Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate (3:1); Revision to the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under the Toxic Substances Control Act (TSCA), 91486-91520 [2024-25758]
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91486
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations
[EPA–HQ–OPPT–2023–0376; FRL–9145–02–
OCSPP]
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–8833; email address:
drewes.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
RIN 2070–AL02
I. Executive Summary
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 751
Decabromodiphenyl Ether and Phenol,
Isopropylated Phosphate (3:1);
Revision to the Regulation of
Persistent, Bioaccumulative, and Toxic
Chemicals Under the Toxic
Substances Control Act (TSCA)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA or Agency) is finalizing
revisions to the regulations for
decabromodiphenyl ether (decaBDE)
and phenol, isopropylated phosphate
(3:1) (PIP (3:1)), two of the five
persistent, bioaccumulative, and toxic
(PBT) chemicals addressed in final rules
issued under the Toxic Substances
Control Act (TSCA) in January 2021.
After receiving additional comments,
the Agency has determined that
revisions to the decaBDE and PIP (3:1)
regulations are necessary to address
implementation issues and to further
reduce the potential for exposures to
decaBDE and PIP (3:1) for humans and
the environment to the extent
practicable.
DATES: This rule is effective on January
21, 2025.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2023–0376, is
available online at https://
www.regulations.gov. Additional
instructions on visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For general information: The TSCA
Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
For technical information regarding
decaBDE: Brooke Porter, Existing
Chemicals Risk Management Division
(7404M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–6388; email address:
porter.brooke@epa.gov.
For technical information regarding
PIP (3:1): Scott Drewes, Existing
Chemicals Risk Management Division
(7404M), Office of Pollution Prevention
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SUMMARY:
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A. Does this action apply to me?
You may be affected by this action if
you manufacture (including import),
process, distribute in commerce, or use
decaBDE or decaBDE-containing
products or articles. Such uses for
decaBDE may include but are not
limited to wire and cable insulation for
nuclear power generation facilities,
plastic shipping pallets, and imported
articles such as replacement parts for
aerospace and automotive parts. You
may also be affected by this action if
you manufacture (including import),
process, distribute in commerce, or use
PIP (3:1) or PIP (3:1)-containing
products or articles. Such uses for PIP
(3:1) may include flame retardants in
plastics, functional fluids in aerospace
and industrial machinery, and plastic
articles that are components of
electronics or electrical articles.
The following list of North American
Industry Classification System (NAICS)
codes is not intended to be exhaustive,
but rather provides a guide to help
readers determine whether this
document might apply to them.
Potentially affected entities may
include:
• Adhesive Manufacturing (NAICS
Code 325520);
• Air and Gas Compressor
Manufacturing (NAICS Code 333912);
• Air-Conditioning and Warm Air
Heating Equipment and Commercial
and Industrial Refrigeration Equipment
Manufacturing (NAICS Code 333415);
• Aircraft Engine and Engine Parts
Manufacturing (NAICS Code 336412);
• Aircraft Manufacturing (NAICS
Code 336411);
• All Other Basic Organic Chemical
Manufacturing (NAICS Code 325199);
• All Other Miscellaneous General
Purpose Machinery Manufacturing
(NAICS Code 333998);
• All Other Plastics Product
Manufacturing (NAICS Code 326199);
• All Other Transportation
Equipment Manufacturing (NAICS Code
336999);
• Analytical Laboratory Instrument
Manufacturing (NAICS Code 334516);
• Appliance Repair and Maintenance
(NAICS Code 811412);
• Audio and Video Equipment
Manufacturing (NAICS Code 334310);
• Automobile and Light Duty Motor
Vehicle Manufacturing (NAICS Code
336110);
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• Automobile and Other Motor
Vehicle Merchant Wholesalers (NAICS
Code 423110);
• Boat Building (NAICS Code
336612);
• Broadwoven Fabric Mills (NAICS
Code 313210);
• Computer and Computer Peripheral
Equipment and Software Merchant
Wholesalers (NAICS Code 432430);
• Computer Storage Device
Manufacturing (NAICS Code 334112);
• Construction Machinery
Manufacturing (NAICS Code 333120);
• Current-Carrying Wiring Device
Manufacturing (NAICS Code 335931);
• Custom Compounding of Purchased
Resins (NAICS Code 325991);
• Electronic Computer Manufacturing
(NAICS Code 334111);
• Farm and Garden Machinery and
Equipment Merchant Wholesalers
(NAICS Code 423820);
• Farm Machinery and Equipment
Manufacturing (NAICS Code 333111);
• Guided Missile and Space Vehicle
Manufacturing (NAICS Code 336414);
• Guided Missile and Space Vehicle
Propulsion Unit Parts Manufacturing
(NAICS Code 336415);
• Heavy Duty Truck Manufacturing
(NAICS Code 336120);
• Household Appliances, Electric
Housewares, and Consumer Electronics
Merchant Wholesalers (NAICS Code
423620);
• Industrial Machinery and
Equipment Merchant Wholesalers
(NAICS Code 423830);
• Industrial Supplies Merchant
Wholesalers (NAICS Code 423840);
• Industrial Truck, Tractor, Trailer
and Stacker Machinery Manufacturing
(NAICS Code 333924);
• Instruments and Related Products
Manufacturing for Measuring,
Displaying, and Controlling Industrial
Process Variables (NAICS 334513);
• Lawn and Garden Tractor and
Home Lawn and Garden Equipment
Manufacturing (NAICS Code 333112);
• Manufacturing and Reproducing
Magnetic and Optical Media (NAICS
Code 334610);
• Materials Recovery Facilities
(NAICS Code 562920);
• Medical, Dental, and Hospital
Equipment and Supplies Merchant
Wholesalers (NAICS Code 423450);
• Mining Machinery and Equipment
Manufacturing (NAICS Code 333131);
• Miscellaneous Intermediation
(NAICS Code 523910);
• Motor and Generator Manufacturing
(NAICS Code 335312);
• Motor Vehicle Body Manufacturing
(NAICS Code 336211);
• Motor Vehicle Electrical and
Electronic Equipment Manufacturing
(NAICS Code 336320);
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• Motor Vehicle Gasoline Engine and
Engine Parts Manufacturing (NAICS
Code 336310);
• Motor Vehicle Supplies and New
Parts Merchant Wholesalers (NAICS
Code 423120);
• Motorcycle, Bicycle and Parts
Manufacturing (NAICS Code 336991);
• New Car Dealers (NAICS Code
441110);
• Nuclear Electric Power Generation
(NAICS Code 221113);
• Other Aircraft Part and Auxiliary
Equipment Manufacturing (NAICS Code
336413);
• Other Basic Inorganic Chemical
Manufacturing (NAICS Code 325180);
• Other Chemical and Allied
Products Merchant Wholesalers (NAICS
Code 424690);
• Other Commercial and Industrial
Machinery and Equipment Rental and
Leasing (NAICS Code 532490);
• Other Communications and Energy
Wire Manufacturing (NAICS Code
335929);
• Other Communications Equipment
Manufacturing (NAICS Code 334290);
• Other Electronic Component
Manufacturing (NAICS Code 334419);
• Other Electronic Parts and
Equipment Merchant Wholesalers
(NAICS Code 432690);
• Other Guided Missile and Space
Vehicle Parts and Auxiliary Equipment
Manufacturing (NAICS Code 336419);
• Other Motor Vehicle Parts
Manufacturing (NAICS Code 336390);
• Paint and Coating Manufacturing
(NAICS Code 325510);
• Petroleum Lubricating Oil and
Grease Manufacturing (324191);
• Petroleum Refineries (NAICS Code
324110);
• Plastics Material and Resin
Manufacturing (NAICS Code 325211);
• Plastics Product Manufacturing
(NAICS Code 3261);
• Plumbing, Heating, and AirConditioning Contractors (NAICS Code
238220);
• Relay and Industrial Control
Manufacturing (NAICS Code 335314);
• Semiconductor and Related Device
Manufacturing (NAICS Code 334413);
• Semiconductor Machinery
Manufacturing (NAICS Code 333242);
• Surface Active Agency
Manufacturing (NAICS Code 325613);
and
• Surgical Appliance and Supplies
Manufacturing (NAICS Code 339113).
To determine whether your entity is
regulated by this action, you should
carefully examine the provisions found
in 40 CFR part 751. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the technical information contacts listed
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under FOR FURTHER INFORMATION
CONTACT.
B. What is the Agency’s authority for
taking this action?
TSCA section 6(h), 15 U.S.C. 2601 et
seq., directs EPA to take expedited
action to complete TSCA section 6(a)
rules on certain PBT chemical
substances. EPA must apply one or
more of the requirements listed in TSCA
section 6(a) to the extent necessary to
meet the TSCA section 6(h)(4) statutory
standard. More specifically, EPA must
take action on those chemical
substances identified in the 2014
Update to the TSCA Work Plan for
Chemical Assessments (Ref. 2) 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. 3).
In response to this directive, in
January 2021, EPA promulgated rules to
regulate the following five PBT
chemical substances: decaBDE (CASRN
1163–19–5); PIP (3:1) (CASRN 68937–
41–7); 2,4,6-tris(tert-butyl)phenol (2,4,6TTBP) (CASRN 732–26–3);
hexachlorobutadiene (HCBD) (CASRN
87–68–3); and pentachlorothiophenol
(PCTP) (CASRN 133–49–3) (Refs. 4, 5, 6,
7, and 8). With the obligation to
promulgate these rules, the Agency also
has the authority to amend them (e.g.,
if circumstances change, including in
relation to the receipt of new
information). It is well settled that EPA
has inherent authority to reconsider,
revise, or repeal past decisions to the
extent permitted by law so long as the
Agency provides a reasoned
explanation. See F.C.C. v. Fox
Television Stations, Inc., 556 U.S. 502,
515 (2009). Based on information
submitted by regulated entities since the
publication of the 2021 decaBDE and
PIP (3:1) final rules, the Agency has
determined that amendments to both
rules are necessary to further reduce the
potential for exposure to the extent
practicable.
C. What action is the Agency taking?
EPA is finalizing revisions to the
decaBDE and PIP (3:1) rules issued
under TSCA (see 40 CFR part 751,
subpart E). Additionally, in response to
comments received on the 2023
proposed rule for decaBDE and PIP (3:1)
(Ref. 1), EPA is also amending the
general provisions at 40 CFR 751.401 to
exclude processing and distribution in
commerce of an article that contains the
chemical substance, and where the
chemical substance has not been newly
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added, for the purpose of repair or
maintenance. EPA is not revising the
chemical-specific provisions for the
other three PBT chemical substances
addressed in 40 CFR part 751, subpart
E (2,4,6-TTBP, HCBD, and PCTP).
1. Decabromodiphenyl Ether (DecaBDE)
DecaBDE is a flame retardant that has
been widely used in textiles, plastics,
adhesives, and polyurethane foam. In
this action, EPA is finalizing revisions
to the 2021 decaBDE final rule to
require the use of personal protective
equipment (PPE) during certain
activities involving decaBDE. EPA is
also finalizing: a prohibition on releases
to water during the manufacturing,
processing, and distribution in
commerce of decaBDE and decaBDEcontaining products; an extension of the
compliance date for the phase-out of
processing and distribution in
commerce of decaBDE-containing wire
and cable insulation for nuclear power
generation facilities; an export
notification requirement for decaBDEcontaining wire and cable for nuclear
power generation facilities; and an
allowance for unintentional amounts of
decaBDE present in products and
articles at concentrations less than 0.1%
by weight. These final revisions are
discussed further in Unit III.F.
2. Phenol, Isopropylated Phosphate (3:1)
(PIP (3:1))
PIP (3:1) is a flame retardant, a
plasticizer, and an anti-compressibility
and anti-wear additive. It is used in
lubricants and hydraulic fluids and in
the manufacture of other compounds.
For PIP (3:1), EPA is finalizing revisions
to the 2021 final rule to require the use
of PPE for the domestic manufacturing
and processing of PIP (3:1) and certain
PIP (3:1)-containing products and
articles. EPA is also finalizing: phaseouts on processing and distribution for
certain uses; new exclusions from the
prohibitions on processing and
distribution in commerce of PIP (3:1) for
use in wire harnesses and electric
circuit boards and for the processing
and distribution in commerce of such
PIP (3:1)-containing harnesses and
circuit boards; an exclusion to allow for
distribution in commerce of new and
replacement parts containing PIP (3:1);
and an allowance for unintentional
amounts of PIP (3:1) present in products
and articles at concentrations less than
0.1% by weight. EPA is not revising the
October 2024 compliance date for
articles not otherwise covered by an
exclusion from prohibition or by an
existing or newly finalized extension to
a phase-out compliance deadline.
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D. Why is the Agency taking this action?
On September 3, 2021, in accordance
with Executive Order 13990, ‘‘Protecting
Public Health and the Environment and
Restoring Science to Tackle the Climate
Crisis,’’ (86 FR 7037, January 25, 2021),
EPA announced its intention to review
the five PBT final rules issued on
January 6, 2021 (Refs. 9 and 10).
Specifically, EPA announced that it
planned to determine whether the rules
were consistent with the
Administration’s policy to limit
exposure to dangerous chemicals and to
identify additional actions that could be
taken to address implementation issues
and to reduce further exposures to these
PBT chemicals to the extent practicable,
as directed by TSCA section 6(h). On
March 8, 2021, EPA also requested
public comment in the Federal Register
on the five 2021 PBT final rules,
including decaBDE and PIP (3:1) (Ref.
11). In particular, EPA sought comment
on whether the five 2021 PBT final rules
sufficiently reduced exposures to these
chemicals, including exposures to
potentially exposed or susceptible
subpopulations and the environment;
on implementation issues associated
with the 2021 PBT final rules; on
compliance issues associated with the
2021 PBT final rules; and on whether to
consider additional or alternative
regulatory measures or approaches.
During the development of the 2021
PBT final rules, EPA conducted
extensive outreach to stakeholders,
including hosting a public webinar to
gather use information on the PBTs,
holding two comment periods on the
Exposure and Use Assessment, and
presenting the notice of proposed
rulemaking at a Small Business
Roundtable hosted by the Small
Business Administration (SBA) Office of
Advocacy to elicit public comment.
Only after the 2021 PBT final rules were
published, a wide variety of
stakeholders from various sectors,
including, for example, the electronics
and electrical manufacturing sector and
their customers, raised significant
concerns about their ability to meet the
March 8, 2021 compliance date for the
processing and distribution of PIP (3:1)
and PIP (3:1)-containing articles (Ref.
12). These stakeholders contended that
they needed significantly more time to
identify whether and where PIP (3:1)
might be present in articles in their
supply chains, find and certify
alternative chemicals, and produce or
import new articles that do not contain
PIP (3:1). EPA met with numerous
stakeholders, including trade
associations, entities who report PIP
(3:1) under the Chemical Data Reporting
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Rule, and other sectors where PIP (3:1)
use was identified. Despite EPA’s
extensive outreach, most stakeholders
that contacted EPA after the rule was
finalized had not commented on its
proposal or otherwise engaged with the
Agency on the PIP (3:1) rulemaking and
did not appear to have previously
surveyed their supply chains to
determine whether PIP (3:1) was being
used (Refs. 5, 10, 11, and 13). Absent
timely input from these stakeholders, in
the 2021 PIP (3:1) final rule EPA
determined that PIP (3:1) was not
widely present in complex articles
outside the aerospace and automotive
sectors. These stakeholders requested an
extension of the compliance dates in
order to clear the existing articles
through the supply chain, find and
certify an alternative chemical, and
produce or import new articles that do
not contain PIP (3:1).
In response to stakeholder input, in
an immediately effective final rule
issued in September 2021, EPA
extended the compliance deadline for
processing and distribution in
commerce of PIP (3:1) for use in articles
and PIP (3:1)-containing articles, unless
subject to an exclusion from or phasein of prohibition, to March 8, 2022 (Ref.
10). In October 2021, EPA proposed a
new extended compliance deadline for
processing and distribution in
commerce of PIP (3:1) for use in articles
and PIP (3:1)-containing articles, unless
subject to an exclusion from or phasein of prohibition, to October 31, 2024,
and finalized that extended compliance
deadline in March 2022 (Refs. 13 and
14). EPA similarly amended the
compliance deadline for recordkeeping
requirements for articles in those
rulemakings.
Additionally, EPA responded to the
comments received on the March 2021
notification that were relevant to the PIP
(3:1) compliance deadline extension and
related issues when the Agency
extended the compliance deadlines in
both the September 2021 PIP (3:1) final
rule and in an October 2021 PIP (3:1)
proposed rule (Refs. 10 and 13).
According to the comments received
prior to and in response to the March
2021 notification and request for
comments, a wide range of key
consumer and commercial goods are
affected by the prohibitions in the 2021
PIP (3:1) final rule such as cellular
telephones, laptop computers, and other
electronic devices and industrial and
commercial equipment used in various
sectors including transportation, life
sciences, and semiconductor production
(Ref. 15). These comments are addressed
in EPA’s September 2021 PIP (3:1) final
rule and October 2021 PIP (3:1)
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proposed rule (Refs. 10 and 13). EPA
reasoned that these extensions would
avoid significant disruption in the
supply chains for certain articles
necessary to the electronics and
electrical manufacturing sector, while
EPA determined whether any further
compliance date extensions were
necessary for certain industry sectors,
including the semiconductor and
equipment manufacturing sectors.
EPA also announced in the September
2021 PIP (3:1) final rule, October 2021
PIP (3:1) proposed rule, and the March
2022 PIP (3:1) final rule that the Agency
intended to consider any additional
information received to further reduce
exposures and assess how
environmental justice could be
promoted through further exposure
reduction to better protect human health
and the environment (Refs. 10, 13, and
14).
In addition, several comments
received raised issues pertaining to
decaBDE. Commenters recommended
further regulation of decaBDE, including
narrowing the replacement part
exclusion to time-limited critical uses,
addressing potential risks from releases
to the environment, restricting the
disposal of decaBDE and decaBDEcontaining products and articles, and
addressing potential risks from
occupational exposure (EPA–HQ–
OPPT–2023–0376–0303, EPA–HQ–
OPPT–2023–0376–0313, EPA–HQ–
OPPT–2021–0202). EPA also received a
comment requesting the Agency hold a
government-to-government consultation
with the Yurok Tribal Council (Ref. 16).
In November 2022, EPA held a one-onone Tribal consultation with the Yurok
Tribal Council. During this consultation,
the Agency received additional
information that informed the Agency of
considerations to reduce potential
exposures to decaBDE, including
labeling and a prohibition on the
releases to water. EPA received no
comments addressing the need for the
extending compliance date for decaBDEcontaining wire and cable insulation for
nuclear power generation facilities.
E. What are the estimated incremental
impacts of this action?
EPA’s estimated incremental impacts
for this rulemaking are presented in an
Economic Analysis document (Ref. 17),
which is available in the docket,
described in more detail in Unit IV., and
is briefly summarized here. The EPA
conducted this analysis for the purpose
of providing the public with as full as
possible an understanding of the
potential impacts of this final action.
The EPA believes this can inform the
public’s understanding, place EPA’s
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action in context, and help identify and
illustrate the extent of potential burdens
and protection.
1. Benefits
As discussed in the 2021 PBT final
rules and Unit II.C., and consistent with
TSCA section 6(h)(2), EPA did not
perform a risk evaluation for decaBDE
or PIP (3:1), nor did EPA develop
quantitative risk estimates. TSCA
section 6(h)(2) makes clear that
Congress did not intend for EPA to
conduct a risk evaluation to support
TSCA section 6(a) rules issued to satisfy
TSCA section 6(h) requirements, but
rather intended for EPA to conduct an
expedited rulemaking process to
‘‘reduce exposures to the extent
practicable’’ pursuant to TSCA section
6(h)(4). EPA also does not interpret
TSCA section 6(c)(2) to require a
quantification of benefits. Under TSCA
section 6(c)(2)(A)(iv), EPA must
consider and publish a statement on the
reasonably ascertainable economic
consequences of the rule, but that
provision does not require
quantification, particularly if
quantification is not possible. While
EPA was not able to quantify the
benefits of reducing human and
environmental exposures to decaBDE or
PIP (3:1), the Economic Analysis
qualitatively discusses the benefits of
reducing exposure under this final rule,
as summarized in Unit IV. (Ref. 17).
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2. Costs
Total quantified annualized social
costs for this final rule are
approximately $400 million at a 3
percent discount rate, and $430 million
at a 7 percent discount rate. Costs at a
2 percent discount rate are estimated at
$390 million (shown in appendix A of
the accompanying Economic Analysis
for this final rule). Of the final rule
costs, those associated with decaBDE
alone were estimated at $86 at a 3
percent discount rate and $128 at a 7
percent discount rate. Costs associated
with PIP (3:1) alone were estimated at
$400 million and $430 million (at 3 and
7 percent discount rates, respectively).
PPE requirements were estimated at
$373 million and $410 million (at 3 and
7 percent discount rates, respectively)
comprising the majority of the total
costs. Comparatively, costs for the 2021
PIP (3:1) final rule were estimated at
approximately $23.6 million at a 3
percent discount rate and $22.8 million
at 7 percent. Costs for this final rule are
associated with new requirements and
therefore were not included in estimates
for the 2021 PIP (3:1) final rule.
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3. Small Entity Impacts
This final rule is estimated to impact
approximately 24,865 small businesses,
all of which pertain to PIP (3:1) and
none for decaBDE. Of these, 860 small
businesses are expected to incur cost
impacts between 1 percent and 3
percent of their annual revenue. No
entities are expected to be impacted
above 3 percent of their annual revenue.
4. Environmental Justice
Since a risk evaluation was not
conducted, EPA’s understanding of the
extent to which reductions in exposure
might reduce risks for communities
with environmental justice (EJ) concerns
is limited. In the Economic Analysis
accompanying this rule (Ref. 17), EPA
relied on available relevant data sources
for PIP (3:1) and decaBDE, including
EPA’s Chemical Data Reporting (CDR),
the U.S. Census Bureau, American
Community Survey (2022), and others to
assess the economic implications of this
final rule. Data, however, are not
sufficiently comprehensive to estimate
the extent to which the final rule will
reduce existing disproportionate
impacts on communities with EJ
concerns. In addition, only a small
subset of the specific facilities (14
facilities reported to 2020 CDR) using
decaBDE and PIP (3:1) have been
identified, so a proximity analysis
examining the characteristics of the
communities surrounding the known
facilities would not be representative of
all exposed communities.
Given the lack of available data, EPA
has determined that it is not practicable
to assess whether this action is likely to
result in new disproportionate impacts
or exacerbate any existing
disproportionate impacts on
communities with EJ concerns. The
restrictions placed on decaBDE and PIP
(3:1) through this final rule will reduce
the potential exposures and risks
associated with the manufacture,
processing, and use of these chemicals.
At a minimum EPA considers that this
final rule will not exacerbate any
baseline EJ concerns and will increase
the level of protection for all affected
populations without having any
disproportionate and adverse human
health or environmental effects on any
population, including children. Certain
exclusions from prohibition and
extensions of compliance dates beyond
those adopted in the 2021 PBT final
rules, however, may partially delay
anticipated reductions in exposure.
5. Children’s Environmental Health
Under the 2021 EPA Policy on
Children’s Health, the Agency considers
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91489
the risks to infants and children
consistently and explicitly during its
decision-making process (Ref. 18).
Certain exclusions and extensions of
compliance dates beyond those adopted
in the 2021 PBT final rules or
subsequent PIP (3:1) final rules,
however, may partially delay these
reductions in exposure. More
information can be found in the
Exposure and Use Assessment
document (Ref. 19).
6. Effects on State, Local, and Tribal
Governments
This final rule will not have any
significant or unique effects on small
governments, or federalism, or Tribal
implications.
II. Background
A. History of This Rulemaking
1. The 2021 PBT Final Rules
a. DecaBDE
The decaBDE 2021 final rule
prohibited 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 included:
• 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.
• 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.
• 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.
• After the end of their service lives,
or 2036, whichever is earlier, for
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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.
• After the end of their service lives
for distribution in commerce of plastic
shipping pallets manufactured prior to
March 8, 2021 that contain decaBDE.
• 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 were 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
were 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.
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b. PIP (3:1)
The 2021 PIP (3:1) final rule
prohibited the processing and
distribution in commerce of PIP (3:1)
and products containing PIP (3:1) except
for the following:
• Processing and distribution in
commerce for use in hydraulic fluids
either for the aviation industry or to
meet military specifications for safety
and performance where no alternative
chemical is available that meets U.S.
Department of Defense specification
requirements;
• Processing and distribution in
commerce for use in lubricants and
greases;
• Processing and distribution in
commerce for use in new and
replacement parts for the automotive
and aerospace industry, and the
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distribution in commerce of those parts
to which PIP (3:1) has been added;
• Processing and distribution in
commerce for use as an intermediate in
a closed system to produce
cyanoacrylate adhesives;
• Processing and distribution in
commerce for use as an adhesive and
sealant until January 6, 2025, after
which such activity is prohibited;
• Processing and distribution in
commerce for use in specialized engine
filters for locomotive and marine
applications;
• Processing for recycling and
distribution in commerce for the
recycling of PIP (3:1)-containing plastic
provided no new PIP (3:1) is added
during the recycling process;
• Processing and distribution in
commerce of articles and products made
from recycled PIP (3:1)-containing
plastic provided no new PIP (3:1) is
added during the recycling process or to
the articles and products made from the
recycled plastic; and
• Processing and distribution in
commerce of PIP (3:1) for use in
photographic printing articles and PIP
(3:1)-containing photographic printing
articles until January 1, 2022.
This final rule also prohibited releases
to water for from manufacture,
processing, distribution in commerce,
and commercial uses that are permitted
to occur, as outlined in the preceding
bullets:
• Persons manufacturing, processing,
and distributing in commerce PIP (3:1)
and products containing PIP (3:1) are
required to notify their customers of
these prohibitions on processing and
distribution, and the prohibition on
releases to water via Safety Data Sheet
(SDS) or labeling.
• Persons manufacturing, processing,
and distributing in commerce PIP (3:1)
are required to maintain, for three years
from the date the record was generated,
ordinary business records related to
compliance with the restrictions,
prohibitions, and other requirements set
forth in this rule. These records must
include a statement that the PIP (3:1), or
the PIP (3:1)-containing products or
articles, are in compliance with 40 CFR
751.407(a) and be made available to
EPA within 30 calendar days upon
request.
2. PIP (3:1) Compliance Date Extensions
Based on the PIP (3:1)-specific
comments received in response to the
March 2021 notification and request for
comments, EPA issued an immediately
effective final rule in September 2021,
which extended the compliance dates
applicable to the processing and
distribution in commerce of certain PIP
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(3:1)-containing articles and the PIP
(3:1) used to make those articles, until
March 8, 2022, along with the
associated recordkeeping requirements
for manufacturers, processors, and
distributors of PIP (3:1)-containing
articles (Ref. 10). While most
commenters on the March 2021
notification and request for comments
requested a longer-term compliance date
extension (Ref. 15), EPA determined
that a short-term extension was
necessary to ensure that the supply
chains for these important articles
continue uninterrupted in the near term
while allowing EPA to conduct notice
and comment rulemaking on a longerterm compliance date extension
generally.
On March 8, 2022, EPA further
extended the compliance deadline
established in the September 2021 final
rule for the processing and distribution
in commerce of PIP (3:1) for use in
certain articles and for the processing
and distribution in commerce of certain
PIP (3:1)-containing articles, from March
8, 2022, to October 31, 2024 (Ref. 14).
The compliance date for the
recordkeeping requirements for
manufacturers, processors, and
distributors of PIP (3:1)-containing
articles was also extended from March
8, 2022, to October 31, 2024. Articles
covered by the phased-in prohibition
include any article not otherwise
covered by an alternative compliance
deadline or exclusion described in 40
CFR 751.407(a)(2)(ii) or (b). EPA
reasoned that this further extension
would avoid significant disruption in
the supply chains for certain articles
and would provide the public with
regulatory certainty, while EPA
determined whether any further
compliance date extensions were
necessary.
3. The 2023 Proposed Rule for DecaBDE
and PIP (3:1)
On November 24, 2023, EPA proposed
updates to the 2021 final decaBDE and
PIP (3:1) rules (Ref. 1). For decaBDE,
EPA proposed the following: requiring a
label on plastic shipping pallets known
to contain decaBDE; requiring PPE use
for certain activities involving decaBDE;
prohibiting the release of decaBDE to
water during manufacturing, processing,
and distribution in commerce;
extending the compliance deadline for
processing and distribution of decaBDEcontaining wire and cable insulation for
use in nuclear power generation
facilities; requiring export notification
for decaBDE-containing wire and cable
for nuclear power generation facilities,
and extending the recordkeeping
requirements from three to five years
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and removing the 30-day timeframe to
make records available.
For PIP (3:1), EPA proposed the
following: requiring PPE for domestic
manufacturing and processing of PIP
(3:1) and certain PIP (3:1)-containing
products and articles; requiring
engineering controls for processing of
PIP (3:1) and PIP (3:1)-containing
products as an intermediate in a closed
system to produce cyanoacrylate
adhesives; requiring new compliance
deadlines for certain exclusions,
modifying existing deadlines, and/or
narrowing existing exclusions for
processing and distribution of PIP (3:1)
for certain excluded uses industries;
adding new exclusions for processing
and distribution of PIP (3:1) for use in
wire harnesses, electric circuit boards,
and sealants and adhesives used on
circuit boards; providing a new, 5-year
compliance deadline for use in Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA)-approved marine
antifouling coating products; and
extending the recordkeeping
requirements from three to five years
and removing the 30-day timeframe to
make records available.
The proposed rule provided a 45-day
public comment period that closed on
January 8, 2024 (Ref. 1). EPA received
a total of 33 public comments in
response to the proposed rule. Since
two of the comments were duplicates,
EPA posted a total of 31 public
comment submissions to
regulations.gov; they are available in the
public docket at EPA–HQ–OPPT–2023–
0376. These comments further informed
EPA’s understanding of the current
status of uses for decaBDE and PIP (3:1).
EPA is publishing in the docket for this
action a separate Response to Comments
(RtC) Document that responds to all
significant comments we received (Ref.
20). Furthermore, EPA held a public
webinar on the proposed rule on
December 14, 2023, in which it
presented an overview of the proposed
changes to the regulations for decaBDE
and PIP (3:1) and accepted verbal
comments. EPA received a total of three
comments from members of the public
during this webinar (Ref. 21).
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B. Activities Not Regulated by This Rule
EPA did not propose to revise and is
not revising the other three PBT final
rules issued under TSCA section 6(h)
for 2,4,6-TTBP, HCBD, or PCTP.
C. EPA’s Implementation of TSCA
Section 6(h)
1. EPA’s TSCA Section 6(h)(1) Findings
As previously detailed in the 2021
decaBDE and PIP (3:1) final rules, for
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chemical substances meeting the
requirements of TSCA section 6(h)(1)(A)
and (B), TSCA section 6(h)(4) required
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 made the requisite
TSCA section 6(h)(1)(A) and (B)
findings for decaBDE and PIP (3:1),
triggering the requirement for a TSCA
section 6(a) rulemaking under TSCA
section 6(h)(4) standard. This final
rulemaking does not amend these
findings.
2. EPA’s Approach to TSCA Section
6(h)(4)
In the 2021 PBT final rules, EPA
explained that it reads the TSCA section
6(h)(4) standard to apply to the
chemical substance generally, thus
requiring EPA to ‘‘address risks’’ and
‘‘reduce exposures’’ to the chemical
substance without focusing on how or
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). Thus, the
2021 PBT final rules address past,
present, and future activity involving
the chemical substance. In the 2021 PBT
final rules, EPA also explained that
because there was no existing risk
evaluation or assessment for each
chemical substance and one was not
contemplated by TSCA section 6(h),
EPA’s implementation of the standard
in TSCA section 6(h)(4) focused on
applying the TSCA sections 6(a) and (c)
requirements in a manner that reduces
exposure to the chemical substance to
the extent practicable. This final
rulemaking does not amend these
interpretations or EPA’s approach for
implementing TSCA section 6(h)(4).
EPA intends that each provision of
this rulemaking be severable. In the
event of litigation staying, remanding, or
invalidating all or a portion of a
particular risk management approach,
EPA intends to preserve all other
portions of the particular risk
management approach and all other risk
management approaches in the rule to
the fullest extent possible. The Agency
considered the risk management options
in TSCA section 6(a) and generally each
of EPA’s particular risk management
approaches to reduce exposure to
decaBDE and PIP (3:1) to the extent
practicable functions independently
from EPA’s other risk management
approaches, which may have different
characteristics leading to EPA’s risk
management decisions. Further, the
Agency crafted this rule so that different
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risk management approaches are
reflected in different provisions or
elements of the rule that are capable of
operating independently. Accordingly,
the Agency has organized the rule so
that if any provision or element of this
rule is determined by judicial review or
operation of law to be invalid, that
partial invalidation will not render the
remainder of this rule invalid.
There are many permutations of this;
accordingly, rather than walking
through each one, EPA is providing
representative examples for illustrative
purposes. First, to the extent a court
were to find that EPA lacked substantial
evidence to support the phase-out of the
processing of one type of decaBDEcontaining product, or otherwise found
flaw with such phase-out, it would have
no bearing on other risk management
approaches in the rule, including other
phase-outs, unless the specific flaw also
applies to these other risk management
approaches. Second, to the extent that a
court were to find that the required
interim workplace protections for the
processing of certain PIP (3:1)containing products until a ban on
processing goes into effect lacked
substantial evidence, or otherwise found
fault with such protections, it would
have no bearing on EPA’s decision to
ban the processing of such PIP (3:1)containing products. The independence
of these risk management approaches is
reflected in the structure of the rule,
which does not intertwine the risk
management approaches, but rather
separately defines each such approach.
3. EPA’s Interpretation of ‘‘to the Extent
Practicable’’ as Used in TSCA Section
6(h)(4)
EPA has previously discussed its
general interpretation of the term
‘‘practicable’’ in the five 2021 PBT final
rules (Refs. 4, 5, 6, 7, and 8), and is not
changing the interpretation.
Nevertheless, EPA has provided a more
fulsome discussion of why its
interpretation is consistent with the
statute. First, EPA’s approach is
consistent with the dictionary
definitions of the phrase ‘‘to the extent
practicable’’ and the term ‘‘practicable,’’
taking into account their plain meaning
and the context of this provision in
section 6 of TSCA.
The phrase ‘‘reduce exposure . . . to
the extent practicable’’ and the term
‘‘practicable’’ within that phrase are not
defined in TSCA section 6(h). Nor is the
phrase or term defined in any context in
which it is used elsewhere in TSCA or
the legislative history. Dictionary
definitions of ‘‘practicable’’ include
technical feasibility as well as
characteristics relating to
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reasonableness and capacity. EPA’s
interpretation takes this plain language
into account. EPA’s interpretation also
takes into consideration the statutory
context for such terminology, including
the different standard and procedural
approaches for a TSCA section 6(a) rule
pursuant to TSCA section 6(h) rules and
a TSCA section 6(a) rule following a risk
evaluation pursuant to TSCA section
6(b)(4). For a more thorough discussion
and examples of the factors EPA took
into consideration, see Section 1–2 of
the Response to Comments document
for this rule.
In sum, the best reading of the TSCA
section 6(h)(4) statutory terms and
context compels consideration of all
reasonably available information on
TSCA sections 6(c)(2) and (d) issues,
including cost. As a result, while cost
does factor into whether a regulatory
option is practicable or the time frame
for triggering a regulatory option is
practicable, EPA also considers, for
example, whether alternatives are
generally available and what reasonable
transition time is needed for identifying
and adopting alternatives, the import of
the products and articles containing
decaBDE or PIP (3:1), and other
regulations or voluntary standards that
address articles under consideration,
based on all available information
before the Agency at the time of the
decision. In the absence of clear
direction from Congress, EPA may take
these concerns into consideration in
determining what further exposure
reductions are practicable.
4. EPA’s Position on Directly Regulating
Occupational Exposures
For purposes of determining whether
worker protection measures are
practicable under TSCA section 6(h)(4),
EPA does not believe it is appropriate to
assume as a general matter that an
applicable Occupational, Safety and
Health Administration (OSHA)
requirement or industry practice is
consistently or always properly applied.
This should not be viewed as an
indication that the Agency believes
there are no occupational safety
protections in place at any location, or
that there is widespread noncompliance
with applicable OSHA standards.
Rather, it reflects the Agency’s
recognition that its interpretation of the
TSCA section 6(h)(4) standard ‘‘to
reduce exposure . . . to the extent
practicable’’ calls for worker protection
measures to reduce the potential for
exposure to PBTs generally, considering
what is achievable, feasible, workable,
and reasonable, in light of the
circumstances. This is the case even in
the absence of a risk evaluation or risk
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assessment and even if existing OSHA
requirements might apply, such as those
under the General Duty Clause of the
Occupational Safety and Health Act (29
U.S.C. 654(a)) or OSHA’s Respiratory
Protection standard (29 CFR 1910.134).
TSCA section 9(d) requires EPA to
consult and coordinate TSCA activities
with OSHA and other relevant Federal
agencies for the purpose of achieving
the maximum applicability of TSCA
while avoiding the imposition of
duplicative requirements. Pursuant to
29 U.S.C. 651 et seq., OSHA requires
that employers provide safe and
healthful working conditions through
enforcement of the General Duty Clause
and by setting and enforcing
occupational safety and health
standards. OSHA also provides training,
outreach, education, and assistance.
Where EPA has reason to believe that
there might be the potential for
exposure to workers to decaBDE and PIP
(3:1), the Agency has considered
whether it is practicable to require
worker protections in addition to
applicable OSHA regulations (e.g., fit
testing and training requirements). To
determine what worker protections
measures are practicable, the Agency
reconsidered the reasonably available
information on the use of industry
worker protection measures, including
best practices, and considered new
information received during
engagements with industry stakeholders
after the 2021 PBT final rules, from
public comments on the March 2021
notification, and public comment on the
proposed rule (Refs. 15, 20, and 22).
This information was used to inform the
finalized requirements for inhalation
and dermal PPE to reduce worker
exposure to decaBDE and PIP (3:1).
EPA also considered the hierarchy of
controls adopted by OSHA and the
National Institute for Occupational
Safety and Health (NIOSH) (i.e.,
prioritization of exposure control
strategies from most protective and
preferred to least protective and
preferred techniques), but only
proposed requiring prescriptive controls
over the hierarchy of controls. In order
of preference, the hierarchy of controls
includes elimination of the hazard,
substitution with a less hazardous
substance, engineering controls,
administrative controls (e.g., training or
exclusion zones with warning signs),
and, finally, use of PPE (Ref. 23). Under
the hierarchy of controls, the use of
respirators should only be considered
after all other measures have been taken
to reduce exposures, and then
consistent with the OSHA Respiratory
Protection Standard at 29 CFR 1910.134.
Under OSHA’s standards, the various
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exposure controls are prioritized
equally, followed by PPE requirements
when necessary.
EPA received several comments on
the Agency’s worker protection
requirements. One commenter (EPA–
HQ–OPPT–2023–0376–0312) argued
that EPA must require owner/operators
to follow the hierarchy of controls in
protecting their workforce. Another
commenter (EPA–HQ–OPPT–2023–
0376–0297) argued that EPA should not
prescribe controls that may not be
appropriate for the particular
circumstances of an individual
workplace. Another commenter (EPA–
HQ–OPPT–2023–0376–0313) stated that
in proposing measures to address
occupational exposures that rely almost
exclusively on the use of PPE, EPA’s
proposal is incompatible with the
‘‘hierarchy of controls’’ for reducing
occupational exposures to toxic
chemicals. The commenter contended
that requiring owners and operators to
install engineering and administrative
controls to the extent they are
practicable would correct this flaw in
the proposed amendments. Multiple
commenters requested that EPA allow
industry to use the hierarchy of controls
to determine which controls may be
appropriate and most protective for that
workplace, rather than prescribing the
required PPE for each use (EPA–HQ–
OPPT–2023–0376–0312, EPA–HQ–
OPPT–2023–0376–0292, EPA–HQ–
OPPT–2023–0376–0297, EPA–HQ–
OPPT–2023–0376–0302). A commenter
also expressed interest in the
development of workplace chemical
protection programs using existing
chemical exposure limits (ECELs) for
PBTs, similar to those proposed for
other risk management rules under
TSCA section 6(a) (EPA–HQ–OPPT–
2023–0376–0312). While EPA
recognizes the concerns raised by
commenters, EPA does not believe it
can develop an ECEL for these two
chemicals without a risk evaluation,
which was neither required nor feasible
given the statutory timeline for
promulgation of rules under TSCA
section 6(h).
While a workplace chemical
protection program that sets an ECEL
and uses the hierarchy of controls
would provide latitude for companies to
determine which elements within the
hierarchy of controls to implement,
developing an ECEL without a risk
evaluation is not practicable for these
chemicals. EPA has decided not to
finalize a requirement to consider the
hierarchy of controls in the absence of
an ECEL. The workplace requirements
for decaBDE and PIP (3:1) were
developed based on stakeholder
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comments, existing industry practices,
and OSHA-required Safety Data Sheets.
See the individual sections related to
workplace protection for decaBDE (Unit
III.C.2.) and PIP (3:1) (Unit III.D.3.).
Although many of the uses where
workplace requirements are being
finalized include requirements to
supply PPE, the last method of control
in the hierarchy of controls, EPA
disagrees with commenters that the
hierarchy of controls was not
considered as a part of this rulemaking
(EPA–HQ–OPPT–2023–0376–0313,
EPA–HQ–OPPT–2023–0376–0312). For
example, the requirement to supply PPE
is limited to the regulated area, which
must be established where ‘‘airborne
concentrations or direct dermal contact
of a specific chemical substance can
reasonably be expected.’’ 40 CFR
751.403. The establishment of the
regulated area provides flexibility to
owners/operators to first utilize one or
a combination of elimination,
substitution, engineering controls or
administrative controls to reduce or
eliminate the necessity to demarcate a
regulated area by eliminating any areas
where exposure can ‘‘reasonably be
expected.’’ If exposure to the chemical
is no longer reasonably expected due to
these controls, the owner/operator
would not be required to establish a
regulated area and the requirement to
supply PPE to potentially exposed
persons under 40 CFR 751.405(e) and
751.407(f) for decaBDE and PIP (3:1),
respectively, would not apply. EPA also
requires the owner/operator to keep
records of the basis for the regulated
area, including monitoring data and
documentation of any controls or
combination of controls that have
reduced exposure to where airborne
concentrations of decaBDE or PIP (3:1)
can no longer reasonably be expected
resulting in a smaller or no regulated
area being established.
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D. Overview of TSCA Sections 6(c) and
26 Considerations
Unless explicitly stated, the following
overview is meant to be a summary of
information previously provided by
EPA in the 2021 decaBDE and PIP (3:1)
final rules regarding TSCA sections 6(c)
and 26 considerations. It is not intended
to serve as new findings under or
interpretations of TSCA section 6(h)(4).
1. TSCA Section 6(c)(2) Considerations
TSCA section 6(c)(2) requires EPA to
consider and publish a statement based
on reasonably available information
with respect to the:
• Health effects of the chemical
substance(s) or mixture(s) and the
magnitude of human exposure;
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• Environmental effects of the
chemical substance(s) or mixture(s) and
the magnitude of exposure to the
environment;
• Benefits of the chemical
substance(s) or mixture(s) for various
uses; and
• Reasonably ascertainable economic
consequences of the rule, including: the
likely effect of the rule on the national
economy, small business, technological
innovation, the environment, and public
health; the costs and benefits of the
proposed and final rule and of the one
or more primary alternative regulatory
actions that EPA considered; and cost
effectiveness of the final rule and of the
one or more primary alternative
regulatory actions that the Agency
considered.
In selecting among prohibitions and
other restrictions available under TSCA
section 6(a), EPA must factor in, to the
extent practicable, these considerations.
Further, in deciding whether to prohibit
or restrict the manufacture, processing,
distribution in commerce, use, or
disposal of a chemical substance or
mixture in a manner that substantially
prevents a specific condition of use of
a chemical substance or mixture, and in
setting an appropriate transition period
for such action, EPA must consider, to
the extent practicable, whether
technically and economically feasible
alternatives that benefit health or the
environment will be reasonably
available as a substitute when the final
prohibition or other restriction takes
effect.
EPA’s summary of the health and
environmental effects of and the
potential for exposure to the two PBT
chemicals subject to this final action can
be found in the support documents for
the 2021 PBT final rules for each
chemical (e.g., the Exposure and Use
Assessment (Ref. 19) and the Hazard
Summary (Ref. 24)).
The costs and benefits of this final
rule and the alternatives EPA
considered, as well as the impacts on
small businesses, are presented in the
Economic Analysis document (Ref. 17).
However, the Agency was not able to
quantitatively estimate the benefits of
this final rule and the alternatives, due
to the absence of a risk evaluation, and
has instead qualitatively described such
benefits.
EPA considered the estimated costs to
regulated entities, as well as the cost to
administer and enforce the options. EPA
considered reasonably available
information about the functionality and
performance efficacy of the regulatory
options and the ability to implement the
use of chemical substitutes or other
alternatives. A discussion of the costs
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EPA considered can be found in Unit
IV., along with a discussion of the
alternatives that the Agency considered.
A discussion of the impacts on small
businesses can also be found in Unit IV.
With respect to the cost-effectiveness
of this final regulatory action, EPA is
unable to perform a traditional costeffectiveness analysis of the options and
alternative options for decaBDE and PIP
(3:1). 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 from an existing
risk evaluation or assessment, the
Agency 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 regulatory action.
However, by evaluating the
practicability of the policy options, the
Agency is confident that it has
considered elements related to the costeffectiveness of the actions, including
the cost and the effect on human and
environmental exposure to decaBDE
and PIP (3:1).
2. TSCA Section 26 Considerations
In accordance with TSCA section
26(h) and considering the requirements
of TSCA section 6(h), EPA used
scientific information, technical
procedures, measures, and
methodologies that are fit for purpose
and consistent with the best available
science to inform the 2021 PBT final
rules. EPA based its determination that
human and environmental exposures to
both decaBDE and PIP (3:1) are likely on
its 2020 Exposure and Use Assessment
(Ref. 19), which underwent a peer
review and public comment process,
and used 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 the Agency’s
decision-making have been subject to
independent verification or peer review
is adequate to justify their use,
collectively, in the record for this final
rule.
In addition, in accordance with TSCA
section 26(i), and considering the
requirements of TSCA section 6(h), EPA
has made scientific decisions based on
the weight of the scientific evidence.
Additionally, in accordance with TSCA
section 26(k), EPA considered
reasonably available information,
including information on occupational
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controls and PPE usage, when finalizing
this TSCA section 6 rule.
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E. Overview, Health Effects, and
Exposure
For the 2019 PBT proposed rule, EPA
prepared an Exposure and Use
Document, summarizing the
information the Agency obtained in its
own research or in response to feedback
prior to and during the rulemaking
process on the types of exposures that
might be relevant to a TSCA section 6(a)
rulemaking under the TSCA section
6(h)(4) standard. As noted in the 2021
PBT final rules, the Exposure and Use
Assessment identified uses of the
chemical substances and found that the
chemical substances had at least one or
more ‘‘condition of use’’ activity where
some exposure was likely, but did not
attempt to precisely classify all
activities for each chemical substance as
a ‘‘condition of use’’.’’ As EPA
explained in the 2021 PBT final rules,
the Agency did not perform a systematic
review or a weight of the scientific
evidence assessment for the hazard
characterization of these chemicals.
TSCA section 6(h)(2) makes clear that
Congress did not intend for EPA to
conduct a risk evaluation to support
TSCA section 6(a) rules issued to satisfy
TSCA section 6(h) requirements, but
rather intended for EPA to conduct an
expedited rulemaking process to
‘‘reduce exposures to the extent
practicable’’ pursuant to TSCA section
6(h)(4). As a result, EPA explained that
the hazard characterizations are not
definitive or comprehensive. Other
hazard information on these chemicals
may exist in addition to the description
in the 2021 PBT final rules and studies
summarized in the Hazard Summary
(Ref. 24). The following sections
summarize the hazard, exposure, and
use information in the 2021 decaBDE
and PIP (3:1) final rules.
1. DecaBDE
As EPA explained in the 2021
decaBDE final rule, 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.
25). DecaBDE is also used as a flame
retardant for multiple applications for
aerospace and automotive vehicles,
including replacement parts for aircraft
and cars (Refs. 26 and 27). Exposure
information for decaBDE is detailed in
EPA’s Exposure and Use Assessment
and the 2021 decaBDE final rule (Refs.
4 and 19). As EPA explained in that
rule, there is potential for exposure to
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decaBDE under the conditions of use at
all stages of its lifecycle (i.e.,
manufacturing; processing; distribution
in commerce; industrial, commercial,
and consumer use; and disposal) of the
chemical. DecaBDE was produced and
released at higher levels in the past, but
releases from manufacturing and
processing activities have declined over
time, as have releases associated with
use, disposal, and recycling activities
(Ref. 19). This decline is in part due to
a voluntary phase-out by the largest
producers and suppliers of decaBDE in
the United States, that committed to end
their production, imports, and sales for
all uses of decaBDE by the end of 2013
(Ref. 17).
As described in the 2021 decaBDE
final rule, 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 can 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 dust via indoor air. Infant
and child exposures can 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 dermal and inhalation contact
with decaBDE (Ref. 19).
Finally, as summarized in the 2021
decaBDE final rule, 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 is
some evidence of genotoxicity and
carcinogenicity. The 2021 decaBDE final
rule and Hazard Summary provides
more information on these hazard
endpoints (Refs. 4 and 24).
For the 2020 CDR submission period,
calendar years 2016–2019, data indicate
that three companies manufactured
(including imported) decaBDE in the
United States (Refs. 17 and 28). The
2020 CDR data indicate a production
volume of less than 1 million pounds
annually from 2016 through 2019,
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however, EPA notes that domestic
production has ceased, and the
identified importers have likely since
stopped using decaBDE (Ref. 28).
