[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 922-932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28693]


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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.

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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: <a href="/cdn-cgi/l/email-protection#ed88818188838f828a8883c39b848e99829f848cad889d8cc38a829b"><span class="__cf_email__" data-cfemail="77121b1b1219151810121959011e140318051e163712071659101801">[email protected]</span></a>.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: <a href="/cdn-cgi/l/email-protection#d98d8a9a98f491b6adb5b0b7bc99bca9b8f7beb6af"><span class="__cf_email__" data-cfemail="feaaadbdbfd3b6918a9297909bbe9b8e9fd0999188">[email protected]</span></a>.

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:
    <bullet> Petroleum Lubricating Oil and Grease Manufacturing (NAICS 
Code 324191);
    <bullet> Other Basic Inorganic Chemical Manufacturing (NAICS Code 
325180);
    <bullet> All Other Basic Organic Chemical Manufacturing (NAICS Code 
325199);
    <bullet> Plastics Material and Resin Manufacturing (NAICS Code 
325211);

[[Page 923]]

    <bullet> All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS Code 325998);
    <bullet> All Other Plastics Product Manufacturing (NAICS Code 
326199);
    <bullet> All Other Rubber Product Manufacturing (NAICS Code 
326299);
    <bullet> Cement Manufacturing (NAICS Code 327310);
    <bullet> Hazardous Waste Treatment and Disposal (NAICS Code 
562211);
    <bullet> Hazardous Waste Collection (562112);
    <bullet> Solid Waste Combustors and Incinerators (NAICS Code 
562213);
    <bullet> Other Chemical and Allied Products Merchant Wholesalers 
(NAICS Code 424690);
    <bullet> Crude Petroleum Extraction (NAICS Code 211120);
    <bullet> Facilities Support Services (NAICS Code 561210);
    <bullet> All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS Code 325998).
    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. HCBD (CASRN 87-
68-3), which is produced only as a byproduct in the production of 
chlorinated solvents, is one such chemical substance. More 
specifically, 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 the 
substance 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 manufacturing (including 
import), processing, and distribution in commerce of HCBD and HCBD-
containing products or articles after March 8, 2021, except for the 
unintentional production of HCBD as a byproduct during the production 
of chlorinated solvents and the processing and distribution of the 
byproduct for burning as a waste fuel. In addition, after March 8, 
2021, manufacturers, processors and distributors of HCBD or HCBD-
containing products or articles must maintain, for three years from the 
date the record is generated, ordinary business records related to 
compliance with the prohibitions and restrictions. This provision is 
not intended to require subject companies to retain records in addition 
to those specified herein, except 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 HCBD, ``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.'' Consistent with that requirement, the Agency is 
finalizing this rule to reduce exposures to HCBD that could occur from 
prohibited activities 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 
Hexachlorobutadiene (HCBD) Under TSCA Section 6(h)'' (Economic 
Analysis) (Ref. 3), is available in the docket and is briefly 
summarized here.
    <bullet> Benefits. EPA was not able to quantify the benefits of 
reducing the potential for human and environmental exposures to HCBD. 
As discussed in more detail in Unit II., EPA did not perform a risk 
evaluation for HCBD, nor did EPA develop quantitative risk estimates. 
Therefore, the Economic Analysis (Ref. 3) qualitatively discusses the 
benefits of reducing the potential for exposure under the final rule 
for HCBD.
    <bullet> Costs. Total quantified annualized social costs for this 
final rule are approximately $77,900 (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.
    <bullet> Small entity impacts. This final rule will impact 
approximately one small entity; which is not expected to incur impacts 
of 1% or greater of their revenue.
    <bullet> 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.
    <bullet> 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 that could occur from 
activities now prohibited under this final rule to HCBD 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-

[[Page 924]]

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 HCBD 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:
    <bullet> 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;
    <bullet> Are not a metal or a metal compound; and
    <bullet> 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 (such as 
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 sections 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 HCBD is one of these five 
chemical substances. In addition, 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 HCBD. As described in the proposed rule, EPA conducted a 
literature review with respect to HCBD to identify, screen, extract, 
and evaluate the 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 HCBD 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 ``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

