Summary of NTP's October 1999 Public Meeting on the Report on Carcinogens Program

On October 21-22, 1999, the National Institute of Environmental Health Sciences and the National Toxicology Program sponsored a two-day public meeting at the Doubletree Hotel in Rockville, MD to discuss ways in which the Report on Carcinogens program could be improved. NTP staff in attendance included the Director, Dr. Kenneth Olden. The meeting was chaired by Dr. Bernard Goldstein, from Rutgers and the University of Medicine & Dentistry of New Jersey. There was a discussion panel consisting of Dr. Lynn Goldman of the Johns Hopkins School of Public Health and Dr. Clay Frederick of Rohm and Haas Company.

Approximately 48 speakers presented oral comments, and there was additional discussion following each series of approximately 10 presentations. The following points and recommendations were made during the meeting:

1. Information should be added to the listings and/or the profiles concerning significant exposure levels, the magnitude of risk, and subpopulations particularly at risk. Federal Focus, Inc. submitted legislative history materials showing that Congress intended such information to be included.

2. The agency is not adhering to its listing criteria for the "known" category in the case of some substances such as dioxin and ethylene oxide because it is relying on animal and mechanistic data to compensate for epidemiologic data which is not sufficient to indicate a causal relationship.

3. The listing criteria should state explicitly that mechanistic data can be used to upgrade as well as downgrade; or they should state that only convincing human evidence can be used to support a "known" listing.

4. Draft Background Documents ("DBD"s) should be released earlier to allow more time for comments. It would be best if there were a document reflecting the rationale for the listing nomination and significant issues that would be made available at the start of the review process when there is a first notice of opportunity for public comment. This document could then evolve into the Draft Background Document prior to the public peer review by the RoC Subcommittee of the Board of Scientific Counselors. NTP already requires a detailed nomination document when listing nominations are submitted by outside parties (but it is not clear whether even those documents are available to the public).

5. There is little or no indication that there has been adequate consideration of public comments. The DBDs do not show a responsiveness or responses to significant issues raised in the public comments.

6. Serious flaws appear in the DBDs and they never get changed as the DBDs move up through the review process. If a review committee such as the RoC Subcommittee does not agree with portions of a DBD, this is never reflected in the DBD or any specific recommendation by the Subcommittee. One would have to try to figure out the Subcommittee's views from being at the public meeting or reading the transcript, and even then the views of all the members would not be evident. Since the RoC Subcommittee is the only outside and public peer review body, and since the DBD is the only document providing a listing rationale, the Subcommittee should produce a separate report if it does not agree with all of the DBD. Minority positions should also be set out.

7. The agency develops an advocacy position on listings early in the review process before there is adequate opportunity for the public to comment on the listing rationale contained in the DBD. Until the DBD is released just a few weeks before the public RoC Subcommittee meeting (the third step in the review process), the public has to adopt a scattergun approach in submitting comments because it has not seen the agency's listing rationale.

8. The RoC Subcommittee does not appear to have adequate time and resources to review the large number of substances scheduled for its two-day review meetings. More time should be allotted to fewer listing proposals, particularly when the agents involved are of widespread public interest or are likely to be controversial.

9. More time should be allowed for public comments at the RoC Subcommittee meetings; and there should be an opportunity for dialogue between the Subcommittee members and those making presentations and others present at the meetings.

10. The RoC Subcommittee public discussion of key issues is usually perfunctory.

11. There should be more epidemiologists on the review committees.

12. In the case of agents for which the database is extensive, it would be advisable to add expert consultants to the RoC Subcommittee and other review committees on an ad hoc basis. On the other hand, scientists who have become expert on a particular database are likely to have developed a bias.

13. There should be transcripts available for all the review meetings (including RG1, RG2, and the NTP Executive Committee).

14. Some of the recommendations should be applied to the 9th RoC, which is currently nearing completion. The 9th Report contains many controversial listing proposals and should not be rushed. Since the reports are required to be biennial, and the 8th RoC was issued in May 1998, the 9th RoC is not due until May 2000 at the earliest. The interval between the 7th and 8th RoCs was four years; and between the 7th and 8th RoCs it was three years. Thus, the agency appears to be rushing unduly to publish the 9th RoC.

15. There should be rigorous criteria for the review of epidemiologic evidence for causal relationship, since it is critical for listing in the "known" category.

16. If the agency is not going to review all of the literature on an agent, it should have selection criteria. Less than 20 percent of the literature on alcoholic beverages was reviewed.

17. There should be a separate category for pharmaceuticals. Such agents have been approved by the FDA as safe, and listing them as known human carcinogens is likely to influence patients to stop taking a beneficial drug unless additional information on benefits and relative risk is supplied.

18. The public RoC Subcommittee meetings should be held in Washington, DC (and possibly other cities) rather than Research Triangle Park, NC (NIEHS headquarters) so that more stakeholders can participate.

19. Agents should not be listed in the "known" category based simply on majority votes; such listing should be done only on the basis of consensus.

20. Many listings are confusing in the absence of more information on what specific compounds or exposure circumstances (including dose) are "known" to cause cancer.

21. The listings have real world impacts. They result in OSHA regulation, and prompt regulation by other Federal agencies and at the state and local level, and lead to product de-selection.

22. What is the usefulness of a simplistic hazard listing if other Federal agencies provide more specific information on risk? The public does not understand the distinction between "hazard" and "risk".

23. The listing process should include an agent-specific workshop early on in the review process before a DBD is prepared and passed on to the review committees.

24. The review process is cumbersome. It could be streamlined by eliminated the RG1 and the Executive Committee reviews. In many instances, Executive Committee members send their alternates to attend, and the alternates have already participated in earlier reviews or are not policy officials.

25. The role of mechanistic data in supporting listings is still not clear.

26. The Delaney-type approach of the RoC listings is outmoded. If some information on dose is not provided, the Reports are not useful.

27. The agency seems to cite IARC when IARC supports the agency's position. RoC listing decisions should be made independently of IARC.

28. There should be more outreach for comments to scientists and other stakeholders who might be knowledgeable but who probably do not read the Federal Register or monitor the NTP Website.

29. There is already too much repetition in the comments process (with three formal opportunities for public comment).

30. Unpublished data should not be considered. But others respond that sometimes large negative (animal) studies are left unpublished, and there should be a way to take such data into account.

31. The agency should comply with the Congressional directive to assess the extent to which existing regulatory measures have reduced risk.

NTP will prepare a transcript of the meeting, expected to be available 4-6 weeks following the meeting. Written comments, including ones submitted by persons not able to attend, can be obtained by requesting them from the agency via fax (919-541-0295) or e-mail (wilson9@niehs.nih.gov).

At the close of the meeting, Dr. Olden stated that the agency will prepare responses to the comments presented and will tell the public what changes it will make.

Updates on agency actions in response to the public comments, and notice of availability of the meeting transcript, will likely be posted on the NTP Website, http://ntp-server.niehs.nih.gov.