[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Rules and Regulations]
[Pages 47782-47806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14405]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 704
[EPA-HQ-OPPT-2021-0357; FRL-8632-01-OCSPP]
RIN 2070-AK99
Asbestos; Reporting and Recordkeeping Requirements Under the
Toxic Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is finalizing
reporting and recordkeeping requirements for asbestos under the Toxic
Substances Control Act (TSCA). EPA is requiring certain persons who
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 this final rule to electronically report
certain exposure-related information. This action results in a one-time
reporting requirement. EPA emphasizes that this requirement includes
asbestos that is a component of a mixture. The information sought
includes presence, types, and 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. EPA and other Federal agencies will
use reported information in considering potential future actions,
including risk evaluation and risk management activities.
DATES: This final rule is effective August 24, 2023.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2021-0357, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). All documents in the docket
are listed on https://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Additional instructions on visiting the docket,
along with more information about dockets generally, is available at
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, as defined
for purposes of this TSCA rulemaking. The use of the term
``manufacture'' in this document encompasses ``import,'' and the term
``manufacturer'' encompasses ``importer.'' Any use of the term
``asbestos'' will apply to asbestos in bulk form, in an article and/or
product, as an impurity, or as a component of a mixture. For a more
thorough discussion of the subject asbestos types, please see Unit
IV.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 that contain asbestos, including as an impurity,
whether or not those chemical substances or mixtures are on the TSCA
Chemical Substance Inventory. The TSCA Chemical Substance Inventory
contains all existing chemical substances--including those with CBI
claims protecting their identity--manufactured, processed, or imported
in the United States that do not qualify for an exemption or exclusion
under TSCA.
This rule does not require reporting on substances that are
excluded from the definition of ``chemical substance'' in TSCA section
3(2)(B). Those exclusions include, but are not limited to: Any
pesticide (as defined by the Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured, processed, or distributed in
commerce for use as a pesticide; any food, food additive, drug,
cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic
Act, when manufactured, processed, or distributed in commerce for use
as a food, food additive, drug, cosmetic or device; tobacco or any
tobacco product; any source material, special nuclear material, or
byproduct material as such terms are defined in the Atomic Energy Act
of 1954; and, any article the sale of which is subject to the tax
imposed by section 4181 of the Internal Revenue Code of 1954.
Substances which have been manufactured or imported for intended use as
any food, food additive, drug, cosmetic, or device as defined by the
Federal Food, Drug, and Cosmetic Act, are not chemical substances under
TSCA.
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, which although the
terms ``business,'' ``company,'' and ``firm'' can have different
meanings in some contexts, all are used to describe entities regulated
under this rule, may include entities identified in:
NAICS code 2122--Metal Ore Mining.
NAICS code 2123--Nonmetallic Mineral Mining and Quarrying.
NAICS code 322--Paper Manufacturing.
[[Page 47783]]
NAICS code 323--Printing and Related Support Activities.
NAICS code 324121--Asphalt Paving Mixture and Block
Manufacturing.
NAICS code 325--Chemical Manufacturing.
NAICS code 326--Plastics and Rubber Products
Manufacturing.
NAICS code 327--Nonmetallic Mineral Product Manufacturing.
NAICS code 331--Primary Metal Manufacturing.
NAICS code 332--Fabricated Metal Product Manufacturing.
NAICS code 333--Machinery Manufacturing.
NAICS code 334--Computer and Electronic Product
Manufacturing.
NAICS code 335--Electrical Equipment, Appliance, and
Component Manufacturing.
NAICS code 336--Transportation Equipment Manufacturing.
NAICS code 337--Furniture and Related Products
Manufacturing.
NAICS code 339--Miscellaneous Manufacturing.
NAICS code 42--Wholesale Trade.
NAICS code 441--Motor Vehicle and Parts Dealers.
NAICS code 444--Building Material and Garden Equipment and
Supplies Dealers.
NAICS code 445110--Supermarkets and Other Grocery
Retailers (except Convenience Retailers).
NAICS code 445131--Convenience Retailers.
NAICS code 449--Furniture, Home Furnishings, Electronics,
and Appliance Retailers.
NAICS code 455--General Merchandise Retailers.
NAICS code 456110--Pharmacies and Drug Retailers.
NAICS code 4571--Gasoline Stations.
NAICS code 459--Sporting Goods, Hobby, Musical Instrument,
Book, and Miscellaneous Retailers.
NAICS code 56221--Hazardous Waste Treatment and Disposal.
NAICS code 562920--Materials Recovery Facilities.
You should carefully examine the regulatory text in this document
to determine if your business is 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 taking this action under section 8(a)(1) of TSCA, 15 U.S.C.
2607(a)(1), 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)(1) 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. 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 if they contain asbestos (the manufacture, importation or
processing of which would be initiated for the first time after August
25, 1989) (40 CFR 763.160 et seq.).
Thus, EPA is exercising 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.
However, 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 exempt from this reporting and recordkeeping
rule with respect to Libby amphibole asbestos; this exemption does not
extend to other types of asbestos. Note that small manufacturers
(including importers) and processors of types of asbestos found in
Libby amphibole (e.g., tremolite) are subject to this rule.
For a more thorough discussion of the one-time reporting
requirements for small manufacturers (including importers) and
processors, see Unit IV.B. EPA has set an annual sales threshold, in
any calendar year from 2019 to 2022, when combined with those of their
ultimate parent company (if any) of $500,000, below which manufacturers
and processors are not subject to the requirements of this rulemaking
(i.e., the manufacturer/processor would need to report if its annual
sales, combined with its parent company, was above $500,000 during
2019, 2020, 2021, and/or 2022).
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 requiring 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
[[Page 47784]]
time of the reporting under this rule may be claimed as confidential.
C. What action is the Agency taking?
EPA is requiring 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 the following types of asbestos as described in more detail in
Unit IV.A. of this document:
Asbestos--CASRN 1332-21-4;
Chrysotile--CASRN 12001-29-5;
Crocidolite--CASRN 12001-28-4;
Amosite--CASRN 12172-73-5;
Anthophyllite--CASRN 77536-67-5;
Tremolite--CASRN 77536-68-6;
Actinolite--CASRN 77536-66-4; and
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]).
If a specific asbestos type is unknown, a submitter will provide
information under the general asbestos form (CASRN 1332-21-4). See Unit
II.B. for more information about what is considered asbestos.
The following is a brief list of the primary data requirements in
this rule. These requirements are described in detail in Unit IV.
1. Asbestos domestic manufacturers (Asbestos Mine and Mill): The
provisions in this rule require asbestos domestic manufacturers to
provide the quantity manufactured of each asbestos type, activity for
each asbestos type (i.e., mining and/or milling), and employee exposure
information associated with each activity. This includes situations in
which asbestos is being mined or milled as an intentional component or
as an impurity, such as in vermiculite, talc, and other substances.
2. Asbestos importers: The provisions in this rule require
importers of asbestos to provide the quantity imported of each asbestos
type, activity for each asbestos type, and employee exposure
information associated with each activity. This includes importers of
mixtures containing asbestos, articles containing asbestos, and
impurities (in articles, bulk materials, or mixtures).
3. Asbestos processors: The provisions in this rule require
processors of asbestos (including processors of mixtures or articles)
to provide the quantity processed per asbestos type, activity for each
asbestos type (i.e., primary and/or secondary processing), and employee
exposure information associated with each activity. This includes both
primary processors and secondary processors of asbestos, as described
in Units IV.F.3. and 4. This includes situations in which asbestos
occurs as an impurity, such as in vermiculite, talc, and other
substances.
D. Why is the Agency taking this action?
The Agency is taking this action to obtain certain information
known to or reasonably ascertainable by manufacturers (including
importers) and processors of asbestos that EPA believes will 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, and other substances), that fall
under the scope of this rule. Reported information will be used by EPA
and other Federal agencies in considering potential actions involving
asbestos, including EPA's TSCA risk evaluation and risk management
activities. Requiring reporting may also increase public access to this
information, which improves information quality overall, and may help
inform and improve compliance assurance and accountability, and drive
industry innovation. This action is also subject to a settlement
agreement, as discussed in Unit II.C.3. 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 (EA) (Ref. 2) of the
potential impacts associated with this rule. The primary purpose of
this rule is to collect detailed data on asbestos uses and exposures.
