[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 894-911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28692]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2019-0080; FRL-10018-88]
RIN 2070-AK58


Phenol, Isopropylated Phosphate (3:1) (PIP 3:1); Regulation of 
Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 
6(h)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing a rule 
under the Toxic Substances Control Act (TSCA) to address its 
obligations under TSCA for phenol, isopropylated phosphate (3:1) (PIP 
(3:1)) (CASRN 68937-41-7), which EPA has determined meets the 
requirements for expedited action under TSCA. This final rule prohibits 
the processing and distribution of PIP (3:1) and PIP (3:1)-containing 
products, with specified exclusions, and prohibits the release of PIP 
(3:1) to water during manufacturing, processing, and distribution. This 
final rule also requires commercial users to follow existing 
regulations and best practices to prevent the release to water of PIP 
(3:1) and products containing PIP (3:1) during use. These requirements 
will result in lower amounts of PIP (3:1) being manufactured, 
processed, distributed in commerce, used and disposed, thereby reducing 
exposures to humans and the environment.

DATES: This final rule is effective February 5, 2021. For purposes of 
judicial review and 40 CFR 23.5, this rule shall be promulgated at 1 
p.m. eastern standard time on January 21, 2021.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2019-0080, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.
    Please note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Ingrid Feustel, Existing 
Chemical Risk Management Division, Office of Pollution Prevention and 
Toxics (7404T), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW,

[[Page 895]]

Washington, DC 20460-0001; telephone number: (202) 564-3199; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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 products containing PIP 
(3:1), especially flame retardants in plastics or functional fluids in 
aircraft and industrial machinery. 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:
     Petroleum Refineries (NAICS Code 324110);
     Petroleum Lubricating Oil and Grease Manufacturing 
(324191);
     Paint and Coating Manufacturing (NAICS Code 32510)
     All Other Basic Organic Chemical Manufacturing (NAICS Code 
325199);
     Plastics Material and Resin Manufacturing (NAICS Code 
325211):
     Adhesive Manufacturing (NAICS Code 325520);
     Polish and Other Sanitation Good Manufacturing (NAICS Code 
325612);
     All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS Code 325998);
     Air-Conditioning and Warm Air Heating Equipment and 
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS 
Code 333415);
     Other Communications Equipment Manufacturing (NAICS Code 
334290);
     Automobile Manufacturing (NAICS Code 336111);
     Other Motor Vehicle Parts Manufacturing (NAICS Code 
336390);
     Automobile and Other Motor Vehicle Merchant Wholesalers 
(NAICS Code 423110);
     Other Chemical and Allied Products Merchant Wholesalers 
(NAICS Code 424690);
     New Car Dealers (NAICS Code 441110);
     Research and Development in the Physical, Engineering, and 
Life Sciences (NAICS Code 541710);
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Section 6(h) of TSCA, 15 U.S.C. 2601 et seq., directs EPA to issue 
a final rule under TSCA section 6(a) on certain persistent, 
bioaccumulative, and toxic (PBT) chemical substances. More 
specifically, EPA must take action on those chemical substances 
identified in the 2014 Update to the TSCA Work Plan for Chemical 
Assessments (Ref. 1) that, among other factors, EPA has a reasonable 
basis to conclude are toxic and that with respect to persistence and 
bioaccumulation score high for one and either high or moderate for the 
other, pursuant to the TSCA Work Plan Chemicals: Methods Document (Ref. 
2). PIP (3:1) (CASRN 68937-41-7) is one such chemical substance. This 
final rule is final agency action for purposes of judicial review under 
TSCA section 19(a).

C. What action is the Agency taking?

    EPA published a proposed rule on July 29, 2019, to address the five 
PBT chemicals EPA identified pursuant to TSCA section 6(h) (84 FR 
36728; FRL-9995-76). After publication of the proposed rule, EPA 
determined to address each of the five PBT chemicals in separate final 
actions. This final rule prohibits the processing and distribution in 
commerce of PIP (3:1) and products containing PIP (3:1) except for the 
following:
     Processing and distribution in commerce for use in 
hydraulic fluids either for the aviation industry or to meet military 
specifications for safety and performance where no alternative chemical 
is available that meets U.S. Department of Defense specification 
requirements;
     Processing and distribution in commerce for use in 
lubricants and greases;
     Processing and distribution in commerce for use in new and 
replacement parts for the automotive and aerospace industry, and the 
distribution in commerce of those parts to which PIP (3:1) has been 
added;
     Processing and distribution in commerce for use as an 
intermediate in a closed system to produce cyanoacrylate adhesives;
     Processing and distribution in commerce for use as an 
adhesive and sealant until January 6, 2025, after which such activity 
is prohibited;
     Processing and distribution in commerce for use in 
specialized engine filters for locomotive and marine applications;
     Processing for recycling and distribution in commerce for 
the recycling of PIP (3:1) containing plastic provided no new PIP (3:1) 
is added during the recycling process;
     Processing and distribution in commerce of articles and 
products made from recycled PIP (3:1)-containing plastic provided no 
new PIP (3:1) is added during the recycling process or to the articles 
and products made from the recycled plastic; and
     Processing and distribution in commerce of PIP (3:1) for 
use in photographic printing articles and PIP (3:1)-containing 
photographic printing articles until January 1, 2022.
    This final rule also prohibits releases to water for from 
manufacture, processing, distribution in commerce, and commercial uses 
that are permitted to occur, as outlined in the preceding bullets.
    Persons manufacturing, processing, and distributing in commerce PIP 
(3:1) and products containing PIP (3:1) are required to notify their 
customers of these prohibitions on processing and distribution, and the 
prohibition on releases to water via Safety Data Sheet (SDS) or 
labeling.
    Persons manufacturing, processing, and distributing in commerce PIP 
(3:1) are required to maintain, for three years from the date the 
record was generated, ordinary business records related to compliance 
with the restrictions, prohibitions, and other requirements set forth 
in this rule. These records must include a statement that the PIP 
(3:1), or the PIP (3:1)-containing products or articles, are in 
compliance with 40 CFR 751.407(a) and be made available to EPA within 
30 calendar days upon request.

D. Why is the Agency taking this action?

    EPA is issuing this final rule to fulfill EPA's obligations under 
TSCA section 6(h) to take timely regulatory action on PBT chemicals, 
including PIP (3:1), ``to address the risks of injury to health or the 
environment that the Administrator determines are presented by the 
chemical substance and to reduce exposure to the substance to the 
extent practicable.'' As required by the statute, the Agency is 
finalizing this rule to reduce exposure to PIP (3:1) to the extent 
practicable.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of these restrictions and 
prohibitions and the associated reporting and recordkeeping 
requirements. The

[[Page 896]]

``Economic Analysis for Regulation of Phenol, Isopropylated Phosphate 
(3:1) (PIP (3:1)) under TSCA section 6(h)'' (Economic Analysis) (Ref. 
3), is available in the docket and is briefly summarized here.
     Benefits. EPA was not able to quantify the benefits of 
reducing human and environmental exposures to PIP (3:1). As discussed 
in more detail in Unit II.A., EPA did not perform a risk evaluation for 
PIP (3:1), nor did EPA develop quantitative risk estimates. Therefore, 
the Economic Analysis (Ref. 3) qualitatively discusses the benefits of 
reducing exposure under the final rule for PIP (3:1), as summarized in 
Unit III.B.2.
     Costs. Total quantified annualized social costs for this 
final rule are approximately $23.8 million at a 3% discount rates, and 
$23.0 million at a 7% discount rate. Potential unquantified costs are 
those associated with testing, reformulation, importation of articles, 
foregone profits, and indirect costs. The limited data available for 
those costs prevents EPA from constructing a quantitative assessment.
     Small entity impacts. This final rule will impact 
approximately four small businesses of which none are expected to incur 
cost impacts of 1% or greater of their revenue.
     Environmental Justice. This final rule will increase the 
level of protection for all affected populations without having any 
disproportionately high and adverse human health or environmental 
effects on any population, including any minority or low-income 
population or children.
     Effects on State, local, and Tribal governments. This 
final rule does not have any significant or unique effects on small 
governments, or federalism or tribal implications.

F. Children's Environmental Health

    Executive Order 13045 applies if the regulatory action is 
economically significant and concerns an environmental health risk or 
safety risk that may disproportionately affect children. While the 
action is not subject to Executive Order 13045, the Agency's Policy on 
Evaluating Health Risks to Children (https://www.epa.gov/children/epas-policy-evaluating-risk-children) is to consider the risks to infants 
and children consistently and explicitly during its decision making 
process. This final rule will reduce the exposures to PIP (3:1) that 
could occur from activities now prohibited under this final rule for 
the general population and for potentially exposed or susceptible 
subpopulations such as children. More information can be found in the 
Exposure and Use Assessment (Ref. 4).

II. Background

A. History of This Rulemaking

    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. 1). As 
required by the statute, EPA issued a proposed rule to address five 
persistent, bioaccumulative, and toxic (PBT) chemicals identified 
pursuant to TSCA section 6(h) (84 FR 36728 (July 29, 2019)). The 
statute required that this be followed by promulgation of a final rule 
no later than 18 months after the proposal. While EPA proposed 
regulatory actions on each chemical substance in one proposal, in 
response to public comments (EPA-HQ-OPPT-2019-0080-0544), (EPA-HQ-OPPT-
2019-0080-0553), (EPA-HQ-OPPT-2019-0080-0556), (EPA-HQ-OPPT-2019-0080-
0562) requesting these five actions be separated, EPA is finalizing 
five separate actions to individually address each of the PBT 
chemicals. EPA intends for the five separate final rules to publish in 
the same issue of the Federal Register. More discussion on these 
comments is in the response to comments document which is available in 
the docket. The details of the proposal for PIP (3:1) are described in 
more detail in Unit II.D.
    Under TSCA section 6(h)(1)(A), chemical substances subject to 
expedited action are those that:
     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 or a successor scoring system;
     Are not a metal or a metal compound; and
     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 TSCA was amended by the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182, 
130 Stat. 448).
    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 (such as 
infants, children, pregnant women, workers, including occupational 
nonusers, consumers, or the elderly), or to the environment on the 
basis of an exposure and use assessment conducted by the Administrator. 
TSCA section 6(h)(2) 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).
    Based on the criteria set forth in TSCA section 6(h), EPA proposed 
to determine that five chemical substances meet the TSCA section 
6(h)(1)(A) criteria for expedited action, and PIP (3:1) is one of these 
five chemical substances. In addition, and in accordance with the 
statutory requirements to demonstrate that exposure to the chemical 
substance is likely under the conditions of use, EPA conducted an 
Exposure and Use Assessment for PIP (3:1). As described in the proposed 
rule, EPA conducted a review of available literature with respect to 
PIP (3:1) to identify, screen, extract, and evaluate reasonably 
available information on use and exposures. This information is in the 
document entitled ``Exposure and Use Assessment of Five Persistent, 
Bioaccumulative and Toxic Chemicals'' (Ref. 4). Based on this review, 
which was subject to peer review and public comment, EPA proposed to 
find that exposure to PIP (3:1) is likely, based on information 
detailed in the Exposure and Use Assessment.

