Pesticides; Draft Guidance for Pesticide Registrants on Voluntary Pesticide Resistance Management Labeling Based on Mode/Target Site of Action on the Pest

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

EPA has developed guidance for pesticide registrants on voluntary pesticide resistance management labeling based on mode/target site of action for pesticide products that are intended for general agricultural use. This effort will help reduce the development of pesticide resistance based on mode/target site of action and lead to better environmental protection. These guidelines are the result of a joint effort of the United States, Canada, and Mexico under the North American Free Trade Agreement (NAFTA). The guidance provides consistency in resistance management labeling being considered for approval in any or all of the countries involved in NAFTA. The Agency seeks public comment on a draft Pesticide Registration (PR) notice entitled “Draft Guidance for Pesticide Registrants on Voluntary Pesticide Resistance Management Labeling Based on Mode/Target Site of Action on the Pest.” This draft PR notice provides guidance to the registrant concerning schemes of classification of pesticides according to their mode/target site of action, a recommended standard presentation and format for showing group identification symbols on end-use product labels, and labeling resistance management strategies in the use directions.

DATES:

Comments, identified by docket control number OPP-00646, must be received on or before July 10, 2000.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00646 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Sharlene R. Matten (7511C), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 605-0514; fax number: (703) 308-7026; e-mail address: matten.sharlene@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who are required to register pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of This Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document and the draft PR notice from the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/. You can also go directly to the listings from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. Fax-on-demand. You may request a faxed copy of the draft PR notice entitled “Draft Guidance for Pesticide Registrants on Voluntary Pesticide Resistance Management Labeling Based on Mode/Target Site of Action on the Pest,” by using a faxphone to call (202) 401-0527 and selecting item 6124. You may also follow the automated menu.

3. In person. The Agency has established an official record for this action under docket control number OPP-00646. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00646 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically. You may submit your comments electronically by e-mail to: “opp-docket@epa.gov,” or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6, Suite 8, or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00646. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want To Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

A. What Guidance Does This PR Notice Provide?

EPA, Pest Management Regulatory Agency of Canada (PMRA), and Cicoplafest of Mexico are committed to long-term pest resistance management through pesticide resistance management and alternative pest management strategies. Under the auspices of NAFTA, the United States, Canada, and Mexico have joined together to develop and publish guidelines for voluntary pesticide resistance management labeling for implementation in North America. The development of these guidelines is part of the activities of the Risk Reduction Subcommittee of the NAFTA Technical Working Group on Pesticides. A uniform approach across North America will help reduce the development of pesticide resistance and support joint registration decisions by providing consistency in resistance management labeling being considered for approval in any or all of the NAFTA countries. To implement this NAFTA initiative, the Office of Pesticide Programs (OPP) of EPA has developed a draft PR notice describing the voluntary pesticide resistance management labeling guidelines based on mode/target site of action for agricultural uses of herbicides, fungicides, bactericides, insecticides, and acaricides. Mode/target site of action refers to the biochemical mechanism by which the pesticide acts on the pest and should not be interpreted to imply that these chemicals share a common mechanism for purposes of cumulative human health risk assessment under the Food Quality Protection Act. (See EPA's document “Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity” located at http://www.epa.gov/fedrgstr/EPA-PEST/1999/February/Day-05/6055.pdf).

The draft PR notice describes schemes of classification of pesticides according to their mode/target site of action (Appendices I-III) provides a recommended standard presentation and format for showing group identification symbols on end-use product labels, and provides guidelines for labeling resistance management strategies in the use directions.

B. What Questions/Issues Should You Consider?

The issues you should consider are as follows:

1. Proposed general classification schemes based on mode/target site of action for herbicides, fungicides, and insecticides (Appendices I-III).

2. Classification of pesticides with unknown mode/target site of action.

3. Proposed general resistance management labeling statements.

C. Why is a PR Notice Guidance and Not a Rule?

The draft PR notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, and to the public. As a guidance document and not a rule, this policy is not binding on either EPA or any outside parties. Although this guidance document provides a starting point for EPA decisions, EPA will depart from this policy where the facts or circumstances warrant. In such cases, EPA will explain why a different course was taken. Similarly, outside parties remain free to assert that this policy is not appropriate for a specific pesticide or that the specific circumstances demonstrate that this policy should be abandoned.

EPA has stated in this notice that it will make available revised guidance after consideration of public comment. Public comment is not being solicited for the purpose of converting this guidance document into a binding rule. EPA will not be codifying this policy in the Code of Federal Regulations. EPA is soliciting public comment so that it can make fully informed decisions regarding the content of this guidance.

The “revised” guidance will not be an unalterable document. Once a “revised” guidance document is issued, EPA will continue to treat it as guidance, not a rule. Accordingly, on a case-by-case basis EPA will decide whether it is appropriate to depart from the guidance or to modify the overall approach in the guidance. In the course of commenting on this guidance document, EPA would welcome comments that specifically address how the guidance document can be structured so that it provides meaningful guidance without imposing binding requirements.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests