TSCA: Targeted For Overhaul

TSCA: Targeted For Overhaul

How will the most significant piece of environmental legislation in years affect you?

During the three months following the April 20 explosion at BP’s Deepwater Horizon rig, as millions of barrels of oil gushed into the Gulf of Mexico and the toll on residents, businesses and the environment looked increasingly bleak, it was hard to imagine that anything good could come from such an unprecedented disaster. Then, in June, the EPA began publicly grappling to produce data on the environmental and human health impacts of the dispersants BP was using to break up the oil. As it turned out, few tests had been done on the dispersants, and federal law protecting business interests made it difficult for EPA to reveal the chemicals they contained. Environmentalists, consumer advocates, and legislators immediately — and just as publicly — posed two frightening questions: why didn’t the EPA know more about a product it had approved for commerce, and why couldn’t it tell the public what chemicals that product contained? Suddenly, a silver lining had emerged from the chaos: the dispersants debate had provided the perfect argument for reform of a 30-year-old, hopelessly outdated environmental law — the Toxic Substances Control Act.

Enacted in 1976, the law gave the newly created Environmental Protection Agency authority to regulate chemical manufacturers and importers through reporting, record-keeping and testing requirements and through restrictions on chemical substances and mixtures in commerce. A progressive statute at the time, TSCA (pronounced like the opera Tosca) is today universally deemed overdue for an overhaul; it is, in fact, the only major environmental statute that has not been reauthorized. Among the most salient criticisms are that the law does not require comprehensive environmental and human health effects testing on each chemical; relies on outmoded forms of chemical testing; does not provide the public with enough information on the contents of chemical formulations; and does not give EPA adequate authority to restrict chemicals that were already in commerce in 1976 (it’s authority over “new” chemicals is somewhat greater).

The BP spill, and the weaknesses in TSCA it revealed, was eerily timely: on April 15, just five days before the rig explosion, Sen. Frank Lautenberg (D-N.J.) had introduced The Safe Chemicals Act (S. 3209), a sweeping piece of legislation intended to reauthorize and strengthen TSCA. A House version, the Toxic Chemicals Safety Act of 2010 (H.R. 5820), was introduced by Reps. Henry Waxman (D-Calif.) and Bobby Rush (D-Ill.) on July 22, just six days after the oil flow was staunched. The implications of the bills’ passage for the public are considerable. (2011 update: Sen. Lautenberg re-introduced the Safe Chemicals Act as S. 847)

“The term ‘industrial chemical’ does not just apply to chemicals used in industrial manufacturing processes, it also includes chemicals used in all sorts of household and consumer goods,” notes Nancy Beck, scientific and policy advisor for Physicians Committee for Responsible Medicine, a Washington-based nonprofit organization that encourages higher standards for ethics and effectiveness in research. “In fact, the chemicals regulated by TSCA include basically all chemicals in commerce other than pesticides and pharmaceuticals, which are regulated by their own respective laws. People are concerned about the potential for exposure to these chemicals through the products they purchase, their homes, their workplaces, and the environment. For many chemicals regulated by TSCA, we don’t have a lot of information.”

According to an analysis conducted last month by the law firm McDermott Will & Emery, both bills would, among other things:

  • Require every chemical substance allowed in commerce to meet a safety standard that will be established by EPA. Whereas currently EPA is required to prove harm before it can regulate a chemical, and no minimum health or environmental data set is required, the reauthorization legislation would shift to industry the legal burden of proving that chemicals are safe, and those that did not meet the safety standard could not be manufactured, processed, or imported.
  • Require industry, through EPA’s safety standard, to establish a reasonable certainty that no harm will result to the general population or to vulnerable populations — such as children, pregnant women, the elderly and those who work with chemical substances — as a result of aggregate exposures to the chemical being regulated. Currently, there is no requirement on industry to assess all sources of exposure to a chemical or to assess risk to vulnerable populations.
  • Require EPA to establish a priority list of 300 “existing” chemical substances — those already in commerce — for review to ensure they meet the safety standard (the House version says this list must include Bisphenol A, formaldehyde, n-hexane, hexavalent chromium, methylene chloride, trichloroethylene and vinyl chloride). EPA would add to the list until all substances in commerce had been evaluated for safety.
  • Require EPA to review and approve all industry claims that information on their chemicals constitutes “confidential business information” (and therefore must be kept secret) before commercialization, and any approved CBI claims would expire after a period of time. Currently, companies are free to claim that most information they submit to the agency is CBI. EPA is not required to review the claims, and they never expire
  • Give EPA authority to require, through an order, additional testing of chemicals. Currently, EPA must promulgate regulations over the course of many years to require testing.

The reauthorization bills represent a sea of change in U.S. chemicals regulation, most notably in the paradigm shift that would force industry to prove that chemicals are safe as opposed to requiring EPA to show they’re unsafe. But as Beck points out, industry’s new responsibility to generate significantly more health and safety information will require an update of the scientific methods used.

“Most information comes from toxicity tests performed on animals, which presents several obstacles to generating data that will protect the public,” Beck notes. “For one thing…the effects observed in animals don’t necessarily apply to humans due to differences in physiology and anatomy. This…information delays chemical regulation, while more testing is conducted to determine whether the animal data is relevant to people or not. Another problem is the expense of animal tests. Because they are so costly, exhaustive testing is not done.”

Cell-based methods and computer models, Beck notes, are “promising new approaches that are much quicker and more affordable — not to mention more reliable and predictive — that will allow us to assess chemical mixtures much more readily.” Both bills contain a section devoted to the reduction of animal testing, including the use of in vitro studies tests and computational toxicology, “but there is still some work to be done,” says Beck. “The bills direct the EPA to fund the development of modern, nonanimal methods, but congressional funding is also needed in order to usher in a new era of better protection without the use of animals.”

The ways and extent to which chemicals regulation under TSCA reform will be funded will likely present one of the major points of controversy as Congress debates the bills, as will the questions of what constitutes an appropriate safety standard, whether and how EPA’s decisions can be challenged, and the extent to which obligation imposed under the safety standard extend down the processing chain to second- and third-hand users. Most stakeholders believe that passage of the bills is unlikely until 2011 or 2012, which gives the public ample time to contact their lawmakers and influence the process.

-Lucy Ament

Fall 2010

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