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NTP Process for Preparation of the Report on Carcinogens

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Overview

A two-page procedural insert reproduced in the front matter of the Report on Carcinogens, Fifteenth Edition (December 2021), prepared by the U.S. National Toxicology Program (NTP) on behalf of the Secretary of Health and Human Services. The insert describes the four-part NTP process by which a substance, mixture, exposure circumstance, or other agent becomes listed in the RoC as either known to be a human carcinogen or reasonably anticipated to be a human carcinogen, the two RoC listing categories. The Report on Carcinogens is a Congressionally-mandated, science-based public health document; each edition is cumulative and incorporates newly reviewed substances alongside those previously listed. The document contains no primary contamination measurements, exposure data, or substance-specific carcinogenicity findings; its contribution to the Heavy Metal Index corpus is as the primary-record procedural account of how the RoC listing recommendations cited elsewhere in the corpus (notably Nickel Compounds and Metallic Nickel — 15th Report on Carcinogens for nickel compounds and metallic nickel) are produced.

Key numbers

  • RoC statutory and institutional framing (p. 1, opening paragraph and Step 1): the Report on Carcinogens is a Congressionally-mandated, science-based public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances (“substances”) that pose a cancer hazard for persons in the United States. The RoC has a substance profile for each listing that includes a description of the substance, its uses and potential sources of exposure, a summary of the scientific information considered key to its listing, and applicable current federal regulations and guidelines to limit exposure. Each edition is cumulative and includes newly reviewed substances and those previously listed. The RoC is prepared by the National Toxicology Program (NTP) on behalf of the Secretary of Health and Human Services. The NTP is a federal interagency program headquartered at the National Institute of Environmental Health Sciences (part of the National Institutes of Health), whose goal is to safeguard the public by identifying substances in the environment that may affect human health (p. 1, footnote 1).
  • The two RoC listing categories (p. 1, opening paragraph): substances are listed as either known to be human carcinogens or reasonably anticipated to be human carcinogens.
  • The four-part RoC preparation process (p. 1, paragraph 3, and the schematic on p. 1):
    1. Select substances for evaluation.
    2. Prepare draft RoC monographs for selected substances.
    3. Convene peer review and finalize RoC monographs.
    4. Submit new listings for approval and publish the RoC.
  • Step 1 — Substance selection (p. 1, §“Step 1”): NTP invites nominations of substances for review from the public or private sector. Nominations may seek to list a new substance, reclassify the listing status of a substance already listed, or remove a listed substance. Nominations may be submitted by mail, by email, or online at http://ntp.niehs.nih.gov/go/152. For each nomination, NTP conducts scoping and problem formulation activities to determine whether adequate information on exposure and carcinogenicity exists to justify evaluation for the RoC; these activities may include preliminary literature searches, public solicitation of information on exposure or ongoing studies of carcinogenicity through the Federal Register and NTP publications, and consultation with external technical advisors and/or NTP partner agencies. Public comments on nominations are posted to the NTP website. NTP uses these inputs to identify substances for evaluation for the RoC.
  • Step 1 — Draft concept document and BSC review (pp. 1-2, §“Step 1” continuation): for each substance proposed for RoC evaluation, NTP prepares a draft concept document, which is informed by the scoping and problem formulation activities. A “concept” is a brief document that presents the rationale, public health significance, and objective of the evaluation; it may also discuss information on exposure, concern for potential carcinogenicity, key scientific issues or questions, and the general approach for preparing the RoC monograph. NTP announces availability of draft concept documents on substance(s) proposed for evaluation and solicits public comments on them through the Federal Register and NTP publications. NTP presents the draft concept document for a substance to the NTP Board of Scientific Counselors (BSC) at a public meeting with opportunity for public comment; the BSC is asked to comment on the merit of the proposed evaluation and provide input on the draft concept document. NTP considers the BSC and public comments, and the NTP Director makes the final determination whether to select the substance for formal RoC evaluation. Concept documents for selected substances are finalized based upon those comments. For each selected substance, NTP sets up a webpage on the NTP website for draft materials related to its RoC evaluation.