B. Other Provisions of TSCA Section 6

    1. EPA's approach for implementing TSCA section 6(h)(4).
    TSCA section 6(h)(4) requires EPA to issue a final TSCA section 
6(a) rule to ``address the risks of injury to health or the environment 
that the Administrator determines are presented by the chemical 
substance and reduce exposure to the substance to the extent 
practicable.'' EPA reads this text to require action on the chemical, 
not specific conditions of use. The approach EPA takes is consistent 
with the language of TSCA section 6(h)(4) and its distinct differences 
from other provisions of TSCA section 6 for chemicals that are the 
subject of required risk evaluations. First, the term ``condition of 
use'' is only used in TSCA section 6(h) in the context of the TSCA 
section 6(h)(1)(B) finding relating to likely exposures under 
``conditions of use'' to ``the general population or to a potentially 
exposed or susceptible subpopulation . . . or the environment.'' In 
contrast to the risk evaluation process under TSCA section

[[Page 897]]

6(b), this TSCA section 6(h)(1)(B) threshold criterion is triggered 
only through an Exposure and Use Assessment regarding the likelihood of 
exposure and does not require identification of every condition of use. 
As a result, EPA collected all the information it could on the use of 
each chemical substance, without regard to whether any chemical 
activity would be characterized as ``known, intended or reasonably 
foreseen to be manufactured, processed, distributed in commerce, used, 
or disposed of,'' and from that information created use profiles and 
then an Exposure and Use Assessment (Ref. 4) to make the TSCA section 
6(h)(1)(B) finding for at least one or more ``condition of use'' 
activities where some exposure is likely. EPA did not attempt to 
precisely classify all activities for each chemical substance as a 
``condition of use'' and thus did not attempt to make a TSCA section 
6(h)(1)(B) finding for all chemical activities summarized in the 
Exposure and Use Assessment (Ref. 4). Second, TSCA section 6 generally 
requires a risk evaluation under TSCA section 6(b) for chemicals based 
on the identified conditions of use. However, pursuant to TSCA section 
6(h)(2), for chemical substances that meet the criteria of TSCA section 
6(h)(1), a risk evaluation is neither required nor contemplated to be 
conducted for EPA to meet its obligations under TSCA section 6(h)(4). 
Rather, as noted in Unit II.B.3., if a previously prepared TSCA risk 
assessment exists, EPA would have authority to use that risk assessment 
to ``address risks'' under TSCA section 6(h)(4), but even that risk 
assessment would not necessarily be focused on whether an activity is 
``known, intended or reasonably foreseen,'' as those terms were not 
used in TSCA prior to the 2016 amendments and a preexisting assessment 
of risks would have had no reason to use such terminology or make such 
judgments. It is for this reason EPA believes that the TSCA section 
6(h)(4) ``address risk'' standard refers to the risks the Administrator 
determines ``are presented by the chemical substance'' and makes no 
reference to ``conditions of use.'' Congress did not contemplate or 
require a risk evaluation identifying the conditions of use as defined 
under TSCA section 3(4). The kind of analysis required to identify and 
evaluate the conditions of use for a chemical substance is only 
contemplated in the context of a TSCA section 6(b) risk evaluation, not 
in the context of an expedited rulemaking to address PBT chemicals.
    Similarly, the TSCA amendments require EPA to ``reduce exposure to 
the substance to the extent practicable,'' without reference to whether 
the exposure if found ``likely'' pursuant to TSCA section 6(h)(1)(B).
    Taking all of this into account, EPA reads its TSCA section 6(h)(4) 
obligation to apply to the chemical substance generally, thus requiring 
EPA to address risks and reduce exposures to the chemical substance 
without focusing on whether the measure taken is specific to an 
activity that might be characterized as a ``condition of use'' as that 
term is defined in TSCA section 3(4) and interpreted by EPA in the Risk 
Evaluation Rule, 82 FR 33726 (July 20, 2017). This approach ensures 
that any activity involving a TSCA section 6(h) PBT chemical, past, 
present or future, is addressed by the regulatory approach taken. Thus, 
under this final rule, processing and distribution in commerce 
activities that are for uses not specifically excluded are prohibited. 
The specified activities with particular exclusions are those which EPA 
determined were not appropriate to regulate under the TSCA section 
6(h)(4) standard. Consistently, based on the Exposure and Use 
Assessment, activities associated with PIP (3:1) that are no longer 
occurring are addressed by this rule and thus the prohibitions adopted 
in this rule reduce the exposures that will result with resumption of 
past activities or the initiation of similar or other activities in the 
future. Therefore, EPA has determined that prohibiting these activities 
will reduce exposures to the extent practicable. The approach taken for 
this final rule is limited to implementation of TSCA section 6(h) and 
is not relevant to any other action under TSCA section 6 or other TSCA 
statutory actions.
    2. EPA's interpretation of practicable.
    The term ``practicable'' is not defined in TSCA. EPA interprets 
this requirement as generally directing the Agency to consider such 
factors as achievability, feasibility, workability, and reasonableness. 
In addition, EPA's approach to determining whether particular 
prohibitions or restrictions are practicable is informed in part by 
certain other provisions in TSCA section 6, such as TSCA section 
6(c)(2)(A), which requires the Administrator to consider health 
effects, exposure, and environmental effects of the chemical substance; 
benefits of the chemical substance; and the reasonably ascertainable 
economic consequences of the rule. In addition, pursuant to TSCA 
section 6(c)(2)(B), in selecting the appropriate TSCA section 6(a) 
regulatory approach, the Administrator is directed to ``factor in, to 
the extent practicable'' those same considerations.
    EPA received comments on the proposed rule regarding this 
interpretation of ``practicable.'' EPA has reviewed these comments and 
believes the interpretation described previously within this Unit is 
consistent with the intent of TSCA and has not changed that 
interpretation. EPA's interpretation of an ambiguous statutory term 
receives deference. More discussion on these comments is in the 
Response to Comments document for this rulemaking (Ref. 5).
    3. EPA did not conduct a risk evaluation or assessment.
    As EPA explained in the proposed rule, EPA does not interpret the 
``address risk'' language to require EPA to determine, through a risk 
assessment or risk evaluation, whether risks are presented. EPA 
believes this reading gives the Administrator the flexibility Congress 
intended for issuance of expedited rules for PBTs and is consistent 
with TSCA section 6(h)(2), which makes clear a risk evaluation is not 
required to support this rulemaking.
    EPA received comments on the proposed rule regarding its 
interpretation of TSCA section 6(h)(4) and regarding EPA's lack of risk 
assessment or risk evaluation of PIP (3:1). A number of commenters 
asserted that while EPA was not compelled to conduct a risk evaluation, 
EPA should have conducted a risk evaluation under TSCA section 6(b) 
regardless. The rationales provided by the commenters for such a risk 
assessment or risk evaluation included that one was needed for EPA to 
fully quantify the benefits to support this rulemaking, and that 
without a risk evaluation, EPA would not be able to determine the 
benefits, risks, and cost effectiveness of the rule in a meaningful 
way. As described by the commenters, EPA would therefore not be able to 
meet the TSCA section 6(c)(2) requirement for a statement of these 
considerations. Regarding the contradiction between the mandate in TSCA 
section 6(h) to expeditiously issue a rulemaking and the time needed to 
conduct a risk evaluation, some commenters argued that EPA would have 
had enough time to conduct a risk evaluation and issue a proposed rule 
by the statutory deadline.
    EPA disagrees with the commenters' interpretation of EPA's 
obligations with respect to chemicals subject to TSCA section 6(h)(4). 
TSCA section 6(h)(4) provides that EPA shall: (1) ``Address the risks 
of injury to health or the environment that the Administrator 
determines are presented by the

[[Page 898]]

chemical substance'' and (2) ``reduce exposure to the substance to the 
extent practicable.'' With respect to the first requirement, that 
standard is distinct from the ``unreasonable risk'' standard for all 
other chemicals for which a section 6(a) rule might be issued. EPA does 
not believe that TSCA section 6(h) contemplates a new evaluation of any 
kind, given that evaluations to determine risks are now addressed 
through the TSCA section 6(b) risk evaluation process and that TSCA 
section 6(h)(2) explicitly provides that no risk evaluation is 
required. Moreover, it would have been impossible to prepare a 
meaningful evaluation under TSCA and subsequently develop a proposed 
rule in the time contemplated for issuance of a proposed rule under 
TSCA section 6(h)(1). Although EPA does not believe the statute 
contemplates a new evaluation of any kind for these reasons, EPA 
reviewed the hazard and exposure information on the five PBT chemicals 
EPA had compiled. However, while this information appropriately 
addresses the criteria of TSCA section 6(h)(1)(A) and (B), it did not 
provide a basis for EPA to develop sufficient and scientifically robust 
and representative risk estimates to evaluate whether or not any of the 
chemicals present an identifiable risk of injury to health or the 
environment.
    Rather than suggesting a new assessment is required, EPA reads the 
``address risk'' language in TSCA section 6(h)(4) to contemplate 
reliance on an existing EPA assessment under TSCA, similar to a risk 
assessment that may be permissibly used under TSCA section 26(l)(4) to 
regulate the chemical under TSCA section 6(a). This interpretation 
gives meaning to the ``address risk'' phrase, without compelling an 
evaluation contrary to TSCA section 6(h)(2) and would allow use of an 
existing determination, or development of a new determination based on 
such an existing risk assessment, in the timeframe contemplated for 
issuance of a proposed rule under TSCA section 6(h). However, there 
were no existing EPA assessments of risk for any of the PBT chemicals. 
Thus, because EPA had no existing EPA risk assessments or 
determinations of risk, the regulatory measures addressed in this final 
rule focus on reducing exposures ``to the extent practicable.''
    In sum, because neither the statute nor the legislative history 
suggests that a new evaluation is compelled to identify and thereby 
provide a basis for the Agency to ``address risks'' and one could not 
be done prior to preparation and timely issuance of a proposed rule, 
and no existing TSCA risk assessment exists for any of the chemicals, 
EPA has made no risk determination finding for any of the PBT 
chemicals. Instead, EPA implements the requirement of TSCA section 
6(h)(4) by reducing exposures of each PBT chemical ``to the extent 
practicable.''
    For similar reasons, EPA does not believe that TSCA section 6(c)(2) 
requires a quantification of benefits, much less a specific kind of 
quantification. Under TSCA section 6(c)(2)(A)(iv), EPA must consider 
and publish a statement, based on reasonably available information, on 
the reasonably ascertainable economic consequences of the rule, but 
that provision does not require quantification, particularly if 
quantification is not possible. EPA has reasonably complied with this 
requirement by including a quantification of direct costs and a 
qualitative discussion of benefits in each of the preambles to the 
final rules. EPA was unable to quantify the indirect costs associated 
with the rule. More discussion on these issues raised in the comments 
is in the Response to Comments document (Ref. 5).
    4. Replacement parts and articles.
    In the preamble to the proposed rule, EPA explained that it did not 
read provisions of TSCA section 6 that conflict with TSCA section 6(h) 
to apply to TSCA section 6(h) rules. Specifically, TSCA sections 
6(c)(2)(D) and (E) require a risk finding pursuant to a TSCA section 
6(b) risk evaluation to regulate replacement parts and articles. Yet, 
TSCA section 6(h) neither compels nor contemplates a risk evaluation to 
precede or support the compelled regulatory action to ``address the 
risks. . .'' and ``reduce exposures to the substance to the extent 
practicable''. TSCA section 6(h)(2) makes clear no risk evaluation is 
required, and the timing required for conducting a risk evaluation is 
not consistent with the timing compelled for issuance of a proposed 
rule under TSCA section 6(h). Moreover, even assuming a prior risk 
assessment might allow a risk determination under the TSCA section 
6(h)(4) ``address risk'' standard, such assessment would still not 
satisfy the requirement in TSCA section 6(c)(2)(D) and (E) for a risk 
finding pursuant to a TSCA section 6(b) risk evaluation. Because of the 
clear conflict between these provisions, EPA determined that those 
provisions of TSCA section 6(c) that assume the existence of a TSCA 
section 6(b) risk evaluation do not apply in the context of this TSCA 
section 6(h) rulemaking. Instead, EPA resolves this conflict in these 
provisions by taking into account the TSCA section 6(c) considerations 
in its determinations as to what measures ``reduce exposure to the 
substance to the extent practicable''.
    Commenters contended that TSCA section 6(c)(2)(D) and (E) bar a 
TSCA section 6(h) rule in the absence of a risk evaluation, 
representing Congress's recognition of the special burdens associated 
with regulating replacement parts and articles, including the 
difficulty of certifying newly designed replacement parts for 
automobiles and aircraft, and the difficulty importers face in knowing 
what chemicals are present in the articles they import. As noted in 
this Unit and further discussed in the Response to Comment document, 
while EPA determined that provisions of TSCA section 6(c)(2)(D) and (E) 
do not apply because they conflict with the requirements of TSCA 
section 6(h), EPA interpreted the ``practicability'' standard in TSCA 
section 6(h)(4) to reasonably contemplate the considerations embodied 
by TSCA section 6(c)(2)(D) and (E). As a result, EPA disagrees with any 
suggestion that the clear conflict between Congress' mandates in TSCA 
section 6(h) and TSCA section 6(c)(2)(D) and (E) must be read to bar 
regulation of replacement parts and articles made with chemicals that 
Congress believed were worthy of expedited action under TSCA section 
6(h) and in the absence of a risk evaluation. The statute does not 
clearly communicate that outcome. Instead, Congress left ambiguous how 
best to address the conflict in these provisions, and EPA's approach 
for taking into consideration the TSCA section 6(c)(2)(D) and (E) 
concepts in its TSCA section 6(h)(4) ``practicability'' determinations 
is a reasonable approach. In addition, with respect to comments that 
TSCA section 6(C)(2)(D) and (E) were intended to address Congress's 
concerns regarding burdens associated with regulation of replacement 
parts and articles, EPA agrees that these concerns are relevant and 
takes them into account in its implementation of the TSCA section 
6(h)(4) mandate, with respect to the circumstances for each chemical. 
Finally, EPA does not believe that Congress intended, through the 
article provisions incorporated into the TSCA amendments, to absolve 
importers of the duty to know what they are importing. Importers can 
and should take steps to determine whether the articles they are 
importing contain chemicals that are prohibited or restricted. 
Therefore, taking the discussion in this Federal Register document and 
the additional discussion in the Response to Comment document on these 
issues into account, EPA is continuing to interpret TSCA

