EPA TSCA Manufacturer-Requested Risk Evaluations (MRREs)
MRREs of DINP and DIDP
In May of 2019, ACC’s High Phthalates Panel (ACC HPP), representing major producers, importers, and users of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and other high molecular weight phthalates, submitted a request for an EPA risk evaluation of DINP and a request for an EPA risk evaluation of DIDP. These manufacturer-requested risk evaluations were made under the 2016 amendments to the Toxic Substances Control Act (TSCA). We consider these requests an important tool that will expedite transparent, fair, and evidence-based risk evaluations of DINP and DIDP as they each are currently used in commercial and consumer products in the United States.
DINP and DIDP are two of the most thoroughly-studied compounds in the world and have been reviewed by numerous government regulatory agencies in the last 6 years, including the European Chemicals Agency (ECHA), the Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and Canada’s Ministry of Environment and Climate Change and Ministry of Health. These agencies found that these high molecular weight phthalates are safe as currently used. We believe that a broad-based risk evaluation of DINP and DIDP is in the interest of consumer confidence in this country.
We look forward to the agency completing these risk evaluations within the timeframe set forth under TSCA, and consistent with the guidance to apply the best available science and to rely on the weight of the evidence, as required by the statute. We stand ready to assist the agency if additional information is needed to complete the reviews.
DIDP and DINP are phthalates — a family of chemical compounds primarily used to make polyvinyl chloride (PVC), sometimes called vinyl, flexible and pliant. Phthalates are used in hundreds of products in our homes, hospitals, cars and businesses.
The high molecular weight phthalates selected to soften plastics are used because of their strong performance, durability and stability. Because these high molecular weight phthalate plasticizers are tightly bound into the material in which they are added, they do not easily migrate out of the product or evaporate.
DINP is primarily used as a plasticizer to impart flexibility to PVC in consumer and industrial applications. These applications include wire and cable coating, building and construction (vinyl tiles, resilient flooring, PVC-backed carpeting, roofing, wall coverings, etc.), automotive (window glazing, doors, acrylic plastisol sealants in wheel wells, underbody coatings and paints), vinyl clothing (raincoats and boots, gloves, etc.), tool handles, flexible tubes, and hoses. Approximately 5% of DINP is used in non-PVC applications such as rubber polymers, inks and pigments, adhesives, sealants, and paints.
DIDP is also primarily used as a plasticizer to impart flexibility to PVC in consumer and industrial applications. These applications include building and construction (electrical wire coating, vinyl tiles, resilient flooring, PVC-backed carpeting, roofing, wall coverings etc.), automotive (upholstery and interior finishes such as synthetic leather for car interior seats and dashboards, undercoating, insulation for wire and cable, window glazing etc.), flexible tubes, profiles, and hoses. Other DIDP applications include use in inks, adhesives, sealants, synthetic lubricants and engine oils.
While they can be employed in a variety of applications, phthalates are not necessarily interchangeable. The characteristics of an individual phthalate often make it well suited to a particular product, allowing manufacturers to meet unique requirements for its use (function and safety specifications), appearance (texture, color, size and shape), and durability and wear.
We have full confidence in the safety of DINP and DIDP, and a manufacturer-requested review is the most expeditious way to have EPA evaluate the safety of key uses of these compounds against rigorous scientific criteria. This assessment of safety – backed by the peer review required by law - is important to businesses and consumers of these important products.
To achieve this goal, industry has voluntarily stepped forward on the strength of over 20 years of research on DINP and DIDP. In fact, the overwhelming international consensus, as found by the European Chemicals Agency (ECHA), the Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and Canada’s Ministry of Environment and Climate Change and Ministry of Health, is that these high molecular weight phthalates are safe as currently used.
We look forward to the EPA completing these risk evaluations within the timeframe set forth in TSCA, and consistent with the guidance to apply the best available science and to rely on the weight of the evidence, as required by the statute. We stand ready to assist the agency if additional information is needed to complete the reviews.
Yes. EPA makes clear that “All risk evaluations, whether EPA-initiated or manufacturer-requested, will be conducted in the same manner.” They will apply the same rigorous scientific criteria and will include expert peer review. A manufacturer requested review is simply the most expeditious way to have these compounds reviewed, which can benefit manufacturers and consumers.