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

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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• All Other Miscellaneous Chemical 

Product and Preparation Manufacturing 

(NAICS Code 325998); 

• All Other Plastics Product 

Manufacturing (NAICS Code 326199); 

• All Other Rubber Product 

Manufacturing (NAICS Code 326299); 

• Cement Manufacturing (NAICS 

Code 327310); 

• Hazardous Waste Treatment and 

Disposal (NAICS Code 562211); 

• Hazardous Waste Collection 

(562112); 

• Solid Waste Combustors and 

Incinerators (NAICS Code 562213); 

• Other Chemical and Allied 

Products Merchant Wholesalers (NAICS 

Code 424690); 

• Crude Petroleum Extraction (NAICS 

Code 211120); 

• Facilities Support Services (NAICS 

Code 561210); 

• 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 HCBDcontaining 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. 

• 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. 

• 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. 

• 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. 

• 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 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– 


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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: 

• 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 (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 


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


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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 nonhazardous wastes. HCBD is listed as a 


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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 casespecific 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, 


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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 HCBDcontaining 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 HCBDcontaining 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 


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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 


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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/assessingandmanaging-chemicals-under-tsca/tscawork-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). 


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


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

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 

■ 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 ‘‘HCBD’’ to 

read as follows: 

Subpart E—Persistent, 

Bioaccumulative, and Toxic Chemicals 

§ 751.403 Definitions. 

* * * * * 

HCBD means the chemical substance 

hexachlorobutadiene (CASRN 87–68–3). 

* * * * * 

■ 3. Add § 751.413 to read as follows: 

§ 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 HCBDcontaining 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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