[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 880-894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28686]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2019-0080; FRL-10018-87]
RIN 2070-AK34


Decabromodiphenyl Ether (DecaBDE); 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 decabromodiphenyl ether (decaBDE) (CASRN 
1163-19-5), which EPA has determined meets the requirements for 
expedited action under of TSCA. This final rule prohibits all 
manufacture (including import), processing, and distribution in 
commerce of decaBDE, or decaBDE-containing products or articles, with 
some exclusions. These requirements will result in lower amounts of 
decaBDE being manufactured, processed, distributed in commerce, used 
and disposed, thus reducing the exposures to humans and the 
environment.

DATES: This final rule is 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: 
Clara Hull, 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: 202-564-3954; email address: <a href="/cdn-cgi/l/email-protection#a1c9d4cdcd8fc2cdc0d3c0e1c4d1c08fc6ced7"><span class="__cf_email__" data-cfemail="caa2bfa6a6e4a9a6abb8ab8aafbaabe4ada5bc">[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#5c080f1f1d71143328303532391c392c3d723b332a"><span class="__cf_email__" data-cfemail="6e3a3d2d2f4326011a0207000b2e0b1e0f40090118">[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 
decabromodiphenyl ether (decaBDE) and decaBDE-containing products and 
articles, especially wire and cable rubber casings, textiles, 
electronic equipment casings, building and construction materials, and 
imported articles such as aerospace and automotive parts. 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> Nuclear Electric Power Generation (NAICS Code 221113);
    <bullet> Power and Communication Line and Related Structures 
Construction (NAICS Code 237130);
    <bullet> Nonwoven Fabric Mills (NAICS Code 313230);
    <bullet> Fabric Coating Mills (NAICS Code 313320);
    <bullet> All Other Basic Organic Chemical Manufacturing (NAICS Code 
325199);
    <bullet> Paint and Coating Manufacturing (NAICS Code 325510);
    <bullet> Custom Compounding of Purchased Resins (NAICS Code 
325991);
    <bullet> All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS Code 325998);
    <bullet> Unlaminated Plastics Film and Sheet (except Packaging) 
Manufacturing (NAICS Code 326113);
    <bullet> Laminated Plastics Plate, Sheet (except Packaging), and 
Shape Manufacturing (NAICS Code 326130);
    <bullet> Urethane and Other Foam Product (except Polystyrene) 
Manufacturing (NAICS Code 326150);
    <bullet> All Other Plastics Product Manufacturing (NAICS Code 
326199);
    <bullet> Copper Rolling, Drawing, Extruding, and Alloying (NAICS 
Code 331420);
    <bullet> Computer and Peripheral Equipment Manufacturing (NAICS 
Code 3341);
    <bullet> Radio and Television Broadcasting and Wireless 
Communications Equipment Manufacturing (NAICS Code 334220);
    <bullet> Other Communications Equipment Manufacturing (NAICS Code 
334290);
    <bullet> Audio and Video Equipment Manufacturing (NAICS Code 
334310);
    <bullet> Other Communication and Energy Wire Manufacturing (NAICS 
Code 335929);
    <bullet> Current-Carrying Wiring Device Manufacturing (NAICS Code 
335931);
    <bullet> Motor Vehicle Manufacturing (NAICS Code 3361), e.g., 
automobile, aircraft, ship, and boat manufacturers and motor vehicle 
parts manufacturers;
    <bullet> Other Motor Vehicle Parts Manufacturing (NAICS Code 
336390);
    <bullet> Aircraft Manufacturing (NAICS Code 336411);
    <bullet> Guided Missile and Space Vehicle Manufacturing (NAICS Code 
336414);
    <bullet> Surgical Appliance and Supplies Manufacturing (NAICS Code 
339113);
    <bullet> Doll, Toy, and Game Manufacturing (NAICS Code 33993);
    <bullet> Automobile and Other Motor Vehicle Merchant Wholesalers 
(NAICS Code 423110);
    <bullet> Motor Vehicle Supplies and New Parts Merchant Wholesalers 
(NAICS Code 423120);
    <bullet> Hotel Equipment and Supplies (except Furniture) Merchant 
Wholesalers (NAICS Code 423440);
    <bullet> Household Appliances, Electric Housewares, and Consumer 
Electronics Merchant
    Wholesalers (NAICS Code 423620);
    <bullet> Sporting and Recreational Goods and Supplies Merchant 
Wholesalers (NAICS Code 423910);
    <bullet> Toy and Hobby Goods and Supplies Merchant Wholesalers 
(NAICS Code 423920);

[[Page 881]]

    <bullet> Other Chemical and Allied Products Merchant Wholesalers 
(NAICS Code 424690);
    <bullet> New Car Dealers (NAICS Code 441110);
    <bullet> Boat Dealers (NAICS Code 441222);
    <bullet> Automotive Parts and Accessories Stores (NAICS Code 
441310);
    <bullet> Furniture Stores (NAICS Code 442110);
    <bullet> Household Appliance Stores (NAICS Code 443141);
    <bullet> Electronics Stores (NAICS Code 443142);
    <bullet> All Other Home Furnishing Stores (NAICS Code 442299);
    <bullet> Children's and Infant's Clothing Stores (NAICS Code 
448130);
    <bullet> Hobby, Toy, and Game Stores (NAICS Code 451120);
    <bullet> General Merchandise Stores (NAICS Code 452);
    <bullet> Electronic Shopping and Mail-Order Houses (NAICS Code 
454110);
    <bullet> Aircraft Maintenance and Repair Services (NAICS Code 
488190);
    <bullet> Traveler Accommodations (NAICS Code 7211);
    <bullet> General Automotive Repair (NAICS Code 811111).
    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. 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). DecaBDE (CASRN 1163-19-5) is one such chemical substance. Other 
chemical substances are being addressed through separate Federal 
Register notices. For the purposes of this final rule, these specific 
chemical substances are hereinafter collectively referred to as the PBT 
chemicals. This final rule is final agency action for purposes of 
judicial review under TSCA section 19(a).

C. What action is the Agency taking?

    EPA published a proposed rule on July 29, 2019, to address the five 
PBT chemicals EPA identified pursuant to TSCA section 6(h) (84 FR 
36728; FRL-9995-76). After publication of the proposed rule, EPA 
determined to address each of the five PBT chemicals in separate final 
actions. This final rule prohibits the manufacture (including import) 
and processing of decaBDE, and products and articles to which decaBDE 
has been added effective 60 days after publication of the final rule, 
and distribution in commerce of products and articles to which decaBDE 
has been added one year after the effective date of the rule. Different 
compliance dates or exclusions from the date of publication of this 
prohibition include:
    <bullet> 18 months for any manufacture, processing and distribution 
in commerce of decaBDE for use in curtains in the hospitality industry, 
and the curtains to which decaBDE has been added.
    <bullet> Two years for any processing and distribution in commerce 
of decaBDE for use in wire and cable insulation in nuclear power 
generation facilities, and the decaBDE-containing wire and cable 
insulation.
    <bullet> Three years for any manufacture, processing and 
distribution in commerce of decaBDE for use in parts installed in and 
distributed as part of new aerospace vehicles, and the parts to which 
decaBDE has been added for such vehicles. After the end of their 
service lives for import, processing, and distribution in commerce of 
aerospace vehicles manufactured before January 7, 2024 that contain 
decaBDE in any part. After the end of their service lives for 
manufacture, processing, and distribution in commerce of decaBDE for 
use in replacement parts for aerospace vehicles, and the replacement 
parts to which decaBDE has been added for such vehicles.
    <bullet> After the end of their service lives, or 2036, whichever 
is earlier, for manufacture, processing, and distribution in commerce 
of decaBDE for use in replacement parts for motor vehicles, and the 
replacement parts to which decaBDE has been added for such vehicles.
    <bullet> After the end of their service lives for distribution in 
commerce of plastic shipping pallets manufactured prior to March 8, 
2021 that contain decaBDE.
    <bullet> Exclusion for processing and distribution in commerce for 
recycling of decaBDE-containing plastic products and articles (i.e., 
the plastic to be recycled is from products and articles that were 
originally made with decaBDE), and for decaBDE-containing products or 
articles made from such recycled plastic, where no new decaBDE is added 
during the recycling or production process.
    Persons manufacturing, processing, and distributing in commerce 
decaBDE or decaBDE-containing products and articles are required to 
maintain, for three years from the date the record is generated, 
ordinary business records related to compliance with this rule that 
include the name of the purchaser, and list the products or articles. 
Excluded from the recordkeeping requirement are persons processing and 
distributing in commerce for; recycling of plastic that contains 
decaBDE, those products and articles containing decaBDE from recycled 
plastic as long as no new decaBDE was added during the recycling 
process, and plastic shipping pallets manufactured prior to the 
effective date of the rule. These records must include a statement that 
the decaBDE, or the decaBDE-containing products and articles, are in 
compliance with 40 CFR 751.405(a) and be made available to EPA within 
30 calendar days upon request.

