| NCTR Centers
of Excellence | National Toxicology Program
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In the mid 1990’s it was recognized that a research focus in the
areas of phototoxicology and photocarcinogenesis was needed by the Food
and Drug Administration (FDA). At the same time, this need was also
recognized within the
National Toxicology Program (NTP). The FDA is a charter member
of the NTP and one of three primary agencies [NIH’s National Institute
for Environmental Health Sciences (NIEHS), CDC’s National Institute of
Occupational Safety and Health (NIOSH) and FDA’s National Center for
Toxicological Research (NCTR)], that have management and oversight
responsibility for the NTP. Since the establishment of an Interagency
Agreement (IAG) in 1992, the FDA and NIEHS have collaborated in
conducting fundamental and applied research at the NCTR on projects of
mutual interest. In 1998, existing animal room and laboratory space was
identified at NCTR for the location of this new research and testing
facility; the space was renovated in 1998-1999 and the phototoxicology
research and testing laboratory becoming fully functional in the fall of
1999. The facility is operated and managed through the FDA-NIEHS IAG.
In 2000, the FDA-NIEHS Phototoxicology Research and Testing
Laboratory was established as the NTP Center for Phototoxicology, one of
three NTP Centers (the other two are the The Interagency Center for the
Evaluation of Alternative Toxicological Methods and the
Center for the Evaluation of Risks to Human Reproduction).
The FDA’s Dr. Paul Howard is the Director of this Center.
The mission of the FDA-NIEHS Center for Phototoxicology is to
evaluate agents of public health concern and to promote and protect
human health by assessing the toxic and/or carcinogenic potential of
chemicals and agents when exposed to light, or when applied to
photo-treated skin. Agents (e.g. drugs, additives, tattoo pigments,
cosmetic ingredients) and/or scientific issues (i.e. test agent and/or
light exposure times, test vehicles/creams, etc.) are typically
nominated for testing in the facility from: 1) FDA [FDA’s regulatory
product centers (CDER, CBER, CVM, CDRH or CFSAN); FDA’s regulatory
offices (OWH, ORA or OOPD) or from NCTR]; 2) other government agencies (NIEHS,
NIOSH, CPSC, EPA, etc.) or 3) other NTP stakeholders (private
individuals, union organizations, public citizens groups, environmental
groups, etc.) Research and testing protocols are designed taking into
consideration regulatory and other scientific concerns. Scientific
oversight is provided by the Toxicology Study Selection and Review
Committee (TSSRC), which has scientific oversight for all studies
conducted under the FDA-NIEHS IAG. All NTP nominated agents also undergo
peer review by NTP Board of Scientific Counselors Technical Reports Peer
Review Subcommittee. While FDA scientists generally have the leadership
(principal investigator) role for studies conducted under the IAG, there
is a multidisciplinary team of FDA, NIEHS and NTP scientists, and other
experts (from other federal agencies, academia and consultants) [who
collectively comprise the TSSRC] who advise, provide peer review, and
monitor research and testing studies so as to maximize the regulatory
utility of the scientific data gleaned from those studies.
As a federally operated research and testing facility, the FDA-NIEHS
Center for Phototoxiclogy is also a resource for other federal agencies.
For example, other federal NTP partners may also use the facility by
nominating agents to the NTP for testing consideration or by requesting
use of the facility for conducting agency-sponsored studies. Under the
latter scenario, such studies can be regulatory in nature or
investigator-initiated studies. The sponsor of such studies may request
use of (and have a place on) the NCP scientific oversight committee (TSSRC).
Coordination for such studies would be made by contacting Dr. Paul
Howard.
The FDA and NIEHS also consider cooperative research and development
agreements (CRADA’s) with scientists and groups outside the federal
government. Research and methods development studies would fall under
CRADA guidelines and would undergo review and need approval by both the
FDA and NIEHS.
The uniqueness of the Center for Phototoxicology include:
6,500 Watt solar light simulators that can generate
terrestrial sunlight
ability to generate light from most any source relevant to the
regulatory mission of the FDA
high-capacity animal facilities with capacity to conduct
simultaneously multiple studies
state-of-the-art facility, dosimetry, and instrument calibration
The goals of the facility include:
continue as a resource within the FDA, providing the FDA Centers
with critical and timely data for risk management decisions regarding
light as a possible factor in public health decisions
contribute to the awareness of phototoxicology and
photocarcinogenicity issues in FDA decision-making
serve as a resource for all FDA Center and NIEHS scientists
interested in phototoxicology
Please address any questions and suggestions
to Dr. Paul Howard at 870-543-7672 or
paul.howard@fda.hhs.gov
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