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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
of PIP 3:1 in the field are possible, for example, in wash-water from airplane parts, which may contain trace amounts of PIP 3:1 EPAHQOPPT2019
00800542; 0562. Although it is not reasonable to expect all release to be completely prevented during the kind of commercial use activities involving PIP
3:1-containing products and therefore not practicable to prohibit such release, it is practicable to require best practices and following existing statutes and regulations e.g., Oil Pollution Act, CWA applicable to commercial uses EPAHQOPPT201900800562. As a result, EPA maintains that prohibiting, as proposed, releases to water from manufacturing, processing, and distribution in commerce is practicable.
However, for commercial use, EPA
modifies the final regulation to accommodate the challenge of compliance when unintentional releases of small or de minimis amounts of PIP
3:1-containing fluid are possible during commercial use. The final rule requires all persons to follow existing regulations and best practices to prevent the release to water of PIP 3:1 and PIP
3:1-containing products during commercial use. Additionally, administrative and judicial procedures for addressing violations of restrictions under other programs consider good faith efforts to comply, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess releases in the event of a violation.
While in some cases EPA has determined that it is not practicable to exercise its section 6a authorities to regulate certain exposures under TSCA
section 6h, outlined in Unit II.F., this is not the case for releases of PIP 3:1
to water for formulated products and end uses. The formulated products and end uses of PIP 3:1 are highly regulated, though unintentional releases are possible. As discussed in this Unit, many regulatory restrictions on releases to water are administered by the EPA
e.g., Oil Pollution Act, CWA. As identified in the 2014 Update to the TSCA Work Plan for Chemical Assessment, PIP 3:1 was rated high 3
for aquatic toxicity, and high 3 for environmental persistence and bioaccumulation. Additionally, PIP 3:1
is used in emerging technologies where there are not yet available alternatives and has increasing production volume in some sectors. As a result, EPA has determined that a restriction on releases to water is appropriate in this case as it emphasizes and codifies the importance of best practices given these circumstances. Based on the above and
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comments on the proposed rule, EPA
therefore maintains that it is practicable to require end users of products which contain PIP 3:1 to follow existing regulations and best practices to prevent the release to water of PIP 3:1 and PIP
3:1-containing products during commercial use, and that codifying that requirement will highlight the importance of reducing environmental release of chemicals regulated by TSCA
section 6h, and reduce exposures that could occur.
11. Downstream notification.
Persons manufacturing, processing, and distributing PIP 3:1 and products containing PIP 3:1 will be required to notify their customers of these prohibitions on processing, distribution, and releases to water. EPA proposed the method of downstream notification was text inserted in sections 1 and 15 of the safety data sheet SDS. Several commenters requested clarification on the downstream notification requirements or suggested changes to the proposed requirement. EPA clarifies in this final rule that the downstream notification requirement applies only to those scenarios where a product has an accompanying SDS.
EPA is also including in this final rule, an alternative method of compliance for downstream notification. If a manufacturer, processor, or distributor chooses, they may include specified text on their label, instead of on their SDS. This alternative allows manufacturers, processors, and distributors to choose the manner of notification most appropriate for their customers and is not intended to broaden the scope of persons subject to the requirement.
Lastly, based on comments received, EPA has delayed the compliance date for downstream notification from 60
days to 180 days for processors and distributors from the date of publication, in order to allow adequate time for the notices to make their way through the supply chain. This length of time would allow downstream processors and distributors to gather information from suppliers and incorporate it in SDSs, and is consistent with the grace period offered under the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation in Europe EPAHQOPPT20190080
0542. Manufacturers including importers of PIP 3:1 are still required to implement downstream notification within 60 days from the date of the publication. Excluded from the downstream notification requirement are articles made from recycled plastics as described in Unit III.A.8., as long as
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no new PIP 3:1 is added during the processing of recycled materials.
12. Recordkeeping.
EPA is requiring that all persons who manufacture, process, or distribute in commerce PIP 3:1 and articles and products containing PIP 3:1 maintain ordinary business records, such as invoices and bills-of-lading, that are related to compliance with the prohibitions and restrictions. EPA
revised this language slightly from the proposal to improve clarity. These records will have to be maintained for a period of three years from the date the record is generated, beginning on March 8, 2021. Exempted from the recordkeeping requirement are articles made from recycled plastics, as described in Unit III.A.8., as long as no new PIP 3:1 is added during the processing of recycled materials. EPA
requested comment on alternative recordkeeping requirements that could help ensure compliance with the regulatory prohibitions, particularly for importers and others who do not produce articles. After reviewing the comments received, EPA has decided to include two additional requirements to help ensure compliance EPAHQ
OPPT201900800539; 0542; 0546;
0549. First, the records that are kept must include a statement that the PIP
3:1, or the PIP 3:1-containing products or articles, are in compliance with 40 CFR 751.407a. The statement need not be included on every business record, such as every invoice or bill of lading, although regulated entities may certainly choose to reformat their documents to include the statement. For example, importers of replacement automobile parts that contain PIP 3:1
who import from the same suppliers over and over need only have a single statement for each part or each supplier.
Finally, EPA is adding a requirement that the records kept pursuant to this final rule be made available to EPA
within 30 calendar days upon request to ensure that EPA can review records in a timely manner.
B. TSCA Section 6c2 Considerations 1. Health effects, exposure, and environmental effects.
PIP 3:1 is toxic to aquatic plants, aquatic invertebrates, sediment invertebrates and fish. Data indicate the potential for reproductive and developmental effects, neurological effects and effects on systemic organs, specifically adrenals, liver, ovary, and heart in mammals. These hazard statements are not based on a systematic review of the available literature and information may exist that could refine the hazard characterization. Additional
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