Regulatory and Legislative Impacts of the Ninth Report on Carcinogens

Introduction

Even though the National Toxicology Program's (NTP) Ninth Report on Carcinogens has not yet been approved or finalized (completion expected Fall 1999), it is already having a significant influence on government policy. Recent developments confirm the hypothesis that federal agency pronouncements - even in preliminary stages - can have substantial effects at the federal, State, and local levels. As a result, extreme care must be taken on the part of agency officials in terms of the statements they make, and public policy makers should bear in mind the preliminary status of the Ninth Report, refraining from reliance on such Report while deliberations are still ongoing.

This section will provide an ongoing forum to identify and discuss various legislative and regulatory actions taken at the federal, State, and local level based upon the Ninth Report. CRE welcomes additional examples suitable for inclusion in this section.

The Report on Carcinogens: NTP's Position vs. Real World Developments

The National Toxicology Program has taken the position that the Report on Carcinogens does not constitute regulatory activity, since its purpose is only for hazard identification, as opposed to risk assessment. NTP states that regulatory impacts generally follow risk assessments, which examine both the inherent hazard potential of a substance or mixture (i.e. its inherent ability to cause negative health effects) and exposure to the population. Thus, NTP argues that the Report on Carcinogens is merely an analytical tool for agencies to use in conducting their own scientific, health-based reviews.

However, legislators and regulators (particularly at the local level) are often unwilling to wait for issuance of final and definitive scientific conclusions on what they believe to be important issues involving public health. Hence, they sometimes rely upon preliminary analyses, such as those presented in draft form (e.g. the current version of the Ninth Report), in formulating legislative and regulatory fixes to perceived problems. They might also formulate policy based upon hazard considerations alone rather than wait for formal risk assessments to be completed. Thus, the Ninth Report on Carcinogens does not represent a theoretical exercise, but is instead fraught with real world implications.

Federal/State/Local Actions Based Upon the Ninth Report on Carcinogens

The following examples demonstrate that legislative and regulatory activity is indeed occurring, based upon proposed substance listings for the Ninth Report on Carcinogens. Again, CRE welcomes further examples which could appropriately be included in this section.

Dioxin

Dioxin (formally 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)) is among the more controversial substances currently under consideration as part of the Ninth Report, with the proposal being to upgrade dioxin to a "known human carcinogen." Agency deliberations concerning the proposed dioxin listing have been unsettled, with the following recitation of events highlighting the scientific uncertainty.

• First, the NIEHS Review Committee for the Report on Carcinogens (RG1) recommended to upgrade dioxin to a known human carcinogen (10 yes votes to 0 no votes).

• The NTP Executive Committee Interagency Working Group for the Report on Carcinogens (RG2) followed suit, recommending upgraded status (8 yes votes to 0 no votes).

• However, the Report on Carcinogens Subcommittee of the NTP Board of Scientific Counselors - the only outside peer review body in the entire NTP process - voted against upgrading dioxin by a 7 to 5 margin (1 abstention). (The final Board of Scientific Counselors vote actually represented a rehearing of arguments on the dioxin listing directed by the NIEHS Director to correct procedural errors in the first consideration of dioxin by the Board.)

• After that, the NTP Executive Committee, made up of senior federal officials from various agencies, voted 8-1 to upgrade dioxin.

• Final recommendations on dioxin and the other substances in the Ninth Report are currently under consideration by the NIEHS/NTP Director, and are expected to be forward to the Secretary of Health and Human Services shortly for final approval.

Thus, one sees that the hazard identification for dioxin is by no means incontrovertible. Add into these considerations the fact that actual exposure to dioxin may be at levels below internationally accepted concentrations of concern, and the propriety of formulating policy on the basis of the dioxin listing proposal is highly questionable.

Dioxin-Related Actions Based upon the Ninth Report on Carcinogens

City and County of San Francisco, City of Oakland, and City of Berkeley Resolutions on Dioxin

In early 1999, San Francisco and Oakland passed ordinances designed to alleviate dioxin exposures to the population from the San Francisco Bay. These reports explicitly mention the Ninth Report as a basis for their actions.¹ Resolution No. 74773 of the City Council of the City of Oakland make a nearly identical reference (February 2, 1999). The ordinances were essentially identical and reflect the coordinated strategy deemed essential to cleaning up the bay. (Ultimately, local officials would like to include all nine of the bay-area counties in their efforts.)

