U.S. EPA Releases TSCA Final Rules for Controlling Five PBT Hazardous Substances
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In January 2021, the U.S. Environmental Protection Agency (EPA) issued the final rules for the control of hazardous substances, in order to reduce exposure to substances, mixtures or articles that containing persistent, bioaccumulative and toxic (PBT). These five substances include 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). The rules come into effect on February 5, 2021, and are gradually implemented on March 8, 2021.

Chemical

Common 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.


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 is prohibiting 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.
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 is prohibiting processing and distribution in commerce of PIP (3:1), and products 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; 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.


EPA is requiring that persons manufacturing, processing, and distributing in commerce PIP (3:1) and products containing PIP (3:1) notify their customers of these restrictions.

EPA is also prohibiting 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.

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 is prohibiting 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 is also prohibiting 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.
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 is prohibiting 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.
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 is prohibiting 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.

TSCA (Toxic Substances Control Act) was implemented by the US Congress in 1976, and the first major reform was carried out in 2016. The bill aims to comprehensively consider the environmental, economic and social impacts of chemical substances circulating in the United States and prevent "unreasonable risks" to human health and the environment.

The TSCA law divides chemical substances in the United States into "existing substances" and "new substances" for management. For substances that are not included in the TSCA list, that is, new substances, if the exemption conditions are not met, the manufacturer or importer of the substance must make a PMN (pre-production) declaration. For "existing substances", companies need to focus on the control requirements of the Significant New Use Rule (SNUR) and the Hazardous Substances final rule. Among them, the final rules on hazardous substances are based on the requirements of TSCA section 6, requiring EPA to take rapid regulatory actions to control persistent, bioaccumulative, and toxic (PBT) chemical substances, and prohibit or restrict the production, processing, and distribution in commerce of hazardous substances.

Enterprises need to understand the regulatory requirements quickly, formulate a management and control plan suitable for their own company, and determine the compliance of their products through testing or supply chain investigations. CIRS C&K Testing can provide enterprises with targeted service solutions, assisting companies in completing hazardous substance investigations, responding to regulatory requirements in a timely manner, reducing corporate export risks, and continuing to follow up on regulatory developments to provide strong technical support for the smooth export of corporate products.

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