[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Pages 19444-19445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program
The National Toxicology Program (NTP) Center for the Evaluation of
Risks to Human Reproduction (CERHR) announces plans for future
evaluations of Methylphenidate and Adderall [reg], Magnesium Sulfate,
and Genistein and Soy Formula; Requests public comments on these
substances; and solicits the nominations of scientists qualified to
serve on expert panels evaluating these compounds.
Summary
The CERHR plans to convene 3 expert panels to evaluate potential
reproductive and developmental toxicities of (1) methylphenidate
(Ritalin [reg]) and Adderall [reg], (2) magnesium sulfate, and (3)
genistein and soy formula. For each evaluation, the expert panel will
consist of approximately 12 scientists, selected for their scientific
expertise in various aspects of reproductive and developmental
toxicology and other relevant areas of science. The CERHR invites the
submission of public comments on any of these substances and the
nomination of scientists to serve on the expert panels for their
evaluation (see below). These meetings are tentatively scheduled for
2004 and 2005 although the exact dates and locations are not yet
established. As plans are finalized, they will be announced in the
Federal Register and posted on the NTP Web site (http://ntp-server.niehs.nih.gov). These expert panel meetings will be open to the
public with time scheduled for oral public comment.
Evaluation of Methylphenidate and Adderall [reg]
Methylphenidate (Ritalin [reg], CAS RN: 113-45-1) and Adderall
[reg] (amphetamine, CASRN: 300-62-9 and dextraamphetamine, CASRN: 51-
64-9) are stimulants used to treat attention deficit disorder with
hyperactivity and narcolepsy in children and adults. Methylphenidate is
also used off-label to treat depression. CERHR selected these chemicals
for expert panel evaluation because of: (1) The increasing use of these
drugs in children, (2) public concern for long-term effects of these
drugs on child development and behavior, (3) the availability of human
exposure data, and (4) findings from developmental studies in humans
and experimental animals.
Evaluation of Magnesium Sulfate
Magnesium sulfate (CASRN: 7487-88-9) is the most common magnesium
salt used for seizure prophylaxis in preeclampsia or seizure control in
eclampsia, and for inhibition of uterine contractions during preterm
labor. CERHR selected this chemical for expert panel evaluation because
of: (1) The existence of an adequate exposure database, (2) concern for
the survival and development of the infant after maternal treatment,
and (3) the availability of developmental toxicity data.
Evaluation of Genistein and Soy Formula
Genistein (CASRN: 446-72-0) is found in some legumes, such as
soybeans and clover, or in products obtained from animals ingesting
genistein-containing feed. Genistein is a phytoestrogen, defined as a
non-steroidal, estrogenic, naturally occurring plant product. It is
found in food, in over-the-counter dietary supplements, and is the
primary phytoestrogen in soy formula. Soy formula is administered to
infants as a supplement or replacement for maternal breast milk or
cow's milk. CERHR selected these substances for expert panel evaluation
because of: (1) The availability of numerous reproductive and
developmental studies in laboratory animals and humans, (2) exposure
information in infants and women of reproductive age, and (3) public
concern for effects on infant or child development.
Request for Public Comment on Substances To Be Evaluated
The CERHR invites input from the public and other interested
parties on these substances, including toxicology information from
completed and ongoing studies, information on planned studies, and
information about current production levels, human exposure, use
patterns, and environmental occurrence. Information and comments should
be forwarded to the CERHR at P.O. Box 12233, MD EC-32, Research
Triangle Park, NC 27709 (mail), (919) 541-3455 (phone), (919) 316-4511
(fax), or [email protected] (e-mail). Information and comments
received by 60 days from the publication date of this notice will be
made available to the CERHR staff and the appropriate expert panel for
consideration in the evaluation and posted on the CERHR Web site.
Request for the Nomination of Scientists for the Expert Panels
The CERHR invites nominations of qualified scientists to serve on
the individual expert panels for: (1) Methylphenidate and Adderall
[reg], (2) magnesium sulfate, and (3) genistein and soy formula.
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 that include: formal academic training and experience in
a relevant scientific field, publications in peer-reviewed journals,
membership in relevant professional societies, certification by an
appropriate scientific board or other entities, and participation in
similar committee activities.
All panel members serve as individual experts in their specific
areas of expertise and not as representatives of their employers or
other organizations. Scientists on the expert panel will be selected to
represent a wide range of expertise, including, but not limited to,
developmental toxicology, reproductive toxicology, neonatology and
child development, epidemiology, general toxicology, pharmacokinetics,
exposure assessment, and biostatistics. Nominations received by 60 days
from the publication date of
[[Page 19445]]
this notice will be considered for these panels and for inclusion in
the CERHR Expert Registry. Nominations, including contact information
and a current curriculum vitae (if possible) should be forwarded to the
CERHR at the address given above.
Background Information About the CERHR
The NTP established the CERHR in June 1998 [Federal Register,
December 14, 1998: Volume 63, Number 239, page 68782]. The 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. Expert panels conduct
scientific evaluations of agents selected by the CERHR in public
forums.
Information about CERHR and its process for nominating agents for
review or scientists for its expert registry can be obtained from its
homepage (http://cerhr.niehs.nih.gov) or by contacting Dr. Shelby
(contact information provided above). The CERHR selects chemicals for
evaluation based upon several factors, including production volume,
extent of human exposure, public concern, and published evidence of
reproductive or developmental toxicity.
CERHR follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process was
published in the Federal Register (July 16, 2001: Volume 66, Number
136, pages 37047-37048) and is available on the CERHR Web site under
``About CERHR'' or in printed copy from the CERHR.
Dated: April 1, 2004.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-8269 Filed 4-12-04; 8:45 am]
BILLING CODE 4140-01-P