[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Proposed Rules]
[Pages 27060-27081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09533]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 704
[EPA-HQ-OPPT-2021-0357; FRL-8632-02-OCSPP]
RIN 2070-AK99
Asbestos; Reporting and Recordkeeping Requirements Under the
Toxic Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing
reporting and recordkeeping requirements for asbestos under the Toxic
Substances Control Act (TSCA). EPA proposes to require certain persons
that manufactured (including imported) or processed asbestos and
asbestos-containing articles (including as an impurity) in the four
years prior to the date of publication of the final rule to
electronically report certain exposure-related information. This action
would result in a one-time reporting obligation. EPA emphasizes that
this proposed requirement would include asbestos that is a component of
a mixture. The information sought includes quantities of asbestos
(including asbestos that is a component of a mixture) and asbestos-
containing articles that were manufactured (including imported) or
processed, types of use, and employee data. Reported information would
be used by EPA and other Federal agencies in considering potential
future actions, including risk evaluation and risk management
activities. EPA is requesting public comment on all aspects of this
proposed rule and has also identified items of particular interest for
public input.
DATES: Comments must be received on or before July 5, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0357, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Daniel R. Ruedy, Data Gathering
and Analysis Division (Mailcode: 7406M), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-7974; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process asbestos. Any use of
the term ``manufacture'' in this document will encompass ``import,''
and the term ``manufacturer'' will encompass ``importer.'' Any use of
the term ``asbestos'' will apply to asbestos in bulk form, in an
article, or as an impurity, or as a component of a mixture. For a more
thorough discussion of the subject asbestos forms, please see Unit
III.A. of this document. You may also be potentially affected by this
action if you manufacture (including import) or process other chemical
substances or mixtures not on the TSCA inventory if they include
asbestos.
The following list of North American Industry Classification System
(NAICS) codes are provided to assist in determining whether this action
might apply to you. This list is not intended to be exhaustive, but
rather provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include entities
identified in:
NAICS code 211--Oil and Gas Extraction;
NAICS code 212--Mining (except Oil and Gas);
NAICS code 325--Chemical Manufacturing;
NAICS code 327--Nonmetallic Mineral Product Manufacturing;
NAICS code 332--Fabricated Metal Product Manufacturing;
NAICS code 336--Transportation Equipment Manufacturing;
NAICS code 339--Miscellaneous Manufacturing;
[[Page 27061]]
NAICS code 447--Gasoline Stations; and
NAICS code 811--Repair and Maintenance.
Additionally, you should carefully examine the proposed regulatory
text in this document to determine if your business would be impacted
by this rule. If you have any questions regarding the applicability of
this action to a particular entity, consult the technical contact
person listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
EPA is proposing this action under the authority of section 8(a) of
the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(a), which
generally authorizes EPA to promulgate rules that require each person,
other than small manufacturers (including importers) or processors, who
manufactures (including import) or processes, or proposes to
manufacture (including import) or process, the chemical substance
identified in the rule, to maintain such records and submit such
reports as the EPA Administrator may reasonably require.
Although TSCA section 8(a)(1) provides an express exemption for
small manufacturers (including importers) and processors, TSCA section
8(a)(3) enables EPA to require small manufacturers (including
importers) and processors to report under TSCA section 8(a) with
respect to a chemical substance that is the subject of a rule proposed
or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the subject
of an order in effect under TSCA sections 4 or 5(e), a consent
agreement under TSCA section 4, or relief that has been granted under a
civil action under TSCA sections 5 or 7. Asbestos is subject to TSCA
section 6 rulemaking under the Asbestos Ban and Phaseout rule of 1989
(Ref. 1). A portion of this rule was overturned in Corrosion Proof
Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991), however, a portion
remains. The remaining portion of EPA's 1989 asbestos ban and phaseout
rule prohibits the manufacture, importation, processing, and
distribution in commerce of: Commercial Paper, Corrugated Paper,
Rollboard, Specialty Paper, Flooring Felt, and New Uses (the
manufacture, importation or processing of which would be initiated for
the first time after August 25, 1989). See 40 CFR 763.160 et seq. Thus
EPA proposes to exercise its authority provided under TSCA section
8(a)(3)(A)(ii) to require small manufacturers (including importers) and
processors of asbestos or asbestos-containing mixtures (other than
Libby Amphibole asbestos) to maintain records and submit reports. Libby
Amphibole asbestos is not subject to an applicable proposed or
promulgated rule under TSCA sections 4, 5(b)(4) or 6, an order in
effect under TSCA section 4 or 5(e), or a consent agreement under TSCA
section 4, nor is it the subject of relief that has been granted under
a civil action under TSCA section 5 or 7. Therefore, small
manufacturers (including importers) and processors of Libby Amphibole
asbestos are expected to be exempt from this proposed reporting and
recordkeeping rule. For a more thorough discussion of the proposed
reporting for small manufacturers (including importers) and processors,
see Unit III.B.
TSCA section 8(a)(1)(A) also excludes from the scope of EPA's
regulatory authority under that paragraph any manufacturer (including
importer) or processor of ``a chemical substance described in
subparagraph (B)(ii).'' TSCA section 8(a)(1)(B)(ii), in turn, provides
EPA authority to require recordkeeping and reporting by each person
(other than a small manufacturer [including importer] or processor) who
manufactures (including imports) or processes, or proposes to
manufacture (including import) or process, a chemical substance ``in
small quantities . . . solely for purposes of scientific
experimentation or analysis or chemical research on, or analysis of,
such substance or another substance, including any such research or
analysis for the development of a product,'' but only to the extent EPA
determines the recordkeeping and/or reporting is necessary for the
effective enforcement of TSCA. EPA is not proposing to require
recordkeeping or reporting by persons who manufacture (including
import) or process, or propose to manufacture (including import) or
process, asbestos in small quantities solely for research or analysis
for the development of a product as described in TSCA section
8(a)(1)(B)(ii). ``Small quantities solely for research and
development'' is defined in 40 CFR 704.3 to mean quantities of a
chemical substance manufactured, imported, or processed or proposed to
be manufactured, imported, or processed solely for research and
development that are not greater than reasonably necessary for such
purposes.
TSCA section 14 imposes requirements for the assertion,
substantiation, and review of information that is claimed as
confidential under TSCA (also known as confidential business
information or CBI. Some information submitted at the time of the
proposed reporting under this rule may be claimed as confidential.
C. What action is the Agency taking?
EPA is proposing to require asbestos manufacturers (including
importers) and processors to report to EPA certain information known to
or reasonably ascertainable by those entities. For this action, the
term ``asbestos'' includes various forms of asbestos, including Libby
Amphibole asbestos, as described in more detail in Unit III.A. of this
document. The following is a brief list of the primary data
requirements being proposed. These proposed requirements are described
in detail in Unit III.
1. Asbestos domestic manufacturers (Asbestos Mine and Mill): The
provisions in this proposed rule would require asbestos domestic
manufacturers to provide the quantity manufactured per asbestos type,
use, and employee exposure information to EPA. This would include
situations in which asbestos is being mined or milled as an intentional
or non-intentional impurity, such as in vermiculite and talc.
2. Asbestos importers: The provisions in this proposed rule would
require importers of asbestos to provide the quantity imported per
asbestos type, use, and employee exposure information. This includes
importers of mixtures containing asbestos, articles containing asbestos
components, and impurities (in articles, bulk materials, or mixtures,
such as in talc and vermiculite).
3. Asbestos processors: The provisions of the proposed rule would
require processors of asbestos (including processors of mixtures or
articles) to provide the quantity processed per asbestos type, use, and
employee exposure information. This includes both primary processors
and secondary processors of asbestos, as described in Units III.F.3.
and 4. This would include situations in which asbestos is appearing as
an intentional or non-intentional impurity, such as in vermiculite and
talc.
D. Why is the Agency taking this action?
The Agency is proposing this action to obtain certain information
known to or reasonably ascertainable by manufacturers (including
importers) and processors of asbestos that EPA believes would help the
Agency better understand the exposures and uses associated with
asbestos, including asbestos in articles and as an impurity (in
articles, bulk materials, or mixtures, such as in talc and
vermiculite), that fall under the scope of this proposal. Reported
information would be used by EPA and other Federal agencies in
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considering potential actions involving asbestos, including EPA's TSCA
risk evaluation and risk management activities. This action is also
subject to a settlement agreement, as discussed in Unit II.C.4. of this
document. For a more thorough discussion of the TSCA risk evaluation
and risk management process, please see Unit II.C.5. of this document.
E. What are the estimated incremental impacts of this action?
EPA has prepared an economic analysis (Ref. 2) of the potential
impacts associated with this proposed rule. The primary purpose of this
proposed rule is the collection of detailed data on asbestos uses and
exposures. Reported information would be used by EPA and other Federal
agencies in considering potential actions involving asbestos, including
EPA's TSCA risk evaluation and risk management activities. EPA
estimates that at least 18 firms may submit reports for 27 sites based
on the intentional manufacturing (including importing) or processing of
asbestos, including mixtures and articles containing asbestos. EPA does
not currently have information on the extent to which asbestos occurs
as an impurity in products that are currently manufactured (including
imported) or processed in the U.S., so the number of firms that may
report for impurities is not estimated.
The industry is expected to incur one-time burdens and costs
associated with rule familiarization, form completion, CBI claim
substantiation, recordkeeping, and electronic reporting activities.
Where asbestos is intentionally manufactured (including imported) or
processed, the estimated average burden and cost per site ranges from
approximately 12 hours and $1,146 to 26 hours and $2,265, depending on
the type of activities the respondent is engaged in and the information
known to or reasonably ascertainable by them. For products where
asbestos occurs as an impurity, the estimated average burden and cost
per site ranges from approximately 17 hours and $1,573 to 40 hours and
$3,334, again depending on the type of activities and the information
that is known to or reasonably ascertainable. EPA estimates a total
industry quantified burden of approximately 1,157 hours, with a
quantified total cost of approximately $99,496.
EPA estimates that at least 14 small firms, which included article
importers, will be affected by the proposed rule. Of those small firms,
12 are expected to have cost impacts of less than 1% of annual
revenues, one is expected to have impacts between 1-3%, and one is
expected to have impacts of more than 3% of annual revenues. Again,
these estimates do not include firms that are impacted by the
requirement to report for impurities. The Agency is expected to incur a
cost of $560,343. The total social burden and cost are therefore
estimated to be approximately 1,157 hours and $659,839, respectively
(Refs. 2 and 3).
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What is TSCA section 8(a)?
TSCA section 8(a)(1) generally authorizes EPA to promulgate rules
that require entities, other than small manufacturers (including
importers) or processors, who manufacture (including import) or
process, or propose to manufacture (including import) or process, a
chemical substance to maintain such records and submit such reports as
the EPA Administrator may reasonably require.
Under TSCA section 8(a)(2), EPA may require reporting and
recordkeeping of the following information:
The common or trade name, chemical identity and molecular
structure of each chemical substance or mixture;
Categories or proposed categories of use for each
substance or mixture;
Total amount of each substance or mixture manufactured
(including imported) or processed, the amounts manufactured (including
imported) or processed for each category of use, and reasonable
estimates of the respective amounts to be manufactured (including
imported) or processed for each of its categories of use or proposed
categories of use;
Descriptions of byproducts resulting from the manufacture
(including import), processing, use, or disposal of each substance or
mixture;
All existing information concerning the environmental and
health effects of each substance or mixture;
The number of individuals exposed, and reasonable
estimates of the number of individuals who will be exposed, to each
substance or mixture in their places of employment and the duration of
their exposure; and
The manner or method of disposal of each substance or
mixture, and any change in such manner or method.
B. What is asbestos?
Asbestos is one or more of a group of highly fibrous silicate
minerals that readily separate into long, thin, strong fibers that have
sufficient flexibility to be woven, are heat resistant and chemically
inert, are electrical insulators, and are therefore suitable for uses
where incombustible, nonconducting, or chemically resistant materials
are required.
Asbestos is a mineral fiber that occurs in rock and soil. Because
of its fiber strength and heat resistance, asbestos has been used in a
variety of building construction materials for insulation and as a fire
retardant. Asbestos has also been used in a wide range of manufactured
goods, mostly in building materials (roofing shingles, ceiling and
floor tiles, paper products, and asbestos cement products), friction
products (automobile clutch, brake, and transmission parts), heat-
resistant fabrics, packaging, gaskets, and coatings (Ref. 3).
For purposes of this proposed rule, EPA considers ``asbestos'' to
include the asbestiform varieties included in the definition of
asbestos in TSCA Title II (added to TSCA in 1986), section 202 and
Libby Amphibole asbestos. ``Asbestos'' is defined in TSCA Title II,
section 202 as the asbestiform varieties of six fiber types--chrysotile
(serpentine), crocidolite (riebeckite), amosite (cummingtonite-
grunerite), anthophyllite, tremolite or actinolite. The general CAS
Registry Number (CASRN) of asbestos is 1332-21-4; this is the only
asbestos on the TSCA Inventory. However, CASRNs are also available for
specific fiber types. See Unit III.A.1. for additional discussion.