2. PIP (3:1)
As explained in the 2021 PBT final
rules, PIP (3:1) is used as a plasticizer,
a flame retardant, an anti-wear additive,
or an anti-compressibility additive in
hydraulic fluid, lubricating oils,
lubricants, greases, various industrial
coatings, adhesives, sealants, and plastic
articles. As a chemical that can perform
several functions simultaneously,
sometimes under extreme conditions, it
has several distinctive applications. For
example, in lubricating oils, PIP (3:1) is
a flame retardant, anti-wear additive,
anti-compressibility additive, or some
combination of the three. In adhesives
and sealants, PIP (3:1) is a plasticizer
and flame retardant (Ref. 19). PIP (3:1)
is also added to paints, coatings, and
plastic components, where it is a
plasticizer or flame-retardant additive.
In the past, some plastic components to
which PIP (3:1) may have been added
included those intended for use by
children. EPA has received comments
that PIP (3:1) acts as a flame-retardant
gel in filters surrounding engines in
some marine and locomotive
applications (EPA–HQ–OPPT–2019–
0080–0569).
Exposure information for PIP (3:1) is
detailed in EPA’s Exposure and Use
Assessment and is summarized here
(Ref. 19). There is potential for exposure
to PIP (3:1) under the conditions of use
at all stages of its lifecycle (i.e.,
manufacturing, processing, distribution
in commerce, use, and disposal). PIP
(3:1) is manufactured, processed,
distributed, used, and disposed of
domestically. For the 2012 CDR
submission period, data indicate that
four sites manufactured (including
imported) PIP (3:1) in the United States.
The total volume of PIP (3:1)
manufactured (including imported) in
the United States was 14,904,236 lbs. in
2011; 3,191,017 lbs. in 2012; 2,968,861
lbs. in 2013; 5,632,272 lbs. in 2014; and
5,951,318 in 2015 (Ref. 28).
For the 2020 CDR submission period,
calendar years 2016–2019, data indicate
that nine sites manufactured (including
imported) PIP (3:1) in the United States
and manufacture (including import)
held steady at between 1 and 10 million
pounds (Refs. 17 and 28).
PIP (3:1) is toxic to aquatic plants,
aquatic invertebrates, sediment
invertebrates, and fish. Data indicate the
potential for reproductive and
developmental effects, neurological
effects, and effects on systemic organs,
specifically the adrenal glands, liver,
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ovaries, and heart in mammals. The
studies presented in the Hazard
Summary, titled ‘‘Environmental and
Human Health Hazards of Five
Persistent, Bioaccumulative and Toxic
Chemicals,’’ describe these hazardous
endpoints (Ref. 29).
III. Final Regulatory and Alternative
Regulatory Actions
A. Regulatory Approach
In this action, EPA is finalizing
revisions to the 2021 decaBDE final rule
and the 2021 and 2022 PIP (3:1) final
rules. EPA has collected additional
information and reconsidered its
application of its interpretation of the
TSCA section 6(h)(4) direction that the
Agency ‘‘reduce exposures to the
substance to the extent practicable,’’
focusing particularly on whether
additional practicable requirements can
reduce occupational exposures,
including those associated with
exclusions. As described throughout
this Unit, EPA has considered the
practicability of the final requirements,
including how potential requirements
and compliance time frames associated
with these requirements could impact
supply chains, including those
prioritized in Executive Order 14017
America’s Supply Chains.
B. Activities EPA Did Not Reevaluate for
This Rulemaking
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1. Disposal
As EPA explained in the 2023
proposed rule, EPA did not propose to
change its 2021 decision not to use its
TSCA section 6(a) authorities to
establish a TSCA regulatory program for
disposal of decaBDE or PIP (3:1). EPA
did not propose such a program and is
not finalizing the suggestions made by
commenters at this time. EPA remains
concerned that developing a new
comprehensive regulation for disposal
of decaBDE and PIP (3:1) under TSCA
section 6(h)(4), in addition to the
existing requirements under RCRA (e.g.,
those for non-hazardous solid waste,
industrial waste), is not practicable. As
explained in the 2021 rulemaking,
imposing a requirement under TSCA
section 6(a) to treat waste containing the
PBT chemicals that are not hazardous
under Resource Conservation and
Recovery Act (RCRA) as if they were
hazardous waste would have impacts on
hazardous waste disposal capacity and
be very expensive for States and local
governments as well as for affected
industries. For more discussion on this
issue, see the 2021 final rules (Refs. 4
and 5).
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2. Commercial Use of Products and
Articles
As also explained in the 2021 PBT
final rules, EPA did not propose
regulations relating to commercial use
of products and articles containing the
PBT chemicals, such as televisions and
computers, because such regulation
would both require testing, which may
not be widely available for a chemical,
and is expected to be extremely
burdensome, necessitating the
development of a test method to allow
for the identification of products
containing PBT chemicals, including
decaBDE and PIP (3:1), 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
channels of trade could occur while the
prohibited items were identified and
replaced. EPA also acknowledged, based
on additional information provided by
industry stakeholders after the 2021 PIP
(3:1) final rule, that international supply
chains are complex, and that complexity
creates challenges for identifying and
finding alternatives to PIP (3:1) in
international supply chains. Taking this
into account, EPA did not reevaluate the
practicability of further exposure
reductions relating to continued
commercial use of products and articles
containing decaBDE and PIP (3:1).
3. Recycling
Finally, in the 2021 PBT final rules,
EPA explained that it did not propose
to use its TSCA section 6(a) authorities
to restrict recycling activities generally.
EPA explained that it recognized the
importance and impact of recycling,
which contributes to the protection of
our environment, and that it would be
overly burdensome and not practicable
to impose restrictions on the recycling
of plastics that may contain decaBDE or
PIP (3:1), or on the use of such recycled
plastic in plastic articles. EPA also
explained that decaBDE and PIP (3:1), if
present, are typically present in such
articles at low levels and that banning
the recycling of plastics containing
decaBDE or PIP (3:1) would require
decaBDE- and PIP (3:1)-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 (Ref.
30). EPA concluded that it would be
difficult to make plastic sorting for this
purpose cost-effective, and that it would
be overly burdensome and not
practicable to prohibit recycling of
decaBDE- and PIP (3:1)-containing
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plastic in the United States. Taking this
into account, EPA did not reevaluate the
practicability of further exposure
reductions relating to a prohibition of,
or further regulatory restrictions on, the
general recycling of decaBDE- and PIP
(3:1)-containing plastic in the United
States at this time. As noted in Unit
III.C., the one exception relates to the
2021 decaBDE final rule authorization
for the continued recycling and
distribution in commerce of existing
plastic shipping pallets that contain
decaBDE for the extent of the pallets’
service life because EPA has determined
it is practicable to regulate when
expensive testing is not necessary to
determine the chemical’s presence in
the article.
C. DecaBDE—Revisions to 40 CFR
751.405
1. Require Signage in Regulated Areas
EPA proposed to require a label on
existing plastic shipping pallets that
contain decaBDE. EPA received several
comments regarding the proposed
labeling requirement for decaBDEcontaining plastic shipping pallets
(EPA–HQ–OPPT–2023–0376–0304,
EPA–HQ–OPPT–2023–0376–0292,
EPA–HQ–OPPT–2023–0376–0311,
EPA–HQ–OPPT–2023–0376–0313).
Specifically, some commenters agreed
with the proposed labeling requirement
but urged EPA to expand the labeling
requirement to all articles containing
decaBDE (EPA–HQ–OPPT–2023–0376–
0313). Other commenters expressed
concern with the labeling requirement
and stated the labels should not apply
to any recyclers (EPA–HQ–OPPT–2023–
0376–0311). Commenters also discussed
implementation concerns regarding the
label and the need for testing of pallets
to determine if decaBDE is present
(EPA–HQ–OPPT–2023–0376–0313,
EPA–HQ–OPPT–2023–0376–0304).
In response to a comment received
during the March 2021 request for
comment, EPA held a government-togovernment Tribal consultation in
November 2022, in which EPA received
comments requesting the Agency
require labeling of plastics that contain
decaBDE (Refs. 16 and 31), EPA
proposed to require a label on existing
plastic shipping pallets that contain
decaBDE. At the time of the proposal,
EPA determined it was practicable to
label existing plastic shipping pallets
containing decaBDE because all plastic
shipping pallets that contain decaBDE
are owned by a single company, and it
was EPA’s understanding that the
company tracked, as part of normal
business operations, each decaBDEcontaining plastic shipping pallet. No
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new decaBDE has been added to the
company’s plastic shipping pallets since
2012 (Ref. 27).
EPA held an additional stakeholder
meeting with the company that recycles
plastic pallets that contain decaBDE
during the public comment period in
December 2023 and received additional
public comments (Refs. 27 and EPA–
HQ–OPPT–2023–0376–0314). Based on
this stakeholder meeting and these
public comments, EPA determined that
its understanding of the company
business model was incorrect as
described in the proposal. Although an
initial bar code is attached to the pallet
after it is molded, these labels are
quickly damaged once introduced into
commerce and are not replaced.
The purpose of EPA’s proposed label
requirement was to provide notice that
PPE is required during the recycling of
plastic shipping pallets contain
decaBDE. The proposed label would
only be seen, if at all, during the initial
step of recycling and the disassembly of
the pallet. Since exposure to decaBDE in
plastic shipping pallets that are in use
and moving throughout commerce is not
expected (Ref. 19), and public
comments indicated that the labels
would likely not be present at the time
of recycling, EPA has determined that
labeling of decaBDE-containing plastic
shipping pallets is not practicable and is
not finalizing the labeling requirement
for plastic shipping pallets that contain
decaBDE.
To reduce potential exposures to
decaBDE during the recycling of plastic
shipping pallets that contain decaBDE,
EPA is finalizing a signage requirement
in the regulated area, defined at 40 CFR
751.403 as ‘‘an area established by the
regulated entity to demarcate areas
where airborne concentrations of a
specific chemical substance can
reasonably be expected.’’ This definition
is intended to include those areas where
plastic pallets are recycled. This sign
will provide notice to workers that PPE
is required to be worn during recycling
of plastic shipping pallets manufactured
before March 8, 2021, which will reduce
potential exposures to decaBDE (see
Unit III.C.2. for more information on
specific PPE requirements). A sign must
be posted at every entry point into the
regulated area that clearly, prominently,
in multiple languages as appropriate,
and in an easily readable font size,
contains the following text:
‘‘Decabromodiphenyl (decaBDE)
(CASRN 1163–19–5), a chemical that
has been identified as a persistent,
bioaccumulative, and toxic (PBT)
chemical by the U.S. Environmental
Protection Agency, may be present in
this regulated area. All persons in this
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regulated area who recycle plastic
shipping pallets that contain decaBDE
are required to wear personal protective
equipment, including respiratory
protection that is at least as protective
as a NIOSH-approved N95 respirator
with an assigned protection factor (APF)
of 10 and dermal protection of gloves
that are chemically resistant to
decaBDE, per regulations at 40 CFR
751.405(e).’’ EPA is not requiring testing
to determine if decaBDE is present in
the plastic shipping pallets.
2. Require Worker Protections for
Certain Activities Involving DecaBDE
EPA proposed to require inhalation
and dermal PPE during certain ongoing
uses listed at 40 CFR 751.405(a)(2) and
(b). To ensure exposures to workers are
reduced to the extent practicable during
domestic manufacturing and processing
of decaBDE and decaBDE-containing
products and articles, EPA is finalizing
at 40 CFR 751.405(e), worker protection
requirements to address potential
respiratory and dermal exposure to
workers during ongoing activities
involving decaBDE, specifically certain
activities where the prohibitions phaseins have not passed (i.e., manufacture
and processing of decaBDE for use in
replacement parts and the manufacture
of such parts, as specified in 40 CFR
751.405(a)(2)(iii) and (iv), and the
processing through recycling of plastic
pallets, as specified in and 40 CFR
751.405(b)). In addition, EPA made
minor modifications to new 40 CFR
751.405(e)(6) to ensure it is clear what
is being excluded and what is not (i.e.,
the processing of decaBDE for recycling
is not included) and 40 CFR 751.405(b)
clarifying that processing of decaBDE
for recycling was not excluded.
EPA is requiring owner or operators to
select and provide respiratory
protection that is at least as protective
as a NIOSH-approved N95 respirator
with an assigned protection factor (APF)
of 10 and gloves that are chemically
resistant to decaBDE. EPA has
determined, based on comments, that it
is practicable to require worker
protection, including PPE, for the
processing of existing plastic shipping
pallets because it is already industry
practice (Ref. 27). Although it is EPA’s
understanding that domestic
manufacturing and processing of
decaBDE for use in new and
replacement parts for motor and
aerospace vehicles has ceased, EPA is
requiring PPE for these uses. This
approach ensures that any ongoing
activity involving decaBDE, past,
present or future, is addressed by this
regulatory approach taken, and thus the
regulations adopted in this rule reduce
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the exposures that will result with
resumption of past activities or the
initiation of similar or other activities in
the future. For all other processing for
recycling activities of decaBDEcontaining plastic from products or
articles and decaBDE-containing
products or articles made from such
recycled plastic, EPA maintains that it
would be impracticable to establish a
testing program to determine if decaBDE
is present. Due to the difficulty in
identifying whether and where decaBDE
is present in an article, EPA is not
requiring worker protections for all
other processing for recycling activities.
EPA is not requiring worker
protections for all ongoing processing of
articles (e.g., processing of decaBDEcontaining wire and cable for use in
nuclear power generation facilities),
because EPA has determined worker
protections are not practicable. This is
because the Agency understands that
the processing of these articles would
result in minimal potential for worker
exposure because, once formulated,
decaBDE is encased in the cured coating
and the potential for worker exposure is
minimal (Ref. 19). EPA is also not
requiring worker protections for
distribution in commerce of decaBDE or
decaBDE-containing products or
articles, since the distribution in
commerce of decaBDE and decaBDEcontaining products or articles would
result in minimal potential for exposure.
Lastly, because EPA generally
understands the potential for exposure
is low during importation, the Agency is
not requiring worker protections for
import of decaBDE and decaBDEcontaining products and articles that
were excluded under the 2021 final
decaBDE rule. Addressing such minimal
potential for exposure through worker
protections would not be practicable
considering the additional costs and
resource burdens (Ref. 19).
For the activities subject to the worker
protection requirements and to reduce
potential occupational exposure during
the recycling process of plastic shipping
pallets that contain decaBDE, EPA is
finalizing the requirement for, at a
minimum, a NIOSH-approved N95
respirator with an APF 10 and gloves
that are chemically resistant to decaBDE
with activity-specific training where
dermal contact with decaBDE is
reasonably expected.
Where PPE is required, EPA is
finalizing its proposal to require
implementation of a PPE program in
alignment with certain elements of
OSHA’s General Requirements for PPE
at 29 CFR 1910.132 and Respiratory
Protection requirements in 29 CFR
1910.134. EPA is requiring that owners
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and operators maintain PPE in a
sanitary, reliable, and undamaged
condition and ensure that each
potentially exposed person who is
required to wear PPE uses such PPE.
Under this final rule, owners and
operators will be required to select and
provide PPE that properly fits each
potentially exposed person who is
required to use PPE. For N95 respirators
with an APF 10, the owner or operator
must ensure that all respirators used in
the workplace are NIOSH-approved as
listed on the NIOSH Certified
Equipment List (Refs. 32 and 33). Where
dermal PPE is required, EPA is
finalizing a requirement that owners
and operators provide gloves that are
chemically resistant to decaBDE with
activity-specific training where dermal
contact with decaBDE is possible (Ref.
34). Owners and operators are also
required to communicate PPE selections
(e.g., demonstration that each item of
PPE selected prevents exposure during
expected duration and conditions of
exposure) to each potentially exposed
person.
EPA uses the term ‘‘potentially
exposed person’’ in this unit, elsewhere
in the preamble, and in the regulatory
text to mean any person who may be
exposed to a chemical substance or
mixture regulated under 40 CFR part
751 subpart E as a result of the use of
that chemical or mixture. ‘‘Any person’’
includes workers, occupational nonusers, employees, independent
contractors, employers, and all other
persons in the work area. One important
reason to define a potentially exposed
person as any person who may be
exposed in the workplace is to
emphasize the broad scope of
exposures. EPA notes that this
definition is intended to apply only in
the context of risk management (e.g.,
workers directly using the chemical,
workers in the vicinity of the use,
students in a laboratory setting). The
term is not intended as a replacement
for the term Potentially Exposed or
Susceptible Subpopulation as defined
by TSCA section 3(12).
EPA is requiring that each owner or
operator comply with OSHA’s
respiratory protection training
requirements at 29 CFR 1910.134(k) and
general PPE training requirements at 29
CFR 1910.132(f) when using respirators
and gloves. Owners and operators must
provide PPE training to all persons
required to use dermal protection or
respiratory protection prior to or at the
time of initial assignment to a job
involving exposure to decaBDE.
EPA is also requiring the
implementation of a respiratory
protection program in alignment with
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29 CFR 1910.134(b), (c)(1), (c)(3) and (4),
(d)(1)(iv), (f), and (g) through (l)), which
requires each owner or operator to select
respiratory protection in accordance
with the guidelines for proper respirator
use, maintenance, fit-testing, medical
evaluation, and training. Owners or
operators who are required to
administer a respiratory protection
program must ensure a respirator is
utilized in accordance with 29 CFR
1910.134(d)(1).
EPA is finalizing its proposal to
require that owners and operators
document respiratory protection used
and PPE program implementation and
retain those records for five years from
the date the record is generated. EPA is
also finalizing its requirement that
owners and operators must document
and keep records of the information on
the PPE program, as applicable, and
make it available to the Agency upon
request. In addition, and in response to
comments, owners and operators must
also keep records related to the basis for
the regulated area as defined in 40 CFR
751.403, as well as provide potentially
exposed persons and their designated
representative(s) an opportunity to
observe records related to the basis of
the PPE or another control measure
selection, including potential
monitoring results that are
representative of the potentially
exposed person’s exposure.
3. Prohibit the Release to Water During
the Manufacturing, Processing, and
Distributing of DecaBDE and DecaBDEContaining Products
EPA proposed to prohibit the releases
to water during the manufacturing,
processing, and distribution in
commerce of decaBDE and decaBDEcontaining products and proposed to
require all persons to follow any
regulations that may apply and best
management practices for preventing
the release of decaBDE to water. EPA
received a comment in support of the
prohibition on certain releases to water
during the manufacturing, processing,
and distribution in commerce of
decaBDE and decaBDE-containing
products (EPA–HQ–OPPT–2023–0376–
0286).
EPA also received comments
requesting EPA expand the provision to
regulate wastewater treatment plants,
landfills, and land-applied sewage
sludge for both decaBDE and PIP (3:1)
(EPA–HQ–OPPT–2023–0376–0303,
EPA–HQ–OPPT–2023–0376–0313).
More discussion of the commenters’
request can be found in the RtC
Document (Ref. 20). After one
commenter expressed concern regarding
the lack of specificity around the ‘‘best
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management practices’’ clause and
receiving no additional information
during the public comment period on
how a prohibition on releases to water
could best be achieved through best
management practices, EPA is not
finalizing the ‘‘best management
practices’’ clause (EPA–HQ–OPPT–
2023–0376–0297). EPA is finalizing the
prohibition on the releases to water
during the manufacturing, processing,
and distribution in commerce of
decaBDE and decaBDE-containing
products, and such persons are required
to follow applicable regulations that
may apply for preventing the release of
decaBDE to water. Applicable
regulations related to this final
prohibition on releases to water may
include restrictions on discharges under
the Federal Water Pollution Control Act
(commonly known as the Clean Water
Act), Safe Drinking Water Act (SDWA),
or analogous State laws. However, EPA
is not amending the 2021 PIP (3:1) final
rule restrictions on release to water,
which retains the requirement to follow
‘‘best management practices.’’
The prohibition on the release to
water during the manufacturing,
processing, and distribution in
commerce of decaBDE and decaBDEcontaining products prevents direct
releases of decaBDE to water. Thus, only
those facilities that are manufacturing,
processing, and/or distributing in
commerce decaBDE and decaBDEcontaining products, including
wastewater treatment plants that engage
in those activities, are subject to the
prohibition on releases to water. This
final rule does not impose restrictions
on sources discharging indirectly to
publicly owned treatment works
(POTWs). EPA is also not imposing
specific requirements for wastewater
treatment plants, unless those facilities
are manufacturing, processing, and/or
distributing decaBDE or decaBDEcontaining products. EPA determined
that it is not practicable to require all
wastewater treatment plants to test and
potentially treat for decaBDE. However,
prohibiting the release from the
manufacturing, processing, and
distribution in commerce of decaBDE
and decaBDE-containing products will
result in an overall reduction in releases
of decaBDE to water generally,
including, any potential release to water
that could happen from being present at
downstream wastewater treatment
plants. See the RtC Document for more
discussion on regulating PBT disposal
(Ref. 20).
After reconsidering the practicability
of prohibiting releases to water due to
the public comments, and the potential
for releases to water, even though there
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are no reported releases, EPA is
finalizing the prohibition on the release
to water to prevent any potential future
releases of decaBDE and to protect
exposed populations (e.g., subsistence
fishers) (Ref. 19). Prohibiting releases to
water highlights the importance of
preventing environmental releases of
decaBDE and PIP (3:1) and reducing
potential exposures. As mentioned in
the Exposure and Use Assessment,
Toxics Release Inventory (TRI) data
show a decrease in releases that are
reported in each industry sector using
decaBDE (Ref. 19). As of 2016, the
number of manufacturing facilities,
textile manufacturing facilities, wire
and cable manufacturing facilities, and
other facilities reporting TRI releases
has decreased from several dozen to
only one manufacturer and 23 other
facilities (Ref. 19). Specifically, the one
manufacturer that released decaBDE to
water prior to 2012, is now prohibited
from manufacturing decaBDE under the
2021 decaBDE final rule. According to
the most recent (2021) TRI data, there
were zero releases of decaBDE to water
(Ref. 35). TRI reporting is required only
for facilities within specific NAICS
codes who have 10 or more full-time
employees, so it is possible that there
were releases outside of the reporting
requirements, but EPA understands this
is unlikely. Prohibiting releases to water
during manufacture, processing, and
distribution in commerce of decaBDE
and decaBDE-containing products will
prevent future releases of decaBDE to
the water from permissible ongoing
activities, reducing the overall potential
for exposure. While in some cases EPA
has determined that it is not practicable
to exercise its TSCA section 6(a)
authorities to regulate certain exposures
under TSCA section 6(h), as outlined in
Unit II.B., this is not the case for certain
releases of decaBDE to water.
EPA is not extending this requirement
to include a prohibition on the release
to water for the processing and
distribution in commerce of decaBDEcontaining articles, including recycled
materials that may contain decaBDE. As
described in more detail in the 2021
decaBDE final rule and the supporting
response to comment document, it
would be extremely burdensome to
identify articles containing decaBDE to
determine if a facility that recycles
articles is subject to this final release to
water prohibition (Ref. 36).
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4. Extend the Compliance Deadline for
Processing and Distribution in
Commerce of DecaBDE-Containing Wire
and Cable Insulation for Use in Nuclear
Power Generation Facilities
EPA proposed to extend the
compliance date, limited to processing
and distribution in commerce of
decaBDE-containing wire and cable
insulation and the components
containing the wire and cable in nuclear
power generation facilities (including
test and research reactors), until after
the end of the service life of the wire
and cable. EPA received several
comments in support of the extended
compliance date for processing and
distribution in commerce of decaBDEcontaining wire and cable insulation for
use in nuclear power generation
facilities (EPA–HQ–OPPT–2023–0376–
0299, EPA–HQ–OPPT–2023–0376–
0300). One commenter stated that an
alternative is available and disagrees
with EPA’s proposal to extend the
compliance deadline (EPA–HQ–OPPT–
2023–0376–0294). However, based on
discussions with the Nuclear Regulatory
Commission (NRC), EPA disagrees with
the commenter that alternative,
decaBDE-free, fully qualified wire and
cables are available that meet the NRC’s
requirements in 10 CFR 50.49,
‘‘Environmental qualification of electric
equipment important to safety for
nuclear power plants,’’ including the
Institute of Electrical and Electronics
Engineers 383 (‘‘IEEE 383’’) standard for
instrumentation and power cable
insulation. Another commenter stated
that the proposed extension for
processing and distribution in
commerce of decaBDE-containing wire
and cable insulation for use in nuclear
power generation facilities is vital, as
these cables and components are
necessary for the safety systems that
prevent release of radioactive materials
into the environment (EPA–HQ–OPPT–
2023–0376–0299). Additional details
can be found in the RtC Document (Ref.
20). EPA is finalizing the proposed
compliance date extension for
processing and distribution in
commerce of decaBDE-containing wire
and cable insulation for use in nuclear
power generation facilities.
As mentioned in the proposal,
decaBDE has been used in Class 1E
cables, which are qualified to meet
industry standards and NRC
requirements in 10 CFR 50.49, including
the Institute of Electrical and
Electronics Engineers 383 (‘‘IEEE 383’’)
standard for instrumentation and power
cable insulation. Recognizing this, and
in response to stakeholder feedback and
engagements with the only known
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supplier of decaBDE-containing wire
and cable, EPA established an extended
compliance deadline of January 6, 2023,
in the 2021 decaBDE final rule, after
which all processing and distribution in
commerce of decaBDE for use in wire
and cable insulation in nuclear power
generation facilities, and decaBDEcontaining wire and cable insulation
was prohibited (40 CFR
751.405(a)(2)(ii)). EPA interprets the
term ‘‘nuclear power generation
facilities’’ to include nuclear reactors as
defined by the NRC in 10 CFR 50.2,
production facilities, test and research
reactors, other utilization facilities not
specifically designed for or used
primarily for the formation of
plutonium or U–233, and reactors
operated under the oversight of the U.S.
Department of Energy (DOE). EPA has
added text in 40 CFR 751.405(a)(2)(ii) to
include one example of the types of
facilities covered by nuclear power
generation facilities. In addition, EPA is
clarifying that 40 CFR 751.405(a)(2)(ii)
and (vi) are not limited to a specific
level of power generation and that EPA
interprets the provision to include
‘‘electrical equipment important to
safety’’ as defined in 10 CFR 50.49(b)
and materials required for the safe
operation of ‘‘Alternate ac source’’ and
‘‘Basic component’’ as defined in 10
CFR 50.2 that include decaBDEcontaining wire and cable.
After the January 6, 2023, extended
compliance deadline in the 2021
decaBDE final rule, EPA received
multiple requests and letters of concern
regarding the availability of decaBDEcontaining wire and cable insulation
used in the nuclear power sector (Refs.
37 and 38). These inquiries and
outreach came shortly after the supplier
of this decaBDE-containing wire and
cable discontinued processing and
distribution in commerce and notified
its customers of its inability to continue
supplying their wire and cable due to
the January 6, 2023, compliance date.
Due to the lack of communication and
engagement between the primary
supplier and their customers, as well as
with EPA, the industry reported to EPA
that they were at risk of not having
qualified wire and cable available,
which could negatively affect both
scheduled maintenance outages and
unplanned equipment failures and,
ultimately, could force multiple nuclear
power plants to be temporarily taken
offline. In response to this, on April 20,
2023, EPA’s Office of Chemical Safety
and Pollution Prevention (OCSPP)
requested that the Office of Enforcement
and Compliance Assurance (OECA)
issue an enforcement statement
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regarding certain entities that are subject
to the prohibitions on processing and
distribution in commerce of decaBDEcontaining wire and cable insulation for
nuclear power generation facilities as a
bridge to this final rule addressing this
use.
In response to this request, EPA’s
OECA issued a temporary ‘‘Enforcement
Statement’’ on May 2, 2023, which
indicates that the Agency does not
intend to pursue enforcement for certain
violations of the prohibition on
processing and distribution in
commerce of decaBDE-containing wire
and cable insulation for nuclear power
generation facilities, including those
component and safety systems that
contain the decaBDE-containing wire
and cable insulation, that went into
effect on January 6, 2023, as long as the
entities involved are diligently working
to qualify their alternative components
in accordance with NRC regulations and
guidance (Ref. 39).
After considering feedback from the
industry and Federal partners, including
DOE and NRC, EPA is finalizing its
proposal to extend the compliance date,
limited to processing and distribution in
commerce of decaBDE-containing wire
and cable insulation and the
components containing the wire and
cable in nuclear power generation
facilities (e.g., production facilities, test
and research reactors), until after the
end of the service life of the wire and
cable, and the components containing
the wire and cable (see 40 CFR
751.405(a)(2)(vi)). Stakeholders have
indicated that existing decaBDEcontaining wire and cable insulation
and components containing the wire
and cable may need to be distributed
and processed for refurbishment,
maintenance, and repair until the wire
and cable is replaced. In addition, EPA’s
‘‘Exposure and Use Assessment of Five
Persistent, Bioaccumulative, and Toxic
Chemicals’’ indicates that although
releases of decaBDE could occur during
the processing of decaBDE to make the
wire and cable, once formulated into the
wire and cable, decaBDE is encased in
the cured coating and the potential for
worker exposure is minimal (Ref. 19).
Therefore, EPA concluded that allowing
the processing and distribution in
commerce of decaBDE-containing wire
and cable insulation and the
components containing the wire and
cable in nuclear power generation
facilities (including test and research
reactors) to continue is necessary and
practicable.
EPA is not allowing resumption of
processing and distribution in
commerce of raw or compounded
decaBDE for use in wire and cable
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insulation in nuclear power generation
facilities. The only known user of raw
or compounded decaBDE has been
permitted to resume these activities for
a limited time under a settlement
agreement that provides a mechanism
for the continued availability of
decaBDE-containing wire and cable
insulation, while the nuclear power
generation facilities undergoes
transition to a decaBDE-free alternative
(Ref. 40). The termination conditions of
the settlement agreement states that it
shall remain in place for five years
following the effective date unless
terminated earlier, while the company’s
customers transition to receipt of Class
1E cable that is decaBDE-free.
5. Require Export Notification for
DecaBDE-Containing Wire and Cable for
Nuclear Power Generation Facilities
EPA proposed to amend the current
rule to require a TSCA section 12(b)
export notice for the export of decaBDEcontaining wire and cable for nuclear
power generation facilities. EPA
received one comment of support and
one comment of opposition related to
the proposed export notification for
decaBDE-containing wire and cable for
nuclear power generation facilities
(EPA–HQ–OPPT–2023–0376–0286,
EPA–HQ–OPPT–2023–0376–0286). The
commenter stated that the export
notification is precedent-setting and
should be a standalone proposal. EPA
disagrees with this commenter and is
finalizing the export notification
requirement for decaBDE-containing
wire and cable for nuclear power
generation facilities.
As mentioned in the proposal to this
final rule, and as discussed in the 2021
decaBDE final rule, decaBDE is listed on
Annex A of the Stockholm Convention
on Persistent Organic Pollutants (the
POPs Convention), which prohibits the
production, use, import, and export of
decaBDE and decaBDE-containing
products and articles for Parties to the
listing decision for decaBDE, unless
otherwise subject to a specific
exemption (Ref. 41). There is no specific
exemption under the POPs Convention
for decaBDE-containing wire and cable
for nuclear power generation facilities,
and thus, EPA did not expect import or
export for this use to occur. However,
since EPA has learned that there is a
need for export of decaBDE-containing
articles for this purpose (Ref. 40), EPA
is finalizing this provision. Although
articles are generally exempt under 40
CFR 707.60(b) from the requirement to
provide notices of export under TSCA
section 12(b), EPA is finalizing its
proposal to amend the 2021 decaBDE
final rule to require a TSCA section
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12(b) export notice for the export of
decaBDE-containing wire and cable for
nuclear power generation facilities.
Such notice requirement was triggered
30 days after publication of the
proposed rule, pursuant to TSCA
section 12(b) and 40 CFR 707.60(a)(3)
and 707.65(a)(1)(i) and (b). The
notification to EPA of such intent to
export will not provide consent by the
importing countries for import of the
shipment; the importing countries may
choose not to permit import of such
shipment. Consistent with 40 CFR
751.7(a), the provisions of subpart D of
40 CFR part 707 still apply to any export
notifications required for decaBDE and
PIP (3:1) under TSCA section 6(h). EPA
is not requiring export notification for
any other articles.
6. Recordkeeping Requirements
EPA proposed to increase the
recordkeeping requirement from three to
five years and to remove the 30-day time
frame to make records available for
decaBDE. EPA received support for the
proposed extended recordkeeping
requirements (EPA–HQ–OPPT–2023–
0376–0313, EPA–HQ–OPPT–2023–
0376–0313). One commenter suggested
EPA extend the recordkeeping
requirements to a much longer period of
time, suggesting 20–30 years as an
appropriate time frame (EPA–HQ–
OPPT–2023–0376–0312). As discussed
in the proposed rule and in more detail
in the RtC Document, the proposed
record retention time frame of five years
is consistent with those associated with
other TSCA section 6(a) rulemakings,
and because it aligns with the statute of
limitations for civil penalty enforcement
(28 U.S.C. 2462). Also, the proposal to
modify the time frame for making
records available from a 30-day time
frame to upon request is critical to the
Agency’s ability to promptly identify
and correct noncompliance (Refs. 1 and
20).
EPA is finalizing its proposal to
increase the recordkeeping requirement
from three to five years and is removing
the 30-day time frame to make records
available for decaBDE and PIP (3:1). In
the 2021 decaBDE final rule, EPA
required that all persons who
manufacture, process, or distribute in
commerce decaBDE and products and
articles containing decaBDE maintain
ordinary business records related to
compliance with the prohibitions and
restrictions for three years and to make
records available within 30 days upon
request. Due to the additional
requirements being finalized in this
rulemaking, specifically those
pertaining to worker safety, EPA
considers that the five-year time frame
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regarding recordkeeping and removal of
the 30-day time frame to make records
available upon request is more
appropriate. Furthermore, this is
consistent with the time frame
associated with other TSCA section 6(a)
rulemakings that include worker
protection requirements. EPA is
confident that extending each rule’s
recordkeeping requirement to a
consistent five-year requirement will
facilitate regulated entities’ compliance
with minimal impact to regulatory
burden. In addition, removal of the 30day time frame to make records
available upon request is critical to the
Agency’s ability to promptly identify
and correct noncompliance. EPA
presumes that the regulated entities
should have the records demonstrating
compliance readily available.
As it relates to recordkeeping for
worker protections, EPA is finalizing its
proposal to require that owners/
operators document respiratory
protection used and PPE program
implementation and retain those records
for five years. One commenter (EPA–
HQ–OPPT–2023–0312) stated that this
information should be available to
workers throughout the period of
potential consequences of an exposure.
EPA has modified the workplace
protection records requirements for both
PIP (3:1) and decaBDE to require that
the owner or operator provide
potentially exposed persons and their
designated representatives an
opportunity to observe records related
to the basis of the PPE or other control
measure selection, including potential
monitoring results that are
representative of the potentially
exposed person’s exposure.
additional information on time frames
that they determined would allow those
industries a reasonable period to
transition from PIP (3:1) to alternatives
(EPA–HQ–OPPT–2021–0202). Where
EPA received information that transition
from PIP (3:1) to an alternative has
already occurred or could occur within
a reasonable transition period, EPA has
determined the modifications are
practicable and is therefore finalizing
such modifications. In other instances,
where commenters were not able to
provide similar information for
determining a reasonable period for
such transition, EPA did not finalize
extending the compliance deadline.
EPA is modifying several exclusions
from prohibitions that were finalized in
the January 6, 2021, PIP (3:1) final rule
(Ref. 5). These final modifications
include narrowing the scope of certain
exclusions, adding prohibition phase-in
dates, and/or in some cases creating
new exclusions from a prohibition for
certain uses. In conjunction with
narrowing the scope of certain
exclusions, EPA is also finalizing
prohibitions, as proposed, through
phase-outs in 40 CFR 751.407(a)(2) on
the manufacture (including import),
processing, and distribution in
commerce of the PIP (3:1)-containing
products and articles for the uses that
were covered by an exclusion. This
restriction will ensure the phase-out of
domestic production and imports of PIP
(3:1)-containing products and articles.
EPA is not generally prohibiting the
manufacturing of PIP (3:1), consistent
with the 2021 PIP (3:1) rulemaking, due
to the number of excluded activities that
EPA has found it impracticable to
prohibit.
D. PIP (3:1)—Revisions to 40 CFR
751.407
a. Lubricants and Greases
EPA is finalizing as proposed the
narrowed exclusion from prohibition in
40 CFR 751.407(b)(1)(ii) for only certain
lubricants and greases. Specifically, the
final exclusion only covers processing
and distribution in commerce of PIP
(3:1) for use in lubricants and greases for
aerospace use and turbine engines, PIP
(3:1)-containing products for use in
lubricants and greases for aerospace use
and turbine engines, and PIP (3:1)containing lubricants and greases for
use in aerospace and turbine
applications. EPA is also finalizing a
prohibition phase-in for non-aerospace
and non-turbine applications, but based
on comments received, EPA is
amending the proposed phase-in
prohibition time frame from 5 years to
15 years. The processing and
distribution in commerce of PIP (3:1) for
use in lubricants and greases, PIP (3:1)containing products for use in
1. Exclusions and Phase-In Prohibitions
EPA reviewed the determinations
underlying the exclusions from
prohibition in the January 2021, PIP
(3:1) final rule to consider whether to
adopt new restrictions for activities
currently excluded, consistent with the
statutory directive to reduce exposure to
the extent practicable (Refs. 13 and 36).
For many of the exclusions, EPA
determined that there were no
technically feasible alternatives or that
the time and cost to identify, research,
and replace PIP (3:1) in supply chains
were impracticable. During the
comment periods following the March
6, 2021, notification, and in comments
on the proposed rule for this
rulemaking, many stakeholders from the
auto, aerospace, semiconductor, heavy
machinery, and other sectors provided
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lubricants and greases, and PIP (3:1)containing lubricants and greases,
excluding aerospace and turbine uses,
likewise will be subject to a 15-year
phased-in prohibition.
EPA proposed the 5-year compliance
time frame because at least one
stakeholder requested a 5-year transition
period to move away from PIP (3:1) for
their applications (Ref. 42). However,
several commenters opposed EPA’s
proposal. Four commenters requested
EPA reconsider the full exclusion in the
2021 final rule. One commenter (EPA–
HQ–OPPT–2023–0376–0307) noted the
regulatory uncertainty associated with
some possible alternatives to PIP (3:1)
being on the TSCA 2014 work plan and
potentially subject to regulation.
Another commenter (EPA–HQ–OPPT–
2023–0376–0284) stated the belief that
for many applications, it is not possible
to estimate how long it will take to
develop an alternative that meets
required performance specifications and
can be stably supplied. Another
commenter stated their belief that they
do not think an alternative could be
found in 30 years. These commenters
recommended a 30-year phase-in
prohibition, only if it included a means
to seek a case-by-case exemption.
Another commenter (EPA–HQ–OPPT–
2023–0376–0295) argued that that the
exclusion was needed in order to
maintain access to PIP (3:1)-containing
lubricants and greases in case
manufacturers reformulate their
products so that they no longer contain
PIP (3:1) and they discontinue selling
these products.
In the 2019 PBT proposed rule, EPA
acknowledged, and continues to
acknowledge in this final rule, that PIP
(3:1) is a crucial anti-wear component
for lubricants and greases that are used
in electronics and other applications
beyond aerospace, and EPA stated its
understanding, based on available
information, that such applications are
not subject to the same extreme
performance conditions. Commenters
did not provide information to support
claims that technically feasible
alternatives could not be identified.
While EPA did not identify specific
alternatives for specific applications,
believing that companies are best able to
do so, EPA identified potential
alternatives in the Economic Analysis
for the 2021 PIP (3:1) final rule. For
these reasons, EPA is not re-instituting
the full exclusion in the 2021 final rule.
EPA is also not adopting a mechanism
for informal extensions in the final rule.
There is no provision under TSCA for
the informal extension of compliance
dates. Future amendments to the
phaseouts in this rule would require
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additional rulemaking. EPA emphasizes
that, as part of the 2021 rulemaking and
this rulemaking processes, EPA has met
with stakeholders and encouraged
stakeholders to inform EPA of any
ongoing activity with decaBDE and PIP
(3:1) and products or articles containing
decaBDE or PIP (3:1), and the
prohibitions or phase-out approaches in
the final rule take the information
gathered into consideration. Thus, EPA
does not expect the need for some kind
of established process for obtaining an
informal extension.
Several commenters proposed
alternative prohibition phase-in periods
for non-aerospace and non-turbine
lubricant and greases. Two commenters
(EPA–HQ–OPPT–2023–0376–0287,
EPA–HQ–OPPT–2023–0376–0289)
recommended EPA finalize the same
timelines for lubricants and greases as
parts for motor vehicles (15 years for
parts for new motor vehicles and 30
years for replacement parts). This is
because alternatives for motor vehicles
is challenging due to the specific
requirements, such as high
temperatures, pressures, and durability,
as well as safety. EPA notes that the
final regulations continue the exclusion
for the processing and distribution of
PIP (3:1)-containing lubricants and
greases for aerospace use and turbine
engines, but otherwise requires the
phase-out of all other PIP (3:1)containing lubricants and greases after
15-years unless there is another
provision authorizing the processing
and distribution of PIP (3:1) for use in
articles, for example for replacement
parts for motor vehicles (40 CFR
751.407(a)(2)(v) and (vi)). See Unit
III.D.1.b. for a further discussion on PIP
(3:1) use in motor vehicles and Unit
III.D.2. for precedence of phase-in
prohibitions.
Two commenters (EPA–HQ–OPPT–
2023–0376–0295, EPA–HQ–OPPT–
2023–0376–0302) asked the Agency to
confirm in the preamble to the final
revised rule that the phrase ‘‘turbine
applications’’ as used in the proposed
regulation refers to the use of PIP (3:1)
formulations in gas turbine engines
(whether for aviation or in nonaviation
aeroderivative gas turbine engines
AGTs), and not other kinds of turbines.
In the proposal, EPA asked for comment
on the scope of the exclusion for
turbines. Because EPA understands that
PIP (3:1)-containing lubricants and
grease may have applications in other
categories of turbines, EPA is not further
narrowing the scope of the exclusion to
only gas turbine engines.
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b. New and Replacement Parts for Motor
Vehicles
EPA proposed to repeal the 2021
exclusion from prohibition in existing
40 CFR 751.407(b)(1)(iii) for new and
replacement parts for motor and
aerospace vehicles and to establish
phase-in prohibitions related to motor
vehicle and aerospace uses. The
proposed 15-year phase in prohibition
of processing and distribution in
commerce of PIP (3:1) and PIP (3:1)containing products for use in parts for
new motor vehicles was based on
industry’s own description of their
experience with transitioning from a
different chemical, albeit under
different circumstances, and the time
frames provided. The aspects of this
exclusion that relate to aerospace
vehicles and wire harnessing and
electric circuit boards are addressed in
Unit III.D.1.c. and Unit III.D.1.d.,
respectively. Multiple industry trade
organizations (EPA–HQ–OPPT–2023–
0376–0285, EPA–HQ–OPPT–2023–
0376–0289, EPA–HQ–OPPT–2023–
0376–0308) expressed support for the
proposed 15-year phased-in prohibition
for new parts and 30-year phase-in for
replacement parts for motor vehicles. At
least one commenter (EPA–HQ–OPPT–
2023–0376–0290) noted that the
proposed compliance dates for motor
vehicles, now being finalized in this
action, appear to be feasible and noted
that a shorter compliance period for
new motor vehicles would not be
feasible, as motor vehicle supply chains
are complex, often rely on foreign
suppliers, and are likely to take 15 years
to phase out the use of PIP (3:1)
completely.
EPA is finalizing its replacement of
the existing exclusion at 40 CFR
751.407(b)(1)(iii) for use of PIP (3:1) and
PIP (3:1)-containing products in new
and replacement parts for motor
vehicles with: (1) a 15-year phase-in
prohibition of processing and
distribution in commerce of PIP (3:1)
and manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in parts for
new motor vehicles (i.e., newly
produced vehicles), and manufacturing
and processing of PIP (3:1)-containing
parts for such new vehicles; and (2) a
30-year phase-in prohibition on
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts for motor vehicles,
and manufacturing and processing of
PIP (3:1)-containing replacement parts
for such vehicles. This final prohibition
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does not apply to PIP (3:1)-containing
parts that are subject to a new exclusion
(e.g., wire harnesses and circuit boards).
Several commenters requested that EPA
clarify this in the regulatory text and
EPA is doing so in this final rule.
In addition, EPA is amending 40 CFR
751.407(a)(2)(v) to correct an error in the
proposed regulatory text. Proposed 40
CFR 751.407(a)(2)(v) read ‘‘. . . all
persons are prohibited from all
processing and distribution in
commerce of PIP (3:1) for use in parts
for new motor vehicles, including heavy
machinery, and manufacturing,
processing, and distribution in
commerce of PIP (3:1)-containing
products for use in parts for new motor
vehicles, including heavy machinery,
PIP (3:1)-containing parts for such new
vehicles, and the new motor vehicles,
including heavy machinery in any
parts.’’ [emphasis added] EPA did not
intend to prohibit the distribution in
commerce of motor vehicles that may
occur in the secondary market, for
example by used car dealers. See Unit
III.D.5. for discussion addressing this
issue for PIP (3:1)-containing cars and
aerospace vehicles. Rather, EPA
intended to prohibit new motor vehicles
from being manufactured with PIP (3:1)containing parts, unless those parts
were subject to another exclusion or
alternative phase-in prohibition. While
EPA received no comments on this
specific provision, other comments are
directly related. In particular, several
commenters asked EPA to clarify that
articles manufactured prior to the
prohibition phase-in can continue to be
imported, moved, distributed, and
processed. These comments are
addressed in Unit III.D.1.b. and Unit
III.D.5. in regard to equipment and other
articles.
Stakeholders representing
manufacturers of new original
equipment and aftermarket components,
systems, and materials for use in
passenger cars and light trucks
indicated that, under the assumption
that an alternative to PIP (3:1) could be
found in the next three to four years, the
industry could transition out of using
PIP (3:1) within a seven-to-ten-year time
frame (Ref. 43). EPA acknowledges that
the time frame contains many
contingencies, which could delay the
adoption of PIP (3:1) alternatives.
Nevertheless, based on the industry’s
own description of their experience
with transitioning from a different
chemical, albeit under different
circumstances, and the time frames
provided, EPA determined a 15-year
phase-in prohibition of processing and
distribution in commerce of PIP (3:1)
and PIP (3:1)-containing products for
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use in parts for new motor vehicles (i.e.,
newly produced vehicles) and a 30-year
phase-in prohibition on manufacturing
and processing of PIP (3:1)-containing
products for use in replacement parts
for motor vehicles, and manufacturing
and processing of PIP (3:1)-containing
parts for such vehicles, as discussed
subsequently, is practicable.
EPA is also finalizing new 40 CFR
751.407(a)(2)(vi) to allow processing
and distribution in commerce for an
additional 15 years (i.e., until 30 years
after the publication date of this final
rule) of PIP (3:1), the manufacturing,
processing, and distribution in
commerce of PIP (3:1)-containing
products for use in replacement parts
for motor vehicles, including heavy
motorized machinery, and the
manufacturing and processing of PIP
(3:1)-containing replacement parts
themselves for such vehicles, and such
vehicles with PIP (3:1)-containing parts
for 30 years after the publication date of
this final rule. The continued
distribution in commerce of PIP (3:1)containing parts for vehicles and the
vehicles and which contains such parts
is discussed in Unit III.D.5. and is
covered under the newly finalized
exclusion in 40 CFR 751.407(b). EPA is
finalizing this 30-year period to ensure
that the option provided to vehicle
manufacturers by 49 U.S.C. 30120 to
remedy the defect or noncompliance by
repairing the vehicle or the equipment
(i.e., part) remains available. EPA
acknowledges that 49 U.S.C. 30120 does
not require manufacturers to supply
replacement parts, but rather to provide
a remedy, which may include either
replacing the equipment with identical
or reasonably equivalent equipment, or
by refunding the purchase price.
In addition, EPA is amending the
language in the phase-in prohibitions to
reference ‘‘heavy motorized machinery’’
instead of ‘‘heavy machinery,’’ as
originally proposed. This is being done
to further clarify what is included in the
phase-in prohibitions in 40 CFR
751.407(a)(2)(v) and (vi). As explained
in the March 2022 PIP (3:1) final rule
extending the PIP (3:1) compliance date,
EPA generally interprets the term
‘‘motor vehicle’’ to mean a transport
vehicle that is propelled or drawn by
mechanical power, such as cars, trucks,
motorcycles, boats, and construction,
agricultural, and industrial machinery.
The phase-in prohibitions in 40 CFR
751.407(a)(2)(v) and (vi) include offroad
motor vehicles, construction vehicles,
like excavators and front-loaders, and
large, motorized equipment, such as
paver, cranes, etc., both for military and
non-military applications. These
provisions and associated compliance
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time frames do not include off-road
stationary equipment and machinery as
discussed by commenters (e.g., non-road
mobile equipment, large scale fixed
installations, large scale stationary
industrial tools, alternative power
applications). However, EPA is
clarifying that off-road stationary
equipment and machinery is included
in its understanding of the types of
equipment that compose the
manufacturing equipment category
under 40 CFR 751.407(a)(2)(ix). See Unit
III.D.1.f. for more detail.
Lastly, in response to comments, EPA
would like to clarify that this
rulemaking does not repeal the ‘‘end
user’’ provision in 40 CFR 751.401(b)(1),
which allows the distribution in
commerce of the chemical substance, or
products and articles that contain the
chemical substance, that has previously
been sold or supplied to an end user
(i.e., an individual or entity that
purchased or acquired the finished good
for purposes other than resale). While
EPA received no comments on this
specific provision, other comments are
directly related. Additional discussion
on continued distribution in commerce
of complex articles containing PIP (3:1)
is in Unit III.D.5.
c. New and Replacement Parts for
Aerospace Vehicles
EPA proposed to repeal the exclusion
from prohibition in 40 CFR
751.407(b)(1)(iii) for new and
replacement parts for aerospace vehicles
and replace it with a phase-in
prohibition that would begin 30 years
after the publication of the final rule on
the processing and distribution in
commerce of PIP (3:1) and the
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in parts
installed in and distributed as part of
new aerospace vehicles, and the parts to
which PIP (3:1) has been added for such
vehicles. EPA also proposed a provision
that after the end of the aerospace
vehicles’ service lives, the
manufacturing, processing, and
distribution in commerce of aerospace
vehicles (i.e., those permissibly
manufactured before the compliance
time frame ends) that contain PIP (3:1)
in any part will be prohibited. Lastly,
EPA proposed that after the end of the
aerospace vehicles service lives, all
persons are prohibited from all
manufacturing, processing, and
distribution in commerce of PIP (3:1)
and PIP (3:1)-containing products for
use in replacement parts for aerospace
vehicles, and the replacement parts to
which PIP (3:1) has been added for such
vehicles. EPA is finalizing these
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provisions with modifications. These
new prohibitions will not apply to PIP
(3:1)-containing parts that are subject to
a new exclusion from prohibition (e.g.,
wire harnesses and circuit boards).
