Regulatory Developments

TSCA:  What Effect Will the TSCA Amendments Have on Proposed and Future Rulemakings?

June 15, 2016

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well as in proposing/promulgating future regulations.

One important change in this regard is the way that Lautenberg (as discussed below) changes the requirements on the U.S. Environmental Protection Agency (EPA) when it includes articles within the scope of Section 5(a)(2) Significant New Use Rules (SNUR). Several relatively recent SNURs, as proposed, included imported/processed articles within their scope and would be affected by this amendment if the article provisions are retained in a final rule. Examples include proposed SNURs on certain polybrominated diphenylethers (PBDE), toluene diisocyanates (TDI), and long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemicals.

One interesting question to consider is the need for EPA to re-propose these SNURs if it intends to retain the requirements on imported/processed articles in the final rule. If these provisions are retained, it appears that EPA would need to re-propose the rule at a minimum to satisfy the requirement at Lautenberg Section 5(a)(5) that EPA make an affirmative finding that the reasonable potential for exposure to the chemical through the article or category of articles justifies notification.

In addition, EPA's Spring 2016 Regulatory agenda lists several SNURs under TSCA that are at the proposed rule stage, including SNURs for alkylpyrrolidone products and certain uses of trichloroethylene (TCE). These rulemakings would need to address the Lautenberg changes in the proposal.

The Spring 2016 Regulatory agenda also lists three proposed rulemakings under TSCA Section 6(a), and a TSCA Section 4 test rule. The former will be affected by Lautenberg while the latter may be affected depending on the approach taken as discussed below.

Background on SNURs Already Proposed by EPA and at the Final Rule Stage

On April 2, 2012, EPA proposed to amend the SNUR for certain PBDEs by designating processing of six PBDEs, or any combination of these chemical substances resulting from a chemical reaction, as a significant new use; designating manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether (decaBDE), for any use that is not ongoing after December 31, 2013, as a significant new use; and making inapplicable the article exemption for SNURs for this action. A person who intends to import or process any of the seven PBDEs included in the proposed SNUR as part of an article for a significant new use would have been required to notify EPA at least 90 days in advance. EPA also proposed a test rule under TSCA that would require any person who manufactures or processes commercial pentabromodiphenyl ether (c-pentaBDE), commercial octabromodiphenyl ether (c-octaBDE), or commercial decaBDE (c-decaBDE), including in articles, for any use after December 31, 2013, to conduct testing on their effects on health and the environment. EPA proposed to designate all discontinued uses of the PBDEs as significant new uses. The test rule would be promulgated if EPA determines that there are persons who intend to manufacture, import, or process c-pentaBDE, c-octaBDE, or c-decaBDE, for any use, including in articles, after December 31, 2013.

On January 15, 2015, EPA issued a proposed SNUR that would designate as a significant new use any use of TDI and related compounds in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. EPA also proposed to make inapplicable the general SNUR exemption from notification for persons who import or process these chemical substances as part of an article. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. According to the Spring 2016 Regulatory Agenda item for the SNUR for TDI and related compounds, EPA intends to promulgate a final rule in September 2016.

As reported in our January 23, 2015, memorandum, "EPA Proposes a Significant New Use Rule That Would Close a Chapter on Perfluorinated Chemicals," on January 21, 2015, EPA proposed amending the SNUR for LCPFAC chemicals by designating as a significant new use manufacturing, including importing, or processing of certain LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses. EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemicals as part of articles, as well as to amend a SNUR for PFAS chemical substances that would make the article exemption inapplicable for import of PFAS chemicals as part of carpets (although EPA makes clear that the proposed SNUR would not apply to processing of these chemicals as part of an article). Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing. According to EPA's Spring 2016 Regulatory Agenda item for the LCPFAC and PFAS SNUR, EPA intends to promulgate a final rule in October 2016.

Background on SNURs at the Proposed Rule Stage

EPA's Spring 2016 Regulatory Agenda lists the following SNURs at the proposed rule stage:

Agenda Stage of Rulemaking Title RIN
Proposed Rule Stage Significant New Use Rule; Alkylpyrrolidone Products 2070-AK09
Proposed Rule Stage Trichloroethylene (TCE); SNUR for Non-Aerosol Spray Degreasers 2070-AK18

According to the abstract for the alkylpyrrolidone products SNUR, EPA is developing a SNUR for N-ethylpyrrolidone (NEP), N-propylpyrrolidone (NPP), N-isopropylpyrrolidone (NiPP), N-isobutylpyrrolidone (NiBP), N-sec-butyl pyrrolidone (N-sec-BP), and N-t-butyl pyrrolidone (NtBP). The SNUR would require persons who intend to manufacture, import, or process these 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 item states that EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2016.

The abstract for the Regulatory Agenda item for TCE states that EPA is proposing a SNUR for certain uses of TCE. The SNUR would require persons who intend to manufacture (including import) or process this chemical substance for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in July 2016 and promulgate a final rule in December 2016.

