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

On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that pesticide manufacturers seeking to register their products with a C. auris claim should use this updated guidance to test the effectiveness of the products against a drug-resistant strain of C. auris.

EPA states that C. auris is an emerging, multidrug-resistant yeast (a type of fungus). It can cause serious infections and spreads easily among hospitalized patients and nursing home residents. C. auris can spread in healthcare settings through contact with contaminated environmental surfaces or equipment, or from person to person. According to the Centers for Disease Control and Prevention (CDC), more than one in three patients with an invasive (e.g., affecting the blood, heart, or brain) C. auris infection die.

In 2017, in consultation with the CDC, EPA issued interim guidance for testing the effectiveness of hospital disinfectants against C. auris. Subsequently, based on input from the CDC on its tracking of clinical cases of multi-drug resistant C. auris isolates in the United States, the laboratory data were generated to ensure antimicrobial efficacy against a more relevant strain of the pathogen.

Working closely with experts from the CDC, EPA conducted a comparative evaluation of isolates and found that the drug-resistant isolates were more tolerant to some disinfectant treatments. Since a drug-resistant isolate (AR Bank #0385) is highly relevant to current outbreaks in the United States, it is considered a suitable test microbe for regulatory purposes.

The guidance provides recommendations for laboratory methodology on how to:

1. produce and store cultures of drug-resistant C. auris, and
2. evaluate the effectiveness of antimicrobial products intended to treat surfaces contaminated with drug-resistant C. auris.

Under the updated guidance, all new products seeking registration with claims against C. auris should test for efficacy using the more relevant strain (AR Bank #0385). Efficacy testing using AR Bank #0381 is acceptable in some cases where the study initiation date is between October 15, 2020, and October 15, 2021. For study initiation dates between October 15, 2020, and October 15, 2021, EPA will accept studies conducted with isolate AR Bank #0381 for products whose active ingredients are either sodium hypochlorite or hydrogen peroxide plus acetic acid. For products with other active ingredients, it will be necessary to retest using isolate AR Bank #0385.

Existing antimicrobial products with C. auris claims based on the previous strain (AR Bank #0381) will be allowed to retain their claim of effectiveness against C. auris. To claim effectiveness against drug-resistant C. auris, EPA requires retesting with the more relevant strain (AR Bank #0385) identified in the updated guidance and according to the revised test method.

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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.

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By Carla N. Hutton

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on the Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders” developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) in 2010.  EFSA states that highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e., use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments).  In the first version of the Guidance, issued in 2014, EFSA included several scenarios for outdoor uses, with an annexed calculator, as well as recommendations for further research.  EFSA has updated the Guidance in 2021 to include additional scenarios and revise default values on the basis of the evaluation of additional evidence.  To support users in performing the assessment of exposure and risk, EFSA further developed an online calculator that reflects the Guidance content.  Comments on the draft updated Guidance are due May 9, 2021.  EFSA will assess all comments submitted in line with the specified criteria.  The relevant EFSA Panel will further consider the comments and take them into consideration if found to be relevant.

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

On November 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of, and requested comments on, the updated Draft Guidance for Plant Regulator Products and Claims, Including Plant Biostimulants (Draft Guidance).  The original Draft Guidance (2019 Draft Guidance) was made available on March 27, 2019.  EPA states that the updated Draft Guidance “incorporates diverse and helpful changes made in response to stakeholder feedback” received during the initial comment period in 2019 and “clarifies which biostimulants, biological substances, and mixtures, in addition to the associated product label claims, EPA considers plant regulators.”

EPA is now seeking comments on those changes.  Comments on the updated Draft Guidance are due on or before December 30, 2020, in docket EPA-HQ-OPP-2018-0258. 85 Fed. Reg. 76562.  EPA states that it anticipates issuing the Draft Guidance in final form in January 2021.

Updates to the Draft Guidance

EPA made several changes to the Draft Guidance.  Of note, the Disclaimer section of the Draft Guidance EPA now states that the “contents of this document do not have the force and effect of law and are not meant to bind the public in any way.”  It states further that the “document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.”

