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Assessing and Managing Chemicals under TSCA
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PERSISTENT, BIOACCUMULATIVE, AND TOXIC (PBT) CHEMICALS UNDER TSCA SECTION 6(H)



As required under the Toxic Substances Control Act (TSCA), as amended by the
Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA issued five
final rules on January 6, 2021, to reduce exposures to certain chemicals that
are persistent, bioaccumulative and toxic (PBT). These chemicals build up in the
environment over time and can therefore have potential risks for exposed
populations, including the general population, consumers and commercial users,
and susceptible subpopulations (such as workers, subsistence fishers, tribes and
children).

Following issuance of Executive Order 13990 (Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis) and other
administration priorities, EPA requested and received comment on the January
2021 PBT rules. Specifically, EPA asked for comment on additional actions that
could be taken to reduce exposures to these PBT chemicals to the extent
practicable. 

In September 2021, EPA announced its intent to initiate a new rulemaking and
anticipates proposing new rules for five PBT chemicals that are the subject of
final risk management rules under TSCA. Additionally, EPA is taking action to
extend the compliance dates for the prohibitions on processing and distribution
and the associated recordkeeping requirement of one of these PBT chemicals,
phenol, isopropylated phosphate (3:1) (PIP (3:1)) until March 8, 2022. This
final rule is effective upon publication.

In October 2021, EPA proposed a rule to further extend the compliance date
applicable to the processing and distribution in commerce of certain PIP
(3:1)-containing articles, and the PIP (3:1) used to make those articles until
October 31, 2024, along with the associated recordkeeping requirements for
manufacturers, processors, and distributors of PIP (3:1)-containing articles.
EPA also provided a description of the specific kinds of information the agency
will require to support any additional extensions to the compliance dates.

EPA will be accepting public comments in docket EPA-HQ-OPPT-2021-0598 on
www.regulations.gov for 60 days from publication of the proposed rule.  Comments
must be received on or before December 27, 2021.

Read the proposed rule.

 * Learn more about the public comment period and compliance date extension for
   PIP (3:1) 
 * Read the January 2021 final rules.
   * Final rule for decabromodiphenyl ether (DecaBDE)
   * Final rule for phenol, isopropylated phosphate (3:1) (PIP (3:1))
   * Final rule for 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
   * Final rule for hexachlorobutadiene (HCBD)
   * Final rule for pentachlorothiophenol (PCTP)
 * Additional information about the final rules can be found in docket
   EPA-HQ-OPPT-2019-0080.

On this page:

 * Uses and risk management for five PBT chemicals under TSCA section 6(h)
   * Decabromodiphenyl ether (DecaBDE)
   * Phenol, isopropylated phosphate (3:1) (PIP (3:1))
   * 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
   * Hexachlorobutadiene (HCBD)
   * Pentachlorothiophenol (PCTP)
 * Additional information

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


USES AND RISK MANAGEMENT FOR FIVE PBT CHEMICALS UNDER TSCA SECTION 6(H)

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on
June 22, 2016, includes a provision under TSCA section 6(h) requiring EPA to
take expedited action on specific PBT chemicals to address risk and reduce
exposures to the extent practicable. EPA identified five PBT chemicals for
expedited action in 2016, following criteria outlined in section 6(h) of TSCA
and issued a proposed rule in 2019. EPA issued final rules on January 6, 2021.
Pursuant to the statute, no risk evaluation was required for these chemicals.

Below is a summary of the uses, identified hazards, and risk management actions
for each of the five PBT chemicals.

Chemical  Uses and Identified Hazards Risk Management Actions Decabromodiphenyl
ether (DecaBDE)

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 communication and electronic equipment, and other
applications. DecaBDE is also used as a flame retardant for multiple
applications for aerospace and automotive vehicles, including replacement parts
for aircraft and cars. Learn more about DecaBDE uses.


