December 6, 2021

Volume XI, Number 340


December 03, 2021

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Isopropylated Phosphate (3:1) – Could Restrictions Impact You?

On March 8, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is seeking additional public comment on five final rules intended to reduce exposure to certain persistent, bioaccumulative, and toxic (PBT) chemicals.  These final rules, issued on January 6, 2021 under the Toxic Substances Control Act (TSCA), include a nearly total prohibition on the processing and distribution in commerce of phenol, isopropylated phosphate (3:1) (PIP (3:1)), as well as products containing PIP (3:1). Companies manufacturing or distributing products containing PIP (3:1) who fail to secure an exemption from EPA in any subsequent revisions to the final rule will be forced to remove products from store shelves and may face substantial losses.

PIP (3:1) is used as a plasticizer, flame retardant, anti-wear additive, anti-static agent, and/or an anti-compressibility additive in numerous applications including:

  • hydraulic fluids

  • lubricating oils

  • lubricants

  • greases

  • paints

  • industrial coatings

  • adhesives

  • sealants

  • textiles

  • polyurethane foam

  • PVC

  • plastics

  • wire covers and harnesses

  • epoxy and phenolic resins

  • synthetic rubber

Following publication of the final rules, numerous industries notified EPA that the prohibition on processing and distribution of both PIP (3:1) and PIP (3:1)-containing articles would severely impact their product lines and supply chains, leading to a reopening of the comment period and a 180-day “No Action Assurance” with regard to the prohibition on processing and distribution in commerce. Note that other elements of the final rule, including prohibitions on release of PIP (3:1) to water, recordkeeping requirements, and downstream notification requirements remain in effect.

Determining whether PIP (3:1) is present in finished products or supply chains can present difficulty, because few other countries currently regulate the use or presence of the chemical; thus, manufacturers and suppliers may not track the inclusion of PIP 3:1 in their products. Industry stakeholders should begin making inquiries immediately as to whether PIP (3:1) is present in their supply chains.  If the use of PIP (3:1) is identified, comments should be prepared and submitted to EPA identifying either (1) the time reasonably required to reformulate or redesign the product(s) to avoid use of PIP (3:1), or (2) why the identified use(s) should not be included in the scope of EPA’s prohibition.

EPA will accept public comments in docket EPA-HQ-OPPT-2021-0202 on for 60 days until May 17, 2021.

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 105

About this Author

Mark J. Vaders FDA Litigation Attorney Womble Bond Dickinson Winston-Salem, NC

Mark Vaders provides cost-effective scientific and legal solutions to clients whose branded products are regulated by the FDA and state agencies. He has assisted in drafting many submissions to FDA’s Center for Tobacco Products, and serves as an in-house resource on vapor product science. His practice also focuses on developing legal- and science-based defenses to product liability lawsuits. Mark has provided counsel to RJ Reynolds Tobacco Company, RJ Reynolds Vapor Company, a leading national supplier of scientific and medical equipment, a global reinsurance provider, and other clients....

Lisa Rushton, Womble Dickinson Law Firm, Raleigh and Washington DC, Corporate and Environmental Law Attorney

An industry-leading environmental transactions attorney, Lisa Rushton guides corporate clients, including global, multi-national, and local corporations, real estate developers, financial institutions and investment funds on matters relating to federal, state, and local environmental, health and safety laws and regulations and was identified by Chambers as one of the leading environmental practitioners for business transactions.

With substantial experience in matters relating to air and water pollution control laws, solid and hazardous waste management and cleanup...