[[Page 899]]

sections 6(c)(2)(D) and 6(c)(2)(E) to be inapplicable to this 
rulemaking. While this interpretation has not changed, EPA has reviewed 
the practicability of regulating replacement parts and articles in 
accordance with the statutory directive in TSCA section 6(h)(4) to 
reduce exposures to the PBT chemicals to the extent practicable. The 
results of those reviews are in Unit III.A.

C. PIP (3:1) Overview, Health Effects, and Exposure

    PIP (3:1) is used as a plasticizer, a flame retardant, an anti-wear 
additive, or an anti-compressibility additive in hydraulic fluid, 
lubricating oils, lubricants and greases, various industrial coatings, 
adhesives, sealants, and plastic articles. As a chemical that can 
perform several functions simultaneously, sometimes under extreme 
conditions, it has several distinctive applications. In lubricating 
oils, PIP (3:1) is a flame retardant, anti-wear additive, anti-
compressibility additive, or some combination of the three. In 
adhesives and sealants, PIP (3:1) is a plasticizer and flame retardant 
(Ref. 4). PIP (3:1) can also be added to paints, coatings, and plastic 
components, where it is a plasticizer or flame-retardant additive. In 
the past, some plastic components to which PIP (3:1) may have been 
added included those intended for use by children. EPA received 
comments that PIP (3:1) acts as a flame-retardant gel in filters 
surrounding engines in some marine and locomotive applications (EPA-HQ-
OPPT-2019-0080-0569).
    Exposure information for PIP (3:1) is summarized here and is 
detailed in EPA's Exposure and Use Assessment (Ref. 4), and the 
proposal. There is potential for exposure to PIP (3:1) under the 
conditions of use at all stages of its lifecycle (i.e., manufacturing, 
processing, use (industrial, commercial, and consumer), distribution, 
and disposal) (Ref. 4). PIP (3:1) is manufactured, processed, 
distributed, and used domestically. For the 2012 Chemical Data 
Reporting (CDR) period, data indicate that four sites manufactured 
(including imported) PIP (3:1) in the United States. For the 2016 CDR 
period, data indicate nine sites manufactured (including imported) PIP 
(3:1) in the United States (Refs. 6 and 7). The total volume of PIP 
(3:1) manufactured (including imported) in the United States was 
14,904,236 lbs in 2011; 3,191,017 lbs in 2012; 2,968,861 lbs in 2013; 
5,632,272 lbs in 2014; and 5,951,318 in 2015 (Ref. 7).
    PIP (3:1) is toxic to aquatic plants, aquatic invertebrates, 
sediment invertebrates, and fish. Data indicate the potential for 
reproductive and developmental effects, neurological effects and 
effects on systemic organs, specifically adrenals, liver, ovary, and 
heart in mammals. The studies presented in the document entitled 
``Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals (Hazard Summary) (Ref. 8) 
demonstrate these hazardous endpoints. EPA did not perform a systematic 
review or a weight of the scientific evidence assessment for the hazard 
characterization of these chemicals. As a result, this hazard 
characterization is not definitive or comprehensive. Other hazard 
information on these chemicals may exist in addition to the studies 
summarized in the Hazard Summary that could alter the hazard 
characterization (Ref. 8).
    In the 2014 Update to the TSCA Work Plan for Chemical Assessments, 
PIP (3:1) scored high (3) for hazard (based on neurotoxicity in mammals 
and aquatic toxicity); high (3) for exposure (based on use as a flame 
retardant in industrial and consumer products); and high (3) for 
persistence and bioaccumulation (based on high environmental 
persistence and high bioaccumulation potential) (Ref. 1). The overall 
screening score for PIP (3:1) was high (9).
    Taking all this into account, and the discussion in Response to 
Comments document and in this Unit and in Unit III., EPA determines in 
this final rule that PIP (3:1) meets the TSCA section 6(h)(1)(A) 
criteria. Comments received pertaining to this finding are discussed 
further in Unit III.A.1. In addition, EPA determines, in accordance 
with TSCA section 6(h)(1)(B), that based on the Exposure and Use 
Assessment and other reasonably available information, exposure to PIP 
(3:1) is likely under the conditions of use to the general population, 
to a potentially exposed or susceptible subpopulation, or the 
environment. EPA's determination is based on the opportunities for 
exposure throughout the lifecycle of PIP (3:1). EPA did not receive any 
comments with information to call the exposure finding into question.

D. EPA's Proposed Rule Under TSCA Section 6(h) for PIP (3:1)

    In the proposed rule (84 FR 36728), EPA proposed to prohibit the 
processing and distribution in commerce of PIP (3:1), and products 
containing the chemical substance except for the following:
     Processing and distribution in commerce for use in 
aviation hydraulic fluid;
     Processing and distribution in commerce for use in 
lubricants and greases; and
     Processing and distribution in commerce for use in new and 
replacement parts for the automotive industry, and the distribution in 
commerce of those parts to which PIP (3:1) has been added.
    EPA proposed to prohibit releases to water from manufacture, 
processing, distribution in commerce, and commercial use activities 
that are permitted to occur. EPA also proposed to require persons 
manufacturing, processing, and distributing PIP (3:1), and products 
containing PIP (3:1), in commerce to notify their customers of these 
prohibitions on processing and distribution, and the prohibition on 
releases to water.
    In addition, EPA proposed to require that all persons who 
manufacture, process, or distribute in commerce PIP (3:1) and articles 
and products containing PIP (3:1) maintain ordinary business records, 
such as invoices and bills-of-lading, that demonstrate compliance with 
the prohibitions and restrictions. EPA proposed that these records 
would have to be maintained for a period of three years from the date 
the record is generated.

E. Public Comments and Other Public Input

    The proposed rule provided a 60-day public comment period, with a 
30-day extension provided (Ref. 5). The comment period closed 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 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. Copies of all the non-CBI 
documents, or redacted versions without CBI, are available in the 
docket for this action.
    In this preamble, EPA has responded to the major comments relevant 
to the PIP (3:1) final rule. Of these comment submissions, thirty 
addressed EPA's proposed regulation of PIP (3:1). Additional discussion 
related to this final action can be found in the Response to Comments 
document (Ref. 5).

[[Page 900]]

F. Activities Not Directly Regulated by This Rule

    EPA is not regulating all activities or exposures to PIP (3:1), 
even though the Exposure and Use Assessment (Ref. 4) identified 
potential for exposures under many conditions of use. One such activity 
is disposal. EPA generally presumes compliance with federal and state 
laws and regulations, including, for example, Resource Conservation and 
Recovery Act (RCRA) and its implementing regulations and state laws, as 
well as the Clean Air Act, the Clean Water Act (CWA), and the Safe 
Drinking Water Act (SDWA). As described in the proposed rule, 
regulations promulgated under the authority of the RCRA govern the 
disposal of hazardous and non-hazardous wastes. Although PIP (3:1) is 
not a listed or characteristic hazardous waste under RCRA, it is 
subject to the requirements applicable to solid waste under Subtitle D 
of RCRA. This means there is a general prohibition on open dumping 
(which includes a prohibition on open burning). Wastes containing this 
chemical that do not otherwise meet the criteria for hazardous waste 
would be disposed of in municipal solid waste landfills (MSWLFs), 
industrial nonhazardous, or, in a few instances, construction/
demolition landfills. Non-hazardous solid waste is regulated under 
Subtitle D of RCRA, and states play a lead role in ensuring that the 
federal requirements are met. The requirements for MSWLFs include 
location restrictions, composite liners, leachate collection and 
removal systems, operating practices, groundwater monitoring, closure 
and post-closure care, corrective action provisions, and financial 
assurance. Industrial waste (non-hazardous) landfills and construction/
demolition waste landfills are primarily regulated under state 
regulatory programs, and in addition they must meet the criteria set 
forth in federal regulations, which may include requirements such as 
siting, groundwater monitoring and corrective action depending upon 
what types of waste are accepted. Disposal by underground injection is 
regulated under both RCRA and SDWA. In view of this comprehensive, 
stringent program for addressing disposal, EPA proposed that it is not 
practicable to impose additional requirements under TSCA on the 
disposal of the PBT chemicals, including PIP (3:1).
    EPA received a number of comments on this aspect of its proposal. 
Some commenters agreed with EPA's proposed determination that it is not 
practicable to regulate disposal, while others disagreed. However, in 
EPA's view, establishing an entirely new disposal program for PIP 
(3:1)-containing wastes would be expensive and difficult to establish 
and administer. In addition, imposing a requirement to treat these 
wastes as if they were listed as hazardous wastes would have impacts on 
hazardous waste disposal capacity and be very expensive for states and 
local governments as well as for affected industries. Therefore, EPA 
has determined that it is not practicable to further regulate PIP 
(3:1)-containing wastes for disposal. More information on the comments 
received and EPA's responses can be found in the Response to Comments 
document (Ref. 5). One commenter, the Institute of Scrap Recycling 
Industries, Inc. (ISRI) (EPA-HQ-OPPT-2019-0080-0559), noted that, while 
EPA proposed to not regulate disposal of the PBT chemicals under TSCA, 
the effect of EPA's proposed prohibition on manufacturing, processing, 
and distribution in commerce would prohibit the processing and 
distribution in commerce of the PBTs and articles and products 
containing the PBT chemicals for disposal. EPA did not intend such an 
effect and has added an exclusion in the final regulatory text for 
processing and distribution in commerce for disposal.
    EPA also proposed not to use its TSCA section 6(a) authorities to 
regulate commercial use of products and articles containing the PBT 
chemicals, such as televisions and computers, because such regulation 
would not be practicable. It would be extremely burdensome, 
necessitating the identification of products containing PIP (3:1), and 
the disposal of countless products and articles that would have to be 
replaced. If EPA prohibited the continued commercial use of these 
items, widespread economic impacts and disruption in the channels of 
trade would occur while the prohibited items were identified and 
replaced. Although some commenters agreed with EPA's proposed 
determination that it is not practicable to regulate commercial use, 
and others disagreed, for the reasons noted in the proposal and 
discussed further in the Response to Comments document (Ref. 5), EPA 
continues to believe that prohibiting or otherwise restricting the 
continued commercial use of products and articles containing PIP (3:1) 
would result in extreme burdens in exchange for what in most cases 
would be minimal exposure reductions. Thus, EPA concludes that it is 
impracticable to prohibit or otherwise restrict the continued 
commercial use of PIP (3:1)-containing products.
    EPA also proposed not to use its TSCA section 6(a) authorities to 
directly regulate occupational exposures. As explained in the proposed 
rule, as a matter of policy, EPA assumes compliance with federal and 
state requirements, such as worker protection standards, unless case-
specific facts indicate otherwise. The OSHA has not established a 
permissible exposure limit (PEL) for PIP (3:1). However, under section 
5(a)(1) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 
654(a)(1), each employer has a legal obligation to furnish to each of 
its employees employment and a place of employment that are free from 
recognized hazards that are causing or are likely to cause death or 
serious physical harm. The OSHA Hazard Communication Standard at 29 CFR 
1910.1200 requires chemical manufacturers and importers to classify the 
hazards of chemicals they produce or import, and all employers to 
provide information to employees about hazardous chemicals to which 
they may be exposed under normal conditions of use or in foreseeable 
emergencies. The OSHA standard at 29 CFR 1920.134(a)(1) requires the 
use of feasible engineering controls to prevent atmospheric 
contamination by harmful substances and requires the use of respirators 
where effective engineering controls are not feasible. The OSHA 
standard at 29 CFR 1920.134(c) details the required respiratory 
protection program. The OSHA standard at 29 CFR 1910.132(a) requires 
the use of personal protective equipment (PPE) by workers when 
necessary due to a chemical hazard; 29 CFR 1910.133 requires the use of 
eye and face protection when employees are exposed to hazards including 
liquid chemicals; and 29 CFR 1910.138 requires the use of PPE to 
protect employees' hands including from skin absorption of harmful 
substances. The provisions of 29 CFR 1910.132(d) and (f) address hazard 
assessment, PPE selection, and training with respect to PPE required 
under 29 CFR 1910.133, 1910.135, 1910.136, 1910.138 and 1910.140. EPA 
assumes that employers will require, and workers will use, appropriate 
PPE consistent with OSHA standards, taking into account employer-based 
assessments, in a manner sufficient to prevent occupational exposures 
that are capable of causing injury.
    EPA assumes compliance with other federal requirements, including 
OSHA standards and regulations. EPA does not read TSCA section 6(h)(4) 
to direct EPA to adopt potentially redundant or conflicting 
requirements. Not only

