EPA Publishes Revisions to Rule Restricting PIP(3:1)
On Friday September 3, EPA made available online a pre-publication version of revisions to its rule affecting PIP(3:1) as part of its rulemaking on persistent, bioaccumulative and toxic (PBT) chemicals. This rule is required under Section 6(h) of TSCA. EPA is extending the compliance date for processing and distribution of PIP(3:1) for use in articles and PIP(3:1) containing articles to March 8, 2022.
EPA limits changes to requirements affecting articles. EPA does not change existing requirements affecting manufacture of adhesives and chemical mixtures. Notably, EPA requires:
- Effective March 8, 2021, EPA prohibits processing and distributing PIP(3:1) for use in products, including distribution of products containing PIP(3:1), unless otherwise specified.
- Effective Jan. 6 2025, EPA prohibits PIP(3:1) for use in adhesives and sealants and placing of any adhesive and sealant product with PIP(3:1) on the market. This prohibition does not apply to PIP(3:1) when used as an intermediate to produce cyanoacrylate adhesives.
- EPA also prohibits discharge of PIP(3:1) to water, effective March 8, 2021.
- Companies placing PIP(3:1) on the market or products containing PIP(3:1) must maintain ordinary business records for three years demonstrating compliance. These could include invoices and bills of lading.
- Companies must also inform parties receiving shipments of restrictions, in writing. Notification can be either by a specified statement in Sections 1 and 15 of the SDS or by a specified label statement.
EPA will also open another comment period with a Notice of Proposed Rulemaking (NPRM) allowing comment about additional extensions for certain PIP(3:1) articles. EPA seeks detailed descriptions of affected articles and phase-out times and requirements. EPA notes that most article manufacturers are still in the early stages of identifying affected articles. As such, EPA deems a brief one-year extension appropriate while it seeks additional information.
Notably, risk mitigation approaches of this PBT rulemaking are of limited precedential value for risk mitigation rules for the first 10 TSCA risk evaluation chemicals. Under Section 6(h) of TSCA, EPA is required to restrict identified PBT chemicals based on a screening level hazard review, whereas the risk evaluation chemicals undergo detailed evaluations by condition of use. Despite the flaws of these evaluations, EPA must consider a variety of factors during risk mitigation. The PBT rulemaking also demonstrates EPA’s flexibility with implementing phase-out times and providing targeted exemptions when industry provides adequate data to justify those decisions.
EPA’s Press Release is available online.
EPA’s Pre-publication version of the rule is available online.
EPA publishes final scoping documents for DIDP and DINP
On August 31, EPA published final scoping documents for two manufacturer-requested risk evaluations, being conducted for diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP). EPA will evaluate conditions of use related to adhesives, sealants, paints and coatings. With publication of final scoping documents, EPA will proceed with hazard and exposure assessments followed by risk characterization and determinations.
The next opportunity for comment will be with publication of a draft risk evaluation, in about two years. EPA is open to receiving data from stakeholders, especially now as it initiates hazard and exposure assessments. Please feel free to reach out to me if you have any relevant information and seek assistance with submission.
EPA plans to analyze exposure levels for indoor dust, indoor air, ambient air, surface water, drinking water, groundwater, sediment, soil, biosolids, fish ingestion, aquatic biota, and terrestrial biota associated with exposure. EPA believes other phthalate esters utilized in similar ways to DIDP and DINP may serve as surrogates. As such, members may be interested in providing EPA with information about limits of this approach. EPA will also review exposure and monitoring data, specific to conditions of use, as collected through OSHA, NIOSH and other agencies, as well data in published literature. EPA has identified potentially relevant OECD Emissions Screening Documents (ESDs) and EPA Generic Scenarios (GSs) corresponding to some conditions of use. For example, EPA has identified the 2015 ESD on the Use of Adhesives (OECD, 2015) and the 2009 ESD on Plastic Additives (OECD, 2009b) and may use these in its evaluation. Members may consider providing information about appropriate methods of evaluation specific to conditions of use and information regarding generic scenarios and screening documents. ACA can assist with submissions. Please feel free to contact me.
Listing of some relevant conditions of use for ACA members follows:
DIDP
- Processing
- a) Incorporation into Formulation and Mixtures –
- Plasticizers (e.g., adhesive and sealant manufacturing; custom compounding of purchased resin; construction materials other; ground injection equipment; paint and coating manufacturing; pigments; plastic material and resin manufacturing;
- Adhesives and Sealants Manufacturing
- b) Incorporation into articles, e.g. Plasticizers (e.g., asphalt paving, roofing, and coating materials manufacturing).
- Industrial Uses – Adhesives and Sealants
III. Commercial Uses – Construction, paint, electrical, and metal products
- Consumer Uses – Construction, paint, electrical, and metal products
DINP
- Processing – Incorporation into formulation, mixtures or reaction products: Adhesive and sealant chemicals, intermediates in formulated products, plasticizer in manufacturing of adhesives, paints and coatings.
- Industrial Uses – Adhesives and sealants, construction and paint products
III. Commercial uses – construction and paint products
- Consumers products – construction and paint products
Additional information is available through EPA’s website for manufacturer-requested risk evaluations.