[[Page 925]]

regulate under the TSCA section 6(h)(4) standard. Consistently, based 
on the Exposure and Use Assessment, activities associated with HCBD 
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 is in the 
Response to Comments document for this rulemaking (Ref. 4).
    3. EPA did not conduct a risk evaluation or 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 a 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 HCBD. 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 
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 the 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. Further discussion on these issues raised in the

[[Page 926]]

comments is in the Response to Comment document. (Ref. 4)

C. HCBD Overview, Health Effects, and Exposure

    HCBD is a halogenated aliphatic hydrocarbon that is produced as a 
byproduct during the manufacture of chlorinated hydrocarbons, 
particularly perchloroethylene, trichloroethylene, and carbon 
tetrachloride (Ref. 6). As described in the proposed rule, the majority 
of HCBD that is unintentionally produced as a byproduct is destroyed 
via incineration by the manufacturer, which EPA views as being 
consistent with the approach taken at the international level under 
Article 6 of the Stockholm Convention. The remainder of the HCBD 
byproduct is sent off-site for incineration or for burning as a waste 
fuel by cement manufacturers in cement kilns (EPA-HQ-OPPT-2016-0738-
0012), an identified source category under Annex C of the Stockholm 
Convention. EPA views this burning of such waste as consistent with the 
approach taken at the international level under Article 6 of the 
Stockholm Convention. EPA has not identified any current intentional 
use of HCBD. The destruction and removal efficiency from incineration 
of the HCBD byproduct is expected to be significant but not complete, 
resulting in potential for air releases from incinerator flue gas and 
land releases from disposal of ash and slag. Minor water releases from 
equipment cleaning are possible (Ref. 5). According to EPA Toxics 
Release Inventory (TRI) data, over 9 million lbs of HCBD byproduct were 
generated by chemical manufacturers in reporting year 2017, with almost 
8.9 million lbs treated for destruction on-site via incineration. TRI 
reports show other waste management activities of HCBD byproduct 
including 58,000 lbs being treated for destruction off-site, 33,000 lbs 
burned for energy recovery off-site, and 2,400 lbs released to air 
(Ref. 7). Exposure information for HCBD is further detailed in EPA's 
Exposure and Use Assessment (Ref. 5) and discussed in the Response to 
Comments (Ref. 4).
    As described in EPA's Environmental and Human Health Hazards of 
Five Persistent, Bioaccumulative, and Toxic Chemicals, HCBD is 
considered a possible human carcinogen (Ref. 8). Inhalation and oral 
animal data for HCBD indicate renal, reproductive, and developmental 
effects in rats (Ref. 8). Health effects included renal adenomas and 
carcinomas, reduced body weight in adults, and reduced fetal body 
weight. Women who are occupationally exposed may transfer HCBD to 
infants via breastmilk (Ref. 5).
    HCBD is toxic to aquatic life following acute and chronic exposures 
at very low concentrations (Ref. 8). Data show acute toxicity in 
aquatic invertebrates, fish and algae, and chronic toxicity in fish. A 
single toxicity test was identified for terrestrial organisms, showing 
reduced chick survival in quail. The Hazard Summary provides more 
information on these hazardous endpoints (Ref. 8). The studies 
presented in the document entitled ``Environmental and Human Health 
Hazards of Five Persistent, Bioaccumulative and Toxic Chemicals (Hazard 
Summary) (Ref. 8) 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), HCBD scored high (3) for hazard (possible human carcinogen); 
moderate (2) for exposure (based on TRI data); and high (3) for 
persistence and bioaccumulation (based on high environmental 
persistence and high bioaccumulation potential). The overall screening 
score for HCBD was high (8) (Ref. 1).
    In consideration of the production, use, and destruction of HCBD, 
the environmental and human health hazards of HCBD, and the public 
comments on the proposed rule that are further discussed in Unit 
III.A., EPA determines that HCBD meets the TSCA section 6(h)(1)(A) 
criteria. EPA determines in accordance with TSCA section 6(h)(1)(B) 
that, based on the Exposure and Use Assessment and the reasonably 
available information, exposure to HCBD 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 
HCBD, including the potential for exposures, and 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 HCBD

    EPA did not propose to regulate HCBD under TSCA section 6(h) 
because of the limited releases and given that the potential for 
exposure from uses of this chemical is already addressed by actions 
taken under other statutes and EPA determined further measures would 
not be practicable. As discussed in the proposed rule, HCBD is 
regulated under various statutes implemented by the Federal Government, 
such as the Clean Air Act (CAA) and Resource Conservation and Recovery 
Act (RCRA). According to TRI data, most of the HCBD manufactured in the 
United States is subsequently destroyed via incineration.
    EPA, however, proposed an alternative regulatory action of 
prohibiting the manufacture of HCBD, which is further discussed in the 
proposed rule.

