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THE FEDERAL REGISTER
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PENTACHLOROTHIOPHENOL (PCTP); REGULATION OF PERSISTENT, BIOACCUMULATIVE, AND
TOXIC CHEMICALS UNDER TSCA SECTION 6(H)
A Rule by the Environmental Protection Agency on 01/06/2021
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Information about this document as published in the Federal Register.
Printed version: PDF Publication Date: 01/06/2021 Agency: Environmental
Protection Agency Dates: This final rule is effective February 5, 2021. For
purposes of judicial review and 40 CFR 23.5, this rule shall be promulgated at 1
p.m. eastern standard time on January 21, 2021. Effective Date: 02/05/2021
Document Type: Rule Document Citation: 86 FR 911 Page: 911-922 (12 pages) CFR:
40 CFR 751 Agency/Docket Numbers: EPA-HQ-OPPT-2019-0080 FRL-10018-89 RIN:
2070-AK60 Document Number: 2020-28689
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* AGENCY:
* ACTION:
* SUMMARY:
* DATES:
* ADDRESSES:
* FOR FURTHER INFORMATION CONTACT:
* SUPPLEMENTARY INFORMATION:
* I. Executive Summary
* A. Does this action apply to me?
* B. What is the Agency's authority for taking this action?
* C. What action is the Agency taking?
* D. Why is the Agency taking this action?
* E. What are the estimated incremental impacts of this action?
* F. Children's Environmental Health
* II. Background
* A. History of This Rulemaking
* B. Other Provisions of TSCA Section 6
* C. PCTP Overview, Health Effects, and Exposure
* D. EPA's Proposed Rule Under TSCA Section 6(h) for PCTP
* E. Public Comments and Other Public Input
* F. Activities Not Directly Regulated by This Rule
* III. Provisions of This Final Rule
* A. Scope and Applicability
* B. TSCA Section 6(c)(2) Considerations
* C. TSCA Section 26(h) Considerations
* IV. References
* V. Statutory and Executive Order Reviews
* A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
* B. Executive Order 13771: Reducing Regulation and Controlling Regulatory
Costs
* C. Paperwork Reduction Act (PRA)
* D. Regulatory Flexibility Act (RFA)
* E. Unfunded Mandates Reform Act (UMRA)
* F. Executive Order 13132: Federalism
* G. Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments
* H. Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks
* I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
* J. National Technology Transfer and Advancement Act (NTTAA)
* K. Executive Order 12898: Federal Actions To Address Environmental Justice
in Minority Populations and Low-Income Populations
* L. Congressional Review Act (CRA)
* List of Subjects 40 CFR Part 751
* PART 751—REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER
SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
* Subpart E—Persistent, Bioaccumulative, and Toxic Chemicals
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PUBLIC INSPECTION
PUBLISHED DOCUMENT
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Start Preamble
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
The Environmental Protection Agency is finalizing a rule under the Toxic
Substances Control Act (TSCA) to address its obligations under TSCA for
pentachlorothiophenol (PCTP) (CASRN 133-49-3), which EPA has determined meets
the requirements for expedited action under TSCA. This final rule prohibits all
manufacturing (including import), processing, and distribution in commerce of
PCTP and PCTP-containing products or articles for any use, unless PCTP
concentrations are at or below 1% by weight. This rule will result in lower
amounts of PCTP being manufactured, processed, and distributed, which will
impact the amount that will be available for use or disposal, thus reducing the
exposures to humans and the environment.
DATES:
This final rule is effective February 5, 2021. For purposes of judicial review
and 40 CFR 23.5, this rule shall be promulgated at 1 p.m. eastern standard time
on January 21, 2021.
ADDRESSES:
The docket for this action, identified by docket identification (ID) number
EPA-HQ-OPPT-2019-0080, 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 (202) 566-1744,
and the telephone number for the OPPT Docket is (202) 566-0280. Please review
the visitor instructions and additional information about the docket available
at http://www.epa.gov/ dockets.
Please note that due to the public health emergency, the EPA Docket Center
(EPA/DC) and Reading Room was closed to public visitors on March 31, 2020. Our
EPA/DC staff will continue to provide customer service via email, phone, and
webform. For further information on EPA/DC services, docket contact information
and the current status of the EPA/DC and Reading Room, please visit
https://www.epa.gov/ dockets.
Start Further Info
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Brooke Porter, Existing Chemical Management
Division, Office of Pollution Prevention and Toxics, (7404T), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001;
telephone number: (202) 564-6388; email address: porter.brooke@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email
address: TSCA-Hotline@epa.gov.
End Further Info End Preamble Start Supplemental Information
SUPPLEMENTARY INFORMATION:
I. EXECUTIVE SUMMARY
A. DOES THIS ACTION APPLY TO ME?
You may be potentially affected by this action if you manufacture (including
import), process, distribute in commerce, or use pentachlorothiophenol (PCTP) or
products or articles that contain PCTP, especially rubber products. The
following list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected entities
may include:
* Sporting and Athletic Goods Manufacturing (NAICS Code 339920);
* Sporting and Recreational Goods and Supplies Merchant Wholesale (NAICS Code
423910);
* Sporting Goods Stores (NAICS Code 451110);
* All Other Rubber Product Manufacturing (NAICS Code 326299).
If you have any questions regarding the applicability of this action to a
particular entity, consult the technical information contact listed under FOR
FURTHER INFORMATION CONTACT.
B. WHAT IS THE AGENCY'S AUTHORITY FOR TAKING THIS ACTION?
Section 6(h) of TSCA, 15 U.S.C. 2601 et seq., directs EPA to issue a final rule
under TSCA section 6(a) on certain persistent, bioaccumulative, and toxic (PBT)
chemical substances. PCTP (CASRN 87-86-5), primarily found as an impurity in the
zinc salt of PCTP, is one such chemical substance. EPA must take action on those
chemical substances identified in the 2014 Update to the TSCA Work Plan for
Chemical Assessments (Ref. 1) that, among other factors, EPA has a reasonable
basis to conclude are toxic and that with respect to persistence and
bioaccumulation score high for one and either high or moderate for the other,
pursuant to the TSCA Work Plan Chemicals: Methods Document (Ref. 2). TSCA
section 6(h) directs EPA to take expedited action on these chemical substances,
regardless of whether that substance is primarily found as an impurity or
byproduct, to reduce exposure to the substance, including to exposure to the
substance as an impurity or byproduct, to the extent practicable. This final
rule is final agency action for purposes of judicial review under TSCA section
19(a).
C. WHAT ACTION IS THE AGENCY TAKING?
EPA published a proposed rule on July 29, 2019 to address the five PBT chemicals
EPA identified pursuant to TSCA section 6(h) (84 FR 36728; FRL-9995-76). After
publication of the proposed rule, EPA determined to address each of the five PBT
chemicals in separate final actions. This final rule prohibits the manufacture
(including import), processing, and distribution in commerce of PCTP and
products and articles containing PCTP, unless PCTP concentrations are at or
below 1% by weight. Specifically, all persons are prohibited from all
manufacturing and processing of PCTP or PCTP-containing products or articles,
unless PCTP concentrations are at or below 1% by weight after March 8, 2021, and
all persons are prohibited from all distribution in commerce of PCTP or
PCTP-containing products or articles, unless PCTP concentrations are at or below
1% by weight after January 6, 2022. In addition, after March 8, 2021, persons
manufacturing, processing, and distributing in commerce PCTP and articles and
products containing PTCP must maintain, for three years from the date the record
is generated, ordinary business records related to compliance with the
prohibitions and restrictions that include the name of the purchaser and list
the products or articles. This Start Printed Page 912provision is not intended
to require subject companies to retain records in addition to those specified
herein, expect as needed pursuant to normal business operations.
D. WHY IS THE AGENCY TAKING THIS ACTION?
EPA is issuing this final rule to fulfill EPA's obligations under TSCA section
6(h) 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.
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 6(h)”
(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.
* 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.
F. CHILDREN'S ENVIRONMENTAL HEALTH
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 Agency's Policy on Evaluating Health Risks to Children
(https://www.epa.gov/ children/ epas-policy-evaluating-risk-children) 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).