Reported information will 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 186
to 1,044 firms may submit reports for 268 to 1,126 sites based on the
manufacturing (including importing) or processing of asbestos,
including mixtures, products, and articles containing asbestos,
including as an impurity. More detail on these estimates and related
assumptions and uncertainties are provided in the revised EA for the
final rule (Ref. 2).
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.
Rule familiarization costs for reporting firms are estimated to require
an average of 24 hours and $2,036 per firm. Where asbestos is
intentionally manufactured or processed, the estimated average form
completion burden and cost per site ranges from 12 hours and $1,243 to
approximately 26 hours and $2,372, depending on the type of activities
in which the respondent is engaged and the information known to or
reasonably ascertainable by them. For articles where asbestos occurs as
an impurity, the estimated average form completion burden and cost per
site ranges from approximately 17 hours and $1,674 to about 39 hours
and $3,451, again depending on the type of activities and the
information that is known or reasonably ascertainable. CBI claim
substantiation, recordkeeping, and electronic reporting activities are
estimated to require approximately 4 hours and $347 per firm.
Manufacturers and processors of articles who believe that asbestos may
have been present as an impurity are also expected to incur one-time
burdens and costs associated with rule familiarization and compliance
determination that average approximately 67 hours and $4,703.
EPA estimates a total industry quantified burden of approximately
4.5 million hours, with a quantified total cost of approximately $319
million to $323 million.
EPA estimates that approximately 66,000 small firms will be
affected by the rule. Of those small firms, 99.93 percent are expected
to have cost impacts of less than 1% of annual revenues, 0.07 percent
are expected to have impacts between 1-3%, and none are expected to
have impacts of more than 3% of annual revenues. Costs to small
businesses range from $4,430 to $11,273 per firm. Total costs to small
entities are approximately $279 million to $283 million. The Agency is
expected to incur a cost of approximately $654,000. The total social
burden and cost are therefore estimated to be approximately 4.5 million
hours and $320 million to $324 million, respectively (Ref. 2).
EPA did not attempt to quantify the benefits of this action. As
discussed in the economic analysis, EPA expects that information
supplied as a result of this rule will allow EPA to more effectively
and expeditiously evaluate risks posed by asbestos and manage them.
Further, requiring reporting may provide the benefit of increased
public access to this information, which improves information quality
overall, and may help inform and improve compliance assurance and
accountability, and drive industry innovation. Asbestos is hazardous to
human health. Ultimately,
[[Page 47785]]
enhancing the risk evaluation process will have positive consequences
for human health and the environment and may enable a more efficient
allocation of EPA's and society's resources.
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, to the extent the
information is known to or reasonably ascertainable by the submitter:
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 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 type
on the TSCA Inventory. However, CASRNs are also available for specific
fiber types. See Unit IV.A.1. for additional discussion.
In addition, EPA is including reporting for Libby amphibole
asbestos (mainly consisting of tremolite [CASRN 77536-68-6], winchite
[CASRN 12425-92-2], and richterite [CASRN 17068-76-7]) in order to help
determine 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 refer
to 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 rule.
EPA has determined reporting on Libby amphibole asbestos' component
parts, winchite and richterite, which are not asbestos types but
commonly comprise Libby amphibole asbestos samples, shall be included
in the scope of this TSCA section 8(a)(1) data collection and be
reported on individually in addition to reporting on Libby amphibole
asbestos (Ref. 5). Any reporting on Libby amphibole asbestos will
improve EPA's understanding of this substance and will 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;
Mesothelioma, a cancer of the thin lining of the lung,
chest and the abdomen and heart; and
Respiratory effects (e.g., asbestosis, non-malignant
respiratory disease, deficits in pulmonary function, diffuse pleural
thickening and pleural plaques).
In the TSCA Risk Evaluation for Asbestos Part I: Chrysotile
Asbestos published in December 2020 (Ref. 6), EPA identified and
evaluated the reasonably available information for chrysotile asbestos,
focusing on inhalation exposures and cancer outcomes as the hazards of
asbestos exposure are well-established (Ref. 7).
For a more thorough discussion on the asbestos types addressed by
this rule, see Unit IV.A.1 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).
[[Page 47786]]
It has been more than 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 rule is modeled after the
1982 data collection but requires more detailed information from
manufacturers (including importers) and processors in addition to
information about asbestos 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 final rule differs from the
existing CDR universe of data collected as it: (a) is a one-time data
collection as opposed to a reoccurring data collection; (b) requires
reporting for naturally-occurring asbestos; (c) requires processors of
asbestos to report (i.e., sites manufacturing (including importing)
and/or processing asbestos are subject to this rule); and (d) requires
reporting by entities who are manufacturing (including importing), and/
or processing asbestos and to whom the asbestos content (i.e., asbestos
type and presence, or asbestos type and quantity, if known) is known or
reasonably ascertainable (see TSCA section 8(a)(2)). ``Known to or
reasonably ascertainable by'' is defined at 40 CFR 704.3 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, 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 in this paragraph. Such an importer should
document its activities to support any claims it might need to make
related to due diligence. This rule also differs from CDR data
collection as it applies to impurities and imported articles, both of
which are exempted from CDR data collection (40 CFR 711.10(b) & (c))
(Ref. 9 and Ref. 10).
3. 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.5. 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 would
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 would sign for publication in the Federal Register a notice of
final action regarding the proposed TSCA section 8(a) rule. Pursuant to
the agreement between the parties, EPA notified Plaintiffs in November
2022 that EPA would miss the deadline to sign the final rule within
eighteen months from the effective date of the agreement, and that it
expected signature in late April 2023.
4. 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 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 for 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
[[Page 47787]]
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.
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 United States.
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 ongoing uses of 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 move into risk management for the unreasonable risk for ongoing uses
of asbestos 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 explained that its
evaluation of asbestos includes the six fiber types listed in TSCA
Title II (added to TSCA in 1986), section 202 (chrysotile (serpentine),
crocidolite (riebeckite), amosite (cummingtonite-grunerite),
anthophyllite, tremolite, or actinolite) and Libby amphibole asbestos
(with tremolite, winchite, and richterite constituents), as well as
asbestos present as an impurity in other substances. EPA expects that
the one-time data collected from this rule will be used in TSCA Risk
Evaluation for Asbestos Part 2 and will also inform risk management
actions for asbestos under TSCA section 6(a).
D. How will EPA use the information to be collected?
Reported information will 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 may provide EPA
with baseline information needed to assess whether certain ``conditions
of use'' of asbestos drive unreasonable risk to human 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 will take into consideration
reasonably available information to inform the TSCA Risk Evaluation for
Asbestos Part 2. Data collected by this rule could help to fill
potential data gaps that EPA may have for asbestos that could better
inform the Part 2 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 2 risk
evaluation, which is expected on or before December 1, 2024.
Additionally, the information collected in this rulemaking will help
inform any required risk management actions following the risk
evaluation process.
For these reasons, EPA believes that the reporting and
recordkeeping requirements in this rule are reasonable. See TSCA
section 8(a)(1)(A).
III. Summary of Public Comments on Proposed Rule
EPA received 27 comments on the proposed rule (87 FR 27060, May 6,
2022 (FRL-8632-02-OCSPP)). Of these, seven comments, from certain
industry stakeholders and ADAO, were in whole or in part requests to
extend the comment period, which EPA denied. Three of the comments were
generally supportive of the proposed rulemaking, with the remainder of
the comments being generally adverse. The comments and EPA responses,
as well as a more thorough summary of the comments received, are
presented in the Response to Public Comments document (Ref. 15) that is
available in the docket for this
[[Page 47788]]
rulemaking and summarized in this unit.
