Rule2021-19516
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Compliance Date Extension
Primary source
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Published
September 17, 2021
Effective
September 17, 2021
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). Specifically, EPA is extending the compliance date 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 from March 8, 2021, to March 8, 2022. For such articles, EPA is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. The articles covered by this amendment include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.
Full Text
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[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Rules and Regulations]
[Pages 51823-51832]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19516]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2021-0202; FRL-6015.5-03-OCSPP]
RIN 2070-AK89
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1);
Compliance Date Extension
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is amending the
regulations applicable to phenol, isopropylated phosphate (3:1) (PIP
(3:1)) promulgated under the Toxic Substances Control Act (TSCA).
Specifically, EPA is extending the compliance date 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 from March 8,
2021, to March 8, 2022. For such articles, EPA is also extending the
compliance date for the recordkeeping requirements applicable to
manufacturers, processors, and distributors from March 8, 2021, to
March 8, 2022. The articles covered by this amendment include a wide
range of key consumer and commercial goods such as cellular telephones,
laptop computers, and other electronic and electrical devices and
industrial and commercial equipment used in various sectors including
transportation, life sciences, and semiconductor production.
DATES: This final rule is effective on September 17, 2021.
ADDRESSES: The docket for this action, identified by docket
identification (ID)
[[Page 51824]]
number EPA-HQ-OPPT-2021-0202, is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room are closed to visitors with
limited exceptions. The staff continue to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Cindy Wheeler, Existing Chemicals Risk Management Division, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-0484; email address: <a href="/cdn-cgi/l/email-protection#c490978785e9948690e9b6b1a8a1b784a1b4a5eaa3abb2"><span class="__cf_email__" data-cfemail="792d2a3a3854293b2d540b0c151c0a391c0918571e160f">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#6b3f38282a4623041f0702050e2b0e1b0a450c041d"><span class="__cf_email__" data-cfemail="3a6e69797b1772554e5653545f7a5f4a5b145d554c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, distribute in commerce, or use phenol,
isopropylated phosphate (3:1) (PIP (3:1)), or PIP (3:1)-containing
articles, especially 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:
<bullet> Petroleum Refineries (NAICS Code 324110);
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS Code
325199);
<bullet> Plastics Material and Resin Manufacturing (NAICS Code
325211);
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS Code 325998);
<bullet> Machinery Manufacturing (NAICS Code 333);
<bullet> Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
Code 333415);
<bullet> Other Communications Equipment Manufacturing (NAICS Code
334290);
<bullet> Computer and Electronic Product Manufacturing (NAICS Code
334);
<bullet> Small Electrical Appliance Manufacturing (NAICS Code
335210);
<bullet> Major Household Appliance Manufacturing (NAICS Code
335220);
<bullet> Motor and Generator Manufacturing (NAICS Code 335312);
<bullet> Switchgear and Switchboard Apparatus Manufacturing (NAICS
Code 335313);
<bullet> Relay and Industrial Control Manufacturing (NAICS Code
335314);
<bullet> Other Communication and Energy Wire Manufacturing (NAICS
Code 335929);
<bullet> Current-carrying Wiring Device Manufacturing (NAICS Code
335931);
<bullet> Transportation Equipment Manufacturing (NAICS Code 336);
<bullet> Musical Instrument Manufacturing (NAICS Code 339992);
<bullet> All Other Miscellaneous Manufacturing (NAICS Code 339999);
<bullet> Other Chemical and Allied Products Merchant Wholesalers
(NAICS Code 424690);
<bullet> Motor Vehicle and Parts Dealers (NAICS Code 441);
<bullet> All Other Home Furnishings Stores (NAICS Code 442299);
<bullet> Electronics and Appliance Stores (NAICS Code 443);
<bullet> Building Material and Garden Equipment and Supplies
Dealers (NAICS Code 444);
<bullet> Research and Development in the Physical, Engineering, and
Life Sciences (NAICS Code 541710).
B. What is the Agency's authority for taking this action?
1. Toxic Substances Control Act (TSCA). TSCA section 6(h), 15
U.S.C. 2605(h), directs EPA to take expedited action on certain
persistent, bioaccumulative, and toxic (PBT) chemical substances. For
chemical substances that meet the statutory criteria, EPA is directed
to issue final rules that address the risks of injury to health or the
environment that the Administrator determines are present and to reduce
exposure to the substance(s) to the extent practicable. In response to
this directive, EPA identified PIP (3:1) as meeting the TSCA section
6(h) criteria and issued a final rule for PIP (3:1) on January 6, 2021
(Ref. 1). The January 2021 final rule prohibits the processing and
distribution of PIP (3:1), PIP (3:1)-containing products, and PIP
(3:1)-containing articles, with specified exclusions; prohibits or
restricts the release of PIP (3:1) to water during manufacturing,
processing, distribution, and commercial use; requires persons
manufacturing, processing, and distributing in commerce PIP (3:1) and
products containing PIP (3:1) to notify their customers of these
prohibitions and restrictions and to keep records. Several different
compliance dates were established, the first of which was March 8,
2021, after which processing and distribution of PIP (3:1), PIP (3:1)-
containing products, and PIP (3:1)-containing articles were prohibited
unless an alternative compliance date or exclusion was otherwise
provided. With the obligation to promulgate these rules, the Agency
also has the authority to amend them if circumstances change, including
in relation to the receipt of new information and in relation to
compliance deadlines established under TSCA section 6(d). 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 FCC v. Fox Television
Stations, Inc., 556 U.S. 502, 515 (2009). Here, as explained further in
Unit I.D., based on information submitted by regulated entities since
the publication of the final rule in January 2021, the Agency has
determined that a limited extension to certain PIP (3:1) revised
compliance dates is appropriate and necessary to address comments that
the original compliance dates were not practicable and did not provide
adequate transition time because they would have caused extensive harm
to the economy and public due to unavailability of critical goods and
equipment. This limited extension to the referenced compliance dates is
intended to allow EPA additional time to consider how best to approach
the concerns raised in comments seeking longer term extensions.