In addition, EPA is proposing to include reporting for Libby
Amphibole asbestos (mainly consisting of tremolite ([CASRN 77536-68-6],
winchite
[[Page 27063]]
[CASRN 12425-92-2], and richterite [CASRN 17068-76-7]) to identify if
this particular type of asbestos continues to be manufactured
(including imported) or processed in the United States. The term
``Libby Amphibole asbestos'' is used in this document to identify the
naturally occurring mixture of amphibole mineral fibers of varying
elemental composition (winchite, richterite, tremolite, etc.) that have
been identified in the Rainy Creek complex near Libby, Montana (Ref.
4). EPA does not anticipate that there is ongoing manufacture
(including import) or processing of the Libby Amphibole asbestos, but
to help confirm this understanding has included this substance in the
scope of this proposed rule.
EPA requests comment on whether reporting on Libby Amphibole
asbestos' component parts, winchite and richterite, which are not
asbestos types but are indicative of the presence of Libby Amphibole
asbestos in a substance, should be included in the scope of this TSCA
section 8(a) data collection and be reported on individually in
addition to reporting on Libby Amphibole asbestos (Ref. 5). Any
reporting on Libby Amphibole asbestos would improve EPA's understanding
of this substance and would inform risk evaluation activities involving
asbestos.
Asbestos is a hazard to human health (Ref. 6). Some of the health
effects caused by exposure to asbestos are:
Lung cancer;
Ovarian cancer;
Laryngeal cancer; and
Mesothelioma, a cancer of the thin lining of the lung,
chest and the abdomen and heart.
As part of the TSCA Risk Evaluation of chrysotile asbestos
published in December 2020 (Ref. 6). EPA evaluated the database of
health effects associated with asbestos exposure cited in U.S. and
international data sources and reviewed and evaluated scientific
information on toxicity, exposure, and hazard. Many authorities have
established that there are causal associations between asbestos
exposures and cancer (Ref. 7).
For a more thorough discussion on the asbestos types addressed by
this proposed rule, see Unit III.A. of this document.
C. What are relevant past and ongoing EPA TSCA actions on asbestos?
1. 1982 Asbestos Reporting Requirements Rule
In 1982, EPA finalized a rule entitled: ``Asbestos Reporting
Requirements'' (47 FR 33198, August 30, 1982) (TSH-FRL-2124-4), under
the authority of TSCA section 8(a) that required one-time reporting to
EPA by asbestos manufacturers, importers, and processors. The
information sought included data on the quantities of asbestos used in
making products, employee exposure data, and waste disposal and
pollution control equipment data. Reported information was used by EPA
and other Federal agencies in considering the regulation of asbestos.
The information gathered as a result of the 1982 data collection
rule was used in the drafting of the 1989 rule entitled ``Asbestos:
Manufacture, Importation, Processing, and Distribution in Commerce
Prohibitions'' (54 FR 29460, July 12, 1989) (FRL-3476-2). In that
action, EPA used TSCA section 6 authority to ban most asbestos-
containing products. However, most of the ban was overturned in 1991 by
the Fifth Circuit Court of Appeals. Corrosion Proof Fittings v. EPA,
947 F.2d 1201 (5th Cir. 1991). As a result, the 1989 asbestos
regulation only bans new uses of asbestos in products that would be
initiated ``for the first time'' after 1989 and five other specific
product types (40 CFR part 763, subpart I).
It has been nearly 40 years since the 1982 rule was implemented,
and EPA needs an updated data collection to better understand the
universe of asbestos types in commerce and the specific entities
presently manufacturing (including importing) and processing asbestos,
including asbestos-containing products. This proposal is modeled after
the 1982 data collection but requires more detailed information from
manufacturers (including importers) and processors in addition to
information about asbestos appearing as an impurity.
2. Chemical Data Reporting (CDR) Rule
In limited circumstances, asbestos has been reported under the
Chemical Data Reporting (CDR) rule (40 CFR part 711). The CDR rule
requires manufacturers (including importers) to provide EPA with
information on the production and use of chemicals in commerce. (Ref.
8). Under CDR, naturally occurring substances (including asbestos),
impurities, and chemical substances when imported as part of articles
are exempted from reporting (Ref. 9). This proposed rule differs from
the existing CDR universe of data collected as it would: (a) Be a one-
time data collection as opposed to a reoccurring data collection; (b)
require reporting for naturally-occurring asbestos; (c) require
processors of asbestos to report (i.e., sites manufacturing (including
importing) and/or processing asbestos would be subject to this rule);
and (d) require reporting by entities who are manufacturing (including
importing), and/or processing asbestos and to whom the asbestos content
is known or reasonably ascertainable (see TSCA section 8(b)(2)).
``Known to or reasonably ascertainable by'' would be defined to include
``all information in a person's possession or control, plus all
information that a reasonable person similarly situated might be
expected to possess, control, or know.'' EPA acknowledges that it is
possible that an importer, particularly an importer of articles
containing asbestos, may not have knowledge that they have imported
asbestos 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. EPA is asking for public comment on importers' anticipated
ability to know or reasonably ascertain whether those entities import
asbestos. This proposed rule would also differ from CDR data collection
as it would apply to impurities and articles, both of which are
exempted from CDR data collection (40 CFR 711.10(b) & (c)) (Ref. 9,
Ref. 10).
3. 2019 Significant New Use Rule (SNUR) for Discontinued Uses of
Asbestos
In 2019, EPA promulgated a SNUR (84 FR 17345, April 25, 2019) (FRL-
9991-33) for the manufacturing (including import) or processing of
asbestos for use in adhesives, sealants, and roof and nonroof coatings;
arc chutes; beater-add gaskets; cement products; extruded sealant tape
and other tape; filler for acetylene cylinders; friction materials
(with certain exceptions); high-grade electrical paper; millboard;
missile liner; packings; pipeline wrap; reinforced plastics; roofing
felt; separators in fuel cells and batteries; vinyl-asbestos floor
tile; woven products; any other building material; and any other use of
asbestos that was not already prohibited under TSCA or under evaluation
in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos.
Activities that were under evaluation in the TSCA Risk Evaluation
for Asbestos Part 1: Chrysotile Asbestos were not subject to the SNUR
since there was ongoing manufacturing (including importing) or
processing for those uses. Those activities not subject to the SNUR
were manufacturing (including importing) or processing for
[[Page 27064]]
the use of chrysotile in asbestos diaphragms; sheet gaskets; oilfield
brake blocks; aftermarket automotive brakes/linings; other vehicle
friction products; and other gaskets. Because all the ongoing uses of
asbestos identified in the SNUR were of chrysotile, any use of
crocidolite, amosite, anthophyllite, tremolite, or actinolite would be
considered a significant new use.
A person wishing to begin manufacturing, importing, or processing
asbestos (including as part of an article) for a significant new use
must first submit a Significant New Use Notice (SNUN) to EPA. Before
any significant new use of asbestos begins, EPA must evaluate it for
potential risks to health and the environment and take any necessary
regulatory action, which may include a prohibition.
4. TSCA Section 21 Petitions on Asbestos
On September 27, 2018, and January 31, 2019, respectively,
petitioners Asbestos Disease Awareness Organization et al. (ADAO) (Ref.
11), and Attorneys General from ten states and the District of Columbia
(the States) (Ref. 12) submitted petitions under TSCA section 21 (15
U.S.C. 2620) requesting EPA to amend the CDR Rule in ways that
petitioners asserted would increase reporting of asbestos. Both
petitions sought to close alleged asbestos CDR reporting gaps
(including immediate submission of asbestos reports), remove the
naturally occurring and byproduct exemptions, lower the reporting
threshold, require reporting by processors, and eliminate the ability
to claim information as confidential, in order to maximize the
information reported to aid the Agency in conducting the ongoing TSCA
section 6 risk evaluation of asbestos and subsequent TCSA Section 6(a)
risk management rule (see Unit II.C.3. for more information). EPA
denied the petitions on December 21, 2018, and April 30, 2019,
respectively, and issued associated explanations for the denials in the
Federal Register on February 12, 2019 (84 FR 3396) (FRL-9988-56) and
May 8, 2019 (84 FR 20062) (FRL-9992-67), respectively, asserting that
the petitioners failed to demonstrate that it is necessary to amend the
CDR rule. EPA's denial was also in part due to a timing issue with the
asbestos risk evaluation. Petitioners filed lawsuits on February 18,
2019, and June 28, 2019, respectively, in the U.S. District Court in
the Northern District of California, reiterating concerns about the
need to amend the CDR rule to increase asbestos reporting. Asbestos
Disease Awareness Organization v. EPA, No. 19-CV-00871; State of
California et al. v. EPA, No. 19-CV-03807. The cases were consolidated.
On December 22, 2020, after full briefing and oral argument, the Court
issued an opinion granting summary judgment to Plaintiffs and denying
summary judgment to EPA.
Following the litigation, EPA reached an agreement with the
Plaintiffs on June 7, 2021. The parties agreed that no later than nine
months from the effective date of the agreement (Ref. 13), EPA will
sign for publication in the Federal Register, a notice of proposed
action to promulgate a rule pursuant to TSCA section 8(a), 15 U.S.C.
2607(a), for the maintenance of records and submission to EPA of
reports by manufacturers (including importers) and processors of
asbestos (including asbestos that is a component of a mixture), and
articles containing asbestos (including as an impurity) that address
the information-gathering deficiencies identified in the Court's
Summary Judgment Order. Additionally, the parties agreed that no later
than eighteen months from the effective date of the agreement (Ref.
13), EPA will sign for publication in the Federal Register a notice of
final action regarding the proposed TSCA section 8(a) rule.
5. TSCA Risk Evaluation for Asbestos
Pursuant to TSCA section 6(b)(4)(A), EPA conducts risk evaluations
to determine whether a chemical substance presents unreasonable risk of
injury to health or the environment, without consideration of costs or
non-risk factors, including an unreasonable risk to potentially exposed
or susceptible subpopulations identified as relevant by the Agency,
under the conditions of use. (15 U.S.C. 2605(b)(4)(A)).
EPA is developing the TSCA Risk Evaluation on asbestos in two
parts. In December 2020, EPA released the TSCA Risk Evaluation for
Asbestos Part 1: Chrysotile Asbestos (Ref. 6), which determined that
chrysotile asbestos presents an unreasonable risk of injury to health
based upon the following conditions of use: Processing and industrial
use of chrysotile asbestos diaphragms in the chlor-alkali industry;
processing and industrial use of chrysotile asbestos-containing sheet
gaskets in chemical production; industrial use and disposal of
chrysotile asbestos-containing brake blocks in the oil industry;
commercial use and disposal of aftermarket automotive chrysotile
asbestos-containing brakes/linings; commercial use and disposal of
other chrysotile asbestos-containing vehicle friction products;
commercial use and disposal of other asbestos-containing gaskets;
consumer use and disposal of aftermarket automotive chrysotile
asbestos-containing brakes/linings; and consumer use and disposal of
other asbestos-containing gaskets.
EPA initially focused the risk evaluation for asbestos on
chrysotile asbestos as this is the only asbestos type that EPA believes
is currently imported, processed, or distributed in the U.S. EPA
informed the public of this decision to focus on ongoing uses of
asbestos and exclude legacy uses and associated disposals in the Scope
of the Risk Evaluation for Asbestos document, published in June 2017
(Ref. 14). However, in late 2019, the court in Safer Chemicals, Healthy
Families v. EPA, 943 F.3d 397, 426-27 (9th Cir. 2019) held that EPA's
Risk Evaluation Rule (82 FR 33726, July 20, 2017) (FRL-9964-38) should
not have excluded ``legacy uses'' (i.e., uses without ongoing or
prospective manufacturing (including importing), processing, or
distribution) or ``associated disposals'' (i.e., future disposal of
legacy uses) from the definition of conditions of use, although the
court did uphold EPA's exclusion of ``legacy disposals'' (i.e., past
disposal). Following this court ruling, EPA continued development of
the risk evaluation for chrysotile asbestos and determined that the
complete TSCA Risk Evaluation for Asbestos would be issued in two
parts. The TSCA Risk Evaluation for Asbestos Part 1: Chrysotile
Asbestos was released in December 2020, allowing the Agency to
expeditiously move into risk management for the unreasonable risk
identified in Part 1.
EPA is currently conducting the TSCA Risk Evaluation for Asbestos
Part 2: Supplemental Evaluation Including Legacy Uses and Associated
Disposals of Asbestos. EPA intends to include in Part 2 of the risk
evaluation the legacy uses and associated disposal of asbestos. For the
purposes of scoping and risk evaluation, EPA has adopted the definition
of asbestos as defined by TSCA Title II (added to TSCA in 1986),
section 202 definition as the ``asbestiform varieties of six fiber
types--chrysotile (serpentine), crocidolite (riebeckite), amosite
(cummingtonite-grunerite), anthophyllite, tremolite or actinolite,''
The TSCA Title II definition identified five amphibole types of
asbestos (crocidolite, amosite, anthophyllite, tremolite, and
actinolite) plus a serpentine type (chrysotile). Part 2 will also
consider Libby Amphibole Asbestos as well as asbestos present as an
impurity in talc and other substances. EPA expects that the data
collected from this proposed rule will
[[Page 27065]]
be used in Part 2 of the TSCA Risk Evaluation for asbestos and will
also inform risk management actions for asbestos under TSCA section
6(a).