The majority of comments on the proposed rule addressed the
economic analysis EPA developed for the proposed rule, with the
majority of commenters stating EPA largely underestimated the burden
the proposed rule would impose. Commenters also suggested the need for
EPA to consider a threshold exemption to reporting, for which nearly
all industry groups expressed support; and wholly exempting asbestos as
an impurity in articles and/or naturally occurring chemical substances.
After considering the public comments, EPA made the following
changes to the EA and rulemaking that are discussed in this unit.
A. How did the estimated number of impacted entities change?
In response to comments received, in its revised EA for the final
rule, EPA estimates the total number of sites subject to this
rulemaking to be 67,647 to 68,505, inclusive of all potentially
affected manufactures and processors subject to this rule, with 186 to
1,044 firms reporting for 268 to 1,126 sites (Ref. 2). This is an
increase of 168 to 1,026 firms and 241 to 1,099 sites from the estimate
for the proposed rule, which did not quantify the number of entities
potentially affected due to the potential presence of asbestos as an
impurity. EPA maintains that use categories where the manufacturing or
processing of asbestos (including asbestos mixtures) or articles
containing asbestos is intended, known, or reasonably foreseen include
chlor-alkali plants, sheeting gasket manufacturing, oilfield brake
blocks, and aftermarket brakes. In response to comments that the number
of estimated entities affected in the proposed rule and EA is
unrealistically or unjustifiably low, as well as identification of
industries that would be likely subject to the rulemaking, EPA has
updated its EA for this rulemaking to estimate the number of affected
entities potentially reporting for asbestos as in impurity (including
impurities present in articles), which were not quantified in the
analysis for the proposed rule. Details on affected entities are
provided in the revised EA, which is available in the public docket for
this rulemaking (Ref. 2).
B. How did the compliance burden associated with the reporting standard
change?
In the proposed rule, EPA was unable to determine the number of
potential manufacturers (including importers) or processors of asbestos
as an impurity in bulk materials or articles that would report due to a
lack of information on the extent to which asbestos occurs as an
impurity in bulk materials or articles. The Agency also recognized that
the universe of entities that would be subject to the rule if finalized
as proposed--particularly with regard to rule familiarization--might be
larger than what the draft EA had estimated. Thus, EPA specifically
sought public comment on the number of manufacturers (including
importers) and processors who may be subject to the proposed rule due
to the presence of asbestos impurities in their products, and on the
related burden and cost for reporting. EPA sought comment on ways to
minimize reporting burden on small manufacturers and processors
pursuant to TSCA section 8(a)(5)(B), such as providing a reporting
threshold based on factors including production volume or asbestos
concentration. EPA received public comment providing additional
information on instances of asbestos being present in very low
concentrations in various products. Therefore, a threshold based on
asbestos concentration or quantity would not satisfy EPA's data needs.
After careful consideration of comments received on the number of
firms that would potentially be subject to the rule (EPA-HQ-OPPT-2021-
0357-0052, EPA-HQ-OPPT-2021-0357-0049), EPA has, based in part on
specific comment and in part on its judgment, revised its EA for the
final rule to estimate the number of firms that may be subject to the
rule because they potentially manufacture or process products
containing asbestos as an impurity, and has revised the total estimated
burden based on that number. At the time of the proposal, EPA estimated
that 27 facilities that were intentionally manufacturing or processing
products containing asbestos would be affected by the rule at an
estimated cost of $99,496 (with a total social cost of $659,839
estimated for the rulemaking, including EPA burden). With the inclusion
of facilities that manufacture or process products containing asbestos
as an impurity, EPA estimates that the rule will affect 96,687 to
97,545 facilities (of which an estimated 268 to 1,126 will submit
reports) at an estimated cost of approximately $319 million to $323
million (with a total social cost estimated to be approximately $320
million to $324 million). More detail on these estimates and related
assumptions and uncertainties are provided in the revised EA for the
final rule (Ref. 2). The increase in estimated total cost from that in
the proposed rule is not driven by an increased compliance or reporting
cost per entity, but is the result of identifying the larger number of
entities that will spend time determining whether they must report for
asbestos present as an impurity. Despite the increased social cost, EPA
estimates that for products where asbestos is used intentionally, the
estimated average burden and cost per site will range from
approximately 12 hours and $1,243 (for secondary processors or
importers of articles or mixtures using Form A) to 26 hours and $2,372
(for bulk importers and primary processors using Form B). For products
where asbestos occurs as an impurity, the estimated average burden and
cost per site will range from approximately 17 hours and $1,674 (for
secondary processors or importers of articles or mixtures using Form A)
to 39 hours and $3,451 (for bulk importers and primary processors using
Form B) and 244 sites are estimated to submit reports. The increased
estimate of social costs in the EA of the final rule reflects the
result of the notice and comment process. These costs reflect an
updated analysis of entities subject to the rule, based on public
comments (EPA-HQ-OPPT-2021-0357-0052, EPA-HQ-OPPT-2021-0357-0049)
received on the proposed rule, rather than substantive changes to
proposed reporting requirements.
C. What changes did EPA make to persons subject to the rule?
TSCA Section 8(a)(5)(B) requires EPA to minimize, to the extent
feasible, the cost of compliance for small manufacturers and
processors, and EPA recognizes that it can alleviate some burden while
continuing to address information needs and ensure that the information
being sought is reported, per the requirements under Section
8(a)(5)(C). While all known or reasonably ascertainable information on
asbestos is of interest to EPA, the Agency recognizes that ultimate
parent companies with comparatively low sales may not have information
on asbestos to submit to EPA and such information is anticipated to be
of much lesser magnitude than submissions provided by entities with
greater sales. EPA received comment (EPA-HQ-OPPT-2021-0357-0046) that
large businesses are more likely than small businesses to have
resources dedicated to collecting information and tracking supply
chains. Small businesses are also more likely to have fewer products or
COUs on which to report. Viewed together, these factors warrant
alleviating the burden of rule familiarization and reporting on some
small businesses for purposes of this
[[Page 47789]]
rule. Further, EPA does not have information to suggest that any of the
smallest entities would have reasonably ascertainable asbestos
information on which to base their reporting or that they would have
information on unique COUs. Such entities, then, would incur rule
familiarization and compliance determination burden without providing
the benefit of submitting data on asbestos. Thus, providing a sales
threshold alleviates the burden of this rule from entities least
positioned to report to the rule. EPA, therefore, has decided to set an
annual sales threshold, when combined with those of their ultimate
parent company (if any), of $500,000, below which manufacturers and
processors are not subject to the requirements of this rulemaking. This
figure represents a sales threshold where most entities throughout
industry sectors that might report on manufacture or processing of
asbestos to this rule remain regulated (i.e., subject to reporting
requirements). EPA estimates that 33,000 to 34,000 otherwise
potentially affected businesses are below the $500,000 sales volume
threshold and thus are not subject to this rulemaking, with the result
that the $500,000 reporting threshold saves small businesses a total of
$138 million to $140 million.
While EPA estimates that between 186 and 1,044 firms will meet the
requirements to submit a report, approximately 67,000 firms with sales
of $500,000 or more will incur average costs of nearly $5,000 for rule
familiarization and compliance determination in order to determine that
they do not need to report. Thus, only 0.3% to 1.5% of large firms
incurring costs due to the rule are estimated to provide data to EPA.
Given that smaller businesses may have fewer resources than large
businesses for collecting information and tracking supply chains, an
even smaller percentage of the 33,000 to 34,000 firms with revenues
under $500,000 would be required to report. Since EPA does not have
information to suggest that the smallest entities would have unique
information on asbestos COUs on which to report, the $500,000 reporting
threshold strikes the appropriate balance between collecting
information on asbestos uses and exposures while minimizing, to the
extent feasible, the cost of compliance for small manufacturers and
processors. Thus, the reporting threshold provides burden relief for
companies where reporting is least anticipated--based on EPA's analysis
and expertise--while minimizing the risk that the Agency is deprived
access to known or reasonably ascertainable information on asbestos.