2. Administrative Procedure Act (APA). APA section 553(d), 5 U.S.C.
553(d), provides that the publication of a substantive rule must occur
no later than 30 days before its effective date, with certain
exceptions. The purpose of this provision is to ``give affected parties
a reasonable time to adjust their behavior before the final rule takes
effect.'' See Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630
(D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099,
1104 (8th Cir. 1977) (quoting legislative history). Of relevance here,
APA section 553(d)(1), 5 U.S.C. 553(d)(1), provides that final rules
shall not become effective until 30 days after publication in the
Federal Register ``except . . . a substantive rule which grants or
recognizes an exemption or relieves a restriction.'' However, when the
agency grants or recognizes an exemption or relieves a restriction,
affected parties do not need a reasonable time to adjust
[[Page 51825]]
because the effect is not adverse. See Indep. U.S. Tanker Owners Comm.
v. Skinner, 884 F.2d 587 (D.C. Cir. 1989) (upholding immediate
effective date for a final rule intended to avoid disruption in
domestic trade by lifting a ban on vessels participating in domestic
shipping), mandate modified on other grounds, 901 F.2d 1116 (D.C. Cir.
1990). EPA has determined that this rule relieves a restriction by
providing additional time for regulated entities to comply with the
applicable requirements. Accordingly, EPA is making this rule effective
immediately upon publication.
C. What action is the Agency taking?
EPA is amending the regulations at 40 CFR 751.407(a)(2) to provide
for a phased-in prohibition for the processing and distributing in
commerce of PIP (3:1) for use in certain articles and for the
processing and distributing in commerce of certain PIP (3:1)-containing
articles. Articles covered by this phased-in prohibition include any
article not otherwise covered by a different compliance deadline or
exclusion described in 40 CFR 751.407(a)(2)(ii) or (b). The compliance
date for the prohibitions on processing and distributing in commerce of
PIP (3:1) for use in articles, and the processing and distributing in
commerce of PIP (3:1)-containing articles in the final rule published
on January 6, 2021 (Ref. 1), as well as for the recordkeeping
requirements, was 60 days after the date of publication, or March 8,
2021. With this amendment, EPA is extending the compliance date for the
processing and distributing in commerce of PIP (3:1) for use in
articles, and the processing and distributing in commerce of PIP (3:1)-
containing articles, to March 8, 2022. With respect to articles covered
by this final rule, EPA is also extending the compliance date from
March 8, 2021, to March 8, 2022, for the recordkeeping requirements
applicable to manufacturers, processors, and distributors of PIP (3:1)-
containing articles. In addition to this final rulemaking, EPA is
planning to issue a separate notice of proposed rulemaking (NPRM) in
the near future to request comment on a further compliance date
extension for certain PIP (3:1)-containing articles, the PIP (3:1) used
to make those articles, and the recordkeeping associated with PIP
(3:1)-containing articles.
D. Why is the Agency taking this action?
EPA is issuing this final rule to address the hardships
inadvertently created by the January 2021 final rule on PIP (3:1) (Ref.
1) due to uses and supply chain challenges that were not communicated
to EPA until after the rule was published. Shortly after the final rule
was published in January 2021, many 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 PIP (3:1)-containing articles (Ref.
2). These stakeholders requested an extension of the compliance date in
order to clear the existing articles through the supply chain, find and
certify an alternative chemical, and produce or import new articles
that do not contain PIP (3:1). In the Federal Register of March 16,
2021 (Ref. 3), EPA requested additional comment on this specific issue
(Ref. 3), as well as on other aspects of all of the TSCA section 6(h)
final rules in general (Refs. 4, 5, 6, 7). According to the comments
received in response to the March comments solicitation, a wide range
of key consumer and commercial goods are affected by the prohibitions
in the 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). This action will
ensure that the supply chains for these important articles continue
uninterrupted in the near term while allowing EPA to take additional
comment on a separate proposal for a longer-term compliance date
extension.
E. What are the incremental economic impacts?
EPA evaluated the potential incremental economic impacts and
determined that these changes reduce the existing burden of this
action. The quantified effect of this compliance date extension
reflects the difference between the incremental cost and benefits of
the final rule as it was originally promulgated and the incremental
cost and benefits of this final rule with the compliance date in place.
Quantified costs were estimated for substitution and recordkeeping by
moving the associated costs, assuming they will be incurred as the
compliance date extension expires. In summary, extending the compliance
date by one year for PIP (3:1)-containing articles would result in an
estimated annualized cost savings of $0.9 million (from a cost of $23.6
million for the original rule to $22.7 million) at a 3 percent discount
rate or $1.3 million (from $22.8 million for the original rule to $21.5
million for this final rule) at a 7 percent discount rate over a 25-
year time horizon. Other qualitative costs savings may include
allowance of more time for manufacturers and retailers to sell articles
prior to the prohibition deadline rather than being forced to dispose
of them, thereby avoiding loss of revenue from those products.
Secondly, any reformulation costs (such as research and development,
laboratory testing, and re-labeling) could be reduced since companies
will have more time to gather information regarding the steps involved
in the reformulation process. The level of these cost savings is
dependent on complexity of achieving needed efficacy, length of time
needed for testing and quality control, and the current status of
development of alternatives, which may vary greatly by sector and end
use product. Lastly, the compliance date extension may provide
additional time for information gathering through the supply chain to
alleviate the necessity for chemical testing of certain articles.
Although the benefits of the final rule were not quantified, the
extension would also postpone decreases in potential releases and
exposures to PIP (3:1). Due to discounting, in a manner similar to
costs, this postponement would lead to lower potential benefits. On
balance, this rule is appropriate in light of the disruptive
consequences of implementing the prohibition without the compliance
extension. The economic consequences (such as loss of supply) could be
severe, given the apparent ubiquity of the chemical in commerce. Thus,
EPA has determined that the cost savings and avoidance of disruption to
industry outweigh the delayed realization of benefits that may accrue
from reduced exposure.
II. Background
A. History of the TSCA Rulemaking on PIP (3:1)
TSCA section 6(h) requires EPA to take expedited regulatory action
under TSCA section 6(a) for certain PBT chemicals identified in the
2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 9).