[[Page 901]]

would it be difficult to support broadly applicable and safe additional 
measures for each specific activity without a risk evaluation and in 
the limited time for issuance of this regulation under TSCA section 
6(h), but imposing such measures without sufficient analysis could 
inadvertently result in conflicting or confusing requirements and make 
it difficult for employers to understand their obligations. Such 
regulations would not be practicable. Rather, where EPA has identified 
worker exposures and available substitutes, EPA is finalizing measures 
to reduce those exposures. As discussed in the proposed rule, EPA 
assumes that the worker protection methods used by employers, including 
in response to existing OSHA regulations, (29 CFR 1910.1200, 29 CFR 
1910.132 through 1910.140), in addition to the regulatory measures 
taken for each chemical, meaningfully reduce the potential for 
occupational exposures. While some commenters agreed with this 
approach, others thought that EPA should establish worker protection 
requirements for those uses that would be allowed to continue under the 
final rule. Information provided to EPA before and during the public 
comment period on the proposed rule indicates that employers are using 
engineering and process controls and providing appropriate personal 
protective equipment (PPE) to their employees consistent with these 
requirements, and EPA received no information on PIP (3:1) to suggest 
this is not the case. Further, EPA has not conducted a risk evaluation 
on PIP (3:1) or any of other PBT chemicals. Without a risk evaluation 
and given the time allotted for this rulemaking, EPA cannot identify 
additional engineering or process controls or PPE requirements that 
would be appropriate to each chemical-specific circumstance. For these 
reasons, EPA has determined that it is not practicable to regulate 
worker exposures in this rule through engineering or process controls 
or PPE requirements.
    EPA received comments regarding the use of PBT chemicals in 
research and development and lab use. Lab use is addressed under newly 
established 40 CFR 751.401(b) as the manufacturing, processing, 
distribution in commerce and use of any chemical substance, or products 
and articles that contain the chemical substance, for research and 
development, as defined in new 40 CFR 751.403. Research and Development 
is defined in new 40 CFR 751.403 to mean laboratory and research use 
only for purposes of scientific experimentation or analysis, or 
chemical research on, or analysis of, the chemical substance, including 
methods for disposal, but not for research or analysis for the 
development of a new product, or refinement of an existing product that 
contains the chemical substance. This will allow, for example, for 
samples of environmental media containing PBTs, such as contaminated 
soil and water, to be collected, packaged and shipped to a laboratory 
for analysis. Laboratories also must obtain reference standards 
containing PBTs to calibrate their equipment, otherwise they may not be 
able to accurately quantify these chemical substances in samples being 
analyzed. However, research to develop new products that use PBTs 
subject to 40 CFR part 751, subpart E, or the refinement of existing 
uses of those chemicals, is not included in this definition, and those 
activities remain potentially subject to the chemical specific 
provisions in 40 CFR part 751, subpart E. EPA believes it is not 
practicable to limit research and development activity as defined, 
given the critical importance of this activity to the detection, 
quantification and control of these chemical substances.
    Finally, EPA received comments regarding requirements for resale of 
PIP (3:1)-containing products and articles, as well as products and 
articles containing other PBT chemicals undergoing Section 6(h) 
rulemaking. One commenter stated that because the proposed definition 
of ``person'' includes ``any natural person,'' the proposed 
prohibitions would seem to apply to anyone selling products or articles 
containing PIP (3:1) at a garage or yard sale (EPA-HQ-OPPT-2019-0080-
0559). EPA did not intend to impose these final PIP (3:1) regulations 
on yard sales or used product or article sales and has added language 
in 40 CFR 751.401 to clarify this. The prohibition and recordkeeping 
requirements in this final rule exclude PIP (3:1)-containing products 
and articles that have previously been sold or supplied to an end user, 
i.e., any person who purchased or acquired the finished good for the 
purposes of resale.

III. Provisions of This Final Rule

A. Scope and Applicability

    EPA carefully considered all public comments related to the 
proposal. This rule finalizes with some modifications EPA's proposal to 
prohibit the processing and distribution in commerce of PIP (3:1), and 
products containing the chemical substance. The following are excluded 
from the prohibition in this final rule:
     Processing and distribution in commerce for use in 
hydraulic fluids either for the aviation industry or to meet military 
specifications for safety and performance where no alternative chemical 
is available that meets U.S. Department of Defense specification 
requirements;
     Processing and distribution in commerce for use in 
lubricants and greases;
     Processing and distribution in commerce for use in new and 
replacement parts for the automotive and aerospace industry, and the 
distribution in commerce of those parts to which PIP (3:1) has been 
added;
     Processing and distribution in commerce for use as an 
intermediate in a closed system to produce cyanoacrylate adhesives;
     Processing and distribution in commerce for use as an 
adhesive and sealant until January 6, 2025, after which such activity 
is prohibited;
     Processing and distribution in commerce for use in 
specialized engine filters for locomotive and marine applications;
     Processing for recycling and distribution in commerce for 
the recycling of PIP (3:1) containing plastic provided no new PIP (3:1) 
is added during the recycling process;
     Processing and distribution in commerce of articles and 
products made from recycled PIP (3:1) containing plastic provided no 
new PIP (3:1) is added during the recycling process or to the articles 
and products made from the recycled plastic; and
     Processing and distribution in commerce of PIP (3:1) for 
use in photographic printing articles and PIP (3:1)-containing 
photographic printing articles until January 1, 2022.
    This final rule also prohibits releases to water from manufacture, 
processing, distribution in commerce, and commercial uses that are 
permitted to occur, as outlined in the preceding bullets.
    Persons manufacturing, processing, and distributing in commerce PIP 
(3:1) and products containing PIP (3:1) are required to notify their 
customers of these prohibitions on processing and distribution, and the 
prohibition on releases to water via Safety Data Sheet (SDS) or 
labeling.
    Persons manufacturing, processing, and distributing in commerce PIP 
(3:1) are required to maintain, for three years from the date the 
record is generated, ordinary business records related to compliance 
with the restrictions, prohibitions, and other requirements set forth 
in this rule. These records must include a statement of compliance with 
this final rule and be made available to

[[Page 902]]

EPA within 30 calendar days upon request.
    1. Inclusion in TSCA Section 6(h).
    In the proposed rule, EPA identified the five chemical substances 
EPA proposed as meeting the TSCA section 6(h)(1)(A) criteria for 
expedited action. PIP (3:1) is one of those five substances, with a 
``high'' bioaccumulation score. The information EPA collected and 
reviewed in developing the proposal provided no basis to call into 
question the scoring for persistence, bioaccumulation, and toxicity 
performed in 2014 for these five PBT chemicals. Four commenters 
addressed classification of PIP (3:1) as a PBT, and one specifically 
took issue with PIP (3:1)'s classification as a PBT under TSCA section 
6(h)(1)(A), with a focus on its bioaccumulation properties. Their 
concerns are described in this final rule and addressed in the Response 
to Comments for this rulemaking (Ref. 5). While one commenter submitted 
additional data, these comments and data submitted do not call into 
question the PIP (3:1) bioaccumulation score identified in the 2014 
Update to the TSCA Work Plan for Chemical Assessments for the reasons 
described in the Response to Comments Document (Ref. 5).
    Four commenters indicated that PIP (3:1) is not considered a PBT by 
the European Chemicals Agency (ECHA), based on information in the 
Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH) dossiers; according to the commenters, therefore PIP (3:1) does 
not meet the TSCA section 6(h)(1)(A) criteria. However, information in 
the REACH dossiers reflect the results of studies submitted to ECHA, 
and not necessarily determinations by ECHA. A single study submitted by 
industry representing results from their particular commercial product 
is not sufficient justification to call into question whether PIP (3:1) 
meets the bioaccumulation criterion. Commercial products may contain 
varying amounts of different isomers which constitute PIP (3:1) thus, a 
study on a particular commercial product alone for a chemical that may 
differ between various commercial products, is not adequate to call 
into question the specified score identified in the 2014 Update to the 
TSCA Work Plan for Chemical Assessments.
    Additionally, PIP (3:1) is a UVCB substance, or a substance of 
unknown or variable composition, complex reaction and biological 
materials. In the case of PIP (3:1), it is a substance of unknown or 
variable composition. The chemical substance PIP (3:1), which is the 
subject of this regulation, has a variable composition in that mixtures 
of or containing PIP (3:1) may contain different proportions of isomers 
of PIP (3:1) or of different chemical congeners. An isomer is defined 
as ``one of several species (or molecular entities) that have the same 
atomic composition (molecular formula) but different line formulae or 
different stereochemical formulae and hence different physical and/or 
chemical properties'' (Ref. 9). A congener is defined as ``one of two 
or more substances related to each other by origin, structure, or 
function'' (Ref. 9). When considering a UVCB substance, the Agency 
considers whether any isomers or congeners which might be present in a 
UVCB substance are bioaccumulative and, if so, EPA considers the UVCB 
substance to be bioaccumulative. In these cases, the Agency has a 
longstanding approach for chemical evaluation and regulation that 
considers whether particular isomers or congeners which might be 
present in an identified substance are, for example, bioaccumulative 
and, as in this case, if so, EPA considers that identified substance to 
meet the criterion (Ref. 10). Because PIP (3:1) is a UVCB, and because 
commercial products may contain varying amounts of different isomers 
which constitute PIP (3:1), and, as detailed in the 2014 Update to the 
TSCA Work Plan for Chemical Assessments and the proposed rule, some of 
those isomers are identified as bioaccumulative, EPA continues to 
consider PIP (3:1) to be bioaccumulative.
    Additionally, EPA does not interpret TSCA section 6(h)(1)(A) to 
require, as the commenter suggests, a ``fresh look'' at the scores for 
or issues of toxicity, persistence, or bioaccumulation of the Work Plan 
chemicals. Requiring EPA to re-evaluate any of these issues would delay 
what Congress intended to be an expedited rulemaking process. It also 
suggests a level of analysis not contemplated by Congress or clearly 
required for this rulemaking given that Congress did not compel risk 
evaluations for any chemicals meeting the TSCA section 6(h)(1) 
criteria. The only required additional assessment is the ``exposure and 
use assessment'' used to make the TSCA section 6(h)(1)(B) finding that 
exposures are likely under the conditions of use.
    To the extent that commenters suggest that EPA used a ``successor 
scoring system'' (via the use and exposure assessment and hazard 
summary) to identify the score for the PBT chemicals, that is not the 
case. The Agency reaffirms that the scores identified in the 2014 
Update to the TSCA Work Plan for Chemical Assessments and referenced in 
the proposed rule are based on the 2012 Methods Document criteria, and 
EPA's responses to comments are based on those criteria. Because of PIP 
(3:1)'s status as a UVCB, any study on a single congener or commercial 
product would need to be considered in the context of all available 
information that informs the persistence and bioaccumulation of PIP 
(3:1). To the extent that commenters are suggesting that the statute 
requires, or that EPA should do an analysis consistent with, a 
systematic review to re-evaluate the persistence and bioaccumulation 
score for PIP (3:1), the Agency notes that it views that effort to be a 
successor scoring system approach. Systematic review or an analysis 
consistent with systematic review is inconsistent with the criteria and 
tools referenced in the 2012 TSCA Work Plan Chemicals: Methods 
Document. If EPA had used a successor scoring system, it would need to 
rescore the chemicals identified on the 2014 Update to the TSCA Work 
Plan for Chemical Assessments and the Agency did not do that and has no 
plans to do that at this time.
    One commenter indicated that EPA has not adequately identified the 
chemical substance. EPA emphasizes that PIP (3:1) has been properly 
identified as the subject of this rulemaking. To clarify, TSCA section 
6(h) requires EPA to issue a proposed rule to address chemicals 
``identified'' in the 2014 Update to the TSCA Work Plan for Chemical 
Assessments and that meet other specified criteria. Chemicals 
``identified'' in the 2014 Update to the TSCA Work Plan for Chemical 
Assessments are specified by chemical name and CASRN. In this case, PIP 
(3:1) is identified as Phenol, isopropylated phosphate (3:1) (iPTPP) 
and with CASRN 68937-41-7.
    2. 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.
    In this final rule EPA amends the language in the proposed rule on 
the exclusion from the processing and distribution in commerce 
restrictions of PIP (3:1) for use in for aviation hydraulic fluid and 
of PIP (3:1)-containing aviation hydraulic fluid, to include an 
exclusion from the prohibition on the processing and distribution in 
commerce of PIP (3:1) for use in hydraulic fluids either for the 
aviation industry or to meet military specifications for safety and 
performance where no alternative chemical is available that meets U.S.

