Toxic Chemical Rules In Limbo

To flag substances that could endanger human health or the environment, the Environmental Protection Agency wants to create a public list of “chemicals of concern,” including some shown to disrupt hormones. The agency drafted a proposal and sent it for review to the White House. There it has languished for two-and-a-half years without any indication of why. It is the policy of the White House and EPA not to comment on proposals under review.

Yet a presidential directive requires action on such proposals within three months. Environmental and health activists say the delay prevents EPA from informing the public about chemicals that could endanger human health or the environment. But opponents of the proposal, such as the chemical industry, argue that what they call a blacklist would hurt the economy.

This is not the only EPA proposal in long-term limbo. For more than a year, the White House has failed to clear a proposal that would limit the ability of companies to claim the identity of chemicals as confidential in health and safety studies that they submit to the agency. EPA also wants manufacturers of nanomaterials to provide it with production and safety data. This proposal, too, has been held up for more than a year. All three proposals fall under the Toxic Substances Control Act (TSCA), although none of them is aimed at restricting the manufacture of chemicals.

These three drafts are technically undergoing regulatory scrutiny by White House analysts. Under a directive issued in 1993 by then-president Bill Clinton and still in force, the White House’s Office of Management & Budget (OMB) must review all pending federal regulations and proposals in part to ensure that their benefits outweigh their compliance costs. As specified in the directive, the review must be completed within 90 days from the time OMB receives the regulations and proposals, with a possible 30-day extension.

As part of the executive branch, EPA has little recourse to challenge lack of action on its draft proposals because OMB, as part of the White House, calls the shots on behalf of the President. EPA could withdraw the draft proposals from OMB review, but such a move would kill them.

OMB regularly keeps some draft rules and proposals beyond the 90-day limit, says Katie Greenhaw, an analyst with the Center for Effective Government, a public interest group formerly known as OMB Watch that monitors federal regulatory policy. On average, however, OMB has taken 55 days to review rules and proposals by federal agencies during the Obama Administration. For EPA, that average is a bit higher, at 63 days, according to OMB’s website at C&EN’s press time.

OMB is not required to explain why it is holding up rules and proposals. Thus, OMB can be a black hole for planned regulatory actions that agencies have expended significant amounts of federal resources to prepare, Greenhaw says.

The three proposals are among about 25 draft EPA regulatory actions under review at the White House—a number that varies from week to week. EPA has more draft rules or proposals pending at the White House than any other agency, according to OMB. A majority of these fall under the Clean Air Act or the Clean Water Act.

Of the three pending actions, the TSCA chemicals of concern list holds the record for the longest EPA proposal under OMB perusal: It’s been under review since May 2010. And it doesn’t appear on a list, released by OMB on Dec. 21, 2012, of regulations or proposals that federal agencies are likely to release in the coming months.

“It’s in suspended animation,” comments Richard A. Denison, senior scientist at the Environmental Defense Fund, an activist group.

TSCA, signed into law in 1976, grants EPA the authority to create a chemicals of concern list. The agency, however, hadn’t attempted to use this power until the Obama Administration took office. Daniel Newton, senior manager for government relations at the Society of Chemical Manufacturers & Affiliates (SOCMA), an industry group, says EPA in the past did not compile the list because it was never clear what Congress wanted the agency to do with it.

EPA’s draft proposal would place eight phthalates, polybrominated diphenyl ethers (PBDEs), and bisphenol A on a newly created TSCA chemicals of concern list, according to information on OMB’s website. Scientific studies have linked all of these compounds to hormone disruption.

Environmental activists have called on OMB to release the proposal. They argue that EPA’s plan to list these substances is justified because of documented widespread human exposure and the hazards the chemicals pose.

Industry groups, including the U.S. Chamber of Commerce, have asserted that placing chemicals on the list would hurt business, kill jobs, and do nothing to improve public health because the list does not regulate any substances. Newton calls the proposal “a de facto blacklist.”

Businesses have also argued that EPA should reveal the reasoning behind picking substances to be on the list. “There were no rigorous and transparent criteria for public stakeholders to have foreseen the selection of chemicals,” Newton tells C&EN.

Scott Jensen, a spokesman for the American Chemistry Council (ACC), an association of chemical producers, says EPA is unlikely to move the chemicals of concern list forward because the agency’s efforts on commercial substances have evolved since the proposal was sent to OMB in May 2010. Specifically, in March 2012, the agency established a formal method for prioritizing commercial compounds for assessment on the basis of their potential to pose risks to health or the environment, Jensen points out (C&EN, March 12, 2012, page 11).