More specifically, under TSCA section 6(h)(1)(A), the subject chemical
substances are those that:
<bullet> EPA has a reasonable basis to conclude are toxic and that
with respect to persistence and bioaccumulation score high for one and
either high or moderate for the other, pursuant to the 2012 TSCA Work
Plan Chemicals: Methods Document (Ref. 10) or a successor scoring
system;
<bullet> Are not a metal or a metal compound; and
[[Page 51826]]
<bullet> Are chemical substances for which EPA has not completed a
TSCA Work Plan Problem Formulation, initiated a review under TSCA
section 5, or entered into a consent agreement under TSCA section 4,
prior to June 22, 2016, the date that the Frank R. Lautenberg Chemical
Safety for the 21st Century Act became law.
In addition, in order for a chemical substance to be subject to
expedited action, TSCA section 6(h)(1)(B) states that EPA must find
that exposure to the chemical substance under the conditions of use is
likely to the general population or to a potentially exposed or
susceptible subpopulation identified by the Administrator, or to the
environment on the basis of an exposure and use assessment conducted by
EPA. For chemical substances subject to TSCA section 6(h), EPA was
directed to issue a proposed rule by June 22, 2019, and a final rule no
later than 18 months after issuance of the proposal. The statute
further provides that the Administrator shall not be required to
conduct risk evaluations on chemical substances that are subject to
TSCA section 6(h)(1).
1. June 2019 proposed rule for PBT chemicals under TSCA section
6(h). EPA issued a proposed rule for PIP (3:1) and four other chemical
substances in June 2019 (Ref. 11). EPA proposed to determine that PIP
(3:1) met the TSCA section 6(h)(1)(A) criteria for expedited action. In
addition, based on an exposure and use assessment for PIP (3:1) (Ref.
12) conducted as directed by TSCA section 6(h)(1)(B) and which was
subject to peer review and public comment, EPA also proposed to find
that exposure to PIP (3:1) is likely.
During the development of the 2019 proposed rule (Ref. 11), EPA
conducted extensive outreach to understand the uses of the five PBTs.
Outreach included a public webinar, a Small Business Roundtable hosted
by the Small Business Administration Office of Advocacy, and meetings
with more than 90 stakeholders. Based on this outreach as well as EPA's
practicability analysis for various prohibitions and restrictions, EPA
proposed extended compliance dates for some uses of PIP (3:1) and
exclusions for others.
The public comment period on the proposal was open for a total of
90 days, closing on October 28, 2019. EPA received a total of 48
comments, with three commenters sending multiple submissions with
attached files, for a total of 58 submissions on the proposal for all
five of the PBT chemicals. This includes the previous request for a
comment period extension (EPA-HQ-OPPT-2019-0080-0526). Two commenters
submitted confidential business information (CBI) or copyrighted
documents with information regarding economic analysis and market
trends. Of the comment submissions, 30 of the approximately 50 comments
addressed EPA's proposed regulation of PIP (3:1). Copies of all the
non-CBI documents, or redacted versions without CBI, are available via
<a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPPT-2019-0080.
2. January 2021 final rule for PIP (3:1) under TSCA section 6(h).
The final rule for PIP (3:1) was published in the Federal Register on
January 6, 2021 (Ref. 1). 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 exposure to PIP (3:1) was likely under the conditions of use to
the general population, to a potentially exposed or susceptible
subpopulation, or the environment. The PIP (3:1) final rule prohibits
processing and distribution in commerce of PIP (3:1), and products or
articles containing the chemical substance, for all uses, except for
the following different compliance dates or exclusions:
<bullet> Use in photographic printing articles after January 1,
2022;
<bullet> Use in aviation hydraulic fluid in hydraulic systems and
use in specialty hydraulic fluids for military applications;
<bullet> Use in lubricants and greases;
<bullet> Use in new and replacement parts for the aerospace and
automotive industries;
<bullet> Use as an intermediate in the manufacture of cyanoacrylate
glue;
<bullet> Use in specialized engine air filters for locomotive and
marine applications;
<bullet> Use in sealants and adhesives after January 6, 2025; and
<bullet> Recycling of plastic that contained PIP (3:1) before the
plastic was recycled, and the articles and products made from such
recycled plastic, so long as no new PIP (3:1) is added during the
recycling or production process.
In addition, the January 2021 final rule requires manufacturers,
processors, and distributors of PIP (3:1) and products containing PIP
(3:1) to notify their customers of these restrictions. Finally, the
rule prohibits releases to water from the remaining manufacturing,
processing, and distribution in commerce activities, and requires
commercial users of PIP (3:1) and PIP (3:1)-containing products to
follow existing regulations and best practices to prevent releases to
water during use.
Also defined at 40 CFR 751.403 for the purposes of 40 CFR part 751,
subpart E, which includes the January 2021 PIP (3:1) final rule, are
the terms ``article'' and ``product'' (Ref. 1). ``Article'' is defined
as a manufactured item: (1) Which is formed to a specific shape or
design during manufacture, (2) Which has end use function(s) dependent
in whole or in part upon its shape or design during end use, and (3)
Which has either no change of chemical composition during its end use
or only those changes of composition which have no commercial purpose
separate from that of the article, and that result from a chemical
reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design. For example, laptop
computers are articles, as are the internal components such as chips,
wiring, and cooling fans. ``Product'' is defined as the chemical
substance, a mixture containing the chemical substance, or any object
that contains the chemical substance or mixture containing the chemical
substance that is not an article. For example, hydraulic fluids and
motor oils are products.
The January 2021 final rule differed from the proposal in several
ways as a result of the information provided during the public comment
period. The exclusions that were based on information received during
the public comment period are the exclusion for the use of PIP (3:1) in
new and replacement parts for aerospace vehicles, as an intermediate in
a closed system to produce cyanoacrylate adhesives, in specialized
engine air filters for locomotive and marine applications, plastics
recycling, and finished products or articles made of recycled plastic.
The final rule also features delayed compliance dates for the use of
PIP (3:1) in photographic printing articles and adhesives and sealants.
