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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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:

• First Aid Guidance Document -- EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.
• First Aid Guidance: Response to Public Comments on 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.

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:

1. 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.
2. 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.
3. 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.

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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.

Commentary

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.

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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.

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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:

Notifications

• 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;
  • Rodenticides;
  • 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.

Commentary

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.

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By Sheryl L. Dolan and Margaret R. Graham

On August 1, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus):

• EPA Microbiology Laboratory Branch (MLB) SOP MB-19:  Growing a Biofilm using the CDC Biofilm Reactor; and
• EPA MLB SOP MB-20:  Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm.

EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically Guidance for Testing the Efficacy of Antimicrobial Products Against Biofilms on Hard, Non-Porous Surfaces.  Drafts of the SOPs and the guidance were initially released in October 2016 for comment.  EPA received comments from nine entities and revised the drafts to incorporate suggested changes.  EPA posted its response to those comments in Docket EPA-HQ-OPP-2016-0357. 

EPA states that the two methods are adapted from ASTM International (ASTM) standard methods.  EPA MLB SOP MB-19 is used to generate the P. aeruginosa or S. aureus biofilm on coupons.  EPA MLB SOP MB-20, the Single Tube Method, then is used to determine the effectiveness of an antimicrobial product in reducing bacteria in biofilm on the coupons. 

Notable aspects of the test criteria and claims guidelines include:

• The mean log density for the test organisms of 8.0 to 9.5 for P. aeruginosa and 7.5 to 9.0 for S. aureus; and
• Product performance criterion of a minimum 6-log reduction.

The guidance lists several examples of claims for efficacy against public health biofilm that EPA states are acceptable.

EPA MLB SOP MB-20 is designed to evaluate the efficacy of antimicrobial products that are water soluble powders or liquid formulations.  If a company wishes to test a different type of product formulation, or test different target microorganisms, or make any other proposed modifications, it would be well advised to submit proposed alternatives to EPA for review and approval.  EPA specifically cautions that the current methodologies are intended for data development to support claims for products registered for use on hard, non-porous surfaces and are not suitable for use sites associated with water systems.

The EPA’s Office of Pesticide Programs’ (OPP) regulation of biofilms has been the subject of increasingly intense commercial interest for years and the availability of this testing guidance is welcome news.  While not all will agree with the approach, the new guidance is a helpful addition to OPP’s testing guidance portfolio.  

More information on antimicrobial pesticides is available on our blog under key phrase Antimicrobial Pesticide.  More information on the methods and guidance is available on EPA’s website and in Docket No. EPA-HQ-OPP-2016-0357.

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By Lynn L. Bergeson and Margaret R. Graham

In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities.  EPA uses an Annual Commitment System (ACS) to track annual regional performance information and results.  Below is a listing of the six programmatic activities and their ACS measures, if applicable:

1. Strengthening state and tribal partnerships through continued effective management of pesticide cooperative agreements.  The guidance states that the “National Pesticide Program depends on cooperative agreements with states and tribes to implement many of the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to help ensure [EPA’s] regulatory decisions and programs achieve intended protections.  For the ACS measure, the commitment target is 100 percent of pesticide program required activities included in grantee work plans completed under pesticide program portion of the FIFRA Grant Guidance.  More information on the activities is listed in the guidance.
2. Assisting in national, regional, and local pollinator protection efforts.  EPA states that “through risk assessment, mitigation, education, and outreach, EPA’s Office of Pesticides Programs’ goal for pollinator protection is to ensure all pollinators, including managed pollinators such as honey bees, and native pollinator including Monarch Butterflies, are protected from adverse effects of pesticide exposure.”  More information on the activities is listed in the guidance.  EPA is not proposing any ACS measures to be associated with this area of focus for FY2018-2019.
3. Effectively implementing the revised pesticides worker protection standard rule.  More information on this rule is available on our blog under key phrase Worker Protection Standard.  EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”
4. Effectively implementing the revised certification of pesticide applicators rule.  Same as above, EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”  More information on this rule is available on our blog under key phrase pesticide applicators.
5. Focusing region-specific pesticide priorities on those areas of greatest need nationally.  EPA states that region-specific pesticide priority areas “support the agency’s national pesticide program efforts. In addition, these projects support one or more of the agency’s Strategic Plan goals and strategies, and directly benefit states and/or tribes.  The region-specific pesticide priority areas to choose from are: (1) promotion of state and tribal pesticide program coordination and communication; (2) bed bug outreach and assistance; (3) promotion, development or support of integrated pest management efforts; (4) support of water quality risk assessment and mitigation; (5) spray drift outreach and incident data collection; and (6) support of emerging public health pesticide issues.  The ACS measure commitment target is one project or initiative contributing to the implementation and enhancement of the region-specific pesticide program priority areas.
6. Toxics Release Inventory (TRI).  For the TRI program, EPA includes three ACS measures on the number of TRI data quality checks:

• The TRI-1 measure allows EPA to track performance of the TRI program, and aid in improving the accuracy and reliability of environmental data.  This measure will provide valuable information as more than 21,000 facilities report to the TRI program annually.
• For FY2018, TRI-1 is a non-commitment measure of data quality calls and emails to 600 facilities in total across all regional offices.
• For FY2019, TRI-1 will be a commitment measure of data quality calls and email to 600 facilities in total across all regional offices.

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By Lynn L. Bergeson and Margaret R. Graham

In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.”  EPA has not yet issued any formal delay notifications. 

The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA (February 21, 2017, per the NASDA website) that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.”  This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision.  NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.”

The WPS final rule including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule – with the exception of two requirements that would be implemented not before January 2018.  More information on the final rule is available in our blog item EPA Publishes Worker Protection Standard Final Rule.

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By Margaret R. Graham

On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final.  This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century.

OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.”  Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”

More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.

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By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments.  EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance.  The two test methods are:

• Single Tube Method with Splashguard for Evaluating Disinfectant Activity against Pseudomonas Biofilm -- 2015 Method Performance Study; and
• Proposed Procedure:  EPA MLB SOP MB-20: Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm.

The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.

The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.”  EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals.  In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.” 

The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims.  The examples of acceptable label claims against public health biofilms are:

1. Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
2. Kills a minimum of 99.9999% of bacteria* in biofilm;
3. Reduces at least 99.9999% of bacteria* growing in biofilm;
4. Formulated to kill 99.9999% of bacteria* in biofilm;
5. Other related claims:

• Kills biofilm bacteria*; and
• Penetrates biofilm, killing the bacteria* living there.

*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].

Examples of acceptable non-public health claims supported by appropriate efficacy data include:

• Slimicide;
• Cleans away microorganism slime/grunge;
• Maintains control of slime; and
• Controls slime-forming microorganisms.

Comments will be accepted until December 5, 2016.

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