The Toxic Substances Control Act (“TSCA”), regulates the dissemination of existing and new chemicals. Its three goals have always been to: 1) “assess and regulate new commercial chemicals before their entrance into the market”; 2) “regulate chemicals which were already existing in 1976 that posed an unreasonable risk to health or to the environment”; and 3) regulate the distribution and use of these chemicals. It prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory of “existing” chemicals (or those subject to one of many exemptions). Producers must submit pre-manufacturing notification (“PMN’S”) to the EPA at least 90 days prior to creating or importing new chemicals for commercial purposes. The federal agency reviews the PMN’S and if it finds an “unreasonable risk to human health or the environment,” it may limit or ban production of the new substance.
When TSCA was passed in 1976, it “grandfathered in” some 60,000 substances that were already in use, making them exempt from review. The law makes it very difficult for the EPA to deem a substance “dangerous” and regulate it as such: in fact, of the 84,000 chemicals now registered for use in the United States, only 200 have been tested and the EPA has only banned five as “dangerous.” As a result of the federal government’s inaction in this area, individual states have banned certain chemicals, creating a regulatory quagmire in which manufacturers have to comply with different standards in different territories.
The law has faced considerable criticism and calls for reform from manufacturers and environmental advocates alike. In 2009, chemical producers called for the law to be “modernized” into a more centralized regulation…to avoid inconsistencies and ambiguities and to avoid the stifling of innovation and job creation. At the same time, environmental groups and state agencies have argued for tighter controls and labeling. In response to public concerns, manufacturers started to incorporate “screening mechanism(s) to diminish and/or prevent the marketing of products containing chemical substances that could potentially adversely affect human health and the environment.” Additionally, the demand for sustainable products has forced the market, to some degree, to adopt more green chemistry. Since 2003, 18 states have passed 71 laws regarding chemicals, and the state of California, in particular, implemented the Green Chemistry Initiative (“CGCI”) in an effort to increase innovation and reduce or eliminate hazardous substances to human health and the environment.
Clearly, technological advancement and invention of new chemicals is ahead of TSCA regulation in the United States. In 2013, two Senators proposed the Chemical Safety Improvement Act (“CSIA”), as TSCA’s first major bipartisan overhaul. The CSIA would have established a new safety standard of “no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance” under “intended conditions of use.” The standard was consistent with TSCA, balancing the potential risks and benefits. If it had passed, the new law would have required the EPA to: 1) use an evaluative framework for decision-making that employs the “best available science” and “science-based criteria;” 2) propose a screening process and selection criteria to identify substances as either “high” or “low” priority for safety assessment and determination; 3) conduct a safety assessment for each high priority substance; 4) determine whether the chemical meets the safety standard under intended conditions of use; 5) eliminate the long regulatory process to obtain information from companies regarding their chemicals; 6) grant the EPA additional flexibility to take action on unsafe chemicals; and 7) require the EPA to declare chemicals “likely to be safe” before they can come to market. The law has yet to be passed. And so the tragic story of TSCA continues.