Office of Pesticide Programs, made a glancing reference to this at the phone conference when he stated EPA and the U.S. Food and Drug Administration (FDA) are “having discussions.” 

According to EPA, use of chlorpyrifos has been in decline due to restrictions at the state level and reduced production. EPA also notes that some alternatives have been registered in recent years for most crops, other chemistries and insect growth regulators are available for certain target pests, and that EPA is committed to reviewing replacements for and alternatives to chlorpyrifos. Some growers, however, are using registered chlorpyrifos products on food crops and hoped to be able to continue certain uses. 

EPA states in the pre-publication notice that some uses in certain areas appear to be able to meet the FQPA standard as evaluated in its 2016 and 2020 risk assessment documents, even if including the full 10x FQPA “extra” safety factor (these assessments are the reference documents EPA cites in its revocation notice). EPA further states that the Ninth Circuit’s order did not provide EPA with time to consider further changes to the use patterns or label restrictions to align with such changes hinted at in the revocation notice, and so EPA is issuing the revocation decision now. This begs the question of whether EPA might consider some continued uses in the future, although even considering any “new” tolerance would be very controversial.

In addition, none of the current actions affect (for now) the tolerances for stored grains using the sister chemical (chlorpyrifos-methyl) with a similar toxicological profile. There also are non-food use applications of chlorpyrifos, for example, mosquito control application of chlorpyrifos sprayed over a large area, that are not affected by the tolerance revocation.

This mix of messages may not be easy to explain to users and the consuming public. 

Issues regarding the timing of the revocations and continued uses are also likely to present challenges for FDA. For example, there are various blended commodities (e.g., animal feed grain, possibly co-mingling harvests from different times) where FDA may be unable to determine what part of any enforcement sample came from a particular date of use.

The orderly transition for treated commodities was designed to avoid public and grower confusion that characterized the episodes of StarLink corn chaos in 2000 or the Cheerios contamination incident in 1994 involving a reported over 100 million boxes of cereal that were eventually destroyed. EPA cites international trade obligations as another reason for the coordinated actions effective in six months to notify foreign trading partners with a “reasonable interval” for adjusting to a changed regulatory situation.

Additional information on chlorpyrifos is available on our blog.


 

By Lisa M. Campbell and Lisa R. Burchi

On July 12, 2021, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register a notice of availability of a petition filed on April 8, 2021, by the Center for Biological Diversity (CBD) requesting that EPA cancel Elanco US Inc.’s (formerly Bayer Healthcare LLC) Product, PNR1427, more commonly known as Seresto (Petition). 86 Fed. Reg. 36546. The Petition also requests that EPA suspend the registration pending the requested cancellation. Seresto has been registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) since 2012 for flea and tick treatment on adult dogs and puppies and on adult cats and kittens.

Comments on the Petition are due on or before September 10, 2021, in docket EPA-HQ-OPP-2021-0409.

Under FIFRA Section 6(b), EPA may cancel a pesticide product’s registration if it appears to EPA that the pesticide, “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment.” In its Petition, CBD states that, “according to a recent aggregate incident summary report, since this product was introduced in 2012, EPA has received over 75,000 adverse incident reports, including at least 1,698 reports linking the use of this product to pet deaths and at least 700 involving human harm.” CBD states this product “contains as active ingredients the neonicotinoid imidacloprid (10%) and the pyrethroid flumethrin (4.5%).” CBD states further, “Understanding each of these ingredients, alone and in combination, is important for understanding the toxicity and risks that their use in Seresto presents to dogs, cats, humans, and exposed threatened and endangered species.” With regard to imidacloprid, CBD states in its Petition, “Neonicotinoids like imidacloprid are most well-known for the harms they cause to pollinator species, including threatened and endangered pollinators like the Poweshiek skipperling (endangered), Dakota skipper (threatened), and rusty patched bumble bee (endangered).” The Petition discusses several studies and EPA risk assessments related to both ingredients, as well as what it describes as the “synergistic effects” of the combination of imidacloprid and flumethrin. CBD argues that Seresto poses an unreasonable risk to human health, pets, and the environment and that EPA should cancel the registration pursuant to FIFRA Section 6(b).

