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August 24, 2016
Proposed TSCA regs by the end of the year
By Timothy P Fagan, Senior Legal Editor - EHS

The Frank R. Lautenberg Chemical Safety for the 21st Century Act has brought about a long overdue reform of the Toxic Substances Control Act (TSCA). The Act was passed to address many of TSCA’s shortcomings and to allow the U.S. Environmental Protection Agency (EPA) more authority to evaluate and mitigate the risks associated with chemicals used in this country.

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At a time when many TSCA stakeholders are dedicating resources to complete the Chemical Data Report (CDR), the EPA is embarking on the regulatory development process to implement the provisions of the new Act. The agency recently held a series of public meetings to gain input from manufacturers, processors, and other stakeholders on how to craft regulations for three key areas addressed by the new legislation:

  • The collection of fees;
  • Procedures to prioritize existing chemicals for review; and
  • Procedure to conduct risk evaluations of high priority chemicals.

During these public meetings, the EPA confirmed the rulemaking timeline established in EPA’s First Year Implementation Plan, with proposed rules expected in December 2016 and final rules to be issued by June 2017.


At the public meetings, the EPA provided industry with information on the types of activities for which the EPA is authorized to collect fees and from whom under the new legislation. These activities include manufacturers and processors that:

  • Are required to submit test data;
  • Submit notification of or information related to the intent to manufacture a new chemical or new use of a chemical;
  • Manufacture or process a chemical that is subject to a risk evaluation; or
  • Request the EPA to conduct a risk evaluation on an existing chemical.

The fees collected may amount to the lower of either $25,000,000 or 25 percent of the costs of administering programs to oversee the aforementioned activities and the handling of confidential business information (CBI).

Prioritizing existing chemicals

Under the new legislation, the EPA is required to evaluate existing chemicals against risk-based safety standards and to eliminate risks identified as being unreasonable. This begins by the EPA developing a regulatory process to identify whether substances are high priority (i.e., they may present unreasonable risks and are subject to risk evaluation) or low priority (i.e., no action is required). Factors that this regulatory process will account for include:

  • Chemicals already on EPA’s TSCA work plan;
  • Persistence and bioaccumulation of a chemical;
  • Known human carcinogens;
  • Acute/chronic toxicity;
  • Exposure;
  • Storage near drinking water; and
  • Conditions of use and volume.

The prioritization process, from initiation to final designation, will take 9 months to 1 year and will include two public comment periods.

Risk evaluations

After the high priority chemicals have been identified, the risk evaluation process begins with the goal of identifying and eliminating unreasonable risks of injury to health or the environment. The EPA is developing a regulatory process by which all risk evaluations will be conducted. This process must account for:

  • The hazards and exposures for the conditions of use of a given chemical, meaning the circumstances under which a chemical is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed; and
  • The risks to susceptible and highly exposed subpopulations, including children and the elderly.

Each risk evaluation must be completed within 3 years from the time the chemical is designated as a high priority chemical. There is the possibility of a 6-month extension.

Looking ahead

The EPA is moving forward quickly to implement key aspects of the TSCA reform legislation. The agency has sought input from stakeholders and is operating on an aggressive schedule to finalize regulations by June of 2017. To meet this schedule, the agency is seeking to propose regulations by December of this year. This will be the next opportunity to provide comments and input on regulations that will shape chemical management in this country for years to come. So, be on the lookout for the proposed regulations as the end of the year approaches.

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