By Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
By Margaret R. Graham
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, Virginia, in the lobby-level Conference Center. EPA’s draft agenda for the PPDC meeting has been posted to the PPDC website.
The PPDC meeting agenda lists the following seven sessions:
- Pesticide Registration Improvement Act (PRIA) -- session goal is to “provide the PPDC with an update on EPA’s progress in implementing PRIA”;
- Smart Label Project/e-CSF -- session goal is to “provide the PPDC with an overview the electronic pesticide label, the benefits to EPA and stakeholders, and next steps”;
- Emerging Application Technologies -- session goal is “to inform the PPDC about how new unmanned aerial vehicle (UAV) technology is working in the field for pesticide applications and how this new technology may benefit the agricultural sector”;
- Benefits of Biological Products: Industry Perspective -- session goal is to explain “BPPD’s focus on low risk products and biopesticides, how EPA encourages low risk products by having a different division and registration timelines and costs” and “how pesticides, whether conventional or biological, are reviewed with rigor and held to the same safety standard”;
- Integrated Mosquito Management Training -- session goal is to “provide awareness of on-line training and manual (in English and Spanish) focusing on Integrated Mosquito Management created by AMCA with funding by the Centers for Disease Control and Prevention”;
- Public Health Workgroup -- session goal is to “report on the progress of the group’s Emergency Preparedness Plan and solicit feedback”; and
- 21st Century Toxicology: OPP’s Efforts on Non-Animal Alternative Testing for the Acute 6-Pack -- session goal is to “update the PPDC on OPP’s recent progress toward the reduction of animal use in testing, and the implementation of alternative methods.”
Nancy Beck, Ph.D., Deputy Assistant Administrator of the Office of Chemical Safety and Pollution Prevention and Richard Keigwin, OPP Director, will make the opening remarks. After the sessions, EPA is providing a 15-minute window for public comments. PPDC meetings are free, open to the public, and no advance registration is required.
By Susan M. Kirsch
On April 12, 2018, House Agriculture Committee Chairman Michael Conaway (R-Texas) released the Committee’s draft Farm Bill reauthorization, the “Agriculture and Nutrition Act of 2018” (H.R. 2). The House Agriculture Committee passed the Farm Bill package on April 18, 2018, setting it up for a floor vote in the House. The 600-plus page draft legislation includes a number of provisions that will be of interest to pesticide registrants and the pesticide user community, including the following sections:
- Section 9119. Enactment of Pesticide Registration Improvement Act of 2017: This provision would enact the Pesticide Registration Improvement Extension Act (known as PRIA-4), which authorizes the U.S. Environmental Protection Agency (EPA) to continue to collect $40 million in registration and maintenance fees critical to supporting the pesticide registration process.
- Section 8303. Consultation under the Endangered Species Act (ESA): Subsection (a) would eliminate ESA Section 7 consultation requirements for U.S. Forest Service projects where a “not likely to adversely affect” determination has been made. Subsection (b) requires ESA Section 7 consultation for forest management activities carried out under the Farm Bill to be completed within a 90-day period.
- Sections 9117 and 9118. Clean Water Act (CWA) Pesticide Permitting: Together these two provisions amend the CWA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to eliminate CWA National Pollutant Discharge Elimination System (NPDES) permitting for FIFRA-compliant pesticide applications. These sections incorporate the regulatory relief language from previously proposed stand-alone bills aimed at eliminating the dual regulation of pesticide applications into, over, and near surface waters, which passed the House in the 115th Congress (H.R. 953) and has been proposed in the Senate (S.340).
The full text of H.R. 2 and a section-by-section summary are available on the House Agriculture Committee Farm Bill webpage along with several related fact sheets. The Agriculture Committee expects to mark-up the bill this week.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
On March 6, 2018, the U.S. Environmental Protection Agency (EPA) issued a proposed rule (pre-publication version available here) to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations (Title 40 of the C.F.R., Part 273), entitled Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations. EPA cites as authority for this change Sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by RCRA, as amended by the Hazardous and Solid Waste Amendments Act (HSWA). EPA states the streamlined Universal Waste regulations are expected to:
- Ease regulatory burdens on retail stores and other establishments that discard aerosol cans by providing a clean, protective system for managing discarded aerosol cans;
- Promote the collection and recycling of aerosol cans;
- Encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors; and
- Result in an annual cost savings of $3.0 million to $63.3 million.
As aerosol cans are “widely used for dispensing a broad range of products” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans. Hazardous waste aerosol cans that contain pesticides are also subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements, including compliance with the instructions on the product label. Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide product products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans. The proposed rule states:
- EPA issued a determination that puncturing aerosol pesticide containers is consistent with the purposes of FIFRA and is therefore lawful pursuant to FIFRA section 2(ee)(6) provided that the following conditions are met:
- The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
- The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof; and
- The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
- EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the universal waste rules.
Comments will be due 60 days after the proposed rule’s publication in the Federal Register.
