Source: http://www.environmentallawportal.com/epa-releases-tsca-final-rule-prioritization
Timestamp: 2017-08-17 03:44:24
Document Index: 753717989

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EPA Releases TSCA Final Rule on Prioritization of High-Priority and Low-Priority Chemical Substances: Environmental Law Portal
On July 20, 2017, EPA issued its final rule, effective September 18, 2017, for prioritizing High- and Low-Priority chemical substances.[1] The rule sets forth a risk-based screening process and criteria for identifying and designating High-Priority Substances, which must undergo risk evaluations, and Low-Priority Substances, which do not meet the High-Priority screening criteria and will not receive a risk evaluation. EPA was required to adopt the rule by section 6(b)(1)(A) of the Toxic Substances Control Act (TSCA), as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act (LCSA).
EPA’s prioritization rule sets forth the process by which EPA will designate chemical substances as either High- or Low-Priority for risk evaluation. The final rule follows and incorporates much, but not all of, of the provisions in EPA’s proposed prioritization rule.[2]
EPA will initiate the prioritization process for a chemical substance of interest once it is confident that all information required to prioritize the chemical substance has been made “reasonably available.”[3] (The preamble indicates that a chemical may be of interest even if it is a recent PMN chemical or classified as inactive through the Inventory Reset process, although EPA does not expect this to be the case often.) EPA will then publish a notice of initiation in the Federal Register identifying the chemical substance and a general explanation for why it chose to initiate prioritization on that substance.[4] This publication will trigger a 90-day public comment period for interested persons to submit relevant information, which may include information that assists EPA with its screening review of the chemical substance.[5]
Are known human carcinogens and have high acute and chronic toxicity.[6]
EPA aims to ensure that, “at any given time” at least 50% of all high-priority risk evaluations are drawn from the 2014 Update.[7]
The first six criteria are drawn directly from section 6(b)(1)(A), and the final is a general catch-all for EPA to consider other, potentially unknown risks. EPA must prioritize a chemical substance without considering costs or other non-risk factors.[8] EPA’s designation of High or Low-Priority turns on whether the substance “may present an unreasonable risk of injury to health or the environment” based on hazard and exposure risks.[9]
As discussed below, the final rule does not include any provision addressing what the proposal had described as pre-prioritization activities. Instead, EPA will generally expect to obtain sufficient information before beginning the prioritization process by using voluntary methods and its authority under section 4 (requiring testing on environmental and health effects); section 8 (requiring submission of health and safety studies); and section 11 (subpoenas), for which there is no time deadline.[10] This provision suggests that EPA hopes to avoid the situation where at the end of the 12-month period for prioritization it still has insufficient information, because section 6(b)(1)(C)(iii) requires EPA in that situation to designate the chemical being prioritized as a High-Priority substance.
Upon determination that a chemical substance meets one or more criteria, EPA will propose to designate the chemical substance either High- or Low-Priority. It will publish the proposed designation in the Federal Register.[11] A proposed designation triggers a second 90-day public review period.[12]
Following the 90-day review period, EPA will make a final designation of a chemical as either a High-Priority or Low-Priority chemical substance. This designation will be published in the Federal Register.[13] A High-Priority designation requires EPA to immediately begin a risk evaluation on the chemical substance. Thus, a High-Priority designation is not a final agency action and is not subject to judicial review.
The final rule states that “designation as a High-Priority Substance is not a finding that the chemical substance presents an unreasonable risk.”[14] Commenters on the proposed rule expressed concerns that a High-Priority designation could stigmatize chemicals before they undergo risk evaluation. EPA responded by amending the proposed rule to provide that it will generally aim to publish information and grounds on which the final designation is supported. For High-Priority substances, EPA will further identify which specific conditions of use were the basis for the designation.[15] Under section 6(b)(2)(B), EPA must designate 20 chemical substances as High-Priority by December 22, 2019.
Conversely, EPA will designate a chemical substance as Low-Priority where none of the chemical’s conditions of use meets the criteria or health or environmental risks of a High-Priority Substance.[16] Section 6(b)(2)(B) requires that EPA designate 20 chemical substances as Low-Priority by December 22, 2019. The preamble explains that determination that a chemical is Low-Priority is considered a final agency action, and as such it is subject to judicial review. That said, EPA may revisit a Low-Priority designation should information become available that demonstrates that the chemical could meet the High-Priority criteria.[17]
As required under section 6(b)(3)(C), the rule provides that EPA must designate at least one High-Priority chemical substance for every substance for which it completes a risk evaluation. This one-for-one substitution does not apply to risk evaluations that were requested by a chemical manufacturer pursuant to 40 C.F.R. § 702.37.[18] The preamble noted that EPA aims to facilitate the one-for-one substitution by identifying the “complete or near-complete risk evaluation that the new High-Priority Substance will replace” in a notice published in Federal Register designating the new High-Priority Substance. EPA aims to designate a new High-Priority Substance no later than 45 days following completion of a risk evaluation.
The proposed rule included a general objective only for identifying High-Priority Substances. However, commenters suggested that the final rule include general objectives for identifying Low-Priority Substances as well. EPA amended the rule to provide general objectives for both High- and Low-Priority Substances.[19]
[1] Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act, Final Rule, 82 Fed. Reg. 33753 (July 20, 2017) (codified as 40 C.F.R. Part 702, Subpart B), https://www.gpo.gov/fdsys/pkg/FR-2017-07-20/pdf/2017-14325.pdf.
[2] 82 Fed. Reg. 4825 (Jan. 17, 2017).
[3] 40 C.F.R. § 702.7(a).
[4] 40 C.F.R. § 702.7(b).
[5] 40 C.F.R. § 702.7(d).
[6] These substances are identified in Beveridge & Diamond, P.C., What’s New About the Revised TSCA (June 2, 2016), http://www.bdlaw.com/assets/htmldocuments/2016-06-02%20What%E2%80%99s%20New%20About%20the%20Revised%20TSCA.pdf, Attachment 1.
[7] 40 C.F.R. § 702.5.
[8] 40 C.F.R. § 702.9(d).
[9] 40 C.F.R. § 702.3.
[10] 40 C.F.R. § 702.5(e).
[11] 40 C.F.R. § 702.9(g).
[12] 40 C.F.R. § 702.9(g).
[13] 40 C.F.R. § 702.11.
[14] 40 C.F.R. § 702.17.
[15] 40 C.F.R. § 702.11(c).
[16] 40 C.F.R. § 702.15.
[17] 40 C.F.R. § 702.15.
[18] 40 C.F.R. § 702.11(d).
[19] 40 C.F.R. § 702.5(a).