D. How will EPA use the information proposed to be collected?
Reported information would be used by EPA and other Federal
agencies in considering potential actions on asbestos, including EPA's
TSCA risk evaluation and risk management activities. Reporting
requirements may provide EPA with baseline information needed to assess
whether certain ``conditions of use'' of asbestos pose an unreasonable
risk to health or the environment under TSCA section 6(b). EPA must
consider reasonably available information as part of the risk
evaluation process under TSCA section 6(b), and as part of any
subsequent risk management rulemaking efforts under TSCA section 6(a).
Reported information would be useful in the risk management stage
because EPA would consider potential risk management actions taking
into account relevant information obtained through this rulemaking.
Understanding the health risks of asbestos and protecting the public,
including potentially exposed or susceptible subpopulations, from these
risks is a priority for EPA.
As part of the risk evaluation process under TSCA section 6(b), EPA
must determine whether asbestos presents an unreasonable risk of injury
to health or the environment, without consideration of costs or other
non-risk factors, including unreasonable risk to relevant potentially
exposed or susceptible subpopulations, under the conditions of use. EPA
must also use scientific information and approaches in a manner that is
consistent with the requirements in TSCA for the best available
science, and ensure decisions are based on the weight of scientific
evidence. See TSCA section 26(h) and (i), 15 U.S.C. 2625(h) and (i). In
order to follow this framework, EPA shall take into consideration
reasonably available information to inform the Part 2 risk evaluation.
Data collected by this rule could help to fill potential data gaps that
EPA may have for asbestos that could better inform Part 2 of the
asbestos risk evaluation. Following risk evaluation, TSCA mandates that
EPA take action if the Agency determines that asbestos presents
unreasonable risk of injury to health or the environment. EPA needs to
ensure that sufficient information is reasonably available on the uses
and trends of asbestos activities to develop a risk management rule
that eliminates the unreasonable risk. The information collected in
this rulemaking may be available to support the Part II risk evaluation
and the final risk evaluation document expected by December 1, 2024.
Additionally, the information collected in this rulemaking will help
inform risk management following the risk evaluation process.
For these reasons, EPA believes that the reporting and
recordkeeping requirements proposed in this document are reasonable.
See TSCA section 8(a)(1)(A).
III. Summary of Proposed Reporting and Recordkeeping Requirements
A. What chemical substances would be reportable under this rule?
EPA is proposing to require the reporting of information on
specific asbestos forms, or if specific information is not known or
reasonably ascertainable, reporting on ``asbestos'' as it is more
generally listed on the TSCA Inventory. EPA is also proposing to
require the reporting of information related to asbestos as it is
manufactured (including imported) or processed in bulk, as a component
of a mixture, in an article, or as an impurity in bulk materials or
products.
See Units III.A.2 and 3 for more details.
1. Asbestos Forms
EPA is proposing to obtain manufacturing (including importing) and
processing information associated with the following different asbestos
forms, and therefore is proposing to require that reporting be
completed for each of the forms, to the extent that the information is
known or reasonably ascertainable. If the specific asbestos type is
unknown, a submitter would provide information under the general
asbestos form (CASRN 1332-21-4). See Unit II.B. for more information
about what is considered asbestos:
Asbestos--CASRN 1332-21-4;
Chrysotile--CASRN 132207-32-0;
Crocidolite--CASRN 12001-28-4;
Amosite--CASRN 2172-73-5;
Anthophyllite--CASRN 77536-67-5;
Tremolite--CASRN 77536-68-6;
Actinolite--CASRN 77536-66-4;
Libby Amphibole Asbestos--CASRN not applicable (mainly
consisting of tremolite [CASRN 77536-68-6], winchite [CASRN 12425-92-
2], and richterite [CASRN 17068-76-7]).
2. Asbestos as an Impurity
Impurity means a chemical substance which is unintentionally
present with another chemical substance (40 CFR 704.3). Asbestos may
occur naturally as an impurity in other products such as talc,
vermiculite, and potentially other substances. These products are
distributed and used in commerce in the United States. For example,
talc, a hydrous magnesium silicate mineral, is used in a wide variety
of applications. Talc deposits can contain asbestos as an impurity that
poses a risk to human health (Ref. 15). If all other reporting
conditions are met, these products would be subject to reporting under
this rule. EPA proposes to collect data on asbestos as an impurity
because EPA may lack data on the extent to which asbestos as an
impurity occurs in products under TSCA jurisdiction that are currently
being manufactured (including imported) or processed. In particular,
data on asbestos as an impurity could better inform the Part 2 asbestos
risk evaluation where EPA will determine and then evaluate the relevant
conditions of use of asbestos in talc.
3. Articles Containing Asbestos
This rule would require reporting on articles containing asbestos
(including as an impurity). An ``article'' is defined in 40 CFR 704.3
as ``a manufactured item (1) which is formed to a specific shape or
design during manufacture, (2) which has end-use function(s) dependent
in whole or in part upon its shape or design during end use, and (3)
which has either no change of chemical composition during its end use
or only those changes of composition which have no commercial purpose
separate from that of the article, and that result from a chemical
reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.'' EPA proposes to
collect more data on imported articles containing asbestos; this data
could inform Part 2 of the TSCA Risk Evaluation for Asbestos where EPA
will determine and then evaluate the relevant conditions of use of such
articles containing asbestos. Articles included in Part 1 of the TSCA
Risk Evaluation for Asbestos included brake blocks for use in the oil
industry, rubber sheets for gaskets used to create a chemical-
containment seal in the production of titanium dioxide, certain other
types of preformed gaskets, and some vehicle friction products (Ref.
18); EPA is interested in identifying if there are other articles or if
there is information about specific forms of asbestos in these
articles.
[[Page 27066]]
4. Asbestos That Is a Component of a Mixture
Under TSCA section 3(10) (15 U.S.C. 2602(10)), the term ``mixture''
means any combination of two or more chemical substances if the
combination does not occur in nature and is not, in whole or in part,
the result of a chemical reaction; except that such term does include
any combination which occurs, in whole or in part, as a result of a
chemical reaction if none of the chemical substances comprising the
combination is a new chemical substance and if the combination could
have been manufactured (including imported) for commercial purposes
without a chemical reaction at the time the chemical substances
comprising the combination were combined. EPA proposes to collect data
on asbestos in circumstances where it is a component of a mixture to
inform Part 2 of the TSCA Risk Evaluation for Asbestos. In the Part 2
Evaluation, EPA will determine the relevant conditions of use of
asbestos in talc; EPA will use the results to evaluate asbestos
exposures and associated risks.
Legislative history affirms that EPA can conduct risk evaluations
on a chemical substance when the substance is present as a component of
a mixture (See Senate Congressional Record, S3511, June 7, 2016): ``In
section 6(b) of TSCA, as amended by the Frank R Lautenberg Chemical
Safety for the 21st Century Act, EPA is directed to undertake risk
evaluations on chemical substances in order to determine whether they
pose an unreasonable risk to health or the environment. Some have
questioned whether the failure to explicitly authorize risk evaluations
on mixtures calls into question EPA's authority to evaluate the risks
from chemical substances in mixtures. The definition of `conditions of
use' . . . plainly covers all uses of a chemical substance, including
its incorporation in a mixture, and thus would clearly enable and
require, where relevant, EPA to evaluate the risks of the chemical
substance as a component of a mixture.''
B. Will small businesses need to report?
Although TSCA section 8(a)(1) provides an exemption for small
manufacturers (including importer) and processors, TSCA section 8(a)(3)
enables EPA to require small manufacturers (including importers) and
processors to report pursuant to TSCA section 8(a) with respect to a
chemical substance that is the subject of a rule proposed or
promulgated under TSCA sections 4, 5(b)(4), or 6, an order in effect
under TSCA sections 4 or 5(e), a consent agreement under TSCA section
4, or relief that has been granted under a civil action under TSCA
sections 5 or 7. Six of the asbestos types subject to this proposal
(chrysotile, crocidolite, amosite, anthophyllite, tremolite, and
actinolite) are subject to a TSCA section 6 rule under the Asbestos Ban
and Phaseout rule of 1989 (Ref. 1) (40 CFR 763.160 et seq.) and
therefore EPA is proposing that these forms of asbestos are not
eligible for a small manufacturer (including importer) or processor
exemption. Although most of the original ban was overturned in 1991 by
the Fifth Circuit Court of Appeals, a portion of the section 6
rulemaking remains in effect (See 40 CFR 763.160 et seq.) Libby
Amphibole asbestos, however, is not subject to an applicable proposed
or promulgated rule under TSCA sections 4, 5(b)(4), or 6; an order
under TSCA sections 4 or 5(e); or a consent agreement under TSCA
section 4; and is not the subject of relief that has been granted under
a civil action under TSCA section 5 or 7. Therefore, EPA is proposing
that Libby Amphibole asbestos continue to be eligible for such an
exemption.
EPA's experience with TSCA Risk Evaluation for Asbestos Part 1:
Chrysotile Asbestos, indicates that small businesses are associated
with certain identified conditions of use associated with asbestos. For
some conditions of use, EPA identified a single business engaged in
each of the activities and, in two cases, the companies were small
businesses. In addition, EPA identified multiple conditions of use for
which it was unable to identify a single company engaged in the
condition of use. Because of the low number of companies found to be
involved in specific conditions of use, it is possible that companies
associated with other conditions of use that need to be considered in
the Part 2 TSCA Risk Evaluation, are small businesses.
Because EPA has much less information on the activities of small
businesses, the Agency is concerned that certain conditions of use for
which the Agency lacks detailed information may be conducted largely or
entirely by small businesses. Given EPA's experience and the
petitioners' concerns (Refs. 11 and 12), the Agency believes that
exempting all small businesses from reporting may exclude most or all
of the reporting for some conditions of use which could severely hinder
EPA's risk evaluation or risk management activities. As a result, EPA
is proposing that small businesses--small manufacturers (including
importers) and processors of asbestos, and asbestos mixtures (other
than Libby Amphibole asbestos)--will need to maintain records and
report under this action.
As discussed previously, at the time of this proposal, Libby
Amphibole asbestos is not the subject of any of the activities
described in TSCA section 8(a)(3) (Unit III.B.) and therefore
manufacturers (including importers) and processors of that substance
may be eligible for a small business exemption.
EPA proposes to use the small manufacturer (including importer)
definition already established at 40 CFR 704.3. Thus, any entity
manufacturing (including importing) Libby Amphibole asbestos would be
considered a small manufacturer and exempt from reporting if it meets
either of these two standards (as adjusted by an inflation index):
Total sales during the most recent year of the reporting
period, combined with those of the parent company, domestic or foreign
(if any), are less than $120 million and the annual production and
importation volume of that chemical substance (i.e., asbestos) does not
exceed 100,000 pounds at any individual plant site. If the annual
production and importation volume of the chemical substance (i.e.,
asbestos) at any individual site owned or controlled by the submitter
is greater than 100,000 pounds, the submitter is required to report for
that particular site unless it qualifies as small under the following
standard.
Total sales during the most recent year of the reporting
period, combined with those of the parent company, domestic or foreign
(if any), are less than $12 million regardless of the quantity of
asbestos produced or imported.
The small manufacturer (including importer) exemption as written in
Small manufacturer and Small government definitions (40 CFR 704.3)
applies to domestic manufacturers and importers, but does not cover
processors. Therefore, EPA proposes a definition for small processors,
functionally identical to that established in 40 CFR 704.20--Chemical
substances manufactured or processed at the nanoscale (Ref. 16). EPA
proposes this definition because it is most similar to the small
manufacturing (including importing) definition already promulgated.
This definition would state: ``Small processor means any processor
whose total annual sales, when combined with those of its parent
company (if any), are less than $12 million.'' Note that in the
nanoscale rule, the total annual sales threshold is $11 million. EPA
increased the threshold to $12 million to align with the non-volume
portion of the TSCA small manufacturer definition, which
[[Page 27067]]
was updated in 2020. The small manufacturer definition has a second
standard that exempts companies on a chemical-by-chemical volume basis
(i.e., 100,000-pound threshold when company sales are less than $120
million), thus exempting small manufacturers for some chemicals but not
for others. The second standard would not be appropriate to include in
the small processor definition because the amount of asbestos in
products may vary drastically. It is also not appropriate because EPA
is not basing reporting requirements on volumes for this rule. Thus,
the volume of asbestos is less applicable as a measure than sales.
EPA requests additional comment on how to best provide guidance for
small processors of Libby Amphibole asbestos.
C. What is the reporting standard?
EPA is proposing that this rule would use the reporting standard
used for certain other TSCA section 8(a) reporting requirements,
including CDR. This standard requires that manufacturers (including
importers) and processors report information to the extent that the
information is known to or reasonably ascertainable by the manufacturer
(including importer) or processor (see TSCA section 8(a)(2)). ``Known
to or reasonably ascertainable by'' includes ``all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know'' (40 CFR 704.3). This reporting standard requires reporting
entities to evaluate their current level of knowledge of their
manufactured products (including imports) or processed products, as
well as evaluate whether there is additional information that a
reasonable person, similarly situated, would be expected to know,
possess, or control. This standard carries with it an exercise of due
diligence, and the information-gathering activities that may be
necessary for manufacturers (including importers) and processors to
achieve this reporting standard may vary from case-to-case.
This standard requires that submitters conduct a reasonable inquiry
within the full scope of their organization (not just the information
known to managerial or supervisory employees). This standard may also
entail inquiries outside the organization to fill gaps in the
submitter's knowledge. Such activities may, though not necessarily,
include phone calls or email inquiries to upstream suppliers or
downstream users or employees or other agents of the manufacturer
(including importer) or processor, including persons involved in the
research and development, import or production, or marketing of
asbestos.