B. The March 16, 2021 Notification and Request for Comments
Shortly after the publication of the January 2021 final rule, a
wide variety of stakeholders from various sectors, including the
electronics and electrical manufacturing community and their customers,
started raising concerns about the March 8, 2021, compliance date in
the final rule 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. 2). These stakeholders contended that they needed
significantly more time in order to identify whether and where PIP
(3:1)
[[Page 51827]]
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). Despite EPA's extensive outreach, most stakeholders
contacting EPA after the rule was finalized did not comment on the
proposal or otherwise engage with the agency on the PIP (3:1)
rulemaking, and do not appear to have previously surveyed their supply
chains to determine if PIP (3:1) was being used. Several indicated that
they did not understand that articles can be regulated under TSCA, and
that, because PIP (3:1) is not regulated by other authorities,
including those of other countries or under international agreements,
there was a lack of awareness relative to its presence in the supply
chain. Absent engagement and timely or specific input from these
stakeholders that could be used as a basis for granting further
extensions or exemptions from the proposed prohibition, in the final
rule EPA believed that PIP (3:1) was not widely present in articles
outside the aerospace and automotive sectors. While some commenters on
the 2019 proposed rule indicated that PIP (3:1) may be present in
articles, their comments were very general and did not identify
specific uses or specific concerns with the March 8, 2021, compliance
date.
Based on the concerns raised by stakeholders shortly after
publication of the final rule, EPA issued a No Action Assurance (NAA)
on March 8, 2021 (Ref. 13), in an effort to ensure that the supply
chains of these important articles were not interrupted while the
agency collected the information needed to best inform subsequent
regulatory efforts. The NAA only described how the agency will exercise
its enforcement discretion; the NAA did not change the March 8, 2021,
compliance date or the continued harm created by that compliance date.
Moreover, the NAA did not prevent citizen suits for violations of the
January 2021 rule. The NAA indicated that EPA would exercise its
enforcement discretion to not pursue enforcement regarding the
prohibition on processing and distribution of PIP (3:1) for use in
articles, and PIP (3:1)-containing articles, for the following
violations:
Shortly after the NAA was issued, EPA published in the ``Proposed
Rules'' section of the Federal Register a notification and request for
specific comments (Ref. 3) to address the concerns that had been raised
by stakeholders regarding PIP (3:1) in articles. While the March 2021
notification and request for comment did not include a specific
alternative compliance date for PIP (3:1)-containing articles and the
PIP (3:1) for use in those articles, the document did describe in
particular the issues raised by industry stakeholders regarding the
March 8, 2021, compliance date, including the types of articles
affected, such as those used in a wide variety of electronics, ranging
from cellular telephones, to robotics used to manufacture
semiconductors, to equipment used to move COVID-19 vaccines and keep
them at the appropriate temperature. The document further outlined the
complexity of international supply chains described by industry
stakeholders and how, according to those stakeholders, that complexity
creates challenges for identifying and finding alternatives to PIP
(3:1) in complex supply chains. Finally, EPA asked commenters to
specifically describe:
<bullet> The articles that would need an alternative compliance
date;
<bullet> The basis for such an alternative compliance date, taking
into consideration the reasons supporting alternative compliance dates
in the final rule already issued, such as the January 1, 2022, date for
photographic printing articles and the January 6, 2025, date for
adhesives and sealants, with supporting documentation; and
<bullet> The additional time needed for specific articles to clear
channels of trade.
EPA received a total of 122 comments in response to the March 2021
notification and request for comment (Ref. 3); 78 of these were from
industry stakeholders, most of whom were concerned about compliance for
PIP (3:1)-containing articles (Ref. 8). Stakeholders concerned about
PIP (3:1)-containing articles reiterated that they needed much more
time, in some cases up to 15 years (Ref. 14), in order to identify
where PIP (3:1) might be present in their supply chains, find and
certify alternatives, and produce or import new articles that do not
contain PIP (3:1).
1. Comments on articles that contain, or potentially contain, PIP
(3:1). During the public comment period, several industry commenters
identified a wide range of articles that may contain PIP (3:1). PIP
(3:1) is used as a flame retardant and plasticizer in plastic articles
such as polyvinyl chloride (PVC) wire covers and casings. Other
articles which have been identified or are being investigated for the
presence of PIP (3:1) include PVC tubes, harnesses, cables, covers,
sleeves, and casings, which include AC power cords and USB cables for
consumer and commercial articles such as laptops, televisions, and
gaming consoles. According to the electrical manufacturing industry a
representative sample of articles made possible by the qualities unique
to PIP (3:1) include medical devices, capacitors, inverters,
generators, transformers, semiconductor wafers, computers, and
electrical appliances (Ref. 15). Manufacturers of construction,
agriculture, forestry, mining, and utility equipment have identified
PIP (3:1) in fire prevention systems, engine emission control systems,
electronics, wiring harnesses, hydraulic hoses, switches, fabrics, PVC
articles, resin in fiberglass articles, paints, elastomers, foam,
resistors, splitters, articles that are alarm components, automatic
tire inflation equipment, and wire sleeving (Ref. 16). According to
another commenter, in construction, agriculture, forestry, mining, and
utility equipment, PIP (3:1) is frequently found in wire harnesses,
starters, water pumps, motor gears, pre-wired motors, ground cables,
and compressors (Ref. 17). The semiconductor manufacturing industry has
identified the use of PIP (3:1) in semiconductor-related manufacturing
equipment (as well as microelectromechanical-related, solar-related,
and LED-related manufacturing equipment), as well as semiconductor
fabrication facilities' support equipment and infrastructure, such as
laboratory, substrate and device (e.g., die) preparation, and assembly
and test operations, including advanced packaging (Ref. 14) as well as
articles that are internal components of high-tech robotics and
manufacturing equipment. Additionally, the chemical has been identified
in articles that are components in scanning electron microscopes
utilized in research, national laboratories, and academia (Ref. 18).
EPA generally agrees with these commenters that PIP (3:1) is used
in a variety of articles, especially in plastic articles that are
components of electronics or electrical articles. Further, at the time
the January 2021 final rule was issued, EPA did not understand the
extent to which PIP (3:1) is used in articles beyond those articles
specifically addressed in that final rule, which are photographic
printing articles, new and replacement parts for aerospace and motor
vehicles, specialized locomotive and marine engine air filters, and
recycled plastics. EPA notes that this final rule does not affect the
compliance dates established for these specific articles in the January
2021 final rule. EPA outlined its understanding on the use of PIP (3:1)
in
[[Page 51828]]
articles in responding to public comments on the January 2021 final
rule, ``[t]here is little evidence to suggest that PIP (3:1) is present
in articles which may be available to consumers, and outside of
activities excluded from the prohibition, little evidence to suggest it
is necessary or present in commercial and industrial articles as well''
(Ref. 26).
