[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Proposed Rules]
[Pages 82287-82312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25714]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2023-0376; FRL-9145-01-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: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing
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 following the
issuance of the 2021 PBT final rules, the Agency has determined that
revisions to the decaBDE and PIP (3:1) regulations are necessary to
address implementation issues and to reduce further exposures. As
required under TSCA, these proposed requirements would, if finalized,
reduce the potential for exposures to humans and the environment to
decaBDE and PIP (3:1) to the extent practicable. The Agency is not
proposing to revise the existing regulations for the other three PBT
chemicals (2,4,6-TTBP, HCBD, and PCTP) at this time.
DATES: Comments must be received on or before January 8, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0376, through https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting and 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, contact: 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, contact: 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), contact: 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 Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
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);
[[Page 82288]]
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);
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).
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
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. 1) that, among other
factors, EPA has a reasonable basis to conclude are toxic and that with
respect to persistence and bioaccumulation score high for one and
either high or moderate for the other, pursuant to the TSCA Work Plan
Chemicals: Methods Document (Ref. 2).
In response to this directive, in January 2021, EPA promulgated
five rules to regulate the following five PBT chemical substances:
decaBDE; PIP (3:1); 2,4,6-TTBP (CASRN 732-26-3); HCBD (CASRN 87-68-3);
and PCTP (CASRN 133-49-3) (Refs. 3, 4, 5, 6, and 7). 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
address
[[Page 82289]]
implementation issues and to further reduce exposure to these chemical
substances to the extent practicable.
C. What action is the Agency taking?
EPA is proposing revisions to the 2021 decaBDE and PIP (3:1) final
rules under TSCA. EPA is not proposing revisions to the other three PBT
rules issued under TSCA section 6(h) for 2,4,6-TTBP, HCBD, and PCTP at
this time.
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
proposing revisions to the 2021 final rule to require the use of
personal protective equipment (PPE) during certain domestic
manufacturing and processing of decaBDE and decaBDE-containing products
and articles and to require a label on plastic shipping pallets that
are known to contain decaBDE. EPA is also proposing to prohibit
releases to water from manufacturing, processing, and distribution in
commerce of decaBDE. EPA is proposing to extend 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 and is proposing to add an export notification requirement
for decaBDE-containing wire and cable for nuclear power generation
facilities. These proposed revisions are discussed further in Unit
III.D.
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 proposing 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, and to phase-in
prohibitions on processing and distribution for certain uses. EPA is
also proposing to add 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 the processing and
distribution in commerce of such PIP (3:1)-containing harnesses and
circuit boards. EPA also is proposing a new 5-year compliance timeframe
for the prohibition of processing and distribution in commerce of PIP
(3:1), so that it may be used as an ingredient of a pesticide product
(i.e., a pesticide product registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for use in anti-fouling paint).
EPA is not proposing to revise the October 2024 compliance date for
articles not otherwise covered by an exclusion from prohibition or by
an existing or newly proposed extension to a phase-out compliance
deadline.
D. Why is the Agency taking this action?
In accordance with the Executive Order 13990, ``Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis,'' (86 FR 7037, January 25, 2021), on September 3, 2021, EPA
announced its intention to review the five PBT final rules issued on
January 6, 2021. The Agency 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). At that time, EPA also requested public comment in the
Federal Register on the five 2021 PBT final rules (Refs. 8 and 9). In
particular, EPA sought comment on whether the 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.
In 2021, shortly after the PBT final rules were published, numerous
stakeholders, 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. 10). In response to stakeholder input, in an immediately
effective final rule 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. 11).
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. 12 and
13). 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. 11 and 12). 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 are necessary for certain industry sectors,
including the semiconductor and manufacture equipment.
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 promote
environmental justice to better protect human health and the
environment (Refs. 11, 12, and 13).
E. What are the estimated incremental impacts of this action?
EPA's Economic Analysis of the estimated impacts with this
rulemaking can be found in the rulemaking docket (Ref. 14). As
described in more detail in the Economic Analysis in Unit IV. and is
briefly summarized here.
1. Benefits
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 proposed rule, as summarized in Unit IV (Ref. 14). As
discussed in the 2021 PBT final rules, and in Unit II.A., 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.
2. Costs
Total quantified annualized social costs for this proposed rule are
approximately $389 million at a 3% discount rates, and $416 million at
a 7% discount rate. Of the proposed rule costs, those associated with
decaBDE alone were estimated at $1,700 at a 3% discount rate and $1,800
at a 7% discount rate. Costs associated with PIP (3:1) were estimated
$389 million and
[[Page 82290]]
$416 million (at 3 and 7% discount rates, respectively.)
3. Small Entity Impacts
This proposed rule, if finalized, would impact approximately 16,205
small businesses, all of which pertained to PIP (3:1) and none for
decaBDE. Of these, 1,399 are expected to incur cost impacts between 1%
and 3% of their annual revenue. No entities are expected to be impacted
above 3% 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 14), EPA relied on
available relevant data sources for PIP (3:1) and decaBDE, including
the U.S. EPA's CDR, the ToxicsStatistics, and others to assess the
economic implications of the proposed rule. Data, however, are not
sufficiently comprehensive to estimate the extent to which the proposed
rule would 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 believes 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. EPA also believes that the
restrictions placed on decaBDE and PIP (3:1) through this proposed rule
would reduce the potential exposures and risks associated with the
manufacture, processing, and use of these chemicals. At a minimum EPA
believes this proposed rule would not exacerbate any baseline
environmental justice concerns and would 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. 15). This proposed rule, if
finalized, would reduce the potential exposures to decaBDE and PIP
(3:1) that could occur from activities that would be prohibited under
this proposed rule for the general population and for potentially
exposed or susceptible subpopulations such as children. 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. 16).
6. Effects on State, Local, and Tribal Governments
This proposed rule, if finalized, would not have any significant or
unique effects on small governments, or federalism, or tribal
implications.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that
you claim to be CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.
II. Background
A. History of this Rulemaking
1. The 2021 PBT Final Rules
a. DecaBDE. EPA published a final rule in the Federal Register on
January 6, 2021, to address its obligations under TSCA section 6(h) for
decaBDE (86 FR 880; FRL-10018-87) (Ref. 3). EPA determined in the final
rule that decaBDE met the TSCA section 6(h)(1)(A) criteria for
expedited action. In addition, EPA determined, in accordance with TSCA
section 6(h)(1)(B), that under the conditions of use, exposure to
decaBDE was likely to the general population, to a potentially exposed
or susceptible subpopulation, and to the environment. The 2021 decaBDE
final rule generally prohibits the manufacture (including import) and
processing of decaBDE, and products and articles containing decaBDE, as
of March 8, 2021. Distribution in commerce of products and articles to
which decaBDE has been added is prohibited as of January 6, 2022. The
2021 decaBDE final rule also included phase-in compliance dates and
exclusions from prohibition:
Allowing 18 months to phase out any manufacture,
processing, and distribution in commerce of decaBDE for use in curtains
in the hospitality industry, and curtains to which decaBDE has been
added.
Providing two years to phase out any 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.
Providing three years to phase out any manufacture,
processing, and distribution in commerce of decaBDE for use in parts
installed in and distributed as part of new aerospace vehicles, and
parts for such vehicles to which decaBDE has been added.
Allowing the import, processing, and distribution in
commerce of aerospace vehicles manufactured before January 8, 2024,
that contain decaBDE in any part, through the end of the aerospace
vehicles' service lives.
Allowing the manufacturing, processing, and distribution
in commerce of aerospace vehicles that contain decaBDE in replacement
parts and replacement parts to which decaBDE has been added for such
vehicles, through the end of the aerospace vehicles' service lives.
Allowing the manufacturing, processing, and distribution
in commerce of motor vehicles the contain decaBDE in replacement parts
and replacement parts to which decaBDE has been added, through the end
of the motor vehicles' service lives or 2036, whichever is earlier.
Allowing the distribution in commerce of plastic shipping
pallets manufactured prior to March 8, 2021, that contain decaBDE
through the end of the plastic shipping pallets' service lives.
Excluding from the general prohibition on processing and
distribution in commerce for recycling
[[Page 82291]]
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, processing and distributing where no new
decaBDE is added during the recycling or production process.
For more information related to the 2021 decaBDE final rule, see 40
CFR 751.405.
b. PIP (3:1). EPA published a final rule for PIP (3:1) in the
Federal Register on January 6, 2021 (Ref. 4). EPA determined in the
final rule that PIP (3:1) met the TSCA section 6(h)(1)(A) criteria for
expedited action. In addition, EPA determined, in accordance with TSCA
section 6(h)(1)(B), that under the conditions of use, exposure to PIP
(3:1) was likely to the general population, to a potentially exposed or
susceptible subpopulation, and to the environment. The 2021 PIP (3:1)
final rule generally prohibited processing and distribution in commerce
of PIP (3:1), and products or articles containing PIP (3:1) after March
8, 2021, for all uses, except for those with different compliance dates
or exclusions from prohibition. The 2021 PIP (3:1) final rules also
included the following compliance dates:
Allowing until January 6, 2025, for the processing and
distributing in commerce of PIP (3:1) for use in adhesives and
sealants, PIP (3:1)-containing products for use in adhesives and
sealants, and PIP (3:1)-containing adhesives and sealants; and
Allowing until January 1, 2022, for the processing and
distributing in commerce of PIP (3:1) for use in photographic printing
articles and PIP (3:1)-containing photographic printing articles.
In addition, the 2021 PIP (3:1) final rule included the following
exclusions from the general prohibition:
Allowing the processing and distribution in commerce of
PIP (3:1) and PIP (3:1)-containing products for use in certain types of
hydraulic fluids, such PIP (3:1)-containing hydraulic fluids, and the
specified systems to which such hydraulic fluid is added;
Allowing 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;
Allowing the processing and distribution in commerce of
PIP (3:1) and PIP (3:1)-containing products for use in new and
replacement parts for motor and aerospace vehicles, the new and
replacement parts to which PIP (3:1) has been added for such vehicles,
and the motor and aerospace vehicles that contain new and replacement
parts to which PIP (3:1) has been added;
Allowing the processing and distribution in commerce of
PIP (3:1) for use as an intermediate in a closed system to produce
cyanoacrylate adhesives;
Allowing the processing and distribution in commerce of
PIP (3:1) for use in specialized engine air filters for locomotive and
marine applications, PIP (3:1)-containing products for use in
specialized engine air filters for locomotive and marine applications,
and PIP (3:1)-containing specialized engine air filters for locomotive
and marine applications; and
Allowing for the recycling of plastics that contained PIP
(3:1) before the plastic was recycled, and the finished products or
articles made of such recycled plastic, so long as no new PIP (3:1) is
added during the production or recycling process.
