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

On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup^®, which contains the active ingredient glyphosate, did not have adequate warning of the “harmful nature of glyphosate under Georgia law.” The District Court ruled that FIFRA preempts Georgia law and Plaintiff’s failure to warn claim because the U.S. Environmental Protection Agency (EPA) classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. Plaintiff appealed.

The Court found that the District Court erred in concluding that the Plaintiff’s failure to warn claim was preempted under FIFRA. In its Opinion, the Court stated that a common-law cause of action, such as the failure to warn claim under Georgia law, would be preempted “if two conditions are met: 1) the state requirement must be for ‘labeling or packaging’ under the language of the statute; and 2) the state requirement is ‘in addition to or different from’ requirements derived from FIFRA.” The Court found that EPA’s registration process “is not sufficiently formal to carry with it the force of law” and instead “at most creates a rebuttable presumption of compliance with FIFRA’s registration process and nothing more.” In addition, with regard to FIFRA’s labeling provisions, the Court found that the Georgia law failure to warn claim is not in addition to or different from FFIRA requirements. Instead, the Court states that the Georgia failure to warn claim “simply enforces the FIFRA cause of action, so it is not expressly preempted.”

The Court also responded to Monsanto’s argument providing several EPA documents indicating that it could not label Roundup as carcinogenic. These included various registration reviews and reregistration eligibility decisions regarding glyphosate products, an EPA paper written about the EPA Scientific Advisory Panel’s independent review of the effects of glyphosate, and “[v]arious papers involving scientific analysis where the EPA concluded that glyphosate did not cause cancer.” Monsanto additionally provided evidence regarding the August 2019 letter from EPA to glyphosate registrants that it would not permit label amendments to include warnings under California’s Proposition 65 that glyphosate is known to the State of California to cause cancer. In that letter, EPA stated that it would consider such language to be “false or misleading,” and thus would not approve of such language on any label and further that registrants were to remove such statements from any approved labels.

The Court found, however, that none of these documents had the “indicia of formality” necessary to meet their standard of review. The Court noted that none of the documents identified were the product of notice and comment rulemaking or formal adjudication, and they did not “‘bespeak the legislative type of activity that would naturally bind’ Monsanto.”  The Court thus remanded this case back to the District Court for further proceedings on the failure to warn claim.

This case potentially places glyphosate registrants in the position of defending themselves for not warning about the potential carcinogenicity of glyphosate despite past EPA statements that any such warning would be considered a violation of FIFRA. Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.

Commentary

Regardless of the outcome of this decision, the long and tortured history of the FIFRA preemption issue was expected to, and certainly will, continue. For many years, the debate over the implications of the FIFRA requirement that the EPA label cannot have conflicting (“different from”) language that would be needed, as the argument goes, to comply with state requirements to provide adequately warnings. To a casual observer, the FIFRA label and EPA review should take care of imposing the necessary conditions to avoid harms since it is axiomatic that “the label is the law,” and, if label directions are followed, EPA expects there would be no “unreasonable adverse effects” caused by the pesticide application. But the case law has evolved over the years not only about the confines of FIFRA but also regarding other “failure to warn” cases involving label instructions and warnings approved by other federal agencies (e.g., the U.S. Food and Drug Administration). The result has been a continued series of cases where the courts, state and federal, have to determine where federal requirements end and freedom for state requirements are allowed. 

In this case, the outcome was a disappointment to the registrant community but is unlikely to stop the flow of litigation on both sides of the preemption arguments. And the recent announcement in April 2022 by the Biden Administration EPA to reverse effectively the 2019 letter to California about FIFRA labels and California’s Proposition 65 requirements (Letter from California’s Office of Environmental Health Hazard Assessment on California Proposition 65 |to EPA) might further muddy the water of what a FIFRA label really does imply regarding state warnings, “right-to-know” requirements, and the like.

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By Lisa R. Burchi

On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.

Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].” 

This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading. 

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

On May 10, 2021, the U.S. Environmental Protection Agency (EPA) announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions.

As part of the registration process for new pesticide products, EPA requires the submission of a Confidential Statement of Formula (CSF). The form lists all the product’s components and percent by weight, along with various additional information.

Currently, CSF applications must be submitted to EPA in hard copy. The new eCSF builder will automatically validate certain data in a CSF application prior to submission to EPA. EPA states this functionality, along with real-time validation of chemical ingredients through EPA’s Substance Registry Services, will make the pesticide registration process more efficient, saving EPA and registrants time and resources. While paper CSF forms remain available, EPA encourages submitting applications electronically, as the review of paper applications could be a longer process.

Users can access the eCSF builder on the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX.

Additional information is available on our blog.

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By Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on April 19, 2021, that Univar Solutions USA, Inc. of Portland, Oregon, will pay a $165,000 penalty for violating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when it failed to label properly its “Woodlife 111” pesticide, which is used as a wood preservative.  EPA notes that under FIFRA, “a pesticide is misbranded if, ‘the labeling accompanying it does not contain directions for use which are necessary … to protect health and the environment’ and if ‘…the label does not contain a warning or caution statement which may be necessary … to protect health and the environment.’”  According to the press release, EPA alleged that between approximately January 1, 2017, and December 31, 2018, Woodlife 111 labels “omitted several required sections important for the protection of the handler and for the environment, including user safety requirements, first aid directions, use of personal protective equipment, and portions of the storage and disposal section.”  EPA states that it cited the company for 33 FIFRA violations when Univar sold and distributed the misbranded pesticide via bulk shipments.  According to the press release, the case resulted from a March 5, 2019, inspection of the Univar facility by the Oregon Department of Agriculture’s EPA-credentialed inspectors.

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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.

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

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. 

