98-21037. Guidance for Identifying Pesticides That Have a Common Mechanism of Toxicity; Notice of Availability and Solicitation of Public Comments

[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Pages 42031-42032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21037]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00542; FRL-5797-9]


Guidance for Identifying Pesticides That Have a Common Mechanism 
of Toxicity; Notice of Availability and Solicitation of Public Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and solicitation of public comments.

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SUMMARY: EPA is soliciting comments on a proposed pesticide policy 
guidance document entitled ``Guidance for Identifying Pesticide 
Chemicals That Have a Common Mechanism of Toxicity, for Use in 
Assessing the Cumulative Toxic Effects of Pesticides.'' This proposed 
guidance document was developed from a background document that was 
announced and made available to the public for comment, and discussed 
publicly at the Federal Insecticide, Fungicide, and Rodenticide (FIFRA) 
Science Advisory Panel (SAP) meeting of March 19-20, 1997. Interested 
parties may request a copy of the Agency's proposed guidance document 
as set forth in the ADDRESSES unit of this Notice.

DATES: Comments must be received by September 8, 1998.

ADDRESSES: By mail, submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: [e-mail]. Follow the instructions under Unit IV. of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential 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.

[[Page 42032]]

A copy of the comment that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential 
will be included in the public docket by EPA without prior notice. The 
public docket is available for public inspection in Rm. 119 at the 
Virginia address given above, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.
    This Notice and the proposed guidance document described herein are 
available by mail or electronically. To obtain electronic copies follow 
the instructions listed under Unit I. of this document. To obtain 
copies by mail contact: Elizabeth Doyle, Office of Pesticide Programs, 
Health Effects Division (7509C), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location, telephone number, and 
e-mail address: Rm. 718G, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA, [phone], e-mail: 
[e-mail].

FOR FURTHER INFORMATION CONTACT: Elizabeth Doyle at the address or 
telephone number listed above.

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

A. Internet

    Electronic copies of this document and the guidance document are 
available from the EPA Home Page at the Federal Register--Environmental 
Documents entry for this document under ``Laws and Regulations'' 
(http://www.epa.gov/fedrgstr/). Copies are also available 
electronically from EPA's Office of Pesticide Programs Home Page 
(http://www.epa.gov/pesticides) under ``FQPA, Science Issues.''

B. Fax-On-Demand

    Using a faxphone call 202-401-0527 and select item 6055 for a copy 
of the guidance document.

II. Background

    This Federal Register notice announces the availability of the 
proposed EPA pesticide policy guidance document entitled ``Guidance for 
Identifying Pesticide Chemicals That Have a Common Mechanism of 
Toxicity, for Use in Assessing the Cumulative Toxic Effects of 
Pesticides.'' This guidance document was developed by EPA in response 
to the recent amendments to FIFRA and the Federal Food, Drug, and 
Cosmetic Act (FFDCA) as promulgated by the Food Quality Protection Act 
of 1996 (FQPA). These amendments require EPA to consider in their 
process of determining safety of a given pesticide the possibility of 
cumulative toxic effects resulting from aggregate exposure to the 
pesticide and other pesticides that are toxic from a common mechanism. 
Hence, in assessing the risks posed by a given pesticide, EPA must also 
assess the combined risks to human health that can result from exposure 
to the pesticide and other pesticides that have a common mechanism of 
toxicity. The guidance document describes the approach that EPA will 
use for identifying and categorizing pesticide chemicals that have 
common mechanisms of toxicity for purposes of assessing the cumulative 
toxic effects of such pesticides. Specifically, the proposed guidance 
document describes:
     EPA's interpretation of common mechanism of toxicity with 
respect to making a determination of safety under FFDCA as amended by 
FQPA.
     The specific steps that need to be taken for identifying, 
inferring, or refuting a common mechanism of toxicity.
     The types of data (and their sources) that are needed for 
doing so.
     How these data are to be used in making decisions 
regarding common mechanisms of toxicity.
     Factors that will be considered when conducting combined 
risk assessments that characterize whether or not cumulative toxic 
effects can reasonably be expected to occur following exposure to two 
or more pesticide substances that are toxic from a common mechanism.

III. Comments

    All public comments concerning the background document were 
presented to the FIFRA Scientific Advisory Panel prior to the March 
1997 meeting. The background document and comments were discussed 
openly at the meeting. Changes recommended by the Panel concerning the 
background document were fully considered by EPA when finalizing the 
guidance document. The recommended changes, as well as a summary of the 
Agency's responses to the changes, are filed in public docket.

IV. Public Record and Electronic Submissions

    The official record for this action, as well as the public version, 
has been established for this action under docket control number ``OPP-
00542'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The 
official record is located at the Virginia address in ``ADDRESSES'' at 
the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [e-mail]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number ``OPP-00542.'' Electronic comments on this 
document may be filed online at many Federal Depository Libraries.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: July 23, 1998.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.

[FR Doc. 98-21037 Filed 8-5-98; 8:45 am]
BILLING CODE 6560-50-F