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 decaBDE, ``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 decaBDE 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 Final Regulation of 
Decabromodiphenyl ether (decaBDE) 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 
decaBDE. As discussed in more detail in Unit II.A., EPA did not perform 
a risk evaluation for decaBDE, nor did EPA develop quantitative risk 
estimates. Therefore, the Economic Analysis (Ref. 3) qualitatively 
discusses the benefits of reducing the exposure under the final rule 
for decaBDE.
    <bullet> Costs. Total quantified annualized social costs for this 
final rule are approximately $157,000 (at both 3%

[[Page 882]]

and 7% discount rates). Quantified costs were developed for rule 
familiarization, product substitution, and recordkeeping. 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 would impact 
approximately 17 small businesses of which none are expected to incur 
cost impacts of 1% of their revenue or greater.
    <bullet> Environmental Justice. This final rule may 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 and other downstream receptors such as 
recreational fishers.
    <bullet> Effects on State, local, and Tribal governments. This 
final rule does 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 exposures to decaBDE that 
could occur from activities now prohibited under this final rule for 
the general population and for potentially exposed or susceptible 
subpopulations such as children. More information can be found in the 
Exposure and Use Assessment (Ref. 4).

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 
persistent, bioaccumulative, and toxic (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. While EPA proposed regulatory 
actions on each chemical substance in one proposal, in response to 
public comments (EPA-HQ-OPPT-2019-0080-0544), (EPA-HQ-OPPT-2019-0080-
0553), (EPA-HQ-OPPT-2019-0080-0556), (EPA-HQ-OPPT-2019-0080-0562) 
requesting these five actions be separated, EPA is finalizing five 
separate actions. EPA intends for the five separate final rules to 
publish in the same issue of the Federal Register. The details of the 
proposal for decaBDE are described in more detail in Unit II.D.
    Under TSCA section 6(h)(1)(A), the subject 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 the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act was enacted.
    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 section 6(h)(2) further provides that the 
Administrator shall not be required to conduct risk evaluations on 
chemical substances that are subject to TSCA section 6(h)(1).
    Based on the criteria set forth in TSCA section 6(h), EPA proposed 
to determine that five chemical substances meet the TSCA section 
6(h)(1)(A) criteria for expedited action, and decaBDE 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 decaBDE. As described in the proposed rule, EPA 
conducted a review of available literature with respect to decaBDE to 
identify, screen, extract, and evaluate reasonably available 
information on use and exposures. This information is in the document 
entitled ``Exposure and Use Assessment of Five Persistent, 
Bioaccumulative and Toxic Chemicals'' (Ref. 4). Based on this review, 
which was subject to peer review and public comment, EPA proposed to 
find that exposure to decaBDE 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 (Ref. 4). 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 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

[[Page 883]]

6(h)(1)(B) finding for all chemical activities summarized in the 
Exposure and Use Assessment. 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 if found ``likely'' pursuant to TSCA section 6(h)(1)(B).
    Taking 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 activities with particular exclusions are those which EPA 
determined were not appropriate to regulate under the TSCA section 
6(h)(4) standard. Consistently, based on the Exposure and Use 
Assessment, activities associated with decaBDE that may no longer be 
occurring, such as domestic manufacture of the chemical substance or 
production of plastic enclosure for electronics, 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. 5).
    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 decaBDE. 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 argued that EPA would have 
had enough time to conduct a risk evaluation and issue a proposed rule 
by the statutory deadline.
    EPA disagrees with the commenters' interpretation of EPA's 
obligations with respect to chemicals subject to TSCA section 6(h)(4). 
TSCA section 6(h)(4) provides that EPA shall: (1) ``Address the risks 
of injury to health or the environment that the Administrator 
determines are presented by the chemical substance'' and (2) ``reduce 
exposure to the substance to the extent practicable.'' With respect to 
the first requirement, that standard is distinct from the 
``unreasonable risk'' standard for all other chemicals for which a 
section 6(a) rule might be issued. EPA does not believe that TSCA 
section 6(h) contemplates a new evaluation of any kind, given that 
evaluations to determine risks are now addressed through the TSCA 
section 6(b) risk evaluation process and that 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

[[Page 884]]

evaluation of any kind for these reasons, EPA reviewed the hazard and 
exposure information on the five PBT chemicals EPA had compiled. 
However, while this information appropriately addresses the criteria of 
TSCA section 6(h)(1)(A) and (B), it did not provide a basis for EPA to 
develop sufficient and scientifically robust and representative risk 
estimates to evaluate whether or not any of the chemicals present an 
identifiable risk of injury to health or the environment.
    Rather than suggesting a new assessment is required, EPA reads the 
``address risk'' language in TSCA section 6(h)(4) to contemplate 
reliance on an existing EPA assessment under TSCA, similar to a risk 
assessment that may be permissibly used under TSCA section 26(l)(4) to 
regulate the chemical under TSCA section 6(a). This interpretation 
gives meaning to the ``address risk'' phrase, without compelling an 
evaluation contrary to TSCA section 6(h)(2), and would allow use of an 
existing determination, or development of a new determination based on 
such an existing risk assessment, in the timeframe contemplated for 
issuance of a proposed rule under TSCA section 6(h). However, there 
were no existing EPA assessments of risk for any of the PBT chemicals. 
Thus, because EPA had no existing EPA risk assessments or 
determinations of risk, the regulatory measures addressed in this final 
rule focus on reducing exposures ``to the extent practicable.''
    In sum, because neither the statute nor the legislative history 
suggests that a new evaluation is compelled to identify and thereby 
provide a basis for the Agency to ``address risks'' and one could not 
be done prior to preparation and timely issuance of a proposed rule, 
and no existing TSCA risk assessment exists for any of the chemicals, 
EPA has made no risk determination finding for any of the PBT 
chemicals. Instead, EPA implements the requirement of TSCA section 
6(h)(4) by reducing exposures of each PBT chemical ``to the extent 
practicable.''
    For similar reasons, EPA does not believe that TSCA section 6(c)(2) 
requires a quantification of benefits, much less a specific kind of 
quantification. Under TSCA section 6(c)(2)(A)(iv), EPA must consider 
and publish a statement, based on reasonably available information, on 
the reasonably ascertainable economic consequences of the rule, but 
that provision does not require quantification, particularly if 
quantification is not possible. EPA has reasonably complied with this 
requirement by including a quantification of direct costs and a 
qualitative discussion of benefits in each of the preambles to the 
final rules. EPA was unable to quantify the indirect costs associated 
with the rule. More discussion on these issues raised in the comments 
is in the Response to Comments document (Ref. 5).
    4. Replacement parts and articles.
    In the preamble to the proposed rule, EPA explained that it did not 
read provisions of TSCA section 6 that conflict with TSCA section 6(h) 
to apply to TSCA section 6(h) rules. Specifically, TSCA sections 
6(c)(2)(D) and (E) require a risk finding pursuant to a TSCA section 
6(b) risk evaluation to regulate replacement parts and articles. Yet, 
TSCA section 6(h) neither compels nor contemplates a risk evaluation to 
precede or support the compelled regulatory action to ``address the 
risks . . .'' and ``reduce exposures to the substance to the extent 
practicable''. TSCA section 6(h)(2) makes clear no risk evaluation is 
required, and the timing required for conducting a risk evaluation is 
not consistent with the timing compelled for issuance of a proposed 
rule under TSCA section 6(h). Moreover, even assuming a prior risk 
assessment might allow a risk determination under the TSCA section 
6(h)(4) ``address risk'' standard, such assessment would still not 
satisfy the requirement in TSCA section 6(c)(2)(D) and (E) for a risk 
finding pursuant to a TSCA section 6(b) risk evaluation. Because of the 
clear conflict between these provisions, EPA determined that those 
provisions of TSCA section 6(c) that assume the existence of a TSCA 
section 6(b) risk evaluation do not apply in the context of this TSCA 
section 6(h) rulemaking. Instead, EPA resolves this conflict in these 
provisions by taking into account the TSCA section 6(c) considerations 
in its determinations as to what measures ``reduce exposure to the 
substance to the extent practicable''.
    Commenters contended that TSCA section 6(c)(2)(D) and (E) bar a 
TSCA section 6(h) rule in the absence of a risk evaluation, 
representing Congress's recognition of the special burdens associated 
with regulating replacement parts and articles, including the 
difficulty of certifying newly designed replacement parts for 
automobiles and aircraft, and the difficulty importers face in knowing 
what chemicals are present in the articles they import. As noted 
earlier in this Unit and further discussed in the Response to Comment 
document, while EPA determined that provisions of TSCA section 
6(c)(2)(D) and (E) do not apply because they conflict with the 
requirements of TSCA section 6(h), EPA interpreted the 
``practicability'' standard in TSCA section 6(h)(4) to reasonably 
contemplate the considerations embodied by TSCA section 6(c)(2)(D) and 
(E). As a result, EPA disagrees with any suggestion that the clear 
conflict between Congress' mandates in TSCA section 6(h) and TSCA 
section 6(c)(2)(D) and (E) must be read to bar regulation of 
replacement parts and articles made with chemicals that Congress 
believed were worthy of expedited action under TSCA section 6(h) and in 
the absence of a risk evaluation. The statute does not clearly 
communicate that outcome. Instead, Congress left ambiguous how best to 
address the conflict in these provisions, and EPA's approach for taking 
into consideration the TSCA section 6(c)(2)(D) and (E) concepts in its 
TSCA section 6(h)(4) ``practicability'' determinations is a reasonable 
approach. In addition, with respect to comments that TSCA section 
6(c)(2)(D) and (E) were intended to address Congress's concerns 
regarding burdens associated with regulation of replacement parts and 
articles, EPA agrees that these concerns are relevant and takes them 
into account in its implementation of the TSCA section 6(h)(4) mandate, 
with respect to the circumstances for each chemical. Finally, EPA does 
not believe that Congress intended, through the article provisions 
incorporated into the TSCA amendments, to absolve importers of the duty 
to know what they are importing. Importers can and should take steps to 
determine whether the articles they are importing contain chemicals 
that are prohibited or restricted. Therefore, as discussed earlier in 
this Unit and in the Response to Comment document, EPA is continuing to 
interpret TSCA sections 6(c)(2)(D) and 6(c)(2)(E) to be inapplicable to 
this rulemaking. While this interpretation has not changed, EPA has 
reviewed the practicability of regulating replacement parts and 
articles in accordance with the statutory directive in TSCA section 
6(h)(4) to reduce exposures to the PBT chemicals to the extent 
practicable. This is discussed further in Unit III.A.