As discussed in the January 2021 PIP
(3:1) final rule, EPA concluded that a
similar reasoning applied to the use of
PIP (3:1) in new and replacement parts
for motor vehicles readily transfers to a
review of the justifications for the use of
PIP (3:1) for new and replacement parts
in aerospace vehicles. EPA
acknowledges the regulatory and safety
requirements for the aerospace industry
are as stringent or more stringent than
those for motor vehicles. In particular,
industry stakeholders noted the time
required to identify an alternative, and
to test and certify its use in parts, to
meet safety requirements, as well as a
lengthy Federal Aviation
Administration approval process. Given
these considerations, EPA is finalizing
longer time periods for the phase-in
prohibitions for the use of PIP (3:1) in
new and replacement parts for
aerospace vehicles.
One commenter (EPA–HQ–OPPT–
2023–0376–0295) recommended that
EPA retain the full exclusion from
prohibitions in the final rule on PIP
(3:1) for new and replacement parts for
aerospace vehicles. The commenter
noted that the Federal Aviation
Administration certification process is
often necessary and may be multiyear,
unpredictable, and lengthy. The
commenter further stated that there may
be significant unknowns during the
process, such as the availability of
candidate formulations, the time needed
to identify all affected parts and to
certify alternatives for the PIP (3:1)
products used to manufacture the parts.
The commenter also believes there is
uncertainty regarding chemical
restrictions the EPA may consider and
their impact on investments in
alternatives research and development.
As discussed in the proposed rule,
while EPA acknowledges the
uncertainty in determining a feasible
time frame for phasing-out the use of
PIP (3:1) in aerospace parts, EPA
understands that the aerospace industry
and motor vehicle industry share
similar uses. EPA acknowledges that
some uses in the aerospace industry
may require more time for an
appropriate substitute to be found
compared with uses in the motor
vehicle industry, given the different
performance and regulatory
requirements the aerospace industry
faces, and has provided a longer phaseout period. Nevertheless, given EPA’s
mandate to reduce exposures to the
extent practicable and the other
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provisions in this final rule, as the
commenter on motor vehicles noted, it
is important to accelerate the material
substitution of PIP (3:1) for alternatives
in the aerospace where it is practicable.
EPA is confident that it has identified,
based on extensive outreach with
industry, those uses (i.e., hydraulic
fluids, lubricants, greases, wire
harnesses, and circuit boards) that it
would not be practicable to phase out.
EPA is finalizing these provisions with
modifications. Specifically, the
prohibition phase-ins for aerospace are
being finalized but with exclusions of
distribution in commerce for PIP (3:1)containing parts for aerospace vehicles
and the vehicles which contains such
parts. This exclusion, now in 40 CFR
751.407(b)(1)(viii), is discussed in more
detail in Unit III.D.5.
d. Wire Harnesses and Circuit Boards
EPA is finalizing the new exclusion
from the prohibition at 40 CFR
751.407(b)(1)(iii) for the processing and
distribution in commerce of PIP (3:1)
and PIP (3:1)-containing products for
use in wire harnesses and circuit
boards, and wire harnesses and circuit
boards containing PIP (3:1). This final
exclusion is based on industry
comments provided in response to the
March 2021 notification opening a
comment period. Commenters have
stated that these components are
required to meet certain mandatory
regulatory and voluntary industry safety
standards (Refs. 44 and 45). According
to commenters, alternatives to PIP (3:1)
for use as a flame retardant and/or
plasticizer in wire harnesses and circuit
boards have not been identified (Ref.
11).
Based on information from
commenters and engagement with
stakeholders, EPA is not aware of a
replacement for PIP (3:1) for use in wire
harnesses and circuit boards that
combines its properties as a plasticizer,
a fire retardant, and an anti-wear
additive. Hence, EPA agrees with
commenters that the replacement for
PIP (3:1) in these uses would likely not
be a direct substitute but might require
multiple chemicals. EPA acknowledges
that the process of replacing PIP (3:1)
with separate chemicals for each
function would likely be time
consuming and costly to certify new
end-use products and articles (Refs. 45
and 46). EPA is not aware of a
technically and economically feasible
alternative for PIP (3:1) that would meet
the performance requirements and
voluntary and regulatory safety
standards for these articles. EPA and
commenters are not aware of industry
efforts to identify or qualify an
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alternative. For these reasons, EPA is
finalizing its proposal that it is
impracticable to prohibit the processing
and distribution in commerce of PIP
(3:1) for use in wire harnesses and
circuit boards and PIP (3:1)-containing
products for use in wire harnesses and
circuit boards, and for wire harnesses
and circuit boards containing PIP (3:1).
Several commenters supported the
exclusion for wire harnesses and circuit
boards. Many commenters also asked
EPA to clarify certain aspects of the
exclusion. Two commenters (EPA–HQ–
OPPT–2023–0376–0284, EPA–HQ–
OPPT–2023–0376–0297) noted that in
the explanations of the reasons why the
exclusion for new and replacement
parts for motor vehicles and aerospace
vehicles is being repealed and replaced
with a prohibition EPA states that the
proposed prohibition would not apply
to PIP (3:1)-containing parts, in
particular for wire harnesses and circuit
boards, that would be subject to a new
exclusion, if adopted as proposed. One
of the commenters asked EPA to clarify
that this exclusion takes precedence in
the situation where other exemptions or
phase-out periods are more limited in
nature. The commenter recommended
that this statement be included in the
written text. EPA accepts this comment
and is adding the following statement,
‘‘except for the activities described in
paragraph (b) of this section or where
another phase-in prohibitions with
longer term deadlines exists as
described in this section’’ to 40 CFR
751.407(a)(2).
One commenter (EPA–HQ–OPPT–
2023–0376–0297) requested that EPA
clarify the scope of the items included
within the exclusion by providing a
definition with a non-exclusive list of
examples. The commenter suggested
that the list of examples be more
expansive than ‘‘wire harnesses and
circuit boards’’ and include any item
that is attached to an electronic circuit
board or that is necessary to secure,
cover, or insulate an electronic
component that gets attached to a circuit
board. EPA is not providing a definition
of wire harnesses or circuit boards. In
the preamble of the proposed rule, EPA
explained that the term ‘‘wire
harnesses’’ includes a broad class of
articles, including but not limited to
terminal and fuse covers, cable sleeves,
casings, connectors, and tapes, used in
a variety of applications, from defense
to aerospace and motor vehicle
applications, to scientific
instrumentation and more. EPA also
explained that the Agency understands
that PIP (3:1) use in electronic
component manufacturing includes the
use of PIP (3:1) in circuit boards as well
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as the use of PIP (3:1)-containing
products for the encapsulation of
electronics components added to circuit
boards and as resins in over molding,
dip molding, insert molding
applications, or conformal coatings.
In explaining EPA’s understanding of
the use of PIP (3:1) in circuit boards,
EPA distinguishes between those
elements that come into direct contact
with parts conducting or storing
electricity and those that do not. The
items the commenter (EPA–HQ–OPPT–
2023–0376–0297) referred to as
necessary ‘‘to secure, cover, or insulate
an electronic component that gets
attached to a circuit board’’ do not come
into direct contact with parts that
conduct or store electricity and
therefore do not necessitate the flameretardant properties of PIP (3:1) in those
components. Hence EPA is not
expanding the scope of the circuit board
exclusion to include these items and
these articles may be subject to the
October 2024 deadline for processing
and the October 2026 deadline for
distribution of PIP (3:1)-containing
articles unless excluded under 40 CFR
751.407 (b) or where another phase-in
prohibitions with longer term deadlines
exists under 40 CFR 751.407(a)(2).
e. Marine Antifouling Coating Product
EPA is finalizing, at 40 CFR
751.407(a)(2)(vii), a five-year
compliance deadline for the prohibition
of processing and distribution in
commerce of PIP (3:1) for use in a
FIFRA-registered marine antifouling
coating product for Department of
Defense uses only. The January 2021
prohibition on processing and
distribution of PIP (3:1) has resulted in
the inability of the U.S. Navy to obtain
a PIP (3:1)-containing, FIFRA-registered
marine antifouling coating product. This
compliance date extension will allow
the U.S. Navy to continue to procure PIP
(3:1)-containing coating while it
identifies an alternative PIP (3:1)-free
formulation.
PIP (3:1) is used as a plasticizer in the
formulation of the marine antifouling
coating product and is an inert
ingredient under FIFRA. In discussion
with the U.S. Navy, it indicated that this
antifouling coating falls under the
‘‘mission critical’’ category because hull
corrosion on ships can have significant
impacts on ship performance. The U.S.
Navy also indicated that it would need
five years to develop a suitable
alternative formulation and undergo
U.S. Navy qualification and testing and
the FIFRA approval process. Because no
technically feasible alternative is
currently available for the U.S. Navy’s
aluminum-hulled ships due to the U.S.
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Navy’s specific performance
requirements, EPA considers it
impracticable to continue prohibiting
the processing and distribution of PIP
(3:1) for use in this marine antifouling
coating product while an alternative is
being developed. EPA understands there
are suitable alternatives for commercial
users and so is limiting this exclusion
to this U.S. Department of Defense
application. EPA is finalizing this new,
5-year compliance deadline under
TSCA section 6(h). One commenter
(EPA–HQ–OPPT–2023–0376–0309)
supports finalizing the proposed
restrictions regarding PIP (3:1) related to
FIFRA-registered marine coatings. EPA
did not receive comments opposing this
provision.
f. Manufacturing Equipment and
Semiconductor Manufacturing Industry
In response to comments, EPA is
amending the proposed compliance
deadline extension of 10 years at 40 CFR
751.407(a)(2)(ix) for processing and
distribution in commerce of PIP (3:1),
and manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products and articles for use
in manufacturing equipment and in the
semiconductor industry. EPA received
several comments on the proposal
regarding articles used in manufacturing
equipment and the semiconductor
industry. Two commenters supported
the 10-year compliance extension for
such articles. Several commenters
sought to include a particular type of
equipment in the articles covered by the
proposed extension or to lengthen the
compliance time period for a particular
type of equipment. For example, one
commenter asked EPA to clarify that the
semiconductor manufacturing
exemption applies to ancillary
operations such as the assembly of usespecific and product-specific packages
and components and to their
installation within other products and
finished articles in which finished
semiconductor packages are used.
Commenters claiming that 10 years was
not sufficient cited complex supply
chains and performance requirements.
Nine commenters noted that these
articles have long service lives and need
repair parts during their service lives.
Taking these comments together, EPA is
finalizing an approach to articles used
in manufacturing equipment and in the
semiconductor industry based on the
approach EPA is using for motor
vehicles. In this final rule, EPA is
adding a compliance deadline extension
of 10 years after the publication of the
final rule for processing and distribution
in commerce of PIP (3:1),
manufacturing, processing, and
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distribution in commerce of PIP (3:1)containing products, and manufacturing
and processing of parts for use in new
manufacturing equipment, including in
the semiconductor industry, and
additional time for the same activities
for use in replacement parts for
equipment used in those industries.
EPA is also expanding the categories of
equipment covered by this approach so
that the new compliance deadlines will
include electronic equipment, heating,
ventilation, air-conditioning, and
refrigeration equipment, water-heating
equipment, and power generating
equipment, including outdoor power
equipment. EPA is amending the
existing compliance deadline to provide
an additional 10 years for new parts for
these additional categories, except for
consumer electronic equipment, which
is still subject to the October 31, 2024
deadline. These phase-in prohibitions to
do not apply to articles subject to
exclusions, in particular wire harnesses
and circuit boards.
As mentioned, the categories are (1)
manufacturing equipment, including
equipment used in the semiconductor
manufacturing industry, (2) electronic
equipment (3) heating, ventilation, airconditioning (HVAC), refrigeration, and
water-heating equipment, and (4) power
generating equipment. Manufacturing
equipment generally refers to industrial
machinery, such as automated
manufacturing equipment, including
robotics, and machine tools, that are an
integral part of manufacturing or
processing a product or article used in
the manufacturing sector, including in
semiconductor manufacturing and its
ancillary support industries. EPA also
includes in the manufacturing category
non-road mobile machines, large scale
fixed installations, and large scale
stationary industrial tools. The
electronic equipment category includes
three subcategories: consumer electronic
equipment, such as cell phones,
computers and laptops, and game
consoles; commercial equipment,
including commercial printers and other
business-to-business supplied
electronics, as well as such as analysis,
measurement, test, monitoring, and
control instruments; and laboratory and
research equipment, such as electron
microscopes and laboratory appliances.
The heating, ventilation, airconditioning, refrigeration, and waterheating equipment category includes
residential and commercial HVAC
equipment as well as commercial
refrigeration equipment. The power
generating equipment category includes
alternative power generation equipment
such as batteries and battery charging
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equipment as well as outdoor power
equipment, such as generators,
lawnmowers, chain saws, snow
throwers, tillers, and other related
products. All these categories are
subject to the new provisions EPA is
finalizing for parts installed in new
equipment, with the exception of
consumer electronic equipment.
In the preamble to the proposal, EPA
explained that the Agency is not further
extending the existing October 31, 2024,
compliance deadline for most other
articles (see Unit III.D.1.vi. in the
proposed rule). EPA also noted the
Agency expects that in several
industries, such as the textile industries,
including consumer electronic
equipment, the existing compliance
time frame for processing and
distribution in commerce of PIP (3:1) for
use in articles and PIP (3:1)-containing
articles ending October 31, 2024, is
sufficient (Ref. 46). EPA also asked for
comments on these proposed
compliance time frames. Based on
comments received, EPA continues to
believe that the October 31, 2024,
compliance deadline is practicable for
the textile and consumer product
industries, including consumer
electronics. For other categories
equipment, including commercial and
research equipment, EPA continues to
be convinced, as several commenters
note, that there are difficulties in
identifying PIP (3:1) in supply chains. In
addition, commenters noted long
development cycles for these types of
equipment, and argued that additional
time is needed to identify, test, certify,
and adopt alternative parts,
components, and finished products, as
well as time to modify the
manufacturing processes to
accommodate an alternative substance.
For these reasons, EPA believes a time
frame shorter than 10 years would not
be practicable for the other categories of
equipment identified. The 10-year
phase-out for manufacturing and
processing of PIP (3:1)-containing parts
for use in new equipment being
finalized applies to manufacturing
equipment, commercial and laboratory
electronic equipment, HVAC,
refrigeration, and water heating
equipment, and power generating
equipment. It prohibits, after 10 years,
all processing, and distribution in
commerce of PIP (3:1) for use in parts
for new equipment, and the
manufacturing, processing and
distribution in commerce of PIP (3:1)containing products for use in parts for
new equipment, and the manufacturing
and processing of parts to which PIP
(3:1) has been added for such
equipment.
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For replacement parts, EPA is
finalizing an approach that accounts for
the variability of service lives of the
different types of equipment both
within each category described
previously and between categories.
Several commenters (EPA–HQ–OPPT–
2023–0376–0288, EPA–HQ–OPPT–
2023–0376–0297, EPA–HQ–OPPT–
2023–0376–0284)) point out that the
equipment produced may be designed
to operate for a decade or longer and
that replacement parts are critical to
keep the equipment running.
Commenters also note that redesigned
parts for existing finished equipment
cannot assure the same or similar
performance, safety, and reliability as
originally designed parts. For
manufacturing equipment, EPA is
allowing for the processing and
distribution in commerce of PIP (3:1),
the manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts, and the
manufacturing and processing of
replacement parts containing PIP (3:1)
for the service lives of such equipment.
Based on comments received,
manufacturing equipment can survive
in operation for decades. For heating,
ventilation, air-conditioning,
refrigeration, and water-heating
equipment, and for power generating
equipment, EPA is allowing for the
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)
products for use in replacement parts,
and manufacturing and processing of
PIP (3:1)-containing replacement parts
for 15 years after the manufacturing ban
on new PIP (3:1)-containing parts, for a
total of 25 years. As discussed
previously for new parts, the Agency
separated the electronic equipment
category into three sub-categories:
consumer, commercial, and laboratory.
For the laboratory category, EPA is
allowing for the processing and
distribution of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts, and manufacturing
and processing of replacement parts
containing PIP (3:1), for the service lives
of such equipment. As with
manufacturing equipment, based on
comments received, laboratory
equipment can last for decades. For the
commercial category, the Agency is
allowing an additional 15 years for the
processing and distribution in
commerce of PIP (3:1), manufacturing,
processing, and distribution in
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commerce of PIP (3:1)-containing
products for use in replacement parts,
and manufacturing and processing of
PIP (3:1)-containing replacement parts
for use in such equipment, after the
manufacturing ban on new PIP (3:1)containing parts, for a total of 25 years.
For both of the commercial and
laboratory categories, users often enter
into contracts that require
manufacturers or dealers to provide
ongoing maintenance for extended
periods of time. For the processing and
distribution in commerce of PIP (3:1)
and the manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts for consumer
electronic equipment and the
manufacturing and processing of PIP
(3:1)-containing replacement parts for
consumer electronic equipment, EPA is
setting a compliance deadline of 7 years.
This aligns with right-to-repair laws that
have been passed or are pending in
many States. While only California,
Colorado, Minnesota, and New York
have passed right to repair laws, 30
States are considering right to repair
laws that address agricultural, digital/
electronic, or other equipment
categories (e.g., motor vehicles,
wheelchairs). Lastly, after the end of the
equipment phase-out time periods, all
persons are prohibited from all
importing and processing of
replacement parts for manufacturing
equipment, heavy machinery,
commercial and laboratory electronic
equipment, HVAC, refrigeration, and
water heating equipment, and power
generating equipment that contain PIP
(3:1) in any part. EPA is finalizing an
exclusion to allow for the distribution in
commerce of PIP (3:1)-containing parts
for equipment and equipment
containing such parts. This is discussed
in more detail in Unit E.
2. Precedence of Phase-In Prohibitions
Several commenters (EPA–HQ–
OPPT–2023–0376–0297, EPA–HQ–
OPPT–2023–0376–0284, EPA–HQ–
OPPT–2023–0376–0295, EPA–HQ–
OPPT–2023–0376–0306, EPA–HQ–
OPPT–2023–0376–0288, EPA–HQ–
OPPT–2023–0376–0310, EPA–HQ–
OPPT–2023–0376–0291) asked EPA to
clarify exclusion and phase-out
precedence. Most commenters requested
that EPA make clear that time-limited
exemptions did not apply where they
were in conflict with an exclusion or
time-limited exemption with a longer
compliance period, and conversely, that
exclusions still applied when they were
in conflict with a time-limited
exemption.
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In the former case, two commenters
(EPA–HQ–OPPT–2023–0376–0284,
EPA–HQ–OPPT–2023–0376–0295)
noted that the current compliance
deadline for PIP (3:1) for use in articles
addressed by 40 CFR 751.407(a)(2)(iii)
does not make clear that such deadline
does not apply to articles subject to
longer alternative compliance deadlines
or exclusions, like articles with PIPcontaining adhesives/sealants or
lubricants/greases. The commenters
noted that the proposed text also did not
address the issue. To avoid
misunderstanding, the commenters
suggested that the existing alternative
compliance deadline at 40 CFR
751.407(a)(2)(i) and the proposed
alternative compliance deadline at 40
CFR 751.407(a)(2)(iv) should also be
described as excepted from the phase-in
prohibition at 40 CFR 751.407(a)(2)(iii).
In response to these comments, EPA is
amending 40 CFR 751.407(a)(2) to
clarify that other phase-in prohibitions
with longer term deadlines in 40 CFR
751.407(a)(2) or exclusions in 40 CFR
751.407(b) may allow the ongoing
manufacture, processing, and/or
distribution in commerce, where the
terms of the longer-term phase-in or
exclusion applies. However, the terms
of the phase-in prohibition with a longer
term for continued processing and
distribution in commerce, for example,
must expressly apply. For example, the
amended regulatory text is clear that
pursuant to 40 CFR 751.407(a)(1) any
processing and distribution of PIP (3:1)
or PIP (3:1)-containing products or
articles is prohibited unless another
provision in 40 CFR 751.407(a)(2) or (b)
authorizes such processing and
distribution in commerce. Neither the
adhesive and sealant phase-in provision
at 40 CFR 751.407(a)(2)(i) nor the
lubricant and grease exclusion at40 CFR
751.407(b)(ii), both in the regulatory text
adopted in 2021, allows the processing
and distribution of PIP (3:1) for use in
producing a PIP (3:1)-containing
adhesive or lubricant product for use in
any type of article. Those provisions
allow a PIP (3:1)-containing lubricant,
for example, to be processed and
distributed in commerce for use, but not
for use in an article. However, there are
other provisions that do allow the
processing and distribution of PIP (3:1)
for use in a specific type of article;
where EPA intended to allow PIP (3:1)
to be processed or distributed in
commerce for use in articles, EPA
included reference to the article type in
the regulatory provision. For example,
40 CFR 751.407(b)(1)(iii) as codified in
2021, and revisions finalized in 40 CFR
751.407(a)(2)(vi), both expressly address
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the processing and distribution of PIP
(3:1) for use in replacement parts. It is
that express reference to the article, i.e.,
the replacement part, that authorizes the
processing and distribution of PIP (3:1)
for that article type. Thus, if there is no
provision authorizing processing and
distribution of PIP (3:1) for use in an
article type, then the prohibition at
current 40 CFR 751.407(a)(2)(iii)
applies. Using the adhesive and
lubricant examples provided by the
commenter, processing and distribution
of PIP (3:1) for use in an adhesive or
lubricant for use in an article type not
otherwise addressed in 40 CFR
751.407(a)(2) or (b) is prohibited by 40
CFR 751.407(a)(2)(iii). This is consistent
with the 2021 responses to comment on
a similar issue.
Similarly, one commenter (EPA–HQ–
OPPT–2023–0376–0297) asked EPA to
make clear that the exclusion related to
circuit boards and harnesses takes
precedence in situations where other
phase-in periods are more limited in
nature. For example, if a PIP (3:1)containing circuit board is used in the
production or repair of a piece of
manufacturing equipment that is used
in semiconductor manufacturing, or is
installed or in need of repair in a piece
of heavy equipment used in automotive
manufacturing, after the extension
period has expired for the
semiconductor manufacturing
equipment or heavy machinery in
automotive manufacturing categories,
the PIP (3:1)-containing circuit board
would still remain subject to the
indefinite exclusion. EPA is clarifying
that the final rule allows for the ongoing
processing and distribution in
commerce of PIP (3:1) for use in wire
harnesses and circuit boards generally,
and that such exclusion is not limited
by the phase-outs in 40 CFR
751.407(a)(2). Thus, processing and
distribution of PIP (3:1) may continue,
for example, when for use in circuit
boards, even after the compliance
deadline has passed for the processing
and distribution in commerce of PIP
(3:1)-containing parts for use in motor or
aerospace vehicles and other articles.
Since this holds as a general rule for 40
CFR 751.407(a)(2) (the phase-in
prohibitions), EPA is adding clarifying
language to the regulatory text at 40 CFR
751.407(a)(2) to except the activities
described in 40 CFR 751.407(b) (the
exclusions from prohibitions).
3. Require Worker Protections During
Manufacturing and Processing of PIP
(3:1)
EPA is finalizing, with minor
modification to recordkeeping
requirements, its proposal to require the
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use of PPE by workers involved in the
manufacturing and processing of PIP
(3:1) and certain products and articles
containing PIP (3:1). EPA proposed to
require inhalation and dermal PPE
during domestic manufacturing and
processing of PIP (3:1) and certain PIP
(3:1)-containing products and articles to
address potential respiratory and dermal
exposure to occupational workers
during certain ongoing domestic
manufacturing or processing activities
involving PIP (3:1), including those for
which EPA is finalizing phase-out
periods. Because EPA generally
presumes the potential for exposure is
low during importation, the Agency did
not propose worker protections for
import of PIP (3:1) and PIP (3:1)containing products and articles. The
Agency also did not propose worker
protection for the processing of certain
PIP (3:1)-containing products and
articles: PIP (3:1)-containing adhesives
and sealants, new and replacement parts
to which PIP (3:1) has been added for
motor and aerospace vehicles, and the
motor and aerospace vehicles that
contain new and replacement parts to
which PIP (3:1) has been added, PIP
(3:1)-containing specialized engine
filters for locomotive and marine
applications, and the products or
articles described in 40 CFR
751.405(b)(1)(vi) and (vii). EPA also
proposed excluding processing of PIP
(3:1) and PIP (3:1)-containing products
for use as an intermediate to produce
cyanoacrylate adhesives when
contained in a closed system under new
40 CFR 751.407(f)(7)(iii). Finally, EPA
also proposed to require that owners/
operators implement a PPE program in
alignment with certain elements of
OSHA’s General Requirements for
Personal Protective Equipment at 29
CFR 1910.132 and Respiratory
Protection requirements in 29 CFR
1910.134. EPA is finalizing these
requirements with slight changes to the
recordkeeping provision (see Unit
III.D.5).
Where PPE is required, EPA is
finalizing its proposal to require
implementation of a PPE program in
alignment with certain elements of
OSHA’s General Requirements for
Personal Protective Equipment at 29
CFR 1910.132 and Respiratory
Protection requirements in 29 CFR
1910.134. EPA is requiring that owners/
operators maintain PPE in a sanitary,
reliable, and undamaged condition and
ensure each potentially exposed person
who is required to wear PPE to use such
PPE. Under this final rule, owners/
operators are required to select and
provide PPE that properly fits each
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potentially exposed person who is
required to use PPE and to communicate
PPE selections (e.g., demonstration that
each item of PPE selected provided
prevents exposure during expected
duration and conditions of exposure) to
each potentially affected person. Where
dermal PPE is required, EPA is
finalizing a requirement that owners
and operators provide gloves that are
chemically resistant to PIP (3:1) with
activity-specific training where dermal
contact with PIP (3:1) is possible.
For the manufacturing and processing
of PIP (3:1) and PIP (3:1)-containing
products for use in new and
replacement parts for motor vehicles,
including heavy machinery, and
aerospace vehicles, EPA is requiring
respiratory protection that must be at
least as protective as a NIOSH-approved
N95 respirator (APF 10). For processing
of PIP (3:1) and PIP (3:1)-containing
products for use in the manufacturing of
cyanoacrylate adhesives, EPA is
finalizing respiratory protection that
must be at least as protective as a
NIOSH-approved APF 50 respirator,
except when the PIP (3:1) or PIP (3:1)containing product is contained in a
closed system. For all other activities
covered, EPA is requiring respirators
that are at least as protective as a
NIOSH-approved APF 10 air-purifying
half mask respirator. Based on
stakeholder comments (Ref. 36) and
OSHA-required Safety Data Sheets, EPA
understands these levels of protection
are already typically used as industry
best practices, although the Agency
lacks reasonably available information
to determine the scale of adoption. For
processing of PIP (3:1) as an
intermediate processing aid in the
manufacturing of cyanoacrylate
adhesives, EPA is requiring engineering
controls such that the processing of PIP
(3:1) must take place in a closed loop
system with general and local exhaust
ventilation provided. EPA understands
that only one company is currently
processing PIP (3:1) for this use, and the
proposed engineering controls are the
current practice of the company.
EPA is finalizing its proposal that the
owner or operator must ensure that all
respirators used in the workplace are
NIOSH-approved as listed on the
NIOSH Certified Equipment List. In
choosing appropriate gloves, EPA
expects that owners/operators consider
the effectiveness of glove type when
preventing exposures from PIP (3:1)
alone and in likely combination with
other chemical substances used in the
work area, the degree of dexterity
required to perform tasks, and the
temperature, as identified in the Hand
Protection section of OSHA’s Personal
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Protective Equipment guidance (Ref.
34). EPA is also finalizing its proposal
to require each owner/operator to
comply with OSHA’s respiratory
protection training requirements at 29
CFR 1910.134(k) and general PPE
training requirements at 29 CFR
1910.132(f) when using respirators and
gloves. Owners/operators must provide
PPE training to all persons required to
use dermal protection or respiratory
protection prior to or at the time of
initial assignment to a job involving
exposure to PIP (3:1).
4. Manufacturing (Including Import) of
PIP (3:1)
Multiple commenters (EPA–HQ–
OPPT–2023–0376–0310, EPA–HQ–
OPPT–2023–0376–0297, EPA–HQ–
OPPT–2023–0376–0288, EPA–HQ–
OPPT–2023–0376–0307, EPA–HQ–
OPPT–2023–0376–0306, EPA–HQ–
OPPT–2023–0376–0290) discussed the
import of PIP (3:1)-containing products
and articles in their comments. As
previously discussed, EPA is finalizing
modifications to several exclusions from
prohibition finalized in the January 6,
2021, PIP (3:1) final rule. These
modifications include narrowing the
scope of certain exclusions, adding
prohibition phase-in dates, and in some
cases creating new exclusions from
prohibition for certain uses. In
narrowing the scope of certain
exclusions, EPA proposed to prohibit
the import of the PIP (3:1)-containing
articles and PIP (3:1)-containing
products for those uses. This is to
restrict the ability for these prohibited
PIP (3:1)-containing articles and PIP
(3:1)-containing products for those uses
to be imported where they are no longer
allowed to be produced in the United
States. EPA is finalizing these phase-in
prohibitions on manufacturing,
including import, for certain uses under
40 CFR 751.407(a)(2) and has made edits
to the regulatory text to make it clear
what is prohibited and excluded. EPA
modified the general provision title
under 40 CFR 751.407(a)(1), to now be
titled ‘‘General prohibition on
processing and distribution in
commerce,’’ [emphasis added] so that it
is clear this provision does not generally
apply to any manufacturing of PIP (3:1)
or PIP (3:1)-containing products and
articles. EPA is not finalizing a general
prohibition on the manufacturing of PIP
(3:1), consistent with the 2021 PIP (3:1)
rulemaking, due to the number of
excluded activities which EPA has
found it impracticable to prohibit. EPA
notes that the absence of a general
prohibition on manufacture of PIP (3:1)
or PIP (3:1)-containing products or
articles does not allow for ongoing
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distribution in commerce of imported
products and articles, where such
distribution in commerce is expressly
prohibited by another provision in 40
CFR 751.407; where EPA has prohibited
the distribution in commerce of a PIP
(3:1) or PIP (3:1)-containing products or
articles, such prohibition would be
applicable to any attempted importation
of such PIP (3:1) or PIP (3:1)-containing
product or article.
5. Recordkeeping Requirements and
Downstream Notification
In the 2021 PIP (3:1) final rule, EPA
required that all persons who
manufacture, process, or distribute in
commerce PIP (3:1) and products and
articles containing PIP (3:1) maintain
ordinary business records related to
compliance with the prohibitions and
restrictions for three years and to make
records available within 30 days upon
request. EPA is increasing the
recordkeeping requirement from three to
five years and removing the 30-day time
frame to make records available. Due to
the additional requirements being
finalized in this rulemaking, specifically
those pertaining to worker safety, EPA
considers the five-year time frame
regarding recordkeeping and removal of
the 30-day time frame to make records
available is more appropriate.
Furthermore, this five-year time frame
aligns with the statute of limitations for
civil penalty enforcement (28 U.S.C.
2462), and it is consistent with the time
frame associated with other TSCA
section 6(a) rulemakings that include
worker protection requirements. EPA is
confident that extending each rule’s
recordkeeping requirement to a
consistent five-year requirement will
facilitate regulated entities’ compliance
with minimal impact to regulatory
burden. In addition, removal of the 30day time frame to make records
available is critical to the Agency’s
ability to promptly identify and correct
noncompliance. EPA presumes that
regulated entities should have the
records demonstrating compliance
readily available.
In addition, as it relates to
recordkeeping for worker protections,
EPA is finalizing its proposal to require
that owners/operators document
respiratory protection used and PPE
program implementation and retain
those records for five years. One
commenter (EPA–HQ–OPPT–2023–
0376–0312) requested that EPA modify
its worker protection recordkeeping
requirements to specify that records be
made available to exposed workers and
their representatives and to extend the
record retention period. This
commenter supports EPA’s decision to
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91507
eliminate the 30-day compliance period,
thus making records immediately
available to the Agency, but emphasized
the importance of making records
available to workers and their
representatives as well. The commenter
stated that this would be consistent with
similar OSHA regulations. Furthermore,
the commenter recommended extending
the recordkeeping requirements to a
much longer period of time, suggesting
20–30 years as an appropriate time
frame. The commenter argued that the
health effects due to exposure to toxic
chemicals can exhibit long latency
periods. This information about latency,
the commenter expressed, should be
available to workers throughout the
period of potential consequences of an
exposure.
As discussed in the proposed rule, the
final five-year time frame is consistent
with those associated with other TSCA
section 6(a) rulemakings and removal of
the 30-day time frame to make records
available is critical to the Agency’s
ability to promptly identify and correct
noncompliance. EPA determined that
regulated entities should have the
records demonstrating compliance
readily available due to previous
recordkeeping requirements for PIP (3:1)
under TSCA; this measure is intended
to make use of ordinary business
records and thus not be overly
burdensome to industry. In response to
the request that EPA require records be
made available to workers and to their
designated representatives as well, EPA
has modified the workplace protection
records requirements for PIP (3:1) to
require that the owner or operator
provide potentially exposed persons
and their designated representative an
opportunity to observe records related
to the basis of the PPE or other control
measure selection, including potential
monitoring results that are
representative of the potentially
exposed person’s exposure.
EPA is also amending the downstream
notification statement that must
accompany shipments of PIP (3:1) or PIP
(3:1) containing products to conform to
the terms of the prohibitions in the final
rule. EPA is providing a 3-month
transition period to update SDS sheets
and an 18-month transition period for
updating labels. EPA believes that this
transition period should allow time to
clear products with old labels through
channels of trade. During the 3-month
transition period, downstream
notification under 40 CFR 751.407(e)(1)
and (2) is still required; entities may use
the new information provided in new 40
CFR 751.407(e)(3) or existing
notification consistent with the
restrictions described in this subpart.
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During the 15-month period between
the SD revision date and the label
revision date, manufacturers,
processors, or distributors are required
to provide the updated SDS with the
‘‘new’’ information when distributing
products with the ‘‘old’’ label.
5. Continued Distribution of PIP (3:1)Containing Articles & Continued
Processing & Distribution of PIP (3:1)Containing Articles for Repair and
Maintenance
EPA received multiple comments on
the continued use of articles, including
finished goods containing such articles,
which may contain PIP (3:1). For
example, some commenters stated that
certain PBT-containing articles would
need to be disposed of or retired from
use earlier than needed due to EPA’s
prohibitions and restrictions which
would not allow for repair or general
maintenance of an existing component.
Such commenters (EPA–HQ–OPPT–
2023–0376–0284, EPA–HQ–OPPT–
2023–0376–0305, EPA–HQ–OPPT–
2023–0376–0293, EPA–HQ–OPPT–
2023–0376–0310) noted that finished
goods move around in distribution
channels and usually stay in inventory
for weeks to several months, that
retailers do not have control over how
quickly these goods are sold and do not
necessarily operate under a first-in, firstout operation, and that retailers would
have difficulty differentiating between
PIP (3:1)-containing articles from nonPIP (3:1)-containing articles, and may
want to return the entire stock of goods
(EPA–HQ–OPPT–2023–0376–0284,
EPA–HQ–OPPT–2023–0376–0293).
Commenters also noted the resulting
negative impact of strictly eliminating
stocks based on a ‘‘distribution in
commerce’’ deadline may cause
enormous economic and environmental
impact (EPA–HQ–OPPT–2023–0376–
0284, EPA–HQ–OPPT–2023–0376–
0293, EPA–HQ–OPPT–2023–0376–
0301, EPA–HQ–OPPT–2023–0376–
0305, EPA–HQ–OPPT–2023–0376–
0310). For example, one of the
commenters noted that premature
obsolescence would result in substantial
economic losses as affected equipment
becomes stranded assets, impacting the
environment and the economy. Another
commenter noted that companies may
carry thousands of spare parts for
discontinued goods for up to and
beyond 10 years so customers can
extend the life of the good (EPA–HQ–
OPPT–2023–0376–0293). Two
commenters also asked EPA to reiterate
that the provision at 40 CFR
751.401(b)(1) permits an article or
product that has been purchased or
acquired other than for resale to be re-
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distributed, leased, or re-sold (EPA–
HQ–OPPT–2023–0376–0297, EPA–HQ–
OPPT–2023–0376–0284). These two
commenters also requested that EPA
make clear that the language in 40 CFR
751.401(b)(1) permits the movement
within the United States of complex
manufacturing equipment and durable
goods that might contain PIP (3:1)containing components when such
equipment or durable goods were
manufactured prior to the date of any
final prohibition in the PIP (3:1)
regulation (EPA–HQ–OPPT–2023–
0376–0297, EPA–HQ–OPPT–2023–
0376–0284). One commenter requested
that EPA make clear that all existing
products and articles that were
manufactured prior to the various final
effective dates in the PBT regulations
are exempt (EPA–HQ–OPPT–2023–
0376–0297). Another commenter noted
that if an article needs to be repaired but
was manufactured before the effective
date of the final rules, it is simply
impossible to check compliance on the
article since the article was not managed
to comply with the rules (EPA–HQ–
OPPT–2023–0376–0284).
EPA is amending the regulatory text
covering PIP (3:1) in a number of
different ways to address these
comments. First, EPA is amending the
proposed regulatory text for a number of
activities addressed in 40 CFR
751.407(a)(2) and adding an additional
regulatory provision in 40 CFR
751.407(b) to make clear that the general
prohibition in 40 CFR 751.407(a)(1) and
the general phase-in prohibition for
articles at 40 CFR 751.407(a)(2)(iii) do
not apply to the distribution in
commerce of certain PIP (3:1)containing articles and the finished
goods containing such articles, like cars,
aerospace vehicles, and complex
equipment. It was not EPA’s intent to
use its TSCA section 6(a) authorities to
restrict the continued distribution and
sale of such parts for such complex
articles, where the manufacture and
process of the part complies with the
phase-in prohibition in 40 CFR
751.407(a)(2). For example, 40 CFR
751.407(a)(2)(v), as proposed, would
have prohibited the distribution in
commerce, after 15 years from the
publication date, of PIP (3:1)-containing
parts for new motor vehicles and the
new motor vehicles containing those
parts.
EPA has amended that provision to
remove the prohibition on distribution
in commerce of such parts and vehicles
and EPA has added a new provision, 40
CFR 751.407(b)(viii), to exclude the
distribution in commerce of such parts
and vehicles from the general
prohibition in 40 CFR 751.407(a)(1) and
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general phase-in prohibition in 40 CFR
751.407(a)(2)(iii). However, to be clear,
the manufacturing and processing of
such parts for such vehicles after 15
years from the date of publication of this
rule is prohibited [and distribution in
commerce of parts that do not comply
with that requirement is not permitted
by 40 CFR 751.407(b)(viii). Thus, as
long as the parts meet the requirements
in 40 CFR 751.407(a)(2)(v) relating to
the manufacture and processing of such
parts, the parts and the vehicles
containing such parts may be
distributed in commerce, for any reason,
including as new or for use or resale.
Similar changes have been made to
similar provisions, i.e., for replacement
parts for motor vehicles addressed in 40
CFR 751.407(a)(2)(vi), new and
replacement parts for aerospace vehicles
addressed in 40 CFR 751.407(a)(2)(vii)
and (viii), respectively, and new and
replacement parts for manufacturing
equipment addressed in 40 CFR
751.407(a)(2)(ix) and (x), respectively. A
prohibition on the distribution in
commerce of these complex articles
would not be practicable; to the
contrary, it would be extremely
burdensome, necessitating the
identification of parts containing PIP
(3:1).
EPA is also amending 40 CFR
751.407(a)(2)(iii) to allow for an
additional two years for the distribution
of PIP (3:1) containing articles subject to
the October 31, 2026, compliance
deadline in order for those articles to
clear channels of trade.
Second, EPA is adding 40 CFR
751.407(b)(1)(viii) to allow processing
and distribution in commerce for
maintenance and repair of existing PIP
(3:1)-containing articles. EPA has stated
in the 2021 final rules that is not
practicable 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 it would be
extremely burdensome, necessitating
the identification of articles, and the
disposal of countless articles that would
have to be identified and replaced. For
similar reasons, EPA does not believe
restricting continued maintenance and
repair of existing PIP (3:1)-containing
articles is practicable. Commenters
raised the need for repair and
maintenance for certain PIP (3:1)containing articles, like equipment and
machinery, which could result in the
distribution in commerce and
processing that would have been
prohibited after relevant phase-in
prohibition dates. Thus, in response to
these comments, EPA is amending the
provisions in 40 CFR 751.407 to exclude
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processing and distribution in
commerce of an article for the purpose
of repair or maintenance, where PIP
(3:1) has not been newly added. This
exclusion is limited to processing where
the PIP (3:1) is not newly added in any
part, and it is limited to repair and
maintenance of a PIP (3:1)-containing
article. It also differs from the existing
‘‘end user’’ provision in 40 CFR
751.401(b)(1), which allows the
distribution in commerce of the
chemical substance, or products and
articles that contain the chemical
substance, that have previously been
sold or supplied to an end user. The
‘‘end user’’ provision does not include
processing as a part of the exclusion,
and it only applies to an individual or
entity that purchased or acquired the
finished good for purposes other than
resale.
Several commenters also supported a
‘‘manufactured-by’’ approach to allow
for the sell-through of existing articles
and spare parts and further processing
and distribution of articles after
compliance deadlines. Commenters
state that manufacturers can only
control the date of manufacture, not the
date of distribution in commerce and,
further, that manufacturers cannot
ensure compliance after the product has
left their control (EPA–HQ–OPPT–
2023–0376–0284, EPA–HQ–OPPT–
2023–0376–0305, EPA–HQ–OPPT–
2023–0376–0293, EPA–HQ–OPPT–
2023–0376–0310). Multiple commenters
advocated for a manufactured-by date
approach that clarifies that products
that contain PIP (3:1) that have been
manufactured prior to the prohibition
dates may continue to be processed and
distributed, and used indefinitely,
allowing for continued servicing of
equipment that are designed to remain
in service for many years with articles
containing PIP (3:1) through the lifetime
of the equipment and not penalizing
dealers with stranded inventory (EPA–
HQ–OPPT–2023–0376–0297, EPA–HQ–
OPPT–2023–0376–0284, EPA–HQ–
OPPT–2023–0376–0305).
As discussed in the response to
comments to the 2019 PBT proposed
rule, EPA does not think, unless
otherwise specified, that all products
and articles containing PBT chemicals
should continue to be processed and
distributed without end, as it is
practicable eventually to build and
service most products that do not
contain PBTs, as goods reach the end of
their service lives and replacement parts
that do not contain PBTs become
available. EPA therefore is not adopting
a generally applicable ‘‘manufactured
by’’ provision. Instead, EPA has
finalized specific phase-in prohibitions
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or exclusions for certain PBT-containing
articles and finalized an exclusion
solely for the purpose of repair and
maintenance of an existing article.
E. Regulatory Threshold Level for
DecaBDE and PIP (3:1)
In the 2021 PBT final rules, EPA
declined to establish a general exclusion
for PBTs produced as a byproduct,
present as an unintentional
contaminant, or present in what
commenters describe as de minimis
quantities (independent of the exclusion
for recycled plastic). When extending
the compliance deadline for PIP (3:1) in
March 2022, EPA received comments on
establishing a de minimis level for PIP
(3:1) (Ref. 47). At that time, EPA
indicated that the Agency would
consider these comments in the context
of the broader rulemaking EPA planned
to undertake for PIP (3:1) and other PBT
chemicals, i.e., in this rulemaking. In
the proposal to this rule, EPA noted that
a commenter (Ref. 48) proposed that
EPA adopt a threshold limit of no less
than 0.001% for the presence of PIP
(3:1) and 0.1% for the presence of
decaBDE in articles. EPA asked for
comments on this proposal, specifically,
and on a de minimis level in general.
During the comment period for this
rule, several commenters requested that
EPA establish a de minimis exemption
for decaBDE and PIP (3:1) (EPA–HQ–
OPPT–2023–0376–0288, EPA–HQ–
OPPT–2023–0376–0292, EPA–HQ–
OPPT–2023–0376–0297). As noted
previously, one commenter proposed
that EPA adopt a threshold limit of no
less than 0.001% for the presence of PIP
(3:1) and 0.1% for the presence of
decaBDE in articles. Another
commenter stated that a de minimis
threshold is consistent with TSCA’s
requirement to reduce exposures ‘‘to the
extent practicable’’ (EPA–HQ–OPPT–
2023–0376–0292). Further, without a
threshold, this commenter and another
stated that regulated entities would not
know whether they are in compliance,
as detection levels are constantly being
reduced and that certainty regarding the
lack or presence of the substance is
unachievable (EPA–HQ–OPPT–2023–
0376–0288, EPA–HQ–OPPT–2023–
0376–0292). One of these commenters
contended it is unworkable and
unreasonable for regulated entities to
potentially have to continually test
materials for the presence of trace levels
of a material that has no appreciable risk
associated with it (EPA–HQ–OPPT–
2023–0376–0292). The Agency received
no comments adverse to a regulatory
threshold for either decaBDE or PIP
(3:1).
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Commenting on PIP (3:1), one
commenter noted that ‘‘the lack of a de
minimis threshold ensures that
manufacturers will need to account for,
and remove, trace amounts of PIP (3:1)
in their products, which will require
expensive lab testing to confirm
(assuming PIP (3:1) can be found above
the limit of detection)’’ (EPA–HQ–
OPPT–2023–0376–0308). One
commenter pointed out the potential for
cross contamination since components
subject to a prohibition may be
manufactured in the same facilities as
components containing PIP (3:1) (EPA–
HQ–OPPT–2023–0376–0305). At least
one commenter requested EPA
distinguish between intentionally added
PIP (3:1) and unintentional impurities
(EPA–HQ–OPPT–2023–0376–0001). A
number of commenters also noted that
in a complex supply chain it may not
always be possible to secure contract
specifications or assurances from
suppliers regarding the presence of PIP
(3:1) and that it would be resource
intensive to demonstrate the complete
absence of a chemical if there is no
threshold to make that determination
(EPA–HQ–OPPT–2023–0376–0310,
EPA–HQ–OPPT–2023–0376–0306,
EPA–HQ–OPPT–2023–0376–0308,
EPA–HQ–OPPT–2023–0376–0288).
For decaBDE, three commenters
argued that a threshold is also needed,
and two commenters recommended that
EPA set it at 0.1% to align with other
major regulatory regimes, such as the
Restriction of Hazardous Substances
(RoHS) (EPA–HQ–OPPT–2023–0376–
0288, EPA–HQ–OPPT–2023–0376–
0292, EPA–HQ–OPPT–2023–0376–
0297). Several commenters on this issue
recommended EPA adopt a 0.1%
concentration level for PIP (3:1) as well.
(EPA–HQ–OPPT–2023–0376–0297,
EPA–HQ–OPPT–2023–0376–0310,
EPA–HQ–OPPT–2023–0376–0306,
EPA–HQ–OPPT–2023–0376–0308). One
of the commenters recommended that,
as a practical matter, EPA establish in
all TSCA section 6(h) regulations for
PBTs a de minimis standard of 0.1% by
weight of the finished product or article.
One commenter (EPA–HQ–OPPT–2023–
0376–0310) argued that a 0.1%
concentration level is consistent with
EPA’s export notification requirement
for known or suspected carcinogens
(EPA–HQ–OPPT–2023–0376–0306,
EPA–HQ–OPPT–2023–0376–0310,
EPA–HQ–OPPT–2023–0376–0308), and
that, while PIP (3:1) is not covered
under Europe’s RoHS, a 0.1%
concentration level is at least consistent
with the level set for most chemicals
under RoHS.
EPA agrees with these comments and
believes that setting a regulatory
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threshold level for unintentional
decaBDE and PIP (3:1) present in
products and articles at less than 0.1%
by weight is a practicable solution,
particularly for situations involving
complex supply chains. This regulatory
threshold level will also aid the
regulated community in complying with
the prohibitions. Commenters noted that
they have limited visibility into their
supply chains and cannot always obtain
assurances from suppliers regarding the
presence of decaBDE in their products
(EPA–HQ–OPPT–2023–0376–0288,
EPA–HQ–OPPT–2023–0376–0292,
EPA–HQ–OPPT–2023–0376–0297).
Commenters also noted that test
methods cannot demonstrate zero
content of any substance. EPA agrees
that testing to zero would not be
practicable due to costs and challenges
with testing for PBTs. The 0.1%
regulatory threshold level for
unintentional levels of decaBDE and PIP
(3:1) provides certainty for entities that
do not intentionally add decaBDE or PIP
(3:1), but where it may be
unintentionally present in their supply
chains below the regulatory threshold
level due to cross-contamination.
Intentional use of decaBDE or PIP (3:1)
in products or articles at any
concentration is prohibited in nonexcluded uses. EPA is not establishing
a regulatory threshold level for
unintentional amounts of other PBTs at
this time.
The regulatory threshold level of
0.1% in this final rule applies to
products and articles measured by
weight, except for any amount present
due to an excluded use or phased-out
use that has not yet reached its
compliance deadline. For complex
assemblies of articles, the regulatory
threshold level applies to each article
individually and not to the complex
assembly as a whole. EPA is not
adopting the interpretation of article
suggested by one commenter, namely
that concentrations of a substance
present in components of an assembly
of articles be measured against the total
weight of the assembly (EPA–HQ–
OPPT–2023–0376–0306). The
commenter stated the belief that EPA’s
interpretation was aligned with this
understanding of how to account for
concentrations of a substance in an
article (EPA–HQ–OPPT–2023–0376–
0306). EPA disagrees, and notes that the
definition of an article, provided at 40
CFR 751.403 provides the clarification
the comment seeks. The term ‘‘article’’
as defined in 40 CFR 751.403,
paragraphs (1) and (2), is a
manufactured item ‘‘[w]hich is formed
to a specific shape or design during
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manufacture,’’ and ‘‘[w]hich has end use
function(s) dependent in whole or in
part upon its shape or design during end
use.’’ EPA determined that the
individual parts of a complex assembly
of parts would meet this definition. EPA
is not providing additional interpretive
guidance at this time, as the Agency
believes the definition of article is
sufficiently clear in this regard.
