By Heather F. Collins, M.S. and Barbara A. Christianson
On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial pesticide products to substitute some combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide feedstocks that are in limited supply due to weather events that occurred in the U.S. Gulf Coast area in February 2021. EPA stated that it is allowing these substitutions even in cases where propylene glycol is added to the formulation or is part of a brand-name mixture in which the full composition is known to the registrant.
The pre-approved alternates are glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5); diethylene glycol (CAS RN 111-46-6); ethylene glycol (CAS RN 107-21-1); and 1,3-propanediol (CAS RN 504-63-2).
EPA emphasizes that this action, known as “Propylene Glycol Phase 2 -- ‘Not In-Kind’ Substitution Mechanism,” relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.
In April 2021, EPA implemented “Propylene Glycol Phase 1 -- ‘In-Kind’ Substitution Mechanism” to allow certain in-kind substitutions to address propylene glycol supply-chain shortages.
These actions require registrants to self-certify that the substitute inert ingredients serve the same function in the product as propylene glycol and that the change will not impact either the validity of any product-specific data submitted in support of the registration or the product’s acute toxicity category or physical/chemical characteristics in a way that would require label modifications. Registrants must also certify that the substitution will not affect the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, or any other factor.
This action is time limited, extending to December 31, 2021. Any registrants who wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.
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:
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, Heather F. Collins, M.S. and Barbara A. Christianson
On April 23, 2020, the U.S. Environmental Protection Agency (EPA) announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19. EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2. EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus.
EPA’s Office of Chemical Safety and Pollution Prevention’s Assistant Administrator Alexandra Dapolito Dunn stated that “EPA is dedicated to its mission of protecting human health and we want all Americans to have access to effective and approved surface disinfectant products,” and emphasized “[w]e also want everyone follow the directions on the product so that we can safely use registered disinfectants and provide critical protection to our families.”
EPA in its announcement stressed when using an EPA-registered surface disinfectant, always follow the product’s directions and:
- Never apply the product to yourself or others. Do not ingest disinfectant products. This includes never applying any product on List N directly to food;
- Never mix products unless specified in the use directions. Certain combinations of chemicals will create highly toxic acids or gases;
- Wash the surface with soap and water before applying disinfectant products if the label mentions pre-cleaning;
- Follow the contact time listed for your product on List N. This is the amount of time the surface must remain visibly wet to ensure efficacy against the virus. It can sometimes be several minutes; and
- Wash your hands after using a disinfectant. This will minimize your exposure to the chemicals in the disinfectant and the pathogen you are trying to kill.
Additional information on EPA’s disinfectant safety messages is available on EPA’s twitter feeds, @EPA and @ChemSafety. These channels will be updated with new materials throughout the COVID-19 crisis.
EPA states it is also continuing to add additional chemicals to its list of common inert ingredients. These actions are intended to help address supply chain issues for EPA-registered disinfectants and other pesticides. It allows manufacturers of already-registered EPA products to change the source of listed inert ingredients.
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.
By Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi
On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment.
This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to require the labeling of 371 inert ingredients in pesticides. EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking. CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Administrative Procedure Act (APA). In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient. EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially: (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.” The Court granted EPA’s motion for judgment on the pleadings in the March 2014 lawsuit, “finding that there was no further relief that [the Court] could offer to plaintiffs and that the action was moot.”
CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].” CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.’” Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure.
In support of its ruling to grant EPA’s motion for summary judgment, the court stated: “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.” The Court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.” In addition, the Court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.”
The decision supports EPA’s discretionary authority to determine how to best manage and address any inert ingredients that may cause unreasonable adverse effects on the environment. EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients. For example, on October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product. Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.
By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom
On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S. Environmental Protection Agency (EPA) and its Administrator Gina McCarthy regarding a 2014 decision by EPA not to proceed with a rulemaking to require disclosure of hazardous inert ingredients on pesticide product labels under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This decision was characterized by EPA as a denial of a petition previously filed by the Plaintiffs.