[[Page 903]]

Department of Defense specification requirements. As noted in the 
proposed rule, these requirements remain necessary for the safe 
operation of commercial and military aircraft.
    Five commenters confirmed or elaborated on the degree to which it 
would be impracticable to replace or reformulate hydraulic fluids 
containing PIP (3:1). Several of those comments supported the concerns 
outlined in the proposed rule, namely that aviation fluids are approved 
by major aircraft manufacturers who work closely with the Federal 
Aviation Administration (FAA), and any change in formula composition 
results in a full requalification process. As described in the proposed 
rule, this process is a joint effort between the fluid manufacturer and 
aircraft manufacturer, and resulting fluids are subject to extensive 
laboratory and field testing. At the end of this iterative evaluation 
process, there is no guarantee that a technically equivalent 
alternative will be developed (Refs. 3, 11 and 12).
    While no comments opposed the exclusion for aviation hydraulic 
fluid specifically, several commenters opposed the exclusions from the 
prohibition on processing and distribution outlined in the proposal 
more broadly, particularly in that the exclusions are not time limited 
(EPA-HQ-OPPT-2019-0080-0546; -0567; -0570; -0572; -0575). Additional 
information is available in the Response to Comments document (Ref. 5).
    EPA received one comment requesting that hydraulic fluid which may 
contain PIP (3:1) for other industries, including use specialized, 
industrial applications that include hydraulic control of valves for 
certain higher pressure, and more extreme environments, also be 
excluded from the rule. As explained in the proposal, for industrial 
hydraulic fluids (excluding aviation), various alternative products not 
containing PIP (3:1) are already available in commerce. However, to the 
commenter's point, synthetic hydraulic fluids which contain low levels 
of PIP (3:1) are certified to military specifications, such as MIL-DTL-
32353A (Ref. 13) and represent an emerging technology in hydraulic 
fluids for various applications important to national security 
including hydraulic lubricating oils for valves in vessels. To that 
end, EPA is expanding the exclusion to ensure inclusion of those 
hydraulic fluids certified to military specifications which may be used 
in industries other than aviation. To be eligible for this exclusion, 
the hydraulic fluid must be required to meet military specifications 
for safety and performance and no alternative chemical is available 
that meets U.S. Department of Defense specification requirements. To 
the extent that PIP (3:1) containing hydraulic fluids are certified for 
turbine hydraulic fluid military specifications, those products would 
be encompassed by aviation hydraulic fluid.
    For hydraulic fluids that are in use by the aviation industry or to 
meet military specifications for safety and performance where no 
alternative chemical is available to the end user to meet U.S. 
Department of Defense specification requirements, their processing and 
distribution in commerce must be excluded from the prohibition. For the 
reasons summarized in Unit III.A.2. and supported by the comments and 
Economic Analysis, the Agency is finalizing the proposed exclusion for 
processing and distribution in commerce for use in hydraulic fluids 
either for the aviation industry or to meet military specifications for 
safety and performance where no alternative chemical is available that 
meets U.S. Department of Defense specification requirements.
    3. Lubricants and greases.
    EPA is finalizing as proposed the exclusion from the processing and 
distribution in commerce restrictions of PIP (3:1) for use in 
lubricants and greases and of PIP (3:1)-containing lubricants and 
greases. Five commenters confirmed or elaborated on the degree to which 
it would be impracticable to replace or reformulate lubricants and 
greases containing PIP (3:1), which, as noted in the proposed rule, are 
necessary for the safe operation of commercial and military aircraft, 
as well as some non-aviation uses such as turbines for power generation 
(EPA-HQ-OPPT-2019-0080-0562; -0536; -0545; -0542; -0539). One commenter 
did not support the exclusion for PIP (3:1) in lubricants and greases, 
citing concerns over potential occupational and consumer exposure (EPA-
HQ-OPPT-2019-0080-0572). EPA does not expect lubricants and greases 
containing PIP (3:1) to be available to consumers or workers in non-
industrial settings, as lubricants and greases that contain PIP (3:1) 
are those that need to function in extreme environments, including 
extreme heat, cold, and high pressure. As mentioned in Unit III.A.2. 
several commenters oppose the exclusions from the prohibition on 
processing and distribution outlined in the proposal more broadly, 
particularly in that the exclusions are not time limited (EPA-HQ-OPPT-
2019-0080-0546; -0567; -0570; -0572; -0575). Additional information is 
available in the Response to Comments document (Ref. 5).
    In the proposal, EPA acknowledged the degree to which PIP (3:1) is 
crucial to the safe and effective performance of lubricants and 
greases, where it functions as a crucial anti-wear component. The 
Agency requested comment on the degree to which PIP (3:1) is crucial to 
the safe and effective performance of lubricants and greases in non-
aviation industries. EPA received information from several commenters 
supporting the lack of alternatives to PIP (3:1) for aviation and non-
aviation industries, the mandatory safety standards that are in place 
for non-aviation lubricants and greases, and the degree to which 
exposures are minimized. Additional details are in the docket and the 
Response to Comments document (Ref. 5). For lubricants and greases to 
be available to the end user, their processing and distribution in 
commerce must be excluded from the prohibition. For the reasons noted 
in Unit III.A.3., EPA is finalizing the proposed exclusion for 
lubricants and greases.
    Several commenters requested clarification on the scope of the 
exclusion for lubricants and greases. One commenter asked if 
metalworking fluids were within the scope of the exclusion. Two 
additional commenters requested clarification that brake fluids used in 
landing gear fall within the scope of lubricants and greases. Another 
noted that the scope should include lubricants used in marine and rail 
engine applications. EPA confirms that all the uses outlined in this 
paragraph, as well as use in aviation and non-aviation lubricants and 
greases more broadly, are within the scope of those lubricants and 
greases excluded from the proposed processing and distribution 
restrictions, as the regulatory definition of lubricants includes any 
chemical substance used to reduce friction, heat, or wear between 
moving or adjacent solid surfaces, or that enhance the lubricity of 
other substances (Ref. 14)
    As requested by a commenter, EPA also confirms that, under the 
final rule, used oils, which fall within the scope of lubricants and 
greases, may continue to be recycled.
    4. New and replacement parts for automobiles.
    EPA is finalizing as proposed the exclusion from the proposed 
processing and distribution in commerce prohibitions of PIP (3:1) for 
use in new and replacement parts for automobiles and of PIP (3:1)-
containing new and replacement parts for automobiles. Numerous 
commenters confirmed or

[[Page 904]]

elaborated on the degree to which it would be impracticable to replace 
or reformulate automobile components that contain PIP (3:1).
    The rationale given by commenters from industry supported the 
information outlined in the proposal; namely, PIP (3:1) is used to meet 
safety standards in new and replacement parts for automobiles and there 
is currently no feasible alternative.
    Three commenters from non-governmental organizations (NGOs) opposed 
the exclusion, noting that it should be time limited (EPA-HQ-OPPT-2019-
0080-0541; -0572; -0575). Two of those NGOs are among commenters 
mentioned in Unit III.A.2. who oppose the exclusions from the 
prohibition on processing and distribution outlined in the proposal 
more broadly, particularly in that the exclusions are not time limited 
(EPA-HQ-OPPT-2019-0080-0546; -0567; -0570; -0572; -0575). EPA 
determined that prohibiting the processing and distribution of PIP 
(3:1) for use in replacement parts is not practicable because PIP (3:1) 
is used to meet safety standards in new and replacement parts for 
automobiles and there is currently no feasible alternative. For those 
same reasons, EPA could not identify a time limit on the exclusion that 
would be practicable. Additional information is available in the 
Response to Comments document (Ref. 5).
    Requiring the automotive industry to reformulate or redesign 
replacement parts for vehicle models currently on the market or 
vehicles no longer being manufactured is not practicable because of the 
safety concerns recognized in Unit III.A.4. Most importantly, any 
restriction on new and replacement parts for the automotive industries 
could increase costs and safety concerns.
    5. New and replacement parts for aerospace vehicles.
    In addition to the exclusion outlined in Unit III.A.4., in this 
final rule, EPA is broadening the scope of the exclusion from the 
proposed processing and distribution in commerce prohibitions to 
include processing and distribution in commerce of PIP (3:1) for use in 
new and replacement parts for aerospace vehicles and processing and 
distribution in commerce of PIP (3:1)-containing new and replacement 
parts for aerospace vehicles. Numerous commenters noted that many of 
the same challenges outlined for automobiles apply equally, if not more 
so, for aerospace vehicles. As noted by the commenters, the aerospace 
sector faces challenges similar to the automotive industry, including a 
multi-tiered international supply chain, strict safety standards, and 
the absence of feasible alternatives for these uses and costs. An 
airplane may be in use for 20 years and will need replacement parts to 
maintain airworthiness (EPA-HQ-OPPT-2019-0080-0545). As with the 
automotive sector, restrictions on new and replacement parts for the 
aerospace industries could increase costs and safety concerns. 
Therefore, EPA is finalizing an exclusion from the proposed processing 
and distribution in commerce prohibitions that includes processing and 
distribution in commerce of PIP (3:1) for use in new and replacement 
parts for aerospace vehicles and processing and distribution in 
commerce of PIP (3:1)-containing new and replacement parts for 
aerospace vehicles.
    6. Adhesives and sealants.
    In the proposal, EPA did not exclude processing or distribution in 
commerce of PIP (3:1) for use in adhesives and sealants or processing 
or distribution in commerce of PIP (3:1)-containing adhesives and 
sealants from the prohibitions on processing and distribution, except 
under those circumstances where an adhesive is part of a new or 
replacement part for an automobile. EPA received numerous comments 
requesting clarification or modification of the proposed regulations 
relative to adhesives. Based on those comments, in the final rule, EPA 
has added an exclusion from the processing and distribution 
prohibitions for the processing and distribution of PIP (3:1) when used 
in a closed system as an intermediate in the production of 
cyanoacrylate adhesives, and additionally delayed the compliance date 
for the prohibitions on the processing and distribution in commerce of 
PIP (3:1) for use in any type of adhesives and sealants and the 
processing and distribution in commerce of PIP (3:1)-containing 
adhesives and sealants, from 60 days to four years.
    Two commenters identified PIP (3:1)'s use as an intermediate in the 
production of cyanoacrylate adhesives (EPA-HQ-OPPT-2019-0538; -0558). 
At the time of proposal, EPA believed there were feasible alternatives 
to PIP (3:1) for this use. However, EPA received additional information 
in a public comment to indicate that while some cyanoacrylate adhesives 
are made without PIP (3:1), PIP (3:1)'s use as an intermediate can be 
central to achieving properties necessary to meet performance standards 
for cyanoacrylates used in important applications including medical, 
military, automotive, and aerospace sectors. PIP (3:1) is not expected 
to be present in the final product since it is used as an intermediate, 
and the manufacturing of cyanoacrylate adhesives occurs in a closed 
system. Therefore, EPA is finalizing an exclusion from the prohibitions 
for the processing and distribution in commerce of PIP (3:1) for this 
use because, without a feasible alternative for these applications, it 
would be impracticable to prohibit.
    The proposed rule did not delay the compliance date beyond the 
rule's effective date; the processing and distribution bans would come 
into effect 60 days after publication of the final rule notice. EPA 
stated in the proposed rule that at that time it had no information 
indicating that a compliance date of 60 days after publication of the 
final rule is not practicable for the activities that would be 
prohibited, or that additional time is needed for products to clear the 
channels of trade. 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 this expedited 
rulemaking, 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 in 
stakeholder dialogues. Such a presumption ensures 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 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. Such presumption also allows for submission of information from 
the sources most likely to have the information that will 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.''
    For the prohibition on the processing and distribution in commerce 
of PIP (3:1) for use in adhesives and sealants, and the processing and 
distribution in commerce of PIP (3:1)-containing adhesives and sealants 
more broadly, EPA is delaying the compliance date of the prohibition 
for four years. A

