National Center for Health Research: August 16, 2018
National Center for Health Research’s Public Comment on Problem Formulations for Risk Evaluations to be Conducted under Toxic Substances Control Act
The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health. We do not accept funding from companies that make products that are the subject of our work.
We strongly support efforts of the Environmental Protection Agency (EPA) to improve chemical review, as required by the 2016 Frank H. Lautenberg Chemical Safety for the 21st Century Act. These first 10 chemical evaluations will set a precedent for future evaluations under this law. Therefore, it is imperative that the EPA adequately and appropriately evaluate these chemicals using sufficient, high quality information on harms, exposure, and conditions of use to evaluate the risks these chemicals pose to health. We oppose the EPA’s proposed “problem formulations” because they would not adequately evaluate exposure, harm or risk. They would exclude many of the uses, exposures, and hazards that would have been included in the risk evaluations that were planned as part of the scoping documents.
Risk evaluations should consider the lifecycle of the chemical, including its manufacture, use, and disposal. If the EPA allows the evaluation to ignore certain aspects of the lifecycle, it will miss exposures and harms caused by the chemical. This includes legacy uses or recently discontinued uses as these uses provide ongoing exposures. For example, asbestos is no longer sold for insulation, but it is still present in buildings throughout the U.S. Current and future maintenance and construction on these buildings will continue to expose people to asbestos for decades.
Risk evaluations should also include all environmental exposure pathways, even those that could be controlled under other EPA-administered environmental statutes. A complete risk evaluation of a chemical needs to include all sources of exposure, but excluding environmental exposures means that many sources of exposure could be missed. Air, drinking water, surface and ground water, and soil are common sources of exposure. If risk evaluations do not account for exposure from these pathways, then they cannot adequately evaluate the potential for harm.
Individuals can come into contact with a chemical from multiple uses, pathways of exposure, and aspects of its lifecycle. Therefore, a comprehensive evaluation must include an aggregation of exposures and risks. Evaluation of a chemical’s risks in isolation is insufficient to determine actual exposure and the likelihood of harm.
Although these chemicals have been on the U.S. market for years or decades, there is still information about risks and exposures that remain unknown. To make an accurate and complete risk evaluation, these gaps in knowledge need to be identified, and EPA should require the collection of needed data. A lack of studies or information about health effects does not mean that there are no health risks. In fact, one of the goals of the 2016 legislation was to ensure that chemicals already on the market are tested to make sure they do not present unreasonable risks of injury to health.
EPA should not assume that some uses, such as solvents for cleaning/degreasing, adhesives/sealants, or paints/coatings only present a minimal or insignificant risk and do not need further evaluation. Many chemicals can cause harm at small exposures. In addition, while the exposure from a single use of a product may be small, exposures from many uses or many products could be much higher. This is especially true for workers who use a product daily or for children and fetuses who may be more sensitive to a small amount of a chemical.
The EPA must continue to improve efforts to thoroughly evaluate chemicals and oppose unnecessary and inappropriate attempts to weaken those evaluations. It is clear that chemicals are harming the health of children and adults in America; reducing those risks must take precedence, as the law mandates.
The Frank H. Lautenberg Chemical Safety for the 21st Century Act was designed to protect workers, consumers who use chemicals, and people who live where chemicals are released into the environment. It represented a bipartisan compromise, with different Members of Congress coming together. Since that time, the EPA leadership has reneged on the important progress regarding the evaluation of the safety of chemicals that the bill was intended to achieve. This is clearly in opposition to the intent of Congress. Whether the EPA is evaluating new or old chemicals, these evaluations must be comprehensive and the data for the evaluations must be scientifically sound. Thorough systematic and comprehensive evaluations of chemicals by the EPA can reduce the risks of chemicals on the U.S. market, saving lives and improving the health of people who live and work in the United States.
Thank you for the opportunity to comment on the problem formulations for the first 10 chemicals.
The National Center for Health Research can be reached through Stephanie Fox-Rawlings, PhD at sfr@center4research.org or at (202) 223-4000.