No. 227 Friday, November 26, 2004	Page A-11
ISSN 1521-9402
News
Toxic Substances Differing Views Expressed on OMB Ideas To Reform National Toxicology Program
Recommendations from the Office of Management and Budget to increase the transparency of the National Toxicology Program as it reviews chemicals for the Report on Carcinogens would either improve that process or create unnecessary delays, according to various organizations interviewed by BNA Nov. 24. Two National Toxicology Program advisers and an official from the industry-supported Center for Regulatory Effectiveness think OMB's suggestions could improve the process used to develop the carcinogens report. But a former NTP toxicologist and a National Research Defense Council scientist said the program already uses sound procedures, and an analyst from OMB Watch is concerned OMB's recommendations could delay the release of information designed to help federal and state agencies protect public health. The representatives spoke with BNA regarding a Nov. 16 letter that John D. Graham sent to the National Institutes of Health. An NIH press officer told BNA that he could not immediately obtain comment on Graham's letter. Graham, administrator of OMB's Office of Information and Regulatory Affairs, wrote NIH Director Elias A. Zerhouni regarding concerns Graham has about the National Toxicology Program. Graham made several recommendations to improve the transparency of the decisionmaking about adding or removing substances from the biennial Report on Carcinogens. NTP, an interagency program that studies chemicals, drugs, and other agents of public health concern, is administered and largely funded by the National Institute of Environmental Health Sciences, one of 27 institutes and offices that comprise the National Institutes of Health. To comply with Section 301 (b) (4) of the Public Health Services Act, NTP makes recommendations as to substances that should be included in or removed from the Report on Carcinogens which lists individual substances, mixtures of chemicals, or exposure circumstances which are known to be human carcinogens or which may reasonably be anticipated to be human carcinogens. The secretary of health and human services decides which substances or types of exposures will be listed in that report. Correction Requests Prompt Suggestions Graham said his concerns were spurred by six information quality correction requests related to the Report on Carcinogens or to NTP's process for reviewing substances for that report. To comply with guidance OMB issued to enhance the quality of information disseminated by the government, federal agencies created procedures by which parties can request corrections to federally disseminated information they say fails to meet OMB's standards (9 DEN B-1, 1/14/02). The six correction requests that relate to NTP "have brought to my attention concerns about how NTP handles comments from the public and scientific advisors," Graham wrote to Zerhouni. "While NTP already has a rigorous process of scientific deliberation, I would like to make three suggestions that ... are likely to further instill public confidence in the NTP process and the Report on Carcinogens," Graham said. First, Graham urged NTP to prepare and disseminate a "response-to-comments" document that would discuss public comments the program receives and how the program responded. Second, Graham suggested NTP staff update documents they prepare describing substances that may be listed in or removed from the report. Those background documents are reviewed by several scientific panels. As those reviews proceed, NTP staff should update the background documents to respond to comments from these scientific advisors, Graham said. "Making these updated documents publicly available would reassure everyone that listing decisions are based on a supporting document that has addressed concerns raised by both the NTP's science advisors and the public," Graham said. "Finally, I suggest that the substance profiles, which appear in the biennial Report on Carcinogens, be reviewed by external reviewers, perhaps [NTP's] Board of Scientific Counselors, before being finalized," Graham said. The profiles describe the chemicals, drugs, or exposures listed in the report. "This layer of review would ensure that the writers of the profiles have incorporated the concerns and issues brought forth by the multiple review groups and have correctly captured and appropriately framed the information that needs to be in the final document of record," Graham wrote. Two Advisers See Merit in Recommendations George P. Daston, a toxicologist who serves on the Board of Scientific Counselors which advises NTP and works for the Proctor and Gamble Co., said he believes NTP staff already do what Graham suggested in his first two recommendations. "However, Dr. Graham's suggestion to make the process more transparent by publishing point-by-point responses to public