By Lynn L. Bergeson and Carla N. Hutton

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  HHS leadership, based on the legal opinion, has ordered FDA’s Federal Register notice to be withdrawn, “meaning these surprise user fees will not need to be paid.”

Commentary

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.

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

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:

• On the product label as part of the full ingredient statement or on the product’s back or side panel with a referral to the full ingredient statement;
• On a website referenced on the product label; or
• On a website that is not directly linked to the product label.

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:

• Petroleum distillates, xylene, or xylene range aromatic solvents > 10%;
• Sodium nitrate > 0.1%; or
• Inert ingredients of toxicological concern (formerly known as “List 1 Inerts”).

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:

• EPA Inerts List;
• International Union of Pure and Applied Chemistry (IUPAC);
• Chemical Abstracts Service (CAS); or
• Consumer Product Ingredient Database Directory.

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:

• Applications to add alternate nomenclature to the label must:
  • Crosswalk link the current CSF nomenclature to any alternate nomenclature as confirmation that the current CSF nomenclature and alternate nomenclature are synonyms of each other (the exact same inert ingredient).  EPA provides a template spreadsheet for the alternate nomenclature crosswalk to link the current CSF nomenclature to any alternate inert ingredient nomenclature.
  • Identify in the cover letter the proposed changes to the alternate nomenclature on product labels and CSFs, the revised CSF (which includes the current and alternate nomenclature) and master label with changes highlighted.
  • For applications to add currently approved nomenclature to the label registrants should include with the application a cover letter identifying the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”
• For applications to add or change a website or QR code to include inert information, applicants must include a cover letter that identifies the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”

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.

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

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:

• Label amendments limiting application to address potential drinking water risks of concern.
• Additional personal protection equipment and application restrictions to address potential occupational handler risks of concern.
• Spray drift mitigation, in combination with the use limitations and application restrictions identified to address drinking water and occupational risks, to reduce exposure to non-target organisms.

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. 

Commentary

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.

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

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.

This year, due to the COVID-19 pandemic, EPA states that most EPA staff continue to telework and are not in the EPA offices; therefore, EPA will not send maintenance fee information by mail this year.  The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website.  When completed, the filing submission should be emailed to .(JavaScript must be enabled to view this email address).  A paper copy should not be sent to EPA.

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:

1. The applicant has 500 or fewer employees globally;
2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that do not exceed $10,000,000; and
3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

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.

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

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

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

Updates to the Draft Guidance

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

Additional changes of interest to the updated Draft Guidance include:

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

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

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

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

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

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

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

Commentary

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

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

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

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.

By Jason E. Johnston

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.

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

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:

• Arthropods: The listed arthropods may cause asthma or trigger allergies, contaminate food, irritate skin, cause direct injury, or carry diseases such as epidemic typhus, trench fever, epidemic relapsing fever, malaria, encephalitis (St. Louis, Eastern, Western, West Nile, and LaCrosse), yellow fever, dengue fever, and many others.
• Vertebrates: The listed organisms have the potential for direct human injury and can act as disease reservoirs for rabies and other diseases. The rats and mice include those that spread rodent-borne diseases and contaminate food for human consumption.
• Microorganisms and acellular particles:  This category includes listed bacteria, fungi, protozoans, viruses, virusoids, and prions. The microorganisms and acellular particles listed in this category cause diseases such as COVID-19, cholera, meningitis, Legionnaire’s Disease, and many others.

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.

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

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.

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

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:

How do I comply with FIFRA if I am selling or distributing a UV light with pesticidal claims?

• Devices do not need to be registered by EPA and, therefore, are not subject to a pre-market review by EPA (although some states require devices to be registered). However, federal regulations require devices to be produced in an EPA-registered pesticide producing establishment and there are production reporting requirements; see 40 C.F.R Part 167.
• Devices must be labeled per federal regulations at 40 C.F.R Part 156. Generally, device labels must include warning and caution statements, directions for use and the EPA establishment number, amongst other label requirements. A description of device label requirements can be found at https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices#labeling.  
• All claims in connection with the sale or distribution of a device must be true and not misleading. FIFRA Section 12(a)(1)(F) specifically prohibits false or misleading labeling (known as misbranding); this includes claims made in marketing materials and on websites. Examples of misbranding are provided at 40 C.F.R 156.10(a)(5) and include, but are not limited to, false or misleading statements concerning product effectiveness (known as efficacy), claims about product safety, false or misleading comparisons with other pesticides or devices, or any statement directly or indirectly implying that the device is recommended or endorsed by any agency of the Federal Government.  Companies are advised to maintain records, with information and data, to substantiate that claims made in regard to devices are not false or misleading.