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 on the proposal for all the PBT chemicals. 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 HCBD final rule. Of the comment submissions, 10 directly 
addressed EPA's proposal regarding HCBD. 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 Final Rule

    EPA is not regulating all activities or exposures to HCBD in this 
rule, even though the Exposure and Use Assessment (Ref. 5) identified 
potential for exposures under conditions of use. One such activity is 
disposal. EPA generally presumes compliance with federal and state laws 
and regulations, including, for example, RCRA and its implementing 
regulations and state laws, as well as the CAA, the Clean Water Act, 
and the Safe Drinking Water Act (SDWA). As described in the proposed 
rule, regulations promulgated under the authority of the RCRA govern 
the disposal of hazardous and non-hazardous wastes. HCBD is listed as a

[[Page 927]]

hazardous constituent under Appendix VIII of 40 CFR part 261 and 
Appendix IX of part 264, providing EPA with authority to regulate 
wastes containing this chemical, and to address releases from RCRA-
permitted treatment, storage and disposal facilities. HCBD is listed as 
a hazardous waste under RCRA in 40 CFR 261.33, Hazard Waste Code U128. 
In addition, HCBD is a constituent that may also cause a waste to be 
defined as a characteristic hazardous waste under 40 CFR 261.24. As a 
hazardous waste, HCBD is subject to regulation under 40 CFR parts 262 
through 265, 268, and parts 270 and 271. HCBD is also a hazardous 
constituent under 40 CFR part 258, Appendix II (Criteria for Municipal 
Solid Waste Landfills, or MSWLF), which is part of the groundwater 
assessment program for corrective action at MSWLFs. 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 for siting, groundwater monitoring and 
corrective action depending upon what types of wastes are accepted. 
Disposal by underground injection is regulated under both RCRA and 
SDWA.
    In addition, the CAA requires EPA to regulate hazardous air 
pollutants (HAP) such as HCBD. CAA section 112 requires that the Agency 
establish National Emission Standards for Hazardous Air Pollutants 
(NESHAP) for the control of hazardous air pollutants from both new and 
existing major sources. The CAA requires the NESHAP to reflect the 
maximum degree of reduction in emissions of HAP that is achievable, 
taking into consideration the cost of achieving the emissions 
reductions, any non-air quality health and environmental impacts, and 
energy requirements. This level of control is commonly referred to as 
maximum achievable control technology (MACT). The CAA also establishes 
a minimum control level for MACT standards known as the MACT ``floor.'' 
The MACT floor is the minimum control level allowed for NESHAP and is 
defined under the CAA section 112(d)(3) (Ref. 9). The chemical 
manufacturers that produce HCBD are in NAICS group 325 and therefore 
fall under the NESHAP regulations for miscellaneous organic chemical 
manufacturing found at 40 CFR part 63 subpart FFFF. These regulations 
require facilities to treat chemicals in their waste streams at high 
efficiencies. For example, emissions from process vents must be reduced 
by greater than or equal to 99% by weight depending on the chemical in 
the waste stream. According to TRI data, chemical manufacturers that 
submit reports for HCBD are treating the byproduct via incineration at 
greater than 99.99% treatment efficiency with some reporting an 
efficiency greater than 99.9999%. Under the CAA, facilities in certain 
industries are required to implement a Leak Detection and Repair (LDAR) 
program to reduce fugitive air emissions. Included in those industries 
are synthetic organic chemical manufacturers that produce the HCBD 
byproduct. The LDAR program requires these facilities to monitor 
components such as pumps, valves, connectors and compressors for leaks. 
When leaks are detected, the facility is required to repair or replace 
the leaking component.
    In view of these comprehensive, stringent programs for addressing 
disposal and air releases, EPA determined that it is not practicable to 
impose additional requirements under TSCA on the disposal and air 
releases of the HCBD byproduct.
    In addition, 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 HCBD. 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 1910.134(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 that 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 HCBD to suggest this is not the 
case. Further,

[[Page 928]]

EPA has not conducted a risk evaluation on HCBD 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.
    Finally, EPA received comments regarding the use of PBT chemicals 
in research and development and laboratory use. Laboratory 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 
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.
    More information on the comments received and EPA's responses can 
be found in the Response to Comments document (Ref. 4).

