By Liz Borkowski 

Here in the U.S., people seem to like the idea of our government ensuring that we’ve got clean air, clean water, and healthy workplaces, and that our exposure to toxic substances is limited. However, we also keep electing politicians who make it hard for federal agencies to ensure these things.

We’ve written before about problems at OSHA, where workers suffer from preventable harm while officials emphasize voluntary compliance at the expense of standard-setting, and at FDA, where a rush to review new drug applications leaves post-market drug safety under-resourced. While presidential appointees heading these agencies deserve a share of the blame (a hefty share, in the case of OSHA’s Edwin Foulke), the legislation governing agency activities often erects hurdles that can slow progress to a crawl. A new report from Environmental Defense shows how this is happening at EPA with toxic chemical legislation.

The Toxic Substances Control Act of 1976 allows EPA to collect or require the development of information about the toxicity of particular chemicals used and produced in the U.S. If it wants to require companies to test their chemicals, though, it has to make certain statutory findings about the substance involved, and that can be a cumbersome process. In High Hopes, Low Marks: A Final Report Card on the High Production Volume Chemical Challenge (via ES&T), Environmental Defense Senior Scientist Richard Denison reports that in the 30+ years since TSCA’s enactment, “EPA has succeeded in compelling hazard testing for about 200 of the tens of thousands of chemicals in US commerce.”

After a series of studies documented major gaps in knowledge about hazards associated with some of the highest-volume chemicals in use, EPA established a voluntary program to try and fill these holes. The High Production Volume Chemical Challenge, launched in 1998, asked chemical manufacturers and importers to “sponsor,” or provide a basic set of hazard data for, HPV chemicals – a list that at the time consisted of 2,782 substances produced or imported into the US in amounts of one million pounds or more annually.

High Hopes, Low Marks applauds the program for what it’s trying to do and recognizes that it would be extremely difficult for EPA to force companies to develop data on this many chemicals. It finds, though, that the agency has “limited recourse to ensure full participation of manufacturers or the timely submission and high quality of hazard data sets developed for HPV chemicals.” The chemical industry was supposed to have submitted its final data sets by 2004, and EPA was supposed to have made it available to the public in 2005. As of July 6, 2007, Dennison reports that the status of the 2,782 HPV chemicals breaks down as follows:

• 15% exempted or removed from the list
• 10% never sponsored
• 15% lack a test plan
• 20% test plan pending
• 40% final data sets completed

Data on forty percent of HPV chemicals is better than nothing, but the quality of those data sets is also an issue. Dennison explains, “The average quality of initial submissions of test plans and robust study summaries, while originally quite good, has declined considerably over the course of the Challenge, especially in the past 18 months.” Since participation is voluntary, it will be hard for the EPA to demand that the companies improve the quality of their work.

The quality of EPA’s work isn’t as high as we might hope, either. It’s been slow to develop test rules for the unsponsored (or “orphan”) chemicals, and when it comes to the HPV database, “much work remains to fully populate it and make it functional and user-friendly.”

In short, the Challenge isn’t going so well. The ED report summarizes some “lessons learned” that might improve the program in the future, but it seems that a better solution might be to amend TSCA to give EPA more authority. That’s what the GAO recommended, anyway, in its 2005 report on EPA chemical regulation:

To improve EPA’s ability to assess the health and environmental risks of chemicals, the Congress should consider amending TSCA to

• provide explicit authority for EPA to enter into enforceable consent agreements under which chemical companies are required to conduct testing;

• give EPA, in addition to its current authorities under section 4 of TSCA, the authority to require chemical substance manufacturers and processors to develop test data based on substantial production volume and the necessity for testing; and

• authorize EPA to share with the states and foreign governments the confidential business information that chemical companies provide to EPA, subject to regulations to be established by EPA in consultation with the chemical industry and other interested parties, that would set forth the procedures to be followed by all recipients of the information in order to protect the information from unauthorized disclosures.

Actually, this sounds kind of like what Lynn R. Goldman, EPA Assistant Administrator For Prevention, Pesticides And Toxic Substances said back in 1998, when the HPV Challenge got its start. In ICIS News, Glenn Hess reported on discussion at an industry-sponsored forum on TSCA:

Dr. Goldman insists changes are need for reviewing new chemicals (TSCA Section V) and managing extremely hazardous substances (TSCA Section VI).

She recommends adopting a modified version of the European approach to evaluating the safety of new industrial chemicals prior to marketing, in which a “base set of health and environmental effects data” is required.

Under TSCA, US chemical manufacturers do not have to provide EPA with toxicological data or information about a chemical’s basic physical characteristics. Dr. Goldman notes that more than half of pre-manufacture notifications are submitted with no toxicity data at all. The US is the only industrialized nation that does not require the submission of such data as part of its new chemical review process. …

“Volunteerism is great, but it only goes so far,” she says. “There will be situations, and industry knows this, where people will not voluntarily come forward [to take risk reduction actions]. And for some in industry, it is less expensive to hire lawyers and fight EPA” than to voluntarily halt the use of an extremely hazardous substance.

Nine years later, we have additional evidence that industry volunteerism does not go far enough. Will legislators heed the call to amend TSCA, or will we be stuck knowing too little about the risks that high-production volume chemicals?

Liz Borkowski works for the Project on Scientific Knowledge and Public Policy (SKAPP) at George Washington University’s School of Public Health and Health Services.

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