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Annual Report for Fiscal Year 2017

Annual Report for Fiscal Year 2017

Special Emphasis Panels

NTP uses ad hoc scientific panels, referred to as special emphasis panels, to provide independent scientific peer review and advice on targeted issues, such as agents of public health concern, new and revised toxicological test methods, and others. These panels help ensure that NTP receives transparent, unbiased, and scientifically rigorous input for its use in making credible decisions about human health hazards, setting research and testing priorities, and evaluating test methods for toxicity screening.

NTP Technical Report Peer Review Panels

NTP Technical Reports are published results of long-term studies, generally 2-year rodent toxicology and carcinogenesis studies. NTP convenes external scientific panels to peer review draft technical reports at public meetings held at NIEHS. All reviews provide the opportunity for public comment. For each technical report, the panel is charged with reviewing the scientific and technical elements and presentation of the study and determining whether the study’s experimental design and conduct support NTP conclusions regarding the carcinogenic activity of the substance tested. One technical report meeting was held in FY 2017, on July 13.

Three draft technical reports were peer reviewed at the July meeting: dietary zinc; 2,3 butanedione; and p-chloro-α,α,α-trifluorotoluene. The peer-review panel included individuals with expertise in molecular carcinogenesis, physiology, pharmacology, inhalation pathology, statistics, inhalation toxicology, genetic toxicology, occupational health, and general toxicology and pathology. Mary Wolfe, Ph.D., served as designated federal officer for the meeting. The panel agreed that elements and presentation of each study were appropriate and NTP’s conclusions in the draft technical reports were sound. Additional information about this meeting can be found on the NTP Technical Reports Peer Review Panels webpage.

Report on Carcinogens Peer Review Panels

NTP follows an established, four-part process in preparing the Report on Carcinogens. The Report monographs are prepared for each candidate substance selected for review and consist of a cancer evaluation component and a substance profile. NTP convenes external scientific panels to peer review draft Report monographs at meetings that are open to the public with time scheduled for oral public comment. The panels are charged with commenting on whether the draft cancer evaluation component is technically correct and clearly stated, whether NTP objectively presents and assesses the scientific evidence, and whether the scientific evidence is adequate for applying the listing criteria. For the draft substance profile, panels are charged with commenting on whether the scientific justification presented supports the preliminary NTP policy decision on the Report listing status.

On July 24, 2017, NTP convened a panel at NIEHS to peer review the draft Report monograph on haloacetic acids, which are found in the environment as byproducts of water disinfection. The panel was charged to:

  1. Comment on whether the draft monograph was technically correct, clearly stated, and objectively presented.
  2. Provide opinion on whether significant human exposure to haloacetic acids as water disinfection byproducts has been found.
The panel voted unanimously to accept NTP’s conclusions on the draft level of evidence for carcinogenicity determination, based on the available scientific evidence in experimental animal and human cancer studies. They also agreed unanimously with NTP’s preliminary listing recommendations in the Report. The review covered viral properties and human exposure, cancer studies in experimental animals, metabolism and mechanistic data, human cancer studies, an overall cancer evaluation, and the draft substance profile. Mary Wolfe, Ph.D., served as designated federal officer for the peer-review meeting. After the meeting, the input from the panel was considered in finalizing the monograph. Additional information about this meeting can be found on the Peer Reviews of Report on Carcinogens Monographs webpage.

NTP Expert Panels

NTP expert panels provide independent advice to NTP on agents of public health concern, new and revised toxicological test methods, or other topics. In August and September 2017, NTP hosted a series of four webinars to provide background information to an expert panel that is planned to convene in FY 2018 on the Draft NTP Approach to Genomic Dose-Response Modeling. The webinar speakers and subjects are listed below.

Webinar 1: The NTP Proposed Approach to Genomic Dose-Response Modeling, August 30
Scott Auerbach, Ph.D., of the National Toxicology Program presented the NTP proposed approach to genomic dose-response modeling. This approach is consistent with the modeling approach the EPA recommends for continuous non-genomic endpoints, which is implemented in its Benchmark Dose Software.

Webinar 2: Overview of the U.S. Army Approach to Genomic Dose-Response Modeling, September 1
Lyle Burgoon, Ph.D., U.S. Army Engineer Research and Development Center, discussed the Good Risk Assessment Value for Environmental Exposures approach. This approach is used in estimating points of departure from dose-response data.

Webinar 3: Overview of the NC State Approach to Genomic Dose-Response Modeling, September 13
Fred Wright, Ph.D., North Carolina State University, gave an overview of the NC State approach to handling genomic dose-response data for cell lines treated with chemicals at varying concentrations.

Webinar 4: An Automated Method to Identify Dose-Responsive Genes and Quantitate Points of Departure (PODs) from Transcriptomic Data, September 25
David Gerhold, Ph.D., National Center for Advancing Translational Sciences, presented an automated method to identify dose-responsive genes and quantitate points of departure from transcriptomic data.

Additional information about the webinar series is available online. General information about NTP expert panel meetings can be found on the NTP Expert Panels webpage.