In setting a regulatory threshold level,
EPA considered other regulatory
thresholds, such as OSHA, which
included a 0.1% threshold for
determining hazards from certain
chemicals to absolve employers from
having to evaluate and list chemicals
present in mixtures in small quantities
that may not result in substantial
exposures, and EPA’s export
notification requirements and reporting
requirements under the Toxics Release
Inventory Reporting under the
Emergency Planning and Community
Right-to-know Act, both of which set a
threshold of 0.1% for some chemicals.
Another example is the European
Union’s Regulation on the registration,
evaluation, authorization and restriction
of chemicals (REACH), which states that
decaBDE ‘‘Shall not be used in the
production of, or placed on the market
in . . . an article, or any part thereof, in
a concentration equal to or greater than
0.1% by weight.’’ (Ref. 49). Suppliers’
familiarity with these levels ought to
reduce the administrative burden
associated with tracking different
thresholds for different uses. EPA also
considered the concentration level of
0.001% for PIP (3:1) suggested by a
commenter (EPA–HQ–OPPT–0376–
0288). This commenter recommended
this lower level when PIP (3:1) is
measured against the weight of the
article as a whole in complex
assemblies, rather than each component
article that makes up the complex
assembly. It is not clear that a regulatory
threshold level this low would be
practicable for individual components
or across industries.
EPA previously reasoned that setting
a single regulatory threshold level of
0.1% for all uses is not practicable,
given the concentrations of these two
chemicals in the supply chain for
different types of products, which
would make establishing a
concentration threshold for each use
overly burdensome and impracticable.
Given the comments from stakeholders
noting that a 0.1% concentration level is
consistent with EPA’s export
notification requirement and is at least
consistent with the level set for most
chemicals under RoHS, EPA now
concludes that stakeholders would be
able to comply with a single regulatory
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threshold level, despite the differing
concentrations for different types of
products and articles.
Since decaBDE and PIP (3:1) are
additive chemicals and are not known
to be present as a byproduct, EPA is not
establishing a regulatory threshold level
where decaBDE or PIP (3:1) is
intentionally added. EPA is confident
that where decaBDE is intentionally
added, it is intended to be present at
concentrations at least an order of
magnitude higher than 0.1% and EPA
has adopted regulatory controls to
address such intentional activities.
Commenters provided information
indicating that an 0.1% concentration is
generally below the levels present in the
majority of intentional uses of PIP (3:1).
However, EPA is aware of the
manufacture and processing of certain
products or articles containing PIP (3:1)
at levels intentionally well below 0.1%
(Ref. 50). In such cases, PIP (3:1) levels
in such products or articles will be
presumed to be intentional and thus the
regulatory threshold level of 0.1%
adopted in this rule would not apply to
those products or articles. Thus, this
regulatory threshold of 0.1% allows a
practicable approach for managing
unintentionally present decaBDE and
PIP (3:1).
EPA had previously declined to set a
regulatory threshold level in part
because EPA asserted that setting a
threshold level would require expensive
testing. However, EPA is making clear
that testing is not required. While that
is the case, companies may choose to do
so if they believe contaminant or
unintentional levels may be present and
wish to document that the levels are
below the 0.1% regulatory threshold
level.
IV. The Reasonably Ascertainable
Economic Consequences of the Final
Rule
A. Overview of Cost Methodology
EPA has evaluated the potential costs
of the final rule. Industry costs may
arise from implementing measures to
protect from exposure or switching from
the manufacture or use of the chemical
to a substitute. These costs include:
reformulation of prohibited products
using alternative chemicals to
manufacture the product, or the price
differential of available substitute
products that do not contain PIP (3:1),
providing workers with the required
personal protective equipment (e.g.,
respirators and gloves), product labeling
or signage to provide notice to workers
that PPE is required to be worn during
recycling, refurbishing, or processing of
existing plastic shipping pallets rule
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familiarization and recordkeeping based
on burdens estimated for other similar
rulemakings. Costs were annualized
over a 30-year period. Other potential
costs include, but are not limited to,
those associated with testing, release
prevention, imported articles, and some
portion of potential revenue loss.
B. Estimated Costs of This Final Rule
Total quantified annualized industry
costs for the final rule are estimated to
be $400 million at a 3 percent discount
rate and $430 million at a 7 percent
discount rate annualized over 30 years.
Costs at a 2 percent discount rates are
estimated at $390 million (shown in
appendix A of the accompanying
Economic Analysis for this final rule).
Of the final rule costs, those associated
with decaBDE alone were
approximately $86 at a 3 percent
discount rate and $128 at a 7 percent
discount rate. Costs associated with PIP
(3:1) were $400 million and $430
million (at 3 and 7 percent discount
rates, respectively.) Of this total, worker
protection (PPE) costs under the final
regulatory option annualized at a 3
percent discount rate is $373 million
and $410 million at a 7 percent discount
rate with PIP (3:1) accounting for all
costs. The reason for the large disparity
in the costs between decaBDE and PIP
(3:1) results from the difference in the
number of firms using each chemical
under the final rule’s regulated
activities. There are only two firms
known to be using decaBDE that will be
impacted by this final rule.
Substantially more firms (up to 26,803)
could potentially be impacted by the
PIP (3:1) final rule requirements based
on the sectors impacted. Prohibition
costs for PIP (3:1) annualized at a 3
percent discount rate were estimated at
$27 million and $20 million annualized
at a 7 percent discount rate. For the
economic analyses for the 2021 PBT
final rules, EPA estimated that it would
need one full-time equivalent (FTE)
employee for implementation (e.g.,
compliance assistance and enforcement)
activities under both the 2021 decaBDE
and PIP (3:1) final rules (two FTE
employees total). This final rule will
modify those existing rules. Therefore,
EPA does not expect that it will require
any additional (incremental) Agency
staff time to implement the rules under
the final revisions (final or primary
alternative options).
1. Benefits
A qualitative discussion of the
potential benefits associated with the
final action for decaBDE and PIP (3:1) is
provided. PIP (3:1) is a neurotoxicant
and aquatic toxicant with high
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manufacturers to develop new chemical
alternatives to PIP (3:1).
persistence and high potential for
bioaccumulation. DecaBDE has been
found to have an association with liver
cancer and benign liver tumors in rats
and mice and had hepatic, renal,
immune, and reproductive toxicity
concerns in animal studies. Research
has also indicated that decaBDE is
acutely toxic to fish and aquatic
invertebrates. As a result of this final
rule, prohibition and PPE requirements,
EPA anticipates decreased potential for
occupational exposures and reduced
potential for exposures to the general
population, potentially exposed or
susceptible subpopulations, and the
environment.
V. References
The following is a listing 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
those listed under FOR FURTHER
INFORMATION CONTACT.
2. 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
primary and alternative regulatory
actions. However, by evaluating the
practicability of the final and alternative
regulatory actions, EPA is confident 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
primary and alternative regulatory
actions.
EPA considered the anticipated effect
of this final rule on the national
economy and concluded that this rule is
highly unlikely to have any measurable
effect on the national economy (Ref. 17).
EPA analyzed the expected impacts on
small business and found that of the
24,865 small businesses potentially
impacted by the rule, 860 are expected
to incur cost impacts between 1 and 3
percent of their annual revenue. No
entities are expected to be impacted
above 3 percent of their annual revenue
(Ref. 17). Finally, EPA has determined
that this final rule is unlikely to have
significant impacts on technological
innovation, although the rule may create
some incentives for chemical
1. EPA. Decabromodiphenyl Ether and
Phenol, Isopropylated Phosphate (3:1);
Revision to the Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under the Toxic Substances Control Act
(TSCA); Proposed Rule. Federal Register
(88 FR 82287, November 24, 2023) (FRL–
9145–01–OCSPP).
2. EPA. TSCA Work Plan for Chemical
Assessments: 2014 Update. October
2014.
3. EPA. TSCA Work Plan Chemicals:
Methods Document. February 2012.
4. EPA. Decabromodiphenyl Ether
(DecaBDE); Regulation of Persistent,
Bioaccumulative, and Bioaccumulative,
and Toxic Chemicals Under TSCA
Section 6(h); Final Rule. Federal
Register (86 FR 880, January 6, 2021)
(FRL–10018–87).
5. EPA. Phenol, Isopropylated Phosphate
(3:1) (PIP (3:1)); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Final Rule.
Federal Register (86 FR 894, January 6,
2021) (FRL–10018–88).
6. EPA. 2,4,6-tris(tert-butyl) phenol (2,4,6TTBP); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Final Rule.
Federal Register (86 FR 866, January 6,
2021) (FRL–10018–90).
7. EPA. Hexachlorobutadiene (HCBD);
Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Final Rule.
Federal Register (86 FR 922, January 6,
2021) (FRL–10018–91).
8. EPA. Pentachlorothiophenol (PCTP);
Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Final Rule.
Federal Register (86 FR 911, January 6,
2021) (FRL–10018–89).
9. Executive Order 13990. Protecting Public
Health and the Environment and
Restoring Science to Tackle the Climate
Crisis. Federal Register (86 FR 7037,
January 25, 2021).
10. EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol,
Isopropylated Phosphate (3:1);
Compliance Date Extension Final Rule.
Federal Register (86 FR 51823,
September 17, 2021) (FRL–6015.5–03–
OCSPP).
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11. EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol,
Isopropylated Phosphate (3:1); Request
for Comments. Federal Register (86 FR
14398, March 16, 2021) (FRL–10021–08).
12. Letter to EPA from the Consumer
Technology Association and the
Information Technology Industry
Council to EPA on March 15, 2021.
Document No. EPA–HQ–OPPT–2021–
0202–0015.
13. EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol,
Isopropylated Phosphate (3:1); Further
Compliance Date Extension Proposed
Rule. Federal Register (86 FR 59684,
October 28, 2021) (FRL–6015.6–01–
OCSPP).
14. EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol,
Isopropylated Phosphate (3:1); Further
Compliance Date Extension Final Rule.
Federal Register (87 FR 12875, March 8,
2022) (FRL–6015.6–02–OCSPP).
15. Comments submitted to EPA. Regulation
of Persistent, Bioaccumulative, and
Toxic Chemicals Under TSCA Section
6(h) on March 16, 2021. Docket ID: EPA–
HQ–OPPT–2021–0202–0001.
16. Yurok Tribe. Public Comment Submitted
to EPA RE: Comments on Regulation of
Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h) on
May 17, 2021. Comment ID: EPA–HQ–
OPPT–2021–0202–0077.
17. EPA. Economic Analysis for Regulation of
Phenol, isopropylated phosphate (3:1)
(PIP (3:1)) and Decabromodiphenyl ether
(DecaBDE) Under TSCA Section 6(h).
October 2024.
18. EPA. 2021 Policy on Children’s Health.
https://www.epa.gov/system/files/
documents/2021-10/2021-policy-onchildrens-health.pdf.
19. EPA. Exposure and Use Assessment of
Five Persistent, Bioaccumulative, and
Toxic Chemicals. December 2020. (For
references and supporting
documentation, see EPA–HQ–OPPT–
2019–0080).
20. EPA. Decabromodiphenyl Ether and
Phenol, Isopropylated Phosphate (3:1);
Revision to the Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under the Toxic Substances Control Act
(TSCA): Response to Public Comments.
October 2024.
21. EPA. Proposed Rule Webinar Transcript.
March 21, 2024. ID: EPA–HQ–OPPT–
2023–0376–0315.
22. Comment from the American Coatings
Association (ACA) to EPA on May 21,
2021. Comment ID: EPA–HQ–OPPT–
2021–0202–0144.
23. Centers for Disease Control and
Prevention (CDC). NIOSH Hierarchy of
Controls. https://www.cdc.gov/niosh/
topics/hierarchy/default.html.
24. EPA. Environmental and Human Health
Hazards of Five Persistent,
Bioaccumulative and Toxic Chemicals.
December 2020. (For references and
supporting documentation, see also
EPA–HQ–OPPT–2019–0080).
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25. EPA. Preliminary Information on
Manufacturing, Processing, Distribution,
Use, and Disposal: Decabromodiphenyl
ether. August 2017. Docket No. EPA–
HQ–OPPT–2016–0724–0002.
26. Stakeholder Comment from Auto
Alliance. February 2018.
27. Stakeholder Comment from iGPS. January
2018.
28. EPA. Access Chemical Data Reporting:
2020 CDR Data. Last updated on May 16,
2022.
29. EPA. Exposure and Use Assessment of
Five Persistent, Bioaccumulative, and
Toxic Chemicals. June 2019.
30. Norwegian Environmental Agency. Final
Report. Literature Study—DecaBDE in
Waste Streams. 2015.
31. Yurok Tribe. Letter to EPA RE: the Tribal
Consultation on DecaBDE Risk
Management Rule on January 3, 2023.
32. Centers for Disease Control and
Prevention (CDC). NIOSH Certified
Equipment List. https://www.cdc.gov/
niosh/npptl/topics/respirators/cel/.
33. Occupational Safety and Health
Administration. Assigned Protection
Factors for the Revised Respiratory
Protection Standard. OSHA 3352–02
2009. https://www.osha.gov/sites/
default/files/publications/3352-APFrespirators.pdf.
34. Occupational Safety and Health
Administration. Personal Protective
Equipment. OSHA 3151–02R 2023.
https://www.osha.gov/sites/default/files/
publications/osha3151.pdf.
35. EPA (2021c). TRI Toxics Tracker, U.S.
Environmental Protection Agency.
https://edap.epa.gov/public/extensions/
TRIToxicsTracker/
TRIToxicsTracker.html.
36. EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h) RIN 2070–
AK34; Response to Public Comments.
December 2020.
37. Letter from the Nuclear Regulatory
Commission to the EPA on March 31,
2023. (EPA–HQ–OPPT–2023–0376–
0230).
38. Letter from the Nuclear Energy Institute
to the EPA on February 10, 2023. (EPA–
HQ–OPPT–2023–0376–0280).
39. EPA. Enforcement Statement Regarding
the Prohibition of Processing and
Distribution in Commerce of
Decabromodiphenyl Ether (DecaBDE)Containing Wire and Cable Insulation in
Nuclear Power Generation Facilities
under 40 CFR 751.405(a)(2)(ii). May 2,
2023. https://www.epa.gov/system/files/
documents/202305/Enforcement
%20Statement%20Regarding%20
DecaBDE%205%202%202023.pdf.
40. EPA. 2023 DecaBDE Settlement: In the
Matter of RSCC Wire & Cable LLC.
Docket No. TSCA–HQ–2023–5006. May
1, 2023. https://yosemite.epa.gov/oa/
EAB_Web_Docket.nsf/Unpublished∼
Final∼Orders/8A750189B8B8E14A
852589A20072ACCC/$File/RSCC
%20CAFO%20final
%20order%202023.05.01%201510.pdf.
41. United Nations Environmental Program
Stockholm Convention on Persistent
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Organic Pollutants (2015). Risk profile
on decabromodiphenyl ether. Report of
the Persistent Organic Pollutants Review
Committee on the work of its eleventh
meeting.
42. Comment submitted to EPA from the
National Elevator Industry, Inc. on
March 24, 2021. Comment ID: EPA–HQ–
OPPT–2021–0202–0131.
43. Comment submitted to EPA from the
Motor & Equipment Manufacturers
Association and the Alliance for
Automotive Innovation on May 20, 2021.
Comment ID: EPA–HQ–OPPT–2021–
0202–0110.
44. Comment to EPA from the Consumer
Technology Association, IPC, and
Information Technology Industry
Council on May 24, 2021. Comment ID:
EPA–HQ–OPPT–2021–0202–0148.
45. Comment submitted to EPA from The
Boeing Company on May 20, 2021.
Comment ID: EPA–HQ–OPPT–2021–
0202–0102.
46. Comment submitted to EPA from the
Association of Equipment Manufacturers
on May 14, 2021. Comment ID: EPA–
HQ–OPPT–2021–0202–0053.
47. Comment submitted to EPA from SEMI
and the Semiconductor Equipment
Association of Japan on May 20, 2021.
Comment ID: EPA–HQ–OPPT–2021–
0202–0121.
48. Letter from the Semiconductor
Equipment and Materials International
(SEMI) to EPA on August 4, 2023.
Comment ID: EPA–HQ–OPPT–2023–
0376–0317.
49. European Union’s Regulation on the
Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH),
Annex XVII: Restrictions on the
Manufacture, Placing on the Market and
Use of Certain Dangerous Substances,
Mixtures and Articles. https://
reachonline.eu/reach/en/annexxvii.html.
50. Fujifilm FUJICHROME Velvia 100® color
film. https://www.fujifilm.com/us/en/
business/professional-photography/film/
velvia-100.
51. EPA. Supporting Statement for an
Information Collection Request (ICR)
under the Paperwork Reduction Act
(PRA); Decabromodiphenyl Ether and
Phenol, Isopropylated Phosphate (3:1);
Revision to the Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
under the Toxic Substances Control Act
(TSCA). Final Rule (RIN 2070–AL02).
EPA ICR No. 2779.02 and OMB Control
No. 2070–0230. October 2024.
VI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action is a ‘‘significant regulatory
action’’ as defined under section 3(f)(1)
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of Executive Order 12866 (58 FR 51735,
October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879,
April 11, 2023). Accordingly, EPA
submitted this action to the Office of
Management and Budget (OMB) for
Executive Order 12866 review.
Documentation of any changes made in
response to the Executive Order 12866
review is available in the docket. EPA
prepared an Economic Analysis of the
potential costs and benefits associated
with this action (Ref. 17). A copy of this
Economic Analysis is available in the
docket, is briefly summarized in Unit
I.E. and discussed in Unit IV.
B. Paperwork Reduction Act (PRA)
The information collection activities
in this rule have been submitted to OMB
for approval under the PRA, 44 U.S.C.
3501 et seq. The Information Collection
Request (ICR) document that EPA
prepared is assigned EPA ICR No.
2779.02 and OMB Control No. 2070–
0230 (Ref. 51). You can find a copy of
the ICR in the docket and it is briefly
summarized here. The information
collection requirements are not
enforceable until OMB approves them.
Respondents/affected entities: See
Unit I.A.
Respondent’s obligation to respond:
Mandatory (TSCA section 6(h) and 40
CFR 751.407).
Frequency of response: On occasion.
Total estimated number of
respondents: 26,805 (12,846
manufacturers/importers/processors and
13,957 distributors).
Total estimated burden: 42,300 hours
(per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $3,288,625 (per
year), includes $0 annualized capital or
operation and maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA regulations in 40 CFR
are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will
announce that approval in the Federal
Register and, as appropriate, display the
OMB control number on the applicable
collection instruments 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.
C. 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
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requirements of this action are small
businesses that manufacture/import,
process, or distribute the chemicals
subject to this final rule. The Agency
has determined that this final rule will
impact approximately 24,865 small
businesses of which 860 (3.46%) are
expected to incur cost impacts between
1 and 3 percent of their annual revenue,
all of which are for PIP (3:1) and none
for decaBDE. The cost per small entity
impacted ranged from ¥$42–$1,146,853
at a 3% discount rate and ¥$128–
$1,272,107 at a 7% discount rate. No
entities for either chemical are expected
to be impacted above 3 percent of their
annual revenue. Details of this analysis
are presented in the Economic Analysis
(Ref. 17), which is in the docket for this
action.
D. Unfunded Mandates Reform Act
(UMRA)
This action contains a Federal
mandate that may result in expenditures
of $183 million in 2023 dollars ($100
million in 1995 dollars adjusted for
inflation using the GDP implicit price
deflator) or more as described in UMRA,
2 U.S.C. 1531–1538, for the private
sector in any one year. Total quantified
annualized social costs for this final rule
are approximately $400 million at a 3
percent discount rate, and $430 million
at a 7 percent discount rate. Costs at a
2 percent discount rate are estimated at
$390 million. These private sector costs
are presented in the Economic Analysis
(Ref. 17), a copy of which is available
in the docket, and are briefly
summarized in Unit I.E. and discussed
in Unit IV.
This action is not subject to the
requirements of sections 202 and 203 of
UMRA because this action imposes no
enforceable duty on any State, local or
Tribal governments and does not
significantly or uniquely affect small
governments. This action only impacts
only imposes enforceable duties on
private sector entities that manufacture
(including import), process, distribute
in commerce, use, or dispose of
decaBDE and PIP (3:1), and government
entities are not engaged in these
activities.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999), because it will not 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 stated in Unit
VI.D., State and local government
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entities are not engaged in the activities
covered by this action. See also the
discussion in Unit I.E.6.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have Tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000), because it will not 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 stated in Unit VI.D., Tribal
government entities are not engaged in
the activities covered by this action. See
also the discussion in Unit I.E.6.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
Executive Order 13045 (62 FR 19885,
April 23, 1997) directs Federal agencies
to include an evaluation of the health
and safety effects of the planned
regulation on children in Federal health
and safety standards and explain why
the regulation is preferable to
potentially effective and reasonably
feasible alternatives. This action is
subject to Executive Order 13045
because it is a significant regulatory
action under section 3(f)(1) of Executive
Order 12866, and the EPA believes that
the environmental health or safety risk
addressed by this action may have a
disproportionate effect on children.
While EPA understands that this action
addresses the health and environmental
risks presented by the PBT chemicals
subject to this action that may have a
disproportionate effect on children, EPA
did not perform a risk assessment or risk
evaluation of these PBT chemicals.
However, the final requirements will
reduce potential exposure to these PBT
chemicals for the general population
and for susceptible subpopulations such
as workers and children. EPA’s
evaluation of the exposure potential of
these PBT chemicals (Ref. 19) and
summary of the health and
environmental hazards that may be
presented by these chemical substances
(Ref. 24) are summarized in Unit II.E.,
with referenced documents available in
the docket. In addition, the regulatory
options analyzed are discussed in Unit
III.
Furthermore, EPA’s Policy on
Children’s Health also applies to this
action. Information on how the Policy
was applied is discussed in Unit I.E.5.
See also the other discussions about the
risks presented by the PBT chemicals
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subject to this action that are provided
throughout this preamble.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy
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.
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I. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve technical
standards under the NTTAA section
12(d), 15 U.S.C. 272.
J. Executive Orders 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations and 14096:
Revitalizing Our Nation’s Commitment
to Environmental Justice for All
EPA believes that it is not practicable
to assess whether the human health or
environmental conditions that exist
prior to this action result in
disproportionate and adverse effects on
communities with EJ concerns
consistent with Executive Order 14096
(88 FR 25251, April 26, 2023) building
on and supplementing Executive Order
12898 (59 FR 7629, February 16, 1994).
EPA’s related evaluation is summarized
in Units I.E.4. and VI., and discussed in
the Economic Analysis (Ref. 17) that is
in the docket.
Since a risk evaluation was not
conducted, EPA’s understanding of the
extent to which reductions in exposure
might reduce risks for communities
with environmental justice concerns is
limited. Data are not sufficiently
comprehensive to estimate the extent to
which the final rule will reduce existing
disproportionate impacts on
communities with EJ concerns. Data on
the worker composition of affected
industries, presented in sections 6.5.1
and 6.5.2 of the Economic Analysis (Ref.
17), provide a general indication of how
different demographic groups in the
worker population may be affected.
Certain exclusions and extensions of
compliance dates beyond the onset of
the final rule may partially delay
addressing these impacts. EPA is
confident that the restrictions that will
be placed on decaBDE and PIP (3:1)
with adoption of this final rule will
reduce the potential exposures, and
therefore, reduce any potential risks,
associated with the manufacture,
processing and use of these chemicals.
EPA cannot confirm which specific
subpopulations are at a disproportionate
risk from exposure nor make a
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quantified estimate of the change in
exposure that will result from the rule.
In addition, only a small subset of the
specific facilities using decaBDE and
PIP (3:1) have been identified, so a
proximity analysis examining the
characteristics of the communities
surrounding the known facilities might
not be representative of all exposed
communities. Some workers will
receive PPE with adoption of the rule,
while others will no longer be exposed
to decaBDE and PIP (3:1). As companies
reformulate with chemical alternatives,
some workers may be exposed to these
alternatives. Local communities will
also be less exposed to decaBDE and PIP
(3:1), though exposure to chemical
alternatives may increase. EPA does not
know which chemical alternatives
industry will ultimately use. Some
alternatives are less toxic than and some
are comparably toxic to decaBDE and
PIP (3:1).
§ 751.403
K. Congressional Review Act (CRA)
§ 751.405
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 meets
the criteria set forth in 5 U.S.C. 804(2).
List of Subjects 40 CFR Part 751
Environmental protection, Chemicals,
Export notification, Hazardous
substances, Import certification,
Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons set forth in
the preamble, EPA is amending 40 CFR
chapter I as follows:
PART 751—REGULATION OF CERTAIN
CHEMICAL SUBSTANCES AND
MIXTURES UNDER SECTION 6 OF THE
TOXIC SUBSTANCES CONTROL ACT
1. The authority citation for part 751
continues to read as follows:
■
Authority: 15 U.S.C. 2605, 15 U.S.C.
2625(l)(4).
2. Amend § 751.401 by adding
paragraph (c) to read as follows:
■
§ 751.401
General.
*
*
*
*
*
(c) Owner and operator requirements.
Any requirement for an owner or
operator or an owner and operator is a
requirement for any individual that is
either an owner or an operator.
■ 3. Amend § 751.403 by adding in
alphabetical order the definitions for
‘‘Potentially exposed person’’ and
‘‘Regulated area’’ to read as follows:
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Definitions.
*
*
*
*
*
Potentially exposed person means any
person who may be exposed to a
chemical substance or mixture regulated
under this subpart as a result of the use
of that chemical or mixture.
*
*
*
*
*
Regulated area means an area
established by the regulated entity to
demarcate areas where airborne
concentrations of a specific chemical
substance can reasonably be expected.
*
*
*
*
*
■ 4. Amend § 751.405 by:
■ a. Revising paragraphs (a)(1) and
(a)(2)(ii);
■ b. Adding paragraph (a)(2)(vi);
■ c. Revising paragraphs (b) and (c)(1)(i)
and (iii); and
■ d. Adding paragraphs (d) through (g).
The revisions and additions read as
follows:
DecaBDE.
(a) * * *
(1) General. (i) 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.
(ii) Unless otherwise specified in this
subpart, the prohibitions and
restrictions of this subpart do not apply
to products or articles containing
decaBDE at concentrations less than
0.1% by weight, if the decaBDE was not
intentionally added to the product or
article.
(2) * * *
(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
(including test and research reactors).
*
*
*
*
*
(vi) After the end of the wire and
cables’ service life, all persons are
prohibited from all processing and
distribution in commerce of decaBDEcontaining wire and cable insulation for
nuclear power generation facilities
(including test and research reactors).
(b) Exclusions to the Prohibition.
Distribution in commerce and recycling
of decaBDE-containing plastic from
products or articles, and processing and
distribution in commerce of decaBDEcontaining products or articles made
from such recycled plastic, where no
new decaBDE is added during the
recycling or production processes is not
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subject to the prohibition in paragraph
(a) of this section.
(c) * * *
(1) * * *
(i) These records must be maintained
for a period of five years from the date
the record is generated.
*
*
*
*
*
(iii) These records must be made
available to EPA upon request.
*
*
*
*
*
(d) Signage in Regulated Areas. (1)
After January 21, 2025, all persons who
process, including recycle, plastic
shipping pallets that contain decaBDE
must place signs at every entry point
into the regulated area.
(2) Each sign must show clearly,
prominently, in multiple languages as
appropriate, and in an easily readable
font size the following text:
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Decabromodiphenyl ether (decaBDE)
(CASRN 1163–19–5), a chemical that has
been identified as a persistent,
bioaccumulative, and toxic (PBT) chemical
by the U.S. Environmental Protection
Agency, may be present in this regulated
area. All persons in this regulated area who
recycle existing plastic shipping pallets that
contain decaBDE are required to wear
personal protective equipment, including
respiratory protection that is at least as
protective as a NIOSH-approved N95
respirator with an assigned protection factor
(APF) of 10 and dermal protection of gloves
that are chemically resistant to decaBDE, per
regulations at 40 CFR 751.405(e).
(e) Workplace protection—(1)
Applicability. After January 21, 2025,
the provisions of this paragraph (e)
apply to any workplaces engaged in
manufacturing and processing of
decaBDE and decaBDE-containing
products and articles, except for those
identified in paragraph (e)(6) of this
section.
(2) Regulated areas. Owners or
operators must establish and maintain
regulated areas as defined in 40 CFR
751.403.
(i) The owner or operator must limit
access to regulated areas to authorized
persons.
(ii) The owner or operator must
demarcate regulated areas from the rest
of the workplace in a manner that
adequately establishes and alerts
persons to the boundaries of the
regulated area and minimizes the
number of authorized persons exposed
to decaBDE within the regulated area.
(iii) The owner or operator must
ensure that each potentially exposed
person is provided with a respirator
according to the requirements of
paragraph (e) of this section and must
ensure that all potentially exposed
persons within the regulated area are
using the provided respirators whenever
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exposures to airborne concentrations of
decaBDE can reasonably be expected.
(iv) The owner or operator must
ensure that while persons are wearing
respirators in the regulated area, they do
not engage in activities that interfere
with respirator seal or performance.
(v) The owner or operator must ensure
that, within a regulated area, persons do
not engage in non-work activities that
may increase exposure to decaBDE.
(3) Respiratory protection. The owner
or operator must provide respiratory
protection to all potentially exposed
persons in the regulated area as
demarcated in accordance with
paragraph (e)(2) of this section, and
according to the provisions outlined in
29 CFR 1910.134(b), (c)(1), (3) and (4),
(d)(1)(iv), (f), and (g) through (l) and, as
specified in this paragraph (e)(3) for
potentially exposed persons to decaBDE
during expected time of use.
(i) For purposes of this paragraph
(e)(3), cross-referenced provisions in 29
CFR 1910.134 applying to an
‘‘employee’’ apply equally to potentially
exposed persons and cross-referenced
provisions applying to an ‘‘employer’’
also apply equally to owners or
operators. Other terms in crossreferenced provisions in 29 CFR
1910.134 that are defined in 29 CFR
1910.134(b) have the meaning assigned
to them in 29 CFR 1910.134(b).
(ii) Owners and operators must
develop and administer a written
respiratory protection program
consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select
respiratory protection that properly fits
each affected person and communicate
respirator selections to each affected
person consistent with the requirements
of 29 CFR 1910.134(f).
(iv) Owners and operators must
provide, ensure use of, and maintain (in
a sanitary, reliable, and undamaged
condition) respiratory protection that is
of safe design and construction for the
applicable condition of use consistent
with the requirements of 29 CFR
1910.134(g) through (j).
(v) Prior to or at the time of initial
assignment to a job involving potential
exposure to decaBDE, owners and
operators must provide training to all
persons required to use respiratory
protection consistent with 29 CFR
1910.134(k).
(vi) Owners and operators must
retrain all persons required to use PPE
at least annually, or whenever the
owner or operator has reason to believe
that a previously trained person does
not have the required understanding
and skill to properly use PPE, or when
changes in the workplace or in PPE to
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91515
be used render the previous training
obsolete.
(vii) The type of respiratory protection
that the owners or operator must select
and provide to potentially exposed
persons must be at least as protective as
a NIOSH-approved N95 respirator (APF
10).
(viii) Owners and operators must
select and provide respirators as
required in paragraph (e)(3) of this
section consistent with the requirements
of 29 CFR 1910.134(d)(1)(iv), and with
consideration of workplace and user
factors that affect respirator performance
and reliability.
(ix) Owners and operators must
ensure that respirators are used in
compliance with the terms of the
respirator’s NIOSH certification.
(x) Owners and operators must
conduct regular evaluations of the
workplace, including consultations with
potentially exposed persons using
respiratory protection, consistent with
the requirements of 29 CFR 1910.134(l),
to ensure that the provisions of the
written respiratory protection program
required under paragraph (e)(3) of this
section are being effectively
implemented.
(xi) The respiratory protection
requirements in this paragraph (e)(3)
represent the minimum respiratory
protection requirements, such that any
respirator affording a higher degree of
protection than the required respirator
may be used.
(4) Dermal protection. (i) Owners or
operators must require the donning of
gloves that are chemically resistant to
decaBDE with activity-specific training
where dermal contact with decaBDE is
reasonably expected. Owners or
operators must minimize and protect
potentially exposed persons from
dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply
and require the donning of dermal PPE
that separates and provides a barrier to
prevent direct dermal contact with
decaBDE in the specific work area
where it is selected for use, selected in
accordance with this paragraph (e)(4)
and provided in accordance with 29
CFR 1910.132(h), to each person who is
reasonably likely to be dermally
exposed in the work area through direct
dermal contact with decaBDE. For the
purposes of this paragraph (e)(4),
provisions in 29 CFR 1910.132(h)
applying to an ‘‘employee’’ also apply
equally to potentially exposed persons,
and provisions applying to an
‘‘employer’’ also apply equally to
owners or operators.
(iii) Dermal PPE that is of safe design
and construction for the work to be
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performed must be provided, used, and
maintained in a sanitary, reliable, and
undamaged condition. Owners and
operators must select PPE that properly
fits each affected person and
communicate PPE selections to each
affected person.
(iv) Owners or operators must provide
training in accordance with 29 CFR
1910.132(f) to all persons required to
use dermal protection prior to or at the
time of initial assignment to a job
involving exposure to decaBDE. For the
purposes of this paragraph (e)(4),
provisions in 29 CFR 1910.132(f)
applying to an ‘‘employee’’ also apply
equally to potentially exposed persons,
and provisions applying to an
‘‘employer’’ also apply equally to
owners or operators.
(v) Owners and operators must retrain
each person required to use dermal
protection at least annually or whenever
the owner or operator has reason to
believe that a previously trained person
does not have the required
understanding and skill to properly use
dermal protection, or when changes in
the workplace or in dermal protection to
be used render the previous training
obsolete.
(5) Workplace protection records. (i)
The owner or operator of workplaces
engaged in the manufacturing and
processing of decaBDE and decaBDEcontaining products and articles, except
for those identified in paragraph (e)(6)
of this section, must retain records of:
(A) The name, workplace address,
work shift, job classification, and work
area of each person reasonably likely to
directly handle decaBDE or handle
equipment or materials on which
decaBDE may be present;
(B) The basis for the regulated area as
defined in § 751.403, including
monitoring data and documentation of
any controls or combination of controls
that have reduced exposure to where
airborne concentrations of decaBDE can
no longer reasonably be expected
resulting in a smaller or no regulated
area being established;
(C) The type of PPE selected by the
owner or operator for use by each of
these persons, the respiratory protection
used by each potentially exposed
person, and PPE program
implementation, including fit-testing
and training;
(D) The basis for the PPE selection
(e.g., demonstration based on
permeation testing or manufacturer
specifications that each item of PPE
selected provides an impervious barrier
to prevent exposure during expected
duration and conditions of exposure,
including the likely combinations of
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chemical substances to which the PPE
may be exposed in the work area); and
(E) Appropriately sized PPE and
training on proper application, wear,
and removal of PPE, and proper care/
disposal of PPE.
(ii) These records must be maintained
for a period of five years from the date
the record is generated.
(iii) These records must be made
available to EPA upon request.
(iv) The owner or operator must
provide potentially exposed persons
and their designate representative an
opportunity to observe records related
to the basis of the PPE or another
control measure selection, including
potential monitoring results that are
representative of the potentially
exposed person’s exposure.
(6) Exclusions. The following are not
subject to the workplace protection
requirements of paragraph (e) of this
section:
(i) Import of decaBDE and decaBDEcontaining products and articles.
(ii) 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,
except for those articles identified in
paragraph (a)(2)(v) of this section.
(iii) Processing addressed in
paragraph (a)(2)(vi) of this section of
decaBDE-containing wire and cable
insulation for use in nuclear power
generation facilities.
(iv) Processing of new and
replacement parts to which decaBDE
has been added for motor and aerospace
vehicles, and the motor and aerospace
vehicles that contain new and
replacement parts to which decaBDE
has been added.
(f) Export notification for decaBDEcontaining products and articles. All
persons intending to export decaBDEcontaining wire and cable for nuclear
power generation facilities (including
test and research reactors) are required
to notify EPA under TSCA section 12(b)
and the provisions of subpart D of 40
CFR part 707. The exemption at 40 CFR
707.60(b) does not apply to decaBDEcontaining wire and cable for nuclear
power generation facilities.
(g) Prohibition on releases to water.
After January 21, 2025, all persons are
prohibited from releasing decaBDE to
water during manufacturing, processing,
and distribution in commerce of
decaBDE and decaBDE-containing
products, and such persons are required
to follow any applicable regulations for
preventing the release of decaBDE.
■ 5. Amend § 751.407 by:
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a. Revising paragraph (a)(1);
b. Adding paragraph (a)(2)
introductory text;
■ c. Revising paragraph (a)(2)(iii);
■ d. Adding paragraphs (a)(2)(iv)
through (xi);
■ e. Revising paragraphs (b)(1)(ii), (iii)
and (vii);
■ f. Adding paragraphs (b)(1)(viii) and
(b)(2);
■ g. Revising paragraphs (d)(1) and (3)
and (e)(3) and (4); and
■ h. Adding paragraphs (e)(5) and (f).
The revisions and additions read as
follows:
■
■
§ 751.407
PIP (3:1).
(a) * * *
(1) General prohibition on processing
and distribution in commerce. Except as
provided in paragraphs (a)(2) and (b) of
this section, all persons are prohibited
from all processing and distributing in
commerce of PIP (3:1), including in PIP
(3:1)-containing products or articles
after March 8, 2021. Except as provided
in paragraphs (a)(2) and (b) of this
section, the prohibitions and restrictions
of this subpart do not apply to products
or articles containing PIP (3:1) at
concentrations less than 0.1 percent by
weight, if the PIP (3:1) was not
intentionally added to the product or
article.
(2) Phase-in prohibitions for specific
uses of PIP (3:1) and PIP (3:1)containing products and articles. Except
for the activities described in paragraph
(b) of this section or where another
phase-in prohibition with longer-term
deadlines exists as described in this
section:
*
*
*
*
*
(iii) After October 31, 2024, all
persons are prohibited from all
processing and distribution of PIP (3:1)
for use in articles and all processing of
PIP (3:1)-containing articles. After
October 31, 2026, all persons are
prohibited from distribution in
commerce of PIP (3:1)-containing
articles.
(iv) After November 21, 2039, all
persons are prohibited from all
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
lubricants and greases and PIP (3:1)containing lubricants and grease.
(v) After November 21, 2039, all
persons are prohibited from all
processing and distribution in
commerce of PIP (3:1) for use in parts
for new motor vehicles, including heavy
motorized machinery, and
manufacturing, processing, and
distribution in commerce of PIP (3:1)-
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containing products for use in parts for
new motor vehicles, including heavy
motorized machinery, and
manufacturing and processing of PIP
(3:1)-containing parts for such new
vehicles.
(vi) After November 19, 2054, all
persons are prohibited from all
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts for motor vehicles,
including heavy motorized machinery,
and manufacturing and processing of
PIP (3:1)-containing replacement parts
for such vehicles.
(vii) After November 19, 2054, all
persons are prohibited from all
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in parts for
new aerospace vehicles, and
manufacturing and processing of PIP
(3:1)-containing parts for such vehicles.
(viii) After the end of the aerospace
vehicles service lives, all persons are
prohibited from all processing and
distribution in commerce of PIP (3:1)
and manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts for aerospace vehicles
and manufacturing and processing of
PIP (3:1)-containing replacement parts
for such vehicles.
(ix) After November 19, 2029, all
persons are prohibited from processing
and distribution in commerce of PIP
(3:1) and manufacturing, processing,
and distribution in commerce of PIP
(3:1)-containing products for use in
marine antifouling coating products that
are registered under the Federal,
Insecticide, Fungicide, Rodenticide Act
and that meet U.S. Department of
Defense specification requirements.
(x) After November 20, 2034, all
persons are prohibited from processing,
and distribution in commerce of PIP
(3:1) and manufacturing, processing,
and distribution in commerce of PIP
(3:1)-containing products for use in
parts for new manufacturing equipment,
including in the semiconductor
industry, for new heating, ventilation,
air-conditioning, refrigeration, and
water-heating equipment, new power
generating equipment, new laboratory
equipment, new commercial electronic
equipment, and the manufacturing and
processing of PIP (3:1)-containing parts
for those equipment.
(xi) After the end of the
manufacturing and laboratory
equipment service lives, all persons are
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prohibited from processing and
distribution in commerce of PIP (3:1)
and manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts and manufacturing
and processing of PIP (3:1)-containing
replacement parts for manufacturing
equipment and laboratory equipment,
respectively. After November 19, 2049
all persons are prohibited from
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts and manufacturing
and processing of PIP (3:1)-containing
replacement parts for heating,
ventilation, air-conditioning,
refrigeration, and water-heating
equipment, for power generating
equipment, and for commercial
electronic equipment. After November
19, 2031 all persons are prohibited from
processing and distribution in
commerce of PIP (3:1) and
manufacturing, processing, and
distribution in commerce of PIP (3:1)containing products for use in
replacement parts and manufacturing
and processing of PIP (3:1)-containing
replacement parts for consumer
electronic equipment.
(b) * * *
(1) * * *
(ii) PIP (3:1) for use in lubricants and
greases for aerospace use and turbine
engines, PIP (3:1)-containing products
for use in lubricants and greases for
aerospace use and turbine engines, and
PIP (3:1)-containing lubricants and
greases for aerospace use and turbine
engines;
(iii) PIP (3:1) and PIP (3:1)-containing
products for use in circuit boards and
wire harnesses, including but not
limited to terminal and fuse covers,
cable sleeves, casings, connectors, and
tapes, and PIP (3:1)-containing circuit
boards and wire harnesses including but
not limited to terminal and fuse covers,
cable sleeves, casings, connectors, and
tapes.
*
*
*
*
*
(vii) Finished products or articles
made of plastic recycled or reused from
products or articles containing PIP (3:1),
where no new PIP (3:1) was added
during the production of the products or
articles made of recycled plastic.
(viii) Articles that contain PIP (3:1),
and where PIP (3:1) has not been newly
added, for the purpose of repair or
maintenance.
(2) Distribution in commerce of:
(i) PIP (3:1)-containing parts for
vehicles meeting the requirements in
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91517
paragraphs (a)(2)(v) through (viii) of this
section, for equipment meeting
requirements in paragraphs (a)(2)(x)
through (xi) of this section, and the
vehicles and equipment that contain
such parts.
(ii) [Reserved]
*
*
*
*
*
(d) * * *
(1) After March 8, 2021, persons who
manufacture, process, or distribute in
commerce PIP (3:1) or PIP (3:1)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. These records
must be maintained for a period of five
years from the date the record is
generated.
*
*
*
*
*
(3) These records must be made
available to EPA upon request.
*
*
*
*
*
(e) * * *
(3) Downstream notification must
occur by inserting the text in paragraphs
(e)(3)(i) and (ii) of this section in the
Safety Data Sheet (SDS) by February 19,
2025, or by including on the label of any
PIP (3:1) or PIP (3:1)-containing product
by May 19, 2026, the label language in
paragraph (e)(3)(iii) of this section:
(i) SDS Section 1(c).
The Environmental Protection Agency
prohibits processing and distribution of this
chemical/product for any use other than: (1)
In hydraulic fluids either for the aviation
industry or to meet military specifications for
safety and performance where no alternative
chemical is available that meets U.S.
Department of Defense specification
requirements, (2) In lubricants and greases
for aerospace and turbine uses and, for all
other lubricant and grease uses before
November 21, 2039, (3) circuit boards and
wire harnesses, including but not limited to
terminal and fuse covers, cable sleeves,
casings, connectors and tapes, (4) As an
intermediate in the manufacture of
cyanoacrylate glue, (5) In specialized engine
air filters for locomotive and marine
applications, (6) In adhesives and sealants
before January 6, 2025, after which use in
adhesives and sealants is prohibited, (7) In
new parts for motor vehicles before
November 21, 2039 and replacement parts for
motor vehicles before November 19, 2054, (8)
In new parts for aerospace vehicles before
November 19, 2054 and replacement parts for
aerospace vehicles after the end of the
aerospace vehicles service lives, (9) In marine
antifouling coating products that are
registered under the Federal Insecticide,
Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense
specification requirements before November
19, 2029, (10) In new manufacturing
equipment, new products or articles in the
semiconductor industry, for new heating,
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations
ventilation, air-conditioning, refrigeration,
and water-heating equipment, new power
generating equipment, new laboratory
equipment, new commercial electronic
equipment, and new consumer electronic
equipment before November 20, 2034, (11)
replacement parts for manufacturing and
laboratory equipment after the end of the
equipment’s service life, (12) replacement
parts for heating, ventilation, airconditioning, refrigeration, and water-heating
equipment, for power generating equipment,
and for commercial electronic equipment
before November 19, 2049, (13) replacement
parts for consumer electronic equipment
before November 19, 2031, (14) in other
articles before October 31, 2024, after which
use in articles other than those with later
phase-in prohibition dates or exclusions is
prohibited. In addition, all persons are
prohibited from releasing PIP (3:1) to water
during manufacturing, processing, and
distribution in commerce, and must follow
all existing regulations and best practices to
prevent the release of PIP (3:1) to water
during the commercial use of PIP (3:1).
ddrumheller on DSK120RN23PROD with RULES2
(ii) SDS Section 15.
The Environmental Protection Agency
prohibits processing and distribution of this
chemical/product for any use other than: (1)
In hydraulic fluids either for the aviation
industry or to meet military specifications for
safety and performance where no alternative
chemical is available that meets U.S.
Department of Defense specification
requirements, (2) In lubricants and greases
for aerospace and turbine uses and lubricants
and, for all other lubricant and grease uses
before November 21, 2039, (3) circuit boards
and wire harnesses, including but not limited
to terminal and fuse covers, cable sleeves,
casings, connectors and tapes, (4) As an
intermediate in the manufacture of
cyanoacrylate glue, (5) In specialized engine
air filters for locomotive and marine
applications, (6) In adhesives and sealants
before January 6, 2025, after which use in
adhesives and sealants is prohibited, (7) In
new parts for motor vehicles before
November 21, 2039 and replacement parts for
motor vehicles before November 19, 2054, (8)
In new parts for aerospace vehicles before
November 19, 2054 and replacement parts for
aerospace vehicles after the end of the
aerospace vehicles service lives, (9) In marine
antifouling coating products that are
registered under the Federal Insecticide,
Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense
specification requirements before November
19, 2029, (10) In new manufacturing
equipment, new products or articles in the
semiconductor industry, for new heating,
ventilation, air-conditioning, refrigeration,
and water-heating equipment, new power
generating equipment, new laboratory
equipment, new commercial electronic
equipment, and new consumer electronic
equipment before November 20, 2034, (11)
replacement parts for manufacturing and
laboratory equipment after the end of the
equipment’s service life, (12) replacement
parts for heating, ventilation, airconditioning, refrigeration, and water-heating
equipment, for power generating equipment,
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and for commercial electronic equipment
before November 19, 2049, (13) replacement
parts for consumer electronic equipment
before November 19, 2031, (14) in other
articles before October 31, 2024, after which
use in articles other than those with later
phase-in prohibition dates or exclusions is
prohibited. In addition, all persons are
prohibited from releasing PIP (3:1) to water
during manufacturing, processing, and
distribution in commerce, and must follow
all existing regulations and best practices to
prevent the release of PIP (3:1) to water
during the commercial use of PIP (3:1).
(iii) Labeling.
The Environmental Protection Agency
prohibits processing and distribution of this
chemical/product for any use other than: (1)
In hydraulic fluids either for the aviation
industry or to meet military specifications for
safety and performance where no alternative
chemical is available that meets U.S.
Department of Defense specification
requirements, (2) In lubricants and greases
for aerospace and turbine uses and, for all
other lubricant and grease uses before
November 21, 2039, (3) circuit boards and
wire harnesses, including but not limited to
terminal and fuse covers, cable sleeves,
casings, connectors and tapes, (4) As an
intermediate in the manufacture of
cyanoacrylate glue, (5) In specialized engine
air filters for locomotive and marine
applications, (6) In adhesives and sealants
before January 6, 2025, after which use in
adhesives and sealants is prohibited, (7) In
new parts for motor vehicles before
November 21, 2039 and replacement parts for
motor vehicles before November 19, 2054, (8)
In new parts for aerospace vehicles before
November 19, 2054 and replacement parts for
aerospace vehicles after the end of the
aerospace vehicles service lives, (9) In marine
antifouling coating products that are
registered under the Federal Insecticide,
Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense
specification requirements before November
19, 2029, (10) In new manufacturing
equipment, new products or articles in the
semiconductor industry, for new heating,
ventilation, air-conditioning, refrigeration,
and water-heating equipment, new power
generating equipment, new laboratory
equipment, new commercial electronic
equipment, and new consumer electronic
equipment before November 20, 2034, (11)
replacement parts for manufacturing and
laboratory equipment after the end of the
equipment’s service life, (12) replacement
parts for heating, ventilation, airconditioning, refrigeration, and water-heating
equipment, for power generating equipment,
and for commercial electronic equipment
before November 19, 2049, (13) replacement
parts for consumer electronic equipment
before November 19, 2031, (14) in other
articles before October 31, 2024, after which
use in articles other than those with later
phase-in prohibition dates or exclusions is
prohibited. In addition, all persons are
prohibited from releasing PIP (3:1) to water
during manufacturing, processing, and
distribution in commerce, and must follow
all existing regulations and best practices to
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Fmt 4701
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prevent the release of PIP (3:1) to water
during the commercial use of PIP (3:1).
(4) Any downstream notification that
occurs under paragraph (e) of this
section between February 19, 2025 and
May 19, 2026, must include a safety
data sheet with the language in
paragraphs (e)(3)(i) and (ii) of this
section unless distributing products
with labels reflecting the language in
paragraph (e)(3)(iii) of this section.
(5) The downstream notification
requirements in paragraph (e) of this
section do not apply to the activities
described in paragraphs (b)(1)(vi) and
(vii) of this section.