  • Step 2 — Draft RoC monograph contents (p. 2, §“Step 2”): the cancer hazard evaluation of a selected substance is captured in an RoC monograph. The RoC monograph typically presents information on human exposure to the substance, especially U.S. exposure, and an assessment of the evidence from cancer studies in humans and experimental animals, mechanisms of carcinogenicity, and other data (such as absorption, distribution, metabolism, and excretion) relevant for evaluating the substance’s potential carcinogenicity. The draft RoC monograph presents NTP’s preliminary conclusions regarding the level of evidence for carcinogenicity from studies in humans or experimental animals and its preliminary RoC listing recommendation. These conclusions are reached by applying the RoC listing criteria (http://ntp.niehs.nih.gov/go/15209) to the cancer assessment. In most instances, the RoC monograph includes the draft substance profile as a separate section; however, in some instances the monograph represents the RoC substance profile.
  • Step 2 — Handbook and protocol (p. 2, §“Step 2” continuation): the specific approach for preparing the draft RoC monograph for a substance is guided by the nature, extent, and complexity of the scientific information and tailored to address the key scientific issues or questions for evaluating whether the substance is a potential cancer hazard. The Handbook for the Preparation of Report on Carcinogens Monographs (http://ntp.niehs.nih.gov/go/rochandbook) provides general instructions on the process. Typically, the first step in the process is to develop a protocol, which addresses the general instructions in the handbook to address the key scientific issues or questions related to the particular substance. The protocol is posted to the substance’s webpage. All public comments received during preparation of the draft RoC monograph for a substance become part of the public record, are posted to the substance’s webpage, and are considered by NTP and any technical advisors during subsequent steps in the RoC evaluation process. NTP also seeks public input on the preliminary RoC listing recommendation for the substance from its partner agencies and then completes the draft RoC monograph, with consideration of all inputs to its development.
  • Step 3 — Peer review and finalization (p. 2, §“Step 3”): NTP publishes a Federal Register notice announcing peer review and availability of the draft RoC monograph and inviting written public comment. NTP follows Department of Health and Human Services peer-review policies (https://aspe.hhs.gov/hhs-information-quality-peer-review), which were developed in accordance with the Office of Management and Budget’s Final Information Quality Bulletin for Peer Review (https://www.whitehouse.gov/sites/default/files/omb/fedreg/2005/011405_peer.pdf), to select and carry out an appropriate peer-review mechanism (e.g., by panel or letter). When peer review occurs by a panel in a public forum, NTP invites the public to attend the meeting and provide oral comments. Peer reviewers are charged to (1) comment on whether the draft RoC monograph is technically correct, clearly stated, and objectively presented; (2) provide opinion on whether there is currently or was in the past significant human exposure to the substance for persons residing in the United States; and (3) vote on whether the scientific evidence supports the level-of-evidence conclusions regarding carcinogenicity and NTP’s preliminary policy decision on the substance’s listing status in the RoC. A report on the peer review is prepared and posted to the substance’s webpage. Based upon the peer-review comments, NTP prepares a revised draft RoC monograph; at a public meeting, NTP provides the NTP Board of Scientific Counselors with information about the peer review. Following the meeting, NTP finalizes the RoC monograph for the substance and posts it to the substance’s webpage. The final monograph represents NTP’s policy recommendation on the substance’s listing status in the RoC.
  • Step 4 — Approval and publication (p. 2, §“Step 4”): NTP submits the draft substance profiles for newly reviewed substances with their recommended listing status to the NTP Executive Committee for consultation and then to the Secretary of Health and Human Services for review and approval. Upon approval by the Secretary, the substance profiles for newly reviewed substances are added to the next edition of the RoC, and the RoC is prepared in electronic format, transmitted to Congress, and published on the NTP website for the public. Periodically, NTP publishes the RoC in both printed and electronic formats, depending upon demand for the printed version. NTP publishes a notice in the Federal Register and NTP publications announcing the listing outcome for each substance that underwent formal evaluation for the RoC and availability of the next edition of the RoC.
  • NTP Executive Committee membership (p. 1, footnote 3): the NTP Executive Committee includes representatives from the Consumer Product Safety Commission, Department of Defense, Environmental Protection Agency, Food and Drug Administration, National Cancer Institute, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, and Occupational Safety and Health Administration. Interagency review of RoC nominations and listings is invited from this committee.
  • Contact and public-access points (p. 1, contact-information block and footnote 4): Office of the Report on Carcinogens, Division of NTP, National Institute of Environmental Health Sciences, P.O. Box 12233, MD K2-14, Research Triangle Park, NC 27709. Contact: Dr. Ruth Lunn, telephone (984) 287-3155, email lunn@niehs.nih.gov. Public comments received on RoC nominations are available at http://ntp.niehs.nih.gov/pubhealth/roc/noms/index.html. The RoC process page is http://ntp.niehs.nih.gov/go/rocprocess. The RoC home page is http://ntp.niehs.nih.gov/go/roc.