C. DecaBDE Overview, Health Effects, and Exposure

    DecaBDE is used as an additive flame retardant in plastic 
enclosures for televisions, computers, audio and video equipment, 
textiles and upholstered articles, wire and cables for communication 
and electronic equipment, and other applications (Ref. 6). DecaBDE is 
also used as a flame retardant for multiple applications for aerospace 
and automotive vehicles, including replacement parts for aircraft and 
cars (Refs. 7, 8). Exposure

[[Page 885]]

information for decaBDE is detailed in EPA's Exposure and Use 
Assessment (Ref. 4), and the proposal. There is potential for exposure 
to decaBDE under the conditions of use at all stages of its lifecycle 
(i.e., manufacturing, processing, use (industrial, commercial, and 
consumer), distribution, and disposal) of the chemical (Ref 4). DecaBDE 
was produced and released at higher levels in the past but continues to 
be released. Releases from manufacturing and processing are declining 
over time, as are releases associated with use, disposal, and recycling 
(Ref. 4).
    Exposure assessments on decaBDE have been conducted by EPA 
(including industry-supplied information as part of the Voluntary 
Children's Chemical Evaluation Program), the National Academy of 
Sciences, and international governments. These assessments describe 
exposure potential for polybrominated diphenyl ethers (PBDEs), 
including decaBDE, through a variety of pathways. Adult and child 
exposures occur via dust ingestion, dermal contact with dust, and 
dietary exposures (such as dairy consumption). Household consumer 
products have been identified as the main source of PBDEs (including 
decaBDE) in house dust. The next highest exposure pathways included 
dairy ingestion, and inhalation of indoor air (via dust). Infant and 
child exposures occur via breastmilk ingestion and mouthing of hard 
plastic toys and fabrics. Occupational exposures for breastfeeding 
women were highest in women engaged in activities resulting in direct 
contact with decaBDE (Ref. 4).
    DecaBDE is toxic to aquatic invertebrates, fish, and terrestrial 
invertebrates. Data indicate the potential for developmental, 
neurological, and immunological effects, general developmental toxicity 
and liver effects in mammals. There was some evidence of genotoxicity 
and carcinogenicity. The studies presented in the document entitled 
``Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals (Hazard Summary) (Ref. 9) 
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), decaBDE scored high (3) for hazard (based on 
developmental effects in mammals and aquatic toxicity); high (3) for 
exposure (based on its use in textiles, plastics, and polyurethane 
foam; and information reported to the 2012 and 2016 Chemical Data 
Reporting (CDR) and the 2017 Toxics Release Inventory (TRI))(Ref. 
10,11,12); and high (3) for persistence and bioaccumulation (based on 
high environmental persistence and high bioaccumulation potential). The 
overall screening score for decaBDE was high (9).
    Taking all this into account, and the discussion in Response to 
Comments Document and in this preamble, EPA determines in this final 
rule that decaBDE meets the TSCA section 6(h)(1)(A) criteria. In 
addition, EPA determines, in accordance with TSCA section 6(h)(1)(B), 
that, based on the Exposure and Use Assessment and other reasonably-
available information, exposure to decaBDE is likely under the 
conditions of use to the general population, to a potentially exposed 
or susceptible subpopulation, or the environment. EPA's determination 
is based on the opportunities for exposure throughout the lifecycle of 
decaBDE, including the potential for consumer exposures. EPA did not 
receive any comments with information to call the exposure finding into 
question.

D. EPA's Proposed Rule Under TSCA Section 6(h) for decaBDE

    In the proposed rule (84 FR 36728), EPA proposed to prohibit the 
manufacture (including import), processing, and distribution in 
commerce of decaBDE, and articles and products to which decaBDE has 
been added. Proposed compliance dates or exclusions from the date of 
publication of the prohibition included:
    <bullet> 18 months for any manufacture, processing and distribution 
in commerce of decaBDE for use in curtains in the hospitality industry, 
and the curtains to which decaBDE has been added.
    <bullet> Three years for manufacture, processing and distribution 
in commerce of decaBDE for use in parts installed in and distributed as 
part of new aerospace vehicles, and the parts to which decaBDE has been 
added for such vehicles.
    <bullet> The exclusion from prohibitions for manufacturing 
(including import), processing, and distribution in commerce for use in 
replacement parts for motor and aerospace vehicles, and the replacement 
parts to which decaBDE has been added for such vehicles.
    <bullet> The exclusion from prohibitions for processing and 
distribution in commerce for recycling of plastic that contains 
decaBDE, (i.e., the plastic to be recycled is from products and 
articles that were originally made with decaBDE), so long as no new 
decaBDE is added during the recycling process.
    <bullet> The exclusion from processing and distribution in commerce 
of finished products and articles made from plastic recycled from 
products and articles containing decaBDE, where no new decaBDE was 
added during the production of the products and articles.
    In addition, EPA proposed to require that all persons who 
manufacture, process, or distribute in commerce decaBDE and decaBDE-
containing products and articles maintain ordinary business records, 
such as invoices and bills-of-lading, that demonstrate compliance with 
the prohibitions and restrictions. EPA proposed that these records 
would have to be maintained for a period of three years from the date 
the record is generated with an exclusion for persons processing and 
distributing in commerce for recycling of plastic that contains 
decaBDE, and those products or articles containing decaBDE from 
recycled plastic, as long as no new decaBDE was added during the 
recycling process.

E. Public Comments and Other Public Input

    The proposed rule provided a 60-day public comment period, with a 
30-day extension provided. (Ref. 5) 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. EPA also communicated with companies, and other 
stakeholders to identify and verify uses of decaBDE. These interactions 
and comments further informed EPA's understanding of the current status 
of uses for decaBDE. Public comments and stakeholder meeting summaries 
are available in the public docket at EPA-HQ-OPPT-2019-0080.
    In this preamble, EPA has responded to the major comments relevant 
to the decaBDE final rule. Of the comment

[[Page 886]]

submissions, 27 directly addressed EPA's proposed regulation of 
decaBDE. Additional discussion related to this final action can be 
found in the Response to Comments document (Ref. 5).