CBD additionally argues that EPA should suspend the registration, asserting that EPA can suspend a pesticide’s registration under FIFRA Section 6(c)(1) when such action is necessary to prevent an “imminent hazard” during the time required for cancellation. The standard to be met to be considered an imminent hazard is high, as “imminent hazard” is defined under FIFRA Section 2(l) as “a situation which exists when the continued use of a pesticide during the time required for [a] cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened.” CBD argues that suspension is warranted in this case because, CDC asserts, both criteria for an imminent hazard are satisfied -- CDC asserts that the products at issue pose both “ongoing and imminent unreasonable adverse effects on the environment and unreasonable hazard to the survival of the endangered rusty patched bumble bee, as well as other imperiled pollinators).”

Commentary

This Petition is one prong in a larger effort by certain groups to halt sales and use of Seresto. EPA’s press release statements indicate that EPA shares some concerns raised by the petitioners, at least with regard to incidents involving pets. EPA further stated in its press release that it is reviewing additional information requested by EPA from the current and former registrant regarding these incidents, and that it will use that information “along with any relevant information received during the public comment on this petition, to determine if any additional action is needed.” It will be important to monitor EPA’s review and response to this petition.


 

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

On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial pesticide products to substitute some combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide feedstocks that are in limited supply due to weather events that occurred in the U.S. Gulf Coast area in February 2021. EPA stated that it is allowing these substitutions even in cases where propylene glycol is added to the formulation or is part of a brand-name mixture in which the full composition is known to the registrant.

The pre-approved alternates are glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5); diethylene glycol (CAS RN 111-46-6); ethylene glycol (CAS RN 107-21-1); and 1,3-propanediol (CAS RN 504-63-2).

EPA emphasizes that this action, known as “Propylene Glycol Phase 2 -- ‘Not In-Kind’ Substitution Mechanism,” relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.

In April 2021, EPA implemented “Propylene Glycol Phase 1 -- ‘In-Kind’ Substitution Mechanism” to allow certain in-kind substitutions to address propylene glycol supply-chain shortages.

These actions require registrants to self-certify that the substitute inert ingredients serve the same function in the product as propylene glycol and that the change will not impact either the validity of any product-specific data submitted in support of the registration or the product’s acute toxicity category or physical/chemical characteristics in a way that would require label modifications. Registrants must also certify that the substitution will not affect the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, or any other factor.

This action is time limited, extending to December 31, 2021. Any registrants who wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.


 

By Carla N. Hutton

The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden -- known as the Assessment Group of Glyphosate (AGG) -- examined all the evidence submitted by the companies that are seeking renewed approval to market the glyphosate in the EU. Glyphosate is currently authorized for use in the EU until December 2022.

ECHA and EFSA will organize parallel consultations on the draft report. These will be open to the public and will be held in the first week of September 2021. According to ECHA, the consultations are the first step in the assessments. ECHA’s Committee for Risk Assessment (RAC) will review the classification of glyphosate under the Classification, Labeling and Packaging (CLP) Regulation. ECHA notes that chemical classification is based solely on the hazardous properties of a substance and does not consider the likelihood of exposure. Exposure is considered as part of the risk assessment process led by EFSA.

Glyphosate currently has a harmonized classification as causing serious eye damage and as toxic to aquatic life with long-lasting effects, prior to and following ECHA’s 2017 assessment. ECHA states that no classification for germ cell mutagenicity, carcinogenicity, or reproductive toxicity was warranted. The AGG proposal does not foresee a change to the existing classification.

Once ECHA adopts its opinion on the classification of glyphosate, EFSA will prepare a final peer review and publish its conclusions, expected in late 2022. Based on this risk assessment, the European Commission (EC) will decide whether to renew glyphosate.


 

By Barbara A. Christianson

On June 4, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will host a webinar for pesticide registrants to provide registrants an overview on how to request Certificates of Registration, commonly known as Gold Seal letters, using the Pesticide Submission Portal. Gold Seal letters serve as proof for pesticide exporters that the product is registered with EPA and meets all necessary registration requirements.

