[Federal Register Volume 66, Number 155 (Friday, August 10, 2001)]
[Notices]
[Pages 42218-42219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20134]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00733; FRL-6797-4]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act 
(FQPA) Scientific Advisory Panel (SAP) review sets of issues being 
considered by the Agency pertaining to: Preliminary Cumulative Hazard 
and Dose-Response Assessment for Organophosphorus Pesticides: 
Determination of Relative Potency and Points of Departure for 
Cholinesterase Inhibition, and Common Mechanism of Action for 
Thiocarbamates and Dithiocarbamates. The meeting is open to the public. 
Seating at the meeting will be on a first-come basis. Individuals 
requiring special accommodations at this meeting, including wheelchair 
access, should contact Paul Lewis at the address listed under FOR 
FURTHER INFORMATION CONTACT at least 5 business days prior to the 
meeting, so appropriate arrangements can be made.

DATES: The meeting will be held from September 5 through September 7, 
2001, from 8:30 am to 5 p.m., as follows:
    September 5 and 6, 2001--Session I-Preliminary Cumulative Hazard 
and Dose-Response Assessment for Organophosphorus Pesticides: 
Determination of Relative Potency and Points of Departure for 
Cholinesterase Inhibition.
    September 7, 2001--Session II-Common Mechanism of Action for 
Thiocarbamates and Dithiocarbamates.

ADDRESSES: The meeting will be held at the Sheraton Crystal City Hotel, 
1800 Jefferson Davis Highway, Arlington, VA 22202. The telephone number 
for the Sheraton Crystal City Hotel is (703) 486-1111.
    Requests to participate 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, your request must identify docket control number 
OPP-00733 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Paul Lewis or Larry Dorsey, Designated 
Federal Officials, Office of Science Coordination and Policy (7202), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5369; fax number: 
(703) 605-0656; e-mail address: [email protected] or 
[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 persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), FIFRA and FQPA. 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. A meeting agenda is now available; EPA's primary 
background documents should be available by late August. In addition, 
the Agency may provide additional background documents as the material 
becomes available. You may obtain electronic copies of these documents, 
and certain other related documents that might be available 
electronically, from the FIFRA SAP Internet Home Page at http://www.epa.gov/scipoly/sap. To access this document on the Home Page 
select Federal Register notice announcing this meeting. You can also go 
directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an administrative record 
for this meeting under docket control number OPP-00733. The 
administrative record consists of the documents specifically referenced 
in this notice, any public comments received during an applicable 
comment period, and other material information, including any 
information claimed as Confidential Business Information (CBI). This 
administrative record includes the documents that are physically 
located in the docket, as well as the documents that are referenced in 
those documents. In addition, the Agency may provide additional 
background documents as the material becomes available. The public 
version of the administrative record, which includes printed, paper 
versions of any electronic comments that may be 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 am to 4 pm, 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is (703) 305-5805.

C. How Can I Request to Participate in this Meeting?

    You may submit a request to participate in this meeting through the 
mail, in person, or electronically. Do not submit any information in 
your request that is considered CBI. To ensure proper receipt by EPA, 
it is imperative that you identify docket control number OPP-00733 in 
the subject line on the first page of your request. Interested persons 
are permitted to file written statements before the meeting. To the 
extent that time permits, and upon advance written request to the 
person listed under FOR FURTHER INFORMATION CONTACT, interested persons 
may be permitted by the Chair of the FIFRA Scientific Advisory Panel to 
present oral statements at the meeting. The request should identify the 
name of the individual making the presentation, the organization (if 
any) the individual will represent, and any requirements for 
audiovisual equipment (e.g., overhead projector, 35 mm projector, 
chalkboard, etc.). There is no limit on the extent of written comments 
for consideration by the Panel, but oral statements before the Panel 
are limited to approximately 5 minutes. The Agency also urges the 
public to submit written comments in lieu of oral presentations. 
Persons wishing to make oral and/or written statements at the meeting 
should contact the person listed under FOR

[[Page 42219]]

FURTHER INFORMATION CONTACT and submit 30 copies of their presentation 
and/or remarks to the Panel. The Agency encourages that written 
statements be submitted before the meeting to provide Panel Members the 
time necessary to consider and review the comments.
    1. By mail. You may submit a request 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. 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 request electronically by e-
mail to: [email protected]. Do not submit any information 
electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or 
ASCII file format and avoid the use of special characters and any form 
of encryption. Be sure to identify by docket control number OPP-00733. 
You may also file a request online at many Federal Depository 
Libraries.

