Guidelines for Voluntary Disclosure of Antimicrobial Ingredient Information on Company Websites and/or Labels

December 2013

Purpose

This document provides guidance to antimicrobial pesticide registrants who voluntarily communicate ingredient information to consumers regarding registered antimicrobial pesticides on their company website and/or product labels. This guidance does not create any binding requirements, although it makes reference to existing statutory and regulatory requirements. The Environmental Protection Agency (“EPA” or the “Agency”) may make changes to this guidance at any time.

Background

EPA is engaged in rulemaking regarding disclosure of the identities of inert ingredients on pesticide labels. In January 2010, the Agency published an Advance Notice of Proposed Rulemaking (http://www.gpo.gov/fdsys/pkg/FR-2010-02-22/pdf/2010-3415.pdf) proposing to increase public availability of the identities of the inert ingredients in pesticide products. In addition, some companies formulating consumer products have begun communicating information to consumers on company websites and/or product labels. Contemporaneous with the rulemaking, EPA has had discussions with the Consumer Specialty Products Association (CSPA) regarding how companies might begin communicating information regarding consumer antimicrobial pesticide ingredients prior to the finalization of this rulemaking.

The result of the discussions between EPA and CSPA is a pilot program for registrants seeking to voluntarily disclose ingredient information on their websites and/or labels based on the guidance provided here. This guidance is a separate activity from the inert ingredient rulemaking, and is neither a substitute for such rulemaking nor a prejudgment regarding the appropriate outcome of such rulemaking.

The document includes two types of guidance:

Guidance regarding useful ways of presenting ingredient information on company websites and on antimicrobial pesticide product labels: This guidance was developed jointly by CSPA and EPA, drawing upon CSPA’s experience with the industry’s voluntary ingredient communication initiative established in January 2010.
Guidance regarding practical considerations companies face when voluntarily disclosing ingredient information on their websites and/or product labels: This guidance was developed solely by the EPA.
Pesticide labeling, as defined in section 2(p) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is subject to EPA’s regulatory authority and includes written and graphic materials that accompany pesticides or are referenced on pesticide labels. Pesticide labeling is subject to the misbranding provisions in FIFRA section 2(q) and 12(a)(1)(E). A pesticide is misbranded under FIFRA section 2(q)(1)(A) if, among other things, its labeling bears any statement, design, or graphic representation which is false or misleading in any particular. EPA has listed examples of label statements that may be considered false or misleading in 40 CFR 156.10(a)(5). Companies must not make false or misleading claims (which may include natural, safer, eco-friendly, etc.) or use false or misleading words or phrases on pesticide labeling. 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. Such misleading disclosures may make the product misbranded.
Information on company websites is not regularly reviewed by EPA, but may be part of the labeling if it is referenced on the product label or materials accompanying the product. Further, under section 12(a)(1)(B) of FIFRA, it is unlawful to sell or distribute a registered pesticide if any claims made for it as a part of its sale or distribution substantially differ from the claims that EPA approved during the registration process. Therefore, even if the website is not referenced on a pesticide’s label, claims cannot be made on the website that substantially differ from what is on the pesticide’s currently approved label. Companies that wish to make changes to pesticide labeling or to request approval of additional claims generally must apply for an amendment to their registration. Some changes may be accomplished through notification, as described in 40 CFR 152.46.

Useful Ways of Presenting Ingredient Information on Company Websites or on Antimicrobial Pesticide Product Labels (Nonbinding Guidance)

