The EPA has declined to grant a petition from environmental groups that requested that the Agency use its authority under Section 4 of the Toxic Substances Control Act (TSCA) to require that manufacturers and processors of chlorinated phosphate esters (CPEs) conduct testing on these substances to determine their health and environmental effects during their full life cycle.
The EPA must grant a Section 4 petition if it finds that the subject chemical substance may present an unreasonable risk of injury under its conditions of use; that existing information and experience are insufficient to reasonably determine or predict the effects of a chemical substance on health or the environment; and that testing of the chemical substance is necessary to develop the missing information.
The EPA says it agrees that the manufacture, distribution in commerce, processing, use, or disposal of the CPE chemicals may present an unreasonable risk of injury to health or the environment. However, in its denial, the Agency says it does not believe that the petitioners demonstrated, for each exposure pathway and hazard endpoint presented in the petition, that the information and experience available to the EPA are insufficient to reasonably determine or predict the effects on health or the environment from any individual condition of use or any combination of such activities or that the specific testing they have identified is necessary to develop such information.
The CPE cluster addressed in the petition comprises three high-production-volume chemicals: tris(2-chloroethyl) phosphate (TCEP); 2-Propanol, 1-chloro-, phosphate (TCPP); and 2-Propanol, 1,3- dichloro-, phosphate (TDCPP). The substances served mainly as flame retardants and are used in additive applications for paints and coatings, textiles, building insulation, and polyurethane foam. CPE flame retardants have been the primary replacements in foam for the polybrominated diphenyl ether flame retardants (PBDEs) that are widely understood to be toxic and were phased out of U.S. production pursuant to voluntary agreements the EPA and industry forged a decade ago.
The petition asserts both that there is sufficient information to find that the CPE cluster may present an unreasonable risk of injury to health or the environment and also that there is insufficient information to understand the nature of those risks specific to exposure pathways. The petitioners identified seven specific gaps that could be filled by industry testing, including effects of dermal and inhalation exposure, reproduction and endocrine toxicity impacts, effects of environmental releases from nonindustrial uses, and effects of exposure to workers involved in manufacturing products with the CPE chemicals.
These data gaps, the petitioners assert, exist in EPA’s 2015 Problem Formulation and Initial Assessment for the CPE Cluster, which was produced under the Agency’s TSCA Work Plan chemical assessments.
“Due to an overall lack of available data or existing data gaps, EPA will be unable to conduct the robust chemical risk evaluations mandated by the reformed TSCA unless it requires manufacturers and processors to develop health and safety information about their chemicals,” stated the petitioners.
Subsequent Data Obtained
While the EPA concedes that the CPE cluster assessment preceded the more rigorous standards imposed by the TSCA amendments, the Agency does not agree that the “gaps” described by the petitioners reasonably require a Section 4 order. According to the EPA, even if those gaps do exist in the Problem Formulation and Initial Assessment, as the petitioners assert, the Agency generally takes the position that its subsequent acquisition of more data over the past 2 years can be used to characterize the risks of the CPE cluster as required by TSCA.
EPA’s denial of the petition was published in the April 12, 2017, FR.