III. Provisions of This Final Rule

A. Scope and Applicability

    EPA carefully considered all public comments related to the 
proposal. This final rule differs from EPA's proposal by finalizing a 
prohibition on the manufacturing (including import), processing, and 
distribution in commerce of HCBD, and HCBD-containing products and 
articles, except for the unintentional production of HCBD as a 
byproduct during the production of chlorinated solvents, and the 
limited processing and distribution of HCBD for burning as a waste 
fuel. The effective date is 30 days after publication of the final 
rule.
    1. Regulating HCBD.
    EPA received comments disagreeing with EPA's proposal not to 
regulate HCBD. One commenter stated that EPA must act under TSCA 
section 6(h) to include a total phase-out of the chemical (EPA-HQ-OPPT-
2019-0080-0575). Another commenter stated that by not prohibiting uses 
of HCBD, EPA's approach allowed ongoing exposures, including to 
potentially exposed and susceptible subpopulations, and potential 
expansion of uses (EPA-HQ-OPPT-2019-0080-0567). Three commenters noted 
that HCBD was listed in the Stockholm Convention on Persistent Organic 
Pollutant (POPs) which prohibits the intentional manufacture of HCBD 
and stated that the manufacture of HCBD should be eliminated (EPA-HQ-
OPPT-2019-0080-0570) (EPA-HQ-OPPT-2019-0080-0567) (EPA-HQ-OPPT-2019-
0080-0531). EPA received one comment supporting EPA's proposal and 
finding that no new risk management measures are required to reduce 
exposure of HCBD to the extent practicable (EPA-HQ-OPPT-2019-0080-
0557).
    In response to comments, EPA is finalizing a prohibition on the 
manufacturing, processing, and distribution 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, that results in processing and distribution in commerce of a 
very limited subset of that byproduct for burning as a waste fuel. 
However, as explained below, EPA disagrees with commenters that a total 
ban of HCBD production as a byproduct is practicable. The potential for 
exposure from incineration and distribution for incineration of the 
byproduct is substantially addressed by actions taken under other 
statutes. As discussed in EPA's proposed rule and in Unit II.F., HCBD 
is regulated under various statutes implemented by the Federal 
Government, such as CAA and RCRA. According to TRI data, most of the 
byproduct HCBD manufactured in the United States is subsequently 
destroyed via incineration due in large part to the high waste 
treatment efficiencies achieved by the chemical manufacturers. Chemical 
manufacturers that submit TRI reports for HCBD byproduct are treating 
the chemical via incineration at greater than 99.99% treatment 
efficiency with some reporting an efficiency greater than 99.9999%.
    Given the known uses and efficiency of the destruction of HCBD 
created as a byproduct, EPA is issuing a final rule to prohibit all 
manufacturing, processing, and distribution in commerce of HCBD and 
products and articles containing HCBD, while recognizing the 
continuation of the production of HCBD as a byproduct during the 
production of chlorinated solvents, and the resulting processing and 
distribution of HCBD for burning as a waste fuel. This final rule 
allows the current, highly regulated, unintentional production as a 
byproduct and incineration and distribution for incineration of such 
byproduct to continue and ensures that other uses do not commence.
    2. HCBD uses.
    Multiple commenters submitted comments to EPA discussing HCBD uses. 
Commenters pointed out that EPA's website had previously identified 
uses of HCBD as a solvent in rubber manufacturing and in hydraulic, 
heat transfer, or transformer fluid (EPA-HQ-OPPT-2019-0080-0575) (EPA-
HQ-OPPT-2019-0080-0546). Commenters further noted that EPA's 
Preliminary Information on Manufacturing, Processing, Distribution, 
Use, and Disposal for HCBD document identified numerous uses for HCBD 
beyond its production as a byproduct (Ref. 4) (EPA-HQ-OPPT-2019-0080-
0575) (EPA-HQ-OPPT-2019-0080-0546). According to one commenter, EPA had 
not addressed these activities in its proposed rule, much less 
established that it would be impracticable to ban these uses to reduce 
exposure. This commenter stated that EPA should ban these past uses 
(EPA-HQ-OPPT-2019-0080-0546). Another commenter felt that EPA's 
proposed rule neglected to discuss or mention legacy uses and legacy 
disposals of PBT chemicals, and other commenters stated that HCBD has 
been listed in Annex A of the Stockholm Convention in order to avoid 
new possible future uses of HCBD (EPA-HQ-OPPT-2019-0080-0541) (EPA-HQ-
OPPT-2019-0080-0531) (EPA-HQ-OPPT-2019-0080-0575).
    In addition, multiple commenters expressed concerns about EPA's 
conclusion that ``a prohibition on the manufacture of HCBD would 
effectively prohibit the manufacture of the three

