E9-29333. Design for the Environment and Factual Product Label Statement Pilot Programs for Antimicrobial Pesticide Products

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Two Workgroups of the Pesticide Program Dialogue Committee (PPDC) worked throughout 2009 on possible pilot programs for certain factual label statements and logos for antimicrobial pesticide products. The Workgroup included representatives from pesticide manufacturers (registrants), State pesticide regulatory agencies, U.S. Department of Agriculture Cooperative Extension Service, environmental and public advocacy groups, EPA’s Office of Pesticide Programs (OPP), and others. With this notice, EPA's Office of Pesticides Programs is announcing the development of two voluntary pilot Programs.

FOR FURTHER INFORMATION CONTACT:

Michael Hardy, Office of Pesticide Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. Background

A. What Action Is the Agency Taking?

OPP worked collaboratively with the PPDC Workgroup to explore the different types of statements and the design fror the environment (DfE) logo on antimicrobial pesticide product labels. OPP has agreed to develop two voluntary pilot Programs. No antimicrobial registrant is required to participate in any of these pilots as they are both voluntary pilots.

The following describes the pilots, including their duration. Detailed instructions about applying for either of the pilots are available on OPP’s Web site at www.epa.gov/​pesticides.

1. Factual label statement pilot program. Increasingly, OPP has faced reviewing pesticide labels that contain purportedly factual statements that imply safety or environmental preferability of products. In each case, OPP must determine that the statements are not false or misleading before approving the label in accordance with FIFRA sections 2(q)(1)(A) and 3(c)(5)(B). This determination is rarely easy in the absence of any data on consumer perceptions of such claims. In order to increase the efficiency of such determinations, OPP and the PPDC workgroup on factual statements attempted to identify types of factual claims that would generally not be misleading and thus could be easily reviewed and approved by OPP.

At this time, the Agency has determined that only a subset of the initially considered factual statements would be generally acceptable on antimicrobial pesticide labels. In order for OPP to approve factual statements that imply safety or environmental preferability outside of this subset, registrants should provide information demonstrating that the statement is true and that consumers and users will not infer more meaning from the statement than what can affirmatively be proven to be true.

This pilot will permit the addition of the following factual statements to antimicrobial pesticide product labels when the terms of OPP’s pilot are met by registrants.

a. Dyes and/or fragrance free statements. OPP will permit for the purposes and duration of this pilot the following label statements to be placed on qualifying antimicrobial pesticide products: “Dye-free,” “Fragrance-free,” and “Dye and fragrance free.” Registrants applying for this pilot must submit as part of their application the current Confidential Statement of Formula (CSF) and a draft label with the new statements. OPP will examine the CSF to verify the dye/fragrance free claim prior to granting use of the label. Upon initial pre-acceptance of the statement(s) by OPP, a final printed label must be submitted to the Agency before the labeling is stamped acceptable.

b. Corporate commitment statements. OPP will permit for the purposes and duration of this pilot the following label statement to be placed on qualifying antimicrobial pesticide products:

For technical assistance or information on [INSERT THE NAME OF THE COMPANY] environmental/sustainability initiatives, go to [INSERT COMPANY WEBSITE].

Registrants applying for this pilot must submit as part of their application a link to their company’s website and their product’s draft label with the new statement. Upon initial pre-acceptance of the statement(s) by OPP, a final printed label must be submitted to the Agency before the labeling is stamped acceptable.

The Agency has decided to allow the addition of information concerning product packaging of an antimicrobial pesticide product, such as the recycled content of the product’s packaging in lieu of a pilot. The Agency examined OPP’s existing Pesticide Registration Notice (PRN) 98-10 “Notifications, Non-Notifications and Minor Formulation Amendments” (http://www.epa.gov/​PR_​Notices/​pr98-10.pdf). The following guidance is given in PRN 98-10 under section IV. Non-Notifications, H. Product Packaging, 1. Recycled Content:

A statement about the recycled content of pesticide packaging itself may be made in accordance with guidance from the Federal Trade Commission.” The Agency has concluded that PRN 98-10 sufficiently provided for label statements about product packaging, and therefore recycled content of product packaging additions may be made through the notification process at any time.

To be considered for this pilot, applicants must adhere to all the terms of the pilot, submit all of the applicable forms and fees (if necessary), and follow the pilot’s mailing/delivery instructions. Please see the detailed instructions on applying for this pilot at http://www.epa.gov/​pesticides.

If EPA determines, at any time during the pilots, that a company is making violative claims either on the product label or associated web sites, the company will be subject to enforcement action under FIFRA and other applicable laws. EPA may exclude any company deemed to be in violation from further participation in either of the pilots.

OPP will start accepting product label amendment applications for the factual label statements pilot program on January 25, 2010. If OPP decides not to allow use of approved factual statements at the end of this pilot, then the last day that pesticide products participating in this pilot can be released for shipment is May 3, 2013.

2. OPP-DfE logo pilot program. OPP is working with EPA’s DfE program in the Office of Pollution Prevention and Toxics (OPPT) to empower consumers to make informed choices when purchasing antimicrobial pesticide products, and encourage registrants to develop pesticide formulations that are at the lower end of the toxicity spectrum.

Participation in this pilot is targeted towards antimicrobial pesticide products that are either Acute Toxicity Categories 3 or 4. In general, Antimicrobial pesticide products with the following characteristics would likely not qualify:

a. Are classified as acute toxicity category 1 or 2.

b. Have known, likely, or suggestive carcinogens.

c. Have known developmental, reproductive, mutagenic, or neurotoxicity issues.

d. Have significant, outstanding data issues for the active ingredient and/or product.

e. The label requires use of personal protective equipment.

Additional criteria can be found at http://www.epa.gov/​pesticides. Participation in the pilot will require both a review under the DfE program as well as OPP’s review of the registration application. Registrants must first submit their products to the DfE program for review along with any data necessary to prove that the product is eligible for recognition under their criteria. Once the DfE program determines that the product meets their program’s criteria, the registrant must then submit to OPP their amendment request, including their draft label with the OPP-DfE logo. OPP will not accept applications that have not completed the DfE review. Details on how to apply for this pilot can be found at http://www.epa.gov/​pesticides.

The new OPP-DfE logo established by EPA may be added to products only when registrants meet the terms of the OPP-DfE Pilot. The acceptable label statement accompanying the OPP-DfE logo is:

For further information concerning the DfE for Pesticides Program, go to http://www.epa.gov/​pesticides.

OPP is creating this OPP-DfE Website to reduce any potential confusion by consumers or registrants between the Pesticides DfE Program and the existing DfE Program for non-pesticide products.

Participation in this pilot requires the submission of a complete application for a PRIA regulatory application and, therefore, is subject to the applicable fees under the Pesticide Registration Improvement Act (PRIA). OPP will complete its review of the amendment according to the PRIA timeframe. To be considered for this pilot, applicants must adhere to all the terms of the pilot, submit all of the applicable forms and fees, and follow the pilot’s mailing/delivery instructions. Please see the detailed instructions on applying for this pilot at http://www.epa.gov/​pesticides.

The DfE program will start accepting applications for the OPP-DfE Logo pilot on December 9, 2009. OPP will start accepting product amendment applications starting on May 3, 2010. This pilot ends on May 3, 2013, and the last day that pesticide products participating in this pilot can be released for shipment is May 3, 2013.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: December 3, 2009.

Martha Monell,

Acting Director, Office of Pesticide Programs.