The far-reaching reforms of the 2016 “Frank R. Lautenberg Chemical Safety for the 21st Century Act” will significantly impact the chemical industry. Primarily, it gives the U.S. Environmental Protection Agency (EPA) the power to determine how a chemical is made, processed, distributed, used and disposed of.
The Act expands the authority of the EPA to order testing of a new or existing chemical to determine its risk to public health. EPA will establish its process for conducting risk evaluation within a year of enactment of the new law. Among other factors, EPA must consider hazard and exposure potential, persistence and bioaccumulation, and storage near significant sources of drinking water.
Importantly, EPA must designate chemicals as high-priority if it concludes, without consideration of costs or other non-risk factors, that the substance may present an unreasonable risk because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA.
In regulating a chemical, the new law requires EPA to consider and publish a statement concerning various aspects, including: the effects and magnitude of exposure; the benefits of the chemical; the reasonably ascertainable economic consequences of the rule; the costs and benefits of the regulatory action, and of one or more primary alternative regulatory actions considered by EPA. EPA is required to consider these aspects in making its selection among the available risk management options, including whether technically and economically feasible alternatives will be available when the proposed action takes effect.
Although under previous law, a new chemical could be manufactured if EPA did not provide within 90 days a response to pre-manufacture notices or significant new use notices. Under the new Act, a chemical producer cannot proceed with manufacture without EPA’s formal determination.
The new law requires EPA to have an annual plan for risk evaluations, which will identify the chemicals expected to be assessed that year. This may have an impact on the use of listed chemicals even before the assessment begins.
There are new Confidential Business Information sections of the Act concerning information not protected from disclosure. A critical aspect in this regard is information from health and safety studies. While the Act does not prohibit the disclosure of such information on chemicals offered for commercial distribution or for which testing or notification is required, it takes care to state that it does not authorize the disclosure of any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture or in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.
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