THE TOXIC SUBSTANCES CONTROL ACT

In principle, all of them should have been tested by now. TSCA says, "It is the policy of the United States that... adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures." [15 U.S.C. paragraph 2601(b)] [1,pgs.23-24]

Now a new report from the Environmental Defense Fund (EDF) scores the chemical industry's and EPA's progress toward the goals of TSCA.[1] EDF concludes that "the policy is largely defunct."[1,pg.24] EDF says, "[F]or most of the important chemicals in American commerce, the simplest safety facts still cannot be found. This report documents that, today, even the most basic toxicity testing results cannot be found in the public record for nearly 75% of the top-volume chemicals in commercial use."[1,pg.7]

EDF revisited a question that was first asked in 1984 by the National Research Council (NRC) of the National Academy of Sciences. In 1984 the NRC studied a random sample of 100 chemicals chosen to fairly represent the roughly 3000 chemicals produced each year in quantities exceeding one million pounds. The NRC concluded in 1984 that 78% of these chemicals lacked even "minimal toxicity information."[2] Now in 1997, EDF has asked the same question, to see if the chemical industry and EPA have made progress since 1984. EDF reports that, today, 71% of the chemicals examined lack minimal toxicity information.

EDF drew its random sample of 100 chemicals from a list of 486 chemicals that are BOTH high production (greater than one million pounds per year, of which there are 2971 chemicals) and that ALSO have been identified as subjects of regulatory attention under major environmental laws.[3] (EDF excluded food additives, tobacco products, drugs, and pesticides because TSCA excludes these chemicals.) These criteria would bias EDF's sample to include chemicals that have at least been minimally tested since a completely untested chemical is unlikely to have been the focus of regulatory attention. Thus the EDF study very likely overstates the availability of toxicity information about high-volume chemicals.

What constitutes minimal toxicity screening information? EDF used a set of criteria developed by the Organisation for Economic Cooperation and Development (OECD), an international organization made up of the world's 19 wealthiest countries, including the U.S. In 1990, with extensive participation by industry, the OECD defined criteria for minimal toxicity screening information for a chemical. (U.S. EPA, on the other hand, has never defined minimal toxicity screening information.) OECD defined minimal toxicity information to include:

• Acute toxicity

• Repeated dose toxicity

• Genetic toxicity (tested in a test tube)

• Genetic toxicity (tested in laboratory animals)

• Reproductive toxicity

• Developmental toxicity/teratogenicity

It is important to note, as EDF says, that the minimal OECD screening information for human health does not include sufficient information to conduct a comprehensive health risk assessment. The data that EDF used to judge the availability of information is minimal PRELIMINARY SCREENING information aimed at answering the question: is this chemical likely to pose a hazard to human health? Here is the EDF scorecard:

• Carcinogenicity tests are missing for 63% of high-volume chemicals.

• Reproductive toxicity is missing for 53% of high-volume chemicals.

• Neurotoxicity tests are missing for 67% of high-volume chemicals.

• Immune system toxicity tests are not available for 86% of high-volume chemicals.

• Studies for evaluating impacts on children (such as postnatal performance and neurotoxicity) have not been done for more than 90% of high-priority chemicals.

• More than half (58%) of the sampled high-priority chemicals have not been tested for any form of chronic toxicity.

Obviously, TSCA has failed. Who is at fault here? The basic problem lies in TSCA itself --another well-intentioned but unsuccessful attempt to 'regulate' corporate behavior. Congress passed TSCA with input from industry and from the environmental community (EDF included), then EPA set TSCA regulations after taking input from the same parties. EDF now acknowledges that TSCA "work[s] poorly in practice" and was "doomed from the start."[1,pg.25]

TSCA has three main sections aimed at gathering toxicity information and protecting public health and the environment:

• Section 4 empowers U.S. Environmental Protection Agency (EPA) to require companies to test chemicals that are currently in use;

• Section 5 requires companies to submit pre-manufacturing notifications (PMNs) to EPA 90 days before a new chemical enters commercial markets;

• Section 6 gives EPA the authority to control any chemical that presents an "unreasonable risk of injury to health or the environment." [15 U.S.C. Section 2605(a)] Control can include anything from a labeling requirement to an outright ban.

