Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 36728-36760 [2019-14022]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Proposed Rules]
[Pages 36728-36760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14022]



[[Page 36727]]

Vol. 84

Monday,

No. 145

July 29, 2019

Part III





Environmental Protection Agency





-----------------------------------------------------------------------





40 CFR Part 751





Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under 
TSCA Section 6(h); Proposed Rule

Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / 
Proposed Rules

[[Page 36728]]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2019-0080; FRL-9995-76]
RIN 2070-AK34


Regulation of Persistent, Bioaccumulative, and Toxic Chemicals 
Under TSCA Section 6(h)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing a rule to address certain persistent, 
bioaccumulative, and toxic chemicals identified pursuant to section 
6(h) of the Toxic Substances Control Act (TSCA). These five chemicals 
are: Decabromodiphenyl ether; phenol, isopropylated phosphate (3:1), 
also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-
butyl)phenol; hexachlorobutadiene; and pentachlorothiophenol. This 
proposed rule would restrict or prohibit manufacture (including 
import), processing, and distribution in commerce for many uses of four 
of these five chemical substances. EPA has evaluated the uses of 
hexachlorobutadiene and is proposing no regulatory action. For the 
other four, this proposal includes recordkeeping requirements. 
Additional downstream notification requirements are proposed for 
phenol, isopropylated phosphate (3:1).

DATES: Comments must be received on or before September 27, 2019. Under 
the Paperwork Reduction Act, comments on the information collection 
provisions are best assured of consideration if the Office of 
Management and Budget (OMB) receives a copy of your comments on or 
before August 28, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0080, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Cindy Wheeler, Chemical Control 
Division, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number (202) 566-0484; email address: 
[email protected]; or Peter Gimlin, National Program Chemicals 
Division, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-0515; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

    The information presented in this preamble is organized as follows:

I. Executive Summary
    A. Does this action apply to me?
    B. What is the Agency's authority for taking this action?
    C. What action is the Agency taking?
    D. Why is the Agency taking this action?
    E. What are the estimated incremental impacts of this action?
    F. What should I consider as I prepare my comments for EPA?
II. Background
    A. Why PBT Chemicals Are of Concern
    B. Overview of TSCA Sections 6(c) and 26 Considerations
    C. TSCA Section 6(h) and the 2014 Update to the TSCA Work Plan 
for Chemical Assessments
    D. Overview of the Chemicals Subject to This Proposed Action
    E. Exposure and Use Assessment and Hazard Summary
III. Regulatory Assessment of the PBT Chemicals
    A. Regulatory Approach
    B. DecaBDE
    C. PIP (3:1)
    D. 2,4,6-TTBP
    E. HCBD
    F. PCTP
IV. Reasonably Ascertainable Economic Consequences of the Proposed 
Rule
    A. Overview of Cost Methodology
    B. Estimated Costs of Proposed and Primary Alternative 
Regulatory Actions
    C. Benefits
V. References
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (FRA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

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 commercially 
use decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate 
(3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 
2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); 
or pentachlorothiophenol (PCTP) or products containing these chemicals, 
especially electronics, plastic products, additives, hydraulic fluids, 
or other industrial fluids. 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:
     Pipe, Duct and Boiler Insulation (NAICS Code 238290);
     Nonwoven Fabric Mills (NAICS Code 313230);
     Fabric Coating Mills (NAICS Code 313320);
     Petroleum Refineries (NAICS Code 324110);
     Petroleum Lubricating Oil and Grease Manufacturing (NAICS 
Code 324191);
     Petrochemical Manufacturing (NAICS Code 325110);
     Other Basic Inorganic Chemical Manufacturing (NAICS Code 
325180);
     All Other Basic Organic Chemical Manufacturing (NAICS Code 
325199);

[[Page 36729]]

     Plastics Material and Resin Manufacturing (NAICS Code 
325211);
     Paint and Coating Manufacturing (NAICS Code 325510);
     Adhesive Manufacturing (NAICS Code 325520);
     Polish and Other Sanitation Good Manufacturing (NAICS Code 
325612);
     Custom Compounding of Purchased Resins (NAICS Code 
325991);
     All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS Code 325998);
     Unlaminated Plastics Film and Sheet (except Packaging) 
Manufacturing (NAICS Code 326113);
     Laminated Plastics Plate, Sheet (except Packaging), and 
Shape Manufacturing (NAICS Code 326130);
     Urethane and Other Foam Product (except Polystyrene) 
Manufacturing (NAICS Code 326150);
     All Other Plastics Product Manufacturing (NAICS Code 
326199);
     All Other Rubber Product Manufacturing (NAICS Code 
326299);
     Cement Manufacturing (NAICS Code 327310);
     Copper Rolling, Drawing, Extruding, and Alloying (NAICS 
Code 331420);
     Machinery Manufacturing (NAICS Code 333);
     Computer and Peripheral Equipment Manufacturing (NAICS 
Code 3341);
     Radio and Television Broadcasting and Wireless 
Communications Equipment Manufacturing (NAICS Code 334220);
     Other Communications Equipment Manufacturing (NAICS Code 
334290);
     Audio and Video Equipment Manufacturing (NAICS Code 
334310);
     Other Communication and Energy Wire Manufacturing (NAICS 
Code 335929);
     Motor Vehicle Manufacturing (NAICS Code 3361), e.g., 
automobile, aircraft, ship, and boat manufacturers and motor vehicle 
parts manufacturers;
     Other Motor Vehicle Parts Manufacturing (NAICS Code 
336390);
     Aircraft Manufacturing (NAICS Code 336411);
     Guided Missile and Space Vehicle Manufacturing (NAICS Code 
336414);
     Household and Institutional Furniture Manufacturing (NAICS 
Code 33712);
     Surgical Appliance and Supplies Manufacturing (NAICS Code 
339113);
     Sporting and Athletic Goods Manufacturing (NAICS Code 
339920);
     Doll, Toy, and Game Manufacturing (NAICS Code 33993);
     Automobile and Other Motor Vehicle Merchant Wholesalers 
(NAICS Code 423110);
     Motor Vehicle Supplies and New Parts Merchant Wholesalers 
(NAICS Code 423120);
     Furniture and Home Furnishing Merchant Wholesalers (NAICS 
Code 4232);
     Insulation Materials (except Wood) Merchant Wholesalers 
(NAICS Code 423330);
     Household Appliances, Electric Housewares, and Consumer 
Electronics Merchant Wholesalers (NAICS Code 423620);
     Sporting and Recreational Goods and Supplies Merchant 
Wholesalers (NAICS Code 423910);
     Toy and Hobby Goods and Supplies Merchant Wholesalers 
(NAICS Code 423920);
     Other Chemical and Allied Products Merchant Wholesalers 
(NAICS Code 424690);
     Farm Supplies Merchant Wholesalers (NAICS Code 424910);
     New Car Dealers (NAICS Code 441110);
     Boat Dealers (NAICS Code 441222);
     Automotive Parts and Accessories Stores (NAICS Code 
441310);
     Furniture Stores (NAICS Code 442110);
     All Other Home Furnishing Stores (NAICS Code 442299) ;
     Gasoline Stations with Convenience Stores (NAICS Code 
447110);
     Other Gasoline Stations (NAICS Code 447190);
     Children's and Infant's Clothing Stores (NAICS Code 
448130);
     Sporting Goods Stores (NAICS Code 451110);
     Hobby, Toy, and Game Stores (NAICS Code 451120)
     General Merchandise Stores (NAICS Code 452);
     Aircraft Maintenance and Repair Services (NAICS Code 
488190);
     All Other Consumer Goods Rental (NAICS Code 532289);
     Hazardous Waste Treatment and Disposal (NAICS Code 
562211);
     Solid Waste Combustors and Incinerators (NAICS Code 
562213);
     Marinas (NAICS Code 713930);
     General Automotive Repair (NAICS Code 811111).
    If you have any questions regarding the applicability of this 
proposed 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 proposed 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, with certain exceptions, 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) EPA published in 2012 (or a successor scoring 
system), and exposure to which is likely under the conditions of use. 
For the purposes of this proposed rule, these specific chemical 
substances are hereinafter collectively referred to as the PBT 
chemicals. TSCA section 6(a) regulatory requirements include: (1) 
Prohibit or otherwise restrict the manufacturing, processing, or 
distribution in commerce of such substances; (2) Prohibit or otherwise 
restrict manufacturing, processing, or distribution in commerce of such 
substances for particular uses or for uses in excess of a specified 
concentration; (3) Require minimum warning labels and instructions; (4) 
Require recordkeeping or testing; (5) Prohibit or regulate any manner 
or method of commercial use; (6) Prohibit or otherwise regulate any 
manner or method of disposal by a manufacturer, processor, or any other 
person who uses or disposes of the chemical for commercial purposes; 
and (7) Direct manufacturers and processors to give notice of the 
determination to distributors and the public and replace or repurchase 
substances. EPA must apply one or more of these requirements to the 
extent necessary to meet the TSCA section 6(h)(4) statutory standard, 
which is discussed in Unit II.C.

C. What action is the Agency taking?

    EPA is proposing to restrict or prohibit certain actions with 
respect to four of the five PBT chemicals subject to this rulemaking. 
As of the effective date of the final rule, affected persons would be 
required to maintain, for three years from the date the record is 
generated, ordinary business records that demonstrate compliance with 
the restrictions, prohibitions, and other requirements.
    The extent of exposure, the severity of the hazard, and thus the 
likely risk of these chemicals varies significantly. For example, the 
evidence suggests that human exposure to hexachlorobutadiene is very 
limited due in large part to the high waste treatment efficiencies 
achieved by the chemical manufacturers. Additionally, the amount and 
type of hazard information

[[Page 36730]]

varies substantially, from relatively well studied chemicals (e.g. 
decabromodiphenyl ether) to data-sparse chemicals (e.g., 
pentachlorothiophenol).
    1. Decabromodiphenyl ether. DecaBDE (Chemical Abstracts Registry 
Service Number (CASRN) 1163-19-5) is a flame retardant that has been 
widely used in textiles, plastics, adhesives, and polyurethane foam. 
For DecaBDE, this proposal would prohibit the manufacture (including 
import), processing, and distribution in commerce of DecaBDE, and 
articles and products to which DecaBDE has been added except for the 
following:
     Manufacture, processing, and distribution in commerce for 
use in parts for new aircraft and aerospace vehicles, and distribution 
in commerce of the new vehicles containing such parts, for a period of 
three years;
     Manufacture, processing, and distribution in commerce for 
use in curtains in the hospitality industry, and the distribution of 
the curtains themselves, for a period of 18 months;
     Manufacture, processing, and distribution in commerce for 
use in replacement parts for the automotive and aerospace industries, 
and distribution in commerce of the replacement parts themselves;
     Processing for recycling and distribution in commerce for 
recycling of plastic that contained DecaBDE before the plastic was 
recycled (i.e., the plastic to be recycled is from articles and 
products that were originally made with DecaBDE), so long as no new 
DecaBDE is added during the recycling process; and
     Processing and distribution in commerce of articles and 
products made from recycled plastic that contained DecaBDE before the 
plastic was recycled, so long as no new DecaBDE was added during the 
recycling process or to the articles and products made from the 
recycled plastic.
    2. Phenol, isopropylated phosphate (3:1). PIP (3:1) (CASRN 68937-
41-7) is a flame retardant, a plasticizer, and an anti-compressibility 
and anti-wear additive. It is used in lubricants and hydraulic fluids 
and in the manufacture of other compounds. For PIP (3:1), which is also 
known as tris(4-isopropylphenyl) phosphate, this proposal would 
prohibit processing and distribution in commerce of the chemical 
substance, 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 automobiles and other motor vehicles, and the 
distribution in commerce of the parts to which PIP (3:1) has been 
added.
    In addition, this rule would prohibit releases to water from the 
non-prohibited processing, distribution in commerce, and commercial use 
activities. Persons manufacturing, processing, and distributing PIP 
(3:1), and products containing PIP (3:1), in commerce would be required 
to notify their customers of these restrictions.
    3. 2,4,6-tris(tert-butyl)phenol. 2,4,6-TTBP (CASRN 732-26-3) is an 
antioxidant that can be used as a fuel additive or lubricant additive, 
as an intermediate in the manufacture of other compounds, and as a 
waste fuel. For 2,4,6-TTBP, this proposal would prohibit the 
distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-
TTBP in any container with a volume of less than 55 gallons for any 
use, in order to effectively prevent the use of 2,4,6-TTBP as a fuel 
additive or fuel injector cleaner by consumers and small commercial 
operations (e.g., automotive repair shops, marinas). It is EPA's intent 
that the 55-gallon container restriction will ensure the continued fuel 
additive or fuel injector cleaner use of this PBT only by commercial 
operators who have the capacity to protect their workers who may come 
into contact with 2,4,6-TTBP and whose workplaces are generally subject 
to the standards promulgated by the Occupational Safety and Health 
Administration (OSHA). This restriction also would prohibit processing 
and distribution in commerce of 2,4,6-TTBP, and products containing 
2,4,6-TTBP, for use as an oil or lubricant additive, regardless of 
container size.
    4. Hexachlorobutadiene. HCBD (CASRN 87-68-3) is produced as a 
byproduct in the production of chlorinated solvents and has also been 
used in the past as an absorbent for gas impurity removal and as an 
intermediate in the manufacture of rubber compounds. For HCBD, EPA has 
evaluated the uses of hexachlorobutadiene and is proposing no 
regulatory action for the reasons described in Unit III.E.
    5. Pentachlorothiophenol. PCTP (CASRN 133-49-3) is used in the 
manufacture of rubber compounds. For PCTP, this proposal would prohibit 
the manufacture (including import), processing, and distribution in 
commerce of PCTP, and products containing PCTP, unless in 
concentrations at or below 1% by weight.
    D. Why is the Agency taking this action?
    EPA is issuing this proposed rule to fulfill EPA's obligations 
under TSCA section 6(h) to take timely regulatory action on PBT 
chemicals--specifically, ``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.'' PBT chemicals remain in the environment for a 
significant period of time and can accumulate in biota. Congress 
directed EPA in TSCA section 6(h) to take expedited regulatory action 
for certain PBT chemicals. As required by the statute, the Agency is 
proposing risk management actions to reduce exposures to the PBT 
chemicals to the extent practicable for the general population, 
potentially exposed or susceptible subpopulations, and the environment. 
Although EPA did not make an affirmative determination that risks are 
presented by the five PBT chemicals due to the language of TSCA section 
6(h), this proposal nevertheless meets the standards of TSCA section 
6(h)(4).

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

    EPA has evaluated the potential costs of these proposed 
restrictions and prohibitions and the associated reporting and 
recordkeeping requirements. The ``Economic Analysis for Proposed 
Regulation of Persistent, Bioaccumulative, and Toxic Chemicals under 
TSCA section 6(h)'' (Economic Analysis) (Ref. 3), which is available in 
the docket, is discussed in Unit IV, and is briefly summarized here. 
Total quantified annualized social costs for the proposed rule under 
the proposed option are approximately $43.5 million (at both 3% and 7% 
discount rates). As discussed in more detail in Unit II.C., EPA did not 
perform risk evaluations for these chemical substances, nor did EPA 
develop quantitative risk estimates. Thus, EPA was not able to quantify 
the benefits of reducing human and environmental exposures to these PBT 
chemicals; therefore, the Economic Analysis (Ref. 3) qualitatively 
discusses the benefits of reducing exposure under the proposed option 
and the primary alternative regulatory action for the five PBT 
chemicals.

[[Page 36731]]

F. What should I consider as I prepare my comments for EPA?

    See the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets when preparing and submitting your comments. Do not submit 
CBI to EPA through regulations.gov or email. Clearly mark the part or 
all of the information that you claim to be CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    EPA requests comment on all aspects of this proposal, including the 
proposed regulatory actions for each of the PBT chemicals, the primary 
alternative regulatory actions, and any other options that EPA has 
considered or should consider. In particular, EPA is requesting comment 
on its proposed determinations with respect to whether exposure is 
likely and whether EPA's proposed regulatory actions achieve the 
statutory directives to ``address the risks of injury to health and the 
environment that the Administrator determines are presented by the 
chemical substance and [. . .] reduce exposure to the substance to the 
extent practicable.'' EPA also requests comment on all aspects of the 
Economic Analysis (Ref. 3) accompanying this action. In taking final 
action on this proposal, following review of comments, EPA may require 
exposure reductions beyond those proposed here, or may reduce the scope 
of the proposed exposure reductions.

II. Background

A. Why PBT Chemicals Are of Concern

    Toxic chemicals that persist and bioaccumulate are of concern 
because they remain in the environment for long periods of time and 
accumulate in the organisms exposed to them (i.e., can build up or 
concentrate in body tissue). A chemical's persistence refers to the 
length of time the chemical can exist in the environment before being 
degraded at rates that prevent substantial buildup of the parent 
chemical in the environment. Bioaccumulation is the net accumulation of 
a chemical by an aquatic organism as a result of uptake from all 
environmental sources. The term refers to both uptake of chemicals by 
aquatic species from water (bioconcentration) and from ingested food 
and sediment residues. PBT chemicals are toxic chemicals that are not 
removed from the environment at rates adequate to prevent exposure to 
aquatic or terrestrial organisms. Following exposure, PBT chemicals 
increase in concentration in the exposed organism's tissues relative to 
the concentrations in environmental media to which they are exposed. 
Chemicals that persist and bioaccumulate have been found in humans, 
other aquatic and terrestrial mammals, fish, shellfish, and birds.
    Biomagnification is the increase in concentration of a chemical in 
the tissue of organisms along a series of predator-prey associations, 
primarily through the mechanism of dietary accumulation and can be an 
additional characteristic of PBT chemicals. Biomagnification in food 
webs results in apex predators (e.g., eagles and orcas) being subject 
to higher exposures of PBT chemicals via food. When humans consume 
organisms from higher trophic levels (e.g., predator fish like tuna or 
swordfish), humans often have increased tissue concentrations of PBT 
chemicals due to biomagnification and therefore are exposed to 
increased concentrations of the chemical.

B. Overview of TSCA Sections 6(c) and 26 Considerations

    1. TSCA section 6(c)(2) considerations. TSCA section 6(c)(2) 
requires EPA to consider and publish a statement based on reasonably 
available information with respect to the:
     Health effects of the chemical substance or mixture and 
the magnitude of human exposure;
     Environmental effects of the chemical substance or mixture 
and the magnitude of exposure of the environment;
     Benefits of the chemical substance or mixture for various 
uses; and
     Reasonably ascertainable economic consequences of the 
rule, including: The likely effect of the rule on the national economy, 
small business, technological innovation, the environment, and public 
health; the costs and benefits of the proposed and final rule and of 
the one or more primary alternative regulatory actions that EPA 
considered; and the cost effectiveness of the proposed rule and of the 
one or more primary alternative regulatory actions that EPA considered.
    In addition, in selecting among prohibitions and other restrictions 
available under TSCA section 6(a), EPA must factor in, to the extent 
practicable, these considerations. Further, in deciding whether to 
prohibit or restrict in a manner that substantially prevents a specific 
condition of use of a chemical substance or mixture, and in setting an 
appropriate transition period for such action, EPA must also consider, 
to the extent practicable, whether technically and economically 
feasible alternatives that benefit health or the environment would be 
reasonably available as a substitute when the proposed prohibition or 
other restriction takes effect.
    EPA's summary of the health and environmental effects of and the 
potential for exposure to the five chemical substances subject to this 
action can be found in Unit II.E., which discusses the Exposure and Use 
Assessment (Ref. 4) and the Hazard Summary (Ref. 5).
    With respect to the costs and benefits of this proposal and the 
alternatives EPA considered, as well as the impacts on small 
businesses, the full analysis is presented in the economic analysis 
document (Ref. 3). Due to the lack of risk information, EPA was not 
able to quantify the benefits of this proposal and the alternatives. A 
qualitative discussion of the potential benefits associated with the 
proposed option for each chemical is provided in Unit IV.C. EPA 
requests comment on all aspects of the benefits attributable to this 
proposed action, including the impacts that the selection of 
substitutes for those uses proposed to be restricted or prohibited may 
have on the anticipated benefits.
    EPA considered the estimated costs to regulated entities as well as 
the cost to administer and enforce the options. EPA took into account 
reasonably available information about the functionality and 
performance efficacy of the regulatory options and the ability to 
implement the use of chemical substitutes or other alternatives. A 
discussion of the costs EPA considered can be found in Units IV.A. and 
IV.B., along with a discussion of the alternatives that EPA considered. 
In addition, a discussion of the impacts on small businesses can be 
found in Unit VI.D.
    With respect to the cost effectiveness of the proposed regulatory 
action and the primary alternative regulatory action, EPA is unable to 
perform a traditional cost-effectiveness analysis of the proposed 
actions and alternatives for the PBT chemicals. 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 proposed and 
alternative regulatory actions. However, by evaluating the

[[Page 36732]]

practicability of the proposed 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 proposed and alternative 
regulatory actions.
    With respect to the anticipated effects of this proposal on the 
national economy, EPA considered the number of businesses and workers 
that would be affected and the costs and benefits to those businesses 
and workers (Ref. 3).
    The benefits of the five PBT chemicals subject to this proposal for 
their various uses are discussed in Unit II.D. The technical 
feasibility, economic feasibility, and reasonable availability of 
alternatives that benefit health or the environment is discussed in 
Unit III., in the Economic Analysis (Ref. 3), and in the document 
entitled ``Persistence, Bioaccumulation, Environmental Hazard and Human 
Health Hazard Ratings for Alternatives to PBT Chemicals Proposed for 
Regulation'' (Ref. 5).
    The dates that the proposed restrictions would take effect are 
discussed in Unit III.
    Finally, with respect to this proposal's effect on technological 
innovation, EPA expects this action to spur innovation, not hinder it 
(Ref. 3). In most cases, a wide variety of alternatives are available 
for the uses that this proposal would prohibit or restrict.
    2. TSCA section 26 considerations. 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 proposed determination that human and 
environmental exposures are likely to the five PBT chemicals subject to 
this action on the Exposure and Use Assessment (Ref. 4) discussed in 
Unit II.E.1, 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 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, can be found in the public 
docket for this action (EPA-HQ-OPPT-2019-0080). In addition, in 
accordance with TSCA section 26(i), EPA has made scientific decisions 
based on the weight of the scientific evidence.

