01-31250. Pesticides; Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The Agency seeks public comment on a draft Pesticide Registration (PR) Notice titled “Guidelines for Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides.” This draft Notice provides criteria that, if met, can result in a greater number of food use EUPs being issued on an expedited basis for conventional pesticides. EUP applications submitted that meet all of the criteria identified in the Notice will be expedited through the Agency's review process and registrants will not need to utilize their priority slots. The Notice applies to all applicants for EUPs for non-antimicrobial, conventional pesticides. The Notice does not apply to biological pesticides because these pesticides present different risk factors and because the Agency has not heard that the lack of biological pesticide EUPs is an issue.

DATES:

Comments, identified by docket control number OPP-00755, must be received on or before February 19, 2002.

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-00755 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Rachel Holloman, Registration Division (7505C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may be of particular interest to those persons who apply for EUPs for conventional pesticides or are required to submit data to EPA to register pesticides or to establish tolerances for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as to growers and grower groups. 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 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,” “ Regulations and Proposed Rules,” 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 Pesticide Registration (PR) Notice titled “Guidelines for Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides,” by using a faxphone to call [phone] and selecting item [6119]. 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-00755. 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 [phone].

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-00755 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, 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 [phone].

3. Electronically. You may submit your comments electronically by E-mail to: [e-mail], 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 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00755. 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?

The purpose of the proposed PR Notice is to provide criteria that, if met, can result in a greater number of food use EUPs being issued on an expedited basis for conventional pesticides.

Before issuing a new EUP, the Agency must review a subset of the toxicity and exposure data that would otherwise be required for full registration under FIFRA and make several statutory findings. When food is to be treated and allowed to enter domestic commerce under the EUP, EPA must determine (under FFDCA) that “there is a reasonable certainty of no harm” from aggregate exposures to the pesticide, including exposures resulting from use under the EUP. Prior to the passage of the Food Quality Protection Act (FQPA), EPA issued approximately 20 EUPs and established corresponding tolerances each year. Since passage of FQPA, however, the Agency has issued only approximately three EUPs for food uses each year. Information gathered under EUPs can be extremely useful and allow growers and others to gain a better understanding of new and emerging pesticide technologies prior to full market introduction, providing opportunity to refine the product's use. The Agency gains valuable information as well on pesticide alternatives for higher-risk pesticides. This information can be used to support both registration and reregistration decisions EPA must make. In response to requests from interested parties, the Agency undertook an effort to ascertain what conditions and criteria could be developed that would allow for more EUPs, while maintaining EPA's ability to meet the applicable safety findings under FIFRA and FFDCA, resulting in the proposed PR Notice.

B. What Questions/Issues Should You Consider and Provide Specific Comments On and/or Data/Information to Explain Why the Agency Should Make Changes?

1. The Agency is proposing certain acreage limitations based upon a determination that crops treated on these limited acreages would have a marginal impact on both acute and chronic dietary risk. The criteria have been developed in such a way that, if the criteria are satisfied, the Agency can easily determine, based upon existing Agency assessments, that the requisite FIFRA and FFDCA safety findings can be met. How might the Agency expand these limitations, while utilizing existing risk assessments, to ensure that the statutory findings are satisfied? Should the Agency consider a sliding scale of acres per total acres planted of a minor crop? If so, what should that scale be to cover all of the diverse micro-climates, soils, growing seasons and cropping practices for the various commodities across the United States?

2. The Agency is proposing no more than 100 acres per watershed using the U.S. Geological Survey's (USGS) watershed definition as one of the “risk criteria” in this proposal. What might EPA consider as other options, to ensure that this criteria is not too confusing and/or too limiting for certain commodity grower industries and/or in certain states so as not to eliminate the possibility of conducting larger scale EUPs under this program?

3. The Agency has proposed several active ingredient criteria for this program, choosing to initially limit the program to those active ingredients which need evaluation prior to registration to ensure growers that the products are effective alternatives to already registered products they know. Along with those criteria, the Agency has proposed other criteria for this program that, if met, could result in a greater number of food use EUPs being issued on an expedited basis. What other criteria might the Agency consider (i.e., “minor crop priorities” being added to the active ingredient criteria), and why?

4. What else, if anything, might the Agency consider incorporating into the proposed program to ensure that the field efficacy and crop tolerance data for minor crops, needed by registrants to add minor crop uses to their labels after tolerances are granted, are provided?

5. What other conventional chemicals might the Agency consider adding to the proposed “eligible pesticides” listing up front (besides those that will be considered, if submitted, on a case-by-case basis)?

C. PR Notices are Guidance Documents

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers and to pesticide registrants. This notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

List of Subjects

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

Dated: December 6, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.