Examples of types of information that are considered to be in a
manufacturer's (including importer's) or processor's possession or
control, or that a reasonable person similarly situated might be
expected to possess, control, or know include: Files maintained by the
manufacturer (including importer) or processor such as marketing
studies, sales reports, or customer surveys; information contained in
standard references showing use information or concentrations of
chemical substances in mixtures, such as a Safety Data Sheet (SDS) or a
supplier notification; and information from the Chemical Abstracts
Service (CAS) or from Dun & Bradstreet (D-U-N-S). This information may
also include knowledge gained through discussions, conferences, and
technical publications.
EPA has provided CDR reporting guidance materials on this reporting
standard, including hypothetical examples of applying the ``known to or
reasonably ascertainable by'' reporting standard in the context of
collecting processing and use data for CDR, which would be instructive
for reporting under this rule as well (Ref. 9). Therefore, EPA
anticipates some submitters under this proposed rule will be familiar
with this reporting standard, and resources are available to support
those submitters who may not be familiar with the standard.
EPA acknowledges that it is possible that a manufacturer (including
importer) or processor, particularly an importer of articles containing
asbestos (including as an impurity), may not have knowledge that they
have imported asbestos and thus not report under this rule, even after
they have conducted their due diligence under this reporting standard
as described previously. 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 (including importer) or processor
does not have actual data (e.g., measurements or monitoring data) to
report to EPA, the manufacturer (including importer) or processor 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.
D. When would reporting be required?
This proposed rule would result in a one-time reporting obligation.
EPA proposes reporting for persons who have manufactured (including
imported) or processed asbestos at any time during the four complete
calendar years prior to the effective date of the final rule. EPA
anticipates that the four calendar years would be 2019 to 2022. These
entities would report to EPA during a three-month submission period,
which EPA proposes would begin six months following the effective date
of the final rule. Therefore, manufacturers (including importers) and
processors would have up to nine months following the effective date of
the final rule to collect and submit all required information to EPA.
EPA believes that providing six months between the effective date
of the rule and the start of the submission period would allow
sufficient time for both the Agency to finalize the reporting tool and
for submitters to familiarize themselves with the rule and compile the
required information. Since this TSCA section 8(a) reporting rule would
result in the collection of similar information to that collected under
CDR, EPA anticipates some submitters would be familiar with the types
of information requested and how to report. EPA believes that three
months would be adequate time for submissions, in addition to the six-
month period between the effective date and the start of the submission
period.
EPA is asking for public comment on the submission period start
date and duration (see Unit IV.), as well as alternative compliance
timelines for small businesses.
E. How would information be reported?
EPA is proposing different reporting requirements based on a two-
part knowledge-based reporting approach in order to obtain as complete
a picture as possible of the manufacturing (including importing),
processing, and use of asbestos. Because asbestos can be included in
small quantities in some products, having a threshold concentration for
reporting would be expected to eliminate much of the information that
may be useful to support EPA's TSCA risk evaluation and risk management
efforts. Therefore, EPA is proposing that reporting would be required
whenever the presence of asbestos is known or reasonably ascertainable.
However, EPA is also aware that there may be circumstances under
which a manufacturer (including importer), or processor is unable to
provide a reliable quantity of the asbestos in their products because
the percentage of asbestos in their products is not known or reasonably
ascertainable by them. For those situations, EPA is proposing a
[[Page 27068]]
short form (Form A) for attestation purposes. For other situations,
submitters that can determine or estimate the quantity would provide
more detailed information in the full form (Form B). EPA anticipates
that most submitters would know or be able to estimate the quantity of
the asbestos and would complete the full form.
1. Determining the Need To Report Using Form A
For entities that are aware of asbestos in their product, but
unable to determine or estimate the quantity manufactured (including
imported) or processed, submitters would provide a subset of the
information required on Form B. This subset would consist of
information related to manufacturing (including importing) or
processing asbestos, including as an impurity, in an article, or as a
component of a mixture, and information about the employees involved
with such activities.
One of the goals of this rule is to ensure EPA has a complete
picture of the status of asbestos in the U.S. Therefore, EPA is
proposing a reporting approach that would ensure that even
circumstances where asbestos appears in smaller or unknown quantities
are captured. Some entities manufacturing (including importing) or
processing asbestos as a component of a mixture or articles containing
asbestos (e.g., the importers of articles), may be aware of asbestos in
their products but unable to determine or estimate the quantity of the
asbestos for reporting purposes. Therefore, EPA is proposing to include
a short form (Form A) for such entities that are aware of a quantity of
asbestos in their products, but unable to determine (or estimate) the
quantity manufactured (including imported) or processed of asbestos to
report.
For a more detailed discussion of the data elements, please see
Unit III.F. EPA anticipates that Form A will be the less common option
of the two reporting forms.
2. Determining the Need To Report Using Form B
EPA proposes that if a quantity of asbestos in a product is known
to or reasonably ascertainable by the submitter then the submitter must
provide the more detailed reporting information required by Form B. For
example, if submitters are able to determine that their quantity is
close to 25 pounds (or another quantity value), they would be required
to report using Form B.
Form B would require specific quantity information per asbestos
type, more detailed processing information, and employee information
(including employee exposure information). EPA is requesting public
comments on whether other information, such as waste and disposal
information, should be reported. For a more detailed discussion on
specifics included in Form B, see Unit III.C.2.
EPA is requesting comment on whether there should be a threshold
for the amount of asbestos when determining whether to report using
Form B and, if so, whether the threshold should be concentration-based
(e.g., a certain percentage of asbestos in the product) or annual
volume-based (e.g., the total volume of asbestos manufactured
[including imported] or processed). In addition, EPA is requesting
comment on whether any submitter under the threshold should
alternatively report using Form A. Having a threshold for Form B but
reporting using Form A for entities under the reporting threshold may
decrease burden on certain submitters while still allowing EPA to
obtain information on all instances where asbestos is a component of a
mixture and all articles with known asbestos content. Asbestos can
occur naturally as impurities in other products that may be handled in
very large volumes, such as talc, vermiculite, and potentially other
substances. A de minimis concentration could reduce the compliance
determination and reporting burdens. Comments suggesting threshold
levels should include the justification for that particular level.
F. What information would be reported in Form A and Form B?
EPA is proposing certain information to be reported in either Form
A or Form B. Unit III.E. describes how to choose which form to use for
reporting. This unit provides a more in-depth overview of the
information to be reported. Each form has sections about respondent
identification, mined or milled bulk asbestos, imported bulk asbestos,
primary processor production, secondary processor production,
importation of mixtures, and importation of articles. Form A is a
subset of Form B. If a data element is included in Form B only, it is
indicated by ``(Form B only)'' following the name of the data element.
1. Respondent Identification Information
EPA is proposing that both Form A and B will include information
associated with identifying the respondent company and site and
information about contacts at the company or site who can respond to
any clarifying or other follow up questions. Specifically, EPA is
proposing that submitters report the following information (proposed 40
CFR 704.180(e)(3)):
U.S. Parent Company Information;
Authorized Official Contact Information;
Technical Contact Information; and
Site Information (including NAICs codes and total number
of employees at site).
In addition, submitters would identify the activity for which they
are reporting, selecting from the list provided in proposed 40 CFR
704.180(e)(4)(i). If more than one activity applies, the submitter
would indicate all that apply. Each activity and the associated data
elements are described in the remainder of this Unit.
2. Mined, Milled, or Imported Bulk Asbestos or Bulk Materials
Containing Asbestos, Including as an Impurity
An asbestos mine or mill is an entity that either mines or mills
asbestos. Mined or extracted asbestos-containing ore is further milled
to produce bulk asbestos. Milling involves the separation of the fibers
from the ore, grading and sorting the fibers, or fiberizing crude
asbestos ore. An importer of Bulk Asbestos imports bulk asbestos into
the customs territory of the U.S. EPA anticipates that companies that
are mining, milling, or importing bulk asbestos will report using Form
B, because the volume of asbestos is likely to be known or reasonably
ascertainable by them.
For companies that are mining, milling, or importing talc,
vermiculite, or another bulk material where asbestos can be found as an
impurity, EPA anticipates that they would report using either Form A or
Form B, based upon their knowledge of the amount of asbestos in their
bulk material.
Specifically, EPA is proposing that sites involved in mining,
milling, or importing asbestos or bulk materials containing asbestos
report certain information associated with those activities, as listed
in proposed 40 CFR 704.180(e)(4)(ii) and (iii), and (e)(5). All
submitters would report the applicable asbestos form associated with
the mining, milling, or importing activity.
a. Bulk asbestos. In addition, EPA is proposing that sites involved
in mining, milling, or importing bulk asbestos, for each asbestos type
and for each year, report the quantity of asbestos and the disposition
of asbestos. Table 3 in proposed 40 CFR 704.180(e)(4)(ii)(B) provides a
list of dispositions from which to select, including: Used on site,
sent to another U.S. site, exported, or
[[Page 27069]]
disposed of. EPA is proposing that a site selecting ``Disposed of
within the U.S.'' would provide additional explanation to indicate the
quantity and type of disposal (e.g., disposed in a landfill).
b. Bulk materials containing asbestos. EPA is proposing that sites
involved in mining, milling, or importing bulk materials containing
asbestos also report the type of bulk material that is manufactured
(including imported) or processed, and for each type of bulk material
and year, report:
The quantity of bulk material quantity by weight (Form B
only);
The percentage of asbestos in the bulk material (Form B
only);
The most specific identity of asbestos (Form B only);
Information describing how you know the amount of asbestos
in the bulk material (Form B only); and
The disposition of the bulk material as described in Unit
III.F.2.a.
3. Primary Processors of Asbestos (Bulk Processing Material, Other Than
Milling), Including as an Impurity
A primary processor starts with bulk asbestos or bulk materials
containing asbestos and makes a mixture that contains asbestos. A
primary processor may simply mix or repackage different types or sizes
of fibers and then sell that product. Mixtures that contain asbestos
are products to which asbestos has been intentionally added and which
can be used or processed further and incorporated into other products.
For example, asbestos cement, asbestos paper, and asbestos-reinforced
plastics are instances where asbestos is contained in a mixture.
Primary processors are defined in the proposed 40 CFR 704.180(a), a
definition adapted from the definition of primary processor in the 1982
Asbestos Reporting Requirements Rule (see Unit II.C.1.).
EPA anticipates that primary processors starting with bulk asbestos
are more likely to report using Form B while those starting with bulk
materials containing asbestos may report using either Form A or Form B.
EPA is proposing that primary processors report, for each year, the
total quantity of asbestos processed (Form B only) and the end product
type (selected from Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B)).
For each product type, report by year:
The most specific identity of asbestos (Form B only);
The total annual production quantity of end product, using
the unit of measure as listed in Table 4 in proposed 40 CFR
704.180(e)(4)(iv)(B);
The percentage of asbestos in the end product (Form B
only);
If the asbestos content is an impurity, how you know about
the presence, amount, and type of asbestos (i.e., do you have test
results (provide the results), how often is testing conducted, other
methods for identifying the asbestos content); and
The disposition of the end product (Form B only) as
described in Unit III.F.2.a.
4. Secondary Processor Production (Processing Asbestos When a Component
of a Mixture and Articles Containing Asbestos), Including as an
Impurity
Secondary processors are those who start with asbestos when it is a
component of a mixture and incorporate the mixture into their own
products. For example, persons who fabricate asbestos cement sheet by
cutting the sheet to make an electrical switch board, or persons who
make garments by cutting an asbestos-containing textile, are secondary
processors. Secondary processors are defined in the proposed 40 CFR
704.180(a), a definition adapted from the definition of primary
processor in the 1982 Asbestos Reporting Requirements Rule (see Unit
II.C.1.).
EPA anticipates that secondary processors may report using either
Form A or Form B. EPA is proposing that secondary processors report,
for each year, the total quantity of asbestos processed (Form B only)
and the end product type (selected from Table 4 in proposed 40 CFR
704.180(e)(4)(iv)(B)). For each product type, report by year:
The most specific identity of asbestos and the quantity of
asbestos (Form B only);
The total annual production quantity of end product, using
the unit of measure as listed in Table 4 in proposed 40 CFR
704.180(e)(4)(iv)(B);
The percentage of asbestos in the end product (Form B
only);
If the asbestos content is an impurity, how you know about
the presence, amount, and type of asbestos (i.e., do you have test
results [provide the results], how often is testing conducted, other
methods for identifying the asbestos content); and
The disposition of the end product (Form B only) as
described in Unit III.F.2.a.
5. Importation of Asbestos as a Component of a Mixture or Articles That
Contain Asbestos, Including as an Impurity
An importer of asbestos contained in a mixture or articles that
contain asbestos, including as an impurity, imports these substances
into the customs territory of the U.S.