[[Page 929]]

solvents'' (trichloroethylene, carbon tetrachloride, and 
perchloroethylene) and therefore that a ban was impracticable. The 
commenters made recommendations for alternative regulatory approaches. 
One commenter stated that EPA had failed to consider banning HCBD, 
except as a byproduct to the manufacture of other chemicals, to reduce 
exposure to the extent practicable (EPA-HQ-OPPT-2019-0080-0546). The 
commenter further stated that EPA could have considered banning all 
manufacture except as a byproduct of manufacture of perchloroethylene, 
trichloroethylene, and carbon tetrachloride, to ensure that HCBD is not 
manufactured for a purpose other than its incidental production as a 
byproduct (EPA-HQ-OPPT-2019-0080-0546).
    EPA appreciates the comments provided regarding HCBD. EPA's 
Preliminary Information on Manufacturing, Processing, Distribution, 
Use, and Disposal for HCBD document was a preliminary summary of 
available information on uses, past and present, of HCBD (Ref. 4). EPA 
requested comment on the document but did not receive confirmation of 
ongoing uses other than those discussed in the proposed rule. EPA has 
not identified any uses of HCBD. The only activity involving HCBD is 
burning as a waste fuel as a result of unintentional HCBD production as 
a byproduct.
    However, recognizing commenters' concern about prohibiting HCBD 
uses that are not currently ongoing to avoid, for example, the return 
of past uses, EPA is finalizing a change from the proposal and is 
prohibiting all manufacturing, processing, and distribution in commerce 
of HCBD and products and articles containing HCBD, but allowing the 
continuation of the unintentional production of HCBD as a byproduct 
during the production of chlorinated solvents and the resulting 
processing and distribution of HCBD for burning as a waste fuel. This 
approach ensures that the types of allowable activities involving HCBD 
are severely limited by precluding the manufacture, processing, or 
distribution of HCBD for a purpose other than its incidental and 
unintentional production as a byproduct and allows burning of that 
byproduct as a waste fuel. Any other activity involving HCBD is 
prohibited by the final rule, and thus the final requirements are 
consistent with restrictions on the intentional production and use of 
HCBD under Annex A of the Stockholm Convention. Moreover, the highly 
regulated burning of the byproduct as a waste fuel is also consistent 
with Article 6 of the same Convention. Thus, the final rule 
requirements reduce the exposures to humans and the environment that 
could occur with any activity involving HCBD not directly related to 
its manufacture as a byproduct or burning as a waste fuel.
    3. Chlorinated Solvents Resulting in HCBD as a Byproduct.
    EPA received comments regarding the chlorinated solvents that 
unintentionally produce HCBD as a byproduct. One commenter recommended 
that EPA consider whether viable alternative synthetic routes exist 
that do not result in such production (EPA-HQ-OPPT-2019-0080-0541). One 
commenter stated that EPA should solicit information, regarding whether 
HCBD-free production methods for chlorinated solvents exist from 
industry before concluding that a ban on HCBD would entail a ban on 
chlorinated solvents (EPA-HQ-OPPT-2019-0080-0551). Another commenter 
stated that EPA must act under section 6(h) to include a total phase-
out of the chemical and any processes that lead to creation of HCBD as 
a byproduct (EPA-HQ-OPPT-2019-0080-0575). Others requested EPA require 
best available techniques and environmental practices to control 
emissions and releases from sources of HCBD, and suggested EPA develop 
a plan to eliminate HCBD to the extent practicable through alternative 
chlorinated solvent manufacturing (EPA-HQ-OPPT-2019-0080-0567).
    EPA appreciates the comments regarding alternatives and actions to 
be taken on chlorinated hydrocarbons, particularly perchloroethylene, 
trichloroethylene, and carbon tetrachloride, that unintentionally 
create HCBD as a byproduct. EPA is not aware of alternative methods for 
the production of chlorinated solvents that do not unintentionally 
produce HCBD as a byproduct and did not receive additional information 
in the comments on the proposal. As discussed in the proposed rule, 
prohibiting all manufacture of HCBD would effectively preclude the 
manufacture of trichloroethylene, carbon tetrachloride and 
perchloroethylene and EPA does not believe precluding manufacture of 
these solvents to reduce the exposure to the HCBD byproduct is 
practicable at this time. EPA is not addressing these three solvents 
during this TSCA section 6(h) rule making, which applies solely to PBT 
chemicals. Additionally, the solvents are the subject of the risk 
evaluation process pursuant to TSCA section 6(b). Where unreasonable 
risks are identified as part of those risk evaluations, EPA is required 
to take action under TSCA section 6(a) to address unreasonable risk. In 
addition, these chlorinated solvents are widely used in dry cleaning, 
metal degreasing, and other industries. To broadly assess the economic 
impact of a prohibition of the manufacture of these three chemicals, 
EPA estimated the potential market value loss by multiplying the 
national production volume of each of these chemicals by an average 
price per pound. This resulted in an estimated impact $213 million to 
$541 million (average $368 million) worth of production (see the 
Economic Analysis for the proposed rule for details on this estimation) 
(Ref. 10). Therefore, EPA's final rule allows the continuation of the 
unintentional production of HCBD as a byproduct during the production 
of chlorinated solvents and processing and distribution of the HCBD 
byproduct for burning as a waste fuel, and prohibits all other 
manufacturing, processing, and distribution in commerce of HCBD and 
products and articles containing HCBD.
    4. Recordkeeping.
    In addition, EPA is requiring that all persons who manufacture, 
process, or distribute in commerce HCBD and HCBD-containing products or 
articles 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.
    HCBD is toxic to aquatic invertebrates, fish, and birds. Data 
indicate the potential for renal, liver, and developmental effects in 
mammals. HCBD has been identified as a possible human carcinogen. The 
studies presented in the Hazard Summary (Ref. 8) demonstrate these 
hazardous endpoints. 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 HCBD health effects, use, and exposure is in Unit II.C. and 
further detailed in the Hazard Summary (Ref. 8). Information on use and 
exposures is also in Unit II.C. and is further detailed in EPA's 
Exposure and Use Assessment (Ref. 5, Ref. 8).
    2. The benefits of the chemical substance or mixture for various 
uses.
    HCBD is unintentionally manufactured as a waste byproduct by 
chemical manufacturers. The majority of

