Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees.” FDA announced the fee rates on December 29, 2020. 85 Fed. Reg. 85646. According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 -- an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pandemic.
According to the complete HHS statement, posted by the Distilled Spirits Council, FDA’s March 2020 guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), “contains no discussion regarding user fees or any indication such fees would be due by these entities, many of which would be entering the drug manufacturing business for the first time.” HHS states that FDA’s action “was not cleared by HHS leadership, who only learned of it through media reports.” The HHS Office of the General Counsel (OGC) reviewed the matter and “determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule. Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19.” Because HHS OGC has determined the FDA’s notice is a legislative rule and that no one at FDA has been delegated authority to issue such a rule, HHS states that the notice is void. HHS leadership, based on the legal opinion, has ordered FDA’s Federal Register notice to be withdrawn, “meaning these surprise user fees will not need to be paid.”
The decision comes as a huge relief to businesses far beyond the distillery industry. FDA is to be commended for ensuring well-intended businesses that redeployed their infrastructure for all the right reasons were not inadvertently penalized for stepping up.
EPA Announces New Policy for Registrants Voluntarily to Disclose Inert Ingredients in Antimicrobial Products
On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry.
Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy:
EPA states that it will allow registrants to use alternate nomenclature to disclose inert ingredients. This policy is effective as of January 16, 2021.
EPA states that there is no statutory or regulatory requirement to identify inert ingredients in the ingredient statement, except when EPA determines that such inert ingredients may pose a hazard to humans or the environment. EPA states that if EPA determines an inert ingredient may pose a hazard, EPA may determine that the name of the inert ingredient must be listed in the ingredient statement on a case-by-case basis for either risk-based or hazard-based reasons. Examples include the following ingredients:
EPA’s long-standing policy, as stated in its Label Review Manual, has been that “if a registrant wants to list a particular inert ingredient in the ingredient statement, the registrant should list all inert ingredients directly below the ingredient statement in descending order by weight. A partial listing on the label could be misleading.” EPA’s new policy applies to voluntary identification of inert ingredients using alternate nomenclature and not to cases where EPA directs registrants to list particular inert ingredients because of risk-based or hazard-based reasons.
EPA states that beginning December 15, 2020, the Office of Pesticide Programs (OPP) will review antimicrobial pesticide applications for voluntary inert ingredient disclosure. Under this new process, EPA states that if a registrant chooses to utilize alternate chemical nomenclature on its product labeling, the registrant must resubmit the Confidential Statement of Formula (CSF) containing the inert ingredient as approved on the existing formulation as well as the alternate chemical nomenclature. EPA requires that a “crosswalk” between the approved nomenclature of the CSF and the alternate nomenclature be provided with the registrants’ non-Pesticide Registration Improvement Extension Act (PRIA 4) application, which will fall under a 90-day review.
If registrants choose to use alternate nomenclature, EPA encourages using the following sources:
If a registrant chooses to disclose voluntarily inert ingredients on the label, the registrant should list all of the inert ingredients directly below the ingredient statement in descending order by weight, so that the list does not interfere with the required labeling information. If space is limited, however, to avoid crowding of required labeling information, a referral statement may be used directing the reader to the back or side panel for the full list of inert ingredients in descending order by weight. The referral statement should be placed directly below the ingredient statement with an asterisk or some other equivalent symbol connecting the “Inert Ingredients” or “Other Ingredients” heading in the ingredient statement with the full list of inert ingredients placed on the back or side panel of the label. For example, an acceptable referral statement is “*See back panel for complete inert ingredient statement,” and acceptable corresponding text on the back panel is “*Inert Ingredients: Inert A, Inert B., etc.”
When registrants choose to add a website address or quick response (QR) code to their labeling that leads to inert ingredient information, EPA asks that registrants, in a cover letter transmitting the labeling amendment application, self-certify that the inert ingredient information provided on the registrant’s website(s) and in other marketing materials is consistent with the information provided on the latest approved CSF.
EPA states that registrants do not need to amend its their master label or notify EPA before adding an inert ingredient statement to a website, provided that the site is not referenced on the product label. In such cases, the application process outlined below does not apply.
EPA states that no other actions should be included with inert ingredient disclosure applications. The following information is required to be included in the application:
According to EPA, the scope of this policy is currently limited to antimicrobial pesticide products. EPA states that it may consider expanding to conventional pesticide and biopesticide products in the future.
