On June 20, 2023, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals that were the subject of premanufacture notices (PMN) and are also subject to an order issued by EPA pursuant to TSCA. 88 Fed. Reg. 39804. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, has made an appropriate determination on the notice, and has taken such actions as are required by that determination. Comments are due July 20, 2023.

In its June 15, 2023, press release, EPA states that the 18 chemicals are made from plastic waste-derived feedstocks and that the proposed SNURs would ensure they are free from unsafe contaminants before they can be used to make transportation fuels. According to EPA, it reviewed and approved the plastic-based feedstocks used to make these fuels in 2015 and 2019. EPA states that at the time it approved them, “the companies provided some data on impurities and these data showed there were no impurities of concern, and in one case the Agency required some additional testing to prove no dioxins were being formed as a result of the pyrolysis process.” EPA “knew less about impurities that may be included in plastic-based feedstocks in 2015 and 2019 than it does today,” however. As a result, the proposed SNURs would require notification to and review by EPA before the manufacturing or processing of the chemicals using waste-derived feedstocks that contain any amount of the following: heavy metals (e.g., arsenic, cadmium, chromium VI, lead, and mercury), dioxins, phthalates, per- and polyfluoroalkyl substances (PFAS), polybrominated diphenyl ethers (PBDE), alkylphenols, perchlorates, benzophenone, bisphenol A (BPA), organochlorine pesticides (OCP), ethyl glycol, methyl glycol, or N-methylpyrrolidone (NMP). EPA notes that this requirement will ensure fuels are not lawfully manufactured or processed using waste-derived feedstocks containing these impurities without additional EPA review. EPA will include requirements to address this issue in future consent orders for any new plastic waste-derived feedstocks.

Additionally, according to EPA, the proposed SNURs would ensure the safety requirements specified in the consent orders for these chemicals apply to all companies that want to manufacture them and would require companies to notify EPA before making, importing, or processing these chemicals for uses other than those listed in the consent orders. EPA states that it will propose SNURs for the chemicals made using bio-based feedstocks in a separate rulemaking.

According to the June 20, 2023, Federal Register notice, the orders require:

• No manufacture, processing, or use of the PMN substances other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 C.F.R. Part 79 or 1090;

• Use of personal protective equipment (PPE) where there is a potential for dermal exposure; and

• Establishment of a hazard communication program.

The proposed SNURs would designate as a significant new use the absence of these protective measures. Additionally, the proposed SNURs would designate the following as a significant new use:

• Manufacture of the PMN substances using feedstocks containing any amount of heavy metals (arsenic, cadmium, chromium VI, lead, mercury), dioxins, phthalates, PFAS, PBDEs, alkylphenols, perchlorates, benzophenone, BPA, OCPs, ethyl glycol, methyl glycol, or NMP. EPA notes that for purposes of the SNURs, PFAS or per- and polyfluoroalkyl substance means a chemical substance that contains at least one of these three structures:

  • R-(CF₂)-CF(R′)Rʺ, where both the CF₂ and CF moieties are saturated carbons;

  • R-CF₂OCF₂-R′, where R and R′ can either be F, O, or saturated carbons; or

  • CF₃C(CF₃)R′Rʺ, where R′ and Rʺ can either be F or saturated carbons.

EPA states that it has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the order, or if a manufacturer or processor is considering submitting a significant new use notice (SNUN) for a significant new use that will be designated by these SNURs. According to EPA, the results of testing for skin irritation, eye irritation, respiratory depression/irritation, hydrocarbon pneumonia/aspiration hazard, reproductive developmental toxicity, systemic toxicity, genetic toxicity, carcinogenicity, aquatic toxicity, and consumer inhalation exposure at gas stations may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the orders do not require these tests, the orders’ restrictions remain in effect until the orders are modified or revoked by EPA based on submission of this or other relevant information.

Commentary

This SNUR, if it is promulgated as proposed, will effectively prohibit entirely the manufacture of the PMN substances (presumably some variations of pyrolysis oils or products derived from pyrolysis oils, based on the public information available).

The proposal is noteworthy for several reasons. First, its timing. On average, 341 days pass between the effective date of a consent order and EPA proposing a SNUR. At 299 days, this proposal is a bit short of that average, so perhaps it is not remarkable, but another 120 PMNs with orders have been waiting on average 700 days since the effective date without a SNUR proposal. EPA would normally include a number of unrelated PMNs in a single SNUR proposal. In this proposal, EPA only included the cases that are the subject of a single consent order. EPA clearly put this SNUR on the fast track.