According to EPA, since launching the digital platform in 2020 in response to the COVID-19 public health emergency, the electronic process has resulted in quicker processing of Gold Seal letters and thorough and complete internal tracking. Due to continuing safety precautions within EPA, it is still unable to produce traditional, paper-based Gold Seal letters. Accordingly, registrants must continue to submit requests through the Pesticide Submission Portal.

Stakeholders interested in attending the presentation can click here to join the online meeting (registration is not required). The webinar will be held on June 14, 2021, at 1:00 p.m. (EDT).

Information on how to request a Gold Seal certificate letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.


 

By Heather F. Collins, M.S.

On April 21, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemptions to the states of Georgia, Minnesota, and Utah permitting the use of BiaXamTM B110-V and BiaXamTM B110-P (BiaXam), adhesive film used as supplemental residual surface coating, in Delta Air Lines planes and facilities in those three states.

According to the EPA Authorizations for Georgia, Minnesota, and Utah (EPA Authorizations), the unregistered product is a transparent adhesive film that contains the unregistered active ingredient, Benzene, 1-(1,1-dimethylethyl)-4-ethenyl-, polymer with ethenylbenzene and 2-methyl-1,3-butadiene, sulfonated (CAS RN 1637665-77-0).  BiaXam is approved for use on indoor hard, nonpliable, nonporous, nonfood-contact surfaces of aircraft, airports, and associated facilities owned or operated by Delta Air Lines, to provide residual control of the SARS-CoV-2, the virus that causes COVID-19.  The adhesive film must be applied by trained applicators to indoor surfaces in airplanes, airports, and related facilities at the Delta Air Lines sites listed on the label.  Prior to application of the BiaXam product, the surface initially must be disinfected using a disinfectant from EPA’s List N – Disinfectants for Use Against SARS-CoV.

The BiaXam film is to be replaced in airplanes at least every 200 days, and in airports and related facilities at least every 100 days. If the film detaches from the surface, degrades, is damaged, becomes irreparably soiled, or its edges or corners begin to peel, the film is to be removed, the surface cleaned and dried using a List N disinfectant, and a new layer of film applied to the surface according to the application instructions on the label.  To maintain protective effect on surfaces that have been treated with BiaXam, only alcohol-based Purell wipes, Matrix Disinfectant/Cleaner #3 (quaternary ammonium based, EPA Reg. No. 1839-168-67026), and Lysol wipes (quaternary ammonium based, EPA Reg. No. 777-114) may be used on film-covered surfaces for routine cleaning and disinfection. The film surface is to be cleaned directly in place and not removed unless replacing. If cleaning products are provided to the public (e.g., airline passengers), only products compatible with BiaXamTM B110-V and BiaXamTM B110-P should be provided.

FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption.  EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency.  EPA’s regulations provide that an emergency exists when:

  • There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
  • There is no registered pesticide or economically or environmentally feasible alternate method of control available.

40 C.F.R. § 166.3.

The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.

EPA’s approval will allow the BiaXam product to be used at facilities owned or controlled by Delta Air Lines, Inc., at specific sites in Georgia, Minnesota, and Utah, on indoor hard, nonpliable, nonporous, and nonfood-contact surfaces in airplanes, airports, and other air-travel related facilities owned or controlled by Delta Air Lines, Inc. including, but not limited to:

  • Airplanes: railings, doorknobs/handles, armrests, seatback touch screens, seatbelt buckles, window shades, overhead bins, and overhead control buttons.
  • Airports and other air-travel related facilities: check-in kiosks and counters, gate counters, railings, doorknobs/handles, luggage bins, desks, keyboards, computer mice, touchscreens, printers, badge readers, plastic divider walls, hard nonporous seating, armrests, and elevator buttons.

The approved Section 18 emergency requests are effective for one year.  Any unexpected adverse effects related to the use of this product must be reported immediately to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval.


 

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 Lara A. Hall, MS, RQAP-GLP and Heather F. Collins, M.S.

On March 17, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis" (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. This new guidance builds upon the final guidance for waiving acute dermal toxicity tests for pesticide formulations published by EPA on November 9, 2016, and is an example of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035.  EPA states that this guidance is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.