This change also aligns with the requirement under TSCA Section
8(a)(5)(B) to minimize, to the extent feasible, the cost of compliance
for small manufacturers and processors. Additionally, this change
aligns with TSCA Section 8(a)(5)(C), which directs EPA to apply
reporting obligations to those persons likely to have information
relevant to the effective implementation.
Accordingly, based on EPA's expertise, the Agency anticipates that
making manufacturers and processors with annual sales greater than or
equal to $500,000 (at the ultimate parent company level) subject to the
rulemaking ensures that EPA receives reporting on each industry sector
impacted by the rule, thereby helping to ensure that the Agency
receives information on as many conditions of use as possible involving
asbestos. For purposes of this rulemaking, EPA is not aware of
instances where entities in a given industry sector with annual sales
less than $500,000 (combined with their parent company) are likely to
have information regarding asbestos that other entities (i.e., those
with greater than or equal to $500,000 in annual sales) in the same
sector would not be able to provide pursuant to the reporting standard.
Further, EPA did not receive any comments on the proposed rule that
identified any unique aspects of the smallest entities, thus based on
EPA's analysis and expertise, and for the reasons identified above, EPA
does not believe that such entities are likely to have information on
their manufacturing or processing of asbestos.
D. How did 40 CFR 704.180(e) change for reporting information?
In response to comments received, EPA added in 40 CFR 704.180(e) an
explicit reference to 704.180(d) to clarify that persons exempted in
704.180(d) (i.e., persons who manufacture or propose to manufacture a
non-isolated intermediate, persons who manufacture or processes or
propose to manufacture or process asbestos only in small quantities for
research and development, persons who are small manufacturers and
processors of Libby asbestos, and persons who manufacture or proposes
to manufacture asbestos solely as a byproduct) are not required to
report.
E. How did the definition of and use of ``bulk materials containing
asbestos'' change?
EPA has changed the appearance of ``bulk materials containing
asbestos'' and its variations to ``bulk materials containing asbestos,
including as an impurity'' and its variations throughout the preamble
and regulatory text.
F. How did the references to talc and vermiculite change?
EPA maintains that talc and vermiculite are some examples of the
bulk commodities that may contain asbestos as an impurity. However,
based on comments received, EPA recognizes that its repeated
identification of these specific bulk materials and solely these
materials as examples of such bulk commodities could be misconstrued
and lead to the belief that asbestos impurities in talc and vermiculite
are both unique to and common in these materials. As such, EPA has
changed the phrase to read ``bulk materials where asbestos can be found
as an impurity (e.g., talc, vermiculite, and other substances)'' on
first reference only and ``bulk materials where asbestos can be found
as an impurity'' thereafter.
IV. Summary of Reporting and Recordkeeping Requirements in the Final
Rule
A. What chemical substances are reportable under this rule?
EPA is requiring the reporting of information on specific asbestos
types, 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 requiring 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 product, including as an impurity. This rule broadly covers
asbestos and includes asbestos in the above non-exhaustive list of
examples.
1. Asbestos Types
EPA is seeking manufacturing (including importing) and processing
information associated with the following different fibrous asbestos
types, and therefore is requiring that reporting be completed for each
of the types, to the extent that the information is known or reasonably
ascertainable:
Asbestos--CASRN 1332-21-4;
Chrysotile--CASRN 12001-29-5;
Crocidolite--CASRN 12001-28-4;
Amosite--CASRN 12172-73-5;
Anthophyllite--CASRN 77536-67-5;
Tremolite--CASRN 77536-68-6;
Actinolite--CASRN 77536-66-4; and
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]).
[[Page 47790]]
If a specific asbestos type is unknown, a submitter will provide
information under the general asbestos form (CASRN 1332-21-4). See Unit
II.B. for more information about what is considered asbestos.
2. Asbestos as an Impurity
Impurity means a chemical substance which is unintentionally
present with another chemical substance as per 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
(Ref. 16). If all other reporting conditions are met (i.e., the person
is not exempted and has annual sales above the reporting threshold),
these products are subject to reporting under this rule. EPA is
collecting data on asbestos as an impurity because EPA lacks 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 TSCA Risk Evaluation for Asbestos Part 2 where
EPA will determine and then evaluate the relevant conditions of use of
asbestos.
3. Articles Containing Asbestos
This rule requires reporting on articles containing asbestos
(including as an impurity). An ``article'' is defined in 40 CFR 704.3
as ``a manufactured item which: (1) is formed to a specific shape or
design during manufacture; (2) has end-use function(s) dependent in
whole or in part upon its shape or design during end use; and (3) 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 will collect more data on imported
articles containing asbestos; these data could inform the TSCA Risk
Evaluation for Asbestos Part 2 where EPA will determine and then
evaluate the relevant conditions of use of such articles containing
asbestos. Articles included in the TSCA Risk Evaluation for Asbestos
Part 1: Chrysotile Asbestos were limited to 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.
17); EPA is interested in identifying if there are other articles
containing asbestos or if there is information about specific types of
asbestos in these articles.
4. Asbestos That Is a Component of a Mixture
Under TSCA section 3(10) (15 U.S.C. 2602(10)), the term ``mixture''
is defined as ``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.'' Under this
reporting rule, EPA will collect data on asbestos in circumstances
where it is a component of a mixture to inform the TSCA Risk Evaluation
for Asbestos Part 2. In the Part 2 risk evaluation, EPA will determine
the relevant conditions of use of asbestos.
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. 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 importers) 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 rule
(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 these types of asbestos may not be 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, small manufacturers and processors of Libby amphibole
asbestos continue to be exempted from reporting.
EPA's experience with the TSCA Risk Evaluation for Asbestos Part 1:
Chrysotile Asbestos indicates that small businesses (as defined by the
Small Business Administration's size standards) are involved in 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 TSCA Risk
Evaluation for Asbestos Part 2 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
[[Page 47791]]
risk evaluation or risk management activities. As a result, EPA is
requiring 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, as
necessary, report under this action.
Based on comments received, EPA determined that it can alleviate
some burden while continuing to address information needs and ensure
that the information being sought is reported. EPA, therefore, has
decided to set an annual sales threshold, when combined with those of
their ultimate parent company (if any) of $500,000, below which
manufacturers (including importers) and processors are not subject to
the requirements of this rulemaking. The burden reduction includes
eliminating rule familiarization, form completion, CBI substantiation,
electronic reporting, and recordkeeping requirements for such entities.
This change aligns with the requirement under TSCA Section 8(a)(5)(B)
to minimize, to the extent feasible, the cost of compliance for small
manufacturers (including importers) and processors while ensuring that,
pursuant to TSCA Section 8(a)(1), the submission of reports and
maintenance of records is necessary for the effective enforcement of
TSCA. EPA believes that making manufacturers (including importers) and
processors with annual sales equal to or greater than $500,000 (at the
ultimate parent company level) subject to the rulemaking ensures that
EPA receives reporting on each industry sector impacted by the rule,
thereby helping to ensure that the Agency receives information on as
many COUs as possible involving asbestos. EPA is not aware of instances
where entities in a given industry sector with sales lower than
$500,000 are likely to have information that other entities (i.e.,
those with equal to or greater than $500,000 in sales) in the same
sector would not be able to provide pursuant to the reporting standard.
This aligns with the requirement under TSCA Section 8(a)(5)(C) to
apply, to the extent feasible, reporting obligations to those persons
likely to have information relevant to the effective implementation of
Title 1 of TSCA.