In addition to FIFRA requirements, importers of all FIFRA-regulated devices must comply with the U.S. Customs and Border Protection (CBP) regulations set forth at 19 C.F.R. §§ 12.110 -12.117. Regulated entities that are importing UV pesticide devices are advised that the products being imported must be in compliance with FIFRA prior to entry into the United States. The EPA regularly coordinates with CBP to identify and reject violative UV pesticide devices at the port of entry.

Can a UV light be a pesticide requiring EPA registration?

Yes. If the UV light product incorporates a substance or mixture of substances to perform its intended pesticidal purpose, then it is considered a pesticide product, not a device, and must be registered with EPA in accordance with FIFRA Section 3 before it can be lawfully sold or distributed in the United States. 

Are UV lights safe and effective?

Unlike chemical pesticides, EPA does not routinely review the safety or efficacy of UV light devices and, therefore, EPA has not conducted a human health risk assessment to determine the safety of these products. For the same reason, EPA cannot confirm whether, or under what circumstances, UV light devices might be effective against any pest, including viruses and bacteria. The effectiveness of any UV light device will depend on a variety of factors including, but 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. 

Consumers are advised to use all pesticidal devices ONLY in accordance with the Directions for Use, which are required to appear on the product label. EPA recommends that consumers contact the manufacturer or seller of the pesticidal device directly if they have any questions about how to use the product, the product’s safety, or the product’s efficacy.

What are the compliance concerns related to UV lights?

There may be members of the UV light industry who are unfamiliar with FIFRA and may not be aware of statutory and regulatory requirements. For example, they may be unaware that it is a violation of FIFRA to sell or distribute pesticidal UV light devices that are misbranded or that have not been produced in an EPA-registered establishment. EPA has been receiving complaints that UV light devices may be in violation of FIFRA. These complaints are being reviewed and EPA intends to pursue enforcement, as appropriate. See EPA’s May 2020 compliance advisory on products making claims to kill the coronavirus that causes COVID 19 at https://www.epa.gov/sites/production/files/2020-05/documents/cornavirus-compliance-advisory.pdf and any subsequent updates.

Regulated entities of any size who voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. To learn more about the EPA’s violation disclosure policies, including conditions for eligibility, please review EPA’s Audit Policy website at https://www.epa.gov/compliance/epas-audit-policy. Most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system - https://www.epa.gov/compliance/epas-edisclosure. Many states also offer incentives for self-policing; please check with the appropriate state agency for more information.

Are you unsure if your product is a device under FIFRA?

EPA has developed a guide concerning pesticide devices that explains what a pesticide device is and how it differs from a pesticide product which requires registration. This guide may be helpful to UV light manufacturers who need to determine if their product is regulated by FIFRA.See https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers. If you are still uncertain about whether your UV light product is a device, you may submit a request for a Device Determination from EPA. Instructions for submitting a request can be found at: https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices#obtain.

Discussion

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.

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

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:

• Modifying the AEZ so it is applicable and enforceable only on an agricultural employer’s property, as proposed.
• Adding clarifying language indicating that pesticide applications that have been suspended due to individuals entering an AEZ on the establishment may be resumed after those individuals have left the AEZ.
• Excepting agricultural employers and handlers from the requirement to suspend applications owing to the presence within the AEZ of persons not employed by the establishment who are in an area subject to an easement that prevents the agricultural employer from temporarily excluding those persons from that area.
• Allowing the owners and their immediate family (as defined in 40 C.F.R. Section 170.305) to shelter in place inside closed buildings, housing, or shelters within the AEZ, and allowing the application performed by handlers to proceed, provided that the owner has instructed the handlers that only the owner’s immediate family are inside the closed shelter and that the application should proceed despite their presence.
• Simplifying and clarifying criteria and factors for determining AEZ distances of either 100 or 25 feet by basing the AEZ on application method.  EPA has removed the language and criteria pertaining to spray quality and droplet size, as proposed, so that all ground spray applications from a height greater than 12 inches are subject to the same 25-foot AEZ.

