Federal Register - June 28, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules month period between the effective date and the start of the submission period.
EPA is also asking for public comment on the submission period start date and duration see Unit V..

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C. What information would be reported?
TSCA section 8a7 specifies that, under the final rule, manufacturers would report on information described in subparagraphs A through G of paragraph 2 of section 8. Therefore, this TSCA section 8a7 rule proposes one-time reporting of the information described in section 8a2A through G, which includes specific chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal.
Specifically, EPA is proposing to request the following information:
1. Chemical name multiple if mixture, or the generic names if the chemical names is CBI.
2. Chemical IDs CASRN, TSCA
Accession Number, or LVE case number.
3. Trade name or common name.
4. Representative molecular structure.
5. Physical form of chemical or mixture.
6. Industrial processing and use:
a. Type of process or use;
b. Sectors;
c. Functional use categoryies;
d. Percent of production volume for each use.
7. Consumer and commercial use:
a. Indicator for whether this is a consumer and/or commercial product;
b. Product category; functional use categoryies;
c. Percent production volume for each use; maximum concentration in any product;
d. Indicator for use in products intended for children.
8. Production volumes:
a. Domestically manufactured;
b. Imported;
c. Directly exported;
d. Maximum first 12 months production volume;
e. Maximum yearly production volume in any 3 years.
9. Indicator for imported but never physically at site.
10. Indicator for site-limited.
11. Maximum quantity stored on-site at any time.
12. Total volume recycled on-site.
13. For byproducts produced during the manufacture, processing, use, or disposal of each PFAS:
a. Chemical names or description if identity is unknown, or the generic names if the byproduct names is CBI;

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b. Chemical IDs CASRN, TSCA
Accession Number, or LVE case number;
c. Indicator for whether the byproducts production resulted from manufacture, process, use, or disposal;
and d. Indicator for whether the byproducts is released to the environment; if so, volume of byproducts released and to which environmental media.
14. Worker exposure: Description of worker activityies at manufacturing site.
15. Worker exposure at the manufacturing site:
a. Number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity;
b. Maximum duration of exposure for any worker, for each worker activity both hours per day and days per year.
16. Worker exposure for each industrial process and use:
a. Number of workers reasonably likely to be exposed for each industrial process and use;
b. Maximum duration of exposure for any worker for each industrial process and use both hours per day and days per year.
17. Worker exposure for each commercial use:
a. Number of workers reasonably likely to be exposed for each commercial use;
b. Maximum duration of exposure for any worker for each commercial use both hours per day and days per year.
18. Description of disposal processes, and description of any changes to the disposal process or methods since 2011.
19. Total volume released:
a. Land disposal;
b. Water releases;
c. Air releases.
20. Total volume incinerated on-site and incineration temperature.
21. All existing information related to health and environmental effects, using the Organization of Economic Cooperation and Development OECD
harmonized template relevant to the existing study, as well as full study reports and any other supporting information for additional information on the use of the OECD harmonized templates, see the discussion in the following section, Unit III.D..
22. Other data relevant to health and environmental effects e.g., rangefinding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports.

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A list of the proposed reporting requirements is available in the docket for public review Ref. 10.
EPA developed an information reporting platform for CDR Ref. 9 and intends to modify it for purposes of this proposed rule. Certain information that is requested in the CDR that falls under TSCA section 8a2A through G
would be required by this proposed rule, such as information on specific chemical identity, categories of use, production volume, byproducts, and number of persons exposed and duration of exposure see Unit III.A.2.
for the discussion on duplicative reporting. In instances where PFAS
manufacturers under this proposed rule have already reported the requested information to EPA, they will not be required to re-report. As discussed in Unit III.A.2, EPA is proposing the reporters simply indicate they have already submitted such information to EPA.
Additionally, any person required to report under this proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them, or a reasonable estimate when actual data are not available i.e., known or reasonably ascertainable, as explained in more detail in Unit II.D.
D. What type of environmental and health effects information is the Agency requesting?
EPA is requesting all existing information concerning the environmental and health effects of the PFAS chemicals covered by this rule. It is intended that environmental and health effects information be interpreted broadly. This information would include but is not limited to:
Toxicity information e.g., in silico, in vitro, animal test results, human data; and Other data relevant to environmental and health effects including range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports.
Chemical identity is always part of a health and safety study, and TSCA
section 14b limits the extent to which health and safety studies and information from studies may be withheld from the public as confidential.
EPA is proposing to require all existing information concerning health and environmental effects be submitted in the format of OECD harmonized templates, where such templates exist for the type of data, in addition to submitting full study reports. OECD

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Federal Register - June 28, 2021

TitreFederal Register

PaysÉtats-Unis

Date28/06/2021

Page count282

Edition count7801

Première édition14/03/1936

Dernière édition24/06/2026

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