C. TSCA Section 6(h) and the 2014 Update to the TSCA Work Plan for 
Chemical Assessments

    1. TSCA sections 6(h) and 6(a). 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. More specifically, under TSCA section 6(h)(1)(A), 
the subject chemical substances 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 the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act became law.
    In addition, in order for a chemical substance to be subject to 
expedited action, TSCA section 6(h)(1)(B) states that EPA must find 
that exposure to the chemical substance under the conditions of use is 
likely to the general population or to a potentially exposed or 
susceptible subpopulation identified by the Administrator (such as 
infants, children, pregnant women, workers or the elderly), or to the 
environment on the basis of an exposure and use assessment conducted by 
EPA. EPA also considers consumers to be a potentially exposed or 
susceptible subpopulation for the purposes of this rule in addition to 
the groups identified in the statutory definition at TSCA section 
3(12), such as workers.
    For chemical substances subject to TSCA section 6(h), EPA must 
issue a proposed rule by June 22, 2019, and a final rule no later than 
18 months after the proposal is issued. The statute further provides 
that the Administrator shall not be required to conduct risk 
evaluations on chemical substances that are subject to TSCA section 
6(h)(1).
    TSCA section 6(a) prohibitions and other restrictions can include 
one or more, or a combination of, the following actions:
     A requirement either prohibiting or otherwise restricting 
the manufacturing, processing, or distribution in commerce of such 
substance or mixture, or limiting the amount of such substance or 
mixture which may be manufactured, processed, or distributed in 
commerce (TSCA section 6(a)(1)).
     A requirement either prohibiting or otherwise restricting 
the manufacture, processing, or distribution in commerce of such 
substance or mixture for (i) a particular use or (ii) a particular use 
in a concentration in excess of a level specified by the Administrator 
in the rule imposing the requirement, or limiting the amount of such 
substance or mixture which may be manufactured, processed, or 
distributed in commerce for (i) a particular use or (ii) a particular 
use in a concentration in excess of a level specified by the 
Administrator in the rule imposing the requirement (TSCA section 
6(a)(2)).
     A requirement that such substance or mixture or any 
article containing such substance or mixture be marked with or 
accompanied by clear and adequate minimum warnings and instructions 
with respect to its use, distribution in commerce, or disposal or with 
respect to any combination of such activities (TSCA section 6(a)(3)).
     A requirement that manufacturers and processors of such 
substance or mixture make and retain records of the processes used to 
manufacture or process such substance or mixture or monitor or conduct 
tests which are reasonable and necessary to assure compliance with the 
requirements of any rule applicable under this subsection (TSCA section 
6(a)(4)).
     A requirement prohibiting or otherwise regulating any 
manner or method of commercial use of such substance or mixture (TSCA 
section 6(a)(5)).
     A requirement prohibiting or otherwise regulating any 
manner or method of disposal of such substance or mixture, or of any 
article containing such substance or mixture, by its manufacturer or 
processor or by any other person who uses, or disposes of, it for 
commercial purposes (TSCA section 6(a)(6)).
     A requirement directing manufacturers or processors of 
such substance or mixture to give notice of such determination to 
distributors in commerce of such substance or mixture and, to the 
extent reasonably ascertainable, to other persons in possession of such 
substance or mixture or exposed to such substance or mixture, to give 
public notice of such determination, and to replace or repurchase such 
substance or mixture as elected by the person to which the requirement 
is directed. Prohibit or otherwise restrict the manufacturing,

[[Page 36733]]

processing, or distribution in commerce of such substances (TSCA 
section 6(a)(7)).
    TSCA section 6(h)(4) directs EPA, in selecting among the 
prohibitions and restrictions in section 6(a), 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 interprets 
the directive in TSCA section 6(h) regarding issuance of a TSCA section 
6(a) rule to require EPA to issue a rule to satisfy TSCA section 6(h) 
requirements, using the regulatory prohibitions and other restrictions 
identified in TSCA section 6(a)(1)-(7), applying other provisions of 
TSCA section 6 applicable to TSCA section 6(a) rules consistent with 
the direction in TSCA section 6(h), but not applying those provisions 
of TSCA section 6(c) that conflict with TSCA section 6(h), in the sense 
that those provisions assume the existence of a TSCA section 6(b) risk 
evaluation, whereas TSCA section 6(h)(2) specifically provides that EPA 
is not required to conduct a risk evaluation. EPA invites public 
comment on this interpretation and seeks input on other possible 
interpretations.
    2. Address risks and reduce exposure to the extent practicable. 
TSCA section 6(h)(1) through (4) requires EPA to issue a 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 began by compiling use information on each of the five PBT 
chemicals that EPA preliminarily determined met the criteria for 
expedited action. Separate use documents were developed for each of the 
five PBT chemicals and made available for public comment in August of 
2017 (Refs. 6, 7, 8, 9, and 10).
    EPA then conducted a review of available literature with respect to 
the PBT chemicals discussed in this proposal to identify, screen, 
extract, and evaluate exposure information reasonably available for 
each. The information gathered is presented in the document entitled 
``Exposure and Use Assessment of Five Persistent, Bioaccumulative and 
Toxic Chemicals'' (Exposure and Use Assessment) (Ref. 4). The exposure 
information presented in the Exposure and Use Assessment document was 
not intended to comprehensively discuss all possible nor use-specific 
exposure scenarios presented by the PBT chemicals evaluated, but rather 
to describe a broad range of potential exposures that would enable EPA 
to determine whether exposure to these PBT chemicals is likely for the 
purposes of TSCA section 6(h)(1)(B). The Exposure and Use Assessment 
was peer reviewed; the peer review comments and the Agency's responses 
can be found in the public docket at EPA-HQ-OPPT-2018-0314.
    In addition, EPA compiled hazard information on the five PBT 
chemicals discussed in this proposal. The information is presented in 
the document entitled ``Environmental and Human Health Hazards of Five 
Persistent, Bioaccumulative, and Toxic Chemicals'' (Hazard Summary) 
(Ref. 5). To create this document, which presents a limited summary of 
the hazards of these chemical substances, environmental and human 
health hazard data were compiled from various primary and secondary 
sources of reasonably available information. The information in the 
Hazard Summary does not represent an exhaustive literature review nor 
is it an analysis of relative importance or comparative dose-response 
among hazards. The hazard data are reported from the literature with no 
additional analysis or assessment.
    The information compiled by EPA in the Exposure and Use Assessment 
is useful in characterizing the exposures by these PBT chemicals. EPA 
identified and included available information about potentially exposed 
and susceptible subpopulations during the development of both the 
Exposure and Use Assessment (Ref. 4) and the Hazard Summary (Ref. 5).
    The statute provides that EPA shall: (1) ``Address the risks of 
injury to health or the environment that the Administrator determines 
are presented by the chemical substance'' and (2) ``reduce exposure to 
the substance to the extent practicable.'' (TSCA section 6(h)(4)). With 
respect to the first requirement, EPA reviewed the hazard and exposure 
information on the five PBT chemicals as described previously. While 
this information identified hazards and exposures for the PBT 
chemicals, the information for these five chemicals 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. EPA does not interpret 
TSCA section 6(h)(4), specifically the language directing EPA to 
``address the risks of injury to health or the environment that the 
Administrator determines are presented,'' to require EPA to determine, 
through a risk assessment or risk evaluation, whether risks are 
presented. EPA believes this reading gives EPA the flexibility Congress 
intended for issuance of an expedited rule for PBTs without compelling 
a risk evaluation to support this rulemaking. 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, the 
characterization is not definitive or comprehensive. Other information 
on these chemicals may exist in addition to the studies summarized in 
the Hazard Summary that could refine the characterization. EPA does not 
believe that a systematic review would change our proposed risk 
management determinations as TSCA section 6(h)(4) requires EPA to 
reduce exposure to the substance to the extent practicable, regardless 
of risk. EPA is seeking public comment on the decision not to pursue a 
systematic review for these five chemicals and the impact of this 
decision on the PBT rulemaking.
    As required by the statute, the Agency is proposing risk management 
actions to reduce exposures to the PBT chemicals to the extent 
practicable. Although EPA did not make an affirmative determination 
that risks are presented by the five PBT chemicals due to the language 
of TSCA section 6(h), this proposal nevertheless meets the standards of 
TSCA section 6(h)(4).
    With respect to the second requirement, 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 a consideration of certain other 
provisions in TSCA section 6. For example, TSCA section 6(c)(2)(A) 
provides a list of factors that EPA must consider in promulgating a 
rule under TSCA section 6(a), and EPA's statement on those factors can 
be found in Unit II.B. Those factors include the costs and benefits of 
the rule, along with the effects on health and the environment, the 
magnitude of human and environmental exposure, the benefits of the 
chemical substance for various uses, and other factors, such as the 
effect of the rule on the national economy, small business, and 
technological innovation. In addition, pursuant to TSCA section 
6(c)(2)(B), in selecting the appropriate TSCA section 6(a) regulatory 
approach to take, EPA is directed to ``factor in, to the extent 
practicable'' those same considerations. EPA invites public comment on 
the

[[Page 36734]]

factors that should be considered in determining whether a particular 
prohibition or restriction is practicable.
    3. The TSCA Work Plan for Chemical Assessments. The 2012 TSCA Work 
Plan Chemicals identified a list of chemicals for assessment by EPA 
(Ref. 11). The screening process for identifying these chemicals is 
described in the TSCA Work Plan Chemicals: Methods Document (Ref. 2). 
Chemicals were evaluated and received a score through the application 
of a numerical algorithm. This score was based on three 
characteristics: hazard, exposure, and potential for persistence/
bioaccumulation. Using this system, chemicals were sorted into one of 
four bins. Chemicals able to be scored on all three characteristics 
were scored as High (3), Moderate (2), or Low (1) based on their 
available information. The data used to determine the hazard score for 
each chemical were obtained through specified data sources (Ref. 2, 
Appendix A). The hazard data reviews on each chemical were not 
exhaustive and did not rise to the level of assessments. Chemicals were 
scored on the basis of readily available data, and no judgment was made 
concerning gaps in or completeness of the available data set for a 
given chemical. The hazard score was determined based on three hazard 
levels, and each hazard level had a corresponding hazard rank (High-3, 
Moderate-2, and Low-1). The concentration ranges or characteristics 
corresponding to each hazard level are identified in the TSCA Work Plan 
Chemicals: Methods Document (Ref. 2, pp. 8-9). The highest hazard rank 
score a chemical received for any single human health or environmental 
toxicity endpoint became its hazard score (Ref. 2).
    Persistence scoring consisted of the evaluation of the potential 
half-life in air, water, soil, and sediment while considering the 
expected partitioning characteristics of the chemicals and all 
potential removal pathways based on standard physical-chemical 
properties and environmental fate parameters. Specified data sources 
(Ref. 2, Appendix B) were searched to locate studies on biotic and 
abiotic transformation (e.g., biodegradation, hydrolysis, photolysis) 
to estimate half-lives for the chemicals in the environment. 
Bioaccumulation scoring consisted of evaluation of bioaccumulation/
bioconcentration (measured or estimated BAF/BCF) data. When BAF data 
were not available, bioconcentration data (measured or estimated) were 
used to evaluate the potential for a chemical to bioaccumulate in 
organisms in the environment. In the absence of test data establishing 
the chemical's measured persistence or bioaccumulation potential, EPA 
used its EPI SuiteTM model to derive a ranking for the 
chemical (Ref. 2).
    Scores were assigned independently for persistence potential and 
bioaccumulation potential; the independent scores were added together 
to derive a single score for persistence/bioaccumulation. Chemicals 
with a combined score of 5-6 were scored as High (3) for persistence/
bioaccumulation, a combined persistence and bioaccumulation score of 3-
4 was scored as Moderate (2), and a combined score of 1-2 was scored as 
Low (1). Chemicals with High or Moderate hazard or persistence/
bioaccumulation scores that could not be scored for exposure because of 
an absence of data, together with chemicals that could not be scored 
for hazard, were identified separately as potential candidates for 
information gathering. In 2014, EPA applied the screening process for 
exposure information described in the TSCA Work Plan Chemicals: Methods 
Document (Ref. 2) to update its list of chemicals on the TSCA Work Plan 
for Chemical Assessments. This update focused primarily on updating the 
exposure score to reflect updated industry data submitted to EPA 
through the Toxics Release Inventory (TRI) (40 CFR part 372) in 2011 
and the TSCA Chemical Data Reporting (CDR) rule (40 CFR part 711) in 
2012 on chemical releases and potential exposures, respectively. The 
2014 Update to the TSCA Work Plan for Chemical Assessments included a 
list of 90 chemicals and chemical categories; the TSCA amendments 
passed in 2016 as part of the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act reference the 2014 Update to the TSCA Work Plan 
for Chemical Assessments in several places, including TSCA section 
6(h).
    In accordance with TSCA section 6(h)(1), chemical substances that 
meet the criteria described therein are subject to expedited rulemaking 
without the risk evaluations required for other TSCA Work Plan 
chemicals prior to initiating TSCA section 6(a) risk management 
actions. EPA interprets the TSCA section 6(h)(1)(A) provision 
pertaining to chemical substances ``that the Administrator has a 
reasonable basis to conclude are toxic,'' as referring to the toxicity 
score identified in the 2014 Update to the TSCA Work Plan for Chemical 
Assessments, and likewise focused on toxicity scores of high or 
moderate. In addition, EPA conducted the screening level literature 
search described in the peer-reviewed Hazard Summary to provide 
additional information and support for the hazard score assigned to 
these five chemicals in the 2014 Update to the TSCA Work Plan for 
Chemical Assessments. The information EPA has collected and reviewed in 
developing this proposal provides no basis to call into question the 
scoring for persistence, bioaccumulation, and toxicity performed in 
2014 for these five PBT chemicals pursuant to the screening process 
described in the TSCA Work Plan Chemicals: Methods Document.
    EPA is proposing to determine that five chemical substances meet 
the TSCA section 6(h)(1)(A) criteria for expedited action. These 
substances are: DecaBDE; PIP (3:1); 2,4,6-TTBP; HCBD; and PCTP.
    A manufacturer of two other chemical substances on the 2014 Update 
to the TSCA Work Plan for Chemical Assessments submitted a timely 
request to EPA for risk evaluations pursuant to TSCA section 6(h)(5). 
As a result of the request, these two chemicals: Ethanone, 1-
(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl) and 
Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-
naphthalenyl) are excluded from this proposed rule (Ref. 12).
D. Overview of the Chemicals Subject to This Proposed Action
    The use information presented in this Unit is based on the EPA's 
review of the available information, as presented in the use documents 
developed for each of the PBT chemicals (Refs. 6, 7, 8, 9, and 10), as 
well as public comments on the use documents and other stakeholder 
input.
    1. Decabromodiphenyl ether (DecaBDE). (i) Use background: DecaBDE 
is used as an additive flame retardant in plastic enclosures for 
televisions, computers, audio and video equipment, textiles and 
upholstered articles, wire and cables for communications and 
electronics, and other applications (Ref. 6). DecaBDE is also used as a 
flame retardant for multiple applications in the aerospace and 
automotive industries, including replacement parts for aircraft and 
cars (Refs. 13 and 14). Examples of products that have been made with 
DecaBDE as a flame retardant include:
     Consumer products made of both hard and soft plastics, 
such as furniture and furnishings, foam in furniture or mattresses, 
computer casings, and other plastic products including toys and other 
children's products (such as play structures);
     Fabrics and textiles, such as apparel, furniture and 
furnishings,

[[Page 36735]]

curtains, and construction and building materials;
     Rubber articles, such as wire casings and other rubber 
articles; and
     Complex articles in road vehicles and other vehicles for 
passengers and goods, such as cars, trucks, and airplanes; and 
machinery and mechanical appliances.
    DecaBDE can also be found in plastic materials recycled from 
plastic products originally made with DecaBDE.
    EPA presented its initial research into DecaBDE uses in the August 
2017 ``Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal'' document on DecaBDE (Ref. 6). EPA 
received comments from 12 entities on the Preliminary Information 
document. EPA also communicated with dozens of companies, industry 
groups, chemical users, academic experts, states, and other 
stakeholders to identify and verify uses of DecaBDE (Ref. 6). These 
interactions and comments further informed EPA's understanding of the 
current status of uses for DecaBDE. Public comments and stakeholder 
meeting summaries are available in the public docket at EPA-HQ-OPPT-
2016-0724.
    In 2009, based on the EPA-Industry DecaBDE Phase-Out Initiative, 
domestic manufacturers and importers of commercially available DecaBDE 
agreed to voluntarily phase out the manufacture and import of the 
chemical no later than December 31, 2013 (Ref. 15). For the 2012 and 
2016 CDR periods, data reported to EPA indicate that five sites 
manufactured (including imported) DecaBDE in the United States between 
2011 and 2015 (Refs. 16 and 17). The total volume of DecaBDE 
manufactured (including imported) in the United States in 2011 was 
18,110,827 lbs (Ref. 16). For the 2016 reporting period, the total 
volume of DecaBDE manufactured (including imported) in the United 
States was 16,696,951 lbs in 2012, between 1,000,000 and 10,000,000 lbs 
in 2013, between 100,000 and 500,000 lbs in 2014, and between 500,000 
and 1,000,000 lbs in 2015. Actual production volume for years 2013 
through 2015 is claimed in CDR as confidential business information 
(Ref. 17). Data reported to EPA from TRI show a general decline of 
DecaBDE releases, with 259,102 lbs of total on- and off-site reported 
releases of DecaBDE from 24 sites in 2016, and 67,248 lbs of total on- 
and off-site reported releases of DecaBDE from 17 sites in 2017. Of 
these 17 sites, one site reported import of the chemical, 14 reported 
processing of DecaBDE, and at the other two sites the specific 
activities are unknown (Refs. 18 and 19). EPA requests comment as to 
why some companies are still processing and using DecaBDE despite 
phase-out initiatives and the availability of relatively inexpensive 
substitutes.
    (ii) What are the beneficial properties of DecaBDE for various 
uses? DecaBDE is a brominated flame retardant that has been added to 
plastics, textiles, and other materials. When fire occurs, DecaBDE and 
other polybrominated diphenyl ethers (PBDEs), are part of vapor-phase 
chemical reactions that interfere with the combustion process, thus 
delaying ignition and inhibiting the spread of fire. DecaBDE has been 
considered an economical flame retardant because relatively small 
quantities are necessary to be effective (Ref. 6).
    (iii) What are the 2014 Update to the TSCA Work Plan for Chemical 
Assessments scores for DecaBDE? DecaBDE scored high (3) for hazard 
(based on developmental effects in mammals and aquatic toxicity); high 
(3) for exposure (based on its use in textiles, plastics, and 
polyurethane foam; and information reported to CDR and TRI); and high 
(3) for persistence and bioaccumulation (based on high environmental 
persistence and high bioaccumulation potential). The overall screening 
score for DecaBDE was high (9).
    (iv) Regulatory actions pertaining to DecaBDE. DecaBDE is regulated 
as a PBT chemical by federal, state, and international agencies. They 
are briefly summarized in this unit. More detailed information can be 
found in the Economic Analysis (Ref. 3). In addition, the OSHA 
regulations discussed in Unit III.A apply to commercial and industrial 
workplaces.
    At the Federal level, under TSCA, DecaBDE was one of the chemical 
substances required to be tested for dioxin/furan contamination as 
outlined in 40 CFR part 766. DecaBDE manufacturing, processing, and use 
information is reportable under CDR (40 CFR part 711). Under the CDR 
rule, EPA collects basic exposure-related information on the types, 
quantities and uses of chemical substances produced domestically and 
imported into the U.S. Under TSCA section 8(e), manufacturers 
(including importers), processors, and distributors must immediately 
notify EPA if they obtain information that supports the conclusion that 
a chemical substance or mixture presents a substantial risk of injury 
to health or the environment. Four such notifications were received for 
DecaBDE between 1996 and 2002. Under the Emergency Planning and 
Community Right-to-Know Act (EPCRA), DecaBDE has been on the TRI list 
of reportable chemicals since 1988 (Ref. 20). TRI tracks the management 
of certain toxic chemicals that may pose a threat to human health and 
the environment. U.S. facilities in different industry sectors must 
report annually how much of each chemical is released to the 
environment or managed through recycling, energy recovery and 
treatment. A release of a chemical for TRI purposes means that it is 
emitted to the air or water, or placed in some type of land disposal.
    Several states have taken action on DecaBDE. In California, DecaBDE 
is listed as a candidate chemical by the Department of Toxic Substances 
Control and as a priority chemical through the California Environmental 
Contaminant Biomonitoring Program. Starting in 2020, California will 
also prohibit the use of flame retardants (including DecaBDE) above 
1000 parts per million (ppm) in children's products, mattresses, and 
upholstered furniture. Hawaii prohibits the manufacture, use, sale, and 
distribution of televisions, computers, upholstered furniture, 
mattresses, and mattress pads containing DecaBDE greater than 0.1% by 
weight. In Maine, DecaBDE is listed as a chemical of high concern; it 
is banned in the use of new shipping pallets (though recycled pallets 
are exempted), and manufacturers or distributors who use DecaBDE in 
certain children's products are required to report to the Department of 
Environmental Protection. In Maryland, the sale of products that 
contain more than 0.1% DecaBDE by mass is prohibited, though the 
recycling of articles containing DecaBDE is exempted. New Jersey and 
Pennsylvania include DecaBDE on their hazardous substances lists under 
right-to-know legislation. DecaBDE is one of Oregon's 66 high priority 
chemicals of concern for children's health. Vermont prohibits DecaBDE 
in certain home products and manufacturers using DecaBDE must report to 
the Vermont Health Department. Washington prohibits the use of DecaBDE 
in children's products, mattresses, electronics, and residential 
furniture (Ref. 3).
    International actions on DecaBDE include Australia listing it as a 
priority existing chemical, which requires the National Industrial 
Chemicals Notification and Assessment Scheme (NICNAS) to fully assess 
the human health and environmental risks of DecaBDE. The draft NICNAS 
report on DecaBDE was completed in May 2019. Canada added DecaBDE to 
its Prohibition of Certain Toxic Substances Regulation, which prohibits 
the

[[Page 36736]]

manufacture, use, sale, offer for sale, or import of DecaBDE unless 
present in a manufactured article. The European Member State Committee 
has identified DecaBDE as a Substance of Very High Concern due to its 
PBT chemical properties. The European Chemical Agency (ECHA) has 
prohibited the manufacture and use of DecaBDE (including in most 
articles at concentrations greater than 0.1% by weight) as of March 
2019 under Annex XVII to the Registration, Evaluation, Authorisation, 
and Restriction of Chemicals (REACH) regulation. DecaBDE is also listed 
as a persistent organic pollutant (POP) under the Stockholm Convention, 
which requires parties to take measures to eliminate production and use 
of the chemical (Ref. 3).
    2. Phenol, isopropylated phosphate (3:1) (PIP (3:1). (i) Use 
background: PIP (3:1) is used as a plasticizer, a flame retardant, an 
anti-wear additive, and/or an anti-compressibility additive in 
hydraulic fluid, lubricating oils, lubricants and greases, epoxy 
coatings for decks of marine shipping vessels, coatings for pipes and 
insulation in construction, adhesives and sealants for insulation, and 
articles. For example, in lubricating oils, PIP (3:1) acts as a flame 
retardant, an anti-wear additive, anti-compressibility additive, or 
some combination of the three, while in adhesives and sealants PIP 
(3:1) acts as a plasticizer and flame retardant (Ref. 4).
    PIP (3:1) has been identified as a possible component in plastic 
products and articles, including children's products, automotive, and 
aerospace products (Ref. 7).
    PIP (3:1) also is added to articles as a plasticizer or flame-
retardant additive in plastic components, adhesives and sealants, and 
paints and coatings. Use of PIP (3:1) in complex articles (such as in 
casings of electronics or components of automobiles), plastic articles 
including furniture and furnishings, and toys intended for children's 
use, has been identified (Ref. 7). PIP (3:1) is sold as a plastic 
flame-retardant additive and is a component of some flame-retardant 
additives for flexible polyurethane foam (Ref. 7). EPA is aware that 
PIP (3:1) is used in antifouling paint; however, EPA does not consider 
this a TSCA use because any pesticide, when manufactured, processed, or 
distributed in commerce as a pesticide does not meet the definition of 
``chemical substance'' under TSCA section 3. To ensure that this is 
clear, EPA is proposing to incorporate the statutory definition of 
``chemical substance'' into 40 CFR part 751, subpart E.
    EPA presented its initial research into PIP (3:1) uses in the 
August 2017 Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal document on PIP (3:1) (Ref. 7). EPA 
received comments from 15 entities on the Preliminary Information 
document. EPA also communicated with companies, industry groups, 
chemical users, states, and other stakeholders to identify and verify 
uses of PIP (3:1) (Ref. 4). These interactions and comments further 
informed EPA's understanding of the uses for PIP (3:1). Public comments 
and stakeholder meeting summaries are available in EPA's docket at EPA-
HQ-OPPT-2016-0730.
    For the 2012 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 (Ref. 17). 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. 17).
    (ii) What are the beneficial properties of PIP (3:1) for the 
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 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. 21).
    PIP (3:1) is a component of additives to help lubricating oils and 
hydraulic fluids meet safety and specific performance standards from 
both military and industry, particularly in the aviation sector (EPA-
HQ-OPPT-2016-0730-0009) (Refs. 22, 23, 24, 25 and 26). It is present in 
lubricating fluids which need to perform at extreme temperatures, both 
hot and cold, as a flame retardant and anti-wear additive (Ref. 4). 
Some lubricants containing PIP (3:1) are formulated to the military 
performance specifications such as MIL-PRF-32014 for use in a 
multipurpose, water resistant, high speed grease in a wide temperature 
range (Refs. 22 and 23). In aviation hydraulic fluid, some phosphate 
ester-based hydraulic fluids contain PIP (3:1) as a flame retardant, 
anti-wear additive, and anti-compressibility additive. While multiple 
hydraulic fluids meet industry performance standards for most 
commercial and military airplanes, for some commercial models, the 
information reasonably available to EPA indicates that only hydraulic 
fluids containing PIP (3:1) can meet safety and air worthiness 
standards. This includes those models which are designed to operate at 
higher pressure systems, that is, 5,000 pounds per square inch (PSI) or 
greater (Ref. 23, 24, and 25). For these systems, additives containing 
PIP (3:1) allow the fluid to remain functional under this high pressure 
at various temperatures and minimize wear in the hydraulic system 
(Refs. 22, 23, 24 and 25).
    (iii) What are the 2014 TSCA Work Plan for Chemical Assessments 
scores for PIP (3:1)? While not among the chemicals screened in 2012, 
PIP (3:1) came to the Agency's attention as part of EPA's analysis of 
flame-retardant chemicals and was subsequently scored using the TSCA 
Work Plan Chemicals: Methods Document (Ref. 2) and added to 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). The overall screening score for PIP (3:1) 
was high (9).
    (iv) Regulatory actions pertaining to PIP (3:1). PIP (3:1) is 
regulated by federal, state, and international agencies. They are 
briefly summarized in this unit. More detailed information can be found 
in the Economic Analysis (Ref. 3). In addition, the OSHA regulations 
discussed in Unit III.A. apply to commercial and industrial workplaces.
    PIP (3:1) was added to the Priority Testing List by the TSCA 
Interagency Testing Committee in May 2012 (77 FR 30855). In addition, a 
high-volume use of PIP (3:1) is in aviation and industrial hydraulic 
fluid and lubricants and greases. If such fluids, lubricants, and 
greases meet the definition of ``used oil'' under 40 CFR 279.1, they 
are subject to Resource Conservation and Recovery Act (RCRA) 
regulations for managing used oil (40 CFR part 279) (Ref. 3).
    With respect to state regulations, PIP (3:1) is listed as a 
candidate chemical and identified as a potential priority monitoring 
chemical in California, and Washington has identified PIP (3:1) as a 
Chemical of High Concern to Children (Ref. 3).

