In 1976, U.S. President Gerald Ford signed the Toxic Substances Control Act, more commonly known as TSCA. The law was passed with the goal of keeping dangerous chemicals off the market and protecting the public from substances that could cause cancer, birth defects and reproductive hazards. While the law directed the Environmental Protection Agency (EPA) to develop procedures for evaluating new chemicals, existing chemicals were grandfathered without review.
The EPA believed that without changes to the existing law, they could not take actions to protect the public from the toxic effects of chemicals. On June 22, 2016, in a bipartisan effort, Congress passed the Frank Lautenberg Chemical Safety for the 21st Century Act (HR 2576, S697) – named after the late senator that worked to bring about the changes needed in the law. For the first time, manufacturing will have the regulatory framework in place to permit innovation within the global marketplace.
Changes in Chemical Evaluations
The revised TSCA makes several important changes in the way chemicals are evaluated. It requires the EPA to evaluate both new and existing chemicals and to publish their findings – under clear and enforceable deadlines. Chemical manufacturers and many other firms have to file pre-manufacture notices and significant new use notices for new chemicals. With the new Act, EPA must also evaluate existing chemicals. Since companies cannot begin the manufacture of these chemicals until they have been approved, it may cause protracted delays in operations.
Under the previous rules, EPA was directed to evaluate chemical safety with a consideration for how affordable the chemical was. However, under the new Act, the chemical assessment will have to be performed purely on the basis of the health risk to the public, including populations more susceptible to potential exposures. The EPA will have the ability to require additional health and safety testing as part of the review process and will allow a full range of control measures – including, but not limited to, labeling, use restrictions and, under certain conditions, phase-out of a chemical.
The new compromise bill resolved some key differences in the House and Senate versions. These differences included the degree of desired transparency in the regulation; whether new chemicals require EPA approval before entering the market; and defining the pathway for industry-requested reviews.
The new Act will make several significant changes. It provides a consistent source of funding to the EPA for conducting these assessments – enabling the EPA to collect up to 25 million dollars a year in user fees from chemical manufacturers. Since the assessments cannot be performed without funding, developing a funding pathway will likely be one of the EPA’s primary goals.
Under the Act, the EPA must update its inventory of existing chemicals and create a risk evaluation process within six months of promulgating rules. It also pre-empts state law from the initiation of risk activities, a major issue under the current rules that permitted states to bypass federal rules on chemical safety.
The EPA must review the pre-manufacture notice procedures, making changes where needed to address the deficiencies. It must also come up with a list of the first ten chemicals it will address in addition to continuing to work on risks of chemicals that were not completed before the new rules. These “priority” existing chemicals include trichloroethylene, methylene chloride and n-methyl pyrrolidone – widely used as cleaners and degreasers. Finding an alternative that is both safe and environmentally-friendly will be a challenge.
The rule will also require industry to report all chemicals manufactured, processed, used or stored in the previous ten years, in order for the EPA to be able to designate an active or inactive status for each chemical. This is likely to be a major task for industry.
In a separate action, mercury compounds (in addition to elemental mercury compounds) will now be banned from export. An inventory of all mercury supply, use and trade in the United States will be required initially and then updated every three years.
As this is an Act, the EPA is required to develop the enabling regulations. Under the current version, the EPA will have until the middle of December 2016 to publish the proposed rule and until mid-June 2017 to publish a final rule. The rules will allow for a certain period of time for the rulemaking process and public hearings – the exact schedule for which has yet to be determined.
This Act will have a profound impact on every company that handles chemicals and especially those that seek approval to manufacture new chemicals. Companies will be responsible for a portion of the cost for reviews undertaken by the EPA and for the entire cost of reviews requested by the industry, unless the EPA already lists that chemical. Industry will also have to develop added expertise in risk assessment for new chemicals, as well as peer and third-party reviews of EPA assessments.
HETI…Providing Regulatory Support and Guidance
HETI’s staff of engineers and industrial hygienists can provide guidance and valuable technical support on TSCA and its impact on business. We have extensive, in-depth experience to provide our clients with valuable professional services needed for assuring and maintaining compliance with the full spectrum of federal and state environmental regulations.