[Federal Register Volume 73, Number 73 (Tuesday, April 15, 2008)]
[Notices]
[Pages 20289-20291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Office of Liaison, Policy and 
Review; Meeting of the NTP Board of Scientific Counselors

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

ACTION: Meeting announcement and request for comments.

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SUMMARY: Pursuant to Public Law 92-463, notice is hereby given of a 
meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP 
BSC is composed of scientists from the public and private sectors and 
provides primary scientific oversight to the NTP Director and evaluates 
the scientific merit of the NTP's intramural and collaborative 
programs.

DATES: The NTP BSC meeting will be held on June 11-12, 2008. The 
deadline for submission of written comments is May 23, 2008, and for 
pre-registering to attend the meeting, including providing notice of 
intent to present oral comments, is June 4, 2008. Persons needing 
interpreting services in order to attend should contact 301-402-8180 
(voice) or 301-435-1908 (TTY). For other accommodations, contact 919-
541-2475 or e-mail [email protected]. Requests should be made at 
least 7 days in advance of the event.

ADDRESSES: The NTP BSC meeting will be held at the Radisson Hotel 
Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 
27709. Public comments on all agenda topics and any other 
correspondence should be submitted to Dr. Barbara Shane, Executive 
Secretary for the NTP BSC, NTP Office of Liaison, Policy and Review, 
NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; 
telephone: 919-541-4253; fax: 919-541-0295; or e-mail: 
[email protected]. Courier address: NIEHS, 111 T.W. Alexander Drive, 
Room A322, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Dr. Barbara Shane (telephone: 919-541-
4253 or e-mail: [email protected]).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

June 11-12, 2008

     Update of NTP activities.
     Center for the Evaluation of Risks to Human Reproduction: 
Peer review of the draft NTP Brief on Bisphenol A.
     Criteria for evaluating outcomes in reproductive, 
developmental, and immunotoxicology studies.
     Report on the NTP BSC Technical Reports Review 
Subcommittee meeting held February 27-28, 2008.
     NTP studies of DNA-based therapies.
     NTP testing program: Proposed research projects on 
dimorpholinodiethyl ether, 2-ethylhexyl-p-methoxycinnamate, furan, 
melamine and cyanuric acid, 4,7,10-trioxatridecane-1,13-diamine, and 
tetravalent and pentavalent vanadium compounds.
     Update on the High Throughput Screening Initiative.
     Update on the Host Susceptibility Program.
    The preliminary agenda, roster of NTP BSC members and ad hoc 
reviewers, proposed NTP research projects, public comments, and any 
additional information, when available, will be posted on the NTP BSC 
meeting Web site (http://ntp.niehs.nih.gov/go/165) or

[[Page 20290]]

may be requested in hardcopy from the Executive Secretary for the NTP 
BSC (see ADDRESSES above). Following the meeting, summary minutes will 
be prepared and made available on the NTP meeting Web site.

Peer Review of the Draft NTP Brief on Bisphenol A

    The NTP Center for the Evaluation of Risks to Human Reproduction 
(CERHR) conducts scientifically based assessments of the potential for 
chemicals to adversely affect human reproduction and development. CERHR 
follows a multi-step process for its evaluations (66 FR 37047). 
Currently, CERHR is conducting an evaluation of bisphenol A (CAS RN: 
80-5-07), a high production volume chemical used primarily in the 
production of polycarbonate plastics and epoxy resins. Polycarbonate 
plastics have many applications including food and drink packaging, 
compact discs, and medical devices, while epoxy resins are used as 
lacquers to coat metal products such as food cans, bottle tops, and 
water supply pipes. CERHR selected bisphenol A for evaluation because 
of its (1) High production volume, (2) widespread human exposure, (3) 
evidence of reproductive toxicity in laboratory animals, and (4) public 
concern.
    As part of its evaluation process, CERHR has prepared the draft NTP 
Brief on bisphenol A that contains the NTP's conclusions and scientific 
support on whether or not exposure to this chemical presents a concern 
for human reproduction or the development of children. The draft brief 
is based on the CERHR Expert Panel Report on Bisphenol A released 
November 30, 2007, public comments on that report (the report and 
comments are available at http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html), and new studies related to the 
toxicity or biological activity of bisphenol A published since the 
February 2007 cut-off date for literature for the expert panel's 
deliberations.
    The draft brief will undergo peer review at the NTP BSC meeting. 
The NTP invites written public comments on the draft NTP Brief on 
Bisphenol A and/or presentation of oral comments at the NTP BSC meeting 
(see ``Request for Comments'' below). The draft brief will be available 
on the CERHR Web site (http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.html) and the NTP BSC meeting Web site (http://ntp.niehs.nih.gov/go/165) on April 15, 2008.