EPA anticipates that an importer of products may report using
either Form A or Form B. EPA is proposing that importers report, for
each year, the total quantity of asbestos processed (Form B only) and
the imported product type (selected from Table 4 in proposed 40 CFR
704.180(e)(4)(iv)(B)). For each product type, report by year:
Whether the imported product including asbestos is
contained in a mixture or a part of an article;
The most specific identity of asbestos and the quantity of
asbestos (Form B only);
The total annual import quantity of the imported product,
using the unit of measure as listed in Table 4 of proposed 40 CFR
704.180(e)(4)(iv)(B);
The percentage of asbestos in the imported product (Form B
only);
Information about how you know about the presence, amount,
and type of asbestos (i.e., do you have test results (provide the
results), how often is testing conducted, other methods for identifying
the asbestos content); and
The disposition of the imported product (Form B only) as
described in Unit III.F.2.a.
6. Employee Information
For each activity reported, EPA is proposing that submitters also
report certain information about the number of employees involved with
the activity. Specifically, EPA is proposing that submitters report the
number of employees associated with the activity, whether personal
protective equipment was used and, if yes, the type of equipment used,
and any workplace exposure measurement assessments such as monitoring
data. When supplying the measurement assessment data, also include
information about how the assessment was conducted and other
explanations to help EPA better understand and use the data.
G. Did EPA consider additional data elements for the proposal?
When evaluating which data elements to include in this proposal,
EPA also considered potentially requiring reporting on additional
information related to current employee exposures, wastewater
treatment, disposal information, and customer sites. EPA presently
believes the additional information might be useful for a more in-depth
analysis of the potential exposures associated with asbestos. However,
EPA also presently believes that the proposed data elements described
in Unit III.F. would provide sufficient information for use by EPA and
other Federal agencies in potential actions involving asbestos,
including
[[Page 27070]]
EPA's TSCA risk evaluation and risk management activities. EPA chose
not to include these additional data elements in this proposed rule in
the interest of maintaining a manageable level of burden for reporting
entities, while also considering the need for creating a manageable
reporting tool.
EPA is seeking public comment on whether any additional data
(particularly, information related to current employee exposures,
wastewater treatment information, additional disposal information, and
customer sites) should be added as required data elements on Form B.
1. Employee Data
EPA considered collecting a more detailed breakdown of the number
and types of employees by work category. This information would enable
the agency to consider exposures to employees conducting different
types of work at a site, including those conducting production,
shipping or receiving, maintenance, waste management, or other
activities.
EPA also considered collecting employee exposure information,
including 8-hr time-weighted average exposures, 15- or 30-minute peak
or maximum exposures, related statistical data (medians, arithmetic
means, standard deviations, etc.), levels of detection and non-
detectable measurements, and descriptions of sampling and analysis,
such as sampling and analytical chemistry methods. Due to the
anticipated burden for reporters in contrast to the usefulness of the
data that the agency could collect, EPA is not including reporting on
these additional employee data elements in this proposed rule.
2. Wastewater Discharge and Waste Disposal Data
EPA considered collecting information related to asbestos or
asbestos-containing discharges, including releases, wastes, and
disposal data. These data included a description of any discharges,
such as to water or to off-site public treatment facilities, and
descriptions of solids disposal, such as to land-based facilities.
Wastewater related information included volumes of wastewater, amount
of asbestos in the wastewater, on-site treatment methods (if any),
National Pollutant Discharge Elimination System (NPDES) permit numbers
and copies of reports, transport to off-site treatment, and removed
solids management. General waste and disposal information included the
identity of the end product being disposed, the form of the waste, the
quantity of asbestos in the waste, the type of land disposal facility
(e.g., impoundment, waste pile, landfill, injection well), and whether
the disposal is on- or off-site. Note, however, that EPA is proposing
that a site reporting ``Disposed of within the U.S.'' in response to
Table 3 would provide additional explanation to indicate the quantity,
address of the disposal facility, and type of disposal (e.g., disposed
in a landfill). EPA believes this level of reporting on waste disposal
data is sufficient for purposes of this data collection. Due to the
anticipated burden for reporters in contrast to the usefulness of the
data that the agency could collect, EPA is not including reporting on
additional data elements related to wastewater discharge and waste
disposal in this proposed rule beyond the disposal explanation that
would be included in response to reporting ``Disposed of within the
U.S.'' in response to Table 3.
3. Air Emissions Data
EPA considered collecting information related to air emissions at
facilities that manufacture (including import) or process asbestos or
asbestos-containing mixtures and products. The information included
sources of emissions, methods of air pollution control, descriptions of
control devices, and pollution control equipment operation and testing
frequency and methods. Due to the anticipated burden for reporters in
contrast to the usefulness of the data that the agency could collect,
EPA is not including reporting on these additional data elements in
this proposed rule.
4. Customer Sites Data
EPA also considered requiring additional information about the
number of customers respondents have. As proposed, this action would
only collect information about asbestos manufacturers (including
importers) and processors. Additional customer information from
companies selling a product could be useful in understanding the
universe of asbestos users. For the reasons described previously, EPA
is not including reporting on these additional employee data elements
in this proposed rule, however, EPA is requesting comment on requiring
manufactures (including importers) and processors of asbestos that are
selling a product that contains asbestos to report the number of
customer sites they have.
H. How would information be submitted to EPA?
EPA is proposing to require electronic reporting similar to the
requirements established in 2013 for submitting other information under
TSCA (see 40 CFR 704.20(e)). EPA is proposing to require submitters to
use EPA's CDX (Central Data Exchange), the Agency's electronic
reporting portal, for all reporting under this rule. In 2013, EPA
finalized a rule to require electronic reporting of certain information
submitted to the Agency under TSCA sections 4, 5, 8(a), and 8(d) (78 FR
72818) (FRL-2013-28510). The final rule followed two previous rules
requiring similar electronic reporting of information submitted to EPA
for TSCA CDR and for premanufacture notices (PMNs). In proposing to
require similar electronic reporting under this rule, EPA expects that
electronic reporting would save time, improve data quality, and
increase efficiencies for both the submitters and the Agency.
EPA developed the Chemical Information Submission System (CISS) for
use in submitting data electronically to the Agency for TSCA sections
4, 5, 6, 8(a), 8(b), 8(d), 8(e), and Title VI. CISS, a web-based
reporting tool housed within the CDX environment, provides submitters
with user-friendly applications to build and submit data packages to
EPA within a secure, encrypted environment. CISS applications provide
for the capture of both fielded data as well as the attachment of
additional information using a wide variety of file types. Submitted
information is rendered into PDF and XML formats, which are provided to
submitters in the form of a Copy of Record.
EPA is proposing to require submitters to follow the same
submission procedures used for other TSCA submissions, i.e., to
register with EPA's CDX and use CISS to prepare a data file for
submission. Registration enables CDX to authenticate user identity. To
submit electronically to EPA via CDX, individuals must first register
with CDX at http://cdx.epa.gov/. To register in CDX, the CDX registrant
(also referred to as ``Electronic Signature Holder'' or ``Public/
Private Key Holder'') agrees to the Terms and Conditions, provides
information about the submitter and organization, selects a username
and password, and follows the procedures outlined in the guidance
document for CDX available at https://cdx.epa.gov/FAQ#CSPP.
Within CDX, CISS is available under the ``Submission for Chemical
Safety and Pesticide Program (CSPP)'' CDX flow. Users who have
previously submitted under TSCA through CDX, including submitting
information under TSCA sections 4 and 5, CDR, or reporting under the
TSCA Inventory Notification (Active-Inactive)
[[Page 27071]]
Requirements rule (82 FR 37520, Aug. 11, 2017) (FRL-9964-22), will
already have the CSPP flow linked to their account. Users reporting to
EPA using other CDX housed applications, including the Toxics Release
Inventory TRI-MEweb, would be able to add the CSPP flow to their
existing CDX accounts.
All submitters would be required to use CISS to prepare their
submissions. CISS guides users through a ``hands-on'' process of
creating an electronic submission. Once a user completes the relevant
data fields and attaches appropriate PDF files, or other file types,
such as XML files, the web-based tool validates the submission by
performing a basic error check and makes sure all the required fields
and attachments are provided and complete. Further instructions for
uploading PDF attachments or other file types, such as XML, and
completing metadata information would be available through CISS
reporting guidance.
CISS also allows the user to choose to ``Preview,'' ``Save,'' or
``Submit'' the data package. Once the submission process is initiated,
the user is asked to certify the information and provide requested
information to complete the submission process. The data package is
then sent, in an encrypted state, to the Agency. The user can login to
the application and check the submission status of their data package.
Upon successful receipt of the submission by EPA, the submission status
of the submissions will be flagged as ``Completed'' and a confirmation
email will be sent to the submitter's CDX inbox. The CDX inbox is used
to notify the users when submissions are received by EPA or to notify
users when a submission-specific communication has been received and
how to locate and access the communication. Information on accessing
the CDX user inbox is provided in the guidance document for CDX at
https://cdx.epa.gov/FAQ#CSPP. To access CISS log into CDX using the
link: https://cdx.epa.gov/ and click on the appropriate user role
associated with the CSPP data flow. For further instructions, visit
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information. Procedures for
reporting under this proposed rule would be similar.
EPA believes that electronic reporting reduces the reporting burden
for submitters by reducing the cost and time required to review, edit,
and transmit data to the Agency. It also allows submitters to share a
draft submission within their organization, and more easily save a copy
for their records or future use. Additionally, EPA believes that some
of the anticipated submitters under this proposed rule have experience
with reporting electronically to EPA through CDX. The resource and time
requirements to review and process data by the Agency will also be
reduced and document storage and retrieval will require fewer
resources. EPA expects to benefit from receiving electronic submissions
and communicating electronically with submitters.
I. How does the rule address claims for treatment of confidential
information?
In a separate rulemaking under development, EPA plans to propose
new provisions concerning the assertion and treatment of CBI claims for
information reported to or otherwise obtained by EPA under TSCA. Unless
otherwise stated in specific TSCA regulations (such as those proposed
here), EPA intends the proposed provisions to govern how CBI claims
made for information submitted under TSCA, including information
submitted under this part, will be asserted, reviewed, and maintained.
In this rulemaking, EPA is proposing in proposed 40 CFR 704.180(h)
that a person submitting a reporting form under this action may claim
some information in the form as confidential at the time of submission,
consistent with TSCA section 14. EPA is also proposing that certain
data elements cannot be claimed as confidential:
Site NAICS code in proposed 40 CFR 704.180(e)(3)(v),
because it represents a general description associated with the
manufacture (including import) or processing of a chemical substance.
Chemical and bulk material identities (as identified in
proposed 40 CFR 704.180(h)(1)(ii)(B)), because the chemical identities
are listed in the asbestos definition in proposed 40 CFR 704.180(a) or
are general identities of bulk materials that are already publicly
known.
Responses that are blank or ``not known or reasonably
ascertainable'' (as identified in proposed 40 CFR 704.180(h)(1)(ii)(C))
because there is no data to claim as confidential.
Health and safety study data (as identified in proposed 40
CFR 704.180(h)(1)(ii)(D)), because, under TSCA section 14(b)(2), such
information is not protected from disclosure. Note, however, that CBI
claims may be asserted to the extent that disclosure of data from
studies would reveal certain information as provided in proposed 40 CFR
704.180(h)(1)(ii)(D)(1)-(3). The electronic reporting tool described in
proposed 40 CFR 704.180(i) enables the submitter of a health and safety
study containing CBI claims to attach a public copy of the study, as
described in proposed 40 CFR 704.180(h)(2)(vi).
TSCA section 14 also requires that the submitter attest to a
statement concerning the confidential status of the information, that
they have a reasonable basis to conclude that release of the
information would likely result in substantial harm to the competitive
position of their business and that the information is not readily
discoverable through reverse engineering. The submitter must certify
that this statement and any substantiation provided are true and
correct. This certification statement will be incorporated into the
electronic reporting tool identified in proposed 40 CFR 704.180(i).
TSCA section 14(c)(3) further requires that substantiation be
provided at the time a confidentiality claim is asserted. However, TSCA
section 14(c)(2) exempts certain information from that substantiation
requirement (e.g., specific production volume). Under the proposed
rule, CBI claims for specific production or import volumes of the
manufacturer need not be substantiated, as identified in proposed 40
CFR 704.180(h)(2)(iv). For all other information submitted under this
proposed rule, submitters are required to substantiate their
confidentiality claims at the time of submission. Substantiation
questions are listed in proposed 40 CFR 704.180(h)(2)(iii) and will be
incorporated into the electronic reporting tool identified in proposed
section 704.180(i). Responses to the substantiation questions that are
not specific to the data element for which a claim of confidentiality
is being substantiated may be inadequate to justify confidential
protection.
Any information which is claimed as confidential will be disclosed
by EPA only in accordance with the procedures and requirements of TSCA
section 14 and 40 CFR part 2, or any TSCA-specific CBI provisions that
may in the future replace or supplement portions of 40 CFR part 2. TSCA
section 14(b)(2) limits confidentiality protections for health and
safety studies and information from health and safety studies regarding
chemical substances that have been offered for commercial distribution,
except to the extent such studies or information reveals ``information
that discloses processes used in the manufacturing (including
importing) or processing of a chemical substance or mixture or, in the
case of a mixture, the portion of the mixture comprised by any of the
chemical substances in the
[[Page 27072]]
mixture''. Additionally, in some cases EPA may consider information
contained in a study as not part of a health and safety study as
defined in TSCA section 3(8). The workplace exposure measurement data
listed in proposed 40 CFR 704.180(e)(5)(iii) are from studies
pertaining to human exposure in the workplace and therefore are
considered health and safety study data. Submitters asserting a
confidentiality claim for such information in health and safety studies
(as well as for other information claimed as confidential) will be
required to submit a sanitized copy of the study, removing only that
information which is claimed as confidential. See proposed 40 CFR
704.180(h)(1)(ii)(D) for additional information regarding health and
safety studies and proposed 40 CFR 704.180(h)(2)(vi)) regarding public
copies.
