On May 14, the Subcommittee on Environment & the Economy of the US House Committee on Energy & Commerce (E&C Committee) unanimously approved a “discussion draft” bill to reform the Toxic Substances Control Act (TSCA) proposed by Subcommittee Chairman John Shimkus (R-IL). The discussion draft, entitled the “TSCA Modernization Act of 2015,” was approved by a 21-0 vote and contained revisions to address concerns that had been raised about some aspects of the original discussion draft that Chairman Shimkus had released earlier this year.
While it is less comprehensive than S.697, the TSCA reform legislation approved by the US Senate Committee on Environment & Public Works on April 28 (which is discussed in our prior blog post), the House discussion draft makes a number of significant changes to the existing TSCA law.
Regulatory Action on Chemicals
The discussion draft gives EPA greater ability to take regulatory action on chemicals by eliminating the current TSCA requirement that EPA must select the “least burdensome” option for action after the agency has determined that a chemical presents or will present an unreasonable risk of injury to health or the environment under its intended conditions of use.
The discussion draft provides that before restricting (or banning) a chemical substance EPA must conduct a “risk evaluation” to determine whether the substance presents an unreasonable risk of injury and must follow certain requirements for considering hazard and exposure data that are set out in the draft bill.
If EPA determines that a chemical substance presents an unreasonable risk based on the risk evaluation, EPA would be required to issue a proposed rule setting forth regulatory action on the substance within 90 days after the risk evaluation is published, with the final rule to be issued within 180 days.
Risk Evaluations for Chemicals
The discussion draft provides that EPA “shall” conduct a risk evaluation on a chemical substance if it determines that the substance may present an unreasonable risk because of potential hazard and a potential route of exposure under the substance’s intended conditions of use. EPA is authorized to conduct risk evaluations of its TSCA Work Plan chemicals without having to first make such a determination, however.
Additionally, the discussion draft requires EPA to conduct a risk evaluation if the manufacturer of the chemical substance requests that the Agency do so, although the manufacturer must pay the cost of the risk evaluation.
EPA would be required to complete a risk evaluation on any chemical within 3 years of its selection for evaluation. Risk evaluations conducted at the request of manufacturers would have to be completed within 180 days. However, if more information is needed, EPA may extend the deadline by up to 90 after receiving the information, or two years after initiating the risk evaluation, whichever is sooner.
The discussion draft bill expressly states that EPA shall not consider costs or other “non-risk” factors when determining whether a chemical substance presents an unreasonable risk (with certain limited exceptions), although costs are to be considered by EPA when taking regulatory action on a substance.
Preemption of State Chemical Regulations
The discussion draft would prohibit any state or political subdivision from regulating a chemical substance if EPA has determined that the chemical does not present an unreasonable risk of injury under its intended conditions of use. The prohibition would apply to both new and existing state chemical regulations. The bill does not preempt restrictions enacted pursuant to state laws pertaining to air and water quality and waste treatment and disposal. The bill also expressly does not preempt state tort and contract law and remedies.
The discussion draft requires EPA to publish a list of chemicals that are considered to be persistent, bio-accumulative, and toxic (PBTs) within nine months after enactment of the bill and, within two years after enactment, designate any such PBT as a “chemical of concern” for which EPA can take regulatory action, if the PBT chemical has a likely exposure to the general population or a vulnerable subpopulation and scores “high” for either persistence and bioaccumulation and “high” or “moderate” for persistence and bioaccumulation.
The discussion draft would make several other changes to the existing TSCA law, including giving EPA the authority to require testing by administrative order for the purposes of conducting the risk evaluations; allow EPA to share confidential business information (CBI) with State, local and tribal government officials and health care professionals under certain conditions; and require CBI claims to be designated, substantiated, and reasserted after ten years. The discussion draft also would require EPA to develop any procedures and guidance to carry out the bill within two years of its enactment and review that procedures and guidance materials every five years thereafter.
The discussion draft still must be formally approved as formal legislation by the entire E&C Committee before it will be considered by the full US House of Representatives. No timeline has been set yet for review by either the E&C Committee or the full House, however. Moreover, members of the Subcommittee already have indicated that the bill likely will be revised further when it is considered by the E&C Committee.