Proposed Rules on Chemicals of Concern, Chemical Identity Pulled From OMB Review

By Pat Rizzuto  


The Environmental Protection Agency has withdrawn a proposed rule that would have established a chemicals of concern list and another proposed rule that would have required manufacturers to disclose the identity of chemicals they would like to make or sell in the United States.

EPA withdrew the proposed rules from the Office of Management and Budget, where they were under review, because the regulatory actions are no longer needed, the agency told Bloomberg BNA Sept. 6 in an emailed statement.

The proposal for a chemicals of concern list had been at OMB since May 5, 2010.

The chemical identity disclosure proposal had been under review at OMB since Dec. 27, 2011.

The American Chemistry Council issued a statement Sept. 6 saying, “We strongly support the agency's decision to withdraw these proposals and commend EPA for choosing a course of action that will ultimately strengthen the performance of the nation's primary chemical management law, the Toxic Substances Control Act (TSCA).

“The proposals were rendered unnecessary when EPA wisely chose to adopt a better approach for prioritizing chemicals and reviewing claims for confidential chemical information under TSCA,” the council said.

Mark Duvall, an attorney with the Washington law firm Beveridge & Diamond P.C., and Christina Franz, senior director of regulatory and technical affairs at the American Chemistry Council, have publicly voiced and written their objections to EPA's proposal to require the disclosure of chemical identity for compounds that have not yet entered commerce (36 CRR 335, 3/19/12).

EDF Criticizes Action

The Environmental Defense Fund is among the public and environmental health advocacy organizations that have argued EPA should be allowed to propose the rules so that all parties could evaluate its intended regulations and comment on them.

In a Sept. 6 blog posting, EDF senior scientist Richard Denison wrote: “While there is room for debate over both the legal and scientific bases for and merits of EPA's proposed actions, the tragedy here is three-fold.”

First, Denison said, EPA's proposals were among the “modest” actions TSCA allows the agency to take.

“Second, by making more information on chemicals' safety publicly available, the actions would have helped the market to make better decisions in the absence or in advance of direct regulatory intervention by EPA,” Denison said.

Third, he said, OMB's Office of Information and Regulatory Affairs (OIRA) ignored its obligation to complete its review of such proposals within 90 days (with an allowance for one 30-day extension) as required by Section 6(b)(2) of Executive Order 12,866.

OIRA: 'Judge and Jury.'

“By blocking EPA from even proposing the rules and taking public comment--which would have been the proper venue for airing questions and concerns from all stakeholders--OIRA has taken on the unauthorized role of serving as judge and jury,” Denison said. “And because none of its reasons for blocking the proposed rules has or will be made public, that outsize role flies in the face of basic principles of transparency and democracy.”

OIRA “effectively denied the public its voice in the rulemaking process,” he said.

Denison urged EPA to continue, and for the public to support, the agency's efforts to manage chemicals.

“These efforts are being stymied, delayed or weakened at every turn by a chemical industry intent on limiting EPA activity under current TSCA, even as it claims to support expanding that authority in the context of TSCA reform.

“And, as evidenced by EPA's withdrawal of the two proposed rules, in the absence of clear requirements and deadlines for making decisions and taking action under TSCA, we can expect that OIRA will continue to constrain EPA's efforts to address the risks to human health and the environment posed by toxic chemicals,” Denison wrote.

Withdrawn Proposals

One proposal EPA withdrew would have--for the first time--used the authority that Section 5(b)(4) of TSCA gives the agency to establish a list of chemicals that may pose a concern (35 CRR 425, 4/25/11).

The second proposal would have addressed information, such as chemical identity, that chemical manufacturers would be required to disclose in health and safety documents they submit to EPA regarding compounds that are not yet available on the U.S. market (36 CRR 5, 1/2/12).

Chemical manufacturers focused particular attention on the second proposal because it addressed compounds they are not yet allowed to make or sell in the United States, but for which they had invested research and development time and money.

EPA's Reasoning

According to EPA's statement, the agency no longer needs the regulations because it has developed a work plan that focuses on 83 chemicals.

It is working to assess the risks of those chemicals and to use regulations or other means to reduce risks if warranted, the agency said (37 CRR 5, 1/7/13).

EPA said this is the process it is using to address concerns instead of using TSCA Section 5(b)(4) authority to simply list chemicals that may pose a concern.

To date, EPA has released five draft risk assessments for public comment and peer review and has identified chemicals it has slated for assessment in 2014.

EPA recently concluded a series of peer-review meetings on trichloroethylene (TCE), one of the five chemicals with a draft risk assessment. EPA reviewed TCE's use as a degreaser in both commercial products and consumer arts and crafts products. EPA said it anticipates making the final risk assessment available in early 2014, and if risks are identified, will pursue risk reduction as warranted.

Confidential Business Information Claims

The agency also withdrew a proposal that would have limited confidential business information (CBI) claims for health and safety studies included in documents accompanying premanufacture notices (PMNs), which manufacturers must file before they are allowed to make a new chemical in or import a new chemical into the United States.

“The information included in these studies are extremely useful in reviewing new chemicals prior to introduction into the marketplace. Limiting CBI claims on this information may result in fewer submissions of these important studies,” EPA said in its Sept. 6 email statement.

“EPA remains committed to increasing the public's access to critical chemical information and will continue making public the studies submitted with new chemical reviews, along with a generic name for any specific chemical which is claimed as confidential,” the agency said.

“EPA continues to try to reduce unwarranted claims of confidentiality and has taken a number of significant steps that have had dramatic results,” the agency continued. “These include tightening policies for CBI claims and declassifying unwarranted confidentiality claims, challenging companies to review existing CBI claims to ensure that they are still valid, and providing easier and enhanced access to a wider array of information.”