The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it has opened the public comment periods for manufacturer requests for the risk evaluations of two chemicals used in plastic production, diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). EPA notes that the manufacturer-requested risk evaluations of DIDP and DINP “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA). EPA states that it “is also taking public comments on additional conditions of use [(COU)] the Agency identified to include in the risk evaluations.” EPA published the Federal Register notices on August 19, 2019, for DIDP and DINP. 84 Fed. Reg. 42914; 84 Fed. Reg. 42912. EPA states that it “encourages comments on any information not included in the manufacturer requests that the commenters believe would be needed to conduct a risk evaluation.” EPA also welcomes any other information relevant to its proposed determinations of the COUs, including information on other COUs of the chemicals than those included in the manufacturer request or in EPA’s proposed determinations. Comments are due October 3, 2019.
ExxonMobil Chemical Company made the request for DIDP through the American Chemistry Council’s High Phthalates Panel (ACC HPP). The Federal Register notice states that DIDP is a phthalate used as a plasticizer to impart flexibility to polyvinyl chloride (PVC) in consumer, commercial, and industrial adhesives, sealants, lubricants, greases, and paints and coatings. According to the notice, the manufacturer submitted two commercial products for risk evaluation under the name DIDP. The manufacturer request for a risk evaluation of DIDP requests that EPA evaluate the following uses:
- DIDP manufacturing;
- DIDP use as a general-purpose plasticizer for PVC used in the following applications:
- Building and construction -- Electrical wire coating, vinyl tiles, resilient flooring, PVC-backed carpeting, wall coverings, and roofing;
- Automotive -- Upholstery and interior finishes (e.g., synthetic leather for car seats, interior PVC skins for dashboards, and shift boot covers), window glazing, body-side molding, automotive undercoating, molded interior applications, insulation for wire and cable, and wire harnesses;
- Other consumer applications -- Flexible tubes, hoses, and profiles; and
- Non-PVC applications -- Inks, adhesives, sealants and paints, and synthetic lubricants and engine oils; and
- Use in PVC for children’s toys and child-care articles -- From 2009-2017, the U.S. Consumer Product Safety Commission (CPSC) placed an interim restriction on the use of DIDP in any children’s toys that can be placed in a child’s mouth or child-care article at levels greater than 0.1%. In 2017, CPSC lifted the interim prohibition on the basis that it “is not necessary to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety.” Thus, DIDP may be used in children’s toys and child-care articles without restriction in the United States, unless there are restrictions within a specific state. One such state restriction is in California, which prohibits DIDP in concentrations greater than 0.1% in a toy or child-care article intended for use by a child under three years of age if that product can be placed in the child’s mouth. The manufacturer, through the ACC HPP, requests that potential DIDP exposure of children from toys and child-care articles be evaluated, consistent with EPA’s stated concerns in its 2012 Phthalates Action Plan.
ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex made the request for DINP through the ACC HPP. The Federal Register notice states that DINP is a phthalate used as a plasticizer and paint additive in consumer and commercial products, as well as numerous manufacturing applications. According to the notice, the manufacturers submitted two commercial products for risk evaluation under the name DINP. The manufacturer request for a risk evaluation of DINP requests that EPA evaluate the following uses:
- DINP manufacturing;
- DINP use as a general-purpose plasticizer for PVC used in the following applications:
- Building and construction -- Wire and cable jacketing, vinyl tiles, resilient flooring, PVC-backed carpeting, wall coverings, roofing, and pool applications;
- Automotive -- Window glazing, wire and cable jacketing, underbody coatings, doors, acrylic plastisol sealants, and windshield adhesive;
- Other consumer applications -- Vinyl clothing (e.g., raincoats, boots, and gloves), tool handles, flexible tubes, and hoses and profiles; and
- Non-PVC applications -- Inks and pigments, adhesives, sealants, and paints; and
- Use in PVC for children’s toys and child-care articles -- Although DINP at concentrations of more than 0.1 percent is prohibited in children's toys and child-care articles by CPSC, the manufacturers request that potential DINP exposure of children from toys and child-care articles be evaluated, consistent with EPA’s stated concerns in its 2012 Phthalates Action Plan.