II. BACKGROUND
A. HISTORY OF THIS RULEMAKING
TSCA section 6(h) requires EPA to take expedited regulatory action under TSCA
section 6(a) 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 6(h) (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 (EPA-HQ-OPPT-2019-0080-0544),
(EPA-HQ-OPPT-2019-0080-0553), (EPA-HQ-OPPT-2019-0080-0556),
(EPA-HQ-OPPT-2019-0080-0562) 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 6(h)(1)(A), the chemical substances subject to expedited
action are those that:
* EPA has a reasonable basis to conclude are toxic and that with respect 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. 114-182, 130 Stat. 448).
In addition, in order for a chemical substance to be subject to expedited
action, TSCA section 6(h)(1)(B) 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 6(h)(2) further provides that the
Administrator shall not be required to conduct risk evaluations on chemical
substances that are subject to TSCA section 6(h)(1).
Based on the criteria set forth in TSCA section 6(h), EPA proposed to determine
that five chemical substances meet the TSCA section 6(h)(1)(A) 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. EPA's approach for implementing TSCA section 6(h)(4).
TSCA section 6(h)(4) requires EPA to issue a final TSCA section 6(a) rule to
Start Printed Page 913“address the risks of injury to health or the environment
that the Administrator determines are presented by the chemical substance and
reduce exposure to the substance to the extent practicable.” EPA reads this text
to require action on the chemical, not specific conditions of use.
The approach EPA takes is consistent with the language of TSCA section 6(h)(4)
and its distinct differences from other provisions of TSCA section 6 for
chemicals that are the subject of required risk evaluations. First, the term
“condition of use” is only used in TSCA section 6(h) in the context of the TSCA
section 6(h)(1)(B) finding relating to likely exposures under “conditions of
use” to “the general population or to a potentially exposed or susceptible
subpopulation . . . or the environment.” In contrast to the risk evaluation
process under TSCA section 6(b), this TSCA section 6(h)(1)(B) threshold
criterion is triggered only through an Exposure and Use Assessment regarding the
likelihood of exposure and does not require identification of every condition of
use. As a result, EPA collected all the information it could on the use of each
chemical substance, without regard to whether any chemical activity would be
characterized as “known, intended or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of,” and from that
information created use profiles and then an Exposure and Use Assessment (Ref.
4) to make the TSCA section 6(h)(1)(B) finding for at least one or more
“condition of use” activities where some exposure is likely. EPA did not attempt
to precisely classify all activities for each chemical substance as a “condition
of use” and thus did not attempt to make a TSCA section 6(h)(1)(B) finding for
all chemical activities summarized in the Exposure and Use Assessment (Ref. 4).
Second, TSCA section 6 generally requires a risk evaluation under TSCA section
6(b) for chemicals based on the identified conditions of use. However, pursuant
to TSCA section 6(h)(2), for chemical substances that meet the criteria of TSCA
section 6(h)(1), a risk evaluation is neither required nor contemplated to be
conducted for EPA to meet its obligations under TSCA section 6(h)(4). Rather, as
noted in Unit II.B.3., if a previously prepared TSCA risk assessment exists, EPA
would have authority to use that risk assessment to “address risks” under TSCA
section 6(h)(4), but even that risk assessment would not necessarily be focused
on whether an activity is “known, intended or reasonably foreseen,” as those
terms were not used in TSCA prior to the 2016 amendments and a preexisting
assessment of risks would have had no reason to use such terminology or make
such judgments. It is for this reason EPA believes that the TSCA section 6(h)(4)
“address risk” standard refers to the risks the Administrator determines “are
presented by the chemical substance” and makes no reference to “conditions of
use.” Congress did not contemplate or require a risk evaluation identifying the
conditions of use as defined under TSCA section 3(4). The kind of analysis
required to identify and evaluate the conditions of use for a chemical substance
is only contemplated in the context of a TSCA section 6(b) risk evaluation, not
in the context of an expedited rulemaking to address PBT chemicals.
Similarly, the TSCA amendments require EPA to “reduce exposure to the substance
to the extent practicable,” without reference to whether the exposure is found
“likely” pursuant to TSCA section 6(h)(1)(B).
Taking all of this into account, EPA reads its TSCA section 6(h)(4) obligation
to apply to the chemical substance generally, thus requiring EPA to address
risks and reduce exposures to the chemical substance without focusing on whether
the measure taken is specific to an activity that might be characterized as a
“condition of use” as that term is defined in TSCA section 3(4) and interpreted
by EPA in the Risk Evaluation Rule, 82 FR 33726 (July 20, 2017). This approach
ensures that any activity involving a TSCA section 6(h) PBT chemical, past,
present or future, is addressed by the regulatory approach taken. Thus, under
this final rule, manufacturing, processing, and distribution in commerce
activities that are not specifically excluded are prohibited. The specified
excluded activities are those which EPA determined were not appropriate to
regulate under TSCA section 6(h)(4) standard. Consistently, based on the
Exposure and Use Assessment, activities associated with PCTP are that are no
longer occurring are addressed by this rule and thus the prohibitions adopted in
this rule reduce the exposures that will result with resumption of past
activities or the initiation of similar or other activities in the future.
Therefore, EPA has determined that prohibiting these activities will reduce
exposures to the extent practicable. The approach taken for this final rule is
limited to implementation of TSCA section 6(h) and is not relevant to any other
action under TSCA section 6 or other TSCA statutory actions.
2. EPA's interpretation of “practicable.”
The term “practicable” is not defined in TSCA. EPA interprets this requirement
as generally directing the Agency to consider such factors as achievability,
feasibility, workability, and reasonableness. In addition, EPA's approach to
determining whether particular prohibitions or restrictions are practicable is
informed in part by certain other provisions in TSCA section 6, such as TSCA
section 6(c)(2)(A), which requires the Administrator to consider health effects,
exposure, and environmental effects of the chemical substance; benefits of the
chemical substance; and the reasonably ascertainable economic consequences of
the rule. In addition, pursuant to TSCA section 6(c)(2)(B), in selecting the
appropriate TSCA section 6(a) regulatory approach, the Administrator is directed
to “factor in, to the extent practicable” those same considerations.
EPA received comments on the proposed rule regarding this interpretation of
“practicable.” EPA has reviewed these comments and believes the interpretation
described previously within this Unit is consistent with the intent of TSCA and
has not changed that interpretation. EPA's interpretation of an ambiguous
statutory term receives deference. More discussion on these comments can be
found in the Response to Comments document for this rulemaking (Ref. 4).
3. EPA did not conduct a risk evaluation or risk assessment.
As EPA explained in the proposed rule, EPA does not interpret the “address risk”
language to require EPA to determine, through a risk assessment or risk
evaluation, whether risks are presented. EPA believes this reading gives the
Administrator the flexibility Congress intended for issuance of expedited rules
for PBTs and is consistent with TSCA section 6(h)(2) which makes clear risk
evaluation is not required to support this rulemaking.
EPA received comments on the proposed rule regarding its interpretation of TSCA
section 6(h)(4) and regarding EPA's lack of risk assessment or risk evaluation
of PCTP. A number of commenters asserted that while EPA was not compelled to
conduct a risk evaluation, EPA should have conducted a risk evaluation under
TSCA section 6(b) regardless. The rationales provided by the commenters for such
a risk assessment or risk evaluation included that one was needed for EPA to
fully quantify the benefits to support this rulemaking, and that without a risk
evaluation, EPA would not be able to determine the Start Printed Page
914benefits, risks, and cost effectiveness of the rule in a meaningful way. As
described by the commenters, EPA would therefore not be able to meet the TSCA
section 6(c)(2) requirement for a statement of these considerations. Regarding
the contradiction between the mandate in TSCA section 6(h) to expeditiously
issue a rulemaking and the time needed to conduct a risk evaluation, some
commenters stated that EPA would have had enough time to conduct a risk
evaluation and issue a proposed rule by the statutory deadline.
EPA disagrees with the commenters' interpretation of EPA's obligations with
respect to chemicals subject to TSCA section 6(h)(4). TSCA section 6(h)(4)
provides that EPA shall: (1) “Address the risks of injury to health or the
environment that the Administrator determines are presented by the chemical
substance” and (2) “reduce exposure to the substance to the extent practicable.”
