[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]
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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]]
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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.
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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);
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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 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.
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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 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
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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).
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
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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).
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
[[Page 91494]]
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,
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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
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
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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 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
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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 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
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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