Additional COUs for DIDP and DINP
EPA identified additional COUs for DIDP and for DINP from a review of recent data submitted under the Chemical Data Reporting (CDR) rule in 2016. In each document, EPA states that as defined under TSCA, COUs are the “circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” According to EPA, though it interprets the circumstances that constitute COUs as largely factual -- “i.e., EPA is to determine whether a chemical substance is actually intended, known, or reasonably foreseen to be used in one or more of the activities listed in the definition” -- EPA’s considerations of the COUs “will inevitably involve the exercise of some discretion.” EPA “will exercise that discretion consistent with the objective of conducting a technically sound, manageable risk evaluation to determine whether a chemical substance -- not just individual uses or activities -- presents an unreasonable risk to health or the environment.” EPA states that it will be guided by its best understanding, informed by legislative text and history, of the circumstances of manufacture, processing, distribution in commerce, use, and disposal “as Congress intended EPA to consider in conducting risk evaluations.”
EPA notes that TSCA “grants some discretion to determine the circumstances that are appropriately considered to be the chemical’s COUs.” In exercising that discretion, EPA states that it “would not generally consider that a single unsubstantiated or anecdotal statement (or even a few isolated statements) on the internet that a chemical can be used for a particular purpose would necessitate concluding that this represented part of the chemical substance’s COUs.”
EPA acknowledges that although the definition could be read literally to include all intentional misuses (e.g., inhalant abuse), as a “known” or “reasonably foreseen” activity in some circumstances, “EPA interprets the risk evaluation process of TSCA section 6(b) as a focus on the continuing flow of chemical substances from manufacture, processing and distribution in commerce into the use and disposal stages of their lifecycle.” EPA states that it believes TSCA “is better interpreted to focus on the prospective flow of the chemical substance, and therefore does not consider legacy uses, or associated disposal as a COU.” EPA will use the statutory definition and EPA’s approach described above to assess whether the circumstances identified in the manufacturer requests for risk evaluations of DIDP and DINP constitute COUs under 40 C.F.R. Section 702.33, and whether those COUs warrant inclusion within the scope of a risk evaluation. Subject to further analysis and public comment, EPA anticipates including activities identified in the requests as COUs in the risk evaluations of DIDP and DINP.
After the comment period closes, EPA will review the comments and within 60 days either grant or deny the requests to conduct risk evaluations. EPA will grant the request if it determines that the request meets all of the following requirements listed under 40 C.F.R. Section 702.37(e)(6)(ii):
- The circumstances identified in the request constitute conditions of use that warrant inclusion in a risk evaluation for the chemical substance;
- EPA has all the information needed to conduct such risk evaluation on the conditions of use that were the subject of the request; and
- All other criteria and requirements of 40 C.F.R. Section 702.37 have been met.
If these requests are granted, the manufacturers would be responsible for half the cost of the risk evaluations.
EPA has once again risen to the challenge of establishing a new process required under new TSCA. EPA is sensibly modeling its process for review of manufacturer-requested substances on its process for substances prioritized by EPA. The details of the risk evaluation should not depend on the source of the risk evaluation, only on the information set available to perform the risk evaluation.
One of the challenges that EPA faces is in defining the end uses that it will include in its assessment. Given that DINP had been banned from toys by CPSC and is banned by California, it is not clear if EPA will identify use in toys as a reasonably foreseeable condition of use. The manufacturers specifically requested that EPA review use in toys, so EPA is likely to include that condition of use.
It will be interesting to watch the process play out. Will EPA find that it has sufficient information to make a reasoned judgment? Will EPA include additional conditions of use that might lead to unreasonable risk, necessitating regulatory action? And perhaps most importantly: What will be the preemptive effect on California’s ban on use in toys if EPA finds no unreasonable risk in that case?