With respect to the first requirement, that standard is distinct from the
“unreasonable risk” standard for all other chemicals for which a section 6(a)
rule might be issued. EPA does not believe that TSCA section 6(h) contemplates a
new evaluation of any kind, given evaluations to determine risks are now
addressed through the TSCA section 6(b) risk evaluation process and TSCA section
6(h)(2) explicitly provides that no risk evaluation is required. Moreover, it
would have been impossible to prepare a meaningful evaluation under TSCA and
subsequently develop a proposed rule in the time contemplated for issuance of a
proposed rule under TSCA section 6(h)(1). Although EPA does not believe the
statute contemplates a new evaluation of any kind for these reasons, EPA
reviewed the hazard and exposure information on the five PBT chemicals EPA had
compiled. However, while this information appropriately addresses the criteria
of TSCA section 6(h)(1)(A) and (B), it did not provide a basis for EPA to
develop sufficient and scientifically robust and representative risk estimates
to evaluate whether or not any of the chemicals present an identifiable risk of
injury to health or the environment.
Rather than suggesting a new assessment is required, EPA reads the “address
risk” language in TSCA section 6(h)(4) to contemplate reliance on an existing
EPA assessment under TSCA, similar to a risk assessment that may be permissibly
used under TSCA section 26(l)(4) to regulate the chemical under TSCA section
6(a). This interpretation gives meaning to the “address risk” phrase, without
compelling an evaluation contrary to TSCA section 6(h)(2) and would allow use of
an existing determination, or development of a new determination based on such
an existing risk assessment, in the timeframe contemplated for issuance of a
proposed rule under TSCA section 6(h). However, there were no existing EPA
assessments of risk for any of the PBT chemicals. Thus, because EPA had no
existing EPA risk assessments or determinations of risk, the regulatory measures
addressed in this final rule focus on reducing exposures “to the extent
practicable.”
In sum, because neither the statute nor the legislative history suggests that a
new evaluation is compelled to identify and thereby provide a basis for the
Agency to “address risks” and one could not be done prior to preparation and
timely issuance of a proposed rule, and no existing TSCA risk assessment exists
for any of the chemicals, EPA has made no risk determination finding for any of
the PBT chemicals. Instead, EPA implements the requirement of TSCA section
6(h)(4) by reducing exposures of each PBT chemical “to the extent practicable.”
For similar reasons, EPA does not believe that TSCA section 6(c)(2) requires a
quantification of benefits, much less a specific kind of quantification. Under
TSCA section 6(c)(2)(A)(iv), EPA must consider and publish a statement, based on
reasonably available information, on the reasonably ascertainable economic
consequences of the rule, but that provision does not require quantification,
particularly if quantification is not possible. EPA has reasonably complied with
this requirement by including a quantification of direct costs and a qualitative
discussion of benefits in each of the preambles to the final rules. EPA was
unable to quantify the indirect costs associated with the rule. More discussion
on the issue raised is in the Response to Comments document (Ref. 4).
4. Replacement parts and articles.
In the preamble to the proposed rule, EPA explained that it did not read
provisions of TSCA that conflict with TSCA section 6(h) to apply to TSCA section
6(h) rules. Specifically, TSCA sections 6(c)(2)(D) and (E) require a risk
finding pursuant to a TSCA section 6(b) risk evaluation to regulate replacement
parts and articles. Yet, TSCA section 6(h) neither compels nor contemplates a
risk evaluation to precede or support the compelled regulatory action to
“address the risks. . .” and “reduce exposures to the substance to the extent
practicable”. TSCA section 6(h)(2) makes clear no risk evaluation is required,
and the timing required for conducting a risk evaluation is not consistent with
the timing compelled for issuance of a proposed rule under TSCA section 6(h).
Moreover, even assuming a prior risk assessment might allow a risk determination
under the TSCA section 6(h)(4) “address risk” standard, such assessment would
still not satisfy the requirement in TSCA section 6(c)(2)(D) and (E) for a risk
finding pursuant to a TSCA section 6(b) risk evaluation. Because of the clear
conflict between these provisions, EPA determined that those provisions of TSCA
section 6(c) that assume the existence of a TSCA section 6(b) risk evaluation do
not apply in the context of this TSCA section 6(h) rulemaking. Instead, EPA
resolves this conflict in these provisions by taking into account the TSCA
section 6(c) considerations in its determinations as to what measures “reduce
exposure to the substance to the extent practicable”.
Commenters contended that TSCA section 6(c)(2)(D) and (E) bar a TSCA section
6(h) rule in the absence of a risk evaluation, representing Congress's
recognition of the special burdens associated with regulating replacement parts
and articles and the difficulty importers face in knowing what chemicals are
present in the articles they import. As noted earlier in this Unit and further
discussed in the Response to Comment document, while EPA determined that
provisions of TSCA section 6(c)(2)(D) and (E) do not apply because they conflict
with the requirements of TSCA section 6(h), EPA interpreted the “practicability”
standard in TSCA section 6(h)(4) to reasonably contemplate the considerations
embodied by TSCA section 6(c)(2)(D) and (E). As a result, EPA disagrees with any
suggestions that the clear conflict between Congress' mandates in TSCA section
6(h) and TSCA section 6(c)(2)(D) and (E) must be read to bar regulation of
replacement parts and articles made with chemicals that Congress believed were
worthy of expedited action under TSCA section 6(h) and in the absence of a risk
evaluation. The statute does not clearly communicate that outcome. Instead,
Congress left ambiguous how best to address the conflict in these provisions,
and EPA's approach for taking into consideration the TSCA section 6(c)(2)(D) and
(E) concepts in its TSCA section 6(h)(4) “practicability” determinations is a
reasonable approach. In addition, with respect to comments that TSCA section
6(c)(2)(D) and (E) were intended to address Congress's concerns regarding
burdens associated with regulation of replacement parts and articles, EPA agrees
that these concerns are relevant Start Printed Page 915and takes them into
account in its implementation of the TSCA section 6(h)(4) mandate, with respect
to the circumstances for each chemical. Finally, EPA does not believe that
Congress intended, through the article provisions incorporated into the TSCA
amendments, to absolve importers of the duty to know what they are importing.
Importers can and should take steps to determine whether the articles they are
importing contain chemicals that are prohibited or restricted. Therefore, as
discussed earlier in this Unit and in the Response to Comment document, EPA is
continuing to interpret TSCA sections 6(c)(2)(D) and 6(c)(2)(E) to be
inapplicable to this rulemaking. While this interpretation has not changed, EPA
has reviewed the practicability of regulating replacement parts and articles in
accordance with the statutory directive in TSCA section 6(h)(4) to reduce
exposures to the PBT chemicals to the extent practicable. This is discussed
further in Unit III.A.
C. PCTP OVERVIEW, HEALTH EFFECTS, AND EXPOSURE
Historically, PCTP was used in rubber manufacturing as a peptizer, or a chemical
that makes rubber more amenable to processing. As described in the proposed
rule, there are few data on end-use products and articles that contain PCTP. For
years, PCTP was produced in the United States, but domestic manufacture appears
to have ceased (Ref. 6). Although it is likely that PCTP is no longer used as a
peptizer, it can be found as an impurity in the zinc salt of PCTP (zinc PCTP)
(CASRN 117-97-5) after zinc PCTP manufacturing (Ref. 7). As shown by a number of
patents, zinc PCTP can be used as a peptizer in rubber manufacturing and as an
ingredient in the rubber core of golf balls to enhance certain performance
characteristics of the ball, such as spin, rebound, and distance (Ref. 8, 9, and
10). EPA considers the presence of PCTP in rubber during manufacturing, whether
as a peptizer or an impurity, to be processing under TSCA. Zinc PCTP is imported
into the United States, with approximately 65,000 lbs. imported in 2017 (Ref.
3). EPA believes that some or all of the zinc PCTP could contain PCTP. The
importation of PCTP, including as an impurity with zinc PCTP, is considered
manufacturing under TSCA.
There is likely exposure to the general population, workers, and the
environment, including water releases from process water and from cleaning the
processing area and equipment, and worker exposure during unloading and transfer
of the chemical. Women of childbearing age exposed in the workplace may transfer
PCTP to infants via breastmilk. Exposure information for PCTP is detailed in
EPA's Exposure and Use Assessment (Ref. 5) and the proposed rule.