[[Page 36737]]

    Internationally, PIP (3:1) is included in the ECHA Classification 
and Labeling Inventory. The ECHA Classification and Labeling Inventory 
is in line with the Globally Harmonized System of Classification and 
Labeling of Chemicals (GHS); OSHA has also incorporated the GHS in its 
Hazard Communication Standard. In Canada, PIP (3:1) was placed on the 
Domestic Substance List (DSL) in 1994 as an Existing Substance not 
subject to the New Substance Notification Regulations. The inclusion of 
PIP (3:1) on the DSL designates it as an existing, rather than a new, 
substance in Canada, the equivalent of being included on the TSCA 
inventory as an active chemical (Ref. 3).
    3. 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP). (i) Use background: 
Uses of 2,4,6-TTBP include domestic manufacture, use as an 
intermediate/reactant in processing, incorporation in formulations and 
mixtures destined for fuel and fuel related additives, as well as 
formulations intended for the maintenance or repair of motor vehicles 
and machinery. Although EPA has not identified current users of 2,4,6-
TTBP for liquid lubricant and grease additives/antioxidants, it found 
indications of current use, and a manufacturer has reported that, it is 
aware that some customers may use its products for this end use, 
although it does not actively market products with 2,4,6-TTBP for 
lubricant applications. Therefore, the Agency proposes, for purposes of 
this rulemaking, to address the use of 2,4,6-TTBP in liquid lubricant 
and grease additives/antioxidants.
    2,4,6-TTBP is an alkylphenol whose primary value is as an 
antioxidant. It is a widely used antioxidant for jet, automotive, and 
marine fuels. Several stakeholders submitted comments to the public 
docket following posting of the document, ``Preliminary Information on 
Manufacturing, Processing, Distribution, Use, and Disposal: 2,4,6-
Tris(tert-butyl)phenol, August 2017'' (Ref. 8), which presented EPA's 
initial research into the uses of 2,4,6-TTBP. One chemical processor 
stated that they sell 2,4,6-TTBP as part of an antioxidant in fuel 
additives for use in gasoline fuels with a concentration of one to 15% 
2,4,6-TTBP; the gasoline fuels, after blending, are packaged and sold 
in mild steel drums (55-gallon volume) or stainless-steel totes (350-
gallon volume) (EPA-HQ-OPPT-2016-0734-0015). The Aerospace Industries 
Association also identified critical uses of 2,4,6-TTBP as a fuel, 
lubricant, and oil additive/antioxidant in formulations designed to 
meet specific technical performance requirements that are documented in 
a number of engineering specifications over the service life of complex 
aerospace products (EPA-HQ-OPPT-2016-0734-0010). The American Petroleum 
Institute also confirmed that their members use 2,4,6-TTBP as an 
antioxidant in gasoline, diesel, and aviation fuels at concentrations 
of between 5 and 50 parts per million to reduce gasoline deposits in 
engines and subsequently reduce emissions (EPA-HQ-OPPT-2016-0734-0006).
    Based on EPA's research and public comments submitted, the only 
large volume domestic manufacturer, and the only manufacturer currently 
reporting to the EPA's CDR with production volumes of 2,4,6-TTBP that 
meet the CDR threshold, is SI Group. Historical CDR data indicate that 
in the 1986 to 1998 reporting years, the aggregate range of production 
of 2,4,6-TTBP was between 1 and 10 million pounds per year, and 
increased to a range of 10 to 50 million pounds per year in reporting 
years 2002 and 2006. The range of production in 2012, 2013, 2014, and 
2015 was claimed as CBI in the 2016 CDR (Ref. 3). There have not been 
any indications of substantial importation of 2,4,6-TTBP into the 
United States from other countries.
    SI Group stated that proprietary chemical mixtures (primarily two, 
Isonox[supreg] 133 and Ethanox[supreg] 4733) contain detectable 
percentages of 2,4,6-TTBP and are used to meet several military 
specifications for use in jet fuel that is supplied and used by the 
U.S. military (Ref. 27). SI Group also stated that they do not sell, 
supply, or distribute into commerce 2,4,6-TTBP in a pure (neat) form, 
and none of their proprietary blended chemical mixtures containing 
2,4,6-TTBP are sold directly to consumers; however, SI Group customers 
use these mixtures to formulate other products containing 2,4,6-TTBP 
that are intended for consumer applications (Ref. 27). SI Group also 
stated that none of its proprietary chemical mixtures containing 2,4,6-
TTBP are actively marketed for use as a lubricant additive; however, 
some of SI Group's customers may use the proprietary chemical mixtures 
for this use (Ref. 27). SI Group also confirmed the sale of an excess 
material stream containing 2,4,6-TTBP, that is used as a waste fuel for 
energy value, which is burned and destroyed during use (Ref. 27).
    2,4,6-TTBP is a co-product with a closely related alkylphenol, 2,6 
di(tert-butyl) phenol (2,6-DTBP), which is also a primary substitute 
for it. Neither chemical can be effectively produced commercially 
without co-production of the other. Approximately 94% of the 2,4,6-TTBP 
produced by SI Group is consumed by the company in internal processes 
(feedstock for further production of alkylphenols). An additional 4% is 
sold as a waste fuel for energy use. Both uses result in the 
destruction of the chemical.
    The remaining 2% of 2,4,6-TTBP produced by SI Group is sold as an 
antioxidant primarily for use in fuel for all uses: Aviation, military, 
industrial, commercial, and consumer use. The chemical is sold in a 
mixture with its co-products, primarily 2,6-DTBP, at a concentration of 
approximately 85% 2,6-DTBP and 12% 2,4,6-TTBP. The 2,4,6-TTBP is 
destroyed when the fuel is consumed in the combustion process when the 
fuel is burned (Ref. 8).
    Antioxidant additives are essential to the storage and transport of 
fuel, as without them, fuel quickly begins to degrade and form harmful 
sludge and varnish. The 2,4,6-TTBP mixtures are the primary 
antioxidants used in aviation, marine, and automotive fuel streams in 
the United States. Many current performance specifications for fuel 
require their use; including for specialty fuels for aviation and the 
military. The majority of the 2,4,6-TTBP mixtures sold are blended into 
the fuel at the refinery or soon after at tank farms prior to 
commercial distribution of the fuel.
    A portion (approximately 6%) of the 2,4,6-TTBP mixtures are sold to 
processors who blend and distribute antioxidant products that are 
intended to be added to the fuel tanks/systems in vehicles or machinery 
by repair shops or the owner/operators of the equipment themselves. 
These fuel stabilizer products are sold to consumers at various retail 
locations, as well as online. These additives are typically sold in 
small bottles containing up to 32 ounces; gallon containers are 
available through some retailers. Specialty products are also sold for 
cleaning fuel injectors or use in 2-stroke engines (pre-blended with 
oil).
    Other countries have reported that 2,4,6-TTBP is, or has been, used 
as an additive in oils and lubricants (EPA-HQ-OPPT-2016-0734-0002). SI 
Group states that it does not actively market products containing 
2,4,6-TTBP for lubricant applications, but that it is aware that some 
customers may use these products in lubricant applications (Ref. 27).

[[Page 36738]]

    (ii) What are the beneficial properties of 2,4,6-TTBP for various 
uses? Regarding the benefit of manufacture, beyond its use as an 
antioxidant, 2,4,6-TTBP has value as a chemical intermediate in the 
production of dialkylphenol chemicals. Moreover, SI Group reports it is 
not possible to significantly suppress the formation of 2,4,6-TTBP 
without severely constraining the yield of other desired dialkylphenol 
products, therefore its manufacture has impacts beyond the commercial 
use of 2,4,6-TTBP itself. The production of other dialkylphenol 
products, including alternative antioxidants, is therefore a benefit of 
ongoing 2,4,6-TTBP manufacture.
    With respect to use as an antioxidant in the general fuel supply, 
EPA has received comment regarding the beneficial properties of 2,4,6-
TTBP as an antioxidant component blended in fuel. SI Group identified 
numerous U.S. military and ASTM standards that its proprietary blended 
products containing 2,4,6-TTBP satisfy for the antioxidant requirements 
in fuel (Ref. 27). Although particular specifications do not list 
2,4,6-TTBP by CASRN or trade name, 2,4,6-TTBP is the preferred 
antioxidant component for fuel standards due to its chemical reaction 
potential and physical property characteristics (Refs. 27 and 28). 
According to the manufacturers and processors, any substitution of 
2,4,6-TTBP with another alkylphenol or antioxidant compound would 
materially change the performance characteristics of that fuel and 
compliance with mandatory reference standards could not be assured 
(Ref. 28). Introducing a new jet fuel component into use involves the 
fuel component supplier, engine manufacturers, airplane makers and 
regulators in a complicated process that may take several years and 
involve significant cost. New fuel additives must be tested and 
approved to ensure they would have no negative impact on engine safety, 
durability or performance (Ref. 27).
    Regarding the retail sale of fuel additives and fuel injector 
cleaners, EPA was unable to find any specifications or standards for 
retail fuel antioxidants or additives that explicitly require the use 
of 2,4,6-TTBP.
    Regarding the use of 2,4,6-TTBP as an antioxidant additive in oil 
and lubricants, EPA was unable to find any specifications or standards 
for oil, lubricant, or grease additives that require the use of 2,4,6-
TTBP.
    (iii) What are the 2014 Updates to the TSCA Work Plan for Chemical 
Assessments scores for 2,4,6-TTBP? 2,4,6-TTBP scored moderate (2) for 
hazard (based on toxicity following chronic exposure including liver 
effects); moderate (2) for exposure (based on its wide use in consumer 
products, presence in indoor environments, and estimation to have 
moderate releases to the environment); and high (3) for persistence and 
bioaccumulation (based on moderate environmental persistence and high 
bioaccumulation potential). The overall screening score for 2,4,6-TTBP 
was high (7).
    (iv) Regulatory actions pertaining to 2,4,6-TTBP. EPA has no 
existing regulations expressly identifying 2,4,6-TTBP, and EPA did not 
identify any existing or developing Federal regulations for 2,4,6-TTBP. 
However, the OSHA regulations discussed in Unit III.A. apply to 
commercial and industrial workplaces.
    With respect to state regulations, the California Department of 
Toxic Substances Control (DTSC) lists 2,4,6-TTBP as a Candidate 
Chemical. A Candidate Chemical must exhibit a hazardous trait and/or an 
environmental or toxicological endpoint and is found on an 
authoritative list under California Code of Regulations section 
69502.2(a) or is listed by DTSC using criteria specified in section 
69502.2(b) (Ref. 3). In Oregon, 2,4,6-TTBP is listed on Oregon 
Department of Environmental Quality's pollutant profiles (Ref. 3) and 
2,4,6-TTBP is listed as a tier 1 persistent pollutant (Ref. 3). With 
respect to international actions, Japan has prohibited the importation, 
manufacture, and use of 2,4,6-TTBP as a Class 1 Specified Chemical 
under the Chemical Substance Control Law (Ref. 3).
    Environment Canada's 2008 screening assessment for 2,4,6-TTBP 
concluded that 2,4,6-TTBP may be entering the environment and meets the 
criteria set out in section 64 of the Canadian Environmental Protection 
Act of 1999. Environment Canada has since completed a risk evaluation 
and in 2016 recommended 2,4,6-TTBP be added to schedule 1 of the 
environmental emergency regulations, at a threshold quantity of 0.22 
tonnes at a concentration of 10%; listing may require persons who own 
or manage specified toxic and hazardous substances at or above the 
specified thresholds to provide required information on the 
substance(s) and their quantities and to prepare and implement 
environmental emergency plans (Ref. 3).
    2,4,6-TTBP is on the European Chemical Agencies (ECHA) 
Classification and Labeling inventory and the European community 
inventory. More detailed information on the state and international 
regulations pertaining to 2,4,6-TTBP can be found in the Economic 
Analysis (Ref. 3).
    4. Hexachlorobutadiene (HCBD). (i) Use background: HCBD is a 
halogenated aliphatic hydrocarbon that is produced as a byproduct 
during the manufacture of chlorinated hydrocarbons, particularly 
perchloroethylene, trichloroethylene, and carbon tetrachloride (Ref. 
29). The majority of what is manufactured is destroyed via incineration 
by the manufacturer. A small percentage of the HCBD is sent off-site 
for incineration or for burning as a waste fuel by cement manufacturers 
in cement kilns (EPA-HQ-OPPT-2016-0738-0012). EPA has not identified 
any uses of HCBD other than burning as a waste fuel. According to TRI 
data, over 9 million lbs of HCBD were generated by chemical 
manufacturers in reporting year 2017, with almost 8.9 million lbs 
treated for destruction on-site via incineration. TRI reports show 
other waste management activities of HCBD including 58,000 lbs being 
treated for destruction off-site, 33,000 lbs burned for energy recovery 
off-site, and 2,400 lbs released to air.
    (ii) What are the beneficial properties of HCBD for the various 
uses? HCBD is manufactured as a waste byproduct by chemical 
manufacturers. The majority of what is manufactured is destroyed via 
incineration by the manufacturer. A small percentage of the HCBD is 
sent off-site for burning as a waste fuel by cement manufacturers.
    (iii) What are the 2014 Update to the TSCA Work Plan for Chemical 
Assessments scores for HCBD? HCBD scored high (3) for hazard (possible 
human carcinogen); moderate (2) for exposure (based on TRI data); and 
high (3) for persistence and bioaccumulation (based on high 
environmental persistence and high bioaccumulation potential). The 
overall screening score for HCBD was high (8).
    (iv) Regulatory actions pertaining to HCBD. Under EPCRA, HCBD has 
been listed on the TRI list of reportable chemicals since 1988 (Ref. 
20). HCBD is a Hazardous Air Pollutant (HAP) under section 112 of the 
Clean Air Act (CAA) as amended in 1990. The Agency has promulgated 
National Emission Standards for Hazardous Air Pollutants (NESHAPs) 
which require the maximum achievable control technology (MACT) for 
major sources in Standard Source Categories. Under the Clean Water Act 
(CWA), HCBD is listed on the Priority Pollutant List and is subject to 
Effluent Guidelines and the requirements of the National Pollutant 
Discharge and Elimination System (NPDES). Under the

[[Page 36739]]

Resource Conservation and Recovery Act (RCRA), HCBD is a hazardous 
constituent and can be characterized as a toxicity characteristic waste 
(Hazardous Waste No. D033) or listed hazardous waste (U128) under RCRA 
when discarded or intended for discard. Under the Comprehensive 
Environmental Response, Compensation and Liability Act, HCBD is 
designated as a hazardous substance with a reportable quantity (RQ) of 
1 lb. More information on the impact of these existing regulations is 
in Unit III.E.
    With respect to other Federal regulations, the Pipeline and 
Hazardous Material Safety Administration in the Department of 
Transportation lists HCBD as a hazardous substance with a reportable 
quantity of 1 lb. In addition, the OSHA regulations discussed in Unit 
III.A. apply to commercial and industrial workplaces.
    Many states have promulgated regulations applicable to HCBD. State 
requirements concerning HCBD include regulations of water quality 
standards, sources of air pollution and management of waste containing 
the chemical. The following states implemented water quality standards 
for HCBD: Arizona, California, Colorado, Connecticut, Delaware, 
Florida, Georgia, Hawaii, Idaho, Indiana, Kentucky, Louisiana, Maine, 
Maryland, Michigan, Missouri, Montana, Nebraska, New Hampshire, New 
Jersey, New Mexico, New York, North Carolina, North Dakota, Oregon, 
Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, 
Texas, Utah, Vermont, Virginia, Washington and Wisconsin. Several 
states have air pollution requirements for HCBD including Idaho, 
Illinois, Maryland, New Hampshire and Ohio.
    Internationally, Austria banned the use of HCBD in 1992 citing its 
carcinogenic and mutagenic properties as well as fetotoxicity and 
negative effects on fertility. In Canada, HCBD is on the Domestic 
Substance List (DSL) as an Existing Substance not subject to the New 
Substance Notification Regulations. It was also added to Schedule 1 of 
the Canadian Environmental Protection Act and to Schedule 1 of the 
Prohibition of Certain Toxic Substances Regulations. HCBD was also 
placed on Canada's Virtual Elimination List. In China, HCBD is in the 
Catalog of Hazardous Chemicals. In the European Union (EU), HCBD is 
listed on the Annex III inventory based on its bioaccumulative 
properties and is subject to Annex V Part 1 of Prior Informed Consent 
(PIC) Regulation. In Germany, HCBD is on the Master List of the German 
Federal Environment Agency (UBA). Under the Chemical Substances Control 
Law of Japan, HCBD was designated a Class I Chemical Substance. Swedish 
Chemicals Agency includes HCBD on a list of phase-out substances. The 
United Kingdom regulates HCBD through several mechanisms including the 
Pollution Prevention and Control regulations, the Food and 
Environmental Protection Act, and the Control of Pesticides 
Regulations.
    Under the Stockholm Convention, HCBD is listed as a persistent 
organic pollutant (POP) under Annex A which requires parties take 
measures to eliminate production and use of the chemical, and under 
Annex C which requires parties to reduce the unintentional releases of 
chemicals.
    For more information about regulatory actions pertaining to HCBD, 
see the Economic Analysis for this proposed rule (Ref. 3).
    5. Pentachlorothiophenol (PCTP). (i) Use background: Historically, 
PCTP was used in rubber manufacturing as a peptizer, a chemical that 
makes rubber more amenable to processing. There are few data, however, 
on end-use products that contain PCTP. For years, PCTP was produced in 
the United States but domestic manufacture appears to have ceased (Ref. 
17). While it is likely that PCTP is no longer used as a peptizer, it 
can be found as an impurity in the zinc salt of PCTP (zinc PCTP) (CASRN 
117-97-5) after zinc PCTP manufacturing (Ref. 30). As shown by a number 
of patents, zinc PCTP can be used as a peptizer in rubber manufacturing 
and as an ingredient in the rubber core of golf balls to enhance 
certain performance characteristics of the ball, such as spin, rebound, 
and distance (Refs. 31 and 32). EPA considers the addition of PCTP to 
rubber during manufacturing, whether as a peptizer or an impurity, to 
be processing under TSCA.
    Zinc PCTP is imported into the United States, with approximately 
65,000 lbs imported in 2017 (Ref. 3). EPA believes that some or all of 
the zinc PCTP could contain PCTP. The importation of PCTP, including as 
an impurity with zinc PCTP, is considered manufacturing under TSCA. EPA 
requests comments as to which chemicals would most likely serve as 
alternatives to ZnPCTP in golf balls, and why golf ball manufacturers 
may not currently choose to use these alternatives.
    (ii) What are the beneficial properties of PCTP for various uses? 
During the manufacture of rubber, PCTP was used as a peptizer to reduce 
the viscosity of rubber during processing. PCTP has been used as a 
mastication agent in the rubber industry and, more specifically, a 
peptizing agent for natural rubber viscosity reduction in the early 
stages of rubber manufacturing (Ref. 33). Mastication and peptization 
are processing stages during which the viscosity of rubber is reduced 
to a level facilitating further processing (Ref. 34). It is possible to 
reduce the viscosity of natural and synthetic rubbers through solely 
mechanical efforts, but peptizers allow this process to be less 
sensitive to varying time and temperature, which improves the 
uniformity between batches (Ref. 33).
    (iii) What are the 2014 Update to the TSCA Work Plan for Chemical 
Assessments scores for PCTP? PCTP scored high (3) for hazard (based on 
toxicity for acute and chronic exposures); low (1) for exposure (based 
on 2012 CDR data); and high (3) for persistence and bioaccumulation 
(based on high environmental persistence and high bioaccumulation 
potential). The overall screening score for PCTP was high (7).
    (iv) Regulatory actions pertaining to PCTP. PCTP was added to the 
TSCA Preliminary Assessment Information Rule (PAIR) Priority Testing 
List in August 2001 (Ref. 35). The PAIR requires manufacturers 
(including importers) of the substances identified to report certain 
production, importation, use, and exposure-related information to EPA. 
PCTP was removed from the Priority Testing List in 2003 because of low 
exposure potential (Ref. 36). In addition, the OSHA regulations 
discussed in Unit III.A. apply to commercial and industrial workplaces.
    With respect to state regulations, California's Department of Toxic 
Substances Control includes PCTP on its Candidate Chemical list based 
on its bioaccumulation, environmental persistence, and toxicity. Maine 
includes PCTP on its list of Chemicals of High Concern. Maryland lists 
PCTP as a Toxic Air Pollutant. The Minnesota Department of Health lists 
PCTP as a Chemical of High Concern for its PBT properties (Ref. 3).
    With respect to international actions, in Canada, PCTP is on the 
Domestic Substance List (DSL) as an ``Existing Substance'' as it met 
the criteria under subsection 73(1) of the Canadian Environmental 
Protection Act, 1999 (CEPA), because it was already in commerce in 
Canada from 1984 to 1986 and thus not subject to the New Substance 
Notification Regulations. In 2008, PCTP was moved to Part 2 of the DSL 
to indicate that it is subject to a Significant New Use Activity under 
subsection 81(3) of CEPA. In the European Union, PCTP is listed on the

[[Page 36740]]

Annex III inventory based on its bioaccumulative properties and, in 
Japan, PCTP is listed as an Existing Chemical under the Chemical 
Substances Control Law (CSCL). More information on the Federal, state 
and international regulations pertaining to PCTP can be found in the 
Economic Analysis (Ref. 3).

