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Annual Report for Fiscal Year 2015

Annual Report for Fiscal Year 2015
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Interagency Agreements

In FY 2015, NIEHS provided support for NTP activities through interagency agreements with other federal agencies.

FDA/NCTR

In December 1992, NIEHS and FDA established a formal interagency agreement (IAA) to conduct toxicology studies on FDA-regulated agents nominated to NTP and studies at NCTR. These studies are designed to provide FDA and other regulatory agencies with hazard identification and dose-response data to support risk assessment and risk management decisions that could affect public health.

This IAA has supported studies on endocrine active agents, dietary supplements, food contaminants, AIDS therapeutics, pediatric medicines, electromagnetic radiation, cosmetics, and nanoscale materials. Studies in these areas have produced 18 published NTP Technical Reports and over 200 peer-reviewed journal publications. Some of the data from the IAA-supported studies have led to an increased understanding of the pharmacokinetics, mechanism of action, or dose-response of substances. Other data have led to refinement of risk assessment models.

CDC/NIOSH

NIEHS/NTP has two interagency agreements (IAAs) with NIOSH. One IAA was established in the early 1990s in response to increased efforts by NTP to study noncancer endpoints. NIOSH and NTP have conducted studies to assess the potential toxicity of exposures to substances such as fungi, mycotoxins, volatile organics, lead, latex, nickel, isocyanates, and beryllium. Studies have included workers such as miners, farmers, health care workers, autoworkers, and firefighters, exposed to mixtures of chemicals. There have also been a number of studies examining how genetic variability in immune-inflammatory-antioxidant responses contributes to the development and severity of inflammatory and allergic disease in people of different occupations.

The second IAA involves multiple projects. NIEHS/NTP and NIOSH have worked to establish methodologies to assess complex mixtures, such as asphalt fume, welding fume, and tungsten fibers. NIOSH and NIEHS/NTP are jointly supporting two large initiatives that evaluate emerging issues in nanotechnology. One project focuses on identifying workplaces engaged in the development, production, and use of engineered nanomaterials, the first objective is to determine the potential for worker exposure to selected engineered nanoparticles. The second objective is to evaluate potential toxicity from workplace exposures to engineered nanomaterials. Another study with similar purpose and design to evaluate occupational exposure to bisphenol A is also in progress.

Many studies performed under these IAAs are published in the peer-reviewed literature and have been used for hazard identification, and regulatory and intervention purposes.

CDC/DLS

NIEHS/NTP and CDC/Division of Laboratory Sciences (DLS) are participating in a pilot study to characterize exposure profiles in a subset of 50 Danish women, who will be enrolled in a larger study of 500 women. The pilot study is designed to assess whether exposure to several common endocrine-disrupting chemicals is related to reproductive health problems, such as infertility, risk of miscarriage, and low birth weight, or childhood obesity or other health outcomes in the children. Endocrine-disrupting chemicals from the organotins and phthalates classes will be evaluated. Blood and urine samples will be collected three times from each woman, once prior to pregnancy and twice during pregnancy. This collaboration between NIEHS/NTP and CDC/DLS facilitates common goals in understanding individual exposure profiles for multiple chemicals in woman of reproductive age.

The chemical analysis has been completed and statistical analysis of co-patterns of exposure is underway. In FY 2015, a paper was published from this study in the journal Talanta about a method for simultaneous determination of organotins in human serum. A second paper about organotin and tin levels in Danish women was submitted.

NIH/NCATS/DPI

This IAA supports ongoing and anticipated studies conducted at the National Center for Advancing Translational Sciences (NCATS)/Division of Pre-Clinical Innovation (DPI), to evaluate high throughput and high content screening assays in support of Tox21. Tox21 is an ongoing collaboration among federal agencies to characterize the potential toxicity of chemicals by using cells and isolated molecular targets instead of laboratory animals. This collaboration between NIEHS/NTP and NCATS/DPI should produce data for substances lacking needed toxicological information that can be used to prioritize substances for further studies, including toxicological evaluation, mechanisms of action investigation, and development of predictive modeling for biological response. The use of the assays should greatly increase the number of substances tested and decrease the cost of testing.

Additional Agreements

NTP also established several smaller interagency agreements to conduct research, listed in the table below.

Additional Interagency Agreements in FY 2015
Study-Agency Description
Sisters Collaborative Study - EPA Research exposure patterns of personal care product use and the association with breast cancer and associated risk factors.
Folic Acid Expert Panel - NIH Office of Dietary Supplements Provide support for conduct of an expert panel to identify research needs related to the safe use of high intakes of folic acid based on consideration of the state of the science.
Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety Workshop - NIH Provide support for conduct of a workshop in FY 2016 to identify potential adverse effects of these agents after both short-term exposure and long-term exposure. More information can be found here on the NTP website.