EPA believes a threshold based on sales will ensure that
representative entities within each industry sector will provide
information to EPA regarding their knowledge of asbestos in their
products as required (i.e., when information on the presence or
quantity of asbestos in their products is known to or reasonably
ascertainable by them). For sectors with varying product lines, EPA
expects that entities with sales equal to or greater than $500,000 will
generally have more products and thus will fairly represent what is
known about the presence of asbestos in such sectors for purposes of
providing information to the Agency. This sales-based threshold also
serves as a proxy for a volume-based threshold (i.e., reporting
contingent on manufacturing or processing more than a certain quantity
during any year of the reporting period) or a quantity- or
concentration-based (i.e., de minimis) threshold, which many commenters
supported. EPA recognizes that certain companies with sales less than
$500,000 may possess relevant information; however, the Agency
anticipates that equivalent information would be known to or reasonably
ascertainable by entities with greater sales, given what commenters
(EPA-HQ-OPPT-2021-0357-0050, EPA-HQ-OPPT-2021-0357-0051) have stated to
be a general lack of information being provided by large manufacturers
(including importers) and suppliers on the presence of asbestos in
materials provided to smaller downstream entities. Therefore, EPA would
receive information on asbestos involving the given sector, which will
inform the Agency's activities under TSCA section 6, as well as
increase information on asbestos that is generally available. Further,
EPA's analysis of industry sectors indicates that this threshold will
ensure that representative sites of every particular sector are subject
to the rulemaking requirements such that COUs unique to any sector(s)
are included.
As noted previously, EPA has determined that it needs certain
information from small businesses for the effective implementation of
TSCA, therefore is not exempting all small businesses from this rule.
The smallest annual sales-based small business size standard is $2.25
million and the largest is $47 million (13 CFR 121.201). Therefore,
while the $500,000 annual sales threshold will limit information
collected from the smallest subset of these companies, whom EPA does
not anticipate would be likely to know or reasonably ascertain that
they have manufactured or processed asbestos, it does not broadly
exclude all small businesses. EPA anticipates larger firms are more
likely to know or reasonably ascertain that they have manufactured or
processed asbestos.
EPA will use the small manufacturer (including importer) definition
already established at 40 CFR 704.3. Thus, any entity manufacturing
(including importing) Libby amphibole asbestos is 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 definition for small manufacturer (including importer) in the
general TSCA section 8 regulations, as written in the Small
manufacturer and Small government definitions (40 CFR 704.3), applies
to domestic manufacturers and importers, but does not cover processors.
Therefore, EPA is using a definition for small processors functionally
identical to that established in 40 CFR 704.20--Chemical substances
manufactured or processed at the nanoscale (Ref. 18) which was
prescribed after consultation with SBA. Likewise, in proposing this
modified definition for this one-time reporting rule, EPA provided
notice and comment on the criteria for small processors and consulted
with the SBA in accordance with TSCA section 8(a)(3)(B). Comments
received and responses thereof are provided in Response to Public
Comments document (Ref. 15).
EPA is finalizing the slightly modified version of the nanoscale
definition for small processors because it is most similar to the
general small manufacturing (including importing) definition already
promulgated. The definition for this rulemaking states: ``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 for this asbestos rulemaking
to $12 million to align with the non-
[[Page 47792]]
volume portion of the TSCA small manufacturer definition in 40 CFR
704.3, which 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 is not 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.
C. What is the reporting standard?
This rule uses 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'' per 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 to 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 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 rule will be familiar with this
reporting standard, and resources are available to support those
submitters who may not be familiar with the standard. In response to
public comments, EPA will provide such guidance and a compliance guide.
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 may
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. See
section A.2.2 of the Response to Comments document for further
discussion of the reporting standard.
D. When is reporting required?
This rulemaking results in a one-time reporting obligation. EPA
requires reporting for persons who have manufactured (including
imported) or processed asbestos, including as an impurity in bulk
materials or products, at any time during the four complete calendar
years prior to the effective date of the final rule. The four calendar
years are 2019 to 2022. These entities will report to EPA during a
three-month submission period, which will begin six months following
the effective date of the final rule. Therefore, manufacturers
(including importers) and processors have up to nine months following
the effective date of this 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 allows 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)(1) reporting rule
results in the collection of similar information to that collected
under CDR, EPA anticipates some submitters will be familiar with the
types of information requested and how to report. EPA received several
comments on the proposed rule requesting that the reporting deadline be
extended by as much as 18 months. EPA evaluated these comments and
determined that three months is adequate time for submissions, in
addition to the six-month period between the effective date and the
start of the submission period. This period (i.e., reporting due by
nine months after the effective date of the rule) deadline is
commensurate with the estimated time needed to obtain and report the
data that this rulemaking requires. Further, ensuring prompt reporting
of these data is necessary to inform EPA's TSCA risk evaluation and
risk management activities involving asbestos.
E. How is information being reported?
EPA is establishing 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, a threshold
concentration for reporting might eliminate much of the information
that may be useful to support EPA's TSCA risk evaluation and risk
management efforts. Therefore, EPA
[[Page 47793]]
is requiring reporting 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 quantity of the asbestos in their products because the
percentage of asbestos in their products is not known to or reasonably
ascertainable by them. For those situations, EPA is providing a short
form (Form A) for attestation purposes. For other situations,
submitters who can determine or estimate the quantity will 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. Because the reporting this
rulemaking requires will be electronic, both Form A and Form B are
integrated into a single reporting tool application; preparers will be
prompted to provide additional Form B data when they indicate they know
or are able to provide a reasonable estimate of the quantity of
asbestos.
1. Determining the Need To Report Using Form A
Submitters who are aware of asbestos in their product, but who are
unable to determine or estimate the quantity manufactured (including
imported) or processed, will use Form A to provide a subset of the
information required on Form B. This subset of information consists 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 known or reasonably ascertainable information regarding of
asbestos manufacturing (including importing) and processing in the
United States. Therefore, EPA is requiring a reporting approach that
will ensure that even circumstances where asbestos exists in unknown
quantities are captured. Some entities manufacturing (including
importing) or processing asbestos as a component of a mixture or
articles containing asbestos (including as an impurity) (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 including the short form (Form A)
for such entities that are aware of presence 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 IV.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 requires 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
of asbestos is close to a given quantity, they are required to report
that quantity using Form B.
Form B requires specific quantity information per asbestos type,
more detailed processing information, and employee information
(including employee exposure information). For a more detailed
discussion on specifics included in Form B, see Unit IV.F.
F. What information will be reported in Form A and Form B?
EPA is requiring certain information to be reported in either Form
A or Form B. Unit IV.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 (i.e., extracted) or milled (e.g., crushed,
grinded) bulk asbestos and bulk material containing 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 requiring that both Form A and B 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 from EPA. Specifically, EPA
is requiring that submitters report the following information (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 will identify the activity for which they
are reporting, selecting from the list provided in 40 CFR
704.180(e)(4)(i). If more than one activity applies, the submitter will
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-containing ore. Mined (i.e., 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 United States. EPA
anticipates that companies who are mining, milling, or importing bulk
asbestos will report using Form B, because the volume of asbestos is
likely known to or reasonably ascertainable by them.
For companies that are mining, milling, or importing bulk materials
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 quantity of asbestos in their bulk material. EPA does not
anticipate that asbestos is produced without a separate commercial
intent during the manufacture, processing, use, or disposal of another
chemical substance or mixture (see 40 CFR 704.3). Thus, EPA has not
lifted the general reporting exemption for persons who manufacture,
import, or proposes to manufacture or import asbestos solely as a
byproduct (see 40 CFR 704.5(b)).
Specifically, EPA is requiring that sites involved in mining,
milling, or importing asbestos or bulk materials containing asbestos,
including as an impurity, report certain information associated with
those activities, as listed in 40 CFR 704.180(e)(4)(ii) and (iii), and
(e)(5). All submitters will report the applicable asbestos type
associated with the mining, milling, or importing activity. Submitters
who import asbestos or bulk materials containing asbestos, including as
an impurity into the United States, but do not receive it at their
physical location (i.e., the material is instead received directly by a
customer) can indicate such material was never physically present at
the site of the importer, if appropriate.
[[Page 47794]]
a. Bulk asbestos. In addition, EPA is requiring 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 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 disposed of. EPA is requiring that a
site selecting ``Disposed of within the U.S.'' provides additional
explanation to indicate the quantity and type of disposal (e.g.,
disposed in a landfill).
b. Bulk materials containing asbestos, including as an impurity.
EPA is requiring that sites involved in mining, milling, or importing
bulk materials containing asbestos, including as an impurity, 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 types of asbestos. If a specific
asbestos type is unknown, a submitter will provide information under
the general asbestos form (CASRN 1332-21-4) (Form B only);
Information describing how the amount of asbestos in the
bulk material is known (Form B only); and
The disposition of the bulk material as described in Unit
IV.F.2.a.