PCTP is toxic to protozoa, fish, terrestrial plants, and birds. Data for
analogous chemicals (pentachloronitrobenzene and hexachlorobenzene) indicate the
potential for liver effects in mammals and systemic (body weight) effects for
PCTP in mammals (no repeated-dose animal or human epidemiological data were
identified for PCTP) (Ref. 11). The studies presented in the document entitled
“Environmental and Human Health Hazards of Five Persistent, Bioaccumulative and
Toxic Chemicals (Hazard Summary) (Ref. 11) demonstrate these hazardous
endpoints. EPA did not perform a systematic review or a weight of the scientific
evidence assessment for the hazard characterization of these chemicals. As a
result, this hazard characterization is not definitive or comprehensive. Other
hazard information on these chemicals may exist in addition to the studies
summarized in the Hazard Summary that could alter the hazard characterization.
In the 2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 1), PCTP
scored high (3) for hazard (based on toxicity for acute and chronic exposures);
low (1) for exposure (based on 2012 CDR data); and high (3) for persistence and
bioaccumulation (based on high environmental persistence and high
bioaccumulation potential). The overall screening score for PCTP was high (7).
In consideration of the production and use of PCTP, the environmental and human
health hazards of PCTP, and the public comments on the proposed rule that are
further discussed in Unit III.A., EPA determines that PCTP meets the TSCA
section 6(h)(1)(A) criteria. In addition, EPA determines, in accordance with
TSCA section 6(h)(1)(B), that, based on the Exposure and Use Assessment and
other reasonably available information, exposure to PCTP under the conditions of
use is likely to the general population, to a potentially exposed or susceptible
subpopulation, or to the environment. EPA's determination is based on the
opportunities for exposure throughout the lifecycle of PCTP, including the
potential for consumer exposures. EPA did not receive any significant comments
or information to call the exposure finding into question.
D. EPA'S PROPOSED RULE UNDER TSCA SECTION 6(H) FOR PCTP
In the proposed rule, EPA proposed to prohibit all manufacturing, processing,
and distribution of PCTP and PCTP-containing products and articles for any use,
unless PCTP concentrations are at or below 1% by weight.
In addition, EPA proposed to require, that all persons who manufacture, process,
or distribute in commerce PCTP and articles and products containing PCTP
maintain ordinary business records, such as invoices and bills-of-lading, that
demonstrate compliance with the prohibitions and restrictions. EPA proposed that
these records will have to be maintained for a period of three years from the
date the record is generated.
E. PUBLIC COMMENTS AND OTHER PUBLIC INPUT
The proposed rule provided a 60-day public comment period, with a 30-day
extension provided (Ref. 4). The comment period closed on October 28, 2019. EPA
received a total of 48 comments, with three commenters sending multiple
submissions with attached files, for a total of 58 submissions. This includes
the previous request for a comment period extension
(EPA-HQ-OPPT-2019-0080-0526). Two commenters submitted confidential business
information (CBI) or copyrighted documents with information regarding economic
analysis and market trends. Copies of all the non-CBI documents, or redacted
versions without CBI, are available in the docket for this action.
In this preamble, EPA has responded to the major comments relevant to the PCTP
final rule. Of the comment submissions, 10 directly addressed EPA's proposed
regulation of PCTP. Additional discussion related to this final action can be
found in the Response to Comments document (Ref. 4).
F. ACTIVITIES NOT DIRECTLY REGULATED BY THIS RULE
EPA is not regulating all activities or exposures to PCTP, even though the
Exposure and Use Assessment (Ref. 5) identified potential for exposures under
many conditions of use. One such activity is disposal. EPA generally presumes
compliance with federal and state laws and regulations, including, for example,
the Resource Conservation and Recovery Act (RCRA) and its implementing
regulations and state laws, as well as the Clean Air Act, the Clean Water Act,
and the Safe Drinking Water Act (SDWA). As described in the Start Printed Page
916proposed rule, regulations promulgated under the authority of RCRA, govern
the disposal of hazardous and non-hazardous wastes. Although PCTP is not a
listed hazardous waste under RCRA, it is subject to the requirements applicable
to solid waste under Subtitle D of RCRA. This means there is a general
prohibition on open dumping, which includes a prohibition on open burning.
Wastes containing this chemical that do not otherwise meet the criteria for
hazardous waste would be disposed of in municipal solid waste landfills
(MSWLFs), industrial nonhazardous, or, in a few instances,
construction/demolition landfills. Non-hazardous solid waste is regulated under
Subtitle D of RCRA, and states play a lead role in ensuring that the federal
requirements are met. The requirements for MSWLFs include location restrictions,
composite liners, leachate collection and removal systems, operating practices,
groundwater monitoring, closure and post-closure care, corrective action
provisions, and financial assurance. Industrial waste (non-hazardous) landfills
and construction/demolition waste landfills are primarily regulated under state
regulatory programs, and in addition they must meet the criteria set forth in
federal regulations which may include requirements such as siting, groundwater
monitoring and corrective action depending upon what type of wastes are
accepted. Disposal by underground injection is regulated under both RCRA and
SDWA. In view of these comprehensive, stringent programs for addressing
disposal, EPA determined that it is not practicable to impose additional
requirements under TSCA on the disposal of the PBT chemicals, including PCTP.
EPA received a number of comments on this aspect of its proposal. Some
commenters agreed with EPA's proposed determination that it is not practicable
to regulate disposal, while others disagreed. However, in EPA's view,
establishing an entirely new disposal program for PCTP-containing wastes would
be expensive and difficult to establish and administer. A requirement to treat
these wastes as if they were listed as hazardous wastes would have impacts on
hazardous waste disposal capacity and be very expensive for states and local
governments, as well as for affected industries. Therefore, EPA has determined
that it is not practicable to further regulate PCTP-containing wastes. More
information on the comments received and EPA's responses can be found in the
Response to Comments document (Ref. 4).
EPA proposed not to use its TSCA section 6(a) authorities to directly regulate
occupational exposures. As explained in the proposed rule, as a matter of
policy, EPA assumes compliance with federal and state requirements, such as
worker protection standards, unless case-specific facts indicate otherwise. The
Occupational Safety and Health Administration (OSHA) has not established a
permissible exposure limit (PEL) for PCTP. However, under section 5(a)(1) of the
Occupational Safety and Health Act of 1970, 29 U.S.C. 654(a)(1), each employer
has a legal obligation to furnish to each of its employees employment and a
place of employment that are free from recognized hazards that are causing or
are likely to cause death or serious physical harm. The OSHA Hazard
Communication Standard at 29 CFR 1910.1200 requires chemical manufacturers and
importers to classify the hazards of chemicals they produce or import, and all
employers to provide information to employees about hazardous chemicals to which
they may be exposed under normal conditions of use or in foreseeable
emergencies. The OSHA standard at 29 CFR 1910.134(a)(1) requires the use of
feasible engineering controls to prevent atmospheric contamination by harmful
substances and requires the use of respirators where effective engineering
controls are not feasible. The OSHA standard at 29 CFR 1910.143(c) details the
required respiratory protection program. The OSHA standard at 29 CFR 1910.132(a)
requires the use of personal protective equipment (PPE) by workers when
necessary due to a chemical hazard; 29 CFR 1910.133 requires the use of eye and
face protection when employees are exposed to hazards including liquid
chemicals; and 29 CFR 1910.138 requires the use of PPE to protect employees'
hands including from skin absorption of harmful substances. The provisions of 29
CFR 1910.132(d) and (f) address hazard assessment, PPE selection, and training
with respect to PPE required under 29 CFR 1910.133, 1910.135, 1910.136,
1910.138, and 1910.140. EPA assumes that employers will require, and workers
will use, appropriate PPE consistent with OSHA standards, taking into account
employer-based assessments, in a manner sufficient to prevent occupational
exposures that are capable of causing injury.
EPA assumes compliance with other federal requirements, including OSHA standards
and regulations. EPA does not read TSCA section 6(h)(4) to direct EPA to adopt
potentially redundant or conflicting requirements. Not only would it be
difficult to support broadly applicable and safe additional measures for each
specific activity without a risk evaluation and in the limited time for issuance
of this regulation under TSCA section 6(h), but imposing such measures without
sufficient analysis could inadvertently result in conflicting or confusing
requirements and make it difficult for employers to understand their
obligations. Furthermore, EPA cannot conclude that broadly imposing specific
measures is practicable for all of the varied workplaces. Rather, where EPA has
identified worker exposures and available substitutes, EPA is finalizing
measures to reduce those exposures. As discussed in the proposed rule, EPA
assumes that the worker protection methods used by employers, including in
response to existing OSHA standards, in addition to the regulatory measures
taken for each chemical, meaningfully reduce the potential for occupational
exposures. Although some commenters agreed with this approach, others thought
EPA should establish worker protection requirements for those uses that would be
allowed to continue under the final rule. Information provided to EPA before and
during the public comment period on the proposed rule indicates that employers
are using engineering and process controls and providing appropriate personal
protective equipment (PPE) to their employees consistent with these requirements
and EPA received no information on PCTP to suggest this is not the case.
