On March 20, 2019, the EPA announced the first group of proposed 20 “high priority” and 20 “low priority” chemicals for prioritization for risk assessment under the Toxic Substances Control Act (TSCA) as amended in 2016. EPA is required, under the 2016 TSCA amendments, to designate 20 chemicals in each category by the end of 2019. Under TSCA Section 2605(b)(1)(B), “high priority” refers to a chemical that the EPA determines, “without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use,” including an unreasonable risk to susceptible populations like workers. The EPA designates a chemical as low priority when this condition is not satisfied.
The EPA’s 20 “high priority” chemicals includes several categories of substances that have similar functions and compositions. For example, a number of phthalate chemicals, used as plasticizers and in other applications, are identified on the high-priority list. The EPA compiled its list from the TSCA 2014 Updated Work Plan and from chemicals it had already spent time analyzing. The 2014 Updated Work Plan designates these 20 chemicals as presenting a high hazard and exposure potential. Meanwhile, the list of low-priority chemicals were derived from the EPA’s Safer Chemical Ingredients List. For example, dipropylene glycol, used in many consumer products including cosmetics, is on the low-priority list. Still, identification of “low priority” candidates does necessarily mean that these chemicals present zero risk; it means that a formal risk evaluation is not warranted at this time.
Since there were no additional chemicals proposed for designation, it is likely that each of these chemicals will be allotted the designation for which it has been proposed by the EPA. Inclusion on the list indicates that the EPA believes that sufficient information exists to designate the chemical on the list as high or low priority. However, the designation of the chemical simply precedes a formal evaluation process. As such, the formal designation of chemicals does not represent a definitive determination by the agency regarding the safety of the chemical or the use of that chemical in any particular application.
The next step is for the EPA to review these chemicals along with public comments received, and make a decision regarding prioritization in the next nine months, as required by TSCA. The EPA will use this period to evaluate the toxicity and exposure levels for the designated chemicals. The EPA will also assess how the chemical is manufactured, used, and distributed.
The publication of this list is bound to have an immediate impact on companies that manufacture these chemicals and products containing them. Companies may submit intital comments until June 19, 2019, on the proposed designations.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].