Pentachlorothiophenol (PCTP); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 911-922 [2020-28689]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 911-922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28689]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2019-0080; FRL-10018-89]
RIN 2070-AK60


Pentachlorothiophenol (PCTP); Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 
https://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 https://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.

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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

[[Page 912]]

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.

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

[[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

[[Page 914]]

benefits, 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

[[Page 915]]

and 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

[[Page 916]]

proposed 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

[[Page 917]]

experimentation 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

[[Page 918]]

using 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).

[[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

[[Page 920]]

that 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. 
https://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

[[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,

[[Page 922]]

as 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).

List of Subjects 40 CFR Part 751

    Environmental protection, Chemicals, Export Notification, Hazardous 
substances, Import certification, Reporting and recordkeeping.

Andrew Wheeler,
Administrator.

    Therefore, for the reasons stated in the preamble, 40 CFR part 751 
is amended as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).


0
2. Amend Sec.  751.403 by adding in alphabetical order the term 
``PCTP'' to read as follows:

Subpart E--Persistent, Bioaccumulative, and Toxic Chemicals


Sec.  751.403   Definitions.

* * * * *
    PCTP means the chemical substance pentachlorothiophenol (CASRN 133-
49-3).
* * * * *

0
3. Add Sec.  751.411 to read as follows:


Sec.  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.

[FR Doc. 2020-28689 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P