Further, EPA has not conducted a risk evaluation on PCTP or any of the other PBT
chemicals. Without a risk evaluation and given the time allotted for this
rulemaking, EPA cannot identify additional engineering or process controls or
PPE requirements that would be appropriate to each chemical-specific
circumstance. For these reasons, EPA has determined that it is not practicable
to regulate worker exposures in this rule through additional engineering or
process controls or PPE requirements.
EPA received comments regarding the use of PBT chemicals in research and
development and lab use. Lab use is addressed under newly established 40 CFR
751.401(b) as the manufacturing, processing, distribution-in-commerce and use of
any chemical substance, or products and articles that contain the chemical
substance, for research and development, as defined in new 40 CFR 751.403.
“Research and Development” is defined in new 40 CFR 751.403 to mean laboratory
and research use only for purposes of scientific Start Printed Page
917experimentation or analysis, or chemical research on, or analysis of, the
chemical substance, including methods for disposal, but not for research or
analysis for the development of a new product, or refinement of an existing
product that contains the chemical substance. This will allow, for example, for
samples of environmental media containing PBTs, such as contaminated soil and
water, to be collected, packaged and shipped to a laboratory for analysis.
Laboratories also must obtain reference standards containing PBTs to calibrate
their equipment, otherwise they may not be able to accurately quantify these
chemical substances in samples being analyzed. However, research to develop new
products that use PBTs subject to 40 CFR part 751, subpart E, or the refinement
of existing uses of those chemicals, is not included in this definition, and
those activities remain potentially subject to the chemical specific provisions
in 40 CFR part, 751 subpart E. EPA believes it is not practicable to limit
research and development activity as defined, given the critical importance of
this activity to the detection, quantification, and control of these chemical
substances.
Finally, EPA received comments regarding requirements for recycling and resale
of PCTP-containing products and articles, as well as other PBT chemicals
undergoing Section 6(h) rulemaking. One commenter stated that because the
proposed definition of “person” includes “any natural person,” the proposed
prohibitions would seem to apply to anyone selling golf balls containing PCTP
above the 1% concentration by weight threshold at a garage or yard sale
(EPA-HQ-OPPT-2019-0080-0559). EPA did not intend to impose these final PCTP
regulations on yard sales or used golf ball sales and has added a provision in
40 CFR 751.401 to clarify this issue. Distribution in commerce of PCTP, or
products and articles that contain PCTP, that have previously been sold or
supplied to an end user are excluded. The prohibition and recordkeeping
requirements in this final rule exclude PCTP-containing products and articles
that have previously been sold or supplied to an end user for purposes other
than resale. An individual or entity that purchased or acquired the finished
good in good faith for purposes other than resale are excluded; for example, a
consumer who resells a product they no longer intend to use or donates a product
or article to charity, such as a golf course that resells used PCTP-containing
golf balls it no longer intends to use, or donates used PCTP-containing golf
balls to charity.
III. PROVISIONS OF THIS FINAL RULE
A. SCOPE AND APPLICABILITY
EPA carefully considered all public comments related to the proposal. This rule
finalizes EPA's proposal to prohibit the manufacturing, processing, and
distribution in commerce of PCTP or PCTP-containing products and articles,
unless PCTP concentrations are at or below 1% by weight, with changes being made
from the proposal to the compliance date of distribution in commerce of PCTP and
PCTP-containing products and articles.
1. Banning PCTP.
EPA received numerous comments regarding the practicability of regulating PCTP.
Specifically, commenters expressed concern with EPA's statement that it would be
“unreasonable, because of the low concentrations of PCTP in golf balls, for
example, and thus, impracticable to prohibit or otherwise restrict the continued
commercial use of the products” (84 FR 145). Some commenters stated that a ban
would be practicable given that EPA had already identified the sole golf ball
manufacturer using PCTP. Commenters also discussed practicability in the context
of availability of PCTP alternatives. Other commenters supported EPA's proposed
rule and stated that EPA's regulation will allow manufacturers to continue the
safe use of zinc PCTP while restricting potentially more dangerous uses of PCTP
in greater concentrations or in its pure form.
EPA received comments from one processor of PCTP (i.e., a golf ball
manufacturer) stating that its processes are currently within the proposed 1%
concentration by weight threshold. This commenter provided data regarding
potential exposures, showing little to no exposure to humans or the environment.
This commenter stated that even if the PCTP product (e.g., within the rubber of
the golf ball's core) is “exposed to the environment through some mechanism, the
[zinc-PCTP] compound is bound-up in the solid rubber that makes up the core
material” (EPA-HQ-OPPT-2019-0080-0566). This commenter also provided EPA with
information from tests assessing leachability of the core material using U.S.
EPA Method 1311 (i.e., the toxicity characteristic leaching procedure (TCLP)).
The TCLP test resulted in non-detectable levels of PCTP leaching from the rubber
cores of golf balls when they were cut in half or quartered. These study results
were provided in EPA Docket EPA-HQ-OPPT-2016-0738.
EPA believes restricting the allowable concentration will result in limited use
options for PCTP and will encourage the use of available PCTP alternatives, if
other PCTP-related production occurs. EPA does not expect any domestic
production of PCTP or domestic use of PCTP to prepare zinc PCTP, which is the
only known intermediate use of PCTP. Import of zinc PCTP may occur but only if
meeting the concentration threshold of 1% by weight or less of PCTP. As a
result, EPA believes these stringent measures will result in limited use of PCTP
and encourage the use of alternatives, if that has not already occurred.
To the extent there are continued manufacturing and processing of products and
articles, within the permitted 1% threshold, the potential for consumer
exposures is not expected from these known activities or products, e.g., as a
component of golf ball cores. Therefore, EPA does not believe it is practicable
to impose a ban on all manufacture and processing of PCTP at this time.
2. 1% Concentration limit.
EPA requested comment on the proposed concentration limit, including whether the
option is practicable, and whether further exposure reductions would be
practicable. EPA specifically requested comment on the practicability of a lower
limit on the PCTP content in zinc PCTP, and whether it is possible to completely
eliminate unreacted PCTP in the manufacture of zinc PCTP. EPA did not receive
comments on an alternative or lower concentration limit. However, some
commenters did express concern that EPA has not demonstrated that levels below
1% by weight do not present risks. Comments regarding eliminating the
concentration limit altogether and issuing a total ban are discussed in Unit
III.A.1. Other commenters supported the proposed concentration limit and one
commenter provided information on studies to support their opinion that “the 1%
concentration threshold provides a more-than-adequate level of safety for
workers and the public, and the available science does not support any further
restrictions” (EPA-HQ-OPPT-2019-0080-0566).
As noted earlier, zinc PCTP is manufactured using PCTP, by reacting PCTP with
zinc oxide, and depending on the yield of the reaction, zinc PCTP may contain
PCTP as an impurity. Zinc PCTP is sold with varying concentrations of zinc salt,
including at a purity of 99% (Ref. 12). According to several patents, golf balls
can be made Start Printed Page 918using zinc PCTP at this purity (Ref. 9). Since
manufacturing or processing zinc PCTP at 99% purity will comply with the
proposed concentration limit, as will zinc PCTP at lower purities that contains
PCTP at or below 1% concentration by weight, EPA believes that the proposed
concentration limit is practicable and is finalizing a limit prohibiting
manufacturing, processing, and distribution in commerce of PCTP or
PCTP-containing products and articles, unless PCTP concentrations are at or
below 1% by weight. Any manufacturing, including import, or processing of zinc
PCTP containing PCTP above the 1% concentration by weight threshold would not be
permitted, including for use in the manufacture of golf balls. In addition, any
manufacturing, including import, or processing of PCTP above the 1%
concentration by weight threshold to create zinc PCTP would not be permitted.
