[Federal Register Volume 66, Number 168 (Wednesday, August 29, 2001)]
[Notices]
[Pages 45677-45679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21569]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34239; FRL-6783-8]


Lindane; Availability of Preliminary Risk Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of documents that were 
developed as part of EPA's pilot public participation process for 
making reregistration eligibility decisions for the organophosphate and 
certain other, non-organophosphate pesticides and for tolerance 
reassessments consistent with the Federal Food, Drug, and Cosmetic

[[Page 45678]]

Act, as amended by the Food Quality Protection Act of 1996 (FQPA). 
These documents are the preliminary human health and ecological fate 
and effects risk assessments and related documents for lindane. This 
notice starts a 60-day public comment period for the preliminary risk 
assessments. Comments are to be limited to issues directly associated 
with lindane and raised by the risk assessments or other documents 
placed in the docket. By allowing access and opportunity for comment on 
preliminary risk assessments, EPA is seeking to strengthen stakeholder 
involvement and help ensure that our decisions 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. The Agency cautions that 
risk assessments at this stage are preliminary only and that further 
refinements of the risk assessments may be appropriate for this 
pesticide. These documents 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.

DATES: Comments, identified by the docket control number OPP-34239 for 
lindane, must be received on or before October 29, 2001.

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 the docket control 
number for lindane in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Mark Howard, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8172; 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 those persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). 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/. 
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 preliminary risk assessments for 
lindane 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 number OPP-34239. 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.

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 the docket control number for lindane, OPP-34239, 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 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 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-34239. 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 listed 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:

[[Page 45679]]

    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 
document.
    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 Action is the Agency Taking?

    EPA is making available preliminary risk assessments that have been 
developed as part of EPA's process for making reregistration 
eligibility decisions for the organophosphate and other pesticides and 
for tolerance reassessments consistent with the FFDCA, as amended by 
the FQPA. The Agency's preliminary human health and ecological fate and 
effects risk assessments and other related documents for lindane are 
available in the individual pesticide dockets. As additional comments, 
reviews, and risk assessment modifications become available, these will 
also be docketed for lindane.
    The Agency cautions that the lindane risk assessments are 
preliminary only and that further refinements may be appropriate. These 
documents 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.
    The Agency is providing an opportunity, through this notice, for 
interested parties to provide written comments and input to the Agency 
on the preliminary risk assessments for the chemicals specified in this 
notice. Such comments and input could address, for example, the 
availability of additional data to further refine the risk assessments, 
such as percent crop treated information or submission of residue data 
from food processing studies, or could address the Agency's risk 
assessment methodologies and assumptions as applied to this specific 
chemical. Comments should be limited to issues raised within the 
preliminary risk assessments and associated documents. EPA will provide 
other opportunities for public comment on other science issues 
associated with the pesticide tolerance reassessment program. Failure 
to comment on any such issues as part of this opportunity will in no 
way prejudice or limit a commenter's opportunity to participate fully 
in later notice and comment processes. All comments should be submitted 
by October 29, 2001 using the methods in Unit I. of the SUPPLEMENTARY 
INFORMATION. Comments will become part of the Agency record for 
lindane.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: August 2, 2001.
Robert McNally,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 01-21569 Filed 8-28-01; 8:45 am]
BILLING CODE 6560-50-S