Toxics Law Faulted

Democrats on Capitol Hill have fired the first shot in what figures to be a long uphill struggle to bring Europe's controversial chemical control policy to America. Legislation introduced last month would dramatically overhaul the way chemicals are regulated in the U.S. and is similar to proposed reforms in the European Union (EU).

The evolving EU policy, known as REACH--Registration, Evaluation & Authorization of Chemicals--would greatly increase the authority of government officials to regulate chemicals and impose strict testing requirements and precautionary restrictions on many widely used substances.

Sen. Frank R. Lautenberg (D-N.J.) asserts that similar measures are needed in the U.S. because legal hurdles in existing law--the 1976 Toxic Substances Control Act (TSCA)--have crippled the government's efforts to protect the public from potentially hazardous chemicals. "Every day, Americans use household products that contain hundreds of chemicals. Most people assume that those chemicals have been proven safe for their families and children. Unfortunately, that assumption is wrong," Lautenberg declares. "We have laws to make sure that pesticides and medicines are safe. But we fail to require similar analysis for the chemicals used in baby bottles, food packages, and thousands of other products. This is inexcusable."

Lautenberg says the legislation he crafted with Sen. James M. Jeffords (I-Vt.)--the Child, Worker & Consumer Safe Chemicals Act--responds to concerns raised by the Government Accountability Office in a July 13 report (GAO-05-458). "EPA does not routinely assess the human health and environmental risks of existing chemicals and faces challenges obtaining the information necessary to do so," according to GAO, the investigative arm of Congress.

The report notes that the Environmental Protection Agency has required testing for fewer than 200 of the 62,000 chemicals used in commerce since the agency began reviewing chemicals in 1979. GAO also found that EPA's reviews of new chemicals "provide limited assurance that health and environmental risks are identified before the chemicals enter commerce." The report says chemical companies generally do not test new chemicals for toxicity or gauge human exposure levels before they are submitted for EPA review, forcing the agency to rely on predictive modeling that "does not ensure that the chemicals' risks are fully assessed before they enter commerce."

Even when EPA has toxicity and exposure information on existing chemicals, GAO says the agency has had difficulty demonstrating that harmful chemicals pose an unreasonable risk. As a result, in almost three decades, EPA has issued regulations to ban or limit the production or restrict the use of only five chemicals.

The Lautenberg-Jeffords bill would fundamentally overhaul the nation's chemical management framework. Manufacturers would be required to submit health and environmental information on new and existing chemicals to EPA. Chemical makers would need to establish that there was "a reasonable certainty of no harm" before distributing their products. A 10-fold safety factor would be built in to account for the unique sensitivity of children.

Under the legislation, EPA would be required to determine the safety of 300 chemicals within the next five years. By 2020, all chemicals distributed in commerce would have to meet the new safety standard for children. Rep. Henry A. Waxman (D-Calif.) is sponsoring a similar bill in the House.

"THIS BILL correctly puts the burden on the chemical industry to prove that their products are safe for infants and children," says Richard Wiles, senior vice president of the Environmental Working Group. "It contains long-overdue protections for the public from the literally thousands of chemicals to which we are exposed, for which there is almost no meaningful safety information."

The chemical industry has sharply criticized REACH as unworkable and unduly burdensome and has already begun mounting a campaign against the Lautenberg-Jeffords proposal. Industry leaders maintain that an overhaul of TSCA is not needed. The legislation, they argue, duplicates or undermines ongoing regulatory activities, makes erroneous assumptions about chemical regulation, and ignores GAO's recommendations for making the statute more effective. "The bill appears designed to make it easy to ban essential and often life-saving products without considering the benefits these products provide," says Kathleen M. Roberts, director of product stewardship for the American Chemistry Council (ACC).

TSCA is working as Congress intended, adds James Cooper, senior government relations manager for the Synthetic Organic Chemical Manufacturers Association (SOCMA). "There are a lot of provisions in the statute that make it difficult for EPA to take regulatory action, but those things were intended to prevent EPA from politicizing chemical risk management. The agency does need to meet certain standards to write rules. That's exactly how it was designed to work by Congress," he remarks.

Cooper says there are a lot of things about chemical regulation that EPA does well. For instance, before a company can bring a newly developed chemical into the market, it must submit a premanufacture notice (PMN), which provides EPA with a variety of information, including the substance's properties, uses, available test data, and anticipated production volume. EPA scientists then determine if the chemical presents an unreasonable risk of injury to health or the environment for the proposed uses. If they conclude that the substance poses such a risk, the agency has the legal authority to prohibit manufacture or distribution of the new chemical.

