[Federal Register Volume 65, Number 135 (Thursday, July 13, 2000)]
[Notices]
[Pages 43329-43331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17754]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00631; FRL-6393-5]


Final Test Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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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

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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) and the Scientific Advisory Board (SAB) and other expert 
scientific organizations. With this notice, EPA is announcing the 
availability of three final test guidelines for three health effects 
end points. These test guidelines (and their OPPTS guideline reference) 
are: Repeated Dose 28-Day Oral Toxicity Study in Rodents (OPPTS 
870.3050), Reproduction/Developmental Toxicity Screening Test (OPPTS 
870.3550), and Combined Repeated Dose Toxicity Study With the 
Reproduction/Developmental Toxicity Screening Test (OPPTS 870.3650).

FOR FURTHER INFORMATION CONTACT: For general information contact:
    Toxic Substances Control Act (TSCA) information contact: TSCA 
Hotline at TAIS/7408, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
554-1404; fax number: (202) 554-5603; e-mail address: [email protected].
    Federal Insecticide, Fungicide, and Rodenticide Act (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; 
telephone number: (703) 305-5017; fax number: (703) 305-5558.
    For technical information contact: Chemical Control Division, 
Office of Pollution Prevention and Toxics (7405), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 260-8130; 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 the Toxic 
Substances Control Act (TSCA), the Federal Food, Drug and Cosmetic Act 
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act 
(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 technical person listed in the FOR FURTHER INFORMATION 
CONTACT.

II. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

A. Electronically

    You may obtain electronic copies of this document, and certain 
other related documents that might be available electronically, from 
the EPA Internet Home Page at http://www.epa.gov/. To access this 
document, on the Home Page select ``Laws and Regulations'' and then 
look up the entry for this document under the ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal 
Register listings at http://www.epa.gov/fedrgstr/.
    You may also obtain copies of test guidelines from the EPA Internet 
Home Page and the U.S. Government Printing Office (GPO). From the EPA 
Internet Home Page select ``Information Resources/Test Methods/OPPTS 
Harmonized Test Guidelines'' at http://www.epa.gov/
OPPTS--Harmonized. Paper copies and disks of the guidelines 
are available from GPO, Washington, DC 20402, or by calling (202) 512-
0132.

B. In Person

    The Agency has established an official record for this proposed 
guideline under docket control number OPP-00631. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch, Rm. 119, Crystal Mall 
x 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Public 
Information and Records Integrity Branch telephone number is (703) 305-
5805.

III. What Action is EPA taking?

    EPA is announcing the availability of three final health effects 
test guidelines. These guidelines are: Repeated Dose 28-Day Oral 
Toxicity Study in Rodents (OPPTS 870.3050), Reproduction/Developmental 
Toxicity Screening Test (OPPTS 870.3550), and Combined Repeated Dose 
Toxicity Study with the Reproduction/Developmental Toxicity Screening 
Test (OPPTS 870.3650). These guidelines are being made available today 
in order to establish a set of harmonized guidelines for use in test 
rules and other actions under TSCA. After establishment of these 
guidelines today, the Agency will then establish new TSCA test 
guidelines in Title 40 of the Code of Federal Regulations (CFR), but in 
the format specified for the CFR. TSCA test guidelines for the three 
endpoints are not now in existence but are needed for planned 
regulatory actions.
    In publishing these harmonized test guidelines, EPA recognizes 
concerns have been expressed about animal testing. EPA is committed to 
avoiding unnecessary or duplicative animal testing. As part of this 
commitment, the Agency plays a important role in the federal 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) (http://iccvam.niehs.nih.gov/home.htm) whose goals 
are: (1) To encourage the reduction of the number of animals used in 
testing; (2) to seek opportunities to replace test methods requiring 
animals with alternative test methods when acceptable alternative 
methods are available; and ( 3) to refine existing test methods to 
optimize animal use when there is no substitute for animal testing. 
Further, where testing is needed to develop scientifically adequate 
data, the Agency is committed to reducing the number of animals used 
for testing, including, whenever possible, by incorporating in vitro 
(non-animal) test methods or other alternative approaches that have 
been scientifically validated and have received regulatory acceptance. 
EPA considers these goals and commitments to be important 
considerations in developing health effects data; however, they must be 
balanced with the essential need to conduct scientifically sound 
chemical hazard/risk assessments in support of the Agency's mission. By 
using the test guidelines cited in today's notice, EPA believes that 
fewer animals will be used when it is necessary to conduct screening 
level testing to fill such data needs and these guidelines will yield 
scientifically sound data.

[[Page 43331]]

IV. How Were these Test Guidelines Developed?

    These guidelines were adapted from the series of the Organization 
for Economic Cooperation and Development (OECD) Guidelines for Testing 
of Chemicals. The OECD guidelines which were adapted and are being 
announced for publication today are: OECD Guideline 407 (Repeated Dose 
28-day Oral Toxicity in Rodents) for OPPTS 870.3050, OECD Guideline 421 
(Reproduction/Developmental Toxicity Screening Test) for OPPTS 
870.3550, and OECD Guideline 422 (Combined Repeated Dose Toxicity Study 
With the Reproduction/Developmental Toxicity Screening Test) for OPPTS 
870.3650. EPA has retained the OECD guideline names. EPA scientists 
reviewed the OECD guidelines and reformatted them to the OPPTS 
harmonized guideline format with only minor editorial changes.
    The OECD test guidelines were developed initially under the OECD 
Chemicals Testing Programme and are updated under the OECD Updating 
Programme for Test Guidelines and the OECD Test Guidelines Programme. 
The OECD test guideline process involves the use of multi-national 
panels of scientific and technical experts who develop guideline drafts 
which are submitted to a review panel. The review process is concluded 
by the endorsement of the guidelines by the OECD Chemicals Group and 
the OECD Environment Committee prior to the formal submission to the 
OECD Council. The OECD Council then adopts the guidelines and publishes 
them in the official OECD Guidelines for Testing of Chemicals.

V. 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) 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, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide an explanation to Congress, 
through 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: June 22, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 00-17754 Filed 7-12-00; 8:45 am]
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