F. Activities Not Directly Regulated by This Rule

    EPA is not regulating all activities or exposures to decaBDE, even 
though the Exposure and Use Assessment (Ref. 4) identified potential 
for exposures under many conditions of use. One such activity is 
disposal. EPA generally presumes compliance with federal and state laws 
and regulations, including, for example, Resource Conservation and 
Recovery Act (RCRA) and its implementing regulations and state laws, as 
well as the Clean Air Act, the Clean Water Act, and the Safe Drinking 
Water Act (SDWA). As described in the proposed rule, regulations 
promulgated under the authority of the RCRA govern the disposal of 
hazardous and non-hazardous wastes. Although decaBDE is not a listed 
hazardous waste under RCRA, it is subject to the requirements 
applicable to solid waste under Subtitle D of RCRA. This means there is 
a general prohibition on open dumping (which includes a prohibition on 
open burning). Wastes containing this chemical that do not otherwise 
meet the criteria for hazardous waste would be disposed of in municipal 
solid waste landfills (MSWLFs), industrial nonhazardous, or, in a few 
instances construction/demolition landfills. Non-hazardous solid waste 
is regulated under Subtitle D of RCRA, and states play a lead role in 
ensuring that the federal requirements are met. The requirements for 
MSWLFs include location restrictions, composite liners, leachate 
collection and removal systems, operating practices, groundwater 
monitoring, closure and post-closure care, corrective action 
provisions, and financial assurance. Industrial waste (non-hazardous) 
landfills and construction/demolition waste landfills are primarily 
regulated under state regulatory programs, and in addition they must 
meet the criteria set forth in federal regulations, which may include 
requirements such as siting, groundwater monitoring and corrective 
action depending upon what types of waste are accepted. Disposal by 
underground injection is regulated under both RCRA and SDWA. In view of 
this comprehensive, stringent program for addressing disposal, EPA 
proposed that it is not practicable to impose additional requirements 
under TSCA on the disposal of the PBT chemicals, including decaBDE.
    EPA received a number of comments on this aspect of its proposal. 
Some commenters agreed with EPA's proposed determination that it is not 
practicable to regulate disposal, while others disagreed. However, in 
EPA's view establishing an entirely new disposal program for decaBDE-
containing wastes would be expensive and difficult to establish and 
administer. In addition, imposing a requirement to treat these wastes 
as if they were listed as hazardous wastes would have impacts on 
hazardous waste disposal capacity and be very expensive for states and 
local governments as well as for affected industries. Therefore, EPA 
has determined that it is not practicable to further regulate decaBDE-
containing wastes for disposal. More information on the comments 
received and EPA's responses can be found in the Response to Comments 
document (Ref. 5). One commenter, the Institute of Scrap Recycling 
Industries, Inc. (ISRI) (EPA-HQ-OPPT-2019-0080-0559) noted that while 
EPA proposed to not regulate disposal of the PBT chemicals under TSCA, 
the effect of EPA's proposed prohibition on manufacturing, processing, 
and distribution in commerce would prohibit the processing and 
distribution in commerce of the PBTs and products and articles 
containing the PBT chemicals for disposal. EPA did not intend such an 
effect, and has added an exclusion in the final regulatory text for 
processing and distribution in commerce for disposal.
    EPA also proposed not to use its TSCA section 6(a) authorities to 
regulate commercial use of products and articles containing the PBT 
chemicals, such as televisions and computers, because such regulation 
would not be practicable. It would be extremely burdensome, 
necessitating the identification of products containing decaBDE, and 
the disposal of countless products and articles, that would have to be 
replaced. If EPA prohibited the continued commercial use of these 
items, widespread economic impacts and disruption in the channels of 
trade would occur while the prohibited items were identified and 
replaced. While some commenters agreed with EPA's proposed 
determination that it is not practicable to regulate commercial use, 
and others disagreed, for the reasons noted in the proposal and 
discussed further in the Response to Comments document (Ref. 5), EPA 
continues to believe that prohibiting or otherwise restricting the 
continued commercial use of products and articles containing decaBDE 
would result in extreme burdens in exchange for what in most cases will 
be low exposure reductions. For example, as discussed in the Exposure 
and Use Assessment, releases from articles are expected to be minimal 
because decaBDE is entrained in the articles and is not expected to 
volatize or migrate readily under normal use (Ref. 4). Thus, EPA 
concludes that it is impracticable to prohibit or otherwise restrict 
the continued commercial use of decaBDE-containing products and 
articles.
    EPA also 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 decaBDE. 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 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,

[[Page 887]]

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. Such regulations would not be 
practicable. 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 decaBDE to suggest this is not the 
case. Further, EPA has not conducted a risk evaluation on decaBDE or 
any of the five 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 engineering or process controls or PPE 
requirements.
    EPA received comments regarding the use of PBT chemicals in 
research and development and lab use. Lab use is addressed under newly 
established 40 CFR 751.401(b) as the manufacturing, processing, 
distribution-in-commerce and use of any chemical substance, or products 
and articles that contain the chemical substance, for research and 
development, as defined in new 40 CFR 751.403. Research and Development 
is defined in new 40 CFR 751.403 to mean laboratory and research use 
only for purposes of scientific experimentation or analysis, or 
chemical research on, or analysis of, the chemical substance, including 
methods for disposal, but not for research or analysis for the 
development of a new product, or refinement of an existing product that 
contains the chemical substance. This will allow, for example, for 
samples of environmental media containing PBTs, such as contaminated 
soil and water, to be collected, packaged and shipped to a laboratory 
for analysis. Laboratories also must obtain reference standards 
containing PBTs to calibrate their equipment, otherwise they may not be 
able to accurately quantify these chemical substances in samples being 
analyzed. However, research to develop new products that use PBTs 
subject to 40 CFR part 751 subpart E, or the refinement of existing 
uses of those chemicals, is not included in this definition, and those 
activities remain potentially subject to the chemical specific 
provisions in 40 CFR part 751 subpart E. EPA believes it is not 
practicable to limit research and development activity as defined, 
given the critical importance of this activity to the detection, 
quantification and control of these chemical substances.
    Finally, EPA received comments regarding requirements for resale of 
decaBDE-containing products and articles, as well as products and 
articles containing other PBT chemicals undergoing TSCA section 6(h) 
rulemaking. One commenter stated that because the proposed definition 
of ``person'' includes ``any natural person,'' the proposed 
prohibitions would seem to apply to anyone selling products or articles 
containing decaBDE at a garage or yard sale. (EPA-HQ-OPPT-2019-0080-
0559) EPA did not intend to impose these final decaBDE regulations on 
yard sales or used product or article sales and has added language in 
40 CFR 751.401 to clarify this. The prohibition and recordkeeping 
requirements in this final rule exclude decaBDE-containing products and 
articles that have previously been sold or supplied to an end user, 
i.e., any person who purchased or acquired the finished good for 
purposes other than resale.

III. Provisions of This Final Rule

A. Scope and Applicability

    EPA carefully considered all public comments and information 
received related to the proposal. This rule finalizes with some 
modifications EPA's proposal to prohibit the manufacturing and 
processing of decaBDE, and products and articles that contain decaBDE, 
except for the following exclusions and delayed compliance dates from 
the date of publication of the prohibition:
    <bullet> One year for distribution in commerce of products and 
articles containing decaBDE.
    <bullet> 18 months for any manufacture, processing and distribution 
in commerce of decaBDE for use in curtains in the hospitality industry, 
and the curtains to which decaBDE has been added.
    <bullet> Two years for any processing and distribution in commerce 
of decaBDE for wire and cable insulation in nuclear power generation 
facilities, and the decaBDE-containing wire and cable insulation.
    <bullet> Three years for any manufacture, processing and 
distribution in commerce of decaBDE for use in parts installed in and 
distributed as part of new aerospace vehicles, and the parts to which 
decaBDE has been added for such vehicles. After the end of their 
service lives for import, processing, and distribution in commerce of 
aerospace vehicles manufactured before three years after the effective 
date of the rule that contain decaBDE in any part. After the end of 
their service lives for manufacture, processing, and distribution in 
commerce for use in replacement parts for aerospace vehicles, and the 
replacement parts to which decaBDE has been added for such vehicles.
    <bullet> After the end of their service lives, or 2036, whichever 
is earlier, for manufacture, processing, and distribution in commerce 
for use in replacement parts for motor vehicles, and the replacement 
parts to which decaBDE has been added for such vehicles.
    <bullet> After the end of their service lives for distribution in 
commerce of plastic shipping pallets manufactured prior to publication 
of the final rule, that contain decaBDE.
    <bullet> The exclusion for processing and distribution in commerce 
for recycling of decaBDE-containing plastic products and articles 
(i.e., the plastic to be recycled is from product and articles that 
were originally made with decaBDE), and for decaBDE containing products 
and articles made from such

