The United States Congress (Congress) is in the final stages of reforming the Toxic Substances Control Act (TSCA; Act; 15 U.S.C. §2601), which originated on October 11, 1976.
The TSCA Modernization Act of 2015 (Act) is a major legislation that imposes reporting, recordkeeping, testing, import/export, and safety evaluation of chemical substances and/or mixtures. Approximately 85,000 chemicals in US commerce are subject to TSCA regulations. Food, drugs, cosmetics, pesticides, and a limited number of other chemical classes are excluded from TSCA regulations, as they are regulated under different laws.
Although TSCA has been amended several times since 1976, Congress members thought that a major reform was necessary to modernize it by capturing the latest developments in risk assessment science and toxicology. The new Act has received overwhelming and uncharacteristic, bipartisan support within Congress and from non-governmental organizations. On June 23, 2015, the House version passed 398-1, and then the Senate version passed unanimously on December 17, 2015. Once the Bill is signed, the Act Administrator, the US Environmental Protection Agency (USEPA), has 2 years to develop any policies, procedures, and guidance related to the Act; however, certain components of the Act will be implemented immediately. For example, the USEPA has to develop a list of chemicals that may have persistent, bioaccumulative, and toxic properties (PBT). This list will be a target for subsequent quantitative human and ecological health risk assessments and, potentially, prohibitions, restrictions, and/or risk management actions. Moreover, Title I Sections 1 through 30 of the Senate Bill contains multiple changes, the most important of which are summarized below.
- Consideration of Sensitive Subpopulations. The reformed Act will introduce for the first time a risk assessment concept of a "potentially exposed subpopulation," which will be defined as a group of individuals with greater exposure potential or increased sensitivity to chemicals.
Impact: In its implementation and interpretation, the USEPA is likely not only to focus on children, but also on any economically-disadvantaged, ethnic, or otherwise sensitive groups, making the selection and evaluation of potentially exposed receptors more technically challenging to deal with. - Conducting Human and Ecological Risk Assessments. The reformed Act has new language specifying the need to conduct "risk evaluations" on health and the environment to ensure that there is no "unreasonable risk of injury."
Impact: The USEPA will be conducting quantitative risk assessments on human health and ecological receptors, and will make its results available to the public. The USEPA will have the power to request product safety testing, with the resulting data specifically supporting the risk assessment process. Risk assessments may be initiated by the USEPA based on the PBT priority, or requested by the manufacturer. The USEPA will have 3 years to complete the risk assessment, or 2 years if the manufacturer requested it. No fewer than ten risk assessments are to be initiated per annum. - Risk-Based Determination. The reformed Act indicates that the Administrator should make its determination based on the outcome of the risk assessment alone. Cost, societal impact, and other non-risk factors shall not weigh in on the "unreasonable risk" decision as they may undermine the fundamental scientific principles.
Impact: The USEPA will have a clear mandate to present the risk assessment results to the public as is. It will be up to risk managers to address the risk assessment outcomes and, perhaps, strive to achieve a zero risk level. The risk management stage can consider costs and other non-risk aspects. - Weight-of-Evidence Approach. The reformed Act for the first time introduces and defines a risk assessment concept of "weight of the scientific evidence for identified hazard and exposure." Specifically, it states, "consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur."
Impact: This explicit legislative language directs the USEPA to perform quantitative exposure assessments where doses are estimated for subsequent comparison to risk-based endpoints. Moreover, the weight-of-evidence paragraphs suggest a desire to employ multiple lines of evidence to ensure robust risk decisions. Quantitative exposure assessments of multiple lines of evidence require extensive data and are very complex, incurring additional effort and cost. - Data Disclosure. New disclosure requirements have been added to enhance access to chemical composition 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."
Impact: While disclosure of chemical information is important in emergency response and chemical safety evaluation, given the proprietary nature of many chemicals and formulations, the new requirement creates confidential business information (CBI) concerns. To counteract this concern, the reformed Act has an option for designating specific information as CBI and submitting it under a separate cover. This information will be protected for 10 years and may be extended as needed. - Scientific Standards. New language has been added to outline specific requirements for evaluating the scientific quality of studies and resulting data. Some of the scientific concepts invoked include relevance and applicability of "scientific and technical procedures, measures, methods, or models,...the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented,...the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized,...and the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models."
Impact: The higher scientific standards specified in the reformed Act place new demands on the competency and experience of toxicologists and risk assessors, both at the USEPA as well as within the industry.
How can GHD help?
The TSCA Modernization Act of 2015 is on its way to become law in 2016 and will significantly increase the legislative pressure and reliance on risk-based determination of new and existing chemicals. Experts predict that this milestone Act will have major impacts on the industry. Accordingly, the regulated community will need additional resources to implement the new chemical regulations.
For more information on the TSCA Modernization Act of 2015 or assistance with its implementation, contact:
Andrew Pawlisz | E: andrew.pawlisz@ghd.com| T: +1 972 679 7872
David Johnson | E: david.r.johnson@ghd.com | T: +1 972 331 5920