Regulatory DevelopmentsApril 11, 2013
On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform the Toxic Substances Control Act (TSCA) and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works (EPW) Committee on a party-line vote in the 112th Congress. In his April 10, 2013, press release, Senator Lautenberg states that, compared to earlier versions of the legislation, the Safe Chemicals Act of 2013 "includes a number of significant changes that reflected input from a broad range of stakeholders including federal agencies, state governments, the chemical industry, and public health advocates." The bill would:
Establish a risk-based chemical management system based on sound science;
Focus attention on priority chemicals;
Secure access to health and safety data;
Protect Americans from harmful chemicals; and
- Promote innovation and protect confidential business information (CBI).
A summary of the bill is available online, and the full text of the bill is available online. A detailed discussion of the 2011 legislation is available in our April 18, 2011, memorandum, which is available online, as well as our thoughts on the bill that emerged from Committee, which is available in our July 26, 2012, memorandum online.
The legislation would revamp the chemical evaluation process by updating the TSCA Inventory of existing chemicals, with the intent to refocus the U.S. Environmental Protection Agency's (EPA) energy on priority chemicals. Once the Inventory is updated, EPA would assess chemicals on the updated Inventory over an extended period of time by creating batches of chemicals for review, each over a five-year period. Within each batch, EPA would identify chemicals that are either of very high concern (which would require expedited risk management) or very low concern (which would require no further action). EPA would also identify chemicals that require additional safety information and those that require a safety standard determination. For the latter category of chemicals requiring a safety standard determination, EPA would focus its resources first on the highest priority chemicals. Risk management, such as use restrictions or labeling, would be required where necessary to ensure a chemical meets the safety standard. If a chemical cannot meet the safety standard, only critical uses of that chemical would be allowed.
For new chemicals, the process would be similar to the process under the existing program. Manufacturers would submit a premanufacture notice (PMN), along with a set of basic information on the chemical. EPA would then perform an initial screening of the chemical based on that information set and other existing information. Chemicals of very low concern would be included on the active Inventory without further review. Chemicals likely to meet the safety standard would also be placed on the Inventory and await further evaluation in the next batch of chemicals. If a new chemical substance was found to be a substance of very high concern or unlikely to meet the safety standard, it would generally be prohibited from entering commerce except for critical uses.
Under the bill, EPA would require new information and testing of chemicals only when necessary. The bill directs EPA to rely on existing information first and require additional testing only to the extent necessary to determine safety. In addition, different tiers of minimum information sets are tailored to fit the different stages of evaluation. This is intended to minimize the data burden for regulated entities, while still providing EPA with the necessary information to make decisions.
EPA would have the authority to require use reporting every four years, similar to the current Chemical Data Reporting (CDR) rule requirements, for both manufacturers and processors. Information required in use reporting is limited to what is already available to companies.
The bill assigns various types of information submitted to EPA into different categories. Information such as trade secrets and precise production information is always eligible for CBI protection. Other types of information are eligible for CBI protection on a case-by-case basis, including the identity of chemicals, which can be protected for a specified period of time based on market conditions; and certain information is never eligible for CBI protection, including health and safety information, EPA decisions, and general market information.
As noted in our July 26, 2012, memorandum, when S. 847 cleared the Senate EPW Committee last July, the legislation, despite being an improvement over earlier versions, "faces a headwind of opposition from Senate Republicans and the chemical industry," a sentiment that continues to apply to the reintroduced bill. As mentioned, this bill text was reported by the full Senate EPW Committee last year, but on a straight party-line vote. The discussion among the Committee members at that time indicated a very significant fraying of the earlier rhetoric, expressed repeatedly since 2009, that the sponsors of the legislation hoped to find a consensus approach to TSCA legislation. Instead, the Committee mark-up was met with a promise of separately drafted legislation supported by the Republican members of the Committee, which obviously when introduced could include some Democratic sponsors who are not members of the EPW Committee. So the prospects for legislation will be affected greatly by the content of any competing legislation as it will indicate how far apart the competing proposals are concerning the central issues that have been difficult to resolve even with the patina of bipartisan discussions about how to move forward.
It is now expected that Senator Vitter (R-LA), ranking minority member of the Committee, will introduce his version of a TSCA reform bill, a possibility that has been discussed in the trade press for months. Until that happens, it is difficult to see much likelihood of progress with Senator Lautenberg's bill and, almost regardless of whether Senator Vitter makes good on introducing his bill, the prospects of any legislation looks unlikely in the House unless there is widespread bipartisan support for any legislative package Thus, while we and many TSCA stakeholders recognize and support the need for revised legislation, as always, "the devil is in the details" and until and unless an alternative legislative proposal is introduced, it is difficult to be very optimistic about progress in the current Congress.