In addition, the final rule required manufacturers, processors, and
distributors of PIP (3:1) and products containing PIP (3:1) to notify
their customers of these restrictions. Finally, the rule prohibited
releases of PIP (3:1) and PIP (3:1)-containing products to water during
manufacturing, processing, and distribution in commerce, and required
commercial users of PIP (3:1) and PIP (3:1)-containing products to
follow existing regulations and best management practices to prevent
releases to water during commercial use (40 CFR 751.407(c)). For more
information related to the 2021 PIP (3:1) Final Rule, see 40 CFR
751.407.
2. The March 2021 notification and request for comments.
Shortly after the publication of the five 2021 PBT final rules, a
wide variety of stakeholders from various sectors began raising
concerns regarding the March 8, 2021, compliance date for the
prohibition on the processing and distributing in commerce of PIP (3:1)
for use in articles and PIP (3:1)-containing articles (Ref. 10). 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). During
the development of the rule, EPA conducted extensive outreach,
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 for the 2021 PBT rules
at a Small Business Roundtable hosted by the Small Business
Administration (SBA) Office of Advocacy to elicit public comment. 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. 4, 8, 11, and 12). 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).
On March 8, 2021, EPA issued a No Action Assurance memorandum
announcing that EPA will exercise its enforcement discretion to not
pursue enforcement actions for certain violations of the prohibitions
on processing and distribution of PIP (3:1) for use in articles, and
the articles to which PIP (3:1) has been added. Such discretion was
conditioned on certain recordkeeping requirements and remained in
effect until September 4, 2021. The purpose of the discretion was,
among other things, ``to avoid widespread disruption of critical supply
chains, while OCSPP develops a final agency action to ensure the
appropriate timeline to prohibit critical complex articles'' (Ref. 52).
In accordance with the Executive Order 13990 ``Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis'' and other relevant executive orders, EPA requested additional
public comments on the five 2021 PBT final rules. On March 16, 2021,
EPA announced its intent to review the five 2021 PBT final rules and
requested public comment (EPA-HQ-OPPT-2021-0202). Specifically, EPA
sought comment on whether there are further exposure reductions that
could be achieved, including exposure reductions for potentially
exposed or susceptible subpopulations and the environment;
implementation issues associated with the five 2021 PBT final rules;
and whether to consider additional or alternative measures or
approaches. EPA specifically asked for comment on issues raised
regarding the compliance date for the prohibition on the processing and
distribution of PIP
[[Page 82292]]
(3:1) for use in articles and PIP (3:1)-containing articles, as well as
any implementation issues (see Unit III.D.1 for more information).
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. 17). These comments are
addressed in EPA's September 2021 PIP (3:1) final rule and October 2021
PIP (3:1) proposed rule (Refs. 11 and 12). EPA received a total of 122
comments in response to the March 2021 notification and request for
comments, most of which regarded issues pertaining to PIP (3:1) (Ref.
17).
In addition, several comments received raised issues pertaining to
decaBDE. Tribal government 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-2021-0202). EPA also received a comment
requesting the Agency hold a government-to-government consultation with
the Yurok Tribal Council (Ref. 26). 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, see
Units III.C.1. and III.C.3. for more information. EPA received no
comments addressing the need for extensions to compliance dates for
decaBDE.
3. 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. 11). While most
commenters on the March 2021 notification and request for comments
requested a longer-term compliance date extension (Ref. 8), 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. 13).
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 are necessary.
4. Activities not regulated by this proposed rule.
EPA is not proposing revisions to the other three PBT rules issued
under TSCA section 6(h) for 2,4,6-TTBP, HCBD, and PCTP at this time.
EPA is not moving forward with reconsideration of the other three final
rules at this time. Due to resource constraints and competing statutory
obligations elsewhere in the existing chemicals risk management
program, EPA is only proposing amendments to 40 CFR part 751, subpart E
for the decaBDE and PIP (3:1) regulations at this time.
B. 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
proposed 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 read 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
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 proposed rulemaking does not amend these
interpretations or EPA's approach for implementing TSCA section
6(h)(4). Rather, this rulemaking is intended to identify further
opportunities to reduce risk to the substances to the extent
practicable based on additional available information received in the
comments to EPA's 2021 request for comment.
As demonstrated by the number of distinct programs addressed in
this rulemaking and the structure of this proposed rule in addressing
them independently, EPA generally intends the rule's provisions to be
severable from each other. EPA expects to provide additional detail on
severability in the final rule once the Agency has considered public
comments and finalized the regulatory language.
3. EPA's interpretation of ``to the extent practicable'' as used in
TSCA section 6(h)(4).
EPA is not changing the general interpretation of the term
``practicable'' as discussed in the five 2021 PBT final rules (86 FR
866, 86 FR 880, 86 FR 922, 86 FR 894, and 86 FR 911). As
[[Page 82293]]
explained in that rulemaking, TSCA section 6(h)(4) provides that EPA
shall: (1) ``Address the risks of injury to health or the environment
that the Administrator determines are presented by the chemical
substance'' and (2) ``reduce exposure to the substance to the extent
practicable'' which EPA reads to apply generally to the chemical and
any potential for exposures within TSCA jurisdiction. With respect to
the first requirement, EPA explained that the TSCA section 6(h)
standard is distinct from the ``unreasonable risk'' standard for all
other chemicals for which a section 6(a) rule might be issued. However,
the phrase is not defined in the statute and there is no legislative
history to explain what Congress intended with this text in section
6(h)(4). Given the ambiguity of this text, EPA further noted that it
had considered the relevance of other provisions in the statute, e.g.,
TSCA section 6(c) and concepts in TSCA section 6(g), and, as discussed
in the response to comment document for the 2021 PBT Final rules,
interprets ``reduce exposures to the extent practicable'' to consider
such factors as ``achievability, feasibility, workability and
reasonableness,'' consistent with dictionary definitions.'' Thus, EPA
noted that ``[w]hether a regulatory option is achievable, feasible,
workable, and reasonable inherently takes into consideration
circumstances, such as the economic burden and complexities with an
option, the utility of the chemical, and whether there are technically
and economically feasible alternatives available for the chemical.''
EPA further explained that its approach is consistent with dictionary
definitions of the term ``practicable'' which inherently includes
considerations outlined in TSCA section 6(c)(2) and 6(g), such as
health effects, magnitude of exposure, and the relative costs and
benefits of the action.
This interpretation of ``to the extent practicable'' for purposes
of TSCA section 6(h)(4) is not amended. The application of this
interpretation was informed by what the Agency could consider during an
expedited rulemaking process and the body of information available to
determine whether a prohibition would be practicable. EPA has collected
additional information and reconsidered its application of this
interpretation, focusing particularly on whether additional practicable
requirements can reduce occupational exposures, including those
associated with previously broadly-stated exclusions.
4. EPA's position on directly regulating occupational exposures.
EPA did not use its TSCA section 6(a) authorities to directly
regulate occupational exposures in the 2021 decaBDE or PIP (3:1) final
rules. As a matter of policy at that time, EPA assumed compliance with
federal and state requirements, such as worker protection standards,
unless case-specific facts indicated otherwise. For example, the
Occupational Safety and Health Administration (OSHA) has not
established a permissible exposure limit (PEL) for decaBDE and PIP
(3:1). However, EPA assumed that employers would require, and workers
would use, appropriate PPE consistent with general OSHA standards,
considering employer-based assessments, in a manner sufficient to
prevent occupational exposures that are capable of causing injury. EPA
also stated that given the time allotted for the TSCA section 6(h)
rulemakings and that no risk evaluation or assessment was required or
feasible in the time available under the statute, EPA could not
identify additional engineering or process controls or PPE requirements
that would be appropriate to each chemical-specific circumstance, and
that imposing such measures without sufficient analysis could
inadvertently result in conflicting or confusing requirements and make
it difficult for employers to understand their obligations. For these
reasons, EPA determined that it was not practicable to regulate worker
exposures in the 2021 rules through engineering or process controls or
PPE requirements. However, due to an increased focus on worker safety
and a change in EPA's assumptions regarding the use of worker
protection measures such as PPE, the Agency is reconsidering the
practicability of requiring worker protections.
For purposes of determining whether worker protection measures are
practicable under TSCA section 6(h)(4), EPA no longer believes it is
appropriate to assume as a general matter that an applicable OSHA
requirement or industry practice is consistently or always properly
applied. This change in assumption 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).
However, 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. 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 under 29 U.S.C. 655. 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 considers it 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 after the 2021 PBT final rules
gathered during engagements with industry stakeholders and from the
March 2021 notification and request for public comment period to
propose these requirements (Ref. 18). This information was used to
inform the proposed requirements for inhalation and dermal PPE to
reduce worker exposure to decaBDE and PIP (3:1).
EPA also considered the National Institute for Occupational Safety
and Health (NIOSH) hierarchy of controls (i.e., prioritization of
exposure control strategies from most protective and preferred to least
protective and preferred techniques). In order of precedence, this
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. 19). 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 under the context of the OSHA
Respiratory Protection Standard at 29 CFR 1910.134. Under OSHA's
standards, the various exposure controls are prioritized
[[Page 82294]]
equally, followed by PPE requirements when necessary. When formulating
the proposed worker protection requirements on the limited time
allotted for the TSCA section 6(h) rulemakings, no risk evaluation or
assessment was required or feasible and an already existing risk
assessment was not available to support calculation of safe exposure
levels for these two chemicals, which would be necessary for EPA to
establish a workplace chemical protection program. Thus, EPA is
proposing specific engineering controls and PPE for one industry
sector, specifically, the use of PIP (3:1) as an intermediate in
cyanoacrylate adhesives in which the Agency had additional information
about existing practice. EPA is requesting comment on the
practicability of worker protection measures that are higher in the
hierarchy of controls (e.g., engineering, and administrative controls)
due to the lack of existing available information.
C. 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 a new proposal of
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 proposed 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 would be reasonably available as a substitute when
the proposed 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
proposed action can be found in the 2021 PBT final rules for each
chemical, the support documents for those final rules (e.g., the
Exposure and Use Assessment (Ref. 16) and the Hazard Summary (Ref.
20)).
The costs and benefits of this proposal and the alternatives EPA
considered, as well as the impacts on small businesses, are presented
in the economic analysis document (Ref. 14). However, the Agency was
not able to quantitatively estimate the benefits of this proposal and
the alternatives, due to the absence of a risk evaluation, and has
instead qualitatively described such benefits. EPA requests comment on
all aspects of the benefits attributable to these proposed regulations.
