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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
EPA within 30 calendar days upon request.
1. Inclusion in TSCA Section 6h.
In the proposed rule, EPA identified the five chemical substances EPA
proposed as meeting the TSCA section 6h1A criteria for expedited action.
PIP 3:1 is one of those five substances, with a high bioaccumulation score.
The information EPA collected and reviewed in developing the proposal provided no basis to call into question the scoring for persistence, bioaccumulation, and toxicity performed in 2014 for these five PBT
chemicals. Four commenters addressed classification of PIP 3:1 as a PBT, and one specifically took issue with PIP
3:1s classification as a PBT under TSCA section 6h1A, with a focus on its bioaccumulation properties. Their concerns are described in this final rule and addressed in the Response to Comments for this rulemaking Ref. 5.
While one commenter submitted additional data, these comments and data submitted do not call into question the PIP 3:1 bioaccumulation score identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments for the reasons described in the Response to Comments Document Ref. 5.
Four commenters indicated that PIP
3:1 is not considered a PBT by the European Chemicals Agency ECHA, based on information in the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH
dossiers; according to the commenters, therefore PIP 3:1 does not meet the TSCA section 6h1A criteria.
However, information in the REACH
dossiers reflect the results of studies submitted to ECHA, and not necessarily determinations by ECHA. A single study submitted by industry representing results from their particular commercial product is not sufficient justification to call into question whether PIP 3:1
meets the bioaccumulation criterion.
Commercial products may contain varying amounts of different isomers which constitute PIP 3:1 thus, a study on a particular commercial product alone for a chemical that may differ between various commercial products, is not adequate to call into question the specified score identified in the 2014
Update to the TSCA Work Plan for Chemical Assessments.
Additionally, PIP 3:1 is a UVCB
substance, or a substance of unknown or variable composition, complex reaction and biological materials. In the case of PIP 3:1, it is a substance of unknown or variable composition. The chemical substance PIP 3:1, which is the subject of this regulation, has a variable
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composition in that mixtures of or containing PIP 3:1 may contain different proportions of isomers of PIP
3:1 or of different chemical congeners.
An isomer is defined as one of several species or molecular entities that have the same atomic composition molecular formula but different line formulae or different stereochemical formulae and hence different physical and/or chemical properties Ref. 9. A
congener is defined as one of two or more substances related to each other by origin, structure, or function Ref. 9.
When considering a UVCB substance, the Agency considers whether any isomers or congeners which might be present in a UVCB substance are bioaccumulative and, if so, EPA
considers the UVCB substance to be bioaccumulative. In these cases, the Agency has a longstanding approach for chemical evaluation and regulation that considers whether particular isomers or congeners which might be present in an identified substance are, for example, bioaccumulative and, as in this case, if so, EPA considers that identified substance to meet the criterion Ref. 10.
Because PIP 3:1 is a UVCB, and because commercial products may contain varying amounts of different isomers which constitute PIP 3:1, and, as detailed in the 2014 Update to the TSCA Work Plan for Chemical Assessments and the proposed rule, some of those isomers are identified as bioaccumulative, EPA continues to consider PIP 3:1 to be bioaccumulative.
Additionally, EPA does not interpret TSCA section 6h1A to require, as the commenter suggests, a fresh look at the scores for or issues of toxicity, persistence, or bioaccumulation of the Work Plan chemicals. Requiring EPA to re-evaluate any of these issues would delay what Congress intended to be an expedited rulemaking process. It also suggests a level of analysis not contemplated by Congress or clearly required for this rulemaking given that Congress did not compel risk evaluations for any chemicals meeting the TSCA section 6h1 criteria. The only required additional assessment is the exposure and use assessment used to make the TSCA section 6h1B
finding that exposures are likely under the conditions of use.
To the extent that commenters suggest that EPA used a successor scoring system via the use and exposure assessment and hazard summary to identify the score for the PBT chemicals, that is not the case. The Agency reaffirms that the scores identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments and
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referenced in the proposed rule are based on the 2012 Methods Document criteria, and EPAs responses to comments are based on those criteria.
Because of PIP 3:1s status as a UVCB, any study on a single congener or commercial product would need to be considered in the context of all available information that informs the persistence and bioaccumulation of PIP 3:1. To the extent that commenters are suggesting that the statute requires, or that EPA
should do an analysis consistent with, a systematic review to re-evaluate the persistence and bioaccumulation score for PIP 3:1, the Agency notes that it views that effort to be a successor scoring system approach. Systematic review or an analysis consistent with systematic review is inconsistent with the criteria and tools referenced in the 2012 TSCA Work Plan Chemicals:
Methods Document. If EPA had used a successor scoring system, it would need to rescore the chemicals identified on the 2014 Update to the TSCA Work Plan for Chemical Assessments and the Agency did not do that and has no plans to do that at this time.
One commenter indicated that EPA
has not adequately identified the chemical substance. EPA emphasizes that PIP 3:1 has been properly identified as the subject of this rulemaking. To clarify, TSCA section 6h requires EPA to issue a proposed rule to address chemicals identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments and that meet other specified criteria. Chemicals identified in the 2014 Update to the TSCA Work Plan for Chemical Assessments are specified by chemical name and CASRN. In this case, PIP 3:1
is identified as Phenol, isopropylated phosphate 3:1 iPTPP and with CASRN 68937417.
2. Hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S.
Department of Defense specification requirements.
In this final rule EPA amends the language in the proposed rule on the exclusion from the processing and distribution in commerce restrictions of PIP 3:1 for use in for aviation hydraulic fluid and of PIP 3:1containing aviation hydraulic fluid, to include an exclusion from the prohibition on the processing and distribution in commerce of PIP 3:1 for use in hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S.

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