3. Primary Processors of Asbestos (Processing Bulk Material, Other Than
Milling), Including as an Impurity
A primary processor starts with bulk asbestos or bulk materials
containing asbestos, including as an impurity and makes a mixture that
contains asbestos as a component. 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 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, including as an impurity, may report
using either Form A or Form B.
EPA is requiring 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 40 CFR 704.180(e)(4)(iv)(B)). For each
product type, report by year:
The most specific types of asbestos (Form B only);
The total annual production quantity of end product, using
the unit of measure as listed in Table 4 in 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 the presence,
amount, and type of asbestos is known (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 IV.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 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 requiring 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 40 CFR
704.180(e)(4)(iv)(B)). For each product type, report by year:
The most specific types 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 40 CFR704.180(e)(4)(iv)(B);
The percentage of asbestos in the end product (Form B
only);
If the asbestos content is an impurity, how the presence,
amount, and type of asbestos is known (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 IV.F.2.a.
5. Importation of Asbestos as a Component of a Mixture or Article That
Contains Asbestos, Including as an Impurity
An importer of asbestos contained in a mixture or article that
contain asbestos, including as an impurity, imports these substances
into the customs territory of the United States.
EPA anticipates that an importer of articles and/or products may
report using either Form A or Form B. EPA is requiring 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 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 types of asbestos and the quantity of
each asbestos type (Form B only);
The total annual import quantity of the imported product,
using the unit of measure as listed in Table 4 of 40 CFR
704.180(e)(4)(iv)(B);
The percentage of asbestos in the imported product (Form B
only);
Information about how the presence, amount, and type of
asbestos is known (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 IV.F.2.a.
Submitters who import asbestos as a component of a mixture or an
article that contains asbestos, including as an impurity can indicate
such material was never physically present at the site of the importer,
if appropriate.
6. Employee Information
For each activity reported, EPA is requiring that submitters also
report certain information about the number of employees involved with
the activity. Specifically, EPA is requiring 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
[[Page 47795]]
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 final rule?
When evaluating which data elements to include in this final rule,
EPA also considered potentially requiring reporting on additional
information related to current employee exposures, wastewater
treatment, disposal information, and customer sites. EPA specifically
sought comment on if additional data elements should be required, and
the majority of commenters were not supportive of additional data
element. EPA chose not to include these additional data elements in
this final rule in the interest of maintaining a manageable level of
burden for reporting entities. EPA also believes that the data elements
described in Unit IV.F. will provide sufficient information for use by
EPA and other Federal agencies in potential actions involving asbestos,
including EPA's TSCA risk evaluation and risk management activities.
1. 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 requiring
that a site reporting ``Disposed of within the U.S.'' in response to
Table 3 must 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 final rule beyond the disposal explanation that will
be included in response to reporting ``Disposed of within the U.S.'' in
response to Table 3.
2. 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 final rule.
3. Customer Sites Data
EPA also considered requiring additional information about the
number of customers respondents have. For the reasons described
previously, EPA is not including reporting on these additional data
elements in this final rule; however, EPA is requiring manufacturers
(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 will information be submitted to EPA?
EPA is requiring electronic reporting similar to the requirements
established in 2013 for submitting other information under TSCA (see 40
CFR 704.20(e)). EPA is requiring that submitters 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, December 4, 2013
(FRL-9394-6)). The final rule followed two previous rules requiring
similar electronic reporting of information submitted to EPA for TSCA
CDR and for premanufacture notices (PMNs). By requiring 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 requiring that submitters 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) 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 are 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
[[Page 47796]]
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 rule are 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 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 is confidential information treated?
In a separate rulemaking, EPA proposed new provisions concerning
the assertion and treatment of CBI claims for information reported to
or otherwise obtained by EPA under TSCA (87 FR 29078, May 12, 2022
(FRL-8223-01-OCSPP)). Unless otherwise stated in specific TSCA
regulations, 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 requiring in 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 providing that certain
data elements cannot be claimed as confidential:
Site NAICS code in 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 40
CFR 704.180(h)(1)(ii)(B)), because the chemical identities are listed
in the asbestos definition in 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 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 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 40 CFR
704.180(h)(1)(ii)(D)(1)-(3). The electronic reporting tool described in
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 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 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 this rule, CBI
claims for specific production or import volumes of the manufacturer
need not be substantiated, as identified in 40 CFR 704.180(h)(2)(iv).
For all other information submitted under this rule, submitters are
required to substantiate their confidentiality claims at the time of
submission. Substantiation questions are listed in 40 CFR
704.180(h)(2)(iii) and will be incorporated into the electronic
reporting tool identified in 40 CFR 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 mixture.'' The workplace exposure
measurement data listed in 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 as provided in 40 CFR
704.180(h)(1)(ii)(D)(1)-(3) in health and safety studies will be
required to submit a sanitized copy of the study, removing only that
information which is claimed as confidential. See 40 CFR
704.180(h)(1)(ii)(D) for additional information regarding health and
safety studies and 40 CFR 704.180(h)(2)(vi)) regarding public copies.
J. What are the recordkeeping requirements?
EPA is requiring 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
[[Page 47797]]
officials. Consistent with the CDR rule, EPA is requiring 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
associated Agency activities are completed. Further, EPA believes the
burden of retaining these records, which are likely electronic, is
minimal.
As demonstrated by the different reporting and recordkeeping
requirements in this rulemaking and the structure of this rule in
addressing them independently, EPA generally intends the rule's
provisions to be severable from each other. As such, to the extent that
any portion of this rule is declared invalid, EPA intends those
provisions to be severable and the remaining provisions continue to be
valid.
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 TSCA Section 8(a) Reporting
and Recordkeeping Requirements for Asbestos. June 2023.
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.
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,
2021. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf.
8. EPA.Determining If You Are a Manufacturer or Importer for
Reporting 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. EPA. Response to Public Comments on Proposed Rule. Asbestos;
Reporting and Recordkeeping Requirements Under the Toxics Substances
Control Act (TSCA).U.S. Environmental Protection Agency, Office of
Chemical Safety and Pollution Prevention (OCSPP), Washington, DC.
RIN 2070-AK99. June 2023.
16. Occupational Safety and Health Administration (OSHA). OSHA
Occupational Chemical Database, Talc (Containing Asbestos). United
States Department of Labor. https://www.osha.gov/chemicaldata/276.
17. U.S. Geological Survey (USGS). Asbestos Statistics and
Information: Mineral Commodity Summaries. 2021. https://pubs.usgs.gov/periodicals/mcs2021/mcs2021-asbestos.pdf.
18. EPA. Final Rule; Chemical Substances When Manufactured or
Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping
Requirements [40 CFR part 704]. Federal Register. 82 FR 3641,
January 12, 2017 (FRL-9957-81).
19. EPA. Information Collection Request (ICR) for the TSCA Section
8(a) Reporting and Recordkeeping Requirements for Asbestos (Final
Rule; RIN 2070-AK99). EPA ICR No. 2711.02 and OMB No. 2070-0222.
June 2023.
20. EPA. Unfunded Mandates Reform Act Statement. Asbestos; Reporting
and Recordkeeping Requirements under the Toxic Substances Control
Act (TSCA); Final. February 2023.
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 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'', as defined
under section 3(f)(1) of Executive Order 12866, as amended by Executive
Order 14094. Accordingly, EPA, submitted this action to the Office of
Management and Budget (OMB) for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. EPA prepared an economic
analysis of the potential costs and benefits associated with this
action (Ref. 2), which is
[[Page 47798]]
summarized in Unit I.E. and available in the docket.
B. Paperwork Reduction Act (PRA)
The information collection requirements in this rule will be
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2711.02 (Ref. 19) and the OMB Control No.
2070-0222. You can find a copy of the ICR document in the docket for
this action, and it is briefly summarized here. The information
collection requirements are not enforceable until OMB approves them.