Additional information is available here.
EPA Issues Proposed Interim Registration Review Decision to Require New Risk Mitigation Measures for Chlorpyrifos
On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos. 85 Fed. Reg. 78849. EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments. The PID proposes the following measures:
EPA states that the PID presents proposed mitigation with the 10-fold (10x) Food Quality Protection Act (FQPA) safety factor, reflecting the uncertainties around doses that may cause pre- and post-natal neurodevelopmental effects. Under FQPA, EPA evaluates new and existing pesticides to ensure they can be used with a reasonable certainty of no harm to infants, children, and adults. EPA is required to consider the special susceptibility of children to pesticides by using an additional 10x safety factor unless adequate data are available to support a different factor. EPA additionally included a FQPA factor of 1x to reflect the range of potential risk estimates of chlorpyrifos, as illustrated in the September 2020 draft risk assessments.
Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021. EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments. Comments can be submitted at EPA-HQ-OPP-2008-0850.
EPA announced that it will also consider the input and recommendations from the September 2020 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting once it releases its report in December 2020. Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment.
The inclusion of both 1x and 10x calculations for the appropriate FQPA safety factor is unusual. EPA states the final decision on the appropriate FQPA safety factor is partly dependent on any recommendations expected from the SAP meeting, which reviewed the “use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.” This is part of a larger and longer evaluation of whether test methods that avoid using test animals can reliably substitute for current test guideline requirements, that is, whether it is appropriate to rely on in vitro test protocols to substitute for current in vivo testing protocols.
EPA’s articulation at this point in time of mitigation needed if the FQPA 10x safety factor is retained may indicate a prediction about the SAP’s likely recommendations. It will be important to monitor developments on this issue closely.
EPA Announces Annual Pesticide Maintenance Fee Forms Available to Download from EPA Website -- Deadline for Paying Is January 15, 2021
The January 15, 2021, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental registrations of distributors, which are identified by a three-element registration number.
The fee for 2021 is $4,000 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Friday, January 15, 2021. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.
For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:
There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.
More information on the annual maintenance fees is available on EPA’s website.
EPA Seeks Comments on Updated Draft Guidance for Pesticide Registrants on Plant Regulators and Claims, Including Plant Biostimulants
On November 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of, and requested comments on, the updated Draft Guidance for Plant Regulator Products and Claims, Including Plant Biostimulants (Draft Guidance). The original Draft Guidance (2019 Draft Guidance) was made available on March 27, 2019. EPA states that the updated Draft Guidance “incorporates diverse and helpful changes made in response to stakeholder feedback” received during the initial comment period in 2019 and “clarifies which biostimulants, biological substances, and mixtures, in addition to the associated product label claims, EPA considers plant regulators.”
EPA is now seeking comments on those changes. Comments on the updated Draft Guidance are due on or before December 30, 2020, in docket EPA-HQ-OPP-2018-0258. 85 Fed. Reg. 76562. EPA states that it anticipates issuing the Draft Guidance in final form in January 2021.
Updates to the Draft Guidance
EPA made several changes to the Draft Guidance. Of note, the Disclaimer section of the Draft Guidance EPA now states that the “contents of this document do not have the force and effect of law and are not meant to bind the public in any way.” It states further that the “document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.”
Additional changes of interest to the updated Draft Guidance include:
In the “Claims Examples” section, EPA further adds the following sentences:
The removal of Table 4 from the Draft Guidance appears to address comments submitted on the 2019 Draft Guidance that criticized EPA for developing a list of active ingredients that would trigger pesticide registration requirements when several of those substances possessed non-pesticidal modes of action. Interestingly, many of the significant proposed changes address issues related to composition and to substances and products with plant regulator and non-plant regulator modes of action, rather than claims. Also of note is EPA’s current intent not to initiate a rulemaking to define plant biostimulant, but instead to rely upon definitions developed by USDA and under review by Congress.
There are a significant number of issues of interest, and those with potentially affected products should review the updated guidance closely.
On November 16, 2020, the U.S. Environmental Protection Agency (EPA) announced that it will now provide pesticide registrants with electronic Certificates of Registration, commonly known as “Gold Seal” letters. A Gold Seal letter from EPA certifies that a product to be exported is registered with EPA and meets all necessary registration requirements. EPA states that this improved process will allow for the electronic Gold Seal letters to be e-mailed to registrants rather than physically mailed.