See Section D on how to add intentionally added ingredients to the product label.
Companies are encouraged to disclose information on all intentionally added ingredients (see item 8 below). The voluntary disclosure of ingredients on a website is not a substitute for any FIFRA labeling requirements.
If companies voluntarily disclose ingredient information on their website under this pilot, they should include the website address (i.e. the website URL) on the product label.
1. a. When a website address is referenced on the pesticide label or in materials accompanying the pesticide, the website is considered labeling under FIFRA section 2(p)(2). Pesticide labeling is subject to the misbranding provisions of FIFRA section 2(q) and 12(a)(1)(E).
2. b. If the website’s address changes, the Agency expects the label to be changed accordingly. Further, to avoid misleading users, the Agency recommends that the superseded website address redirect to the new address until product referencing the old address has been exhausted.
When registrants display registered products on their website, they should include the EPA registration numbers.
Companies are encouraged to make their ingredient websites bilingual.
Companies should use a widely recognized chemical naming scheme. While EPA does not endorse any specific nomenclature systems for purposes of this guidance, options include the use of chemical names for inert ingredients as given in EPA’s InertFinder database (http://iaspub.epa.gov/apex/pesticides/f?p=175:1:) or as listed in EPA’s Substance Registry System (www.epa.gov/srs/). The use of chemical names as listed in the International Union of Pure and Applied Chemistry (IUPAC) at www.iupac.org, and the Chemical Abstracts Service at http://cas.org/, the International Nomenclature of Cosmetic Ingredients (INCI) at http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=ref_data.functions or the CSPA’s Consumer Products Ingredients Dictionary at www.cspa.org are other options. The Agency suggests that the registrant choose the simplest corresponding ingredient name available in these databases. All ingredient names should be accurate, widely-recognized by the public, non-proprietary and not false or misleading.
A product’s fragrance may be designated as “fragrance” with optional reference to the company’s palette of fragrance ingredients. This is noted since most fragrance ingredients come directly from the fragrance house as proprietary mixtures and the individual components are unknown to the registrant.
The website should include a .pdf of the MSDS or Safety Data Sheet if any ingredient requires listing in accordance with OSHA regulations found at www.osha.gov/dsg/hazcom/SDSitems.html.
Companies should identify ingredients in their alternate formulations.
Companies should maintain the product information website for at least two years after the product is no longer in the channels of trade.

How To Add Voluntary Ingredient Disclosure Information To Antimicrobial Pesticide Product Labeling

A company can add additional labeling statements or inert ingredients to the Ingredients Statement section of the label by submitting an application for an amendment to the registration. The application must state that the amendment is in connection with the Voluntary Ingredient Disclosure effort. The Application for Registration (EPA Form 8570-1) as provided in 40 CFR152.5 should also include copies of revised labeling with the proposed. Provided that the application for amendment does not include any changes requiring the submission of data or other scientific reviews or assessment on the part of the Agency, the amendment does not require the submission of registration service fees under the Pesticide Registration Improvement Act (PRIA). EPA will review the amendment application and determine whether the proposed changes are acceptable. Registrants will be notified in writing of the Agency’s decision.
A company can add a website address to the labeling through the notification process indicating that the notification is in connection with the Voluntary Ingredient Disclosure effort. A label claim describing the purpose of the website can also be added by notification if it is in agreement with PR Notice 98-10.
Registrants may submit a notification as provided in 40 CFR §152.46 in accordance with the procedures in PR Notice 98-10 for each product registration being changed. This action does not require the submission of registration service fees under the Pesticide Registration Improvement Act (PRIA). EPA may review the website to ensure that the language is in agreement with the formulation information on file with the Agency. Should the website not yet contain this information, the registrant should indicate when it is expected that the website will be updated to disclose the active and inert ingredient information. The registrant should submit a copy of the labeling (with changes clearly identified). The application form must bear the following statements:

“Notification of Voluntary Ingredient Disclosure effort per PR Notice 98-10.” “This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula 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 this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under section 12 and 14 of FIFRA.”

Document Submission

When submitting notifications or amendments in connection with the Voluntary Ingredient Disclosure effort, please send the submission to:

Submissions via the U.S. Postal Service: Address the submission using the official mailing address and mail codes below:

Document Processing Desk (Code _______)
Office of Pesticide Programs (7504P)
U. S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Submissions via Hand Delivery or Courier Delivery: Deliveries by you or a commercial courier should be directed to:

Document Processing Desk (Code _______)
Office of Pesticide Programs (7504P)
U. S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202-4501

Contact Information

For information regarding the Voluntary Ingredient Disclosure Guidance, contact:

SanYvette Williams, DVM
Special Assistant/RMB1
EPA/OCSPP/OPP/AD
Ariel Rios Bldg MS (7510P)
1200 PA AVE N.W.
Washington, DC 20460
Williams.sanyvette@epa.gov

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