2. Comments on the challenges associated with determining whether
articles contain PIP (3:1). Commenters described in detail the
challenges associated with determining whether a particular article
contains PIP (3:1), especially for complex goods that contain thousands
of individual parts. For example, commenters from the consumer
electronics sector noted that articles that are components for their
complex goods are sourced on a worldwide market and a manufacturer may
have upwards of 5,000 suppliers for potentially 100,000 or more
component articles across all product lines (Ref. 19). These commenters
note that manufacturers do not receive a list of every chemical within
each part or component article that ultimately goes into a finished
electronic article because ingredient lists are highly proprietary and
confidential. Rather, companies provide functionality, performance,
safety and quality specifications of a part or component article to
their supply chain, including specifications regarding chemical
restrictions. According to these commenters, suppliers are provided
lists of restricted chemicals on at least an annual basis, or more
frequently if there is a triggering event, such as a new government
restriction. Suppliers are notified of the lead time for the
restriction of the chemical and any testing that may be required, and
the suppliers communicate that information upstream to their own
suppliers.
According to these commenters (Ref. 19), the task of determining
whether PIP (3:1) is used in a component article in a finished
electronic good is further complicated by the many article
manufacturers being unable to identify or confirm the PIP (3:1) content
of articles, such as supplied parts, components or commercial and
consumer goods, without laboratory testing. Laboratory testing can run
up to $5,000 per product and take up to one (1) month. As a result,
companies must rely on material declarations by suppliers as a more
practicable and reliable approach to determine the usage of PIP (3:1)
within an article.
Other commenters echo these concerns. Comments from the heating,
ventilation, air conditioning, and refrigeration industry note that
manufacturers are currently working their way through tens of thousands
of stock-keeping units (SKUs), each having hundreds of associated
component articles and spare parts (Ref. 20). They contend that their
suppliers have generally not been forthright about the presence of PIP
(3:1) in their component articles and parts, even after receiving
notification that the use of PIP (3:1) in component articles must be
disclosed. According to these commenters, some suppliers continue to
claim that they will not disclose the chemical makeup of component
articles as the composition is confidential intellectual property. In
response, some of the larger manufacturers have started testing
component articles to compensate for this lack of transparency, but
testing is time-consuming and costly and most smaller businesses do not
have the resources to undertake testing.
The semiconductor industry and the testing and measurement industry
noted that their industries differ from the consumer electronics
industry and the automotive industry, in that their industries are
high-mix, low-volume industries, meaning that manufacturer portfolios
are typically comprised of a large number of unique goods with
relatively low unit sales (Refs. 14, 21). Their equipment is primarily
custom built to order and sold directly to professional and industrial
customers by the manufacturers (Ref. 21). The semiconductor industry
typically places only 600 to 6,000 units of semiconductor manufacturing
and related equipment into U.S. commerce each year and it is not
uncommon for small groups of model units to be customized to an end
user's particular needs (Ref. 14). According to this commenter, this is
in stark contrast to most consumer goods, in which individual similar
model units are placed into U.S. commerce in much greater number, and
to the automotive and aerospace sectors, in which goods are
manufactured in lower quantities but which are quite similar from model
unit to model unit (Ref. 14). The semiconductor industry further noted
that their sector's ability to obtain material composition data from
across their supply chain is limited due to three factors: (1) The
length and complexity of the supply chain; (2) the preponderance of
suppliers located outside of the U.S.; and (3) the tens of thousands of
parts incorporated into each article eventually manufactured or
distributed in commerce within the U.S.
EPA generally recognizes the challenges described by these
commenters in determining whether and where PIP (3:1) is present in
articles in their supply chains and how long it may take to clear those
PIP (3:1)-containing articles through the channels of trade. As to
comments relating to testing, as most commenters note, there are a
number of alternative steps to testing that an importer or a domestic
manufacturer can take to ensure that an article does not contain PIP
(3:1). The customer can include a specification in their purchase
contracts with suppliers that articles be made without PIP (3:1). The
customer can also request that their suppliers provide them with a
written statement or certification that the purchased or supplied goods
are made without PIP (3:1). Of course, testing is always an option, but
EPA recognizes that this may be a more expensive option.
3. Comments on compliance date considerations for PIP (3:1)-
containing articles. Nearly all of the industry commenters responding
to EPA's March 2021 notification and request for comment (Ref. 3)
stated that they needed several years to phase PIP (3:1) out of their
articles. Many contended that they needed much longer, up to fifteen
years (Refs. 14, 18) assuming that it is even feasible to do so.
Commenters identified a number of steps that would be needed in order
to complete a phase-out of PIP (3:1) in articles. These steps include:
(1) Identifying where PIP (3:1) is present; (2) identifying and testing
substitutes; (3) testing and re-certifying (as needed) the replacement
article; and (4) distributing the replacement article throughout the
supply chain. Many commenters provided detailed timelines for the steps
needed to replace PIP (3:1).
For example, the consumer electronics industry noted that, while
companies had begun to survey their suppliers as soon as the final rule
was published, because of the large number of parts and suppliers
involved for most manufacturers, they anticipated that completing the
survey would take between six and twelve months (Ref. 19). They also
noted that, because PIP (3:1) is not regulated in other international
markets, there is a general lack of awareness regarding the chemical
throughout the supply chain and the industry expects the surveys to
take closer to twelve months than six.
According to the consumer electronics industry commenters, once PIP
(3:1) is identified in a particular part by a particular supplier, the
supplier must identify and investigate alternatives to PIP (3:1) that
can meet regulatory requirements and manufacturer requirements with
respect to functionality, performance, safety and quality (Ref. 19).