Identified Hazards – DecaBDE is toxic to aquatic
invertebrates, fish, and terrestrial invertebrates.
Data indicate the potential for developmental,
neurological, and immunological effects, general
developmental toxicity, liver effects, and carcinogenicity. While many uses of
DecaBDE have ceased, EPA has concluded that humans or the environment are likely
exposed to DecaBDE under the conditions of use identified in the final rule.

EPA prohibited the manufacture (including import), processing, and distribution
in commerce of decaBDE, and products containing decaBDE, for all uses, except
for the following:

 * 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, after which the prohibition would go into effect;
 * Processing and distribution in commerce for use in wire and cable insulation
   in nuclear power generation facilities, and the distribution of the wire and
   cable insulation that contains decaBDE, for a period of two years, after
   which the prohibition would go into effect;
 * Manufacture, processing, and distribution in commerce for use in parts for
   new aerospace vehicles, and distribution in commerce of the new vehicles
   containing such parts, for a period of three years, after which the
   prohibitions would go into effect;
 * Manufacture, processing, and distribution in commerce for those aerospace
   vehicles produced with decaBDE containing parts will be excluded from the
   prohibition until the end of their service lives; manufacture, processing,
   and distribution in commerce for use in replacement parts for aerospace
   vehicles, and distribution in commerce of the replacement parts themselves;
 * Manufacture, processing, and distribution in commerce for use in replacement
   parts in motor vehicles, and distribution in commerce of the replacement
   parts themselves until the end of the vehicles service lives or 2036,
   whichever is earlier;
 * Distribution in commerce of plastic shipping pallets manufactured prior to
   the publication of the final rule that contain decaBDE until the end of the
   pallets service lives; and
 * Processing 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), and the articles and products made from such recycled plastic so
   long as no new decaBDE is added during the recycling or production process.

Phenol, isopropylated phosphate (3:1)
(PIP (3:1))

PIP (3:1) is used as a plasticizer, a flame retardant, an anti-wear additive, or
an anti-compressibility additive in hydraulic fluid, lubricating oils,
lubricants and greases, various industrial coatings, adhesives, sealants, and
plastic articles. As a chemical that can perform several functions
simultaneously, sometimes under extreme conditions, it has several distinctive
applications. Learn more about PIP (3:1) uses.

Identified Hazards – 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, heart, and lungs.

EPA prohibited processing and distribution in commerce of PIP (3:1), and
products and articles containing the chemical substance, for all uses, except
for the following:

 * Processing and distribution in commerce for use in aviation hydraulic fluid
   in hydraulic systems and use in specialty hydraulic fluids for military
   applications; 
 * Processing and distribution in commerce for use in lubricants and greases;
 * Processing and distribution in commerce for use in new and replacement parts
   for the aerospace and automotive industries;
 * Processing and distribution in commerce for use as an intermediate in the
   manufacture of cyanoacrylate glue;
 * Processing and distribution in commerce for use in specialized engine air
   filters for locomotive and marine applications;
 * Processing and distribution in commerce for use in sealants and adhesives
   until January 6, 2025; and
 * Processing and distribution in commerce for recycling of plastic that
   contained PIP (3:1) before the plastic was recycled (i.e., the plastic to be
   recycled is from articles and products that were originally made with PIP
   (3:1), and the articles and products made from such recycled plastic so long
   as no new PIP (3:1) is added during the recycling or production process.
 * Processing and distribution in commerce for use in certain key consumer and
   commercial goods (articles) until March 8, 2022. EPA has proposed further
   extending this compliance date until October 31, 2024. 

EPA required that persons manufacturing, processing, and distributing in
commerce PIP (3:1) and products containing PIP (3:1) notify their customers of
these restrictions. However, the compliance date for recordkeeping associated
with certain consumer and commercial PIP (3:1)-containing articles mentioned
above is March 8, 2022. EPA has proposed further extending this compliance date
until October 31, 2024. 

