Rule2022-04945
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 8, 2022
Effective
March 8, 2022
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 prohibition on processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, until October 31, 2024, along with the compliance date for the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. This final rule follows issuance of a proposed rule for public comment on October 28, 2021; comments on the proposed rule are responded to in this action.
Full Text
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<title>Federal Register, Volume 87 Issue 45 (Tuesday, March 8, 2022)</title>
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[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Rules and Regulations]
[Pages 12875-12887]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04945]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2021-0598; FRL-6015.6-02-OCSPP]
RIN 2070-AK95
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further
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
prohibition on processing and distribution in commerce of certain PIP
(3:1)-containing articles, and the PIP (3:1) used to make those
articles, until October 31, 2024, along with the compliance date for
the associated recordkeeping requirements for manufacturers,
processors, and distributors of PIP (3:1)-containing articles. This
final rule follows issuance of a proposed rule for public comment on
October 28, 2021; comments on the proposed rule are responded to in
this action.
DATES: This final rule is effective on March 8, 2022. For purposes of
judicial review and 40 CFR 23.5, this rule shall be promulgated at 1
p.m. eastern standard time on March 22, 2022.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2021-0598, 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 opened
to visitors by appointment only. 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#d88c8b9b99f5889a8cf5aaadb4bdab98bda8b9f6bfb7ae"><span class="__cf_email__" data-cfemail="02565141432f5240562f70776e6771426772632c656d74">[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#5a0e09191b7712352e3633343f1a3f2a3b743d352c"><span class="__cf_email__" data-cfemail="a6f2f5e5e78beec9d2cacfc8c3e6c3d6c788c1c9d0">[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,
[[Page 12876]]
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
action 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
presented and that 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).
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. 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). Here, as explained further in Unit I.D. and Unit
IV.A, based on information submitted by regulated entities, the Agency
has determined that revised compliance dates are necessary to address
detailed information submitted in comments demonstrating that the
original compliance dates were not practicable and did not provide
adequate transition time consistent with TSCA section 6(d)(1) because
compliance with the original compliance date and initially extended
compliance date would have caused extensive harm to the economy and
public due to unavailability of critical goods and equipment.
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.
F.C.C., 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.'' When the agency grants or recognizes an exemption or
relieves a restriction, affected parties do not need a reasonable time
to adjust 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?
The January 2021 final rule for PIP (3:1) prohibits the processing
and distribution in commerce 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 in commerce, and commercial
use; and 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 60 days after publication, or March 8, 2021, after which processing
and distribution in commerce 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. A
final rule issued in September 2021 extended the compliance date
applicable to the prohibition on 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,
along with the compliance date for the associated recordkeeping
requirements for PIP (3:1)-containing articles (Ref. 2).
This final rule amends the regulations at 40 CFR 751.407(a)(2)(iii)
and (d)(4) to further extend the phased-in prohibition, 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. The
[[Page 12877]]
compliance date for the recordkeeping requirements for manufacturers,
processors, and distributors of PIP (3:1)-containing articles is 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).
D. Why is the Agency taking this action?
EPA is further extending the compliance dates applicable to the
prohibition on processing and distribution in commerce of PIP (3:1) for
use in certain articles, and the processing and distribution in
commerce of certain PIP (3:1)-containing articles, to further address
the hardships inadvertently created by the January 2021 final rule on
PIP (3:1) (Ref. 1) due to impacted 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. 3). In the Federal Register of March
16, 2021 (Ref. 4), EPA requested additional comment on this specific
issue, as well as on other aspects of all the TSCA section 6(h) final
rules (Refs. 1, 5, 6, 7, and 8). According to the comments received in
response to the March 2021 notification and request for comments, a
wide range of key consumer and commercial goods were 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. 9). In September
2021, EPA issued a final rule that extended the compliance date
applicable to the prohibition on 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
compliance date for the associated recordkeeping requirements for
manufacturers, processors, and distributors of PIP (3:1)-containing
articles (Ref. 2). The September 2021 final rule provided a necessary
short-term extension to avoid immediate and significant disruption in
the supply chains for certain 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). Shortly thereafter, EPA issued a proposal to further
extend the compliance dates to October 31, 2024 (Ref. 10). This final
rule extending the compliance dates from March 8, 2022, until October
31, 2024, is based on the detailed information provided by several
industry commenters in response to the proposal.
E. What are the incremental economic impacts?
Pursuant to TSCA section 6(c)(2), EPA evaluated the potential
incremental economic impacts of further extending the compliance
deadline and determined that the changes being finalized in this action
would reduce the existing burden of the March 8, 2022, compliance date.
The quantified effect of this compliance date extension (from March 8,
2022, to October 31, 2024) reflects the difference between the
incremental cost and benefits of the January 2021 final rule as it was
originally promulgated and the incremental cost and benefits of this
final rule with the new compliance date in place. This was estimated as
the difference between the cost and benefits of the final rule after
the compliance extension to March 8, 2022, and the cost and benefits of
this final rule with an October 31, 2024, compliance date. Quantified
costs for substitution and recordkeeping were estimated to be incurred
later than they would have been under the January 2021 rule, assuming
they will be incurred when the compliance date extension expires. In
summary, extending the compliance date from March 8, 2022, to October
31, 2024, for PIP (3:1)-containing articles results in an estimated
annualized cost savings of $1.8 million (from $24.1 to $22.3 million)
at a 3 percent discount rate or $2.4 million (from $23.4 to $21.0
million) at a 7 percent discount rate over a 25-year time horizon.
While the Agency has no data to quantify this, qualitative costs
savings may include savings stemming from the additional 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. In addition to these cost savings,
reformulation (which can include research and development, laboratory
testing, and re-labeling) will be facilitated once an acceptable
substitute is identified given that companies will have more time to
gather information regarding the steps involved in the reformulation
process. Cost reductions for reformulation are not certain, however,
since the time required for the regulated community to identify viable
substitutes can be complex and unpredictable. 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 about supply chain impacts that could
alleviate the necessity for chemical testing of certain articles to
identify whether and where PIP (3:1) might be present in their supply
chains.