By Heather F. Collins, M.S. and Margaret R. Graham
On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines. The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests. 83 Fed. Reg. 8666. The three final guidelines are:
EPA states these “test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions.”
EPA issued draft guidelines in June 2015 and solicited comments. EPA states that some comments received on those draft guidelines have been incorporated into the final versions. EPA states that the revision “is more user friendly and clarifies topics such as confirmatory data, repeat testing, hard water formulation, wetness determination testing for towelettes, and internal toilet testing … [and] also includes information on supplemental testing policies such as lower certified limits, revision of the AOAC Use Dilution Method performance standards and clarified technical details for efficacy testing.”
Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov, in Docket No. EPA-HQ-OPP-2015-0276. More information on test guidelines is available on our blog.
By Lisa M. Campbell and Lisa R. Burchi
On February 14, 2018, the U.S. Environmental Protection Agency (EPA) and Amazon Services LLC (Amazon) entered into a Consent Agreement and Final Order (CAFO) whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately four thousand alleged violations under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the distribution of unregistered pesticide products. Amazon neither admitted nor denied the specific factual allegations, which included:
- Between January 1, 2013, and November 1, 2015, Amazon distributed, held for distribution, held for shipment, or shipped two unregistered pesticide products called “3pcs Cockroach Cockroaches Bugs Ants Roach Kills Chalk”; and “Miraculous Insecticide Chalk” on multiple occasions in the United States.
- Between January 1, 2013, and March 1, 2016, Amazon distributed, held for distribution, held for shipment, or shipped three unregistered pesticide products called “HUA Highly Effective Cockroach Killer Bait Powder”; “R.B.T.Z. Safe Highly Effective Roach Killer Bait Powder Indoor”; “HUA Highly Effective Fly Killing Bait Powder”; and “Ars Mat 60 pcs. Refil for ARS Electric Mosquito Killer Convenient, Clean & Smokeless” on multiple occasions in the United States.
Amazon also agreed to implement a supplemental environmental project (SEP) consisting of the development, deployment, and operation of a publicly available eLearning course, downloadable educational materials, and test on FIFRA requirements and associated regulations (eLearning Project). Although no monetary amount was specified for the implementation of the SEP, the eLearning Project will be a significant undertaking, as the materials will be available in three languages (English, Spanish, and Chinese) and Amazon will require all of its Amazon.com sellers to complete the eLeaming course and pass an associated test prior to allowing such Amazon.com sellers to sell products identified as pesticides. The only circumstance when this requirement will not apply to Amazon.com sellers is when a seller can “demonstrate that the seller's existing compliance program is sufficient to ensure products sold via Amazon.com comply with FIFRA.”
More information on FIFRA enforcement issues is available on our blog under key word enforcement.
By Lynn L. Bergeson and Sheryl Lindros Dolan
On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology. The notice was published in the Federal Register on October 5, 2017. 82 Fed. Reg. 46500. Guidance for Industry #236, “Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products” (Guidance), provides information for industry and other stakeholders regarding the regulatory oversight of articles, including substances, for use in or on mosquitoes (mosquito-related products). FDA states that it is providing the Guidance to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other circumstances under which such products are regulated by EPA as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Scope of Guidance
FDA notes that the Guidance is important in light of the public health urgency of countering the spread of mosquito-borne disease such as that caused by the Zika virus. While novel mosquito control technologies have gained greater attention, there has been confusion regarding FDA and EPA jurisdiction over such products. FDA, working collaboratively with EPA, is providing the Guidance to clarify the regulatory oversight of mosquito-related products. This includes, but is not limited to, those produced through biotechnology.
The Guidance includes the following examples of new animal drugs regulated by FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans; and
- Products intended to prevent mosquito-borne disease in humans or animals.
Examples of pesticide products regulated by EPA are “[p]roducts intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development).”
Guidance for Sponsors/Manufacturers of Products Intended for use on Mosquitoes
In the Guidance, FDA encourages sponsors of mosquito-related products, other than those that are “intended to prevent, destroy, repel, or mitigate mosquitoes by controlling a mosquito population,” to contact FDA early in the development process. FDA states that if a developer has a jurisdictional question, such as which agency or agencies would have oversight of a mosquito-related product that is expressly intended for both mosquito population control and human disease suppression, the developer may contact either or both agencies via the contacts listed. FDA and EPA will consult with each other on the jurisdictional question, “as is already common practice.” The agencies may suggest a joint meeting among EPA, FDA, and the sponsor to discuss appropriate pathways to market.
The guidance notes that FDA, EPA, and the U.S. Department of Agriculture (USDA) have committed to clarifying how the federal government intends to regulate genetically engineered insects as described in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products. More information on the National Strategy is available in our September 21, 2016, memorandum White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products.
