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Phototoxicology
NTP/NCTR Center for Phototoxicology
History
In the mid 1990’s FDA recognized a need for research focused in the areas of phototoxicology and photocarcinogenesis. 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 became 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 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.
Mission
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 with consideration of 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 the 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 Phototoxicology 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.
Uniqueness of the Center
- 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
Goals of the Facility
- 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 Centers and NIEHS scientists interested in phototoxicology
Current NTP-Supported Projects
- Alpha and Beta Hydroxy (topically applied)
- Aloe Vera (topically applied)
- Retinyl Palmitate (topically applied)
- Permanent Makeup Ink (intradermal)
- Nanoscale Silver (topically and orally applied)
- Titanium Dioxide (topically and intradermally applied)
Current FDA or Other Supported Projects
- Phototoxicity of Tattoo Ink Pigments
- Allele-Specific p53 Mutation
- TP-ras p16 INK4a Transgenic Mouse
Future Direction of Phototoxicology Studies
The NCTR Center for Phototoxicology/NTP Center for Phototoxicology (NCP) was created to meet the phototoxicology and photocarcinogenesis research and testing needs of both the FDA and the NTP. In this leadership role, the NCP will continue to provide important scientific information needed for risk assessment and risk management decisions. In addition, NCP will be a resource for other federal research and regulatory agencies thereby providing guidance and giving advice on issues involving photo-irradiation and phototoxicology (e.g., potential risk from chemical and UV exposure; design and execution of phototoxicology studies, etc.).
- FDA Mission and NTP Vision/Roadmap Support: NCP is located at FDA's National Center for Toxicological Research (NCTR). FDA’s primary mission is to promote and protect the health of the American public and NCTR supports that mission by providing high-quality scientific data to FDA’s regulatory product centers. As the NTP and its partners implement the NTP Roadmap to achieve the NTP vision for the 21st century (http://www.ntp.gov), the NCP will support the NTP Roadmap by developing and applying new mechanistic toxicology tools for identification of biomarkers predictive of toxic or carcinogenic events prior to the phenotypic expression of those events. Creating, validating and understanding how this new type of scientific information can be used in regulatory decision making will be a priority for the NCP.
- Evolution of Phototoxicology: There are many aspects of phototoxicology and photocarcinogenesis where new advances in biochemical techniques can enhance the information gained from a study, or result in a change in study design. As an example, the NCP is examining the utility of digital photography in documenting clinical observations in the test animals and as an instrument for measuring skin changes. Another example is examination of genomic changes as predictive biomarkers for skin cancer development. In addition, the NCP is currently evaluating various statistical methods by which tumor multiplicity can be factored into result interpretation and also developing computer modeling programs which predict skin tumor growth and growth patterns. The NCP will continue to provide leadership by advancing the science of phototoxicology.
Contact Information
Please address any questions and suggestions to Dr. Paul Howard at 870-543-7672 or paul.howard@fda.hhs.gov.
Contact Us
- 870-543-7130
National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Road
Jefferson, AR 72079