With respect to benefits, pursuant to TSCA section 6(h)(2), for
chemical substances that meet the criteria of TSCA section 6(h)(1), a
risk evaluation is not required to be conducted for EPA to meet its
obligations under TSCA section 6(h). As discussed in the January 2021
final rule, while EPA reviewed hazard and exposure information for the
PBT chemicals, this information did not provide a basis for EPA to
develop scientifically robust and representative risk estimates to
evaluate whether or not any of the chemicals present a risk of injury
to health or the environment. Benefits were not quantified due to the
lack of risk estimates. Although the benefits of the January 2021 and
September 2021 final rules 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 due to continued
exposures. On balance, this further extension of the compliance dates
is appropriate to prevent the disruptive consequences of implementing
the March 8, 2022, compliance date without a further compliance
extension. The economic consequences (such as loss of supply) could be
severe, given the apparent extent 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. The January 2021 Final Rule
A 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)
[[Page 12878]]
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 prohibited processing and distribution in
commerce of PIP (3:1), and products or articles containing the chemical
substance, for all uses after March 8, 2021, 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, provided no new PIP (3:1) is added during the
recycling or production 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 to water from the remaining manufacturing, processing, and
distribution in commerce activities, 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 use.
Also defined at 40 CFR 751.403 for the purposes of 40 CFR part 751,
subpart E, which includes the PIP (3:1) final rule, are the terms
``article'' and ``product'' (Ref. 5). ``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.
B. The March 2021 Notification and Request for Comments and the No
Action Assurance
Shortly after the publication of the January 2021 final rule, a
wide variety of stakeholders from various sectors started raising
concerns about 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. 3). 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). Despite EPA's extensive
outreach (Refs. 1, 2, 4 and 10), 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.
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, 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 (Ref. 11). The NAA was written to expire on September 4, 2021,
or ``the effective date of a final action addressing the compliance
date for the prohibition on processing and distributing in commerce of
PIP (3:1), including in PIP (3:1)-containing articles, whichever occurs
earlier.'' In addition, shortly after the NAA was issued, EPA published
in the ``Proposed Rules'' part of the Federal Register a notification
and request for comments on the five final PBT rules in general and,
more specifically, on the compliance date issues with respect to PIP
(3:1)-containing articles that had been raised by stakeholders (Ref.
4). The March 2021 Federal Register notification and request for
comments is described in detail in EPA's October 2021 proposal (Ref.
10). EPA received a total of 122 comments in response to the March 2021
notification and request for comments (Ref. 9), nearly all of which
addressed PIP (3:1) issues. Based on the comments received in response
to the March 2021 notification and request for comments, EPA issued a
final rule in September 2021, extending 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. 2). While most commenters on the March
2021 notification and request for comments requested a longer
compliance date extension (Ref. 9), 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.
C. The October 2021 Proposal
Accordingly, in October 2021, EPA proposed to further extend until
October 31, 2024, the compliance dates for the prohibition on the
distribution in commerce of certain PIP (3:1)-containing articles, and
the PIP (3:1) used to make those articles, along with the compliance
date for the associated recordkeeping requirements for manufacturers,
processors, and distributors of PIP (3:1)-containing articles (Ref.
10). EPA based the October 2021 proposal on the comments received on
the March 2021 notification and request for comments, as well as
information EPA received from stakeholders after the January 2021 final
rule was published but prior to the issuance of the March 2021
notification and request for comments.
Industry stakeholders commenting on the March 2021 notification and
request for comments contended that they needed more time 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). As described in the October 2021 proposed rule,
industry commenters identified a wide range of articles that may
contain PIP (3:1), which generally is used as a flame retardant and
plasticizer in plastic articles (Refs. 9 and 10). Commenters on the
March 2021 notification and request
[[Page 12879]]
for comments also described the challenges associated with determining
whether a particular article contains PIP (3:1), especially for complex
goods that contain thousands of individual parts. Some commenters
stated that article manufacturers may be unable to identify or confirm
the PIP (3:1) content of articles, such as supplied parts and
components, without laboratory testing, which can be expensive and
time-consuming. 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. However, the
ability to obtain material composition data from across the supply
chain may be limited (Ref. 12).
As described in the October 2021 proposal, nearly all of the
industry commenters responding to EPA's March 2021 notification and
request for comments stated that they needed several years to phase PIP
(3:1) out of their articles (Refs. 9 and10). Estimated timelines
provided by commenters in response to the March 2021 notification and
request for comments ranged from 2.25 years to 15 years or more (Ref.
9). Given the varying estimates, and the lack of detail accompanying
some of those estimates, EPA proposed to further extend the compliance
dates until October 31, 2024, which was consistent with the lower end
of the time estimates provided by commenters. EPA reasoned that this
would avoid significant disruption in the supply chains for certain
articles and would provide the public with regulatory certainty while
EPA determines whether any further compliance date extensions are
necessary for certain industry sectors, based on information submitted
in the context of revisions to the PBT rules more generally. As
announced in March 2021 and in the October 2021 proposal, EPA intends
to consider any additional information of this kind in the context of
revisions to the final PBT rules to further reduce exposures, promote
environmental justice, and better protect human health and the
environment. More information on the March 2021 notification and
request for comments, and a summary of the comments received in
response to the notification, are in the October 2021 proposal (Ref.
10).
III. Comments on the October 2021 Proposal
EPA received a total of 40 public comments on the October 2021
proposal: 38 from industry stakeholders, one from environmental, public
health, children's health organizations, and one from a tribal
partnership group (Ref. 13). Many of the industry commenters on this
proposal also commented on the March 2021 notification and request for
comments, some providing additional details about their efforts to
identify PIP (3:1) in their supply chains since the earlier public
comment period.
A. Comments Supporting the Proposed Compliance Dates or Further
Extensions
Approximately one-third of the industry commenters on the October
2021 proposal expressed qualified support for the proposed compliance
date of October 31, 2024, for the prohibition on the processing and
distribution in commerce of certain PIP (3:1)-containing articles and
the PIP (3:1) used to make those articles.