The information collection activities in the rule include a one-
time reporting by companies that manufacture (including import) or
process asbestos of certain information to EPA and the requirement to
maintain corresponding records.
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 human 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).
Understanding the health risks of asbestos and protecting the public
and potentially exposed or susceptible subpopulations from these risks
is a priority for EPA. Data collected by this rule could help to fill
data gaps that EPA may have in exposure 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 to health or the environment.
EPA needs to ensure that sufficient information is reasonably available
on the uses and trends of asbestos activities to conduct the asbestos
Part 2 Risk Evaluation, and if the Agency determines asbestos presents
unreasonable risk based on that risk evaluation, then develop a risk
management rule that would address any unreasonable risk.
TSCA section 14 imposes requirements for the assertion,
substantiation, and review of information that is claimed as
confidential under TSCA. Some information submitted at the time of the
reporting under this rule may be claimed as confidential.
Respondents/affected entities: Asbestos manufacturers (including
importers) and processors. See also Unit I.A.
Respondent obligation to respond: Mandatory. TSCA section 8(a) and
40 CFR 704.180.
Frequency of response: One time.
Total estimated number of respondents: 375.
Total estimated number of responses: 375.
Total estimated burden: 1.5 million hours (per year average).
Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $107.7 million (per year average), 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 for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this 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, in
an article, and as an impurity in any of the four full calendar years
prior to the effective date of this rule. The Agency has determined
that approximately 66,000 small firms may be affected by the rule. In
the proposed rule, because EPA did not estimate the number of
manufacturers or processors of impurities, EPA estimated that 15 small
businesses would be affected. The total cost to small businesses is
$279 million to $283 million, essentially all of which is an increase
compared to the estimates for the proposed rule (since EPA did not
estimate the number of manufacturers or processors of impurities at the
proposed rule stage). There are 32,000 to 33,000 small businesses that
are not subject to this rule because their revenues are less than
$500,000. (The range is based on the potential number of firms that
otherwise would have reported for importing aftermarket automotive
brakes in the absence of the $500,000 threshold.) The $500,000
reporting threshold saves small businesses a total of $138 million to
$140 million.
Costs to small businesses range from $4,430 per firm (for firms
reporting on products that intentionally contain asbestos) to $11,273
per firm (for firms reporting on asbestos present as an impurity). Of
small firms affected by the rule, 99.93 percent are expected to have
cost impacts of less than 1% of annual revenues, 0.07 percent are
expected to have impacts between 1-3 percent, and none are expected to
have impacts of more than 3 percent of annual revenues. Details of this
analysis are presented in the Economic Analysis (Ref. 2).
One small oilfield brake block importer, 2 small gasket
manufacturers, and 9 to 849 small firms in the aftermarket automotive
brake industry are predicted to report. The average cost for these
small firms is $4,430, as shown in Table 7-14 of the Economic Analysis
(Ref. 2). The cost impact to these firms is less than 1% of revenues,
which does not represent a significant impact on these small firms.
As shown in Table 7-14 of the Economic Analysis (Ref. 2), 166 small
firms are predicted to report for asbestos present as an impurity, at
an average cost of $11,273. Of these firms, 118 have a cost impact of
less than 1% of revenues and 48 have a cost impact between 1% and 3% of
revenues. This does not represent a significant impact on these small
firms.
Table 7-14 of the Economic Analysis (Ref. 2) also indicates that
there are 65,335 small firms estimated to conduct compliance
determination for asbestos as an impurity but not submit a report,
incurring an average cost of $4,703. All of these firms have cost
impacts of less than 1% of revenues, and thus do not incur significant
impacts.
D. Unfunded Mandates Reform Act (UMRA)
This action contains a federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for
state, local and tribal governments, in the aggregate, or for the
private sector in any one year. Accordingly, the EPA has prepared a
written statement (Ref. 20) as required under UMRA section 202 that is
included in the docket for this action and is briefly summarized here.
1. Authorizing Legislation. This rule is issued under the authority
of TSCA section 8(a)(1), 15 U.S.C. 2607 (a)(1).
2. Benefit-Cost Analysis. EPA has prepared an economic analysis to
[[Page 47799]]
evaluate, among other things, the benefits and costs of this rule (Ref.
2). The rule is calculated to result in a total one-time cost to the
private sector of $319 million to $323 million. When adjusted for
inflation, the $100 million UMRA threshold is equivalent to
approximately $170 million. Thus, the cost of the rule to the private
sector in the aggregate exceeds the inflation-adjusted UMRA threshold.
Because this is an information-collecting rule, EPA is not able to
quantitatively measure the associated benefits. However, the rule may
supply information on asbestos to which Federal agencies (and the
public) do not currently have access. By enhancing the data supplied to
risk-screening and risk-management programs, EPA expects to more
effectively and expeditiously evaluate and manage any potential
unreasonable risk posed by asbestos. The more EPA can base its
decisions on actual data rather than on assumptions, the better EPA is
able to tailor its risk management decisions to the level of actual
risk, whether higher or lower than it would be if based on assumptions
alone. Ultimately, enhancing the risk evaluation process will have
positive consequences for human health and the environment and may
enable a more efficient allocation of EPA's and society's resources.
3. Impacts on State, local, and Tribal governments. This rule does
not contain a significant Federal intergovernmental mandate because it
neither imposes enforceable duties on State, local, or Tribal
governments nor reduces an authorized amount of Federal financial
assistance provided to State, local, or tribal governments. This rule
contains no regulatory requirements that might significantly or
uniquely affect small governments. The rule would require reporting
from certain persons who manufactured (including imported) or processed
asbestos and asbestos-containing articles (including as an impurity and
as a component of a mixture). Governments do not typically engage in
these activities, so State, local, and tribal government entities are
not expected to be subject to the rule's requirements. This action is
not subject to the requirements of UMRA section 203 because it contains
no regulatory requirements that might significantly or uniquely affect
small governments.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999) because it will
not have substantial direct effects on 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.
Thus, Executive Order 13175 does not apply to this action.
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) because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. It does not have substantial direct
effects on tribal government because EPA does not anticipate that
asbestos was manufactured (including imported) or processed by tribes
so this rulemaking is not expected to impose substantial direct
compliance costs on tribal governments. Thus, Executive Order 13175
does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying 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 Executive Order 13045. This
action is not subject to Executive Order 13045, because it does not
concern an environmental health or safety risk. Since this action does
not concern human health, EPA's Policy on Children's Health also does
not apply.
Although this action does not concern an environmental health or
safety risk, this one-time data collection will provide information
that will be used to support the ongoing EPA risk evaluation of
asbestos under TSCA, among other activities. The purpose of a TSCA risk
evaluation is to determine whether a chemical substance presents an
unreasonable risk to health or the environment, under the conditions of
use, including an unreasonable risk to a relevant potentially exposed
or susceptible subpopulation. As required by TSCA section (6)(b), EPA
established a process to conduct these risk evaluations, see the final
rule entitled ``Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act'' (82 FR 33726, July 20, 2017
(FRL-9964-38)) (Risk Evaluation Rule). Pursuant to TSCA and the Risk
Evaluation Rule, as part of the risk evaluation process, EPA must (1)
evaluate both hazard and exposure, (2) exclude consideration of costs
or other non-risk factors, (3) use scientific information and
approaches in a manner that is consistent with the requirements in TSCA
for the best available science, and (4) ensure decisions are based on
the weight-of-scientific-evidence. EPA also believes that the
information obtained as a result of this one-time data collection could
also be used by the public, government agencies and others to identify
potential problems, set priorities, and take appropriate steps to
reduce any potential human health or environmental risks identified in
the TSCA risk evaluation.
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'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy. Further, we have concluded that this action is not
likely to have any adverse effect on the supply, distribution or use of
energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards under the
NTTAA section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or Indigenous
peoples) and low-income populations.
