[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Notices]
[Pages 33444-33445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16388]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Independent
Scientific Peer Review Panel Report: Evaluation of the Validation
Status of Alternative Ocular Safety Testing Methods and Approaches:
Notice of Availability and Request for Public Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request for comments.
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SUMMARY: NICEATM, in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM), convened
an independent international scientific peer review panel (hereafter,
Panel) on May 19-21, 2009, to evaluate test methods and approaches with
the potential to reduce and refine the use of animals for ocular safety
testing. These evaluations included the following:
A proposal for the routine use of topical anesthetics,
systemic analgesics, and humane endpoints to avoid and minimize pain
and distress during in vivo ocular irritation testing.
The in vivo low volume eye test (LVET).
The use of the bovine corneal opacity and permeability
(BCOP), the Cytosensor Microphysiometer[reg] (CM), the isolated chicken
eye (ICE), the isolated rabbit eye (IRE), and the hen's egg test--
chorioallantoic membrane (HET-CAM) test methods for identifying
moderate and mild ocular irritants and substances not labeled as ocular
irritants.
Nonanimal testing strategies that use the BCOP, CM, and/or
EpiOcularTM (EO) test methods to assess the eye irritation
potential of antimicrobial cleaning products to determine their
appropriate U.S. Environmental Protection Agency ocular hazard
classification.
The Panel report from this meeting is now available. The report
contains (1) The Panel's evaluation of the validation status of the
test methods and testing strategies and (2) the Panel's comments on the
draft ICCVAM test method recommendations. NICEATM invites public
comment on the Panel report. The report is available on the NICEATM-
ICCVAM Web site at http://iccvam.niehs.nih.gov/docs/ocutox_docs/OcularPRPRept2009.pdf or by contacting NICEATM at the address given
below.
DATES: Written comments on the Panel report should be received by
August 28, 2009.
ADDRESSES: NICEATM prefers that comments be submitted electronically by
e-mail to [email protected]. Comments can also be submitted via the
NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm. Written comments can be sent by mail or fax to Dr.
William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop:
K2-16, Research Triangle Park, NC 27709; (fax) 919-541-0947. Courier
address: NIEHS, NICEATM, 530 Davis Drive, Room 2035, Durham, NC 27713.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, (telephone)
919-541-2384, (fax) 919-541-0947 and (e-mail) [email protected].
SUPPLEMENTARY INFORMATION:
Background
NICEATM announced the convening of an independent scientific peer
review
[[Page 33445]]
panel to review and comment on the draft background review documents
(BRDs) and summary review documents (SRDs) and draft recommendations,
as well as the availability of the draft documents for public comment,
in March 2009 (74 FR 14556). The Panel met in public session on May 19-
21, 2009, at Consumer Product Safety Commission Headquarters in
Bethesda, MD. The Panel reviewed the draft ICCVAM documents for
completeness, errors, and omissions of any existing relevant data or
information. The Panel then evaluated the information in the draft
documents to determine the extent to which each of the applicable
criteria for validation and acceptance of toxicological test methods
(ICCVAM 2003) had been appropriately addressed. The Panel then
considered the ICCVAM draft recommendations and commented on the extent
that the recommendations were supported by the information provided in
the draft BRDs or SRDs.
ICCVAM organized a 2005 symposium (70 FR 18037) on Minimizing Pain
and Distress in Ocular Toxicity Testing where experts recommended that
topical anesthetics and systemic analgesics should be routinely
administered before in vivo ocular safety testing to avoid or minimize
pain and distress that might occur during and after the initial
application of test substances. The experts also recommended that
systemic analgesics should routinely be administered when there are
clinical signs indicative of pain or distress. The experts further
recommended that humane endpoints to end a study early should be
identified and used routinely. ICCVAM requested data (72 FR 26396),
compiled available information on the use of topical anesthetics,
systemic analgesics, and humane endpoints during in vivo ocular safety
testing, and developed draft recommendations for implementing such
practices.
