[Federal Register Volume 65, Number 140 (Thursday, July 20, 2000)]
[Notices]
[Pages 45055-45056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18516]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00670; FRL-6598-7]


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 2-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act 
(FQPA) Scientific Advisory Panel (SAP) to review a set of scientific 
issues being considered by the Agency pertaining to an assessment of 
the human carcinogenic potential of malathion. 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 that appropriate arrangements can be made.

DATES: The meeting will be held on August 17 and 18 from 8:30 a.m. to 
4:30 p.m.

ADDRESSES: The meeting will be held at Holiday Inn--Ballston, 4610 
North Fairfax Drive, Arlington, VA. The telephone number for the 
Holiday Inn Hotel is: (703) 243-9800.
    Requests to participate may be submitted by mail, electronically, 
or inperson. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, your request must identify docket control number 
OPP-00670 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Paul Lewis, Designated Federal 
Official, Office of Science Coordination and Policy (7101C), 
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].

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 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. A meeting agenda and copies of EPA primary 
background documents for the meeting will be available by mid-July. You 
may obtain electronic copies of this document, 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-00670. The 
administrative record consists of the documents specifically referenced 
in this notice, any public comments received during an applicable 
comment period, and other information related to an assessment of the 
carcinogenic potential of malathion, including any information claimed 
as Confidential Business Information (CBI). This administrative

[[Page 45056]]

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 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 a.m. to 4 p.m., 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-00670 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 advanced written request to the 
person listed under ``FOR FURTHER INFORMATION CONTACT,'' interested 
persons may be permitted by the Chair of the FIFRA SAP 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 length 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 should notify the person listed under 
``FOR FURTHER INFORMATION CONTACT'' and submit 40 copies of the summary 
information. 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-00670. 
You may also file a request online at many Federal Depository 
Libraries.

II. Background

A. Purpose of the Meeting

    This 2-day meeting concerns the evaluation of the human 
carcinogenic potential of malathion. In accordance with the EPA 
Guidelines for Carcinogen Risk Assessment (Preliminary Draft, July 
1999), the EPA, Office of Pesticide Programs, has proposed to classify 
malathion as having ``suggestive evidence of carcinogenicity but not 
sufficient to assess human carcinogenic potential'' by all routes of 
exposure. This classification was based on the following factors: (1) 
occurrence of liver tumors in male and female B6C3F1 mice and in female 
Fischer 344 rats only at excessive doses; (2) the presence of a few 
rare tumors, oral palate mucosa in females and nasal respiratory 
epithelium in male and female Fischer 344 rats. These tumors cannot be 
distinguished as either treatment-related or due to random occurrence; 
(3) the evidence for mutagenicity is not supportive of a mutagenic 
concern in carcinogenicity; and (4) malaoxon, a structurally-related 
chemical, is not carcinogenic in male or female Fischer 344 rats. With 
the exception of one nasal and one oral tumor in female rats, all other 
tumor types were determined to occur at excessive doses or were 
unrelated to treatment with malathion. The toxicology data considered 
included chronic toxicity, carcinogenicity, subchronic toxicity, and 
mutagenicity studies on malathion and as well as carcinogenicity and 
mutagenicity studies on malaoxon.

B. Panel Report

    Copies of the Panel's report of their recommendations will be 
available approximately 45 working days after the meeting, and 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: July 13,2000.
Steven Galson,
Director, Office of Science Coordination and Policy, Office of 
Pesticide Programs.
[FR Doc. 00-18516 Filed 7-18-00; 1:23 pm]
BILLING CODE 6560-50-F