E. Exposure and Use Assessment and Hazard Summary

    1. Summary of the Exposure and Use Assessment. An exposure and use 
assessment was conducted for the five PBT chemicals using the following 
information: (a) Chemical and physical-chemical properties, (b) use 
descriptions, (c) expected environmental partitioning, (d) lifecycle 
and potential sources, (e) environmental monitoring, (f) biomonitoring, 
(g) modeled intake and doses from existing studies, (h) trends in the 
data, (i) summary information from completed exposure assessments and 
review of peer-review articles published at the time of preparation of 
the exposure and use assessment, (j) representative exposure scenarios, 
and (k) information provided by public comment and peer review. This 
information helps to identify potential exposure scenarios that are the 
combination of sources/uses, environmental pathways, and receptors.
    Lifecycle diagrams were developed and qualitative evaluations 
describing relative potential for occupational exposure of the five PBT 
chemicals were performed to assess release to different media from 
various industrial operations. Though environmental partitioning of 
chemicals in various media were considered, uses and processes for each 
of these five PBT chemicals have variations of releases in different 
media. A comprehensive literature search was performed to collect 
environmental and bio-monitoring information to assess the likely 
exposure of the general population, consumers, occupational 
populations, potentially exposed or susceptible subpopulations, and the 
environment from the conditions of use of the PBT chemicals.
    Only a few monitoring studies were reported for PIP (3:1) and 
2,4,6-TTBP. Thus, a supplemental search was conducted to identify 
closely related chemicals. Based on EPA scientific review and 
evaluations, triphenyl phosphate (TPP) and 2,4-di-tert-butylphenol 
(2,4-DTBP) were considered as surrogate chemicals for PIP (3:1) and 
2,4,6-TTBP, respectively. These surrogates were selected based on 
availability of data, structural similarity, similar use, and 
reasonably close physical-chemical properties. PCTP was also found to 
have limited data; however, no surrogate chemicals were identified for 
PCTP using these criteria.
    Multiple approaches were considered to construct non-specific 
exposure scenarios. Comparison of exposure scenarios revealed source 
attribution. The relative complexity of source attribution varied 
depending on the continuum of available uses/sources and the media 
considered. For example, total dust concentrations in a residence 
represent contributions from multiple sources. Similarly, internal dose 
measured in biota represents total exposure from multiple media and 
sources. This source attribution can be qualitative or quantitative. 
Qualitative descriptors (e.g., higher, lower potential for exposure) 
were used to characterize exposures, and uncertainties were 
acknowledged across the exposure scenarios.
    2. Proposed TSCA section 6(h)(1)(B) exposure finding. In this unit 
EPA provides an overview of the potential exposures for each PBT 
chemical. The possible exposures are described within the context of 
the lifecycle of the chemical, e.g., exposures during manufacturing, 
processing, distribution, use and disposal. However, EPA notes that 
these exposures are possible, not necessarily probable nor known. This 
is especially so in instances where regulatory controls mandated by 
other statutes are applicable. As discussed in Unit III.A., EPA 
generally expects there is compliance with Federal and state laws, such 
as worker protection standards or disposal restrictions, unless case-
specific facts indicate otherwise.
    EPA is proposing to determine in accordance with TSCA section 
6(h)(1)(B) that, based on the Exposure and Use Assessment and other 
reasonably-available information, exposure to the five PBT chemicals 
under the conditions of use is likely to the general population, to a 
potentially exposed or susceptible subpopulation, or the environment, 
which is the threshold for expedited action under TSCA section 6(h). 
EPA's proposed determination is based on the opportunities for exposure 
throughout the lifecycle of each of the five PBT chemicals including, 
for some, consumer exposures.
    (i) DecaBDE. Exposure information for DecaBDE is summarized here 
and is detailed in EPA's Exposure and Use Assessment (Ref. 4).
    The most likely sources of releases and occupational exposures 
during the manufacturing condition of use of DecaBDE are associated 
with fugitive dust. These include air releases from transfer and 
packaging operations (fugitive dust to ambient air, as well as dust 
that is collected and channeled through a dedicated point as a stack 
release) and solid waste from floor sweepings, disposal of used 
transfer containers containing residual DecaBDE, and liquid waste from 
equipment cleaning. Fugitive vapor air releases are not expected due to 
the chemical's low vapor pressure. Releases to land are possible when 
floor sweepings and other solid waste are collected and disposed in 
landfills. Similarly, the collection and disposal of liquid equipment 
cleaning solutions has the potential of generating liquid waste 
containing DecaBDE (aqueous waste to surface waters and sent to 
publicly owned treatment works, and organic waste collected and sent 
for other disposal or waste treatment such as incineration). Historical 
and recent TRI data confirm primary releases are to air, followed by 
landfill and water (Ref. 4). As noted previously, under TRI, a release 
of a chemical means that it is emitted to the air or water, or placed 
in some type of land disposal. These releases may be regulated under 
other environmental statutes, such as the CAA, CWA, or RCRA. 
Occupational exposures from inhalation and dermal exposure to dust are 
possible during transfer and packaging operations and from fugitive 
dust emissions from process operations if workers are unprotected. The 
OSHA regulations discussed in Unit III.A. apply to industrial and 
commercial workplaces. More specifically, the OSHA regulations at 29 
CFR 1910.132 require employers to assess a workplace to determine if 
hazards are present or likely to be present which necessitate the use 
of personal protective equipment (PPE). If the employer determines 
hazards are present or likely to be present, the employer must select 
the types of PPE that will protect against the identified hazards, 
require employees to use that PPE, communicate the selection decisions 
to each affected employee, and select PPE that properly fits each 
affected employee. Thus, EPA would not expect workers in industrial and 
commercial workplaces to be unprotected.
    During processing conditions of use, DecaBDE is combined with other 
ingredients (e.g., monomers) and then molded, extruded, formed into 
final products, or applied to a finished article, where curing may 
occur (Ref. 4). Releases to air, land, and water may occur from DecaBDE 
and DecaBDE

[[Page 36741]]

flame-retardant formulations (solids and liquids), as well as from off-
specification products containing the additive flame retardant. Air 
releases (fugitive dust and dust collected and channeled to a stack) 
may occur from transfer operations. Releases to land may occur during 
disposal of transfer containers containing residual material, 
collection and disposal of floor sweepings, and disposal of off-spec 
product. Equipment and general area cleaning with aqueous cleaning 
materials may result in releases to water. Current and historical TRI 
data indicate the primary releases are to air, followed by landfill and 
water (Ref. 4). Occupational exposures from inhalation and dermal 
exposure to dust may occur during transfer and packaging operations and 
from fugitive dust emissions from process operations if workers are 
unprotected. Dermal exposure to liquids is possible from incidental 
contact of liquid flame-retardant formulations containing DecaBDE 
during transfer, loading, and mixing operations. Occupational exposures 
may occur when the bags of flame retardant are emptied into a hopper 
prior to mixing if workers are unprotected. Once formulated, DecaBDE is 
encased in the polymer matrix and the potential for worker exposure is 
reduced significantly (Ref. 4).
    DecaBDE is present in plastic that may be recycled and subsequently 
reused. Releases from recycling facilities may occur from discarded 
material that cannot be recycled and reclaimed and is disposed in 
landfills. Releases to air and water are expected to be minimal during 
most recycling processes because DecaBDE is entrained in the articles 
and is not expected to volatize or migrate readily from the facility 
during recycling operations. However, there is potential for 
volatilization and releases to air if recycling involves heating and 
melting the DecaBDE-containing plastic article, and, thus, inhalation 
exposures if workers are unprotected. Limited occupational exposure to 
workers at recycling facilities is possible from dermal contact during 
handling of plastic material that is received and introduced into 
recycling operations, and from inhalation exposure to dust from 
grinding and shredding operations, if workers are unprotected.
    DecaBDE is combined with other ingredients and incorporated into 
the back coating of various textiles, such as curtains, via roll or dip 
coating processes. Releases may occur from disposal of transfer 
containers associated with DecaBDE formulations, disposal of waste from 
equipment and area cleaning, disposal of off-spec product, and disposal 
of bath dumps. Historical TRI data indicate most releases during this 
processing activity are associated with disposal to landfills, with 
smaller quantities released to air, and with minimal releases to water. 
If workers are unprotected, inhalation exposures may occur due to: 
Fugitive dust generated from unloading and transfer of the solid flame 
retardant into mixing vessels; mist generated from the squeezing of the 
immersed fabric with rollers; from the roll coating application during 
back coating; and, after the coating operations are complete, during 
fabric cutting. If workers are unprotected, dermal exposures to solid 
and liquid DecaBDE mixtures in fabric finishing may occur from 
unloading operations, mixing finishing baths, equipment cleaning, and 
spilling (Ref. 4).
    DecaBDE is combined with other ingredients and then molded, 
extruded, formed into final products, or applied to wire or cable (Ref. 
4). Releases may occur from transfer operations, volatilization from 
extrusions, disposal of transfer containers, waste from equipment and 
area cleaning, and disposal of off-spec product. Historical TRI data 
indicate most releases during this processing activity are associated 
with disposal to landfills, with smaller quantities released to air, 
and with minimal or no releases to water (Ref. 4). If workers are 
unprotected, inhalation exposure from fugitive dust that is generated 
from unloading and transfer of the flame retardant into mixing vessels 
and from vapors generated during extrusion may occur. If workers are 
unprotected, dermal exposure is most likely during formulation when the 
bags of flame retardant are emptied into a hopper prior to mixing. Once 
formulated, DecaBDE is encased in the cured coating and the potential 
for worker exposure is minimal.
    Article components containing DecaBDE, such as fabrics and plastic 
parts, are incorporated into finished products, such as automobiles and 
aircraft. Releases to land may occur from disposal of off-spec products 
that contain DecaBDE. Releases to air and water are expected to be 
minimal because DecaBDE is entrained in the articles and is not 
expected to volatize or migrate readily under normal use. Occupational 
exposure from dermal contact with article components during 
installation is possible if workers are unprotected. Inhalation 
exposure is not expected due to the low potential for volatilization.
    Articles treated with DecaBDE are used in the home, in business 
settings, and in the transportation sector. DecaBDE has also been found 
in children's products such as plastic play structures and toys, though 
DecaBDE is present only in low (below 0.1%) concentrations in many 
cases. DecaBDE is also found in plastics used as components in 
electrical appliances and equipment such as stereos, computers, 
televisions, circuit boards, casings, and cable insulation. Other uses 
in the transportation and construction sector are in the fabrics of 
automobiles, aircrafts, and in building materials (Ref. 4). DecaBDE's 
primary use is in high impact polystyrene-based products that are used 
in plastics, specifically in plastic enclosures for televisions, 
computers, and audio and video equipment. It is also used in textiles 
and upholstered articles (including carpets, upholstery fabric, 
curtains, and cushions), and wire and cables for communications and 
electronics (Refs. 4 and 6). The quantity of DecaBDE in these articles 
is unknown. Releases from these articles may occur when DecaBDE 
migrates from the articles during use (e.g., in homes and business 
settings), disposal, and waste management. Occupational dermal 
exposures are expected to be minimal from handling and repackaging 
articles. Inhalation and dermal exposures are possible during recycling 
operations if workers are unprotected (e.g., recycling of plastics) 
(Ref. 4). The end-of-life disposal and waste handling options for 
products containing DecaBDE include disposal in landfills, recycling 
and incineration (Ref. 4).
    Exposure assessments on DecaBDE have been conducted by the EPA 
(including industry-supplied information as part of the Voluntary 
Children's Chemical Evaluation Program), the National Academy of 
Sciences, and international governments. These assessments describe 
exposure potential for PBDEs, including DecaBDE, through a variety of 
pathways. Adult and child exposures occur via dust ingestion, dermal 
contact with dust, and dietary exposures (such as dairy consumption). 
Household consumer products have been identified as the main source of 
PBDEs (including DecaBDE) in house dust. The next highest exposure 
pathways included dairy ingestion, and inhalation of indoor air (via 
dust). Infant and child exposures occur via breastmilk ingestion and 
mouthing of hard plastic toys and fabrics. Occupational exposures for 
breastfeeding women were highest in women engaged in activities 
resulting in direct contact with DecaBDE (Ref. 4).
    Experimental product testing studies suggest that DecaBDE can be 
emitted from articles during use through

[[Page 36742]]

abrasion and direct transfer to dust on surfaces. Based on DecaBDE's 
physical-chemical properties, ingestion of settled dust through routine 
hand-to-mouth and object-to-mouth contact is likely the primary 
exposure route for articles. The inhalation pathway also contributes to 
exposure when suspended particles deposited in the upper airway are 
subsequently swallowed. The dermal pathway likely contributes a smaller 
proportion of total exposure.
    Numerous monitoring studies have shown that DecaBDE has been 
detected in a wide variety of media such as indoor dust, air, water, 
soil, human blood, and fish. Dietary exposure through the food-chain 
and trophic transfer may contribute to presence in biological matrices 
(human blood, fish, etc.).
    Exposure to ecological receptors has been well documented, with 
several biomonitoring studies reporting levels in tissues of 
invertebrates, fish, and birds (Ref. 4). Environmental and biological 
levels are typically higher near point sources. However, DecaBDE has 
also been detected in remote areas indicating potential for long-range 
transport.
    DecaBDE was produced and released at higher levels in the past but 
continues to be released. Releases from manufacturing and processing 
are declining over time, as are releases associated with use, disposal, 
and recycling (Ref. 4).
    (ii) PIP (3:1). As discussed briefly in Unit II.D.2, PIP (3:1), 
CASRN 68937-41-7 is a mixture of isomers. The proportion of various 
isomers within a mixture is often proprietary, and can affect the 
performance of the product, as well as its hazard and ecological 
persistence and bioaccumulation. Most of the existing studies of PIP 
(3:1) represent exposures to whole commercial products; however, the 
amount of PIP (3:1) within the studied formula varies greatly in 
content and propylation configurations. In these studies, exposure to 
other chemicals within the product, such as triphenyl phosphate, which 
is often present in mixtures of PIP (3:1) in concentrations from 5-10%, 
may influence the magnitude of exposure to PIP (3:1) from commercial 
products, and the effects observed.
    Exposure information for PIP (3:1) is briefly summarized here and 
is detailed in EPA's Exposure and Use Assessment (Ref. 4).
    PIP (3:1) is manufactured, processed, distributed, and used 
domestically. There is potential for exposure to PIP (3:1) under the 
conditions of use at all stages of the lifecycle (i.e., manufacturing, 
processing, use (industrial, commercial, and consumer), distribution, 
and disposal) of the chemical (Ref. 4).
    During the manufacturing condition of use, fugitive air releases 
from various process steps, water releases from separation and drying 
steps as well as equipment and area cleaning, and land releases from 
disposal of spent filters are possible.
    During the processing into formulas conditions of use, releases to 
air, water, and land are possible from the associated unit operations. 
The primary sources of release include container residue, process 
equipment cleaning, and disposal of off-spec products.
    PIP (3:1) is an additive flame retardant that is used in a variety 
of articles including plastic resins, foam, and synthetic rubber. Flame 
retardants in general are incorporated into products in one of two 
manners. They are either chemically bound to the product matrix as 
``reactive'' mixtures, or they are dissolved in the polymer materials 
as ``additives.'' Additive flame retardants are not chemically bound 
and are relatively unattached to the polymer matrix. Therefore, they 
have the increased potential of migrating from products to the 
surrounding environment during normal use.
    Fugitive air releases of PIP (3:1) are expected to be minimal due 
to its low vapor pressure. Water and land releases are not expected 
from waste hydraulic fluids and greases because used fluids and grease 
are typically collected for reuse or incineration (Ref. 4).
    If workers are unprotected, dermal exposure to PIP (3:1) (full or 
partial hand immersion, splashing, or spraying) is possible from 
handling hydraulic fluids and lubricants and greases. Inhalation 
exposure to fugitive vapors is expected to be minimal, but inhalation 
exposure to mist is possible if the fluid is spray-applied and if 
workers are not wearing appropriate personal protective equipment. 
Transportation workers, aside from those who regularly handle these 
fluids, can also be exposed to hydraulic fluid vapor; for example, 
airline crews can be exposed to hydraulic or engine oil smoke or fumes 
(Ref. 4).
    PIP (3:1) is also added to coatings, adhesives, and sealants for a 
variety of industrial uses. Potential application methods of these 
coatings to industrial substrates may include roll, dip, and spray 
processes. The quantity of releases and level of occupational exposures 
varies with each process; however, each presents possible releases to 
all media (air, water, land) and exposures (inhalation of vapors or 
mists and dermal exposure to liquids).
    While release of PIP (3:1) is possible, the data on PIP (3:1) 
pathways and endpoints are limited, even when looking at an analogue 
like triphenyl phosphate. The reasonably available data are generally 
consistent with the fate summary and reported physical-chemical 
properties in that PIP (3:1) was detected in indoor dust, soil, ambient 
air, and sediment in higher concentrations and was not reported in 
other media.
    Triphenyl phosphate, or TPP, is used as an analogue for PIP (3:1) 
in EPA's Exposure and Use Assessment. TPP is present in formulated 
products with PIP (3:1), sometimes in concentrations of 5-10%. The 
larger body of TPP data provides insight into the expected patterns of 
environmental partitioning and uptake of PIP (3:1), but not as being 
indicative of the levels of PIP (3:1) that should be expected or the 
toxicity of PIP (3:1). In the literature search, information was 
identified showing that TPP or its metabolites were detected or 
estimated in human blood, dermal wipes, fish, terrestrial 
invertebrates, birds, and terrestrial mammals.
    (iii) 2,4,6-TTBP. Exposure information for 2,4,6-TTBP is briefly 
summarized here and is detailed in EPA's Exposure and Use Assessment 
(Ref. 4)
    Fuel additive formulations containing 2,4,6-TTBP in solution may be 
shipped to end users in a variety of container types. Fugitive air 
releases of 2,4,6-TTBP are expected to be minimal (due to the low vapor 
pressure) from unloading and transfer operations. It is expected that 
the majority of 2,4,6-TTBP is destroyed (burned) as the fuel it is 
added to is consumed. Releases may occur from disposal of empty 
transport containers and waste absorbents used to clean spills and 
leaks from loading operations. Waste from equipment cleaning with 
organic cleaning solutions is anticipated to be collected for 
incineration. Water releases are possible from equipment and general 
area cleaning with aqueous cleaning solutions. Dermal exposure to 
2,4,6-TTBP to workers may occur from transfer and fuel loading 
operations. Dermal exposure resulting from manufacturing and processing 
conditions of use at manufacturing facilities and fuel production 
facilities is expected to be minimal due to the use of appropriate 
engineering controls and personal protective equipment (PPE). At the 
manufacturer facilities, worker PPE consists of nitrile gloves, 
chemical-resistant slicker suits, chemical resistant boots, respirators 
with face shield and hard hats; workers are trained and

[[Page 36743]]

monitored in the correct use of their PPE. Sampling during production 
is accomplished using controlled sampling spigots, which prevent 
aerosol formation, splashing and spillage, minimizing potential worker 
exposure. Controlled sampling spigots are also used for transfer 
activities (loading and unloading) (EPA-HQ-OPPT-2018-0314-0018). 
Refineries, fuel distribution and fuel storage facilities also operate 
with appropriate engineering controls, PPE, working worker training, 
leak detection and spill control measures; vapor recovery systems are 
used during distribution and storage (EPA-HQ-OPPT-2016-0734-0006). Once 
blended into fuel, the resultant concentration of 2,4,6-TTBP in fuel is 
low, in the 5 to 50 ppm range, limiting the exposure resulting from 
handling and spills or leaks.
    Use of retail fuel additive products which are sold in small 
containers by mechanics and consumers to service cars, boats, small 
engines, etc., present opportunities for release and dermal exposure 
during transfer activities if workers are unprotected. Spillage may 
occur when the product is being pouring into fuel tanks and storage 
cans. Product containers may also leak during transportation, handling, 
storage and disposal. Used containers are disposed of in the municipal 
solid waste stream without special handling.
    If released to the indoor environment, 2,4,6-TTBP could partition 
to particulates and dust based on its chemical relationship with 
organic carbon compared to that of air. If released into a sanitary 
sewer system or storm water system, 2,4,6-TTBP would likely transport 
to nearby wastewater treatment plants due to relative mobility in water 
due to high water solubility and low KOC (soil organic carbon/water 
partitioning coefficient).
    EPA did not identify any studies with extractable 2,4,6-TTBP data 
in drinking water or any studies with detectable levels of 2,4,6-TTBP 
in soil, sludge/biosolids, or vegetation/diet. Additionally, EPA did 
not identify any studies with detectable levels of 2,4,6-TTBP in human 
blood (serum), other human organs, aquatic invertebrates, aquatic 
vertebrates, terrestrial invertebrates, birds, or terrestrial mammals.
    (iv) HCBD. Exposure information for HCBD is briefly summarized here 
and is detailed in EPA's Exposure and Use Assessment (Ref. 4).
    HCBD is manufactured as a byproduct by chemical manufacturing 
facilities. Most of the chemical is destroyed by incineration with a 
small percentage released to air via stack and fugitive emissions. 
Waste containing HCBD is blended with conventional fuels and burned in 
cement kilns for energy recovery. EPA has not identified any uses of 
HCBD other than burning as a waste fuel. The destruction and removal 
efficiency from incineration of HCBD is expected to be significant but 
not complete, resulting in air releases from incinerator flue gas and 
land releases from disposal of ash and slag. Minor water releases from 
equipment cleaning are possible (Ref. 4).
    Multiple studies show that HCBD has been detected in a wide variety 
of media. Higher concentrations were reported in ambient air, surface 
water, soil, and sediment. Lower concentrations were reported in 
drinking water, indoor air, and sludge/biosolids. TRI data show that 
HCBD is released to air annually from chemical manufacturers, with 
approximately 2,400 lbs released in 2017. TRI data indicate that the 
number of reporting facilities and the total domestic release 
quantities to all media have remained relatively constant since 2000 
(Ref. 7).
    (v) PCTP. Exposure information for PCTP is briefly summarized here 
and is detailed in EPA's Exposure and Use Assessment (Ref. 4).
    Since PCTP is a dry powder, the most likely sources of releases and 
occupational exposures from the manufacturing condition of use are 
associated with fugitive dust, if workers are unprotected. These 
include air releases from transfer and packaging operations (fugitive 
dust to ambient air as well as dust that is collected and channeled 
through a dedicated point as a stack release) and solid waste from 
floor sweepings, disposal of used transfer containers containing 
residual PCTP, and liquid waste from equipment cleaning. Fugitive vapor 
air releases are not expected due to the low vapor pressure. Releases 
to land are possible when floor sweepings and other solid waste are 
collected and disposed in landfills. Similarly, the collection for 
disposal of liquid equipment cleaning solutions has the potential of 
generating liquid waste containing PCTP (aqueous waste to surface 
waters and sent to publicly owned treatment works, and organic waste 
collected and sent for other disposal or waste treatment such as 
incineration). Occupational exposures from inhalation of fugitive dust 
and dermal exposure to dust from transfer and packaging operations and 
from fugitive dust emissions from processing conditions of use are 
possible if workers are unprotected. However, dermal exposure to 
liquids is not anticipated. Similarly, inhalation exposure to fugitive 
vapors is not expected due to PCTP's low vapor pressure (Ref. 4).
    Although releases of PCTP after the zinc PCTP is incorporated into 
rubber are expected to be minimal, releases of additives from rubber 
manufacturing are possible to water, air, and land (predominantly prior 
to reaction process completion). Water releases are expected to be most 
prevalent. Sources include process wastewater from cooling or heating 
medium and vulcanization, where water has direct contact with the 
rubber mixture. Releases to water can also occur from equipment and 
general area cleaning. Releases are possible from the disposal of off-
spec product and empty transfer containers. Air releases are expected 
to be minimal due to the low vapor pressure of PCTP. Occupational 
inhalation and dermal exposure to dust is possible from unloading and 
transfer operations when the PCTP mixture is added to process equipment 
if workers are unprotected. Once incorporated into the rubber 
formulation, the potential for worker exposure is not expected (Ref. 
4).
    3. Hazard summary. The purpose of the Hazard Summary is to describe 
the hazards of the five PBT chemicals. EPA did not perform a systematic 
review of the literature to characterize the hazards of the five PBT 
chemicals, and instead performed a limited survey of the reasonably 
available scientific information. The information in this document does 
not represent an exhaustive literature review nor is it an analysis of 
relative importance or comparative dose-response among hazards. Due to 
Congress' direction in TSCA to expeditiously regulate PBTs on the 2014 
Work Plan and because risk evaluations were not required by Congress, 
EPA prepared a fit-for-purpose summary of the hazards presented by the 
five PBT chemicals. EPA leveraged previous data compilations and 
existing information, wherever possible, as the initial data-gathering 
approach and to survey the environmental and human health hazard data 
and information. EPA did not evaluate the strengths and weaknesses of 
individual studies, nor did EPA select studies to inform a point of 
departure. The hazard data are reported from the literature with no 
additional analysis or assessment. Reasonably available hazard 
information is tabulated and briefly summarized within this document; 
hazard values, unless noted otherwise (e.g., normalized to percent 
active ingredient or purity), are as reported by authors, and were not 
selected for use in conjunction with any particular

[[Page 36744]]

exposure pathway(s), risk assessment scenarios, or dose-response 
analysis conducted by EPA. The Hazard Summary does take into 
consideration public and peer review comments. Hazard information that 
became available after the beginning of the peer review and public 
comment process in June 2018 is not captured in the Hazard Summary. EPA 
requests comments making the Agency aware of any more recent hazard 
information available.
    Environmental and human health hazard data were compiled from 
various primary and secondary sources of publicly available 
information. The hazard summaries relevant to environmental hazard data 
include toxicological information following acute and chronic exposures 
for both aquatic and terrestrial wildlife. Due to a general lack of 
data found for 2,4,6-TTBP and PCTP in the primary and secondary sources 
initially searched, additional literature searches were conducted for 
environmental hazard data for these chemicals. Generally, more aquatic 
toxicity data following acute exposures are available for all five PBT 
chemicals than are available for aquatic toxicity data following 
chronic exposures. For four of the five PBT chemicals, excluding PCTP, 
data were available for organisms spanning three trophic levels.
    The hazard summaries relevant to human health focus on repeated-
dose studies in laboratory mammals because these chemicals are expected 
to persist and bioaccumulate in the environment and result in repeated 
exposures to exposed human populations. In addition, in vitro studies 
in cells and acute studies in mammals were included to characterize the 
health concerns that were not examined in repeated-dose studies in 
mammals. Available published and unpublished repeated-dose toxicity 
data were tabulated according to health endpoints and the identified 
studies are briefly summarized. Human health hazard data are presented 
in the context of any available existing toxicological assessments. In 
some cases, the identified studies did not observe any toxicological 
effects. EPA did not conduct an analysis of relative importance of the 
endpoints reported or do a comparative dose-response among hazards.
    The environmental and human health hazards of the five PBT 
chemicals are summarized here. These hazard statements are not based on 
a systematic review of the available literature and information may 
exist that could refine the hazard characterization.
    DecaBDE: DecaBDE is toxic to aquatic invertebrates, fish, and 
terrestrial invertebrates. Data indicate the potential for 
developmental, neurological, and immunological effects, general 
developmental toxicity and liver effects in mammals. There was some 
evidence of genotoxicity. There was some evidence of carcinogenicity. 
The studies presented in this document demonstrate these hazardous 
endpoints.
    PIP (3:1): 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 this document 
demonstrate these hazardous endpoints.
    2,4,6-TTBP: 2,4,6-TTBP is toxic to aquatic plants, aquatic 
invertebrates, and fish. Data indicate the potential for liver and 
developmental effects. The studies presented in this document 
demonstrate these hazardous endpoints.
    HCBD: HCBD is toxic to aquatic invertebrates, fish, and birds. Data 
indicate the potential for renal, liver, and developmental effects in 
mammals. HCBD has been identified as a possible human carcinogen. The 
studies presented in this document demonstrate these hazardous 
endpoints.
    PCTP: PCTP is toxic to protozoa, fish, terrestrial plants, and 
birds. Data for analogous chemicals (pentachloronitrobenzene and 
hexachlorobenzene) indicate the potential for liver effects in mammals 
and systemic (body weight) effects for PCTP in mammals (no repeated-
dose animal or human epidemiological data were identified for PCTP). 
The studies presented in this document demonstrate these hazardous 
endpoints.