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 proposed 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 believes 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(h) 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 in its
2020 Exposure and Use Assessment (Ref. 16), 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 proposed 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.
D. 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 the types of exposures that could occur, but such
information was not intended to identify ``conditions 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. As a result, EPA
explained that the hazard characterizations are not definitive or
comprehensive. Other hazard
[[Page 82295]]
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. 20). The following sections summarize the hazard and
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. 21). DecaBDE is also used as a flame
retardant for multiple applications for aerospace and automotive
vehicles, including replacement parts for aircraft and cars (Refs. 22
and 23). Exposure information for decaBDE is detailed in EPA's Exposure
and Use Assessment and the 2021 decaBDE final rule (Refs. 3 and 16). 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, use [industrial,
commercial, and consumer], 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 are
releases associated with use, disposal, and recycling activities (Ref.
16). 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. 14).
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
indoor air (via dust). 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. 16).
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 provide
more information on these hazardous endpoints (Ref. 20).
For the 2020 Chemical Data Reporting (CDR) submission period,
calendar years 2016-2019, data indicate that three companies
manufactured (including imported) decaBDE in the United States (Refs.
14 and 24). The 2020 CDR data indicate a production volume of less than
1 million pounds annually from 2016 thru 2019, however, EPA notes that
domestic production has ceased, and the identified importers have
likely since stopped using decaBDE (Ref. 24).
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. 16). 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. 16). 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 [industrial, commercial, and consumer], and disposal).
PIP (3:1) is manufactured, processed, distributed, and used
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. 24). 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. 14 and
24). 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. 24).
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,
ovaries, and heart in mammals. The studies presented in the 2019 Hazard
Summary, titled ``Environmental and Human Health Hazards of Five
Persistent, Bioaccumulative and Toxic Chemicals,'' describe these
hazardous endpoints (Ref. 25).
III. Proposed Regulatory and Alternative Regulatory Actions
A. Regulatory Approach
In this action, EPA is proposing 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 (see Unit II.B.3. and Unit II.B.4.
for additional details), including those associated with exclusions. As
described throughout this Unit, EPA has considered the practicability
of the proposed and alternative regulatory actions. EPA considered how
potential restrictions on the use of PIP (3:1) and decaBDE and the
compliance timeframes associated with certain actions could impact
supply chains, including those
[[Page 82296]]
prioritized in Executive Order 14017 America's Supply Chains.
B. Activities EPA Did Not Reevaluate for This Rulemaking
As explained in the 2021 decaBDE and PIP (3:1) final rules, at this
time, EPA is not proposing to use its TSCA section 6(a) authorities to
regulate all activities or exposures to decaBDE and PIP (3:1), although
its Exposure and Use Assessment identified potential for exposures
(Ref. 16). One such activity is disposal. As described in the 2021 PBT
rulemakings, regulations promulgated under the authority of the
Resource Conservation and Recovery Act (RCRA) govern the disposal of
hazardous and non-hazardous wastes. Although decaBDE and PIP (3:1) are
not listed or characteristic hazardous wastes under RCRA, they are
subject to the requirements applicable to solid waste under Subtitle D
of RCRA. This means there is a general prohibition on open dumping,
which includes a prohibition on open burning (e.g. the subtitle D ban
on open dumping is at 42 U.S.C. 6945). Wastes containing chemicals that
do not otherwise meet the criteria for hazardous waste would be
disposed of in municipal solid waste landfills (MSWLFs), industrial
nonhazardous landfills, or, in a few instances, construction/demolition
landfills. Non-hazardous solid waste is regulated under Subtitle D of
RCRA, and states play a lead role in ensuring that the federal
requirements are met (see 40 CFR part 239). The requirements for MSWLFs
are discussed in further detail in the 2021 PBT final rules. In those
rules, EPA also explained that establishing an entirely new disposal
program for decaBDE-containing and PIP (3:1)-containing wastes would be
not practicable. Both 2021 decaBDE and PIP (3:1) final rules discuss
how this type of program would be difficult to establish and
administer, as well as costly. In addition, treating these wastes in a
manner similar to wastes listed as hazardous wastes would have impacts
on hazardous waste treatment and disposal capacity and have resource
impacts for states and local governments, as well as for affected
industries (Refs. 3 and 4). Taking this into account, EPA did not
reevaluate the practicability of further exposure reductions relating
to disposal of decaBDE and PIP (3:1), as well as decaBDE- and PIP
(3:1)-containing wastes.
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
commercially available for a chemical, and 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) at this time.
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. 27). 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 already known to contain decaBDE
for the extent of the pallets' service life because EPA believes it is
practicable to regulate when the expensive testing is not necessary to
determine the chemical's presence in the article.
C. DecaBDE--Proposed Revisions to 40 CFR 751.405
1. Require a label on existing plastic shipping pallets that
contain decaBDE.
a. Description of the proposed regulatory action. EPA is proposing
to require a label on existing plastic shipping pallets that contain
decaBDE. As mentioned in Unit II.A., after holding an additional tribal
consultation, EPA received comments requesting the Agency to label
plastics that contain decaBDE (Ref. 28). New plastic shipping pallets
containing newly added decaBDE are prohibited under the 2021 decaBDE
final rule (40 CFR 751.405(b)). EPA determined it is practicable to
label existing plastic shipping pallets containing decaBDE because all
plastic shipping pallets are owned by a single company, and such
company is aware of and tracks, as part of normal business operations,
each decaBDE-containing plastic shipping pallet. No new decaBDE has
been added to the company's plastic shipping pallets since 2012 (Ref.
23). EPA is not proposing additional testing requirements to determine
if decaBDE is present in the plastic shipping pallets.
The proposed label would provide notice to workers that PPE is
required to be worn during recycling, refurbishing, or processing of
existing plastic shipping pallets that contain decaBDE, which would
reduce potential exposures to decaBDE, see Unit III.C.2 for more
information on specific PPE requirements. EPA is proposing that the
label must be securely attached to the plastic shipping pallet that is
known to contain decaBDE and is requesting comment on whether the
labels should be required to be available in multiple languages if
necessary (e.g., notice would be in a language that the potentially
exposed person understands, including a non-English language version
representing the language(s) of the largest group(s) of workers who
cannot readily comprehend or read English). EPA understands that the
company typically attaches a label when it has possession of a plastic
pallet in its inventory (i.e., after a pallet is returned from being
rented out) as part of normal business practice. EPA is proposing that
[[Page 82297]]
the labeling information must show clearly, prominently, and in an
easily readable font size, the following text: ``This pallet contains
decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5), a chemical that
has been identified as persistent, bioaccumulative, and toxic (PBT) by
the U.S. Environmental Protection Agency. All persons who recycle or
process this pallet are required to wear personal protective equipment,
per regulations at 40 CFR 751.405(e). The use of decaBDE is restricted
under 40 CFR 751.405: All persons are prohibited from all manufacturing
(including importing), processing, or distribution in commerce of
decaBDE or decaBDE-containing products or articles, except for select
uses, including those for plastic shipping pallets at 40 CFR
751.405(a)(2)(v) and (b). After the end of the pallets' service life,
all persons are prohibited from all distribution in commerce of plastic
shipping pallets that contain decaBDE and were manufactured prior to
March 8, 2021.'' EPA is requesting comment on the practicability of the
proposed label and the language EPA has proposed to require on each
label.
b. Description of the primary alternative regulatory option
considered. As a primary alternative regulatory option, EPA considered
requiring a label on all recycled plastic articles that may contain
decaBDE to aid in directions for worker protections. EPA considered
this option because of a government-to-government consultation with the
Yurok Tribal Council and comments received after this consultation
(Ref. 28). However, EPA considered it would not be practicable to label
all recycled plastic articles that may contain decaBDE (e.g.,
replacement parts for aerospace or motor vehicles). As mentioned in
Unit II.D., domestic manufacture of decaBDE has ceased; however,
decaBDE-containing articles may still be imported into the United
States. Although decaBDE's use has been largely phased out, the Truck
and Engine Manufacturers Association (EMA), in comments on the 2019
proposed PBT rule, cautioned EPA that their member manufacturers'
supply chains are very complex, and chemicals may be introduced into a
part ``as many as seven layers deep into the supply chain'' (Ref. 29).
Due to the complexity of supply chains, it is difficult to identify
whether and where decaBDE is added in an article, hence making it
difficult to determine where a label would be attached.
2. Require use of PPE for certain activities involving decaBDE.
a. Description of the proposed regulatory action. To ensure minimal
potential for exposure to workers during domestic manufacturing and
processing of decaBDE and decaBDE-containing products and articles, EPA
is broadly proposing certain PPE requirements to address potential
respiratory and dermal exposure to occupational workers during
permitted ongoing activities involving decaBDE, with several proposed
exclusions, including those which are being phased out. Due to the
broad prohibition on manufacturing and processing in the 2021 decaBDE
final rule and that several permitted uses will be phased out before
rule finalization, the proposed protections would generally be required
for certain ongoing uses listed at 40 CFR 751.405(a)(2) and 751.405(b).
For recycling activities, EPA is proposing to require respiratory
and dermal PPE, NIOSH-approved N95 respirator with an assigned
protection factor (APF) of 10 and gloves that are chemically resistant
to decaBDE, only during the recycling process of plastic shipping
pallets that are known to contain decaBDE. After EPA considered
additional information on industry use of PPE, the Agency concluded
that it is practicable to require PPE during the manufacturing and
processing of certain decaBDE and decaBDE-containing products and
articles. EPA believes based on comments that it is practicable to
require PPE for the processing of existing plastic shipping pallets
because it is already industry practice (Ref. 23). For other all other
recycling activities, due to the difficulty in identifying whether and
where decaBDE is present in an article, EPA maintains that it would be
impracticable to establish a testing program to determine if decaBDE is
present.
EPA is not proposing to require PPE for processing of decaBDE-
containing wire and cable for use in nuclear power generation
facilities, the 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. This is because the Agency believes 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.
16). EPA is also not proposing to require PPE for distribution in
commerce of decaBDE or decaBDE-containing products or articles, since
the distribution in commerce of these decaBDE-containing products or
articles would result in minimal potential for exposure. Lastly,
because EPA generally believes the potential for exposure is low during
importation, the Agency is not proposing to require worker protections
for import of decaBDE and decaBDE-containing products and articles.
Addressing such minimal potential for exposure through worker
protections would not be practicable considering the additional costs
and resource burdens (Ref. 16).
For the activities subject to the proposed PPE requirements and to
reduce potential occupational exposure during the recycling process of
plastic shipping pallets known to contain decaBDE, EPA is proposing to
require, at a minimum, a NIOSH-approved N95 respirator with an assigned
protection factor (APF) of 10 and gloves that are chemically resistant
to decaBDE with activity-specific training where dermal contact with
decaBDE is possible.
