[Federal Register Volume 62, Number 23 (Tuesday, February 4, 1997)]
[Notices]
[Pages 5228-5229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2713]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00461; FRL-5575-3]
Self-Certification of Product Chemistry and Acute Toxicity Data;
Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is soliciting comments on a proposed product chemistry
self-certification program. The proposal is available in a draft
Pesticide Regulation (PR) Notice entitled ``Self-Certification of
Product Chemistry Data'' which is available upon request. Interested
parties may request a copy of the Agency's proposed policy as set forth
in the ADDRESSES unit of this notice.
DATES: Comments must be submitted on or before April 7, 1997.
ADDRESSES: Submit written comments identified by the docket control
number OPP-00461 by mail to: Public Response Section, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring comments directly to the OPP docket which is located in Rm. 1132
of Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PR
Notice is available by contacting the person whose name appears under
FOR FURTHER INFORMATION CONTACT.
Comments may also be submitted electronically by sending electronic
mail (e-mail) to: [email protected]. Electronic comments must
be submitted as an ASCII file avoiding the use of special characters
and any form or encryption. Comments will also be accepted on disks in
WordPerfect in 5.1 file format or ASCII file format. All comments and
data in electronic form must be identified by the docket number ``OPP-
00461.'' No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic comments on this document may be filed
online at many Federal Depository Libraries. Additional information on
electronic submissions can be found in the SUPPLEMENTARY INFORMATION
unit of this document.
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. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice. All written comments will be available for
public inspection in Rm. 1132 at the Virginia address given above from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
[[Page 5229]]
FOR FURTHER INFORMATION CONTACT: For information concerning product
chemistry data: By mail: Sami Malak (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 4th
Floor, CS-1, 2800 Jefferson Davis Highway, Arlington, VA, (703) 308-
8392, e-mail: [email protected].
For information concerning acute toxicity: By mail: Tina Levine
(7505W), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location, telephone
number, and e-mail address: 6th Floor, CS-1, 2800 Jefferson Davis
Highway, Arlington, VA, (703) 308-8393, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Product Chemistry Data
The proposed program entails self-certification of certain product
chemistry data of manufacturing-use products and end-use products
produced by a non-integrated formulation system. Products eligible for
self-certification are formulated from registered sources. This program
is voluntary and is intended to simplify and accelerate the processing
of applications for registration and reregistration while maintaining
protection of public health and the environment.
Under the self-certification program, applicants will submit a one-
page summary of the product's physical/chemical characteristics, a
self-certification statement, and a Good Laboratory Practices
statement, but will no longer be required to submit the supporting data
for those studies. However, registrants must retain in their possession
studies conducted in substantial conformity with Agency guidelines and
must submit such studies if requested by EPA. The requirements
pertaining to the physical/chemical characteristics for chemical
pesticides are outlined in a table under 40 CFR 158.190.
This Federal Register notice announces the availability of the
draft PR Notice and solicits comment on the proposed policy. If, after
reviewing any comments, EPA determines that changes to the Notice are
warranted, the Agency will revise the draft PR Notice prior to release.
II. Acute Toxicity Data
In May 1996, EPA proposed a program whereby industry would self-
certify the results of acute toxicity studies and product labeling for
products in Category III and IV [Notice of Availability (61 FR 26178,
May 24, 1996) and Draft PR Notice entitled ``Self-Certification of
Acute Toxicity Studies'' (May 15, 1996)]. Originally, EPA expected to
implement the program this fall. However, comments received from
industry, environmental groups, and others regarding this proposed
program expressed concerns with the program. The environmental groups
and others felt it would compromise the Agency's oversight role in this
area and was a gateway to further erosion of Agency oversight. The
industry believed that the proposed penalties were too severe. In
addition, when the acute toxicity self-certification program was first
considered, there were over 500 acute toxicity packages pending in the
Agency. There was often a 2-year wait for these reviews. Due to many
reinvention and process improvements which have been adopted, this is
no longer the case. Currently, there are fewer than 90 active acute
toxicity packages pending; fewer than 10 packages have been in review
more than EPA's target review time of 90 days. As a result of these
considerations, EPA has further evaluated the role of self-
certification of acute toxicity data in OPP and has concluded that it
is not necessary to implement this program. Rather, the Agency will
continue to reinvent and improve its internal review processes to
assure that acute toxicity reviews are performed and completed in a
timely manner.
III. Public Record
A record has been established for this action under docket number
``OPP-00461'' (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 public
record is located in Rm. 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this action, as well as the public version,
as described above will be kept in paper form. Accordingly, EPA will
transfer all comments received electronically into printed, paper form
as they are received and will place the paper copies in the official
record which will also include all comments submitted directly in
writing. The official record is the paper record maintained at the
address in ADDRESSES at the beginning of this document.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: January 27, 1997.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 97-2713 Filed 2-3-97; 8:45 am]
BILLING CODE 6560-50-F