[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Notices]
[Pages 14556-14557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7220]



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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); Announcement 
of an Independent Scientific Peer Review Panel on Alternative Ocular 
Safety Testing Methods; Availability of Draft Background Review 
Documents (BRD); Request for Comments

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Meeting announcement and request for comments.

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SUMMARY: NICEATM, in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM), announces 
a public meeting of an independent scientific peer review panel (Panel) 
on alternative ocular safety testing methods. The Panel will evaluate 
(1) the validation status of a testing strategy that proposes the use 
of three in vitro test methods to assess the eye irritation potential 
of antimicrobial cleaning products (AMCPs), (2) the validation status 
of four in vitro test methods for identifying moderate (EPA Category 
II, UN Globally Harmonized System of Classification and Labeling of 
Chemicals (GHS) Category 2A) and mild (EPA Category III, GHS Category 
2B) ocular irritants and substances not classified as ocular irritants 
(EPA Category IV, GHS Not Classified), (3) the validation status of the 
in vivo Low Volume Eye Test, and (4) 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 Panel will review draft ICCVAM summary review documents and 
draft BRDs and evaluate the extent to which established validation and 
acceptance criteria have been adequately addressed for each proposed 
test method and strategy. The Panel also will be asked to comment on 
the extent to which the information included in the BRDs supports 
ICCVAM's draft test method recommendations.
    NICEATM invites public comments on the draft ICCVAM summary review 
documents, BRDs, and draft ICCVAM test method recommendations. All 
documents will be available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/ocutox/PeerPanel09.htm. Documents will be 
posted no later than April 1, 2009.

DATES: The meeting is scheduled for May 19-21, 2009, from 8:30 a.m. to 
5 p.m. each day. The deadline for registration to attend the meeting 
and submission of written comments is May 15, 2009.

ADDRESSES: The meeting will be held at the U.S. Consumer Products 
Safety Commission (CPSC) Headquarters, Bethesda Towers Building, 4330 
East West Highway, Bethesda, MD. Persons needing special assistance in 
order to attend, such as sign language interpretation or other 
reasonable accommodation, should contact 301-402-8180 (voice) or 301-
435-1908 TTY (text telephone) at least seven business days before the 
event.

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, 530 Davis 
Drive, Room 2035, Durham, NC 27713.

SUPPLEMENTARY INFORMATION:

Background

    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]), 
describes a testing strategy that uses the Cytosensor Microphysiometer 
[supreg], EpiOcular \TM\, and Bovine Corneal Opacity and Permeability 
(BCOP) assays to assess the eye irritation potential of AMCPs and to 
determine the appropriate EPA ocular hazard classification category. 
NICEATM and ICCVAM reviewed the BRD, requested additional data and 
information, and compiled draft recommendations and a draft ICCVAM 
summary review document. The Panel will first consider the current 
validation status of each of the three in vitro test methods and then 
consider the validation status of the proposed testing strategy. The 
Panel will also review the validation status of the in vivo Low Volume 
Eye Test, which is proposed as reference data to partially substantiate 
the validity of the in vitro test methods used in the test strategy.
    ICCVAM previously published recommendations on the use of four in 
vitro test methods (the BCOP, the isolated chicken eye test method, the 
isolated rabbit eye test method, and the hen's egg test-choriallantoic 
membrane test method) for identifying ocular corrosives and severe 
irritants for hazard classification and labeling purposes (available at 
http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm). The 
ICCVAM recommendations were submitted to and accepted by ICCVAM member 
agencies (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 have prepared draft 
BRDs assessing their current validation status for this purpose/
application.
    ICCVAM developed draft recommendations for the routine use of 
topical anesthetics, systemic analgesics, and humane endpoints to avoid 
or minimize pain and distress during in vivo ocular irritation testing. 
The proposal is based on recommendations by experts at a 2005 symposium 
Minimizing Pain and Distress in Ocular Toxicity Testing (co-sponsored 
by NICEATM-ICCVAM, the European Centre for the Evaluation of 
Alternative Methods [ECVAM], and the European Cosmetics Association) 
[http://iccvam.niehs.nih.gov/meetings/ocumeet/sympinfo.htm] that 
topical anesthetics and systemic analgesics should routinely be 
administered before ocular testing to avoid or minimize pain and 
distress that might occur during and after the initial application of 
test articles. The symposium experts also recommended that systemic 
analgesics should routinely be administered when there is evidence of 
potentially painful ocular damage or when there are clinical signs 
indicative of pain or distress. The experts also identified specific 
ocular injuries that would not be expected to reverse within 21 days, 
and therefore could be used as humane endpoints to end a study early. 
ICCVAM requested data (72 FR 26396) and then compiled available 
information on using topical anesthetics or systemic analgesics. The 
Panel will review the available information and comment on draft ICCVAM 
recommendations for the routine use of analgesics, anesthetics, and 
humane endpoints.
    ICCVAM is also cooperating with ECVAM on the peer review evaluation 
of four cell-based in vitro ocular test methods by an ECVAM Scientific 
Advisory Committee (ESAC) Peer Review Panel. The four methods, 
Cytosensor [supreg], Fluorescein Leakage, Neutral Red Release, and the 
Red Blood

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Haemaolysis Test Method, are being evaluated for their usefulness and 
limitations for identifying ocular corrosives and severe irritants 
(i.e., EPA Category I, European Union (EU) R41, GHS Category 1) and 
substances not classified as ocular irritants (i.e., EPA Category IV, 
EU Not Labeled, GHS Not Classified). ECVAM prepared BRDs for the four 
methods and links to these documents will be available on the ICCVAM 
Web site by April 1, 2009. ICCVAM developed draft recommendations on 
the usefulness and limitations of the four test methods based on the 
information in the BRDs. Public comments on the BRDs and draft 
recommendations are invited. The Panel will also be asked to comment on 
the ICCVAM draft recommendations.

