57360 Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices 

TABLE 1—TESTING RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES— 

Continued 

Substance [CAS No.] Nominated by 1 Nomination rationale Preliminary study 

recommendations 2

Triclosan [3380–34–5] ................... Private Individual and U.S. Food 

and Drug Administration.

Widespread use in consumer 

products; frequent and longterm exposure for all age 

groups; lack of adequate toxicity data for dermal exposures.

—Carcinogenicity studies via dermal administration. 

—Phototoxicity studies. 

—Reproductive toxicity studies. 

1 National Institute of Environmental Health Sciences (NIEHS). 

2The term ‘‘comprehensive toxicological characterization’’ in this table refers to the approximate scope of a research program to address toxicological data needs. The types of toxicological studies that would be considered by NTP staff during the conceptualization and design of a research program are biomolecular screening, in vitro mechanistic, in vitro and in vivo genotoxicity, absorption, disposition, metabolism, and elimination, short-term repeat dose (2–4 weeks) in vivo studies, subchronic toxicity (13–26 weeks), chronic toxicity (1–2 years), carcinogenicity in conventional or genetically modified rodent models, organ systems toxicity (immunotoxicity, reproductive and developmental toxicity, neurotoxicity), in 

vivo mechanistic, toxicokinetics, and other special studies as appropriate (e.g., chemistry, toxicogenomics, phototoxicity). 

To facilitate review of proposed 

research projects by the NTP BSC and 

the public, NTP staff developed a draft 

research concept document for each 

nomination recommended for study. A 

research concept is a brief document 

outlining the nomination or study 

rationale, and the significance, study 

approach, and expected outcome of a 

proposed research program tailored for 

each nomination. The purpose of these 

research concepts is to outline the 

general elements of a program of study 

that would address the specific issues 

that prompted the nomination, but also 

encompass studies that may address 

larger public health issues or topics in 

toxicology that could be addressed 

appropriately through studies on the 

nominated substance(s). Draft research 

concepts for the new nominations listed 

in Table 1 will be available on the NTP 

BSC meeting page (http:// 

ntp.niehs.nih.gov/go/165) by October 9, 

2008. 

Attendance and Registration 

The meeting is scheduled for 

November 20–21, 2008, beginning at 

8:30 a.m. on each day and continuing to 

5 p.m. on November 20 and on 

November 21 until adjournment. The 

meeting is open to the public with 

attendance limited only by the space 

available. Individuals who plan to 

attend are encouraged to register online 

at the NTP BSC meeting Web site 

(http://ntp.niehs.nih.gov/go/165) by 

November 13, 2008, to facilitate 

planning for the meeting. The NTP is 

making plans to videocast the meeting 

through the Internet at http:// 

www.niehs.nih.gov/news/video/live. 

Request for Comments 

Written comments submitted in 

response to this notice should be 

received by November 6, 2008. 

Comments will be posted on the NTP 

BSC meeting Web site and persons 

submitting them will be identified by 

their name and affiliation and/or 

sponsoring organization, if applicable. 

Persons submitting written comments 

should include their name, affiliation (if 

applicable), phone, e-mail, and 

sponsoring organization (if any) with 

the document. 

Time will be allotted during the 

meeting for the public to present oral 

comments to the NTP BSC on the 

agenda topics. Each organization is 

allowed one time slot per agenda topic. 

At least 7 minutes will be allotted to 

each speaker, and if time permits, may 

be extended to 10 minutes at the 

discretion of the NTP BSC chair. 

Persons wishing to present oral 

comments are encouraged to pre-register 

on the NTP meeting Web site. 

Registration for oral comments will also 

be available on-site, although time 

allowed for presentation by on-site 

registrants may be less than that for preregistered speakers and will be 

determined by the number of persons 

who register at the meeting. 