Both ordinances contain a number of inaccuracies, including a statement that dioxin is a "known human carcinogen", attributing the finding to the NTP draft report. The National Toxicology Program is only now considering the proposed listing of dioxin as a known human carcinogen, and no final decision has been reached. In support of their measures, the local resolutions contain references to an October 1997 review by one of the NTP committees (i.e. Board of Scientific Counselors) reviewing the dioxin listing; however, that same review was later voided because it was determined that the review may have been inadequate, and the matter was scheduled for review at the NTP Board of Scientific Counselors meeting in December 1998. As noted previously, the review resulted in a vote that dioxin should not be classified as a know human carcinogen. Thus, the scientific underpinnings of the Oakland and San Francisco ordinances are not based upon a consensus position of scientific experts.

Some of the specifics of the San Francisco and Oakland ordinances include:

• Local government departments would report to the Board of Supervisors on strategies "...to ensure that less-toxic, non-chlorinated, sustainable alternative products and processes, such as chlorine-free paper and PVC-free plastics, are actively supported and used...."
• A report would be made as to the costs of local health care institutions reducing their usage of PVC products and eventually becoming PVC-free.
• Dioxin pollution was designated as a high priority for immediate action to protect public health and restore water quality.
• The San Francisco Commission on the Environment was to establish a task force to identify sources of local dioxin pollution, to develop pollution prevention strategies, and to make any further recommendations to implement the intent of the resolution.
• Education campaigns would be adopted to inform people about the environmental and health effects of dioxin.
• It was resolved to send a letter to the U.S. Environmental Protection Agency in support of EPA's proposal to require community right-to-know reporting of dioxin releases. It would also support EPA's decision to make dioxin pollution in San Francisco Bay a high priority under the Clean Water Act (sec. 303(d)).

The City of Berkeley, CA, and another San Francisco Bay Area jurisdiction, followed the lead of OAkland and San Francisco and passed a resolution on September 14, 1999, to eliminate sources of dioxin pollution.

These California cities then took their dioxin reesolutions to the Association of Bay Area Governments (ABAG), in hopes of having that body convene a regional task force to formulate and implemement a coordinated plan to eliminate dioxin emissions and exposures across the area. The ABAG Executive Committeemet on September 16, 1999. While ABAG declined the invitation to form a task force, it did pass a resolution17-99, entitled "RESOLUTION SUPPORTING EFFORTS TO UNDERSTAND MANAGEAND REDUCE DIOXIN COMPOUNDS IN SAN FRANCISCOBAY AREA WATERS AND ENVIRONMENT." According to the resolution, "ABAG urges regional, state and federal regulatory agencies to increasetheir efforts to understand and prevent dioxins in the Bay Area...." The ABAG Executive Director was also authorized to assist the local governments in assembling the proper regulatory agancies, creating a work plan, and securing funding.

Click here to see the full text of the San Francisco measure.

Click here to see the full text of the Oakland measure.

Click here to see the full text of the Berkeley measure.

Click here to see the full text of the Association of the Bay Area Governments measure.

Correspondence Related to the San Francisco/Oakland Dioxin Measures

Multinational Business Services, Inc. (MBS), an international regulatory consulting firm, has been actively involved in issues dealing with a variety of substances proposed for listing in the Ninth Report on Carcinogens, including dioxin. Thus, MBS felt compelled to correspond with the relevant California officials in order to point out various scientific and procedural inaccuracies involving dioxin. These letters will illustrate the above issue and the interplay of the draft Ninth Report on Carcinogens and public policy in much greater detail.

• MBS Letter to the San Francisco Board of Supervisors and the Oakland City Council (December 29, 1998)

• Response Letter from Sue Bierman (San Francisco Board of Supervisors) to MBS (January 21, 1999)

• Letter from the City of Oakland to MBS (July 12, 1999)

• MBS Letter to the City of Oakland (August 5, 1999)

¹ Resolution No. 021-98-COE of the Commission on the Environment of the City and County of San Francisco (September 8, 1998) states in relevant part:

"Whereas, dioxin is dangerous to human health, is ubiquitous in the worldwide environment and is a known human carcinogen and reproductive toxicant;"

The citation for the "known human carcinogen" portion of the above quote includes:

"3. International Agency for Research on Cancer (IARC) of the World Health Organizations, United Nations, 1997. National Toxicology Program Board of Scientific Counselors of the National Institute of Environmental Health Sciences, 1997.

Resolution No. 74773 of the City Council of the City of Oakland made a nearly identical reference (February 2, 1999).

Resolution 60, 196-N.S. of the Berkeley City Council made a nearly identical reference (September 14, 1999).