Policy on Voluntary Disclosure of Antimicrobial Ingredient Information on Company Websites or Labels
Overview
The U.S. Environmental Protection Agency (EPA) allows registrants of antimicrobial pesticides to voluntarily disclose all inert ingredients on their product labels and/or through a company website.
Disclosure of inert ingredients is voluntary. There is no statutory or regulatory requirement at the federal level to identify inert ingredients except where it has been required on a case-by-case basis. In such cases, the following information does not apply.
EPA allows registrants to use alternate nomenclature to disclose inert ingredients.
Registrants can choose to disclose inert ingredients in three ways:
- 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.
This is policy is effective as of Jan. 16, 2020.
Inert Ingredient Disclosure on Pesticide Labeling
EPA regulates pesticide product labels under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). False and misleading statements on pesticide labeling are a violation of FIFRA’s provisions against misbranding. See FIFRA sections 2(q) and 12(a)(1)(E).
Registrants should not disclose a partial list of inert ingredients. Selectively disclosing only those ingredients widely known to be safe (e.g., water) may in some cases mislead consumers regarding the safety of the entire formulation. Thus, EPA’s longstanding policy per the Label Review Manual is 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.”
The inert ingredient statement should not crowd or obscure required label information. To avoid being considered misbranded, information required by FIFRA must be presented such that it is “likely to be read and understood by the ordinary individual under customary conditions of purchase and use” (40 CFR § 156.10(a)(2)). EPA encourages registrants to list inert ingredients directly below the ingredient statement in descending order by weight, in a location that does not interfere with the required labeling information.
If space is limited, 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.”.
For additional guidelines on formatting for ingredient statements, please see Chapter 5 of the Label Review Manual.
Alternate Nomenclature
Registrants can choose to use alternate chemical nomenclature for disclosing inert ingredients on labels and websites. EPA strongly encourages registrants that choose to use alternate nomenclature to use the following sources:
- U.S. Environmental Protection Agency Inerts List
- International Union of Pure and Applied Chemistry (IUPAC);
- Chemical Abstracts Service (CAS); or
- Consumer Product Ingredients Database’s Directory Exit
Inert Ingredient Disclosure on Websites
Any website referenced directly on a product label (for example, through a URL or QR code) is legally considered labeling under FIFRA and is subject to Agency review. Claims made on these websites are bound by the same requirements as product labels. To add a reference to a website on a product label, follow the application process outlined below. This involves including the provided disclaimer on the website and self-certifying that the information provided on the website is consistent with the latest Confidential Statement of Formula (CSF).
Websites that are not directly referenced on product labels should be consistent with the product label. If the website includes claims that substantially differ from what EPA approved during the registration process, that may result in the product being in violation of FIFRA.
Companies do not need to amend their master label or notify EPA before adding an inert ingredient statement to a website provided the site is not referenced on the product label. In such cases, the application process outlined below does not apply.
Application Process for Voluntary Inert Ingredient Disclosure
Inert ingredient disclosure applications should be submitted via a non-PRIA amendment. No other actions should be included with the inert ingredient disclosure application. As EPA gains experience reviewing this type of non-PRIA amendment, we may allow inert ingredient disclosure applications to be included with other actions.
The following information should be included as part of the application:
- For applications to add alternative nomenclature to the labels:
- Spreadsheet linking the current CSF nomenclature to any alternate inert ingredient nomenclature, CAS number, reference database name and website link for alternate nomenclature as confirmation that the current CSF nomenclature and alternate nomenclature are synonyms of each other (i.e., the exact same inert ingredient). See an example.
- Cover letter identifying the proposed change(s) 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 labels:
- 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. Sec. 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. Sec. 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. Sec. 136(j) and 136(l).”
- For applications to add or change a website or QR code to include inert information:
- 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. Sec. 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. Sec. 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. Sec. 136(j) and 136(l).
Additional Regulatory Information
The information on this website is consistent with the memorandum to OPP staff from Alexandra Dapolito Dunn, Esq., Assistant Administrator, dated December 10, 2020.
With the release of this updated policy for inert ingredient disclosure described above, the Agency has decided to discontinue the 2011 pilot project allowing for disclosure of inert ingredients for antimicrobial products.
Currently, the scope of this voluntary inert ingredient disclosure process is limited to antimicrobial pesticide products; however, the Agency may consider expanding its process to conventional pesticides and biopesticide products.
Labeling is defined in FIFRA Section 2(p)(2), 7 U.S.C. Sec. 136(p)(2), in part, as meaning labels and all other written, printed, or graphic material accompanying a pesticide or device at any time or to which reference is made on the label or in accompanying literature.
Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, defoliant, or nitrogen stabilizer, within the definition at FIFRA Section 2(b). Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than the active ingredient, which is intentionally included in a pesticide product. 40 C.F.R. § 158.300.
FIFRA Section 2(q)(1)(A), 7 U.S.C. Sec. 136(q)(1)(A), states that a pesticide is misbranded if its labeling bears any statement that is false or misleading. That includes statements related to the pesticide’s ingredients.
Inert ingredients are not required to be identified in the ingredient statement except when EPA determines that such inert ingredients may pose a hazard to man or the environment, 40 C.F.R. § 156.10(g)(7). In such a situation, 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”).
As specified in FIFRA Section 2(q)(1)(E), 7 U.S.C. Sec. 136(q)(1)(E), the product could be considered misbranded if the information required by FIFRA “is not prominently placed [ ] with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling)” that it is “likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” If a registrant chooses to voluntarily disclose inert ingredients on the label, they should list all of the inert ingredients directly below and separate from the ingredient statement in descending order by weight, so that it does not interfere with the required labeling information.