The five chemicals designated under the proposed rule include: decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1); (PIP (3:1)), also known as tris(4-isopropyl phenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol aka (PCTP).
decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(isopropyl phenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).
The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.
For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1). Publication of the proposed rule in the Federal Register will begin a 60-day comment period.
Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), TSCA Section 6(h) requires EPA to propose Section 6(a) regulatory action by June 22, 2019, on chemicals from the 2014 update of the TSCA Work Plan that meet the PBT requirements specified in Section 6(h). The proposed Section 6(a) rules must, pursuant to Section 6(h)(4), “address the risks” presented by the chemicals and reduce exposure “to the extent practicable.” EPA identified five PBT chemicals that meet the statutory criteria — DecaBDE; PIP (3:1); 2,4,6-TTBP; HCBD; and PCTP.
What Action Is EPA Taking?
EPA is proposing to restrict or prohibit certain actions with respect to four of the five PBT chemicals subject to the rulemaking — DecaBDE; PIP (3:1); 2,4,6-TTBP; and PCTP. 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.
EPA states that the extent of exposure, the severity of the hazard, and thus the likely risk of these chemicals varies significantly. For example, according to EPA, the evidence suggests that human exposure to HCBD “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 vary substantially, from relatively well-studied chemicals (e.g., DecaBDE) to data-sparse chemicals without significant hazard data (e.g., PCTP).
The proposed rule includes hazard summaries for each of the five PBT chemicals. According to the proposed rule, 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.” EPA states that “[d]ue 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 general-purpose summary of the hazards presented by the five PBT chemicals.” The proposed rule briefly summarizes “reasonably available hazard information.” EPA requests public comments making it aware of any more recent hazard information available. EPA notes that the hazard statements “are not based on a systematic review of the available literature and information may exist that could refine the hazard characterization.”
DecaBDE is a flame retardant that has been widely used in textiles, plastics, adhesives, and polyurethane foam. For DecaBDE, the proposed rule 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;
EPA states that 2,4,6-TTBP 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, the proposed rule 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 fewer than 55 gallons for any use to 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). According to the proposed rule, 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). The 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.The hazard statement states:2,4,6-TTBP is toxic to aquatic plants, aquatic invertebrates, and fish. Data indicate the potential for liver and developmental effects.HCBDHCBD 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 states that it has evaluated the uses of hexachlorobutadiene and is proposing no regulatory action.
The hazard statement states:
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.
PCTP is used in the manufacture of rubber compounds. For PCTP, the proposed rule would prohibit the manufacture (including import), processing, and distribution in commerce of PCTP, and products containing PCTP, unless in concentrations at or below one percent by weight.
The hazard statement states:
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 (bodyweight) effects for PCTP in mammals (no repeated-dose animal or human epidemiological data were identified for PCTP).
EPA is expected to finalize the proposed Rule and publish it in the Federal Register following the end of the public comment period.