CRE Letter to Director of NIEHS

January 28, 1999

Dr. Kenneth Olden
Director
National Institute of Environmental Health Sciences
111 T. W. Alexander Dr.
Bldg. 101, B241
Research Triangle Park, NC 27709

Dear Dr. Olden:

I am writing to you in your capacity as the Secretary's principal advisor for the Report on Carcinogens Program to recommend, on behalf of the Center for Regulatory Effectiveness¹, that a broad issue which goes to the heart of the purpose of the Program be brought before the NTP Executive Committee at its next meeting, and that the issue also be addressed by you and the Secretary in making final decisions on the contents of the upcoming 9th Report on Carcinogens.

The issue, and several options for addressing it, are discussed in some detail in the attached paper. Two specific examples of agents under review for the upcoming 9th Report on Carcinogens which present the issue are discussed: tamoxifen and alcoholic beverages. The issue is basically this:

• In the past it has been the practice to provide only extremely limited information in Report on Carcinogens listings -- i.e., stating simply whether an agent is "known" or "reasonably anticipated" to be carcinogenic.

• For some agents, this simple form of listing can be misleading and lead to harm to public health because the Reports listings do not provide information on health benefits, which in some cases might be considerably greater than the hazard. There is a lack of information coordination among Federal agencies in some cases, with some describing health benefits of substances, while others emphasize only potential adverse effects of the same substances.

• No government agency has taken responsibility for developing a coordinated approach that provides information on both benefits and hazards in appropriate cases.

The attached paper points out that there is recent Federal legislation and expressions of Congressional policy concerning the importance of this issue and the need to address it through appropriate guidance. While such guidance is being considered by OMB and individual agencies, the Department of Health and Human Services is faced with having to move ahead to finalize the 9th Report on Carcinogens. Therefore, we have proposed some specific options for handling this matter in the 9th Report. These options are both short-term and long-term. Utilizing the special "Reviewed But Not Listed" appendix recommended for boot and shoe manufacturing in the 9th Report, or deferral, for example, are short-term methods of addressing the issue; but a long-term approach should consider public and OMB input and the option of setting up a special "Qualified Listings" category for certain substances for which additional listing information is necessary to avoid public confusion and potential detriment to public health.

The three options outlined at the end of the attached paper are --

1. Utilize a "Reviewed But Not Listed" category recommended by two of the RoC review committees.

2. Add a new listing category for "Qualified Listings".

3. Defer action to the 10th Report.

We are taking the liberty of distributing this letter to members of the NTP Executive Committee. We are also providing it to members of the RoC Subcommittee of the NTP Board of Scientific Counselors and the Board in case you might also wish to seek their views on this subject. We also recommend consultation with OMB's Office of Information and Regulatory Affairs.

We would be pleased to discuss this further at your convenience. Assuming the issue is brought before the Executive Committee, we would appreciate being informed of the action taken.

Sincerely,

William G. Kelly, Jr.
Executive Director

cc:	Members of the NTP Executive Committee Members of the RoC Subcommittee of the NTP Board of Scientific Counselors Members of the NTP Board of Scientific Counselors OMB Office of Information and Regulatory Affairs

¹ The Center for Regulatory Effectiveness is a consortium of trade associations and companies, with a local government advisory panel, that was established several years ago to develop recommendations for Congress and Federal agencies on ways to improve the implementation of Federal programs, with particular emphasis on issues that involve multiple agencies.