894 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

■ 2. Amend § 751.403 by adding in 

alphabetical order the term ‘‘DecaBDE’’ 

to read as follows: 

Subpart E—Persistent, 

Bioaccumulative, and Toxic Chemicals 

§ 751.403 Definitions. 

* * * * * 

DecaBDE means the chemical 

substance decabromodiphenyl ether 

(CASRN 1163–19–5). 

* * * * * 

■ 3. Add § 751.405 to read as follows: 

§ 751.405 DecaBDE. 

(a) Prohibition. (1) General. Except as 

provided in paragraphs (a)(2) and (b) of 

this section, all persons are prohibited 

from all manufacturing and processing 

of decaBDE or decaBDE-containing 

products or articles after March 8, 2021, 

and all persons are prohibited from all 

distribution in commerce of decaBDE or 

decaBDE-containing products or articles 

after January 6, 2022. 

(2) Phase-in of Prohibitions for 

Specific Uses of decaBDE and decaBDEcontaining Products or Articles. (i) After 

July 6, 2022, all persons are prohibited 

from all manufacturing, processing, and 

distribution in commerce decaBDE for 

use in curtains in the hospitality 

industry, and the curtains to which 

decaBDE has been added. 

(ii) After January 6, 2023, all persons 

are prohibited from all processing and 

distribution in commerce of decaBDE 

for use in wire and cable insulation in 

nuclear power generation facilities, and 

decaBDE-containing wire and cable 

insulation. 

(iii) After January 8, 2024, all persons 

are prohibited from all manufacturing, 

processing, and distribution in 

commerce of decaBDE for use in parts 

installed in and distributed as part of 

new aerospace vehicles, and the parts to 

which decaBDE has been added for such 

vehicles. After the end of the aerospace 

vehicles service lives, all persons are 

prohibited from all importing, 

processing, and distribution in 

commerce of aerospace vehicles 

manufactured before January 8, 2024 

that contain decaBDE in any part. After 

the end of the aerospace vehicles service 

lives, all persons are prohibited from all 

manufacture, processing and 

distribution in commerce of decaBDE 

for use in replacement parts for 

aerospace vehicles, and the replacement 

parts to which decaBDE has been added 

for such vehicles. 

(iv) After the end of the vehicles 

service lives or 2036, whichever is 

earlier, all persons are prohibited from 

all manufacture, processing and 

distribution in commerce of decaBDE 

for use in replacement parts for motor 

vehicles, and the replacement parts to 

which decaBDE has been added for such 

vehicles. 

(v) After the end of the pallets’ service 

life, all persons are prohibited from all 

distribution in commerce of plastic 

shipping pallets that contain decaBDE 

and were manufactured prior March 8, 

2021. 

(b) Exclusions to the Prohibition. 

Processing and distribution in 

commerce for recycling of decaBDEcontaining plastic from products or 

articles and decaBDE-containing 

products or articles made from such 

recycled plastic, where no new decaBDE 

is added during the recycling or 

production processes is not subject to 

the prohibition in paragraph (a) of this 

section. 

(c) Recordkeeping. (1) After March 8, 

2021, all persons who manufacture, 

process, or distribute in commerce 

decaBDE or decaBDE-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. 

(i) These records must be maintained 

for a period of three years from the date 

the record is generated. 

(ii) These records must include a 

statement that the decaBDE or the 

decaBDE-containing products or articles 

are in compliance with 40 CFR 

751.405(a). 

(iii) These records must be made 

available to EPA within 30 calendar 

days upon request. 

(2) The recordkeeping requirements in 

paragraph (c)(1) do not apply to the 

activities described in paragraphs 

(a)(2)(v) and (b) of this section. 

[FR Doc. 2020–28686 Filed 1–5–21; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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, 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 895 

Washington, DC 20460–0001; telephone 

number: (202) 564–3199; email address: 

feustel.ingrid@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

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 


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896 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

‘‘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-riskchildren) 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 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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 


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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 


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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, antiwear 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). 


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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 nonhazardous 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. Nonhazardous 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 


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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 


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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. 


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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 nonaviation 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 nonaviation 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 


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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 nongovernmental 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 multitiered 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 


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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 


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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 


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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 costeffectiveness 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 


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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/assessingandmanaging-chemicals-under-tsca/tscawork-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/lawsregulations-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 


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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 

■ 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). 

■ 2. Amend § 751.403 by adding in 

alphabetical order the terms ‘‘Lubricants 

and grease’’ and ‘‘PIP (3:1)’’ to read as 

follows: 

§ 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). 

* * * * * 

■ 3. Add § 751.407 to read as follows: 

§ 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 


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910 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

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 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 751 

[EPA–HQ–OPPT–2019–0080; FRL–10018– 

89] 

RIN 2070–AK60 

Pentachlorothiophenol (PCTP); 

Regulation of Persistent, 

Bioaccumulative, and Toxic Chemicals 

Under TSCA Section 6(h) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency is finalizing a rule under the 

Toxic Substances Control Act (TSCA) to 

address its obligations under TSCA for 

pentachlorothiophenol (PCTP) (CASRN 

133–49–3), which EPA has determined 

meets the requirements for expedited 

action under TSCA. This final rule 

prohibits all manufacturing (including 

import), processing, and distribution in 

commerce of PCTP and PCTPcontaining products or articles for any 

use, unless PCTP concentrations are at 

or below 1% by weight. This rule will 

result in lower amounts of PCTP being 

manufactured, processed, and 

distributed, which will impact the 

amount that will be available for use or 

disposal, thus reducing the 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: Brooke 

Porter, Existing Chemical Management 

Division, Office of Pollution Prevention 

and Toxics, (7404T), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–6388; 

email address: porter.brooke@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

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 

pentachlorothiophenol (PCTP) or 

products or articles that contain PCTP, 

especially rubber products. 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: 

• Sporting and Athletic Goods 

Manufacturing (NAICS Code 339920); 

• Sporting and Recreational Goods 

and Supplies Merchant Wholesale 

(NAICS Code 423910); 

• Sporting Goods Stores (NAICS Code 

451110); 

• All Other Rubber Product 

Manufacturing (NAICS Code 326299). 

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. PCTP 

(CASRN 87–86–5), primarily found as 

an impurity in the zinc salt of PCTP, is 

one such chemical substance. 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). 

TSCA section 6(h) directs EPA to take 

expedited action on these chemical 

substances, regardless of whether that 

substance is primarily found as an 

impurity or byproduct, to reduce 

exposure to the substance, including to 

exposure to the substance as an 

impurity or byproduct, to the extent 

practicable. 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 manufacture (including 

import), processing, and distribution in 

commerce of PCTP and products and 

articles containing PCTP, unless PCTP 

concentrations are at or below 1% by 

weight. Specifically, all persons are 

prohibited from all manufacturing and 

processing of PCTP or PCTP-containing 

products or articles, unless PCTP 

concentrations are at or below 1% by 

weight after March 8, 2021, and all 

persons are prohibited from all 

distribution in commerce of PCTP or 

PCTP-containing products or articles, 

unless PCTP concentrations are at or 

below 1% by weight after January 6, 

2022. In addition, after March 8, 2021, 

persons manufacturing, processing, and 

distributing in commerce PCTP and 

articles and products containing PTCP 

must maintain, for three years from the 

date the record is generated, ordinary 

business records related to compliance 

with the prohibitions and restrictions 

that include the name of the purchaser 

and list the products or articles. This 


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