Additional changes of interest to the updated Draft Guidance include:

• Revised Definitions of “Plant Biostimulant”:  In the 2019 Draft Guidance, EPA sought comments on whether it should develop, through rulemaking procedures, a definition for plant biostimulant.  EPA states that subsequent to the release of the 2019 Draft Guidance, the U.S. Department of Agriculture (USDA) issued a Report to Congress on Plant Biostimulants that included two new definitions of plant biostimulants.  As a result, EPA states that it does not plan to develop a separate definition of plant biostimulants.  In the Draft Guidance, EPA deleted the Proposed European Commission definition of plant biostimulant and added two of USDA’s new definitions of plant biostimulants:
  • 2019 USDA Report Alternative Definition 1:  A plant biostimulant is a naturally-occurring substance, its synthetically derived equivalent, or a microbe that is used for the purpose of stimulating natural processes in plants or in the soil in order to, among other things: improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve characteristics of the soil as a medium for plant growth. The characteristics may be physical, chemical, and/or biological. The plant biostimulant may be used either by itself or in combination with other substances or microbes for this purpose.
  • 2019 USDA Report Alternative Definition 2:  A plant biostimulant is a substance(s), microorganism(s), or mixtures thereof, that, when applied to seeds, plants, the rhizosphere, soil or other growth media, act to support a plant’s natural nutrition processes independently of the biostimulant’s nutrient content. The plant biostimulant thereby improves nutrient availability, uptake or use efficiency, tolerance to abiotic stress, and consequent growth, development, quality or yield.
• Clarification of Focus on Pesticide Claims and Composition:  In the section “Pesticide Products Required to be Registered,” EPA has added the following paragraph:

The Agency historically has had a claims-based approach to pesticide regulation, but emphasizes that the term “claims-based” does not mean “claims-only based.” As the Agency has explained, “…the term “pesticide product” will be used to describe a particular pesticide in the form in which it is (or will be) registered and marketed, including the product’s composition, packaging and labeling.” (49 FR 37917, September 26, 1984.) The Agency has always considered the composition of a product, as well as its associated claims, when making a regulatory determination, which is reflected in 40 CFR 152.15.

In the “Claims Examples” section, EPA further adds the following sentences:

When claims for increased or decreased growth, yield, germination, maturation, etc. are consequent to intended uses of products or substances as plant nutrients (fertilizers), plant inoculants, soil amendments, and/or as other non-pesticidal uses, such products and substances may be excluded from regulation under FIFRA in the absence of any plant regulator claims. The example claims listed in Tables 1a through 1c are specifically tied to the exclusions from the FIFRA definition of a plant regulator and are worded as such. When such claims for accelerating or retarding the rate of growth, or maturation, the behavior of plants, or the produce thereof are made without qualification or reference to a specific exclusion, such claims are and will continue to be considered plant regulator claims.

• Revisions to Claim Examples:  EPA has modified the examples of plant nutrition, plant inoculant, soil amendment, generic non-pesticidal, and pesticidal claims as set forth in Tables 1a, 1b, 1c, 2, and 3.  Some of the changes move a claim from one chart to another.  EPA has added that certain claims can improve foliar and seed nutrient conditions.  Perhaps most importantly, EPA has added a footnote to each chart that the stated examples “are not comprehensive and other claims may include other synonymous terms and phrases.”
• Discussion of Plant Regulator Active Ingredients:  EPA has deleted what was Table 4 in the 2019 Draft Guidance, which provided a list of active ingredients contained in EPA registered products having modes of action that trigger regulation under FIFRA as a pesticide.  Instead, EPA has added three new sections:
  • Substances that have no other use than as plant regulators or pesticides:  EPA has identified certain substances that “are generally recognized to have no other significant commercially valuable use, either alone or in combination with other substances, other than use as plant regulators (i.e., as pesticides).”  These include corn glutens; L-glutamic acid (LGA) and gamma-aminobutyric acid (GABA); homobrassinolide and other brassinosteroids; lysophosphatidylethanolamine (LPE); 1-Octanol; and sodium o-nitrophenolate, sodium p-nitrophenolate, and sodium guaiacolate.
  • Substances that may have plant regulator and non-plant regulator activity:  EPA has identified “substances with additional modes of action, not considered to be plant regulator modes of action that may include, but are not limited to: the alleviation of abiotic stressors (e.g., temperature and water stress); increased water and nutrient use efficiency and/or uptake; increased availability of inorganic nutrients in the soil to plant roots and seeds; increased absorption of inorganic nutrients applied to plant foliage; and changes to the biotic and abiotic characteristics of soils making them a better medium for plant growth.”  Those described by EPA include complex polymeric polyhydroxy acids (CPPAs) and humic acids (HAs); and seaweed extracts (SWE).
  • Regulatory approaches for substances and products that have multiple plant regulator and non-plant regulator modes of action:  The Draft Guidance now states the following:

The Agency recognizes that CPPA, humic acids, seaweed extracts and other PBS products may possess multiple modes of action that are occurring simultaneously when applied to plant foliage, roots, seeds, other propagules, and to the soil.  The Agency also recognizes that not all uses of PBS may be intended for plant regulator or other pest control purposes.  If it can be demonstrated that a particular product has the activity claimed on the product label (and any other informational media) and does not make any plant regulator or pest control claims on the product label (and any other informational media) it may be excluded from FIFRA regulation.  Pursuant to 40 CFR 152.15(b), the Agency will consider whether a substance “has no significant commercially valuable use” other than as a pesticide, when considering whether the substance (or product) is a pesticide.  If it can be demonstrated that the substances contained in such products may have significant commercially valuable uses other than as plant regulators (i.e., pesticides), they may be excluded from regulation under FIFRA in the absence of any plant regulator claims (see examples in Table 3) and in the absence of any other pesticidal claims (e.g., anti-plant pathogen claims).  Review of such “multiple use” products may be conducted by the Agency under PRIA Code M009.

For example, if a product containing seaweed extracts or humic acids is intended for use in alleviating abiotic stress (e.g., extreme temperature, drought/salt stress) on plants, or for stimulating increased nutrient assimilation from the soil, is labeled using product claim examples (Tables 1a-c and 2), and can provide product performance data supporting such product claims, the product may be excluded from regulation under FIFRA.

Commentary

The removal of Table 4 from the Draft Guidance appears to address comments submitted on the 2019 Draft Guidance that criticized EPA for developing a list of active ingredients that would trigger pesticide registration requirements when several of those substances possessed non-pesticidal modes of action.  Interestingly, many of the significant proposed changes address issues related to composition and to substances and products with plant regulator and non-plant regulator modes of action, rather than claims.  Also of note is EPA’s current intent not to initiate a rulemaking to define plant biostimulant, but instead to rely upon definitions developed by USDA and under review by Congress.

There are a significant number of issues of interest, and those with potentially affected products should review the updated guidance closely.

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

On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects.  This new draft guidance is part 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.

According to EPA, the draft dermal toxicity guidance would allow applicants to request waivers for acute dermal toxicity studies on single-active ingredients used to develop end-use products.  The new draft guidance also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both formulations and technical chemicals in 2017.  The draft guidance is in addition to the final guidance for waiving acute dermal toxicity tests published by EPA in November 2016 for pesticide formulations.

In developing the guidance, EPA states that it conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 active ingredients across numerous chemical classes and toxicity categories.  Fumigants and rodenticides were excluded from this 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.  EPA concluded that its requirements for such acute dermal toxicity studies provide little to no added value in regulatory decision making.  EPA states that this guidance, when finalized, is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.

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.  Once the guidance is issued in final form, EPA states that applicants who wish to pursue waivers for these studies would submit formal waiver requests as part of the registration application through existing processes and cite the guidance as support for the requests.  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.

Comments on the draft guidance are due on or before November 9, 2020, and can be submitted at http://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2016-0093.

EPA also announced the launch of its new webpage that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and work plans tied to the larger Toxicology in the 21st Century Initiative across the federal government.  The directive, issued by EPA Administrator Andrew Wheeler in September 2019, calls for EPA to reduce animal testing and to reduce funding 30 percent by 2025 and eliminate it by 2035.  EPA states that its actions to date to support these efforts include:

• In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety.
• In December 2019, EPA convened a conference for achieving reduced animal testing in chemical safety research and updated its list of New Approach Methodologies (NAM) that could be used in EPA’s work under the amended Toxic Substances Control Act, including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
• In June 2020, EPA released a NAMs work plan that details how EPA plans to develop, test, and apply chemical safety testing approaches without the use of animals.
• In February 2020, EPA issued final guidance waiving the subacute dietary testing of pesticides on birds when the additional information is unnecessary to support a pesticide registration decision, which is expected to save 720 test animals annually.
• In July 2020, EPA announced new guidance to reduce unnecessary testing on fish, which is expected to save 240 test animals annually.

