[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20672-20673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Recommendations on In Vitro Ocular Safety Testing Methods and
Strategies and Routine Use of Topical Anesthetics, Systemic Analgesics,
and Humane Endpoints for Ocular Safety Testing
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Notice of availability.
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SUMMARY: U.S. Federal agency responses to ICCVAM test method
recommendations on alternative testing methods and strategies proposed
to further reduce and refine the use of animals for assessing the
ocular hazard potential of chemicals and products are now available.
ICCVAM recommended a pain management procedure that should always be
used to avoid pain and distress when it is determined necessary to
conduct the rabbit eye test for regulatory safety purposes. ICCVAM also
recommended the Cytosensor Microphysiometer (CM) test method as a
screening test (1) to identify some types of substances that will not
cause sufficient injury to require eye hazard labeling and (2) to
identify some types of substances that may cause permanent or severe
eye injuries. ICCVAM previously forwarded recommendations to Federal
agencies and made these recommendations available to the public (75 FR
57027). In accordance with the ICCVAM Authorization Act of 2000 (42
U.S.C. 285l-3), agencies have notified ICCVAM in writing of their
findings and ICCVAM is making these responses available to the public.
Federal agency responses are available on the NICEATM-ICCVAM Web site
at http://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm. The
ICCVAM recommendations are provided in ICCVAM test method evaluation
reports that are available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/ocutox/OcuAnest-TMER.htm, http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm, http://iccvam.niehs.nih.gov/methods/ocutox/AMCP-TMER.htm, and http://iccvam.niehs.nih.gov/methods/ocutox/LVET.htm.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle
Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
[email protected]. Courier address: NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
The U.S. Environmental Protection Agency (EPA) requested that
ICCVAM (1) evaluate the current validation status of the bovine corneal
opacity and permeability (BCOP), hen's egg test-chorioallantoic
membrane (HET-CAM), isolated chicken eye (ICE), and isolated rabbit eye
(IRE) test methods; (2) identify in vivo ocular toxicity reference data
to support the validation of in vitro test methods; (3) explore ways of
alleviating pain and distress from current in vivo ocular safety
testing; and (4) review the state of the science and the availability
of in vitro test methods for assessing mild or moderate ocular
irritants. The highest priority activity, an evaluation of the BCOP,
HET-CAM, ICE, and IRE test methods for their usefulness and limitations
for identifying potential ocular corrosives and severe irritants, was
completed in 2006 (NIH Publication No. 07-4517). Based on this
evaluation, U.S. Federal agencies subsequently accepted the BCOP and
ICE test methods for certain regulatory testing purposes without the
need for animal testing. The Organisation for Economic Co-operation and
Development (OECD) subsequently adopted the BCOP and ICE test methods
in 2009 as international OECD Test Guidelines 437 and 438, respectively
(OECD 2009a, OECD 2009b). The International Organization for
Standardization (ISO) adopted the BCOP and ICE test methods as ISO
Standard 10993-10 in 2010 (ISO 2010).
ICCVAM recently completed additional test method evaluations
relevant to the original EPA nomination and a subsequent EPA request
that ICCVAM evaluate a proposed in vitro testing strategy for
identifying the ocular hazard potential of antimicrobial cleaning
products. Information is provided about ICCVAM's evaluation and the
committee's recommendations for the alternative testing methods and
strategies proposed to further reduce and refine the use of animals for
assessing the ocular hazard potential of chemicals and products in four
ICCVAM Test Method Evaluation Reports: (1) Recommendations for Routine
Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints
to Avoid or Minimize Pain and Distress in Ocular Safety Testing (NIH
Publication No. 10-7514), (2) Current Validation Status of In Vitro
Test Methods Proposed for Identifying Eye Injury Hazard Potential of
Chemicals and Products (NIH Publication No. 10-7553), (3) Current
Validation Status of a Proposed In Vitro Testing Strategy for U.S.
Environmental Protection Agency Ocular Hazard Classification and
Labeling of Antimicrobial Cleaning Products (NIH Publication No. 10-
7513), and (4) Recommendation to Discontinue Use of the Low Volume Eye
Test for Ocular Safety Testing (NIH Publication No. 10-7515).
Agency Responses to ICCVAM Recommendations
In September 2010, ICCVAM forwarded final test method
recommendations for ocular safety testing methods and strategies to
U.S. Federal agencies for consideration, in accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C.