Given that PIP (3:1) is typically used in electronic component
[[Page 51829]]
articles to meet safety standards related to flammability, a component
article that includes a PIP (3:1) alternative will have to be certified
to the applicable safety standard (Ref. 19). Common safety standards
that apply to consumer electronics, according to the commenters,
include Underwriters Laboratory UL94, entitled ``Tests for Flammability
of Plastic Material for Part in Devices and Applications,'' and UL498,
entitled ``Attachment Plugs and Receptacles.'' The timeline for
retesting and recertification of replacement component articles is
determined by the certification organization, and consumer electronics
manufacturers estimate that testing could take anywhere from 3 to 24
months (Ref. 19).
The commenters detail the next steps in replacing a PIP (3:1)-
containing component article (Ref. 19). Once the manufacturer of the
finished consumer electronics good receives the replacement component
article, the manufacturer will conduct its own internal quality
assessments. The manufacturer will conduct an initial assessment on
whether the component article works, has the correct performance
characteristics, and maintains brand integrity. Once these basic
parameters have been evaluated, the manufacturer will assemble the
component article into a consumer electronics good and conduct an
overall quality assessment, which may include smoke and ignition
testing, current leakage testing, and temperature testing, among other
things (Ref. 19). At that point, the reworked good is sent for third-
party certification. If the substituted component article is considered
critical by the certification body, full retesting and recertification
of the good may be necessary. Industry commenters anticipate that full
retesting and recertification will be required, given the use of PIP
(3:1) from a fire safety perspective and the fact that the types of
component articles where PIP (3:1) is used play critical roles in the
goods. Manufacturers anticipate that this recertification step will
take anywhere from six to thirty months (Ref. 19). Finally, according
to these commenters, a minimum of one year is needed to move the newly-
remanufactured goods throughout the supply chain. This commenter
further contended that a chemical phase out in response to a
restriction in the European Union under the Restriction on Hazardous
Substances (RoHS) 2, a product-level compliance program for electrical
and electronic equipment, is typically effective four years from the
date of notice by the European Union (Ref. 19).
Other industries provided similarly detailed descriptions of the
length of time needed to replace PIP (3:1)-containing component
articles. The heavy equipment sector stated that their design cycles
are typically seven years from start to finish, and that this would
likely be the amount of time needed to identify whether and to what
extent PIP (3:1) exists in the supply chain, confirm the function of
PIP (3:1) for the end-use application, identify alternatives, re-design
for the alternative rather than PIP (3:1), test the replacement
component article for safety, regulatory, and quality requirements, and
re-introduce the good into the market (Ref. 16). According to this
commenter, the testing requirements often take the longest time to
complete during a redesign because heavy-duty industrial equipment
operates in demanding and severe operating conditions over a long
product life cycle. Such equipment is reportedly subject to various
fire safety and flammability regulatory requirements set by the
National Highway Traffic Safety Administration (Flammability Test for
Motor Vehicle Interiors, 49 CFR 571.302), the Occupational Safety and
Health Administration (Fire Protection and Prevention, 29 CFR 1926.24
and 1926.151), the Mine Safety and Health Administration (various fire
prevention provisions, including 30 CFR part 35 and 30 CFR 75.1100,
75.1911, and 77.1100), and the Federal Railroad Administration (49 CFR
parts 216, 223, 229, 231, 232, 238). Additionally, according to this
commenter, engine emission sensors designed for off-road equipment to
comply with the Clean Air Act currently rely on PIP (3:1) to survive
the high-temperature environment in the engine compartment (Ref. 16).
A unique problem reported by this commenter and several others in
the heavy equipment sector is that their supply chains often overlap
with much larger industries, such as the automotive and aerospace
sectors (Refs. 16, 17, 22, 23, and 24). A recent survey by one
commenter found that 61% of the surveyed suppliers in the heavy
equipment sector also provided parts and materials to the automotive
industry (Ref. 16). According to this commenter, despite the
significant overlap in suppliers, there are key differences in the
product design lifecycles and volumes between the industries. Heavy-
duty, industrial professional use equipment is decidedly lower volume
with a higher diversity of goods than those found in the consumer
automotive market. As the automotive sector is currently excluded from
the January 2021 PIP (3:1) final rule, the current regulations allow
suppliers to provide automotive parts that contain PIP (3:1) to their
automotive manufacturers. With the higher variability of goods and
lower volume nature of the heavy-duty, industrial equipment sector,
commenters assert that the manufacturers of this non-automotive
equipment will need to utilize custom made parts which, if available,
could cost between two and ten times the normal price of the automotive
parts that they would ordinarily use (Ref. 24).
In contrast to the industry commenters, who all stated that the
March 8, 2021, compliance date for PIP (3:1)-containing articles was
not practicable, a comment submitted by three environmental public
interest groups in response to EPA's March 2021 notification and
request for comment (Ref. 3) stated that industry had been given
sufficient notice of EPA's intent to regulate PIP (3:1) in articles and
did not believe that EPA should excuse their failure to comment in a
timely manner (Ref. 25). This commenter further noted that any
exclusions or extended compliance dates should be considered under the
stringent criteria of TSCA section 6(g), which requires EPA to
determine one of the following: (1) That the condition of use is a
critical or essential use with no feasible safer alternatives; or (2)
that compliance with a requirement would significantly disrupt the
national economy, national security, or critical infrastructure; or (3)
that the specific condition of use provides a substantial benefit to
health, the environment, or public safety.
EPA generally agrees with the industry commenters on the steps
required to phase PIP (3:1) out of articles in their supply chains.
Industry must first determine where PIP (3:1) is present; identify
alternatives to PIP (3:1), and then design, test, and recertify, as
necessary, the new articles made without PIP (3:1). Those new articles
must then be distributed throughout the supply chain. However, some
commenters provided detailed estimates of the time needed to take these
steps while others did not. For example, comments from the consumer
technology sector gave estimates for completing each one of these
steps, with the overall timeline ranging from 2.25 years to 6.5 years
(Ref. 19). Estimated timelines provided by commenters in response to
the March 2021 notification and request for comment (Ref. 3) ranged
from 2.25 years to 15 years or more (Refs. 19, 14). Given the varying
estimates, and the lack of detail
[[Page 51830]]
accompanying some of those estimates, EPA has determined that a
relatively short compliance date extension until March 8, 2022, is
necessary to avoid immediate and significant disruption in the supply
chains for important articles, to provide the public with regulatory
certainty in the near term, and to allow EPA additional time to further
evaluate the need to again extend the compliance deadlines for PIP
(3:1).