J. What are the recordkeeping requirements?
EPA is proposing that each person who reports under this part must
maintain records that document information reported under this part
and, in accordance with TSCA, permit access to and the copying of such
records by EPA officials. Consistent with the CDR rule, EPA is
proposing a five-year recordkeeping period, beginning on the last date
of the submission period. The five-year retention requirement generally
corresponds with the statute of limitations for TSCA violations.
Information in this one-time data collection will be used by EPA for
risk evaluation and risk management activities, and the companies must
maintain the records for five years in the event that EPA has follow-up
questions as the agency activities are completed. Further, EPA believes
the burden of retaining these records, which are likely electronic, is
minimal.
IV. Request for Comments
EPA requests comment on the content of this proposed rule and the
Economic Analysis prepared in support of this proposed rule (Ref. 2).
In addition, EPA is providing a list of issues on which the Agency is
specifically requesting public comment. EPA encourages all interested
persons to submit comments on these issues, and to identify any other
relevant issues as well. This input will assist the Agency in
developing a final rule that successfully addresses information needs
while minimizing potential reporting burdens associated with the rule.
EPA requests that commenters making specific recommendations include
supporting documentation where appropriate.
1. EPA is soliciting comment on the total number of manufactures
(including importers) and processors that will be impacted by the
promulgation of this rule, and on the related burden and costs for
reporting. In addition, due to the lack of information on the extent to
which asbestos occurs as an impurity, EPA was unable to determine the
number of potential manufacturers (including importers) or processors
of asbestos as an impurity that would report under this rule. EPA is
soliciting public comment on the number of manufacturers (including
importers) and processors that may be subject to the proposed rule due
to the presence of impurities in their products, and on the related
burden and cost for reporting.
2. As described further in Unit III.B., because there is no
existing small processers definition that would be applicable under
TSCA section 8(a), EPA is requesting comment on how to best provide
guidance for small processors of Libby Amphibole asbestos.
3. As described further in Unit III.C.2, EPA is seeking comment on
what additional guidance, if any, might be useful for helping entities,
including small businesses, understand the reporting standard, as well
as to how the reporting standard would apply to impurities.
As described further in Unit III.D., EPA is requesting public
comment on the submission start date and duration, including for small
businesses.
4. As described further in Unit III.E.2., EPA is requesting comment
on whether there should be a threshold for reporting using Form B and,
if so, whether the threshold should be concentration-based (e.g., a
certain percentage) or annual volume-based. In addition, EPA is
requesting comment on whether any submitter under the threshold should
alternatively report using Form A. Having a threshold for Form B may
decrease burden on certain submitters while still allowing EPA to
obtain information on all bulk materials, mixtures, and articles with
known asbestos content. The substances subject to the rule can occur
naturally as impurities in other products that may be handled in very
large volumes, such as talc, vermiculite, and potentially other
substances. A de minimis concentration could reduce the compliance
determination and reporting burdens. Comments suggesting threshold
levels should include the justification for that particular level.
5. As described further in Unit III.F. and first mentioned in Unit
III.F.3., EPA is requesting comment on whether there should be other
end product types listed in Table 4 in proposed 40 CFR
704.180(e)(4)(iv)(B). In addition, EPA is interested in whether the
units of measure listed with the product types are appropriate.
6. As described further in Unit III.G., EPA identifies additional
data elements related to employee data, wastewater discharge and waste
disposal, air emissions data and customer sites data, considered for
this proposed rule and is soliciting public comment on whether any of
the additional data elements should be included in the action. While
EPA believes the proposed data elements in Unit III.F provide
sufficient information for use by EPA and other Federal agencies in
potential actions involving asbestos, EPA is seeking comment on whether
any additional data elements should be included in this action.
7. As described further in Unit III.AC.2, EPA is seeking comment on
what additional guidance, if any, might be useful.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Final Rule; Asbestos: Manufacture, Importation, Processing,
and Distribution in Commerce Prohibitions. Federal Register. 54 FR
29460. July 12, 1989. (FRL-3476-2).
2. EPA, OPPT. Economic Analysis for the Proposed TSCA Section 8(a)
Reporting and Recordkeeping Requirements for Asbestos. February 4,
2022.
3. EPA. Learn About Asbestos. EPA website. https://www.epa.gov/asbestos/learn-about-asbestos.
4. EPA. IRIS Toxicological Review of Libby Amphibole Asbestos (Final
Report). U.S. Environmental Protection Agency, Washington, DC, EPA/
635/R-11/002F, 2014. https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1026tr.pdf.
[[Page 27073]]
5. Agency for Toxic Substances and Disease Registry (ATSDR). Summary
Report: Exposure to Asbestos-Containing Vermiculite from Libby,
Montana, at 28 Processing Sites in the United States. U.S.
Department of Health and Human Services, Agency for Toxic Substances
and Disease Registry, Atlanta, GA, 2008. https://www.atsdr.cdc.gov/asbestos/sites/national_map/Summary_Report_102908.pdf and https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/783510.
6. EPA. Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos.
U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP). Washington, DC, EPA-740-R1-8012, 2020.
https://www.epa.gov/sites/default/files/2020-12/documents/1_risk_evaluation_for_asbestos_part_1_chrysotile_asbestos.pdf.
7. National Toxicology Program (NTP). Asbestos, CAS No. 1332-21-4.
In Report on Carcinogens (15th ed.).: U.S. Department of Health and
Human Services, Public Health Service, Research Triangle Park, NC,
2001. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf.
8. EPA. Determining If You Are a Manufacturer or Importer for
Reporting. EPA website. https://www.epa.gov/chemical-data-reporting/determining-if-you-are-manufacturer-or-importer-required-report.
9. EPA. Instructions for Reporting 2020 TSCA Chemical Data Reporting
(pp. 45-47).: U.S. Environmental Protection Agency, Office of
Pollution Prevention and Toxics (OPPT) Washington, DC, 2020. https://www.epa.gov/sites/default/files/2020-12/documents/instructions_for_reporting_2020_tsca_cdr_2020-11-25.pdf.
10. EPA. TSCA Chemical Data Reporting Fact Sheet: Articles. U.S.
Environmental Protection Agency, Office of Pollution Prevention and
Toxics (OPPT) Washington, DC, 2012. https://www.epa.gov/sites/default/files/documents/articlesfactsheetforcdr_reporting_080312.pdf.
11. Asbestos Disease Awareness Organization (ADAO), American Public
Health Association (APHA), Center for Environmental Health (CEH),
Environmental Health Strategy Center (EHSC), Environmental Working
Group (EWG), Safer Chemicals, Healthy Families (SCHF) to Andrew
Wheeler, Administrator, U.S. Environmental Protection Agency.
Petition under TSCA Section 21 to Require Reporting on Asbestos
Manufacture, Importation and Use under TSCA Section 8(a). September
27, 2018. https://www.epa.gov/sites/default/files/2018-10/documents/adao-asbestos-cdr-petition-all.pdf.
12. The Attorneys General of Massachusetts, California, Connecticut,
Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon,
Pennsylvania, Rhode Island, Vermont, Washington, and the District of
Columbia to Andrew Wheeler, Administrator, U.S. Environmental
Protection Agency. Petition Under TSCA Section 21(a) for EPA to
Issue an Asbestos Reporting Rule to Require Reporting under TSCA
Section 8(a). January 31, 2019. https://www.epa.gov/sites/default/files/2019-02/documents/tsca_section_21_rulemaking_petiton_for_asbestos_reporting_1_31_2019_2.pdf.
13. Settlement Agreement, Case Nos. 3:19-CV-00871-EMC; 3:19-CV-
03807-EMC. Asbestos Disease Awareness Organization, et al.,
Plaintiffs, v. U.S. Environmental Protection Agency, et al.,
Defendants. June 7, 2021.
14. EPA. Scope of the Risk Evaluation for Asbestos. U.S.
Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention (OCSPP), Washington, DC, EPA-740-R1-7008, 2017.
https://www.epa.gov/sites/default/files/2017-06/documents/asbestos_scope_06-22-17.pdf.
15. Occupational Safety and Health Administration (OSHA). OSHA
Occupational Chemical Database, Talc (Containing Asbestos). United
States Department of Labor. https://www.osha.gov/chemicaldata/276.
16. Chemical Substances When Manufactured or Processed as Nanoscale
Materials; TSCA Reporting and Recordkeeping Requirements, 40 CFR
part 704 (2017). https://www.federalregister.gov/documents/2017/01/12/2017-00052/chemical-substances-when-manufactured-or-processed-as-nanoscale-materials-tsca-reporting-and.
17. EPA. Information Collection Request (ICR) for the TSCA Section
8(a) Reporting and Recordkeeping Requirements for Asbestos (Proposed
Rule). EPA ICR No. 2711.01 and OMB No. 2070-[NEW]. February 4, 2022.
18. U.S. Geological Survey (USGS). Asbestos Statistics and
Information: Mineral Commodity Summaries. 2021. https://pubs.usgs.gov/periodicals/mcs2021/mcs2021-asbestos.pdf.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket. EPA prepared an
economic analysis of the potential costs and benefits associated with
this action (Ref. 2), which is available in the docket and summarized
in Unit I.E. (Ref. 2).
B. Paperwork Reduction Act (PRA)
The information collection requirements in this proposed rule have
been submitted to OMB for review and comment under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) document prepared
by EPA has been assigned the EPA ICR No. 2711.01 (Ref. 17). You can
find a copy of the ICR in the docket for this action, and it is briefly
summarized here.
The information collection activities in the proposed rule include
a one-time reporting requirement and recordkeeping requirements.
Companies that manufacture (including import) or process asbestos must
report certain information to EPA and maintain corresponding records.
Respondents/affected entities: Chrysotile asbestos manufacturers
(including importers) and processors. See Unit I.A. for a list of
potentially affected entities.
Respondent's obligation to respond: Mandatory. TSCA section 8(a)
and proposed 40 CFR 704.180.
Estimated number of respondents: 27.
Frequency of response: One time.
Total estimated burden: 1,157 hours (per report). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $99,496 (per report), which 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 are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers for certain EPA
regulations is consolidated in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to EPA using the docket identified at
the beginning of this proposed rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs using
the interface at www.reginfo.gov/public/do/PRAMain. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. Since OMB is required to
make a decision concerning the ICR between 30 and 60 days after
receipt, OMB must receive comments no later
[[Page 27074]]
than June 6, 2022. 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 persons who have manufactured (including imported), or
processed asbestos, including asbestos as a component of a mixture,
asbestos in articles, and asbestos as an impurity in the four full
calendar years prior to the effective date of this rule. EPA estimates
that at least 14 small firms will be affected by the proposed rule. Of
those small firms, which include importers of articles and processors,
12 are expected to have cost impacts of less than 1% of annual
revenues, one is expected to have impacts between 1-3%, and one is
expected to have impacts of more than 3% of annual revenues. These
estimates do not include firms that are impacted by the requirement to
report for impurities, which EPA was unable to identify. Based on
information available to EPA, the Agency does not believe there are a
substantial number of such firms. Further, EPA believes that impacts to
any such firms would not significantly alter the Agency's analysis
under the RFA. Details of this analysis are presented in the Economic
Analysis (Ref. 2).
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. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments or the
private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications, as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). In EPA's
experience, states do not engage in the activities that would make them
subject to the requirements in the proposed rule. As such this action
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 does not have
substantial direct effects on tribal government because asbestos is not
manufactured (including imported) or processed by tribes and would not
impose substantial direct compliance costs on tribal governments.
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 to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045, because it is a data
gathering rulemaking and does not concern an environmental health risk
or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution in Commerce, or Use
This action is not a ``significant energy action'' under 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
OMB's Office of Information and Regulatory Affairs as a ``significant
energy action.'' This action is not expected to affect energy use,
energy supply or energy prices.
I. National Technology Transfer and Advancement Act (NTTAA)
This proposed rulemaking does not involve technical standards. As
such, NTTAA section 12(d), 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
The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because this action does not
establish an environmental health or safety standard. The collected
information, however, will be used by EPA and other Federal agencies to
inform considerations of potential future actions involving asbestos,
potentially including risk evaluation and risk management activities
that could benefit underserved communities and indigenous peoples.
List of Subjects in 40 CFR Part 704
Chemicals, Confidential business information, Environmental
protection, Hazardous substances, Reporting and recordkeeping
requirements.
Dated: April 22, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
For the reasons set forth in the preamble, it is proposed that 40
CFR chapter I be amended as follows:
PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS
0
1. The authority citation for part 704 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
0
2. Add Sec. 704.180 to subpart B to read as follows:
Subpart B--Chemical-Specific Reporting and Recordkeeping Rules
* * * * *
Sec. 704.180 Asbestos.
(a) Definitions.
The definitions in subpart A of this part apply to Sec. 704.180
unless otherwise specified in this section.
Asbestos is a collective term meaning any of the substances listed
in Table 1 of this paragraph.
Table 1 in Sec. 704.180(a)--CASRN of Asbestos Types
------------------------------------------------------------------------
CASRN Asbestos type
------------------------------------------------------------------------
1332-21-4..................... Asbestos.
