Federal Register - January 6, 2021
Versione di testo Cosa è?Dateas è un sito indipendente non affiliato a entità governative. La fonte dei documenti PDF che pubblichiamo qui è l'entità governativa indicata in ciascuno di essi. Le versioni in testo sono trascrizioni che realizziamo per facilitare l'accesso e la ricerca di informazioni, ma possono contenere errori o non essere complete.
Source: Federal Register
912
Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
provision is not intended to require subject companies to retain records in addition to those specified herein, expect as needed pursuant to normal business operations.
Effects on State, local, and Tribal governments. This final rule will not have any significant or unique effects on small governments, or federalism or tribal implications.
D. Why is the Agency taking this action?
F. Childrens Environmental Health
EPA is issuing this final rule to fulfill EPAs obligations under TSCA section 6h to take timely regulatory action on PBT chemicals, including PCTP, to address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and to reduce exposure to the substance to the extent practicable. As required by the statute, the Agency is finalizing this rule to reduce exposures to PCTP to the extent practicable.
Executive Order 13045 applies if the regulatory action is economically significant and concerns an environmental health risk or safety risk that may disproportionately affect children. While the action is not subject to Executive Order 13045, the Agencys Policy on Evaluating Health Risks to Children https www.epa.gov/
children/epas-policy-evaluating-riskchildren is to consider the risks to infants and children consistently and explicitly during its decision making process. This final rule will reduce the exposure to PCTP that could occur from activities now prohibited under this final rule for the general population and for potentially exposed or susceptible subpopulations such as children. More information can be found in the Exposure and Use Assessment Ref. 5.
jbell on DSKJLSW7X2PROD with RULES5
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of these restrictions and prohibitions and the associated reporting and recordkeeping requirements. The Economic Analysis for Regulation of Pentachlorothiophenol PCTP Under TSCA Section 6h Economic Analysis Ref. 3, is available in the docket and is briefly summarized here.
Benefits. EPA was not able to quantify the benefits of reducing the potential for human and environmental exposures to PCTP. As discussed in more detail in Unit II.A., EPA did not perform a risk evaluation for PCTP, nor did EPA develop quantitative risk estimates. Therefore, the Economic Analysis Ref. 3 qualitatively discusses the benefits of reducing the exposure under the final rule for PCTP, as summarized in Unit III.B.2.
Costs. Total quantified annualized social costs for this final rule are approximately $108,000 at both 3%
and 7% discount rates. Potential unquantified costs and are those associated with testing, reformulation, importation of articles, foregone profits, and indirect costs. The limited data available for those costs prevents EPA
from constructing a quantitative assessment.
Small entity impacts. This final rule will impact approximately one small business of which the one small entity is not expected to incur impacts of 1%
of their revenue or greater.
Environmental Justice. This final rule will increase the level of protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population or children.
VerDate Sep<11>2014
21:01 Jan 05, 2021
Jkt 253001
II. Background A. History of This Rulemaking TSCA section 6h requires EPA to take expedited regulatory action under TSCA section 6a for certain PBT
chemicals identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments Ref. 1. As required by the statute, EPA issued a proposed rule to address five PBT chemicals identified pursuant to TSCA section 6h 84 FR
36728, July 29, 2019. The statute required that this be followed by promulgation of a final rule no later than 18 months after the proposal.
Although EPA proposed regulatory actions on each chemical substance in one proposal, in response to public comments EPAHQOPPT2019
00800544, EPAHQOPPT2019
00800553, EPAHQOPPT2019
00800556, EPAHQOPPT2019
00800562 requesting these five actions be separated, EPA is finalizing five separate actions to individually address each of the PBT chemicals. EPA intends for the five separate final rules to publish in the same issue of the Federal Register. More discussion on these comments is in the Response to Comments document which is available in the docket Ref. 4. The details of the proposal for PCTP are described in more detail in Unit II.D.
Under TSCA section 6h1A, the chemical substances subject to expedited action are those that:
EPA has a reasonable basis to conclude are toxic and that with respect
PO 00000
Frm 00048
Fmt 4701
Sfmt 4700
to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the 2012 TSCA Work Plan Chemicals:
Methods Document or a successor scoring system;
Are not a metal or a metal compound; and Are chemical substances for which EPA has not completed a TSCA Work Plan Problem Formulation, initiated a review under TSCA section 5, or entered into a consent agreement under TSCA section 4, prior to June 22, 2016, the date that TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act Pub. L. 114182, 130 Stat. 448.
In addition, in order for a chemical substance to be subject to expedited action, TSCA section 6h1B states that EPA must find that exposure to the chemical substance under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator e.g., infants, children, pregnant women, workers, or the elderly or to the environment, on the basis of an exposure and use assessment conducted by the Administrator. TSCA section 6h2
further provides that the Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to TSCA section 6h1.
Based on the criteria set forth in TSCA section 6h, EPA proposed to determine that five chemical substances meet the TSCA section 6h1A
criteria for expedited action, and PCTP
is one of these five chemical substances.
In addition, and in accordance with the statutory requirements to demonstrate that exposure to the chemical substance is likely under the conditions of use, EPA conducted an Exposure and Use Assessment for PCTP. As described in the proposed rule, EPA conducted a review of available literature with respect to PCTP to identify, screen, extract, and evaluate reasonably available information on use and exposures. This information is in the document entitled Exposure and Use Assessment of Five Persistent, Bioaccumulative and Toxic Chemicals Ref. 5. Based on this review, which was subject to peer review and public comment, EPA proposed to find that exposure to PCTP is likely based on information detailed in the Exposure and Use Assessment.
B. Other Provisions of TSCA Section 6
1. EPAs approach for implementing TSCA section 6h4.
TSCA section 6h4 requires EPA to issue a final TSCA section 6a rule to
E:FRFM06JAR5.SGM
06JAR5