Specifically, Plaintiffs and others previously petitioned EPA in 2006 to require label disclosure of some 370 substances used as inert ingredients in pesticide products that Plaintiffs claim are known to be hazardous to human health and the environment. In 2009, EPA decided to partially grant the 2006 petition and issued an advance notice of proposed rulemaking to require disclosure of hazardous inert ingredients on pesticide labels. When EPA did not pursue the rulemaking, the Plaintiffs filed a suit on March 5, 2014, alleging unreasonable delay. On May 22, 2014, EPA issued a letter explaining that EPA had decided not to proceed with a proposed rule and stating that “this amended response constitutes a denial of the  petitions.”
In the May 22, 2014, letter, EPA cited some legal arguments by registrants in opposition to the proposed rule, including a contention that inert ingredients are entitled to confidential treatment as a class, and that EPA cannot compel disclosure of inert ingredients based solely on hazard without considering exposure. In the letter, EPA stated that it has concluded that it “can achieve greater reduction in the risks from use of pesticides containing potentially hazardous inert ingredients through a series of non-rule actions designed to reduce the presence of hazardous inert ingredients in specific pesticide products.” EPA also set forth its plan to prioritize pesticide inert ingredients for increased scrutiny, as well as a list of voluntary and regulatory actions that could be used, as appropriate, to address potential risks from inert ingredients.
In the Complaint, Plaintiffs request that the court: (1) declare that EPA’s May 22, 2014, decision violates FIFRA and is arbitrary, capricious, and runs counter to the evidence in the record; (2) remand the case to EPA with instructions to consider the evidence weighing in favor of disclosure of inert pesticide ingredients, including the abundance of documentation regarding toxicity and potential risks of exposure to inert pesticide ingredients; (3) retain jurisdiction over this matter until such time as EPA complies with its duties to control unreasonable risk as set forth under FIFRA, including the risks posed by hazardous inert ingredients, and completes its rulemaking to increase disclosure of inert ingredients contained in pesticide products; and (4) award Plaintiffs their costs of litigation.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
The U.S. Environmental Protection Agency (EPA) has announced its new more “user-friendly” website for minimum risk pesticides. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) and EPA’s implementing regulations at 40 C.F.R. § 152.25(f), pesticides meeting certain criteria (e.g., containing only specified, listed active and inert ingredients, not bearing public health claims) are determined by EPA to pose little to no risk to human health or the environment and exempt from FIFRA registration requirements. EPA states the website “highlights the most-requested information and has been redesigned based on historic website traffic, with a focus on stakeholders who are interested in manufacturing, selling or distributing minimum risk pesticides.” Specifically, the website is now focused on four main areas:
* About Minimum Risk Pesticides;
* Conditions to Qualify as a Minimum Risk Pesticide Product;
* Clarifications about Minimum Risk Active and Inert Ingredients; and
* Regulation and Enforcement of Minimum Risk Pesticides.
Although the scope of application of minimum risk pesticides has been the focus of proposed regulatory changes in recent years, EPA states that this website is not intended to include any regulatory changes or new requirements. There is, however, a December 2010 rule proposing changes to the minimum risk pesticide requirements that has yet to be issued in final. It is noteworthy that EPA has highlighted and clarified its Section 25(b) policies, but has not yet issued a final rule. A memorandum regarding EPA’s proposed rule is available at http://www.lawbc.com/regulatory-developments/entry/epa-proposes-revisions-to-minimum-risk-exemption-for-pesticides/.
Instead, EPA states it has included more information to be clearer about the conditions that a product must meet to be considered minimum risk. Any clarifications of the applicable requirements could be helpful for manufacturers that are responsible for ensuring compliance at the federal level for minimum risk pesticides since EPA does not review or approve such registrations. It is important to note that minimum risk pesticides exempt from EPA registration are still frequently subject to registration requirements at the state level, and state regulators perennially identify non-compliance by products asserting eligibility for minimum risk status. Any outreach that makes the eligibility and compliance requirements clearer should assist companies in navigating both federal and state requirements.
The address for the new website is www2.epa.gov/minimum-risk-pesticides.