132207-32-0................... Chrysotile.
12001-28-4.................... Crocidolite.
2172-73-5..................... Amosite.
77536-67-5.................... Anthophyllite.
77536-68-6.................... Tremolite.
[[Page 27075]]
77536-66-4.................... Actinolite.
NA............................ Libby Amphibole (mainly consisting of
tremolite [CASRN 77536-68-6], winchite
[CASRN 12425-92-2], and richterite
[CASRN 17068-76-7]).
------------------------------------------------------------------------
Bulk asbestos means any quantity of asbestos fiber of any type or
grade, or combination of types or grades, that is mined or milled with
the purpose of obtaining asbestos. This term does not include asbestos
that is produced or processed as a contaminant or an impurity.
Bulk materials containing asbestos means bulk materials in which
asbestos is being mined or milled as a contaminant or an impurity, such
as in vermiculite or talc.
Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of CDR data, reports, and other information, or its successors.
Form A means an abbreviated form for persons that know or can
reasonably ascertain that they manufactured (including imported) or
processed asbestos, including as an impurity, during the reporting
period described in paragraph (f) but do not know and cannot reasonably
ascertain the amount of asbestos manufactured (including imported) or
processed by them.
Form B means the standard form to be used by persons that know or
can reasonably ascertain that they manufactured (including imported) or
processed asbestos, including as an impurity, during the reporting
period described in paragraph (f) and know or can reasonably ascertain
how much asbestos they manufactured (including imported) or produced.
Primary processor means a person that starts with bulk asbestos or
bulk materials containing asbestos and makes a mixture that contains
asbestos as a component.
Secondary processor means a person that further processes asbestos,
after primary processing of asbestos is completed, as a component of a
mixture, or an article containing asbestos.
Small processor means any processor whose total annual sales, when
combined with those of its parent company (if any), are less than $12
million.
(b) Substance for which reports must be submitted.
The requirements of this section apply to asbestos, including
asbestos in bulk form, as a component of a mixture, in an article, and
as an impurity.
(c) Persons who must report.
Persons who have manufactured (including imported), or processed
asbestos, including asbestos as a component of a mixture, asbestos in
articles, and asbestos as an impurity in the four full calendar years
prior to the effective date of this rule must report under this
subpart.
(d) Persons exempt from reporting.
A person who is subject to reporting requirements pursuant to
paragraph (c) is exempt from the requirements in this subpart to the
extent that the person and that person's use of asbestos is described
in this paragraph.
(1) Non-isolated intermediate. A person who manufactures or
proposes to manufacture asbestos, as described in paragraph (c), solely
as a non-isolated intermediate is exempt from the reporting
requirements of this subpart.
(2) Research and development. A person who manufactures (including
imports), processes, or proposes to manufacture (including import), or
process asbestos, as described in paragraph (c), only in small
quantities solely for research and development is exempt from the
reporting requirements of this subpart.
(3) Small manufacturers (including importers) and processors. Small
manufacturers (including importers) and processors are exempt from the
reporting requirements of this subpart for the substance Libby
Amphibole only.
(e) Reporting information to EPA.
Persons described in paragraph (c) of this section must report to
EPA the following information, to the extent known to or reasonably
ascertainable by them. In the event that specific numeric data is not
known or is not reasonably ascertainable by the submitter, then
reasonable estimates may be submitted.
(1) Required forms. Report using the appropriate Form, based on
whether you know or can reasonably ascertain a quantity for asbestos.
(i) Form A. Report using Form A if you know or can reasonably
ascertain that asbestos is a component of a mixture or article but are
unable to determine the asbestos quantity by weight.
(ii) Form B. Report using Form B if you know or can reasonably
ascertain a quantity for asbestos.
(2) A certification statement signed and dated by an authorized
official of the submitter company. The authorized official must certify
that the submitted information has been completed in compliance with
the requirements of this part and that the confidentiality claims made
on Form A or Form B are true and correct. The certification must be
signed and dated by the authorized official for the submitter company,
and provide that person's name, official title, and email address.
(3) Company and plant site information. The following currently
correct company and plant site information must be reported for each
site at which a reportable chemical substance is manufactured
(including imported) or processed (see Sec. 704.3 for the ``site'' for
importers):
(i) Company name. The highest-level U.S. parent company name,
address, and Dun and Bradstreet D-U-N-S[supreg] (D&B) number. A
submitter under this part must obtain a D&B number for the U.S. parent
company if none exists.
(ii) Authorized official. The name of a person who will serve as
Authorized Official for the submitter company, and who will be able to
sign the certification statement as described in paragraph (e)(1), the
Authorized Official's full mailing address, telephone number, and email
address.
(iii) Point of contact. The name of a person who will serve as
technical contact for the submitter company, and who will be able to
answer questions about the information submitted by the company to EPA,
the contact person's full mailing address, telephone number, and email
address.
(iv) Site information. The site name, full street address,
including the county or parish (or other jurisdictional indicator) in
which the plant site is located. Also report the following:
(A) The appropriate D&B number for the plant site. If none exists,
you must obtain a D&B number for the reported site.
(B) Other site identification numbers, including the Facility
Registry Service (FRS) identification number, if they exist.
(v) Applicable NAICS code. The six-digit North American Industry
Classification System (NAICS) code(s) of the site.
[[Page 27076]]
(vi) Number of employees. The total number of employees at the
site. Select from among the ranges of employees listed in Table 2 of
this paragraph and report the corresponding code (i.e., W1 through W8):
Table 2 in Sec. 704.180(e)(3)(vi)--Codes for Reporting Number of
Employees
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1............................... Fewer than 10 employees.
W2............................... At least 10 but fewer than 25
employees.
W3............................... At least 25 but fewer than 50
employees.
W4............................... At least 50 but fewer than 100
employees.
W5............................... At least 100 but fewer than 500
employees.
W6............................... At least 500 but fewer than 1,000
employees.
W7............................... At least 1,000 but fewer than 10,000
employees.
W8............................... At least 10,000 employees.
------------------------------------------------------------------------
(4) Activity information. The following activity information must
be reported.
(i) Type of activity at reporting site. Report all that apply.
(A) Mining of bulk asbestos or bulk materials containing asbestos.
(B) Milling of bulk asbestos or bulk materials containing asbestos.
(C) Importing of bulk asbestos or bulk materials containing
asbestos.
(D) Primary processing of bulk asbestos or bulk materials
containing asbestos.
(E) Secondary processing of mixtures or articles containing
asbestos.
(F) Importing of mixtures or articles containing asbestos.
(ii) Form B only. For mining, milling, or importing of bulk
asbestos reported under activity in paragraph (e)(4)(i)(A) through (C),
report by year:
(A) The most specific asbestos type that applies. Select from among
the asbestos types listed in Table 1 of paragraph (a) in this section.
If the specific asbestos type is not known or reasonably ascertainable,
report the general listing, asbestos CASRN 1332-21-4.
(B) For each asbestos type, report
(1) Quantity of asbestos, in pounds.
(2) Disposition of asbestos (see Table 3 in paragraph (e)(4)(ii)(B)
of this section).
Table 3 in Sec. 704.180(e)(4)(ii)(B)--Disposition
------------------------------------------------------------------------
Code Disposition description
------------------------------------------------------------------------
1................................ Used on-site, including further
processed.
2................................ Stored on-site.
3................................ Sent to another U.S. site (including
intra-company transfer) for use or
processing.
4................................ Stored at another U.S. site
(including intra-company transfer).
5................................ Exported outside of the U.S. without
further processing.
6................................ Disposed of within the U.S.
(explain).
7................................ Other (explain).
------------------------------------------------------------------------
(iii) Reporting information for mining, milling, or importing of
bulk materials containing asbestos. For mining, milling, or importing
of bulk materials containing asbestos reported under the activity
identified in paragraph (e)(4)(i)(A) through (C), report by year:
(A) Bulk material type manufactured or processed (e.g., talc,
vermiculite).
(B) For Form B only, for each bulk material type:
(1) Quantity of bulk material manufactured or processed.
(2) Percent asbestos by weight in bulk material.
(3) The most specific asbestos type that applies. Select from among
the asbestos types listed in Table 1 in paragraph (a) of this section.
If the specific asbestos type is not known or reasonably ascertainable,
report the general listing, asbestos CASRN 1332-21-4.
(4) Any testing of or test results assessing the asbestos content
of your bulk material in the applicable reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your bulk material and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the bulk
materials.
(C) For each bulk material type, the disposition of bulk material
(see Table 3 in paragraph (e)(4)(ii)(B) of this section).
(iv) Reporting information for primary processors. For primary
processing reported under activity identified in paragraph (e)(4)(i)(D)
of this section, report by year:
(A) For Form B only, the total quantity of asbestos processed.
(B) End product type, selecting from products listed in Table 4 in
paragraph (e)(4)(iv)(B) of this section. If your end product is not
listed, report ``other'' and provide a brief description. For each end
product type, report:
(1) For Form B only, the most specific asbestos type that applies.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos type is not known or
reasonably ascertainable, report the general listing, asbestos CASRN
1332-21-4. Report also the total annual quantity of asbestos type
processed.
(2) The total annual production quantity of end products produced,
using the associated unit of measure listed in Table 4 in paragraph
(e)(4)(iv)(B) of this section. If a unit of measure is not listed,
provide the unit of measure associated with the quantity reported.
(3) For Form B only, the percentage of asbestos in the end product.
(4) For Form B only, the disposition of the end product (see Table
3 in paragraph (e)(4)(ii)(B) of this section).
(5) For Form B only, explain if you tested or received test results
assessing the asbestos content of your end product in the applicable
reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your end product and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertain the presence and amount of asbestos in the end
product.
Table 4 in Sec. 704.180(e)(4)(iv)(B)--End Product Types
------------------------------------------------------------------------
Code Name Unit of measure
------------------------------------------------------------------------
Papers, Felts, or Related Products
------------------------------------------------------------------------
01.......................... Commercial paper.... Short Tons.
02.......................... Rollerboard......... Short Tons.
03.......................... Millboard........... Short Tons.
[[Page 27077]]
04.......................... Pipeline wrap....... Short Tons.
05.......................... Beater-add gasketing Short Tons.
paper.
06.......................... High-grade Short Tons.
electrical paper.
07.......................... Unsaturated roofing Short Tons.
felt.
08.......................... Saturated roofing Short Tons.
felt.
09.......................... Flooring felt....... Short Tons.
10.......................... Corrugated paper.... Short Tons.
11.......................... Specialty paper Short Tons.
(specify generic
name).
12.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Floor Coverings
------------------------------------------------------------------------
13.......................... Vinyl asbestos floor Square yards.
tile.
14.......................... Asbestos felt backed Square yards.
vinyl flooring.
15.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Asbestos Cement Products
------------------------------------------------------------------------
16.......................... A/C pipe and Short Tons.
fittings.
17.......................... A/C sheet, flat..... 100 sq. ft.
18.......................... A/C sheet corrugated 100 sq. ft.
19.......................... A/C shingle......... Squares.
20.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Transportation Friction Materials (Including Aircrafts, Marine Vessels,
Railroad Engine and Railcars, and Other Vehicles)
------------------------------------------------------------------------
21.......................... Drum brake lining Pieces.
(light-medium
vehicle).
22.......................... Disc brake pads Pieces.
(light-medium
vehicle).
23.......................... Disc brake pads Pieces.
(heavy vehicle).
24.......................... Brake block (heavy Pieces.
equipment).
25.......................... Clutch facings (all) Pieces.
26.......................... Automatic Pieces.
transmission
friction components.
27.......................... Friction materials Pieces.
(industrial and
commercial).
28.......................... Custom automotive Pieces.
body filler.
29.......................... Transmissions....... Pieces.
30.......................... Mufflers............ Pieces.
31.......................... Radiator top Pieces.
insulation.
32.......................... Radiator sealant.... Pieces.
33.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Appliances
------------------------------------------------------------------------
34.......................... Appliance Industrial Pieces.
and consumer
(specify generic
name).
35.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Construction Products
------------------------------------------------------------------------
36.......................... Boiler and furnace Pieces.
baffles.
37.......................... Decorated building Pieces.
panels.
38.......................... Asbestos cement Pieces.
sheet.
39.......................... Flexible Air Pieces.
Conductor.
40.......................... Hoods and Vents..... Pieces.
41.......................... Portable Pieces.
construction
building.
42.......................... Roofing, saturated.. Pieces.
43.......................... Roof shingles....... Pieces.
44.......................... Wallboard........... Pieces.
45.......................... Wall/roofing panels. Pieces.
46.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Electrical Products and Components
------------------------------------------------------------------------
47.......................... Cable insulation.... Pieces.
48.......................... Electronic motor Pieces.
components.
49.......................... Electrical Pieces.
resistance supports.
50.......................... Electrical Pieces.
switchboard.
51.......................... Electrical switch Pieces.
supports.
52.......................... Electrical wire Pieces.
insulation.
53.......................... Motor armature...... Pieces.
54.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
[[Page 27078]]
Fire and Heat Shielding Equipment and Components
------------------------------------------------------------------------
55.......................... Arc deflectors...... Pieces.
56.......................... Fire doors.......... Pieces.
57.......................... Fireproof absorbent Short tons.
paper.
58.......................... Heat shields........ Pieces.