EPA is proposing 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 proposing to require that owners and operators ensure
that each potentially exposed person who is required to wear PPE use
and maintain PPE in a sanitary, reliable, and undamaged condition.
Owners and operators would 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, EPA is proposing 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 (Refs. 30 and 31). In choosing appropriate gloves, EPA expects
owners and operators would consider the effectiveness of the glove type
when preventing exposures from decaBDE 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 PPE guidance (Ref. 32). Owners
and operators would also be 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 affected
person.
EPA is proposing to require each owner or operator to comply with
OSHA's general PPE training requirements at 29 CFR 1910.132(f) when
using respirators and gloves. EPA is proposing that owners and
operators
[[Page 82298]]
provide PPE training to each potentially exposed person who is required
to wear PPE prior to or at the time of initial assignment to a job
involving potential exposure to decaBDE.
EPA is also proposing to require implementation of a respiratory
protection program in alignment with 29 CFR 1910.134(a) 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. EPA is also
proposing that owners or operators who would be required to administer
a respiratory protection program be required to supply a respirator
selected in accordance with 29 CFR 1910.134(d)(1).
EPA proposes to require that owners and operators document
respiratory protection used and PPE program implementation and retain
those records for five years. EPA proposes to require that owners and
operators document and keep records of the following information on the
PPE program, as applicable, and make it available to the Agency upon
request:
(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 and the type of PPE selected to be worn by each of these
persons;
(B) 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); and
(C) Documentation that the selection appropriately sized PPE and
training on proper application, wear, and removal of PPE, and proper
care/disposal of PPE occurred.
EPA is proposing to require that each owner or operator supply PPE,
selected in accordance with 40 CFR 751.405(e), to each potentially
exposed person within 60 days after publication of the final rule.
b. Description of the primary alternative regulatory option
considered. As a primary alternative regulatory option, EPA considered
requiring respiratory and dermal PPE during all recycling processes of
decaBDE-containing plastic products and articles. However, as stated in
Unit III.B. and in the 2021 PBT final rules, EPA did not propose to use
its TSCA section 6(a) authorities to restrict recycling activities
generally. EPA did not reevaluate the practicability of further
exposure reductions relating to prohibiting, or further regulatory
restrictions on, the general recycling of decaBDE-containing plastic in
the United States. As mentioned in the 2021 response to comment
document, in order to determine if decaBDE is present in plastics at
recycling facilities, a testing program would need to be established
(Ref. 33). EPA further explained that that it would also 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-containing plastic in the United States. EPA continues to
expect, as mentioned in the 2021 response to comment document, that the
amount of recycled plastic that contains decaBDE from recycled plastic
to decline due to compliance with the prohibitions in the 2021 decaBDE
final rule and as substitute flame retardants replace existing products
that contained decaBDE (Ref. 33).
3. Prohibit the release to water.
EPA is proposing to prohibit the releases to water during the
manufacturing, processing, and distribution in commerce of decaBDE,
decaBDE-containing products, and all persons are required to follow any
regulations that may apply and best management practices for preventing
the release of decaBDE to water. Applicable regulations related this
proposed prohibition on releases to water may include restrictions on
discharges under the Federal Water Pollution Control Act (commonly
known as the CWA)), Safe Drinking Water Act (SDWA), or analogous State
laws. As mentioned in Unit II.A., after holding an additional tribal
consultation, EPA received comments requesting the Agency prohibit
releases of decaBDE to water (Ref. 28). Although EPA is aware of
studies showing decaBDE in surface water, there have been no reported
releases to water to the Toxics Release Inventory (TRI) since 2012
(Ref. 34). After reconsidering the practicability of prohibiting
releases to water due to the tribe's comments, and the potential for
releases to water, even though there are no reported such releases, EPA
is proposing to prohibit the release to water to prevent any potential
future releases of decaBDE and protect exposed populations (e.g.,
subsistent fishers) (Ref. 16). EPA is requesting comments on additional
details of how a prohibition on releases to water could best be
achieved through best management practices, such as engineering
controls, process changes, work practices, emergency procedures, or
other measures to prevent releases.
While it is EPA's understanding that releases of decaBDE to water
are not occurring, prohibiting releases to water highlights the
importance of preventing environmental releases of chemicals regulated
by TSCA section 6(h) and reducing potential exposures. As mentioned in
the Exposure and Use Assessment, TRI data show a decrease in releases
that are reported in each industry sector using decaBDE. 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. 16). Specifically,
the one manufacturer that released 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. 34). 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 believes this is unlikely.
Prohibiting releases to water during manufacture, processing, and
distribution in commerce of decaBDE and decaBDE-containing products
would prevent future releases of decaBDE to the water from permissible
ongoing activities, reducing the overall potential for exposures. 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
releases of decaBDE to water.
EPA is not proposing to extend 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, with the exception of plastics
shipping pallets known to contain decaBDE. As described in more detail
in the 2021 decaBDE final rule and the 2021 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 proposed release to water prohibition (Ref. 33).
4. Extend the compliance extension for processing and distribution
in commerce of decaBDE-containing wire and cables insulation for use in
nuclear power generation facilities.
[[Page 82299]]
DecaBDE has been used in Class 1E cables, which are qualified to
meet industry standards and the Nuclear Regulatory Commission's (NRC)
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. 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 is 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
Department of Energy and has added text to the exclusion in 40 CFR
751.405(a)(2)(ii) for clarification. In addition, EPA is clarifying
that 40 CFR 751.405(a)(2)(ii) and new (a)(2)(vi) are not limited to a
specific level of power generation and that the exclusion includes
``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 components'' as defined in 10 CFR 50.2 which
include decaBDE-containing wire and cable. EPA requests comment on if
there are any additional points of clarification related to the
description of the excluded activity.
After the January 6, 2023, extended compliance deadline in the 2021
decaBDE final rule, EPA received multiple requests and letters of
concern regarding decaBDE in wire and cable insultation used in the
nuclear power sector (Refs. 35 and 36). 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 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 a
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 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 which 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. 37).
After considering feedback from the industry and federal partners,
including the U.S. Department of Energy and NRC, EPA is proposing 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 research and test reactors), until after the end
of the service life of the wire and cable and the component 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 (Ref. 16), once formulated into the
wire and cable, decaBDE is encased in the cured coating and the
potential for worker exposure is minimal (Ref. 16). Therefore, EPA
concluded allowing this use to continue is necessary and practicable,
while being unlikely to result in exposure to decaBDE.
EPA is not proposing to allow 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 supplier of this 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
industry undergoes transition to a decaBDE-free alternative (Ref. 38).
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.
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. 39). There is no specific exemption under
the POPs Convention for decaBDE-containing wire and cable for nuclear
power plant generation facilities, and thus, EPA did not expect import
or export for this use to occur. However, EPA recently learned that
there is a need for export of decaBDE-containing articles for this
purpose. Therefore, although articles are generally exempt under 40 CFR
707.60(b) for notices of export under TSCA section 12(b), EPA is
proposing to amend the current rule to require a TSCA section 12(b)
export notice for export of decaBDE-containing wire and cable for
nuclear power generation facilities. Such notice requirement is
triggered 30 days after publication of this proposed rule, pursuant to
TSCA section 12(b) and 40 CFR 707.65(a)(1)(i) and (b). The proposed
notification to EPA of such intent to export would 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 subpart A of Part 751, the provisions of subpart D of 40 CFR
[[Page 82300]]
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.
EPA is requesting comment on whether additional downstream
notification requirements for products and articles known to contain
decaBDE would reduce the potential for exposure to decaBDE. The
downstream notification for which the Agency is requesting comment
would include additional text in sections 1 and 15 of a safety data
sheet (SDS) or specific language on the label of the decaBDE-containing
product or article in question.
6. Extend recordkeeping requirements from three to five years and
remove timeframe to make records available.
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. EPA is
proposing to increase the recordkeeping requirement from three to five
years and to remove the 30-day timeframe to make records available for
decaBDE and PIP (3:1). Due to the additional requirements being
proposed in this rulemaking, specifically those pertaining to worker
safety, EPA believes that the five-year timeframe regarding
recordkeeping and removal of the 30-day timeframe to make records
available is more appropriate. Furthermore, this is consistent with the
timeframe associated with other TSCA section 6(a) rulemakings which
include worker protection requirements. EPA believes 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 believes that the regulated
entities should have the records demonstrating compliance readily
available.
D. PIP (3:1)--Proposed Revisions to 40 CFR 751.407
1. Modify existing exclusions and add new exclusions.
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. 12 and 33). For many of the exclusions, EPA
determined 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 period following the
March 6, 2021, notification, 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 proposes 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 propose extending the phase-out deadline.
EPA is requesting comment on the practicability of these proposed
modifications.
a. Description of the proposed regulatory action. EPA is proposing
to modify several exclusions from prohibition finalized in the January
6, 2021, PIP (3:1) final rule (Ref. 4). These proposed 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 is also proposing 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 not proposing to generally prohibit the
manufacturing of PIP (3:1), consistent with the 2021 PBT rulemaking,
due to the number of excluded activities which EPA has found it
impracticable to prohibit.
i. Lubricants and greases.
EPA is proposing to narrow the exclusion from prohibition in 40
CFR751.407(b)(1)(ii) for 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. Under this proposal, the exclusion from prohibition would
be narrowed to allow only for the processing and distribution in
commerce of PIP (3:1), PIP (3:1)-containing products, and PIP (3:1)-
containing lubricants and greases for use in aerospace and turbine
applications. The processing and distribution in commerce of PIP (3:1),
PIP (3:1)-containing products, and PIP (3:1)-containing lubricants and
greases for all other uses, including but not limited to use in motor
vehicles and industrial machinery, would be subject to a 5-year phased-
in prohibition. EPA has acknowledged (Ref. 4) and continues to
acknowledge the degree to which PIP (3:1) is a crucial anti-wear
component for aerospace lubricants and greases, which is needed to
perform at a wide range of temperatures and pressures. EPA understands
there are some non-aerospace uses of these lubricants and greases where
PIP (3:1) is a crucial anti-wear component, such as turbines used in
power generation or in marine settings (Ref. 40). However, as discussed
in the 2021 PIP (3:1) proposed rule (Ref. 12), uses in non-aircraft
machinery and non-turbine equipment may not be subject to these same
environmental stresses or safety and performance requirements from
industry and government as the uses in the aerospace sector and
turbines. As discussed in the 2020 Economic Analysis (Ref. 41), several
potential chemical substitutes for PIP (3:1) exist. Three unique
chemical substitutes of PIP (3:1) have been confirmed and an additional
ten potential chemical substitutes have been identified, including some
for non-aerospace and non-turbine lubricants and greases that are
currently available on the market.
