By Carla N. Hutton
On September 2, 2022, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published an advance notice of proposed rulemaking (ANPR) seeking input from stakeholders about how to update its organic regulations on inert ingredients in pesticides used in organic production. 87 Fed. Reg. 54173. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the U.S. Environmental Protection Agency’s (EPA) regulatory framework for inert ingredients. According to the ANPR, information from public comments would inform AMS’s approach to this topic, including any proposed revisions of the USDA organic regulations. On October 11, 2022, AMS extended the comment period to December 31, 2022. 87 Fed. Reg. 61268.
According to AMS, the ANPR seeks input from stakeholders about how to rectify the USDA organic regulations’ references to outdated EPA policy on inert ingredients used in pesticide products. AMS states that the outdated references are inconsistent with current EPA requirements and that this causes problems in the organic industry and for AMS’s administration of the USDA organic regulations.
AMS notes that inert ingredients, also identified as “other ingredients” on pesticide labels, are substances other than the “active” (i.e., pesticidal) ingredients included in formulated pesticide products. Inert ingredients may function as adjuvants, solvents, diluents, stabilizers, or preservatives. AMS states that pesticide labels do not typically disclose the identity (common or chemical name) of the inert ingredients in the product.
For organic crop and livestock production, current USDA organic regulations allow EPA List 3 and List 4 inert ingredients to be used in pesticide products when the product includes active ingredients permitted by the organic regulations. According to AMS, together, EPA List 3 and List 4 include more than 2,700 inert ingredients. AMS states that it does not know how many of these inert ingredients are included in products used in organic production, “but it is likely a relatively small subset of these 2,700 ingredients.” Because the Food Quality Protection Act of 1996 (FQPA) mandated that EPA develop tolerances (or tolerance exemptions) for inert ingredients used in food-contact products, new and existing inert ingredients are approved for use through EPA’s rulemaking process. As a result, EPA no longer updates the EPA lists referenced in the USDA organic regulations.
AMS’s National Organic Program (NOP) seeks comments that will assist in assessing the feasibility of alternatives that could replace the references to the outdated EPA lists. Information submitted in response to the ANPR will inform AMS’s approach to this topic, including any proposed revisions of the USDA organic regulations. AMS seeks comments to identify alternatives, as well as to receive information about obstacles and the costs and benefits of options. According to AMS, stakeholders that may be affected by future actions on this topic include pesticide manufacturers, certified organic operations, consumers, certifying agents, and other interested parties.
By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) announced it is extending supply-chain flexibilities for registrants of certain conventional and biopesticide products to alleviate a supply-chain issue facing the pesticide industry.
This is an extension of EPA’s July 2, 2021, action when EPA implemented supply-chain flexibilities that allowed registrants to substitute a combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide (PO) feedstocks. This was intended to address the limited supply of PO feedstocks due to weather events that occurred in the U.S. Gulf Coast in February 2021. This action was originally set to expire on December 31, 2021, but EPA has extended these supply-chain flexibilities until December 31, 2022, due to continued disruptions to production.
EPA emphasized in its initial July 2021 action that this 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.
The pre-approved alternates for propylene glycol, a derivative of PO feedstocks, include:
- 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/or
- 1,3-propanediol (CAS RN 504-63-2).
These substitutions can be added to a product formulation or a brand name mixture.
Registrants must self-certify that the substitute inert ingredients will:
- Serve the same function in the product as propylene glycol;
- Maintain the validity of product-specific data submitted in support of the registration;
- Maintain the product’s acute toxicity category and physical/chemical characteristics such that no label modifications are required; and
- Maintain the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, and any other factor.
EPA states that any registrants that wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.
Supply-chain issues have become a national concern whether one is shopping for furniture or manufacturing pesticides. The Biden Administration across government agencies and programs has sought ways to ease difficulties as part of a national response to economic disruptions caused by the COVID-19 pandemic. Pesticide ingredients may not be subject to as much media coverage as consumer products, but in the end, could have impacts affecting availability of disinfectants and other pesticide products. In the broader economy, supply-chain issues have been identified as a factor affecting the availability of pesticides used to help meet the food and fiber production needs of the nation, along with concerns about freight capacity limiting the normal distribution of crop inputs and ultimately affecting the movement of finished crops.
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, 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.
By Sheryl Lindros Dolan
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.
By Lynn L. Bergeson
On October 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA developed an alternative strategy designed to reduce the risks posed by hazardous inert ingredients in pesticide products more effectively than by disclosure rulemaking. EPA outlined its strategy in a May 22, 2014, letter to the petitioners, which is available online. Many of the 72 inert ingredients targeted for removal are on the list of 371 inert ingredients identified by the petitioners as hazardous. The 72 chemicals are not currently being used as inert ingredients in any pesticide product. The list of chemicals is available online.
Ingredients that are directly responsible for controlling pests such as insects or weeds are called active ingredients. An inert ingredient is any substance that is intentionally included in a pesticide that is not an active ingredient. Comments are due November 21, 2014. General information on inert ingredients can be found online.