[[Page 888]]

recycled plastic, where no new decaBDE is added during the recycling or 
production process.
    Affected persons manufacturing, processing, and distributing in 
commerce decaBDE or decaBDE-containing products and articles are 
required to maintain, for three years from the date the record is 
generated, ordinary business records related to compliance with the 
restrictions, prohibitions, and other requirements, with an exclusion 
for persons processing and distributing in commerce for; recycling of 
plastic that contains decaBDE, those products and articles containing 
decaBDE from recycled plastic as long as no new decaBDE was added 
during the recycling process, and plastic shipping pallets manufactured 
prior to the effective date of the rule. These records must include a 
statement of compliance with this final rule and be made available to 
EPA within 30 calendar days upon request.
    1. General prohibition and exclusions.
    EPA received comments supporting and opposing the proposed general 
prohibition on manufacture, processing and distribution in commerce of 
decaBDE and products and articles containing decaBDE. A few commenters 
suggested a total ban would be practicable instead of the proposed 
prohibition with exclusions. EPA disagrees, and believes that this rule 
prohibits the manufacture, processing and distribution in commerce for 
use of decaBDE to the extent practicable, reducing any potential 
activities involving the chemical as a whole, while allowing for 
several industries to safely finish and replace their applications of 
the chemical substance. However, even these uses of decaBDE are not 
unlimited and therefore are expected to decline until they cease 
completely. EPA may review these particular practicability 
determinations in the future. The prohibition on manufacture, 
processing and distribution in commerce for all but excluded activities 
is expected to result in the reduced potential for exposures. The 
practicability of prohibiting an excluded activity is further discussed 
in this Unit and in the Response to Comment document.
    2. Hospitality curtains.
    As described in the proposed rule, with respect to curtains used in 
the hospitality industry, EPA understands that most of the industry has 
moved away from using decaBDE as a flame retardant. However, EPA is 
aware of one small business that is still using decaBDE while it 
searches for a replacement flame retardant. EPA believes that 18 months 
from the date of publication of the final rule, rather than an 
immediate compliance date from manufacturing, processing, and 
distribution in commerce, is the soonest practicable date for the small 
business to find a substitute.
    3. Aviation and automotive replacement parts and new aviation 
parts.
    As described in the proposed rule, aerospace and automotive 
vehicles have included parts made with decaBDE, and in many cases 
decaBDE has been used to meet various flame-retardant standards. Based 
on comments received, all production of new automotive vehicles with 
decaBDE-containing parts will have ceased prior to the effective date 
for this rule; aerospace vehicles will cease such production within a 
3-year timeframe. However, the decaBDE-containing parts originally 
produced for such automotive or for such aerospace vehicles may require 
replacement parts to meet flame-retardancy standards through the end of 
the service lifves of the vehicles. Any transition to alternatives for 
those replacement parts will require verification to meet these 
standards.
    Imposing immediate restrictions on replacement parts for those 
vehicles could increase costs and safety concerns, but, as noted in 
this Unit, without meaningful exposure reductions. As a result, in this 
final rule, EPA is adopting an alternative compliance deadline of 2036 
for motor vehicles and the end of the service lives for aerospace 
vehicles from the prohibition on the manufacture (including import), 
processing, and distribution in commerce of decaBDE for use in 
aerospace or automotive replacement parts, and the replacement parts 
that contain decaBDE. The manufacture (including import), processing, 
and distribution in commerce of decaBDE for use in new automotive parts 
will be prohibited, as discussed further in this Unit, and the 
manufacture (including import), processing, and distribution in 
commerce of decaBDE for use in new aerospace parts will be prohibited 
three years after publication of the final rule. For the purpose of 
this rule, replacement parts are those parts designed before the rule 
promulgation date to replace parts already made with decaBDE. Thus, for 
example, this exclusion does not allow replacement parts containing 
decaBDE to be manufactured, processed or distributed in commerce to 
replace parts that were not previously designed to contain decaBDE.
    EPA's alternative compliance deadline for replacement parts for 
these vehicles results from several considerations. Article components 
containing decaBDE for finished parts in automobiles and aircraft have 
limited releases. (Exposure and Use Assessment). In addition to limited 
releases, and therefore limited exposures, as further discussed in the 
proposed rule and in the Response to Comment document, identifying and 
adopting appropriate substitutes for use in replacement parts for these 
vehicles can be a complex and time-consuming process. Further, the 
scope of this alternative compliance deadline is limited. For 
automotive vehicles, the scope is limited only to those parts intended 
to replace decaBDE-containing parts for automotive vehicles already 
produced; no new parts may be produced for new automotive vehicles 
under this alternative deadline. For aerospace vehicles, the scope is 
similarly limited to only those parts intended to replace decaBDE-
containing parts for aerospace vehicles produced before the 3-year 
compliance deadline for such vehicles. That means those aerospace parts 
and the vehicles will have already been designed and in the production 
process; no newly designed parts may be produced using decaBDE even 
during the 3-year alternative compliance period, and after the 3-year 
compliance period only replacement parts, as defined earlier in the 
Unit, will be permitted. Finally, the compliance deadlines in each case 
are consistent with comments provided, e.g., identifying 15 years as 
the needed period for retaining replacement parts for automotive 
vehicles, and identifying the aerospace vehicle service life as the 
needed period for retaining replacement parts for aerospace vehicles. 
(Ref. 7, EPA-HQ-OPPT-2019-0080-0542) Such compliance deadlines also 
align with the specified exemption for use of decaBDE in parts for such 
vehicles in the Stockholm Convention. For the use of replacement parts 
for automotive vehicles, for example, EPA is not aware of any decaBDE-
containing parts that are outside the scope of the replacement parts 
listed in Annex A, Part IX of the Stockholm Convention (Ref. 13). In 
the case of aerospace vehicles, the timeframe provided in this final 
rule is actually narrower (more restrictive) than the timeframe 
provided by the Stockholm Convention. These examples support that the 
market for replacement parts containing decaBDE will have diminished by 
the compliance dates in this rule. Three commenters requested EPA 
change its statutory interpretation

[[Page 889]]