Second, the SNUR deviates from the terms of the consent order and, as a result, EPA is voiding the exemption at 40 C.F.R. Section 721.45(i) for those entities that are bound by and abiding by a Section 5(e) order. This puts the submitter of the PMNs in an odd position of having to rebut EPA’s presumption of unreasonable risk in a very short timeframe (30 days) without the benefit of EPA’s underlying logic (more on this below).

Third, the new provision of the SNUR does not relate to the PMN products, byproducts formed with, or impurities in the PMN substances. Rather, the SNUR specifies that the PMN substances may not be manufactured from feedstocks that contain a list of specified substances. EPA does not explain the proposed SNUR (but may do so in supporting information posted to the Docket, which was not available at the time of this writing) or why it views this list of substances as a potential risk when present in the feedstocks. EPA does point to several references as sources of information that the list of specified substances may be present in plastic and waves its hands toward a vague possibility of risk. Several of the specified substances are sufficiently similar to the feedstock chemical(s) that one would reasonably expect those substances also to be converted in the pyrolysis or other chemical transformations.

For example, alkyl phenols are almost entirely hydrocarbons that, like the plastic feedstocks, are likely to react during pyrolysis. Furthermore, even if they do not react during pyrolysis, there is no reason to think that the alkylphenols will not be combusted in a resultant fuel product or be destroyed or separated from the product in subsequent processing. The specified metals may not be converted by the chemical transformation process, but neither are they likely to be in the distillation fractions. Halogenated material in the feedstocks may lead to halogenated components in the products, but the answer there is to test the products for halogenated impurities, not to prohibit their presence at any level in the feedstock. EPA had, presumably, analytic results of the composition of the products. In our experience, such composition is necessary to establish chemical identity and for EPA to make a reasoned evaluation of the risk of the PMN substances. Did the composition show any of the problematic substances, or byproducts, or impurities resulting from the process? If not, EPA’s vague concerns seem to be that, vague.

Fourth, EPA provides no de minimis level below which the SNUR does not apply. This is especially problematic for any manufacturer of any of the PMN substances, because a manufacturer will have to document the absolute absence of all the specified substances in all batches of all feedstocks used. This is problematic because, even if a company could test all of the feedstock it uses (already an impracticable expectation), one can only detect down to an analytic level of detection. No supplier will represent to a customer that a component is never present at any level because that is scientifically unprovable; at best, a supplier will represent that a component is below some specified level.

Fifth, for the first time of which we are aware, EPA has provided a basis for its view that the specified list of substances may be present in plastic. We applaud EPA providing a factual basis for what it views as reasonably foreseen. In our experience, that “somebody might” undertake a condition of use was sufficient for EPA to view it as foreseeable. While we agree that it is reasonably foreseen that the specified substances could be present in feedstocks, the presence of such substances in the feedstocks does not suggest that there is or may be an unreasonable risk from the products.

Finally, EPA is departing from its long-standing practice and has proposed regulating existing chemicals (the specified components) as new chemicals. A manufacturer of any of the PMN substances could manufacture the PMN substances from pristine feedstocks (that contain none of the specified substances) with no problematic byproducts or impurities and subsequently blend any of the specified problematic substances into the product and distribute that mixture for further processing or use.

Our strong view is that the proposed changes to the SNUR are unwarranted from both a scientific and legal basis. If EPA has concerns about the presence of the list of problematic substances, it should work with the submitter to evaluate how such substances may lead to problematic components in the products. In past pyrolysis oil cases, EPA has mandated testing for the presence of dioxin in the products. Such a requirement has at least a basis for the concern --polyvinylchloride (PVC) may be mixed in with the polyolefin feedstocks, and the pyrolysis of PVC may produce dioxin or dioxin-like byproducts. EPA may have a reason to broaden its concern to other halogens (fluorine, bromine), but the solution is to focus on the products, not the feedstocks. In our view, EPA should work with the submitter (the holder of the consent order) to evaluate if and how any of the specified substances form problematic byproducts during manufacturing of the PMN substances and develop a testing program similar to the one EPA has used in the past for other pyrolysis oils. The result of that work can become part of the consent order and, subsequently, can be embodied in the corresponding SNUR.