[Federal Register Volume 67, Number 241 (Monday, December 16, 2002)]
[Notices]
[Pages 77064-77065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31612]


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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: [email protected].
    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: [email protected].
    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: [email protected].

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

[[Page 77065]]

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]
BILLING CODE 6560-50-S