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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules
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with this action Ref. 13, which is available in the docket and is summarized in Unit I.E. Any changes made in response to OMB
recommendations have been documented in the docket for this action as required by section 6a3E of Executive Order 12866.
B. Paperwork Reduction Act PRA
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request ICR
document that EPA prepared has been assigned EPA ICR number 2682.01 Ref.
15. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
The reporting requirements identified in the proposed rule would enable EPA
to meet the statutory obligations required by TSCA section 8a7 and collect data related to the identities, manufacture, use, exposure, and disposal of PFAS manufactured in the United States since 2011. These proposed reporting requirements would also help the Agency to collect existing information on the health and environmental effects of PFAS. EPA
intends to use information collected under the rule to assist in chemical assessments under TSCA, and to inform any additional work necessary under environmental protection mandates beyond TSCA. Respondents may claim some of the information reported to EPA
under the proposed rule as CBI under TSCA section 14. TSCA section 14c requires a supporting statement and certification for confidentiality claims asserted after June 22, 2016.
Respondents/affected entities:
Manufacturers including importers of PFAS since January 1, 2011.
Respondents obligation to respond:
Mandatory 15 U.S.C. 2607a7.
Estimated number of respondents:
234.
Frequency of response: Once.
Total estimated burden: 122,104
hours per year. Burden is defined at 5
CFR 1320.3b.
Total estimated cost: $9,820,813 per year, includes no annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for the EPAs regulations in 40
CFR are listed in 40 CFR part 9.
Submit your comments on the Agencys need for this information, the accuracy of the provided burden
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estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMBs Office of Information and Regulatory Affairs via email to oira_
submissions@omb.eop.gov, Attention:
Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than July 28, 2021. The EPA will respond to any ICR-related comments in the final rule.
C. Regulatory Flexibility Act RFA
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA 5 U.S.C. 601 et seq..
The small entities subject to the requirements of this action are manufacturers including importers of PFAS. EPA estimates that 59 small firms would be affected by the proposed rule.
Of those small firms, 46% would have cost impacts of less than 1% of annual revenues, 19% would have impacts between 13%, and 35% would have impacts of more than 3% of annual revenues. The affected small businesses subject to the proposed rule are expected to incur $1,788,506 in costs for this one-time reporting, with per-firm costs estimated to range from $16,864 to $92,390. However, EPA is unable to estimate the number of small entity importers of articles that are subject to this proposed rule due to a lack of available data on importers of articles containing PFAS. Imported articles are exempt from the CDR Rule under 40
CFR 711.10b. Similarly, under TRI
reporting, listed toxic chemicals contained in articles that are processed or otherwise used at a covered facility are exempt from reporting threshold determinations and release and other waste management calculations. EPA is unaware of publicly available data that provides the information on the article importers needed to develop the estimates. Without available data, EPA
does not have a representative subset of firms to reference as a basis for estimates and thus cannot estimate the number of importers of articles that will be affected.
However, EPA expects that article importers may incur a range of costs depending on the number of articles they import, their level of knowledge of their imported articles, the complexity of supply chains, and whether PFAS is present in their articles. Importers of articles that contain PFAS may incur costs for rule familiarization $69.79 per firm; identifying the type of imported
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articles that potentially use PFAS
$1,641$1,932 per firm; identifying suppliers involved $1,185 per firm;
collecting data from suppliers $0644
per article; and recordkeeping $12 per firm. Details of this analysis are presented in the Economic Analysis of the proposed rule Ref. 14, which is available in the docket.
D. Unfunded Mandates Reform Act UMRA
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C.
15311538, and does not significantly or uniquely affect small governments. The requirements of this action would primarily affect manufacturers including importers of PFAS. The total quantified one-time costs of the proposed rule are approximately $9.8
million.
E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 64 FR 43255, August 10, 1999. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 65 FR 67249, November 9, 2000. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, E.O. 13175 does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045
62 FR 19885, April 23, 1997 as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of covered regulatory action in section 2202 of the Executive Order. This action is not a covered regulatory action because it is not economically significant under Executive Order 12866 and it does not concern an environmental health risk or safety risk. Although this action would not establish an environmental standard
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