(f) Workplace protection—(1)
Applicability. After January 21, 2025,
the provisions of this paragraph (f)
apply to workplaces engaged in the
manufacturing and processing of PIP
(3:1) and PIP (3:1)-containing products
and articles, except for those identified
in paragraph (f)(7) of this section.
(2) Regulated areas. Owners or
operators must establish and maintain
regulated areas as defined in § 751.403.
(i) The owner or operator must limit
access to regulated areas to authorized
persons.
(ii) The owner or operator must
demarcate regulated areas from the rest
of the workplace in a manner that
adequately establishes and alerts
persons to the boundaries of the
regulated area and minimizes the
number of authorized persons exposed
to PIP (3:1) within the regulated area.
(iii) The owner or operator must
ensure each potentially exposed person
is provided with a respirator according
to the requirements of paragraph (f) of
this section and must ensure that all
potentially exposed persons within the
regulated area are using the provided
respirators whenever exposures to
airborne concentrations of PIP (3:1) can
reasonably be expected.
(iv) The owner or operator must
ensure that while persons are wearing
respirators in the regulated area, they do
not engage in activities that interfere
with respirator seal or performance.
(v) The owner or operator must ensure
that, within a regulated area, persons do
not engage in non-work activities that
may increase exposure to PIP (3:1).
(3) Respiratory protection. The owner
or operator must provide respiratory
protection to all potentially exposed
persons in the regulated area as
demarcated in accordance with
paragraph (f)(2) of this section, and
according to the provisions outlined in
29 CFR 1910.134(b), (c)(1), (3) and (4),
(d)(1)(iv), (f), and (g) through (l) and as
specified in this paragraph (f)(3) for
potentially exposed persons to PIP (3:1)
during expected time of use.
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(i) For purposes of this paragraph
(f)(3), cross-referenced provisions in 29
CFR 1910.134 applying to an
‘‘employee’’ apply equally to potentially
exposed persons and cross-referenced
provisions applying to an ‘‘employer’’
also apply equally to owners or
operators. Other terms in crossreferenced provisions in 29 CFR
1910.134 that are defined in 29 CFR
1910.134(b) have the meaning assigned
to them in 29 CFR 190.134(b).
(ii) Owners and operators must
develop and administer a written
respiratory protection program
consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select
respiratory protection that properly fits
each affected person and communicate
respirator selections to each affected
person consistent with the requirements
of 29 CFR 1910.134(f).
(iv) Owners and operators must
provide, ensure use of, and maintain (in
a sanitary, reliable, and undamaged
condition) respiratory protection that is
of safe design and construction for the
applicable condition of use consistent
with the requirements of 29 CFR
1910.134(g) through (j).
(v) Prior to or at the time of initial
assignment to a job involving potential
exposure to PIP (3:1) owners and
operators must provide training to all
persons required to use respiratory
protection consistent with 29 CFR
1910.134(k).
(vi) Owners and operators must
retrain all persons required to use PPE
at least annually, or whenever the
owner or operator has reason to believe
that a previously trained person does
not have the required understanding
and skill to properly use PPE, or when
changes in the workplace or in PPE to
be used render the previous training
obsolete.
(vii) The type of respiratory protection
that the owner or operator must select
and provide to potentially exposed
persons must be at least as protective as
a NIOSH-approved APF 10 air-purifying
half mask respirator except for those
uses identified in paragraphs (f)(3)(viii)
and (ix) of this section.
(viii) The type of respiratory
protection that owners or operators
must select and provide to potentially
exposed persons must be at least as
protective as a NIOSH-approved N95
respirator (APF 10) for the
manufacturing and processing of PIP
(3:1), and PIP (3:1)-containing products
for use in new and replacement parts for
motor vehicles, including heavy
machinery, and aerospace vehicles.
(ix) The type of respiratory protection
that owners or operators must select and
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provide to potentially exposed persons
must be at least as protective as a
NIOSH-approved APF 50 purifying
respirator for use as an intermediate to
produce cyanoacrylate adhesives when
PIP (3:1) and PIP (3:1)-containing
products are not contained in a closed
system (i.e., except as described in
paragraph (f)(7)(iii) of this section).
(x) Owners and operators must select
and provide respirators as required in
paragraph (f)(3) of this section
consistent with the requirements of 29
CFR 1910.134(d)(1)(iv), and with
consideration of workplace and user
factors that affect respirator performance
and reliability.
(xi) Owners and operators must
ensure that respirators are used in
compliance with the terms of the
respirator’s NIOSH certification.
(xii) Owners and operators must
conduct regular evaluations of the
workplace, including consultations with
potentially exposed persons using
respiratory protection, consistent with
the requirements of 29 CFR 1910.134(l),
to ensure that the provisions of the
written respiratory protection program
required under paragraph (f)(3) of this
section are being effectively
implemented.
(xiii) The respiratory protection
requirements in this paragraph (f)(3)
represent the minimum respiratory
protection requirements, such that any
respirator affording a higher degree of
protection than the required respirator
may be used.
(4) Dermal protection. (i) Owners or
operators must require the donning of
gloves that are chemically resistant to
PIP (3:1) with activity-specific training
where dermal contact with PIP (3:1) is
reasonably expected. Owners or
operators must minimize and protect
potentially exposed persons from
dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply
and require the donning of dermal PPE
that separates and provides a barrier to
prevent direct dermal contact with PIP
(3:1) in the specific work area where it
is selected for use, selected in
accordance with this paragraph (f)(4)
and provided in accordance with 29
CFR 1910.132(h), to each person who is
reasonably likely to be dermally
exposed in the work area through direct
dermal contact with PIP (3:1) For the
purposes of this paragraph (f)(4),
provisions in 29 CFR 1910.132(h)
applying to an ‘‘employee’’ also apply
equally to potentially exposed persons,
and provisions applying to an
‘‘employer’’ also apply equally to
owners or operators.
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(iii) Dermal PPE that is of safe design
and construction for the work to be
performed must be provided, used, and
maintained in a sanitary, reliable, and
undamaged condition. Owners and
operators must select PPE that properly
fits each affected person and
communicate PPE selections to each
affected person.
(iv) Owners or operators must provide
training in accordance with 29 CFR
1910.132(f) to all persons required to
use dermal protection prior to or at the
time of initial assignment to a job
involving exposure to PIP (3:1). For the
purposes of this paragraph (f)(4),
provisions in 29 CFR 1910.132(f)
applying to an ‘‘employee’’ also apply
equally to potentially exposed persons,
and provisions applying to an
‘‘employer’’ also apply equally to
owners or operators.
(v) Owners and operators must retrain
each person required to use dermal
protection at least annually or whenever
the owner or operator has reason to
believe that a previously trained person
does not have the required
understanding and skill to properly use
dermal protection, or when changes in
the workplace or in dermal protection to
be used render the previous training
obsolete.
(5) Engineering controls. Owners or
operators manufacturing cyanoacrylate
adhesives using PIP (3:1) as an
intermediate processing aid must use
the following engineering controls:
(i) Must take place in a closed loop
system, and
(ii) General and local exhaust
ventilation must be provided.
(6) Workplace protection records. (i)
Owners or operators subject to
requirements described in this section
must retain records of:
(A) The name, workplace address,
work shift, job classification, and work
area of each person reasonably likely to
directly handle PIP (3:1) or handle
equipment or materials on which PIP
(3:1) may be present, and the type of
PPE selected to be worn by each of these
persons;
(B) The basis for the regulated area as
defined in § 751.403, including
monitoring data and documentation of
any controls or combination of controls
that have reduced exposure to where
airborne concentrations of PIP (3:1) can
no longer reasonably be expected
resulting in a smaller or no regulated
area being established;
(C) The type of PPE selected by the
owner or operator for use by each of
these persons, the respiratory protection
used by each potentially exposed person
and PPE program implementation,
including fit-testing and training;
E:\FR\FM\19NOR2.SGM
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES2
(D) The basis for PPE selection (e.g.,
demonstration based on permeation
testing or manufacturer specifications
that each item of PPE selected provides
an impervious barrier to prevent
exposure during expected duration and
conditions of exposure, including the
likely combinations of chemical
substances to which the PPE may be
exposed in the work area);
(E) Appropriately sized PPE and
training on proper application, wear,
and removal of PPE, and proper care/
disposal of PPE; and
(F) For owners and operators using
PIP (3:1) as an intermediate processing
aid in the manufacturing of
cyanoacrylate adhesives, compliance
with paragraph (f)(5) of this section.
(ii) These records must be maintained
for a period of five years from the date
the record is generated.
(iii) These records must be made
available to EPA upon request.
VerDate Sep<11>2014
19:00 Nov 18, 2024
Jkt 265001
(iv) The owner or operator must
provide potentially exposed persons
and their designated representative an
opportunity to observe records related
to the basis of the PPE or another
control measure selection, including
potential monitoring results that is
representative of the potentially
exposed person’s exposure.
(7) Exclusions. The following are not
subject to the workplace protection
requirements of paragraph (f) of this
section:
(i) Import of PIP (3:1) and PIP (3:1)containing products and articles.
(ii) Processing of PIP (3:1)-containing
adhesives and sealants, specialized
engine filters for locomotive and marine
applications, and the products or
articles described in paragraphs
(b)(1)(vi) and (vii) of this section.
(iii) Processing of PIP (3:1)-containing
new and replacement parts to which PIP
(3:1) has been added for motor and
PO 00000
Frm 00036
Fmt 4701
Sfmt 9990
aerospace vehicles and for
manufacturing, HVAC, refrigeration and
water heating equipment, electric and
electronic equipment, and power
generating equipment and the motor
and aerospace vehicles, manufacturing,
HVAC, refrigeration and water heating
equipment, electric and electronic
equipment, and power generating
equipment that contain new and
replacement parts to which PIP (3:1) has
been added.
(iv) Processing of PIP (3:1) and PIP
(3:1)-containing products for use as an
intermediate to produce cyanoacrylate
adhesives when PIP (3:1) and PIP (3:1)containing products are contained in a
closed system as described in paragraph
(f)(6) of this section are not subject to
the provisions of paragraphs (f)(3) and
(4) of this section.
[FR Doc. 2024–25758 Filed 11–18–24; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\19NOR2.SGM
19NOR2
Agencies
[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Rules and Regulations]
[Pages 91486-91520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25758]
[[Page 91485]]
Vol. 89
Tuesday,
No. 223
November 19, 2024
Part II
Environmental Protection Agency
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40 CFR Part 751
Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate (3:1);
Revision to the Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under the Toxic Substances Control Act (TSCA); Final Rule
Federal Register / Vol. 89 , No. 223 / Tuesday, November 19, 2024 /
Rules and Regulations
[[Page 91486]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2023-0376; FRL-9145-02-OCSPP]
RIN 2070-AL02
Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate
(3:1); Revision to the Regulation of Persistent, Bioaccumulative, and
Toxic Chemicals Under the Toxic Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing revisions to the regulations for decabromodiphenyl ether
(decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of
the five persistent, bioaccumulative, and toxic (PBT) chemicals
addressed in final rules issued under the Toxic Substances Control Act
(TSCA) in January 2021. After receiving additional comments, the Agency
has determined that revisions to the decaBDE and PIP (3:1) regulations
are necessary to address implementation issues and to further reduce
the potential for exposures to decaBDE and PIP (3:1) for humans and the
environment to the extent practicable.
DATES: This rule is effective on January 21, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0376, is available online
at https://www.regulations.gov. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For general information: The TSCA Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
For technical information regarding decaBDE: Brooke Porter,
Existing Chemicals Risk Management Division (7404M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-6388; email address: [email protected].
For technical information regarding PIP (3:1): Scott Drewes,
Existing Chemicals Risk Management Division (7404M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8833; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be affected by this action if you manufacture (including
import), process, distribute in commerce, or use decaBDE or decaBDE-
containing products or articles. Such uses for decaBDE may include but
are not limited to wire and cable insulation for nuclear power
generation facilities, plastic shipping pallets, and imported articles
such as replacement parts for aerospace and automotive parts. You may
also be affected by this action if you manufacture (including import),
process, distribute in commerce, or use PIP (3:1) or PIP (3:1)-
containing products or articles. Such uses for PIP (3:1) may include
flame retardants in plastics, functional fluids in aerospace and
industrial machinery, and plastic articles that are components of
electronics or electrical articles.
The following list of North American Industry Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document might apply to
them. Potentially affected entities may include:
Adhesive Manufacturing (NAICS Code 325520);
Air and Gas Compressor Manufacturing (NAICS Code 333912);
Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
Code 333415);
Aircraft Engine and Engine Parts Manufacturing (NAICS Code
336412);
Aircraft Manufacturing (NAICS Code 336411);
All Other Basic Organic Chemical Manufacturing (NAICS Code
325199);
All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS Code 333998);
All Other Plastics Product Manufacturing (NAICS Code
326199);
All Other Transportation Equipment Manufacturing (NAICS
Code 336999);
Analytical Laboratory Instrument Manufacturing (NAICS Code
334516);
Appliance Repair and Maintenance (NAICS Code 811412);
Audio and Video Equipment Manufacturing (NAICS Code
334310);
Automobile and Light Duty Motor Vehicle Manufacturing
(NAICS Code 336110);
Automobile and Other Motor Vehicle Merchant Wholesalers
(NAICS Code 423110);
Boat Building (NAICS Code 336612);
Broadwoven Fabric Mills (NAICS Code 313210);
Computer and Computer Peripheral Equipment and Software
Merchant Wholesalers (NAICS Code 432430);
Computer Storage Device Manufacturing (NAICS Code 334112);
Construction Machinery Manufacturing (NAICS Code 333120);
Current-Carrying Wiring Device Manufacturing (NAICS Code
335931);
Custom Compounding of Purchased Resins (NAICS Code
325991);
Electronic Computer Manufacturing (NAICS Code 334111);
Farm and Garden Machinery and Equipment Merchant
Wholesalers (NAICS Code 423820);
Farm Machinery and Equipment Manufacturing (NAICS Code
333111);
Guided Missile and Space Vehicle Manufacturing (NAICS Code
336414);
Guided Missile and Space Vehicle Propulsion Unit Parts
Manufacturing (NAICS Code 336415);
Heavy Duty Truck Manufacturing (NAICS Code 336120);
Household Appliances, Electric Housewares, and Consumer
Electronics Merchant Wholesalers (NAICS Code 423620);
Industrial Machinery and Equipment Merchant Wholesalers
(NAICS Code 423830);
Industrial Supplies Merchant Wholesalers (NAICS Code
423840);
Industrial Truck, Tractor, Trailer and Stacker Machinery
Manufacturing (NAICS Code 333924);
Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS 334513);
Lawn and Garden Tractor and Home Lawn and Garden Equipment
Manufacturing (NAICS Code 333112);
Manufacturing and Reproducing Magnetic and Optical Media
(NAICS Code 334610);
Materials Recovery Facilities (NAICS Code 562920);
Medical, Dental, and Hospital Equipment and Supplies
Merchant Wholesalers (NAICS Code 423450);
Mining Machinery and Equipment Manufacturing (NAICS Code
333131);
Miscellaneous Intermediation (NAICS Code 523910);
Motor and Generator Manufacturing (NAICS Code 335312);
Motor Vehicle Body Manufacturing (NAICS Code 336211);
Motor Vehicle Electrical and Electronic Equipment
Manufacturing (NAICS Code 336320);
[[Page 91487]]
Motor Vehicle Gasoline Engine and Engine Parts
Manufacturing (NAICS Code 336310);
Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS Code 423120);
Motorcycle, Bicycle and Parts Manufacturing (NAICS Code
336991);
New Car Dealers (NAICS Code 441110);
Nuclear Electric Power Generation (NAICS Code 221113);
Other Aircraft Part and Auxiliary Equipment Manufacturing
(NAICS Code 336413);
Other Basic Inorganic Chemical Manufacturing (NAICS Code
325180);
Other Chemical and Allied Products Merchant Wholesalers
(NAICS Code 424690);
Other Commercial and Industrial Machinery and Equipment
Rental and Leasing (NAICS Code 532490);
Other Communications and Energy Wire Manufacturing (NAICS
Code 335929);
Other Communications Equipment Manufacturing (NAICS Code
334290);
Other Electronic Component Manufacturing (NAICS Code
334419);
Other Electronic Parts and Equipment Merchant Wholesalers
(NAICS Code 432690);
Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS Code 336419);
Other Motor Vehicle Parts Manufacturing (NAICS Code
336390);
Paint and Coating Manufacturing (NAICS Code 325510);
Petroleum Lubricating Oil and Grease Manufacturing
(324191);
Petroleum Refineries (NAICS Code 324110);
Plastics Material and Resin Manufacturing (NAICS Code
325211);
Plastics Product Manufacturing (NAICS Code 3261);
Plumbing, Heating, and Air-Conditioning Contractors (NAICS
Code 238220);
Relay and Industrial Control Manufacturing (NAICS Code
335314);
Semiconductor and Related Device Manufacturing (NAICS Code
334413);
Semiconductor Machinery Manufacturing (NAICS Code 333242);
Surface Active Agency Manufacturing (NAICS Code 325613);
and
Surgical Appliance and Supplies Manufacturing (NAICS Code
339113).
To determine whether your entity is regulated by this action, you
should carefully examine the provisions found in 40 CFR part 751. If
you have any questions regarding the applicability of this action to a
particular entity, consult the technical information contacts listed
under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
TSCA section 6(h), 15 U.S.C. 2601 et seq., directs EPA to take
expedited action to complete TSCA section 6(a) rules on certain PBT
chemical substances. EPA must apply one or more of the requirements
listed in TSCA section 6(a) to the extent necessary to meet the TSCA
section 6(h)(4) statutory standard. More specifically, EPA must take
action on those chemical substances identified in the 2014 Update to
the TSCA Work Plan for Chemical Assessments (Ref. 2) 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. 3).
In response to this directive, in January 2021, EPA promulgated
rules to regulate the following five PBT chemical substances: decaBDE
(CASRN 1163-19-5); PIP (3:1) (CASRN 68937-41-7); 2,4,6-tris(tert-
butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); hexachlorobutadiene (HCBD)
(CASRN 87-68-3); and pentachlorothiophenol (PCTP) (CASRN 133-49-3)
(Refs. 4, 5, 6, 7, and 8). With the obligation to promulgate these
rules, the Agency also has the authority to amend them (e.g., if
circumstances change, including in relation to the receipt of new
information). It is well settled that EPA has inherent authority to
reconsider, revise, or repeal past decisions to the extent permitted by
law so long as the Agency provides a reasoned explanation. See F.C.C.
v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009). Based on
information submitted by regulated entities since the publication of
the 2021 decaBDE and PIP (3:1) final rules, the Agency has determined
that amendments to both rules are necessary to further reduce the
potential for exposure to the extent practicable.
C. What action is the Agency taking?
EPA is finalizing revisions to the decaBDE and PIP (3:1) rules
issued under TSCA (see 40 CFR part 751, subpart E). Additionally, in
response to comments received on the 2023 proposed rule for decaBDE and
PIP (3:1) (Ref. 1), EPA is also amending the general provisions at 40
CFR 751.401 to exclude processing and distribution in commerce of an
article that contains the chemical substance, and where the chemical
substance has not been newly added, for the purpose of repair or
maintenance. EPA is not revising the chemical-specific provisions for
the other three PBT chemical substances addressed in 40 CFR part 751,
subpart E (2,4,6-TTBP, HCBD, and PCTP).
1. Decabromodiphenyl Ether (DecaBDE)
DecaBDE is a flame retardant that has been widely used in textiles,
plastics, adhesives, and polyurethane foam. In this action, EPA is
finalizing revisions to the 2021 decaBDE final rule to require the use
of personal protective equipment (PPE) during certain activities
involving decaBDE. EPA is also finalizing: a prohibition on releases to
water during the manufacturing, processing, and distribution in
commerce of decaBDE and decaBDE-containing products; an extension of
the compliance date for the phase-out of processing and distribution in
commerce of decaBDE-containing wire and cable insulation for nuclear
power generation facilities; an export notification requirement for
decaBDE-containing wire and cable for nuclear power generation
facilities; and an allowance for unintentional amounts of decaBDE
present in products and articles at concentrations less than 0.1% by
weight. These final revisions are discussed further in Unit III.F.
2. Phenol, Isopropylated Phosphate (3:1) (PIP (3:1))
PIP (3:1) is a flame retardant, a plasticizer, and an anti-
compressibility and anti-wear additive. It is used in lubricants and
hydraulic fluids and in the manufacture of other compounds. For PIP
(3:1), EPA is finalizing revisions to the 2021 final rule to require
the use of PPE for the domestic manufacturing and processing of PIP
(3:1) and certain PIP (3:1)-containing products and articles. EPA is
also finalizing: phase-outs on processing and distribution for certain
uses; new exclusions from the prohibitions on processing and
distribution in commerce of PIP (3:1) for use in wire harnesses and
electric circuit boards and for the processing and distribution in
commerce of such PIP (3:1)-containing harnesses and circuit boards; an
exclusion to allow for distribution in commerce of new and replacement
parts containing PIP (3:1); and an allowance for unintentional amounts
of PIP (3:1) present in products and articles at concentrations less
than 0.1% by weight. EPA is not revising the October 2024 compliance
date for articles not otherwise covered by an exclusion from
prohibition or by an existing or newly finalized extension to a phase-
out compliance deadline.
[[Page 91488]]
D. Why is the Agency taking this action?
On September 3, 2021, in accordance with Executive Order 13990,
``Protecting Public Health and the Environment and Restoring Science to
Tackle the Climate Crisis,'' (86 FR 7037, January 25, 2021), EPA
announced its intention to review the five PBT final rules issued on
January 6, 2021 (Refs. 9 and 10). Specifically, EPA announced that it
planned to determine whether the rules were consistent with the
Administration's policy to limit exposure to dangerous chemicals and to
identify additional actions that could be taken to address
implementation issues and to reduce further exposures to these PBT
chemicals to the extent practicable, as directed by TSCA section 6(h).
On March 8, 2021, EPA also requested public comment in the Federal
Register on the five 2021 PBT final rules, including decaBDE and PIP
(3:1) (Ref. 11). In particular, EPA sought comment on whether the five
2021 PBT final rules sufficiently reduced exposures to these chemicals,
including exposures to potentially exposed or susceptible
subpopulations and the environment; on implementation issues associated
with the 2021 PBT final rules; on compliance issues associated with the
2021 PBT final rules; and on whether to consider additional or
alternative regulatory measures or approaches.
During the development of the 2021 PBT final rules, EPA conducted
extensive outreach to stakeholders, including hosting a public webinar
to gather use information on the PBTs, holding two comment periods on
the Exposure and Use Assessment, and presenting the notice of proposed
rulemaking at a Small Business Roundtable hosted by the Small Business
Administration (SBA) Office of Advocacy to elicit public comment. Only
after the 2021 PBT final rules were published, a wide variety of
stakeholders from various sectors, including, for example, the
electronics and electrical manufacturing sector and their customers,
raised significant concerns about their ability to meet the March 8,
2021 compliance date for the processing and distribution of PIP (3:1)
and PIP (3:1)-containing articles (Ref. 12). These stakeholders
contended that they needed significantly more time to identify whether
and where PIP (3:1) might be present in articles in their supply
chains, find and certify alternative chemicals, and produce or import
new articles that do not contain PIP (3:1). EPA met with numerous
stakeholders, including trade associations, entities who report PIP
(3:1) under the Chemical Data Reporting Rule, and other sectors where
PIP (3:1) use was identified. Despite EPA's extensive outreach, most
stakeholders that contacted EPA after the rule was finalized had not
commented on its proposal or otherwise engaged with the Agency on the
PIP (3:1) rulemaking and did not appear to have previously surveyed
their supply chains to determine whether PIP (3:1) was being used
(Refs. 5, 10, 11, and 13). Absent timely input from these stakeholders,
in the 2021 PIP (3:1) final rule EPA determined that PIP (3:1) was not
widely present in complex articles outside the aerospace and automotive
sectors. These stakeholders requested an extension of the compliance
dates in order to clear the existing articles through the supply chain,
find and certify an alternative chemical, and produce or import new
articles that do not contain PIP (3:1).
In response to stakeholder input, in an immediately effective final
rule issued in September 2021, EPA extended the compliance deadline for
processing and distribution in commerce of PIP (3:1) for use in
articles and PIP (3:1)-containing articles, unless subject to an
exclusion from or phase-in of prohibition, to March 8, 2022 (Ref. 10).
In October 2021, EPA proposed a new extended compliance deadline for
processing and distribution in commerce of PIP (3:1) for use in
articles and PIP (3:1)-containing articles, unless subject to an
exclusion from or phase-in of prohibition, to October 31, 2024, and
finalized that extended compliance deadline in March 2022 (Refs. 13 and
14). EPA similarly amended the compliance deadline for recordkeeping
requirements for articles in those rulemakings.
Additionally, EPA responded to the comments received on the March
2021 notification that were relevant to the PIP (3:1) compliance
deadline extension and related issues when the Agency extended the
compliance deadlines in both the September 2021 PIP (3:1) final rule
and in an October 2021 PIP (3:1) proposed rule (Refs. 10 and 13).
According to the comments received prior to and in response to the
March 2021 notification and request for comments, a wide range of key
consumer and commercial goods are affected by the prohibitions in the
2021 PIP (3:1) final rule such as cellular telephones, laptop
computers, and other electronic devices and industrial and commercial
equipment used in various sectors including transportation, life
sciences, and semiconductor production (Ref. 15). These comments are
addressed in EPA's September 2021 PIP (3:1) final rule and October 2021
PIP (3:1) proposed rule (Refs. 10 and 13). EPA reasoned that these
extensions would avoid significant disruption in the supply chains for
certain articles necessary to the electronics and electrical
manufacturing sector, while EPA determined whether any further
compliance date extensions were necessary for certain industry sectors,
including the semiconductor and equipment manufacturing sectors.
EPA also announced in the September 2021 PIP (3:1) final rule,
October 2021 PIP (3:1) proposed rule, and the March 2022 PIP (3:1)
final rule that the Agency intended to consider any additional
information received to further reduce exposures and assess how
environmental justice could be promoted through further exposure
reduction to better protect human health and the environment (Refs. 10,
13, and 14).
In addition, several comments received raised issues pertaining to
decaBDE. Commenters recommended further regulation of decaBDE,
including narrowing the replacement part exclusion to time-limited
critical uses, addressing potential risks from releases to the
environment, restricting the disposal of decaBDE and decaBDE-containing
products and articles, and addressing potential risks from occupational
exposure (EPA-HQ-OPPT-2023-0376-0303, EPA-HQ-OPPT-2023-0376-0313, EPA-
HQ-OPPT-2021-0202). EPA also received a comment requesting the Agency
hold a government-to-government consultation with the Yurok Tribal
Council (Ref. 16). In November 2022, EPA held a one-on-one Tribal
consultation with the Yurok Tribal Council. During this consultation,
the Agency received additional information that informed the Agency of
considerations to reduce potential exposures to decaBDE, including
labeling and a prohibition on the releases to water. EPA received no
comments addressing the need for the extending compliance date for
decaBDE-containing wire and cable insulation for nuclear power
generation facilities.
E. What are the estimated incremental impacts of this action?
EPA's estimated incremental impacts for this rulemaking are
presented in an Economic Analysis document (Ref. 17), which is
available in the docket, described in more detail in Unit IV., and is
briefly summarized here. The EPA conducted this analysis for the
purpose of providing the public with as full as possible an
understanding of the potential impacts of this final action. The EPA
believes this can inform the public's understanding, place EPA's
[[Page 91489]]
action in context, and help identify and illustrate the extent of
potential burdens and protection.
1. Benefits
As discussed in the 2021 PBT final rules and Unit II.C., and
consistent with TSCA section 6(h)(2), EPA did not perform a risk
evaluation for decaBDE or PIP (3:1), nor did EPA develop quantitative
risk estimates. TSCA section 6(h)(2) makes clear that Congress did not
intend for EPA to conduct a risk evaluation to support TSCA section
6(a) rules issued to satisfy TSCA section 6(h) requirements, but rather
intended for EPA to conduct an expedited rulemaking process to ``reduce
exposures to the extent practicable'' pursuant to TSCA section 6(h)(4).
EPA also does not interpret TSCA section 6(c)(2) to require a
quantification of benefits. Under TSCA section 6(c)(2)(A)(iv), EPA must
consider and publish a statement on the reasonably ascertainable
economic consequences of the rule, but that provision does not require
quantification, particularly if quantification is not possible. While
EPA was not able to quantify the benefits of reducing human and
environmental exposures to decaBDE or PIP (3:1), the Economic Analysis
qualitatively discusses the benefits of reducing exposure under this
final rule, as summarized in Unit IV. (Ref. 17).
2. Costs
Total quantified annualized social costs for this final rule are
approximately $400 million at a 3 percent discount rate, and $430
million at a 7 percent discount rate. Costs at a 2 percent discount
rate are estimated at $390 million (shown in appendix A of the
accompanying Economic Analysis for this final rule). Of the final rule
costs, those associated with decaBDE alone were estimated at $86 at a 3
percent discount rate and $128 at a 7 percent discount rate. Costs
associated with PIP (3:1) alone were estimated at $400 million and $430
million (at 3 and 7 percent discount rates, respectively). PPE
requirements were estimated at $373 million and $410 million (at 3 and
7 percent discount rates, respectively) comprising the majority of the
total costs. Comparatively, costs for the 2021 PIP (3:1) final rule
were estimated at approximately $23.6 million at a 3 percent discount
rate and $22.8 million at 7 percent. Costs for this final rule are
associated with new requirements and therefore were not included in
estimates for the 2021 PIP (3:1) final rule.
3. Small Entity Impacts
This final rule is estimated to impact approximately 24,865 small
businesses, all of which pertain to PIP (3:1) and none for decaBDE. Of
these, 860 small businesses are expected to incur cost impacts between
1 percent and 3 percent of their annual revenue. No entities are
expected to be impacted above 3 percent of their annual revenue.
4. Environmental Justice
Since a risk evaluation was not conducted, EPA's understanding of
the extent to which reductions in exposure might reduce risks for
communities with environmental justice (EJ) concerns is limited. In the
Economic Analysis accompanying this rule (Ref. 17), EPA relied on
available relevant data sources for PIP (3:1) and decaBDE, including
EPA's Chemical Data Reporting (CDR), the U.S. Census Bureau, American
Community Survey (2022), and others to assess the economic implications
of this final rule. Data, however, are not sufficiently comprehensive
to estimate the extent to which the final rule will reduce existing
disproportionate impacts on communities with EJ concerns. In addition,
only a small subset of the specific facilities (14 facilities reported
to 2020 CDR) using decaBDE and PIP (3:1) have been identified, so a
proximity analysis examining the characteristics of the communities
surrounding the known facilities would not be representative of all
exposed communities.
Given the lack of available data, EPA has determined that it is not
practicable to assess whether this action is likely to result in new
disproportionate impacts or exacerbate any existing disproportionate
impacts on communities with EJ concerns. The restrictions placed on
decaBDE and PIP (3:1) through this final rule will reduce the potential
exposures and risks associated with the manufacture, processing, and
use of these chemicals. At a minimum EPA considers that this final rule
will not exacerbate any baseline EJ concerns and will increase the
level of protection for all affected populations without having any
disproportionate and adverse human health or environmental effects on
any population, including children. Certain exclusions from prohibition
and extensions of compliance dates beyond those adopted in the 2021 PBT
final rules, however, may partially delay anticipated reductions in
exposure.
5. Children's Environmental Health
Under the 2021 EPA Policy on Children's Health, the Agency
considers the risks to infants and children consistently and explicitly
during its decision-making process (Ref. 18). Certain exclusions and
extensions of compliance dates beyond those adopted in the 2021 PBT
final rules or subsequent PIP (3:1) final rules, however, may partially
delay these reductions in exposure. More information can be found in
the Exposure and Use Assessment document (Ref. 19).
6. Effects on State, Local, and Tribal Governments
This final rule will not have any significant or unique effects on
small governments, or federalism, or Tribal implications.
II. Background
A. History of This Rulemaking
1. The 2021 PBT Final Rules
a. DecaBDE
The decaBDE 2021 final rule prohibited 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 included:
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.
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.
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.
After the end of their service lives, or 2036, whichever
is earlier, for
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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.
After the end of their service lives for distribution in
commerce of plastic shipping pallets manufactured prior to March 8,
2021 that contain decaBDE.
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 were 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 were 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.
b. PIP (3:1)
The 2021 PIP (3:1) final rule prohibited the processing and
distribution in commerce of PIP (3:1) and products containing PIP (3:1)
except for the following:
Processing and distribution in commerce for use in
hydraulic fluids either for the aviation industry or to meet military
specifications for safety and performance where no alternative chemical
is available that meets U.S. Department of Defense specification
requirements;
Processing and distribution in commerce for use in
lubricants and greases;
Processing and distribution in commerce for use in new and
replacement parts for the automotive and aerospace industry, and the
distribution in commerce of those parts to which PIP (3:1) has been
added;
Processing and distribution in commerce for use as an
intermediate in a closed system to produce cyanoacrylate adhesives;
Processing and distribution in commerce for use as an
adhesive and sealant until January 6, 2025, after which such activity
is prohibited;
Processing and distribution in commerce for use in
specialized engine filters for locomotive and marine applications;
Processing for recycling and distribution in commerce for
the recycling of PIP (3:1)-containing plastic provided no new PIP (3:1)
is added during the recycling process;
Processing and distribution in commerce of articles and
products made from recycled PIP (3:1)-containing plastic provided no
new PIP (3:1) is added during the recycling process or to the articles
and products made from the recycled plastic; and
Processing and distribution in commerce of PIP (3:1) for
use in photographic printing articles and PIP (3:1)-containing
photographic printing articles until January 1, 2022.
This final rule also prohibited releases to water for from
manufacture, processing, distribution in commerce, and commercial uses
that are permitted to occur, as outlined in the preceding bullets:
Persons manufacturing, processing, and distributing in
commerce PIP (3:1) and products containing PIP (3:1) are required to
notify their customers of these prohibitions on processing and
distribution, and the prohibition on releases to water via Safety Data
Sheet (SDS) or labeling.
Persons manufacturing, processing, and distributing in
commerce PIP (3:1) are required to maintain, for three years from the
date the record was generated, ordinary business records related to
compliance with the restrictions, prohibitions, and other requirements
set forth in this rule. These records must include a statement that the
PIP (3:1), or the PIP (3:1)-containing products or articles, are in
compliance with 40 CFR 751.407(a) and be made available to EPA within
30 calendar days upon request.
2. PIP (3:1) Compliance Date Extensions
Based on the PIP (3:1)-specific comments received in response to
the March 2021 notification and request for comments, EPA issued an
immediately effective final rule in September 2021, which extended the
compliance dates applicable to the processing and distribution in
commerce of certain PIP (3:1)-containing articles and the PIP (3:1)
used to make those articles, until March 8, 2022, along with the
associated recordkeeping requirements for manufacturers, processors,
and distributors of PIP (3:1)-containing articles (Ref. 10). While most
commenters on the March 2021 notification and request for comments
requested a longer-term compliance date extension (Ref. 15), EPA
determined that a short-term extension was necessary to ensure that the
supply chains for these important articles continue uninterrupted in
the near term while allowing EPA to conduct notice and comment
rulemaking on a longer-term compliance date extension generally.
On March 8, 2022, EPA further extended the compliance deadline
established in the September 2021 final rule for the processing and
distribution in commerce of PIP (3:1) for use in certain articles and
for the processing and distribution in commerce of certain PIP (3:1)-
containing articles, from March 8, 2022, to October 31, 2024 (Ref. 14).
The compliance date for the recordkeeping requirements for
manufacturers, processors, and distributors of PIP (3:1)-containing
articles was also extended from March 8, 2022, to October 31, 2024.
Articles covered by the phased-in prohibition include any article not
otherwise covered by an alternative compliance deadline or exclusion
described in 40 CFR 751.407(a)(2)(ii) or (b). EPA reasoned that this
further extension would avoid significant disruption in the supply
chains for certain articles and would provide the public with
regulatory certainty, while EPA determined whether any further
compliance date extensions were necessary.
3. The 2023 Proposed Rule for DecaBDE and PIP (3:1)
On November 24, 2023, EPA proposed updates to the 2021 final
decaBDE and PIP (3:1) rules (Ref. 1). For decaBDE, EPA proposed the
following: requiring a label on plastic shipping pallets known to
contain decaBDE; requiring PPE use for certain activities involving
decaBDE; prohibiting the release of decaBDE to water during
manufacturing, processing, and distribution in commerce; extending the
compliance deadline for processing and distribution of decaBDE-
containing wire and cable insulation for use in nuclear power
generation facilities; requiring export notification for decaBDE-
containing wire and cable for nuclear power generation facilities, and
extending the recordkeeping requirements from three to five years
[[Page 91491]]
and removing the 30-day timeframe to make records available.
For PIP (3:1), EPA proposed the following: requiring PPE for
domestic manufacturing and processing of PIP (3:1) and certain PIP
(3:1)-containing products and articles; requiring engineering controls
for processing of PIP (3:1) and PIP (3:1)-containing products as an
intermediate in a closed system to produce cyanoacrylate adhesives;
requiring new compliance deadlines for certain exclusions, modifying
existing deadlines, and/or narrowing existing exclusions for processing
and distribution of PIP (3:1) for certain excluded uses industries;
adding new exclusions for processing and distribution of PIP (3:1) for
use in wire harnesses, electric circuit boards, and sealants and
adhesives used on circuit boards; providing a new, 5-year compliance
deadline for use in Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)-approved marine antifouling coating products; and extending the
recordkeeping requirements from three to five years and removing the
30-day timeframe to make records available.
The proposed rule provided a 45-day public comment period that
closed on January 8, 2024 (Ref. 1). EPA received a total of 33 public
comments in response to the proposed rule. Since two of the comments
were duplicates, EPA posted a total of 31 public comment submissions to
regulations.gov; they are available in the public docket at EPA-HQ-
OPPT-2023-0376. These comments further informed EPA's understanding of
the current status of uses for decaBDE and PIP (3:1). EPA is publishing
in the docket for this action a separate Response to Comments (RtC)
Document that responds to all significant comments we received (Ref.
20). Furthermore, EPA held a public webinar on the proposed rule on
December 14, 2023, in which it presented an overview of the proposed
changes to the regulations for decaBDE and PIP (3:1) and accepted
verbal comments. EPA received a total of three comments from members of
the public during this webinar (Ref. 21).
B. Activities Not Regulated by This Rule
EPA did not propose to revise and is not revising the other three
PBT final rules issued under TSCA section 6(h) for 2,4,6-TTBP, HCBD, or
PCTP.
C. EPA's Implementation of TSCA Section 6(h)
1. EPA's TSCA Section 6(h)(1) Findings
As previously detailed in the 2021 decaBDE and PIP (3:1) final
rules, for chemical substances meeting the requirements of TSCA section
6(h)(1)(A) and (B), TSCA section 6(h)(4) required 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 made the requisite TSCA section 6(h)(1)(A) and (B)
findings for decaBDE and PIP (3:1), triggering the requirement for a
TSCA section 6(a) rulemaking under TSCA section 6(h)(4) standard. This
final rulemaking does not amend these findings.
2. EPA's Approach to TSCA Section 6(h)(4)
In the 2021 PBT final rules, EPA explained that it reads the TSCA
section 6(h)(4) standard to apply to the chemical substance generally,
thus requiring EPA to ``address risks'' and ``reduce exposures'' to the
chemical substance without focusing on how or 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). Thus, the 2021
PBT final rules address past, present, and future activity involving
the chemical substance. In the 2021 PBT final rules, EPA also explained
that because there was no existing risk evaluation or assessment for
each chemical substance and one was not contemplated by TSCA section
6(h), EPA's implementation of the standard in TSCA section 6(h)(4)
focused on applying the TSCA sections 6(a) and (c) requirements in a
manner that reduces exposure to the chemical substance to the extent
practicable. This final rulemaking does not amend these interpretations
or EPA's approach for implementing TSCA section 6(h)(4).
EPA intends that each provision of this rulemaking be severable. In
the event of litigation staying, remanding, or invalidating all or a
portion of a particular risk management approach, EPA intends to
preserve all other portions of the particular risk management approach
and all other risk management approaches in the rule to the fullest
extent possible. The Agency considered the risk management options in
TSCA section 6(a) and generally each of EPA's particular risk
management approaches to reduce exposure to decaBDE and PIP (3:1) to
the extent practicable functions independently from EPA's other risk
management approaches, which may have different characteristics leading
to EPA's risk management decisions. Further, the Agency crafted this
rule so that different risk management approaches are reflected in
different provisions or elements of the rule that are capable of
operating independently. Accordingly, the Agency has organized the rule
so that if any provision or element of this rule is determined by
judicial review or operation of law to be invalid, that partial
invalidation will not render the remainder of this rule invalid.
There are many permutations of this; accordingly, rather than
walking through each one, EPA is providing representative examples for
illustrative purposes. First, to the extent a court were to find that
EPA lacked substantial evidence to support the phase-out of the
processing of one type of decaBDE-containing product, or otherwise
found flaw with such phase-out, it would have no bearing on other risk
management approaches in the rule, including other phase-outs, unless
the specific flaw also applies to these other risk management
approaches. Second, to the extent that a court were to find that the
required interim workplace protections for the processing of certain
PIP (3:1)-containing products until a ban on processing goes into
effect lacked substantial evidence, or otherwise found fault with such
protections, it would have no bearing on EPA's decision to ban the
processing of such PIP (3:1)-containing products. The independence of
these risk management approaches is reflected in the structure of the
rule, which does not intertwine the risk management approaches, but
rather separately defines each such approach.
3. EPA's Interpretation of ``to the Extent Practicable'' as Used in
TSCA Section 6(h)(4)
EPA has previously discussed its general interpretation of the term
``practicable'' in the five 2021 PBT final rules (Refs. 4, 5, 6, 7, and
8), and is not changing the interpretation. Nevertheless, EPA has
provided a more fulsome discussion of why its interpretation is
consistent with the statute. First, EPA's approach is consistent with
the dictionary definitions of the phrase ``to the extent practicable''
and the term ``practicable,'' taking into account their plain meaning
and the context of this provision in section 6 of TSCA.
The phrase ``reduce exposure . . . to the extent practicable'' and
the term ``practicable'' within that phrase are not defined in TSCA
section 6(h). Nor is the phrase or term defined in any context in which
it is used elsewhere in TSCA or the legislative history. Dictionary
definitions of ``practicable'' include technical feasibility as well as
characteristics relating to
[[Page 91492]]
reasonableness and capacity. EPA's interpretation takes this plain
language into account. EPA's interpretation also takes into
consideration the statutory context for such terminology, including the
different standard and procedural approaches for a TSCA section 6(a)
rule pursuant to TSCA section 6(h) rules and a TSCA section 6(a) rule
following a risk evaluation pursuant to TSCA section 6(b)(4). For a
more thorough discussion and examples of the factors EPA took into
consideration, see Section 1-2 of the Response to Comments document for
this rule.
In sum, the best reading of the TSCA section 6(h)(4) statutory
terms and context compels consideration of all reasonably available
information on TSCA sections 6(c)(2) and (d) issues, including cost. As
a result, while cost does factor into whether a regulatory option is
practicable or the time frame for triggering a regulatory option is
practicable, EPA also considers, for example, whether alternatives are
generally available and what reasonable transition time is needed for
identifying and adopting alternatives, the import of the products and
articles containing decaBDE or PIP (3:1), and other regulations or
voluntary standards that address articles under consideration, based on
all available information before the Agency at the time of the
decision. In the absence of clear direction from Congress, EPA may take
these concerns into consideration in determining what further exposure
reductions are practicable.
4. EPA's Position on Directly Regulating Occupational Exposures
For purposes of determining whether worker protection measures are
practicable under TSCA section 6(h)(4), EPA does not believe it is
appropriate to assume as a general matter that an applicable
Occupational, Safety and Health Administration (OSHA) requirement or
industry practice is consistently or always properly applied. This
should not be viewed as an indication that the Agency believes there
are no occupational safety protections in place at any location, or
that there is widespread noncompliance with applicable OSHA standards.
Rather, it reflects the Agency's recognition that its interpretation of
the TSCA section 6(h)(4) standard ``to reduce exposure . . . to the
extent practicable'' calls for worker protection measures to reduce the
potential for exposure to PBTs generally, considering what is
achievable, feasible, workable, and reasonable, in light of the
circumstances. This is the case even in the absence of a risk
evaluation or risk assessment and even if existing OSHA requirements
might apply, such as those under the General Duty Clause of the
Occupational Safety and Health Act (29 U.S.C. 654(a)) or OSHA's
Respiratory Protection standard (29 CFR 1910.134).
TSCA section 9(d) requires EPA to consult and coordinate TSCA
activities with OSHA and other relevant Federal agencies for the
purpose of achieving the maximum applicability of TSCA while avoiding
the imposition of duplicative requirements. Pursuant to 29 U.S.C. 651
et seq., OSHA requires that employers provide safe and healthful
working conditions through enforcement of the General Duty Clause and
by setting and enforcing occupational safety and health standards. OSHA
also provides training, outreach, education, and assistance. Where EPA
has reason to believe that there might be the potential for exposure to
workers to decaBDE and PIP (3:1), the Agency has considered whether it
is practicable to require worker protections in addition to applicable
OSHA regulations (e.g., fit testing and training requirements). To
determine what worker protections measures are practicable, the Agency
reconsidered the reasonably available information on the use of
industry worker protection measures, including best practices, and
considered new information received during engagements with industry
stakeholders after the 2021 PBT final rules, from public comments on
the March 2021 notification, and public comment on the proposed rule
(Refs. 15, 20, and 22). This information was used to inform the
finalized requirements for inhalation and dermal PPE to reduce worker
exposure to decaBDE and PIP (3:1).
EPA also considered the hierarchy of controls adopted by OSHA and
the National Institute for Occupational Safety and Health (NIOSH)
(i.e., prioritization of exposure control strategies from most
protective and preferred to least protective and preferred techniques),
but only proposed requiring prescriptive controls over the hierarchy of
controls. In order of preference, the hierarchy of controls includes
elimination of the hazard, substitution with a less hazardous
substance, engineering controls, administrative controls (e.g.,
training or exclusion zones with warning signs), and, finally, use of
PPE (Ref. 23). Under the hierarchy of controls, the use of respirators
should only be considered after all other measures have been taken to
reduce exposures, and then consistent with the OSHA Respiratory
Protection Standard at 29 CFR 1910.134. Under OSHA's standards, the
various exposure controls are prioritized equally, followed by PPE
requirements when necessary.
EPA received several comments on the Agency's worker protection
requirements. One commenter (EPA-HQ-OPPT-2023-0376-0312) argued that
EPA must require owner/operators to follow the hierarchy of controls in
protecting their workforce. Another commenter (EPA-HQ-OPPT-2023-0376-
0297) argued that EPA should not prescribe controls that may not be
appropriate for the particular circumstances of an individual
workplace. Another commenter (EPA-HQ-OPPT-2023-0376-0313) stated that
in proposing measures to address occupational exposures that rely
almost exclusively on the use of PPE, EPA's proposal is incompatible
with the ``hierarchy of controls'' for reducing occupational exposures
to toxic chemicals. The commenter contended that requiring owners and
operators to install engineering and administrative controls to the
extent they are practicable would correct this flaw in the proposed
amendments. Multiple commenters requested that EPA allow industry to
use the hierarchy of controls to determine which controls may be
appropriate and most protective for that workplace, rather than
prescribing the required PPE for each use (EPA-HQ-OPPT-2023-0376-0312,
EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-
2023-0376-0302). A commenter also expressed interest in the development
of workplace chemical protection programs using existing chemical
exposure limits (ECELs) for PBTs, similar to those proposed for other
risk management rules under TSCA section 6(a) (EPA-HQ-OPPT-2023-0376-
0312). While EPA recognizes the concerns raised by commenters, EPA does
not believe it can develop an ECEL for these two chemicals without a
risk evaluation, which was neither required nor feasible given the
statutory timeline for promulgation of rules under TSCA section 6(h).
While a workplace chemical protection program that sets an ECEL and
uses the hierarchy of controls would provide latitude for companies to
determine which elements within the hierarchy of controls to implement,
developing an ECEL without a risk evaluation is not practicable for
these chemicals. EPA has decided not to finalize a requirement to
consider the hierarchy of controls in the absence of an ECEL. The
workplace requirements for decaBDE and PIP (3:1) were developed based
on stakeholder
[[Page 91493]]
comments, existing industry practices, and OSHA-required Safety Data
Sheets. See the individual sections related to workplace protection for
decaBDE (Unit III.C.2.) and PIP (3:1) (Unit III.D.3.).
Although many of the uses where workplace requirements are being
finalized include requirements to supply PPE, the last method of
control in the hierarchy of controls, EPA disagrees with commenters
that the hierarchy of controls was not considered as a part of this
rulemaking (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2023-0376-0312).
For example, the requirement to supply PPE is limited to the regulated
area, which must be established where ``airborne concentrations or
direct dermal contact of a specific chemical substance can reasonably
be expected.'' 40 CFR 751.403. The establishment of the regulated area
provides flexibility to owners/operators to first utilize one or a
combination of elimination, substitution, engineering controls or
administrative controls to reduce or eliminate the necessity to
demarcate a regulated area by eliminating any areas where exposure can
``reasonably be expected.'' If exposure to the chemical is no longer
reasonably expected due to these controls, the owner/operator would not
be required to establish a regulated area and the requirement to supply
PPE to potentially exposed persons under 40 CFR 751.405(e) and
751.407(f) for decaBDE and PIP (3:1), respectively, would not apply.
EPA also requires the owner/operator to keep records of the basis for
the regulated area, including monitoring data and documentation of any
controls or combination of controls that have reduced exposure to where
airborne concentrations of decaBDE or PIP (3:1) can no longer
reasonably be expected resulting in a smaller or no regulated area
being established.
D. Overview of TSCA Sections 6(c) and 26 Considerations
Unless explicitly stated, the following overview is meant to be a
summary of information previously provided by EPA in the 2021 decaBDE
and PIP (3:1) final rules regarding TSCA sections 6(c) and 26
considerations. It is not intended to serve as new findings under or
interpretations of TSCA section 6(h)(4).