Under the new process, a company must submit a written request to EPA, identifying the company name, the EPA Registration Number at issue, and the country to which the product will be exported. The Pesticide Registration Improvement Extension Act (PRIA 4) category is M006 and will cover up to five Gold Seal letters for one product with a one-month decision time. The fee for fiscal year 2020-2021 is $291. EPA states that because the fee is low and EPA’s timeframe to respond is short, this category is not eligible for small business waivers. EPA also clarifies that distributor products are not eligible for Gold Seal letters.
Information on how to request a Gold Seal letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.
This announcement is a welcome improvement to the existing process, providing a key flexibility during the COVID-19 public health emergency. EPA expects to transition permanently to this digital process, which it notes allows for faster processing, better tracking, and greater consistency.
On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19: Herbs and Spices Group.” 85 Fed. Reg. 70976. The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4). EPA received comments from eight entities and revised the original proposed rule in response to those comments.
The major components of the new rule are a revision of the commodity definition for marjoram; the addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19: Herbs and Spices Group” with two new expanded crop groups, “Crop Group 25: Herb Group” and “Crop Group 26: Spice Group.” Recognizing that the existing combined Crop Group 19 Herbs and Spices Group limited the establishment of crop group tolerances, EPA created the two new separate crop groups to benefit herb and spice growers. EPA states that the anticipated economic benefit of the new crop groups is estimated to be a cost savings of $51.8 million annually.
The crop groups in the final rule include even more commodities than those listed in the proposal. Crop Group 25 includes 418 herb commodities directly and 25 indirectly through the modification of the definition of edible flowers in 40 C.F.R. Section 180.1. Crop Group 26 includes 205 spice commodities. The final rule specifies all commodities in the new crop groups and the subgroups therein (i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup. The effective date of the final rule is January 5, 2021.
On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment. 85 Fed. Reg. 70146.
EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance. According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations, when making decisions and plans about future public health actions.
Since this list’s original publication in 2002, new vector-borne diseases have been identified and pests that had been previously thought of as benign or nuisance pests have been found to impact adversely public health. EPA, CDC, and USDA collaborated to update the list to incorporate significant changes regarding vector-borne diseases and related research, and eliminate gaps or ambiguities in the current pests list.
EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2) and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider).
Draft PR Notice 2020-X describes the groups of pests and their potential impact on public health as follows:
The complete list of pests is identified in draft PR Notice 2020-X in Appendix A.
EPA states that the list does not affect the regulatory status of any registration or application for registration of any pesticide product.
Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.
EPA Requests Comments on Its Proposal to Add Chitosan to Minimum Risk Pesticide Active Ingredient List
On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b). 85 Fed. Reg. 69307.
The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption. EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA). EPA states that no comments were submitted on that notice by USDA or any other person. EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.” On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.
EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.” According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan. Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.
Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701. EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.
Additional information on chitosan is available on our blog.
EPA Announces the Issuance of an Advisory on UV Lights That Claim to Kill or Be Effective against Viruses and Bacteria
On October 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria.
EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices when sold or distributed with claims to kill or be otherwise effective against viruses and/or bacteria, unless an exception applies, and must comply with certain statutory and regulatory requirements. This is the second Compliance Advisory issued by EPA relating to UV light devices, as an Advisory issued in May 2020 entitled “What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19” also addressed in part whether UV light devices could make claims against the coronavirus.
The Advisory reiterates that UV lights sold or distributed with claims that the lights can be used for preventing, destroying, repelling, trapping, or mitigating any pests, which include plants, animals, viruses, bacteria, or other micro-organisms, are regulated by EPA under FIFRA as a device. UV lights without such claims would not be subject to FIFRA. According to the Advisory, pesticidal devices are subject to certain regulatory requirements under FIFRA, one of which is a prohibition of false or misleading labeling claims.
The Advisory answers the following questions:
UV light devices are a heightened focus of EPA, whose import and enforcement officials have been reviewing materials (e.g., import documents, websites) related to devices and increasingly bringing enforcement actions against companies for FIFRA violations. These actions can address circumstances when a pesticide device is not produced in a registered establishment or when the label does not include certain requirement elements, but more recently EPA seems particularly interested in the claims that are being made with regard to these devices and whether those claims are “false and misleading” under EPA’s regulations.
