[Federal Register Volume 68, Number 58 (Wednesday, March 26, 2003)]
[Notices]
[Pages 14635-14636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7057]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0324; FRL-7282-2]


Revised Final Health Effects Test Guideline; Skin Sensitization; 
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this notice, EPA is announcing the availability of the 
revised final test guideline for Series 870-Health Effects Test 
Guidelines, OPPTS 870.2600 Skin Sensitization. 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, as warranted, 
including peer review by the Scientific Advisory Panel (SAP), the 
Scientific Advisory Board (SAB) and other expert scientific 
organizations, as well as determination of validation status by the 
Interagency Coordinating Committee for Validation of Alternative 
Methods (ICCVAM).

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 contact: Ronald Ward, Ph.D., Risk 
Assessment Division (7403M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8926; 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-2002-0324. 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

[[Page 14636]]

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 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 Guideline, OPPTS 870.2600 
Skin Sensitization. In 1996, the SAP reviewed the use of the Local 
Lymph Node Assay (LLNA) as a screening method in the Agency's 
harmonized test guideline OPPTS 870.2600 Skin sensitization. The LLNA 
is a test method for assessing the potential allergic contact 
dermatitis (skin sensitization) of chemicals and compounds. In January 
2001, the assay was found to be scientifically valid by ICCVAM peer 
review (Ref. 1) as an alternative method, where applicable, to the 
traditional guinea pig tests (Guinea Pig Maximization Test (GPMT) (Ref. 
2) and Buehler tests (Ref. 3)) which are currently accepted by 
regulatory authorities. This alternative test also provides animal 
welfare advantages. The Agency has now revised its harmonized test 
guideline OPPTS 870.2600 Skin Sensitization to incorporate the LLNA for 
use as an alternative method for assessing skin sensitization under the 
appropriate circumstances. The availability of the draft revised final 
test guideline OPPTS 870.2600 was announced in the Federal Register on 
September 12, 2001 (66 FR 47478) (FRL-6801-6). The draft revised 
guideline was reviewed by EPA's SAP in a public meeting on December 11, 
2001, and recommendations of the SAP were incorporated into the revised 
test protocol. The guideline has been harmonized with OECD test 
guideline 429 Skin Sensitization: Local Lymph Node Assay which was 
adopted by OECD on April 24, 2002. It should be recognized that there 
are certain testing situations that may necessitate the use of 
traditional guinea pig tests. The LLNA may not be appropriate for all 
types of test materials, such as certain metallic compounds, high 
molecular weight proteins, strong dermal irritants and materials that 
do not sufficiently adhere to the ear for an acceptable period of time 
during treatment. When using the LLNA, particular care should be taken 
to ensure that hydrophilic materials are incorporated into a vehicle 
system that wets the skin and does not immediately run off. Thus, 
wholly aqueous vehicles or test materials and runny liquids are to be 
avoided. In all instances, the tester must document that appropriate 
techniques were used to facilitate adherence to the mouse ear for an 
adequate exposure duration. It may be possible to use the LLNA to test 
some of these materials if appropriate techniques are used to 
facilitate adherence. In situations for test materials where the LLNA 
is not applicable or may provide unreliable or problematic results, the 
GPMT tests are recommended. Although the LLNA, GPMT, or Buehler tests 
are considered to be acceptable tests, it is recognized that other 
tests may give useful results. If other tests are used, the 
investigator must provide justification/reasoning for use of other 
procedures and methods and protocols must be provided. A positive and 
negative control group must be included in each test.

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.

V. References

    The following references are cited in this document.
    (1) The Murine Local Lymph Node Assay: A Test Method for Assessing 
the Allergic Contact Dermatitis Potential of Chemicals/Compounds. 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM), National Institutes of Environmental Health Sciences, 
NIH Publication No. 99-4494 (1999). (Document available at http://iccvam.niehs.nih.gov/methods/llnadocs/llnarep.pdf.)
    (2) Magnusson, B. Identification of contact sensitizers by animal 
assay. Contact Dermatology 6:46 (1980).
    (3) Buehler, L.V. Occ1usive patch method for skin sensitization in 
guinea pigs: the Buehler method. Food and Chemical Toxicology 32:97101 
(1994).

List of Subjects

    Environmental protection, Chemical testing, Test guideline.


    Dated: March 11, 2003.
Susan B. Hazen,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 03-7057 Filed 3-25-03; 8:45 am]
BILLING CODE 6560-50-S