59.......................... Molten metal Pieces.
handling equipment.
60.......................... Oven and stove Short tons.
insulation.
61.......................... Pipe wrap........... Pieces.
62.......................... Stove lining, wood Pieces.
and coal.
63.......................... Stove pipe rings.... Pieces.
64.......................... Sleeves............. Pieces.
65.......................... Thermal Insulation.. Short tons.
66.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Textiles and Clothing
------------------------------------------------------------------------
67.......................... Cloth............... Pounds.
68.......................... Thread, yarn, lap, Pounds.
roving, cord, rope,
or wick.
69.......................... Aprons.............. Pieces.
70.......................... Boots............... Pieces.
71.......................... Gloves and mittens.. Pieces.
72.......................... Hats and helmets.... Pieces.
73.......................... Overgaiters......... Pieces.
74.......................... Suits............... Pieces.
75.......................... Aluminized cloth.... Short Tons.
76.......................... Rope or braiding.... Short Tons.
77.......................... Yarn, lap or roving. Short Tons.
78.......................... Wicks............... Short Tons.
79.......................... Bags................ Pieces.
80.......................... Belting............. Short Tons.
81.......................... Blankets............ Pieces.
82.......................... Carpet padding...... Short Tons.
83.......................... Commercial/ Short Tons.
industrial dryer
felts.
84.......................... Draperies........... Pieces.
85.......................... Drip cloths......... Pieces.
86.......................... Fire hoses.......... Pieces.
87.......................... Ironing board pads Pieces.
and insulation.
88.......................... Mantles, lamp or Pieces.
catalytic heater.
89.......................... Packing and Pieces.
packaging
components.
90.......................... Piano and organ Pieces.
felts.
91.......................... Rugs................ Pieces.
92.......................... Tape................ Pieces.
93.......................... Theater curtains.... Pieces.
94.......................... Umbrellas........... Pieces.
95.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Gaskets
------------------------------------------------------------------------
96.......................... Sheet gasketing, Pieces.
rubber encapsulated
beater addition.
97.......................... Sheet gasketing, Pieces.
rubber encapsulated
compressed.
98.......................... Compressed sheet Pieces.
gasketing (other).
99.......................... Metal reinforced Pieces.
gaskets.
100......................... Automotive gaskets.. Pieces.
101......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Marine Equipment and Supplies
------------------------------------------------------------------------
102......................... Caulks, marine...... Pounds.
103......................... Liners, pond or Pieces.
canal.
104......................... Marine bulkheads.... Pieces.
105......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Paints, Coatings, Sealants and Compounds
------------------------------------------------------------------------
106......................... Asphaltic compounds. Pounds.
107......................... Automotive/truck Gallons.
body coatings.
108......................... Buffing and Pounds.
polishing compounds.
109......................... Caulking and Pounds.
patching compounds.
110......................... Drilling fluid...... Gallons.
111......................... Flashing compounds.. Pounds.
112......................... Furnace cement...... Pounds.
[[Page 27079]]
113......................... Glazing compounds... Pounds.
114......................... Plaster and stucco.. Pounds.
115......................... Pump valve, flange Pieces.
and tank sealing
components.
116......................... Roof coatings....... Gallons.
117......................... Textured paints..... Gallons.
118......................... Tile cement......... Pounds.
119......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Other Products
------------------------------------------------------------------------
120......................... Sheet gasketing Square Yards.
(other than beater-
add).
122......................... Packing............. Pounds.
123......................... Paints and surface Gallons.
coatings.
124......................... Adhesives and Gallons.
sealants.
125......................... Asbestos-reinforced Pounds.
plastics.
126......................... Insulation materials (Specify).
not elsewhere
classified (specify
generic name).
127......................... Mixed or repackaged Short Tons.
asbestos.
128......................... Aerial distress Pieces.
flares.
129......................... Acoustical product.. Pieces.
130......................... Ammunition wadding.. Pieces.
131......................... Ash trays........... Pieces.
132......................... Baking sheets....... Pieces.
133......................... Blackboards......... Pieces.
134......................... Candlesticks........ Pieces.
135......................... Chemical tanks and Pieces.
vessels.
136......................... Filters............. Pieces.
137......................... Grommets............ Pieces.
138......................... Gun grips........... Pieces.
139......................... Jewelry making Pieces.
equipment.
140......................... Kilns............... Pieces.
141......................... Lamp sockets........ Pieces.
142......................... Light bulbs (all Pieces.
types).
143......................... Linings for vaults, Pieces.
safes, humidifies
and filing cabinets.
144......................... Phonograph records.. Pieces.
145......................... Pottery clay........ Pounds.
146......................... Welding rod coatings Pieces.
147......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
(v) Reporting information for secondary processors. For secondary
processing reported under the activity identified in paragraph
(e)(3)(i)(E) of this section, report by year:
(A) For Form B only, the estimated total quantity of asbestos
processed.
(B) End product type listed in Table 4 in paragraph (e)(4)(iv)(B)
of this section. For each product type, report:
(1) For Form B only, the most specific asbestos type that applies.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos type is not known or
reasonably ascertainable, report the general listing, asbestos CASRN
1332-21-4. Also report the quantity of asbestos.
(2) The total annual production quantity of the end products
produced, using the associated unit of measure listed in Table 4 in
paragraph (e)(4)(iv)(B) of this section.
(3) For Form B only, the percentage of asbestos in the end product.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your products and what method
and type of test was used for determining asbestos content, and provide
the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the end
product.
(4) For Form B only, the disposition of the end product (see Table
3 in paragraph (e)(4)(ii)(B) of this section).
(vi) Reporting information for importers. For importing reported
under activity identified in paragraph (e)(4)(i)(F) of this section,
report by year:
(A) For Form B only, the estimated total quantity of asbestos
imported.
(B) Imported product type (Table 4 (e)(4)(iv)(B). For each imported
product type, report:
(1) Whether the imported product is a mixture or an article.
(2) For Form B only, the most specific asbestos type that applies.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos type is not known or
reasonably ascertainable, report the general listing, asbestos CASRN
1332-21-4. Also report the quantity of asbestos type.
(3) The total annual import quantity of the imported product, using
the associated unit of measure listed in Table 4 in paragraph
(e)(4)(iv)(B) of this section.
(4) For Form B only, the percentage of asbestos in the product.
(5) For Form B only, explain if you tested or received test results
assessing the asbestos content of your imported product in the
applicable reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your imported product and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the
imported product.
(6) For Form B only, the disposition of the imported product (see
Table 3 in paragraph (e)(4)(ii)(B) of this section).
[[Page 27080]]
(5) Employee information. For each activity reported, report the
following information about employees at the associated site:
(i) Number of employees involved with activity. Select from among
the ranges of employees listed in Table 2 in paragraph (e)(3)(vi) of
this section and report the corresponding code (i.e., W1 through W8).
(ii) Is personal protective equipment used? If yes, identify the
type(s) of personal protective equipment used.
(iii) For Form B only, submit any workplace exposure measurement
assessments and data (e.g., monitoring).
(f) When to report.
All information reported to EPA under this section must be
submitted during the applicable submission period. The submission
period shall begin six months following the effective date of this rule
and last for three months.
(g) Recordkeeping requirements.
Each person who reports under this part must maintain records that
document information reported under this part and in accordance with
TSCA, permit access to, and the copying of such records by EPA
officials. Relevant records must be retained for a period of five years
beginning on the last day of the submission period.
(h) Confidentiality claims.
(1) Assertion of confidentiality claims--(i) Generally. Any person
submitting information under this part may assert a confidentiality
claim for that information, except for information described in
paragraph (h)(1)(ii) of this section. Any such confidentiality claims
must be asserted electronically, pursuant to Sec. 704.180(i), at the
time the information is submitted. Information claimed as confidential
in accordance with this section will be treated and disclosed in
accordance with the procedures in 40 CFR part 2 and section 14 of TSCA.
(ii) Exceptions. Confidentiality claims may not be asserted with
respect to the following:
(A) Site NAICS code required by Sec. 704.180(e)(3)(v);
(B) For chemical identities and bulk material forms required by
Sec. Sec. 704.180(e)(4)(ii)(A), (iii)(A), (iii)(B)(3), (iv)(B)(1),
(v)(B)(1), and (vi)(B)(2);
(C) Any data element that is left blank or designated as ``not
known or reasonably ascertainable;'' or
(D) Health and safety data required by Sec. 704.180(e)(5)(iii),
except that the following information may be claimed as confidential:
(1) Information that would reveal processes used in the
manufacturing, importing, or processing of the substance or mixture, or
the portion of a mixture comprised by any of the substances in the
mixture, provided that the information is expressly identified as
revealing processing information or portion of a mixture;
(2) Company name or address, financial statistics, and product
codes used by a company and contained in a study; and
(3) Information other than company name or address, financial
statistics, and product codes used by a company, which is contained in
a study, the disclosure of which would clearly be an unwarranted
invasion of personal privacy (such as individual medical records).
(iii) Certification statement for claims. An authorized official
representing a person asserting a claim of confidentiality must certify
that the submission complies with the requirements of this part by
signing and dating the following certification statement:
``I certify that all claims for confidentiality asserted with
this submission are true and correct, and all information submitted
herein to substantiate such claims is true and correct. Any knowing
and willful misrepresentation is subject to criminal penalty
pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken
reasonable measures to protect the confidentiality of the
information; (2) I have determined that the information is not
required to be disclosed or otherwise made available to the public
under any other Federal law; (3) I have a reasonable basis to
conclude that disclosure of the information is likely to cause
substantial harm to the competitive position of my company; and (4)
I have a reasonable basis to believe that the information is not
readily discoverable through reverse engineering.''
(2) Substantiation.--(i) Requirement to substantiate.
Confidentiality claims must be substantiated at the time of submission
to EPA, unless exempt under paragraph (h)(2)(v) of this section.
(ii) Information in substantiations may be claimed as confidential.
Such claims must be accompanied by the certification described in
paragraph (h)(1)(iii),but need not be themselves substantiated.
(iii) Substantiation questions for all claims. Answers to the
following questions must be provided for each confidentiality claim in
a TSCA submission:
(A) Please specifically explain what harm to the competitive
position of your business would be likely to result from the release of
the information claimed as confidential. How would that harm be
substantial? Why is the substantial harm to your competitive position
likely (i.e., probable) to be caused by release of the information
rather than just possible? If you claimed multiple types of information
to be confidential (e.g., site information, exposure information,
environmental release information), explain how disclosure of each type
of information would be likely to cause substantial harm to the
competitive position of your business.
(B) Has your business taken precautions to protect the
confidentiality of the disclosed information? If yes, please explain
and identify the specific measures, including but not limited to
internal controls, that your business has taken to protect the
information claimed as confidential. If the same or similar information
was previously reported to EPA as non-confidential (such as in an
earlier version of this submission), please explain the circumstances
of that prior submission and reasons for believing the information is
nonetheless still confidential.
(C)(1) Is any of the information claimed as confidential required
to be publicly disclosed under any other Federal law? If yes, please
explain.
(2) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(3) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(D) Is the claim of confidentiality intended to last less than 10
(ten) years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1 (one) and 10 (ten) years) or the specific
date after which the claim is withdrawn.
(E) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances
associated with the prior determination, whether the information was
found to be entitled to confidential treatment, the entity that made
the decision, and the date of the determination.
(iv) Exemptions from the substantiation requirement.
[[Page 27081]]
Confidentiality claims are exempt from the requirement to substantiate
the claim at the time of submission for the data elements required
pursuant to paragraphs (e)(4)(ii)(B)(1), (iii)(B)(1), (iv)(A),
(iv)(B)(2), (v)(A), (v)(B)(2), (vi)(A), and (vi)(B)(3) of this section.
(v) No claim of confidentiality. Information not claimed as
confidential in accordance with the requirements of this section may be
made public without further notice.
(vi) Public copies. Submissions and their accompanying attachments
that include a confidentiality claim must be accompanied, at the time
of submission, by a public version of the submission and any
attachments, with all information that is claimed as confidential
removed. Only information that is claimed as confidential may be
redacted or removed. Generally, a public copy that removes all or
substantially all of the information would not meet the requirements of
this paragraph.
(A) Where the electronic reporting tool contains a checkbox or
other means of designating with specificity what information is claimed
as confidential, no further action by the submitter is required to
satisfy this requirement.
(B) For all other information claimed as confidential, including
but not limited to information in attachments and in substantiations
required under paragraph (h) of this section, the submitter must
prepare and attach a public copy. Submissions with public or sanitized
copies that are entirely blank or that are substantially reduced in
length as compared to the CBI version will not meet the requirements of
this paragraph (h)(2)(vi) of this section.
(i) Electronic reporting.
You must use the EPA Central Data Exchange (CDX) to complete and
submit the information required under this section. Submissions may
only be made as set forth in this paragraph. Submissions must be sent
electronically to EPA using the asbestos reporting tool in CDX. The
information submitted and all attachments (unless the attachment
appears in scientific literature) must be in English. All information
must be true and correct. Access the asbestos reporting tool and
instructions, as follows:
(1) By website. Access the asbestos reporting tool via the CDX
homepage at https://cdx.epa.gov/ and follow the applicable
instructions.
(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-
1404 or [email protected].
[FR Doc. 2022-09533 Filed 5-5-22; 8:45 am]
BILLING CODE 6560-50-P