Persons registering to make oral 

comments are asked, if possible, to send 

a copy of their statement to the 

Executive Secretary for the NTP BSC 

(see ADDRESSES above) by November 13, 

2008, to enable review by the NTP BSC 

prior to the meeting. Written statements 

can supplement and may expand the 

oral presentation. If registering on-site 

and reading from written text, please 

bring 40 copies of the statement for 

distribution to the NTP BSC and NIEHS/ 

NTP staff and to supplement the record. 

Background Information on the NTP 

Board of Scientific Counselors 

The NTP BSC is a technical advisory 

body comprised of scientists from the 

public and private sectors that provides 

primary scientific oversight to the 

overall program and its centers. 

Specifically, the NTP BSC advises the 

NTP on matters of scientific program 

content, both present and future, and 

conducts periodic review of the program 

for the purpose of determining and 

advising on the scientific merit of its 

activities and their overall scientific 

quality. Its members are selected from 

recognized authorities knowledgeable in 

fields such as toxicology, pharmacology, 

pathology, biochemistry, epidemiology, 

risk assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. NTP BSC 

meetings are held annually or 

biannually. 

Dated: September 23, 2008. 

Samuel H. Wilson, 

Acting Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Center for the Evaluation of Risks to 

Human Reproduction (CERHR); 

Announcement of Plans for Updated 

Evaluations of Genistein and Soy 

Formula; Request for Public 

Comments and Nomination of Expert 

Panel Members 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Notice of expert panel 

evaluation of the reproductive and 

developmental toxicities of genistein 

and soy formula. 

SUMMARY: The CERHR plans to convene 

an expert panel to conduct updated 

evaluations of the scientific evidence 

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Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices 57361 

regarding the potential reproductive 

and/or developmental toxicity 

associated with exposure to genistein 

and soy formula begun in 2006. The 

expert panel will consist of 

approximately 10–12 scientists selected 

for their scientific expertise in various 

aspects of reproductive and 

developmental toxicology and other 

relevant areas of science. CERHR invites 

the submission of information about 

ongoing studies or upcoming 

publications on these substances that 

might be considered for inclusion in the 

evaluations and the nomination of 

scientists to serve on the expert panel 

(see SUPPLEMENTARY INFORMATION

below). This meeting is tentatively 

scheduled for spring or summer 2009, 

although the exact date and location are 

not yet set. As plans are finalized, they 

will be announced in the Federal 

Register and posted on the CERHR Web 

site (http://cerhr.niehs.nih.gov). CERHR 

expert panel meetings are open to the 

public with time scheduled for oral 

public comment. 

DATES: Comments received by 

November 17, 2008 will be made 

available to CERHR staff and the expert 

panel for consideration in the 

evaluation and posted on the CERHR 

Web site. Nominations of scientists 

received by November 17, 2008 will be 

considered for this panel and for 

inclusion in the CERHR Expert Registry. 

ADDRESSES: Public comments and any 

other correspondence should be 

submitted to Dr. Michael D. Shelby, 

CERHR Director, NIEHS, P.O. Box 

12233, MD EC–32, Research Triangle 

Park, NC 27709 (mail), 919–541–3455 

(phone), 919–316–4511 (fax), or 

shelby@niehs.nih.gov (e-mail). Courier 

address: CERHR, 79 T.W. Alexander 

Drive, Building 4401, Room 102, 

Research Triangle Park, NC 27709. 

SUPPLEMENTARY INFORMATION: 

Background 

Genistein (CAS RN: 446–72–0) is a 

phytoestrogen found in some legumes, 

especially soybeans. Phytoestrogens are 

non-steriodal, estrogenic compounds 

that occur naturally in some plants. In 

plants, nearly all genistein is linked to 

a sugar molecule and this genisteinsugar complex is called genistin. 

Genistin and genistein are found in 

many food products, especially soybased foods such as tofu, soy milk, and 

soy infant formula, and in some overthe-counter dietary supplements. Soy 

formula is fed to infants as a 

supplement or replacement for human 

milk or cow milk. 

On March 15–17, 2006, CERHR 

convened an expert panel to conduct 

evaluations of the potential 

reproductive and developmental 

toxicities of genistein and soy formula. 