Following EPA's announcement to reconsider the PBT rules (Ref. 8),
the Agency met with stakeholders to discuss their ongoing need for PIP
(3:1)-containing lubricants and greases to meet performance standards
and due to the lack of suitable alternatives. In addition, during the
March 2021 notification and comment period, EPA received five comments
either stating that no alternative existed or requesting the Agency
maintain the existing exclusion for lubricants and greases. Two
stakeholders indicated that they were working to identify alternatives
to and/or eliminate PIP (3:1) from lubricant and grease formulation,
while acknowledging for some applications they might not be able to
find a replacement. At least one stakeholder requested a 5-year
transition period to move away from PIP (3:1) for their applications
(Ref. 42). Because there are available alternatives to the use of PIP
(3:1) and given the absence of comment with specific information on the
need
[[Page 82301]]
for PIP (3:1) to meet performance standards for non-aerospace, non-
turbine lubricants and greases, EPA is proposing a 5-year phased-in
prohibition. EPA is requesting comment on whether there are performance
requirements that might impact compliance with this transition period,
or whether there are other considerations that would impact EPA's
conclusion that the phase-out is practicable, the suitability of
alternatives to meet any performance requirements for non-aerospace and
non-turbine uses, as well as the reasonableness of the proposed time
period for the prohibition phase-in for those uses. In addition, EPA is
requesting comment on the economic and technical feasibility of
alternatives, and whether it would be practicable, where alternatives
are not technically and economically feasible, to reduce exposures
through worker protections alone. EPA is also requesting comment on
whether the exclusion should be modified in another way, specifically
as it relates to certain turbine uses.
ii. New and replacement parts for motor vehicles.
EPA is proposing to repeal the exclusion from prohibition for new
and replacement parts for motor and aerospace vehicles in existing 40
CFR 751.407(b)(1)(iii). The aspects of this exclusion that relate to
aerospace vehicles and wire harnessing and electric circuit boards are
addressed in Unit III.D.1.a.iii and Unit III.D.1.a.iv, respectively. As
to motor vehicles, EPA is proposing to repeal 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 and is
proposing to replace it with a prohibition that would begin in 15
years. The proposed prohibition states that no later than 15 years from
publication of the final rule, 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 for new
motor vehicles, including heavy machinery, and the parts to which PIP
(3:1) has been added for such vehicles would be prohibited. Similarly,
after such time, the manufacturing, processing, and distribution in
commerce of new motor vehicles, including heavy machinery with PIP
(3:1)-containing parts would be prohibited per 40 CFR
751.407(a)(2)(iv). This proposed prohibition would not apply to PIP
(3:1)-containing parts that would be subject to a new exclusion, if
adopted as proposed (e.g., wire harnesses and circuit boards).
Consistent with the discussion in the January 6, 2021, PIP (3:1) and
decaBDE final rules, EPA continues to interpret TSCA section 6(c)(2)(D)
to be inapplicable to TSCA section 6(h) rulemakings. Specifically, TSCA
sections 6(c)(2)(D) and (E) require a risk finding pursuant to a TSCA
section 6(b) risk evaluation to regulate replacement parts and
articles. Yet, TSCA section 6(h) neither compels nor contemplates a
risk evaluation to precede or support the compelled regulatory action
to ``address the risks . . .'' and ``reduce exposures to the substance
to the extent practicable''. While this interpretation has not changed,
EPA has reviewed the practicability of regulating replacement parts and
articles in accordance with the statutory directive in TSCA section
6(h)(4) to reduce exposures to the PBT chemicals to the extent
practicable.
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
timeframe 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 believes a 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 (i.e., newly produced vehicles)
and a 30-year phase-in prohibition on processing and distribution in
commerce for replacement parts and the motor vehicles with PIP (3:1)-
containing parts, as discussed below, is practicable.
EPA is also proposing in new 40 CFR 751.407(a)(2)(v) to allow
processing and distribution in commerce for an additional 15 years
(i.e., until 30 years after the publication date of the final rule) of
PIP (3:1) and the manufacturing, processing, and distribution in
commerce of PIP (3:1)-containing products for use in replacement parts
for motor vehicles, including heavy machinery, the 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
the final rule. EPA's proposal does not impact the existing ``end
user'' example at 40 CFR 751.401. EPA is proposing 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.
Lastly, 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. EPA is
proposing to include a reference to ``heavy machinery'' in the
exclusion to clarify this.
iii. New and replacement parts for aerospace vehicles.
EPA is proposing to repeal the exclusion from prohibition for new
and replacement parts for aerospace vehicles described currently in 40
CFR 751.407(b)(1)(iii). EPA is proposing to replace the exclusion from
prohibition with a prohibition at 40 CFR 751.407(a)(2)(vi) 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. In addition, EPA is proposing that, after
the end of the aerospace vehicles' service lives, the importing,
processing, and distribution in commerce, of aerospace vehicles (i.e.,
those permissibly manufactured before the compliance timeframe ends)
that contain PIP (3:1) in any part would be prohibited. EPA is also
proposing at 40 CFR 751.407(a)(2)(vi) to prohibit manufacturing,
processing, and distribution in commerce of PIP (3:1), PIP (3:1)-
containing products for use in replacement parts, and PIP (3:1)-
containing replacement parts, after the end of the aerospace vehicle
service lives. These new prohibitions would not apply to PIP (3:1)-
containing parts that would be subject to a new exclusion from
prohibition, if adopted as proposed (e.g., wire harnesses and circuit
boards).
As discussed in the January 2021 PIP (3:1) final rule, EPA
concluded a similar reasoning applied to the use of PIP (3:1)
[[Page 82302]]
in new and replacement parts for motors 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
proposing longer time periods for the phase-in prohibitions for the use
of PIP (3:1) in new and replacement parts for aerospace vehicles. EPA
request comment on the appropriateness of a 30-year time period for
this phased-in prohibition or whether the length of time should be
longer (e.g., 40 years).
iv. Wire harnesses and circuit boards.
EPA is proposing a 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 proposed exclusion is based on industry comments
provided in response to the March 2021 notification opening a comment
period. EPA has proposed that wire harnesses include 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 medical instrumentation and more. In these articles, PIP (3:1) is
used as a plasticizer and flame retardant. EPA also 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 overmolding, dip molding, insert
molding applications, or conformal coatings. Hence, EPA is also
proposing to exclude from prohibition the processing and distribution
in commerce of PIP (3:1) and PIP (3:1)-containing products for use in
circuit boards. Commenters have stated that these components, namely
circuit boards and wire harnesses, 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. 8).
Due to 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 proposing
to determine 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). EPA requests comment on the availability of
potential alternatives for PIP (3:1) for use in wire harnesses and
circuit boards that would ensure that these products and articles would
meet performance requirements and voluntary and regulatory safety
standards.
v. Marine antifouling coating product.
EPA is proposing, at new 40 CFR 751.407(a)(2)(vii), to add a five-
year compliance deadline for the prohibition of processing and
distribution 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. 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 believes there are suitable alternatives for commercial users, and
so is limiting this exclusion to this U.S. Department of Defense
application. EPA is proposing this new, 5-year compliance deadline
under TSCA section 6(h), not TSCA section 6(g).
vi. Manufacturing equipment and semiconductor manufacturing
industry.
Based on comments received after the March 16, 2021, notification
and request for comments, EPA is proposing to revise 40 CFR
751.407(a)(2)(viii) to add a compliance deadline extension of 10 years
for processing and distribution in commerce of certain PIP (3:1)-
containing articles and the PIP (3:1) used to process those articles,
namely for use in manufacturing equipment and in the semiconductor
manufacturing industry. As discussed in Unit II.A.2., after the January
2021 PIP (3:1) final rule was published, a number of stakeholders from
a variety of industrial sectors, including electronics and electrical
manufacturing, semiconductor manufacturing, and manufacturing
equipment, requested an extension of the compliance date to allow time
to clear the existing articles through the supply chain, to find and
certify an alternative chemical, and to produce or import new articles
or complex goods that do not contain PIP (3:1) (Ref. 10). These
stakeholders informed EPA of new information regarding the use of PIP
(3:1) as a flame retardant and plasticizer in plastic components such
as wire covers and casings. Other components that were identified
include, but are not limited to, polyvinyl chloride tubes, harnesses,
cables, covers, sleeves, and casings, as well as internal components of
high-tech robotics and manufacturing equipment. Stakeholders have
identified PIP (3:1) in components in scanning electron microscopes
utilized in research, national laboratories, academia; in manufacturing
and electronic components utilized for electronic design and assembly;
and in electronics and semiconductor
[[Page 82303]]
manufacturing equipment (Ref. 44). Commenters also indicated that a
wide range of key consumer and commercial goods were 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. 8,
docket no., EPA-HQ-OPPT-2021-0202). EPA subsequently amended 40 CFR
751.407(a)(iii) to extend the compliance deadline for the phase-out of
the processing and distribution in commerce of PIP (3:1) for use in
articles and PIP (3:1)-containing articles until October 31, 2024 (Ref.
13).
EPA is now proposing to revise the compliance deadline at current
40 CFR 751.407(a)(2)(iii) to allow an additional 10 years for the
processing and distribution in commerce of PIP (3:1) for use in
articles and of PIP (3:1)-containing articles for use in manufacturing
equipment and in semiconductor manufacturing. EPA is not proposing to
further extend the existing October 31, 2024, compliance deadline for
most other articles (see Unit III.D.4). EPA received stakeholder
comments providing detailed information regarding timeframes to
identify, replace, and recertify PIP (3:1)-containing articles in use
within their often-complex supply chains and these comments suggest
that a 10-year phase-out for use in manufacturing equipment and in
semiconductor manufacturing is practicable and provides a reasonable
transition period (Refs. 46, 47, and 48). EPA also received a comment
in which a semiconductor industry stakeholder group stated that ``[w]e
have not learned of any situation where a reduction or elimination of
PIP (3:1) or decaBDE was not technically possible'' (Refs. 57). The
commenter also stated that ``we have found in our investigations that
it is generally feasible for the suppliers of components containing PIP
(3:1) or decaBDE to redesign the components for compliance.'' However,
this commenter also provided additional recommendations which EPA is
taking comment on in Unit V. Several commenters note that there are
difficulties in identifying PIP (3:1) in supply chains and 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.
However, comments provide timeframes consistent with a 10-year period
for transition and thus EPA does not believe that a shorter time frame
would be practicable or reasonable.