EPA will host its Second Annual Conference on the State of the Science on Development and Use of NAMs for Chemical Safety Testing virtually on October 19 and 20, 2020.  Additional information on EPA’s efforts to reduce animal testing is available here.

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

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents.  The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or withdrawal of the guidance documents. 

Information available about each guidance document listed on the Portal includes:

• A concise name for the guidance document;
• The date on which the guidance document was issued;
• The date on which the guidance document was posted to the web portal
• An agency unique identifier;
• A hyperlink to the guidance document;
• The general topic addressed by the guidance document; and
• A summary of the guidance documents’ content.

EPA states that the “guidance documents lack the force and effect of law, unless expressly authorized by statute or incorporated into a contract” and EPA “may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”

The portal is broken down by office, including regional offices:

• Office of Air and Radiation (OAR)
• Office of Chemical Safety and Pollution Prevention (OCSPP)
• Office of Enforcement and Compliance Assurance (OECA)
• Office of General Counsel (OGC)
• Office of International and Tribal Affairs (OITA)
• Office of Land and Emergency Management (OLEM)
• Office of Mission Support (OMS)
• Office of Research and Development (ORD)
• Office of Water (OW)
• All EPA Regional offices

Currently, there are a total of 1,735 guidance documents listed under OCSPP.  Within the 1,735 documents, 117 appear to be specific to FIFRA. Examples of guidance documents included in the portal are:

• Inert Ingredients Overview and Guidance;
• Exporting Unregistered Pesticides: Foreign Purchaser Acknowledgement Statements;
• EPA's Regulation of Biotechnology for Use in Pest Management;
• CPARD USER GUIDE: For State Lead Agency (SLA) and Tribal Representatives with Certification Plans (CPs);
• Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines;
• Pesticide Registration Manual;
• Guidance on FIFRA 24(c) Registrations;
• Design for the Environment Logo for Antimicrobial Pesticide Products;
• Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants;
• Structured Product Labeling (SPL) Draft Implementation Guide with Validation Procedures and User Guide;
• Reregistration and Other Review Programs Predating Pesticide Registration Review;
• FIFRA Pesticides Export Policy: Questions & Answers Issue: Research and Development Pesticides; Active Ingredient Concentrations;
• State FIFRA Issues, Research, and Evaluation Group Final Guidance for State Lead Agencies for the Development and Implementation of Managed Pollinator Protection Plans; and
• E-FAST, Down the Drain Assessment Model.

Under OECA, there are six documents specific to FIFRA.  The guidance documents included in this portal are:

• Compliance Advisory: High Number of Complaints Related to Alleged Misuse of Dicamba Raises Concerns;
• Good Laboratory Practices - Questions and Answers;
• EPA and Association of American Pesticide Control Officials (AAPCO) Advisory Notice on Pesticide-related E-Commerce;
• Fact Sheet on Pesticides Sales in E-Commerce;
• Documents with Questions and Answers on FIFRA Pesticides Export Policy; and
• FIFRA Pesticide Export Policy: Interpretive Guidance: Multilingual Labeling.

Of note, the portal sets forth an option for petitioning EPA to modify or withdraw a guidance document from the Portal by completing an online form.  The required information to submit using the online form is name, email address, unique identifier of the guidance document, the office and/or region, and comments related to the withdrawal or modification of the guidance document.

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By Kelly N. Garson and Carla N. Hutton

On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures.  In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability to address human health and environmental risks prior to pesticide product registration.  OIG will conduct the audit from EPA headquarters.  According to the memorandum, the anticipated benefits of this audit include determining whether EPA has adequate controls to address human health and environmental risks prior to pesticide product registration.

