NTP — Anthraquinone Report: HHS Response to Rfc

07/16/2004

July 16, 2004

Mr. Jerry A. Cook 
Technical Director 
Chemical Products Corporation 
P.O. Box 2470 
Cartersville, Georgia 30120-1692

Re: Request for Correction submitted February 6, 2004

Dear Mr. Cook:

I am responding to the Request for Correction (Request) that you submitted on behalf of the Chemical Products Corporation (CPC) under the National Institutes of Health (NIH) "Guidelines for Ensuring the Quality of Information Disseminated to the Public" (NIH Guidelines).1 The Request concerns a revised National Toxicology Program (NTP) draft report on toxicology and carcinogenicity studies of anthraquinone (Draft TR-494)2. NTP posted the draft report on an NIH web site as part of its existing public comment process for these draft reports. See 68 Fed. Reg. 6796 (Dec. 3, 2003). Following a thorough review, we believe that the NIH Guidelines are not applicable to your request and that the existing public comment process is the appropriate mechanism for handling your complaint.

NTP's process for obtaining public comment and peer review of draft Technical Reports is standardized and well established. NTP posts and requests public comment on its draft reports to facilitate review by the Technical Reports Review Subcommittee (Subcommittee) of NTP's Board of Scientific Counselors. The Subcommittee provides scientific peer review of the findings and conclusions of draft NTP Technical Reports. Before the Subcommittee meets, NTP posts the draft reports on the web site referenced above and publishes a meeting notice in the Federal Register requesting public comment on the draft reports to be discussed. The front cover of these draft reports, including Draft TR-494, contains the following disclaimer:

This is a DRAFT Technical Report prepared for public review and comment. Until this DRAFT has been reviewed and approved by the NTP Board of Scientific Counselors' Technical Reports Review Subcommittee in public session, the interpretations described herein do not represent the official scientific position of the National Toxicology Program. Following peer review, readers should contact the NTP for the final version of this Technical Report (emphasis added).

This disclaimer plainly explains that the information contained in the draft reports is not an official view of the government, but only a preliminary draft circulated for purposes of obtaining public comment and peer review. Following the request for public comments, copies of all written comments are provided to the Subcommittee members, posted for public view, and archived on an NTP web site (http://ntp-server.niehs.nih.gov). Additionally, the public is invited to present comments orally at the Subcommittee's meeting. Following the meeting, a summary of the Subcommittee's recommendations are placed on the above-referenced web site. NTP considers these recommendations and all public comments before finalizing the draft reports. It is NTP's practice to remove the draft reports from the web site following peer review.

Regarding Draft TR-494, the Subcommittee met on Feburary 17, 2004, to review it and other reports. Consistent with its practice, NTP provided your Request to the Subcommittee as a public comment on Draft TR-494 and posted it on the web site. After the peer review, the Subcommittee's recommendations for TR-494 were posted on the web site and the draft report was removed3. Once the report is finalized and published, it will be available on the NTP web site and from EHP Online (http:ehp.niehs.nih.gov).

NIH Guidelines, consistent with HHS and OMB Guidelines, apply to information that the Agency disseminates to the public and represents as "fact or the agency's views." 4 Information that does not fall into this category, e.g., scientific research papers that do not constitute agency views, are supposed to include "disclaimers alerting the audience that [the papers] do not represent official views of the NIH."5

NTP's Draft TR-494 does not a represent "fact or agency views." It is a draft posted for public comment in anticipation of preparing a final information product. It is clearly labeled as a draft that does not represent agency views and, therefore, it is not subject to the NIH Guidelines. Rather, as the NIH Guidelines make clear, the appropriate agency mechanism for handling your complaint is the existing NTP process for soliciting public comment on draft Technical Reports.

In this case, the existing NTP procedures for obtaining public comment and preparing draft Technical Reports, described above, include well-established procedural safeguards that allow affected persons, such as yourself, to raise concerns about the quality of information examined and prepared by the agency. Accordingly, NIH used these existing procedures to respond to your complaint. Following this established procedure for handling public comments on draft NTP Technical Reports was not only the most efficient and effective method for ensuring that your concerns were considered in the peer review of Draft TR-494, but was also the most appropriate.

You may appeal the agency's decision either in writing or electronically within 30 days of receiving this response. Your request should state the reasons for your appeal. It does not need to reference a tracking number. The request may be sent electronically toInfoQuality@od.nih.gov or in hard copy to the Associate Director for Communications, Office of the Director, National Institutes of Health, Building 1, Room 344, 1 Center Drive, Bethesda, Maryland 20892. If the appeal is sent in hard copy, please clearly mark the appeal and outside envelope with the phrase "Information Quality Appeal."

We appreciate your comments and hope the information provided above helps to clarify the state of our work with anthraquinone and our efforts to communicate this work to the public.

Sincerely,

Susan R. Cornell 
Office of Communications and Public Liaison, NIH 
Building 31, Room 5B35 
9000 Rockville Pike 
Bethesda, MD 20892

cc: B. Greenberg, DHHS


1These guidelines were issued pursuant to, and are consistent with: (1) the Department of Health and Human Services "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public" (HHS Guidelines); (2) the Office of Management and Budget "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies" (OMB Guidelines); and (3) section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001.

2Although you reference both the "Draft Abstract" and the Draft TR-494 in your letter, your comments are exclusively limited to the Draft TR-494.

3Although the NTP removes the draft report from the website after peer review, a limited number of copies remain available upon request. If someone requests a copy after peer review, a copy of the draft report and the actions from the peer review meeting are provided.

4OMB Guidelines, Section V(5), 67 Fed. Reg. 8460; HHS Guidelines, Section D(2)(e); NIH Guidelines, Section II(2).

5NIH Guidelines, Section II(1).

Last Revised:  August, 2004