EPA is requesting comment on the scope and timeframe of this
compliance date extension and the narrower scope of uses covered by
this more limited extension beyond 2024. While EPA expects that in
several industries, such as the textile (Ref. 51)and consumer product
(Ref. 53) industries, the existing compliance timeframe 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, EPA
also recognizes the challenges described by commenters with complex
supply chains and the potential need for a longer compliance date
extension in certain other industries and is choosing the ten year
period as a practicable length of time during which the manufacturing
equipment and semiconductor industries should be able to move to
alternatives.
b. Description of the primary alternative regulatory action.
EPA is also considering longer phase-in timeframes for certain
existing exclusions from prohibition. EPA considered a 30-year time
limit on processing and distribution in commerce of PIP (3:1) and PIP
(3:1)-containing products for use in lubricants and greases for
aerospace and turbine applications, and PIP (3:1)-containing lubricants
and greases for aerospace and turbine applications. As previously
mentioned, stakeholders indicated that they were working to move away
from the use of PIP (3:1), but that there could be applications where
they might not be able to find a replacement. EPA is requesting comment
on the timeframe needed to transition to PIP (3:1)-free lubricant and
greases for this use and whether there are other industries, other than
for aerospace and turbine applications, that may also need more time.
EPA also considered a longer phase-out timeframe of 20 years for
the prohibition of processing and distribution in commerce of PIP (3:1)
and PIP (3:1)-containing products for use in wire harnesses and
electric circuit boards, manufacturing equipment, and in the
semiconductor industry. The 2021 OCSPP request for a ``No Action
Assurance'' (Ref. 49) outlines the many articles in which PIP (3:1) is
used. In order to clear supply chains and ensure an effective
transition to alternatives, EPA considered a 20-year transition period
for these PIP (3:1) containing articles. Articles with an end use in
new and replacement parts for vehicles would be excluded from this time
limit.
2. Require PPE during manufacturing and processing of PIP (3:1).
EPA is proposing to require inhalation and dermal PPE during
domestic manufacturing and processing of PIP (3:1) and certain PIP
(3:1)-containing products and articles. As discussed in Unit II. and in
this Unit III.C.2. for decaBDE, EPA believes there is potential for
reduction in worker exposure to PIP (3:1) by requiring PPE where EPA is
aware of employers in specific sectors that are already providing
appropriate PPE to their employees. EPA is proposing PPE requirements
to address potential respiratory and dermal exposure to occupational
workers during certain ongoing domestic manufacturing or processing
activities involving PIP (3:1), including those which EPA is proposing
phase out periods. Because EPA generally believes the potential for
exposure is low during importation, the Agency is not proposing to
require worker protections for import of PIP (3:1) and PIP (3:1)-
containing products and articles. The Agency is also not proposing to
require 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 is also 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)(8)(iii). This is consistent with the
practices of the one company using PIP (3:1) for this use and EPA
believes it is protective due to proposed requirements under new 40 CFR
751.407(f)(6) which would address PIP (3:1) through engineering
controls.
EPA is proposing 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 proposing to require
owners and operators ensure each potentially exposed person who is
required to wear PPE to use and maintain PPE in a sanitary, reliable,
and undamaged condition. Owners and operators would be required to
select and provide PPE that properly fits each
[[Page 82304]]
potentially exposed person who is required to use PPE and to
communicate PPE selections (e.g., demonstration that each item of PPE
selected provides prevents exposure during expected duration and
conditions of exposure) to each affected person.
While EPA is proposing implementation of a PPE program in alignment
with OSHA's, the Agency is also prescribing the level of PPE that must
be worn based on the reasonably available information the Agency has
regarding the adoption of those levels by industry. Where EPA is
prescribing the use of PPE, the Agency is not supplanting OSHA
requirements but clarifying the level of PPE that the Agency considers
is practicable under TSCA section 6(h). For all activities covered
under the worker protection proposed regulations, EPA is proposing that
owners or operators be required to 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 proposing respiratory
protection which 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 proposing respiratory protection which 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 under the proposed PPE
regulations, EPA is proposing respirators that are at least as
protective as a NIOSH-approved APF 10 air-purifying half mask
respirator. Based on stakeholder comments (Ref. 33) and OSHA-required
Safety Data Sheets, EPA believes 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.
EPA is proposing 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 owners and operators would consider 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 Protective
Equipment guidance (Ref. 32).
EPA is proposing to require each owner or operator to comply with
OSHA's general PPE training requirements at 29 CFR 1910.132(f) when
using respirators and gloves. EPA is proposing that owners and
operators would provide PPE training to each potentially exposed person
who is required to wear PPE prior to or at the time of initial
assignment to a job involving potential exposure to PIP (3:1).
EPA proposes to require that owners and operators document
respiratory protection used and PPE program implementation and retain
those records for five years. EPA proposes to require that owners and
operators document in the PPE program the following information, as
applicable, and make it available to the Agency upon request:
(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 present
and the type of PPE selected to be worn by each of these persons;
(B) 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); and
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE.
3. Require engineering controls for processing of PIP (3:1) and PIP
(3:1)-containing products as an intermediate processing aid in the
manufacturing of cyanoacrylate adhesives.
Based on information gathered during consultations with industry
stakeholders (Ref. 50), EPA is proposing, at new 40 CFR 751.407(f)(6),
to require engineering controls for the processing of PIP (3:1) as an
intermediate processing aid in the manufacturing of cyanoacrylate
adhesives. According to stakeholders, the production process using PIP
(3:1) is carried out in an automated batch distillation plant and in a
closed system.
EPA previously maintained that it was not practicable to prescribe
engineering controls that were duplicative of those required under OSHA
(OSHA 29 CFR 1910.134(a)(1)), which requires the use of feasible
engineering controls to prevent atmospheric contamination. As discussed
in Unit II.B.4., for purposes of determining whether worker protection
measures are practicable under TSCA section 6(h)(4), EPA no longer
believes it is appropriate to assume as a general matter that an
applicable OSHA requirement is consistently or always properly applied,
and the Agency considered when worker protection measures higher up the
NIOSH hierarchy of controls than PPE could practicably be required. For
the processing of PIP (3:1) as an intermediate processing aid in the
manufacturing of cyanoacrylate adhesives, EPA has reasonably available
information submitted by an industry participant regarding the use of
engineering controls. Based on that information, EPA is proposing to
require engineering controls for the processing of PIP (3:1) as an
intermediate processing aid in the manufacturing of cyanoacrylate
adhesives such that the processing of PIP (3:1) must take place in a
closed loop system with general and local exhaust ventilation provided.
EPA believes 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. Thus, there were no costs for this proposed
requirement (Ref. 14). EPA is requesting comment on whether all
processing of PIP (3:1) as an intermediate processing aid in the
manufacturing of cyanoacrylate adhesives uses this type of system and
the feasibility of the cyanoacrylate adhesive industry to implement
engineering controls.
4. Extend recordkeeping requirements from three to five years and
remove timeframe to make records available.
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
proposing to increase the recordkeeping requirement from three to five
years and to remove the 30-day timeframe to make records available. Due
to the additional requirements being proposed in this rulemaking,
specifically those pertaining to worker safety, EPA believes that the
five-year timeframe regarding recordkeeping and removal of the 30-day
timeframe to make records available is more appropriate. Furthermore,
this is consistent with the
[[Page 82305]]
timeframe associated with other TSCA section 6(a) rulemakings which
include worker protection requirements. EPA believes 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 timeframe to make
records available is critical to the Agency's ability to promptly
identify and correct noncompliance. EPA believes that regulated
entities should have the records demonstrating compliance readily
available.
IV. The Reasonably Ascertainable Economic Consequences of the Proposed
Rule
A. Overview of Cost Methodology
EPA has evaluated the potential costs of the proposed 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 included: 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, gloves, and/or goggles), product or
article labeling to indicate that it contains the regulated
chemical(s), rule 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 Proposed Rule
Total quantified annualized industry costs for the proposed rule
are estimated to be $389 million at a 3% discount rate and $416 million
at a 7% discount rate annualized over 30 years. Of the proposed rule
costs, those associated with decaBDE alone were approximately $1,700 at
a 3% discount rate and $1,800 at a 7% discount rate. Costs associated
with PIP (3:1) were $389 million and $416 million (at 3 and 7% discount
rates, respectively.) Of this total, worker protection (PPE) costs
under the proposed regulatory option annualized at a 3% discount rate
is $355 million and $392 million at a 7% 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 proposed rule's regulated
activities. There are only two firms known to be using decaBDE that
would be impacted by the proposed rule. Substantially more firms (up to
19,018) could potentially be impacted by the PIP (3:1) proposed rule
requirements based on the sectors impacted. Prohibition costs for PIP
(3:1) annualized at a 3% discount rate were estimated at $33 million
and $24 million annualized at a 7% 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
proposed rule would modify the existing rules. Therefore, EPA does not
expect that it will require any additional (incremental) Agency staff
time to implement the rules under the proposed revisions (proposed or
primary alternative options).
1. Benefits.
A qualitative discussion of the potential benefits associated with
the proposed 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 proposed
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 proposed 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 believes that it has
considered elements related to the cost effectiveness of the actions,
including the cost and the effect on exposure to the PBT chemicals of
the primary and alternative regulatory actions.
EPA considered the anticipated effect of this proposed rule on the
national economy and concluded that this rule is highly unlikely to
have any measurable effect on the national economy (Ref. 14). EPA
analyzed the expected impacts on small business and found that no small
entities are expected to experience impacts of more than 1% of revenues
(Ref. 54). Finally, EPA has determined that this rule is unlikely to
have significant impacts on technological innovation, although the rule
may create some incentives for chemical manufacturers to develop new
chemical alternatives to PIP (3:1).
V. Request for Comments
EPA requests comment on all aspects of this proposal, including the
proposed regulatory actions, the compliance dates for all the actions
in this proposal, the primary alternative regulatory actions, and any
other options that EPA has considered or should consider for both
decaBDE and PIP (3:1). EPA is requesting comment on whether the
Agency's proposed regulatory actions achieve the statutory directives
to ``reduce exposure to the substance to the extent practicable'' (15
U.S.C. 2605(h)(4)). In addition, as previously noted, EPA's
understanding of the extent to which reductions in exposure might
reduce risks for communities with EJ concerns is limited. EPA is
therefore interested in any feedback or data that could aide in the
quantification of human health impacts to exposed populations, in order
to assess the extent to which impacts to communities with environmental
justice concerns are reduced by the proposed rule.