EPA also prohibited releases to water from the remaining manufacturing,
processing, and distribution in commerce activities, and requiring commercial
users of PIP (3:1) and PIP (3:1)-containing products to follow existing
regulations and best practices to prevent releases to water during use. 

2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)

2,4,6-TTBP is used as an intermediate/reactant in processing and is incorporated
into formulations destined for fuel and fuel-related additives, as well as into
formulations intended for the maintenance or repair of motor vehicles and
machinery, including in oils and lubricants. Learn more about 2,4,6-TTBP uses.

Identified Hazards – 2,4,6-TTBP is toxic to aquatic plants, aquatic
invertebrates, and fish. Surveyed animal data indicate the potential for liver
and developmental effects. The studies presented in this document demonstrate
these hazardous endpoints. EPA has concluded that exposure to 2,4,6-TTBP under
the conditions of use is likely.

EPA prohibited the distribution in commerce of 2,4,6-TTBP and products
containing 2,4,6-TTBP at concentrations above 0.3% by weight in any container
with a volume of less than 35 gallons 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).

EPA also prohibited the 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 in
concentrations above 0.3% by weight regardless of container size.
Hexachlorobutadiene (HCBD) HCBD is used as a halogenated aliphatic hydrocarbon
that
is produced as a byproduct during the manufacture of
chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene, and
carbon tetrachloride and is subsequently burned as a waste fuel. Learn more
about HCBD uses.

Identified Hazards – HCBD is toxic to aquatic invertebrates, fish, and birds,
and has been identified as a possible human carcinogen. Data indicate the
potential for renal, reproductive, and developmental effects.

EPA prohibited the manufacturing (including import), processing, and
distribution in commerce of HCBD and HCBD-containing products or articles,
except for the unintentional production of HCBD as a byproduct during the
production of chlorinated solvents, and the processing and distribution in
commerce of HCBD for burning as a waste fuel.

Pentachlorothiophenol (PCTP)

PCTP, which is also called PCTP, is used to make rubber more pliable in
industrial uses. Learn more about PCTP uses.

Identified Hazards – PCTP is toxic to protozoa, fish, terrestrial plants, and
birds. Data for analogous chemicals (pentachloronitrobenzene and
hexachlorobenzene) indicate the potential for liver and reproductive effects.
However, no animal or human hazard data has been identified. EPA prohibited the
manufacture (including import), processing, and distribution in commerce of
PCTP, and products or articles containing PCTP, unless PCTP concentrations are
at or below 1% by weight.


ADDITIONAL INFORMATION


LETTER PEER REVIEWS OF EXPOSURE AND HAZARD INFORMATION

EPA conducted letter peer reviews of exposure and hazard information for the
five PBT chemicals. EPA also accepted written comments on the charge questions
and other documents to be considered by the peer reviewers. These materials are
available in docket EPA-HQ-OPPT-2018-0314.

Learn more about the letter peer reviews.


WEBINAR

On Thursday, September 7, 2017, at 2 pm EDT, EPA hosted a webinar, “Use
Information for Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under
TSCA Section 6(h).” This webinar provided background on the requirements for PBT
chemicals under amended TSCA and explained to interested parties the process for
gathering use and exposure information the five PBT chemicals.

 * View the meeting agenda.
 * View EPA’s presentation.


PUBLIC DOCKETS

The public docket for all five final rules is EPA-HQ-OPPT-2019-0080.

Additionally, EPA previously established public dockets for each of the five PBT
chemicals to facilitate receipt of information on exposure and use which may be
useful to the agency’s rulemaking effort. To read the comments EPA received,
visit the docket for each chemical.

 * DecaBDE – EPA-HQ-OPPT-2016-0724
 * PIP (3:1) – EPA-HQ-OPPT-2016-0730
 * 2,4,6-TTBP – EPA-HQ-OPPT-2016-0734
 * HCBD – EPA-HQ-OPPT-2016-0738
 * PCTP – EPA-HQ-OPPT-2016-0739

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Last updated on November 5, 2021