CERHR selected genistein and soy 

formula for expert panel evaluation 

because of (1) The availability of 

numerous reproductive and 

developmental toxicity studies in 

laboratory animals and humans, (2) the 

availability of information on exposures 

in infants and women of reproductive 

age, and (3) public concern for effects on 

infant or child development. The expert 

panel reports were released for public 

comment on May 5, 2006 (Federal 

Register Vol. 71, No. 94, pp. 28368, May 

16, 2006). Next, on November 8, 2006 

(Federal Register Vol. 71, No. 216, pp. 

65537, November 8, 2006), CERHR staff 

released draft NTP Briefs on Genistein 

and Soy Formula that provided the 

NTP’s interpretation of the potential for 

genistein and soy formula to cause 

adverse reproductive and/or 

developmental effects in exposed 

humans. CERHR has not completed 

these evaluations, finalized the briefs, or 

issued NTP–CERHR monographs on 

these substances. Since 2006, a 

substantial number of new publications 

related to human exposure or 

reproductive and/or developmental 

toxicity have been published for these 

substances and CERHR has determined 

that updated evaluations of genistein 

and soy formula are needed. 

Request for Comments 

The CERHR invites the public and 

other interested parties to submit 

information and comments on genistein 

and soy formula including toxicology 

and epidemiologic information from 

completed and ongoing studies, 

information on planned studies, and 

information about current production 

levels, human exposure, use patterns, 

and environmental occurrence. 

Request for the Nomination of Scientist 

for the Expert Panel 

The CERHR invites nominations of 

qualified scientists to serve on the 

expert panel. Panelists are primarily 

drawn from the CERHR Expert Registry 

and/or the nomination of other 

scientists who meet the criteria for 

listing in that registry which include: 

formal academic training and 

experience in a relevant scientific field, 

publications in peer-reviewed journals, 

membership in relevant professional 

societies, and certification by an 

appropriate scientific board or other 

entities. Nominations should include 

contact information and current 

curriculum vitae (if possible) and be 

forwarded to CERHR (see ADDRESSES). 

Final selection of individuals to serve 

on the expert panel will be made in 

accordance with the Federal Advisory 

Committee Act and Department of 

Health and Human Services 

implementing regulations. 

All panel members serve as 

individual experts and not as 

representatives of their employers or 

other organizations. Scientists on the 

expert panel represent a wide range of 

expertise including, but not limited to, 

developmental toxicology, reproductive 

toxicology, epidemiology, general 

toxicology, medicine, pharmacokinetics, 

exposure assessment, and biostatistics. 

Background Information on the CERHR 

The NTP established CERHR in 1998 

(Federal Register, December 14, 1998, 

Vol. 63, No. 239, page 68782). CERHR 

is a publicly accessible resource for 

information about adverse reproductive 

and/or developmental health effects 

associated with exposure to 

environmental and/or occupational 

exposures. CERHR follows a formal 

process for the evaluation of selected 

substances that includes opportunities 

for public input. 

CERHR invites the nomination of 

substances for review or scientists for its 

expert registry. Information about 

CERHR and the nomination process can 

be obtained from its homepage (http:// 

cerhr.niehs.nih.gov) or by contacting Dr. 

Michael Shelby, CERHR Director (see 

ADDRESSES). CERHR selects substances 

for evaluation based upon several 

factors including production volume, 

potential for human exposure from use 

and occurrence in the environment, 

extent of public concern, and extent of 

data from reproductive and 

developmental toxicity studies. Expert 

panels conduct scientific evaluations of 

substances selected by CERHR in public 

forums. Following these evaluations, 

CERHR prepares the NTP–CERHR 

monograph on the substance evaluated. 

The monograph is transmitted to 

appropriate federal and state agencies 

and made available to the public. 

Dated: September 23, 2008. 

Samuel H. Wilson, 

Acting Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E8–23173 Filed 10–1–08; 8:45 am] 

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