III. Regulatory Assessment of the PBT Chemicals

A. Regulatory Approach

    1. Developing options: Stakeholder engagement and consultations. In 
addition to the consultations described in Unit VI, EPA sought comment 
from experts on and users of the five PBT chemicals. The purpose of 
these discussions was to create awareness and educate stakeholders on 
the provisions under TSCA section 6(h); obtain input from 
manufacturers, processors, distributors, users, academics, advisory 
councils, and members of the public health community about past and 
present uses of the PBT chemicals; identify practices related to the 
use of the PBT chemicals; determine the importance of the PBT chemicals 
in their various industries; compile knowledge about critical uses, 
substitute chemicals or processes in various sectors; identify various 
industry standards and performance specifications; identify health 
effects; and craft potential risk reduction strategies. To this end, 
EPA held a public meeting via webinar in September 2017, and attended a 
``Fire Retardants in Plastics'' conference hosted by Applied Marketing 
Information in April 2018. Where appropriate, EPA followed up on 
pertinent details or issues raised in comments. EPA has met with, or 
otherwise communicated with, more than 50 companies, including 
manufacturers, processors, distributors, and chemical users as well as 
trade associations and other non-government organizations to discuss 
the topics outlined in this paragraph, and these discussions are cited 
throughout this notice where they informed analysis.
    2. Potential exposures that EPA is not proposing to regulate. In 
general, there are some activities or exposures that EPA is not 
proposing to regulate, even though the Exposure and Use Assessment 
(Ref. 4) identified exposures or potential exposures. One of these is 
disposal. Under RCRA, there are comprehensive regulations governing the 
disposal of hazardous and non-hazardous wastes. These range from 
requirements for RCRA Subtitle C hazardous waste incinerators, which 
must generally meet a destruction and removal efficiency of 99.99% or 
more, to hazardous waste landfills, which include a double liner, 
double leachate collection and removal systems, leak detection system, 
run on, runoff, and wind dispersal controls, and a construction quality 
assurance program, to municipal solid waste landfills, which must 
implement certain requirements that are similar to some of the Subtitle 
C requirements, to industrial nonhazardous and construction/demolition 
waste landfills. Industrial nonhazardous and construction/demolition 
waste landfills are primarily regulated under state regulatory 
programs, but they must meet the criteria set forth in Federal 
regulations for siting, groundwater monitoring and corrective action 
and a prohibition on open dumping. Disposal by underground injection is 
regulated under both RCRA and the Safe Drinking Water Act. In view of 
this comprehensive, stringent program for addressing disposal, EPA is 
proposing to determine that it is not practicable to impose additional 
requirements under

[[Page 36745]]

TSCA on the disposal of these PBT chemicals.
    EPA is also not generally proposing to use its TSCA section 6(a) 
authorities to regulate commercial use of products containing the PBT 
chemicals. For example, EPA is not proposing to prohibit the continued 
commercial use of articles or products that contain DecaBDE or PIP 
(3:1), such as commercial aircraft. Such a prohibition would not be 
practicable; to the contrary, it would be extremely burdensome, 
necessitating the identification of products containing DecaBDE or PIP 
(3:1), and the disposal of countless products, such as televisions and 
computers, that would have to be replaced with new products. If the 
continued commercial use of vehicles containing DecaBDE or PIP (3:1) 
were prohibited, it would result in widespread economic impacts and 
disruption in the channels of trade while the prohibited parts or 
fluids were identified and replaced. EPA believes that, for most 
products containing the PBT chemicals, it would be either extremely 
burdensome, for vehicles, or unreasonable, because of the low 
concentrations of PCTP in golf balls, for example, and, thus, 
impracticable to prohibit or otherwise restrict the continued 
commercial use of the products.
    Finally, EPA is not proposing to directly regulate occupational 
exposure through mandated controls such as engineering controls or use 
of personal protective equipment (PPE), such as gloves or respirators. 
EPA expects there is compliance with federal and state laws, such as 
worker protection standards, unless case-specific facts indicate 
otherwise, and therefore existing OSHA regulations for worker 
protection and hazard communication will prevent occupational exposures 
that are capable of causing injury from occurring. OSHA has not 
established permissible exposure limits (PELs) for any of the five PBT 
chemicals. However, under section 5(a)(1) of the Occupational Safety 
and Health Act of 1970, 29 U.S.C. 654, each employer has a legal 
obligation to furnish to each of its employees a place of employment 
that are free from recognized hazards that are causing or are likely to 
cause death or serious physical harm.
    Moreover, the OSHA hazard communication regulations at 29 CFR 
1910.1200 require chemical manufacturers and importers to classify the 
hazards of chemicals they produce/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. 
Specifically, manufacturers/importers are required to:
     Evaluate and classify chemicals produced in their 
workplace in accordance with specified hazard categories;
     Ensure that hazardous chemicals are labeled, tagged, 
marked or have another form of warning (unless the distributor fulfills 
this requirement);
     Obtain or develop a safety data sheet (SDS) for each 
hazardous chemical they produce or import; and
     Ensure that employers and distributors are provided an 
appropriate SDS with their initial shipment, and with the first 
shipment after any SDS update.
    Employers must:
     Develop, implement and maintain a written hazard 
communication program at each workplace;
     Have an SDS in the workplace for each hazardous chemical 
which they use;
     Maintain copies of the SDS for each hazardous chemical and 
ensure that they are readily accessible to employees; and
     Provide employees with effective information and training 
on hazardous chemicals in their work area.
    The OSHA regulations at 29 CFR 1910.132 through 1910.140 prescribe 
certain requirements for employers regarding eye, face, respiratory, 
head, foot and hand protections; electrical protective equipment; and 
personal fall protection systems. In general, employers must assess a 
workplace to determine if hazards are present, or are likely to be 
present, which necessitate the use of personal protective equipment 
(PPE). If the employer determines such hazards are present, or likely 
to be present, the employer must:
     Select the types of PPE that will protect against the 
identified hazards;
     Require affected employees to use that PPE;
     Communicate selection decisions to each affected employee; 
and
     Select PPE that properly fits each affected employee.
    EPA expects that employers will require, and workers will use, 
appropriate PPE consistent with 29 CFR 1910.132, taking into account 
employer-based assessments, in a manner sufficient to prevent 
occupational exposures that are capable of causing injury. Based upon 
information from and discussions with industry, EPA understands that 
engineering controls or PPE is routinely used in workplaces where the 
PBT chemicals are being manufactured, processed, or used. For example, 
one commenter, an aviation hydraulic fluid formulator, described the 
precautions taken to minimize employee exposure at its facility. 
Mandatory PPE includes approved latex/nitrile safety gloves, long-
sleeved, flame retardant shirts, flame retardant pants, and eye 
protection. In addition, employees are instructed to handle aviation 
hydraulic fluids in a closed system or where adequate exhaust 
ventilation is provided (EPA-HQ-OPPT-2016-0730-0006, EPA-HQ-OPPT-2016-
0730-0007). Another commenter stated that their employees are required 
to use PPE consisting of nitrile gloves, chemical-resistant slicker 
suits, chemical resistant boots, respirator with face shield, and a 
hardhat. This commenter stated that employees were expected to be 
trained and monitored in the correct use of the PPE (EPA-HQ-OPPT-2018-
0314-0018). Because EPA is proposing to, over time, prohibit the 
manufacture, processing, and distribution in commerce of the PBT 
chemicals for most uses, thus eliminating potential worker exposures 
associated with those activities, EPA believes exposures will be 
reduced to the extent practicable. EPA is not aware of any exposures to 
unprotected workers for the PBT chemicals, based on information 
gathered by EPA specific to these chemicals. Therefore, any additional 
workplace regulations that EPA could impose are unlikely to result in 
meaningful exposure reductions. Elimination of the hazardous chemical 
from the workplace, however, is the most preferred and most effective 
control measure identified in the recommended hierarchy of controls 
(Ref. 37) to protect workers from workplace hazards.
    3. Request for comment on proposed and alternative regulatory 
actions. EPA requests comment on all aspects of the proposed and 
alternative regulatory actions discussed in this unit, including 
comment on whether the proposed regulatory actions reduce exposures to 
the extent practicable and whether there are other actions that EPA 
should consider taking under TSCA section 6.
    In addition, for all of the PBT chemicals other than HCBD, 
recordkeeping generally consisting of ordinary business records would 
be required. EPA is proposing to require that the required records be 
kept for a period of three years. EPA requests comment on whether the 
recordkeeping time period is appropriate and adequate, considering the 
supply chains for the PBT chemicals and regulated products and articles 
made with the PBT chemicals, and the length of time that such chemicals 
and products may

[[Page 36746]]

remain in commerce. EPA specifically requests comment on whether the 
recordkeeping time period should be five years instead of three years. 
The statute of limitations for violations of TSCA is five years; thus, 
a five-year record retention period would require the preservation of 
records for the time period that a matter could be investigated and an 
enforcement action commenced.
    The proposed regulatory action for each PBT chemical is based on 
the information that EPA has on the chemical. While, as previously 
noted, EPA generally expects that there is compliance with Federal and 
state laws, such as worker protection standards or disposal 
requirements, unless case-specific facts indicate otherwise, EPA has 
varying amounts of information on how compliance with these legal 
obligations is accomplished. For example, for 2,4,6-TTBP, EPA received 
two very informative comments on the PPE in use and the engineering and 
process controls that reduce occupational and environmental exposures 
(EPA-HQ-OPPT-2016-0734-0006; EPA-HQ-OPPT-2018-0314-0018). While EPA 
expects that these or similar measures are being taken to control 
exposures for the other 4 PBT chemicals, EPA does not have the same 
detailed information for them, and therefore requests comment on the 
extent to which such measures are being taken for the other four PBT 
chemicals.

B. DecaBDE

    1. Description of the proposed regulatory action. EPA is proposing 
to prohibit, as of 60 days after the publication date of the final 
rule, the manufacture, processing and distribution in commerce of 
DecaBDE, and articles and products containing DecaBDE except those 
described further in this unit.
    EPA is not proposing to prohibit the processing for recycling of 
plastic from articles containing DecaBDE, so long as no new DecaBDE is 
added during the recycling process. EPA is also not proposing to 
prohibit the distribution in commerce of such plastic, either before or 
after recycling. Finally, EPA is not proposing to prohibit the 
processing and distribution in commerce of DecaBDE in articles and 
products that are made of plastic that was recycled from articles 
containing DecaBDE, so long as no DecaBDE was added during the 
production of the articles and products made of recycled plastic. EPA 
is aware that many different types of articles that contain plastic are 
recycled at the end of their useful life, and some of these articles, 
such as electronic equipment, were originally made with a flame 
retardant like DecaBDE. As EPA noted on the occasion of ``America 
Recycles Day'' on November 15, 2018, EPA recognizes the importance and 
impact of recycling, which contributes to American prosperity and the 
protection of our environment. In addition to helping to protect the 
environment by keeping valuable materials out of landfills, the U.S. 
recycling industry is an important economic driver and provides more 
than 757,000 jobs and $6.7 billion annually in tax revenues. EPA does 
not want to create disincentives for recycling by increasing the burden 
on the recycling of plastic. EPA believes that it would be overly 
burdensome and not practicable to impose restrictions on the recycling 
of plastics that may contain DecaBDE, or on the use of recycled plastic 
in plastic articles, because the DecaBDE is typically present in such 
articles at low levels (Ref. 38).
    EPA is not proposing to regulate the manufacture, processing, or 
distribution in commerce of DecaBDE-containing replacement parts for 
the aerospace and automotive industries. TSCA section 6(c)(2)(D) states 
that replacement parts for complex durable goods and complex consumer 
goods that are designed before the rule promulgation date must be 
exempt from a rule issued under TSCA section 6(a), unless EPA finds 
that the replacement parts contribute significantly to the risk 
identified in a risk evaluation under TSCA section 6(b). TSCA section 
6(h)(2) specifically provides that EPA is not required to conduct 
section 6(b) risk evaluations when conducting a TSCA section 6(a) 
rulemaking on PBTs. EPA notes that most of the PBT provisions in TSCA 
section 6(c) apply to any rulemaking under TSCA section 6(a), but some 
TSCA section 6(c) provisions cross-reference TSCA section 6(b) and 
assume the existence of a risk evaluation conducted thereunder. EPA's 
interpretation is that, where it has not conducted a TSCA section 6(b) 
risk evaluation, those provisions of TSCA section 6(c) that assume the 
existence of a TSCA section 6(b) rulemaking do not apply. Specifically, 
EPA's interpretation is that the following provisions of TSCA section 
6(c) do not apply to a TSCA section 6(a) rulemaking conducted to 
address PBTs under TSCA section 6(h) if EPA has not conducted a TSCA 
section 6(b) risk evaluation: TSCA section 6(c)(1) (setting deadlines 
for TSCA section 6(a) rulemakings by reference to the date of issuance 
of a TSCA section 6(b) risk evaluation), and TSCA section 6(c)(2)(D) 
and (E) (addressing the regulation of replacement parts for complex 
durable goods and articles by reference to the findings contained in a 
risk evaluation under TSCA section 6(b)). EPA invites public comment on 
this interpretation and seeks input on other possible interpretations.
    According to comments received from the Aerospace Industries 
Association (AIA) (on the PBDE SNUR), interior non-metallic parts of an 
airplane must meet the flammability standards in 14 CFR part 25 and in 
many cases, a flame retardant such as DecaBDE has been used to meet 
these standards. The aerospace industry expects to have phased out of 
DecaBDE in new aircraft within three years (Ref. 39). However, because 
there are many aircraft currently in use with components made with 
DecaBDE, replacement parts will still be needed for decades.
    Aircraft and their replacement parts must be certified by the FAA 
under 14 CFR part 21. The AIA states that a typical active service life 
span of aerospace industry products such as aircraft often is 30-40 
years or longer. In order to safely maintain and operate these 
aircraft, certified replacement parts must be available. EPA 
understands that it can take years to develop, qualify, and certify 
replacement parts, although, due to the aerospace industry's ongoing 
phase-out of DecaBDE, suitable alternatives to DecaBDE have likely been 
identified for many replacement parts. Nevertheless, the replacement 
parts must meet specified standards and go through the process of being 
certified by the FAA. Due to the time and expense involved in 
certifying replacement parts, the AIA asserts that it is not feasible 
to change the part design and recertify the large number of replacement 
parts that may contain DecaBDE for aircraft currently in use. In light 
of this information, EPA believes that requiring the aerospace industry 
to recertify replacement parts is not practicable, and therefore is not 
proposing to regulate DecaBDE-containing replacement parts for 
aerospace industry products for aircraft manufactured prior to the 
effective/publication date of the rule.
    Replacement parts for the automotive industry must also meet 
specified standards, though there is no similar certification process. 
The Federal Motor Vehicle Safety Standards, codified at 49 CFR part 
571, includes a standard for the flammability of interior materials at 
49 CFR 571.302. This standard establishes a test for flammability, 
including a specific test method for making the determination. EPA 
understands that DecaBDE has often

[[Page 36747]]

been used to meet this flammability standard. While EPA expects that 
the automotive industry will have phased out of DecaBDE for new 
automobiles by the time a final rule would be issued and take effect 
(Ref. 13), they will still have to maintain the availability of 
replacement parts for vehicles manufactured prior to that date. 
According to the automotive industry, there are customer and legal 
requirements which generally require the automotive sector to maintain 
supplies of replacement parts for 15 years, such as the requirement in 
42 U.S.C. 30120(g) to provide defect remedies at no charge for a period 
of 15 years after the affected vehicle was sold to its first purchaser 
(Ref. 13). The automotive industry asserts that a phase out of DecaBDE 
for these parts could mean that suppliers and manufacturers must 
redesign, source, and validate parts for many vehicles no longer in 
production, ultimately producing new sets of compliant parts (which 
could require retooling production lines) while scrapping currently 
retained parts (EPA-HQ-OPPT-2016-0735-0094). Further, economic 
disruption could occur if the automobile industry were required to 
rapidly reformulate replacement parts for countless makes, models, and 
years, especially if this resulted in a period of unavailability of key 
replacement parts (EPA-HQ-OPPT-2016-0735-0094). In light of this 
information, EPA believes that requiring the automotive industry to 
reformulate replacement parts for vehicles no longer being manufactured 
is not practicable, and therefore is not proposing to regulate DecaBDE-
containing replacement parts for motor vehicles manufactured prior to 
the effective date of the rule.
    Most importantly, any restriction on replacement parts for the 
aerospace and automobile industries could increase costs and safety 
concerns without meaningful exposure reductions. This is because, as 
previously noted, article components containing DecaBDE for finished 
products in automobiles and aircraft have limited releases. More 
specifically, releases to air and water are expected to be minimal 
because DecaBDE is entrained in the articles and is not expected to 
volatilize or migrate readily under normal use. Additionally, releases 
to land may occur from disposal of products that contain DecaBDE. 
Finally, occupational exposure from dermal contact with article 
components during installation is possible only if workers are 
unprotected and inhalation exposure is not expected due to the low 
potential for volatilization.
    EPA's proposed practicability determination is not time-limited, in 
that EPA is not proposing to prohibit the manufacture, processing, and 
distribution in commerce of DecaBDE for use in replacement parts, and 
the replacement parts themselves after a certain period of time. As 
noted, replacement parts for aerospace vehicles will be needed for 
decades. The automotive industry has commented that replacement parts 
are generally needed for 15 years, and EPA believes that, in most 
cases, replacement parts containing DecaBDE will not be manufactured, 
processed, or distributed in commerce after 15 years. EPA does not 
believe it is reasonable or practicable to regulate DecaBDE-containing 
replacement parts for the automotive industry after 15 years, in the 
unlikely event that such parts are available or needed.
    EPA requests comment on the proposed determination that it is not 
practicable to regulate DecaBDE-containing replacement parts for the 
aerospace and automotive industries. EPA also requests comment on 
whether, instead of a determination that it is not practicable to 
regulate these parts, EPA should consider an exemption under TSCA 
section 6(g) for them. EPA believes that, for both the aerospace and 
automotive industries, regulation of replacement parts would result in 
the disruption of critical infrastructure.
    However, EPA is proposing to prohibit the addition of DecaBDE to 
products and articles, other than replacement parts for the aerospace 
and automotive industries. An exploratory analysis indicated that 
DecaBDE migration from articles like toys does not represent a risk 
concern due to the mouthing behaviors (e.g., teething), based on the 
available information (Ref. 40). EPA believes that it is practicable to 
reduce exposures by prohibiting the addition of DecaBDE to these 
products and articles during the production process.
    EPA is proposing a compliance date of three years for new aerospace 
parts to align with the Aerospace Industries Association's voluntary 
phase-out of DecaBDE, and a compliance date of 18 months for ongoing 
manufacture of curtains used in the hospitality industry to allow for 
the orderly transition to a replacement coating chemical. These 
compliance dates are intended to allow the products to clear the 
channels of trade prior to the compliance date.
    EPA has 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, other than those for which later 
compliance dates are being proposed, or that additional time is needed 
for products to clear the channels of trade.
    In addition, EPA is proposing to require, as of 60 days after the 
date that the final rule is published, all persons who manufacture, 
process, or distribute in commerce DecaBDE for non-prohibited uses, and 
non-prohibited articles and products to which DecaBDE has been added, 
to maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate compliance with the prohibitions and 
restrictions. These records would have to be maintained for a period of 
three years from the date the record is generated. This recordkeeping 
requirement does not apply to the processing and distribution in 
commerce of plastic for recycling, recycled plastic, and articles and 
products made with recycled plastic, so long as no DecaBDE is added to 
the recycled plastic and the articles and products made with recycled 
plastic.
    TSCA authorizes EPA to investigate, through inspections and the use 
of administrative subpoenas, and to collect information on the imported 
products and manufactured materials used to produce those products. EPA 
uses these tools to help ensure compliance with regulatory requirements 
for manufactured (including imported), processed, or distributed 
products, including those containing DecaBDE, among other chemicals. 
EPA's National Program Guidance for the Office of Enforcement and 
Compliance Assurance identifies the agency's focus on monitoring the 
compliance of chemical substances and articles imported into the United 
Stated in coordination with U.S. Customs and Border Patrol (CBP).
    EPA requests comment on ways that importers and others, who do not 
produce articles, can ensure that they are in compliance with this 
prohibition. One option would be for these entities to contract with 
their suppliers to supply only goods that comply with this prohibition. 
EPA could establish a requirement that persons who import, process, or 
distribute articles, or certain categories of articles such as consumer 
electronics, rubber wire casings and plastic children's products, 
obtain and retain ordinary business records, such as invoices, and that 
such records must include a written statement from the supplier that 
the articles were not made with DecaBDE. Compliance with such a 
recordkeeping requirement would constitute compliance with the 
prohibition on the addition of DecaBDE

