ACA Submits Comments to EPA on New Chemicals Review Program under Amended TSCA
Last month, ACA submitted comments to the U.S. Environmental Protection Agency (EPA) on the agency’s New Chemicals Review Program under the amended Toxic Substances Control Act (TSCA). The updated federal law mandates that EPA evaluate new chemicals prior to commercialization for any unreasonable risks to public health and the environment.
Since January 2017, EPA has released multiple proposed regulations that will impact how EPA evaluates chemicals used in the coatings industry. ACA has remained engaged in the rulemaking process, submitting multiple sets of comments and participating in public meetings with EPA.
The amended TSCA requires EPA to make one of several determinations regarding whether a new chemical presents unreasonable risk of injury to health or the environment, and/or whether there is enough information to make said determination. ACA submitted comments to EPA to help ensure efficient, thorough, and reasonable review of chemicals under Section 5.
With changes implemented by the Lautenberg Act, EPA not only evaluates uses identified by the PMN submitter, but also those “reasonably foreseen” uses EPA identifies. In its comments, ACA asked EPA to clearly define “reasonably foreseen” uses. ACA urged the agency to develop a set of guidelines or protocol for the agency to evaluate reasonably foreseeable uses, thereby bringing transparency to the entire process. ACA noted that several member companies have submitted pre-manufacture notices (PMNs) to EPA for new chemicals that are only to be used in very specific uses (i.e., specific industrial processes, or not for commercial or consumer use). Additional uses, as well as legacy uses, should not be considered when evaluating the PMN. “A set of clearly defined guidelines would help ensure that the EPA is focusing its resources on evaluating the uses specified in the PMN, as submitted by those who are most familiar with the chemical,” ACA stated. ACA also noted that however EPA chooses to regulate new chemicals — be it through Significant New Use Reviews (SNURs) or 5(e) consent orders — the agency may require testing for any uses that have not been authorized. If a use of a chemical that was not “reasonably foreseen” arises, EPA has the authority and jurisdiction to require testing to determine what specific hazards would be associated with the new use.
ACA also recommended that EPA’s 90-day review period should start when the agency receives a completed PMN submission and end with a non-consent order SNUR, unless the agency is able to come to an agreement with the submitter regarding an extension. “EPA should be able to make a determination fairly early in the review process as to whether or not they believe the details listed in the PMN will result in a non-consent order SNUR or a consent order. We urge the Agency to expedite the process as much as possible, so that manufacturing is able to commence.”
Recognizing that the PMN review process is complex, requiring coordination between the submitter, the program manager, the toxicologists, engineers and a variety of other related departments, ACA underscored to EPA the need for a more transparent and open exchange of pertinent documents and assessments back to the submitters. ACA believes this would streamline the process, and ensure that all issues are acknowledged in a timely manner.
ACA also urged EPA to use the best available science and data when conducting PMN assessments. This might require using data from chemicals management programs around the world (Canada, REACH, and others), provided they meet certain standards. “We understand that EPA currently has non-disclosure agreements (NDA) with certain other chemicals management programs, to improve efficiency in processing new chemicals review.” ACA strongly encouraged EPA to develop as many of these NDAs as possible, so that there is a constant exchange of the best available science around the world. ACA
believes that ‘best available science’ means prioritizing the use of actual studies with legitimate results, and strongly discouraged EPA from relying too heavily on models that use default assumptions. Regarding workplace exposure data specifically, ACA recommended that EPA work with submitters due to their extensive knowledge of their own processes.
Concerned about EPA’s chemical categorization process, ACA stated it believes testing should be streamlined and standardized by category, noting that the current level of required and suggested tier testing is not necessary for every chemical category. Instead, ACA encouraged EPA to follow the testing format that is used by Schedule 10 in Canada, where the tests are established in advance but the conditions can be modified for specific chemical categories. This would streamline the process, so that there are no potential or unforeseen complications purely based on whether or not a reviewer agrees with what has already been done.