The U.S. Environmental Protection Agency (EPA) announced on June 7, 2018, that Charlotte Bertrand, Acting Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, signed a final rule that will add a category of 13 specific nonylphenol ethoxylates (NPE) to the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). EPA states that this addition “ensures the most up-to-date information is easily accessible to the public.” On its web page regarding the final rule, EPA states that it is issuing the final rule “because we have determined that longer-chain NPEs can break down in the environment to short-chain NPEs and nonylphenol, both of which are highly toxic to aquatic organisms. For this reason, EPA has determined that NPEs meet [EPCRA] section 313(d)(2)(C) toxicity listing criteria.” The final rule will apply for the reporting year beginning January 1, 2019, with the first reporting forms due July 1, 2020. The final rule is effective November 30, 2018. EPA has posted a pre-publication version of the final rule.

Background

EPCRA Section 313 requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts exceeding the reporting threshold levels to report annually their environmental releases and other waste management quantities of such chemicals. Under Section 6607 of the Pollution Prevention Act (PPA), these facilities must also report pollution prevention and recycling data for such chemicals. To add a chemical to the list of toxic chemicals, EPA must demonstrate that at least one of the following criteria is met:

• Acute human health effects criterion (EPCRA Section 313(d)(2)(A)): The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases;

• Chronic human health effects criterion (EPCRA Section 313(d)(2)(B)): The chemical is known to cause or can reasonably be anticipated to cause in humans: cancer or teratogenic effects, or serious or irreversible reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects; and

• Environmental effects criterion (EPCRA Section 313(d)(2)(C)): The chemical is known to cause or can reasonably be anticipated to cause, because of its toxicity, its toxicity and persistence in the environment, or its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administrator, to warrant reporting under this Section.

Final Rule

EPA describes NPEs as “nonionic surfactants used in a wide variety of industrial applications and consumer products such as adhesives, wetting agents, emulsifiers, stabilizers, dispersants, defoamers, cleaners, paints, and coatings.” According to EPA, “[s]hort-chain NPEs are highly toxic to aquatic organisms, and longer-chain NPEs, while not as toxic as short-chain NPEs, can break down in the environment to short-chain NPEs and nonylphenol, both of which are highly toxic to aquatic organisms.”

On November 16, 2016, EPA proposed listing NPEs as a category that would include the 13 NPEs currently listed on the Toxic Substances Control Act Inventory. In the final rule, EPA states that it proposed to add short-chain NPEs to the EPCRA Section 313 toxic chemical list “because they are highly toxic to aquatic organisms with toxicity values well below 1 [milligram per liter (mg/L)].” Therefore, according to EPA, it “believed that the evidence was sufficient for listing short-chain NPEs . . . pursuant to EPCRA section 313(d)(2)(C) based on the available ecological toxicity data.” According to EPA, while long-chain NPEs are not as toxic as short-chain NPEs, they “are known to become more toxic as they degrade in the environment to produce products that include highly toxic short-chain NPEs and nonylphenol.” EPA added nonylphenol, which “is even more toxic to aquatic organisms than short-chain NPEs,” to the EPCRA Section 313 toxic chemical list based on its toxicity to aquatic organisms on September 30, 2014. Since long-chain NPEs are “a source of degradation products that are highly toxic to aquatic organisms,” EPA states that it “believed that the evidence was also sufficient for listing long-chain NPEs . . . pursuant to EPCRA section 313(d)(2)(C) based on the available ecological toxicity and environmental fate data.”

EPA stated in the proposed rule that it did not believe it was appropriate to consider exposure for chemicals that are highly toxic based on a hazard assessment when determining if a chemical can be added for environmental effects pursuant to EPCRA Section 313(d)(2)(C). EPA thus “did not believe that an exposure assessment was necessary or appropriate for determining whether NPEs meet the criteria of EPCRA section 313(d)(2)(C).”

Of the six comments submitted on the proposed rule, EPA states that the Alkylphenols & Ethoxylates Research Council (APERC) submitted the only extensive comments. APERC disagreed that long-chain NPEs are “highly toxic” to the aquatic environment, arguing that EPA defined in the proposed rule and its supporting documents as ecotoxicity values below aquatic concentrations of 1 mg/L. EPA responds that it typically limits its consideration of highly toxic “to those chemicals that cause acute aquatic toxicity at about 1 mg/L or less and chronic aquatic toxicity at 0.1 mg/L or less.” According to EPA, the purpose of these values is not to determine which chemicals are toxic, but to determine if exposure should be part of EPA’s listing decision. EPA states that “these are not absolute values and they do not preclude consideration of other factors such as the environmental fate of the chemical.” While not as toxic to aquatic organisms as nonylphenol and short-chain NPEs, EPA reiterates that “long-chain NPEs are still toxic to aquatic organisms.” Because longer chain NPEs break down to shorter chain NPEs in the environment, they become more toxic. For chemicals that are low to moderately ecotoxic, EPA notes that it may consider exposure factors such as environmental fate. EPA states that its assessment of long-chain NPEs “is that, depending on chain length, they are low to moderately toxic to aquatic organisms but that their environmental fate results in the formation of highly toxic nonylphenol and short-chain NPEs.”

Commentary

EPA’s decision to require TRI reporting for NPEs has resulted in the first rule promulgated that is derivative of the nonylphenol/nonylphenol ethoxylate (NP/NPE) Action Plan. EPA also proposed a TSCA Significant New Use Rule (SNUR) on NP/NPEs, but has yet to publish that rule in final. The TRI NPE category includes the linear alkyl identities that EPA argued in the NP/NPE SNUR are not in commerce. Presumably, EPA decided to include the linear identities in the TRI rule to ensure that EPA receives data on all variants of NPE regardless of the final outcome of the SNUR action.

EPA’s inclusion of NPEs for TRI reporting reflects EPA’s significant concern for the aquatic toxicity of short-chain NPEs and the longer-chain NPEs, which EPA expects to degrade to short-chain NPEs. EPA reiterated its justification of including long-chain NPEs based on the fact that the degradation products are “a direct result of the chemical properties of the parent compound that determine its environmental fate, and as such should be considered part of the chemical's toxicity.” Furthermore, EPA concludes that long-chain NPEs cause “‘or may reasonably be anticipated to cause’ the relevant adverse” environmental effects. The NPE reporting along with the NP reporting that was already required will give EPA a more complete picture of NP in the environment, regardless of whether the NP was directly released or formed as a result of NPE degradation.

Notably, EPA did not include health endpoints in its justification for TRI reporting. EPA so decided despite the fact that NP is a suspected endocrine disruptor and that EPA has, during its review of notices submitted under TSCA Section 5, raised significant health concerns for inhalation of surfactants. The results of additional NPE reporting may well be used to inform NP/NPE health and ecological assessments.