Reviews of Process and Procedures for the Report on Carcinogens (RoC)

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In 1994, the NTP Director initiated a review of the RoC to (1) broaden input for the preparation of the report, (2) broaden the scope of scientific review associated with the RoC, and (3) provide review of the criteria used for listing substances in the RoC. This review of the criteria was open to the public and included participation by, and input from, many interested parties, including academia, industry, labor, private organizations, and federal, state, and local agencies. In 1996, the Secretary approved the revised criteria, which allow for consideration of all relevant information, including mechanism of action, when making decisions about listing nominations in the RoC, and the NTP Director announced revisions to the process for reviewing nominations for listing in or removal from the RoC. The revised process included: (1) addition of an external peer review that would be conducted by members of the NTP Board of Scientific Counselors in a public forum with opportunity for public comment, (2) opportunities for additional public input throughout the review process, and (3) establishment of a formal review mechanism for the consideration of removing (delisting) substances from the RoC. The NTP began using the revised process and revised criteria with the 8th RoC, which was published in 1998.

During preparation of the 8th and 9th RoCs, the NTP received comments from interested stakeholders on the proposed listings, the listing criteria and the procedures used in review of nominations to the RoC. In response to this input, the NTP held a public meeting in October 1999 to revisit the review process and the listing criteria. The NTP appreciated the input received at this meeting and moved forward with implementing some changes in the review process for preparing future RoCs. The NTP felt that changes in the listing criteria were not needed at that time. The NTP has continued to consider public comments received on the review process and listing criteria by holding a public meeting in January of 2004 and conducting its own internal evaluation of the process used for the review of nominations to the 10th and 11th RoCs. The NTP has prepared and released responses to the public comments made and the discussions that occurred at the 1999 and 2004 meetings.

Following the 2004 meeting, the NTP went through an exercise to revise the RoC review process to enhance the scientific development of the report and address guidance in the Office of Management and Budget (OMB) Peer Review Bulletin. These revisions also considered input made at the 2004 meeting. On August 17, 2006, the NTP released the proposed process for preparation of the 12th RoC and invited public comment (71FR47507). The NTP has reviewed the public comments on the draft process, prepared and released a response to these comments and finalized the RoC review process for the 12th RoC [72 FR 72 18999 16Apr07].