2019-21719. Significant New Use Rule on Certain Chemical Substances; Partial Withdrawal (PMN P-13-270)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Partial withdrawal of proposed rule.

SUMMARY:

EPA is withdrawing part of a proposed rule, published in the Federal Register on January 7, 2015, that proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances. This withdrawal covers only the portion of the proposed rule that would have established a SNUR for the chemical substance generically described as aromatic dibenzoate, which was the subject of premanufacture notice (PMN) P-13-270. EPA has received test data for this chemical substance and based on its review is withdrawing the proposed SNUR for the chemical substance.

DATES:

As of October 8, 2019, EPA withdraws the proposed addition of 40 CFR 721.10735, which published in the Federal Register of January 7, 2015 (80 FR 845) (FRL-9919-23).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0760, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

A list of potentially affected entities is provided in the Federal Register of January 7, 2015 (80 FR 845) (FRL-9919-23). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

II. What proposed SNUR is being withdrawn?

In the Federal Register of January 7, 2015 (80 FR 845) (FRL-9919-23), EPA issued proposed SNURs for 13 chemical substances, including the chemical substance generically described as aromatic dibenzoate, which was the subject of PMN P-13-270. EPA proposed a SNUR for this PMN substance that would designate certain activities as significant new uses based on a finding that the substance may cause significant adverse environmental effects and met the concern criteria at § 721.170(b)(4)(ii). The proposed SNUR would require notification before any use of the substance resulting in surface water concentrations exceeding 1 part per billion (ppb). In this Federal Register notice, EPA is only withdrawing the single proposed SNUR for PMN P-13-270 (proposed to be codified as 40 CFR 721.10735).

III. Why is that proposed SNUR being withdrawn?

Prior to the proposed SNUR, in the Federal Register of July 9, 2014 (79 FR 39268) (FRL-9910-01), EPA issued a direct final SNUR on this chemical substance in accordance with the procedures in 40 CFR 721.160(c)(3)(i). EPA received a notice of intent to submit adverse comments on the direct final SNUR, and, as required by 4 CFR 721.160(c)(3)(ii), EPA withdrew the direct final SNUR in the Federal Register of September 4, 2014 (79 FR 52563) (FRL-9915-69), which was subsequently followed by the issuance of the proposed rule in the Federal Register of January 7, 2015. The record for both the original direct final SNUR and the direct final SNUR withdrawal for this chemical substance was established as docket EPA-HQ-OPPT-2014-0166, and the record for the subsequent proposed rule was established as docket EPA-HQ-OPPT-2014-0760.

Subsequent to the January 7, 2015 proposed SNUR, the PMN submitter conducted an acute 96-hour toxicity test in nematodes. The data were in agreement with, and further supported (weight-of-evidence), the Agency's original acute aquatic toxicity values of no effects at saturation. The PMN submitter also submitted an aerobic biodegradation study that indicated that the substance is inherently biodegradable under aerobic conditions, with an estimated half-life of 135 days. Due to the low water solubility of the PMN substance (0.004 mg/L), EPA then recommended a chronic sediment toxicity test as potentially useful in evaluating the chronic exposures of the substance in a sediment environment. The PMN submitter conducted this testing, which provided a sediment chronic value of 537.4 mg/kg (geometric mean of the no-observed and low-observed adverse effect concentrations, or NOEC and LOEC), based on the measurement endpoint of emergence ratio for aquatic invertebrates. The concentration of concern (COC) for sediment-dwelling organisms was calculated by EPA, using an uncertainty factor of 10, to be 53.74 mg/kg.

Using a weight-of-evidence approach (taking into account the low water solubility of the substance, no adverse effects at the substance's saturation limit observed in the results from the submitted aqueous test data, and the significant difficulty of getting the substance into aqueous test solutions), EPA considers the substance to have a low (aqueous-only) environmental hazard. Further, the Agency determined that there is low acute and chronic aqueous-only ecological risk for the substance based on anticipated manufacture, processing and use exposure scenarios and low environmental hazard.

EPA calculated a maximum benthic sediment concentration of approximately 50 mg/kg for the substance using the Point Source Calculator (PSC) (https://www.epa.gov/​tsca-screening-tools/​point-source-calculator-version-105-psc-v105) aquatic model to estimate chemical concentrations in sediment from point sources, with low-end receiving stream flow. This sediment concentration value (a reasonable high-end estimate of exposure) is below the sediment-based COC, supporting the conclusion that the sediment concentrations of the substance are not expected to reach the sediment-based COC. As a result, the Agency also determined that the substance does not pose a significant environment risk to sediment-dwelling organisms resulting from the release and use of the substance and concludes that the substance does not meet the criteria under § 721.170(b).

Based on these conclusions from the review of all available scientific evidence, EPA is withdrawing the 2015 proposed SNUR for this chemical substance. Copies of the data and Agency review are available in the docket for the proposed rule, EPA-HQ-OPPT-2014-0760.

List of Subjects in 40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Dated: September 26, 2019.

Tala Henry,

Deputy Director, Office of Pollution Prevention and Toxics.