[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14816-14818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Office of Chemical Nomination
and Selection; Announcement of and Request for Public Comment on
Toxicological Study Nominations to the NTP
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health.
ACTION: Notice; request for comments and additional information.
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SUMMARY: The NTP continuously solicits and accepts nominations for
toxicological studies to be undertaken by the program. Nominations of
substances of potential human health concern are received from federal
agencies, the public, and other interested parties. These nominations
are subject to several levels of review before selections for testing
are made and toxicological studies are designed and implemented. This
notice (1) Provides brief background information and preliminary study
recommendations regarding nine nominations for study by the NTP (Table
1), (2) solicits public comment on the nominations and study
recommendations, and (3) requests the submission of additional relevant
information for consideration by the NTP in its continued review of
these nominations. An electronic copy of this announcement, supporting
documents for each nomination, and further information on the NTP and
the NTP Study Nomination and Review Process can be accessed through the
NTP Web site (http://ntp.niehs.nih.gov/; select ``Nominations to the
Testing Program'').
DATES: Comments or information should be submitted by May 10, 2007.
ADDRESSES: Correspondence should be addressed to Dr. Scott A. Masten,
Director, Office of Chemical Nomination and Selection, NIEHS/NTP, 111
T.W. Alexander Drive, P.O. Box 12233, Research Triangle Park, North
Carolina 27709; telephone: 919-541-5710; FAX: 919-541-3647; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Background Information
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. Nominations can be submitted to the
[[Page 14817]]
NTP at http://ntp.niehs.nih.gov/; select ``Nominations to the Testing
Program'' or by contacting Dr. Scott Masten (see ADDRESSES above).
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 also solicited for studies that permit the testing of
hypotheses to enhance the predictive ability of future NTP studies,
address mechanisms of toxicity, or fill significant gaps in the
knowledge of the toxicity of classes of chemical, biological, or
physical agents.
Study nominations may entail the evaluation of a variety of health-
related effects including, but not limited to, reproductive and
developmental toxicity, genetic toxicity, immunotoxicity,
neurotoxicity, metabolism and disposition, and carcinogenicity in
appropriate experimental models. In reviewing and selecting nominations
for study, the NTP also considers legislative mandates that require
responsible private sector organizations to evaluate their products for
health and environmental effects. The possible human health
consequences of anticipated or known human exposure, however, remain
the over-riding factor in the NTP's decision to study a particular
substance.
Nominations undergo a multi-step, formal process of review.
Briefly, during the entire nomination review and selection process, the
NTP works with staff at other federal agencies and interested parties
to supplement information about nominated substances and ensure that
regulatory and public health needs are addressed. 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 Board of Scientific Counselors (BSC)--an external
scientific advisory body, the NTP Executive Committee--the NTP federal
interagency policy body, and the public. Preliminary study
recommendations for each nomination are developed and refined by the
nominator, NTP staff, and the ICCEC and may be further refined as the
formal review process continues. The NTP considers recommendations from
the BSC and the NTP Executive Committee, public comments received on
the nominations, and other available information in selecting candidate
substances for study. The NTP initiates appropriate toxicology and
carcinogenicity studies as time and resources permit.
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'').
Request for Comments and Additional Information
The NTP invites interested parties to submit written comments or
supplementary information on the nominated substances and study
recommendations that appear in Table 1. 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. Comments
should be submitted by May 10, 2007; however, the NTP welcomes comments
or additional information on these study nominations at any time. The
NTP will not respond to submitted comments; however, all information
received will become part of the official record that the NTP considers
in its ongoing review of these nominations. Persons submitting comments
should include their name, affiliation, mailing address, phone, fax, e-
mail address, and sponsoring organization (if any) with the submission.
Written submissions will be made publicly available electronically on
the NTP Web site as they are received (http://ntp.niehs.nih.gov/;
select ``Nominations to the Testing Program'').
Background Information on the NTP Office of Chemical Nomination and
Selection
The NTP Office of Chemical Nomination and Selection (OCNS) manages
the solicitation, receipt, and review of NTP toxicology study
nominations. The OCNS conducts an initial review of each study
nomination received to determine whether the substance or issue has
been adequately studied or has been previously considered by the NTP.
For nominations not eliminated from consideration or deferred at this
stage, the OCNS initiates a formal review process, as described above.
The OCNS also ensures adequate background information is available to
support the review for each nomination and corresponds with interested
parties regarding the status of NTP study nominations. For further
information on the OCNS visit the NTP Web site (http://ntp.niehs.nih.gov; select ``Nominations to the Testing Program'') or
contact Dr. Masten (see ADDRESSES above).
