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Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Rules and Regulations
Are chemical substances for which EPA has not completed a TSCA Work Plan Problem Formulation, initiated a review under TSCA section 5, or entered into a consent agreement under TSCA section 4, prior to June 22, 2016, the date that the Frank R. Lautenberg Chemical Safety for the 21st Century Act became law.
In addition, in order for a chemical substance to be subject to expedited action, TSCA section 6h1B states that EPA must find that exposure to the chemical substance under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or to the environment on the basis of an exposure and use assessment conducted by EPA.
For chemical substances subject to TSCA section 6h, EPA was directed to issue a proposed rule by June 22, 2019, and a final rule no later than 18 months after issuance of the proposal. The statute further provides that the Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to TSCA
section 6h1.
1. June 2019 proposed rule for PBT
chemicals under TSCA section 6h.
EPA issued a proposed rule for PIP 3:1
and four other chemical substances in June 2019 Ref. 11. EPA proposed to determine that PIP 3:1 met the TSCA
section 6h1A criteria for expedited action. In addition, based on an exposure and use assessment for PIP
3:1 Ref. 12 conducted as directed by TSCA section 6h1B and which was subject to peer review and public comment, EPA also proposed to find that exposure to PIP 3:1 is likely.
During the development of the 2019
proposed rule Ref. 11, EPA conducted extensive outreach to understand the uses of the five PBTs. Outreach included a public webinar, a Small Business Roundtable hosted by the Small Business Administration Office of Advocacy, and meetings with more than 90 stakeholders. Based on this outreach as well as EPAs practicability analysis for various prohibitions and restrictions, EPA proposed extended compliance dates for some uses of PIP 3:1 and exclusions for others.
The public comment period on the proposal was open for a total of 90 days, closing on October 28, 2019. EPA
received a total of 48 comments, with three commenters sending multiple submissions with attached files, for a total of 58 submissions on the proposal for all five of the PBT chemicals. This includes the previous request for a comment period extension EPAHQ
OPPT201900800526. Two
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commenters submitted confidential business information CBI or copyrighted documents with information regarding economic analysis and market trends. Of the comment submissions, 30 of the approximately 50 comments addressed EPAs proposed regulation of PIP 3:1.
Copies of all the non-CBI documents, or redacted versions without CBI, are available via https
www.regulations.gov in docket ID
number EPAHQOPPT20190080.
2. January 2021 final rule for PIP 3:1
under TSCA section 6h. The final rule for PIP 3:1 was published in the Federal Register on January 6, 2021
Ref. 1. EPA determined in the final rule that PIP 3:1 met the TSCA section 6h1A criteria for expedited action.
In addition, EPA determined, in accordance with TSCA section 6h1B, that exposure to PIP 3:1 was likely under the conditions of use to the general population, to a potentially exposed or susceptible subpopulation, or the environment. The PIP 3:1 final rule prohibits processing and distribution in commerce of PIP 3:1, and products or articles containing the chemical substance, for all uses, except for the following different compliance dates or exclusions:
Use in photographic printing articles after January 1, 2022;
Use in aviation hydraulic fluid in hydraulic systems and use in specialty hydraulic fluids for military applications;
Use in lubricants and greases;
Use in new and replacement parts for the aerospace and automotive industries;
Use as an intermediate in the manufacture of cyanoacrylate glue;
Use in specialized engine air filters for locomotive and marine applications;
Use in sealants and adhesives after January 6, 2025; and Recycling of plastic that contained PIP 3:1 before the plastic was recycled, and the articles and products made from such recycled plastic, so long as no new PIP 3:1 is added during the recycling or production process.
In addition, the January 2021 final rule requires manufacturers, processors, and distributors of PIP 3:1 and products containing PIP 3:1 to notify their customers of these restrictions.
Finally, the rule prohibits releases to water from the remaining manufacturing, processing, and distribution in commerce activities, and requires commercial users of PIP 3:1
and PIP 3:1-containing products to follow existing regulations and best practices to prevent releases to water during use.

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Also defined at 40 CFR 751.403 for the purposes of 40 CFR part 751, subpart E, which includes the January 2021 PIP 3:1 final rule, are the terms article and product Ref. 1.
Article is defined as a manufactured item: 1 Which is formed to a specific shape or design during manufacture, 2
Which has end use functions dependent in whole or in part upon its shape or design during end use, and 3
Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design. For example, laptop computers are articles, as are the internal components such as chips, wiring, and cooling fans. Product is defined as the chemical substance, a mixture containing the chemical substance, or any object that contains the chemical substance or mixture containing the chemical substance that is not an article. For example, hydraulic fluids and motor oils are products.
The January 2021 final rule differed from the proposal in several ways as a result of the information provided during the public comment period. The exclusions that were based on information received during the public comment period are the exclusion for the use of PIP 3:1 in new and replacement parts for aerospace vehicles, as an intermediate in a closed system to produce cyanoacrylate adhesives, in specialized engine air filters for locomotive and marine applications, plastics recycling, and finished products or articles made of recycled plastic. The final rule also features delayed compliance dates for the use of PIP 3:1 in photographic printing articles and adhesives and sealants.
B. The March 16, 2021 Notification and Request for Comments Shortly after the publication of the January 2021 final rule, a wide variety of stakeholders from various sectors, including the electronics and electrical manufacturing community and their customers, started raising concerns about the March 8, 2021, compliance date in the final rule for the prohibition on the processing and distributing in commerce of PIP 3:1 for use in articles and PIP 3:1-containing articles Ref. 2.
These stakeholders contended that they needed significantly more time in order to identify whether and where PIP 3:1

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