1. TSCA Section 6(c)(2) Considerations
TSCA section 6(c)(2) requires EPA to consider and publish a
statement based on reasonably available information with respect to
the:
Health effects of the chemical substance(s) or mixture(s)
and the magnitude of human exposure;
Environmental effects of the chemical substance(s) or
mixture(s) and the magnitude of exposure to the environment;
Benefits of the chemical substance(s) or mixture(s) for
various uses; and
Reasonably ascertainable economic consequences of the
rule, including: the likely effect of the rule on the national economy,
small business, technological innovation, the environment, and public
health; the costs and benefits of the proposed and final rule and of
the one or more primary alternative regulatory actions that EPA
considered; and cost effectiveness of the final rule and of the one or
more primary alternative regulatory actions that the Agency considered.
In selecting among prohibitions and other restrictions available
under TSCA section 6(a), EPA must factor in, to the extent practicable,
these considerations. Further, in deciding whether to prohibit or
restrict the manufacture, processing, distribution in commerce, use, or
disposal of a chemical substance or mixture in a manner that
substantially prevents a specific condition of use of a chemical
substance or mixture, and in setting an appropriate transition period
for such action, EPA must consider, to the extent practicable, whether
technically and economically feasible alternatives that benefit health
or the environment will be reasonably available as a substitute when
the final prohibition or other restriction takes effect.
EPA's summary of the health and environmental effects of and the
potential for exposure to the two PBT chemicals subject to this final
action can be found in the support documents for the 2021 PBT final
rules for each chemical (e.g., the Exposure and Use Assessment (Ref.
19) and the Hazard Summary (Ref. 24)).
The costs and benefits of this final rule and the alternatives EPA
considered, as well as the impacts on small businesses, are presented
in the Economic Analysis document (Ref. 17). However, the Agency was
not able to quantitatively estimate the benefits of this final rule and
the alternatives, due to the absence of a risk evaluation, and has
instead qualitatively described such benefits.
EPA considered the estimated costs to regulated entities, as well
as the cost to administer and enforce the options. EPA considered
reasonably available information about the functionality and
performance efficacy of the regulatory options and the ability to
implement the use of chemical substitutes or other alternatives. A
discussion of the costs EPA considered can be found in Unit IV., along
with a discussion of the alternatives that the Agency considered. A
discussion of the impacts on small businesses can also be found in Unit
IV.
With respect to the cost-effectiveness of this final regulatory
action, EPA is unable to perform a traditional cost-effectiveness
analysis of the options and alternative options for decaBDE and PIP
(3:1). 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 from an existing risk evaluation or assessment, the Agency 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 regulatory action. However, by evaluating
the practicability of the policy options, the Agency is confident that
it has considered elements related to the cost-effectiveness of the
actions, including the cost and the effect on human and environmental
exposure to decaBDE and PIP (3:1).
2. TSCA Section 26 Considerations
In accordance with TSCA section 26(h) and considering the
requirements of TSCA section 6(h), EPA used scientific information,
technical procedures, measures, and methodologies that are fit for
purpose and consistent with the best available science to inform the
2021 PBT final rules. EPA based its determination that human and
environmental exposures to both decaBDE and PIP (3:1) are likely on its
2020 Exposure and Use Assessment (Ref. 19), which underwent a peer
review and public comment process, and used 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 the Agency's decision-making have been subject to
independent verification or peer review is adequate to justify their
use, collectively, in the record for this final rule.
In addition, in accordance with TSCA section 26(i), and considering
the requirements of TSCA section 6(h), EPA has made scientific
decisions based on the weight of the scientific evidence. Additionally,
in accordance with TSCA section 26(k), EPA considered reasonably
available information, including information on occupational
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controls and PPE usage, when finalizing this TSCA section 6 rule.
E. Overview, Health Effects, and Exposure
For the 2019 PBT proposed rule, EPA prepared an Exposure and Use
Document, summarizing the information the Agency obtained in its own
research or in response to feedback prior to and during the rulemaking
process on the types of exposures that might be relevant to a TSCA
section 6(a) rulemaking under the TSCA section 6(h)(4) standard. As
noted in the 2021 PBT final rules, the Exposure and Use Assessment
identified uses of the chemical substances and found that the chemical
substances had at least one or more ``condition of use'' activity where
some exposure was likely, but did not attempt to precisely classify all
activities for each chemical substance as a ``condition of use''.'' As
EPA explained in the 2021 PBT final rules, the Agency did not perform a
systematic review or a weight of the scientific evidence assessment for
the hazard characterization of these chemicals. TSCA section 6(h)(2)
makes clear that Congress did not intend for EPA to conduct a risk
evaluation to support TSCA section 6(a) rules issued to satisfy TSCA
section 6(h) requirements, but rather intended for EPA to conduct an
expedited rulemaking process to ``reduce exposures to the extent
practicable'' pursuant to TSCA section 6(h)(4). As a result, EPA
explained that the hazard characterizations are not definitive or
comprehensive. Other hazard information on these chemicals may exist in
addition to the description in the 2021 PBT final rules and studies
summarized in the Hazard Summary (Ref. 24). The following sections
summarize the hazard, exposure, and use information in the 2021 decaBDE
and PIP (3:1) final rules.
1. DecaBDE
As EPA explained in the 2021 decaBDE final rule, 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. 25). DecaBDE is also used as a flame
retardant for multiple applications for aerospace and automotive
vehicles, including replacement parts for aircraft and cars (Refs. 26
and 27). Exposure information for decaBDE is detailed in EPA's Exposure
and Use Assessment and the 2021 decaBDE final rule (Refs. 4 and 19). As
EPA explained in that rule, there is potential for exposure to decaBDE
under the conditions of use at all stages of its lifecycle (i.e.,
manufacturing; processing; distribution in commerce; industrial,
commercial, and consumer use; and disposal) of the chemical. DecaBDE
was produced and released at higher levels in the past, but releases
from manufacturing and processing activities have declined over time,
as have releases associated with use, disposal, and recycling
activities (Ref. 19). This decline is in part due to a voluntary phase-
out by the largest producers and suppliers of decaBDE in the United
States, that committed to end their production, imports, and sales for
all uses of decaBDE by the end of 2013 (Ref. 17).
As described in the 2021 decaBDE final rule, 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 can 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
dust via indoor air. Infant and child exposures can 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 dermal and inhalation contact
with decaBDE (Ref. 19).
Finally, as summarized in the 2021 decaBDE final rule, 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 is some evidence of genotoxicity and
carcinogenicity. The 2021 decaBDE final rule and Hazard Summary
provides more information on these hazard endpoints (Refs. 4 and 24).
For the 2020 CDR submission period, calendar years 2016-2019, data
indicate that three companies manufactured (including imported) decaBDE
in the United States (Refs. 17 and 28). The 2020 CDR data indicate a
production volume of less than 1 million pounds annually from 2016
through 2019, however, EPA notes that domestic production has ceased,
and the identified importers have likely since stopped using decaBDE
(Ref. 28).
2. PIP (3:1)
As explained in the 2021 PBT final rules, PIP (3:1) is used as a
plasticizer, a flame retardant, an anti-wear additive, or an anti-
compressibility additive in hydraulic fluid, lubricating oils,
lubricants, greases, various industrial coatings, adhesives, sealants,
and plastic articles. As a chemical that can perform several functions
simultaneously, sometimes under extreme conditions, it has several
distinctive applications. For example, in lubricating oils, PIP (3:1)
is a flame retardant, anti-wear additive, anti-compressibility
additive, or some combination of the three. In adhesives and sealants,
PIP (3:1) is a plasticizer and flame retardant (Ref. 19). PIP (3:1) is
also added to paints, coatings, and plastic components, where it is a
plasticizer or flame-retardant additive. In the past, some plastic
components to which PIP (3:1) may have been added included those
intended for use by children. EPA has received comments that PIP (3:1)
acts as a flame-retardant gel in filters surrounding engines in some
marine and locomotive applications (EPA-HQ-OPPT-2019-0080-0569).
Exposure information for PIP (3:1) is detailed in EPA's Exposure
and Use Assessment and is summarized here (Ref. 19). There is potential
for exposure to PIP (3:1) under the conditions of use at all stages of
its lifecycle (i.e., manufacturing, processing, distribution in
commerce, use, and disposal). PIP (3:1) is manufactured, processed,
distributed, used, and disposed of domestically. For the 2012 CDR
submission period, data indicate that four sites manufactured
(including imported) PIP (3:1) in the United States. The total volume
of PIP (3:1) manufactured (including imported) in the United States was
14,904,236 lbs. in 2011; 3,191,017 lbs. in 2012; 2,968,861 lbs. in
2013; 5,632,272 lbs. in 2014; and 5,951,318 in 2015 (Ref. 28).
For the 2020 CDR submission period, calendar years 2016-2019, data
indicate that nine sites manufactured (including imported) PIP (3:1) in
the United States and manufacture (including import) held steady at
between 1 and 10 million pounds (Refs. 17 and 28).
PIP (3:1) is toxic to aquatic plants, aquatic invertebrates,
sediment invertebrates, and fish. Data indicate the potential for
reproductive and developmental effects, neurological effects, and
effects on systemic organs, specifically the adrenal glands, liver,
[[Page 91495]]
ovaries, and heart in mammals. The studies presented in the Hazard
Summary, titled ``Environmental and Human Health Hazards of Five
Persistent, Bioaccumulative and Toxic Chemicals,'' describe these
hazardous endpoints (Ref. 29).
III. Final Regulatory and Alternative Regulatory Actions
A. Regulatory Approach
In this action, EPA is finalizing revisions to the 2021 decaBDE
final rule and the 2021 and 2022 PIP (3:1) final rules. EPA has
collected additional information and reconsidered its application of
its interpretation of the TSCA section 6(h)(4) direction that the
Agency ``reduce exposures to the substance to the extent practicable,''
focusing particularly on whether additional practicable requirements
can reduce occupational exposures, including those associated with
exclusions. As described throughout this Unit, EPA has considered the
practicability of the final requirements, including how potential
requirements and compliance time frames associated with these
requirements could impact supply chains, including those prioritized in
Executive Order 14017 America's Supply Chains.
B. Activities EPA Did Not Reevaluate for This Rulemaking
1. Disposal
As EPA explained in the 2023 proposed rule, EPA did not propose to
change its 2021 decision not to use its TSCA section 6(a) authorities
to establish a TSCA regulatory program for disposal of decaBDE or PIP
(3:1). EPA did not propose such a program and is not finalizing the
suggestions made by commenters at this time. EPA remains concerned that
developing a new comprehensive regulation for disposal of decaBDE and
PIP (3:1) under TSCA section 6(h)(4), in addition to the existing
requirements under RCRA (e.g., those for non-hazardous solid waste,
industrial waste), is not practicable. As explained in the 2021
rulemaking, imposing a requirement under TSCA section 6(a) to treat
waste containing the PBT chemicals that are not hazardous under
Resource Conservation and Recovery Act (RCRA) as if they were hazardous
waste would have impacts on hazardous waste disposal capacity and be
very expensive for States and local governments as well as for affected
industries. For more discussion on this issue, see the 2021 final rules
(Refs. 4 and 5).
2. Commercial Use of Products and Articles
As also explained in the 2021 PBT final rules, EPA did not propose
regulations relating to commercial use of products and articles
containing the PBT chemicals, such as televisions and computers,
because such regulation would both require testing, which may not be
widely available for a chemical, and is expected to be extremely
burdensome, necessitating the development of a test method to allow for
the identification of products containing PBT chemicals, including
decaBDE and PIP (3:1), 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 channels of trade could occur while the prohibited
items were identified and replaced. EPA also acknowledged, based on
additional information provided by industry stakeholders after the 2021
PIP (3:1) final rule, that international supply chains are complex, and
that complexity creates challenges for identifying and finding
alternatives to PIP (3:1) in international supply chains. Taking this
into account, EPA did not reevaluate the practicability of further
exposure reductions relating to continued commercial use of products
and articles containing decaBDE and PIP (3:1).
3. Recycling
Finally, in the 2021 PBT final rules, EPA explained that it did not
propose to use its TSCA section 6(a) authorities to restrict recycling
activities generally. EPA explained that it recognized the importance
and impact of recycling, which contributes to the protection of our
environment, and that it would be overly burdensome and not practicable
to impose restrictions on the recycling of plastics that may contain
decaBDE or PIP (3:1), or on the use of such recycled plastic in plastic
articles. EPA also explained that decaBDE and PIP (3:1), if present,
are typically present in such articles at low levels and that banning
the recycling of plastics containing decaBDE or PIP (3:1) would require
decaBDE- and PIP (3:1)-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
(Ref. 30). EPA concluded that it would be difficult to make plastic
sorting for this purpose cost-effective, and that it would be overly
burdensome and not practicable to prohibit recycling of decaBDE- and
PIP (3:1)-containing plastic in the United States. Taking this into
account, EPA did not reevaluate the practicability of further exposure
reductions relating to a prohibition of, or further regulatory
restrictions on, the general recycling of decaBDE- and PIP (3:1)-
containing plastic in the United States at this time. As noted in Unit
III.C., the one exception relates to the 2021 decaBDE final rule
authorization for the continued recycling and distribution in commerce
of existing plastic shipping pallets that contain decaBDE for the
extent of the pallets' service life because EPA has determined it is
practicable to regulate when expensive testing is not necessary to
determine the chemical's presence in the article.
C. DecaBDE--Revisions to 40 CFR 751.405
1. Require Signage in Regulated Areas
EPA proposed to require a label on existing plastic shipping
pallets that contain decaBDE. EPA received several comments regarding
the proposed labeling requirement for decaBDE-containing plastic
shipping pallets (EPA-HQ-OPPT-2023-0376-0304, EPA-HQ-OPPT-2023-0376-
0292, EPA-HQ-OPPT-2023-0376-0311, EPA-HQ-OPPT-2023-0376-0313).
Specifically, some commenters agreed with the proposed labeling
requirement but urged EPA to expand the labeling requirement to all
articles containing decaBDE (EPA-HQ-OPPT-2023-0376-0313). Other
commenters expressed concern with the labeling requirement and stated
the labels should not apply to any recyclers (EPA-HQ-OPPT-2023-0376-
0311). Commenters also discussed implementation concerns regarding the
label and the need for testing of pallets to determine if decaBDE is
present (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-2023-0376-0304).
In response to a comment received during the March 2021 request for
comment, EPA held a government-to-government Tribal consultation in
November 2022, in which EPA received comments requesting the Agency
require labeling of plastics that contain decaBDE (Refs. 16 and 31),
EPA proposed to require a label on existing plastic shipping pallets
that contain decaBDE. At the time of the proposal, EPA determined it
was practicable to label existing plastic shipping pallets containing
decaBDE because all plastic shipping pallets that contain decaBDE are
owned by a single company, and it was EPA's understanding that the
company tracked, as part of normal business operations, each decaBDE-
containing plastic shipping pallet. No
[[Page 91496]]
new decaBDE has been added to the company's plastic shipping pallets
since 2012 (Ref. 27).
EPA held an additional stakeholder meeting with the company that
recycles plastic pallets that contain decaBDE during the public comment
period in December 2023 and received additional public comments (Refs.
27 and EPA-HQ-OPPT-2023-0376-0314). Based on this stakeholder meeting
and these public comments, EPA determined that its understanding of the
company business model was incorrect as described in the proposal.
Although an initial bar code is attached to the pallet after it is
molded, these labels are quickly damaged once introduced into commerce
and are not replaced.
The purpose of EPA's proposed label requirement was to provide
notice that PPE is required during the recycling of plastic shipping
pallets contain decaBDE. The proposed label would only be seen, if at
all, during the initial step of recycling and the disassembly of the
pallet. Since exposure to decaBDE in plastic shipping pallets that are
in use and moving throughout commerce is not expected (Ref. 19), and
public comments indicated that the labels would likely not be present
at the time of recycling, EPA has determined that labeling of decaBDE-
containing plastic shipping pallets is not practicable and is not
finalizing the labeling requirement for plastic shipping pallets that
contain decaBDE.
To reduce potential exposures to decaBDE during the recycling of
plastic shipping pallets that contain decaBDE, EPA is finalizing a
signage requirement in the regulated area, defined at 40 CFR 751.403 as
``an area established by the regulated entity to demarcate areas where
airborne concentrations of a specific chemical substance can reasonably
be expected.'' This definition is intended to include those areas where
plastic pallets are recycled. This sign will provide notice to workers
that PPE is required to be worn during recycling of plastic shipping
pallets manufactured before March 8, 2021, which will reduce potential
exposures to decaBDE (see Unit III.C.2. for more information on
specific PPE requirements). A sign must be posted at every entry point
into the regulated area that clearly, prominently, in multiple
languages as appropriate, and in an easily readable font size, contains
the following text: ``Decabromodiphenyl (decaBDE) (CASRN 1163-19-5), a
chemical that has been identified as a persistent, bioaccumulative, and
toxic (PBT) chemical by the U.S. Environmental Protection Agency, may
be present in this regulated area. All persons in this regulated area
who recycle plastic shipping pallets that contain decaBDE are required
to wear personal protective equipment, including respiratory protection
that is at least as protective as a NIOSH-approved N95 respirator with
an assigned protection factor (APF) of 10 and dermal protection of
gloves that are chemically resistant to decaBDE, per regulations at 40
CFR 751.405(e).'' EPA is not requiring testing to determine if decaBDE
is present in the plastic shipping pallets.
2. Require Worker Protections for Certain Activities Involving DecaBDE
EPA proposed to require inhalation and dermal PPE during certain
ongoing uses listed at 40 CFR 751.405(a)(2) and (b). To ensure
exposures to workers are reduced to the extent practicable during
domestic manufacturing and processing of decaBDE and decaBDE-containing
products and articles, EPA is finalizing at 40 CFR 751.405(e), worker
protection requirements to address potential respiratory and dermal
exposure to workers during ongoing activities involving decaBDE,
specifically certain activities where the prohibitions phase-ins have
not passed (i.e., manufacture and processing of decaBDE for use in
replacement parts and the manufacture of such parts, as specified in 40
CFR 751.405(a)(2)(iii) and (iv), and the processing through recycling
of plastic pallets, as specified in and 40 CFR 751.405(b)). In
addition, EPA made minor modifications to new 40 CFR 751.405(e)(6) to
ensure it is clear what is being excluded and what is not (i.e., the
processing of decaBDE for recycling is not included) and 40 CFR
751.405(b) clarifying that processing of decaBDE for recycling was not
excluded.
EPA is requiring owner or operators to select and provide
respiratory protection that is at least as protective as a NIOSH-
approved N95 respirator with an assigned protection factor (APF) of 10
and gloves that are chemically resistant to decaBDE. EPA has
determined, based on comments, that it is practicable to require worker
protection, including PPE, for the processing of existing plastic
shipping pallets because it is already industry practice (Ref. 27).
Although it is EPA's understanding that domestic manufacturing and
processing of decaBDE for use in new and replacement parts for motor
and aerospace vehicles has ceased, EPA is requiring PPE for these uses.
This approach ensures that any ongoing activity involving decaBDE,
past, present or future, is addressed by this regulatory approach
taken, and thus the regulations 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. For all other
processing for recycling activities of decaBDE-containing plastic from
products or articles and decaBDE-containing products or articles made
from such recycled plastic, EPA maintains that it would be
impracticable to establish a testing program to determine if decaBDE is
present. Due to the difficulty in identifying whether and where decaBDE
is present in an article, EPA is not requiring worker protections for
all other processing for recycling activities.
EPA is not requiring worker protections for all ongoing processing
of articles (e.g., processing of decaBDE-containing wire and cable for
use in nuclear power generation facilities), because EPA has determined
worker protections are not practicable. This is because the Agency
understands that the processing of these articles would result in
minimal potential for worker exposure because, once formulated, decaBDE
is encased in the cured coating and the potential for worker exposure
is minimal (Ref. 19). EPA is also not requiring worker protections for
distribution in commerce of decaBDE or decaBDE-containing products or
articles, since the distribution in commerce of decaBDE and decaBDE-
containing products or articles would result in minimal potential for
exposure. Lastly, because EPA generally understands the potential for
exposure is low during importation, the Agency is not requiring worker
protections for import of decaBDE and decaBDE-containing products and
articles that were excluded under the 2021 final decaBDE rule.
Addressing such minimal potential for exposure through worker
protections would not be practicable considering the additional costs
and resource burdens (Ref. 19).
For the activities subject to the worker protection requirements
and to reduce potential occupational exposure during the recycling
process of plastic shipping pallets that contain decaBDE, EPA is
finalizing the requirement for, at a minimum, a NIOSH-approved N95
respirator with an APF 10 and gloves that are chemically resistant to
decaBDE with activity-specific training where dermal contact with
decaBDE is reasonably expected.
Where PPE is required, EPA is finalizing its proposal to require
implementation of a PPE program in alignment with certain elements of
OSHA's General Requirements for PPE at 29 CFR 1910.132 and Respiratory
Protection requirements in 29 CFR 1910.134. EPA is requiring that
owners
[[Page 91497]]
and operators maintain PPE in a sanitary, reliable, and undamaged
condition and ensure that each potentially exposed person who is
required to wear PPE uses such PPE. Under this final rule, owners and
operators will be required to select and provide PPE that properly fits
each potentially exposed person who is required to use PPE. For N95
respirators with an APF 10, the owner or operator must ensure that all
respirators used in the workplace are NIOSH-approved as listed on the
NIOSH Certified Equipment List (Refs. 32 and 33). Where dermal PPE is
required, EPA is finalizing a requirement that owners and operators
provide gloves that are chemically resistant to decaBDE with activity-
specific training where dermal contact with decaBDE is possible (Ref.
34). Owners and operators are also required to communicate PPE
selections (e.g., demonstration that each item of PPE selected prevents
exposure during expected duration and conditions of exposure) to each
potentially exposed person.
EPA uses the term ``potentially exposed person'' in this unit,
elsewhere in the preamble, and in the regulatory text to mean any
person who may be exposed to a chemical substance or mixture regulated
under 40 CFR part 751 subpart E as a result of the use of that chemical
or mixture. ``Any person'' includes workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area. One important reason to define a potentially exposed
person as any person who may be exposed in the workplace is to
emphasize the broad scope of exposures. EPA notes that this definition
is intended to apply only in the context of risk management (e.g.,
workers directly using the chemical, workers in the vicinity of the
use, students in a laboratory setting). The term is not intended as a
replacement for the term Potentially Exposed or Susceptible
Subpopulation as defined by TSCA section 3(12).
EPA is requiring that each owner or operator comply with OSHA's
respiratory protection training requirements at 29 CFR 1910.134(k) and
general PPE training requirements at 29 CFR 1910.132(f) when using
respirators and gloves. Owners and operators must provide PPE training
to all persons required to use dermal protection or respiratory
protection prior to or at the time of initial assignment to a job
involving exposure to decaBDE.
EPA is also requiring the implementation of a respiratory
protection program in alignment with 29 CFR 1910.134(b), (c)(1), (c)(3)
and (4), (d)(1)(iv), (f), and (g) through (l)), which requires each
owner or operator to select respiratory protection in accordance with
the guidelines for proper respirator use, maintenance, fit-testing,
medical evaluation, and training. Owners or operators who are required
to administer a respiratory protection program must ensure a respirator
is utilized in accordance with 29 CFR 1910.134(d)(1).
EPA is finalizing its proposal to require that owners and operators
document respiratory protection used and PPE program implementation and
retain those records for five years from the date the record is
generated. EPA is also finalizing its requirement that owners and
operators must document and keep records of the information on the PPE
program, as applicable, and make it available to the Agency upon
request. In addition, and in response to comments, owners and operators
must also keep records related to the basis for the regulated area as
defined in 40 CFR 751.403, as well as provide potentially exposed
persons and their designated representative(s) an opportunity to
observe records related to the basis of the PPE or another control
measure selection, including potential monitoring results that are
representative of the potentially exposed person's exposure.
3. Prohibit the Release to Water During the Manufacturing, Processing,
and Distributing of DecaBDE and DecaBDE-Containing Products
EPA proposed to prohibit the releases to water during the
manufacturing, processing, and distribution in commerce of decaBDE and
decaBDE-containing products and proposed to require all persons to
follow any regulations that may apply and best management practices for
preventing the release of decaBDE to water. EPA received a comment in
support of the prohibition on certain releases to water during the
manufacturing, processing, and distribution in commerce of decaBDE and
decaBDE-containing products (EPA-HQ-OPPT-2023-0376-0286).
EPA also received comments requesting EPA expand the provision to
regulate wastewater treatment plants, landfills, and land-applied
sewage sludge for both decaBDE and PIP (3:1) (EPA-HQ-OPPT-2023-0376-
0303, EPA-HQ-OPPT-2023-0376-0313). More discussion of the commenters'
request can be found in the RtC Document (Ref. 20). After one commenter
expressed concern regarding the lack of specificity around the ``best
management practices'' clause and receiving no additional information
during the public comment period on how a prohibition on releases to
water could best be achieved through best management practices, EPA is
not finalizing the ``best management practices'' clause (EPA-HQ-OPPT-
2023-0376-0297). EPA is finalizing the prohibition on the releases to
water during the manufacturing, processing, and distribution in
commerce of decaBDE and decaBDE-containing products, and such persons
are required to follow applicable regulations that may apply for
preventing the release of decaBDE to water. Applicable regulations
related to this final prohibition on releases to water may include
restrictions on discharges under the Federal Water Pollution Control
Act (commonly known as the Clean Water Act), Safe Drinking Water Act
(SDWA), or analogous State laws. However, EPA is not amending the 2021
PIP (3:1) final rule restrictions on release to water, which retains
the requirement to follow ``best management practices.''
The prohibition on the release to water during the manufacturing,
processing, and distribution in commerce of decaBDE and decaBDE-
containing products prevents direct releases of decaBDE to water. Thus,
only those facilities that are manufacturing, processing, and/or
distributing in commerce decaBDE and decaBDE-containing products,
including wastewater treatment plants that engage in those activities,
are subject to the prohibition on releases to water. This final rule
does not impose restrictions on sources discharging indirectly to
publicly owned treatment works (POTWs). EPA is also not imposing
specific requirements for wastewater treatment plants, unless those
facilities are manufacturing, processing, and/or distributing decaBDE
or decaBDE-containing products. EPA determined that it is not
practicable to require all wastewater treatment plants to test and
potentially treat for decaBDE. However, prohibiting the release from
the manufacturing, processing, and distribution in commerce of decaBDE
and decaBDE-containing products will result in an overall reduction in
releases of decaBDE to water generally, including, any potential
release to water that could happen from being present at downstream
wastewater treatment plants. See the RtC Document for more discussion
on regulating PBT disposal (Ref. 20).
After reconsidering the practicability of prohibiting releases to
water due to the public comments, and the potential for releases to
water, even though there
[[Page 91498]]
are no reported releases, EPA is finalizing the prohibition on the
release to water to prevent any potential future releases of decaBDE
and to protect exposed populations (e.g., subsistence fishers) (Ref.
19). Prohibiting releases to water highlights the importance of
preventing environmental releases of decaBDE and PIP (3:1) and reducing
potential exposures. As mentioned in the Exposure and Use Assessment,
Toxics Release Inventory (TRI) data show a decrease in releases that
are reported in each industry sector using decaBDE (Ref. 19). As of
2016, the number of manufacturing facilities, textile manufacturing
facilities, wire and cable manufacturing facilities, and other
facilities reporting TRI releases has decreased from several dozen to
only one manufacturer and 23 other facilities (Ref. 19). Specifically,
the one manufacturer that released decaBDE to water prior to 2012, is
now prohibited from manufacturing decaBDE under the 2021 decaBDE final
rule. According to the most recent (2021) TRI data, there were zero
releases of decaBDE to water (Ref. 35). TRI reporting is required only
for facilities within specific NAICS codes who have 10 or more full-
time employees, so it is possible that there were releases outside of
the reporting requirements, but EPA understands this is unlikely.
Prohibiting releases to water during manufacture, processing, and
distribution in commerce of decaBDE and decaBDE-containing products
will prevent future releases of decaBDE to the water from permissible
ongoing activities, reducing the overall potential for exposure. While
in some cases EPA has determined that it is not practicable to exercise
its TSCA section 6(a) authorities to regulate certain exposures under
TSCA section 6(h), as outlined in Unit II.B., this is not the case for
certain releases of decaBDE to water.
EPA is not extending this requirement to include a prohibition on
the release to water for the processing and distribution in commerce of
decaBDE-containing articles, including recycled materials that may
contain decaBDE. As described in more detail in the 2021 decaBDE final
rule and the supporting response to comment document, it would be
extremely burdensome to identify articles containing decaBDE to
determine if a facility that recycles articles is subject to this final
release to water prohibition (Ref. 36).
4. Extend the Compliance Deadline for Processing and Distribution in
Commerce of DecaBDE-Containing Wire and Cable Insulation for Use in
Nuclear Power Generation Facilities
EPA proposed to extend the compliance date, limited to processing
and distribution in commerce of decaBDE-containing wire and cable
insulation and the components containing the wire and cable in nuclear
power generation facilities (including test and research reactors),
until after the end of the service life of the wire and cable. EPA
received several comments in support of the extended compliance date
for processing and distribution in commerce of decaBDE-containing wire
and cable insulation for use in nuclear power generation facilities
(EPA-HQ-OPPT-2023-0376-0299, EPA-HQ-OPPT-2023-0376-0300). One commenter
stated that an alternative is available and disagrees with EPA's
proposal to extend the compliance deadline (EPA-HQ-OPPT-2023-0376-
0294). However, based on discussions with the Nuclear Regulatory
Commission (NRC), EPA disagrees with the commenter that alternative,
decaBDE-free, fully qualified wire and cables are available that meet
the NRC's requirements in 10 CFR 50.49, ``Environmental qualification
of electric equipment important to safety for nuclear power plants,''
including the Institute of Electrical and Electronics Engineers 383
(``IEEE 383'') standard for instrumentation and power cable insulation.
Another commenter stated that the proposed extension for processing and
distribution in commerce of decaBDE-containing wire and cable
insulation for use in nuclear power generation facilities is vital, as
these cables and components are necessary for the safety systems that
prevent release of radioactive materials into the environment (EPA-HQ-
OPPT-2023-0376-0299). Additional details can be found in the RtC
Document (Ref. 20). EPA is finalizing the proposed compliance date
extension for processing and distribution in commerce of decaBDE-
containing wire and cable insulation for use in nuclear power
generation facilities.
As mentioned in the proposal, decaBDE has been used in Class 1E
cables, which are qualified to meet industry standards and NRC
requirements in 10 CFR 50.49, including the Institute of Electrical and
Electronics Engineers 383 (``IEEE 383'') standard for instrumentation
and power cable insulation. Recognizing this, and in response to
stakeholder feedback and engagements with the only known supplier of
decaBDE-containing wire and cable, EPA established an extended
compliance deadline of January 6, 2023, in the 2021 decaBDE final rule,
after which 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 was
prohibited (40 CFR 751.405(a)(2)(ii)). EPA interprets the term
``nuclear power generation facilities'' to include nuclear reactors as
defined by the NRC in 10 CFR 50.2, production facilities, test and
research reactors, other utilization facilities not specifically
designed for or used primarily for the formation of plutonium or U-233,
and reactors operated under the oversight of the U.S. Department of
Energy (DOE). EPA has added text in 40 CFR 751.405(a)(2)(ii) to include
one example of the types of facilities covered by nuclear power
generation facilities. In addition, EPA is clarifying that 40 CFR
751.405(a)(2)(ii) and (vi) are not limited to a specific level of power
generation and that EPA interprets the provision to include
``electrical equipment important to safety'' as defined in 10 CFR
50.49(b) and materials required for the safe operation of ``Alternate
ac source'' and ``Basic component'' as defined in 10 CFR 50.2 that
include decaBDE-containing wire and cable.
After the January 6, 2023, extended compliance deadline in the 2021
decaBDE final rule, EPA received multiple requests and letters of
concern regarding the availability of decaBDE-containing wire and cable
insulation used in the nuclear power sector (Refs. 37 and 38). These
inquiries and outreach came shortly after the supplier of this decaBDE-
containing wire and cable discontinued processing and distribution in
commerce and notified its customers of its inability to continue
supplying their wire and cable due to the January 6, 2023, compliance
date. Due to the lack of communication and engagement between the
primary supplier and their customers, as well as with EPA, the industry
reported to EPA that they were at risk of not having qualified wire and
cable available, which could negatively affect both scheduled
maintenance outages and unplanned equipment failures and, ultimately,
could force multiple nuclear power plants to be temporarily taken
offline. In response to this, on April 20, 2023, EPA's Office of
Chemical Safety and Pollution Prevention (OCSPP) requested that the
Office of Enforcement and Compliance Assurance (OECA) issue an
enforcement statement
[[Page 91499]]
regarding certain entities that are subject to the prohibitions on
processing and distribution in commerce of decaBDE-containing wire and
cable insulation for nuclear power generation facilities as a bridge to
this final rule addressing this use.
In response to this request, EPA's OECA issued a temporary
``Enforcement Statement'' on May 2, 2023, which indicates that the
Agency does not intend to pursue enforcement for certain violations of
the prohibition on processing and distribution in commerce of decaBDE-
containing wire and cable insulation for nuclear power generation
facilities, including those component and safety systems that contain
the decaBDE-containing wire and cable insulation, that went into effect
on January 6, 2023, as long as the entities involved are diligently
working to qualify their alternative components in accordance with NRC
regulations and guidance (Ref. 39).
After considering feedback from the industry and Federal partners,
including DOE and NRC, EPA is finalizing its proposal to extend the
compliance date, limited to processing and distribution in commerce of
decaBDE-containing wire and cable insulation and the components
containing the wire and cable in nuclear power generation facilities
(e.g., production facilities, test and research reactors), until after
the end of the service life of the wire and cable, and the components
containing the wire and cable (see 40 CFR 751.405(a)(2)(vi)).
Stakeholders have indicated that existing decaBDE-containing wire and
cable insulation and components containing the wire and cable may need
to be distributed and processed for refurbishment, maintenance, and
repair until the wire and cable is replaced. In addition, EPA's
``Exposure and Use Assessment of Five Persistent, Bioaccumulative, and
Toxic Chemicals'' indicates that although releases of decaBDE could
occur during the processing of decaBDE to make the wire and cable, once
formulated into the wire and cable, decaBDE is encased in the cured
coating and the potential for worker exposure is minimal (Ref. 19).
Therefore, EPA concluded that allowing the processing and distribution
in commerce of decaBDE-containing wire and cable insulation and the
components containing the wire and cable in nuclear power generation
facilities (including test and research reactors) to continue is
necessary and practicable.
EPA is not allowing resumption of processing and distribution in
commerce of raw or compounded decaBDE for use in wire and cable
insulation in nuclear power generation facilities. The only known user
of raw or compounded decaBDE has been permitted to resume these
activities for a limited time under a settlement agreement that
provides a mechanism for the continued availability of decaBDE-
containing wire and cable insulation, while the nuclear power
generation facilities undergoes transition to a decaBDE-free
alternative (Ref. 40). The termination conditions of the settlement
agreement states that it shall remain in place for five years following
the effective date unless terminated earlier, while the company's
customers transition to receipt of Class 1E cable that is decaBDE-free.
5. Require Export Notification for DecaBDE-Containing Wire and Cable
for Nuclear Power Generation Facilities
EPA proposed to amend the current rule to require a TSCA section
12(b) export notice for the export of decaBDE-containing wire and cable
for nuclear power generation facilities. EPA received one comment of
support and one comment of opposition related to the proposed export
notification for decaBDE-containing wire and cable for nuclear power
generation facilities (EPA-HQ-OPPT-2023-0376-0286, EPA-HQ-OPPT-2023-
0376-0286). The commenter stated that the export notification is
precedent-setting and should be a standalone proposal. EPA disagrees
with this commenter and is finalizing the export notification
requirement for decaBDE-containing wire and cable for nuclear power
generation facilities.
As mentioned in the proposal to this final rule, and as discussed
in the 2021 decaBDE final rule, decaBDE is listed on Annex A of the
Stockholm Convention on Persistent Organic Pollutants (the POPs
Convention), which prohibits the production, use, import, and export of
decaBDE and decaBDE-containing products and articles for Parties to the
listing decision for decaBDE, unless otherwise subject to a specific
exemption (Ref. 41). There is no specific exemption under the POPs
Convention for decaBDE-containing wire and cable for nuclear power
generation facilities, and thus, EPA did not expect import or export
for this use to occur. However, since EPA has learned that there is a
need for export of decaBDE-containing articles for this purpose (Ref.
40), EPA is finalizing this provision. Although articles are generally
exempt under 40 CFR 707.60(b) from the requirement to provide notices
of export under TSCA section 12(b), EPA is finalizing its proposal to
amend the 2021 decaBDE final rule to require a TSCA section 12(b)
export notice for the export of decaBDE-containing wire and cable for
nuclear power generation facilities. Such notice requirement was
triggered 30 days after publication of the proposed rule, pursuant to
TSCA section 12(b) and 40 CFR 707.60(a)(3) and 707.65(a)(1)(i) and (b).
The notification to EPA of such intent to export will not provide
consent by the importing countries for import of the shipment; the
importing countries may choose not to permit import of such shipment.
Consistent with 40 CFR 751.7(a), the provisions of subpart D of 40 CFR
part 707 still apply to any export notifications required for decaBDE
and PIP (3:1) under TSCA section 6(h). EPA is not requiring export
notification for any other articles.
6. Recordkeeping Requirements
EPA proposed to increase the recordkeeping requirement from three
to five years and to remove the 30-day time frame to make records
available for decaBDE. EPA received support for the proposed extended
recordkeeping requirements (EPA-HQ-OPPT-2023-0376-0313, EPA-HQ-OPPT-
2023-0376-0313). One commenter suggested EPA extend the recordkeeping
requirements to a much longer period of time, suggesting 20-30 years as
an appropriate time frame (EPA-HQ-OPPT-2023-0376-0312). As discussed in
the proposed rule and in more detail in the RtC Document, the proposed
record retention time frame of five years is consistent with those
associated with other TSCA section 6(a) rulemakings, and because it
aligns with the statute of limitations for civil penalty enforcement
(28 U.S.C. 2462). Also, the proposal to modify the time frame for
making records available from a 30-day time frame to upon request is
critical to the Agency's ability to promptly identify and correct
noncompliance (Refs. 1 and 20).
EPA is finalizing its proposal to increase the recordkeeping
requirement from three to five years and is removing the 30-day time
frame to make records available for decaBDE and PIP (3:1). In the 2021
decaBDE final rule, EPA required that all persons who manufacture,
process, or distribute in commerce decaBDE and products and articles
containing decaBDE maintain ordinary business records related to
compliance with the prohibitions and restrictions for three years and
to make records available within 30 days upon request. Due to the
additional requirements being finalized in this rulemaking,
specifically those pertaining to worker safety, EPA considers that the
five-year time frame
[[Page 91500]]
regarding recordkeeping and removal of the 30-day time frame to make
records available upon request is more appropriate. Furthermore, this
is consistent with the time frame associated with other TSCA section
6(a) rulemakings that include worker protection requirements. EPA is
confident that extending each rule's recordkeeping requirement to a
consistent five-year requirement will facilitate regulated entities'
compliance with minimal impact to regulatory burden. In addition,
removal of the 30-day time frame to make records available upon request
is critical to the Agency's ability to promptly identify and correct
noncompliance. EPA presumes that the regulated entities should have the
records demonstrating compliance readily available.
As it relates to recordkeeping for worker protections, EPA is
finalizing its proposal to require that owners/operators document
respiratory protection used and PPE program implementation and retain
those records for five years. One commenter (EPA-HQ-OPPT-2023-0312)
stated that this information should be available to workers throughout
the period of potential consequences of an exposure. EPA has modified
the workplace protection records requirements for both PIP (3:1) and
decaBDE to require that the owner or operator provide potentially
exposed persons and their designated representatives an opportunity to
observe records related to the basis of the PPE or other control
measure selection, including potential monitoring results that are
representative of the potentially exposed person's exposure.
D. PIP (3:1)--Revisions to 40 CFR 751.407
1. Exclusions and Phase-In Prohibitions
EPA reviewed the determinations underlying the exclusions from
prohibition in the January 2021, PIP (3:1) final rule to consider
whether to adopt new restrictions for activities currently excluded,
consistent with the statutory directive to reduce exposure to the
extent practicable (Refs. 13 and 36). For many of the exclusions, EPA
determined that there were no technically feasible alternatives or that
the time and cost to identify, research, and replace PIP (3:1) in
supply chains were impracticable. During the comment periods following
the March 6, 2021, notification, and in comments on the proposed rule
for this rulemaking, many stakeholders from the auto, aerospace,
semiconductor, heavy machinery, and other sectors provided additional
information on time frames that they determined would allow those
industries a reasonable period to transition from PIP (3:1) to
alternatives (EPA-HQ-OPPT-2021-0202). Where EPA received information
that transition from PIP (3:1) to an alternative has already occurred
or could occur within a reasonable transition period, EPA has
determined the modifications are practicable and is therefore
finalizing such modifications. In other instances, where commenters
were not able to provide similar information for determining a
reasonable period for such transition, EPA did not finalize extending
the compliance deadline.
EPA is modifying several exclusions from prohibitions that were
finalized in the January 6, 2021, PIP (3:1) final rule (Ref. 5). These
final modifications include narrowing the scope of certain exclusions,
adding prohibition phase-in dates, and/or in some cases creating new
exclusions from a prohibition for certain uses. In conjunction with
narrowing the scope of certain exclusions, EPA is also finalizing
prohibitions, as proposed, through phase-outs in 40 CFR 751.407(a)(2)
on the manufacture (including import), processing, and distribution in
commerce of the PIP (3:1)-containing products and articles for the uses
that were covered by an exclusion. This restriction will ensure the
phase-out of domestic production and imports of PIP (3:1)-containing
products and articles. EPA is not generally prohibiting the
manufacturing of PIP (3:1), consistent with the 2021 PIP (3:1)
rulemaking, due to the number of excluded activities that EPA has found
it impracticable to prohibit.
a. Lubricants and Greases
EPA is finalizing as proposed the narrowed exclusion from
prohibition in 40 CFR 751.407(b)(1)(ii) for only certain lubricants and
greases. Specifically, the final exclusion only covers processing and
distribution in commerce of PIP (3:1) for use in lubricants and greases
for aerospace use and turbine engines, PIP (3:1)-containing products
for use in lubricants and greases for aerospace use and turbine
engines, and PIP (3:1)-containing lubricants and greases for use in
aerospace and turbine applications. EPA is also finalizing a
prohibition phase-in for non-aerospace and non-turbine applications,
but based on comments received, EPA is amending the proposed phase-in
prohibition time frame from 5 years to 15 years. The processing and
distribution in commerce of PIP (3:1) for use in lubricants and
greases, PIP (3:1)-containing products for use in lubricants and
greases, and PIP (3:1)-containing lubricants and greases, excluding
aerospace and turbine uses, likewise will be subject to a 15-year
phased-in prohibition.
EPA proposed the 5-year compliance time frame because at least one
stakeholder requested a 5-year transition period to move away from PIP
(3:1) for their applications (Ref. 42). However, several commenters
opposed EPA's proposal. Four commenters requested EPA reconsider the
full exclusion in the 2021 final rule. One commenter (EPA-HQ-OPPT-2023-
0376-0307) noted the regulatory uncertainty associated with some
possible alternatives to PIP (3:1) being on the TSCA 2014 work plan and
potentially subject to regulation. Another commenter (EPA-HQ-OPPT-2023-
0376-0284) stated the belief that for many applications, it is not
possible to estimate how long it will take to develop an alternative
that meets required performance specifications and can be stably
supplied. Another commenter stated their belief that they do not think
an alternative could be found in 30 years. These commenters recommended
a 30-year phase-in prohibition, only if it included a means to seek a
case-by-case exemption. Another commenter (EPA-HQ-OPPT-2023-0376-0295)
argued that that the exclusion was needed in order to maintain access
to PIP (3:1)-containing lubricants and greases in case manufacturers
reformulate their products so that they no longer contain PIP (3:1) and
they discontinue selling these products.
In the 2019 PBT proposed rule, EPA acknowledged, and continues to
acknowledge in this final rule, that PIP (3:1) is a crucial anti-wear
component for lubricants and greases that are used in electronics and
other applications beyond aerospace, and EPA stated its understanding,
based on available information, that such applications are not subject
to the same extreme performance conditions. Commenters did not provide
information to support claims that technically feasible alternatives
could not be identified. While EPA did not identify specific
alternatives for specific applications, believing that companies are
best able to do so, EPA identified potential alternatives in the
Economic Analysis for the 2021 PIP (3:1) final rule. For these reasons,
EPA is not re-instituting the full exclusion in the 2021 final rule.
EPA is also not adopting a mechanism for informal extensions in the
final rule. There is no provision under TSCA for the informal extension
of compliance dates. Future amendments to the phaseouts in this rule
would require
[[Page 91501]]
additional rulemaking. EPA emphasizes that, as part of the 2021
rulemaking and this rulemaking processes, EPA has met with stakeholders
and encouraged stakeholders to inform EPA of any ongoing activity with
decaBDE and PIP (3:1) and products or articles containing decaBDE or
PIP (3:1), and the prohibitions or phase-out approaches in the final
rule take the information gathered into consideration. Thus, EPA does
not expect the need for some kind of established process for obtaining
an informal extension.
Several commenters proposed alternative prohibition phase-in
periods for non-aerospace and non-turbine lubricant and greases. Two
commenters (EPA-HQ-OPPT-2023-0376-0287, EPA-HQ-OPPT-2023-0376-0289)
recommended EPA finalize the same timelines for lubricants and greases
as parts for motor vehicles (15 years for parts for new motor vehicles
and 30 years for replacement parts). This is because alternatives for
motor vehicles is challenging due to the specific requirements, such as
high temperatures, pressures, and durability, as well as safety. EPA
notes that the final regulations continue the exclusion for the
processing and distribution of PIP (3:1)-containing lubricants and
greases for aerospace use and turbine engines, but otherwise requires
the phase-out of all other PIP (3:1)-containing lubricants and greases
after 15-years unless there is another provision authorizing the
processing and distribution of PIP (3:1) for use in articles, for
example for replacement parts for motor vehicles (40 CFR
751.407(a)(2)(v) and (vi)). See Unit III.D.1.b. for a further
discussion on PIP (3:1) use in motor vehicles and Unit III.D.2. for
precedence of phase-in prohibitions.
Two commenters (EPA-HQ-OPPT-2023-0376-0295, EPA-HQ-OPPT-2023-0376-
0302) asked the Agency to confirm in the preamble to the final revised
rule that the phrase ``turbine applications'' as used in the proposed
regulation refers to the use of PIP (3:1) formulations in gas turbine
engines (whether for aviation or in nonaviation aeroderivative gas
turbine engines AGTs), and not other kinds of turbines. In the
proposal, EPA asked for comment on the scope of the exclusion for
turbines. Because EPA understands that PIP (3:1)-containing lubricants
and grease may have applications in other categories of turbines, EPA
is not further narrowing the scope of the exclusion to only gas turbine
engines.
b. New and Replacement Parts for Motor Vehicles
EPA proposed to repeal the 2021 exclusion from prohibition in
existing 40 CFR 751.407(b)(1)(iii) for new and replacement parts for
motor and aerospace vehicles and to establish phase-in prohibitions
related to motor vehicle and aerospace uses. The proposed 15-year phase
in prohibition of processing and distribution in commerce of PIP (3:1)
and PIP (3:1)-containing products for use in parts for new motor
vehicles was based on industry's own description of their experience
with transitioning from a different chemical, albeit under different
circumstances, and the time frames provided. The aspects of this
exclusion that relate to aerospace vehicles and wire harnessing and
electric circuit boards are addressed in Unit III.D.1.c. and Unit
III.D.1.d., respectively. Multiple industry trade organizations (EPA-
HQ-OPPT-2023-0376-0285, EPA-HQ-OPPT-2023-0376-0289, EPA-HQ-OPPT-2023-
0376-0308) expressed support for the proposed 15-year phased-in
prohibition for new parts and 30-year phase-in for replacement parts
for motor vehicles. At least one commenter (EPA-HQ-OPPT-2023-0376-0290)
noted that the proposed compliance dates for motor vehicles, now being
finalized in this action, appear to be feasible and noted that a
shorter compliance period for new motor vehicles would not be feasible,
as motor vehicle supply chains are complex, often rely on foreign
suppliers, and are likely to take 15 years to phase out the use of PIP
(3:1) completely.
EPA is finalizing its replacement of the existing exclusion at 40
CFR 751.407(b)(1)(iii) for use of PIP (3:1) and PIP (3:1)-containing
products in new and replacement parts for motor vehicles with: (1) a
15-year phase-in prohibition of processing and distribution in commerce
of PIP (3:1) and manufacturing, processing, and distribution in
commerce of PIP (3:1)-containing products for use in parts for new
motor vehicles (i.e., newly produced vehicles), and manufacturing and
processing of PIP (3:1)-containing parts for such new vehicles; and (2)
a 30-year phase-in prohibition on processing and distribution in
commerce of PIP (3:1) and manufacturing, processing, and distribution
in commerce of PIP (3:1)-containing products for use in replacement
parts for motor vehicles, and manufacturing and processing of PIP
(3:1)-containing replacement parts for such vehicles. This final
prohibition does not apply to PIP (3:1)-containing parts that are
subject to a new exclusion (e.g., wire harnesses and circuit boards).
Several commenters requested that EPA clarify this in the regulatory
text and EPA is doing so in this final rule.
In addition, EPA is amending 40 CFR 751.407(a)(2)(v) to correct an
error in the proposed regulatory text. Proposed 40 CFR 751.407(a)(2)(v)
read ``. . . all persons are prohibited from all processing and
distribution in commerce of PIP (3:1) for use in parts for new motor
vehicles, including heavy machinery, and manufacturing, processing, and
distribution in commerce of PIP (3:1)-containing products for use in
parts for new motor vehicles, including heavy machinery, PIP (3:1)-
containing parts for such new vehicles, and the new motor vehicles,
including heavy machinery in any parts.'' [emphasis added] EPA did not
intend to prohibit the distribution in commerce of motor vehicles that
may occur in the secondary market, for example by used car dealers. See
Unit III.D.5. for discussion addressing this issue for PIP (3:1)-
containing cars and aerospace vehicles. Rather, EPA intended to
prohibit new motor vehicles from being manufactured with PIP (3:1)-
containing parts, unless those parts were subject to another exclusion
or alternative phase-in prohibition. While EPA received no comments on
this specific provision, other comments are directly related. In
particular, several commenters asked EPA to clarify that articles
manufactured prior to the prohibition phase-in can continue to be
imported, moved, distributed, and processed. These comments are
addressed in Unit III.D.1.b. and Unit III.D.5. in regard to equipment
and other articles.
