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BETTER CHEMICAL TESTING URGED Environmental group calls for more screening by U.S. companies of potentially toxic, high-production chemicals

Jeff Johnson C&EN Washington

Arecent call by an environmental , group for U.S. chemical companies to voluntarily screen some 3,000 high-production chemicals for toxicity to humans is enjoying quiet support from many in the Environmental Protection Agency. They hope the plea will help invigorate and broaden industry interest in a long-running, but dawdling, international voluntary chemical testing program.

The testing proposal was made by the Environmental Defense Fund (EDF)a group with a history of willingness to work with industryand is modeled on an international program established seven years ago by the U.S. and 13 other member countries of the Organization for Economic Cooperation & Development (OECD). The 1990 agreement also involved EPA as well as several U.S. chemical companies and the Chemical Manufacturers Association (CMA).

OECD recognized the need for more thorough chemical testing and set a target

Auer: issue of public availability

of conducting basic toxicity screening tests for 2,550 high-production chemicals. However, the program has languished, with results for few chemicals emerging from the OECD testing process.

EDF's request would create a limited U.S. version of the program and would gready speed up the rate of voluntary testing, a goal supported by top officials in EPA's Office of Prevention, Pesticides & Toxic Substances, which oversees U.S. chemical testing. In large part, they say, EPA's support reflects the difficultyif not failureto comprehensively test high-volume chemicals under the Toxic Substances Control Act (TSCA).

On July 29, EDF wrote the chief executive officers of the top 100 U.S. chemical producers asking that the companies promptly "find and disclose at least basic toxicity testing data on all high-production-volume chemicals that your company currently makes and sells."

EDF gave the CEOs until Sept. 29 to say if they would comply with the request, and EDF officials promised to widely publicize the CEOs' responses. EDF's letter set March 1,1999, as the deadline for screening data for chemicals made and sold in the U.S. in quantities exceeding 10 million lb per year, and Jan. 1, 2000, as the deadline for screening tests for volumes above 1 million lb. In all, about 3,000 chemicals would be covered (C&EN, Aug. 4, page 29).

Driving EDF's request, it said, was a study showing that health screening tests were inadequate for 71% of the 3,000 chemicals used in highest volumes in the U.S. The study was done by EDF, and it updated a similar one, completed by the National Academy of Sciences in 1984, that said 78% of high-production-volume chemicals lacked even minimal health screening tests at that time.

Noting the lack of progress, David P. Rail, who helped set up the NAS study and led the National Institute of Environmental Health Sciences from 1971 to 1990, warns that "any assumption of

overall chemical safety in this country is based on ignorance, not fact." Rail, who now is a science adviser to several organizations, including EDF, calls on the companies to take on direct responsibility for testing their own chemicals.

The testing model EDF and Rail endorse for use by U.S. chemical companies is OECD's Screening Information Data Set (SIDS). They claim the cost would be cheap. Using OECD cost figures of $20,000 to $150,000 per chemical per screening test, EDF estimates that testing for all 3,000 chemicals would cost the top 100 companies less than two-thirds of a cent per dollar of profit, noting that the industry I d profits of $29.4 billion last year. This is 'he same number reported in C&EN's lop 100 for 1996 (May 5, page 27).

Today, 18 countries take part in the SIDS process that creates a "dossier" of data on a range of chemical information, such as physical and chemical properties, sources and extent of exposure, fate, and limited toxicological data for humans and the environment. The dossier provides basic information to help guide risk management decisions. The countries have divided up the 2,550 chemicals, with the U.S. s share being 25% of the total. Countries and chemical companies volunteer to supply the data, all of which are made public.

EDF's attention has centered on a portion of the SIDS datathe human toxicological information. This includes tests for acute toxicity, repeated dose toxicity, genetic toxicity (in vitro and in vivo), developmental toxicity (including teratogenicity), and reproductive toxicity.

U.S. chemical companies strongly back the SIDS program, especially as an alterna-

Kaplan: TSCA Is costly, time-consuming

SEPTEMBER 8, 1997 C&EN 27

tive to TSCA Section 4, a formal rulemaking process that EPA may use to gather test data on chemicals in commerce, according to A. Michael Kaplan, DuPont's manager of regulatory affairs. "EPA's approach with Section 4 test rules is to put a check in every box. It's very expensive and time-consuming. And how will we put a dent in the large number of chemicals in commerce if we have to test for all possible end points?"

Instead, Kaplan, who took part in the initial OECD discussions that created SIDS, says the screening program generates enough toxicity data to make risk decisions to either put a chemical aside or conduct more elaborate tests.

The onus, he notes, Ms to industry to volunteer and "sponsor" a chemical and to search for published and unpublished toxicity studies or conduct them if necessary.

Kaplan and other industry scientists take issue with EDF's report, however, and say a huge number of chemical studies already exist and are spread throughout many public databases as well as in industry files. They say EDF may have looked in the wrong place. They are

joined by EPA officials in their doubts, but several people in EPA also acknowledge limited publicly available test data exist for many high-production chemicals, especially those on the market before TSCA testing requirements became law.

I think the premise EDF is arguing is one EPA has supported for a long time," says Charles M. Auer, director of EPA's chemical control division. "There is a problem with public availability of basic screening information on chemicals."

The issue of public availability is what led OECD to the SIDS program in the first place, Auer says. "There is this notion that you've got all these high-volume chemicals used around the world and it is very difficult to conduct even preliminary assessments on them because you lack even basic information.

"The SIDS approach makes sense and is in the realm of the achievable," Auer continues. "We are not talking about spending multi-million-dollar sums on thousands of chemicals but spending considerably less and then sorting through and deciding where you should go if you need to improve your understanding."

