EPA Finalizes Process for Reviewing New Chemicals
EPA has finalized a rule that changes the way the agency reviews new chemicals. The rule’s requirements concern agency practices related to granting exemptions, determinations of safety, and procedural issues.
The rule makes per- and polyfluoroalkyl substances (PFAS) ineligible for exemptions from the full review process. EPA can grant such exemptions for chemicals that are manufactured in low quantities or that have low environmental releases or little human exposure. Some PFAS have received these exemptions in the past. The new rule eliminates this possibility.
Additionally, exemptions will no longer be granted for certain persistent, bioaccumulative, or toxic (PBT) chemicals. These compounds are highly toxic, resistant to degradation, and move easily through the environment. “EPA expects that most exemptions for PBT chemical substances will not be granted,” according to the text of the rule. “However, EPA agrees that there are instances where PBT chemical substances can be managed under an exemption.”
Once the rule goes into effect, EPA will be required to make formal determinations of safety for every new chemical that manufacturers submit to the agency for approval. Previously, EPA made such determinations for only about 20 percent of new chemical submissions. These submissions come to the agency in the form of premanufacture notices (PMNs), significant new use notices (SNUNs), and—for microorganisms with commercial applications—microbial commercial activity notices (MCANs). Under the rule, EPA must make one of five safety determinations for each of these notices before a new chemical can be manufactured or processed. The possible determinations include that a substance presents, may present, or does not present an unreasonable risk or injury to health or the environment. EPA’s other options are to determine that insufficient information is available to evaluate the effects of the substance, or that its production quantities are large enough to anticipate that substantial amounts will enter the environment or result in substantial human exposure.
Among other procedural changes, the rule addresses the agency’s longstanding practice of allowing entities to submit information about a substance after EPA begins its review. Previously, late submissions did not alter EPA’s review timeframe. The new rule continues to allow late submissions, but it states that the review will restart unless the entity demonstrates that the information “was not known to or reasonably ascertainable by the submitter at the time of the initial notice submission.”
The rule goes into effect 30 days after its publication in the Federal Register. A pre-publication copy of the rule (PDF) is available from the EPA website. For more information, refer to the agency’s news release.