1. Summary of Public Comments Supporting Extension of Compliance Dates
A commenter from the heating, ventilation, air-conditioning, and
refrigeration (HVACR) industry noted that their comments on the March
2021 notification and request for comments provided two scenarios for
the length of time needed to eliminate PIP (3:1) in their supply chains
(Ref. 14). While the first scenario resulted in an estimate of three
years to complete the phase-out of PIP (3:1), the commenter noted that
this was a best-case scenario, assuming that a number of potential
difficulties with identifying PIP (3:1) in the supply chain and
scheduling scarce laboratory time for recertifications would be
eliminated. The more realistic scenario, according to this commenter,
was the scenario that estimated that a period of five years would be
needed to eliminate PIP (3:1) in their supply chain. This commenter
reiterated concerns with the process for eliminating PIP (3:1), noting
that it remains difficult to obtain information from suppliers, testing
is an expensive and time-consuming alternative, and that it will be
challenging to find and test substitute chemicals with the fire-
retardant characteristics of PIP (3:1) for every application. The
commenter further explained that the industry is dealing with a
shortage of acrylonitrile butadiene styrene plastic due to the ongoing
COVID-19 pandemic as well as a mandatory refrigerant transition.
Finally, this commenter contended that the compliance date should be a
``manufactured-by'' date, rather than a processing and distribution in
commerce prohibition, and expressed concern over the need for
replacement parts for equipment that is produced before the
``manufactured-by'' date.
Commenters from the consumer technology sector noted that they had
originally estimated in their comments on the March 2021 notification
and request for comments that they would need four years to phase PIP
(3:1) out of their articles, but now believe that they can achieve this
by October 31, 2024 (Ref 15). They conditioned their support for the
2024 date on the date being a ``manufactured-by'' date, rather than a
prohibition on processing and distribution in commerce, and also raised
the issue of replacement parts for consumer articles produced before
the ``manufactured-by'' date.
The home appliance industry also supported the October 2024 date,
noting that their comments on the March 2021 notification and request
for comments recommended a three-year extension of the compliance date.
They also requested that the compliance date be applied as a
``manufactured-by'' date, and that there be an exclusion for spare or
replacement parts (Ref. 16).
Other commenters maintained that they would need more time to
complete a phase-out of PIP (3:1) from their supply chains. A commenter
from the electrical manufacturing industry stated that they would need
at least five years to eliminate PIP (3:1) in their articles, and eight
years would be preferred (Ref. 17). The commenter described the
complexity of the sector's supply chains, estimating that six to twelve
months would be needed to identify PIP (3:1) in articles and two to
three years would be needed to identify an alternative, after which it
would be necessary to test and certify components made with the
alternative. This commenter also noted that it would be very expensive
to replace PIP (3:1) throughout the electrical manufacturing industry.
Finally, this commenter stated that an additional three years would be
needed for ``sell-through,'' i.e., allowing articles made with PIP
(3:1) to clear the supply chain.
Several commenters from the semiconductor manufacturing industry
indicated that they would need a phase-out timeline of at least fifteen
years (Refs. 12, 18, and 19). One commenter noted that the same
considerations that led EPA to exclude new and replacement parts for
the aerospace and automotive industry from the January 2021 final rule
could be applied to the semiconductor manufacturing industry and,
therefore, that industry should also be excluded (Ref. 12). This
commenter suggested a fifteen-year delay in the compliance date for the
semiconductor manufacturing industry, which was consistent with the
comments this commenter provided in May 2021. The commenter provided a
chart showing the typical cycle for one part going through an
engineering change under
[[Page 12880]]
normal conditions. While the chart showed that the process could be
completed in ten years, and that process steps could overlap, the
commenter noted that a PIP (3:1) phase-out would involve the entire
industry going through these processes for many parts at once, leading
to numerous logjams. The commenter estimated that 30 months would be
needed to identify PIP (3:1)-containing components in the supply chain,
20 months would be needed to identify and test alternatives, 6 to 48
months would be needed to requalify suppliers to the manufacturer's
requirements, 18 months would be needed to laboratory testing and
recertification, and 36 months would be needed for customer
qualification (Ref. 12).
In addition to comments regarding the extension of compliance dates
for prohibitions, one commenter further requested that EPA make the
compliance date for recordkeeping for excluded articles, such as new
and replacement automotive parts, consistent with the recordkeeping
compliance date for articles that are the subject of this rulemaking
(Ref. 20).
2. EPA Response
EPA notes that one-third of the commenters overall estimated that
impacted industries would be able to comply with the October 2024
compliance date, albeit with some reservations related to replacement
parts, the ability to sell articles produced before the compliance
date, and pandemic impacts on global supply chains. EPA appreciates the
efforts that many of the commenters made to provide the details
requested by EPA in the October 2021 proposal as to:
<bullet> The specific uses of PIP (3:1) in articles throughout
their supply chains;
<bullet> Concrete steps taken to identify, test, and qualify
substitutes for those uses, including details on the substitutes tested
and the specific certifications that would require updating;
<bullet> Estimates of the time required to identify, test, and
qualify substitutes with supporting documentation; and
<bullet> Documentation of the specific need for replacement parts,
which may include the documented service life of the equipment and
specific identification of any applicable regulatory requirements for
the assurance of replacement parts.
EPA also appreciates the comments that provide updated estimates of
needed time to comply and which provide more detailed information than
was provided in response to the March 2021 notification and request for
comments. Overall, EPA finds the description of concrete steps taken in
some industries to identify alternatives or continue engaging in phase-
outs to provide a compelling rationale for the need for an extension of
the compliance date to October 31, 2024, with an expectation that in
several industries this extension would be sufficient. While EPA
appreciates the information submitted by some commenters to support a
further compliance date extension beyond October 31, 2024, EPA also
recognizes that, for many industries, the collection of this
information is still ongoing. EPA does not find that the Agency has
sufficient information at this time to identify an appropriate
compliance date beyond October 31, 2024, or to justify extending the
compliance date beyond October 31, 2024. As commenters stated,
obtaining information from suppliers continues to present challenges,
and EPA anticipates that additional time to investigate supply chains
as well as substitute chemicals will result in more robust information
regarding the need for compliance date extensions beyond October 31,
2024, including the number of years that will be needed to qualify the
substitutes and distribute them throughout the supply chain. As
discussed in the October 2021 proposal and in more detail in Unit
IV.B., EPA will consider any additional information on this issue in
the context of the broader rulemaking EPA plans to undertake for PIP
(3:1) and other PBTs. As part of that broader rulemaking, EPA will also
review the justifications underlying the exclusions in the January 2021
PIP (3:1) final rule to consider whether to adopt new restrictions for
activities currently excluded, such as new and replacement automotive
and aerospace vehicle parts, consistent with the statutory directive to
reduce exposure to the extent practicable.
