14556 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 

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. 

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) 

niceatm@niehs.nih.gov. 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 ®, 

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 ®, Fluorescein Leakage, 

Neutral Red Release, and the Red Blood 


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Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 14557 

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 

niceatm@niehs.nih.gov. 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 


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