History

In 1998 it was recognized that a research focus in the areas of Phototoxicology and Photocarcinogenesis was needed at NCTR to further support the regulatory mission of the Food & Drug Administration (FDA). At the same time this need was also recognized within the National Toxicology Program (NTP) of the National Institute for Environmental Health Sciences (NIEHS). An Interagency Agreement (IAG) existed between the FDA and NIEHS since 1992 to coordinate and jointly fund toxicological studies of mutual interest. This IAG was used to jointly develop a phototoxicological facility at NCTR. Scientists at FDA Centers and Argus Research Laboratories (now part of Charles River Companies) provided expertise and guidance in designing the new facilities. Existing space was renovated in 1998-1999 and the facility became functional in 1999. The facility was named as one of the NTP centers for research excellence, the NTP Center for Phototoxicology. It is also referred to as the Center for Phototoxicology at NCTR.

Mission

The mission of the Center for Phototoxicology is to address the toxic or carcinogenic potential of chemicals when exposed to light, or when applied to photo-treated skin. The research conducted in this facility is nominated through one of three mechanisms. The majority of the nominations will come from the FDA Centers, or other government agencies, through the NTP IAG. The research program that is put in place for one of these nominations takes into consideration the data needed by the nominating FDA Center for risk assessment or regulatory decision making, and must take into consideration the toxicology and cancer bioassay requirements of the NTP. The NCTR Principal Investigator for each of the nominations (research program) organizes a multidisciplinary team to define the problem, coordinate the research at NCTR, and provide results to the FDA Centers and NTP. The second mechanism for nominating chemicals for phototoxicity testing is through NCTR investigator-initiated protocols. These protocols are subject to review at NCTR, FDA Centers, and external peer-review, and usually focus on mechanisms of phototoxicity of a particular chemical. The third mechanism for nominating chemicals is through collaboration or through cooperative research agreements with investigators outside NCTR. These protocol are subject to the same internal- and external- peer-review scrutiny; however, the purpose of the collaboration is to take advantage of the uniqueness of the facilities at NCTR.

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 simultaneously conduct 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