EPA states that many of the changes proposed in November 2019 were retained in the final rule.  Changes that were made include the following:

• The final rule adds clarifications and revisions to the regulatory text regarding providing an immediate family exemption to the AEZ requirements.  The final rule provides that the AEZ exemption for the immediate family members applies only when the farm owner or immediately family members are inside an enclosed building within the AEZ.
• The final rule also clarifies that owners may permit handlers to continue with applications when the owner’s family is inside an enclosed structure or home, provided that the owner has expressly instructed the handlers that only the owner’s immediate family members are inside the closed shelter and that the application should proceed despite their presence within that structure.

The final rule is available at EPA-HQ-OPP-2017-0543.  Additional information on the revisions to the AEZ requirements is available here.

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

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.

By Barbara A. Christianson

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.

By Lisa M. Campbell and Lisa R. Burchi

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.” 

Commentary

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 SSURO also provided for the movement of subject products for the purpose of consolidating the products for a rework project whereby Respondent, among other things, would replace the filter manufactured with nanosilver contained in each unit with a filter that was not manufactured with a pesticidal substance, affix a sticker with modified language over any pesticidal claims on the product packaging, and remove all pesticidal claims made for the subject products in Respondent’s online marketing

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.

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

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:

• Base Bacteria -- Consistent with EPA Guideline 810.2200, Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) should be used to support the case residual disinfectant claim.
• Conduct testing on three product lots at the lower certified limit (LCL) for each bacterium.  In accordance with the OCSPP 810.2000 Test Guideline, certificates of analysis should be submitted to substantiate the tested concentration.
• Residual testing to support additional vegetative bacteria is not needed.  Claims can be bridged from the standard disinfectant (non-residual data) for additional bacteria.  For example, if a product has data to support a base disinfectant claim (Staphylococcus aureus and Pseudomonas aeruginosa) and data to support disinfectant claims for additional vegetative bacteria (e.g., Escherichia coli or MRSA), residual data are only needed for the base bacteria, and not additional bacteria, to support residual claims for those vegetative bacteria for which base disinfectant claims are supported.
• According to the Residual Self-Sanitization Method, durability testing should include 12 wear cycles, consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim.  Each wear cycle consists of four passes (two back and forth) of the abrasion material over the surface followed by re-inoculation.  Additional details can be found in the method.
• Products should achieve a ≥ 5-log reduction in ≤ 10 minutes ± 5 seconds for qualifying bacteria when compared to the parallel abrasion and re-inoculation controls to support residual disinfectant claims.
• According to the OCSPP 810.2200 Test Guideline, the performance standard and time to meet the performance standard are consistent with the standards for non-residual disinfectants.
• At this time, expedited review is limited to residual disinfection claims of 24 hours or less based on data generated in accordance with the re-inoculation and abrasion cycles specified in the referenced protocol.

1. Residual Virucidal Claims

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.

• To support residual virucidal claims, acceptable non-residual virucidal efficacy (3-log reduction) should be demonstrated for the product at ≤ 10-minute contact time consistent with the OCSPP 810.2200 Product Performance Test Guideline.
• Residual virucidal data should be generated for the most difficult to kill virus that that the product claims to kill.  Claims for residual effect against the other viruses can be bridged from the non-residual virucidal data supporting the product.  For additional information on selecting the most difficult to kill virus, see EPA’s Emerging Viral Pathogens Guidance.
  • To be considered for List N, virus testing should include a non-enveloped virus or a human coronavirus (SARS-CoV-2 or human coronavirus 229E).
• Testing on two product lots should be conducted at the LCL.
• According to the Residual Self-Sanitization Method, durability testing should include 12 wear cycles consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim.  Each wear cycle consists of four passes of the abrasion material over the surface followed by re-inoculation.  Additional details can be found in the method.
• Products should achieve ≥ 3-log reduction in ≤ 10 minutes ± 5 seconds for the hardest to kill virus when compared to the parallel abrasion and re-inoculation controls to support residual virucidal claims.
  • The performance standard and contact times are consistent with the standard non-residual disinfectants.
• At this time, expedited review is limited to residual disinfection claims of 24 hours or less based on data generated in accordance with the re-inoculation and abrasion cycles specified in the referenced protocol.

