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:
The goals of the facility include:
Please address any questions and suggestions to Dr. Paul Howard at 870-543-7672 or email@example.com