[[Page 20673]]
285l-3) (75 FR 57027). The ICCVAM Authorization Act requires member
agencies to review ICCVAM test method recommendations and notify ICCVAM
in writing of their findings no later than 180 days after receipt of
recommendations. The Act also requires ICCVAM to make ICCVAM
recommendations and agency responses available to the public. Agency
responses should include identification of relevant test methods for
which the ICCVAM test method recommendations may be added or
substituted and indicate any revisions or planned revisions to existing
guidelines, guidances, or regulations to be made in response to these
recommendations.
ICCVAM agencies concurred with the test method recommendations for
the in vitro ocular safety testing methods and strategies and support
the routine use of topical anesthetics, systemic analgesics, and humane
endpoints for ocular safety testing. Several agencies also indicated
that they would communicate the ICCVAM recommendations to stakeholders
and encourage their appropriate use. Agency responses are available at
http://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm.
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that require, use,
generate, or disseminate toxicological and safety testing information.
ICCVAM conducts technical evaluations of new, revised, and alternative
safety testing methods with regulatory applicability and promotes the
scientific validation and regulatory acceptance of toxicological and
safety testing methods that more accurately assess the safety and
hazards of chemicals and products and that reduce, refine (decrease or
eliminate pain and distress), or replace animal use. The ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a
permanent interagency committee of the NIEHS under NICEATM. NICEATM
administers ICCVAM, provides scientific and operational support for
ICCVAM-related activities, and conducts independent validation studies
to assess the usefulness and limitations of new, revised, and
alternative test methods and strategies. NICEATM and ICCVAM work
collaboratively to evaluate new and improved test methods and
strategies applicable to the needs of U.S. Federal agencies. NICEATM
and ICCVAM welcome the public nomination of new, revised, and
alternative test methods and strategies for validation studies and
technical evaluations. Additional information about ICCVAM and NICEATM
can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
References
ICCVAM. 2006. ICCVAM Test Method Evaluation Report: In Vitro Ocular
Toxicity Test Methods for Identifying Severe Irritants and
Corrosives. NIH Publication No. 07- 4517. Research Triangle Park,
NC: NIEHS. Available: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendations
for Routine Use of Topical Anesthetics, Systemic Analgesics, and
Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular
Safety Testing. NIH Publication No. 10-7514. Research Triangle Park,
NC: NIEHS. Available: http://iccvam.niehs.nih.gov/methods/ocutox/OcuAnest-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current
Validation Status of In Vitro Test Methods Proposed for Identifying
Eye Injury Hazard Potential of Chemicals and Products. NIH
Publication No. 10-7553. Research Triangle Park, NC: NIEHS.
Available: http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current
Validation Status of a Proposed In Vitro Testing Strategy for U.S.
Environmental Protection Agency Ocular Hazard Classification and
Labeling of Antimicrobial Cleaning Products. NIH Publication No. 10-
7513. Research Triangle Park, NC: NIEHS. Available: http://iccvam.niehs.nih.gov/methods/ocutox/AMCP-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendation
to Discontinue Use of The Low Volume Eye Test for Ocular Safety
Testing. NIH Publication No. 10-7515. Research Triangle Park, NC:
NIEHS. Available: http://iccvam.niehs.nih.gov/methods/ocutox/LVET.htm.
ISO. 2010. Biological evaluation of medical devices--10993 Part 10:
Tests for irritation and skin sensitization. Available for purchase
at: http://www.iso.org/iso/home.htm.
OECD. 2009a. Test Guideline 437. Bovine Corneal Opacity and
Permeability Test Method for Identifying Ocular Corrosives and
Severe Irritants, adopted September 2009. In: OECD Guidelines for
Testing of Chemicals. Paris: OECD. Available: http://www.oecd-ilibrary.org/environment/test-no-437-bovine-corneal-opacity-and-permeability-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264076303-en.
OECD. 2009b. Test Guideline 438. Isolated Chicken Eye Test Method
for Identifying Ocular Corrosives and Severe Irritants, adopted
September 2009. In: OECD Guidelines for Testing of Chemicals. Paris:
OECD. Available: http://www.oecd-ilibrary.org/environment/test-no-438-isolated-chicken-eye-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264076310-en.
Dated: April 1, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-8938 Filed 4-12-11; 8:45 am]
BILLING CODE 4140-01-P