2. Labeling and additional information (both bactericidal and virucidal)

• Products are eligible for inclusion on List N following adherence to the Emerging Viral Pathogens guidance or appropriate testing for a qualifying virus (e.g., SARS-CoV-2 or human coronavirus 229E).
• These products may be used as stand-alone disinfectants and do not need a label disclaimer that they are a “supplement to standard disinfection” since they meet the general criteria for disinfectants (effective in ≤ 10 minutes with appropriate log reductions for bacteria and virus).

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.

1. Antimicrobial Surface Coatings and Films

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:

• Test Organisms
  • Bacteria -- Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) are the qualifying bacteria required to support supplemental residual antimicrobial surface claims for the proposed claim duration (e.g., one week, two weeks).
    • Testing should be conducted on three product lots per bacterium at the LCL.
  • To support claims for additional bacteria, testing should be conducted according to the method but with a reduced number of product lots.
    • Two lots of product for each bacterium at the nominal concentration.
  • Viruses -- All viruses for which claims are desired should be tested.  The most difficult to kill virus should be subjected to the durability assessment using coating carriers followed by the efficacy assessment to support the proposed duration (e.g., one week, two weeks).  All other viruses should be tested using coated carriers that were not subjected to the durability procedure.
    • Assessment of virucidal efficacy on the coated carriers should be conducted consistent with ASTM E1053, the standard method specified in EPA’s 810.2200 Efficacy Test Guideline.
    • Two lots of product at the LCL should be tested for the most difficult to kill virus.  Two lots of product at the nominal concentration should be tested for additional viruses.
      • To be considered as a supplement to List N, virus testing should include a non-enveloped virus or a human coronavirus (SARS-CoV-2 or human coronavirus 229E).
• Stainless steel carriers will be used to support claims for coatings on hard, nonporous surfaces.  Use sites should be limited to hard, non-porous surfaces.  Additional material types (e.g., porous materials or textiles) may be proposed by the registrant upon consultation with EPA prior to submission.
• The recommended number of abrasions (touches) and cycles of exposure to cleaning or disinfecting chemicals are provided in the method to substantiate durability claims.  The method also specifies the chemical disinfecting solutions to simulate cycles of in-service disinfection and cleaning.  Additional details can be found in the method.
  • Ten cycles of abrasion and/or chemical exposure is equivalent to one week of durability.  The number of cycles can be increased in one-week increments to support claims up to four weeks.
  • If a product is incompatible with one or more of the test chemistries, this should be discussed with EPA in advance and may limit use sites and surfaces depending on the nature of the incompatibility.  EPA does not have a standard method for determining incompatibility.  This may be based on research and development data or known incompatibilities with the coating material, for example.
• This protocol may be modified for films upon consultation with EPA in advance of submission.
• If an applicant intends to claim supplemental residual effects longer than four weeks, it should consult with EPA in advance of submission.  EPA states that because the ongoing antimicrobial integrity of coatings and films will not be readily visible, it is important that end users have a reasonable expectation of durability.
• Products should achieve a 99.9% reduction (3-log) for both bacteria and viruses in comparison to untreated controls within a maximum of two hours but not less than one hour, as EPA is concerned that observations taken before the inoculum has dried (e.g., less than one hour) on the surface may not provide an accurate assessment of the product.
  • The time to achieve performance begins at the time of inoculation.

