Page 14 - ILMA Compoundings - September 2021

INDUSTRY RUNDOWN International Insight

New Chemical Approvals Post-Lautenberg

By James Eggenschwiler
Since the beginning of this year, the U.S. Environmental rule (SNUR), which will control the commercialization and
Protection Agency (EPA) has initiated extraordinary use of the new chemical substance throughout the supply
changes in its approach to reviewing and approving chain in the U.S.
new chemical substances. With a reorganization ini- This policy change, as it has been termed by the EPA
tiative that began in the fall of 2020, the agency began review staff, carries implications too numerous to include
a reinvention of its internal processes and priorities here. Nevertheless, immediate commercial impact alone
concerning its assessment of risk and its self-perceived is troublesome. Consider that, regardless of the risk pro-
mandate to strictly control downstream use of new file indicated by the data, the EPA intends to ignore its
chemicals in the supply chain. The result, so far, has statutory mandate to identify any chemicals by Lautenberg’s
been a systematic expansion of data requirements and first criteria — not likely to present an unreasonable risk
the imposition of downstream controls that had been of harm. The agency’s policy is that no such new chemical
reserved for the exceptions. PMN can exist. This means for each PMN, the submitter
must sign a consent order as an essential first step for the
NEW CHEMICAL SUBSTANCE PMNS EPA to authorize commercialization of the new chemical.
As many can recall, prior to the Frank R. Lautenberg With that, each distributor and end user of the new chem-
Chemical Safety for the 21st Century Act being signed into ical must sign an identical consent order applicable to the
law in 2016, the EPA had 90 days to review a new chemical period that precedes the issuance and Toxic Substances Con-
substance pre-manufacturing notice (PMN) and identify trol Act (TSCA) listing of the ultimate SNUR. By the EPA
risks of mammalian or environmental harm. On day 91, the staff’s best estimate, the TSCA listing and publication of the
PMN became automatically approved by the EPA unless the SNUR will typically require a year following the signing of
agency identified specific risks that justified restrictive mea- the consent order. Once the new substance is TSCA-listed,
sures concerning the use of the chemical substance. Many with the SNUR appropriately identified in the listing, the
affectionately referred to this as the “pocket approval.” consent order requirement ceases for all involved.
When Congress passed the Lautenberg Act, the review
process for new chemical substances changed in several NEW CHEMICAL SUBSTANCE LVES
ways. Perhaps the most dramatic change required the EPA to A second expression of the EPA’s new self-perceived man-
officially determine for new chemical substances that (1) the date to strictly control downstream use of new chemicals
substance is not likely to present an unreasonable risk of harm, has also surfaced recently with regard to its policies con-
(2) the substance presents a likely risk of harm that requires cerning per- and polyfluoroalkyl substances (PFAS). Within
the EPA to impose restrictive measures (this combines two the PFAS topic there are numerous illustrations of policy
of the options presented in Lautenberg), or (3) the EPA lacks overreach that will be reserved for future comment. But par-
sufficient data to make a determination, in which case the ticularly noteworthy here is the EPA’s approach to existing
agency rejects the PMN application altogether. low-volume exemptions (LVEs) for PFAS substances.
In January, the EPA quietly communicated to PMN In July, the EPA issued a policy statement that identified
applicants that review staff will no longer issue a risk deter- the agency’s perspective that LVEs are an inappropriate
mination that the PMN substance is not likely to present an method for gaining EPA approval for new PFAS chemicals
unreasonable risk of harm. With this, the agency added that under TSCA. This policy statement referenced the brief
all new chemical PMN application approvals will require (30 days) review period authorized by Lautenberg for
the applicant to agree to and abide by a consent order until LVE review. The policy statement went on to call for the
the agency publishes a corresponding significant new use voluntary withdrawal of more than 600 authorized LVEs,

12 SEPTEMBER 2021 | COMPOUNDINGS | ILMA.ORG