By Lynn L. Bergeson and Carla N. Hutton

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469).  EDF v. EPA, No. 4:21-cv-03-BMM.  On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful.  On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement.  The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’”  In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.”  According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.”  EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”

Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Joe Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.  According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.”  The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis.  The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy.  For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.”  In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.”  The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program.  We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo).  With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.

By Lisa M. Campbell and Heather F. Collins, M.S.

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the states of Oklahoma and Arkansas, permitting American Airlines to use SurfaceWise2, believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces, in specific airport facilities and planes.  EPA also has revised the terms of use for SurfaceWise2 for all current emergency exemptions. 

EPA’s initial emergency exemption for the state of Texas issued on August 24, 2020, specified that the product remained effective for seven days.  According to its updated labels for all three states, EPA has now approved claims that SurfaceWise2 provides residual surface control of the coronavirus SARS-CoV-2 on surfaces that are undisturbed for up to 30 days.  The updated labels state “When used in accordance with the directions for use, SurfaceWise^®2 provides residual surface control of coronaviruses, including SARS-CoV-2, for up to 30-days on undisturbed (e.g., are not routinely disinfected with List N products) non-porous treated surfaces.” 

Of note, EPA also states in its announcement that SurfaceWise2 should be reapplied every time surfaces are disinfected to ensure continuous product performance as exposure to prolonged wetness may adversely impact the efficacy of the product.  The updated labels state in the Directions for Use that the user must “Reapply SurfaceWise^®2 after surfaces are disinfected to ensure continuous product performance” and “Do not expose SurfaceWise^®2 to prolonged wetness as this may adversely impact the efficacy of the product.”

FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption.  EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency.  EPA’s regulations provide that an emergency exists when:

• There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
• There is no registered pesticide or economically or environmentally feasible alternate method of control available.

40 C.F.R. § 166.3.

The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.

In this case, EPA approved the Section 18 emergency exemption request for SurfaceWise2 -- a product manufactured by Allied BioScience.  SurfaceWise2 is a surface coating that Allied BioScience states inactivates viruses and bacteria within two hours of application and continues to work against them for up to 30 days, on undisturbed non-porous treated surfaces.  EPA’s approvals will allow Texas, Oklahoma, and Arkansas to permit American Airlines airport facilities and planes at specific locations identified on the label and two Total Orthopedics Sports & Spine Clinics in Texas to use SurfaceWise2 under certain conditions.  The approved Section 18 emergency requests are effective for one year. This public health exemption will expire August 24, 2021.  As new data emerge, EPA may alter the terms of the product’s emergency uses, as it did with the modifications discussed here. 

Additional information on Section 18 emergency exemption requests and SARS-CoV-2 is available here.

By Lisa M. Campbell and Lisa R. Burchi

In January 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a revised compliance advisory (Advisory) on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.  EPA first issued this guidance on June 1, 2020, and it is discussed in our blog here.

The Advisory has been revised significantly, reflecting new developments and experience since the Advisory was first issued.  

The first section of the Advisory addresses “Products claiming to be effective against the coronavirus causing COVID-19.”  That title has changed, as well as the language throughout the Advisory, to refer now to products that are “effective against” the coronavirus, instead of products that “kill” the coronavirus.

EPA has added a new section entitled “What is the difference between an EPA registration number and an EPA establishment number?”  Presumably, this is intended to address confusion among some with regard to this important difference.  The Advisory now states: 

An EPA establishment number is not the same as an EPA registration number. An EPA registration number signifies that the pesticide and its claims have been reviewed and approved by EPA. An establishment number identifies the EPA-registered location where the product was produced.  EPA provides a National List of Active EPA-Registered Foreign and Domestic Pesticide and/or Device-Producing Establishments at: https://www.epa.gov/compliance/national-list-active-epa-registered-foreign-and-domestic-pesticide-andor-device-producing.

The section entitled “Devices that claim to kill the coronavirus” has been significantly modified.  In particular, EPA has now deleted from the Advisory language that “ozone generators, 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.”  Instead, the Advisory states legal requirements applicable to devices, namely that the labels “include adequate warning and caution statements and directions for use” and have an EPA establishment number.  EPA further adds the following: “Additionally, making false or misleading labeling claims about the safety or efficacy of a pesticidal device is prohibited and could result in the issuance of a Stop Sale, Use, or Removal Order and penalties under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).”