TSCA Section 4 says EPA can issue "test rules" (requirements for toxicity testing) but it puts the agency in a catch-22 position: the agency must have data in order to require data. Before EPA can issue a "test rule (i.e., ask for testing) on a specific chemical, the agency must first show either (1) that the chemical may present an 'unreasonable risk' or (2) both that it is produced in major quantities AND that either 'substantial' exposures are occurring in quantitative terms (either numbers of people being exposed, or pounds of material being released) or that 'significant' exposures are occurring in qualitative terms (a case-by-case evaluation of the impact of exposures). Obviously, 'substantial' exposures cannot be proven if quantitative information on releases of the chemical or exposures to the chemical is lacking. And 'significant' exposures cannot be proven without information on the chemical's toxicity. In addition, before issuing a 'test rule,' EPA must also show that existing data are insufficient and that testing is 'necessary.' In court, chemical corporations trip up EPA on all these points.[1,pgs.26,30-31,note 26] EPA has developed "testing actions" for only 263 chemicals over the last 20 years, a period during which at least 20,000 new chemicals have come into use.

TSCA section 5 requires that EPA receive "premanufacture notification" (PMN) 90 days before a new chemical goes onto the market. EPA then has 45 days in which to challenge the manufacturer to provide more test data. However, the law does not require that any toxicity data accompany the original PMN --data are optional --so EPA usually has no scientific basis on which to demand additional data. More than half of all PMNs are submitted without any toxicity data.

The contents of a PMN are not binding and thus there is no incentive for a manufacturer to insure that its original submission is accurate or reliable. Once EPA has finished its review of a PMN, the manufacturer need not limit uses or production levels to those described in the PMN. Manufacturers are even allowed to revise PMNs while EPA is reviewing them. When learning that EPA was considering controls on a chemical, manufacturers have gone back and revised the exposure estimates for a chemical, to avoid EPA action. They also have revised PMNs to show lower releases than previously estimated and they have added claims that the chemicals will be used in zero-discharge systems.

TSCA section 6 gives EPA sweeping powers to control chemicals. Under TSCA section 6, EPA has the authority to control any chemical that poses an "unreasonable risk of injury to health or the environment." But of course proving an "unreasonable risk" in a court of law is a challenge that the government is usually not up to. Compared to EPA, even a mid-sized corporation has many more lawyers and much more money to spend defending its 'right' to expose the public to toxins. In 20 years, EPA has taken Section 6 actions against only 5 chemicals or classes of chemicals. These include dioxin waste disposal; hexavalent chromium use in cooling towers; ending the manufacture of PCBs (a regulation required in the text of TSCA itself); metal fluids; and lead paint disclosures.

In sum: sections 4, 5, and 6 --the meat and bones of TSCA --simply do not work. The law is a failure.

Within chemical corporations, the absence of toxicity data is taken to be proof of safety. For example, the Chemical Manufacturers Association said in 1996, "Generally speaking, the philosophy of risk-based... management of chemicals... allows for the continued safe use of chemicals.... Through [this] approach, we can ensure that chemicals are used safely." But there are no data to back up such a junk science claim.

Meanwhile, between 1987 and 1992, production of basic chemicals in the U.S. increased 18%, a growth rate of 3.3% each year.

Having shown conclusively that regulation of the chemical industry hasn't worked, what is EDF's solution to this large and growing problem? More regulation. EDF favors expanding the "right to know" provisions of federal law to give citizens more information about the poisons that industry is dumping into communities day after day.

This little report from EDF is first-class work. Unfortunately, the authors of the report seem unable to imagine anything beyond the failed strategies of the last 20 years. They seem to be saying, "What we've specialized in for 20 years hasn't worked. It was doomed from the start. So now we must redouble our efforts to try to get Congress and EPA to give us more of the same." Very mysterious thinking.

[2] National Research Council, TOXICITY TESTING (Washington, D.C.: National Academy Press, 1984).

[3] The 'major laws' include these federal statutes: the Clean Air Act; the Clean Water Act; the Comprehensive Emergency Response, Compensation and Liability Act (Superfund); the Emergency Planning and Community Right to Know Act (TRI); the Federal Insecticide, Fungicide and Rodenticide Act; the Occupational Safety and Health Act; and the Safe Drinking Water Act, and these California statutes: the Air Toxics 'Hot Spots' Information and Assessment Act; the California Occupational Safety and Health Act; the California Safe Drinking Water Act; the Safe Drinking Water and Toxic Enforcement Act (Proposition 65).

[4] For environmental fate and pathways, the OECD lists the following basic information needs: photodegradation (by estimation); stability in water (by estimation); monitoring data (environmental); transport and distribution between environmental compartments; and aerobic biodegradability. For ecotoxicology the OECD lists the following data needs: acute toxicity to fish; acute toxicity to daphnids (chronic toxicity if there is concern for possible long-term effects); toxicity to algae; appropriate terrestrial toxicity tests (if significant exposure is expected in the terrestrial environmental compartment or aquatic testing is not possible. [1,pg.34]

Descriptor terms: edf; studies; tsca; toxic substances control act; regulation; epa; environmental defense fund; toxic ignorance; toxicity testing;