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On April 6, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “New Chemical Risk Management Actions under TSCA.” The slides include an embedded voiceover recording of the webinar. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process.
Jim Alwood, EPA, reviewed the five determinations that EPA makes and the risk management options for each:
- Presents an unreasonable risk of injury to health or the environment: EPA must issue an order under TSCA Section 5(f) or a rule under TSCA Section 6(a) to restrict or prohibit the chemical substance;
- Insufficient information to permit a reasoned evaluation and may present an unreasonable risk: Once EPA makes this determination, it is required to take action to prevent identified risks. EPA will issue a TSCA Section 5(e) order, typically a consent order. According to Alwood, EPA usually allows commercialization with restrictions. If testing is required, it is generally due at a specified point after commercialization, but if the risks cannot be controlled, then testing might be required before commercialization. Alwood stated that he does not think EPA will be requiring testing for biofuels because those are well characterized.
- Produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities or there may be significant or substantial human exposure: EPA has the same sort of risk management options (issuing a TSCA Section 5(e) order, typically a consent order; allowing commercialization with restrictions; and testing, if required, generally due at a specified point after commercialization).
- Information is insufficient to permit a reasoned evaluation of the risk: Alwood noted that this is a new determination under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alwood stated that he does not expect EPA to make this determination for many biofuels. EPA is required to take action pending the development of information and typically does so through a TSCA Section 5(e) consent order. According to Alwood, testing is generally required before commercialization.
- Not likely to present an unreasonable risk: According to Alwood, EPA will probably not make this determination often for biofuels because most biofuels have known risks. Commercialization can begin immediately after the determination is made.
Alwood reviewed significant new use rules (SNUR), which identify a potential new use of a chemical as a “significant new use.” If a chemical is the subject of a SNUR, anyone intending to manufacture, import, and/or process the chemical for a significant new use must notify EPA at least 90 days before commencing that new use by submitting a significant new use notice (SNUN). EPA must review the SNUN and make one of the five determinations described above. Alwood stressed that a SNUR is not a ban or restriction on the use of a chemical, but acknowledged that it may not feel that way and may seem like a restriction. EPA uses SNURs to examine new uses where the uses may create concerns by changing the exposure of people or the environment to those chemicals.
Alwood stated that EPA does not need to make a risk determination to issue a SNUR; it just has to determine that the use in the PMN can change. TSCA requires EPA to consider:
- The projected volume of manufacturing and processing of a chemical substance;
- The extent to which a use changes the type and/or form of exposure of humans and/or the environment to a chemical substance;
- The extent to which a use changes the magnitude and duration of exposure of humans and/or the environment to a chemical substance; and
- The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
Alwood stated that TSCA consent orders apply only to the PMN submitter, and a SNUR extends the restrictions in the consent order to other manufacturers, importers, and processors to ensure a level playing field. Under the Lautenberg Act, EPA must consider promulgating a SNUR after it issues a TSCA Section 5(e) consent order. If EPA does not issue a SNUR, it must explain why it has not. EPA will include the consent order exemptions and exclusions in the SNUR. According to Alwood, EPA receives only ten to 15 SNURs a year, not many.
Alwood noted that since his February 23, 2022, presentation, EPA has issued a few consent orders for biofuels. EPA made a “may present an unreasonable risk” determination and will issue a SNUR. Examples of typical consent order conditions include:
- Use only as a fuel or other use identified in the PMN;
- If there is potential exposure to BTEX chemicals (benzene, toluene, ethylbenzene, and xylene), then the consent order will reference following the Occupational Safety and Health Administration (OSHA) requirements for monitoring and meeting those exposure limits;
- The consent order will also reference complying with other applicable EPA and OSHA regulations for handling, storing, and disposal of gasoline and/or petroleum products; and
- If the biofuel is imported, the consent order will limit use to import as a fuel.
Alwood noted that for most biofuel consent orders, EPA will have dermal protection requirements.
During the question and answer session, Alwood stated that EPA has finished the review process for two biofuel PMNs, and there are more in the pipeline. If the TSCA hotline cannot answer a question concerning a PMN, it will refer the caller to the New Chemicals Program. When asked how someone beside the PMN submitter will know what uses EPA has evaluated, Alwood responded that if the PMN submitter has not claimed the use as confidential, it will include it in the Federal Register notice. According to Alwood, EPA tries to do its best to make sure the requirements that everyone has to follow are not confidential. Alwood received a question asking how processors know what requirements apply to them when using the chemical as intended. Alwood stated that there is language in consent orders requiring the PMN submitter to inform customers about the requirements in the consent order. SNUR regulations require companies to tell customers about the existence of a SNUR. Alwood noted that while there is a biofuels review team, stakeholders may have heard that EPA is having trouble meeting the 90-day review period for PMNs for any chemical substance. EPA determines which uses of a chemical are foreseeable through literature searches, patent searches, and searching its PMN database for similar PMNs that it has reviewed. Although there is no timeframe in which EPA must issue a SNUR after signing a TSCA Section 5(e) consent order, Alwood commented that it is in EPA’s interest to issue the SNUR as quickly as possible. Under the Lautenberg Act, EPA does not consider the replacement benefits of a PMN substance, and instead evaluates a new chemical substance, including a biofuel, only on its conditions of use. According to Alwood, EPA can consider replacement benefits at the risk management stage.
Commentary
EPA is to be commended for presenting a well-organized and useful webinar. EPA is also to be commended for creating an innovative program designed to streamline the review of new biobased or waste-derived chemicals that could displace current, higher GHG-emitting transportation fuels. Stakeholders in the biofuels space are urged to avail themselves of EPA’s outreach and training efforts.