Regarding commenters' statements that compliance date extensions
should be combined with a further regulatory change allowing for a
``manufactured-by'' date, rather than a processing and distribution in
commerce prohibition, EPA's response is provided in Unit III.D.2.
Regarding compliance dates for recordkeeping, based on the comments
received from the non-road mobile machinery and other similar
industries (described in more details in comments requesting exclusions
from the prohibitions), EPA understands that the scope of the exclusion
for new and replacement motor vehicle parts is broader than what would
strictly be considered the automotive industry, and not all suppliers
eligible for the motor vehicle parts exclusion participate in the
automotive industry's recordkeeping system. EPA recognizes the benefits
in extending the recordkeeping compliance date in the way described by
the commenter; details of the recordkeeping compliance date extension
are described in Unit IV.B.
B. Comments Supporting Exclusions
A number of commenters from the construction, agriculture, mining,
forestry and utility industries, which EPA is referring to as the non-
road mobile machinery industry, argued that they should be afforded the
same exclusion that was provided in the January 2021 final rule for new
and replacement parts for the aerospace and automotive industries.
1. Summary of Public Comments Supporting Exclusions
One commenter from the non-road mobile machinery industry stated
that this industry faces the same types of safety, design,
manufacturing and purchasing issues experienced by the aerospace and
automotive sectors (Ref. 22). According to the commenter, this leads to
overlapping supply chains with the much-larger aerospace and automotive
industries. As a result of these overlapping supply chains, the
exclusions granted to the aerospace and automotive industries, without
a similar exclusion for the non-road mobile machinery industry, greatly
complicate efforts to comply with the provisions of the January 2021
final rule in that the non-road mobile machinery industry may be forced
to find new suppliers to provide replacements for PIP (3:1)-containing
components at a higher cost.
As an alternative to an exclusion, this commenter stated that they
would need seven years to eliminate PIP (3:1)-containing components
from their supply chain. The commenter provided a detailed timeline in
support of this assertion, as well as an estimate of the costs that
would be incurred in eliminating PIP (3:1). Other commenters supported
a seven-year delayed compliance date as an alternative to their
preferred approach of excluding the heavy machinery industry (Refs. 22
and 23).
Relatedly, commenters representing the automotive and similar
industries, such as the non-road mobile machinery industry, requested
that EPA clarify several provisions. Several commenters noted that EPA
had provided its understanding of the meaning of the term ``motor
vehicle,'' as that term is used in the January 2021 final rule, to
stakeholders upon request (Ref. 20, 22, and 24). These commenters asked
that
[[Page 12881]]
EPA provide its understanding of the term ``motor vehicle'' in the
regulatory text itself, or in a companion guidance document.
2. EPA Response
EPA appreciates the detailed estimates that several commenters
provided describing the time that would be needed to identify PIP (3:1)
in their supply chain, find and test alternatives, recertify and
requalify parts and finished goods, and distribute them through the
supply chain (Ref. 21). EPA notes that some of the articles produced by
these commenters would be considered motor vehicles. As EPA has stated
in response to stakeholder inquiries (Refs. 20, 22, and 24), 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. To the extent that the commenters produce motor
vehicles, they are currently covered under the exclusion provided in
the January 2021 final rule for new and replacement motor vehicle
parts. However, as EPA announced in the March 2021 notification and
request for comments and further described in the October 2021
proposal, EPA, as part of its planned future rulemaking on all five of
the PBTs, will review the justifications underlying the exclusions 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.
4 and 10). As noted previously, in the future rulemaking, EPA will also
consider comments addressing any need for a further extension to
compliance dates that have already been extended. For example, in the
upcoming rulemaking, EPA intends to evaluate whether a compliance date
can be established for new automotive parts that contain PIP (3:1). As
part of that evaluation, EPA will consider a similar compliance date
for adjacent industries, such as non-road mobile machinery, given that
they share supply chains. Similarly, EPA appreciates the suggestion
from the commenters regarding a definition of ``motor vehicle'' in the
regulatory text and will consider proposing such a definition in
relevant regulatory text as part of the upcoming broader rulemaking on
PIP (3:1) and other PBT chemicals.
C. Comments Opposed to Further Compliance Date Extensions
In contrast to industry commenters, commenters from environmental,
public health, children's health organizations, or tribal partnership
groups contended that no additional compliance date delay was
warranted.
1. Summary of Public Comments Opposed to Further Compliance Date
Extensions
Two commenters expressed concern over the additional exposures that
could result from further extensions to the compliance date, including
to children, persons who are exposed to PIP (3:1) through multiple
pathways, subsistence fishers and others who are likely to have higher
dietary exposures than those of the general population, and persons
exposed through the disposal of PIP (3:1)-containing materials at
certain landfills and through open burning (Refs. 25 and 26).
One comment from several environmental, public health, and
children's health organizations stated that an extension of the
compliance date would perpetuate exposure to a toxic chemical contrary
to the statutory requirement to take expedited action to reduce
exposure to the extent practicable for the PBT chemicals (Ref. 25). The
comment emphasized that a further extension of the compliance deadline
would reward industry's lack of participation in the regulatory process
that preceded the January 2021 final rules, and stated their position
that EPA failed to justify the proposed compliance extension by
dismissing its impact on exposure risks, instead focusing only on
industry hardship, and that this approach contravenes Congress' intent
in TSCA. The commenter cited EPA's proposed rule to note that PIP (3:1)
is among the highest scoring PBT chemicals based on its scores for
hazard, exposure, and persistence and bioaccumulation. The commenter
also stated that, because the general prohibition against PIP (3:1)
took effect within sixty days, the commenter believed that EPA had not
considered whether there were steps that could be taken during a multi-
year phase-in period to reduce exposure to PIP (3:1), such as public
notifications and labeling of products containing PIP (3:1) or
additional safeguards for the workers who manufacture, recycle, or
dispose of those products (Ref. 25). Additionally, the comment cited
studies in stating that the proposed extension will be especially
harmful to communities where PIP (3:1) is manufactured, imported,
released, and disposed of, and that multiple exposures to PIP (3:1)
would have a disproportionate impact on those communities that raise
environmental justice concerns. The commenter added that the proposed
extension will be especially harmful to children, providing citations
of industry reports of the presence of PIP (3:1) in children's
products. Finally, the commenter requested that EPA initiate
information gathering rulemakings under TSCA section 8(a) to prevent
any future attempts by industry to evade regulatory control on the
basis of ignorance of chemicals present in products and supply chains.
