[Federal Register: March 26, 2003 (Volume 68, Number 58)]
[Notices]
[Page 14635-14636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr03-72]
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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: 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 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: ward.ron@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-2002-0324. 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
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
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]
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