EPA Holds Webinar on New Chemical Risk Management Actions for Biofuels

April 07, 2022

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(Bergeson & Campbell) On April 6, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “New Chemical Risk Management Actions under TSCA.” 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 a 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.

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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.

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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. READ MORE

Cancer-causing gas emission spikes continue at refineries:The Environmental Integrity Project released data showing releases of benzene rose at many refineries, underscoring the continuing challenge to EPA in reining in emissions of a particularly dangerous pollutant. (E&E News)

GROUP WARNS OF REFINERY EMISSIONS: (Politico's Morning Energy)

Excerpt from Politico's Morning Energy: GROUP WARNS OF REFINERY EMISSIONS: A dozen U.S. oil refineries in 2021 emitted the carcinogen benzene at rates exceeding EPA's "action level" of 9 micrograms, according to a report from Environmental Integrity Project based on fenceline monitoring.

Refinery owners may have already acted to correct high emissions from last year, but EIP Executive Director Eric Schaeffer says that’s not enough. “EPA and the oil refining industry really need to do more to crack down … because the fenceline concentrations at too many refineries are high enough to pose a potential threat to neighborhoods that are close by.” READ MORE