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Annual Report for Fiscal Year 2016

Annual Report for Fiscal Year 2016

Interagency Agreements

In FY 2016, NIEHS provided support for NTP activities through interagency agreements with other federal agencies.


In December 1992, NIEHS and FDA established a formal interagency agreement 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 interagency agreement 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 250 peer-reviewed journal publications. Some of the data from the interagency agreement-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.


NIEHS/NTP has two interagency agreements with NIOSH. One interagency agreement was established in the early 1990s in response to increased efforts by NTP to study noncancer endpoints. NIOSH and NIEHS/NTP have conducted studies to assess the potential toxicity of exposures to substances such as fungi, mycotoxins, volatile organics, lead, latex, nickel, isocyanates, nanomaterials, and beryllium in occupationally exposed populations. Studies have included workers such as miners, farmers, health care workers, autoworkers, and firefighters exposed to mixtures of chemicals. Several studies examine how genetic variability in immune-inflammatory-antioxidant responses contributes to the development and severity of inflammatory and allergic disease in people of different occupations. NIEHS/NTP and NIOSH are also leveraging the capability of a unique acoustical generating system located at NIOSH to evaluate the potential health effects of exposure to airborne molds in short-term toxicology studies.

The second interagency agreement 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, and to conduct exposure assessments in occupational settings to identify toxicologically relevant exposures. During FY 2016, NIEHS/NTP and NIOSH completed a study evaluating occupational exposure to bisphenol A. Two additional projects are ongoing. The first focuses on an assessment of occupational exposure to alternative flame retardants used in manufacturing, construction, and service industries. The second project assesses exposure to polycyclic aromatic hydrocarbons by applicators of coal tar sealants.

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


This interagency agreement supports ongoing and anticipated studies conducted at the National Center for Advancing Translational Sciences/Division of Pre-Clinical Innovation, 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 2016

Study-Agency Description
Development of Tools for Evaluating NTP's Effectiveness - U.S. Department of Energy Research and development of tools, such as web-mining, that NIEHS can use in its research evaluations of the NTP's effectiveness.
Accelerating Development and Use of Computational Methods and Models - U.S. Environmental Protection Agency Accelerate development and use of computational methods and models for quantitative and qualitative assessments of the risks of environmental chemicals.