Regulatory Developments

NTP Holds Listening Session on Proposed Revisions to RoC Review Process

November 30, 2011 PRINT

On November 29, 2011, the National Toxicology Program (NTP) held a listening session on its proposed revisions to the review process for the Report on Carcinogens (RoC). According to NTP, its proposed changes are intended to "enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner. The NTP also seeks to maintain critical elements of the existing process including external scientific and public involvement, scientific rigor, and external peer review." NTP received criticism for its 12th RoC, which it published in June 2011. The 12th RoC listed formaldehyde as a known human carcinogen, "based on sufficient evidence of carcinogenicity from studies in humans." Just a few months earlier, the National Academies of Science (NAS), which reviewed the U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) draft assessment for formaldehyde, concluded in its April 2011 report that EPA failed to justify its conclusion that formaldehyde causes specific types of leukemia. The 12th RoC also listed styrene as a reasonably anticipated human carcinogen. The Styrene Information and Research Center immediately filed suit against the Department of Health and Human Services (DHHS), which includes NTP, claiming the listing "is contrary to the weight of scientific evidence and is based primarily on improper and unreviewed information and manipulation of data which further demonstrates that it is arbitrary, capricious, an abuse of discretion, and not in accordance with law." Styrene Information and Research Center v. HHS, D.C. Cir., No. 11-cv-1079. More information on NTP's proposed revisions to the RoC review process is available in our November 1, 2011, memorandum online.

Speakers during the November 29, 2011, listening session included:

  • Dr. George Cruzan, ToxWorks;
     
  • Mr. John Schweitzer, American Composites Manufacturers Association;
     
  • Ms. Lori Luchak, Miles Fiberglass & Composites;
     
  • Mr. Jay Merrell, Industrial Dielectrics, Inc.;
     
  • Dr. Richard Belzer, Regulatory Checkbook;
     
  • Mr. Robert Lacovara, Convergent Composites;
     
  • Mr. Marcus Bingham, Clarion Bathware;
     
  • Mr. William Rudersdorf, Composites One LLC;
     
  • Mr. Richard Higgins, HK Research Corporation;
     
  • Mr. Thomas Hoskinson, Gruber Systems, Inc.;
     
  • Dr. James Bus, The DOW Chemical Company;
     
  • Mr. Frank Sizemore, AOC LLC;
     
  • Mr. Perry Bennett, Molded Fiber Glass Companies;
     
  • Mr. Roger Mola, Fiber-Tech Industries, Inc.;
     
  • Mr. Barry Clayton, Reichhold, Inc.;
     
  • Mr. Craig Peterson, Xerxes Corporation;
     
  • Mr. Steve Risotto, American Chemistry Council;
     
  • Mr. W. Caffey Norman, Patton Boggs LLP/Halogenated Solvents Industry Alliance; and
     
  • Dr. Kenneth Mundt, ENVIRON International Corporation.

NTP stated that it will post written comments after the comment deadline ends on November 30, 2011, on its website. NTP recorded the listening session and will provide the audio upon request.

After an introduction by Dr. John Bucher, Associate Director, NTP, Dr. Mary Wolfe, Deputy Program Director for Policy, NTP, provided an overview of the proposed revised review process. The remainder of the listening session was devoted to public comments. Several points were repeated in the comments: NTP's proposed revisions do not actually increase the transparency of its decision-making process; the role of the Board of Scientific Counselors (BSC) has been minimized -- it no longer votes on RoC listings, and the charge for the BSC is too narrow; the "peer review" process is not independent of NTP, and, in fact, NTP may choose its own ad hoc panel of reviewers rather than using the BSC, and does not address conflicts of interest; and NTP will not provide a response to comments. Several commenters suggested that providing a response to comments to peer reviewers could help focus the peer reviewers on more substantive comments. Other comments addressed the impact of listing decisions on businesses, including being denied coverage by their insurance carriers.

Several commenters referred to NAS's April 2011 report, Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde, which includes, in Chapter 7, a "roadmap for revision" of EPA's IRIS assessment process. The NAS report found that a "major, overarching issue is the use of weight of evidence in hazard identification," and commenters claim that the RoC suffers from the same flaw as EPA's IRIS assessments. The NAS report is available online. Commenters also cited President Barack Obama's March 9, 2009, memorandum on scientific integrity, which is available online, and calls for "transparency in the preparation, identification, and use of scientific and technological information in policymaking." The memorandum also states that the "selection of scientists and technology professionals for positions in the executive branch should be based on their scientific and technological knowledge, credentials, experience, and integrity."

NTP stated it will review both the written and oral comments on its proposed review process and consider what changes, if any, might be needed. NTP intends to post the final RoC review process on the RoC website and present it at the next BSC meeting on December 15, 2011. Numerous commenters suggested that, if NTP were truly interested in obtaining and considering public comment, it would not be presenting the final revised review process only two weeks after the comment deadline. Although several commenters requested an extension of the comment deadline, NTP denied all requests. More information regarding the BSC meeting is available online.


 
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