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On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse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 This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on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 The new draft guidance also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both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 The draft guidance is in addition to the final guidance for waiving acute dermal toxicity tests published by EPA in November 2016 for pesticide formulations.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.
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.
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:
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):
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.
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.
By Lisa M. Campbell and Lisa R. Burchi
On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to public comments. Links to the final guidance and to the response to public comments documents are below:
EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.” EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label.
On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category.
In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.” Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.”
EPA also listed three recommendations for registrants to consider when printing their container labels:
- For Toxicity Category I products, EPA strongly recommends that registrants consider placing duplicative first aid language on the very back page of the booklet/accordion/saddle stitch label that is immediately “stuck” to the container in case the booklet/accordion/saddle stitch label is accidentally removed.
- Regardless of whether a registrant chooses to place the first aid statements for Toxicity Categories II and III products on a visible front, back, side or inside panel, EPA recommends that duplicative first aid language appear on the very back page of the booklet/accordion/saddle stitch label that is immediately attached to the container in case the booklet/accordion/saddle stitch label is accidentally removed. EPA states that this recommendation is not intended to suggest other information that registrants typically include on the very back page should be moved elsewhere.
- EPA recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers. Per 40 C.F.R. Part 156.10(a)(4), the labels are to be “securely attached” to the immediate container of the pesticide product. EPA believes that in many instances these labels are easily removed which is why, EPA states, it believes many registrants have already chosen to put the duplicative first aid statements on the very last page of the label that is attached to the container.
Registrants should review this guidance carefully, as this issue has been the subject of concern and controversy for a number of registrants.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced.
In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treatment uses.” EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.” EPA’s announcement states that “the analysis showed that the data required to support registration could be substantially reduced and still be protective of human health.”
EPA developed two decision trees detailing the process for determining the residue chemistry field trial data requirements for seed-treatment uses: one for potato seed-piece (PSP) treatments only and another one for all remaining crops. EPA states that this case study demonstrates that application of the guidance set forth in these decision trees can, for both manufacturers and the agency, “potentially save considerable resources in terms of conducting, submitting, and reviewing the studies while still obtaining the data necessary to support seed-treatment pesticide registrations.”
The outlined procedure and memo document will supersede EPA’s previous guidance issued on October 28, 1999, entitled “Classification of Seed Treatments as Food or Nonfood Uses.”
More information is available on EPA’s Determining the Number of Field Trials Required to Register Seed-Treatment Uses webpage.
This announcement of improved review procedures allows EPA to cite both greater coordination across national borders (working with Canada), and reduce unnecessary data requirements. This would fit with the current Administration’s emphasis on reducing regulatory burdens and fostering greater innovation in regulated arenas. It also might be seen as general “good government,” as it updates guidance which is now almost twenty years old. Since seed treatment technology and associated policy issues have both evolved over the years, such a review and revision would seem timely regardless of any larger political directive.
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson
On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.
PR Notices are issued by the Office of Pesticide Programs (OPP). EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PRN 98-10 in a table. Those changes include:
In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:
- F. Product Composition: (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification. Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
- F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume. Under the proposed PR Notice, these terms were removed.
Minor Formulation Amendments
- A. Minor Formulation Amendments: (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
- A. Minor Formulation Amendments: (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review.
- A. Minor Formulation Amendments: (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product.
- Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
- Pet spot-on products;
- Change to an active ingredient source;
- Change to nominal concentration of the active ingredient; or
- Addition of new or additional Confidential Statements of Formula (CSF).
EPA Procedures to Review Notifications
Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same.
One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.
Registrants Submitting Minor Formulation Amendments
Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs. EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.
Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.
Registrants should review the draft PR Notice carefully, as it includes important changes. For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe. As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification. Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market. Comments on issues of concern should be considered.