[Federal Register: December 16, 2002 (Volume 67, Number 241)]
[Notices]
[Page 77064-77065]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de02-45]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0325; FRL-7282-3]
Revised Final Health Effects Test Guidelines; Acute Toxicity
Testing-Background and Acute Oral Toxicity; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA has established a unified library for test guidelines
issued by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS) for use in testing chemical substances to develop data for
submission to EPA under the Toxic Substances Control Act (TSCA), the
Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). These test
guidelines represent an Agency effort that began in 1991 to harmonize
the test guidelines within OPPTS, as well as to harmonize the OPPTS
test guidelines with those of the Organization for Economic Cooperation
and Development (OECD). The process for developing and amending these
test guidelines includes public participation and the extensive
involvement of the scientific community, including peer review by the
Scientific Advisory Panel (SAP), the Scientific Advisory Board (SAB)
and other expert scientific organizations. Guidelines are also
reviewed, when appropriate, by the Interagency Coordinating Committee
for Alternative Methods (ICCVAM) for determination of validation
status. With this notice, EPA is announcing the availability of the
revised final test guidelines for Series 870-Health Effects Test
Guidelines, OPPTS 870.1000 Acute Toxicity Testing-Background and OPPTS
870.1100 Acute Oral Toxicity.
FOR FURTHER INFORMATION CONTACT: For general information contact: TSCA
information contact: TSCA Hotline at TAIS/7408, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
FIFRA information contact: Communications Services Branch (7506C),
Field and External Affairs Division, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-5017; fax
number: (703) 305-5558.
For FIFRA technical information contact: Deborah McCall,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-7109; e-mail
address: mccall.deborah@epa.gov.
For TSCA technical information on OPPTS 870.1100 contact: Elizabeth
Margosches, Risk Assessment Division (7403M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-7636; e-mail address: margosches.elizabeth@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
This action is directed to the public in general. Although this
action may be of particular interest to those persons who are or may be
required to conduct testing of chemical substances under TSCA, FFDCA,
or FIFRA, 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.
II. How Can I Get Copies of This Document and Other Related
Information?
A. Docket
EPA has established an official public docket for this action under
docket identification (ID) number OPP-2002-0325. The official public
docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
B. Electronic Access
You may access this Federal Register document electronically
through the EPA Internet under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/.You may also obtain copies of test
guidelines from the EPA Internet Home Page at http://www.epa.gov/opptsfrs/home/guidelin.htm
.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit II.A. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
III. What Action is EPA Taking?
EPA is announcing the availability of the revised final test
guideline for Series 870-Health Effects Test Guidelines, OPPTS 870.1100
Acute Oral Toxicity. An improved Up-and-Down Procedure (UDP) protocol
for acute oral toxicity testing was developed, by a team of regulatory
and industry scientists, that is better able to provide the types of
testing data needed for U.S. agencies to make regulatory decisions. The
revised protocol includes a primary test, a limit test, and
determination of the confidence intervals for the LD50. A software
program to assist laboratory users in the conduct of the test was also
developed. The revised final test guideline was reviewed by EPA's SAP
in a public meeting on December 12, 2001, which was announced in the
Federal Register on November 15, 2001 (66 FR 57438) (FRL-6811-1), and
recommendations of the SAP were incorporated into the test protocol.
The ICCVAM reviewed the protocol at an open meeting on July 25, 2000,
and again in a public teleconference meeting held on July 21, 2001,
where changes recommended in the earlier meeting were reviewed and
accepted. The improved UDP was adopted as test guideline 425 by OECD in
December 2001. The UDP in this guideline is of value in reducing the
number of animals required to determine the acute oral toxicity of a
chemical. In addition to the estimation of LD50 and confidence
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intervals, the test allows the observation of signs of toxicity.
Moreover, use of OECD guidance for humane endpoints should reduce the
overall suffering of animals in this type of test. The Agency strongly
recommends the use of the revised UDP to meet the testing requirements
for industrial chemicals and registration of pesticides. Acute oral
toxicity studies using the UDP which are initiated after December 17,
2002, should be in accordance with the UDP described in this guideline.
Two other alternative guidelines are available through OECD (420 Acute
Oral Toxicity-Fixed Dose Method and 423 Acute Oral Toxicity-Acute Toxic
Class Method). These methods assess lethality within a dose range. The
Agency is also making available revised final test guideline OPPTS
870.1000 Acute Toxicity Testing-Background to reflect revision of the
OPPTS 870.1100 Acute Oral Toxicity test guideline and acceptability of
two other OECD alternative guidelines.
IV. Are There Any Applicable Voluntary Consensus Standards That EPA
Should Consider?
This notice of availability does not involve a proposed regulatory
action that would require the Agency to consider voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA requires EPA to provide an explanation to
Congress, through Office of Management and Budget (OMB), when the
Agency decides not to use available and applicable voluntary consensus
standards when the NTTAA directs the Agency to do so.
List of Subjects
Environmental protection, Chemical testing, Test guideline.
Dated: December 11, 2002.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 02-31612 Filed 12-12-02; 9:03 am]
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