to exempt these replacement parts using the replacement parts provision 
under TSCA section 6(c)(2)(D) instead of a practicability determination 
under TSCA section 6(h); however, for the reasons stated in Unit II.B., 
EPA is continuing to interpret TSCA section 6(c)(2)(D) to be 
inapplicable to this rulemaking. Other commenters challenged a complete 
exclusion for replacement parts, as discussed in Unit III.A.1. EPA 
agrees it is practicable to impose the specified alternative compliance 
deadline for the prohibition on the manufacture, processing and 
distribution in commerce of decaBDE for use in replacement parts.
    In addition, as noted in the proposed rule and according to 
comments received from various industries, including the Aerospace 
Industries Association (AIA) (Ref. 5), the aerospace industry expects 
to have phased out its use of decaBDE in new aircraft products by the 
end of 2023. As a result, EPA is finalizing its proposed compliance 
date to allow the manufacture, processing and distribution in commerce 
for use of decaBDE and products and articles containing decaBDE, for 
use in new parts produced through 2023. In addition, the manufacture, 
processing and distribution in commerce of decaBDE for use in 
replacement parts intended for aerospace vehicles will continue to be 
allowed until the end of the service lives of the vehicles. However, 
this compliance deadline does not allow the manufacture, processing or 
distribution in commerce of decaBDE for parts that are newly designed 
for such new aerospace vehicles. This compliance deadline is based on 
comments received indicating the intent to phase-out use of decaBDE in 
parts for aerospace vehicles already designed, but which specify the 
need for replacement parts for the service lives of the vehicles to 
avoid the high cost of identifying appropriate and safe alternatives 
for vehicles already designed and in production, but for a limited 
period of time. (EPA-HQ-OPPT-2019-0080-0542) The deadline for new parts 
also is more restrictive than the Stockholm Convention's specific 
exemption for use of decaBDE in parts for those aerospace vehicles with 
designs approved by 2022, and thus further supports that the market for 
parts containing decaBDE for these vehicles will have diminished by the 
compliance date in this rule. For similar reasons, EPA is also not 
prohibiting the manufacture (including import), processing and 
distribution in commerce of whole aircraft manufactured within that 
specified compliance deadline and containing those new parts with 
decaBDE. With respect to motor vehicles, comments received from 
automotive industries, including the Motor Equipment and Manufacturers 
Association (MEMA) (EPA-HQ-OPPT-2019-0080-0547) indicate that the 
automotive industry will have phased out use of decaBDE for newly 
produced motor vehicles by the effective date of this final rule and 
therefore the final rule prohibits any manufacture, processing or 
distribution in commerce of decaBDE for any use in motor vehicles 
manufactured after the effective date of the rule.
    Thus, for all the reasons noted, the prohibitions and compliance 
deadlines adopted in this final rule for the aerospace and automotive 
industries will reduce exposures to the extent practicable as required 
under TSCA section 6(h)(4) and will do so as ``soon as practicable'' 
pursuant to TSCA section 6(d)(1)(D), while allowing a reasonable 
transition time as contemplated by TSCA section 6(d)(1)(E).
    4. Recycling and recycled products and articles.
    EPA received submissions from 14 environmental groups that 
recommended EPA remove the exclusions for recycling. Commenters 
disagreed that it would be overly burdensome and not practicable to 
impose restrictions on the recycling of decaBDE containing plastic of 
products and articles that may contain decaBDE. The commenters cited 
and attached the Stockholm Convention 2015 Report of the Persistent 
Organic Pollutants Review Committee on the work of its eleventh 
meeting: Risk Management Evaluation on decabromodiphenyl ether 
(commercial mixture, c-decaBDE) (Ref. 13), which did not include 
recycling exemptions.
    EPA recognizes the importance and impact of recycling, which 
contributes to American prosperity and the protection of our 
environment. EPA believes that it would be overly burdensome and not 
practicable to impose restrictions on the recycling of plastics that 
may contain decaBDE, or on the use of recycled plastic in plastic 
articles, because the decaBDE is typically present in such articles at 
low levels (Ref. 14). Because these articles typically contain low 
levels of decaBDE and taking into account the significant prohibitions 
being adopted in this rulemaking that are in alignment or more 
stringent than requirements under the Stockholm Convention and the 
general movement to use of substitutes, EPA expects the amount of 
recycled plastic that contains decaBDE from recycled plastic to 
significantly decline over time. In contrast, banning the recycling of 
plastics containing decaBDE would require this decaBDE-containing 
plastic to be identified through prohibitively expensive and 
complicated testing, and separated from other types of plastic before 
recycling, which is usually done manually. EPA believes it would be 
difficult to make plastic sorting for this purpose to be cost-
effective, and that it would be overly burdensome and not practicable 
to prohibit recycling of decaBDE-containing plastic in the United 
States at this time. Further discussion on the burdens with prohibiting 
recycling are in the Response to Comments document (Ref. 5).
    5. Plastic shipping pallets.
    EPA received a comment from a company requesting to continue to 
process and distribute in commerce their existing inventory of plastic 
shipping pallets that contain decaBDE previously added as a flame 
retardant. (EPA-HQ-OPPT-2019-0080-0535) Although the company ceased its 
use of decaBDE in the manufacture of new pallets prior to 2013, those 
previously manufactured pallets are still in use and being rented for 
use. This final rule allows such continued rental and use until the end 
of the service lives of the pallet, at which point it may be recycled 
into new plastic pallets consistent with 40 CFR 751.405(b). No new 
decaBDE may be added during this recycling process. Based on the 
comment received, EPA has added a delayed compliance date for the 
continued distribution in commerce of such pallets.
    6. Wire and cable insulation.
    EPA requested comment from companies still processing and using 
wire and cable insulation containing decaBDE despite phase-out 
initiatives and the availability of relatively inexpensive substitutes. 
One commenter responded that while alternatives were available, they 
would need more time to successfully test and qualify an alternative 
chemical to decaBDE to meet the Institute of Electrical and Electronics 
Engineers (IEEE) 383 standard for instrumentation and power cable 
insulation for nuclear power plants. (EPA-HQ-OPPT-2019-0080-0583) 
Considering the unique safety certifications to qualify and approve an 
alternative chemical for this use, EPA has added a compliance delay of 
two years for the prohibition on the manufacture, processing and 
distribution in commerce of decaBDE for use in wire and cable 
insulation and of decaBDE containing wire and cable insulation.

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    7. Compliance Dates for the Prohibition.
    The proposed rule did not delay the compliance date beyond the 
rule's effective date; the processing and distribution bans would come 
into effect 60 days after publication of the final rule notice. EPA 
stated in the proposed rule that at that time it had no information 
indicating that a compliance date of 60 days after publication of the 
final rule is not practicable for the activities that would be 
prohibited, or that additional time is needed for products to clear the 
channels of trade. The phrases ``as soon as practicable'' and 
``reasonable transition period'' as used in TSCA section 6(d)(1) are 
undefined, and the legislative history on TSCA section 6(d) is limited. 
Given the ambiguity in the statute, for purposes of this expedited 
rulemaking, EPA presumed a 60-day compliance date was ``as soon as 
practicable,'' unless there was support for a lengthier period of time 
on the basis of reasonable available information, such as information 
submitted in comments on the Exposure and Use Assessment or in 
stakeholder dialogues. Such a presumption ensures the compliance 
schedule is ``as soon as practicable,'' particularly in the context of 
the TSCA section 6(h) rules for chemicals identified as persistent, 
bioaccumulative and toxic, and given the expedited timeframe for 
issuing a TSCA section 6(h) proposed rule did not allow time for 
collection and assessment of new information separate from the comment 
opportunities during the development of and in response to the proposed 
rule. Such presumption also allows for submission of information from 
the sources most likely to have the information that will affect an EPA 
determination on whether or how best to adjust the compliance deadline 
to ensure that the final compliance deadline is both ``as soon as 
practicable'' and provides a ``reasonable transition period.''
    EPA received public comments regarding the 60-day compliance date 
for the prohibition in the proposed rule. Many commenters stated that 
this date would be unrealistic and requested that EPA phase in the 
compliance deadlines for the bans on importation or distribution of 
products and articles containing decaBDE over a longer period following 
promulgation of the final rule. In addition, commenters requested that 
EPA allow products and articles containing decaBDE that are 
manufactured and imported prior to the compliance deadlines to be 
distributed thereafter without restriction and that this would be 
needed to prevent an untold number of lawfully manufactured and 
imported products and articles from suddenly becoming unsaleable, which 
would result in significant costs for retailers and importers. Other 
commenters supported the compliance date.
    However, in response to retail and business commenters requesting 
additional time given complex supply chains and the need to educate 
downstream users, EPA is extending the compliance date for distribution 
in commerce to one year after publication of the final rule. Extending 
the compliance date for one year will, as commenters note, allow 
additional time for products and articles containing decaBDE that were 
produced prior to the effective date for the prohibition on manufacture 
and processing to clear channels of trade. However, EPA is not 
extending the compliance date for manufacture or processing of these 
products and articles containing decaBDE, and therefore is not 
extending the compliance date for import which under TSCA section 3 is 
a subset of manufacture activities. Unless reasonably available 
information otherwise supports that it is not practicable to impose a 
60-day compliance deadline for manufacture, which includes import, or 
for processing of decaBDE and decaBDE-containing products and articles, 
for purposes of meeting EPA's obligations under TSCA section 6(h), EPA 
presumes a compliance date of 60 days is ``as soon as practicable.'' 
EPA received only general comments taking the position, without 
support, that the 60-day compliance period for the prohibition on 
manufacture or processing is not practicable. Specified exclusions to 
the manufacturing compliance date are described in Unit I.C.
    8. Recordkeeping.
    EPA is requiring that all persons who manufacture, process, or 
distribute in commerce decaBDE and products and articles containing 
decaBDE maintain ordinary business records, such as invoices and bills-
of-lading, related to compliance with the prohibitions and 
restrictions. 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. Exempted from the recordkeeping requirement are persons 
processing and distributing in commerce for recycling of decaBDE 
containing plastic products or articles and decaBDE containing products 
or articles made from such recycled plastic as long as no new decaBDE 
is added during the recycling process, and persons distributing in 
commerce until the end of their service life plastic shipping pallets 
manufactured prior to the publication of the final rule. EPA requested 
comment on alternative recordkeeping requirements that could help 
ensure compliance with the decaBDE prohibitions, particularly for 
importers and others who do not produce articles. After reviewing the 
comments received, EPA has decided to include two additional 
requirements to help ensure compliance (EPA-HQ-OPPT-2019-0080-0539; -
0542; -0546; -0549). First, the records that are kept must include a 
statement that the decaBDE, or the decaBDE-containing products and 
articles, are in compliance with 40 CFR 751.405(a). The statement need 
not be included on every business record, such as every invoice or bill 
of lading, although regulated entities may certainly choose to reformat 
their documents to include the statement. Importers of replacement 
automobile parts that contain decaBDE who, for example, import from the 
same suppliers over and over, need only have a single statement for 
each part or each supplier. Finally, EPA is adding a requirement that 
the records kept pursuant to this final rule be made available to EPA 
within 30 calendar days upon request to ensure that EPA can review 
records in a timely manner.

