The United States (US) Congress and Senate recently took a major step to reform the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601 of 1976. After the successful Senate vote on December 17, 2015, the reconciled version of the Senate bill passed the House with Amendments on May 24, 2016, and then the Senate on June 7, 2016. It is expected to be signed by President Barack Obama within days. The current version of the bill can be found online at https://www.congress.gov/bill/114th-congress/house-bill/2576/text.
The TSCA Modernization Act (Act) is a major legislation that imposes reporting, recordkeeping, testing, import/export, and safety evaluation of chemical substances and/or mixtures. Title I Sections 1 through 20 of the amended bill contain multiple redactions on various fundamental issues, ranging from conducting risk-based assessments on toxic chemicals to securing funding for the US Environmental Protection Agency (USEPA) to administer the new law. Some of the more notable aspects of the final version include the following:
- Establishment of risk-based process. The bill, by rule, requires "the establishment of a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The process to designate the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed."
- Consideration of sensitive subpopulations. The reformed Act introduces and defines for the first time a risk assessment concept of "potentially exposed subpopulation," which is defined as "a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly."
- Development of new information. USEPA will "...require the development of new information for the purposes of prioritizing a chemical substance under section 6 (b) only if is necessary to establish the priority of the substance..." This information may be developed by the manufacturer or processor of a chemical substance under review.
- Reduced animal testing. Testing on animals, especially on vertebrates, will be reduced and/or eliminated in favor of development and implementation of alternate test methods, such as computational toxicology, bioinformatics, high-throughput screening, in-vitro testing, systems biology, and other approaches recognized by national and international agencies.
- Tiered testing. When requiring the development of new information, USEPA will employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are needed.
- Formation of industry consortia. The bill specifies the option of forming industry consortia to jointly conduct testing to avoid unnecessary duplication of effort, provided that the test results are made available to USEPA.
- No consideration of costs in risk determination. USEPA, in making the chemical risk determination whether the significant new use presents an unreasonable/risk of injury to health or the environment, shall not take into consideration financial costs, societal, or other non-risk factors.
- Consultation with the Occupational Safety and Health Administration (OSHA). When worker exposure is of concern, USEPA will consult with OSHA prior to adopting any prohibition or other restriction relating to a chemical substance.
- Number of risk assessments per year. Initially, USEPA will initiate risk assessment for 10 chemical substances per year, drawn from the 2014 TSCA Work Plan for Chemical Assessments, gradually increasing (over 3.5 years) to 20 per year on high-priority substances. USEPA will have up to 3 years to complete each risk assessment.
- Risk assessment requests. A manufacturer may request that a particular substance undergo a risk assessment by USEPA, with priority given to substances for which the restrictions imposed by one or more states have the potential to have a significant impact on interstate commerce or health or the environment.
- Data disclosure. New disclosure requirements have been added to enhance access to chemical information by officials, scientists, federal/state emergency responders, and health practitioners. Moreover, the reformed Act specifically names the requirement for disclosure of "formulas, including molecular structures." However, confidentiality can be claimed and maintained for certain chemicals for up to 10 years, with the option to renew.
- Non-compliance penalties. Monetary fines for noncompliance have been increased; some were raised to a high of $1 million per organization, plus criminal penalties of up to $250,000 per individual and/or imprisonment for up to 15 years, should there be instances of imminent danger of death or serious bodily injury.
- State pre-emption. Under the new bill, the states have largely been preempted from developing their own TSCA-like risk assessments and legislation independent of the bill.
- Science advisory committee on chemicals. The bill indicates that USEPA shall establish a Science Advisory Committee on Chemicals, composed of representatives from science, government, labor, public health, public interest, animal protection, industry, and other groups relevant to determining chemical safety.
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In summary, the nearly 200-page reformed TSCA bill contains a number of new requirements that while improving the understanding of risks and chemical safety in the United States, will undoubtedly add to the compliance burden on the regulated community.
For more information, please contact Andrew Pawlisz | E: andrew.pawlisz@ghd.com | T: +1 972 679 7872.