EPA Releases Final TSCA Scope Document for First Two Phthalate Chemicals

The Biden administration continues its rollback of environmental policies employed by the prior administration, as evidenced by the U.S. Environmental Protection Agency’s (EPA) recent release of final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of two chemicals in the phthalates family—diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).

The DIDP and DINP scope document is clearly of immediate concern to those who manufacture those chemicals, as they will be directly affected by any regulatory changes resulting from the TSCA risk evaluations. However, these are only the first two chemicals to be considered under the recently released Biden administration policies expanding the scope of all future TSCA risk evaluations. These risk evaluations can be seen as a “template” for the Biden administration’s new risk evaluation policies that could eventually touch a wide array of chemical manufacturers and users.

Phthalates are widely used to increase flexibility in plastics and plastic coatings in everyday products such as toys, medical devices, kitchen utensils, food packaging, electronics, cosmetics and adhesives, to name just a few. Phthalates are said to contribute to infertility, diabetes, and cancer. On the federal level, phthalates are regulated by:

• (a) the Food and Drug Administration (26 different phthalates in various products that come into contact with food must be lower than 1% by weight (21 C.F.R. § 178.3740)); and
• (b) the Consumer Product Safety Commission (toys and childcare products cannot contain more than 0.1% by weight of eight listed phthalates (16 C.F.R. § 1307).

Several states have their own regulatory initiatives to limit phthalates that run the gambit: California’s labeling initiative (CAphthalates) and restrictions on certain chemicals in cosmetics starting in 2025 (Toxic Free Cosmetics Act); the state of Washington’s limits on phthalates in children’s products and larger initiative to identify safer alternatives to certain chemicals (RCW 70.240 et seq.; WAC 173-334 et seq. (reporting rule); and RCW 70A.350 et seq.); and Maine’s newly adopted prohibition on the sale of food packaging containing phthalates, as well as inducing inks, dyes, pigments, adhesives, stabilizers, coatings, plasticizers, or any other additives (L.D. 1433 (H.P. 1043)).

Given the emerging patchwork approach, a more comprehensive analysis and management of phthalates in products may be welcome. The EPA appears to be taking initial steps to provide a path toward a more comprehensive management of phthalates using its authority under TSCA, starting with DIDP and DINP. TSCA authorizes the EPA to conduct a risk evaluation of chemicals already in use in products to determine whether those chemicals present an unreasonable risk to public health or the environment under the conditions of use (TSCA 15 U.S.C. § 2605 and 40 C.F.R. 702.37). Under this authority, the EPA granted the request of manufacturers of DIDP and DINP to conduct an analysis of those chemicals in 2019.

The first step in a TSCA risk evaluation is to develop a “scope” document for public comment. For DIDP and DINP, a draft scope document was published in the fall of 2020, opening a 45-day public comment period (EPA Document No. EPA-740-D-20-033). However, the final scope documents were not released by the EPA until August 2021 (Final Scope of the Risk Evaluation for Di-isononyl Phthalate (DINP) CASRN 28553-12-0 (epa.gov) and Final Scope of the Risk Evaluation for Di-isodecyl Phthalate (DIDP) CASRN 26761-40-0 (epa.gov)).

With the change in the administration, what happened between the draft scope document publication and the final scope document is most interesting. In June 2021, the EPA announced a change in policy for TSCA risk evaluations (EPA Announces Path Forward for TSCA Chemical Risk Evaluations | US EPA). Under this new policy, the EPA can consider exposure by means not traditionally considered within a TSCA analysis. For example, while a traditional TSCA analysis may not include exposure pathways such as air, water, and disposal, the risk evaluation would include such exposure pathways. Further, the risk evaluation can now include both (a) more specific “fenceline community” considerations to understand exposure to those living near facilities manufacturing the chemical in question (also reflecting the Biden administration’s renewed focus on environmental justice), and (b) revisiting the previously used assumption that all employees appropriately use personal protective equipment in chemical handling. Finally, the EPA will look at chemicals not only on an as-used basis for each current use, but it will consider whether one determination covering all uses is warranted—what the EPA has termed the “whole substance” approach. This expanded analysis reflects considerations that likely would not have been part of a risk analysis of DIDP or DINP (or other phthalates) prior to this 2021 policy change.

While the DIDP and DINP scope document is clearly critical to manufacturers of those chemicals and potentially others who have an interest in the products containing these chemicals, these scope documents are also instructive as a guide to a more general understanding of how the new TSCA risk evaluation policy will be implemented by the Biden administration.

Interested parties may contact Dawn Lamparello in the K&L Gates, Newark, New Jersey offices here, or Janessa Glenn in the K&L Gates, Austin, Texas offices here.