B. TSCA Section 6(c)(2) Considerations

    1. Health effects, exposure, and environmental effects.
    DecaBDE is toxic to aquatic invertebrates, fish, and terrestrial 
invertebrates. Data indicate the potential for developmental, 
neurological, and immunological effects, general developmental toxicity 
and liver effects in mammals. Additionally, toxicological studies 
indicated evidence of genotoxicity and evidence of carcinogenicity. 
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 decaBDE's health 
effects, use, and exposure is in Unit II.C. and is further detailed in 
EPA's Hazard Summary (Ref. 9) and Exposure and Use Assessment (Ref. 4).
    2. The benefits of the chemical substance or mixture for various 
uses.
    DecaBDE is a brominated flame retardant that has been added to 
plastics, textiles, and other materials. When fire occurs, decaBDE and 
other PBDEs, are part of vapor-phase chemical reactions that interfere 
with the combustion process, thus delaying ignition and inhibiting the 
spread of fire. DecaBDE has been considered an

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economical flame retardant because relatively small quantities are 
necessary to be effective (Ref 4).
    3. The reasonably ascertainable economic consequences of the rule.
    i. Overview of cost methodology. EPA has evaluated the potential 
costs of the final action for decaBDE. Costs of the final rule were 
estimated based on the assumption that under regulatory limitations on 
decaBDE, processors that use decaBDE in their products would switch to 
available alternative chemicals to manufacture the product, or to 
products that do not contain decaBDE. For decaBDE, the costs were 
assessed based on chemical substitutes only. Substitution costs were 
estimated on the industry level using the price differential between 
the cost of the chemical and identified substitutes. Costs for rule 
familiarization and recordkeeping were estimated based on burdens 
estimated for other similar rulemakings. Costs were annualized over a 
25-year period. Other potential costs include, but are not limited to, 
those associated with testing, reformulation, distribution, 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).
    ii. Estimated costs of this final rule. Total quantified annualized 
industry costs for the final rule are $2,012 at the 3% discount rate 
and $2,100 at the 7% discount rate annualized over 25 years. Total 
annualized Agency costs associated with implementation of the final 
rule were based on EPA's best judgment and experience with other 
similar rules. For the final regulatory action, EPA estimated it will 
require 1 FTE at $155,152 per year (Ref. 3).
    Total quantified annualized social costs for the final rule are 
estimated to be $157,000 at both 3% and 7% discount rate. As described 
earlier in Unit III.B.3., potential costs such as testing, 
reformulation, release prevention, and imported articles, could not be 
quantified due to lack of data availability to estimate quantified 
costs. These costs are discussed qualitatively in the Economic Analysis 
(Ref. 3).
    iii. Benefits. As discussed in Unit II.A., while EPA reviewed 
hazard and exposure information for the PBT chemicals, this information 
did not provide a basis for EPA to develop scientifically robust and 
representative risk estimates to evaluate whether or not any of the 
chemicals present a risk of injury to health or the environment. 
Benefits were not quantified due to the lack of risk estimates. A 
qualitative discussion of the potential benefits associated with the 
final action for decaBDE is provided. DecaBDE is persistent and 
bioaccumulative and has been associated with developmental neurological 
effects, developmental immunological effects, general developmental 
toxicity, and thyroid and liver effects in mammals, as well as with 
toxicity in aquatic organisms. Under this final rule, manufacturing, 
processing and distribution in commerce will be prohibited, except for 
specific exclusions and different compliance dates as detailed in Unit 
I.C. With reduced manufacturing, processing and distribution of decaBDE 
and decaBDE-containing products and articles, EPA anticipates that this 
regulation will result in a phase-out of decaBDE use overall, and 
therefore a reduced presence of decaBDE in products and articles. These 
impacts will result in the decreased potential for exposures to workers 
in the industrial sectors that currently use decaBDE, and the decreased 
potential for releases of decaBDE to the environment, including through 
disposal activities. With decreased potential for releases to the 
environment and reduced presence in products and articles, there will 
also be decreased potential for exposures for the general population or 
potentially exposed or susceptible subpopulations. Thus, the final 
regulatory action will have benefits for the environment, general 
population, and potentially exposed or susceptible subpopulations, and 
benefits to health for workers. Substitute chemicals should be 
carefully selected to realize benefits to human health and the 
environment because there are numerous potential substitutes for 
decaBDE.
    iv. Cost effectiveness, and effect on national economy, small 
business, and technological innovation. With respect to the cost 
effectiveness of the final regulatory action and the primary 
alternative regulatory action, EPA is unable to perform a traditional 
cost-effectiveness analysis of the actions and alternatives for the PBT 
chemicals. As discussed in the proposed rule, the cost effectiveness of 
a policy option would properly be calculated by dividing the annualized 
costs of the option by a final outcome, such as cancer cases avoided, 
or to intermediate outputs such as tons of emissions of a pollutant 
curtailed. Without the supporting analyses for a risk determination, 
EPA is unable to calculate either a health-based or environment-based 
denominator. Thus, EPA is unable to perform a quantitative cost-
effectiveness analysis of the final and alternative regulatory actions. 
However, by evaluating the practicability of the final and alternative 
regulatory actions, EPA believes that it has considered elements 
related to the cost effectiveness of the actions, including the cost 
and the effect on exposure to the PBT chemicals of the final and 
alternative regulatory actions.
    EPA considered the anticipated effect of this rule on the national 
economy and concluded that this rule is highly unlikely to have any 
measurable effect on the national economy (Ref. 3). EPA analyzed the 
expected impacts on small business and found that no small entities are 
expected to experience impacts of more than 1% of revenues (Ref. 3). 
Finally, EPA has determined that this rule is unlikely to have 
significant impacts on technological innovation, although the rule may 
create some incentives for chemical manufacturers to develop new 
chemical alternatives to decaBDE.
    4. Consideration of alternatives.
    EPA believes that there are viable substitutes that may be used as 
an alternative to decaBDE. In January 2014, EPA's Design for the 
Environment (DfE) published an alternatives assessment for decaBDE 
(Ref. 15). EPA identified 29 potential functional, viable alternatives 
to decaBDE for use in select polyolefins, styrenics, engineering 
thermoplastics, thermosets, elastomers, or waterborne emulsions and 
coatings (Ref. 15).

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. EPA based its 
determination that human and environmental exposures to decaBDE are 
likely in the Exposure and Use Assessment (Ref. 4) discussed in Unit 
II.A.2., which underwent a peer review and public comment process, as 
well as using best available science and methods sufficient to make 
that determination. The extent to which the various information, 
procedures, measures, and methodologies, as applicable, used in EPA's 
decision making have been subject to independent verification or peer 
review is adequate to justify their use, collectively, in the record 
for this rule. Additional information on the peer review and public 
comment process, such as the peer review plan, the peer review report, 
and the Agency's Response to Comments document, are in the public 
docket for this action (EPA-HQ-OPPT-2018-0314). In