The National Tribal Toxics Council (NTTC), an EPA Tribal
Partnership group, stated that, prior to the original compliance date,
EPA had provided more than adequate advance notice as well as ample
opportunities for stakeholder engagement, and thus further extensions
are not warranted. The commenter emphasized that any regulatory action
that pertains to PBTs has significant tribal implications, and
expressed concern that the rule would result in 31 additional months of
PIP (3:1) products being disposed in or near tribal lands without
monitoring for environmental releases (Ref. 26).
2. EPA Response
EPA appreciates the commenters' descriptions of their concerns,
their input during the current and previous rulemakings, and their
support of EPA's stakeholder engagement process. EPA agrees that
earlier industry stakeholder engagement during the multiple years the
original PIP (3:1) regulation was under development would have been of
great help to EPA in crafting practicable compliance dates for various
industry sectors as is required by TSCA section 6(d)(1). EPA also
acknowledges that PIP (3:1) scores high for hazard, exposure, and
persistence and bioaccumulation. However, EPA finds the information
industry stakeholders have provided in response to the March 2021 and
October 2021 notices to be compelling justification for the necessity
of extension of the relevant compliance dates to October 2024 because
of the potential for significant disruption to the supply chains for
important articles such as HVACR equipment and personal electronics.
EPA appreciates the recommendations for steps that could be taken
to phase out PIP (3:1) or further reduce exposure, such as the public
notifications or worker protections the commenter described. EPA will
consider these recommendations as part of EPA's planned future
rulemaking on
[[Page 12882]]
PIP (3:1) and other PBTs, as described in the October 2021 proposal,
and EPA will be seeking more detailed comments and information on
issues of this kind to determine whether additional measures as
proposed would be practicable. Similarly, as part of that future
rulemaking, EPA will assess how environmental justice could be promoted
through further exposure reduction. While EPA has taken note of the
information provided by the commenters on the reports of PIP (3:1) in
products used by children, as well as the potential impacts on
communities near importers of PIP (3:1), EPA emphasizes that the agency
has not determined at what level exposure to PIP (3:1) represents a
risk to human health or the environment. In the future rulemaking on
PIP (3:1) and other PBTs, EPA intends to identify whether exposure to
PIP (3:1) could be further practicably reduced, including by reducing
or removing current exclusions from prohibitions or by modifying
compliance timeframes. EPA emphasizes that, as part of the future
rulemaking, information such as that provided in the comment will be
considered.
Regarding the concerns raised in both comments regarding tribes and
environmental justice communities, EPA recognizes that while the
compliance date extension may result in the potential for exposures
that might otherwise have been precluded, EPA does not have information
to suggest that such potential exposures are likely to be substantial
or direct. For example, according to another commenter, the risk of
exposure to PIP (3:1) to workers, consumers, and end-users is low
because the PIP (3:1) is generally incorporated into the composition
(polymer matrix) of the components that are internal to equipment
accessible only by trained technicians (Ref. 14). In contrast, EPA does
know that the use of PIP (3:1) for these articles in the near term is
necessary to avoid significant disruption to the supply chains for
certain important articles such as HVACR systems and personal
electronic devices such as cellular telephones. Thus, an earlier
compliance date would not be practicable or provide a reasonable
transition period as is required by TSCA section 6(d)(1). More
information on TSCA section 6(d) is provided in Unit IV.A. As EPA works
to develop planned future rulemakings on PIP (3:1) and other PBTs,
described in the October 2021 proposal, EPA will consider to what
extent impacts to tribes and environmental justice communities could be
reduced further and welcomes NTTC's interest in tribal consultation and
developing a more effective process for determining whether an action
is of tribal significance.
EPA agrees with commenters' concern regarding several industries'
lack of information on the presence of chemicals in their supply
chains, particularly in imported articles. EPA notes that the
commenters' recommendation for promulgation of a rule under TSCA
section 8 is outside the scope of this compliance date extension.
D. Comments on Other Topics
Commenters also provided information on other topics, including
their interest in a ``manufactured-by'' date for articles,
applicability of the rule to replacement parts, and establishment of a
de minimus threshold. Additionally, a commenter requested clarification
of downstream notification requirements.
1. Summary of Comments on Other Topics
Many of the industry commenters stated that the compliance date
referenced in the proposal should be a ``manufactured-by'' date, rather
than a compliance date for a prohibition on processing and distribution
in commerce. By this, the commenters generally meant that any article
manufactured before the ``manufactured-by'' date could be processed and
distributed in commerce at any time in the future without restriction.
One commenter noted that the only date that the industry has control
over is the date by which an article is manufactured (Ref. 15). The
commenter asserted that manufacturers of consumer goods and EPA could
more readily determine compliance using this approach because a
``manufactured-by'' date can be confirmed based on unique product
identifiers, such as lot or serial numbers, that are often marked on
the article. According to the commenter, retailers do not have control
over how quickly goods are sold and do not necessarily operate under a
first-in, first-out system, which adds to the challenge of inventory
management. The commenter further stated that in the absence of a
``manufactured-by'' compliance date, retailers would be unable to
determine whether a good was compliant, i.e., does not contain PIP
(3:1). This commenter stated that an ``imported-by'' date would present
challenges for the industry, primarily due to the potential for import
delays associated with the process itself as well as with shipping,
which have been exacerbated by the COVID-19 pandemic. However, the
commenter stated that an ``imported-by'' date would be more manageable
for the industry than a compliance date associated with distribution in
commerce.
Another commenter stated that the date of compliance should be a
``manufactured-by'' date for domestically produced articles, and an
``imported-by'' date for those articles produced abroad (Ref. 27). This
commenter noted that distributors do not necessarily ship finished
goods based on when they receive them, and it may be difficult for
manufacturers, importers, distributors, and retailers to differentiate
with certainty between goods that appear the same but may have
different chemical compositions. This commenter further noted that a
distribution in commerce prohibition is also unworkable because
distribution in commerce has been very broadly interpreted by EPA to
include, in some cases, any movement of a regulated product, even among
facilities within the same business enterprise and its affiliates and
subsidiaries.
