What is New in the Chemical Safety Law?
Many of us working in the clinical trial and global public health arenas are familiar with the stringent United States (U.S.) and international drug safety laws and regulations ensure patient safety. But we might not often think about chemicals people are exposed to everyday that are not covered under those laws and regulations because they are not drugs, cosmetics, or food. In the past, these industrial chemicals, found in everything from fragrances to tires, have been regulated much less rigorously. However, a recent regulatory update for industrial chemicals aims to change that by increasing the review of these chemicals to ensure their impact on health is understood in a timely manner.
In the U.S., regulations for the safety testing of chemical substances and mixtures are delineated in the Toxic Substances Control Act (TSCA), which was passed in 1976 to help keep dangerous industrial chemicals off the market. Despite good intentions, in the 40 years since the law was passed, only a handful of the chemicals on the market were reviewed to assess their impact on health, and over 80,000 commercial chemicals never evaluated for safety.1-4 In fact, only five chemicals (polychlorinated biphenyls, fully halogenated chlorofluoroalkanes, dioxin, asbestos, and hexavalent chromium) and nitrites mixed with one of four chemicals (mixed mono and diamides of an organic acid, triethanolamine salts of a substituted organic acid, triethanolanime salt of tricarboxylic acid, and tricarboxylic acid) have been banned.3
To address this regulatory problem and reform the TSCA, President Obama signed a bipartisan bill to, the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016. Key features of the new TSCA regulations are: 1
There are some significant changes to the initial TSCA regulations. For example, TSCA initially included a “Grandfather” clause — chemicals already in existence as of 1976 were considered in compliance, without any requirement to review them for safety 1. Under the new law, EPA must prioritize and evaluate chemicals on a specific schedule. In the future, EPA’s Chemicals Program will have to assess as many as 20 chemicals concurrently. Another change is that the EPA will now evaluate a chemical’s safety purely based on the health risks it poses — including the risk to vulnerable groups like children and the elderly, and workers who use chemicals daily. This is a significant update to the initial law which often prevented regulators from taking action to protect public health and the environment — even when a chemical posed a known health threat —because the initial TSCA also considered economic cost of the ban. To facilitate the required updates, the EPA will be able to collect up to $25 million a year in user fees from chemical manufacturers and processers, supplemented by Congressional budgeting 1.
Since June 22, 2016, EPA has already taken swift action to reduce exposure to five persistent, bioaccumulative, and toxic (PBT) chemicals 2 and will bypass a full risk evaluation for them. The five PBT chemicals undergoing expedited review are: the flame retardants decabromodiphenyl ethers and tris(4-isopropylphenyl) phosphate; hexachlorobutadiene, which is found in rubber and lubricants and used as a solvent; pentachlorothio-phenol, a chemical that softens rubber; and 2,4,6-tris(tert-butyl)phenol, a fuel or lubricant additive. Two other PBT chemicals used in fragrances (ethanone, 1-[1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl] and ethanone, 1-[1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl]) were not expedited and will receive full risk evaluations 2. EPA also selected the first 10 existing chemicals that will be subject to risk evaluation under the new TSCA: 1,4-dioxane, 1-bromopropane, asbestos, carbon tetrachloride, cyclic aliphatic bromide cluster, methylene chloride, n-methylpyrrolidone, pigment violet 29, tetrachloroethylene, and trichloroethylene 5. EPA has 3 years to conduct its last 10 risk evaluations, with a possible 6 month extension.
Even before the new law was implemented, the National Library of Medicine (NLM) was promoting transparency of information regarding industrial chemicals to the public. TRI has been proud to support this work for the past 14 years by developing the Hazardous Substances Data Bank (HSDB) for NLM. Multiple sources of information are consulted by the company to complete this task, including government health and safety data. However, for many of the industrial chemicals, public health and safety data are extremely limited, or not available at all. The public transparency required by the new TSCA law will help to remove this information gap in the future.
Footnotes
About the Authors
Christiane Voss, Ph.D., is a Medical Writer responsible for updating the HSDB for the NLM. She has conducted extensive research in organelle structure and lipid transport in Saccharomyces cerevisiae at the National Institutes of Health; autophagy in Plasmodium species at the Johns Hopkins Bloomberg School of Public Health; and on Saccharomyces cerevisiae at the University of Stuttgart.
Andrei Komarov, M.D., Ph.D., DABT, is certified in general toxicology by the American Board of Toxicology. Dr. Komarov is Manager, Health and Environmental Assessment responsible for leading the HSDB contract at TRI.He has previously studied the role of free radicals and nitric oxide in cardiovascular health at the George Washington University School of Medicine.
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