EPA requests comment on the performance requirements and the
suitability of alternatives to meet any performance requirements for
non-aviation and non-turbine uses, as well as the reasonableness of the
proposed time period for the prohibition phase-in for those uses. In
addition, EPA requests comment on the economic and technical
[[Page 82306]]
feasibility of alternatives, and whether it would be practicable, where
alternatives are not technically and economically feasible, to reduce
exposures through worker protections alone. EPA is also requesting
comment on whether the exclusion from prohibition could be further
narrowed, specifically as it related to certain turbine uses.
EPA requests comment on the availability of potential alternatives
for PIP (3:1) for use in wire harnesses and circuit boards that would
ensure that these products and articles would meet performance
requirements and voluntary and regulatory safety standards.
EPA is requesting comment on the scope and timeframe of the 10-year
compliance date extension for processing and distribution in commerce
of certain PIP (3:1)-containing articles and the PIP (3:1), and PIP
(3:1) products used in those articles for use in manufacturing
equipment and in the semiconductor manufacturing industry, including
information on whether and why a longer timeframe or exclusion may be
necessary especially for replacement parts in order to account for
complex supply chains and to clear channels of trade.
In addition, in a more recent letter to EPA dated August 4, 2023, a
semiconductor industry stakeholder group provided additional comments
to EPA: including a recommendation 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, comments on EPA's interpretation of
``article,'' a recommendation that EPA incorporate a manufactured-by
approach to account for the complexity of the global supply chain and
the time required to productize components compliant with the rule, and
that EPA should incorporate an exclusion for semiconductor
manufacturing and related equipment replacement parts (Ref. 57). EPA is
also requesting comment on the availability of analytical test
detection methods for PIP (3:1) and the practicability of implementing
a testing program for the presence of PIP in products and articles. EPA
has addressed a portion of these comments in the 2021 rulemaking. For
example, EPA has addressed the request for an exclusion for PBTs
present at low threshold limits as an unintentional contaminant or
present as in de minimis quantities (independent of the exclusion for
recycled plastics) reasoning that, where it is practicable to reduce
exposures, the statute provides no such exceptions. EPA believes that
there are any number of reasonable steps that can be taken to determine
whether a product or article is compliant with the PBT regulations,
such as contract specifications that describe the chemicals that may
not be used, or a statement from the supplier that the articles
furnished do not contain specific prohibited chemicals. However, EPA is
requesting comment on this as well as the others provided to EPA by
this semiconductor stakeholder. EPA requests comment on amending the
downstream notification requirement at 40 CFR 751.407(e) for PIP (3:1)-
containing products to require language in the Safety Data sheet to
notify workers using spray applications of the presence of PIP (3:1),
or alternatively to require a warning or other label statement affixed
to PIP (3:1)-containing products with spray applications. EPA requests
comment on whether notification for workers using spray applications
would reduce exposures, the practicability of such requirements, and
what notification statements or warning labels would be effective at
reducing exposures. This request for comment includes whether the
notifications or warning labels should be available in multiple
languages, if necessary (e.g., notice would be in a language that the
potentially exposed person understands, including a non-English
language version representing the language(s) of the largest group(s)
of workers who cannot readily comprehend or read English).
EPA requests comment on whether additional downstream notification
requirements for products and articles known to contain decaBDE would
reduce the potential for exposure for decaBDE, and whether the labels
for plastic pallets should also be required to be available in multiple
languages if necessary. The downstream notification for which the
Agency is requesting comment would include additional text in sections
1 and 15 of an SDS or specific language on the label of the product or
article in question.
EPA also requests comment on all aspects of the Economic Analysis
accompanying this action. In taking final action on this proposal,
following review of comments, EPA may require exposure reductions
beyond those proposed here, or may reduce the scope of the proposed
exposure reductions.
VI. 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 the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
October 2014.
2. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012.
3. 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).
4. 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).
5. 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).
6. 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).
7. 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).
8. 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).
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. 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.
11. 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).
12. 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).
[[Page 82307]]
13. 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).
14. EPA. Economic Analysis for Regulation of Phenol, isopropylated
phosphate (3:1) (PIP (3:1) and Decabromodiphenyl ether (DecaBDE)
Under TSCA Section 6(h). November 2023.
15. EPA. 1995 Policy on Evaluating Health Risks to Children. https://www.epa.gov/sites/default/files/201405/documents/1995_childrens_health_policy_statement.pdf.
16. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. December 2020. (For references
and supporting documentation, see also EPA-HQ-OPPT-2019-0080).
17. 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.
18. Comment from the American Coatings Association (ACA) to EPA on
May 21, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0144.
19. Centers for Disease Control and Prevention (CDC). NIOSH
Hierarchy of Controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html.
20. 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).
21. EPA. Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: Decabromodiphenyl ether. August
2017. Docket No. EPA-HQ-OPPT-2016-0724-0002.
22. Stakeholder Comment from Auto Alliance. February 2018.
23. Stakeholder Comment from iGPS. January 2018.
24. EPA. Access Chemical Data Reporting: 2020 CDR Data. Last updated
on May 16, 2022.
25. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. June 2019.
26. 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.
27. Norwegian Environmental Agency. Final Report. Literature Study--
DecaBDE in Waste Streams. 2015.
28. Yurok Tribe. Letter to EPA RE: the Tribal Consultation on
DecaBDE Risk Management Rule on January 3, 2023.
29. Comment submitted to EPA by the Truck and Engine Manufacturers
Association (EMA) on October 29, 2019. Comment ID: EPA-HQ-OPPT-2019-
0080-0550.
30. Centers for Disease Control and Prevention (CDC). NIOSH
Certified Equipment List. https://www.cdc.gov/niosh/npptl/topics/respirators/cel/.
31. 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.
32. Occupational Safety and Health Administration. Personal
Protective Equipment. OSHA 3151-02R 2023. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
33. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h) RIN 2070-AK34; Response to Public
Comments. December 2020.
34. EPA (2021c). TRI Toxics Tracker, U.S. Environmental Protection
Agency. https://edap.epa.gov/public/extensions/TRIToxicsTracker/TRIToxicsTracker.html.
35. Placeholder: Letter from the Nuclear Regulatory Commission to
the EPA on March 31, 2023. (EPA-HQ-OPPT-2023-0376).
36. Placeholder: Email from the Nuclear Energy Institute to the EPA
on March 9, 2023, 2023. (EPA-HQ-OPPT-2023-0376).
37. 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.
38. 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.
39. 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.
40. EPA. Stakeholder Meeting Notes with Akin Gump on September 27,
2018. Docket No. EPA-HQ-OPPT-2019-0080-0017.
41. EPA. Economic Analysis for Regulation of Phenol, Isopropylated
Phosphate (3:1) (PIP (3:1)) Under TSCA Section 6(h). December 16,
2020.
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. Comment submitted to EPA from the Power Tool Institute, Inc. on
May 18, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0067.
49. Comment submitted to EPA from Leonhardt Environmental, PC on May
6, 2021. Comment ID: EPA-HQ-OPPT-2021-0202-0035.
50. Comment submitted to EPA by Japan Agricultural Machinery
Manufacturers Association on May 20, 2021. Comment ID: EPA-HQ-OPPT-
2021-0202-0112.
51. Comment submitted to EPA by Chemical Users Coalition on May 24,
2021. Comment ID: EPA-HQ-OPPT-2021-0202-0135.
52. EPA. Letter from EPA's Office of Chemical Safety and Pollution
Prevention to EPA's Office of Enforcement and Compliance Assurance
RE: Request for No Action Assurance Regarding the Prohibition of
Processing and Distribution of Phenol Isopropylated Phosphate (3:1),
PIP (3:1), for Use in Articles and PIP (3:1) containing Articles
under 40 CFR 751.407(a)(1). March 8, 2021. https://www.epa.gov/sites/default/files/2021-03/documents/10021-08_memo_freedhoff_to_starfield_tsca_pip_31_naa_signed_2021-03-08.pdf.
53. Comment submitted to EPA from Daniel D. Masakowski, Director of
Materials Development, RSCC on the Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) on
January 29, 2020. Comment ID: EPA-HQ-OPPT-2019-0080-0583.
54. Keweenaw Bay Indian Community. Re: Notification of Consultation
and Coordination on a Rulemaking Under the Toxic Substances Control
Act: Regulation of Persistent, Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h). September 25, 2018.
55. Harper, Barbara and Ranco, Darren, in collaboration with the
Maine Tribes. Wabanaki Traditional Cultural Lifeways Exposure
Scenario. July 9, 2009. Referenced in the 2021 Final PBT Rule.
56. 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); Proposed Rule (RIN 2070-
AL02). EPA ICR No. 2779.01 and OMB Control No. 2070-NEW. November
2023.
[[Page 82308]]
57. Comment submitted to EPA by SEMI on August 4, 2023. Comment ID;
TBA
VII. 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 in
section 3(f)(1) 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 OMB for review under
Executive Order 12866. 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 proposed rule (Ref. 14). A copy of this
economic analysis is also available in the docket and is briefly
summarized in Unit I.E. and discussed in Unit IV.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 2779.01 (Ref. 56). You can find
a copy of the ICR in the docket for this rulemaking and it is briefly
summarized here.
Respondents/affected entities: See Unit I.A.
Respondent's obligation to respond: Mandatory under TSCA section
6(h) and 40 CFR 751.407.
Estimated number of respondents: 19,020 (13,550 manufacturers/
importers/processors, and 5,470 distributors).
Frequency of response: On occasion.
Total estimated burden: 34,497 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $2,640,103 (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.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to EPA using the docket identified at the
beginning of this rule. EPA will respond to any ICR-related comments in
the final rule. You may also send your ICR-related comments to OMB's
Office of Information and Regulatory Affairs using the interface at
https://www.reginfo.gov/public/do/PRAMain. Find this ICR by selecting
``Currently under Review--Open for Public Comments'' or by using the
search function. OMB must receive comments no later than December 26,
2023.
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 proposed rule. The Agency has
determined that this proposed rule, if finalized, would impact
approximately 16,205 small businesses of which 1,399 are expected to
incur cost impacts between 1% and 3% of their annual revenue, all of
which were for PIP (3:1) and none for decaBDE. The cost per small
entity ranged from $4,254 to $1,134,821 (with an average of $124,650)
at a 3% discount rate and ranged from $4,227 to $1,134,786 (with an
average of $124,651, at a 7% discount rate). No entities for either
chemical are expected to be impacted above 3% of their annual revenue.
Details of this analysis are presented in the Economic Analysis (Ref.
14), which is in the public docket for this action.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate of $100 million
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this proposed rule are not expected to affect state, local, or Tribal
governments because the rule impacts only entities that manufacture
(including import), process, distribute in commerce, use, or dispose
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.
