On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 chemical substances for an activity that is designated 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 intended use 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, made an appropriate determination on the notice, and taken such actions as are required with that determination.  The rule will be effective on October 1, 2018.  Written adverse comment must be received by August 31, 2018.  If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule.

EPA also issued, on August 1, 2018, a Notice of Proposed Rulemaking for this rule.  83 Fed. Reg. 37455.  As indicated above, if adverse comment is received on one or more SNURs in the direct final rule, EPA will withdraw the specific SNURs and proceed under the proposed rule.  If no adverse comment is received on one or more SNURs in the direct final rule, those SNURs will become effective.

TSCA Section 5(a)(2) authorizes EPA to determine that a use of a chemical substance is a “significant new use.”  EPA must make this determination after considering all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance;

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. 

TSCA authorizes EPA to consider any other relevant factors as well.

EPA states that to determine what would constitute a significant new use for the 145 chemical substances that are the subject of these SNURs, it considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed above.

Once EPA determines that a use of a chemical substance is a significant new use, TSCA Section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use.  Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence.  If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA Section 5(g) to make public, and submit for publication in the Federal Register, a statement of its findings.

For each of the 145 chemical substances, the direct final rule includes information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.  This information may include testing required in a TSCA Section 5(e) order to be conducted by the PMN submitter, as well as testing not required to be conducted but that would also help characterize the potential health and/or environmental effects of the PMN substance.  According to the direct final rule, any recommendation for information identified by EPA was made based on EPA’s consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance.  Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.  The direct final rule states that EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN.  EPA “encourages all SNUN submitters to contact EPA to discuss any potential future testing.”

Commentary

We are pleased to see EPA take these long-delayed actions to implement SNURs on this set of new chemicals.  We note that all of the SNURs concern new chemicals for which EPA made TSCA Section 5(a)(3)(B)(ii)(I) “may present” determinations and all are also subject to TSCA Section 5(e) consent orders.  Thus, while we welcome this step forward, we wait in anticipation for other possible SNURs on new chemicals under the new law, specifically for possible SNURs on new chemicals for which EPA has made TSCA Section 5(a)(3)(B)(i) “insufficient information” determinations and TSCA Section 5(a)(3)(C) “not likely” determinations. 

There are a few things to note that EPA has done differently in the direct final SNUR:

• Likely in anticipation of expected adverse comment, EPA has taken the step of issuing in parallel a proposed rule for this set of SNURs, thus providing a means for more timely resolution of cases for which adverse comment is received under the direct final rule.

• EPA has included discussion of the way that the TSCA Section 4 animal welfare provisions were considered in developing testing recommendations. 

• The preamble notes that TSCA Section 5(e) consent orders with triggered testing now require that triggered tests be submitted 14 weeks before hitting the trigger.  Previously this was 12 weeks in advance.  The rule seems to invite submitters to submit the triggered testing as part of a SNUN (thus the change to 14 weeks).

• EPA also seems to have revised its regulatory procedure for reviewing bona fide intents to manufacture (bona fide) for confidential business information (CBI) uses and volumes.  We had observed in an earlier memorandum on proposed modifications to the SNUR procedures (81 Fed. Reg. 49598 (Aug. 28, 2016); final rule expected September 2018), TSCA Reform:  Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors, that the procedure proposed as well as that in 40 C.F.R. § 721.1725(b)(1)(iv) violated CBI requirements by allowing CBI disclosures to submitters of bona fides.  The current direct final rule requires that bona fide submitters identify the specific use and, regarding volume triggers, the rule states “[‌b]ecause of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger.  Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.”  This approach thus differs from 40 C.F.R. § 721.1725(b)(1)(iv) which states that “[‌i]f EPA tells the person that the intended use is not a significant new use under paragraph (a)(2)(i) of this section, EPA will tell the  person what activities would constitute a significant new use."  

• The SNUR was signed by the Office Director indicating that the delegation of signature authority to the Chemical Control Division Director did not operate in this case.