Dated: March 21, 2007.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and
National Toxicology Program.
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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Aminopyridines: 2-Aminopyridine NCI.................. Moderate production and --Toxicological
[504-29-0], 3-Aminopyridine [462- use; acutely toxic; lack characterization
08-8], 4-Aminopyridine [504-24-5]. of adequate toxicological including chronic
data; suspicion of toxicity and
toxicity and carcinogenicity studies
carcinogenicity based on for 2-aminopyridine.
structure. --Short-term mechanistic
studies for 3- and 4-
aminopyridine.
--Comparative
neurotoxicity studies
for 2-, 3-, and 4-
aminopyridine.
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Artificial butter flavoring United Food and Evidence of lung disease --Chronic toxicity and
mixture and certain components: Commercial Workers in exposed workers and carcinogenicity studies
Acetoin [513-86-0], Diacetyl [431- International Union. respiratory toxicity in via inhalation in rats.
03-8]. short-term animal --Mechanistic studies.
toxicity studies.
Asbestos, naturally occurring and National Center for Widespread community --Mineral
atypical forms [1332-21-4]. Environmental Health/ exposure in certain characterization.
Agency for Toxic geographic locales; --In vitro durability and
Substances and insufficient dose- toxicity studies.
Disease Registry, response data to --Subchronic and chronic
U.S. Environmental characterize risk from toxicity/carcinogenicity
Protection Agency. exposure to studies via inhalation.
``unregulated'' --Studies should utilize
asbestiform mineral test materials
fibers and naturally representative of
occurring fibrous mineral minerals identified in
``mixtures''. Libby, MT and at other
Naturally Occurring
Asbestos (NOA) sites.
Diethyl phthalate [84-66-2]....... National Institute of Widespread consumer --Multigeneration oral
Environmental Health exposure through use in reproductive and
Sciences. cosmetics and personal developmental toxicity
care products; studies
insufficient toxicity --Toxicokinetic studies
data to assess potential (oral and dermal
reproductive hazard. routes).
2',2''-Dithiobisbenzanilide [135- NCI.................. High production volume; --Genotoxicity studies.
57-9]. potential worker and --Metabolism studies.
consumer exposures; lack
of adequate toxicological
data; suspicion of
toxicity based on
structure.
2-Methoxy-4-nitroaniline [97-52-9] NCI.................. High production volume; --Toxicological
potential worker characterization.
exposures; lack of --Short-term mechanistic
adequate toxicological studies to predict
data; positive carcinogenic potential.
mutagenicity data; strong
suspicion of toxicity and
carcinogenicity based on
structure.
Nanoscale materials Nanoscale gold U.S. Food and Drug Widespread and increasing --Nanoscale materials
[7440-57-5] Nanoscale silver Administration. use in drug, food and characterization.
[7440-22-4]. cosmetic products; lack --Metabolism and
of adequate toxicological pharmacokinetic studies.
and pharmacokinetic data; --Acute, subacute and
need to evaluate whether subchronic toxicity
the current required studies.
tests are adequate to --Mechanistic studies to
detect adverse biological assess the role of size
and toxicological events. and surface coating on
biological disposition
and toxicity.
Pentaethylenehexamine [4067-16-7]. NCI.................. High production volume; No studies at this time
potential worker due to the irritant and
exposures; lack of corrosive nature of this
adequate toxicological compound.
data; positive
mutagenicity data.
o-Phthalaldehyde [643-79-8]....... National Institute Widespread and increasing --Toxicological
for Occupational use as a disinfectant in characterization
Safety and Health. health care settings; including studies to
lack of adequate and assess dermal
publicly available irritation, dermal
toxicological data; toxicity, and
potential skin and sensitization and
respiratory sensitizer. asthmagenic potential.
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\1\ National Cancer Institute (NCI).
\2\ The term ``toxicological characterization'' in this table includes studies for genotoxicity, subchronic
toxicity, and chronic toxicity/carcinogenicity as determined to be appropriate during the conceptualization
and design of a research program to address toxicological data needs. Other types of studies (e.g., metabolism
and disposition, immunotoxicity, and reproductive and developmental toxicity) may be conducted as part of a
complete toxicological characterization; however, these types of studies are not listed unless they are
specifically recommended.
[FR Doc. E7-5831 Filed 3-28-07; 8:45 am]
BILLING CODE 4140-01-P