While some commenters (Refs. 15 and 27) stated that the only
compliance date should be a ``manufactured-by'' date, or ``imported-
by'' date, other commenters indicated that a restriction on
distribution in commerce might be workable as long as sufficient time
was provided for articles manufactured before the ``manufactured-by''
date to move through the channels of trade to the end user. These
commenters often used the phrase ``sell-through'' to describe the date
by which sales of articles manufactured before the ``manufactured-by''
date must cease. Two commenters stated that a three-year ``sell-
through'' date would be adequate (Refs. 17 and 28). One commenter
representing the retail industry indicated that the minimum time needed
would be 18 months, based on more-detailed information provided by a
retailer of electronic products (Ref. 29). This commenter noted that
more time would be needed for products that tend to sell more slowly,
such as furniture.
Many of the industry commenters also expressed concern over the
applicability of the January 2021 final rule's provisions only to some
types of replacement parts. One commenter noted that HVACR and water-
heating equipment can safely remain in operation for as long as fifty
years or more and, in many cases, buildings are designed and built
around such equipment, making it difficult to replace (Ref. 28). This
commenter contended that to ensure that this critical HVACR and water
heating equipment can still function in the future, the components
[[Page 12883]]
and parts used in servicing the equipment must be able to be used
without restriction. Another commenter stated that components or parts
of articles typically are held by the manufacturer until needed for
repair or replacement (Ref. 15). The commenter noted that electronic
finished goods may have warranties upwards of fifteen years, meaning
that components or parts of articles for repair or replacement can be
kept in a manufacturer's warehouse for well over a decade. This
commenter further explained that, when transitioning from one
generation of an electronic finished good to the next, spare parts for
the first generation are bought under a ``last time buy'' from the
supplier to create the inventory of spare parts needed to support
warranty claims. After this ``last time buy'', the tooling needed to
manufacture those parts is decommissioned. The commenter further noted
that spare and replacement parts or articles that contain PIP (3:1)
would be expected to be in inventory well past the proposed October
2024 compliance date, but the ``manufactured-by'' date approach would
solve this problem.
A number of commenters recommended that EPA establish a de minimis
threshold for PIP (3:1) regulation, particularly in articles.
Commenters gave a variety of reasons for why EPA should establish a
threshold level. One commenter stated that the difficulty in
determining whether PIP (3:1) is present in a component article was at
least partly due to potential discomfort with claiming absolute
``zero'' PIP (3:1) when there is ambiguity about how that will be
determined or whether it is feasible to determine due to the potential
for miniscule contamination (Ref. 30). This commenter contended that
ambiguity in the material declaration process makes that process
extremely time consuming and adds months to the process for each
supplier. Other commenters also expressed concern for the potential for
trace contamination and the feasibility of controlling such
contamination (Refs. 15 and 31). Another commenter noted the high
expense that is entailed by having to test down to the detection limit
in the absence of a de minimis threshold (Ref. 21). Yet another
commenter noted that other chemical regulatory programs such as REACH
incorporate a de minimis threshold (Ref. 16).
One commenter requested that EPA clarify the downstream
notification requirements for manufacturers, processors, and
distributors of PIP (3:1) for use in certain articles, and whether
those requirements would be extended along with the compliance dates
for the prohibition on processing and distribution of certain PIP (3:1)
containing articles (Ref. 27).
2. EPA Response
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, how long it may take to clear those
PIP (3:1)-containing articles through the channels of trade, and the
steps needed to phase PIP (3:1) out of articles in the supply chain.
EPA will consider these comments in the context of the broader
rulemaking EPA plans to undertake for PIP (3:1) and other PBT chemicals
(Ref. 10). In that rulemaking, EPA plans to request public comment on
the utility as well as the drawbacks of a ``manufactured-by'' date and
the amount of time needed for articles to clear the channels of trade,
the applicability of the rule to replacement parts, and a de minimis
threshold in the context of reducing exposure to PIP (3:1) to the
extent practicable. Regarding the request for clarification regarding
downstream notification requirements, EPA is not extending the
compliance date for downstream notification requirements to align with
the extended compliance dates for PIP (3:1)-containing articles in this
final rule. The downstream notification requirements apply only to the
chemical PIP (3:1) and mixtures (products) that contain the chemical
PIP (3:1); they are not applicable to PIP (3:1) containing articles.
However, EPA is conforming the required downstream notification
language with the compliance date extensions. Details of these
amendments are in Unit IV.C.
IV. Provisions of this Final Rule
A. Establishing a Revised Compliance Date
TSCA section 6(d) includes a number of provisions relating to
establishment of effective or compliance dates in rules promulgated
under TSCA section 6. Specifically, 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 TSCA section
6(d)(1)(D) requires EPA to specify mandatory compliance dates for full
implementation of ban or phase-out requirements under a TSCA section
6(a) rule, 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 term
``practicable'' as used in the phrase ``to the extent practicable'' in
TSCA section 6(h) is undefined, the phrases ``as soon as practicable''
and ``reasonable transition period'' as used in TSCA section 6(d)(1)
are also undefined, and the legislative history on each provision is
limited. Given the ambiguity in the statute, for purposes of the
January 2021 final rule under TSCA section 6(h), EPA presumed a 60-day
compliance date was ``as soon as practicable'' where EPA determined a
prohibition or restriction was 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 allowed 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 was both ``as soon
as practicable'' and provides a ``reasonable transition period.''
As noted in the September 2021 final rule and the October 2021
proposal, despite significant outreach efforts, EPA did not receive
timely or specific input from certain stakeholders during any public
comment periods prior to issuance of the January 2021 final rule
regarding the presence of PIP (3:1) in myriad articles (Refs. 2 and
10). Absent
[[Page 12884]]
this input, in the January 2021 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 comments, and the
communications received before that document published in in the
Federal Register, presented new information demonstrating that a 60-day
compliance date was not practicable and did not provide a reasonable
transition period for the full implementation of a ban or phase-out for
many industries.
