I GOVERNMENT

Better Risk Assessment Emerges From More Sophisticated Science Data

• A better understanding of how chemicals cause disease will allow the government to fine-tune risk assessment methods

A dvances in the ability of scientists PL· to measure how chemicals cause

J L J L disease is leading to a quiet and slow change in the way the gov­ernment measures risks posed by these substances. Scientists at the annual meeting of the American Industrial Health Council (AIHC) discussed the changes coming from inside and outside government institutions.

'There is a growing consensus with­in the scientific community that our ex­panding knowledge of mechanisms, pharmacokinetics, and related scientific disciplines enables us to carry out a much more sophisticated and accurate assessment of risk based upon a greatly expanded knowledge base/' said R. Wiley Bourne Jr., executive vice presi­dent of Eastman Chemical Co. and chairman of AIHCs board of directors.

Bourne stressed to the AIHC partici­pants that it is important to spread the word about this available scientific knowledge. "It has been very difficult to get this growing consensus incorporated into government policies that were es­tablished more than a decade ago/' he said. This, indeed, has been one of the major objectives of AIHC since its founding in 1977—persuading the gov­ernment to incorporate better science into its regulatory decision-making.

Bourne said such efforts are beginning to pay off. Risk assessment issues now are being studied at the international level by groups such as the Organization for Economic Cooperation & Develop­ment and the International Agency for Research on Cancer. The United Nations International Program on Chemical Safe­

ty (IPCS) is also becoming more promi­nent in trying to resolve international differences on risk assessment.

Addressing these international issues at the AIHC meeting was Michel J. Mer­cier, director of IPCS. The program oper­ates as a cooperative venture of the In­ternational Labor Organization, the UN Environment Program, and the World Health Organization. IPCS's primary ob­jectives include preparing evaluations of the risk to human health from exposure to certain chemicals, developing meth­ods for assessing or predicting such health effects, and helping countries strengthen their chemical safety capabil­ities.

Although the program has operated since 1980, it has acquired expanded du­ties as a result of the UN Conference on Environment & Development, the so-called Earth Summit, held in Rio de Ja­neiro last June. One specific task IPCS was given was to convene an interna­tional meeting to help UN organizations build more extensive partnerships with governments, industries, trade unions, consumers, and professional organiza-

Bourne: spread available knowledge

tions with respect to chemical safety is­sues. Mercier admitted he didn't know when this meeting would be held, b e cause no funds have been provided for it.

However, international meetings on risk assessment present a problem, ac­cording to several conference partici­pants. Different nations have developed different scales by which to weigh risk, and the scales don't always agree. IPCS has been given the task by the UN of working on harmonization of risk as­sessments. For an industry as global as that of chemicals, such harmonization is very important. Without it, if s possible, for instance, to have a compound or product listed as a carcinogen in one country, but not in another. Such incon­sistencies present barriers to global trade and could especially put the U.S. at a disadvantage.

Two leading government administra­tors told the conference that the need to change risk assessment methods is rec­ognized within their agencies. The Envi­ronmental Protection Agency's William H. Farland, director of the office of health and environmental assessment, said risk assessment at the agency is in an evolutionary stage. Its guidelines were established in 1986, but the agency continues to struggle with a number of issues, such as how often to use qualita­tive or quantitative approaches, how to communicate risk, and, what Farland calls the tyranny of the numbers.

Farland also described some of the problems expected when U.S. and Euro­pean agencies try to resolve differences in the way each assesses risk. He noted the U.S. seems committed to high levels of public participation in decision­making and to complete separation of mathematical risk assessment from qual­itative risk management. It also seems to have a preoccupation with cancer, he added. In Europe, decisions are made by panels of experts that are allowed a greater use of qualitative information and compromise; the public, for the most part, trusts the experts to make de-

20 DECEMBER 14,1992 C&EN

Gon: agencies' product of choice is fear

cisions. In addition, the public is not so focused on one disease but instead has broad public health concerns.

EPA is looking at attempts to harmo­nize the different assessment approaches of federal agencies such as the Occupa­tional Safety & Health Administration and the Food & Drug Administration, and wants more research to improve the scientific databases on which risk is cal­culated. Farland said the government must develop better methods for com­paring risks because the need to trans­late scientific risk numbers into informa­tion that can be understood by the gen­eral public is paramount.

