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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules are available to support those reporters who may not be familiar with the standard. EPA acknowledges that it is possible that an importer, particularly an importer of articles containing PFAS, may not have knowledge that they have imported PFAS and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described in this paragraph. Such an importer should document its activities to support any claims it might need to make related to due diligence.
In the event that a manufacturer does not have actual data e.g., measurements or monitoring data to report to EPA, the manufacturer would be required to make reasonable estimates of such information. Reasonable estimates may rely, for example, on approaches such as mass balance calculations, emissions factors, or best engineering judgment.

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D. Why are small businesses not excluded from reporting similar to Chemical Data Reporting CDR and other section 8a reporting?
Unlike TSCA section 8a1, which provides an express exemption for small manufacturers and processors, TSCA
section 8a7 specifically states that each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance shall be subject to the rule.
Rather than amend TSCA section 8a1, Congress chose to add an entirely new, standalone subsection to TSCA section 8a. This indicates an intent for TSCA section 8a7 to constitute separate, freestanding rulemaking authority; therefore, it is not constrained by requirements and provisions in TSCA section 8a1.
However, in carrying out TSCA
section 8, EPA shall, to the extent feasible: A Not require reporting which is unnecessary or duplicative; B
Minimize the cost of compliance with TSCA section 8 and the rules issued thereunder on small manufacturers and processors; and C Apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this subchapter TSCA section 8a5.
E. How will EPA use the information?
TSCA section 8a7 is silent on how the information collected under the TSCA section 8a7 rule is to be used.
However, collecting information on PFAS identities, uses, production volumes by category of use, byproducts, environmental and health effects, workers exposure, and disposal supports the Agencys mission in the
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PFAS Action Plan to identify and better understand these chemicals and to increase scientific research on them.
EPA intends to use information on these chemicals to support assessments of new and existing chemicals under TSCA. For instance, information collected under this proposed rule will help inform future assessments of potential exposure to these PFAS. The Agency would also benefit from receiving all existing information related to human health and environmental effects of such substances, in order to fulfill additional environmental protection mandates beyond the TSCA program. For instance, information on PFAS use, exposure, and effects may be used to inform regulatory activities under the Safe Drinking Water Act 42 U.S.C. 300f et seq., the Resource Conservation and Recovery Act 42 U.S.C. 6901 et seq., and the Comprehensive Environmental Response, Compensation, and Liability Act 42 U.S.C. 9601 et seq., while data on PFAS manufacturing sites and disposal methods may support contaminants characterizations conducted to support contaminated site work and solid waste management programs.
Additionally, TSCA section 9e requires the EPA Administrator to make information related to exposure or releases available to other EPA offices or federal agencies if such exposures may be prevented or reduced under another law. EPA may share such information collected under this proposed rule as appropriate.
III. Summary of Proposed Reporting and Recordkeeping Requirements EPA is proposing reporting and recordkeeping requirements for manufacturers of PFAS pursuant to TSCA section 8a7.
A. What chemical substances would be reportable under this rule?
1. Reportable chemicals substances.
Under TSCA section 8a7, EPA must collect information on chemical substances that are perfluoroalkyl or polyfluoroalkyl substances or PFAS.
EPA has determined that any PFAS that fall within the structural definition, described below, are the PFAS referred to in TSCA section 8a7. For this proposed rule, EPA has identified at least 1,364 chemical substances and mixtures that are PFAS and would potentially be subject to reporting under the final rule, if they have been manufactured in any year since January 1, 2011.
For the purposes of this proposed action, the structural definition of PFAS

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includes perand polyfluorinated substances that structurally contain the unit R-CF2-CFRR. Both the CF2
and CF moieties are saturated carbons and none of the R groups R, R or R
can be hydrogen. It should be noted that this structural definition of PFAS is a working definition which has been used by EPAs Office of Pollution Prevention and Toxics when identifying PFAS on the TSCA Inventory. This definition may not be identical to other definitions of PFAS used within EPA and/or other organizations. To assist potential reporters with determining whether certain substances may be covered under this structural definition, EPA has identified specific PFAS covered by this proposed rule. These will be included as non-exhaustive examples in the rule where it is possible to do so without divulging information claimed as CBI.
The scope of PFAS examples listed in this proposal includes:
All PFAS listed as active on the TSCA Inventory. This includes PFAS
that are identified by CAS number;
confidential chemicals whose generic names contain fluor and are identified by Accession number; and confidential chemicals whose generic names do not contain fluor, and therefore, are not listed by CASRNs, Accession numbers, or low-volume exemptions LVE case numbers see note on structural diagram examples below.
All PFAS that are subject to TSCA
section 5 new chemicals LVE
applications per 40 CFR 723.50 that have been granted by EPA. This includes the PFAS that were subject to granted LVE applications that have since been withdrawn by the LVE
application submitter. Additional discussion on LVEs is below.
Under TSCA section 5, any person who intends to manufacture a chemical not on the TSCA Inventory must first notify EPA. Typically, this is done by submission of a premanufacture notice PMN Ref. 8. However, for lowvolume chemical substances i.e., chemical substances manufactured at no more than 10,000 kg per year companies can submit a LVE
application to EPA per 40 CFR 723.50.
EPA may either grant or deny an LVE
submission after review, but LVEs that are granted are not listed on the Inventory, unlike PMN chemical substances. Therefore, EPA is also providing a list of PFAS chemicals for which EPA granted an LVE notice.
LVE submitters may choose to withdraw their granted LVE application.
In order to compile a comprehensive dataset as authorized under TSCA
section 8a7, EPA is including these
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