EPA Webinar on TSCA Chemicals and Biofuels Risk Management


On April 6, 2022, the U.S. Environmental Protection Agency (EPA) hosted a webinar on “New Chemical Risk Management Actions Under TSCA.” As noted in our January 24, 2022 blog post, in January 2022, the EPA announced an effort to streamline the review of new bio-based or waste-derived chemicals that could replace current, more gas-emitting transportation fuels. greenhouse effect (GHG). The EPA states that to support this effort, it offers outreach and training activities to stakeholders interested in biofuels. According to the EPA, the webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining simplified approaches to risk assessment and risk management measures, and providing information on how to navigate the New Chemicals Prefabrication Notice (PMN) process.

Jim Alwood, EPA, reviewed the five decisions made by the EPA and the risk management options for each:

  • Poses an unreasonable risk of harm 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;

  • Insufficient information to allow a reasoned assessment and may present an unreasonable risk: once the EPA has made this decision, it is required to take measures to prevent the identified risks. The EPA will issue a TSCA Section 5(e) order, usually a consent order. According to Alwood, the EPA generally allows marketing with restrictions. If testing is required, it is usually due at a specific time after market, but if the risks cannot be controlled, testing may be required before market. Alwood said he doesn’t think the EPA will require testing for biofuels because they are well characterized.

  • Produced in substantial quantities and can reasonably be expected to enter the environment in substantial quantities or there may be significant or substantial human exposure: EPA has the same type of risks (issuance of a TSCA Section 5(e) order, usually a consent order; marketing authorization with restrictions; and testing, if required, usually due at a specific post-market time).

  • Information is insufficient to allow a reasoned assessment of risk: Alwood noted that this is a redetermination under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alwood said he doesn’t expect the EPA to make that decision for many biofuels. The EPA is required to take action pending the development of the information and typically does so through a consent order under TSCA Section 5(e). According to Alwood, testing is usually required before marketing.

  • Unlikely to pose an unreasonable risk: According to Alwood, the EPA probably won’t make this decision often for biofuels, because most biofuels have known risks. Marketing can begin immediately after determination.

Alwood reviewed the Significant New Use Rules (SNURs), which identify a potential new use of a chemical as a “significant new use”. If a chemical is subject to a SNUR, anyone intending to manufacture, import, and/or process the chemical for a significant new use must notify EPA at least 90 days prior to begin this new use by submitting a Significant New Use Notice (SNUN). EPA must review the SNUN and make one of the five decisions described above. Alwood emphasized that a SNUR is not a ban or restriction on the use of a chemical, but acknowledged that it may not look that way and may appear to be a restriction. The EPA uses SNURs to review new uses where the uses may create concerns by changing human or environmental exposure to these chemicals.

Alwood said the EPA does not need to determine risk to issue a SNUR; it only has to determine if the use in the PMN can change. TSCA requires the 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 human and/or environmental exposure to a chemical; and

  • The reasonably anticipated manner and methods of manufacture, processing, commercial distribution and disposal of a chemical substance.

Alwood said TSCA consent orders only apply to the PMN bidder, and a SNUR extends the consent order restrictions to other manufacturers, importers and processors to ensure a level playing field. Under the Lautenberg Act, the EPA must consider issuing a SNUR after issuing a consent order under TSCA Section 5(e). If the EPA does not issue a SNUR, it must explain why it did not. EPA will include consent order exemptions and exclusions in the SNUR. According to Alwood, the EPA only receives ten to fifteen SNURs a year, not many.

Alwood noted that since its February 23, 2022 presentation, the EPA has issued a few consent orders for biofuels. The EPA has issued a “may present an unreasonable risk” ruling and will issue a SNUR. The following are examples of typical terms of a consent order:

  • 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), the consent order will reference Occupational Safety and Health Administration (OSHA) requirements to monitor and meet these exposure limits. exposure ;

  • The consent order will also refer to compliance with other applicable EPA and OSHA regulations for handling, storage, and disposal of gasoline and/or petroleum products; and

  • If the biofuel is imported, the consent order will limit its use for import as fuel.

Alwood noted that for most biofuel consent orders, the EPA will have skin protection requirements.

During the question and answer session, Alwood said the EPA has completed the review process for two biofuel NMPs, and there are more in the pipeline. If the TSCA Hotline cannot answer a question regarding a PMN, it will direct the caller to the New Chemicals Program. When asked how anyone next to the PMN proponent will know what uses the EPA has assessed, Alwood replied that if the PMN proponent has not claimed the use as confidential, they will include it in the Federal Register notice. According to Alwood, the EPA tries to do its best to ensure that the requirements everyone must follow are not confidential. Alwood received a question asking how processors know what requirements apply to them when using the chemical as intended. Alwood said there is language in consent orders requiring the PMN issuer to inform customers of the requirements of the consent order. SNUR regulations require companies to inform their customers of the existence of a SNUR. Alwood noted that while there is a Biofuels Review Team, stakeholders may have heard that the EPA is struggling to meet the 90-day PMN review period for any chemical. . The EPA determines which uses of a chemical are foreseeable through literature searches, patent searches, and searches of its PMN database for similar PMNs it has reviewed. Although there is no time frame within which the EPA must issue a SNUR after signing a consent order under TSCA Section 5(e), Alwood noted that it is within the EPA’s interest in issuing the SNUR as soon as possible. Under the Lautenberg Act, the EPA does not consider the replacement benefits of a PMN substance and instead evaluates a new chemical substance, including a biofuel, solely on its conditions of use. According to Alwood, the EPA may consider alternative benefits at the risk management stage.

Remark

The EPA is to be commended for presenting a well-organized and helpful webinar. The EPA is also to be commended for creating an innovative program designed to streamline the review of new bio-based or waste-derived chemicals that could replace current, more GHG-emitting transportation fuels. Biofuels stakeholders are encouraged to take advantage of EPA’s outreach and training efforts.

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