Yet OMB’s reason for delaying release of the list for so long—or not sending it back to EPA—is unclear.

The trade secret proposal in limbo at OMB would reduce the number of confidentiality claims made by chemical manufacturers in health and safety studies that they submit to the agency. Under TSCA, the agency has access to these confidential data but must protect them from disclosure.

EPA makes available to the public versions of health and safety studies, but it redacts information claimed as proprietary. In these public files companies often use generic descriptors—such as a substituted nitrogen-containing heterocycle—that could apply to thousands of substances instead of the chemical’s actual identity. Activists and public health researchers contend that without the chemical’s identity, or at least a more targeted classification that would apply to a narrower group of compounds, the publicly available studies are essentially meaningless.

EPA, some companies, and some trade associations agree that businesses have overused TSCA confidentiality claims in the past. During the past three years, EPA has cracked down on trade secret assertions in health and safety studies for chemicals that are already on the market. In addition, a number of chemical companies, at EPA’s urging, have voluntarily lifted claims, including those on chemical identity, they made years ago.

The proposal pending at OMB since December 2011 would take this effort a step further. In most cases, it would prohibit confidentiality claims in health and safety studies for the chemical identities of compounds about to be introduced to the market. Before a company can commercialize a new chemical, TSCA requires the firm to submit a premanufacture notice to EPA. In some cases, producers supply health and safety data along with the notices, although TSCA does not require them to do so.

Companies say the planned proposal would harm innovation because they would have to make public, and thus reveal to their competitors, the chemical identity of new products.

Newton calls the pending proposal “extremely important to some of President Obama’s most loyal supporters who are demanding more transparency regardless of the threat to innovation by doing so.”

Denison says having a chemical identity included in publicly available health and safety studies is particularly important for new compounds designed to replace widely used substances that have turned out to be problematic. An example is substitutes for PBDE flame retardants, he says. Industry is shifting away from once widely used PBDEs because of potential adverse health impacts and environmental persistence, which have been documented by scientific studies (C&EN, Oct. 29, 2012, page 34). The public has a right to know about the safety of new fire retardants to ensure that they offer health and environmental benefits over PBDEs, Denison says.

SOCMA supports the use of improved generic classifications instead of exact chemical identities in publicly available studies on new chemicals, Newton says. This would allow public access to data while protecting companies’ proprietary information, he says. Likewise, ACC is urging EPA to work with industry and environmental groups to come up with guidance on improving generic descriptors so they could be used to search toxicological literature for studies on structurally related compounds.

The chances that this proposal will be made public this year, however, may be slim. It doesn’t appear on OMB’s recently released list of expected proposals and regulations.

But the nanomaterials proposal under review for more than a year is on that list.

The rule would require manufacturers of nanomaterials to provide EPA with data on their production volume, exposure, and release, as well as unpublished health and safety data. The proposed reporting “will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment,” according to OMB’s website. The draft proposal, in OMB’s hands since November 2011, is similar to previous TSCA rules requiring the same sort of information from manufacturers of chemicals that are not nanomaterials.

In addition, the proposal would require producers to notify EPA before commercializing nanoscale materials for a significant new use. “The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment,” OMB’s website explains. This part of the proposal is the same as significant new-use notifications that the agency requires of manufacturers of certain bulk chemicals.

Newton says the proposal “could be a serious threat to innovation in a promising field that continues to advance.”

Denison says he thinks this draft proposal is caught up in a debate in the White House over the government’s dual and conflicting roles in promoting nanotechnology and regulating the potential risks of nanomaterials. EPA’s planned action, he points out, does not suggest that nanomaterials pose risks. Instead, it is aimed at filling data gaps so the agency can understand what nanomaterials are being produced and how they are used.

In the end, Greenhaw of the Center for Effective Government points out that if the White House released the proposals, they would simply be available for public comment and would not take effect for months to years. That’s because before they could become final, EPA would have to respond to comments and may have to revise the proposals. Then OMB would review the draft final regulations and could demand that EPA modify them before they are issued.

The reasons for delay of the three rules may never be known. But Greenhaw says it isn’t because OMB needs more time to finish its work. A year, she says, “is plenty of time to conduct a thorough review.”