In 2007, ICCVAM published (70 FR 66451) recommendations on the use
of four in vitro test methods (BCOP, ICE, IRE, HET-CAM) for identifying
ocular corrosives and severe irritants for hazard classification and
labeling purposes. The ICCVAM recommendations were submitted to and
accepted by ICCVAM member agencies (more information at http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_recommend.htm). One
of the ICCVAM recommendations was to consider the validation status of
these four in vitro ocular test methods for identifying mild and
moderate ocular irritants and substances not classified as ocular
irritants. NICEATM and ICCVAM requested data (72 FR 31582), compiled
available information, prepared draft BRDs assessing their current
validation status for this purpose, and developed draft recommendations
for their use.
In January 2008, a BRD titled, An In Vitro Approach for EPA
Labeling of Anti-Microbial Cleaning Products, was submitted to NICEATM
for review. This BRD, prepared by the Institute for In Vitro Sciences
in collaboration with the Alternative Testing Working Group (comprised
of seven consumer product companies [Clorox, Colgate Palmolive, Dial,
EcoLabs, Johnson Diversey, Procter and Gamble, and SC Johnson]),
proposes a testing strategy that uses the CM [supreg],
EpiOcularTM, and BCOP test methods to assess the eye
irritation potential of antimicrobial cleaning products and to
determine appropriate EPA ocular hazard classification categories for
such products. NICEATM and ICCVAM reviewed the BRD, requested
additional data and information (73 FR 18535), and compiled draft
recommendations and a draft ICCVAM SRD. ICCVAM also reviewed the
validation status of the LVET, which is proposed as a reference test
method to partially substantiate the validity of the in vitro test
methods used in the test strategy.
Availability of the Peer Panel Report
The Panel's conclusions and recommendations are detailed in the
Independent Scientific Peer Review Panel Report: Evaluation of the
Validation Status of Alternative Ocular Safety Testing Methods and
Approaches which is available along with the draft documents reviewed
by the Panel and the draft ICCVAM test method recommendations at http://iccvam.niehs.nih.gov/methods/ocutox/PeerPanel09.htm.
Request for Public Comments
NICEATM invites the submission of written comments on the Panel
report. When submitting written comments, please refer to this Federal
Register notice and include appropriate contact information (name,
affiliation, mailing address, phone, fax, e-mail, and sponsoring
organization, if applicable). All comments received will be made
publicly available via the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/ocutox/PeerPanel09.htm. ICCVAM will
consider the Panel report along with public comments and comments made
by the Scientific Advisory Committee on Alternative Toxicological
Methods (SACATM) at their June 25-26, 2009 meeting (74 FR 19562) when
finalizing test method recommendations. Final ICCVAM recommendations
will be published in ICCVAM test method evaluation reports, which will
be forwarded to relevant Federal agencies for their consideration. The
evaluation reports will also be available to the public on the NICEATM-
ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/ocutox/ocutox.htm and by request from NICEATM (see ADDRESSES above).
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate toxicological information. ICCVAM conducts technical
evaluations of new, revised, and alternative methods with regulatory
applicability, and promotes the scientific validation and regulatory
acceptance of toxicological test methods that more accurately assess
the safety and hazards of chemicals and products and that refine,
reduce, and 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 and
provides scientific and operational support for ICCVAM-related
activities. NICEATM and ICCVAM work collaboratively to evaluate new and
improved test methods applicable to the needs of U.S. Federal agencies.
Additional information about ICCVAM and NICEATM can be found on their
Web site (http://iccvam.niehs.nih.gov).
SACATM was established January 9, 2002, and is composed of
scientists from the public and private sectors (67 FR 11358). SACATM
provides advice to the Director of the NIEHS, ICCVAM, and NICEATM
regarding the statutorily mandated duties of ICCVAM and activities of
NICEATM. Additional information about SACATM, including the charter,
roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/ see ``Advisory Board & Committees'' (or directly at
http://ntp.niehs.nih.gov/go/167).
Reference
ICCVAM. 2003. ICCVAM Guidelines for the Nomination and Submission of
New, Revised, and Alternative Test Methods. NIH Publication No. 03-
4508. Research Triangle Park, NC: NIEHS. Available at: http://iccvam.niehs.nih.gov.
Dated: July 3, 2009.
John R. Bucher,
Associate Director, NTP.
[FR Doc. E9-16388 Filed 7-10-09; 8:45 am]
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