[[Page 905]]

commenter noted that the 60-day compliance period does not allow 
adequate time to transition to alternatives and would effectively ban 
an adhesive (EPA-HQ-OPPT-2019-0080-0558). PIP (3:1) may act as a flame 
retardant within a formulation to meet industry flammability standards, 
and while alternatives are available, time is required to recertify new 
formulations to the required safety standards. The requested delay is 
within the bounds of time periods necessary to certify products to 
performance and safety standards in other sectors, including the 
automotive sector (EPA-HQ-OPPT-2019-0080-0036). Therefore, EPA agrees 
that more time is necessary to transition to available alternatives in 
the adhesives and sealants sector and will extend the compliance date 
of the restriction to four years from the publication of the final 
rule, which is ``as soon as practicable'' and provides a ``reasonable 
transition period,'' pursuant to TSCA section 6(d)(1), while reducing 
exposure ``to the extent practicable'' as required by TSCA section 
6(h)(4).
    EPA also clarifies that, regardless of the compliance date for the 
prohibition on the processing and distribution of PIP (3:1)-containing 
adhesives and sealants, processing and distribution of PIP (3:1) for 
use in adhesives and sealants in new or replacement parts for 
automobiles or aerospace and processing and distribution of such PIP 
(3:1)-containing adhesives and sealants are excluded from the general 
prohibition.
    7. Specialized engine air filters for marine and locomotive 
applications.
    In the proposal, EPA did not exclude processing or distribution in 
commerce of PIP (3:1) for use in specialized engine air filters for 
marine and locomotive applications from the prohibitions on processing 
and distribution. Based on a public comment (EPA-HQ-OPPT-2019-0080-
0569), in this final rule, EPA has added an exclusion from the 
processing and distribution prohibitions for the processing and 
distribution of PIP (3:1) when used in specialized engine air filters 
for marine and locomotive applications and the processing and 
distribution of such PIP (3:1)-containing engine air filters.
    The identified filters clean the combustion air intake for large, 
heavy duty industrial diesel engines, and prevent abrasive particles 
from entering the engines. The PIP (3:1) gel within the filters is the 
only identified substance able to self-extinguish in the event of 
sparks and to maintain its functionality at freezing temperatures. 
Based on information received in the comment, EPA believes that it 
would not be practicable to prohibit processing or distribution of PIP 
(3:1) for this use, due to the critical role of PIP (3:1) for the 
functionality of heavy duty industrial diesel engines important to the 
transportation sector, and the lack of alternatives currently in use or 
under development.
    8. Articles made from recycled plastics.
    In the proposed rule, EPA requested comment on the extent to which 
plastic articles containing PIP (3:1) are recycled and whether the 
recycling of such plastic, and the manufacture, processing, and 
distribution in commerce of plastic items made from such recycled 
plastic, should be specifically excluded from this rule. EPA received 
numerous comments either supporting or opposing such exclusion, and EPA 
received no substantive information pertaining to PIP (3:1)'s presence 
in recycled plastics. Therefore, EPA is excluding articles made from 
recycled plastics containing PIP (3:1) and to which no PIP (3:1) has 
been added from the prohibitions in this final rule. This exclusion 
will allow processing, distribution, and use of PIP (3:1) in recycled 
products, when no new PIP (3:1) has been added. EPA is excluding from 
the processing and distribution prohibitions the processing and 
distribution in commerce of articles and products made from recycled 
PIP (3:1) containing plastic that has no new PIP (3:1) added during the 
recycling process or added to the articles and products made from the 
recycled plastic. A prohibition on these processing and distribution 
activities would result in potentially very high costs associated with 
testing and compliance assurance with respect to all articles and, 
based on reasonably available information at this time, without 
meaningful exposure reductions. Because PIP (3:1)'s addition to 
plastics will be prohibited, with a certain exclusion, over time PIP 
(3:1) will decrease in plastics overall, and, it follows, in recycled 
plastics. Additional details are in the docket and the Response to 
Comments document (Ref. 5).
    9. Photographic printing articles.
    EPA received one comment requesting a TSCA section 6(g) critical 
use exemption for use of PIP (3:1) in photographic printing articles. 
PIP (3:1) is used as a solvent in photographic paper with commercial 
end uses in many sectors. Domestic manufacture and processing of PIP 
(3:1) for use in photographic printing articles was discontinued in 
October 2016 (Ref. 15). However, photographic printing articles 
containing PIP (3:1) are already in the channels of U.S. trade and are 
intended for import through October 2020, before the required 
promulgation of the TSCA section 6(h) final rule. As a result, the 
commenter requests additional time to allow for the continued 
processing and distribution in commerce of these articles. The 
commenter expects to cease import of articles containing PIP (3:1) and 
instead import the same product using an alternative to PIP (3:1) by 
October 1, 2020, and the shelf life and distribution period of existing 
stocks of articles is expected to be around 18 months (EPA-HQ-OPPT-
2019-0080-0584). Exposure is unlikely during processing and 
distribution, and an immediate prohibition would require the commenter 
to dispose of the product all at once thereby increasing the 
incremental exposure from the disposal of film articles. EPA agrees an 
immediate prohibition is not practicable. It is costly to require 
disposal of articles already in the channels of U.S. trade by the time 
the rule is finalized and made effective, including costs for removal, 
disposal, and replacement. In addition, such action has potential to 
increase exposure by concentrating disposals in times and space, as 
opposed to allowing the articles to complete their natural lifecycle 
and be disposed of over time. Therefore, EPA adds a compliance date of 
January 1, 2022, for the prohibition on processing and distribution in 
commerce of photographic printing articles, in order to allow time to 
permit existing stocks of articles to clear the channels of trade, 
which is ``as soon as practicable'' and provides a ``reasonable 
transition period,'' pursuant to TSCA section 6(d)(1), while reducing 
exposure ``to the extent practicable'' as required by TSCA section 
6(h)(4).
    10. Releases to water.
    EPA proposed to prohibit releases to water from the manufacturing, 
processing, distribution in commerce, and commercial use activities 
that are permitted to occur (e.g., use in hydraulic fluid, use in 
lubricants and greases, and use in new and replacement parts for the 
automotive industry). EPA is finalizing this proposal with some 
modification to accommodate the challenges of preventing releases to 
water during commercial use. Manufacturing, processing, and 
distribution of products containing PIP (3:1) takes place in contained 
environments, and sometimes even closed systems. These products also 
are used in the field. This is particularly true in the aviation 
sector. End uses of PIP (3:1) in hydraulic fluids and lubricants and 
greases are highly regulated, however, inadvertent releases

[[Page 906]]

