[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: <a href="/cdn-cgi/l/email-protection#0c637c7c2168636f6769784c697c6d616d656022697c6d226b637a"><span class="__cf_email__" data-cfemail="dfb0afaff2bbb0bcb4baab9fbaafbeb2beb6b3f1baafbef1b8b0a9">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#ff929e939e94d18c9e9296bf9a8f9e929e9693d19a8f9ed1989089"><span class="__cf_email__" data-cfemail="f99498959892d78a989490b99c899894989095d79c8998d79e968f">[email protected]</span></a>.
    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: 
<a href="/cdn-cgi/l/email-protection#b1ddd4c7d8dfd49fc5d8dfd0f1d4c1d0dcd0d8dd9fd4c1d09fd6dec7"><span class="__cf_email__" data-cfemail="e78b82918e8982c9938e8986a78297868a868e8bc9829786c9808891">[email protected]</span></a>.

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:
    <a href="/cdn-cgi/l/email-protection#deb1aeaef3bab1bdb5bbaa9ebbaebfb3bfb7b2f0bbaebff0b9b1a8"><span class="__cf_email__" data-cfemail="7c130c0c5118131f1719083c190c1d111d151052190c1d521b130a">[email protected]</span></a>
    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


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