[Federal Register Volume 65, Number 12 (Wednesday, January 19, 2000)]
[Notices]
[Pages 2947-2948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1063]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00621; FRL-6385-7]


Pesticides: Data Submitter Rights for Data Submitted in Support 
of Tolerance Actions; Notice of Availability

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  EPA is announcing the availability for comment of a paper 
discussing options to enable the Agency to appropriately implement the 
new provisions contained in section 408(i) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA) to address exclusive use and compensation 
rights for data submitted to EPA in support of tolerance and tolerance 
exemption actions.

DATES:  Comments, identified by docket control number OPP-00621, must 
be received on or before March 20, 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. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00621 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  Cameo G. Smoot, Field and External 
Affairs Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 305-5454; fax number: (703) 305-5884; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to you if you submit data to EPA in support of 
establishing or maintaining tolerances for pesticides, or are a 
pesticide registrant or a person applying for pesticide registration 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
You may also be interested in commenting if you submit data to EPA in 
support of an exemption from a tolerance. 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 applicability of this action to a particular 
entity, 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 certain other related documents that might be available 
electronically, 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/. You may obtain a copy of the options paper titled ``Data 
Submitter Rights for Data Submitted in Support of Tolerance Actions'' 
described in this notice by accessing this Federal Register notice 
using the Federal Register--Environmental Documents cite on the EPA's 
Internet and selecting ``Related Documents.'' Hard copies of the 
options paper are available by consulting with the person listed under 
``FOR FURTHER INFORMATION CONTACT.''
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-00621. 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 Hwy., 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-00621 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, 401 M St., SW., 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 Hwy., 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: ``[email protected],'' or you can submit a computer disk as 
described in this unit. 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-00621. 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

[[Page 2948]]

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 rule or collection 
activity.
    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. What Action is the Agency Taking?

    EPA is making available for comment an options paper on exclusive 
use and data compensation rights for data submitted to the Agency in 
support of tolerance and tolerance exemption actions. As part of the 
Food Quality Protection Act of 1996, Congress amended section 408(i) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) addressing such 
rights. The Agency is currently evaluating how to implement this new 
provision and is seeking public comment. The options paper briefly 
discusses the new section 408(i) of the FFDCA and the Agency's 
practices regarding data compensation and exclusive use; the current 
compensation and exclusive use process the Agency implements under 
section 3 of the FIFRA, and presents three options for implementing the 
new provision. The options represent different interpretations focusing 
on who the data submitters may be. However, the Agency also seeks 
comments on other interpretations of section 408(i) and suggested 
procedures for implementing any option. Commenters are particularly 
encouraged to offer suggestions for workable procedures for their 
preferred options.
    EPA will consider the comments received and develop a detailed 
proposal for implementing data rights under section 408(i) of FFDCA.

List of Subjects

    Environmental protection, Pesticide tolerances, Data compensation.

    Dated: January 5, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-1063 Filed 1-18-00; 8:45 am]
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