In its “Compliance Concerns” section, EPA states it continues to pursue enforcement against products making false and misleading claims regarding their efficacy against the coronavirus, adding that it is “particularly concerned with pesticide and pesticide device products sold online on e-commerce platforms that are fraudulent, counterfeit, and/or otherwise ineffective.” 

EPA has added new language to address a particular issue with regard to “residual” claims:

In the United States, it is unlawful to distribute or sell a pesticide which includes claims that it will kill a particular pathogen, unless that pesticide is registered by EPA and that particular claim has been deemed acceptable by the agency. In some instances, companies have unlawfully added additional claims to the labels of their registered pesticide products that have not been approved by EPA. For example, a claim for persisting or long-lasting effect against viruses, referred to as “residual claims” (i.e., claims that a product provides an ongoing antimicrobial effect beyond the initial time of application, ranging from days to weeks to months), may be accepted by EPA only when supported by acceptable studies demonstrating satisfactory residual efficacy. Until EPA approves a residual claim, it cannot lawfully be included on a registered product as part of distribution or sale. For more information on residual claims, see: https://www.epa.gov/coronavirus/there-anything-i-can-do-make-surfaces-resistant-sars-cov-2.  For more information on registering products with residual claims, see EPA’s Interim Guidance: https://www.epa.gov/pesticide-registration/interim-guidance-expedited-review-products-adding-residual-efficacy-claims.

Commentary

Of interest among the changes to the Advisory is the removal of the language stating that pesticide devices could not make claims against the coronavirus unless they had been specifically “tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.”  While any such testing may be necessary to demonstrate efficacy or appropriate directions for use, EPA had not previously stated what particular testing was required for devices or against what testing standard it would determine whether a device claim is “false or misleading.”  It remains important 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 James V. Aidala

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

• Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
• Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed include the following:

1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
2. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
6. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.

By Lisa M. Campbell and Heather F. Collins, M.S.

On January 15, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the states of Georgia and Tennessee permitting the use of an air treatment product, Grignard Pure, in health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings -- including government facilities -- where people are conducting activity deemed essential by the state.  According to the EPA Authorizations for Georgia and Tennessee (EPA Authorizations), Grignard Pure forms a mist with activity against airborne SARS-CoV-2, the virus that causes COVID-19.  It contains the active ingredient triethylene glycol (TEG), an ingredient commonly used in fog machines for concerts and theater productions. 

FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption.  EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency.  EPA’s regulations provide that an emergency exists when:

• There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
• There is no registered pesticide or economically or environmentally feasible alternate method of control available.

40 C.F.R. § 166.3.

The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.

EPA’s approval will allow the Grignard Pure product to be applied in Georgia and Tennessee in certain indoor spaces where adherence to current public health guidelines is impractical or difficult to maintain.  The areas where it can be used under the exemption include breakrooms, locker rooms, bathrooms, lobbies, elevators, eating areas, and food preparation areas within health care facilities, intrastate transportation, food processing facilities, and indoor spaces within buildings.  According to the EPA Authorizations, Grignard Pure may only be applied by trained professionals through a building’s HVAC system or using portable devices positioned strategically in an indoor space.  Additionally, the label states that use of Grignard Pure does not eliminate the need for critical precautions like mask wearing and social distancing.  Signs must be posted to indicate that a space is being treated and to advise that the product may cause temporary irritation to sensitive individuals.

Based on a review of laboratory testing data, EPA states that it expects that when used as directed, Grignard Pure will inactivate continuously 98 percent of airborne SARS-CoV-2 particles. Grignard Pure was tested against a surrogate virus that is harder to kill than SARS-CoV-2.

The approved Section 18 emergency requests are effective for one year.  Any unexpected adverse effects related to the use of this product must be reported immediately to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval.

By Heather F. Collins, M.S.

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production.  The report, filed through the submittal of EPA Form 3540-16:  Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed.  The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS).  Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports.  Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.  EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report, as the majority of EPA staff are still working remotely and may not be on site to receive mailed reports.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

• EPA Form 3540-16:  Pesticide Report for Pesticide-Producing and Device-Producing Establishments
• Instructions for Completing EPA Form 3540-16 (available within the ZIP file)
• Electronic Reporting for Pesticide Establishments

Further information is available on EPA’s website.

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.