[[Page 36748]]

to products and articles. EPA requests comment on the merits of this 
approach and other approaches to achieving compliance.
    2. Description of the primary alternative regulatory action 
considered. EPA considered an alternative regulatory action of 
prohibiting the manufacture, processing and distribution in commerce of 
articles containing DecaBDE at levels above 0.1% by weight. The 0.1% 
level was determined from consultations with academics and experts as a 
means to differentiate between DecaBDE that was added to the article 
versus DecaBDE that may have been present in the plastic from which the 
article was made, and from existing state regulations on DecaBDE. This 
option would be in addition to the prohibitions outlined in Unit 
III.B.2 and would exclude replacement parts for the automotive and 
aerospace industries. The delayed compliance dates for curtain 
manufacturing and new aerospace parts would also remain for this 
option. Requiring industry to meet a level of 0.1% in recycled plastic 
articles would also result in a significant burden by effectively 
requiring companies manufacturing (including importing) articles out of 
recycled plastics to test their products for levels of DecaBDE or risk 
being out of compliance (Ref. 3). In general, EPA understands that most 
testing methods cannot distinguish between brominated flame retardants, 
or between polybrominated diphenyl ether (PBDE) congeners, and that 
more expensive and time-consuming test methods are necessary to 
determine whether DecaBDE is present (Ref. 41). Therefore, EPA does not 
believe this option is practicable.
    3. Evaluation of whether the regulatory actions address the TSCA 
section 6(h)(4) standard. This proposal would, over time, eliminate the 
introduction of new DecaBDE into the supply chain. Cost-effective and 
technically feasible substitutes are readily available for all uses of 
DecaBDE (Ref. 3). However, as previously noted, EPA has determined that 
it would be impracticable to use the TSCA section 6(a) regulatory tools 
to address DecaBDE that is already in products in commercial use or the 
disposal of products. For similar reasons, EPA is not proposing to 
prohibit the recycling of plastic which may contain DecaBDE, such as 
high-impact polystyrene. An element of practicability is 
reasonableness. EPA does not believe it is reasonable, and thereby 
practicable, to impose a large burden on society through the further 
reduction or elimination of low concentrations of DecaBDE in articles 
made from recycled materials. The already low content of DecaBDE in 
recycled plastic would be expected to continue declining, as fewer and 
fewer products are made with DecaBDE. In order to ensure that plastics 
made with DecaBDE are not recycled into any new articles and products, 
the incoming waste plastic would have to be sorted and tested for 
articles most likely to contain DecaBDE, such as television cabinets, 
electronics cases, and most types of high impact polystyrene, which 
would be rejected for recycling and instead be disposed of in a 
landfill, or the incoming waste could be tested for DecaBDE content. 
EPA considered, as a primary alternative regulatory action to the 
proposed option, a percentage limit on DecaBDE in products. While this 
option may also reduce exposures in comparison to the proposed option, 
EPA believes that the testing burden, including the ability to test 
specifically for DecaBDE that would need to be assumed as a compliance 
method by processors and distributors, could be considerable and would 
make that option impracticable (Ref. 3). More information on these 
testing burdens and the economic impacts of the primary alternative 
regulatory action in general can be found in Unit IV.B. and in the 
Economic Analysis (Ref. 3).
    With respect to the recycling of plastics that contain DecaBDE, EPA 
requests comment on whether one particular situation warrants a 
different approach. While it is EPA's understanding that plastic 
pallets are no longer being made with DecaBDE as a flame retardant, 
they are being recycled back into plastic pallets when they become 
damaged and are no longer usable. The pallets were made with DecaBDE to 
begin with, and the pallet producers are aware of the DecaBDE content, 
which is likely to be higher than that present in general plastics 
recycling streams. EPA is still proposing to determine that it is not 
practicable to prohibit the recycling of plastic pallets because, as 
previously noted, releases from article components are expected to be 
minimal because DecaBDE is entrained in the articles and is not 
expected to volatize or migrate readily under normal use. However, EPA 
requests comment on this proposed determination and whether there are 
actions that EPA should consider taking under TSCA section 6 with 
respect to the recycling of plastic pallets.
    EPA also considered issues with compliance dates, taking into 
account input from stakeholders. The aerospace industry has been 
working towards the elimination of DecaBDE in new aircraft and 
aerospace vehicles. However, the design and certification of new 
aircraft, for instance, is a complicated and lengthy process and, as a 
consequence, some additional time is necessary to ensure a reasonable 
transition for this industry (EPA-HQ-OPPT-2016-0724-0006). The 
Aerospace Industries Association has volunteered to remove DecaBDE from 
all new aerospace parts by 2023 (Ref. 39). Thus, EPA believes a 
compliance date to begin three years from the publication date of the 
final rule, rather than an a more immediate compliance date, is the 
soonest practicable timeframe for the aerospace industry to comply with 
a prohibition on DecaBDE in new aerospace vehicles and new parts for 
such vehicles, and for products containing DecaBDE to clear the 
channels of trade.
    With respect to curtains used in the hospitality industry, EPA 
understands that most of the industry has moved away from using DecaBDE 
as a flame retardant. However, EPA is aware of one small business that 
is still using DecaBDE while it searches for a replacement flame 
retardant. EPA believes that 18 months from the date of publication of 
the final rule, rather than an immediate compliance date, is the 
soonest practicable date for the small business to redesign or find a 
substitute for the curtain production process, and for treated curtains 
to clear the channels of trade.
    4. Consideration of chemical alternatives (substitutes) in deciding 
whether to propose to prohibit or restrict DecaBDE. EPA believes that 
there are viable substitutes for all uses of DecaBDE. In January 2014, 
EPA's Design for the Environment (DfE) published an alternatives 
assessment for DecaBDE (Ref. 42). EPA identified 29 potential 
functional, viable alternatives to DecaBDE for use in select 
polyolefins, styrenics, engineering thermoplastics, thermosets, 
elastomers, or waterborne emulsions and coatings (Ref. 42).
    (i) Health and environmental effects of the chemical alternatives 
or substitute methods. The human health endpoints evaluated in EPA's 
DfE alternatives assessment include acute toxicity, carcinogenicity, 
genotoxicity, reproductive toxicity, developmental toxicity, 
neurotoxicity, repeated-dose toxicity, skin sensitization, respiratory 
sensitization, eye irritation, and dermal irritation (Ref. 42). Acute 
and chronic aquatic toxicity endpoints and persistence and 
bioaccumulation potential were also evaluated as part of this 
assessment. DecaBDE and the identified alternatives were ranked on 
these endpoints according to the methodology outlined in EPA's DfE

[[Page 36749]]

alternatives assessment and given a hazard ranking between very low and 
very high. While some of the available alternatives were found to have 
hazard profiles similar to DecaBDE, there are other available 
alternatives that ranked lower than DecaBDE for each hazard endpoint 
(Ref. 42).
    (ii) Technical feasibility, economic feasibility, and reasonable 
availability of the chemical alternatives or substitute methods. 
Several potential substitutes for DecaBDE exist, specific to each use. 
In total, 27 unique chemical substitutes were identified for DecaBDE 
through EPA's DfE Alternatives Assessment, published in 2014. Two were 
removed from the original list of 29 for the purposes of this 
rulemaking since they are synergists without flame-retardant properties 
and not considered alternatives. An additional six were identified 
through internet research for a total of 33 substitutes (Ref. 3). 
Specific substitutes may be favored by industry based on the ability to 
easily replace DecaBDE, efficacy, price and availability, relative 
human health or environmental concerns, or other qualities of the 
substitute that may or may not impact the final product. Appropriate 
substitutes for DecaBDE vary depending on the material and application 
method being used to apply them. However, cost-effective and 
technically feasible substitutes are generally available for all uses 
of DecaBDE (Ref. 3).

C. PIP (3:1)

    1. Description of the proposed regulatory action. EPA is proposing 
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; and
     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 the parts to which PIP (3:1) has been added.
    EPA is not proposing to regulate the processing or distribution in 
commerce of PIP (3:1) or PIP (3:1)-containing products for use in new 
or replacement parts for the automotive industry, or distribution in 
commerce of such parts that contain PIP (3:1). EPA understands that PIP 
(3:1) may be used to meet anti-flammability standards and for other 
uses (EPA-HQ-OPPT-2018-0314-0026). Economic disruption could occur if 
the automotive industry were required to rapidly reformulate 
replacement parts for countless makes, models, and years, especially if 
this resulted in a period of unavailability of key replacement parts 
(EPA-HQ-OPPT-2016-0735-0094). Restrictions on distribution in commerce 
of replacement parts that contain PIP (3:1) would have a similar 
effect. As with DecaBDE, EPA believes that requiring the automotive 
industry to reformulate replacement parts for vehicles no longer being 
manufactured is not practicable, and therefore is not proposing to 
regulate PIP (3:1)-containing replacement parts for motor vehicles 
manufactured prior to the effective date of the rule. Most importantly, 
any restriction on replacement parts for the automotive industries 
could increase costs and safety concerns without meaningful exposure 
reductions for those same pathways described in Unit III.B.1. For these 
same reasons, EPA is not proposing to regulate the processing and 
distribution in commerce of PIP (3:1) or PIP (3:1)-containing products 
for use in new parts containing PIP (3:1) for the automotive industry, 
or distribution in commerce of such parts that contain PIP (3:1). EPA 
has received information from the automotive industry indicating that 
there are a number of new parts made with PIP (3:1) and that 
substitutes for PIP (3:1) in these parts have not been identified and 
tested (Refs. 43 and 44). EPA acknowledges the importance of PIP (3:1) 
components to the automotive industry and the difficulties of 
reformulation. As with replacement parts, any restriction on the 
processing and distribution in commerce of new parts for the automotive 
industry could increase costs and safety concerns without meaningful 
exposure reductions. For this proposal, EPA considers new parts to be 
newly-manufactured parts that are designed for use in automobiles and 
other vehicles that will be produced for the model year beginning after 
the effective date of the final rule. Replacement parts are also newly-
manufactured parts that are designed for use in automobiles and other 
vehicles that will have been produced for the model year beginning 
before the effective date of the final rule and earlier model years.
    In addition, EPA is not proposing to restrict the manufacture of 
PIP (3:1) so that the allowable processing and distribution may 
continue, but is proposing to impose recordkeeping and downstream 
notification requirements on manufacturers. Manufacturing occurs in a 
closed system and generally there is no waste produced in the 
manufacturing, so existing best practices are expected to mitigate 
potential releases to the environment (Ref. 4).
    EPA is proposing to prohibit releases to water from the processing, 
distribution in commerce, and commercial use activities that are 
permitted to occur, i.e., use in aviation hydraulic fluid, use in 
lubricants and greases, and use in new and replacement parts for the 
automotive industry. Persons manufacturing, processing, and 
distributing PIP (3:1), and products containing PIP (3:1), in commerce 
would be required to notify their customers of these prohibitions on 
processing and distribution, and the prohibition on releases. 
Additionally, EPA requests comment on additional details of how a 
prohibition on releases to water could best be achieved in the aircraft 
maintenance space.
    In addition, EPA is proposing to require, as of 60 days after the 
date that the final rule is published, all persons who manufacture, 
process, or distribute in commerce PIP (3:1) and articles and products 
containing PIP (3:1) to maintain ordinary business records, such as 
invoices and bills-of-lading, that demonstrate compliance with the 
prohibitions and restrictions. These records would have to be 
maintained for a period of three years from the date the record is 
generated.
    TSCA authorizes EPA to investigate, through inspections and the use 
of administrative subpoenas, and to collect information on the imported 
products and manufactured materials used to produce those products. EPA 
use these tools to help ensure compliance with regulatory requirements 
for manufactured (including imported), processed, or distributed 
products, including those containing PIP (3:1), among other chemicals. 
EPA's National Program Guidance for the Office of Enforcement and 
Compliance Assurance identifies the agency's focus on monitoring the 
compliance of chemical substances and articles imported into the United 
States in coordination with U.S. Customs and Border Patrol (CBP).
    EPA has 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. However, EPA requests 
comment on whether additional time is needed for products to clear the 
channels of trade.
    EPA acknowledges that PIP (3:1) is an important anti-wear additive 
in aviation hydraulic fluid for commercial aircraft and commercial 
derivative military aircraft, including for emerging

[[Page 36750]]

technologies such as 5,000 PSI hydraulic systems. It is the Agency's 
understanding that PIP (3:1)-containing hydraulic fluids are currently 
the only fluids recommended for these high-pressure hydraulic systems. 
EPA is requesting comment on the degree to which alternative hydraulic 
fluids without PIP (3:1) are available for aircraft operating at 3,000 
PSI, and documented performance differences between phosphate ester 
based hydraulic fluids with and without PIP (3:1) in the aviation 
sector.
    EPA also acknowledges the degree to which PIP (3:1) is a crucial 
anti-wear component for aviation lubricants and greases, which need to 
perform at a wide range of temperatures and pressures. EPA has excluded 
lubricants and greases for aviation and non-aviation uses from the 
proposed prohibition on processing and distribution. EPA understands 
there are some non-aviation uses of these lubricants and greases where 
PIP (3:1) is a crucial anti-wear component, such as turbines used in 
power generation or in marine settings (Ref. 23). Therefore, EPA is 
proposing to determine that it is not practicable to regulate the 
presence of PIP (3:1) in lubricants and greases in general. However, 
EPA acknowledges that uses in non-aircraft machinery may not be subject 
to these same environmental stresses or safety and performance 
requirements from industry and government as uses in the aviation 
sector. Therefore, EPA is requesting 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. This includes information about 
alternatives with equivalent performance (or lack thereof), safety 
standards, information about standard use practices and exposure, and 
any other relevant information, for lubricants and greases used in 
turbines or other machinery derived from aviation but applied to a 
stationary technology such as power generation, and other military or 
commercial uses.
    In addition, EPA is requesting comment on the concentration by 
weight of PIP (3:1) currently present in products for the excluded 
uses, as well as the concentration required for critical application in 
aviation and other industries, and trends in these concentrations which 
may accompany changes in technology over time. EPA believes the upper 
bounds of the levels present in commerce for use in aviation hydraulic 
fluids to be 20% concentration by weight and aviation lubricants and 
greases to be 5% concentration by weight. While EPA does not have 
reason to believe that uses in excess of these levels are occurring, 
EPA acknowledges that these products are of significant importance in 
commercial and military aviation, including for emerging technologies 
such as 5,000 PSI hydraulic systems. EPA does not want to unnecessarily 
inhibit the development of more efficient aircraft, but large increases 
in the concentrations of PIP (3:1) in the non-prohibited hydraulic 
fluids and lubricants and greases could result in greater exposures. 
EPA requests comment on whether a concentration limit should be imposed 
on these non-prohibited uses. The uses of PIP (3:1) containing products 
in these sectors is discussed further in Unit III.C.3.
    In addition, EPA is specifically requesting comment on the extent 
to which plastic articles that contain 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. The exclusion 
would be similar to the exclusion discussed in Unit III.B.1. for 
recycled plastics that contain DecaBDE. While EPA is aware that many of 
the plastics in the recycling stream contain DecaBDE, EPA does not have 
information on the content of PIP (3:1) in articles being recycled. As 
noted in Unit II.D.2.i., PIP (3:1) has been identified as a possible 
component in plastic products and articles, including children's 
products and automotive and aerospace products. In addition, PIP (3:1) 
has also been used as a component of flame retardants used in 
polyurethane foam. EPA also requests comment on the extent to which 
polyurethane foam that contains PIP (3:1) is recycled, the amount of 
PIP (3:1) that remains in the recycled material, and whether an 
exclusion should be considered for recycling of polyurethane foam.
    2. Description of the primary alternative regulatory action 
considered. EPA considered an alternative regulatory action for PIP 
(3:1) of prohibiting 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 for aircraft hydraulic systems designed to 
operate at pressure equal to or greater than 3,000 pounds per square 
inch (PSI) for a period of 20 years;
     Processing and distribution in commerce for use in 
aviation lubricants and greases for a period of 20 years; and
     Processing and distribution in commerce for use in new and 
replacement parts for the automotive industry, and the distribution in 
commerce of the parts to which PIP (3:1) has been added.
    A 20-year time-limited exemption would be proposed under TSCA 
section 6(g)(1)(B) for use in aviation hydraulic fluids for aircraft 
hydraulic systems operating at equal to or greater than 3,000 PSI at 
the currently present in commerce, and aviation lubricants and greases 
at concentration currently present in commerce. Under the primary 
alternative action, like with the proposed action, EPA would prohibit 
releases to water from the processing, distribution in commerce, and 
commercial use activities that are not prohibited. In addition, like 
with the proposed action, persons manufacturing, processing, and 
distributing in commerce PIP (3:1), and products containing PIP (3:1), 
would be required to notify their customers of each of these 
restrictions.
    The primary alternative regulatory action differs from the proposed 
action in that specified allowed uses in aviation would be subject to 
an exemption under TSCA section 6(g) rather than excluded from the 
prohibition of uses under TSCA section 6(a). The proposed time-frame 
for this exemption would be 20 years, after which time the exemption 
would expire or be extended via rulemaking.
    3. Evaluation of whether the regulatory actions address the TSCA 
section 6(h)(4) standard. As discussed here, there are readily 
available alternatives for all uses except the specific uses described 
in Unit II.D.2.i and Unit II.D.2.ii, namely in aviation hydraulic 
fluids lubricants and greases. Additionally, as previously mentioned, 
EPA is not proposing regulatory controls on the manufacturing of PIP 
(3:1) beyond recordkeeping and downstream notification requirements. As 
stated in Unit III.C.1., manufacturing occurs in a closed system and 
generally there is no waste produced in the manufacturing, so existing 
best practices are likely to mitigate potential releases to the 
environment (Ref. 4).
    Lubricants, greases, and aviation hydraulic fluids are excluded 
from the proposed regulation because they are necessary to maintain the 
airworthiness of aircraft, no other substitutes are currently 
available, and the burden of creating and testing new formulations 
which can meet the equivalent safety and performance standards is high 
(Ref. 3). Aviation fluids are approved by major aircraft manufacturers 
who work closely with the FAA, and any change

[[Page 36751]]

in formula composition results in a full requalification process. 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, 23 and 24). These aviation lubricants and greases 
are sometimes used for other machinery such as turbines used in power 
generation. For lubricants and greases in other industries, EPA has 
included a request for comment outlining additional information that 
would be useful in Unit III.C.1. Thus, EPA is not proposing to prohibit 
manufacture, processing, or distribution for the aviation uses 
described in Unit II.D.2 because doing so is not practicable. By 
prohibiting the majority of processing and distribution of the 
chemical, and placing certain restrictions on processing, distribution, 
and use for hydraulic fluid and lubricants and greases in aviation, 
including a prohibition on release to water, the regulatory approach 
reduces exposures to the extent practicable.
    Manufacturers have described alternative chemicals that are 
available for the functional applications of PIP (3:1) as a 
plasticizer, flame retardant, and anti-wear additive (Ref. 4). In many 
sectors, this claim by manufacturers is supported by stakeholder 
engagement. While possible chemical alternatives or alternative 
products exist in many sectors, these alternatives lack field testing 
in formulation for key uses in aviation, including emerging 
technologies of high-pressure aviation hydraulic systems. (Refs. 23 and 
24, and 25). Therefore, EPA believes that prohibitions on processing, 
distribution, and use, including the alternative approach which could 
take effect upon the expiration of an exemption, are not practicable 
for certain uses of PIP (3:1) important to airworthiness in commercial 
aviation and aerospace.
    4. Consideration of chemical alternatives (substitutes) in deciding 
whether to prohibit or restrict PIP (3:1). Based on an analysis of 
likely alternatives, EPA believes that there are viable substitutes for 
all uses of PIP (3:1), except for uses in aviation hydraulic fluids and 
aviation lubricants and greases.
    (i) Health and environmental effects of the chemical alternatives 
or substitute methods. EPA conducted an analysis of three identified 
likely substitutes for PIP (3:1) based on the process described in the 
TSCA Work Plan Chemicals: Methods Document (Ref. 2). Those substitutes 
all scored lower than PIP (3:1) in at least one criterion. For example, 
2-ethylhexyl diphenyl phosphate ester (CAS 1241-94-7) and isodecyl, 
diphenyl phosphate (CAS 29761-21-5) both scored lower than PIP (3:1) in 
persistence, bioaccumulation, and human hazard. In addition, phenol, 
isobutylenated, phosphate (3:1) (CAS 68937-40-6) scored lower than PIP 
(3:1) in human and environmental hazard (Ref. 45).
    (ii) Technical feasibility, economic feasibility, and reasonable 
availability of the chemical alternatives or substitute methods. As 
discussed in Unit II.D.4, viable substitutes are available for many of 
the uses of PIP (3:1). In their comment, the Israel Chemical Limited 
(ICL) company stated that there are readily available alternatives for 
many of the functional uses of PIP (3:1), including as a plasticizer, 
flame retardant, and anti-wear additive. These alternative chemicals 
could act as replacements for PIP (3:1) within formulas in various 
industries. In sectors such as paints and coatings, adhesives and 
sealants, and plastics, PIP (3:1) containing products represent a small 
market share, and the elimination of said products would not have a 
significant effect on small businesses (Ref. 3). For industrial 
hydraulic fluids (excluding aviation), various alternative products to 
those containing PIP (3:1) are already in commerce.
    PIP (3:1) is used in the aviation industry in hydraulic fluid to 
achieve the necessary anti-wear and anti-compressibility performance 
for formulas maintaining the airworthiness of commercial and military 
aircraft. While alternative formulas have been identified for use in 
several models of aircrafts, there are no feasible alternative formulas 
for hydraulic fluid that meet the requisite performance specification 
and safety standards for hydraulic systems designed to operate at 
pressures equal to or greater than 5,000 PSI (Refs. 23 and 24, and 25). 
Therefore, there are currently no technically feasible alternative 
formulas available for some PIP (3:1)-containing hydraulic fluids in 
the aviation sector for hydraulic systems designed to operate at 
pressures equal to or greater than 5,000 PSI.
    Furthermore, PIP (3:1) is a component of a lubricant additive which 
is used primarily for its anti-wear properties. There are also 
currently no technically feasible alternative formulas available for 
some PIP (3:1)-containing and lubricants and greases in the aviation 
sector, which are formulated to industry and military specifications 
(Refs. 22, 23, 24, 26, and 46).
    The economic feasibility of alternatives for all uses other than 
these specialized aviation uses is discussed in the economic analysis 
for this proposed action (Ref. 3).