Thus, the manufacture and processing of PCTP and the presence of PCTP in any
products and articles is significantly impacted by the prohibitions codified in
the final rule. EPA believes restricting the allowable concentration will result
in limited use options for PCTP and will encourage the use of available PCTP
alternatives, if other PCTP-related production occurs. EPA is finalizing a limit
for PCTP concentrations above 1% by weight rather than prohibiting any
manufacture or processing of PCTP for this reason.
3. Compliance date for the prohibitions.
The proposed rule did not delay the compliance date beyond the rule's effective
date; the manufacturing and processing bans would come into effect 60 days after
publication of the final rule notice. EPA stated in the proposed rule that at
that time it had no information indicating that a compliance date of 60 days
after publication of the final rule is not practicable for the activities that
would be prohibited, or that additional time is needed for products to clear the
channels of trade. The phrases “as soon as practicable” and “reasonable
transition period” as used in TSCA section 6(d)(1) are undefined, and the
legislative history on TSCA section 6(d) is limited. Given the ambiguity in the
statute, for purposes of this expedited rulemaking, EPA presumed a 60-day
compliance date was “as soon as practicable,” unless there was support for a
lengthier period of time on the basis of reasonable available information, such
as information submitted in comments on the Exposure and Use Assessment or in
stakeholder dialogues. Such a presumption ensures the compliance schedule is “as
soon as practicable,” particularly in the context of the TSCA section 6(h) rules
for chemicals identified as persistent, bioaccumulative and toxic, and given the
expedited timeframe for issuing a TSCA section 6(h) proposed rule did not allow
time for collection and assessment of new information separate from the comment
opportunities during the development of and in response to the proposed rule.
Such presumption also allows for submission of information from the sources most
likely to have the information that will impact an EPA determination on whether
or how best to adjust the compliance deadline to ensure that the final
compliance deadline chosen is both “as soon as practicable” and provides a
“reasonable transition period.”
EPA received public comments regarding the 60-day compliance date for the
prohibition in the proposed rule. Commenters stated that this date would be
unrealistic and requested that EPA phase in the compliance deadlines for the
bans on importation or distribution of products and articles containing PCTP
over a longer period following promulgation of the final rule
(EPA-HQ-OPPT-2019-0080-0549, EPA-HQ-OPPT-2019-0080-0557). In addition, one
commenter requested EPA allow products or articles containing PCTP that are
manufactured and imported prior to the compliance deadlines to be distributed
thereafter without restriction (EPA-HQ-OPPT-2019-0080-0549). Commenters stated
this would be needed to prevent an untold number of lawfully manufactured and
imported articles from suddenly becoming unsaleable, which would result in
significant costs for retailers and importers. Other commenters supported the
compliance date (EPA-HQ-OPPT-2019-0080-0566).
However, in response to commenters requesting additional time for products and
articles to clear the channels of trade, e.g., given complex supply chains,
including the request for a sell-through provision to clear products and
articles containing PCTP prior to the compliance deadlines, EPA is extending the
compliance date for the prohibition on distribution in commerce to one year.
Extending the compliance date to one year will, as commenters note, allow
additional time for products and articles containing PCTP that were produced
prior to the compliance date for the prohibition on manufacture and processing
to clear channels of trade.
EPA is not extending the compliance date for the prohibition on manufacture and
therefore is not extending the compliance deadline for the prohibition on import
which under TSCA section 3 is a subset of manufacture activities. Unless
reasonably available information otherwise supports that it is not practicable
to impose a 60-day compliance deadline for manufacture, which includes import,
or for processing of PCTP and PCTP-containing products and articles, for
purposes of meeting EPA's obligations under TSCA section 6(h), EPA presumes a
compliance date of 60 days is “as soon as practicable.” EPA received only
general comments taking the position, without support, that the 60-day
compliance period for the prohibition on manufacture or processing is not
practicable, while also receiving more specific support from a manufacturer of
PCTP-containing products for the proposed 60-day timeframe
(EPA-HQ-OPPT-2019-0080-0566).
Therefore, this final rule includes a compliance date of 60 days after
publication of the final rule for the restrictions on manufacturing and
processing and, to address commenters' concerns, a compliance date of one year
after the publication of this final rule for the restrictions on distribution in
commerce of PCTP and PCTP-containing products and articles, unless PCTP
concentrations are at or below 1% by weight.
4. Recordkeeping.
In addition, EPA is requiring that all persons who manufacture, process, or
distribute in commerce PCTP and articles and products containing PCTP maintain
ordinary business records related to compliance with the prohibitions and
restrictions, such as invoices and bills-of-lading. EPA revised this language
slightly from the proposal to improve clarity. These records will have to be
maintained for a period of three years from the date the record is generated,
beginning on March 8, 2021.
B. TSCA SECTION 6(C)(2) CONSIDERATIONS
1. Health effects, exposure, and environmental effects.
PCTP is toxic to protozoa, fish, terrestrial plants, and birds, with data for
analogous chemicals indicating the potential for liver effects in mammals and
systemic effects for PCTP in mammals. These hazard statements are not based on a
systematic review of the available literature and information may exist that
could refine the hazard characterization. Additional information about PTCP's
health effects, use, and exposure is in Unit II.C. and is further detailed in
EPA's Hazard Summary (Ref. 11) and Exposure and Use Assessment (Ref. 5).Start
Printed Page 919
2. The benefits of the chemical substance or mixture for various uses.
During the manufacture of rubber, PCTP has been used as a peptizer to reduce the
viscosity of rubber during processing. PCTP has been used as a mastication agent
in the rubber industry and, more specifically, a peptizing agent for natural
rubber viscosity reduction in the early stages of rubber manufacturing (Ref.
13). Mastication and peptization are processing stages during which the
viscosity of rubber is reduced to a level facilitating further processing (Ref.
14). It is possible to reduce the viscosity of natural and synthetic rubbers
through solely mechanical efforts, but peptizers allow this process to be less
sensitive to varying time and temperature, which improves the uniformity between
batches (Ref. 13).
3. The reasonably ascertainable economic consequences of the rule.
a. Overview of cost methodology. EPA has evaluated the potential costs of the
final action for PCTP. Costs of the final rule were estimated based on the
assumption that under regulatory limitations on PCTP, processors that use PCTP
in their products would switch to available alternative chemicals to manufacture
the product, or to products and articles that do not contain PCTP. Costs were
assessed based on the assumption that manufacturers will use an alternative
chemical, rather than an evaluation of the pricing of pre-existing PCTP-free
products. For PCTP, the costs were assessed based on chemical substitutes only.
Substitution costs were estimated on the industry level using the price
differential between the cost of the chemical (or chemical product) and
identified substitutes. Costs for rule familiarization and recordkeeping were
estimated based on burdens estimated for other similar rulemakings. Costs were
annualized over a 25-year period. Other potential costs include, but are not
limited to, those associated with testing, reformulation, release prevention,
imported articles, and some portion of potential revenue loss. However, these
costs are discussed only qualitatively, due to lack of data availability to
estimate quantified costs. More details of this analysis are presented in the
Economic Analysis (Ref. 3).
b. Estimated costs of this final rule. Total quantified annualized industry
costs for the final rule are approximately $30,000 (at both 3% and 7% discount
rates annualized over 25 years). Total annualized Agency costs associated with
implementation of the final rule were based on EPA's best judgment and
experience with other similar rules. For the final regulatory action, EPA
estimates it will require 0.5 FTE at $77,600 per year (Ref. 3).
Total quantified annualized social costs for the final rule are approximately
$108,000 (at both 3% and 7% discount rates). As described earlier in Unit
III.B.3, potential costs such as testing, reformulation, release prevention, and
imported articles, could not be quantified due to lack of data availability to
estimate quantified costs. These costs are discussed qualitatively in the
Economic Analysis (Ref. 3).
c. Benefits. As discussed in Unit II.A., while EPA reviewed hazard and exposure
information for the PBT chemicals, this information did not provide a basis for
EPA to develop scientifically robust and representative risk estimates to
evaluate whether or not any of the chemicals present a risk of injury to health
or the environment. Benefits were not quantified due to the lack of risk
estimates. A qualitative discussion of the potential benefits associated with
the final action for PCTP is provided. PCTP is persistent, bioaccumulative, and
an aquatic toxicant. There are limited data on the potential effects of PCTP in
mammals and no data were identified on the potential effects of PCTP in humans.
