Legislation moving through Congress to modernize the Toxic Substances Control Act (TSCA) will impose new limits on the ability of businesses to protect confidential information (CBI) that is submitted to the Environmental Protection Agency (EPA) when risk assessments are conducted on chemicals regulated by the agency.
On June 23, the House of Representatives overwhelmingly approved the TSCA Modernization Act (H.R. 2576), which gives the EPA greater authority to obtain toxicity and other data from companies. The reforms could impose new burdens on manufacturers and processors, including more reporting and testing. At the same time, business groups say they support the legislation because it will establish a science-based chemicals management program founded on risk-based safety standards.
“It is clear that a more workable and effective national chemical regulatory program is needed to further ensure the safe use of chemicals, encourage innovation, and protect American jobs,” wrote the American Alliance for Innovation, a group of industry trade associations representing large and small businesses, in a June 2 letter to the House Energy and Commerce Committee. “We believe that H.R. 2576 can help accomplish this goal.”
The TSCA, enacted in 1976, authorizes the EPA to screen existing and new chemical products that aren’t subject to other federal laws. Excluded categories of products include food, drugs, cosmetics, and pesticides. The agency can force a manufacturer or chemical processor to conduct tests to determine the effects of chemicals in consumer goods and limit the uses of those chemicals based on the results. As part of the process, the EPA collects a range of data, including health and safety studies on chemicals, some of which may be claimed as CBI by the submitter.
According to an analysis by the Environmental Defense Fund, the identities of about 17,000 chemicals screened by the EPA are protected as CBI by their makers. The EPA, the group says, is only able to challenge CBI claims on a case-by-case basis, and there is no mandate to review those claims.
Under the legislation approved by the House, manufacturers and chemical processors would be allowed to request that information submitted during a risk assessment remain confidential. The request would have to include a justification for a designation and a certification that the information isn’t publicly available. The EPA would be barred from disclosing confidential information, except under emergency circumstances, such as a release of the chemical into the environment or when a doctor or health professional is treating a case of exposure. The legislation provides that confidentiality designations would expire after 10 years and requests to extend confidentiality for an additional 10 years are allowed.
Similar legislation (S. 697) was approved by the Senate Environment and Public Works Committee on April 28. That legislation differs from the House-passed bill in a number of ways. With respect to CBI, unlike the House bill, the Senate bill requires the EPA to review the validity of all claims, including those made in the past, by chemical manufacturers that the information they submit is confidential. Even between 10-year intervals, the Senate bill allows the EPA to review and require re-substantiation of CBI claims.
At a Bipartisan Policy Center forum on June 25, Rep. John Shimkus (R-IL) and Sen. Tom Udall (D-NM) indicated that Senate Majority Leader McConnell plans to bring the TSCA reform bill to the floor in the near future and that House and Senate staff are currently working on ways to integrate the different legislative approaches to facilitate a final agreement between the two chambers.