B. Compliance Dates in this Final Rule
Based upon EPA's analysis of the comments received on the October
2021 proposal, along with the information provided in comments received
on the March 2021 notification and request for comments, EPA is
extending until October 31, 2024, the compliance date for the
prohibition on processing and distribution in commerce of PIP (3:1)-
containing articles, and the PIP (3:1) used to make those articles. As
discussed in the October 2021 proposal, and in the response to comments
earlier, the October 2024 compliance date is consistent with the lower
end of the time estimates provided by commenters on the March 2021
notification and request for comments. As described in Unit III.A.,
approximately one-third of the commenters on the October 2021 proposal
estimated that they would be able to comply with the October 2024
compliance date, albeit with some reservations related to replacement
parts, the ability to sell articles produced before the compliance
date, and COVID-19 pandemic impacts on global supply chains. EPA has
determined that this further extension of the March 8, 2022 compliance
date to October 31, 2024, for the prohibition on processing and
distribution in commerce is necessary to avoid significant disruption
in the supply chains for certain articles, such as HVACR equipment and
consumer electronics, and will provide a measure of regulatory
certainty while industry collects and submits additional information to
inform whether a further compliance date extension may be necessary for
certain industry sectors, such as the semiconductor manufacturing
industry. While EPA expects that that in several industries this
extension would be 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 industries. The
compliance date extension to October 31, 2024, will allow EPA
additional time to further evaluate the need to again extend the
compliance deadlines for PIP (3:1) for certain industries such as the
semiconductor manufacturing industry. As discussed in the October 2021
proposal and in more detail in Unit II.C., EPA plans to consider this
information in the context of revisions to PIP (3:1) and other PBT
rules more generally.
EPA is also extending the recordkeeping compliance date in 40 CFR
751.407(d) for PIP (3:1)-containing articles until October 31, 2024.
Because industry is still in the process of identifying whether and
where PIP (3:1) is present in many of the articles in their supply
chains, it would be difficult, if not impossible, for them to supply
the required information. Additionally, as described earlier, a public
comment requested that EPA make the compliance date for recordkeeping
for excluded articles, such as new and replacement automotive parts,
consistent with the recordkeeping compliance date for articles that are
the subject of this rulemaking (Ref. 20). Based on the comments
received from the non-road mobile machinery and other similar
industries, EPA understands that not all suppliers eligible for the
motor vehicle parts exclusion participate in the automotive industry's
recordkeeping system. Therefore, EPA is extending the recordkeeping
compliance dates specified in paragraphs 40 CFR 751.407 (a)(2)(iii) and
(d)(4) from March 8, 2022, to October 31, 2024. However, the compliance
dates specified in 40 CFR 751.407(a)(2)(ii) remain in effect.
EPA also recognizes that, for many industries, the collection of
information on the presence of PIP (3:1) in their supply chains is
still ongoing. As discussed in the October 2021 proposal, EPA will
consider any additional information of this kind in the context of the
broader rulemaking EPA plans to undertake for PIP (3:1) and other PBT
chemicals (Ref. 10). In that future rulemaking, EPA also plans to
consider the comments, discussed in Unit III.D., regarding a
``manufactured-by'' date, replacement parts, and a de minimis
threshold.
C. Conforming Amendments to the Downstream Notification Requirements
In reviewing the comments received on the October 2021 proposal
(e.g., Ref. 27), EPA realized that the downstream notification
requirements in the January 2021 final rule could be misleading,
resulting in potential confusion for the regulated community. 40 CFR
751.407(e) requires manufacturers, processors, and distributors in
commerce of PIP (3:1) and PIP (3:1)-containing products to provide
notification of the restrictions on the chemical substance to their
customers, either through specific mandatory language on a Safety Data
Sheet (SDS) or a label. EPA notes that the notification requirements
only apply to the chemical PIP (3:1) or to products containing the
chemical PIP (3:1). As discussed in Unit II.A., the term ``product''
excludes articles. Therefore, the downstream notification requirements
on 40 CFR 751.407(e) do not apply to PIP (3:1)-containing articles.
However, the mandatory language in 40 CFR 751.407(e)(3)(i) through
(iii) does not reflect the fact that EPA is extending the compliance
date for the prohibition on processing and distribution in commerce of
certain PIP (3:1)-containing articles. Thus, purchasers of PIP (3:1)
and PIP (3:1)-containing products who intend to use them in articles
may be confused by the mandatory language on an SDS or a label that
says that they may not use the PIP (3:1) or PIP (3:1)-containing
product in this manner. Therefore, EPA is amending the mandatory
language at 40 CFR 751.407(e)(3)(i) through (iii) to conform to the
compliance date extension for the prohibition on processing and
distribution in commerce of certain PIP (3:1)-containing articles.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult 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. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Compliance Date Extension. Federal Register (86 FR 51823,
September 17, 2021) (FRL-6015.5-03-OCSPP).
[[Page 12885]]
3. 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.
4. 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).
5. 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. 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).
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. 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).
9. Comments submitted to EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h). EPA-
HQ-OPPT-2021-0202-0001.
10. EPA. Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate
(3:1); Further Compliance Date Extension. Federal Register (86 FR
59684, October 28, 2021) (FRL-6015.6-01-OCSPP).
11. 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>.
12. Comment submitted by SEMI to EPA on December 22, 2021. EPA-HQ-
OPPT-2021-0598-0038.
13. Comments submitted to EPA. Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h);
Phenol, Isopropylated Phosphate (3:1); Further Compliance Date
Extension. EPA-HQ-OPPT-2021-0598-0001.
14. Comment submitted by Air Conditioning, Refrigeration, and
Heating Institute (AHRI) to EPA on December 21, 2021. EPA-HQ-OPPT-
2021-0598-0027.
15. Comment submitted by Consumer Technology Association (CTA), IPC
and Information Technology Industry Council (ITI) to EPA on December
21, 2021. EPA-HQ-OPPT-2021-0598-0030.
16. Comment submitted by the Alliance of Home Appliance
Manufacturers (AHAM) to EPA on December 23, 2021. EPA-HQ-OPPT-2021-
0598-0033.
17. Comment submitted by the National Electrical Manufacturers
Association (NEMA) to EPA on December 22, 2021. EPA-HQ-OPPT-2021-
0598-0031.
18. Comment submitted by the Semiconductor Industry Association
(SIA) to EPA on December 21, 2021. EPA-HQ-OPPT-2021-0598-0025.