[[Page 930]]

what is manufactured is destroyed via incineration by the manufacturer. 
A small percentage of the HCBD is sent off-site for burning as a waste 
fuel by cement manufacturers.
    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 HCBD. 
Costs of the final rule were estimated based on the assumption that 
under regulatory limitations on HCBD, processors that use HCBD in their 
products would switch to available alternative chemicals to manufacture 
the product, or to products that do not contain HCBD. 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, 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 is 
$354. 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 $77,576 per year (Ref. 3).
    Total quantified annualized social costs for the final rule are 
estimated to be $77,930 (at both 3% and 7% discount rates annualized 
over 25 years). As described earlier in Unit III.B.3, potential costs 
such as testing, reformulation, 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., although 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 HCBD is 
provided. HCBD is persistent, bioaccumulative, and a possible human 
carcinogen. It is not intentionally manufactured in the United States. 
Since EPA is effectively excluding from prohibition all current 
activities involving HCBD as a byproduct, no benefits to human health 
or the environment are expected; the benefit is the prevention of 
individuals from being occupationally exposed to HCBD via the 
inhalation and dermal routes in the future. The toxicity of potential 
substitutes for HCBD has not been assessed at this time.
    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.
    4. Consideration of alternatives.
    EPA has not identified any uses of HCBD. Therefore, chemical 
alternatives were not considered.

