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The agency says it is currently finalizing the two action plans for bisphenol A (BPA) and benzidine dyes from its initial list of substances. At the end of December 2009 it posted the first four action plans on phthalates, long-chain perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDEs) in products, and short-chain chlorinated paraffins.  The action plans outline the concerns that each chemical may present and identify specific steps the agency intends to take to address these concerns. EPA is also in the process of developing a list of potential chemicals for future action plan development and anticipates making that information available this summer.

Proposals moving forward to change US chemical regulation

WASHINGTON (April 23, 10:30 a.m. ET) -- It is uncertain, and probably unlikely, that legislation to reform how chemicals are regulated at the federal level will emerge this year. But, after a year of posturing by all sides, the first concrete step toward reforming the 34-year-old Toxic Substances Control Act is now a reality with the introduction of bills in both the Senate and the House to reform TSCA. TSCA governs how the U.S. Environmental Protection Agency regulates chemicals.

There are differences between the Safe Chemicals Act introduced April 15 by Sen. Frank Lautenberg, D-N.J, and the TSCA reform measure proposed by Rep. Henry Waxman, D-Calif., and Rep. Bobby Rush, D-Ill. But essentially, the bills would shift the burden of proof to industry to show that chemicals are safe, rather than the current approach which requires EPA to show that chemicals would cause “unreasonable risk.”

In addition, the bills would require a minimum dataset of use and exposure information for all chemicals, require EPA to assess chemical risks to a health-based safety standard, look at how chemicals impact sensitive subpopulations such as children and expectant mothers, and establish a framework for EPA to more quickly regulate chemicals identified as chemicals of concern.

Under TSCA, EPA has only been able to regulate five chemicals and require testing for roughly 200 of the estimated 80,000 chemicals in commerce.

“Reforming TSCA is a priority for the Obama administration, not just the EPA,” said Steve Owens, assistant administrator of the EPA office of Chemical Safety and Pollution Prevention at a recent conference. Because of the current restrictions imposed by TSCA, Owens said “EPA has been left without the ability to provide the American people assurance that chemicals they and their children use are safe,”

“We are hopeful that will change soon,” Owens said. “TSCA reform needs to give EPA the tools to ensure chemicals are safe and give people the information they need to know about the chemicals in their homes and in the products they use.”

Many of the reform provisions in the bills reflect the recommendations outlined last fall by EPA, the concerns expressed by members of the Safer Chemicals, Healthy Families coalition that represents more than 210 organizations and 11 million individuals, and the principles for reform outlined by the American Chemistry Council, which began calling for reform a year ago in the aftermath of chemical product bans by states and state initiatives to regulate chemicals.

“This is pretty much a monumental sea change from the status quo,” said Richard Denison, senior scientist with the Environmental Defense Fund. “Right now, EPA has a very high burden of proof it must meet before it can regulate a chemical. That would change. The burden of proof [for safety] would be borne by industry rather than government having to prove there is harm.”

Under the proposed reform, EPA would be required to assess chemicals to a health-based safety standard and also have more authority to expedite the regulation of chemicals of highest concern.

“This is a milestone in our fight to overhaul our nation’s chemical policy and will go a long way toward bringing our nation’s chemical policy into the 21st century,” said Andy Igrejas, director of the SCHF coalition.

Likewise, ACC President Cal Dooley said the chemical industry was “encouraged” because the bills reflect “some aspects of the principles” of TSCA reform that ACC released last year, including “the need to prioritize chemicals for evaluation [and] a risk-based approach to EPA safety reviews.”

Not surprisingly, both industry and non-government organizations had some concerns about the initial proposals.

“This bill makes an effort to address the need to prioritize chemicals, [but it] overreaches in its attempt to impose a new approach to regulating chemicals,” said Lawrence Sloan, president and CEO of the Society of Chemical Manufacturers and Affiliates. “We have serious reservations with the minimum data-set requirement and extending it to all new uses of existing chemicals. We need to avoid a standard that is too restrictive and avoid a one-size-fits-all and guilty until proven innocent approach.”

ACC said it was concerned that the changes could hamper innovation, that the decision-making standard could be “legally and technically impossible” to meet, and that the proposed reform could create “a lack of regulatory uniformity [and] undermine business certainty” by allowing states to adopt their own regulations.

Similarly, Denison said EDF has several reservations, particularly about a provision that he said “would allow hundreds of new chemicals every year to enter the market and be used in products without first requiring them to be safe.”

As Denison explained, new chemicals would be assessed against a set of criteria to determine whether they are potentially hazardous and only those that are “flagged” would have to first go through a safety determination. “Everything else would be allowed to come on the market and would only be subject to safety determination years later.”

In addition, Denison said there is concern that the proposed reform does not give EPA “clear authority to restrict” what he called “the worst of the worst chemicals and only requires EPA to consider, not adopt, the National Academy of Sciences recommendations that the agency look at the aggregate exposure of people to chemicals.

“We want a system that assesses the risks of chemicals based on real world exposure to all sources of chemicals because people are exposed to multiple chemicals in multiple ways and not exposed to a single chemical at a time,” Denison said. “The chemical industry wants to perpetuate a system that suggests we are only exposed to one chemical at a time and from one source at a time. But that is short-sighted. We need to look at the aggregate exposure of people to chemicals.”

Michael Green, professor of pediatrics at Stanford University, agreed.

“Aggregate and cumulative exposure to chemicals is a significant issue because the exposure from an individual chemical might well be below a significant level,” but multiple chemical exposures could raise that risks to a level of concern. However, he added that there is still “not a lot of research on cumulative effects because we don’t yet have the science to deal with it.”

Other provisions of the Lautenberg bill would:

Require manufacturers to provide a minimum data set for each chemical they produce, and give EPA authority to request additional data needed to make a safety determination.

Require EPA to prioritize chemicals based on hazard and exposure characteristics.

Require EPA to identify communities that are “hot spots” for toxic chemicals and take action to reduce exposures in those areas.

Require EPA to create a public database of information about each chemical

Narrow the conditions under which manufacturers could claim information is confidential.

“We believe all chemicals must have health and safety data information developed and made available to the public,” said Denison. To take any other approach would leave us in the dark.”

Even though the House has established an expedited schedule to move the bill out of the committee by mid-summer, Dooley, Sloan and Denison believe that with less than 20 weeks left in the legislative session, the timeframe may be too short to move the bill through both the Senate and House

“We have come a long way on this issue in the past year, but I don’t think it is likely we will get something this year,” said Denison.

The bottom line is we need a workable and effective approach to chemical management in the United States to bring us current and we need to do it in a way so that we meet health and environmental protection goals while still assuring U.S. competitiveness.

Current Issues

Proposals moving forward to change US chemical regulation