Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 911 

regulations and best practices to prevent 

the release of PIP (3:1) to water during 

the commercial use of PIP (3:1).’’ 

(4) The downstream notification 

requirements in this paragraph (e) do 

not apply to the activities described in 

paragraphs (b)(1)(vi) and (vii) of this 

section. 

[FR Doc. 2020–28692 Filed 1–5–21; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 PCTPcontaining 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. 

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. 

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 


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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-riskchildren) is to consider the risks to 

infants and children consistently and 

explicitly during its decision making 

process. This final rule will reduce the 

exposure to PCTP that could occur from 

activities now prohibited under this 

final rule for the general population and 

for potentially exposed or susceptible 

subpopulations such as children. More 

information can be found in the 

Exposure and Use Assessment (Ref. 5). 

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 


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‘‘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 


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914 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

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 


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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 PCTPcontaining 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 


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proposed rule, regulations promulgated 

under the authority of RCRA, govern the 

disposal of hazardous and nonhazardous 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 PCTPcontaining 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 


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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 PCTPcontaining 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 PCTPcontaining 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 


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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 sellthrough 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 PCTPcontaining 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 PCTPcontaining 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). 


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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 costeffectiveness 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 PCTPcontaining 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 


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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-chemicalsunder-tsca/tsca-work-planchemical-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/lawsregulations-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 


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(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, 


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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 

■ 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). 

■ 2. Amend § 751.403 by adding in 

alphabetical order the term ‘‘PCTP’’ to 

read as follows: 

Subpart E—Persistent, 

Bioaccumulative, and Toxic Chemicals 

§ 751.403 Definitions. 

* * * * * 

PCTP means the chemical substance 

pentachlorothiophenol (CASRN 133– 

49–3). 

* * * * * 

■ 3. Add § 751.411 to read as follows: 

§ 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-oflading. 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 751 

[EPA–HQ–OPPT–2019–0080; FRL 10018–91] 

RIN 2070–AK61 

Hexachlorobutadiene (HCBD); 

Regulation of Persistent, 

Bioaccumulative, and Toxic Chemicals 

Under TSCA Section 6(h) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is finalizing a rule under 

the Toxic Substances Control Act 

(TSCA) to address its obligations under 

TSCA for hexachlorobutadiene (HCBD) 

(CASRN 87–68–3), 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 HCBD and 

HCBD-containing products or articles, 

recognizing that there is unintentional 

production of HCBD as a byproduct 

during the production of chlorinated 

solvents, and that results in distribution 

in commerce of a very limited subset of 

that byproduct for burning as a waste 

fuel. These requirements will impact the 

amount of HCBD that will be 

manufactured, processed, distributed in 

commerce, used or disposed, thus 

reducing the exposures to humans and 

the environment from those activities 

prohibited under this final rule. 

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. 

FOR FURTHER INFORMATION CONTACT:

For technical information contact: 

Victoria Ellenbogen, Existing Chemicals 

Risk Management Division, Office of 

Pollution Prevention and Toxics, 

(7404T), Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–2053; email address: 

ellenbogen.victoria@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. 

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 

hexachlorobutadiene (HCBD) and 

HCBD-containing products or articles. 

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: 

• Petroleum Lubricating Oil and 

Grease Manufacturing (NAICS Code 

324191); 

• Other Basic Inorganic Chemical 

Manufacturing (NAICS Code 325180); 

• All Other Basic Organic Chemical 

Manufacturing (NAICS Code 325199); 

• Plastics Material and Resin 

Manufacturing (NAICS Code 325211); 


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