D. 2,4,6-TTBP

    1. Description of the proposed regulatory action. EPA is proposing 
to restrict the distribution in commerce of TTBP and products 
containing 2,4,6-TTBP in containers with a volume of less than 55 
gallons. This will effectively prevent use of 2,4,6-TTBP as a retail 
fuel additive or fuel injector cleaner by consumers.
    Exposure to humans and the environment would be reduced by 
eliminating retail uses of 2,4,6-TTBP that have a high potential for 
releases. This proposal intentionally would not impact use of this 
chemical in the nation's fuel supply system (i.e., at refineries and 
bulk petroleum storage facilities), where the distribution, transfer, 
blending, and general end use of 2,4,6-TTBP-containing blends/mixtures 
is managed through highly regulated engineered controls designed to 
mitigate environmental and human health exposures. EPA believes that 
much, if not all use of 2,4,6-TTBP containing blends/mixtures at 
refineries and petroleum storage facilities are sourced in quantities 
larger than 55 gallons at a time; and are typically sourced by the 
tanker or batch load in quantities over 500 gallons at a time.
    As such, EPA is also taking comment on the optimal container size 
limit to impose: For instance, whether a 35-gallon container size would 
impact industrial use less while also preventing the commercial and 
retail sale of products with 2,4,6-TTBP. EPA would welcome information 
submitted to the docket for this action that provides data or 
information related to the proposed restriction on container size.
    For this regulation, EPA is proposing to define 2,4,6-TTBP to mean 
the chemical substance 2,4,6-tris(tert-butyl)phenol (CASRN 732-26-3) at 
any concentration above 0.01% by weight. EPA believes this 
concentration limit would distinguish between products which contain 
2,4,6-TTBP as a functional additive and those in which it may be 
present in low concentrations as a byproduct or impurity. 2,4,6-TTBP is 
a co-product and byproduct present in other alkylphenols, including 
other antioxidants that are potential substitutes for it. 
Significantly, this lower limit would also ensure that this prohibition 
does not unintentionally apply to fuels which have been treated with 
antioxidant additives containing 2,4,6-TTBP, an outcome EPA does not

[[Page 36752]]

intend. One commenter stated that the chemical is added to fuels at 
concentrations of 5 to 50 ppm, approximately 0.0005% to 0.005%, or less 
than half the concentration limit proposed by EPA (EPA-HQ-OPPT-2016-
0734-0006). Thus, EPA is not proposing to regulate fuel after it has 
been treated with antioxidants containing 2,4,6-TTBP; EPA is only 
proposing to regulate the retail additives containing 2,4,6-TTBP that 
are used to treat the fuel. A regulation prohibiting the presence of 
2,4,6-TTBP in gasoline and other fuels would effectively prohibit the 
use of this antioxidant at refineries to treat bulk fuels, because it 
would prohibit the commercial use of the treated fuel in smaller 
vehicles including automobiles. As discussed in Unit II.D.3.(i) of this 
notice, EPA believes this is a critical use in the nation's fuel 
supply.
    EPA is also proposing to prohibit processing and distribution in 
commerce of 2,4,6-TTBP for use as an additive in oils and lubricants. 
There are numerous available substitutes for this use of 2,4,6-TTBP. 
For clarity, EPA is proposing a definition of oil and lubricant 
additive for this rule to mean any intentional additive to a product of 
any viscosity intended to reduce friction between moving parts, whether 
mineral oil or synthetic base, including engine crankcase oils and 
bearing greases.
    EPA has 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.
    EPA is proposing for recordkeeping that after 60 days following the 
date of publication of the final rule, distributors of 2,4,6 TTBP and 
products containing 2,4,6-TTBP must maintain ordinary business records, 
such as invoices and bills-of-lading, that demonstrate that 2,4,6-TTBP 
is not distributed in containers with a volume less than 55 gallons or 
for use as an oil and lubricant additive. These records must be 
maintained for a period of three years from the date the record is 
generated.
    2. Description of the primary alternative regulatory action 
considered. EPA considered an alternative regulatory action of 
prohibiting the distribution in commerce of 2,4,6-TTBP in fuel 
additives and fuel injector cleaners intended for consumer/retail use. 
Like the proposed action, this approach would define 2,4,6-TTBP with a 
concentration of 2,4,6-TTBP; a level of 0.01% by weight. This 
alternative would include defining the end uses for which distribution 
of 2,4,6-TTBP is prohibited: retail sale of fuel additives and fuel 
injector cleaners. Distributors of chemical mixtures containing 2,4,6-
TTBP above the specified level would be required to notify purchasers 
of the presence of 2,4,6-TTBP in the product and the prohibition on its 
sale for retail use. Records of sales and notification to customers 
would be maintained by distributors. Should the Agency not finalize 
provisions related to the container size threshold, downstream 
notification would need to be a regulatory requirement. While this 
approach would achieve the same or similar exposure reduction as the 
limit on container sizes proposed in this rule, EPA believes this 
alternative approach would potentially impact more retail sellers and 
users, be more difficult to enforce, and impose a greater compliance 
burden on the regulated community for notification and recordkeeping 
requirements. This approach would potentially also affect distribution 
of large volumes of 2,4,6-TTBP to industrial users, such as refineries, 
who are not engaged in processing and distribution of fuel additive 
products for commercial and consumer sales.
    3. Evaluation of whether the regulatory actions address the TSCA 
section 6(h)(4) standard. The proposed approach allows for the 
processing and distribution for use in the industrial/commercial fuel 
sector where prohibitions or restrictions on 2,4,6-TTBP mixtures would 
not be practicable due to its essential use in the nation's fuel supply 
system. As discussed in Unit II.D.3.(i) of this notice, this chemical 
is a component of antioxidant mixtures that are widely used in this 
country and essential for the storage and transport of fuel, and these 
mixtures cannot be substituted without affecting numerous commercial 
and military fuel specifications for stability and quality. Although 
not quantified for this proposed rule, the expense of certifying a new 
alternative fuel additive would be significant and take years, 
particularly for aviation applications. In addition, as discussed in 
Unit II.E.2.(iii) of this notice, the potential for exposure from the 
manufacturing, processing, and distribution for commercial use and the 
commercial use is significantly mitigated by use of industrial 
engineering controls and safeguards. Releases of 2,4,6- TTBP from 
retail additive use and disposal are more likely than in industrial 
settings where engineered controls are highly likely to be in place. In 
contrast, EPA believes the proposed restriction on the processing and 
distribution for use of 2,4,6-TTBP in the retail products is 
practicable because alternative antioxidants are readily available for 
those products and can be substituted in those products without undue 
burden. Thus, EPA does not believe a complete prohibition on 2,4,6-TTBP 
is practicable given its essential use in the nation's fuel supply. 
Furthermore, its co-production with other alkylphenols is significant, 
in that prohibiting the manufacture of 2,4,6-TTBP would restrict, if 
not prevent, the production of other dialkylphenol products, including 
alternative antioxidants.
    4. Consideration of chemical alternatives (substitutes) in deciding 
whether to propose to prohibit or restrict 2,4,6-TTBP. Based on a 
screening level analysis of likely alternatives, as noted previously, 
EPA believes that there are readily available substitutes for the 
retail fuel additives, as well as oil and lubricant additives 
containing 2,4,6-TTBP. EPA believes that the overwhelming predominance 
in the marketplace of oil and lubricant products that do not contain 
2,4,6-TTBP is itself sufficient evidence of the availability of those 
substitute chemicals or products.
    (i) Health and environmental effects of the chemical alternatives 
or substitute methods. EPA conducted a screening level analysis of two 
possible substitutes for 2,4,6-TTBP based on the TSCA Work Plan 
Chemicals: Methods Document (Ref. 2). One alternative antioxidant 
suitable as a fuel additive is 2,4-dimethyl-6-tert-butylphenol, CASRN 
1879-09-0, and the other is 2,6-di-tert-butyl-p-cresol, also known as 
butylated hydroxytoluene or BHT, CASRN 128-37-0. Both chemicals have a 
lower bioaccumulation potential than 2,4,6-TTBP, but equivalent or 
higher scores for persistence, environmental hazard and human health 
hazard (Ref. 45). However, BHT is used as a food additive: It is 
approved by FDA for use as a food additive (21 CFR 172.115) and in the 
European Union, its use is permitted in foods by the European Food 
Safety Authority under E321 (Ref. 47). BHT is also used in personal 
care products and cosmetics. EPA seeks public comment on whether the 
proposed action is practicable given it could result in increased use 
of alternatives to 2,4,6-TTBP with comparable persistence and hazard 
scores. EPA did not assess the hazard of the chemical mixtures in 
commercial products containing 2,4,6-TTBP, nor did it assess the hazard 
of substitute products that do not contain 2,4,6-TTBP, so no 
conclusions as to the relative hazard of product substitutes can be 
drawn.

[[Page 36753]]

    (ii) Technical feasibility, economic feasibility, and reasonable 
availability of the chemical alternatives or substitute methods. 
Alternatives to fuel additives and fuel injector cleaner products 
containing 2,4,6-TTBP exist. The alternative chemical 2,4-dimethyl-6-
tert-butylphenol is currently used as an antioxidant fuel additive in 
jet fuels, gasolines and aviation gas, among other uses. BHT is used as 
a fuel additive for its antioxidant properties, and in addition to its 
uses in fuels, including jet fuels, it is also used in hydraulic 
fluids, turbine and gear oils, making it a suitable substitute for such 
uses of 2,4,6-TTBP in oils and lubricants that may be occurring (Ref. 
48). While EPA did not identify the specific alternative chemicals used 
in each product, for the Economic Analysis (Ref. 3), EPA was able to 
determine 35 product substitutes for commercial fuel stabilizer 
products and 15 product substitutes for commercial fuel injector 
cleaner products (for purposes of the analysis, product substitutes are 
considered those that serve the same purpose but do not contain 2,4,6-
TTBP). The appropriate product substitute will vary depending on type 
of engine for which the use is intended.

E. HCBD

    1. Description of the proposed regulatory action. EPA is not 
proposing to regulate HCBD under TSCA section 6(h) because the 
potential for exposure from uses of this chemical is already addressed 
by actions taken under other statutes and further measures are not 
practicable. As stated elsewhere in this preamble, HCBD is regulated 
under various statutes implemented by the Federal Government, such as 
the CAA and RCRA, and most states. According to TRI data, most of the 
HCBD manufactured in the United States is subsequently destroyed via 
incineration. Of the over 9 million lbs of HCBD in waste reported to 
TRI, only 2,400 lbs is released to the environment due in large part to 
the high waste treatment efficiencies achieved by the chemical 
manufacturers. Most of these releases to the environment are via 
fugitive and stack air emissions, with little or no quantities released 
to other media (Ref. 19).
    The CAA requires EPA to regulate hazardous air pollutants (HAP) 
such as HCBD. CAA section 112 requires that the Agency establish 
National Emission Standards for Hazardous Air Pollutants (NESHAP) for 
the control of HAP from both new and existing major sources. The CAA 
requires the NESHAP to reflect the maximum degree of reduction in 
emissions of HAP that is achievable, taking into consideration the cost 
of achieving the emissions reductions, any non-air quality health and 
environmental impacts, and energy requirements. This level of control 
is commonly referred to as maximum achievable control technology 
(MACT). The CAA also establishes a minimum control level for MACT 
standards known as the MACT ``floor.'' The MACT floor is the minimum 
control level allowed for NESHAP and is defined under the CAA section 
112(d)(3) (Ref. 49).
    The chemical manufacturers that produce HCBD are in NAICS group 325 
and therefore fall under the NESHAP regulations for miscellaneous 
organic chemical manufacturing found at 40 CFR part 63 subpart FFFF. 
These regulations require facilities to treat chemicals in their waste 
streams at high efficiencies. For example, emissions from process vents 
must be reduced by greater than or equal to 99% by weight depending on 
the chemical in the waste stream. According to TRI data, chemical 
manufacturers that submit reports for HCBD are treating the chemical 
via incineration at greater than 99.99% treatment efficiency with some 
reporting an efficiency greater than 99.9999%.
    Under the CAA, facilities in certain industries are required to 
implement a Leak Detection and Repair (LDAR) program to reduce fugitive 
air emissions. Included in those industries are synthetic organic 
chemical manufacturers that produce HCBD. The LDAR program requires 
these facilities to monitor components such as pumps, valves, 
connectors and compressors for leaks. When leaks are detected, the 
facility is required to repair or replace the leaking component.
    HCBD is also regulated under RCRA. The statute's implementing 
regulations, among other things, list HCBD as a hazardous constituent 
under 40 CFR part 261 (Identification and Listing of Hazardous Waste; 
specifically, under sections 261.24 and 261.33), which identifies solid 
wastes which are subject to regulation as hazardous wastes under 40 CFR 
parts 262 through 265, 268, and parts 270 and 271. HCBD is a hazardous 
constituent under 40 CFR part 258, Appendix II (Criteria for Municipal 
Solid Waste Landfills), which establishes criteria for the design and 
operation of municipal solid waste landfills.
    Taking into account the many existing controls on activities that 
might affect exposures to HCBD, the only meaningful further reductions 
that might be achieved would be by prohibiting manufacture of HCBD. 
However, prohibiting the manufacture of HCBD would effectively preclude 
the manufacture of trichloroethylene, carbon tetrachloride and 
perchloroethylene. EPA does not believe this would be practicable as 
explained further in this Unit.
    2. Description of the primary alternative regulatory action 
considered. EPA considered an alternative regulatory action of 
prohibiting the manufacture of HCBD, but EPA does not believe this 
would be a practicable regulatory option. HCBD is a byproduct of the 
manufacture of the solvents perchloroethylene, trichloroethylene, and 
carbon tetrachloride (Ref. 29). A prohibition on the manufacture of 
HCBD would effectively prohibit the manufacture of the three solvents. 
Because of the extensive use of perchloroethylene, trichloroethylene, 
and carbon tetrachloride (Ref. 3), EPA believes that it is not 
practicable to completely prohibit the production of these chemicals by 
prohibiting the manufacture of HCBD. Additionally, these chemicals are 
the subject of the risk evaluation process pursuant to TSCA section 
6(b). Where unreasonable risks are identified as part of those risk 
evaluations, EPA is required to take action under TSCA section 6(a) to 
address unreasonable risk.
    3. Evaluation of whether the regulatory actions address the TSCA 
section 6(h)(4) standard. EPA is not proposing to regulate HCBD under 
TSCA section 6(h) because releases resulting in exposures have been 
nearly eliminated through actions under other statues such as the CAA 
and RCRA. The Agency does not believe it is practicable to reduce 
exposures of HCBD further than what has already been done under other 
statutes. The Agency requests comment on the practicability of further 
reducing exposures of HCBD.
    4. Consideration of chemical alternatives (substitutes) in deciding 
whether to prohibit or restrict HCBD. EPA has not identified any uses 
of HCBD other than burning as a waste fuel. Therefore, chemical 
alternatives were not considered.

F. PCTP

    1. Description of the proposed regulatory action. EPA is proposing 
to prohibit the manufacturing and processing of PCTP for any use in 
concentrations of above 1% by weight. PCTP can be found in zinc PCTP at 
concentrations above 1% depending on the yield of the reaction used to 
create the zinc PCTP (Ref. 30). As a result, this proposal would result 
in lower amounts of PCTP being manufactured and processed, used or 
disposed, thus

[[Page 36754]]

reducing exposures to human health and the environment.
    Zinc PCTP, which may contain PCTP as an impurity, is used in the 
manufacture of golf balls. Zinc PCTP is sold at varying concentrations, 
including at a purity of 99% (Ref. 50). According to several patents, 
golf balls can be made using zinc PCTP at this purity (Ref. 32). 
Manufacturing or processing zinc PCTP at 99% purity would comply with 
the proposed concentration limit, as would zinc PCTP at lower purities 
that contains PCTP at or below 1% concentration. Because of the 
availability of zinc PCTP at a 99% purity, and the fact that it can be 
used to manufacture rubber, in particular the rubber in golf balls, EPA 
believes that the concentration limit for PCTP is a practicable way to 
reduce exposures to the chemical. The Agency further believes that 
completely prohibiting the presence of PCTP in zinc PCTP would be 
overly burdensome and therefore impracticable. EPA requests comment on 
the proposed concentration limit, including whether the option is 
practicable, and whether further exposure reductions would be 
practicable. EPA specifically requests comment on the practicability of 
a lower limit on the PCTP content in zinc PCTP, and whether it is 
possible to completely eliminate unreacted PCTP in the manufacture of 
zinc PCTP.
    EPA has 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.
    In addition, EPA is proposing to require, as of 60 days after the 
date that the final rule is published, all persons who manufacture, 
process, or distribute in commerce PCTP and articles and products 
containing PCTP to maintain ordinary business records, such as invoices 
and bills-of-lading, that demonstrate compliance with the prohibitions 
and restrictions. These records would have to be maintained for a 
period of three years from the date the record is generated.
    2. Description of the primary alternative regulatory action 
considered. EPA considered an alternative regulatory action of 
prohibiting manufacturers and processors from releasing the chemical to 
the environment. To ensure that no releases occur, manufacturers and 
processors would have to institute such measures as work practices, 
emergency procedures, engineering controls, or other measures to 
eliminate environmental releases. PCTP in waste would have to be 
collected and destroyed. For example, PCTP in ambient air within the 
facility would have to be collected and either destroyed onsite or sent 
offsite for treatment. The prohibition would apply to all releases, 
including accidental releases, to all environmental media. The Agency 
requests comment on this alternative approach, including the measures 
or performance standards that could be implemented to further reduce 
exposure, and the practicability of the option.
    3. Evaluation of whether the regulatory actions address the TSCA 
section 6(h)(4) standard. The proposed reduction in the concentration 
of PCTP in mixtures would result in lower amounts of the chemical that 
may be manufactured and processed and subsequently available for 
release, resulting in a reduction in exposures.
    Historically, PCTP was used in rubber manufacturing as a peptizer, 
a chemical that makes rubber more amenable to processing. While it is 
likely that PCTP is no longer intentionally used as a peptizer, it can 
be found as an impurity in the zinc salt of PCTP (zinc PCTP) (CASRN 
117-97-5). Zinc PCTP can be manufactured by reacting PCTP with zinc 
oxide. Depending on the yield of the reaction, some unreacted PCTP can 
remain in the mixture as an impurity (Ref. 30). As shown by a number of 
patents, zinc PCTP can be used as a peptizer in rubber manufacturing 
including as an ingredient in the rubber core of golf balls (Refs. 31 
and 32) to enhance certain performance characteristics of the ball such 
as spin, rebound, and distance (Ref. 31). Zinc PCTP does not appear to 
be manufactured domestically (Ref. 17) but rather it is imported into 
the United States (Ref. 3).
    4. Consideration of chemical alternatives (substitutes) in deciding 
whether to prohibit or restrict PCTP. Based on a screening level 
analysis of likely alternatives based on the TSCA Work Plan Chemicals: 
Methods Document (Ref. 2), EPA believes that there are viable 
substitutes for PCTP in rubber manufacturing. While EPA is not 
proposing to prohibit the use of PCTP at concentrations at or below 1%, 
it is possible that some manufacturers and processors may choose to use 
alternatives instead of using PCTP at the proposed concentration limit. 
At this time, EPA does not know whether golf balls are currently being 
made with halogenated organosulfur compound substitutes. Based on 
information from patents, EPA believes that use of these substitutes 
may be occurring in golf ball manufacturing (Refs. 31, 32, 51). 
Further, only one golf ball manufacturer has confirmed that it 
incorporates PCTP into its golf balls. EPA believes this limited use of 
PCTP is sufficient evidence of the availability of substitutes.
    (i) Health and environmental effects of the chemical alternatives 
or substitute methods. EPA conducted a screening level analysis of 
several possible substitutes for PCTP based on the TSCA Work Plan 
Chemicals: Methods Document (Ref. 2). The potential alternatives were 
evaluated and scored on three characteristics: Hazard, exposure and the 
potential for persistence and/or bioaccumulation. Two chemicals, 
diphenyldisulfide and 2,2'-dibenzamidodiphenyl disulfide, scored lower 
for at least one characteristic (Ref. 3). With respect to another 
chemical, pentafluorothiophenol, there was not enough information 
available to score each characteristic (Ref. 45).
    (ii) Technical feasibility, economic feasibility, and reasonable 
availability of the chemical alternatives or substitute methods. 2,2'-
dibenzamidodiphenyl disulfide (DBD), which is considered to be less 
toxic and reacts similarly, can be used in place of PCTP (Ref. 33). In 
golf ball cores, other halogenated organosulfur compounds can be used 
as a substitute for PCTP (Ref. 51). EPA requests comment on the extent 
to which these substitutes are used in the manufacture of golf balls.

IV. Reasonably Ascertainable Economic Consequences of the Proposed Rule

A. Overview of Cost Methodology

    EPA has evaluated the potential costs of the proposed and primary 
alternative regulatory actions for the PBT chemicals. Costs of the 
proposed rule were estimated based on the assumption that under 
regulatory limitations on the PBT chemicals, processors that use the 
regulated chemical in their products would switch to available 
alternative chemicals to manufacture the product, or to products that 
do not contain the chemical. Approaches for the analysis of each 
regulated chemical varied according to whether the focus was on 
chemical substitutes or product substitutes, depending on the uses for 
each chemical. For DecaBDE and PCTP, the costs were assessed based on 
chemical substitutes only. For PIP (3:1) and 2,4,6-TTBP, costs were 
assessed based on product substitutes where product information was 
more substantial than information on chemical substitutes alone.
    Substitution costs were estimated on the industry level using the 
price

[[Page 36755]]

differential between the cost of the chemical (or 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), which is in the public docket for this 
action.

B. Estimated Costs of Proposed and Primary Alternative Regulatory 
Actions

    Total quantified annualized industry costs for the proposed rule is 
$43.1 million (at both 3% and 7% discount rates). Total quantified 
annualized industry costs for the primary alternative regulatory action 
are $414 million (at both 3% and 7% discount rates). For DecaBDE, total 
quantified annualized industry costs for the proposed rule under both 
the proposed and the primary alternative regulatory actions are zero. 
For PIP (3:1), total quantified annualized industry costs for the 
proposed rule are $34.7 million (at both 3% and 7% discount rates), and 
$38.1 million (3% discount rate) or $37.6 million (7% discount rate) 
for the primary alternative regulatory action. For 2,4,6-TTBP, total 
quantified annualized industry costs for the proposed rule under both 
the proposed and the primary alternative regulatory actions are $8.4 
million (at both 3% and 7% discount rates). For HCBD, the proposed 
action is not to regulate; therefore, there is no industry cost 
associated. For HCBD, the annualized costs to industry associated with 
the primary alternative regulatory action are estimated to total $368 
million (at both 3% and 7% discount rates). For PCTP, total quantified 
annualized industry costs for the proposed rule are $0.03 million (at 
both 3% and 7% discount rates), and negligible for the primary 
alternative regulatory action. Total annualized Agency costs associated 
with implementation of the proposed rule were based on EPA's best 
judgment and experience with other similar rules. For the proposed 
regulatory action, EPA estimates it will require 3 FTE at $465,000 per 
year. For the primary alternative regulatory option, EPA estimates 3.5 
FTE at $543,000 (Ref. 3).
    Total quantified annualized social costs for the proposed rule are 
$43.5 million (at both 3% and 7% discount rates). Total quantified 
social costs for the proposed rule under the primary alternative 
regulatory action are $415 million (at both 3% and 7% discount rates).
    As described in Unit IV.A., 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), which is in the public docket for this action. EPA requests 
comment on all aspects of the costs that may be incurred as a result of 
this proposed action. EPA has the following specific requests for 
comment on costs:
    EPA requests comment on potential costs of testing, such laboratory 
testing, that manufacturers or importers may choose to undertake on 
articles or components of articles to determine whether they contain 
the regulated chemical substance, and at what concentration.
    EPA requests comment on potential costs of reformulation with 
substitute chemicals in the uses that are proposed to be restricted or 
prohibited. Such costs may be incurred by affected entities such as 
processors and may be related to activities such as research and 
development, laboratory testing, product re-labeling, and other 
activities necessary to use substitute chemicals in formulated 
products. EPA is also interested in soliciting comment on the time it 
may take for reformulation that would meet the current performance 
standards.
    There are specific requirements to prevent releases to the 
environment for processors and distributors of PIP (3:1) under the 
proposed option, and for manufacturers, processors and distributors of 
PCTP under the primary alternative option. EPA requests comment on 
potential costs of engineering controls, process changes, or other 
measures that firms may undertake to prevent releases to the 
environment for the subject PBT chemicals.
    EPA requests comment on potential costs related to ensuring 
compliance for imported articles affected by the proposed rule. While 
the rule does not prescribe specific steps that an importer must take 
to identify specific substances in imported articles, EPA is interested 
in understanding potential costs such as testing, communication with 
suppliers, or other measures that may be incurred at the discretion of 
any individual importer to ensure compliance.
    EPA requests comment on potential costs and firm-level impacts, 
including possibility of firm closure, related to loss of revenue due 
to reduced demand for the subject PBT chemicals in the uses that are 
proposed to be restricted or prohibited. EPA is also interested in 
information related to the extent to which affected manufacturers 
(including importers) are willing and able to supply substitute 
chemicals and the net financial effects for the affected firms.
    Finally, EPA requests comment on the likelihood, nature, and extent 
of potential changes in the domestic and foreign composition of the 
supply chain for the five PBT chemicals and continued availability for 
non-restricted uses due to reduced demand in the uses that are proposed 
to be restricted or prohibited by the proposed rule.