2. Antimicrobial Surface Coatings and Films -- Labeling and Additional Information

EPA states that this new category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces.  EPA provides the following additional information:

• As these products do not meet the criteria for a disinfectant due to the longer contact time and lower performance standard, claims for residual disinfectant are not acceptable.  As above, contact times for disinfectants are ≤ 10 minutes and with a higher performance standard for bacteria.
• Products should carry the following prominent label qualifier that they are a supplement to standard disinfection and cleaning:
  • “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
• For products eligible only for supplemental residual antimicrobial claims, EPA intends to require as a term of registration that the label and labeling state, “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant.”
• Although these products will not be eligible for List N, they will be eligible as a supplement to List N (N.1) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants.
• The following are example acceptable product label claims:
  • “Kills 99.9% of [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program/protocol for up to X days.”
  • “Continuously reduces [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program for up to X days.”

3. Fixed/Solid Surfaces Including Solid Copper and Other Metals and Solid Impregnated Materials and Paints -- Method Recommendation

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.

• Test Organisms
  • Bacteria -- Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) are the qualifying bacteria used to support supplemental residual surface claims.
    • Testing should be conducted on three product lots per bacterium at the LCL.
  • To support claims for additional bacteria, testing should be conducted according to the method but with a reduced number of product lots.
    • Two lots of product for each bacterium at the nominal concentration.
  • Viruses -- All viruses for which claims are desired should be tested.  The most difficult to kill virus should be subjected to the durability assessment in the copper method, followed by the efficacy assessment.  All other viruses should be tested using test carriers that were not subjected to the durability procedure.
    • Assessment of virucidal efficacy on the coated carriers should be conducted consistent with ASTM E1053, the standard method specified in EPA’s 810.2200 Efficacy Test Guideline.
    • Two lots of product at the LCL should be tested for the most difficult to kill virus.  Two lots of product at the nominal concentration should be tested for additional viruses.
• The recommended number of abrasions (touches) and cycles of exposure to cleaning or disinfecting chemicals are provided in the method in order to substantiate durability claims.  The method also specifies the chemical solutions to simulate cycles of disinfection and cleaning.
  • As the durability of these types of products can be readily observed, duration claims are not necessary.  This is consistent with currently registered copper-containing surface products and paints.
  • If a product is incompatible with one or more of the test chemistries, this should be discussed with EPA in advance and may limit use sites and surfaces, depending on the nature of the incompatibility.  EPA states that it does not have a standard method for determining incompatibility.  This may be based on research and development data or known incompatibilities with the coating material, for example.
• This protocol can be modified for other metals or solid impregnated surfaces or paints upon consultation with EPA.
• Products should achieve a 99.9% reduction (3-log) for both bacteria and viruses in comparison to untreated controls within two hours.
  • The time to achieve performance begins at the time of inoculation.

4. Fixed/Solid Surfaces Including Solid Copper and Other Metals and Solid Impregnated Materials and Paints -- Labeling and Additional Information

EPA states that these products should be labeled as supplemental residual antimicrobial surfaces.  EPA states the following with regard to these products:

• As these products do not meet the criteria for a disinfectant due to the longer contact time and lower performance standard, claims for residual disinfectant are not acceptable.
• Products should carry the following prominent label qualifier that they are a supplement to standard disinfection and cleaning:
  • “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
• For products eligible only for supplemental residual antimicrobial claims, EPA intends to require as a term of registration that the label and labeling should state, “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant.”
• Although these products will not be eligible for List N, they will be eligible as a supplement to List N (N.1) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants.  The following are example acceptable product label claims:
  • “Kills 99.9% of [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program/protocol.”
  • “Continuously reduces [insert microorganism/s] within two hours of exposure when used as part of a comprehensive infection control program.”

5. Supplemental Residual Antimicrobial Products -- Stewardship Program

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:

• Advertising and promotional materials that clearly and consistently include a disclaimer that the product does not meet EPA’s standards for disinfectants and is intended to supplement the use of EPA-registered disinfectants.
• Outreach to the infection control community;
• Customer feedback consisting of product issues/concerns, adverse events, compliance challenges/observations, and contraindications/adverse events gathered through quarterly registrant-initiated surveys, customer complaints, and suggestion boards; and
• Development of a stewardship website.

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.