EPA disagrees with the commenter who contended that any compliance
date extension should be evaluated under TSCA section 6(g). As noted in
response to similar comments on the 2019 proposed rule, ``TSCA section
6(h)(4) directs EPA to issue regulations that reduce exposure to PBT
chemicals `to the extent practicable,' not to regulate beyond the point
of practicability and then issue [section 6(g)] exemptions that would
limit the scope of those regulations'' (Ref. 26, at p. 44). EPA views
this compliance date extension as consistent with this standard, and as
discussed in Unit III, with the requirements of TSCA section 6(d) to
ensure that the compliance dates are ``as soon as practicable'' and
provide a ``reasonable transition period,'' because this action is
necessary to avoid immediate and significant disruption in the supply
chains for important articles, such as cellular telephones and the
HVACR equipment used to cool people, buildings, and to transport and
store COVID-19 vaccines and keep them at the appropriate temperature,
not as an excuse for a failure to comment earlier in this rulemaking
process.
III. Provisions of This Final Rule
A. Establishing a Compliance Date Under TSCA Section 6(d)
TSCA section 6(d)(1)(A) directs EPA to specify a date on which the
TSCA section 6(a) rule is to take effect that is ``as soon as
practicable.'' TSCA section 6(d)(1)(B) requires EPA to specify
mandatory compliance dates for each requirement of a rule promulgated
under TSCA section 6(a), which must be as soon as practicable but no
later than five years after promulgation except as provided in
subsections (C) and (D) or in the case of a use exempted under TSCA
section 6(g). TSCA section 6(d)(1)(C) states that EPA must specify
mandatory compliance dates for the start of ban or phase-out
requirements under a TSCA section 6(a) rule, which must be as soon as
practicable but no later than five years after promulgation, except in
the case of a use exempted under TSCA section 6(g); and subsection (D)
requires EPA to specify mandatory compliance dates for full
implementation of ban or phase-out requirements, which must be as soon
as practicable. Additionally, TSCA section 6(d)(1)(E) directs EPA to
provide for a reasonable transition period.
As noted in the preamble to the January 2021 final rule, the
phrases ``as soon as practicable'' and ``reasonable transition period''
as used in TSCA section 6(d)(1) are undefined, and the legislative
history on TSCA section 6(d) is limited. Given the ambiguity in the
statute, for purposes of the final rule under TSCA section 6(h), EPA
presumed a 60-day compliance date was ``as soon as practicable,''
unless there was support for a lengthier period of time on the basis of
reasonably available information, such as information submitted in
comments on the Exposure and Use Assessment or on the proposed rule, or
in stakeholder dialogues. At the time, EPA believed that such a
presumption would ensure that the compliance schedule is ``as soon as
practicable,'' particularly in the context of the TSCA section 6(h)
rules for chemicals identified as persistent, bioaccumulative and
toxic, and given that the expedited timeframe for issuing a TSCA
section 6(h) proposed rule did not allow time for collection and
assessment of new information separate from the comment opportunities
during the development of and in response to the proposed rule. EPA
noted that this approach also allows for submission of information from
the sources most likely to have the information that would impact an
EPA determination on whether or how best to adjust the compliance
deadline to ensure that the final compliance deadline chosen is both
``as soon as practicable'' and provides a ``reasonable transition
period.''
As previously noted, EPA did not receive timely or specific input
from certain stakeholders during any public comment periods prior to
issuance of the 2019 proposed rule or in response to the proposed rule
regarding the presence of PIP (3:1) in myriad articles. Absent this
input, in the final rule EPA determined that PIP (3:1) was not widely
present in articles outside the aerospace and automotive sectors and
that the presumption that a 60-day compliance date was practicable was
appropriate. The comments received in response to EPA's March 2021
notification and request for comment (Ref. 3), and the communications
received before that document published in the Federal Register,
presented new information demonstrating that a 60-day compliance date
was not a reasonable transition period for the full implementation of a
ban or phase-out for many industries.
B. Compliance Date Extension
From the comments received in response to EPA's March 2021
notification and request for comment (Ref. 3), as well the information
provided during stakeholder meetings since the publication of the
January 2021 final rule on PIP (3:1), it is clear to EPA that the
compliance date for PIP (3:1) and PIP (3:1)-containing articles, but
not PIP (3:1)-containing products, must be extended. While some
commenters provided detailed descriptions of the affected articles and
detailed timelines for the phasing out of PIP (3:1) from these
articles, most did not provide the specificity that EPA was looking for
in response to the March 2021 notification and request for comment
(Ref. 3). In addition, many commenters stated that they were still in
the early stages of identifying the affected articles (Ref. 19).
Therefore, EPA has determined that a relatively short compliance date
extension until March 8, 2022, is necessary to avoid immediate and
significant disruption in the supply chains for important articles, to
provide the public with regulatory certainty in the near term, and to
allow EPA additional time to further evaluate the need to again extend
the compliance deadlines for PIP (3:1).
In addition to this final rule, EPA is planning to issue a separate
NPRM in the near future to provide an opportunity for stakeholders to
submit comments on the need for an additional compliance date extension
for certain PIP (3:1)-containing articles, and the PIP (3:1) used to
make those articles, and to include in their comments specific
information detailing the necessity of such an extension. EPA is
seeking this additional comment because EPA does not yet have
sufficient information on which to base a decision on the length of
time that will ultimately be needed for the affected industry sectors
to comply with the prohibitions in the January 2021 final rule. During
this upcoming comment period, EPA expects that industry will be able to
provide more detailed information on the number and type of articles
affected by the January 2021 final rule, given the ongoing work on the
identification process and the additional six months as of the date
that the comment period will close.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other
[[Page 51831]]
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. 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).
2. Letter from the Consumer Technology Association (CTA) and the
Information Technology Industry Council (ITI) to EPA on March 15,
2021. EPA-HQ-OPPT-2021-0202-0015.
3. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Proposed Rule; Request for
Comments. Federal Register (86 FR 14398, March 16, 2021) (FRL-10021-
08).