NTP Testing Program: Proposed Research Projects

    The NTP actively seeks to identify and select for study chemicals 
and other substances for which sufficient information is not available 
to adequately evaluate potential human health hazards. The NTP 
accomplishes this goal through a formal open nomination and selection 
process. Substances considered appropriate for study generally fall 
into two broad, yet overlapping categories: (1) Substances judged to 
have high concern as possible public health hazards based on the extent 
of human exposure and/or suspicion of toxicity and (2) substances for 
which toxicological data gaps exist and additional studies would aid in 
assessing potential human health risks, e.g., by facilitating cross-
species extrapolation or evaluating dose-response relationships. 
Nominations are subject to a multi-step, formal process of review 
before selections for testing are made and toxicological studies are 
designed and implemented. The nomination review and selection process 
is accomplished through the participation of representatives from the 
NIEHS, other federal agencies represented on the Interagency Committee 
for Chemical Evaluation and Coordination (ICCEC), the NTP BSC, the NTP 
Executive Committee--the NTP federal interagency policy body, and the 
public. The nomination review and selection process is described in 
further detail on the NTP Web site (http://ntp.niehs.nih.gov; select 
``Nominations to the Testing Program'').
    Table 1 lists new nominations to be reviewed at the NTP BSC 
meeting. Background documents for each nomination are available on the 
NTP Web site at http://ntp.niehs.nih.gov/go/nom. The NTP invites 
interested parties to submit written comments, provide supplementary 
information, and/or present oral comments at the NTP BSC meeting on the 
nominated substances and preliminary study recommendations that appear 
in Table 1 (see ``Request for Comments'' below). The NTP welcomes 
toxicology study information from completed, ongoing, or anticipated 
studies, as well as information on current U.S. production levels, use 
or consumption patterns, human exposure, environmental occurrence, or 
public health concerns for any of the nominated substances. The NTP is 
interested in identifying appropriate animal and non-animal 
experimental models for mechanistic-based research, including 
genetically modified rodents and high-throughput in vitro test methods, 
and as such, solicits comments regarding the use of specific in vivo 
and in vitro experimental approaches to address questions relevant to 
the nominated substances and issues under consideration. Although the 
deadline for submission of written comments to be considered at the NTP 
BSC meeting is May 23, 2008 (see ``Request for Comments'' below), the 
NTP welcomes comments or additional information on these study 
nominations at any time.

         Table 1.--Testing Recommendations for Substances Nominated to the NTP for Toxicological Studies
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                                                                                            Preliminary study
         Substance  [CAS No.]              Nominated by \1\       Nomination rationale     recommendations \2\
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Dimorpholinodiethyl ether [6425-39-4]  NCI....................  High production volume;  --Initial toxicological
                                                                 potential worker         characterization.
                                                                 exposures; lack of      --Studies to assess the
                                                                 adequate toxicological   potential for
                                                                 data; suspicion of       nitrosation.
                                                                 toxicity based on
                                                                 structure.
2-Ethylhexyl p-methoxycinnamate [5466- NCI....................  High production volume;  --Comprehensive
 77-3].                                                          widespread consumer      toxicological
                                                                 exposure as a common     characterization
                                                                 sunscreen active         including
                                                                 ingredient; reported     carcinogenicity and
                                                                 estrogenic and           developmental toxicity
                                                                 reproductive effects.    studies.
                                                                                         --Characterization of
                                                                                          photodecomposition
                                                                                          products.
4,7,10-Trioxatridecane-1,13-diamine    NCI....................  High production volume;  --Biomolecular
 [4246-51-9].                                                    potential worker         screening studies.
                                                                 exposures; lack of      --Genotoxicity studies.
                                                                 adequate toxicological
                                                                 data; acutely toxic.

[[Page 20291]]

 
Vanadium, tetravalent and pentavalent  NIEHS, U.S.              Widespread occurrence    --Comprehensive
 forms.                                 Environmental            as drinking water        toxicological
                                        Protection Agency.       contaminant and use as   characterization.
                                                                 a dietary supplement;   --Chronic toxicity and
                                                                 EPA Drinking Water       carcinogenicity
                                                                 Contaminant Candidate    studies via oral route
                                                                 List research need;      of administration.
                                                                 pentavalent form is     --Multi-generation
                                                                 carcinogenic via the     reproductive and
                                                                 inhalation route;        developmental toxicity
                                                                 inadequate data to       studies.
                                                                 assess risk of oral
                                                                 exposures.
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\1\ National Institute of Environmental Health Sciences (NIEHS); National Cancer Institute (NCI).
\2\ The terms ``initial toxicological characterization'' and ``comprehensive toxicological characterization'' in
  this table refer 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 for each are:
--Initial toxicological characterization: Biomolecular screening, in vitro mechanistic, in vitro and in vivo
  genotoxicity, absorption, disposition, metabolism, and elimination, and short-term repeat dose (2-4 weeks) in
  vivo studies.
--Comprehensive toxicological characterization: All of the aforementioned plus 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 appropriately 
addressed through studies on the nominated agent. 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 May 7, 
2008.
    In addition to review of the new nominations in Table 1, the NTP 
BSC will review proposed research projects for (1) furan [CAS RN: 110-
00-9]; and (2) melamine [CAS RN: 108-78-1] and cyanuric acid [CAS RN: 
108-80-5]. Draft research concepts for these proposed projects will be 
available on the NTP BSC meeting page (http://ntp.niehs.nih.gov/go/165) 
by May 7, 2008.

Attendance and Registration

    The meeting is scheduled for June 11-12, 2008, beginning at 8:30 
a.m. on each day and continuing to 5 p.m. on June 1 and on June 12 
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 June 4, 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 May 23, 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. 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 pre-
registered 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 June 4, 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: April 4, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E8-7831 Filed 4-11-08; 8:45 am]
BILLING CODE 4140-01-P