The new final guidance document also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both end-use product formulations and technical chemicals in 2017. 

In developing the new guidance, EPA states that the Office of Pesticide Programs (OPP) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 AIs across numerous chemical classes and toxicity categories in the EPA pesticide categorization scheme.  The overall purpose of this analysis was to address the utility of the acute dermal toxicity study for single AIs in pesticide labeling, such as the signal word and precautionary statements. Fumigants and rodenticides were excluded from this retrospective analysis based on their physical state and/or anticipated exposures to them. EPA concluded that:

  • For 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category; 
  • For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category;
  • Thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective; 
  • For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements; and
  • The acute dermal toxicity studies provide little to no added value in regulatory decision making. 

EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides.  Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.

Additional information on EPA’s efforts to reduce animal testing is available here.


 

By James V. Aidala and Carla N. Hutton

On March 3, 2021, the Farmworker Association of Florida, Environmental Working Group, and Center for Biological Diversity petitioned the U.S. Court of Appeals for the District of Columbia Circuit for review of the U.S. Environmental Protection Agency’s (EPA) order registering the use of the pesticide aldicarb on oranges and grapefruit in Florida as set forth in:

EPA published a Federal Register notice on December 7, 2020, announcing that it had received applications to register new uses for pesticide products containing aldicarb, a currently registered active ingredient.  85 Fed. Reg. 78851.  The proposed use was on oranges and grapefruit in Florida and Texas.  EPA’s January 12, 2021, Registration Decision states that during the application review, the registrant amended its request and the use was limited by amount of product that can be sold and distributed (i.e., 2,500,000 pounds product) for use during an application season (November 15 to April 30), limited to oranges and grapefruit in Florida, only, and will expire after the third application season (April 30, 2023).  The Registration Decision states that EPA “is conditionally approving the uses on oranges and grapefruit to the products MEYMIK TECHNICAL (EPA Reg. No. 87895-2), AGLOGIC 15GG (EPA Reg. No. 87895-4) and AGLOGIC 15GG OG (EPA Reg. No. 87895-7).”  According to the Registration Decision, “[t]hese conditional, time-limited registrations will allow for a narrow use of aldicarb on oranges and grapefruit in Florida to help in the control of certain insects, mites, and nematodes, including [Asian citrus psyllid (ACP)].”  EPA notes that in conditionally approving these new uses for the existing products under Section 3(c)(7)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it determined that there are insufficient data to register these uses unconditionally.

Commentary

EPA’s justification for allowing these uses centers on the need for products to control, or at least slow down the spread of, citrus-greening disease (spread by the ACP-vectored bacterial disease Huanglongbing (HLB)).  The registration rationale notes that growers have seen up to an 80 percent reduction in production value due to the disease.  This registration appears to be a time-limited registration in order to have another pest control tool while further research continues to attempt to find a more permanent solution to controlling the disease.  EPA’s rationale describes past registrations of aldicarb that have provided extensive data and reviews of the required health and ecological assessments to meet the FIFRA standards.  A time-limited registration also makes EPA’s assessment “easier” insofar as there is no presumption of long-term chronic exposure to the pesticide beyond the time-limited period.  The tolerances for aldicarb had continued to remain in place to allow for use on imported food after earlier reviews determined the tolerance levels met the relevant standards (including risks to children).  These additional uses on domestic crops was determined not to change the analytical basis of the tolerance assessment (example:  the amount of orange juice consumed does not change if a domestic or foreign supplier is the source).

At the same time, aldicarb has been a controversial pesticide for much of its history.  As a carbamate insecticide, its mode of action is cholinesterase inhibition, which has raised issues about possible long-term neurological or other developmental effects from carbamate or organophosphate pesticides.  And, as a potent insecticide, some would say there will likely be impacts on pollinators even if label directions are followed.  Lastly, arguments over possible risks to farmworkers, assessed to be acceptable in the registration decision, may prove to be an early test of the stated commitment to review more closely decisions with possible environmental justice implications under the new Biden Administration.


 

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.


 
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