OIG is an independent office created by the Inspector General Act of 1978, as amended.  Though located within EPA, Congress funds OIG separately to ensure independence as it conducts activities such as audits and investigations to determine the efficiency and effectiveness of EPA’s operations and programs.  Following the audit, OIG will prepare a report that may include recommendations for corrective actions OCSPP should take based upon OIG’s findings.  More information on OIG’s previous reports and audit system is available on OIG’s website.  Recent OIG reports regarding the implementation of FIFRA include:

• EPA Needs to Determine Strategies and Level of Support for Overseeing State Managed Pollinator Protection Plans (August 2019):  Honey bee pollination adds more than $15 billion in value to U.S. agricultural crops each year.  According to OIG, the number of managed honey bee colonies in the United States has declined from 5.7 million colonies in the 1940s to 2.7 million colonies in 2015; and
• Tribal Pesticide Enforcement Comes Close to Achieving EPA Goals, but “Circuit Rider” Inspector Guidance Needed (October 2019):  OIG states that improvements in the “circuit rider” program can enable EPA better to detect and prevent pesticide misuse and unnecessary risks to human health and the environment in Indian country.

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By Lisa M. Campbell, Sheryl Lindros Dolan, and Margaret R. Graham, M.S.

On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258.  EPA issued the notice of availability in the Federal Register on March 27, 2019.  84 Fed. Reg. 11538.  Comments on the draft guidance are due by May 28, 2019. 

EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants (PBS) to regulation under FIFRA as plant regulators.  While EPA has not yet promulgated a regulatory definition for a PBS, the draft guidance describes a PBS as “a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.”  EPA is seeking comment on the draft guidance itself, as well as on whether it should develop a definition for PBSs.  EPA states that there is currently no statutory definition for PBSs under FIFRA and that development of a definition for PBSs would require rulemaking.  The guidance also notes that the 2018 Farm Bill, enacted on December 20, 2018, does provide a statutory definition for PBSs, which is:  “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.” 

In developing the draft guidance, EPA states that it “considered whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide” and that “a key consideration is what claims are being made on product labels.”  Further, as FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition, “many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.”

The draft guidance provides several examples of both product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims.  The examples are described in the Tables below.

• “Product label claims generally considered ‘non-pesticidal’ (i.e. non-plant regulator claims),” including:  “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c):

• “Generic product label claims for products not covered by the exclusions in the FIFRA Section 2(v) definition of a plant regulator,” including “examples of generic product label claims generally considered by the Agency to be ‘non-pesticidal’” (Table 2):

• “Plant regulator product label claims that are consistent with the FIFRA Section 2(v) plant regulator definition” including “examples of label claims that are considered … to be plant growth regulator claims that trigger regulation under FIFRA as a pesticide” (Table 3):

• “EPA-registered, naturally-occurring, plant regulator active ingredients having modes of action and associated product label claims that are consistent with the FIFRA definition of a plant regulator” (Table 4):

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By Timothy D. Backstrom and Lisa M. Campbell

On June 14, 2018, the U.S. Environmental Protection Agency (EPA) announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use.  The prepublication version of the NOA is available on EPA’s website.  The NOA confirms that the publication “triggers the WPS requirement that training programs must include all of the topics specified in the 2015 revisions to the WPS.”  Because the 2015 WPS rule is already in effect, employers must provide expanded training addressing these topics within 180 days of publication.  The expanded training materials that are the subject of the NOA were developed through a cooperative agreement with the Pesticide Education Resources Collaborative (PERC), and are available on PERC’s website.

EPA previously issued a Federal Register notice on December 21, 2017, stating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zone.”  In this 2017 notice, EPA stated that it did not expect to issue the NOA for  training materials addressing the 2015 WPS rule until after completing a rulemaking concerning these proposed revisions.  This deferral of the NOA would have significantly delayed the expanded training for handlers and agricultural workers contemplated by the 2015 rule.  In the NOA, EPA states that it is still reconsidering the same three requirements, and that “if those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.”

On May 30, 2018, two complaints were filed against EPA in the United States District Court for the Southern District of New York challenging EPA’s decision to defer publication of the NOA.    More information on these lawsuits is available in our blog item "Lawsuits Filed in Federal District Court Regarding WPS Training Delay."  Because publication of the new NOA will afford the plaintiffs in these cases all of the substantive relief they were seeking, it appears that these actions will now be moot other than any request for attorney’s fees and costs incurred by the plaintiffs.