Stakeholders representing manufacturers of new original equipment
and aftermarket components, systems, and materials for use in passenger
cars and light trucks indicated that, under the assumption that an
alternative to PIP (3:1) could be found in the next three to four
years, the industry could transition out of using PIP (3:1) within a
seven-to-ten-year time frame (Ref. 43). EPA acknowledges that the time
frame contains many contingencies, which could delay the adoption of
PIP (3:1) alternatives. Nevertheless, based on the industry's own
description of their experience with transitioning from a different
chemical, albeit under different circumstances, and the time frames
provided, EPA determined a 15-year phase-in prohibition of processing
and distribution in commerce of PIP (3:1) and PIP (3:1)-containing
products for
[[Page 91502]]
use in parts for new motor vehicles (i.e., newly produced vehicles) and
a 30-year phase-in prohibition on manufacturing and processing of PIP
(3:1)-containing products for use in replacement parts for motor
vehicles, and manufacturing and processing of PIP (3:1)-containing
parts for such vehicles, as discussed subsequently, is practicable.
EPA is also finalizing new 40 CFR 751.407(a)(2)(vi) to allow
processing and distribution in commerce for an additional 15 years
(i.e., until 30 years after the publication date of this final rule) of
PIP (3:1), the manufacturing, processing, and distribution in commerce
of PIP (3:1)-containing products for use in replacement parts for motor
vehicles, including heavy motorized machinery, and the manufacturing
and processing of PIP (3:1)-containing replacement parts themselves for
such vehicles, and such vehicles with PIP (3:1)-containing parts for 30
years after the publication date of this final rule. The continued
distribution in commerce of PIP (3:1)-containing parts for vehicles and
the vehicles and which contains such parts is discussed in Unit
III.D.5. and is covered under the newly finalized exclusion in 40 CFR
751.407(b). EPA is finalizing this 30-year period to ensure that the
option provided to vehicle manufacturers by 49 U.S.C. 30120 to remedy
the defect or noncompliance by repairing the vehicle or the equipment
(i.e., part) remains available. EPA acknowledges that 49 U.S.C. 30120
does not require manufacturers to supply replacement parts, but rather
to provide a remedy, which may include either replacing the equipment
with identical or reasonably equivalent equipment, or by refunding the
purchase price.
In addition, EPA is amending the language in the phase-in
prohibitions to reference ``heavy motorized machinery'' instead of
``heavy machinery,'' as originally proposed. This is being done to
further clarify what is included in the phase-in prohibitions in 40 CFR
751.407(a)(2)(v) and (vi). As explained in the March 2022 PIP (3:1)
final rule extending the PIP (3:1) compliance date, EPA generally
interprets the term ``motor vehicle'' to mean a transport vehicle that
is propelled or drawn by mechanical power, such as cars, trucks,
motorcycles, boats, and construction, agricultural, and industrial
machinery. The phase-in prohibitions in 40 CFR 751.407(a)(2)(v) and
(vi) include offroad motor vehicles, construction vehicles, like
excavators and front-loaders, and large, motorized equipment, such as
paver, cranes, etc., both for military and non-military applications.
These provisions and associated compliance time frames do not include
off-road stationary equipment and machinery as discussed by commenters
(e.g., non-road mobile equipment, large scale fixed installations,
large scale stationary industrial tools, alternative power
applications). However, EPA is clarifying that off-road stationary
equipment and machinery is included in its understanding of the types
of equipment that compose the manufacturing equipment category under 40
CFR 751.407(a)(2)(ix). See Unit III.D.1.f. for more detail.
Lastly, in response to comments, EPA would like to clarify that
this rulemaking does not repeal the ``end user'' provision in 40 CFR
751.401(b)(1), which allows the distribution in commerce of the
chemical substance, or products and articles that contain the chemical
substance, that has previously been sold or supplied to an end user
(i.e., an individual or entity that purchased or acquired the finished
good for purposes other than resale). While EPA received no comments on
this specific provision, other comments are directly related.
Additional discussion on continued distribution in commerce of complex
articles containing PIP (3:1) is in Unit III.D.5.
c. New and Replacement Parts for Aerospace Vehicles
EPA proposed to repeal the exclusion from prohibition in 40 CFR
751.407(b)(1)(iii) for new and replacement parts for aerospace vehicles
and replace it with a phase-in prohibition that would begin 30 years
after the publication of the final rule on the processing and
distribution in commerce of PIP (3:1) and the manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in parts installed in and distributed as part of new
aerospace vehicles, and the parts to which PIP (3:1) has been added for
such vehicles. EPA also proposed a provision that after the end of the
aerospace vehicles' service lives, the manufacturing, processing, and
distribution in commerce of aerospace vehicles (i.e., those permissibly
manufactured before the compliance time frame ends) that contain PIP
(3:1) in any part will be prohibited. Lastly, EPA proposed that after
the end of the aerospace vehicles service lives, all persons are
prohibited from all manufacturing, processing, and distribution in
commerce of PIP (3:1) and PIP (3:1)-containing products for use in
replacement parts for aerospace vehicles, and the replacement parts to
which PIP (3:1) has been added for such vehicles. EPA is finalizing
these provisions with modifications. These new prohibitions will not
apply to PIP (3:1)-containing parts that are subject to a new exclusion
from prohibition (e.g., wire harnesses and circuit boards).
As discussed in the January 2021 PIP (3:1) final rule, EPA
concluded that a similar reasoning applied to the use of PIP (3:1) in
new and replacement parts for motor vehicles readily transfers to a
review of the justifications for the use of PIP (3:1) for new and
replacement parts in aerospace vehicles. EPA acknowledges the
regulatory and safety requirements for the aerospace industry are as
stringent or more stringent than those for motor vehicles. In
particular, industry stakeholders noted the time required to identify
an alternative, and to test and certify its use in parts, to meet
safety requirements, as well as a lengthy Federal Aviation
Administration approval process. Given these considerations, EPA is
finalizing longer time periods for the phase-in prohibitions for the
use of PIP (3:1) in new and replacement parts for aerospace vehicles.
One commenter (EPA-HQ-OPPT-2023-0376-0295) recommended that EPA
retain the full exclusion from prohibitions in the final rule on PIP
(3:1) for new and replacement parts for aerospace vehicles. The
commenter noted that the Federal Aviation Administration certification
process is often necessary and may be multiyear, unpredictable, and
lengthy. The commenter further stated that there may be significant
unknowns during the process, such as the availability of candidate
formulations, the time needed to identify all affected parts and to
certify alternatives for the PIP (3:1) products used to manufacture the
parts. The commenter also believes there is uncertainty regarding
chemical restrictions the EPA may consider and their impact on
investments in alternatives research and development. As discussed in
the proposed rule, while EPA acknowledges the uncertainty in
determining a feasible time frame for phasing-out the use of PIP (3:1)
in aerospace parts, EPA understands that the aerospace industry and
motor vehicle industry share similar uses. EPA acknowledges that some
uses in the aerospace industry may require more time for an appropriate
substitute to be found compared with uses in the motor vehicle
industry, given the different performance and regulatory requirements
the aerospace industry faces, and has provided a longer phase-out
period. Nevertheless, given EPA's mandate to reduce exposures to the
extent practicable and the other
[[Page 91503]]
provisions in this final rule, as the commenter on motor vehicles
noted, it is important to accelerate the material substitution of PIP
(3:1) for alternatives in the aerospace where it is practicable. EPA is
confident that it has identified, based on extensive outreach with
industry, those uses (i.e., hydraulic fluids, lubricants, greases, wire
harnesses, and circuit boards) that it would not be practicable to
phase out. EPA is finalizing these provisions with modifications.
Specifically, the prohibition phase-ins for aerospace are being
finalized but with exclusions of distribution in commerce for PIP
(3:1)-containing parts for aerospace vehicles and the vehicles which
contains such parts. This exclusion, now in 40 CFR 751.407(b)(1)(viii),
is discussed in more detail in Unit III.D.5.
d. Wire Harnesses and Circuit Boards
EPA is finalizing the new exclusion from the prohibition at 40 CFR
751.407(b)(1)(iii) for the processing and distribution in commerce of
PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses
and circuit boards, and wire harnesses and circuit boards containing
PIP (3:1). This final exclusion is based on industry comments provided
in response to the March 2021 notification opening a comment period.
Commenters have stated that these components are required to meet
certain mandatory regulatory and voluntary industry safety standards
(Refs. 44 and 45). According to commenters, alternatives to PIP (3:1)
for use as a flame retardant and/or plasticizer in wire harnesses and
circuit boards have not been identified (Ref. 11).
Based on information from commenters and engagement with
stakeholders, EPA is not aware of a replacement for PIP (3:1) for use
in wire harnesses and circuit boards that combines its properties as a
plasticizer, a fire retardant, and an anti-wear additive. Hence, EPA
agrees with commenters that the replacement for PIP (3:1) in these uses
would likely not be a direct substitute but might require multiple
chemicals. EPA acknowledges that the process of replacing PIP (3:1)
with separate chemicals for each function would likely be time
consuming and costly to certify new end-use products and articles
(Refs. 45 and 46). EPA is not aware of a technically and economically
feasible alternative for PIP (3:1) that would meet the performance
requirements and voluntary and regulatory safety standards for these
articles. EPA and commenters are not aware of industry efforts to
identify or qualify an alternative. For these reasons, EPA is
finalizing its proposal that it is impracticable to prohibit the
processing and distribution in commerce of PIP (3:1) for use in wire
harnesses and circuit boards and PIP (3:1)-containing products for use
in wire harnesses and circuit boards, and for wire harnesses and
circuit boards containing PIP (3:1).
Several commenters supported the exclusion for wire harnesses and
circuit boards. Many commenters also asked EPA to clarify certain
aspects of the exclusion. Two commenters (EPA-HQ-OPPT-2023-0376-0284,
EPA-HQ-OPPT-2023-0376-0297) noted that in the explanations of the
reasons why the exclusion for new and replacement parts for motor
vehicles and aerospace vehicles is being repealed and replaced with a
prohibition EPA states that the proposed prohibition would not apply to
PIP (3:1)-containing parts, in particular for wire harnesses and
circuit boards, that would be subject to a new exclusion, if adopted as
proposed. One of the commenters asked EPA to clarify that this
exclusion takes precedence in the situation where other exemptions or
phase-out periods are more limited in nature. The commenter recommended
that this statement be included in the written text. EPA accepts this
comment and is adding the following statement, ``except for the
activities described in paragraph (b) of this section or where another
phase-in prohibitions with longer term deadlines exists as described in
this section'' to 40 CFR 751.407(a)(2).
One commenter (EPA-HQ-OPPT-2023-0376-0297) requested that EPA
clarify the scope of the items included within the exclusion by
providing a definition with a non-exclusive list of examples. The
commenter suggested that the list of examples be more expansive than
``wire harnesses and circuit boards'' and include any item that is
attached to an electronic circuit board or that is necessary to secure,
cover, or insulate an electronic component that gets attached to a
circuit board. EPA is not providing a definition of wire harnesses or
circuit boards. In the preamble of the proposed rule, EPA explained
that the term ``wire harnesses'' includes a broad class of articles,
including but not limited to terminal and fuse covers, cable sleeves,
casings, connectors, and tapes, used in a variety of applications, from
defense to aerospace and motor vehicle applications, to scientific
instrumentation and more. EPA also explained that the Agency
understands that PIP (3:1) use in electronic component manufacturing
includes the use of PIP (3:1) in circuit boards as well as the use of
PIP (3:1)-containing products for the encapsulation of electronics
components added to circuit boards and as resins in over molding, dip
molding, insert molding applications, or conformal coatings.
In explaining EPA's understanding of the use of PIP (3:1) in
circuit boards, EPA distinguishes between those elements that come into
direct contact with parts conducting or storing electricity and those
that do not. The items the commenter (EPA-HQ-OPPT-2023-0376-0297)
referred to as necessary ``to secure, cover, or insulate an electronic
component that gets attached to a circuit board'' do not come into
direct contact with parts that conduct or store electricity and
therefore do not necessitate the flame-retardant properties of PIP
(3:1) in those components. Hence EPA is not expanding the scope of the
circuit board exclusion to include these items and these articles may
be subject to the October 2024 deadline for processing and the October
2026 deadline for distribution of PIP (3:1)-containing articles unless
excluded under 40 CFR 751.407 (b) or where another phase-in
prohibitions with longer term deadlines exists under 40 CFR
751.407(a)(2).
e. Marine Antifouling Coating Product
EPA is finalizing, at 40 CFR 751.407(a)(2)(vii), a five-year
compliance deadline for the prohibition of processing and distribution
in commerce of PIP (3:1) for use in a FIFRA-registered marine
antifouling coating product for Department of Defense uses only. The
January 2021 prohibition on processing and distribution of PIP (3:1)
has resulted in the inability of the U.S. Navy to obtain a PIP (3:1)-
containing, FIFRA-registered marine antifouling coating product. This
compliance date extension will allow the U.S. Navy to continue to
procure PIP (3:1)-containing coating while it identifies an alternative
PIP (3:1)-free formulation.
PIP (3:1) is used as a plasticizer in the formulation of the marine
antifouling coating product and is an inert ingredient under FIFRA. In
discussion with the U.S. Navy, it indicated that this antifouling
coating falls under the ``mission critical'' category because hull
corrosion on ships can have significant impacts on ship performance.
The U.S. Navy also indicated that it would need five years to develop a
suitable alternative formulation and undergo U.S. Navy qualification
and testing and the FIFRA approval process. Because no technically
feasible alternative is currently available for the U.S. Navy's
aluminum-hulled ships due to the U.S.
[[Page 91504]]
Navy's specific performance requirements, EPA considers it
impracticable to continue prohibiting the processing and distribution
of PIP (3:1) for use in this marine antifouling coating product while
an alternative is being developed. EPA understands there are suitable
alternatives for commercial users and so is limiting this exclusion to
this U.S. Department of Defense application. EPA is finalizing this
new, 5-year compliance deadline under TSCA section 6(h). One commenter
(EPA-HQ-OPPT-2023-0376-0309) supports finalizing the proposed
restrictions regarding PIP (3:1) related to FIFRA-registered marine
coatings. EPA did not receive comments opposing this provision.
f. Manufacturing Equipment and Semiconductor Manufacturing Industry
In response to comments, EPA is amending the proposed compliance
deadline extension of 10 years at 40 CFR 751.407(a)(2)(ix) for
processing and distribution in commerce of PIP (3:1), and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products and articles for use in manufacturing equipment and
in the semiconductor industry. EPA received several comments on the
proposal regarding articles used in manufacturing equipment and the
semiconductor industry. Two commenters supported the 10-year compliance
extension for such articles. Several commenters sought to include a
particular type of equipment in the articles covered by the proposed
extension or to lengthen the compliance time period for a particular
type of equipment. For example, one commenter asked EPA to clarify that
the semiconductor manufacturing exemption applies to ancillary
operations such as the assembly of use-specific and product-specific
packages and components and to their installation within other products
and finished articles in which finished semiconductor packages are
used. Commenters claiming that 10 years was not sufficient cited
complex supply chains and performance requirements. Nine commenters
noted that these articles have long service lives and need repair parts
during their service lives. Taking these comments together, EPA is
finalizing an approach to articles used in manufacturing equipment and
in the semiconductor industry based on the approach EPA is using for
motor vehicles. In this final rule, EPA is adding a compliance deadline
extension of 10 years after the publication of the final rule for
processing and distribution in commerce of PIP (3:1), manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products, and manufacturing and processing of parts for use in new
manufacturing equipment, including in the semiconductor industry, and
additional time for the same activities for use in replacement parts
for equipment used in those industries. EPA is also expanding the
categories of equipment covered by this approach so that the new
compliance deadlines will include electronic equipment, heating,
ventilation, air-conditioning, and refrigeration equipment, water-
heating equipment, and power generating equipment, including outdoor
power equipment. EPA is amending the existing compliance deadline to
provide an additional 10 years for new parts for these additional
categories, except for consumer electronic equipment, which is still
subject to the October 31, 2024 deadline. These phase-in prohibitions
to do not apply to articles subject to exclusions, in particular wire
harnesses and circuit boards.
As mentioned, the categories are (1) manufacturing equipment,
including equipment used in the semiconductor manufacturing industry,
(2) electronic equipment (3) heating, ventilation, air-conditioning
(HVAC), refrigeration, and water-heating equipment, and (4) power
generating equipment. Manufacturing equipment generally refers to
industrial machinery, such as automated manufacturing equipment,
including robotics, and machine tools, that are an integral part of
manufacturing or processing a product or article used in the
manufacturing sector, including in semiconductor manufacturing and its
ancillary support industries. EPA also includes in the manufacturing
category non-road mobile machines, large scale fixed installations, and
large scale stationary industrial tools. The electronic equipment
category includes three subcategories: consumer electronic equipment,
such as cell phones, computers and laptops, and game consoles;
commercial equipment, including commercial printers and other business-
to-business supplied electronics, as well as such as analysis,
measurement, test, monitoring, and control instruments; and laboratory
and research equipment, such as electron microscopes and laboratory
appliances. The heating, ventilation, air-conditioning, refrigeration,
and water-heating equipment category includes residential and
commercial HVAC equipment as well as commercial refrigeration
equipment. The power generating equipment category includes alternative
power generation equipment such as batteries and battery charging
equipment as well as outdoor power equipment, such as generators,
lawnmowers, chain saws, snow throwers, tillers, and other related
products. All these categories are subject to the new provisions EPA is
finalizing for parts installed in new equipment, with the exception of
consumer electronic equipment.
In the preamble to the proposal, EPA explained that the Agency is
not further extending the existing October 31, 2024, compliance
deadline for most other articles (see Unit III.D.1.vi. in the proposed
rule). EPA also noted the Agency expects that in several industries,
such as the textile industries, including consumer electronic
equipment, the existing compliance time frame for processing and
distribution in commerce of PIP (3:1) for use in articles and PIP
(3:1)-containing articles ending October 31, 2024, is sufficient (Ref.
46). EPA also asked for comments on these proposed compliance time
frames. Based on comments received, EPA continues to believe that the
October 31, 2024, compliance deadline is practicable for the textile
and consumer product industries, including consumer electronics. For
other categories equipment, including commercial and research
equipment, EPA continues to be convinced, as several commenters note,
that there are difficulties in identifying PIP (3:1) in supply chains.
In addition, commenters noted long development cycles for these types
of equipment, and argued that additional time is needed to identify,
test, certify, and adopt alternative parts, components, and finished
products, as well as time to modify the manufacturing processes to
accommodate an alternative substance.
For these reasons, EPA believes a time frame shorter than 10 years
would not be practicable for the other categories of equipment
identified. The 10-year phase-out for manufacturing and processing of
PIP (3:1)-containing parts for use in new equipment being finalized
applies to manufacturing equipment, commercial and laboratory
electronic equipment, HVAC, refrigeration, and water heating equipment,
and power generating equipment. It prohibits, after 10 years, all
processing, and distribution in commerce of PIP (3:1) for use in parts
for new equipment, and the manufacturing, processing and distribution
in commerce of PIP (3:1)-containing products for use in parts for new
equipment, and the manufacturing and processing of parts to which PIP
(3:1) has been added for such equipment.
[[Page 91505]]
For replacement parts, EPA is finalizing an approach that accounts
for the variability of service lives of the different types of
equipment both within each category described previously and between
categories. Several commenters (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-
OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284)) point out that the
equipment produced may be designed to operate for a decade or longer
and that replacement parts are critical to keep the equipment running.
Commenters also note that redesigned parts for existing finished
equipment cannot assure the same or similar performance, safety, and
reliability as originally designed parts. For manufacturing equipment,
EPA is allowing for the processing and distribution in commerce of PIP
(3:1), the manufacturing, processing, and distribution in commerce of
PIP (3:1)-containing products for use in replacement parts, and the
manufacturing and processing of replacement parts containing PIP (3:1)
for the service lives of such equipment. Based on comments received,
manufacturing equipment can survive in operation for decades. For
heating, ventilation, air-conditioning, refrigeration, and water-
heating equipment, and for power generating equipment, EPA is allowing
for the processing and distribution in commerce of PIP (3:1) and
manufacturing, processing, and distribution in commerce of PIP (3:1)
products for use in replacement parts, and manufacturing and processing
of PIP (3:1)-containing replacement parts for 15 years after the
manufacturing ban on new PIP (3:1)-containing parts, for a total of 25
years. As discussed previously for new parts, the Agency separated the
electronic equipment category into three sub-categories: consumer,
commercial, and laboratory. For the laboratory category, EPA is
allowing for the processing and distribution of PIP (3:1) and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products for use in replacement parts, and manufacturing and
processing of replacement parts containing PIP (3:1), for the service
lives of such equipment. As with manufacturing equipment, based on
comments received, laboratory equipment can last for decades. For the
commercial category, the Agency is allowing an additional 15 years for
the processing and distribution in commerce of PIP (3:1),
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products for use in replacement parts, and manufacturing and
processing of PIP (3:1)-containing replacement parts for use in such
equipment, after the manufacturing ban on new PIP (3:1)-containing
parts, for a total of 25 years. For both of the commercial and
laboratory categories, users often enter into contracts that require
manufacturers or dealers to provide ongoing maintenance for extended
periods of time. For the processing and distribution in commerce of PIP
(3:1) and the manufacturing, processing, and distribution in commerce
of PIP (3:1)-containing products for use in replacement parts for
consumer electronic equipment and the manufacturing and processing of
PIP (3:1)-containing replacement parts for consumer electronic
equipment, EPA is setting a compliance deadline of 7 years. This aligns
with right-to-repair laws that have been passed or are pending in many
States. While only California, Colorado, Minnesota, and New York have
passed right to repair laws, 30 States are considering right to repair
laws that address agricultural, digital/electronic, or other equipment
categories (e.g., motor vehicles, wheelchairs). Lastly, after the end
of the equipment phase-out time periods, all persons are prohibited
from all importing and processing of replacement parts for
manufacturing equipment, heavy machinery, commercial and laboratory
electronic equipment, HVAC, refrigeration, and water heating equipment,
and power generating equipment that contain PIP (3:1) in any part. EPA
is finalizing an exclusion to allow for the distribution in commerce of
PIP (3:1)-containing parts for equipment and equipment containing such
parts. This is discussed in more detail in Unit E.
2. Precedence of Phase-In Prohibitions
Several commenters (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-
0376-0284, EPA-HQ-OPPT-2023-0376-0295, EPA-HQ-OPPT-2023-0376-0306, EPA-
HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-
0376-0291) asked EPA to clarify exclusion and phase-out precedence.
Most commenters requested that EPA make clear that time-limited
exemptions did not apply where they were in conflict with an exclusion
or time-limited exemption with a longer compliance period, and
conversely, that exclusions still applied when they were in conflict
with a time-limited exemption.
In the former case, two commenters (EPA-HQ-OPPT-2023-0376-0284,
EPA-HQ-OPPT-2023-0376-0295) noted that the current compliance deadline
for PIP (3:1) for use in articles addressed by 40 CFR
751.407(a)(2)(iii) does not make clear that such deadline does not
apply to articles subject to longer alternative compliance deadlines or
exclusions, like articles with PIP-containing adhesives/sealants or
lubricants/greases. The commenters noted that the proposed text also
did not address the issue. To avoid misunderstanding, the commenters
suggested that the existing alternative compliance deadline at 40 CFR
751.407(a)(2)(i) and the proposed alternative compliance deadline at 40
CFR 751.407(a)(2)(iv) should also be described as excepted from the
phase-in prohibition at 40 CFR 751.407(a)(2)(iii). In response to these
comments, EPA is amending 40 CFR 751.407(a)(2) to clarify that other
phase-in prohibitions with longer term deadlines in 40 CFR
751.407(a)(2) or exclusions in 40 CFR 751.407(b) may allow the ongoing
manufacture, processing, and/or distribution in commerce, where the
terms of the longer-term phase-in or exclusion applies. However, the
terms of the phase-in prohibition with a longer term for continued
processing and distribution in commerce, for example, must expressly
apply. For example, the amended regulatory text is clear that pursuant
to 40 CFR 751.407(a)(1) any processing and distribution of PIP (3:1) or
PIP (3:1)-containing products or articles is prohibited unless another
provision in 40 CFR 751.407(a)(2) or (b) authorizes such processing and
distribution in commerce. Neither the adhesive and sealant phase-in
provision at 40 CFR 751.407(a)(2)(i) nor the lubricant and grease
exclusion at40 CFR 751.407(b)(ii), both in the regulatory text adopted
in 2021, allows the processing and distribution of PIP (3:1) for use in
producing a PIP (3:1)-containing adhesive or lubricant product for use
in any type of article. Those provisions allow a PIP (3:1)-containing
lubricant, for example, to be processed and distributed in commerce for
use, but not for use in an article. However, there are other provisions
that do allow the processing and distribution of PIP (3:1) for use in a
specific type of article; where EPA intended to allow PIP (3:1) to be
processed or distributed in commerce for use in articles, EPA included
reference to the article type in the regulatory provision. For example,
40 CFR 751.407(b)(1)(iii) as codified in 2021, and revisions finalized
in 40 CFR 751.407(a)(2)(vi), both expressly address
[[Page 91506]]
the processing and distribution of PIP (3:1) for use in replacement
parts. It is that express reference to the article, i.e., the
replacement part, that authorizes the processing and distribution of
PIP (3:1) for that article type. Thus, if there is no provision
authorizing processing and distribution of PIP (3:1) for use in an
article type, then the prohibition at current 40 CFR 751.407(a)(2)(iii)
applies. Using the adhesive and lubricant examples provided by the
commenter, processing and distribution of PIP (3:1) for use in an
adhesive or lubricant for use in an article type not otherwise
addressed in 40 CFR 751.407(a)(2) or (b) is prohibited by 40 CFR
751.407(a)(2)(iii). This is consistent with the 2021 responses to
comment on a similar issue.
Similarly, one commenter (EPA-HQ-OPPT-2023-0376-0297) asked EPA to
make clear that the exclusion related to circuit boards and harnesses
takes precedence in situations where other phase-in periods are more
limited in nature. For example, if a PIP (3:1)-containing circuit board
is used in the production or repair of a piece of manufacturing
equipment that is used in semiconductor manufacturing, or is installed
or in need of repair in a piece of heavy equipment used in automotive
manufacturing, after the extension period has expired for the
semiconductor manufacturing equipment or heavy machinery in automotive
manufacturing categories, the PIP (3:1)-containing circuit board would
still remain subject to the indefinite exclusion. EPA is clarifying
that the final rule allows for the ongoing processing and distribution
in commerce of PIP (3:1) for use in wire harnesses and circuit boards
generally, and that such exclusion is not limited by the phase-outs in
40 CFR 751.407(a)(2). Thus, processing and distribution of PIP (3:1)
may continue, for example, when for use in circuit boards, even after
the compliance deadline has passed for the processing and distribution
in commerce of PIP (3:1)-containing parts for use in motor or aerospace
vehicles and other articles. Since this holds as a general rule for 40
CFR 751.407(a)(2) (the phase-in prohibitions), EPA is adding clarifying
language to the regulatory text at 40 CFR 751.407(a)(2) to except the
activities described in 40 CFR 751.407(b) (the exclusions from
prohibitions).
3. Require Worker Protections During Manufacturing and Processing of
PIP (3:1)
EPA is finalizing, with minor modification to recordkeeping
requirements, its proposal to require the use of PPE by workers
involved in the manufacturing and processing of PIP (3:1) and certain
products and articles containing PIP (3:1). EPA proposed to require
inhalation and dermal PPE during domestic manufacturing and processing
of PIP (3:1) and certain PIP (3:1)-containing products and articles to
address potential respiratory and dermal exposure to occupational
workers during certain ongoing domestic manufacturing or processing
activities involving PIP (3:1), including those for which EPA is
finalizing phase-out periods. Because EPA generally presumes the
potential for exposure is low during importation, the Agency did not
propose worker protections for import of PIP (3:1) and PIP (3:1)-
containing products and articles. The Agency also did not propose
worker protection for the processing of certain PIP (3:1)-containing
products and articles: PIP (3:1)-containing adhesives and sealants, new
and replacement parts to which PIP (3:1) has been added for motor and
aerospace vehicles, and the motor and aerospace vehicles that contain
new and replacement parts to which PIP (3:1) has been added, PIP (3:1)-
containing specialized engine filters for locomotive and marine
applications, and the products or articles described in 40 CFR
751.405(b)(1)(vi) and (vii). EPA also proposed excluding processing of
PIP (3:1) and PIP (3:1)-containing products for use as an intermediate
to produce cyanoacrylate adhesives when contained in a closed system
under new 40 CFR 751.407(f)(7)(iii). Finally, EPA also proposed to
require that owners/operators implement a PPE program in alignment with
certain elements of OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132 and Respiratory Protection requirements in
29 CFR 1910.134. EPA is finalizing these requirements with slight
changes to the recordkeeping provision (see Unit III.D.5).
Where PPE is required, EPA is finalizing its proposal to require
implementation of a PPE program in alignment with certain elements of
OSHA's General Requirements for Personal Protective Equipment at 29 CFR
1910.132 and Respiratory Protection requirements in 29 CFR 1910.134.
EPA is requiring that owners/operators maintain PPE in a sanitary,
reliable, and undamaged condition and ensure each potentially exposed
person who is required to wear PPE to use such PPE. Under this final
rule, owners/operators are required to select and provide PPE that
properly fits each potentially exposed person who is required to use
PPE and to communicate PPE selections (e.g., demonstration that each
item of PPE selected provided prevents exposure during expected
duration and conditions of exposure) to each potentially affected
person. Where dermal PPE is required, EPA is finalizing a requirement
that owners and operators provide gloves that are chemically resistant
to PIP (3:1) with activity-specific training where dermal contact with
PIP (3:1) is possible.
For the manufacturing and processing of PIP (3:1) and PIP (3:1)-
containing products for use in new and replacement parts for motor
vehicles, including heavy machinery, and aerospace vehicles, EPA is
requiring respiratory protection that must be at least as protective as
a NIOSH-approved N95 respirator (APF 10). For processing of PIP (3:1)
and PIP (3:1)-containing products for use in the manufacturing of
cyanoacrylate adhesives, EPA is finalizing respiratory protection that
must be at least as protective as a NIOSH-approved APF 50 respirator,
except when the PIP (3:1) or PIP (3:1)-containing product is contained
in a closed system. For all other activities covered, EPA is requiring
respirators that are at least as protective as a NIOSH-approved APF 10
air-purifying half mask respirator. Based on stakeholder comments (Ref.
36) and OSHA-required Safety Data Sheets, EPA understands these levels
of protection are already typically used as industry best practices,
although the Agency lacks reasonably available information to determine
the scale of adoption. For processing of PIP (3:1) as an intermediate
processing aid in the manufacturing of cyanoacrylate adhesives, EPA is
requiring engineering controls such that the processing of PIP (3:1)
must take place in a closed loop system with general and local exhaust
ventilation provided. EPA understands that only one company is
currently processing PIP (3:1) for this use, and the proposed
engineering controls are the current practice of the company.
EPA is finalizing its proposal that the owner or operator must
ensure that all respirators used in the workplace are NIOSH-approved as
listed on the NIOSH Certified Equipment List. In choosing appropriate
gloves, EPA expects that owners/operators consider the effectiveness of
glove type when preventing exposures from PIP (3:1) alone and in likely
combination with other chemical substances used in the work area, the
degree of dexterity required to perform tasks, and the temperature, as
identified in the Hand Protection section of OSHA's Personal
[[Page 91507]]
Protective Equipment guidance (Ref. 34). EPA is also finalizing its
proposal to require each owner/operator to comply with OSHA's
respiratory protection training requirements at 29 CFR 1910.134(k) and
general PPE training requirements at 29 CFR 1910.132(f) when using
respirators and gloves. Owners/operators must provide PPE training to
all persons required to use dermal protection or respiratory protection
prior to or at the time of initial assignment to a job involving
exposure to PIP (3:1).
4. Manufacturing (Including Import) of PIP (3:1)
Multiple commenters (EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-
0376-0297, EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0307, EPA-
HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0290) discussed the
import of PIP (3:1)-containing products and articles in their comments.
As previously discussed, EPA is finalizing modifications to several
exclusions from prohibition finalized in the January 6, 2021, PIP (3:1)
final rule. These modifications include narrowing the scope of certain
exclusions, adding prohibition phase-in dates, and in some cases
creating new exclusions from prohibition for certain uses. In narrowing
the scope of certain exclusions, EPA proposed to prohibit the import of
the PIP (3:1)-containing articles and PIP (3:1)-containing products for
those uses. This is to restrict the ability for these prohibited PIP
(3:1)-containing articles and PIP (3:1)-containing products for those
uses to be imported where they are no longer allowed to be produced in
the United States. EPA is finalizing these phase-in prohibitions on
manufacturing, including import, for certain uses under 40 CFR
751.407(a)(2) and has made edits to the regulatory text to make it
clear what is prohibited and excluded. EPA modified the general
provision title under 40 CFR 751.407(a)(1), to now be titled ``General
prohibition on processing and distribution in commerce,'' [emphasis
added] so that it is clear this provision does not generally apply to
any manufacturing of PIP (3:1) or PIP (3:1)-containing products and
articles. EPA is not finalizing a general prohibition on the
manufacturing of PIP (3:1), consistent with the 2021 PIP (3:1)
rulemaking, due to the number of excluded activities which EPA has
found it impracticable to prohibit. EPA notes that the absence of a
general prohibition on manufacture of PIP (3:1) or PIP (3:1)-containing
products or articles does not allow for ongoing distribution in
commerce of imported products and articles, where such distribution in
commerce is expressly prohibited by another provision in 40 CFR
751.407; where EPA has prohibited the distribution in commerce of a PIP
(3:1) or PIP (3:1)-containing products or articles, such prohibition
would be applicable to any attempted importation of such PIP (3:1) or
PIP (3:1)-containing product or article.
5. Recordkeeping Requirements and Downstream Notification
In the 2021 PIP (3:1) final rule, EPA required that all persons who
manufacture, process, or distribute in commerce PIP (3:1) and products
and articles containing PIP (3:1) maintain ordinary business records
related to compliance with the prohibitions and restrictions for three
years and to make records available within 30 days upon request. EPA is
increasing the recordkeeping requirement from three to five years and
removing the 30-day time frame to make records available. Due to the
additional requirements being finalized in this rulemaking,
specifically those pertaining to worker safety, EPA considers the five-
year time frame regarding recordkeeping and removal of the 30-day time
frame to make records available is more appropriate. Furthermore, this
five-year time frame aligns with the statute of limitations for civil
penalty enforcement (28 U.S.C. 2462), and it is consistent with the
time frame associated with other TSCA section 6(a) rulemakings that
include worker protection requirements. EPA is confident that extending
each rule's recordkeeping requirement to a consistent five-year
requirement will facilitate regulated entities' compliance with minimal
impact to regulatory burden. In addition, removal of the 30-day time
frame to make records available is critical to the Agency's ability to
promptly identify and correct noncompliance. EPA presumes that
regulated entities should have the records demonstrating compliance
readily available.
In addition, as it relates to recordkeeping for worker protections,
EPA is finalizing its proposal to require that owners/operators
document respiratory protection used and PPE program implementation and
retain those records for five years. One commenter (EPA-HQ-OPPT-2023-
0376-0312) requested that EPA modify its worker protection
recordkeeping requirements to specify that records be made available to
exposed workers and their representatives and to extend the record
retention period. This commenter supports EPA's decision to eliminate
the 30-day compliance period, thus making records immediately available
to the Agency, but emphasized the importance of making records
available to workers and their representatives as well. The commenter
stated that this would be consistent with similar OSHA regulations.
Furthermore, the commenter recommended extending the recordkeeping
requirements to a much longer period of time, suggesting 20-30 years as
an appropriate time frame. The commenter argued that the health effects
due to exposure to toxic chemicals can exhibit long latency periods.
This information about latency, the commenter expressed, should be
available to workers throughout the period of potential consequences of
an exposure.
As discussed in the proposed rule, the final five-year time frame
is consistent with those associated with other TSCA section 6(a)
rulemakings and removal of the 30-day time frame to make records
available is critical to the Agency's ability to promptly identify and
correct noncompliance. EPA determined that regulated entities should
have the records demonstrating compliance readily available due to
previous recordkeeping requirements for PIP (3:1) under TSCA; this
measure is intended to make use of ordinary business records and thus
not be overly burdensome to industry. In response to the request that
EPA require records be made available to workers and to their
designated representatives as well, EPA has modified the workplace
protection records requirements for PIP (3:1) to require that the owner
or operator provide potentially exposed persons and their designated
representative an opportunity to observe records related to the basis
of the PPE or other control measure selection, including potential
monitoring results that are representative of the potentially exposed
person's exposure.
EPA is also amending the downstream notification statement that
must accompany shipments of PIP (3:1) or PIP (3:1) containing products
to conform to the terms of the prohibitions in the final rule. EPA is
providing a 3-month transition period to update SDS sheets and an 18-
month transition period for updating labels. EPA believes that this
transition period should allow time to clear products with old labels
through channels of trade. During the 3-month transition period,
downstream notification under 40 CFR 751.407(e)(1) and (2) is still
required; entities may use the new information provided in new 40 CFR
751.407(e)(3) or existing notification consistent with the restrictions
described in this subpart.
[[Page 91508]]
During the 15-month period between the SD revision date and the label
revision date, manufacturers, processors, or distributors are required
to provide the updated SDS with the ``new'' information when
distributing products with the ``old'' label.
5. Continued Distribution of PIP (3:1)-Containing Articles & Continued
Processing & Distribution of PIP (3:1)-Containing Articles for Repair
and Maintenance
EPA received multiple comments on the continued use of articles,
including finished goods containing such articles, which may contain
PIP (3:1). For example, some commenters stated that certain PBT-
containing articles would need to be disposed of or retired from use
earlier than needed due to EPA's prohibitions and restrictions which
would not allow for repair or general maintenance of an existing
component. Such commenters (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-
2023-0376-0305, EPA-HQ-OPPT-2023-0376-0293, EPA-HQ-OPPT-2023-0376-0310)
noted that finished goods move around in distribution channels and
usually stay in inventory for weeks to several months, that retailers
do not have control over how quickly these goods are sold and do not
necessarily operate under a first-in, first-out operation, and that
retailers would have difficulty differentiating between PIP (3:1)-
containing articles from non-PIP (3:1)-containing articles, and may
want to return the entire stock of goods (EPA-HQ-OPPT-2023-0376-0284,
EPA-HQ-OPPT-2023-0376-0293). Commenters also noted the resulting
negative impact of strictly eliminating stocks based on a
``distribution in commerce'' deadline may cause enormous economic and
environmental impact (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-
0376-0293, EPA-HQ-OPPT-2023-0376-0301, EPA-HQ-OPPT-2023-0376-0305, EPA-
HQ-OPPT-2023-0376-0310). For example, one of the commenters noted that
premature obsolescence would result in substantial economic losses as
affected equipment becomes stranded assets, impacting the environment
and the economy. Another commenter noted that companies may carry
thousands of spare parts for discontinued goods for up to and beyond 10
years so customers can extend the life of the good (EPA-HQ-OPPT-2023-
0376-0293). Two commenters also asked EPA to reiterate that the
provision at 40 CFR 751.401(b)(1) permits an article or product that
has been purchased or acquired other than for resale to be re-
distributed, leased, or re-sold (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-
OPPT-2023-0376-0284). These two commenters also requested that EPA make
clear that the language in 40 CFR 751.401(b)(1) permits the movement
within the United States of complex manufacturing equipment and durable
goods that might contain PIP (3:1)-containing components when such
equipment or durable goods were manufactured prior to the date of any
final prohibition in the PIP (3:1) regulation (EPA-HQ-OPPT-2023-0376-
0297, EPA-HQ-OPPT-2023-0376-0284). One commenter requested that EPA
make clear that all existing products and articles that were
manufactured prior to the various final effective dates in the PBT
regulations are exempt (EPA-HQ-OPPT-2023-0376-0297). Another commenter
noted that if an article needs to be repaired but was manufactured
before the effective date of the final rules, it is simply impossible
to check compliance on the article since the article was not managed to
comply with the rules (EPA-HQ-OPPT-2023-0376-0284).
EPA is amending the regulatory text covering PIP (3:1) in a number
of different ways to address these comments. First, EPA is amending the
proposed regulatory text for a number of activities addressed in 40 CFR
751.407(a)(2) and adding an additional regulatory provision in 40 CFR
751.407(b) to make clear that the general prohibition in 40 CFR
751.407(a)(1) and the general phase-in prohibition for articles at 40
CFR 751.407(a)(2)(iii) do not apply to the distribution in commerce of
certain PIP (3:1)-containing articles and the finished goods containing
such articles, like cars, aerospace vehicles, and complex equipment. It
was not EPA's intent to use its TSCA section 6(a) authorities to
restrict the continued distribution and sale of such parts for such
complex articles, where the manufacture and process of the part
complies with the phase-in prohibition in 40 CFR 751.407(a)(2). For
example, 40 CFR 751.407(a)(2)(v), as proposed, would have prohibited
the distribution in commerce, after 15 years from the publication date,
of PIP (3:1)-containing parts for new motor vehicles and the new motor
vehicles containing those parts.
EPA has amended that provision to remove the prohibition on
distribution in commerce of such parts and vehicles and EPA has added a
new provision, 40 CFR 751.407(b)(viii), to exclude the distribution in
commerce of such parts and vehicles from the general prohibition in 40
CFR 751.407(a)(1) and general phase-in prohibition in 40 CFR
751.407(a)(2)(iii). However, to be clear, the manufacturing and
processing of such parts for such vehicles after 15 years from the date
of publication of this rule is prohibited [and distribution in commerce
of parts that do not comply with that requirement is not permitted by
40 CFR 751.407(b)(viii). Thus, as long as the parts meet the
requirements in 40 CFR 751.407(a)(2)(v) relating to the manufacture and
processing of such parts, the parts and the vehicles containing such
parts may be distributed in commerce, for any reason, including as new
or for use or resale. Similar changes have been made to similar
provisions, i.e., for replacement parts for motor vehicles addressed in
40 CFR 751.407(a)(2)(vi), new and replacement parts for aerospace
vehicles addressed in 40 CFR 751.407(a)(2)(vii) and (viii),
respectively, and new and replacement parts for manufacturing equipment
addressed in 40 CFR 751.407(a)(2)(ix) and (x), respectively. A
prohibition on the distribution in commerce of these complex articles
would not be practicable; to the contrary, it would be extremely
burdensome, necessitating the identification of parts containing PIP
(3:1).
EPA is also amending 40 CFR 751.407(a)(2)(iii) to allow for an
additional two years for the distribution of PIP (3:1) containing
articles subject to the October 31, 2026, compliance deadline in order
for those articles to clear channels of trade.
Second, EPA is adding 40 CFR 751.407(b)(1)(viii) to allow
processing and distribution in commerce for maintenance and repair of
existing PIP (3:1)-containing articles. EPA has stated in the 2021
final rules that is not practicable 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 it would be extremely burdensome, necessitating the
identification of articles, and the disposal of countless articles that
would have to be identified and replaced. For similar reasons, EPA does
not believe restricting continued maintenance and repair of existing
PIP (3:1)-containing articles is practicable. Commenters raised the
need for repair and maintenance for certain PIP (3:1)-containing
articles, like equipment and machinery, which could result in the
distribution in commerce and processing that would have been prohibited
after relevant phase-in prohibition dates. Thus, in response to these
comments, EPA is amending the provisions in 40 CFR 751.407 to exclude
[[Page 91509]]
processing and distribution in commerce of an article for the purpose
of repair or maintenance, where PIP (3:1) has not been newly added.
This exclusion is limited to processing where the PIP (3:1) is not
newly added in any part, and it is limited to repair and maintenance of
a PIP (3:1)-containing article. It also differs from the existing ``end
user'' provision in 40 CFR 751.401(b)(1), which allows the distribution
in commerce of the chemical substance, or products and articles that
contain the chemical substance, that have previously been sold or
supplied to an end user. The ``end user'' provision does not include
processing as a part of the exclusion, and it only applies to an
individual or entity that purchased or acquired the finished good for
purposes other than resale.
Several commenters also supported a ``manufactured-by'' approach to
allow for the sell-through of existing articles and spare parts and
further processing and distribution of articles after compliance
deadlines. Commenters state that manufacturers can only control the
date of manufacture, not the date of distribution in commerce and,
further, that manufacturers cannot ensure compliance after the product
has left their control (EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-2023-
0376-0305, EPA-HQ-OPPT-2023-0376-0293, EPA-HQ-OPPT-2023-0376-0310).
Multiple commenters advocated for a manufactured-by date approach that
clarifies that products that contain PIP (3:1) that have been
manufactured prior to the prohibition dates may continue to be
processed and distributed, and used indefinitely, allowing for
continued servicing of equipment that are designed to remain in service
for many years with articles containing PIP (3:1) through the lifetime
of the equipment and not penalizing dealers with stranded inventory
(EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0284, EPA-HQ-OPPT-
2023-0376-0305).
As discussed in the response to comments to the 2019 PBT proposed
rule, EPA does not think, unless otherwise specified, that all products
and articles containing PBT chemicals should continue to be processed
and distributed without end, as it is practicable eventually to build
and service most products that do not contain PBTs, as goods reach the
end of their service lives and replacement parts that do not contain
PBTs become available. EPA therefore is not adopting a generally
applicable ``manufactured by'' provision. Instead, EPA has finalized
specific phase-in prohibitions or exclusions for certain PBT-containing
articles and finalized an exclusion solely for the purpose of repair
and maintenance of an existing article.
E. Regulatory Threshold Level for DecaBDE and PIP (3:1)
In the 2021 PBT final rules, EPA declined to establish a general
exclusion for PBTs produced as a byproduct, present as an unintentional
contaminant, or present in what commenters describe as de minimis
quantities (independent of the exclusion for recycled plastic). When
extending the compliance deadline for PIP (3:1) in March 2022, EPA
received comments on establishing a de minimis level for PIP (3:1)
(Ref. 47). At that time, EPA indicated that the Agency would consider
these comments in the context of the broader rulemaking EPA planned to
undertake for PIP (3:1) and other PBT chemicals, i.e., in this
rulemaking. In the proposal to this rule, EPA noted that a commenter
(Ref. 48) proposed that EPA adopt a threshold limit of no less than
0.001% for the presence of PIP (3:1) and 0.1% for the presence of
decaBDE in articles. EPA asked for comments on this proposal,
specifically, and on a de minimis level in general.
During the comment period for this rule, several commenters
requested that EPA establish a de minimis exemption for decaBDE and PIP
(3:1) (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0292, EPA-HQ-
OPPT-2023-0376-0297). As noted previously, one commenter proposed that
EPA adopt a threshold limit of no less than 0.001% for the presence of
PIP (3:1) and 0.1% for the presence of decaBDE in articles. Another
commenter stated that a de minimis threshold is consistent with TSCA's
requirement to reduce exposures ``to the extent practicable'' (EPA-HQ-
OPPT-2023-0376-0292). Further, without a threshold, this commenter and
another stated that regulated entities would not know whether they are
in compliance, as detection levels are constantly being reduced and
that certainty regarding the lack or presence of the substance is
unachievable (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0292).
One of these commenters contended it is unworkable and unreasonable for
regulated entities to potentially have to continually test materials
for the presence of trace levels of a material that has no appreciable
risk associated with it (EPA-HQ-OPPT-2023-0376-0292). The Agency
received no comments adverse to a regulatory threshold for either
decaBDE or PIP (3:1).
Commenting on PIP (3:1), one commenter noted that ``the lack of a
de minimis threshold ensures that manufacturers will need to account
for, and remove, trace amounts of PIP (3:1) in their products, which
will require expensive lab testing to confirm (assuming PIP (3:1) can
be found above the limit of detection)'' (EPA-HQ-OPPT-2023-0376-0308).
One commenter pointed out the potential for cross contamination since
components subject to a prohibition may be manufactured in the same
facilities as components containing PIP (3:1) (EPA-HQ-OPPT-2023-0376-
0305). At least one commenter requested EPA distinguish between
intentionally added PIP (3:1) and unintentional impurities (EPA-HQ-
OPPT-2023-0376-0001). A number of commenters also noted that in a
complex supply chain it may not always be possible to secure contract
specifications or assurances from suppliers regarding the presence of
PIP (3:1) and that it would be resource intensive to demonstrate the
complete absence of a chemical if there is no threshold to make that
determination (EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-OPPT-2023-0376-0306,
EPA-HQ-OPPT-2023-0376-0308, EPA-HQ-OPPT-2023-0376-0288).
For decaBDE, three commenters argued that a threshold is also
needed, and two commenters recommended that EPA set it at 0.1% to align
with other major regulatory regimes, such as the Restriction of
Hazardous Substances (RoHS) (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-
2023-0376-0292, EPA-HQ-OPPT-2023-0376-0297). Several commenters on this
issue recommended EPA adopt a 0.1% concentration level for PIP (3:1) as
well. (EPA-HQ-OPPT-2023-0376-0297, EPA-HQ-OPPT-2023-0376-0310, EPA-HQ-
OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0308). One of the commenters
recommended that, as a practical matter, EPA establish in all TSCA
section 6(h) regulations for PBTs a de minimis standard of 0.1% by
weight of the finished product or article. One commenter (EPA-HQ-OPPT-
2023-0376-0310) argued that a 0.1% concentration level is consistent
with EPA's export notification requirement for known or suspected
carcinogens (EPA-HQ-OPPT-2023-0376-0306, EPA-HQ-OPPT-2023-0376-0310,
EPA-HQ-OPPT-2023-0376-0308), and that, while PIP (3:1) is not covered
under Europe's RoHS, a 0.1% concentration level is at least consistent
with the level set for most chemicals under RoHS.