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.
Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, the Agency consulted with tribal officials during
the development of this action. EPA consulted with representatives of
Tribes via teleconference on August 31, 2018, and September 6, 2018,
concerning the prospective regulation of these five PBT chemicals under
TSCA section 6(h). Tribal members were encouraged to provide additional
comments after the teleconferences. EPA received two comments from the
Keweenaw Bay Indian Community and Maine Tribes (Refs. 54 and 55). EPA
also met with the National Tribal Toxics Council (NTTC) in Washington,
DC. During the NTTC meeting, the Agency provided background information
on the available regulatory options under 6(a) and a summary of the
information gathered on the five PBT chemicals. Officials from NTTC
expressed support for EPA regulations to reduce exposures to the
general population and susceptible subpopulations. On November 7, 2022,
EPA held a one-on-one tribal consultation with the Yurok Tribal
Council, where the Agency received additional information that informed
the Agency of considerations to reduce potential exposures to decaBDE,
a summary of this consultation is provided in Unit II.A.2.
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
[[Page 82309]]
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 believes 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 proposed requirements
would 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. 16) and summary of the health and environmental hazards
that may be presented by these chemical substances (Ref. 20) are in the
docket. In addition, as briefly discussed in Unit I.E.5., EPA's Policy
on Children's Health also applies to this action. See also the other
discussions about the risks presented by the PBT chemicals 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 Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes 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 in accordance with Executive Order 12898 (59 FR 7629, February
16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 2023).
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
proposed rule would 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. 14), provides 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 rule may partially delay addressing these impacts. EPA believes
that the restrictions that would be placed on decaBDE and PIP (3:1)
with adoption of this proposed rule would 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 be also 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 and some are comparably toxic to decaBDE and PIP (3:1).
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 proposes
to amend 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. 751.403 by adding in alphabetical order the term
``regulated area'' to read as follows:
Sec. 751.403 Definitions.
* * * * *
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations or direct dermal contact
of a specific chemical substance can reasonably be expected.
* * * * *
0
3. Amend Sec. 751.405 by:
0
a. Revising paragraph (a)(2)(ii);
0
b. Adding paragraphs (a)(2)(vi);
0
c. Revising paragraphs (c)(1)(i) and (iii); and
0
d. Adding paragraphs (d), (e), (f), and (g).
The revision and additions read as follows:
Sec. 751.405 DecaBDE.
(a) * * *
(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
research and test 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 research and test reactors).
* * * * *
(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) Labeling.
(1) After [DATE 1 YEAR AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], all persons who process, including recycle, plastic shipping
pallets that are known to contain decaBDE must securely attach a label
to each pallet. For purposes of this section, ``securely attach'' shall
mean that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. Each label must show
clearly, prominently, and in an easily readable font size the following
text:
This shipping pallet contains decabromodiphenyl ether (decaBDE)
(CASRN
[[Page 82310]]
1163-19-5), a chemical that has been identified as persistent,
bioaccumulative, and toxic (PBT) by the U.S. Environmental
Protection Agency. All persons who recycle or process this pallet
are required to wear personal protective equipment, per regulations
at 40 CFR 751.405(e). The use of decaBDE is restricted under 40 CFR
751.405, all persons are prohibited from all manufacturing
(including importing), processing, or distribution in commerce of
decaBDE or decaBDE-containing products or articles, except for
select uses, including those for plastic shipping pallets at 40 CFR
751.405(a)(2)(v) and (b). After the end of the pallets' service
life, all persons are prohibited from all distribution in commerce
of plastic shipping pallets that contain decaBDE and were
manufactured prior to March 8, 2021.
(e) Workplace protection.
(1) Applicability. After [DATE 60 DAYS AFTER DATE OF PUBLICATION IN
THE FEDERAL REGISTER], the provisions of paragraph (e) of this section
apply to any workplaces, engaged in manufacturing and processing of
decaBDE and decaBDE-containing products and articles, except for those
identified in paragraph (e)(7) of this section.
(2) Regulated areas. Owners or operators must establish and
maintain regulated areas as defined in 40 CFR 751.403 wherever a
potentially exposed person's exposure to airborne concentrations or
direct dermal contact of decaBDE can reasonably be expected.
(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 supply a respirator that complies
with the requirements of paragraph (e) of this section and must ensure
that all 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 which interfere with respirator seal or performance.
(v) Whenever any direct dermal contact with decaBDE may occur
within the regulated area the owner or operator must supply and ensure
all persons are using dermal PPE that complies with the requirements of
paragraph (e) of this section.
(vi) 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(a) through (l) and as specified in this paragraph for
potentially exposed persons to decaBDE during expected time of use.
(i) The type of respiratory protection that regulated entities must
select and provide to potentially exposed persons must be at least as
protective as a NIOSH-approved N95 respirator (APF 10).
(ii) [Reserved]
(4) Dermal protection. 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 possible.
(5) Training. The owner or operator must provide PPE training in
accordance with 29 CFR 1910.132(f) to all persons required to use PPE
under this subsection. The training shall be provided prior to or at
the time of initial assignment to a job involving potential exposure to
decaBDE.
(6) Workplace protection records. (i) The owner or operator subject
to the requirements described in this section must retain records of:
(A) The name, workplace address, work shift, job classification,
work area of each person reasonably likely to directly handle decaBDE
or handle equipment or materials on which decaBDE may be present, 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;
(B) 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); and
(C) 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.
(7) Exclusions. The following are not subject to the provision of
paragraph (e) of this section:
(i) Import of decaBDE and decaBDE-containing products and articles.
(ii) Processing for recycling of decaBDE-containing plastic from
products or articles and decaBDE-containing products or articles made
from such recycled plastic, where no new decaBDE is added during the
recycling or production processes, except for those 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. After [DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], all persons intending to export decaBDE-containing wire and
cable for nuclear power generation facilities (including research and
test 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 [DATE 60 DAYS AFTER
DATE OF PUBLICATION IN THE FEDERAL REGISTER], all persons are
prohibited from releasing decaBDE to water during manufacturing,
processing, and distribution in commerce of decaBDE, decaBDE-containing
products, and all persons are required to follow any applicable
regulations and best management practices for preventing the release of
decaBDE.
0
4. Amend Sec. 751.407 by:
0
a. Revising paragraphs (a)(2)(iii) and adding paragraphs (a)(2)(iv)
through (ix); and
0
b. Revising paragraphs (b)(1)(ii) and (iii), (d)(1) and (3); and
0
c. Adding paragraph (f).
The revisions and additions read as follows:
Sec. 751.407 PIP (3:1).
(a) * * *
(2) * * *
(iii) After October 31, 2024, except as provided in paragraphs
(a)(2)(ii),
[[Page 82311]]
(a)(2)(ix), and (b) of this section, all persons are prohibited from
all processing and distribution in commerce of PIP (3:1) for use in
articles and PIP (3:1)-containing articles.
(iv) After [DATE 5 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], except as provided in paragraph (b)(1)(ii) of this section,
all persons are prohibited from all processing and distribution in
commerce of PIP (3:1) and manufacturing, processing, and distribution
of PIP (3:1)-containing products for use in lubricants and greases and
PIP (3:1)-containing lubricants and greases.
(v) After [DATE 15 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], 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.
(vi) After [DATE 30 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], 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 machinery, PIP
(3:1)-containing replacement parts, and the motor vehicles, including
heavy machinery, that contain such replacement parts.
(vii) After [DATE 30 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], 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 installed in and distributed as part of new aerospace
vehicles, and PIP (3:1)-containing parts for such vehicles. After the
end of the aerospace vehicles service lives, all persons are prohibited
from all importing, processing, and distribution in commerce of
aerospace vehicles manufactured before [DATE 30 YEARS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER] that contain PIP (3:1) in any
part. 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.
(viii) After [DATE 5 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], 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.
(ix) After November 25, 2033, all persons are prohibited from
processing, and distribution in commerce of PIP (3:1), and
manufacturing, processing, and distribution of PIP (3:1)-containing
products and articles for use in manufacturing equipment and in the
semi-conductor industry.
* * * * *
(b) * * *
(1) * * *
(ii) PIP (3:1) for use in lubricants and greases for aerospace and
turbine uses, PIP (3:1)-containing products for use in lubricants and
greases for aerospace and turbine use, and PIP (3:1)-containing
lubricants and greases for aerospace and turbine uses;
(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;
* * * * *
(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.
* * * * *
(f) Workplace protection.
(1) Applicability. After January 23, 2024, 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 as provided in paragraph (f)(8) of this section.
(2) Regulated areas. Owners or operators must establish and
maintain regulated areas as defined in 40 CFR 751.403 wherever a
potentially exposed person's exposure to airborne concentrations or
direct dermal contact of PIP (3:1) can reasonably be expected.
(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 supply a respirator that complies
with the requirements of paragraph (f) of this section and must ensure
that all 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 which interfere with respirator seal or performance.
(v) Whenever any direct dermal contact with PIP (3:1) may occur
within the regulated area the owner or operator must supply and ensure
all persons are using dermal PPE that complies with the requirements of
paragraph (f) of this section.
(vi) 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(a) through (l) and as specified in this paragraph for
potentially exposed persons to PIP (3:1) during expected time of use.
(i) The type of respiratory protection that regulated entities 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 paragraph (f)(3)(ii) and
(iii) of this section.
(ii) The type of respiratory protection that regulated entities
must select and provide to potentially exposed persons
[[Page 82312]]
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.
(iii) The type of respiratory protection that regulated entities
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)(8)(iii) of this section).
(4) Dermal protection. 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 possible.
(5) Training. The owner or operator must provide PPE training in
accordance with 29 CFR 1910.132(f) to all persons required to use PPE
under this subsection. The training shall be provided prior to or at
the time of initial assignment to a job involving potential exposure to
PIP (3:1).
(6) 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.
(7) Workplace protection records. Owners or operators subject to
requirements described in this section must retain records of:
(A) The name, workplace address, work shift, job classification,
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, the
type of PPE selected to be worn by each of these persons, the
respiratory protection used by each potentially exposed person and PPE
program implementation, including fit-testing and training;
(B) 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); and
(C) 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.
(8) Exclusions.
(i) Import of PIP (3:1) and PIP (3:1)-containing products and
articles are not subject to the provision of paragraph (f) of this
section.
(ii) 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 such 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 paragraph
(b)(1)(vi) and (vii) of this section are not subject to the provisions
of paragraph (f) of this section.
(iii) 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 provision of paragraph (f)(3) and (4) of this section.
* * * * *
[FR Doc. 2023-25714 Filed 11-22-23; 8:45 am]
BILLING CODE 6560-50-P