Methods (brief)

Procedural-record reproduction of the NTP front-matter description of the four-part Report on Carcinogens preparation process, drawn from the Fifteenth Edition (December 2021) front matter. No analytical chemistry, statistical analysis, exposure assessment, or substance-specific carcinogenicity assessment is performed within this two-page insert; its function is to describe the institutional workflow by which RoC listings are produced. Substance-level carcinogenicity findings are reported separately in the substance-profile chapters of the Fifteenth Report on Carcinogens, each of which is the proper primary-record source page when citing the specific RoC listing decision (the companion source page Nickel Compounds and Metallic Nickel — 15th Report on Carcinogens for nickel compounds and metallic nickel is the corpus example). The institutional pipeline reported here (nomination → scoping/concept → BSC review → draft monograph → external peer review → NTP Director finalization → Executive Committee consultation → Secretary HHS approval → publication) is the procedural foundation that supports treating Report on Carcinogens listings as A-tier regulatory evidence under docs/conventions §Evidence grading: each listed substance has passed independent scientific peer review, public-comment review, BSC review, NTP Director finalization, interagency Executive Committee consultation, and Secretarial HHS approval, with all draft materials and peer-review reports posted to the public record.

Implications

  • Certification (HMTc): This source is the primary-record procedural account of how NTP RoC listings are produced. For any HMTc category in which an RoC listing figures as supporting carcinogenicity evidence, this source documents the institutional process behind that classification — peer review, public comment, BSC consultation, Director finalization, interagency Executive Committee consultation, Secretarial HHS approval — and is the citation of record when HMTc materials need to demonstrate the procedural rigor underlying the RoC listing they cite. The specific substance-profile carcinogenicity classifications themselves are not in this 2-page procedural PDF; those are reported in the per-substance profiles of the Fifteenth Report on Carcinogens and should be cited via the corresponding substance-profile source pages (e.g., Nickel Compounds and Metallic Nickel — 15th Report on Carcinogens for nickel compounds and metallic nickel).
  • Courses: Useful as the primary-record explainer of how NTP produces the RoC. The four-step pipeline (nomination → concept/scoping/BSC → draft monograph → peer review → finalization → publication) is the foundational regulatory-process taxonomy for students who need to understand why the RoC carries the weight it does in carcinogenicity classification work, alongside the IARC monographs and EPA IRIS process. The interagency Executive Committee membership list documents the federal coordination structure behind the RoC listings.
  • App: Not directly relevant to ingredient contamination_profile data. The RoC listing status of a substance is a categorical attribute (known carcinogen / reasonably anticipated carcinogen / not listed) that could become a tag on the metal-page surfaces in the app (e.g., flagging the carcinogen classification status of each of the ten HMI metals); the present source describes how those classifications are produced, not the classifications themselves.

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