EPA agrees with these comments and believes that setting a
regulatory
[[Page 91510]]
threshold level for unintentional decaBDE and PIP (3:1) present in
products and articles at less than 0.1% by weight is a practicable
solution, particularly for situations involving complex supply chains.
This regulatory threshold level will also aid the regulated community
in complying with the prohibitions. Commenters noted that they have
limited visibility into their supply chains and cannot always obtain
assurances from suppliers regarding the presence of decaBDE in their
products (EPA-HQ-OPPT-2023-0376-0288, EPA-HQ-OPPT-2023-0376-0292, EPA-
HQ-OPPT-2023-0376-0297). Commenters also noted that test methods cannot
demonstrate zero content of any substance. EPA agrees that testing to
zero would not be practicable due to costs and challenges with testing
for PBTs. The 0.1% regulatory threshold level for unintentional levels
of decaBDE and PIP (3:1) provides certainty for entities that do not
intentionally add decaBDE or PIP (3:1), but where it may be
unintentionally present in their supply chains below the regulatory
threshold level due to cross-contamination. Intentional use of decaBDE
or PIP (3:1) in products or articles at any concentration is prohibited
in non-excluded uses. EPA is not establishing a regulatory threshold
level for unintentional amounts of other PBTs at this time.
The regulatory threshold level of 0.1% in this final rule applies
to products and articles measured by weight, except for any amount
present due to an excluded use or phased-out use that has not yet
reached its compliance deadline. For complex assemblies of articles,
the regulatory threshold level applies to each article individually and
not to the complex assembly as a whole. EPA is not adopting the
interpretation of article suggested by one commenter, namely that
concentrations of a substance present in components of an assembly of
articles be measured against the total weight of the assembly (EPA-HQ-
OPPT-2023-0376-0306). The commenter stated the belief that EPA's
interpretation was aligned with this understanding of how to account
for concentrations of a substance in an article (EPA-HQ-OPPT-2023-0376-
0306). EPA disagrees, and notes that the definition of an article,
provided at 40 CFR 751.403 provides the clarification the comment
seeks. The term ``article'' as defined in 40 CFR 751.403, paragraphs
(1) and (2), is a manufactured item ``[w]hich is formed to a specific
shape or design during manufacture,'' and ``[w]hich has end use
function(s) dependent in whole or in part upon its shape or design
during end use.'' EPA determined that the individual parts of a complex
assembly of parts would meet this definition. EPA is not providing
additional interpretive guidance at this time, as the Agency believes
the definition of article is sufficiently clear in this regard.
In setting a regulatory threshold level, EPA considered other
regulatory thresholds, such as OSHA, which included a 0.1% threshold
for determining hazards from certain chemicals to absolve employers
from having to evaluate and list chemicals present in mixtures in small
quantities that may not result in substantial exposures, and EPA's
export notification requirements and reporting requirements under the
Toxics Release Inventory Reporting under the Emergency Planning and
Community Right-to-know Act, both of which set a threshold of 0.1% for
some chemicals. Another example is the European Union's Regulation on
the registration, evaluation, authorization and restriction of
chemicals (REACH), which states that decaBDE ``Shall not be used in the
production of, or placed on the market in . . . an article, or any part
thereof, in a concentration equal to or greater than 0.1% by weight.''
(Ref. 49). Suppliers' familiarity with these levels ought to reduce the
administrative burden associated with tracking different thresholds for
different uses. EPA also considered the concentration level of 0.001%
for PIP (3:1) suggested by a commenter (EPA-HQ-OPPT-0376-0288). This
commenter recommended this lower level when PIP (3:1) is measured
against the weight of the article as a whole in complex assemblies,
rather than each component article that makes up the complex assembly.
It is not clear that a regulatory threshold level this low would be
practicable for individual components or across industries.
EPA previously reasoned that setting a single regulatory threshold
level of 0.1% for all uses is not practicable, given the concentrations
of these two chemicals in the supply chain for different types of
products, which would make establishing a concentration threshold for
each use overly burdensome and impracticable. Given the comments from
stakeholders noting that a 0.1% concentration level is consistent with
EPA's export notification requirement and is at least consistent with
the level set for most chemicals under RoHS, EPA now concludes that
stakeholders would be able to comply with a single regulatory threshold
level, despite the differing concentrations for different types of
products and articles.
Since decaBDE and PIP (3:1) are additive chemicals and are not
known to be present as a byproduct, EPA is not establishing a
regulatory threshold level where decaBDE or PIP (3:1) is intentionally
added. EPA is confident that where decaBDE is intentionally added, it
is intended to be present at concentrations at least an order of
magnitude higher than 0.1% and EPA has adopted regulatory controls to
address such intentional activities. Commenters provided information
indicating that an 0.1% concentration is generally below the levels
present in the majority of intentional uses of PIP (3:1). However, EPA
is aware of the manufacture and processing of certain products or
articles containing PIP (3:1) at levels intentionally well below 0.1%
(Ref. 50). In such cases, PIP (3:1) levels in such products or articles
will be presumed to be intentional and thus the regulatory threshold
level of 0.1% adopted in this rule would not apply to those products or
articles. Thus, this regulatory threshold of 0.1% allows a practicable
approach for managing unintentionally present decaBDE and PIP (3:1).
EPA had previously declined to set a regulatory threshold level in
part because EPA asserted that setting a threshold level would require
expensive testing. However, EPA is making clear that testing is not
required. While that is the case, companies may choose to do so if they
believe contaminant or unintentional levels may be present and wish to
document that the levels are below the 0.1% regulatory threshold level.
IV. The Reasonably Ascertainable Economic Consequences of the Final
Rule
A. Overview of Cost Methodology
EPA has evaluated the potential costs of the final rule. Industry
costs may arise from implementing measures to protect from exposure or
switching from the manufacture or use of the chemical to a substitute.
These costs include: reformulation of prohibited products using
alternative chemicals to manufacture the product, or the price
differential of available substitute products that do not contain PIP
(3:1), providing workers with the required personal protective
equipment (e.g., respirators and gloves), product labeling or signage
to provide notice to workers that PPE is required to be worn during
recycling, refurbishing, or processing of existing plastic shipping
pallets rule
[[Page 91511]]
familiarization and recordkeeping based on burdens estimated for other
similar rulemakings. Costs were annualized over a 30-year period. Other
potential costs include, but are not limited to, those associated with
testing, release prevention, imported articles, and some portion of
potential revenue loss.
B. Estimated Costs of This Final Rule
Total quantified annualized industry costs for the final rule are
estimated to be $400 million at a 3 percent discount rate and $430
million at a 7 percent discount rate annualized over 30 years. Costs at
a 2 percent discount rates are estimated at $390 million (shown in
appendix A of the accompanying Economic Analysis for this final rule).
Of the final rule costs, those associated with decaBDE alone were
approximately $86 at a 3 percent discount rate and $128 at a 7 percent
discount rate. Costs associated with PIP (3:1) were $400 million and
$430 million (at 3 and 7 percent discount rates, respectively.) Of this
total, worker protection (PPE) costs under the final regulatory option
annualized at a 3 percent discount rate is $373 million and $410
million at a 7 percent discount rate with PIP (3:1) accounting for all
costs. The reason for the large disparity in the costs between decaBDE
and PIP (3:1) results from the difference in the number of firms using
each chemical under the final rule's regulated activities. There are
only two firms known to be using decaBDE that will be impacted by this
final rule. Substantially more firms (up to 26,803) could potentially
be impacted by the PIP (3:1) final rule requirements based on the
sectors impacted. Prohibition costs for PIP (3:1) annualized at a 3
percent discount rate were estimated at $27 million and $20 million
annualized at a 7 percent discount rate. For the economic analyses for
the 2021 PBT final rules, EPA estimated that it would need one full-
time equivalent (FTE) employee for implementation (e.g., compliance
assistance and enforcement) activities under both the 2021 decaBDE and
PIP (3:1) final rules (two FTE employees total). This final rule will
modify those existing rules. Therefore, EPA does not expect that it
will require any additional (incremental) Agency staff time to
implement the rules under the final revisions (final or primary
alternative options).
1. Benefits
A qualitative discussion of the potential benefits associated with
the final action for decaBDE and PIP (3:1) is provided. PIP (3:1) is a
neurotoxicant and aquatic toxicant with high persistence and high
potential for bioaccumulation. DecaBDE has been found to have an
association with liver cancer and benign liver tumors in rats and mice
and had hepatic, renal, immune, and reproductive toxicity concerns in
animal studies. Research has also indicated that decaBDE is acutely
toxic to fish and aquatic invertebrates. As a result of this final
rule, prohibition and PPE requirements, EPA anticipates decreased
potential for occupational exposures and reduced potential for
exposures to the general population, potentially exposed or susceptible
subpopulations, and the environment.
2. 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 primary and alternative
regulatory actions. However, by evaluating the practicability of the
final and alternative regulatory actions, EPA is confident 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 primary and alternative regulatory actions.
EPA considered the anticipated effect of this final rule on the
national economy and concluded that this rule is highly unlikely to
have any measurable effect on the national economy (Ref. 17). EPA
analyzed the expected impacts on small business and found that of the
24,865 small businesses potentially impacted by the rule, 860 are
expected to incur cost impacts between 1 and 3 percent of their annual
revenue. No entities are expected to be impacted above 3 percent of
their annual revenue (Ref. 17). Finally, EPA has determined that this
final 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 PIP (3:1).
V. References
The following is a listing 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 those
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate
(3:1); Revision to the Regulation of Persistent, Bioaccumulative,
and Toxic Chemicals Under the Toxic Substances Control Act (TSCA);
Proposed Rule. Federal Register (88 FR 82287, November 24, 2023)
(FRL-9145-01-OCSPP).
2. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
October 2014.
3. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012.
4. EPA. Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent,
Bioaccumulative, and Bioaccumulative, and Toxic Chemicals Under TSCA
Section 6(h); Final Rule. Federal Register (86 FR 880, January 6,
2021) (FRL-10018-87).
5. EPA. Phenol, Isopropylated Phosphate (3:1) (PIP (3:1));
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under
TSCA Section 6(h); Final Rule. Federal Register (86 FR 894, January
6, 2021) (FRL-10018-88).
6. EPA. 2,4,6-tris(tert-butyl) phenol (2,4,6-TTBP); Regulation of
Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section
6(h); Final Rule. Federal Register (86 FR 866, January 6, 2021)
(FRL-10018-90).
7. EPA. Hexachlorobutadiene (HCBD); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final
Rule. Federal Register (86 FR 922, January 6, 2021) (FRL-10018-91).
8. EPA. Pentachlorothiophenol (PCTP); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final
Rule. Federal Register (86 FR 911, January 6, 2021) (FRL-10018-89).
9. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
10. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Compliance Date Extension Final Rule. Federal Register (86 FR
51823, September 17, 2021) (FRL-6015.5-03-OCSPP).
[[Page 91512]]
11. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Request for Comments. Federal Register (86 FR 14398, March
16, 2021) (FRL-10021-08).
12. Letter to EPA from the Consumer Technology Association and the
Information Technology Industry Council to EPA on March 15, 2021.
Document No. EPA-HQ-OPPT-2021-0202-0015.
13. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Further Compliance Date Extension Proposed Rule. Federal
Register (86 FR 59684, October 28, 2021) (FRL-6015.6-01-OCSPP).
14. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Further Compliance Date Extension Final Rule. Federal
Register (87 FR 12875, March 8, 2022) (FRL-6015.6-02-OCSPP).
15. Comments submitted to EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) on
March 16, 2021. Docket ID: EPA-HQ-OPPT-2021-0202-0001.
16. Yurok Tribe. Public Comment Submitted to EPA RE: Comments on
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under
TSCA Section 6(h) on May 17, 2021. Comment ID: EPA-HQ-OPPT-2021-
0202-0077.
17. EPA. Economic Analysis for Regulation of Phenol, isopropylated
phosphate (3:1) (PIP (3:1)) and Decabromodiphenyl ether (DecaBDE)
Under TSCA Section 6(h). October 2024.
18. EPA. 2021 Policy on Children's Health. https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.
19. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. December 2020. (For references
and supporting documentation, see EPA-HQ-OPPT-2019-0080).
20. EPA. Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate
(3:1); Revision to the Regulation of Persistent, Bioaccumulative,
and Toxic Chemicals Under the Toxic Substances Control Act (TSCA):
Response to Public Comments. October 2024.
21. EPA. Proposed Rule Webinar Transcript. March 21, 2024. ID: EPA-
HQ-OPPT-2023-0376-0315.
22. Comment from the American Coatings Association (ACA) to EPA on
May 21, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0144.
23. Centers for Disease Control and Prevention (CDC). NIOSH
Hierarchy of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html.
24. EPA. Environmental and Human Health Hazards of Five Persistent,
Bioaccumulative and Toxic Chemicals. December 2020. (For references
and supporting documentation, see also EPA-HQ-OPPT-2019-0080).
25. EPA. Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: Decabromodiphenyl ether. August
2017. Docket No. EPA-HQ-OPPT-2016-0724-0002.
26. Stakeholder Comment from Auto Alliance. February 2018.
27. Stakeholder Comment from iGPS. January 2018.
28. EPA. Access Chemical Data Reporting: 2020 CDR Data. Last updated
on May 16, 2022.
29. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. June 2019.
30. Norwegian Environmental Agency. Final Report. Literature Study--
DecaBDE in Waste Streams. 2015.
31. Yurok Tribe. Letter to EPA RE: the Tribal Consultation on
DecaBDE Risk Management Rule on January 3, 2023.
32. Centers for Disease Control and Prevention (CDC). NIOSH
Certified Equipment List. https://www.cdc.gov/niosh/npptl/topics/respirators/cel/.
33. Occupational Safety and Health Administration. Assigned
Protection Factors for the Revised Respiratory Protection Standard.
OSHA 3352-02 2009. https://www.osha.gov/sites/default/files/publications/3352-APF-respirators.pdf.
34. Occupational Safety and Health Administration. Personal
Protective Equipment. OSHA 3151-02R 2023. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
35. EPA (2021c). TRI Toxics Tracker, U.S. Environmental Protection
Agency. https://edap.epa.gov/public/extensions/TRIToxicsTracker/TRIToxicsTracker.html.
36. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h) RIN 2070-AK34; Response to Public
Comments. December 2020.
37. Letter from the Nuclear Regulatory Commission to the EPA on
March 31, 2023. (EPA-HQ-OPPT-2023-0376-0230).
38. Letter from the Nuclear Energy Institute to the EPA on February
10, 2023. (EPA-HQ-OPPT-2023-0376-0280).
39. EPA. Enforcement Statement Regarding the Prohibition of
Processing and Distribution in Commerce of Decabromodiphenyl Ether
(DecaBDE)-Containing Wire and Cable Insulation in Nuclear Power
Generation Facilities under 40 CFR 751.405(a)(2)(ii). May 2, 2023.
https://www.epa.gov/system/files/documents/202305/Enforcement%20Statement%20Regarding%20DecaBDE%205%202%202023.pdf.
40. EPA. 2023 DecaBDE Settlement: In the Matter of RSCC Wire & Cable
LLC. Docket No. TSCA-HQ-2023-5006. May 1, 2023. https://
yosemite.epa.gov/oa/EAB_Web_Docket.nsf/Unpublished~Final~Orders/
8A750189B8B8E14A852589A20072ACCC/$File/
RSCC%20CAFO%20final%20order%202023.05.01%201510.pdf.
41. 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.
42. Comment submitted to EPA from the National Elevator Industry,
Inc. on March 24, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0131.
43. Comment submitted to EPA from the Motor & Equipment
Manufacturers Association and the Alliance for Automotive Innovation
on May 20, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0110.
44. Comment to EPA from the Consumer Technology Association, IPC,
and Information Technology Industry Council on May 24, 2021. Comment
ID: EPA-HQ-OPPT-2021-0202-0148.
45. Comment submitted to EPA from The Boeing Company on May 20,
2021. Comment ID: EPA-HQ-OPPT-2021-0202-0102.
46. Comment submitted to EPA from the Association of Equipment
Manufacturers on May 14, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-
0053.
47. Comment submitted to EPA from SEMI and the Semiconductor
Equipment Association of Japan on May 20, 2021. Comment ID: EPA-HQ-
OPPT-2021-0202-0121.
48. Letter from the Semiconductor Equipment and Materials
International (SEMI) to EPA on August 4, 2023. Comment ID: EPA-HQ-
OPPT-2023-0376-0317.
49. European Union's Regulation on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), Annex XVII:
Restrictions on the Manufacture, Placing on the Market and Use of
Certain Dangerous Substances, Mixtures and Articles. https://reachonline.eu/reach/en/annex-xvii.html.
50. Fujifilm FUJICHROME Velvia 100[supreg] color film. https://www.fujifilm.com/us/en/business/professional-photography/film/velvia-100.
51. EPA. Supporting Statement for an Information Collection Request
(ICR) under the Paperwork Reduction Act (PRA); Decabromodiphenyl
Ether and Phenol, Isopropylated Phosphate (3:1); Revision to the
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals under
the Toxic Substances Control Act (TSCA). Final Rule (RIN 2070-AL02).
EPA ICR No. 2779.02 and OMB Control No. 2070-0230. October 2024.
VI. 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 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined under
section 3(f)(1)
[[Page 91513]]
of Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
Executive Order 12866 review. Documentation of any changes made in
response to the Executive Order 12866 review is available in the
docket. EPA prepared an Economic Analysis of the potential costs and
benefits associated with this action (Ref. 17). A copy of this Economic
Analysis is available in the docket, is briefly summarized in Unit I.E.
and discussed in Unit IV.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared is
assigned EPA ICR No. 2779.02 and OMB Control No. 2070-0230 (Ref. 51).
You can find a copy of the ICR in the docket and it is briefly
summarized here. The information collection requirements are not
enforceable until OMB approves them.
Respondents/affected entities: See Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 6(h)
and 40 CFR 751.407).
Frequency of response: On occasion.
Total estimated number of respondents: 26,805 (12,846
manufacturers/importers/processors and 13,957 distributors).
Total estimated burden: 42,300 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $3,288,625 (per year), includes $0 annualized
capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and, as appropriate, display the OMB control number on the
applicable collection instruments 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.
C. 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 the chemicals subject to this final rule. The Agency has
determined that this final rule will impact approximately 24,865 small
businesses of which 860 (3.46%) are expected to incur cost impacts
between 1 and 3 percent of their annual revenue, all of which are for
PIP (3:1) and none for decaBDE. The cost per small entity impacted
ranged from -$42-$1,146,853 at a 3% discount rate and -$128-$1,272,107
at a 7% discount rate. No entities for either chemical are expected to
be impacted above 3 percent of their annual revenue. Details of this
analysis are presented in the Economic Analysis (Ref. 17), which is in
the docket for this action.
D. Unfunded Mandates Reform Act (UMRA)
This action contains a Federal mandate that may result in
expenditures of $183 million in 2023 dollars ($100 million in 1995
dollars adjusted for inflation using the GDP implicit price deflator)
or more as described in UMRA, 2 U.S.C. 1531-1538, for the private
sector in any one year. Total quantified annualized social costs for
this final rule are approximately $400 million at a 3 percent discount
rate, and $430 million at a 7 percent discount rate. Costs at a 2
percent discount rate are estimated at $390 million. These private
sector costs are presented in the Economic Analysis (Ref. 17), a copy
of which is available in the docket, and are briefly summarized in Unit
I.E. and discussed in Unit IV.
This action is not subject to the requirements of sections 202 and
203 of UMRA because this action imposes no enforceable duty on any
State, local or Tribal governments and does not significantly or
uniquely affect small governments. This action only impacts only
imposes enforceable duties on private sector entities that manufacture
(including import), process, distribute in commerce, use, or dispose of
decaBDE and PIP (3:1), and government entities are not engaged in these
activities.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not 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 stated in Unit VI.D., State and local government entities are not
engaged in the activities covered by this action. See also the
discussion in Unit I.E.6.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not 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 stated in Unit VI.D., Tribal
government entities are not engaged in the activities covered by this
action. See also the discussion in Unit I.E.6.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. This action is subject
to Executive Order 13045 because it is a significant regulatory action
under section 3(f)(1) of Executive Order 12866, and the EPA believes
that the environmental health or safety risk addressed by this action
may have a disproportionate effect on children. While EPA understands
that this action addresses the health and environmental risks presented
by the PBT chemicals subject to this action that may have a
disproportionate effect on children, EPA did not perform a risk
assessment or risk evaluation of these PBT chemicals. However, the
final requirements will reduce potential exposure to these PBT
chemicals for the general population and for susceptible subpopulations
such as workers and children. EPA's evaluation of the exposure
potential of these PBT chemicals (Ref. 19) and summary of the health
and environmental hazards that may be presented by these chemical
substances (Ref. 24) are summarized in Unit II.E., with referenced
documents available in the docket. In addition, the regulatory options
analyzed are discussed in Unit III.
Furthermore, EPA's Policy on Children's Health also applies to this
action. Information on how the Policy was applied is discussed in Unit
I.E.5. See also the other discussions about the risks presented by the
PBT chemicals
[[Page 91514]]
subject to this action that are provided throughout this preamble.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy
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.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on communities with EJ
concerns consistent with Executive Order 14096 (88 FR 25251, April 26,
2023) building on and supplementing Executive Order 12898 (59 FR 7629,
February 16, 1994). EPA's related evaluation is summarized in Units
I.E.4. and VI., and discussed in the Economic Analysis (Ref. 17) that
is in the docket.
Since a risk evaluation was not conducted, EPA's understanding of
the extent to which reductions in exposure might reduce risks for
communities with environmental justice concerns is limited. Data are
not sufficiently comprehensive to estimate the extent to which the
final rule will reduce existing disproportionate impacts on communities
with EJ concerns. Data on the worker composition of affected
industries, presented in sections 6.5.1 and 6.5.2 of the Economic
Analysis (Ref. 17), provide a general indication of how different
demographic groups in the worker population may be affected. Certain
exclusions and extensions of compliance dates beyond the onset of the
final rule may partially delay addressing these impacts. EPA is
confident that the restrictions that will be placed on decaBDE and PIP
(3:1) with adoption of this final rule will reduce the potential
exposures, and therefore, reduce any potential risks, associated with
the manufacture, processing and use of these chemicals. EPA cannot
confirm which specific subpopulations are at a disproportionate risk
from exposure nor make a quantified estimate of the change in exposure
that will result from the rule. In addition, only a small subset of the
specific facilities using decaBDE and PIP (3:1) have been identified,
so a proximity analysis examining the characteristics of the
communities surrounding the known facilities might not be
representative of all exposed communities. Some workers will receive
PPE with adoption of the rule, while others will no longer be exposed
to decaBDE and PIP (3:1). As companies reformulate with chemical
alternatives, some workers may be exposed to these alternatives. Local
communities will also be less exposed to decaBDE and PIP (3:1), though
exposure to chemical alternatives may increase. EPA does not know which
chemical alternatives industry will ultimately use. Some alternatives
are less toxic than and some are comparably toxic to decaBDE and PIP
(3:1).
K. 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 meets the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons set forth in the preamble, EPA is
amending 40 CFR chapter I as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.401 by adding paragraph (c) to read as follows:
Sec. 751.401 General.
* * * * *
(c) Owner and operator requirements. Any requirement for an owner
or operator or an owner and operator is a requirement for any
individual that is either an owner or an operator.
0
3. Amend Sec. 751.403 by adding in alphabetical order the definitions
for ``Potentially exposed person'' and ``Regulated area'' to read as
follows:
Sec. 751.403 Definitions.
* * * * *
Potentially exposed person means any person who may be exposed to a
chemical substance or mixture regulated under this subpart as a result
of the use of that chemical or mixture.
* * * * *
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance can reasonably be expected.
* * * * *
0
4. Amend Sec. 751.405 by:
0
a. Revising paragraphs (a)(1) and (a)(2)(ii);
0
b. Adding paragraph (a)(2)(vi);
0
c. Revising paragraphs (b) and (c)(1)(i) and (iii); and
0
d. Adding paragraphs (d) through (g).
The revisions and additions read as follows:
Sec. 751.405 DecaBDE.
(a) * * *
(1) General. (i) 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.
(ii) Unless otherwise specified in this subpart, the prohibitions
and restrictions of this subpart do not apply to products or articles
containing decaBDE at concentrations less than 0.1% by weight, if the
decaBDE was not intentionally added to the product or article.
(2) * * *
(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 (including test
and research reactors).
* * * * *
(vi) After the end of the wire and cables' service life, all
persons are prohibited from all processing and distribution in commerce
of decaBDE-containing wire and cable insulation for nuclear power
generation facilities (including test and research reactors).
(b) Exclusions to the Prohibition. Distribution in commerce and
recycling of decaBDE-containing plastic from products or articles, and
processing and distribution in commerce of decaBDE-containing products
or articles made from such recycled plastic, where no new decaBDE is
added during the recycling or production processes is not
[[Page 91515]]
subject to the prohibition in paragraph (a) of this section.
(c) * * *
(1) * * *
(i) These records must be maintained for a period of five years
from the date the record is generated.
* * * * *
(iii) These records must be made available to EPA upon request.
* * * * *
(d) Signage in Regulated Areas. (1) After January 21, 2025, all
persons who process, including recycle, plastic shipping pallets that
contain decaBDE must place signs at every entry point into the
regulated area.
(2) Each sign must show clearly, prominently, in multiple languages
as appropriate, and in an easily readable font size the following text:
Decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5), a chemical
that has been identified as a persistent, bioaccumulative, and toxic
(PBT) chemical by the U.S. Environmental Protection Agency, may be
present in this regulated area. All persons in this regulated area
who recycle existing plastic shipping pallets that contain decaBDE
are required to wear personal protective equipment, including
respiratory protection that is at least as protective as a NIOSH-
approved N95 respirator with an assigned protection factor (APF) of
10 and dermal protection of gloves that are chemically resistant to
decaBDE, per regulations at 40 CFR 751.405(e).
(e) Workplace protection--(1) Applicability. After January 21,
2025, the provisions of this paragraph (e) apply to any workplaces
engaged in manufacturing and processing of decaBDE and decaBDE-
containing products and articles, except for those identified in
paragraph (e)(6) of this section.
(2) Regulated areas. Owners or operators must establish and
maintain regulated areas as defined in 40 CFR 751.403.
(i) The owner or operator must limit access to regulated areas to
authorized persons.
(ii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the regulated area and minimizes
the number of authorized persons exposed to decaBDE within the
regulated area.
(iii) The owner or operator must ensure that each potentially
exposed person is provided with a respirator according to the
requirements of paragraph (e) of this section and must ensure that all
potentially exposed persons within the regulated area are using the
provided respirators whenever exposures to airborne concentrations of
decaBDE can reasonably be expected.
(iv) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated
area, persons do not engage in non-work activities that may increase
exposure to decaBDE.
(3) Respiratory protection. The owner or operator must provide
respiratory protection to all potentially exposed persons in the
regulated area as demarcated in accordance with paragraph (e)(2) of
this section, and according to the provisions outlined in 29 CFR
1910.134(b), (c)(1), (3) and (4), (d)(1)(iv), (f), and (g) through (l)
and, as specified in this paragraph (e)(3) for potentially exposed
persons to decaBDE during expected time of use.
(i) For purposes of this paragraph (e)(3), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are
defined in 29 CFR 1910.134(b) have the meaning assigned to them in 29
CFR 1910.134(b).
(ii) Owners and operators must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator
selections to each affected person consistent with the requirements of
29 CFR 1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(v) Prior to or at the time of initial assignment to a job
involving potential exposure to decaBDE, owners and operators must
provide training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(vii) The type of respiratory protection that the owners or
operator must select and provide to potentially exposed persons must be
at least as protective as a NIOSH-approved N95 respirator (APF 10).
(viii) Owners and operators must select and provide respirators as
required in paragraph (e)(3) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(ix) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(x) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29
CFR 1910.134(l), to ensure that the provisions of the written
respiratory protection program required under paragraph (e)(3) of this
section are being effectively implemented.
(xi) The respiratory protection requirements in this paragraph
(e)(3) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(4) Dermal protection. (i) Owners or operators must require the
donning of gloves that are chemically resistant to decaBDE with
activity-specific training where dermal contact with decaBDE is
reasonably expected. Owners or operators must minimize and protect
potentially exposed persons from dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with decaBDE in the specific work area where it is
selected for use, selected in accordance with this paragraph (e)(4) and
provided in accordance with 29 CFR 1910.132(h), to each person who is
reasonably likely to be dermally exposed in the work area through
direct dermal contact with decaBDE. For the purposes of this paragraph
(e)(4), provisions in 29 CFR 1910.132(h) applying to an ``employee''
also apply equally to potentially exposed persons, and provisions
applying to an ``employer'' also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the
work to be
[[Page 91516]]
performed must be provided, used, and maintained in a sanitary,
reliable, and undamaged condition. Owners and operators must select PPE
that properly fits each affected person and communicate PPE selections
to each affected person.
(iv) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to decaBDE. For the purposes of this paragraph (e)(4),
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(v) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use dermal protection,
or when changes in the workplace or in dermal protection to be used
render the previous training obsolete.
(5) Workplace protection records. (i) The owner or operator of
workplaces engaged in the manufacturing and processing of decaBDE and
decaBDE-containing products and articles, except for those identified
in paragraph (e)(6) of this section, must retain records of:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to directly handle
decaBDE or handle equipment or materials on which decaBDE may be
present;
(B) The basis for the regulated area as defined in Sec. 751.403,
including monitoring data and documentation of any controls or
combination of controls that have reduced exposure to where airborne
concentrations of decaBDE can no longer reasonably be expected
resulting in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by
each of these persons, the respiratory protection used by each
potentially exposed person, and PPE program implementation, including
fit-testing and training;
(D) The basis for the PPE selection (e.g., demonstration based on
permeation testing or manufacturer specifications that each item of PPE
selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area); and
(E) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE.
(ii) These records must be maintained for a period of five years
from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons
and their designate representative an opportunity to observe records
related to the basis of the PPE or another control measure selection,
including potential monitoring results that are representative of the
potentially exposed person's exposure.
(6) Exclusions. The following are not subject to the workplace
protection requirements of paragraph (e) of this section:
(i) Import of decaBDE and decaBDE-containing products and articles.
(ii) 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, except for those articles identified in paragraph
(a)(2)(v) of this section.
(iii) Processing addressed in paragraph (a)(2)(vi) of this section
of decaBDE-containing wire and cable insulation for use in nuclear
power generation facilities.
(iv) Processing of new and replacement parts to which decaBDE has
been added for motor and aerospace vehicles, and the motor and
aerospace vehicles that contain new and replacement parts to which
decaBDE has been added.
(f) Export notification for decaBDE-containing products and
articles. All persons intending to export decaBDE-containing wire and
cable for nuclear power generation facilities (including test and
research reactors) are required to notify EPA under TSCA section 12(b)
and the provisions of subpart D of 40 CFR part 707. The exemption at 40
CFR 707.60(b) does not apply to decaBDE-containing wire and cable for
nuclear power generation facilities.
(g) Prohibition on releases to water. After January 21, 2025, all
persons are prohibited from releasing decaBDE to water during
manufacturing, processing, and distribution in commerce of decaBDE and
decaBDE-containing products, and such persons are required to follow
any applicable regulations for preventing the release of decaBDE.
0
5. Amend Sec. 751.407 by:
0
a. Revising paragraph (a)(1);
0
b. Adding paragraph (a)(2) introductory text;
0
c. Revising paragraph (a)(2)(iii);
0
d. Adding paragraphs (a)(2)(iv) through (xi);
0
e. Revising paragraphs (b)(1)(ii), (iii) and (vii);
0
f. Adding paragraphs (b)(1)(viii) and (b)(2);
0
g. Revising paragraphs (d)(1) and (3) and (e)(3) and (4); and
0
h. Adding paragraphs (e)(5) and (f).
The revisions and additions read as follows:
Sec. 751.407 PIP (3:1).
(a) * * *
(1) General prohibition on processing and distribution in commerce.
Except as provided in paragraphs (a)(2) and (b) of this section, all
persons are prohibited from all processing and distributing in commerce
of PIP (3:1), including in PIP (3:1)-containing products or articles
after March 8, 2021. Except as provided in paragraphs (a)(2) and (b) of
this section, the prohibitions and restrictions of this subpart do not
apply to products or articles containing PIP (3:1) at concentrations
less than 0.1 percent by weight, if the PIP (3:1) was not intentionally
added to the product or article.
(2) Phase-in prohibitions for specific uses of PIP (3:1) and PIP
(3:1)-containing products and articles. Except for the activities
described in paragraph (b) of this section or where another phase-in
prohibition with longer-term deadlines exists as described in this
section:
* * * * *
(iii) After October 31, 2024, all persons are prohibited from all
processing and distribution of PIP (3:1) for use in articles and all
processing of PIP (3:1)-containing articles. After October 31, 2026,
all persons are prohibited from distribution in commerce of PIP (3:1)-
containing articles.
(iv) After November 21, 2039, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in lubricants and greases and PIP (3:1)-containing
lubricants and grease.
(v) After November 21, 2039, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) for use in parts
for new motor vehicles, including heavy motorized machinery, and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
[[Page 91517]]
containing products for use in parts for new motor vehicles, including
heavy motorized machinery, and manufacturing and processing of PIP
(3:1)-containing parts for such new vehicles.
(vi) After November 19, 2054, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in replacement parts for motor vehicles, including
heavy motorized machinery, and manufacturing and processing of PIP
(3:1)-containing replacement parts for such vehicles.
(vii) After November 19, 2054, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in parts for new aerospace vehicles, and manufacturing
and processing of PIP (3:1)-containing parts for such vehicles.
(viii) After the end of the aerospace vehicles service lives, all
persons are prohibited from all processing and distribution in commerce
of PIP (3:1) and manufacturing, processing, and distribution in
commerce of PIP (3:1)-containing products for use in replacement parts
for aerospace vehicles and manufacturing and processing of PIP (3:1)-
containing replacement parts for such vehicles.
(ix) After November 19, 2029, all persons are prohibited from
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in marine antifouling coating products that are
registered under the Federal, Insecticide, Fungicide, Rodenticide Act
and that meet U.S. Department of Defense specification requirements.
(x) After November 20, 2034, all persons are prohibited from
processing, and distribution in commerce of PIP (3:1) and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products for use in parts for new manufacturing equipment,
including in the semiconductor industry, for new heating, ventilation,
air-conditioning, refrigeration, and water-heating equipment, new power
generating equipment, new laboratory equipment, new commercial
electronic equipment, and the manufacturing and processing of PIP
(3:1)-containing parts for those equipment.
(xi) After the end of the manufacturing and laboratory equipment
service lives, all persons are prohibited from processing and
distribution in commerce of PIP (3:1) and manufacturing, processing,
and distribution in commerce of PIP (3:1)-containing products for use
in replacement parts and manufacturing and processing of PIP (3:1)-
containing replacement parts for manufacturing equipment and laboratory
equipment, respectively. After November 19, 2049 all persons are
prohibited from processing and distribution in commerce of PIP (3:1)
and manufacturing, processing, and distribution in commerce of PIP
(3:1)-containing products for use in replacement parts and
manufacturing and processing of PIP (3:1)-containing replacement parts
for heating, ventilation, air-conditioning, refrigeration, and water-
heating equipment, for power generating equipment, and for commercial
electronic equipment. After November 19, 2031 all persons are
prohibited from processing and distribution in commerce of PIP (3:1)
and manufacturing, processing, and distribution in commerce of PIP
(3:1)-containing products for use in replacement parts and
manufacturing and processing of PIP (3:1)-containing replacement parts
for consumer electronic equipment.
(b) * * *
(1) * * *
(ii) PIP (3:1) for use in lubricants and greases for aerospace use
and turbine engines, PIP (3:1)-containing products for use in
lubricants and greases for aerospace use and turbine engines, and PIP
(3:1)-containing lubricants and greases for aerospace use and turbine
engines;
(iii) PIP (3:1) and PIP (3:1)-containing products for use in
circuit boards and wire harnesses, including but not limited to
terminal and fuse covers, cable sleeves, casings, connectors, and
tapes, and PIP (3:1)-containing circuit boards and wire harnesses
including but not limited to terminal and fuse covers, cable sleeves,
casings, connectors, and tapes.
* * * * *
(vii) Finished products or articles made of plastic recycled or
reused from products or articles containing PIP (3:1), where no new PIP
(3:1) was added during the production of the products or articles made
of recycled plastic.
(viii) Articles that contain PIP (3:1), and where PIP (3:1) has not
been newly added, for the purpose of repair or maintenance.
(2) Distribution in commerce of:
(i) PIP (3:1)-containing parts for vehicles meeting the
requirements in paragraphs (a)(2)(v) through (viii) of this section,
for equipment meeting requirements in paragraphs (a)(2)(x) through (xi)
of this section, and the vehicles and equipment that contain such
parts.
(ii) [Reserved]
* * * * *
(d) * * *
(1) After March 8, 2021, persons who manufacture, process, or
distribute in commerce PIP (3:1) or PIP (3:1)-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. These records must
be maintained for a period of five years from the date the record is
generated.
* * * * *
(3) These records must be made available to EPA upon request.
* * * * *
(e) * * *
(3) Downstream notification must occur by inserting the text in
paragraphs (e)(3)(i) and (ii) of this section in the Safety Data Sheet
(SDS) by February 19, 2025, or by including on the label of any PIP
(3:1) or PIP (3:1)-containing product by May 19, 2026, the label
language in paragraph (e)(3)(iii) of this section:
(i) SDS Section 1(c).
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet
military specifications for safety and performance where no
alternative chemical is available that meets U.S. Department of
Defense specification requirements, (2) In lubricants and greases
for aerospace and turbine uses and, for all other lubricant and
grease uses before November 21, 2039, (3) circuit boards and wire
harnesses, including but not limited to terminal and fuse covers,
cable sleeves, casings, connectors and tapes, (4) As an intermediate
in the manufacture of cyanoacrylate glue, (5) In specialized engine
air filters for locomotive and marine applications, (6) In adhesives
and sealants before January 6, 2025, after which use in adhesives
and sealants is prohibited, (7) In new parts for motor vehicles
before November 21, 2039 and replacement parts for motor vehicles
before November 19, 2054, (8) In new parts for aerospace vehicles
before November 19, 2054 and replacement parts for aerospace
vehicles after the end of the aerospace vehicles service lives, (9)
In marine antifouling coating products that are registered under the
Federal Insecticide, Fungicide, and Rodenticide Act and that meet
U.S. Department of Defense specification requirements before
November 19, 2029, (10) In new manufacturing equipment, new products
or articles in the semiconductor industry, for new heating,
[[Page 91518]]
ventilation, air-conditioning, refrigeration, and water-heating
equipment, new power generating equipment, new laboratory equipment,
new commercial electronic equipment, and new consumer electronic
equipment before November 20, 2034, (11) replacement parts for
manufacturing and laboratory equipment after the end of the
equipment's service life, (12) replacement parts for heating,
ventilation, air-conditioning, refrigeration, and water-heating
equipment, for power generating equipment, and for commercial
electronic equipment before November 19, 2049, (13) replacement
parts for consumer electronic equipment before November 19, 2031,
(14) in other articles before October 31, 2024, after which use in
articles other than those with later phase-in prohibition dates or
exclusions is prohibited. In addition, all persons are prohibited
from releasing PIP (3:1) to water during manufacturing, processing,
and distribution in commerce, and must follow all existing
regulations and best practices to prevent the release of PIP (3:1)
to water during the commercial use of PIP (3:1).
(ii) SDS Section 15.
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet
military specifications for safety and performance where no
alternative chemical is available that meets U.S. Department of
Defense specification requirements, (2) In lubricants and greases
for aerospace and turbine uses and lubricants and, for all other
lubricant and grease uses before November 21, 2039, (3) circuit
boards and wire harnesses, including but not limited to terminal and
fuse covers, cable sleeves, casings, connectors and tapes, (4) As an
intermediate in the manufacture of cyanoacrylate glue, (5) In
specialized engine air filters for locomotive and marine
applications, (6) In adhesives and sealants before January 6, 2025,
after which use in adhesives and sealants is prohibited, (7) In new
parts for motor vehicles before November 21, 2039 and replacement
parts for motor vehicles before November 19, 2054, (8) In new parts
for aerospace vehicles before November 19, 2054 and replacement
parts for aerospace vehicles after the end of the aerospace vehicles
service lives, (9) In marine antifouling coating products that are
registered under the Federal Insecticide, Fungicide, and Rodenticide
Act and that meet U.S. Department of Defense specification
requirements before November 19, 2029, (10) In new manufacturing
equipment, new products or articles in the semiconductor industry,
for new heating, ventilation, air-conditioning, refrigeration, and
water-heating equipment, new power generating equipment, new
laboratory equipment, new commercial electronic equipment, and new
consumer electronic equipment before November 20, 2034, (11)
replacement parts for manufacturing and laboratory equipment after
the end of the equipment's service life, (12) replacement parts for
heating, ventilation, air-conditioning, refrigeration, and water-
heating equipment, for power generating equipment, and for
commercial electronic equipment before November 19, 2049, (13)
replacement parts for consumer electronic equipment before November
19, 2031, (14) in other articles before October 31, 2024, after
which use in articles other than those with later phase-in
prohibition dates or exclusions is prohibited. In addition, all
persons are prohibited from releasing PIP (3:1) to water during
manufacturing, processing, and distribution in commerce, and must
follow all existing regulations and best practices to prevent the
release of PIP (3:1) to water during the commercial use of PIP
(3:1).
(iii) Labeling.
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet
military specifications for safety and performance where no
alternative chemical is available that meets U.S. Department of
Defense specification requirements, (2) In lubricants and greases
for aerospace and turbine uses and, for all other lubricant and
grease uses before November 21, 2039, (3) circuit boards and wire
harnesses, including but not limited to terminal and fuse covers,
cable sleeves, casings, connectors and tapes, (4) As an intermediate
in the manufacture of cyanoacrylate glue, (5) In specialized engine
air filters for locomotive and marine applications, (6) In adhesives
and sealants before January 6, 2025, after which use in adhesives
and sealants is prohibited, (7) In new parts for motor vehicles
before November 21, 2039 and replacement parts for motor vehicles
before November 19, 2054, (8) In new parts for aerospace vehicles
before November 19, 2054 and replacement parts for aerospace
vehicles after the end of the aerospace vehicles service lives, (9)
In marine antifouling coating products that are registered under the
Federal Insecticide, Fungicide, and Rodenticide Act and that meet
U.S. Department of Defense specification requirements before
November 19, 2029, (10) In new manufacturing equipment, new products
or articles in the semiconductor industry, for new heating,
ventilation, air-conditioning, refrigeration, and water-heating
equipment, new power generating equipment, new laboratory equipment,
new commercial electronic equipment, and new consumer electronic
equipment before November 20, 2034, (11) replacement parts for
manufacturing and laboratory equipment after the end of the
equipment's service life, (12) replacement parts for heating,
ventilation, air-conditioning, refrigeration, and water-heating
equipment, for power generating equipment, and for commercial
electronic equipment before November 19, 2049, (13) replacement
parts for consumer electronic equipment before November 19, 2031,
(14) in other articles before October 31, 2024, after which use in
articles other than those with later phase-in prohibition dates or
exclusions is prohibited. In addition, all persons are prohibited
from releasing PIP (3:1) to water during manufacturing, processing,
and distribution in commerce, and must follow all existing
regulations and best practices to prevent the release of PIP (3:1)
to water during the commercial use of PIP (3:1).
(4) Any downstream notification that occurs under paragraph (e) of
this section between February 19, 2025 and May 19, 2026, must include a
safety data sheet with the language in paragraphs (e)(3)(i) and (ii) of
this section unless distributing products with labels reflecting the
language in paragraph (e)(3)(iii) of this section.
(5) The downstream notification requirements in paragraph (e) of
this section do not apply to the activities described in paragraphs
(b)(1)(vi) and (vii) of this section.
(f) Workplace protection--(1) Applicability. After January 21,
2025, the provisions of this paragraph (f) apply to workplaces engaged
in the manufacturing and processing of PIP (3:1) and PIP (3:1)-
containing products and articles, except for those identified in
paragraph (f)(7) of this section.
(2) Regulated areas. Owners or operators must establish and
maintain regulated areas as defined in Sec. 751.403.
(i) The owner or operator must limit access to regulated areas to
authorized persons.
(ii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the regulated area and minimizes
the number of authorized persons exposed to PIP (3:1) within the
regulated area.
(iii) The owner or operator must ensure each potentially exposed
person is provided with a respirator according to the requirements of
paragraph (f) of this section and must ensure that all potentially
exposed persons within the regulated area are using the provided
respirators whenever exposures to airborne concentrations of PIP (3:1)
can reasonably be expected.
(iv) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated
area, persons do not engage in non-work activities that may increase
exposure to PIP (3:1).
(3) Respiratory protection. The owner or operator must provide
respiratory protection to all potentially exposed persons in the
regulated area as demarcated in accordance with paragraph (f)(2) of
this section, and according to the provisions outlined in 29 CFR
1910.134(b), (c)(1), (3) and (4), (d)(1)(iv), (f), and (g) through (l)
and as specified in this paragraph (f)(3) for potentially exposed
persons to PIP (3:1) during expected time of use.
[[Page 91519]]
(i) For purposes of this paragraph (f)(3), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are
defined in 29 CFR 1910.134(b) have the meaning assigned to them in 29
CFR 190.134(b).
(ii) Owners and operators must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator
selections to each affected person consistent with the requirements of
29 CFR 1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(v) Prior to or at the time of initial assignment to a job
involving potential exposure to PIP (3:1) owners and operators must
provide training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(vii) The type of respiratory protection that the owner or operator
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved APF 10 air-purifying half mask
respirator except for those uses identified in paragraphs (f)(3)(viii)
and (ix) of this section.
(viii) The type of respiratory protection that owners or operators
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved N95 respirator (APF 10) for the
manufacturing and processing of PIP (3:1), and PIP (3:1)-containing
products for use in new and replacement parts for motor vehicles,
including heavy machinery, and aerospace vehicles.
(ix) The type of respiratory protection that owners or operators
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved APF 50 purifying respirator for use
as an intermediate to produce cyanoacrylate adhesives when PIP (3:1)
and PIP (3:1)-containing products are not contained in a closed system
(i.e., except as described in paragraph (f)(7)(iii) of this section).
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(3) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29
CFR 1910.134(l), to ensure that the provisions of the written
respiratory protection program required under paragraph (f)(3) of this
section are being effectively implemented.
(xiii) The respiratory protection requirements in this paragraph
(f)(3) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(4) Dermal protection. (i) Owners or operators must require the
donning of gloves that are chemically resistant to PIP (3:1) with
activity-specific training where dermal contact with PIP (3:1) is
reasonably expected. Owners or operators must minimize and protect
potentially exposed persons from dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with PIP (3:1) in the specific work area where it is
selected for use, selected in accordance with this paragraph (f)(4) and
provided in accordance with 29 CFR 1910.132(h), to each person who is
reasonably likely to be dermally exposed in the work area through
direct dermal contact with PIP (3:1) For the purposes of this paragraph
(f)(4), provisions in 29 CFR 1910.132(h) applying to an ``employee''
also apply equally to potentially exposed persons, and provisions
applying to an ``employer'' also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the
work to be performed must be provided, used, and maintained in a
sanitary, reliable, and undamaged condition. Owners and operators must
select PPE that properly fits each affected person and communicate PPE
selections to each affected person.
(iv) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to PIP (3:1). For the purposes of this paragraph (f)(4),
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(v) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use dermal protection,
or when changes in the workplace or in dermal protection to be used
render the previous training obsolete.
(5) Engineering controls. Owners or operators manufacturing
cyanoacrylate adhesives using PIP (3:1) as an intermediate processing
aid must use the following engineering controls:
(i) Must take place in a closed loop system, and
(ii) General and local exhaust ventilation must be provided.
(6) Workplace protection records. (i) Owners or operators subject
to requirements described in this section must retain records of:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to directly handle PIP
(3:1) or handle equipment or materials on which PIP (3:1) may be
present, and the type of PPE selected to be worn by each of these
persons;
(B) The basis for the regulated area as defined in Sec. 751.403,
including monitoring data and documentation of any controls or
combination of controls that have reduced exposure to where airborne
concentrations of PIP (3:1) can no longer reasonably be expected
resulting in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by
each of these persons, the respiratory protection used by each
potentially exposed person and PPE program implementation, including
fit-testing and training;
[[Page 91520]]
(D) The basis for PPE selection (e.g., demonstration based on
permeation testing or manufacturer specifications that each item of PPE
selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(E) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE; and
(F) For owners and operators using PIP (3:1) as an intermediate
processing aid in the manufacturing of cyanoacrylate adhesives,
compliance with paragraph (f)(5) of this section.
(ii) These records must be maintained for a period of five years
from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons
and their designated representative an opportunity to observe records
related to the basis of the PPE or another control measure selection,
including potential monitoring results that is representative of the
potentially exposed person's exposure.
(7) Exclusions. The following are not subject to the workplace
protection requirements of paragraph (f) of this section:
(i) Import of PIP (3:1) and PIP (3:1)-containing products and
articles.
(ii) Processing of PIP (3:1)-containing adhesives and sealants,
specialized engine filters for locomotive and marine applications, and
the products or articles described in paragraphs (b)(1)(vi) and (vii)
of this section.
(iii) Processing of PIP (3:1)-containing new and replacement parts
to which PIP (3:1) has been added for motor and aerospace vehicles and
for manufacturing, HVAC, refrigeration and water heating equipment,
electric and electronic equipment, and power generating equipment and
the motor and aerospace vehicles, manufacturing, HVAC, refrigeration
and water heating equipment, electric and electronic equipment, and
power generating equipment that contain new and replacement parts to
which PIP (3:1) has been added.
(iv) Processing of PIP (3:1) and PIP (3:1)-containing products for
use as an intermediate to produce cyanoacrylate adhesives when PIP
(3:1) and PIP (3:1)-containing products are contained in a closed
system as described in paragraph (f)(6) of this section are not subject
to the provisions of paragraphs (f)(3) and (4) of this section.
[FR Doc. 2024-25758 Filed 11-18-24; 8:45 am]
BILLING CODE 6560-50-P