In January 2020, at the beginning of the SARS-CoV-2 public health emergency, EPA activated its Emerging Viral Pathogens guidance (Guidance).  EPA published this Guidance in August 2016, to set forth procedures for EPA to respond to the potential need for products to combat emerging viral pathogens that are not on EPA-registered disinfectant labels.  The Guidance allows product registrants to make limited off-label claims of their product’s efficacy against SARS-CoV-2, provided in part that there are efficacy data that have already been reviewed by EPA that demonstrate their products are effective against harder-to-kill viruses than SARS-CoV-2. 

Since activating its Guidance for the first time, EPA has reviewed amendments for already EPA-registered surface disinfectants on an expedited basis and developed a list -- List N -- of products that meet its criteria under the Guidance for use against SARS-CoV-2.  List N currently includes 469 products and is updated weekly.  In many cases, EPA states that it was able to approve claims in as little as 14 days.

The 13 products approved include 12 unique products from the manufacturer Lonza and one additional Lysol product from Reckitt Benckiser.  The 13 products approved are:

• Lonza Formulation S-21 (EPA Reg. No. 6836-75);
• Lonza Formulation S-18 (EPA Reg. No. 6836-77);
• Lonza Formulation R-82 (EPA Reg. No. 6836-78);
• Lonza Formulation S-18F (EPA Reg. No. 6836-136);
• Lonza Formulation R-82F (EPA Reg. No. 6836-139);
• Lonza Formulation S-21F (EPA Reg. No. 6836-140);
• Lonza Formulation DC-103 (EPA Reg. No. 6836-152);
• Lonzaguard RCS-256 (EPA Reg. No. 6836-346);
• Lonzaguard RCS-128 (EPA Reg. No. 6836-347);
• Lonzaguard RCS-128 PLUS (EPA Reg. No. 6836-348);
• Lonzaguard RCS-256 PLUS (EPA Reg. No. 6836-349);
• Lonzaguard R-82G (EPA Reg. No. 6836-381); and
• Lysol^® Disinfecting Wipes (All Scents) (EPA Reg. No. 777-114).

Additional information is available here.

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By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi

On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate.  The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution.  The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”)  The U.S. Environmental Protection Agency (EPA) also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”)

A Prop 65 warning is required when the California Office of Environmental Health Hazard Assessment (OEHHA) determines that a product contains a substance that has been classified as a human carcinogen by certain authoritative bodies, including the International Agency for Research on Cancer (IARC).  Based on an IARC determination that glyphosate is “probably carcinogenic” in humans, OEHHA listed glyphosate in July 2017 as a chemical known to the State of California to cause cancer, thereby triggering Prop 65 warning requirements.  Despite the IARC determination, every other authoritative body that has considered the matter (including EPA, the European Commission, and the World Health Organization) has reached a contrary determination that glyphosate is not likely to be carcinogenic in humans.  California’s imposition of a Prop 65 warning for glyphosate was challenged in 2018 by the registrant Bayer and a coalition of farming groups and industry stakeholders, who obtained a preliminary injunction against enforcement of the warning.

Before entering the new permanent injunction, the District Court considered whether California’s regulation of commercial speech should be scrutinized under the lower standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission.  The Zauderer standard only applies to mandatory disclosure of “purely factual and uncontroversial information,” and the Court found that the Prop 65 warning for glyphosate is “misleading” and therefore neither factual nor uncontroversial.  Under the Central Hudson level of scrutiny, a governmental agency may only restrict commercial speech when the restriction directly advances an important governmental interest and where the restriction is not more extensive than necessary to serve that interest.  The Court found that the Prop 65 warning for glyphosate is misleading, and therefore does not directly advance the interest of the state in informing consumers regarding potential cancer hazards, and that the asserted state interest could be effectively advanced by other measures that do not burden freedom of speech in the same manner.

California argued that no Prop 65 warning would actually be required for glyphosate in practice because OEHHA has set a quantitative “safe harbor” level for glyphosate exposure, but the court found that this would not prevent parties other than California from bringing separate enforcement actions to enforce the listing.  Since a Prop 65 warning only needs to be “clear and reasonable,” California also proposed several alternative forms for a warning that would meet state requirements, but the court found these alternate warnings to all be misleading as well.  Based on all of these factors, the court decided to enjoin permanently the enforcement of Prop 65 warning requirements for glyphosate as an unconstitutional burden on commercial speech.

Commentary

Under FIFRA Section 24(b), no state may impose any labeling for a registered pesticide that differs from the labeling approved by EPA.  Although EPA has sometimes been willing to accommodate state labeling requirements or preferences within the labeling approved under FIFRA, there are necessary limits to this practice.  When label language sought by a state becomes misleading, approving it would also be expressly contrary to FIFRA.  How much precedential effect this decision may have with respect to other state requirements for labeling in the future is an issue that registrants should monitor closely. 

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

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.

EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2.  These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2.  This process does not replace the review process of all other submitted antimicrobial products.

EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).

The following submissions may qualify for expedited review:

Amendments for Currently Registered Products

• A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
• A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
• A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.

New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.

• A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
• A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).

Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here. 

EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. 

For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2.  EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs.  Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.

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

On March 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients. 

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

• Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
• Ethanol, CASRN 64-17-5;
• Glycolic Acid, CASRN 79-14-1;
• Hydrochloric Acid, CASRN 7647-01-0;
• Hypochlorous Acid, CASRN 7790-92-3;
• Hydrogen Peroxide, CASRN 7722-84-1;
• L-Lactic Acid, CASRN 79-33-4; and
• Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

• A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
• The active ingredient; and
• The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10 and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

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

On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19.  EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain. 

EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF).  EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.

EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels.  Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review.  EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.

Additional information on EPA’s list of commodity inert ingredients is available here. 

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.

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