of PIP (3:1) in the field are possible, for example, in wash-water from 
airplane parts, which may contain trace amounts of PIP (3:1) (EPA-HQ-
OPPT-2019-0080-0542; -0562). Although it is not reasonable to expect 
all release to be completely prevented during the kind of commercial 
use activities involving PIP (3:1)-containing products and therefore 
not practicable to prohibit such release, it is practicable to require 
best practices and following existing statutes and regulations (e.g., 
Oil Pollution Act, CWA) applicable to commercial uses (EPA-HQ-OPPT-
2019-0080-0562). As a result, EPA maintains that prohibiting, as 
proposed, releases to water from manufacturing, processing, and 
distribution in commerce is practicable. However, for commercial use, 
EPA modifies the final regulation to accommodate the challenge of 
compliance when unintentional releases of small or de minimis amounts 
of PIP (3:1)-containing fluid are possible during commercial use. The 
final rule requires all persons to follow existing regulations and best 
practices to prevent the release to water of PIP (3:1) and PIP (3:1)-
containing products during commercial use. Additionally, administrative 
and judicial procedures for addressing violations of restrictions under 
other programs consider good faith efforts to comply, including 
preventative and corrective actions, as well as root cause analyses to 
ascertain and rectify excess releases in the event of a violation.
    While in some cases EPA has determined that it is not practicable 
to exercise its section 6(a) authorities to regulate certain exposures 
under TSCA section 6(h), outlined in Unit II.F., this is not the case 
for releases of PIP (3:1) to water for formulated products and end 
uses. The formulated products and end uses of PIP (3:1) are highly 
regulated, though unintentional releases are possible. As discussed in 
this Unit, many regulatory restrictions on releases to water are 
administered by the EPA (e.g., Oil Pollution Act, CWA). As identified 
in the 2014 Update to the TSCA Work Plan for Chemical Assessment, PIP 
(3:1) was rated high (3) for aquatic toxicity, and high (3) for 
environmental persistence and bioaccumulation. Additionally, PIP (3:1) 
is used in emerging technologies where there are not yet available 
alternatives and has increasing production volume in some sectors. As a 
result, EPA has determined that a restriction on releases to water is 
appropriate in this case as it emphasizes and codifies the importance 
of best practices given these circumstances. Based on the above and 
comments on the proposed rule, EPA therefore maintains that it is 
practicable to require end users of products which contain PIP (3:1) to 
follow existing regulations and best practices to prevent the release 
to water of PIP (3:1) and PIP (3:1)-containing products during 
commercial use, and that codifying that requirement will highlight the 
importance of reducing environmental release of chemicals regulated by 
TSCA section 6(h), and reduce exposures that could occur.
    11. Downstream notification.
    Persons manufacturing, processing, and distributing PIP (3:1) and 
products containing PIP (3:1) will be required to notify their 
customers of these prohibitions on processing, distribution, and 
releases to water. EPA proposed the method of downstream notification 
was text inserted in sections 1 and 15 of the safety data sheet (SDS). 
Several commenters requested clarification on the downstream 
notification requirements or suggested changes to the proposed 
requirement. EPA clarifies in this final rule that the downstream 
notification requirement applies only to those scenarios where a 
product has an accompanying SDS.
    EPA is also including in this final rule, an alternative method of 
compliance for downstream notification. If a manufacturer, processor, 
or distributor chooses, they may include specified text on their label, 
instead of on their SDS. This alternative allows manufacturers, 
processors, and distributors to choose the manner of notification most 
appropriate for their customers and is not intended to broaden the 
scope of persons subject to the requirement.
    Lastly, based on comments received, EPA has delayed the compliance 
date for downstream notification from 60 days to 180 days for 
processors and distributors from the date of publication, in order to 
allow adequate time for the notices to make their way through the 
supply chain. This length of time would allow downstream processors and 
distributors to gather information from suppliers and incorporate it in 
SDSs, and is consistent with the grace period offered under the 
Registration, Evaluation, Authorisation and Restriction of Chemicals 
regulation in Europe (EPA-HQ-OPPT-2019-0080-0542). Manufacturers 
(including importers) of PIP (3:1) are still required to implement 
downstream notification within 60 days from the date of the 
publication. Excluded from the downstream notification requirement are 
articles made from recycled plastics as described in Unit III.A.8., as 
long as no new PIP (3:1) is added during the processing of recycled 
materials.
    12. Recordkeeping.
    EPA is requiring that all persons who manufacture, process, or 
distribute in commerce PIP (3:1) and articles and products containing 
PIP (3:1) maintain ordinary business records, such as invoices and 
bills-of-lading, that are related to compliance with the prohibitions 
and restrictions. EPA revised this language slightly from the proposal 
to improve clarity. These records will have to be maintained for a 
period of three years from the date the record is generated, beginning 
on March 8, 2021. Exempted from the recordkeeping requirement are 
articles made from recycled plastics, as described in Unit III.A.8., as 
long as no new PIP (3:1) is added during the processing of recycled 
materials. EPA requested comment on alternative recordkeeping 
requirements that could help ensure compliance with the regulatory 
prohibitions, particularly for importers and others who do not produce 
articles. After reviewing the comments received, EPA has decided to 
include two additional requirements to help ensure compliance (EPA-HQ-
OPPT-2019-0080-0539; -0542; -0546; -0549). First, the records that are 
kept must include a statement that the PIP (3:1), or the PIP (3:1)-
containing products or articles, are in compliance with 40 CFR 
751.407(a). The statement need not be included on every business 
record, such as every invoice or bill of lading, although regulated 
entities may certainly choose to reformat their documents to include 
the statement. For example, importers of replacement automobile parts 
that contain PIP (3:1) who import from the same suppliers over and over 
need only have a single statement for each part or each supplier. 
Finally, EPA is adding a requirement that the records kept pursuant to 
this final rule be made available to EPA within 30 calendar days upon 
request to ensure that EPA can review records in a timely manner.

B. TSCA Section 6(c)(2) Considerations

    1. Health effects, exposure, and environmental effects.
    PIP (3:1) is toxic to aquatic plants, aquatic invertebrates, 
sediment invertebrates and fish. Data indicate the potential for 
reproductive and developmental effects, neurological effects and 
effects on systemic organs, specifically adrenals, liver, ovary, and 
heart in mammals. These hazard statements are not based on a systematic 
review of the available literature and information may exist that could 
refine the hazard characterization. Additional

[[Page 907]]

information about PIP (3:1) health effects, use, and exposure is in 
Unit II.C. and is further detailed in EPA's Hazard Summary (Ref. 8) and 
Exposure and Use Assessment (Ref. 4).
    2. The benefits of the chemical substance or mixture for various 
uses.
    PIP (3:1) has multiple functional uses, including as a plasticizer, 
flame retardant, anti-wear additive, or as an anti-compressibility 
additive (Ref. 4). When PIP (3:1) is included in a formula, it is often 
for a combination of these functional uses; for example, as a flame 
retardant and an anti-wear additive. Additionally, PIP (3:1) is an 
isomer mixture, and through manufacturing, the proportion of various 
isomers can be manipulated to achieve specific properties which can 
affect the performance of a formula (Ref. 16). As an additional 
benefit, when used as an intermediate in the processing of 
cyanoacrylate glues, PIP (3:1) aids in the ability of these glues to 
meet the requisite performance standards for specialized markets (EPA-
HQ-OPPT-2019-0080-0538).
    3. The reasonably ascertainable economic consequences of the rule.
    i. Overview of cost methodology. EPA has evaluated the potential 
costs of the final action for PIP (3:1). Costs of the final rule were 
estimated based on the assumption that under regulatory limitations on 
PIP (3:1), processors that use PIP (3:1) in their products would switch 
to available alternative chemicals to manufacture the product, or to 
products that do not contain PIP (3:1). Substitution costs were 
estimated on the industry level using the price differential between 
the cost of the chemical product and identified substitutes. Costs for 
rule familiarization and recordkeeping were estimated based on burdens 
estimated for other similar rulemakings. Costs were annualized over a 
25-year period. Other potential costs include, but are not limited to, 
those associated with testing, reformulation, release prevention, 
imported articles, and some portion of potential revenue loss. However, 
these costs are discussed only qualitatively, due to lack of data 
availability to estimate quantified costs. More details of this 
analysis are presented in the Economic Analysis (Ref. 3).
    ii. Estimated costs of this final rule. Total quantified annualized 
industry costs for the final rule is $23.6 million at a 3% discount 
rate and $22.8 million at a 7% discount rate annualized over 25 years. 
Total annualized Agency costs associated with implementation of the 
final rule were based on EPA's best judgment and experience with other 
similar rules. For the final regulatory action, EPA estimates it will 
require 1 FTE at $155,152 per year (Ref. 3).
    Total quantified annualized social costs for the final rule are 
$23.8 million at a 3% discount rates, and $23.0 million at a 7% 
discount rate. As described earlier in Unit III.B.3, potential costs 
such as testing, reformulation, release prevention, and imported 
articles, could not be quantified due to lack of data availability to 
estimate quantified costs. These costs are discussed qualitatively in 
the Economic Analysis (Ref. 3).
    iii. Benefits. As discussed in Unit II.A. and the Response to 
Comments Document, 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. A qualitative discussion of the potential 
benefits associated with the final action for PIP (3:1) is provided. 
PIP (3:1) is a neurotoxicant and aquatic toxicant with high persistence 
and high potential for bioaccumulation. Under this final rule, PIP 
(3:1) is prohibited for processing and distribution in all uses except 
for those specifically excluded from the prohibition, as detailed in 
Unit I.C. Additionally, releases to water are prohibited during 
manufacturing, processing, and distribution, and are restricted during 
commercial use. EPA anticipates that these requirements will result in 
decreased potential for occupational exposures, decreased potential for 
PIP (3:1) releases, and reduce potential for exposures to the general 
population, potentially exposed or susceptible subpopulations, and the 
environment.
    iv. Cost effectiveness, and effect on national economy, small 
business, and technological innovation. With respect to the cost 
effectiveness of the final regulatory action and the primary 
alternative regulatory action, EPA is unable to perform a traditional 
cost-effectiveness analysis of the actions and alternatives for the PBT 
chemicals. As discussed in the proposed rule, the cost effectiveness of 
a policy option would properly be calculated by dividing the annualized 
costs of the option by a final outcome, such as cancer cases avoided, 
or to intermediate outputs such as tons of emissions of a pollutant 
curtailed. Without the supporting analyses for a risk determination, 
EPA is unable to calculate either a health-based or environment-based 
denominator. Thus, EPA is unable to perform a quantitative cost-
effectiveness analysis of the final and alternative regulatory actions. 
However, by evaluating the practicability of the final and alternative 
regulatory actions, EPA believes that it has considered elements 
related to the cost effectiveness of the actions, including the cost 
and the effect on exposure to the PBT chemicals of the final and 
alternative regulatory actions.
    EPA considered the anticipated effect of this rule on the national 
economy and concluded that this rule is highly unlikely to have any 
measurable effect on the national economy (Ref. 3). EPA analyzed the 
expected impacts on small business and found that no small entities are 
expected to experience impacts of more than 1% of revenues (Ref. 3). 
Finally, EPA has determined that this rule is unlikely to have 
significant impacts on technological innovation, although the rule may 
create some incentives for chemical manufacturers to develop new 
chemical alternatives to PIP (3:1).
    4. Consideration of alternatives.
    EPA believes there are viable substitutes for PIP (3:1), except for 
the specified processing and distribution in commerce activities 
excluded from the final rule. In addition, EPA conducted an analysis of 
three identified potential substitutes for PIP (3:1) based on the 
process described in the TSCA Work Plan Chemicals: Methods Document 
(Ref. 2). Those potential substitutes all scored lower than PIP (3:1) 
in at least one criterion, indicating lower concern for hazard, 
exposure, or bioaccumulation/persistence. The economic feasibility of 
alternatives for all activities other than those excluded from the 
final rule is discussed in the Economic Analysis (Ref. 3).

C. TSCA Section 26 Considerations

    In accordance with TSCA section 26(h) and taking into account the 
requirements of TSCA section 6(h), EPA has used scientific information, 
technical procedures, measures, and methodologies that are fit for 
purpose and consistent with the best available science. For example, 
EPA based its determination that human and environmental exposures are 
likely with PIP (3:1) on the Exposure and Use Assessment (Ref. 4) 
discussed in Unit II.A.2., which underwent a peer review and public 
comment process, as well as using best available science and methods 
sufficient to make that determination. The extent to which the various 
information, procedures, measures, and methodologies, as applicable, 
used in EPA's decision making have been subject to independent 
verification or peer review

[[Page 908]]

is adequate to justify their use, collectively, in the record for this 
rule. Additional information on the peer review and public comment 
process, such as the peer review plan, the peer review report, and the 
Agency's Response to Comments document, are in the public docket for 
the peer review (Docket ID Number EPA-HQ-OPPT-2018-0314). In addition, 
in accordance with TSCA section 26(i), and taking into account the 
requirements of TSCA section 6(h), EPA has made scientific decisions 
based on the weight of the scientific evidence.

