Final Rules from EPA Address Five PBT Chemicals

The EPA issued final rules to reduce exposure to five persistent, bioaccumulative and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA) on December 22, 2020.

“PBT chemicals are of particular concern not only because they are toxic but also because they remain in the environment for long periods of time and can build up or accumulate in the body,” according to the EPA press release. “Addressing these chemicals is a critical step in the agency’s efforts to protect the health of Americans – including children, workers, and subsistence fishers.”

The final rules “limit or prohibit the manufacture (including import), processing, and/or distribution in commerce” of the five chemicals identified for expedited action, which include:

• “Decabromodiphenyl ether (DecaBDE): A 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”;
• “Phenol, isopropylated phosphate (3:1) (PIP (3:1)): 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”;
• “2,4,6-tris(tert-butyl) phenol (2,4,6-TTBP): An intermediate/reactant in processing, and is incorporated into formulations destined for fuel and fuel-related additives”;
• “Hexachlorobutadiene (HCBD): A chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons”; and
• “Pentachlorothiophenol (PCTP): A chemical used to make rubber more pliable in industrial uses.”

The final rules and the EPA PBT website identify the hazards and risk management procedures for these chemicals.

DecaBDE

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 is likely exposed to decaBDE under certain conditions of use.

Acceptable uses include:

• 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 2 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 3 years, after which the prohibitions would go into effect;
• Manufacture, processing, and distribution in commerce for those aerospace vehicles produced with decaBDE-containing parts, which 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 before 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.

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, ovaries, heart, and lungs.

Acceptable uses include:

• 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.

The 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.

The 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-TTBP

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 EPA has concluded that exposure to 2,4,6-TTBP under the conditions of use is likely.

The 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).

The 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 a lubricant additive in concentrations above 0.3% by weight regardless of container size.

HCBD

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.

The 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 by-product during the production of chlorinated solvents, and the processing and distribution in commerce of HCBD for burning as a waste fuel.

PCTP

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 have been identified.

The 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.

Other PBTs

The EPA also announced it had received a manufacturer’s request for risk evaluations “for two other PBT chemicals within the octahydro-tetramethyl-naphthalenyl-ethanone (OTNE) chemical category.” A public comment period is expected to be announced soon for these two chemicals.