comments is a reasonable one. I don't think that this will pose an excessive burden to the staff, as I believe that they already consider public comments in a systematic way," he continued. Adding an additional peer review to the profiles of substances in the report also is a reasonable suggestion, Daston said, but added "I don't know whether the Board of Scientific Counselors is the right group to provide that oversight." Graham's letter is not criticizing NTP for being nonresponsive, said another NTP advisor, who asked not to be identified. "He's saying that people can't tell how [NTP is] responding," the advisor said. "NTP would just be doing what EPA already does. I think Graham's recommendations certainly can't hurt, and might actually help." Jim Tozzi, who formerly served as deputy director of OMB's regulatory review office and now works with the Center for Regulatory Effectiveness, said NTP would improve the Report on Carcinogens if it followed Graham's suggestions. Report Called 'Shopping List' for Lawyers However, Tozzi said, the most important aspect of Graham's letter is its message that OMB is paying attention to the quality of information disseminated by non-regulatory agencies. One of the reasons Congress passed the "Data Quality Act" was to ensure non-regulatory information which can have a significant impact on affected parties is required to achieve certain standards of quality, Tozzi said. Tozzi was referring to Section 515 of the Treasury appropriations act for fiscal year 2001 (Pub. Law 106-554) which told OMB to issue guidance to improve the quality of federally disseminated information. That section of the appropriations bill, which does not have a formal name, is also called the "Information Quality Act." Being listed in the Report on Carcinogens triggers a variety of regulatory and other actions including lawsuits, Tozzi said, describing the report as a "shopping list for plaintiffs' lawyers." Each suggestion Graham made would improve NTP's process for deciding what is listed or removed from the report, Tozzi said. Extensive Reforms Called Unnecessary George Lucier, a toxicologist who formerly managed the National Toxicology Program and now consults for Environmental Defense, said in the mid-1990s, after an extensive consultation process with stakeholders, the program made substantial changes to its procedures for listing or removing substances from the Report on Carcinogens. "I'm not saying they shouldn't be tweaked from time to time, modified to address new concerns," Lucier said, but significant changes are not needed. Graham may not realize, said Lucier, that the NTP Executive Committee, which consists of representatives of 10 agencies, already reviews substance profiles before they appear in the report to ensure public and scientific concerns raised during the review process have been addressed. Updating the background documents that the scientific panels review could confuse parties tracking NTP's reviews, Lucier said, referring to Graham's second recommendation. However, it would make sense for NTP staff to prepare a summary of both the public comment and scientific advice it receives and the way those issues were addressed, Lucier said. Delays Feared Lucier agreed with a concern voiced by Sean Moulton, senior policy analyst with OMB Watch, a public interest group. If NTP were to follow Graham's suggestions it would take much longer for the program to issue analyses of substances that may be added to or removed from the report, Lucier and Moulton said. Moulton further criticized the OMB letter as being focused on process not substance. OMB should make sure that there is a problem with the reports NTP helps prepare before the office recommends procedures that would impede the program's efforts to provide information about substances that may harm people, Moulton said. Moulton criticized OMB as being opposed to burdening the regulated community but having "no problem increasing the burden of agencies." NRDC Says Program Addressing Concerns Jennifer Sass, a scientist with the Natural Resources Defense Council, said NTP has already taken or is planning to take actions to address the concerns voiced in OMB's letter. She referred to changes NTP is trying to make to address concerns voiced in a meeting in January (18 DEN A-6, 01/29/04 ). For example, NTP has already changed its Web site to make it much easier for the public to find documents on substances that may be listed or removed from the carcinogens report and to find public comments about those documents, Sass said. OMB's letter about the National Toxicology Program is available at https://www.whitehouse.gov/omb/inforeg/prompt/nih_ntp111604.pdf on the World Wide Web. NTP's response to public comments previously received about the preparation and review of the Report on Carcinogens is available at https://ntp-server.niehs.nih.gov/ntp/meetings/2004/NTPresponseFINAL092104.pdf on the World Wide Web.