A proposed chemical safety standard in a federal bill designed to reform how chemicals are managed would create a burden “that would be almost impossible to meet,” according to Cal Dooley, president of the American Chemistry Council. That reform bill also has “some significant flaws,” he said.
The bill, introduced in late July, would jeopardize the plastics industry's ability to innovate and excel in product development, Dooley added.
“We have made reform and modernization of the Toxic Substances Control Act one of our highest priorities” for the past two years, he said in a teleconference July 28, one day in advance of his testimony before the House Subcommittee on Commerce, Trade, and Consumer Protection.
But while the bill, introduced by Rep. Henry Waxman, D-Calif., “has made some improvements over a discussion draft, we still think that it has significant flaws that need to be modified to ensure that we can continue” to provide safe chemicals, Dooley said.
That view of HR 5820 is shared by many business associations, including the Society of Chemical Manufacturers and Affiliates, and the National Association of Manufacturers — but not by Safer Chemicals, Healthy Families, which is a coalition of 250 environmental and public health groups.
“People have been led to believe that chemicals are proven safe before [they are] added to products we use every day, but the law doesn't offer that protection,” said coalition director Andy Igrejas.
Under TSCA provisions during the past 34 years, the Environmental Protection Agency has been able to regulate only five chemicals and require testing for roughly 200 of the estimated 80,000 chemicals in commerce.
“This legislation gives EPA both the authority and a mandate” to do that, said Igrejas, as it would require the chemical industry to demonstrate the safety of its products rather than require EPA to prove they are unsafe.
“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.”
TSCA reform isn't expected to pass before the current legislative session ends this year, but it is expected to be enacted in the next session.
Not only would the standard require companies to prove that the use of any chemical offered into commerce does not result in any significant risk or harm to consumers, they also would have to perform “an assessment of the aggregate exposure” that occurs from all products with that chemical and from ambient levels of that chemical in the soil, water and air.
“That is a burden that would be almost impossible for a company to meet,” said Dooley.
“If you have a chemical that is part of a product and it is going to be a new use [of that chemical],” said Dooley, “before you could introduce the product into the marketplace, you would not only have to focus on the exposure and risk from that product to a consumer, but you would be required as a company to determine all other uses of that chemical that are currently in commerce, do an assessment of the aggregate exposure, and assess the ambient levels of that chemical in commerce.”
“That is an area where we clearly think the legislation is flawed,” said Dooley. “At the very least, even if you could meet that standard, it would be so costly and time-consuming that it would result in the development of that product not occurring in the U.S. And quite likely, it would create an incentive for the development of that product to move offshore.”
“We contend that you can provide the same margin of safety to consumers by really focusing on the exposure resulting from the chemical in that product that has been introduced into the marketplace.”
NAM and SOCMA officials agreed.
“In its current form, the bill hurts manufacturers' ability to innovate and remain competitive in a global marketplace,” said Keith McCoy, vice president for energy and resources policy at NAM. “It dramatically expands the scope of the EPA's authority over every sector of our nation's economy, sets unrealistic standards and timeframes, and puts unnecessary burdens on manufacturers with new and inconsistent statutory requirements.”
“The definitions in the bill would vastly broaden the scope of TSCA,” added SOCMA CEO and president Lawrence Sloan. The sheer scope and the lack of definitions in the bill raise major concerns, especially in regard to the safety standard, he said, as the bill would require that safety determinations be made on a per-use basis, with the word 'use' largely undefined in the bill.
Sloan said SOCMA supports the notion that every industrial chemical in commerce must eventually be assessed, but said the association has serious reservations with the minimum data set requirement provision of the bill.
Under the bill, manufacturers and processors would be required to generate an MDS in every case, and that process at EPA would likely take years because of the rule-making and public comment periods.
“The bill would likely shift production to developing countries, outside the reach of U.S. law,” said Sloan.
Arlington, Va.-based ACC has similar reservations about provisions in the bill that regulate new chemicals that come into the marketplace.
“It would be very, very difficult to even know how to gather [the necessary] information,” Dooley said. “There are a lot of start-up companies that clearly are going to be in a very difficult position to get these products to market.”
“You have to careful that you don't create such a regulatory burden for U.S. manufacturers with our chemical management policies that it gives a competitive advantage to chemical manufacturers and product manufacturers outside the United States,” Dooley said.
In addition, Dooley said another provision of HR 5820 that would impose similar requirements on importers “would place a burden on retailers that could not be met.”
“Target and Best Buy and Wal-Mart would have to go out and identify every other product in commerce that has that chemical and do aggregate exposure testing,” he said. “We believe that also is a serious flaw in the legislation.”
Sloan of SOCMA said his members also are concerned about a provision that would allow states to adopt their own TSCA-like programs — which would prevent a single overriding federal standard.
He's also concerned that the provisions to protect confidential business information and intellectual property rights aren't strong enough. “We have witnessed China develop many off-shoot products and chemicals using stolen proprietary informa- tion,” Sloan said.
Dooley has similar concerns regarding confidential business information and intellectual property rights, but said that the current provision in the bill is an improvement over the draft version, as it would allow companies to apply for a five-year extension for protection of confidential business information — which would otherwise expire after five years.
“If there is only a five-year protection for confidential business information, it certainly is a deterrent for innovation as well as for developing products,” Dooley said.
The proposed TSCA reforms would require a minimum data set of use and exposure information for all chemicals, establish a framework for EPA to more quickly regulate chemicals identified as “chemicals of concern” and require EPA to assess chemical risks to a health-based safety standard and to look at how chemicals impact sensitive subpopulations such as children and expectant mothers.
It would also require chemical manufacturers to provide basic health and safety information for all chemicals as a condition for them remaining in or entering the market, and require them to make that information public.
“We believe that you need to identify and prioritize chemicals that post the greatest concerns in terms of safety” and require greater and more extensive data for them, said Dooley. “But for others that we know propose a minimal risk, you should just require a minimal data set. But there is a great lack of clarity [in the legislation] of what would be required.”