Document ID: EPA-HQ-OPP-2009-0888-0001
Agency: epa
Document Type: Notice
Title: Design for the Environment and Factual Product Label Statement Pilot Programs for Antimicrobial Pesticide Products
Posted Date: 2009-12-09T05:00Z

[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Notices]               
[Page 65119-65120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de09-49]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0888; FRL-8803-5]

 
Design for the Environment and Factual Product Label Statement 
Pilot Programs for Antimicrobial Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: (703) 308-6432; 
fax number: (703) 308-4776; e-mail address: hardy.michael@epa.gov.

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-

[[Page 65120]]

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.

[FR Doc. E9-29333 Filed 12-8-09; 8:45 am]

BILLING CODE 6560-50-S