TSCA Section 6(a) Rulemakings

EPA's Spring 2016 Regulatory Agenda lists the following TSCA Section 6(a) rulemakings, all of which are at the proposed rule stage:

Agenda Stage of Rulemaking Title RIN
Proposed Rule Stage Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) 2070-AK03
Proposed Rule Stage N-Methylpyrrolidone (NMP) and Methylene Chloride; Rulemaking Under TSCA Section 6(a) 2070-AK07
Proposed Rule Stage Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a); Vapor Degreasing 2070-AK11

According to the abstract for the TCE TSCA Section 6(a) rule, EPA intends to issue an NPRM in September 2016. The abstracts for the other two rulemakings state that EPA intends to issue NPRMs in October 2016. EPA identified each chemical for risk evaluation as part of its TSCA Work Plan for Chemical Assessments and, per Lautenberg Section 17, amended TSCA Section 26(p)(3), EPA can continue to apply the risk determinations that it had previously completed "prior to the development of a policy, procedure, or guidance" made pursuant to the Lautenberg amendments.

All of these proposed rules under Section 6(a) would need to meet the new requirements in Lautenberg, meaning that they are likely to be the first cases through the new legal process and procedure outlined in Lautenberg Section 6.

Background on the Section 6(a) Cases

In the TCE rulemaking abstract (RIN 2070-AK03), EPA states that, in the June 2014 TSCA Work Plan Chemical Risk Assessment for TCE, EPA identified risks associated with commercial degreasing and some consumer uses. EPA states that it is initiating rulemaking under TSCA Section 6 to address the risks of TCE when used as a spotting agent in dry cleaning and in commercial and consumer aerosol spray degreasers, if EPA finds that there is a reasonable basis to conclude that the risks to human health or the environment are unreasonable.

According to the abstract for the NMP and methylene chloride rulemaking (RIN 2070-AK07), NMP and methylene chloride are used in commercial processes and in consumer products in residential settings. In the August 2014 TSCA Work Plan Chemical Risk Assessment for methylene chloride and the March 2015 TSCA Work Plan Chemical Risk Assessment for NMP, EPA identified risks associated with commercial and consumer paint and varnish stripping uses. EPA states that it is initiating rulemaking under TSCA Section 6 to address these risks, if EPA finds that there is a reasonable basis to conclude that the risks to human health or the environment are unreasonable.

The abstract for the TCE rulemaking concerning vapor degreasing (RIN 2070-AK11) states that in the June 2014 TSCA Work Plan Chemical Risk Assessment for TCE, EPA identified risks associated with commercial vapor degreasing. EPA is initiating rulemaking under TSCA Section 6 to address these risks, if EPA finds that there is a reasonable basis to conclude that the risks to human health or the environment are unreasonable.

The determinations required in all these rulemakings will now be made against the requirements in Lautenberg.

TSCA Section 4 Test Rule

According to an item in EPA's 2016 Regulatory Agenda, EPA is preparing a TSCA Section 4 test rule for various esters of brominated phthalate acids to obtain specific data on human health, fate, and environmental effects for various esters of brominated phthalate acids. EPA states that the chemicals were identified for further assessment under the TSCA Work Plan for Chemical Assessments and that the Work Plan indicates that chemical risk assessments will be conducted if, as a result of scoping and problem formulation, there are exposures of concern, identified hazards, and sufficient data for quantitative analysis. In August 2015, EPA published a problem formulation and data needs assessment on the brominated phthalates cluster flame retardants after scoping and problem formulation concluded that the toxicological and exposure profile for the cluster was incomplete and inadequate to develop a TSCA Work Plan risk assessment. According to the Regulatory Agenda item, the purpose of the proposed Section 4 test rule is to obtain the necessary data to characterize hazard and exposure to enable EPA to conduct a risk assessment under TSCA. The item states that EPA intends to issue an NPRM in December 2016 and promulgate a final rule in December 2017. This action could be taken using the "finding approach" in TSCA Section 4(a)(1) (which was retained with conforming changes in Lautenberg). Alternatively, EPA could decide to use its new "additional testing authority" under Lautenberg Section 4(a)(2), which involves use of rules, orders, or consent agreements to require testing needed to perform a risk evaluation under Section 6(b). Alternatively, EPA might rely on the authority at Lautenberg Section 4(a)(2)(B) concerning testing needed to establish the priority of such chemicals. Actions under Section 4(a)(2) do not require the making of findings as required under old TSCA, although if an order or other authority under this provision is used, EPA would need to meet the Statement of Need requirement at Subsection (3) in taking the action.

Commentary

We draw these cases to your attention because they could be the first actions to be taken using Lautenberg Sections 4(a)(2), 5(a)(2), and 6(a) as the principal authority for the regulations (other provisions in Lautenberg would also apply as appropriate). As such, it will be important to follow these actions closely, even if you are not involved with the subject chemicals, given the precedential nature of the first such actions taken. If you have a commercial or other interest in the specific chemicals, it is all the more important to monitor and participate in these initiatives to ensure the letter and spirit of Lautenberg are being observed in implementing these new rulemaking requirements.


 
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