Under the final regulatory action, manufacture and processing of PCTP and
PCTP-containing products and articles will be limited to PCTP concentrations of
1% by weight or lower. With the final rule, there will be lower concentrations
of PCTP in products and articles. These impacts will decrease the potential for
dermal and inhalation PCTP exposures in workers involved in the manufacturing
and processing of PCTP-containing products and articles, e.g., rubber products
and golf balls, and decrease the potential for releases of PCTP to the
environment, including through disposal activities. With decreased potential for
releases to the environment and reduced presence of PCTP in products and
articles, there will also be a decrease of the potential for exposures in the
general population and potentially exposed or susceptible subpopulations,
including through consumption of food from the persistence and bioaccumulation
of food in animals or through persistence and uptake in agricultural food
products. Thus, by reducing the concentration threshold for manufacturing and
processing of PCTP for use in products and articles overall, the final
regulatory action will have benefits for the environment, general population,
and potentially exposed or susceptible subpopulations, such as workers.
d. Cost effectiveness, and effect on national economy, small business, and
technological innovation. With respect to the cost effectiveness of the final
regulatory action and the primary alternative regulatory action, EPA is unable
to perform a traditional cost-effectiveness analysis of the actions and
alternatives for the PBT chemicals. As discussed in the proposed rule, the cost
effectiveness of a policy option would properly be calculated by dividing the
annualized costs of the option by a final outcome, such as cancer cases avoided,
or to intermediate outputs such as tons of emissions of a pollutant curtailed.
Without the supporting analyses for a risk determination, EPA is unable to
calculate either a health-based or environment-based denominator. Thus, EPA is
unable to perform a quantitative cost-effectiveness analysis of the final and
alternative regulatory actions. However, by evaluating the practicability of the
final and alternative regulatory actions, EPA believes that it has considered
elements related to the cost effectiveness of the actions, including the cost
and the effect on exposure to the PBT chemicals of the final and alternative
regulatory actions.
EPA considered the anticipated effect of this rule on the national economy and
concluded that this rule is highly unlikely to have any measurable effect on the
national economy (Ref. 3). EPA analyzed the expected impacts on small business
and found that no small entities are expected to experience impacts of more than
1% of revenues (Ref. 3). Finally, EPA has determined that this rule is unlikely
to have significant impacts on technological innovation, although the rule may
create some incentives for chemical manufacturers to develop new chemical
alternatives to PCTP.
4. Consideration of alternatives.
As the result of a screening level analysis of likely alternatives based on the
TSCA Work Plan Chemicals: Methods Document (Ref. 2), EPA believes that there are
viable substitutes for PCTP in rubber manufacturing. Although this final rule is
not prohibiting the manufacture or processing of PCTP and PCTP-containing
products and articles for any use when PCTP concentrations are at or below 1% by
weight, it is possible that some manufacturers and processors may choose to use
alternatives instead of using PCTP at the concentration limit. At this time, EPA
does not know whether products, including golf balls, are currently being made
with halogenated organosulfur compound substitutes instead of PCTP. Based on
information from patents, EPA believes Start Printed Page 920that use of these
substitutes may be occurring in golf ball manufacturing (Ref. 8, 9, and 15).
Further, only one golf ball manufacturer has confirmed that it incorporates PCTP
into its golf balls. EPA believes this limited use of PCTP is sufficient
evidence of the availability of substitutes.
The potential alternatives were evaluated and scored on three characteristics:
Hazard, exposure and the potential for persistence and/or bioaccumulation. Two
chemicals, diphenyldisulfide and 2,2′-dibenzamidodiphenyl disulfide, scored
lower for at least one characteristic (Ref. 3). With respect to
pentafluorothiophenol, there was not enough information available to score each
characteristic (Ref. 16).
C. TSCA SECTION 26(H) CONSIDERATIONS
In accordance with TSCA section 26(h) and taking into account the requirements
of TSCA section 6(h), EPA has used scientific information, technical procedures,
measures, and methodologies that are fit for purpose and consistent with the
best available science. For example, EPA based its determination that human and
environmental exposures to PCTP are likely in the Exposure and Use Assessment
(Ref. 5) discussed in Unit II.A.2, which underwent a peer review and public
comment process, as well as using best available science and methods sufficient
to make that determination. The extent to which the various information,
procedures, measures, and methodologies, as applicable, used in EPA's decision
making have been subject to independent verification or peer review is adequate
to justify their use, collectively, in the record for this rule. Additional
information on the peer review and public comment process, such as the peer
review plan, the peer review report, and the Agency's response to comments, are
in the public docket for this action (EPA-HQ-OPPT-2018-0314). In addition, in
accordance with TSCA section 26(i) and taking into account the requirements of
TSCA section 6(h), EPA has made scientific decisions based on the weight of the
scientific evidence.
IV. REFERENCES
The following is a list of the documents that are specifically referenced in
this document. The docket includes these documents and other information
considered by EPA, including documents that are referenced within the documents
that are included in the docket, even if the referenced document is not
physically located in the docket. All records in docket EPA-HQ-OPPT-2019-0080
are part of the record for this rulemaking. For assistance in locating these
other documents, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. October 2014.
https://www.epa.gov/ assessingand-managing-chemicals-under-tsca/
tsca-work-plan-chemical-ssessments-2014-update. Accessed March 1, 2019.
2. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012.
https://www.epa.gov/ sites/ production/ files/ 2014-03/ documents/ work_ plan_
methods_ document_ web_ final.pdf. Accessed March 1, 2019.
3. EPA. Economic Analysis for Regulation of Pentachlorothiophenol (PCTP) Under
TSCA Section 6(h). December 2020.
4. EPA. Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under
TSCA Section 6(h); Response to Public Comments. December 2020. (Docket
EPA-HQ-OPPT-2019-0080).
5. EPA. Exposure and Use Assessment of Five Persistent, Bioaccumulative, and
Toxic Chemicals. December 2020. (EPA-HQ-OPPT-2019-0080-0518).
6. EPA. Public Database 2016 Chemical Data Reporting. Washington, DC: US
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
7. Lucas, CR; Peach, ME. (1970). Reactions of Pentachlorothiophenol. Canadian
Journal of Chemistry. 48:1869.
8. Watanabe, Hideo; Kasashima, Atuski, Multi-piece solid golf ball. US Patent
Number US7367901B2, filed January 11, 2007, and published May 6, 2008.
9. Kennedy III, Thomas J., Binette, Mark L., Golf ball, US Patent Number
20060019771, filed July 20, 2004, and published January 26, 2006.
10. EPA. Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Pentachlorothiophenol. August 2017.
(EPA-HQ-OPPT-2016-0739-0003).
11. EPA. Environmental and Human Health Hazards of Five Persistent,
Bioaccumulative and Toxic Chemicals. December 2020.
12. American Elements. Los Angeles, CA. Zinc Chlorothiophenolate.
https://www.americanelements.com/ zincchlorothiophenolate-117-97-5. Accessed
March 3, 2019.
13. National Library of Medicine. ToxNet, Hazardous Substance Data Bank.
Pentachlorothiophenol: CASRN: 133-49-3. https://toxnet.nlm.nih.gov/ cgi-bin/
sis/ search2/ f? ./ temp/ ~ebPHHj:1 Accessed March 4, 2019.
14. Struktol Company of America, LLC. Stow, OH. Rubber Handbook. 2004.
http://www.struktol.com/ pdfs/ RubberHB.pdf. Accessed March 4, 2019.
15. Voorheis PR, Rajagopalan M. Golf ball core compositions comprising
unsaturated long chain organic acids and their salts. US Patent Number:
US6762247B2, filed September 9, 2002, published July 13, 2004.
16. EPA. Persistence, Bioaccumulation, Environmental Hazard and Human Health
Hazard Ratings for Alternatives to PBT Chemicals Proposed for Regulation. April
2019.
17. Keweenaw Bay Indian Community. Re: Notification of Consultation and
Coordination on a Rulemaking Under the Toxic Substances Control Act: Regulation
of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h).
September 25, 2018.
18. Harper, Barbara and Ranco, Darren, in collaboration with the Maine Tribes.
Wabanaki Traditional Cultural Lifeways Exposure Scenario. July 9, 2009.
V. STATUTORY AND EXECUTIVE ORDER REVIEWS
Additional information about these statutes and Executive Orders can be found at
https://www.epa.gov/ laws-regulations-and-executive-orders.