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 
the HCBD byproduct 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 final 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-2019-0080). 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 Hexachlorobutadiene 
(HCBD) 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).

[[Page 931]]

    5. EPA. Exposure and Use Assessment of Five Persistent, 
Bioaccumulative, and Toxic Chemicals. December 2020.
    6. United Nations Environment Program Stockholm Convention on 
Persistent Organic Pollutants (2012). Risk profile on 
hexachlorobutadiene. Report of the Persistent Organic Pollutants 
Review Committee on the work of its eighth meeting.
    7. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Hexachlorobutadiene. August 2017. 
(EPA-HQ-OPPT-2016-0738-0004).
    8. EPA. Environmental and Human Health Hazards of Five 
Persistent, Bioaccumulative and Toxic Chemicals. December 2020.
    9. EPA. National Emission Standards for Hazardous Air 
Pollutants: Miscellaneous Organic Chemical Manufacturing; Final 
Rule. Federal Register (63 FR 63852, Nov. 10, 2003) (FRL-7551-3)
    10. EPA. Economic Analysis for Proposed Regulation of 
Persistent, Bioaccumulative, and Toxic Chemicals under TSCA section 
6(h). June 2019.
    11. 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.
    12. 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 
Orders 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 Final Regulation of Hexachlorobutadiene (HCBD) 
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 the 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 manufacturers 
(including importers), processors, and distributors of HCBD.
    Respondent's obligation to respond: Mandatory (40 CFR 751.413).
    Estimated number of respondents: 9.
    Frequency of response: On occasion.
    Total estimated burden: 4.5 hours (per year). Burden is defined at 
5 CFR 1320.3(b).
    Total estimated cost: $354 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    The ICR submitted to OMB for approval under OMB Control No. 2070-
0213 addresses the paperwork requirements of this final rule as well as 
the paperwork requirements of the other final rules addressing PBT 
chemicals under TSCA section 6(h) promulgated by EPA elsewhere in this 
issue of the Federal Register. For the combined paperwork requirements 
of all five final rules, EPA estimates a total of 102 respondents, 88 
burden hours (per year), and a cost of approximately $6,920 (per year) 
that includes no annualized capital or operation and 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 and the other final rules 
addressing PBT chemicals under TSCA section 6(h).

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. One small business, an importer, is expected to be 
affected by the rule familiarization and recordkeeping requirements of 
the final rule. The one small entity assessed is not expected to incur 
impacts of 1% (or greater) of their revenue. Because this entity's 
impacts are less than 1%, EPA presumes no significant economic impact 
on a substantial number of small entities. 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 total quantified annualized 
social costs for this final rule are approximately $77,900 (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

[[Page 932]]

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 (Refs. 11 and 12).

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. While 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 HCBD, the available data indicate exposure to HCBD may 
disproportionately affect children, and effects information indicating 
developmental effects. This regulation will reduce the exposure to HCBD 
that could occur from the prohibited activities 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).

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 by 
the Administrator of the Office of Information and Regulatory Affairs 
as a significant energy action.

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, 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 HCBD in this final rule will reduce the 
potential for 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 in 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 
``HCBD'' to read as follows:

Subpart E--Persistent, Bioaccumulative, and Toxic Chemicals


Sec.  751.403   Definitions.

* * * * *
    HCBD means the chemical substance hexachlorobutadiene (CASRN 87-68-
3).
* * * * *

0
3. Add Sec.  751.413 to read as follows:


Sec.  751.413   HCBD.

    (a) Prohibition. After March 8, 2021, all persons are prohibited 
from all manufacturing, processing and distribution in commerce of HCBD 
and HCBD-containing products or articles, except for the following:
    (1) Unintentional production of HCBD as a byproduct in the 
production of chlorinated solvents; and
    (2) Processing and distribution in commerce of HCBD for burning as 
a waste fuel.
    (b) Recordkeeping. After March 8, 2021, manufacturers, processors 
and distributors of HCBD or HCBD-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. 2020-28693 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P


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