Peer Review Panel Meeting

    This meeting will take place May 19-21, 2009, at the CPSC 
Headquarters, Bethesda Towers Building, 4330 East West Highway, 
Bethesda, MD. It will begin at 8:30 a.m. and is scheduled to conclude 
each day at approximately 5 p.m. The meeting is open to the public at 
no charge, with attendance limited only by the space available. The 
Panel will consider the draft ICCVAM summary review documents and/or 
BRDs for each test method and evaluate the extent to which established 
validation and acceptance criteria are adequately addressed (as 
described in Validation and Regulatory Acceptance of Toxicological Test 
Methods: A Report of the ad hoc Interagency Coordinating Committee on 
the Validation of Alternative Methods, NIH Publication No. 97-3981, 
available at http://iccvam.niehs.nih.gov/docs/about_docs/validate.pdf). The Panel will then comment on the extent to which each 
of the draft ICCVAM test method recommendations is supported by the 
information provided in the corresponding draft BRD(s). The Panel is 
expected to review the test methods and testing strategy for labeling 
AMCPs first, followed by the four test methods used to identify mild 
and moderate irritants, and finally the use of anesthetics, analgesics, 
and humane endpoints when conducting in vivo eye irritation tests in 
rabbits.
    Additional information about the meeting, including a roster of the 
Panel members and the draft agenda, will be posted on the NICEATM-
ICCVAM Web site (http://iccvam.niehs.nih.gov/methods/ocutox/PeerPanel09.htm) two weeks before the meeting. This information will 
also be available after that date by contacting NICEATM (see FOR 
FURTHER INFORMATION CONTACT above).

Attendance and Registration

    In order to facilitate planning for this meeting, persons wishing 
to attend are asked to register by May 15, 2009, via the NICEATM-ICCVAM 
Web site (http://iccvam.niehs.nih.gov/contact/reg_form_OcuPanel.htm). 
Visitor information, area map, driving directions, and CPSC contact 
information are available at http://www.cpsc.gov/about/contact.html.

Availability of the Documents

    The draft summary review documents, draft BRDs, and draft ICCVAM 
test method recommendations will be posted no later than April 1, 2009, 
on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/methods/ocutox/PeerPanel09.htm), or by contacting NICEATM (see FOR FURTHER 
INFORMATION CONTACT above).

Request for Public Comments

    NICEATM invites the submission of written comments on the draft 
ICCVAM summary review documents, draft BRDs, and draft ICCVAM test 
method recommendations by May 15, 2009. NICEATM prefers that comments 
be submitted electronically via the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via e-mail to 
[email protected]. Written comments may also be sent by mail, fax, 
or email to Dr. William Stokes, Director, NICEATM, at the address 
listed above (see FOR FURTHER INFORMATION CONTACT). When submitting 
written comments, please refer to this Federal Register notice and 
include appropriate contact information (name, affiliation, mailing 
address, phone, fax, email, and sponsoring organization, if 
applicable). NICEATM will post all comments on the NICEATM-ICCVAM Web 
site (http://iccvam.niehs.nih.gov) identified by the individual's name 
and affiliation or sponsoring organization (if applicable). NICEATM 
will provide these comments to the Panel and ICCVAM agency 
representatives and make them available to the public at the meeting.
    Opportunity will be provided for members of the public to present 
oral comments at designated times during the peer review. Up to seven 
minutes will be allotted per speaker. If you wish to present oral 
statements at the meeting (one speaker per organization), contact 
NICEATM (see FOR FURTHER INFORMATION CONTACT above) by May 15, 2009. 
Please provide a written copy of your comments with contact information 
(name, affiliation, mailing address, phone, fax, email, and sponsoring 
organization, if applicable) when registering to make oral comments. If 
it is not possible to provide a copy of your statement in advance, 
please bring 40 copies to the meeting for distribution to the Panel and 
to supplement the record. Written statements can supplement and expand 
the oral presentation. Please provide NICEATM with copies of any 
supplementary written statement using the guidelines outlined above.
    Summary minutes and the Panel's final report will be available 
following the meeting on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov). ICCVAM will consider the Panel's conclusions and 
recommendations and any public comments received in finalizing their 
test method recommendations for these methods.

Background Information on ICCVAM and NICEATM

    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).

    Dated: March 20, 2009.
John R. Bucher,
Associate Director, NTP.
[FR Doc. E9-7220 Filed 3-30-09; 8:45 am]
BILLING CODE 4140-01-P