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on people of color, low-
income populations and/or Indigenous peoples. As explained in Unit
II.B., asbestos
[[Page 47800]]
exposure is a hazard to human health. This action establishes a one-
time reporting requirement for asbestos that requires companies to
report to EPA certain exposure-related information known to or
reasonably ascertainable by those entities as discussed in detail in
Unit IV.F. At this time, EPA is not able to provide an assessment of
potential exposures that may be identified as a result of the one-time
reporting requirement in this rule and thus cannot determine whether
the human health or environmental conditions that exist prior to this
action have the potential to result in disproportionate and adverse
effects on people of color, low-income populations and/or Indigenous
peoples. This action establishes a one-time reporting requirement and
would not change any existing disproportionate and adverse effects on
people of color, low-income populations and/or Indigenous peoples.
The information obtained as a result of this action may be used to
support the ongoing EPA risk evaluation for asbestos, which may result
in risk management activities. EPA also believes that the information
obtained as a result of this action could be used by the public
(including people of color, low-income populations and/or Indigenous
peoples) to inform their behavior as it relates to sources of asbestos
exposure or by government agencies and others to identify potential
problems, set priorities, and take appropriate steps to reduce any
potential human health or environmental risks.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 704
Chemicals, Confidential business information, Environmental
protection, Hazardous substances, Reporting and recordkeeping
requirements.
Dated: June 30, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons set forth in the preamble, EPA is
amending 40 CFR chapter I, Subchapter R 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. Amend subpart B by adding Sec. 704.180 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 (a).
Table 1 to Paragraph (a)--CASRN of Asbestos Types
------------------------------------------------------------------------
CASRN Asbestos type
------------------------------------------------------------------------
1332-21-4..................... Asbestos.
12001-29-5.................... Chrysotile.
12001-28-4.................... Crocidolite.
12172-73-5.................... Amosite.
77536-67-5.................... Anthophyllite.
77536-68-6.................... Tremolite.
77536-66-4.................... Actinolite.
NA............................ Libby amphibole asbestos (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 an impurity.
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 who 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) of this section 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 who 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) of this section and know or can
reasonably ascertain how much asbestos they manufactured (including
imported) or produced.
Primary processor means a person who starts with bulk asbestos or
bulk materials containing asbestos, and makes a mixture that contains
asbestos as a component.
Secondary processor means a person who further processes asbestos,
after primary processing of asbestos is completed, including 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, in
an article and/or product, as an impurity, or as a component of a
mixture.
(c) Persons who must report. Persons (i.e., plant sites) who have
manufactured (including imported), or processed asbestos, including
asbestos as a component of a mixture, asbestos in articles, or asbestos
as an impurity in the four full calendar years prior to the effective
date of this rule, and with annual sales greater than or equal to
[[Page 47801]]
$500,000, in any calendar year from 2019 to 2022, when combined with
those of their ultimate parent company (if any), must report under this
subpart.
(d) Persons exempt from reporting. A person who is subject to
reporting requirements pursuant to paragraph (c) of this section 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
(d).
(1) Non-isolated intermediate. A person who manufactures or
proposes to manufacture asbestos, as described in paragraph (c) of this
section, 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) of this section, 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 Libby amphibole asbestos
only.
(4) Byproducts. A person who manufactures (including imports) or
proposes to manufacture (including import) asbestos solely as a
byproduct is exempt from the reporting requirements of this subpart.
(e) Reporting information to EPA. Persons described in paragraph
(c) of this section and not described and exempted in paragraph (d) 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 are not known or are 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, including as a component of a mixture or
article, or as an impurity, 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, including as a component of a
mixture or article, or as an impurity.
(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 definition
of ``site,'' which includes what ``site'' means 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)(2) of
this section, 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.
(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 (e) and report the corresponding code (i.e., W1 through
W8):
Table 2 to Paragraph (e)--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,
including as an impurity.
(B) Milling of bulk asbestos or bulk materials containing asbestos,
including as an impurity.
(C) Importing of bulk asbestos or bulk materials containing
asbestos, including as an impurity.
(1) For importing only. For importing only, if the imported bulk
material was never physically present at the reporting site.
(2) [Reserved]
(D) Primary processing of bulk asbestos or bulk materials
containing asbestos, including as an impurity.
(E) Secondary processing of asbestos, including as a component of a
mixture, or an article containing asbestos.
(F) Importing of asbestos, including as a component of a mixture,
or an article containing asbestos.
(ii) For importing only. For importing only, if the imported bulk
material was never physically present at the reporting site.
(iii) Form B only. For mining, milling, or importing of bulk
asbestos reported under activity in paragraphs (e)(4)(i)(A) through (C)
of this section, 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) Report. For each asbestos type, report the following:
(1) Quantity of asbestos, in pounds.
(2) Disposition of asbestos (see Table 3 to this paragraph (e)).
[[Page 47802]]
Table 3 to Paragraph (e)--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).
------------------------------------------------------------------------
(iv) Reporting information for mining, milling, or importing of
bulk materials containing asbestos, including as an impurity. For
mining, milling, or importing of bulk materials containing asbestos
reported under the activity identified in paragraphs (e)(4)(i)(A)
through (C) of this section, report by year:
(A) Bulk material type manufactured or processed.
(B) For Form B only, for each bulk material type:
(1) Quantity of bulk material manufactured or processed.
(2) Percent asbestos impurity by weight in bulk material.
(3) The most specific asbestos type that applies. Select from among
the asbestos types listed in Table 1 to 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 of this paragraph (e)).
(D) For importing only, if the imported bulk material was never
physically present at the reporting site.
(v) 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 of
this paragraph (e). 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 types that apply.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos types are not known or
reasonably ascertainable, report the general listing, ``asbestos CASRN
1332-21-4''. Report also the total annual quantity of each of the
asbestos types processed.
(2) The total annual production quantity of end products produced,
using the associated unit of measure listed in Table 4 of this
paragraph (e). 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 of this paragraph (e)).
(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 to Paragraph (e)--End Product Types
------------------------------------------------------------------------
End product unit of
Code Name measure
------------------------------------------------------------------------
Papers, Felts, and Related Products
------------------------------------------------------------------------
01.......................... Commercial paper.... Short Tons.
02.......................... Rollerboard......... Short Tons.
03.......................... Millboard........... Short Tons.
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).
------------------------------------------------------------------------
[[Page 47803]]
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).
------------------------------------------------------------------------
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.
[[Page 47804]]
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.
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.
[[Page 47805]]
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, humidifiers
and filing cabinets.
144......................... Phonograph records.. Pieces.
145......................... Pottery clay........ Pounds.
146......................... Welding rod coatings Pieces.
147......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
(vi) Reporting information for secondary processors. For secondary
processing reported under the activity identified in paragraph
(e)(4)(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 of this paragraph (e). For
each product type, report:
(1) For Form B only, the most specific asbestos types that apply.
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 each type of asbestos.
(2) The total annual production quantity of the end products
produced, using the associated unit of measure listed in Table 4 of
this paragraph (e).
(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 of this paragraph (e)).
(vii) Reporting information for importers. For importing reported
under an 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 of this paragraph (e)). 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 types that apply.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If a specific asbestos type is not known or reasonably
ascertainable, report the general listing, ``asbestos CASRN 1332-21-
4''. Also report the quantity of each asbestos type.
(3) The total annual import quantity of the imported product, using
the associated unit of measure listed in Table 4 of this paragraph (e).
(4) Whether the imported asbestos was never physically present at
the reporting site.
(5) For Form B only, the percentage of asbestos in the product.
(6) 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.
(7) For Form B only, the disposition of the imported product (see
Table 3 of this paragraph (e)).
(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 of this paragraph (e) 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
[[Page 47806]]
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: I have taken
reasonable measures to protect the confidentiality of the
information; I have determined that the information is not required
to be disclosed or otherwise made available to the public under any
other Federal law; 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 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)(iv) 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) of this section, 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.
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)(iii)(B)(1), (iv)(B)(1), (v)(A),
(v)(B)(2), (vi)(A), (vi)(B)(2), (vii)(A), and (vii)(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. 2023-14405 Filed 7-24-23; 8:45 am]
BILLING CODE 6560-50-P