NTP Proposes to Revise RoC Review Process

Suggested changes aim to address industry concerns.

By Lynn L. Bergeson

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On October 31, 2011, the National Toxicology Program (NTP) published a notice inviting comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. This is good news, as I'll explain.

The proposal is a step in the right direction.

The RoC is a congressionally mandated, biennial document that identifies substances that may pose a hazard to human health because of their carcinogenicity. Designation as a RoC chemical has regulatory and commercial implications. For example, classifications under the Hazard Communication Standard must reflect designations by the RoC. Commercially, becoming listed as a RoC chemical may erode or even eliminate sales.

For many years, industry has expressed concern over lack of transparency and participation in the RoC process. NTP now is proposing changes to "enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner."

NTP's proposed RoC review process has four parts: 1) nomination and selection of candidate substances; 2) scientific evaluation of candidate substances; 3) public release of the draft RoC monograph and its peer review; and 4) Health and Human Services (HHS) approval and release of the latest edition of RoC.

Nomination and selection of candidate substances. NTP invites interested parties to seek to list a new substance in the RoC, reclassify the status of a substance already listed, or remove a listed substance.

The Office of the RoC (ORoC) initially assesses a nomination to determine whether information is sufficient to justify its formal evaluation. Under the proposed review process, ORoC would share nominations with its agency partners, including most federal agencies, and then would prepare a concept document for each proposed substance. Under the existing process, NTP announces nominations proposed for review and solicits public comment. NTP presents the draft concept for a substance to the NTP Board of Scientific Counselors (BSC) at a public meeting with opportunity for public comment. The change better ensures that nominations are vetted among federal agencies before going before the BSC.

Scientific evaluation of candidate substances. Information for evaluating a candidate substance must come from publicly available, peer-reviewed sources. Under the proposed review process, the nature, extent and complexity of the scientific information would guide OroC's approach to develop the cancer evaluation component. This approach is more flexible and tailored to enable using the most appropriate mechanisms to obtain external advice and address scientific issues, and may vary among substances. The approach may include external scientific input (e.g., from an expert panel, workshop or individual technical advisors), public input or interagency input.

Public release of draft RoC monograph and peer review. Under the proposed review process, NTP would release the revised draft RoC Monograph for public comment and then convene a meeting of an external advisory group to peer review the revised draft RoC monograph. The peer-review charge is two-fold: to comment on the cancer evaluation component and the substance profile. The peer-review report of the deliberations would be posted on the RoC website. The current process also includes a peer review by the BSC but the board is "not asked to review the NTP's decision regarding listing status." The change would expand the scope of the review, thus providing greater transparency and broader participation.

HHS approval and release of latest edition of RoC. Every two years, NTP submits newly reviewed candidate substances and its recommended listing status to the Secretary of HHS for review and approval. The substance profiles for new listings approved by the Secretary are added to the RoC. NTP publishes notices announcing the listing outcome for each candidate substance and posts its response to the peer-review report on the RoC website. NTP isn't recommending changes to this part of the process.

NEXT STEPS
Comments on the proposal were due by November 30, 2011. NTP also slated a public listening session for November 29, 2011. As of this writing, however, the American Chemistry Council has submitted requests for extending the comment period to 90 days and rescheduling the public meeting to two to three weeks after the submission deadline for written comments; NTP hasn't yet responded to these requests. Interested stakeholders are urged to monitor this proposal because meaningful changes in the RoC listing process are needed.


LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at Lbergeson@putman.net.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.

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