C. Benefits

    As discussed in Unit II.C., 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 proposed and alternative 
actions for each chemical is provided.
    DecaBDE is persistent and bioaccumulative and has been associated 
with developmental neurological effects, developmental immunological 
effects, general developmental toxicity, and thyroid and liver effects 
in mammals, as well as with toxicity in aquatic organisms. Under EPA's 
proposed regulatory action, persons would be prohibited from 
manufacturing, processing and distributing DecaBDE in commerce and as 
an intentional component of any articles, with limited compliance 
delays and/or exclusions allowed for uses by certain industries (e.g., 
aerospace). Exposures to humans and the environment would thus decrease 
as a result of the proposed regulatory action, and thus there would be 
benefits to health and the environment.
    The primary alternative option would further reduce exposure to 
DecaBDE by including the prohibition of the manufacture, processing, or 
distribution in commerce of articles containing the chemical above 0.1 
percent of mass weight. In effect, this would include a prohibition of 
recycled materials that contain above 0.1% DecaBDE. While data on the 
volume of recycled materials that contain DecaBDE above this threshold 
are not available, in cases

[[Page 36756]]

where articles exceed this threshold, there would be an associated 
reduction of the amount of exposure.
    HCBD is persistent, bioaccumulative, and a possible human 
carcinogen. It is not intentionally manufactured in the United States. 
Since EPA is not proposing any regulatory action for HCBD, no benefits 
to health or the environment are expected as a result of the rule. The 
primary alternative regulatory action considered is a prohibition on 
the manufacture of HCBD. This would require reducing or eliminating 
production of the chemicals for which HCBD is produced as a byproduct. 
While this primary alternative option would further reduce release to 
the environment, it would require substantial change to the markets for 
chlorinated solvents that may not be warranted due to the low levels of 
release of HCBD that have already been realized.
    PCTP is persistent, bioaccumulative, and an aquatic toxicant. There 
are limited data on the potential effects of PCTP in mammals and no 
data were identified on the potential effects of PCTP in humans. Under 
the proposed regulatory action, manufacture and processing of PCTP 
would be limited to concentrations of 1% or lower. With lower 
concentrations in mixtures, the proposed regulatory action would 
decrease dermal and inhalation PCTP exposures in workers involved in 
the manufacture of golf balls, if the workers are unprotected, and 
decrease releases of PCTP to the environment. With decreased releases 
to the environment there would also eventually be a decrease of 
exposures in the general population generally and as a result of 
consumption of contaminated food. Thus, by reducing PCTP, the proposed 
regulatory action would have benefits for the environment and potential 
benefits to health for workers, if they are unprotected.
    Under the primary alternative regulatory action, EPA would prohibit 
manufacturers and processors from releasing the chemical to the 
environment. This would require manufacturers to implement industrial 
controls that would prevent releases to air, water, or land. If the 
costs to install and operate such controls are higher than the cost to 
switch to substitute chemicals for ZnPCTP, then firms would likely 
switch to substitute chemicals, as they would under the proposed 
action, and with a similar reduction in exposure to PCTP.
    PIP (3:1) is a neurotoxicant and aquatic toxicant with high 
persistence and high potential for bioaccumulation. It would be 
prohibited for processing and distribution in all uses under the 
proposed regulatory action, with the exception of certain uses in 
aviation and automobile products. Concentrations of PIP (3:1) would be 
limited in these aviation products, and releases to water as a result 
of their use would be prohibited. Therefore, occupational exposures, if 
workers are unprotected, and exposures to the environment would 
decrease as a result of the proposed regulatory action, and thus there 
would be benefits to health and the environment.
    Under the primary alternative regulatory action, remaining uses of 
PIP (3:1) in aviation products would also be prohibited following a 10-
year exemption. Under this scenario, exposures to PIP (3:1) would be 
expected to decrease as outlined previously, with additional decreases 
in exposures for workers in the aviation sector, if they are 
unprotected.
    2,4,6-TTBP is persistent and bioaccumulative, and has been 
associated with liver toxicity and reproductive and developmental 
effects in mammals. Under the proposed regulatory action, it would be 
prohibited for distribution in containers less than 55 gallons and be 
prohibited in processing and distribution as an additive to oil/
lubricants. Therefore, the rule is expected to reduce consumer 
exposures to 2,4,6-TTBP and occupational exposure in certain 
industries, if workers are unprotected, as well as releases to the 
environment from consumer use, and thus, there would be benefits to 
health and the environment.
    Under the primary alternative regulatory action, the container 
requirement component would be replaced by a limit of 0.01% on the 
allowable concentration of 2,4,6-TTBP in consumer/retail fuel additive 
formulations. Since both actions would require reformulation of fuel 
additives containing 2,4,6-TTBP, decreases in exposures to 2,4,6-TTBP 
are expected to be similar in each case.

V. References

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

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. 
October 2014. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-assessments-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 Proposed Regulation of Persistent, 
Bioaccumulative, and Toxic Chemicals under TSCA section 6(h). June 
2019.
4. EPA. Exposure and Use Assessment of Five Persistent, 
Bioaccumulative, and Toxic Chemicals June 2019.
5. EPA. Environmental and Human Health Hazards of Five Persistent, 
Bioaccumulative and Toxic Chemicals. June 2019.
6. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Decabromodiphenyl Ether. August 
2017. (EPA-HQ-OPPT-2016-0724-0002).
7. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Phenol, isopropylated, phosphate 
(3:1). August 2017. (EPA-HQ-OPPT-2016-0730-0003).
8. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: 2,4,6-Tris(tert-butyl)phenol. 
August 2017. (EPA-HQ-OPPT-2016-0734-0002).
9. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Hexachlorobutadiene. August 2017. 
(EPA-HQ-OPPT-2016-0738-0004).
10. EPA. Preliminary Information on Manufacturing, Processing, 
Distribution, Use, and Disposal: Pentachlorothiophenol. August 2017. 
(EPA-HQ-OPPT-2016-0739-0003).
11. EPA. TSCA Work Plan Chemicals. June 2012. https://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf, accessed March 2019.
12. EPA. Letter acknowledging receipt of request for risk 
evaluations under TSCA section 6(h). Wendy Cleland-Hamnett, 
Director, Office of Pollution Prevention and Toxics to International 
Flavors and Fragrances, Inc. September 28, Washington, DC.
13. EPA. Stakeholder Comment from Auto Alliance. February 2018.
14. EPA. Stakeholder Comment from iGPS. January 2018.
15. EPA. Certain Polybrominated Diphenylethers; Significant New Use 
Rule and Test Rule. Proposed Rule. Federal Register (77 FR 19862, 
April 2, 2012) (FRL-8889-3).
16. EPA. Public Database 2012 Chemical Data Reporting. Washington, 
DC: US Environmental Protection Agency, Office of Pollution 
Prevention and Toxics.
17. EPA. Public Database 2016 Chemical Data Reporting. Washington, 
DC: US

[[Page 36757]]

Environmental Protection Agency, Office of Pollution Prevention and 
Toxics.
18. EPA. (2016). Toxics Release Inventory (TRI) Basic Plus Data 
Files.
19. EPA. (2017). Toxics Release Inventory (TRI) Basic Plus Data 
Files.
20. EPA. Toxic Chemical Release Reporting; Community Right-to-know. 
Final Rule. Federal Register (53 FR 4500, February 16, 1988) (FRL-
3298-2).
21. EPA. Stakeholder Meeting with ICL. August 30, 2018. EPA Docket 
EPA-HQ-OPPT-2019-0080.
22. Boeing Submission Re: Information supporting a Critical Use 
Exemption Request for phenol, isopropylated, phosphate (3:1) in 
Aerospace Uses (Docket ID Number: EPA-HQ-OPPT-2016-0730). February 
12, 2019.
23. EPA. Stakeholder Meeting with Akin Gump. September 27, 2018. EPA 
Docket EPA-HQ-OPPT-2019-0080.
24. EPA. Stakeholder Meeting with Boeing. May 2, 2018. EPA Docket 
EPA-HQ-OPPT-2019-0080.
25. EPA. Stakeholder Meeting with Airbus. February 5, 2019. EPA 
Docket EPA-HQ-OPPT-2019-0080.
26. EPA. Stakeholder Meeting with Lockheed Martin. March 25, 2019. 
EPA Docket EPA-HQ-OPPT-2019-0080.
27. SI Group. Comments for the economic impact of 2,4,6-tri-tert-
butylphenol (2,4,6-TTBP); letter from Kevin M. Kransler to Doug 
Parsons, EPA. December 21, 2018.
28. EPA. Afton Chemical conference call with U.S. EPA, regarding 
2,4,6-TTBP chemical uses. July 28, 2017.
29. United Nations Environment Program Stockholm Convention on 
Persistent Organic Pollutants (2012). Risk profile on 
hexachlorobutadiene. Report of the Persistent Organic Pollutants 
Review Committee on the work of its eighth meeting.
30. Lucas, CR; Peach, ME. (1970). Reactions of 
Pentachlorothiophenol. Canadian Journal of Chemistry. 48:1869.
31. Watanabe, Hideo; Kasashima, Atuski, Multi-piece solid golf ball. 
US Patent Number US7367901B2, filed January 11, 2007, and published 
May 6, 2008.
32. Kennedy III, Thomas J., Binette, Mark L., Golf ball, US Patent 
Number 20060019771, filed July 20, 2004, and published January 26, 
2006.
33. National Library of Medicine. ToxNet, Hazardous Substance Data 
Bank. Pentachlorothiophenol: CASRN: 133-49-3. https://
toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~ebPHHj:1 Accessed 
March 4, 2019.
34. Struktol Company of America, LLC. Stow, OH. Rubber Handbook. 
2004. https://www.struktol.com/pdfs/RubberHB.pdf. Accessed March 4, 
2019.
35. EPA. Preliminary Assessment Information Reporting; Addition of 
Certain Chemicals. Final Rule. Federal Register (66 FR 38955, July 
26, 2001) (FRL-6783-6).
36. EPA. Fifty-First Report of the TSCA Interagency Testing 
Committee to the Administrator; Receipt of Report and Request for 
Comments. Federal Register (68 FR 8975, February 26, 2003) (FRL-
7285-7).
37. Department of Labor. Occupational Safety and Health 
Administration. Recommended Practices for Safety and Health 
Programs. https://www.osha.gov/shpguidelines/hazard-prevention.html. 
Accessed April 16, 2019.
38. Norwegian Environmental Agency. (2015) Final Report. Literature 
Study--DecaBDE in Waste Streams.
39. Aerospace Industries Association (AIA). Consultation on Products 
containing PBDEs. Letter to Environment Canada. December 13, 2013.
40. EPA. Exploratory Analysis for DecaBDE in Children's Toys. April 
2019.
41. Tu, Chuanhoing & Prest, Harry F., Agilent Technologies. 
Determination of Polybrominated Diphenyl Ethers in Polymeric 
Materials Using the 6890 GC/5973N inert MSD with Electron Impact 
Ionization. April 5, 2005.
42. EPA. (2014). An Alternatives Assessment for the Flame Retardant 
Decabromodiphenyl Ether (DecaBDE).
43. Alliance of Automobile Manufacturers and Motor and Equipment 
Manufacturers Association. Submission RE: Critical Use Exemption 
Request for Phenol, Isopropylated, Phosphate 3:1 in Automotive Uses. 
April 5, 2019.
44. Alliance of Automobile Manufacturers and Motor and Equipment 
Manufacturers Association. Meeting on Phenol, Isopropylated, 
Phosphate (3:1) (PIP) in Automotive Uses. OIRA E.O. 12866 Meeting. 
June 13, 2019.
45. EPA. Persistence, Bioaccumulation, Environmental Hazard and 
Human Health Hazard Ratings for Alternatives to PBT Chemicals 
Proposed for Regulation. April 2019.
46. EPA. Stakeholder Meeting with Nye Lubricants. November 14, 2018. 
EPA Docket EPA-HQ-OPPT-2019-0080.
47. UK Food Standards Agency. (2019). EU Approved Additives and E 
Numbers (E321--Butylated Hydroxytoluene (BHT). https://www.food.gov.uk/business-guidance/eu-approved-additives-and-e-numbers#h_4. Accessed March 11, 2017.
48. Innospec. (2007). Fuel Additives Product Summary. https://login.innospecinc.com/assets/_files/documents/dec_07/cm__1197641587_FS_Product_Summary_US.pdf. Accessed March 18, 2019.
49. EPA. National Emission Standards for Hazardous Air Pollutants: 
Miscellaneous Organic Chemical Manufacturing; Final Rule. Federal 
Register (63 FR 63852, Nov. 10, 2003) (FRL-7551-3)
50. American Elements. Los Angeles, CA. Zinc Chlorothiophenolate. 
https://www.americanelements.com/zinc-chlorothiophenolate-117-97-5. 
Accessed March 3, 2019.
51. Voorheis PR, Rajagopalan M. Golf ball core compositions 
comprising unsaturated long chain organic acids and their salts. US 
Patent Number: US6762247B2, filed September 9, 2002, published July 
13, 2004.
52 Keweemaw 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.
53. Harper, Barbara and Ranco, Darren, in collaboration with the 
Maine Tribes. Wabanaki Traditional Cultural Lifeways Exposure 
Scenario. July 9, 2009.

VI. Statutory and Executive Order Reviews

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

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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review 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. 
The Economic Analysis (Ref. 3) is available in the docket and is 
summarized in Unit IV.

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

    This action is expected to be subject to the requirements for 
regulatory actions specified in Executive Order 13771 (82 FR 9339, 
February 3, 2017). Details on the estimated costs of this proposed rule 
can be found in EPA's analysis of the potential costs and benefits 
associated with this action (Ref. 3).

C. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et 
seq. The Information Collection Request (ICR) document that the EPA 
prepared has been assigned EPA ICR number 2599.01. You can find a copy 
of the ICR in the docket for this rule, and it is briefly summarized 
here.
    Respondents/affected entities: The entities expected to respond are 
companies that manufacture/import, process, or distribute any of the 
five PBT chemicals included in this proposed rule for the uses covered 
by this proposed rulemaking. A list of NAICS codes associated with 
these companies is provided in Unit I.A.

[[Page 36758]]

    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: A total of 81 companies are 
expected to be impacted by the proposed option. However, these may be 
underestimates due to companies that EPA is unaware would be affected.
    Frequency of response: Costs are calculated on an annual basis.
    Total estimated burden: Total estimated annual paperwork burden for 
the proposed option is 50.2 hours.
    Total estimated cost: The fully loaded wage rate used to estimate 
these costs is $78.63. As such, there are expected to be a total of 
approximately $3,940 in annual paperwork costs associated with the 
proposed rule over the three years of the ICR period.
    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 the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to the EPA using the docket identified at 
the beginning of this rule. You may also send your ICR-related comments 
to OMB's Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for the EPA. Since 
OMB is required to make a decision concerning the ICR between 30 and 60 
days after receipt, OMB must receive comments no later than August 28, 
2019. The EPA will respond to any ICR-related comments in the 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 the chemicals subject to this proposed rule. The Agency has 
determined that 24 of the 81 entities potentially subject to the 
proposed rule are small entities, including fourteen entities for 
DecaBDE, zero entities for HCBD, one entity for PCTP, five entities for 
PIP (3:1) and four entities for 2,4,6-TTBP. None (0%) of the small 
entities for any of the chemicals assessed are expected to incur 
impacts of 1% or greater. Details of this analysis are presented in the 
Economic Analysis (Ref. 3), which is in the public docket for this 
action.

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 does not 
significantly or uniquely affect small governments. The requirements of 
this action would primarily affect manufacturers, processors, and 
distributors of four PBT chemicals. The total quantified annualized 
social costs for the proposed rule under the proposed option are 
approximately $43.5 million (at both 3% and 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, as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000) because it does 
not have substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes. Thus, Executive Order 13175 does not 
apply to this action.
    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, the 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 these five PBT chemicals under 
TSCA section 6(h). Tribal members were encouraged to provide additional 
comments after the teleconferences. EPA received two comments from the 
Keweenaw Bay Indian Community and Maine Tribes (Refs. 52 and 53). EPA 
also met with the National Tribal Toxics Council (NTTC) in Washington, 
DC. During the NTTC meeting, EPA provided background information on the 
available regulatory options under 6(a) and a summary of the 
information gathered on the five PBT chemicals. Officials from NTTC 
expressed support for EPA regulations to reduce exposures to the 
general population and susceptible subpopulations.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks 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. As discussed, 
while EPA believes that the health and environmental risks presented by 
the PBT chemicals subject to this action may have a disproportionate 
effect on children and that this action addresses those risks, EPA did 
not perform a risk assessment or risk evaluation of these PBT 
chemicals. However, the proposed requirements would reduce exposure to 
these PBT chemicals for the general population and for susceptible 
subpopulations such as workers and children. EPA's evaluation of the 
exposure potential of these PBT chemicals (Ref. 4) and summary of the 
health and environmental hazards that may be presented by these 
chemical substances (Ref. 5) are in the public docket for this action.

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

    This action is not a ``significant energy action'' under 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. While this action proposes to regulate a fuel additive, because 
the restrictions are limited to fuel additives purchased and used by 
consumers, it will not significantly affect the nation's fuel supply.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards, and is 
therefore not subject to considerations under NTTAA section 12(d), 15 
U.S.C. 272.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The 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

[[Page 36759]]

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

List of Subjects in 40 CFR Part 751

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

    Dated: June 21, 2019.
Andrew R. Wheeler,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority:  15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).

0
2. Add reserved subpart D and add Subpart E, consisting of Sec. Sec.  
751.401 through 751.411, to read as follows:

Subpart D--[Reserved]

Subpart E--Persistent, Bioaccumulative, and Toxic Chemicals

Sec.
751.401 General.
751.403 Definitions.
751.405 DecaBDE.
751.407 PIP (3:1).
751.409 2,4,6-TTBP.
751.411 PCTP.


Sec.  751.401  General.

    This subpart establishes prohibitions and restrictions on the 
following persistent, bioaccumulative, and toxic chemicals in 
accordance with TSCA section 6(h), 15 U.S.C. 2605(h): Decabromodiphenyl 
ether; phenol, isopropylated phosphate (3:1), also known as tris(4-
isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol; and 
pentachlorothiophenol.


Sec.  751.403  Definitions.

    The definitions in subpart A of this part apply to this subpart 
unless otherwise specified in this section.
    2,4,6-TTBP means the chemical substance 2,4,6-tris(tert-
butyl)phenol (CASRN 732-26-3) at any concentration above 0.01 percent 
by weight.
    Chemical substance means any organic or inorganic substance of a 
particular molecular identity.
    (1) Such term includes any combination of such substances occurring 
in whole or in part as a result of a chemical reaction or occurring in 
nature, and any element or uncombined radical.
    (2) Such term does not include:
    (i) Any mixture,
    (ii) Any pesticide (as defined in the Federal Insecticide, 
Fungicide, and Rodenticide Act) when manufactured, processed, or 
distributed in commerce for use as a pesticide,
    (iii) Tobacco or any tobacco product,
    (iv) Any source material, special nuclear material, or byproduct 
material (as such terms are defined in the Atomic Energy Act of 1954 
and regulations issued under such Act),
    (v) Any article the sale of which is subject to the tax imposed by 
section 4181 of the Internal Revenue Code of 1954 (determined without 
regard to any exemptions from such tax provided by section 4182 or 4221 
or any other provision of such Code) and any component of such an 
article (limited to shot shells, cartridges, and components of shot 
shells and cartridges), and
    (vi) Any food, food additive, drug, cosmetic, or device (as such 
terms are defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act) when manufactured, processed, or distributed in commerce 
for use as a food, food additive, drug, cosmetic, or device. The term 
``food'' as used in this definition's paragraph (2)(vi) includes 
poultry and poultry products (as defined in sections 4(e) and 4(f) of 
the Poultry Products Inspection Act), meat and meat food products (as 
defined in section 1(j) of the Federal Meat Inspection Act), and eggs 
and egg products (as defined in section 4 of the Egg Products 
Inspection Act).
    DecaBDE means the chemical substance decabromodiphenyl ether (CASRN 
1163-19-5).
    Oil and lubricant additive means any additive to a product of any 
viscosity intended to reduce friction between moving parts, whether 
mineral oil or synthetic base, including engine crankcase and gear oils 
and bearing greases.
    PCTP means the chemical substance pentachlorothiophenol (CASRN 133-
49-3)
    PIP (3:1) means the chemical substance phenol, isopropylated 
phosphate (3:1), also known as tris(4-isopropylphenyl) phosphate (CASRN 
68937-41-7).


Sec.  751.405  DecaBDE.

    (a) Prohibitions. After [date 60 calendar days after the date of 
publication of the final rule], all persons are prohibited from 
manufacturing, processing and distributing in commerce DecaBDE, or 
DecaBDE-containing products or articles, except for the following:
    (1) Processing and distribution in commerce for recycling of 
plastic from products or articles containing DecaBDE, where no new 
DecaBDE is added during the recycling process.
    (2) Processing and distribution in commerce of DecaBDE in finished 
products or articles made of plastic recycled from products or articles 
containing DecaBDE, where no new DecaBDE was added during the 
production of the products or articles made of recycled plastic.
    (3) Manufacture, processing, and distribution in commerce of 
DecaBDE for use in replacement parts for automobiles and other motor 
vehicles and aircraft and aerospace vehicles, and the replacement 
parts, to which DecaBDE has been added, for such vehicles.
    (4) After [date 3 years after the date of publication of the final 
rule], manufacture, processing and distribution in commerce of DecaBDE 
for use in parts installed in and sold as part of new aerospace 
vehicles, and the parts to which DecaBDE has been added for such 
vehicles.
    (5) After [date 18 months after the date of publication of the 
final rule], manufacture, processing and distribution in commerce of 
DecaBDE for use in curtains in the hospitality industry, and the 
curtains to which DecaBDE has been added.
    (b) Recordkeeping. (1) After [date 60 calendar days after the date 
of publication of the final rule], 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, that demonstrate 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) The recordkeeping requirements in paragraph (b)(1) of this 
section do not apply to the activities described in paragraph (a)(1) 
and (2) of this section.


Sec.  751.407  PIP (3:1).

    (a) Prohibitions. (1) After [date 60 calendar days after the date 
of publication of the final rule], all persons are prohibited from 
processing and distributing in commerce PIP (3:1) or PIP (3:1)-
containing products or articles, except for the following:
    (i) Processing and distribution in commerce of PIP (3:1) and PIP 
(3:1)-containing products for use in aviation hydraulic fluid.

[[Page 36760]]

    (ii) Processing and distribution in commerce of PIP (3:1) and PIP 
(3:1)-containing products for use in lubricants and greases.
    (iii) Processing and distribution in commerce of PIP (3:1) and PIP 
(3:1)-containing products for use in new and replacement parts for 
automobiles and other motor vehicles, and distribution in commerce of 
the new and replacement parts to which PIP (3:1) has been added for 
such vehicles.
    (2) After [date 60 calendar days after the date of publication of 
the final rule], all persons are prohibited from releasing PIP (3:1) to 
water during manufacturing, processing, distribution in commerce, and 
commercial use of PIP (3:1).
    (b) Downstream notification. Each person who manufactures, 
processes, or distributes in commerce PIP (3:1) or PIP (3:1)-containing 
products or articles for any use after [date 60 calendar days after the 
final rule] must, prior to or concurrent with the shipment, notify 
companies to whom PIP (3:1) is shipped, in writing, of the restrictions 
described in this subpart. Notification must occur by inserting the 
following text in the Safety Data Sheet (SDS) provided with the PIP 
(3:1) or with any PIP (3:1)-containing product:
    (1) SDS Section 1.(c): ``The Environmental Protection Agency 
prohibits processing and distribution of this chemical/product for any 
use other than in aviation hydraulic fluid in aircraft systems 
lubricants and greases, and new or replacement parts for automobiles 
and other motor vehicles. In addition, all persons are prohibited from 
releasing PIP (3:1) to water during manufacturing, processing, 
distribution in commerce, and commercial use of PIP (3:1).''
    (2) SDS Section 15: ``The Environmental Protection Agency prohibits 
processing and distribution of this chemical/product for any use other 
than in aviation hydraulic fluid in aircraft, lubricants and greases, 
and new or replacement parts for automobiles and other motor vehicles. 
In addition, all persons are prohibited from releasing PIP (3:1) to 
water during manufacturing, processing, distribution in commerce, and 
commercial use of PIP (3:1).''
    (c) Recordkeeping. Each person who manufactures, processes, or 
distributes in commerce PIP (3:1) or PIP (3:1)-containing products or 
articles after [date 60 calendar days after the date of publication of 
the final rule] must maintain ordinary business records, such as 
invoices and bills-of-lading, that demonstrate 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.


Sec.  751.409  2,4,6-TTBP.

    (a) Prohibitions. (1) After [date 60 calendar days after the date 
of publication of the final rule], all persons are prohibited from 
distributing in commerce 2,4,6-TTBP in containers with a volume less 
than 55 gallons.
    (2) After [date 60 calendar days after the date of publication of 
the final rule], all persons are prohibited from processing and 
distributing in commerce 2,4,6-TTBP for use as an oil and lubricant 
additive.
    (b) Recordkeeping. After [date 60 calendar days after the date of 
publication of the final rule], distributors of 2,4,6 TTBP must 
maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate 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.


Sec.  751.411  PCTP.

    (a) Prohibition. After [date 60 calendar days after the date of 
publication of the final rule], all persons are prohibited from 
manufacturing, processing and distributing in commerce PCTP or PCTP-
containing products or articles unless in concentrations at or below 1% 
by weight.
    (b) Recordkeeping. After [date 60 calendar days after the date of 
publication of the final rule], manufacturers, processors and 
distributors of PCTP or PCTP-containing products or articles must 
maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate 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.

[FR Doc. 2019-14022 Filed 7-26-19; 8:45 am]
 BILLING CODE 6560-50-P