A. EXECUTIVE ORDER 12866: REGULATORY PLANNING AND REVIEW AND EXECUTIVE ORDER
13563: IMPROVING REGULATIONS AND REGULATORY REVIEW
This action is a significant regulatory action that was submitted to the Office
of Management and Budget (OMB) for review under Executive Order 12866 (58 FR
51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes
made in response to OMB recommendations have been documented in the docket for
this action as required by section 6(a)(3)(E) of Executive Order 12866.
EPA prepared an economic analysis of the potential costs and benefits associated
with this action. A copy of this economic analysis, Economic Analysis for
Pentachlorothiophenol Start Printed Page 921(PCTP) Regulation of Under TSCA
Section 6(h) (Ref. 3), is in the docket and is briefly summarized in Unit III.
B.3.
B. EXECUTIVE ORDER 13771: REDUCING REGULATION AND CONTROLLING REGULATORY COSTS
This action is considered a regulatory action under Executive Order 13771 (82 FR
9339, February 3, 2017). Details on the estimated costs of this final rule can
be found in the Economic Analysis (Ref. 3), which is briefly summarized in Unit
III.B.3.
C. PAPERWORK REDUCTION ACT (PRA)
The information collection activities in this rule have been submitted for
approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection
Request (ICR) document that the EPA prepared has been assigned EPA ICR number
2599.02 and OMB Control No. 2070-0213. A copy of the ICR is available in the
docket for this rule, and it is briefly summarized here. The information
collection requirements are not enforceable until OMB approves them.
Respondents/affected entities: Entities potentially affected by paperwork
requirements of this final rule include 4 processors and 1 distributor.
Respondent's obligation to respond: Mandatory (40 CFR 751.411).
Estimated number of respondents: 5.
Frequency of response: On occasion.
Total estimated burden: 2.5 hours (per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $196.50 (per year), includes $0 annualized capital or
operation & maintenance costs.
An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40
CFR part 9. When OMB approves this ICR, the Agency will announce that approval
in the Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
D. REGULATORY FLEXIBILITY ACT (RFA)
I certify that this action will not have a significant economic impact on a
substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The
small entities subject to the requirements of this action are small businesses
that manufacture/import, process, or distribute PCTP. In total, only one small
business is expected to be affected by the final action. This small business is
not expected to experience negative impacts of more than 1% of revenue. Because
there is only one small business directly impacted and negative impacts are less
than 1%, EPA presumes no significant economic impact on a substantial number of
small entities (no SISNOSE). No small entities are expected to experience
impacts of more than 1% of revenues. Details of this analysis are presented in
the Economic Analysis (Ref. 3).
E. UNFUNDED MANDATES REFORM ACT (UMRA)
This action does not contain an unfunded mandate of $100 million or more as
described in UMRA, 2 U.S.C. 1531-1538, and will not significantly or uniquely
affect small governments. The final rule is not expected to result in
expenditures by State, local, and Tribal governments, in the aggregate, or by
the private sector, of $100 million or more (when adjusted annually for
inflation) in any one year. Accordingly, this final rule is not subject to the
requirements of sections 202, 203, or 205 of UMRA. The requirements of this
action will primarily affect processors, and a distributor of PCTP. The total
quantified annualized social costs for this final rule under are approximately
$108,000 (at both 3% and 7% discount rate), which does not exceed the
inflation-adjusted unfunded mandate threshold of $160 million.
F. EXECUTIVE ORDER 13132: FEDERALISM
This action does not have federalism implications because it is not expected to
have substantial direct effects on the states, on the relationship between the
national government and the states, or on the distribution of power and
responsibilities among the various levels of government as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). Thus, Executive Order
13132 does not apply to this action.
G. EXECUTIVE ORDER 13175: CONSULTATION AND COORDINATION WITH INDIAN TRIBAL
GOVERNMENTS
This action does not have tribal implications because it is not expected to have
substantial direct effects on tribal governments, on the relationship between
the Federal Government and the Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes as
specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Thus,
Executive Order 13175 does not apply to this final rule.
Consistent with the EPA Policy on Consultation and Coordination with Indian
Tribes, EPA consulted with tribal officials during the development of this
action. EPA consulted with representatives of Tribes via teleconference on
August 31, 2018, and September 6, 2018, concerning the prospective regulation of
the five PBT chemicals under TSCA section 6(h).
Tribal members were encouraged to provide additional comments after the
teleconferences. EPA received two comments from the Keweenaw Bay Indian
Community and Maine Tribes (Ref. 17 and 18).
H. EXECUTIVE ORDER 13045: PROTECTION OF CHILDREN FROM ENVIRONMENTAL HEALTH AND
SAFETY RISKS
This action is not subject to Executive Order 13045 (62 FR 19885, April 23,
1997) because it is not an economically significant regulatory action as defined
by Executive Order 12866. Although the action is not subject to Executive Order
13045, the Agency considered the risks to infants and children under EPA's
Policy on Evaluating Health Risks to Children. EPA did not perform a risk
assessment or risk evaluation of PTCP. More information can be found in the
Exposure and Use Assessment (Ref. 5). This regulation will reduce the exposure
to PCTP for the general population and for potentially exposed or susceptible
subpopulations such as workers and children.
I. EXECUTIVE ORDER 13211: ACTIONS CONCERNING REGULATIONS THAT SIGNIFICANTLY
AFFECT ENERGY SUPPLY, DISTRIBUTION, OR USE
This action is not a “significant energy action” as defined in Executive Order
13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy and has not
otherwise been designated as a significant energy action by the Administrator of
the Office of Information and Regulatory Affairs (OIRA).
J. NATIONAL TECHNOLOGY TRANSFER AND ADVANCEMENT ACT (NTTAA)
This rulemaking does not involve any technical standards. Therefore, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
K. EXECUTIVE ORDER 12898: FEDERAL ACTIONS TO ADDRESS ENVIRONMENTAL JUSTICE IN
MINORITY POPULATIONS AND LOW-INCOME POPULATIONS
EPA believes that this action does not have disproportionately high and adverse
health or environmental effects on minority populations, low-income populations
and/or indigenous peoples, Start Printed Page 922as specified in Executive Order
12898 (59 FR 7629, February 16, 1994). The documentation for this decision is
contained in the Economic Analysis (Ref. 3), which is in the public docket for
this action. EPA believes that the restrictions on PCTP in this final rule will
reduce exposure in the United States, thus benefitting all communities,
including environmental justice communities.
L. CONGRESSIONAL REVIEW ACT (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a
rule report to each House of the Congress and to the Comptroller General of the
United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Start List of Subjects
LIST OF SUBJECTS 40 CFR PART 751
* Environmental protection
* Chemicals
* Export Notification
* Hazardous substances
* Import certification
* Reporting and recordkeeping
End List of Subjects Start Signature
Andrew Wheeler,
Administrator.
End Signature
Therefore, for the reasons stated in the preamble, 40 CFR part 751 is amended as
follows:
Start Part
PART 751—REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER SECTION 6
OF THE TOXIC SUBSTANCES CONTROL ACT
End Part Start Amendment Part
1. The authority citation for part 751 continues to read as follows:
End Amendment Part Start Authority
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
End Authority Start Amendment Part
2. Amend § 751.403 by adding in alphabetical order the term “PCTP” to read as
follows:
End Amendment Part
SUBPART E—PERSISTENT, BIOACCUMULATIVE, AND TOXIC CHEMICALS
§ 751.403
Definitions.
* * * * *
PCTP means the chemical substance pentachlorothiophenol (CASRN 133-49-3).
* * * * *
Start Amendment Part
3. Add § 751.411 to read as follows:
End Amendment Part
§ 751.411
PCTP.
(a) Prohibition. After March 8, 2021, all persons are prohibited from all
manufacturing and processing of PCTP or PCTP-containing products or articles,
unless PCTP concentrations are at or below 1% by weight. After January 6, 2022,
all persons are prohibited from all distribution in commerce of PCTP or
PCTP-containing products or articles, unless PCTP concentrations are at or below
1% by weight.
(b) Recordkeeping. After March 8, 2021, manufacturers, processors and
distributors of PCTP or PCTP-containing products or articles must maintain
ordinary business records related to compliance with the prohibitions,
restrictions and other provisions of this section, such as invoices and
bills-of-lading. These records must be maintained for a period of three years
from the date the record is generated.
End Supplemental Information
[FR Doc. 2020-28689 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P
PUBLISHED DOCUMENT
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