IV. References

    The following is a list of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. 
October 2014. https://www.epa.gov/assessingand-managing-chemicals-under-tsca/tsca-work-plan-chemical-ssessments-2014-update. Accessed 
March 1, 2019.
2. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012. 
https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Accessed March 1, 2019.
3. EPA. Economic Analysis for Regulation of Phenol, isopropylated 
phosphate (3:1) (PIP (3:1)) Under TSCA Section 6(h). December 2020.
4. EPA. Exposure and Use Assessment of Five Persistent, 
Bioaccumulative, and Toxic Chemicals. December 2020.
5. EPA. Regulation of Persistent, Bioaccumulative, and Toxic 
Chemicals under TSCA Section 6(h), Response to Public Comments. July 
2020.
6. EPA. Public Database 2012 Chemical Data Reporting.
7. EPA. Public Database 2016 Chemical Data Reporting.
8. EPA. Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals. December 2020.
9. International Union of Pure and Applied Chemistry. Compendium of 
Chemical Terminology, 2nd ed. (the ``Gold Book''). Compiled by A. D. 
McNaught and A. Wilkinson. Blackwell Scientific Publications, Oxford 
(1997). Online version (2019-) created by S. J. Chalk. ISBN 0-
9678550-9-8. https://doi.org/10.1351/goldbook. Search terms: 
``Isomer'' and ``congener.''
10. EPA. (2015). TSCA New Chemicals Review Program Standard Review 
Assessment on Medium-Chain Chlorinated Parafins (PMN P-12-0282, P-
12-0283) and Long-Chain Chlorinated Parafins (PMN P-12-0284). 
December 22, 2015. https://www.epa.gov/sites/production/files/2015-12/documents/dover_-_standard_review_risk_assessment_p-12-0282-0284_docket_0.pdf. Accessed March 1, 2019.
11. EPA. Stakeholder Meeting with Akin Gump. September 27, 2018. EPA 
Docket ID EPA-HQ-OPPT-2019-0080.
12. EPA. Stakeholder Meeting with Boeing. May 2, 2018. EPA Docket ID 
EPA-HQ-OPPT-2019-0080.
13. U.S. Department of Defense. Detail Specification Hydraulic & 
Lubricating Oil, Synthetic Hydrocarbon Base. MIL-DTL-32353A (August 
24, 2012). Downloaded from https://quicksearch.dla.mil/qsSearch.aspx. December 8, 2020.
14. EPA. Instructions for Reporting 2016 TSCA Chemical Data 
Reporting. June 2016.
15. EPA. Stakeholder Meeting with Fujifilm. February 12, 2017. EPA 
Docket ID EPA-HQ-OPPT-2019-0080.
16. EPA. Stakeholder Meeting with ICL. August 30, 2018. EPA Docket 
ID EPA-HQ-OPPT-2019-0080.
17. Keweenaw Bay Indian Community. Re: Notification of Consultation 
and Coordination on a Rulemaking Under the Toxic Substances Control 
Act: Regulation of Persistent, Bioaccumulative, and Toxic Chemicals 
Under TSCA Section 6(h). September 25, 2018.
18. Harper, Barbara and Ranco, Darren, in collaboration with the 
Maine Tribes. Wabanaki Traditional Cultural Lifeways Exposure 
Scenario. July 9, 2009.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review under Executive 
Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 
(76 FR 3821, January 21, 2011). Any changes made in response to OMB 
recommendations have been documented in the docket for this action as 
required by section 6(a)(3)(E) of Executive Order 12866.
    EPA prepared an economic analysis of the potential costs and 
benefits associated with this action. A copy of this economic analysis, 
entitled Economic Analysis for Regulation of Phenol, isopropylated 
phosphate (3:1) (PIP (3:1)) Under TSCA Section 6(h) (Ref. 3) is in the 
docket and is briefly summarized in Unit III.B.3.

B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    This action is considered a regulatory action under Executive Order 
13771 (82 FR 9339, February 3, 2017). Details on the estimated costs of 
this final rule can be found in the Economic Analysis (Ref. 3), which 
is briefly summarized in Unit.III.B.3.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the PRA, 44 U.S.C. 3501 et seq. The Information Collection 
Request (ICR) document that the EPA prepared has been assigned EPA ICR 
number 2599.02 and OMB Control No. 2070-0213. A copy of the ICR is 
available in the docket for this rule, and it is briefly summarized 
here. The information collection requirements are not enforceable until 
OMB approves them.
    Respondents/affected entities: Entities potentially affected by 
paperwork requirements of this final rule include five manufacturers/
importers, 14 processors, and 13 distributors.
    Respondent's obligation to respond: Mandatory (40 CFR 751.407).
    Estimated number of respondents: 32.
    Frequency of response: On occasion.
    Total estimated burden: 36 hours (per year). Burden is defined at 5 
CFR 1320.3(b).
    Total estimated cost: $2,831 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves 
this ICR, the Agency will announce that approval in the Federal 
Register and publish a technical amendment to 40 CFR part 9 to display 
the OMB control number for the approved information collection 
activities contained in this final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The small entities subject to the requirements of 
this action are small businesses that manufacture/import, process, or 
distribute PIP (3:1). In total, four small businesses are expected to 
be

[[Page 909]]

affected by the final action. Of the four small entities assessed, none 
(0%) are expected to experience impacts of more than 1% of revenues. 
Because only four small businesses are directly impacted and impacts 
are less than 1% for all small entities, EPA presumes no significant 
economic impact on a substantial number of small entities (no SISNOSE). 
Details of this analysis are presented in the Economic Analysis (Ref. 
3).

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and will not 
significantly or uniquely affect small governments. The final rule is 
not expected to result in expenditures by State, local, and Tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more (when adjusted annually for inflation) in any one year. 
Accordingly, this final rule is not subject to the requirements of 
sections 202, 203, or 205 of UMRA. The total quantified annualized 
social costs for this final rule are approximately $23.8 million at a 
3% discount rates, and $23.0 million at a 7% discount rate, which does 
not exceed the inflation-adjusted unfunded mandate threshold of $160 
million.

F. Executive Order 13132: Federalism

    This action does not have federalism implications because it is not 
expected to have substantial direct effects on the states, on the 
relationship between the national government and the states, or on the 
distribution of power and responsibilities among the various levels of 
government as specified in Executive Order 13132 (64 FR 43255, August 
10, 1999). Thus, Executive Order 13132 does not apply to this action.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications because it is not 
expected to have substantial direct effects on tribal governments, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes as specified in Executive Order 
13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does 
not apply to this final rule.
    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, EPA consulted with tribal officials during the 
development of this action. EPA consulted with representatives of 
Tribes via teleconference on August 31, 2018, and September 6, 2018, 
concerning the prospective regulation of the five PBT chemicals under 
TSCA section 6(h).
    Tribal members were encouraged to provide additional comments after 
the teleconferences. EPA received two comments from the Keweenaw Bay 
Indian Community and Maine Tribes (Refs. 17 and 18).

H. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not an economically significant 
regulatory action as defined by Executive Order 12866. Although the 
action is not subject to Executive Order 13045, the Agency considered 
the risks to infants and children under EPA's Policy on Evaluating 
Health Risks to Children. EPA did not perform a risk assessment or risk 
evaluation of PIP (3:1), however available data indicate the potential 
for reproductive and developmental effects from PIP (3:1). More 
information can be found in the Exposure and Use Assessment (Ref. 4) 
and the ``Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals'' (Ref. 8). This regulation will 
reduce exposure to PIP (3:1) for the general population and for 
potentially exposed or susceptible subpopulations such as workers and 
children.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy and has not otherwise been designated by 
the Administrator of the Office of Information and Regulatory Affairs 
as a significant energy action.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve any technical standards. 
Therefore, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to 
this action.

K. 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 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). The 
documentation for this decision is contained in the Economic Analysis 
(Ref. 3), which is in the public docket for this action.

L. 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 40 CFR Part 751

    Environmental protection, Chemicals, Export Notification, Hazardous 
substances, Import certification, Reporting and recordkeeping.

Andrew Wheeler,
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.  751.403 by adding in alphabetical order the terms 
``Lubricants and grease'' and ``PIP (3:1)'' to read as follows:


Sec.  751.403   Definitions.

* * * * *
    Lubricants and grease mean any product used to reduce friction, 
heat, or wear between moving or adjacent solid surfaces, or that 
enhance the lubricity of other substances.
    PIP (3:1) means the chemical substance phenol, isopropylated 
phosphate (3:1) (CASRN 68937-41-7).
* * * * *

0
3. Add Sec.  751.407 to read as follows:


Sec.  751.407   PIP (3:1).

    (a) Prohibitions. (1) General. Except as provided in paragraphs 
(a)(2) and (b) of this section, all persons are prohibited from all 
processing and distributing in commerce of PIP (3:1), including in PIP 
(3:1)-containing products or articles after March 8, 2021.
    (2) Phase-in Prohibitions for Specific uses of PIP (3:1) and PIP 
(3:1)-containing products and articles. (i) After January 6, 2025, all 
persons are

[[Page 910]]

prohibited from all processing and distributing in commerce of PIP 
(3:1) for use in adhesives and sealants, PIP (3:1)-containing products 
for use in adhesives and sealants, and PIP (3:1)-containing adhesives 
and sealants.
    (ii) After January 1, 2022, all persons are prohibited from all 
processing and distributing in commerce of PIP (3:1) for use in 
photographic printing articles and PIP (3:1)-containing photographic 
printing articles.
    (b) Exclusions. The following activities are not subject to the 
prohibitions in paragraph (a) of this section.
    (1) Processing and distribution in commerce of:
    (i) PIP (3:1) for use in hydraulic fluids either for the aviation 
industry or to meet military specifications for safety and performance 
where no alternative chemical is available that meets U.S. Department 
of Defense specification requirements, PIP (3:1)-containing products 
for use in such hydraulic fluids, and PIP (3:1)-containing 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.
    (ii) PIP (3:1) for use in lubricants and greases, PIP (3:1) 
containing products for use in lubricants and greases, and PIP (3:1)-
containing lubricants and greases.
    (iii) PIP (3:1) and PIP (3:1)-containing products for use in new 
and replacement parts for motor and aerospace vehicles, the new and 
replacement parts to which PIP (3:1) has been added for such vehicles, 
and the motor and aerospace vehicles that contain new and replacement 
parts to which PIP (3:1) has been added;
    (iv) PIP (3:1) and PIP (3:1)-containing products for use as an 
intermediate in a closed system to produce cyanoacrylate adhesives;
    (v) PIP (3:1) for use in specialized engine air filters for 
locomotive and marine applications, PIP (3:1) containing products for 
use in specialized engine air filters for locomotive and marine 
applications, and PIP (3:1)-containing specialized engine air filters 
for locomotive and marine applications;
    (vi) Plastic for recycling from products or articles containing PIP 
(3:1), where no new PIP (3:1) is added during the recycling process; 
and
    (vii) Finished products or articles made of plastic recycled from 
products or articles containing PIP (3:1), where no new PIP (3:1) was 
added during the production of the products or articles made of 
recycled plastic.
    (2) Reserved.
    (c) Prohibition on releases to water. After March 8, 2021, all 
persons are prohibited from releasing PIP (3:1) to water during 
manufacturing, processing and distribution in commerce of PIP (3:1) and 
PIP (3:1) containing products, and all persons are required to follow 
all applicable regulations and best management practices for preventing 
the release of PIP (3:1) and PIP (3:1)-containing products to water 
during commercial use.
    (d) Recordkeeping. (1) After March 8, 2021, persons who 
manufacture, process, or distribute in commerce PIP (3:1) or PIP (3:1)-
containing products or articles must maintain ordinary business 
records, such as invoices and bills-of-lading, related to compliance 
with the prohibitions, restrictions, and other provisions of this 
section. These records must be maintained for a period of three years 
from the date the record is generated.
    (2) These records must include a statement that the PIP (3:1), or 
the PIP (3:1)-containing products or articles, are in compliance with 
40 CFR 751.407(a).
    (3) These records must be made available to EPA within 30 calendar 
days upon request.
    (4) The recordkeeping requirements in this paragraph (d)(1) do not 
apply to the activities described in paragraphs (b)(1)(vi) and (vii) of 
this section.
    (e) Downstream notification. (1) Each person who manufactures PIP 
(3:1) for any use after March 8, 2021 must, prior to or concurrent with 
the shipment, notify persons to whom PIP (3:1) is shipped, in writing, 
of the restrictions described in this subpart.
    (2) Each person who processes or distributes in commerce PIP (3:1) 
or PIP (3:1)-containing products for any use after July 6, 2021 must, 
prior to or concurrent with the shipment, notify persons to whom PIP 
(3:1) is shipped, in writing, of the restrictions described in this 
subpart.
    (3) Notification must occur by inserting the text in paragraphs 
(e)(3)(i) and (e)(3)(ii) in the Safety Data Sheet (SDS) or by including 
on the label of any PIP (3:1) or PIP (3:1)-containing product the label 
language in paragraph (e)(3)(iii):
    (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, 
and (6) in adhesives and sealants before January 6, 2025, after which 
use in adhesives and sealants 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, 
and (6) in adhesives and sealants before January 6, 2025, after which 
use in adhesives and sealants 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 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, 
and (6) in adhesives and sealants before January 6, 2025, after which 
use in adhesives and sealants 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

[[Page 911]]

regulations and best practices to prevent the release of PIP (3:1) to 
water during the commercial use of PIP (3:1).''
    (4) The downstream notification requirements in this paragraph (e) 
do not apply to the activities described in paragraphs (b)(1)(vi) and 
(vii) of this section.

[FR Doc. 2020-28692 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P