The new FDA guidance states that products intended to prevent mosquito-borne disease in humans or animals are regulated as new animal drugs subject to FDA jurisdiction, but products intended to control mosquito populations would be regulated by EPA as pesticides. That FDA and EPA are attempting to clarify their respective jurisdictions is appreciated. Potential commenters may wish to consider whether the guidance offers sufficient clarity for product development planning purposes. If “products intended to prevent mosquito-borne disease in humans or animals” are under FDA jurisdiction, the status of mosquito repellents currently registered by EPA that make claims about repelling mosquitoes that carry the Zika virus, the West Nile virus, or other viruses is unclear. Additionally, it would seem that the Oxitec mosquito is intended to reduce the mosquito population, among other goals. The Guidance is a good start, but further clarification likely will be needed to support emerging technologies.
More information is available in our memorandum FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products.
By Sheryl Lindros Dolan and Heather F. Collins, M.S.
On September 29, 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 antimicrobials against spores of Clostridium difficile (C. diff):
EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically “Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium difficile on Hard Non-Porous Surfaces.” EPA states that these test methods and guidance “provide a framework for registrants who seek to make a claim for antimicrobial pesticide products to control C. difficile spores on hard, non-porous surfaces.”
C. diff is an anaerobic, spore-forming bacterium and a frequent cause of hospital-acquired infections. The spores survive on hard surfaces such as glass, metals, and plastics that are commonly found in health-care settings. Hospitals and other health care facilities often use antimicrobial pesticides to reduce the number of spores on environmental surfaces. Registrants seeking antimicrobial product registrations with claims to control C. diff will need to carefully review these documents as they consider the efficacy data that EPA will likely require to support these claims, as well as the claims that can be made and supported for these products.
EPA MLB SOP MB-28 describes the test methodology for producing and storing standardized spore suspensions of C. diff based on ASTM E2839, Standard Test Method for Production of C. difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents (ASTM International). A spore suspension should be developed and qualified according to EPA MLB SOP MB-28 before an efficacy evaluation can be performed using method EPA MLB SOP MB-31. EPA MLB SOP MB-31 describes a quantitative method intended for evaluating the sporicidal efficacy of liquid disinfectants against spores of C. diff on inanimate, hard, non-porous surfaces.
EPA solicited comments on the clarity of the test method SOPs and the regulatory guidance in December 2016. EPA received comments from 12 entities. The primary areas of comment included the following:
- Test carrier interaction;
- Additional method validation;
- Verification testing;
- Soil load;
- Use of a standard setting organization to publish test methods;
- Proposed revisions to the guidance document; and
- Proposed revisions to the standard operating procedures.
EPA revised the drafts to incorporate suggested changes. EPA posted its response to those comments in Docket No. EPA-HQ-OPP-2016-0753-0026.
Some of the changes to the guidance document based on submitted comments include clarifying:
- Three batches of test product should be tested on independent test days;
- The inclusion of the three-part soil load is used for all test, control, and test system control carriers; and
- The current document supersedes the previous 2014 guidance document.
The new guidance proposes updated standard label claims and special instructions that are intended to provide greater clarity to the user community.
EPA’s response to comments and other documents associated with this action are available in Docket No. EPA-HQ-OPP-2016-0753 at www.regulations.gov. The methods and guidance also are found on EPA’s Antimicrobial Testing Methods & Procedures Developed by EPA's Microbiology Laboratory webpage, at the Methods tab as Method IDs MB-28 and MB-31, and at the Guidance tab as Sporicidal Claims Against Clostridium difficile.
C. diff is widely recognized as one of the most common causes of healthcare-acquired infection. C. diff infections, spread by transmission of bacterial spores, have proven difficult to prevent. EPA’s new guidance and test methods are intended to clarify the efficacy standards that pesticide products claiming to reduce C. diff spores must meet, as well as the associated claims that can be made. This guidance should bring more clarity to pesticide registrants seeking to register such products and to healthcare facilities in their identification of registered pesticide products that may help them to reduce C. diff spores and thus help with prevention efforts.
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 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.
By Jason E. Johnston, M.S.
On May 31, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of its Food Contact Sanitizing Solutions Model (FCSSM), a pesticide risk assessment model that has been developed to “estimate indirect dietary exposure to components of sanitizing solutions used in commercial settings.” EPA states that “the model offers guidance for estimating exposure where there may be inadvertent transfer of residue to edible items prepared or transported on surfaces treated with these pesticides.” The model consists of spreadsheets that automatically calculate dietary exposure and risk estimates based on data entered by the user. The model estimates exposures to antimicrobial active ingredients listed under 40 C.F.R. § 180.940(b) and 40 C.F.R. § 180.940(c), where 940(b) includes uses in dairy processing equipment and food processing equipment and utensils, while 940(c) excludes dairy processing equipment. FCSSM does not apply to active ingredients listed under 40 C.F.R. § 180.940(a), which are used on food contact surfaces in public eating places as well as dairy and food processing equipment. For this case, EPA’s established methodology remains in place. Compared to the simple calculation method used previously for these use scenarios, the major new feature of the FCSSM is the separate calculations of both acute and chronic dietary exposures for the general U.S. population and eight subpopulations. EPA also released a user guide that provides background information on the model and familiarizes users with the inputs required to run the model.
More information about the FCSSM as well as other models used for pesticide risk assessments is available on EPA’s website.