However, the pace of screening chemicals is another matter. So far, only 33 chemicals have been fully characterized with their screening data made public through the International Registry of Potentially Toxic Chemicals (http:// irptc. unep.ch/irptc/irptc. html). About 109 chemicals have been assessed, but their dossiers have not been placed in a publicly accessible archive. About 400 are somewhere in the SIDS system, according to EPA and OECD figures.

For its share, the U.S. has wrapped up and "archived" five chemicals; 10 more are near completion; data for nine require final editing, EPA says. EDF estimates that it will take 25 to 30 years to complete the processif the current rate continues. But EPA officials say it has had to pressure chemical companies even to sustain this pace.

While representatives of chemical companies and CMA say they back the SIDS program, particularly its voluntary nature, industry commitment appears far from deep.

According to EPA figures for SIDS, 82 U.S. chemical companies have agreed to provide data for at least one chemical out of the U.S. share of 640. But 42 say they will provide information for only one chemical. Only three companies took on more than 20 chemicals since the program began.

"We've got some pretty big companies that have only taken on a few chemicals and some of the majors haven't taken any," says Auer. "If EDF's request broadens support among U.S. industries, we certainly would welcome that."

Broad and sustained industry support is essential for the voluntary, nonregulatory program to work, Auer says. Participation reached a low last year when Auer wrote CMA and company representatives saying U.S. companies had fallen far behind in their commitment to sponsor chemicals. Because of a lack of interest by the chemical industry, Auer said, EPA was considering issuing a TSCA Section 4 test rule to gather SIDS information.

"While the voluntary SIDS efforts by U.S. companies have been adequate to carry us to this point, I have significant doubts that a sufficient amount of this important testing and assessment work will be undertaken and completed via continued reliance on a purely voluntary scheme," Auer wrote.

The threat worked: "Volunteers" came forth, and EPA avoided issuing the test rule. Now, 29 chemicals are undergoing the next round of SIDS review by U.S. companies.

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The turn to TSCA was something Auer did not want to make. "TSCA has been in operation for two decades and we still have only limited information available for even major commodity chemicals," Auer says.

In large part, he blames limitations in the law. To require testing of chemicals that were in production before TSCA became law, EPA must use a complex rulemaking process with many opportunities for administrative and legal challenges.

Concerning U.S. industry's commitment to SIDS, Sandra L. Tirey, assistant vice president of regulatory affairs for the 192-member CMA, sees it differently. In the totality of the program, there has been quite a lot of work done by U.S. chemical companies."

Tirey says EPA has pressed U.S. companies to screen chemicals for which little basic data existed, while other countries have taken responsibility for chemicals that have been well characterized by U.S. industry. The result, she says, is that U.S. companies have provided more than

their "global share" of SIDS research and far more than the 25% that EPA had agreed to provide.

The lack of volunteers referred to in Auer's letter, Tirey says, was caused by a reaction from industry that it was being saddled with more than its share of testing. When EPA agreed to changes that would make volunteering more attractive, she says, more industries came forth.

"We want to see the SIDS process work, and there is a global need for this information," she says. But she adds that the international flavor of the program is hampered by the unwillingness of countries to accept research conducted outside their borders, and that has been a problem with the program.

Meanwhile, officials at several chemical companies say they take EDF's letter very seriously and are preparing a response by the Sept. 29 date, but are unwilling to comment at this time. Their response will show how successful EDF was in pushing a TSCA alternative.^

Superfund reports go to Congress The Environmental Protection Agency has submitted a set of three reports to Congress evaluating the agency's Super-fund program for fiscal 1992, 1993, and 1994. These reports neatly coincide with moves in the Senate to pass a new Super-fund reform bill.

The reports are required under the 1986 Superfund amendments and provide detailed information on the overall progress of Superfund implementation. They include data on feasibility studies, remedial and enforcement actions, and estimates of how much it will cost the government to complete the Superfund program.

During the three years covered in these reports, the number of hazardous waste sites EPA had in its Superfund information system rose from 36,4(X) in 1992 to 38,6(X) in 1994. The agency was able to consistently complete assessments of about 95% of these sites during the three years. And the national priority list of Superfund sites rose as wellfrom 1,275 in 1992 to 1,355 in 1994so sites continued to be added faster than they were coming off.

One feature of these documents is a description of improvements EPA has made to the Superfund process. The agency reports that a new model for cleanup action started in 1992 has streamlined the process, primarily by eliminating overlaps between the Superfund removal program

and the remedial cleanup program, according to EPA. Administrative improvements are highlighted to 1993, when EPA says it worked to reduce transaction costs, increase community involvement, ensure environmental justice, and strengthen the role of states. Streamlining the work on remedial cleanup actions and continued emphasis on community and state involvement were themes for 1994, the agency states.

Since the enactment of Superfund legislation at the end of 1980, EPA reports it has received $13.6 billion in budget authority for the program through 1994. The agency estimates the total cost for cleanup of the current national priority list sites will be more than $17.4 billion for fiscal 1995 and beyond, bringing the total government expense of the program to about $31 billion.

Congressional action on Superfund reform picked up quickly following the August recess. Sen. John H. Chafee (R-R.I.), chairman of the Environment & Public Works Committee, announced a new draft of S. 8, the Superfund reform bill, and a group of Senate Democrats announced that they are preparing a substitute bill of their own for S. 8 (see page 9). Hearings on the bills were held last week, and Chafee plans a committee markup on the legislation for Sept. 11.

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BETTER CHEMICAL TESTING URGED