FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public meeting.

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: lewis.paul@epa.gov.

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 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: “opp-docket@epa.gov.” 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