Ensuring that claims related to the efficacy of the device are not considered by EPA to be “false and misleading” can be especially difficult based on the facts that EPA does not review and approve data that support the claims being made, and also that EPA has not historically provided guidance as to the type of data that it would require to support an efficacy claim for a pesticide device. This Advisory is interesting to the extent that EPA sets forth various factors to be considered when determining the effectiveness of a UV light device. These factors include, but are not limited to “the device’s duration of use, distance of the light from the surface intended to be treated, the UV wavelength, the specific pest being targeted, the strength or wattage of the UV light bulb, the age of the UV light bulb, shadow areas or other factors.” The May 2020 Advisory further states that “UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.” (Emphasis in original.) In light of the two advisories, it is critical for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.
On October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.” According to EPA, the targeted changes improve the enforceability and workability of the AEZ requirements, decrease regulatory burdens for farmers, and maintain critical worker protections. EPA also states the revisions made to the AEZ are consistent with the 2018 Pesticide Registration Improvement Extension Act of 2018 (PRIA 4).
The final AEZ requirements will go into effect on December 29, 2020.
EPA initially promulgated the WPS regulation in 1992 under EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorities to protect farm workers from pesticide exposures in production agriculture. According to EPA, “WPS is a uniform set of requirements for workers, handlers, and their employers that are generally applicable to all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its requirements complement the product-specific labeling restrictions and are intended to minimize occupational exposures generally.”
In 2015, EPA issued significant revisions to the 1992 WPS. Of particular significance, 2015 revisions included a new provision requiring agricultural employers to keep workers and all other individuals out of the AEZ during outdoor pesticide applications. The AEZ was set at 25 feet in all directions for ground pesticide applications when sprayed from a height greater than 12 inches, and 100 feet in all directions for outdoor aerial, air blast, air-propelled, fumigant, smoke, mist, and fog pesticide applications. This provision was controversial, however, with state regulators expressing concerns with enforcing the complex AEZ requirements and farm owners expressing concerns with applying and complying with pesticide regulations.
EPA states in the final rule that it clarified and simplified the AEZ requirements based in part on input from state pesticide regulatory agencies and agricultural stakeholders after the adoption of the 2015 WPS rule. Consistent with PRIA 4, EPA is implementing changes related only to the AEZ requirements in the WPS. These targeted changes include:
EPA states that many of the changes proposed in November 2019 were retained in the final rule. Changes that were made include the following:
On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report). 85 Fed. Reg. 68327. Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before December 28, 2020.
EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions. The table below details the actions completed in FY 2018.
Table 1. Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)
EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has been more consistent in recent years, with 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.
On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses. This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes COVID-19. While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied.
EPA announced in an October 26, 2020, memorandum that it is seeking feedback from the public on the expedited process, design elements for evaluating residual product claims, and the test methods associated with this initiative.
All comments on the interim guidance must be submitted to Docket Number EPA-HQ-OPP-2020-0529 on or before January 4, 2021.
The interim guidance documents -- Interim Method for Evaluating the Efficacy of Antimicrobial Surface Coatings, Interim Guidance - Expedited Review for Products Adding Residual Efficacy Claims, and Interim Method for the Evaluation of Bacterial Activity of Hard, Non-Porous Copper-Containing Surface Products -- are available in Docket Number EPA-HQ-OPP-2020-0529. More information on the interim guidance is available on our blog.
On October 15, 2020, the U.S. Environmental Protection Agency (EPA) announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver. Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of Arrival in violation of FIFRA Section 12(a)(2)(N). As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400. The Consent Agreement and Final Order (CAFO) is available here.
According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims. With regard to the incorporation of nanosilver, there currently are no nanosilver pesticide products registered with EPA for use in home appliances to disinfect the ambient air or protect the health of the user. The only nanosilver pesticides that are currently registered with EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration, or odors. In those cases, the products (textiles) incorporated with nanosilver can be exempt from FIFRA registration under the “treated article” exemption. With regard to the claims, EPA states that claims it considers pesticidal include “antibacterial filter,” and “helps eliminate bacteria in the air that can make breathing difficult.”
The penalty in this case is significant, and represents a potentially growing trend for penalty amounts substantially higher than past cases. This trend is due at least in part to the inflation adjustments to statutory civil penalty amounts, as discussed further here.
