EPA Holds Webinar on TSCA Requirements and PMN Process for Biofuels
On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. 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. According to EPA, it has received more than 30 biofuel PMNs “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the [Renewable Fuel Standard (RFS)] program and help support the goals of energy security through increasing domestic production” within the United States. Future webinars will cover the TSCA Inventory, nomenclature, and Bona Fide process; new chemicals risk assessments, including applications of the tools, models, and databases; and new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).
Jim Alwood, EPA, reviewed the PMN process. As outlined in EPA’s slides, which include an embedded voiceover recording of the webinar, under TSCA Section 5, any person planning to manufacture or import a non-exempt chemical substance must submit a PMN to EPA before beginning that activity. Alwood noted that even biofuels may have multiple uses, and these uses need to be identified in the PMN. Although analogue data are not required to be submitted, Alwood suggested that if a submitter has a good analogue to the new chemical to let EPA know.
During the notice review period, EPA will make one of five affirmative findings:
- Presents an unreasonable risk of injury to health or the environment: TSCA requires EPA to take action to protect against unreasonable risks. According to Alwood, the important point is that EPA must restrict or prohibit use of the new chemical to prevent unreasonable risks. EPA typically does not make this finding because it is unusual to have data supporting this finding for the new chemical.
- Not likely to present an unreasonable risk: According to Alwood, EPA will not make this finding for most biofuels, but it is currently working on a PMN that might meet the criteria. He stated that he does not expect it to happen often.
- Information is insufficient to permit a reasoned evaluation of the risk: EPA is required to take action, and typically does so through a consent order. According to Alwood, testing is generally required before commercialization.
- Insufficient information to permit a reasoned evaluation and may present an unreasonable risk: EPA 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 EPA will make this finding for most PMN substances, including most biofuels.
- 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: According to Alwood, most biofuels will meet this criteria based on their production volume and how they are used. Alwood stated that EPA will typically make a finding of insufficient information to permit a reasoned evaluation and may present an unreasonable risk, but EPA might make this finding if exposure is the only issue. EPA typically issues a consent order and allows commercialization with restrictions.
Alwood presented possible risk management outcomes based on a recently issued biofuels order. EPA made a determination that the biofuel “may present an unreasonable risk.” EPA issued a TSCA Section 5 consent order 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 order will reference following the Occupational Safety and Health Administration (OSHA) requirements for monitoring and meeting those exposure limits;
- The order will also reference complying with other applicable EPA and OSHA regulations for handling, storing, and disposal of gasoline/petroleum products; and
- If the biofuel is imported, order will limit use to import as a fuel.
Alwood noted that although it was not included in the slide, EPA usually requires the use of dermal protection.
During the question and answer session, Alwood stated that EPA will limit the uses to those reported in the PMN. EPA will try to make the consent order broad enough to allow the biofuel to be used in most fuels, and as a chemical intermediate if that is part of the PMN. If there is another use that is identified later, that would be a new use and require that a significant new use notice (SNUN) be submitted to EPA. According to Alwood, when reviewing a new microorganism like algae or bacteria, EPA has a separate review process for microbial commercial activity notices (MCAN). When asked about whether byproducts burned for fuel are exempt from PMN requirements, Alwood responded that if the substance is truly a byproduct from another process involving a chemical on the TSCA Inventory and the byproduct is burned as fuel, that is fine. He suggested that this would be a good prenotice question. According to Alwood, Sustainable Futures has information on how EPA does its risk assessments, and companies can run chemicals through models to try to figure out how EPA will do the assessment. EPA will provide more information on risk assessments and models in a future webinar. Alwood stated that PMN submitters that later need to file a SNUN need to tell EPA about all uses, including those already reported in the PMN. EPA will accept alternatives to animal testing, and Alwood noted that TSCA mandates that EPA consider alternatives. Alwood suggested that companies can discuss this with EPA in a prenotice meeting or ask EPA about the alternative test and whether EPA will accept it. There is no requirement for how quickly EPA responds to prenotice questions, but Alwood stated that EPA tries to respond as quickly as possible. Alwood acknowledged that EPA has been having issues with PMN reviews in general, and that the first biofuel PMNs have taken longer to review than EPA would have liked. Alwood estimated that it would take EPA four to six months to review a biofuel PMN with a consent order.
EPA has announced the following webinars for stakeholders interested in the biofuels sector:
- March 9, 2022: TSCA Inventory, nomenclature, and Bona Fide process;
- March 23, 2022: New Chemicals Program risk assessments and applications of the tools and models; and
- April 6, 2022: New Chemicals Program risk management actions, TSCA Section 5 orders, and SNURs.
This webinar follows up on EPA’s compliance advisory from December 2020, in which EPA reminded manufacturers and importers that hydrocarbon distillate cuts generally include the source (e.g., petroleum) in the substance identity and petroleum-based substances are not identical for TSCA nomenclature purposes with biobased substances. Clearly, EPA had reason to believe it necessary to clarify its view of TSCA nomenclature.
EPA’s announcement may have triggered a number of biobased hydrocarbon cut PMNs. Because the hazards of hydrocarbons are well-understood and the uses are not novel, EPA appears to have concluded that it can, with a fairly reproducible process, come to a risk management decision more efficiently.
EPA states that the order and SNUR requirements will not apply to the new substances once those substances are incorporated into the final product. With this conclusion, EPA clearly views the regulatory framework (including the Clean Air Act and Clean Water Act) and standard industrial practices for the blended are sufficient to control releases and exposures to the extent that the biofuels do not present an unreasonable risk to health or the environment. A view with which we agree and that we wholeheartedly support. What is not clear is why EPA does not hold a similar view to the new substances prior to blending into the final product.
In any case, this practice is a significant step forward in lowering the barrier to the commercialization of new, biobased hydrocarbon distillates, and we hope that EPA will continue to look for opportunities to allow more sustainable products to be commercialized on an even regulatory playing field with incumbent products.