4. 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).
5. EPA. Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final
Rule. Federal Register (86 FR 880, January 6, 2021) (FRL-10018-87).
6. 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).
7. EPA. Hexachlorobutadiene (HCBD); Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Final
Rule. Federal Register (86 FR 922, January 6, 2021) (FRL-10018-91).
8. Comments submitted to EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h). Docket
ID EPA-HQ-OPPT-2021-0202-0001.
9. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
October 2014. <a href="https://www.epa.gov/assessingandmanaging-chemicals-under-tsca/tscawork-plan-chemical-assessments-2014-update">https://www.epa.gov/assessingandmanaging-chemicals-under-tsca/tscawork-plan-chemical-assessments-2014-update</a>.
10. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012.
<a href="https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf">https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf</a>.
11. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Proposed Rule. Federal Register
(84 FR 36728, July 29, 2019) (FRL-9995-76).
12. EPA. Exposure and Use Assessment of Five Persistent,
Bioaccumulative, and Toxic Chemicals. December 2020.
13. EPA. No Action Assurance Regarding 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. <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/public-comment-period-pbt-rules-and-no-action-assurance">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/public-comment-period-pbt-rules-and-no-action-assurance</a>.
14. Comment submitted by SEMI and the Semiconductor Equipment
Association of Japan (SEAJ) to EPA on May 17, 2021. EPA-HQ-OPPT-
2021-0202-0121.
15. Comment submitted by National Electrical Manufacturers
Association (NEMA) to EPA on May 17, 2021. EPA-HQ-OPPT-2021-0202-
0117.
16. Comment submitted by the Association of Equipment Manufacturers
(AEM) to EPA on May 13, 2021. EPA-HQ-OPPT-2021-0202-0053.
17. Comment submitted by CNH Industrial to EPA on May 14, 2021. EPA-
HQ-OPPT-2021-0202-0065.
18. Comment submitted by Hitachi High-Tech America Inc. to EPA on
May 17, 2021. EPA-HQ-OPPT-2021-0202-0093.
19. Comment submitted by the Consumer Technology Association (CTA)
and the Information Technology Industry Council (ITI) to EPA on May
17, 2021. EPA-HQ-OPPT-2021-0202-0148.
20. Comment submitted by the Air-Conditioning, Heating and
Refrigeration Institute (AHRI) to EPA on May 17, 2021. EPA-HQ-OPPT-
2021-0202-0143.
21. Comment submitted by the Test & Measurement Coalition (T&M) to
EPA on May 17, 2021. EPA-HQ-OPPT-2021-0202-0122.
22. Comment submitted by LBX Company, LLC to EPA on May 17, 2021.
EPA-HQ-OPPT-2021-0202-0082.
23. Comment submitted by Clark Equipment Company to EPA on May 17,
2021. EPA-HQ-OPPT-2021-0202-0095.
24. Comment submitted by Outdoor Power Equipment Institute (OPEI) to
EPA on May 17, 2021. EPA-HQ-OPPT-2021-0202-0125.
25. Comment submitted by Safer Chemicals Healthy Families (SCHF) et
al. to EPA on May 17, 2021. EPA-HQ-OPPT-2021-0202-0096.
26. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals under TSCA Section 6(h); Response to Public Comments.
December 2020. EPA-HQ-OPPT-2019-0080-0647.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www2.epa.gov/lawsregulations/laws-and-executive-orders">https://www2.epa.gov/lawsregulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was submitted to the
Office of Management and Budget (OMB) for review under Executive Orders
12866 and 13563 (76 FR 3821, January 21, 2011). Any changes made in
response to OMB review have been reflected in the docket for this
action.
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection
activities or burden subject to OMB review and approval under the PRA,
44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). OMB has
previously approved the information collection activities contained in
the existing regulations and associated burden under OMB Control No.
2070-0213 (EPA ICR No. 2599.02). An agency may not conduct or sponsor,
and a person is not required to respond to a collection of information
that requires OMB approval under PRA, unless it has been approved by
OMB and displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations in title 40 of the CFR, after appearing
in the Federal Register, are listed in 40 CFR part 9, and included on
the related collection instrument or form, if applicable.
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. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. This final rule extends the compliance
date for a prohibition on the processing and distributing in commerce
of PIP (3:1) for use in certain articles and the processing and
distributing in commerce of certain PIP (3:1)-containing articles,
along with the associated recordkeeping requirements, from March 8,
2021, to March 8, 2022. EPA has therefore concluded that this action
will relieve regulatory burden for all directly regulated small
entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no
[[Page 51832]]
enforceable duty on any state, local or tribal governments or the
private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). 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). This final rule
will not impose substantial direct compliance costs on Indian tribal
governments. Thus, Executive Order 13175 does not apply to this action.
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not a ``covered regulatory action'' under Executive
Order 13045 (62 FR 19885, April 23, 1997) because it is not an
economically significant regulatory action as defined by Executive
Order 12866.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This is not a ``significant energy action'' as defined in Executive
Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not otherwise been designated by the Administrator of
the Office of Information and Regulatory Affairs as a significant
energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards. As such, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
EPA believes that this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). As
discussed in Unit II., this action is necessary to avoid widespread
disruptions in the supply chains for a wide variety of essential goods
and would not otherwise materially alter the final rule as published.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Dated: September 3, 2021.
Michael S. Regan,
Administrator.
Therefore, for the reasons set forth in the preamble, 40 CFR part
751 is amended as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.407 by adding paragraph (a)(2)(iii) and revising
paragraph (d)(4) to read as follows:
Sec. 751.407 PIP (3:1).
(a) * * *
(2) * * *
(iii) After March 8, 2022, except as provided in paragraphs
(a)(2)(ii) 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.
* * * * *
(d) * * *
(4) The recordkeeping requirements in paragraph (d) of this section
do not apply to the activities described in paragraphs (b)(1)(vi) and
(vii) of this section. The recordkeeping requirements in paragraph (d)
of this section also do not apply to PIP (3:1)-containing articles
until March 8, 2022.
* * * * *
[FR Doc. 2021-19516 Filed 9-16-21; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.