19. Comment submitted by Hitachi High-Tech America, Inc. (HTA) to
EPA on December 22, 2021. EPA-HQ-OPPT-2021-0598-0041.
20. Comment submitted by Alliance for Automotive Innovation and
Motor & Equipment Manufacturers Association (MEMA) to EPA on
December 23, 2021. EPA-HQ-OPPT-2021-0598-0046.
21. Comment submitted by the Association of Equipment Manufacturers
(AEM) to EPA on December 23, 2021. EPA-HQ-OPPT-2021-0598-0047.
22. Comment submitted by Truck and Engine Manufacturers Association
(EMA) to EPA on December 23, 2021. EPA-HQ-OPPT-2021-0598-0044.
23. Comment submitted by Kubota North America Corporation (KNA) to
EPA on December 21, 2021. EPA-HQ-OPPT-2021-0598-0028.
24. Comment submitted by the Outdoor Power Equipment Institute
(OPEI) to EPA on December 22, 2021. EPA-HQ-OPPT-2021-0598-0032.
25. Comment submitted by Alaska Community Action on Toxics et al. to
EPA on December 23, 2021. EPA-HQ-OPPT-2021-0598-0043.
26. Comment submitted by National Tribal Toxics Council (NTTC) To
EPA on December 27, 2021. EPA-HQ-OPPT-2021-0598-0057.
27. Comment submitted by Chemical Users Coalition (CUC) to EPA on
December 22, 2021. EPA-HQ-OPPT-2021-0598-0036.
28. Comment submitted by Air Conditioning, Heating, and
Refrigeration Institute (AHRI) to EPA on December 21, 2022. EPA-HQ-
OPPT-2021-0598-0027.
29. Comment submitted by the Retail Industry Leaders Association
(RILA) to EPA on December 27, 2021. EPA-HQ-OPPT-2021-0598-0055.
30. Comment submitted by Advanced Medical Technology Association
(AdvaMed) to EPA on December 17, 2021. EPA-HQ-OPPT-2021-0598-0022.
31. Comment submitted by Thermo Fisher Scientific to EPA on December
24, 2021. EPA-HQ-OPPT-2021-0598-0049.
VI. 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, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this rule is any significant adverse economic
impact on small entities, and the Agency is certifying that this rule
will not have a significant economic impact on a substantial number of
small entities because the rule relieves regulatory burden. This action
would extend 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, 2022, to October 31, 2024. EPA has
therefore concluded that this action would relieve regulatory burden
for all directly regulated small entities.
[[Page 12886]]
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 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) because it does
not have substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes. 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 report containing this rule and other required
information 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.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, 40 CFR part 751
is amended as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.407:
0
a. In paragraphs (a)(2)(iii) and (d)(4) by removing ``March 8, 2022''
and adding ``October 31, 2024'' in its place; and
0
b. By revising paragraphs (e)(3)(i) through (iii).
The revisions read as follows:
Sec. 751.407 PIP (3:1).
* * * * *
(e) * * *
(3) * * *
(i) SDS Section 1(c). ``The Environmental Protection Agency
prohibits processing and distribution of this chemical/product for any
use other than: (1) In hydraulic fluids either for the aviation
industry or to meet military specifications for safety and performance
where no alternative chemical is available that meets U.S. Department
of Defense specification requirements, (2) lubricants and greases, (3)
New or replacement parts for motor and aerospace vehicles, (4) as an
intermediate in the manufacture of cyanoacrylate glue, (5) In
specialized engine air filters for locomotive and marine applications,
(6) In adhesives and sealants before January 6, 2025, after which use
in adhesives and sealants is prohibited, and (7) in other articles
before October 31, 2024, after which use in articles other than new or
replacement parts for motor and aerospace vehicles or specialized
engine air filters for locomotive and marine applications is
prohibited. In addition, all persons are prohibited from releasing PIP
(3:1) to water during manufacturing, processing, and distribution in
commerce, and must follow all existing regulations and best practices
to prevent the release of PIP (3:1) to water during the commercial use
of PIP (3:1).''; and
(ii) SDS Section 15. ``The Environmental Protection Agency
prohibits processing and distribution of this chemical/product for any
use other than: (1) In hydraulic fluids either for the aviation
industry or to meet military specifications for safety and performance
where no alternative chemical is available that meets U.S. Department
of Defense specification requirements, (2) lubricants and greases, (3)
new or replacement parts for motor and aerospace vehicles, (4) as an
intermediate in the manufacture of cyanoacrylate glue, (5) In
specialized engine air filters for locomotive and marine applications,
(6) in adhesives and sealants before January 6, 2025, after which use
in adhesives and sealants is prohibited, and (7) in other articles
before October 31, 2024, after which use in articles other than new or
replacement parts for motor and aerospace vehicles or specialized
engine air filters for locomotive and marine applications is
prohibited. In addition, all persons are prohibited from releasing PIP
(3:1) to water during manufacturing, processing, and distribution in
commerce, and must follow all existing regulations and best practices
to prevent the release of PIP (3:1) to water during the commercial use
of PIP (3:1).''; or
(iii) Labeling. ``The Environmental Protection Agency prohibits
processing and distribution of this chemical/product for any use other
than: (1) In hydraulic fluids either for the aviation industry or to
meet military specifications for safety and performance where no
alternative chemical is available that meets U.S. Department of Defense
specification
[[Page 12887]]
requirements, (2) lubricants and greases, (3) new or replacement parts
for motor and aerospace vehicles, (4) as an intermediate in the
manufacture of cyanoacrylate glue, (5) In specialized engine air
filters for locomotive and marine applications, (6) In adhesives and
sealants before January 6, 2025, after which use in adhesives and
sealants is prohibited, and (7) in other articles before October 31,
2024, after which use in articles other than new or replacement parts
for motor and aerospace vehicles or specialized engine air filters for
locomotive and marine applications is prohibited. In addition, all
persons are prohibited from releasing PIP (3:1) to water during
manufacturing, processing, and distribution in commerce, and must
follow all existing regulations and best practices to prevent the
release of PIP (3:1) to water during the commercial use of PIP (3:1).''
* * * * *
[FR Doc. 2022-04945 Filed 3-7-22; 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.