[Federal Register Volume 66, Number 153 (Wednesday, August 8, 2001)]
[Notices]
[Pages 41587-41589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19573]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34243; FRL-6789-3]


Thiophanate-methyl; Availability of Risk Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of risk assessments 
that were developed as part of EPA's process for making pesticide 
Reregistration Eligibility Decisions (REDs) and tolerance reassessments 
consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA). These risk 
assessments are the human health and ecological risk assessments and 
related documents for thiophanate-methyl. This notice also starts a 60-
day public comment period for the risk assessments. By allowing access 
and opportunity for comment on the risk assessments, EPA is seeking to 
strengthen stakeholder involvement and help ensure decisions made under 
FQPA are transparent and based on the best available information. The 
tolerance reassessment process will ensure that the United States 
continues to have the safest and most abundant food supply.

DATES: Comments, identified by the docket control number OPP-34243 for 
thiophanate-methyl, must be received on or before October 9, 2001.

[[Page 41588]]


ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit II. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify the docket control 
number for thiophanate-methyl, OPP-34243, in the subject line on the 
first page of your response.

FOR FURTHER INFORMATION CONTACT: Deanna Scher, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-7043; 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, nevertheless, a 
wide range of stakeholders will be interested in obtaining the risk 
assessments for thiophanate-methyl, including environmental, human 
health, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the use of pesticides on 
food. Since other entities also may 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/. 
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/. In 
addition, copies of the pesticide risk assessments released to the 
public may also be accessed at http://www.epa.gov/pesticides/reregistration/status.htm.
    2. In person. The Agency has established an official record for 
this action under docket control numbers OPP-34243. The official record 
consists of the documents specifically referenced in this action, 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.

II. How Can I Respond to this Action?

A. 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 for the specific chemical of 
interest in the subject line on the first page of your response.
    1. By mail. Submit comments to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver comments to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division, Office of Pesticide Programs, 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. Submit electronic comments 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. Electronic comments must be submitted as an ASCII file, 
avoiding the use of special characters and any form of encryption. 
Comments and data will also be accepted on standard computer disks in 
WordPerfect 6.1/8.0/9.0 or ASCII file format. All comments in 
electronic form must be identified by the docket control number of the 
chemical of specific interest. Electronic comments may also be filed 
online at many Federal Depository Libraries.

B. How Should I Handle CBI Information 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 listed under FOR FURTHER INFORMATION CONTACT.

III. What Action is the Agency Taking?

    EPA is making available to the public the risk assessments that 
have been developed as part of the Agency's interim public 
participation process for tolerance reassessment and reregistration. 
During the next 60 days, EPA will accept comments on the human health 
and ecological risk assessments and other related documents for 
thiophanate-methyl, available in the individual pesticide docket. Like 
other REDs for pesticides developed under the interim process, the 
Thiophanate-methyl RED will be made available for public comment.
    EPA and USDA have been using a pilot public participation process 
for the assessment of organophosphate pesticides since August 1998. In 
considering how to accomplish the movement from the current pilot being 
used for the organophosphate pesticides to the public participation 
process that will be used in the future for non-organophosphates, such 
as thiophanate-methyl, EPA and USDA have adopted an interim public 
participation process. EPA is using this interim process in reviewing 
the non-organophosphate pesticides scheduled to complete tolerance 
reassessment and reregistration in 2001 and early 2002. The interim 
public participation process ensures public access to the Agency's risk 
assessments while also allowing EPA to meet its reregistration 
commitments. It takes into account that the risk assessment development 
work

[[Page 41589]]

on these pesticides is substantially complete. The interim public 
participation process involves: A registrant error correction period; a 
period for the Agency to respond to the registrant's error correction 
comments; the release of the refined risk assessments and risk 
characterizations to the public via the docket and EPA's internet 
website; a significant effort on stakeholder consultations, such as 
meetings and conference calls; and the issuance of the risk management 
decision document (i.e., RED) after the consideration of issues and 
discussions with stakeholders. USDA plans to hold meetings and 
conference calls with the public (i.e., interested stakeholders such as 
growers, USDA Cooperative Extension Offices, commodity groups, and 
other Federal government agencies) to discuss any identified risks and 
solicit input on risk management strategies. EPA will participate in 
USDA's meetings and conference calls with the public. This feedback 
will be used to complete the risk management decisions and the RED. EPA 
plans to conduct a close-out conference call with interested 
stakeholders to describe the regulatory decisions presented in the RED. 
REDs for pesticides developed under the interim process will be made 
available for public comment.
    Included in the public version of the official record are the 
Agency's risk assessments and related documents for thiophanate-methyl. 
As additional comments, reviews, and risk assessment modifications 
become available, these will also be docketed. The thiophanate-methyl 
risk assessments reflect only the work and analysis conducted as of the 
time they were produced and it is appropriate that, as new information 
becomes available and/or additional analyses are performed, the 
conclusions they contain may change.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: June 15, 2001.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 01-19573 Filed 8-7-01; 8:45 a.m.]
BILLING CODE 6560-50-S