In addition to the civil penalty, the CAFO states that Electrolux has replaced the filters manufactured with nanosilver and removed the online and on-box pesticidal claims for the products it had imported, as well as some additional products already in the United States. The CAFO states:
The CAFO further states that “Respondent offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver within its possession regardless of the date those products were imported.” To date, EPA states that Electrolux has brought over 500,000 air conditioners and dehumidifiers into compliance.
On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. EPA’s guidance specifies scientific testing requirements for two different types of products: (1) disinfectants that also provide residual efficacy, and (2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard List N disinfectants.
In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. These laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.
While EPA does not have an approved standard method to support virus claims for these types of products, EPA states that the following information is intended to provide interim guidance on the study design elements necessary to support these types of claims. EPA states that it may consider other methods or studies to support residual efficacy claims, provided they are scientifically sound. Applicants are highly encouraged to consult with EPA prior to submitting. Of significant interest, EPA states that products may make both types of residual claims provided that they are supported by the appropriate data.
Due to lab capacity concerns, EPA plans to consider non-GLP (Good Laboratory Practice) data to support residual claims, provided that the study submission accurately represents how the study differs from the GLP standards in the 40 C.F.R. Section 160.12 statement of non-compliance. Additional details provided in the EPA guidance on how to qualify products for residual disinfectants or supplemental residual antimicrobial products are briefly outlined below.
Residual Disinfectant Claims
Residual disinfectants must clear a higher standard of efficacy than supplemental residual antimicrobial products. Residual disinfectant products must be effective within 10 minutes of a virus or bacteria contacting a treated surface and must remain effective for up to 24 hours. Surfaces treated with residual disinfectants must not require additional cleaning or disinfection during this window. EPA-approved residual disinfectant products are eligible to be added to List N. In addition, long-lasting coating products must satisfy all requirements for standard disinfectant claims (non-residual) to be eligible for residual disinfectant claims and must have undergone testing to support standard disinfectant claims.
To support a claim as a residual bactericidal disinfectant, applicants should use EPA’s Residual Self-Sanitization Protocol with the following modifications:
EPA’s Residual Self-Sanitization Protocol with the modifications below should be used to support residual virucidal claims. Virucidal efficacy should be assessed consistent with the principles of ASTM E1053 (e.g., recovery, cytotoxicity, neutralization, and calculations), the standard virucidal method detailed in OCSPP 810.2200 Product Performance Test Guideline.
Supplemental Residual Antimicrobial Products
Supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years. These products can supplement, but not replace, routine cleaning and disinfection using products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19). Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but will be added to a separate List N appendix.
Qualifying antimicrobial surface coatings, films, fixed/solid, and paint products should demonstrate efficacy against vegetative bacteria first before virus claims can be supported. These products are not required to meet the efficacy standards for disinfectants and can only be approved for use as supplements to standard disinfection. The duration of residual effectiveness claims that EPA will consider for expedited review depends on the type of product, as outlined below.
For these products, EPA states that EPA’s draft Performance of Antimicrobial Surface Coatings on Hard Non-porous Surfaces for qualifying bacteria should be used. EPA provides the following additional information for products on which virus claims would be added:
EPA states that this new category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces. EPA provides the following additional information:
EPA states that these products should use EPA’s Draft Copper Surface Protocol for qualifying bacteria. EPA provides the following additional information for products that wish to have virus claims added.
EPA states that these products should be labeled as supplemental residual antimicrobial surfaces. EPA states the following with regard to these products:
EPA intends to require, as a term of registration, that registrants of all supplemental residual antimicrobial products prepare and implement a written stewardship plan designed to support the responsible use of supplemental residual coatings and antimicrobial surface products. Unlike conventional antimicrobial products, EPA believes that these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices. EPA expects that plans would be submitted for EPA review and approval during the registration process, or shortly thereafter (e.g., within two months after the registration date). An approvable plan would address the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products. EPA states that plans should include, at a minimum, the following elements:
EPA states further that “if EPA determines at any time following registration that the Plan is not being adequately or timely implemented or does not effectively ensure the product’s safe and effective use, the registration may be cancelled by the Agency.” It is not clear from the statement whether EPA intends such a cancellation to be a term of the registration or whether it would be undertaken pursuant to the standard FIFRA cancellation procedures.