Federal Register - June 28, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules
intended to mitigate health or safety risks, the information that would be submitted to EPA in accordance with this proposed rule would be used to inform the Agencys decision-making process regarding chemical substances to which children may be disproportionately exposed. This information may also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, which would allow the Agency and others to take appropriate action to investigate and mitigate those risks.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a significant energy action as defined in Executive Order 13211 66 FR 28355, May 22, 2001 because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not otherwise been designated by the Administrator of OMBs Office of Information and Regulatory Affairs as a significant energy action.

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I. National Technology Transfer and Advancement Act NTTAA
Because this action does not involve any technical standards, NTTAA section 12d, 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, lowincome populations and/or indigenous peoples, as specified in Executive Order 12898 59 FR 7629, February 16, 1994.
The requirements of the proposed rule are directed at manufacturers including importers of PFAS chemicals for which basic production, use, and toxicity information is currently unavailable.
The costs and the benefits of the proposed rule would not be disproportionately distributed across different geographic regions or among different categories of individuals.
Consumers of these chemical products, workers who come into contact with these chemical substances, and communities neighboring PFAS
manufacturing sites could benefit from EPAs assessment of information required under the proposed rule. The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in
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determining the potential hazards and risks associated with PFAS chemicals.
Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.
List of Subjects in 40 CFR Part 705
Chemicals, Environmental protection, Hazardous Materials, Recordkeeping, and Reporting Requirements.
Dated: June 10, 2021.
Michal Freedhoff, Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

Therefore, for the reasons stated in the preamble, the Environmental Protection Agency proposes to amend 40 CFR
chapter I by adding part 705 to read as follows:
PART 705REPORTING AND
RECORDKEEPING REQUIREMENTS
FOR CERTAIN PERAND
POLYFLUOROALKYL SUBSTANCES
Sec.
705.1. Scope.
705.3. Definitions.
705.5. Substances for which reports must be submitted.
705.10. Persons who must report.
705.15. What information to report.
705.20. When to report.
705.22. Duplicative reporting.
705.25. Recordkeeping requirements.
705.30. Confidentiality claims.
705.35. Electronic reporting.
Authority: 15 U.S.C. 2607a7.
705.1

Scope.

This part specifies reporting and recordkeeping procedures for manufacturers including importers of certain perand polyfluoroalkyl substances hereafter referred to as PFAS under section 8a7 of the Toxic Substances Control Act TSCA.
705.3

Definitions.

Central Data Exchange or CDX means EPAs centralized electronic submission receiving system.
Chemical Information Submission System or CISS means EPAs electronic, web-based reporting tool for the completion and submission of data, reports, and other information, or its successors.
Commercial use means the use of a chemical substance or a mixture containing a chemical substance including as part of an article in a commercial enterprise providing saleable goods or services.
Consumer use means the use of a chemical substance or a mixture
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containing a chemical substance including as part of an article when sold to or made available to consumers for their use.
Environmental or health effects information means any information of any effect of a chemical substance or mixture on health or the environment or on both. This includes all health and safety studies.
1 Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any information that bears on the effects of a chemical substance on health or the environment would be included.
2 Examples are:
i Longand short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
ii Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem microcosm studies.
iii Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.
iv Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
Health and safety studies means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a
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Federal Register - June 28, 2021

TitoloFederal Register

PaeseStati Uniti

Data28/06/2021

Conteggio pagine282

Numero di edizioni7801

Prima edizione14/03/1936

Ultima edizione24/06/2026

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