Many of these same ideas were ad­vanced by Kenneth Olden, director of the National Institute of Environmental Health Sciences. 'The major problem is with inadequate, inappropriate, and in­complete science/' he said. Research needs he listed include better methods for determining individual exposures, more sensitive biomarkers of disease, increased emphasis on noncancer end-points such as neurotoxicity and terato­genicity, more human and clinical data, and greater emphasis on research into disease mechanisms. He noted that he has reorganized the National Toxicology Program to try to get more interaction among agency scientists carrying out cancer risk assessments.

Although some movement in the gov­ernment is apparent, scientists outside the federal agencies are still critical of the government's risk assessment methods. One critic of government risk science is

Philip H. Abelson, biophysicist and long-time deputy editor of Science maga­zine. "Unless the methods of risk assess­ment are reformed, the eventual direct costs of regulations will mount into the trillions of dollars," Abelson said at the meeting. In addition to mounting regu­latory costs, he added, extremely conser­vative risk assessments will increase costly litigation, cause unwarranted public anxiety, erode the nation's re­search and development capacity, and decrease international competitiveness.

Abelson's main complaint is with the use of in-bred, cancer-prone species of mice. He cited examples, including risk assessments for trichloroethylene and methylene chloride, in which cancer risk has been extrapolated to humans based on its occurrence in these mice even though known cellular and metabolic differences between humans and mice make extrapolation invalid. "Once it is determined that the evidence for carci­nogenicity is flawed, regulations should be modified promptly," he said.

Gio Batta Gori, former deputy director of the National Cancer Institute and now director of the Health Policy Center, a consulting company, also cited examples in which rodent data apparently were used inappropriately to estimate human cancer risk. But he went on to question the motives of the federal regulatory agencies. Gori said the powerful regula­tory industry that has risen during the past quarter century has few of the checks and balances expected in our government. "Like other industries, it sells products for profit. In the context of an affluent society less motivated to take risks, the product of choice is fear," Gori said. Only by continuing to make people afraid, usually of getting cancer, can these regulatory agencies prosper. If these fears are not kept alive and re­newed, he said, the agencies face "irrele­vance and oblivion."

Gori believes some form of health and safety regulation is necessary, but says much of the regulation he sees is self-serving. He said scientists should "collect enough honesty to tell policy­makers and the public that presently we have no credible scientific tools for prospective human cancer risk assess­ments." Future research on animals and humans should proceed with the goal of coming up with better methods for estimating risks than the outdated methods relied on today, he added.

David Hanson

Federal Alert-new regulations This listing highlights regulations and notices published in the Federal Regis­ter from Oct. 5 to Dec. 4, 1992. Com­plete information can be found on the pages listed for the particular issue.

• PROPOSED Environmental Protection Agency— Begins initial phase of Clean Air Act rules by establishing nitrogen oxides emissions limitations for coal-fired utilities; comments by Jan. 25, 1993 (Nov. 25, page 55632).

Requires industrial pretreatment stan­dards for phenol and 2,4-dimethylphe-nol based on new analysis of data from water treatment works; comments by Dec. 31 (Dec. 1, page 56884).

Food & Drug Administration—Cre­ates National Laboratory Accredita­tion Program to certify labs that ana­lyze food products for pesticide resi­dues; comments by Jan. 19,1993 (Nov. 20, page 54727).

• FINAL Environmental Protection Agency— Adds three wastes generated during production of various chlorinated tol­uenes to list of hazardous wastes from specific sources; effective April 15, 1993 (Oct. 15, page 47376).

Approves interim case-by-case ex­tension of capacity variance for haz­ardous soil waste that results from a lack of demonstrated available treat­ment technology; effective through May 8,1993 (Oct. 20, page 47772).

Prohibits land disposal of container­ized liquid hazardous wastes mixed with sorbents that biodegrade or re­lease liquids when compressed dur­ing landfill operations; effective May 18,1993 (Nov. 18, page 54452).

Prescribes content, timing, and method of service for citizens' suits filed under 1986 Superfund amend­ments; effective Jan. 22, 1993 (Nov. 23, page 55038).

• NOTICES Agency for Toxic Substances & Dis­ease Registry—Lists 38 priority haz­ardous substances as needing expo­sure and toxicity data so agency can complete toxicological profiles for health assessments at hazardous waste sites (Nov. 16, page 54150).

Environmental Protection Agency— Selects Chicago Board of Trade to administer auctions and sales of transferable emissions allowances of sulfur dioxide and nitrogen oxides under Clean Air Act; effective Oct. 7 (Oct. 7, page 46167).

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