More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.

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By Timothy D. Backstrom

On May 30, 2018, two complaints were filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Southern District of New York.  Both of these suits concern a decision by EPA to defer publication of a notice of availability (NOA) of training materials prepared pursuant to the Agricultural Worker Protection Standard (WPS), 40 C.F.R. Part 170.  The WPS was originally promulgated in 1974, substantially amended in 1992, and then revised again in 2015.  Although the 2015 revisions to the WPS are currently in effect, employers are not required to adopt new training programs for agricultural workers and handlers until 180 days after EPA publishes the NOA announcing the availability of the new training materials in the Federal Register. 

On December 21, 2017, EPA issued a Federal Register notice indicating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zones.”  In this 2017 notice, EPA acknowledged that the WPS provisions it will propose to revise are already in effect and that training materials consistent with the 2015 rule have already been prepared, but stated that EPA does not expect to issue the NOA for these new training materials until after it completes a rulemaking concerning the proposed revisions to the 2015 WPS rule.  The plaintiffs in both of the new district court cases are challenging the decision of EPA to defer issuance of the NOA, which has delayed the timetable for expanded training for agricultural workers and handlers contemplated by the 2015 WPS rule.

The first of two complaints was filed by Rural & Migrant Ministry, et al. (RAM) v. EPA, Case No. 1:18-cv-04743.  RAM’s complaint includes four causes of action based on EPA’s failure to issue the NOA.  RAM alleges that this failure is “arbitrary and capricious,” constitutes “agency action unlawfully withheld and unreasonably delayed,” and violates the publication requirements of the Administrative Procedure Act (APA) and the Federal Register Act.  RAM requests a declaratory judgment that EPA has violated the APA and the Federal Register Act, and injunctive relief to require immediate publication of the NOA.

The second complaint was filed by the States of New York, California, and Maryland, New York v. Pruitt, Case No. 1:18-cv-04739.  These State plaintiffs also contend that EPA’s failure to publish the NOA is “arbitrary and capricious,” and constitutes “action unlawfully withheld or unreasonably delayed.”  Like RAM, the State plaintiffs seek a declaratory judgment and an injunction requiring that EPA immediately publish the NOA for the expanded training materials.  EPA will presumably seek consolidation of the two cases, which both challenge the same EPA actions and seek comparable relief.

The principal question presented by these two WPS cases is whether EPA can lawfully defer full implementation of the expanded training required by the 2015 WPS while it undertakes and completes a new rulemaking to revise certain provisions of the same rule.  Although EPA acknowledges that it has prepared the written materials needed to effectuate the expanded training required by the 2015 WPS, EPA will likely argue that it is both more efficient and less confusing for employers and workers to use the existing training materials until after EPA has finished revising the WPS.  In contrast, the plaintiffs in these two cases will argue that the 2015 WPS is already in effect, and that the protection for workers associated with the expanded training required by this rule has been improperly delayed by EPA without any prior notice and comment rulemaking.

The decision by EPA to defer full implementation of the 2015 WPS while EPA considers potential revisions to the WPS may be deemed analogous in some respects to other EPA actions that delayed the effective date for a rule expanding requirements for certified applicators who apply restricted use pesticides (RUP).  In a decision issued by the U.S. District Court for the Northern District of California on March 21, 2018, the court vacated several EPA actions that had delayed the effective date for the RUP rule, holding that EPA was required to provide notice and opportunity for comment before taking such actions and that EPA lacked “good cause” for acting without notice and comment.  See Order Granting Plaintiffs’ Motion for Summary Judgment, Pineros Y Campesinos Unidoa Del Noroeste v. Pruitt, Case No. 17-cv-03434-JSW.

The current cases may be distinguished from the actions EPA took to defer the effective date for the RUP rule because EPA has declined to take affirmative action to effectuate certain requirements in the 2015 WPS, rather than deferring the effective date for any of the requirements in that rule.  It remains to be seen whether the district court will consider this procedural distinction to warrant a different outcome.

More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.

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