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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. 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 Final Regulation of Decabromodiphenyl 
ether (DecaBDE) Final Rule Under TSCA Section 6(h). July 2020.
4. EPA. Exposure and Use Assessment of Five Persistent, 
Bioaccumulative, and Toxic Chemicals. December 2020.
5. EPA Regulation of Persistent, Bioaccumulative, and Toxic Chemicals 
under TSCA 6(H) Response to Comments. December 2020. (Docket EPA-HQ-
OPPT-2019-0080).
6. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Decabromodiphenyl ether. August 2017. 
(EPA-HQ-OPPT-2016-0724-0002).
7. Stakeholder Comment from Auto Alliance. February 2018.
8. Stakeholder Comment from iGPS. January 2018.
9. EPA. Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals. December 2020.
10. EPA. Public Database 2012 Chemical Data Reporting. Washington, DC: 
US Environmental Protection Agency, Office of Pollution Prevention and 
Toxics.
11. EPA. Public Database 2016 Chemical Data Reporting. Washington, DC: 
US Environmental Protection Agency, Office of Pollution Prevention and 
Toxics.
12. EPA. Toxics Release Inventory (TRI) Basic Plus Data Files. 2017.
13. United Nations Environmental Program Stockholm Convention on 
Persistent Organic Pollutants (2015). Risk profile on decabromodiphenyl 
ether. Report of the Persistent Organic Pollutants Review Committee on 
the work of its eleventh meeting.
14. Norwegian Environmental Agency. (2015) Final Report. Literature 
Study--DecaBDE in Waste Streams.
15. EPA. An Alternatives Assessment for the Flame Retardant 
Decabromodiphenyl Ether (DecaBDE). January 2014. https://www.epa.gov/sites/production/files/2014-05/documents/decabde_final.pdf. Accessed 
March 1, 2019.
16. 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.
17. Harper, Barbara and Ranco, Darren, in collaboration with the Maine 
Tribes. Wabanaki Traditional Cultural Lifeways Exposure Scenario. July 
9, 2009.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review under Executive 
Order 12866 (58 FR 51,735 (Oct. 4, 1993)) and Executive Order 13563 (76 
FR 3821 (Jan. 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 Decabromodiphenyl ether 
(DecaBDE) 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 (Feb. 3, 2017)). Details on the estimated costs of 
this final rule can be found in the Economic Analysis (Ref. 3), which 
is briefly summarized in Unit III.B.3.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been 
submitted for approval to OMB under the PRA. 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.
    Affected persons manufacturing, processing, and distributing in 
commerce decaBDE or decaBDE-containing products and articles are 
expected to familiarize themselves with the rule and are required to 
maintain, for three years from the date the record is generated, 
ordinary business records related to compliance with the restrictions, 
prohibitions, and other requirements, with an exclusion for persons 
processing and distributing in commerce for; recycling of plastic that 
contains decaBDE, those products and articles containing decaBDE from 
recycled plastic as long as no new decaBDE was added during the 
recycling process, and plastic shipping pallets manufactured prior to 
the effective date of the rule.
    Respondents/affected entities: Entities potentially affected by 
paperwork requirements of this final rule include 17 importers, 26 
processors, and five distributors. The total number of respondents is 
46, given that two entities are both importers and processors.
    Respondent's obligation to respond: Mandatory. (40 CFR 751.407).
    Estimated number of respondents: 46.
    Frequency of response: On occasion.
    Total estimated burden: 39 hours (per year). Burden is defined at 5 
CFR 1320.3(b).
    Total estimated cost: $3,014 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40

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CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency 
will announce that approval in the Federal Register and publish a 
technical amendment to 40 CFR part 9 to display the OMB control number 
for the approved information collection activities contained in this 
final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The small entities subject to the requirements of 
this action are small businesses that manufacture/import, process, or 
distribute decaBDE. In total, 17 small businesses are expected to be 
affected by the final action. Of the 17 small entities assessed, none 
(0%) are expected to experience negative impacts of more than 1% of 
revenues. Because only 17 small businesses are directly impacted and 
negative impacts are less than 1% for all small entities, EPA presumes 
no significant economic impact on a substantial number of small 
entities (no SISNOSE). 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 would 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 the final rule are approximately $157,000 (at 
both 3% and 7% discount rates), which does not exceed the inflation-
adjusted unfunded mandate threshold of $160 million.

F. Executive Order 13132: Federalism

    This action does not have federalism implications because it is not 
expected to have substantial direct effects on the states, on the 
relationship between the National Government and the states, or on the 
distribution of power and responsibilities among the various levels of 
government as specified in Executive Order 13132 (64 FR 43255, August 
10, 1999). Thus, Executive Order 13132 does not apply to this action.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications because it is not 
expected to have substantial direct effects on tribal governments, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes as specified in Executive Order 
13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does 
not apply to this final rule.
    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, the EPA consulted with tribal officials during the 
development of this action. EPA consulted with representatives of 
Tribes via teleconference on August 31, 2018, and September 6, 2018, 
concerning the prospective regulation of the five PBT chemicals under 
TSCA section 6(h).
    Tribal members were encouraged to provide additional comments after 
the teleconferences. EPA received two comments from the Keweenaw Bay 
Indian Community and Maine Tribes (Ref. 16, 17).

H. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not an economically significant 
regulatory action as defined by Executive Order 12866. Although the 
action is not subject to Executive Order 13045, the Agency considered 
the risks to infants and children under EPA's Policy on Evaluating 
Health Risks to Children. EPA did not perform a risk assessment or risk 
evaluation of decaBDE, however available data indicate exposure to 
decaBDE may disproportionately affect children, and information 
indicates decaBDE is a neurodevelopment toxicant and has been detected 
in breastmilk. More information can be found in the Exposure and Use 
Assessment (Ref. 4) and the ``Environmental and Human Health Hazards of 
Five Persistent, Bioaccumulative and Toxic Chemicals'' (Ref. 9). This 
regulation will reduce the exposure to decaBDE for the general 
population and for potentially exposed or susceptible subpopulations 
such as workers and children.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy and has not been designated by the 
Administrator of the Office of Information and Regulatory Affairs of 
the Office of Management and Budget as a significant energy action.

J. National Technology Transfer and Advancement Act (NTTAA)

    Because this action does not involve any technical standards, 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

    The 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 in on decaBDE in this final rule will reduce the 
potential for exposure in the United States over time, 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).


[[Page 894]]



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

Subpart E--Persistent, Bioaccumulative, and Toxic Chemicals


Sec.  751.403  Definitions.

* * * * *
    DecaBDE means the chemical substance decabromodiphenyl ether (CASRN 
1163-19-5).
* * * * *

0
3. Add Sec.  751.405 to read as follows:


Sec.  751.405  DecaBDE.

    (a) Prohibition. (1) General. Except as provided in paragraphs 
(a)(2) and (b) of this section, all persons are prohibited from all 
manufacturing and processing of decaBDE or decaBDE-containing products 
or articles after March 8, 2021, and all persons are prohibited from 
all distribution in commerce of decaBDE or decaBDE-containing products 
or articles after January 6, 2022.
    (2) Phase-in of Prohibitions for Specific Uses of decaBDE and 
decaBDE-containing Products or Articles. (i) After July 6, 2022, all 
persons are prohibited from all manufacturing, processing, and 
distribution in commerce decaBDE for use in curtains in the hospitality 
industry, and the curtains to which decaBDE has been added.
    (ii) After January 6, 2023, all persons are prohibited from all 
processing and distribution in commerce of decaBDE for use in wire and 
cable insulation in nuclear power generation facilities, and decaBDE-
containing wire and cable insulation.
    (iii) After January 8, 2024, all persons are prohibited from all 
manufacturing, processing, and distribution in commerce of decaBDE for 
use in parts installed in and distributed as part of new aerospace 
vehicles, and the parts to which decaBDE has been added for such 
vehicles. After the end of the aerospace vehicles service lives, all 
persons are prohibited from all importing, processing, and distribution 
in commerce of aerospace vehicles manufactured before January 8, 2024 
that contain decaBDE in any part. After the end of the aerospace 
vehicles service lives, all persons are prohibited from all 
manufacture, processing and distribution in commerce of decaBDE for use 
in replacement parts for aerospace vehicles, and the replacement parts 
to which decaBDE has been added for such vehicles.
    (iv) After the end of the vehicles service lives or 2036, whichever 
is earlier, all persons are prohibited from all manufacture, processing 
and distribution in commerce of decaBDE for use in replacement parts 
for motor vehicles, and the replacement parts to which decaBDE has been 
added for such vehicles.
    (v) After the end of the pallets' service life, all persons are 
prohibited from all distribution in commerce of plastic shipping 
pallets that contain decaBDE and were manufactured prior March 8, 2021.
    (b) Exclusions to the Prohibition. Processing and distribution in 
commerce for recycling of decaBDE-containing plastic from products or 
articles and decaBDE-containing products or articles made from such 
recycled plastic, where no new decaBDE is added during the recycling or 
production processes is not subject to the prohibition in paragraph (a) 
of this section.
    (c) Recordkeeping. (1) After March 8, 2021, all persons who 
manufacture, process, or distribute in commerce decaBDE or decaBDE-
containing products or articles must maintain ordinary business 
records, such as invoices and bills-of-lading related to compliance 
with the prohibitions, restrictions, and other provisions of this 
section.
    (i) These records must be maintained for a period of three years 
from the date the record is generated.
    (ii) These records must include a statement that the decaBDE or the 
decaBDE-containing products or articles are in compliance with 40 CFR 
751.405(a).
    (iii) These records must be made available to EPA within 30 
calendar days upon request.
    (2) The recordkeeping requirements in paragraph (c)(1) do not apply 
to the activities described in paragraphs (a)(2)(v) and (b) of this 
section.

[FR Doc. 2020-28686 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P


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