"During the new chemical review process, a lot of PMNs are withdrawn because the chemicals do present some kind of risk," Cooper notes. "EPA will often inform a company that it has issues with a PMN, and the company will choose to withdraw it rather than putting something out there that might be risky."

ACC's Roberts says TSCA provides EPA with substantial authority and regulatory tools to manage chemical risks. "Back in 1976, as is still true today, there was a recognition that we don't live in a zero-risk world. So Congress directed EPA to base its actions on unreasonable risk. My view is that TSCA is still an effective statute. It isn't perfect, but it does give the right tools to EPA," she remarks.

THE CLAIM that TSCA ties the hands of regulators is also disputed. To restrict or ban a chemical, EPA must demonstrate that the substance poses "unreasonable risks," a standard not well-defined under the law. The agency must then propose the least burdensome option to protect public health or the environment, and also determine that the benefits of regulation outweigh the cost. GAO says EPA "has found it difficult to meet all of these requirements for rule-making."

Cooper says litigation is largely to blame. EPA has not banned an industrial chemical since 1989, when it tried to phase out asbestos, a known carcinogen. The ban was revoked in 1991 when a federal appeals court ruled that the agency had failed to prove it was necessary to protect public health.

"EPA tried to ban all uses of asbestos without realizing that there might be some critical uses, like the jackets that firemen wear," Cooper explains. "So instead of trying to restrict certain uses where asbestos wasn't absolutely necessary, they tried to do an all-out ban and lost in court."

He says EPA has been "a little gun-shy" because ending up in court is "very resource-intensive." Although the standards EPA must meet to ban a chemical are high, Cooper believes they should be. "If they weren't, you would see things like what's occurring in Europe where they are going to ban [six] phthalates. They really don't have the scientific evidence to back up that people are at risk. Yet they are going to ban them anyway, and that's a political decision that has nothing to do with science."

Rewriting TSCA to more closely resemble REACH would hamper innovation and encourage U.S. chemical companies to move more of their operations to India, China, and other Asian nations, industry officials say.

"The argument that this legislation could foster innovation is absurd," Cooper says. "The number of new chemicals introduced in Europe over the past 10 years since they began requiring up-front testing is nowhere near the number introduced in the U.S. We are a much more innovative country. You're not going to get safer chemicals if you erect market barriers, such as high costs. Innovation is going to suffer."

TSCA critics charge that for the vast majority of chemicals on the U.S. market, there is almost no information available about their potential hazards. "Study after study has shown we have dozens, if not hundreds, of synthetic chemicals in our bodies, yet we have very little information about how they impact our health," Jeffords says. "This legislation will for the first time require that the chemicals our children come in contact with each day are properly tested and reviewed."

But industry officials say the bill ignores the 1998 High Production Volume (HPV) Challenge Program, under which chemical makers are voluntarily compiling and making publicly available screening information on substances that are produced or imported in quantities greater than 1 million lb per year. To date, the industry has provided EPA with information on nearly 1,300 chemicals.

"During the course of the program, what we've come to realize is that the great majority of data really was available; it just wasn't publicly available," Roberts says. "Part of the reason is that a lot of the studies were negative, and there's no requirement to submit those to EPA. So the data were there. They just weren't in a searchable database." Out of the 2,800 HPV chemicals, she notes that fewer than 300 studies were initiated to fill data gaps.

EPA says changes in the law are unnecessary. TSCA already provides the agency with "strong legal authority" to require chemical testing, says Susan B. Hazen, EPA's principal deputy assistant administrator. In addition, she notes that EPA has conducted premarket reviews of more than 40,000 new chemicals. "We have restricted or otherwise regulated over 1,600 of these chemicals, while a similar number have been withdrawn by the manufacturer, often in the face of EPA action," she remarks.

Lautenberg acknowledges that his bill is unlikely to advance very far in the Republican-controlled Congress. But he hopes its introduction will spark a public debate that will eventually lead to TSCA reform.

SOCMA's Cooper believes that TSCA's critics simply do not understand the law and the broad authority it gives to EPA. "I don't think the agency has always implemented the statute in an effective manner, but that doesn't mean it can't work," he says. "The direction EPA is taking is going to revolutionize risk management in the future, and it's not based on any statute. It's using collaborative partnerships to do environmental problem solving. That's the wave of the future."