II. Background

A. Purpose of the Meeting

Session I--Preliminary Cumulative Hazard and Dose-Response Assessment 
for Organophosphorus Pesticides--Determination of Relative Potency and 
Points of Departure for Cholinesterase Inhibition
    The Food Quality Protection Act (FQPA) of 1996 requires EPA to 
consider the cumulative effect to human health that can result from 
exposure to pesticides that have a common mechanism of toxicity. Over 
the last 2 years, the Office of Pesticide Programs (OPP) has presented 
to the FIFRA Scientific Advisory Panel (SAP) for comment proposed 
guidance, tools and methodologies for conducting cumulative risk 
assessments. In September 2000, a case study on 24 organophosphorus 
pesticides was presented to the SAP to demonstrate methods for 
determining the cumulative risk.
    In order to accomplish the reassessment of 66% of pesticide 
tolerances by August 3, 2002, as required by the FQPA, the Agency needs 
to complete the tolerance reassessment for the organophosphorus 
pesticides by performing a cumulative risk assessment for this group. 
Therefore, the Agency intends to complete the Preliminary Cumulative 
Risk Assessment for the Organophosphorus Pesticides by December 2001. 
Toward this end, the Agency has considered the SAP written comments on 
the approach that was outlined in the September 27, 2000 SAP Report 
entitled ``Endpoint Selection and Determination of Relative Potency in 
Cumulative Hazard and Dose-response Assessment: A Pilot Study of 
Organophosphorus Pesticide Chemicals'' (This and related reports can be 
obtained at the SAP web site at http://www.epa.gov/scipoly/sap.). The 
current document has revised the relative potency factor analysis by 
incorporating the recommendations of the SAP.
    The purpose of the current review is to seek comment from the SAP 
on whether the revised hazard and dose-response method on the 
organophosphorus pesticides has adequately addressed the September 2000 
SAP comments.
Session II--Common Mechanism of Action for Thiocarbamates and 
Dithiocarbamates
    At a public meeting held in September 1999, the SAP recommended 
that the Agency address effects of concern reported in studies 
conducted on thiocarbamates and dithiocarbamate pesticides. The Agency 
has since prepared two documents that describe: (1) The Agency's 
cumulative risk assessment of a common assessment group of 
thiocarbamates; and (2) The results of the Agency's evaluation of 
common effects induced by the dithiocarbamates by a common method of 
toxicity. The approach to assessment of thiocarbamates was to identify 
a common effect that might be attributable to a common mechanism and to 
conduct a screening level cumulative dietary (food) assessment to 
determine if grouping them based on the common effect and concurrent 
exposures to the group would reveal the potential for cumulative 
dietary risks. This assessment was conducted using the assumption that 
neuropathological effects induced by the thiocarbamates may be 
attributed to a common mechanism of toxicity. The screening approach 
also assumed 100% of crop treated with each thiocarbamate registered 
for use on crops and used tolerance levels for the exposure component 
of the assessment rather than a more refined estimate of actual 
residues.
    The Agency's analysis of the dithiocarbamates indicated that they 
share a common metabolite that is associated with the induction of a 
common toxicity and that exposure to this group of chemicals will 
require an aggregation of the residue of that metabolite that may be 
formed following treatment of crops with these pesticides.
    The purpose of this session is to seek the SAP's recommendations on 
the Agency work since the September 1999 SAP meeting.

B. Panel Report

    The Agency anticipates that the Panel's report of their 
recommendations will be available approximately 60 days after the 
meeting. The Panel's report will be posted on the FIFRA SAP web site or 
may be obtained by contacting the Public Information and Records 
Integrity Branch at the address or telephone number listed in Unit I. 
of this document.

List of Subjects

    Environmental protection.

    Dated: August 2, 2001.
Andy Privee, Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 01-20134 Filed 8-9-01; 8:45 a.m.]
BILLING CODE 6560-50-S