[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Proposed Rules]
[Pages 26922-26933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12513]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2018-0159; FRL-9978-76]
RIN 2070-AK45
Asbestos; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing a significant new use rule (SNUR) for asbestos as defined
under the Asbestos Hazard Emergency Response Act. The proposed
significant new use of asbestos (including as part of an article) is
manufacturing (including importing) or processing for certain uses
identified by EPA as no longer ongoing. The Agency has found no
information indicating that the following uses are ongoing, and
therefore, the following uses are subject to this proposed SNUR:
Adhesives, sealants, and roof and non-roof coatings; arc chutes;
beater-add gaskets; extruded sealant tape and other tape; filler for
acetylene cylinders; high-grade electrical paper; millboard; missile
liner; pipeline wrap; reinforced plastics; roofing felt; separators in
fuel cells and batteries; vinyl-asbestos floor tile; and any other
building material (other than cement). Persons subject to the SNUR
would be required to notify EPA at least 90 days before commencing any
manufacturing (including importing) or processing of asbestos
(including as part of an article) for a significant new use. The
required notification initiates EPA's evaluation of the conditions of
use associated with the intended use within the applicable review
period. Manufacturing (including importing) and processing (including
as part of an article) for the significant new use may not commence
until EPA has conducted a review of the notice, made an appropriate
determination on the notice, and taken such actions as are required in
association with that determination.
DATES: Comments must be received on or before August 10, 2018.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0159, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Robert Courtnage, National
Program Chemicals Division (Mail Code 7404T), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-1081; 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. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, or distribute in commerce asbestos as
defined by TSCA Title II, Section 202 (15 U.S.C. 2642) (including as
part of an article). The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
Construction (NAICS code 23)
Manufacturing (NAICS codes 31-33)
Wholesale Trade (NAICS code 42)
[[Page 26923]]
Transportation (NAICS code 48)
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA (15
U.S.C.2601 et seq.). Persons who import or process any chemical
substance governed by a final SNUR are subject to the TSCA section 13
(15 U.S.C. 2612) import certification requirements and the
corresponding regulations at 19 CFR 12.118 through 12.127 (see also 19
CFR 127.28). Those persons must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA, including any SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B.
In addition, asbestos, as defined in this proposed rule, is already
subject to TSCA section 6(a) (40 CFR part 763, subparts G and I) rules
that trigger the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b); see also 40 CFR 721.20). Any person who exports or
intends to export asbestos must comply with the export notification
requirements in 40 CFR part 707, subpart D; however, although EPA is
proposing to make inapplicable the exemption at 40 CFR 721.45(f) for
persons who import or process any asbestos as part of an article in a
category listed in Table 2, the Agency is not proposing to require
export notification for articles containing asbestos.
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2) (see
Unit IV). Once EPA determines that a use of a chemical substance is a
significant new use, TSCA section 5(a)(1) requires persons to submit a
significant new use notice (SNUN) to EPA at least 90 days before they
manufacture (including import) or process the chemical substance for
that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA further prohibits such
manufacturing (including importing) or processing from commencing until
EPA has conducted a review of the notice, made an appropriate
determination on the notice, and taken such actions as are required in
association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As
described in Unit V., the general SNUR provisions are found at 40 CFR
part 721, subpart A.
C. What action is the Agency taking?
EPA is proposing a SNUR for asbestos, using the definition in TSCA
Title II, Section 202, which defines asbestos as the ``asbestiform
varieties of six fiber types--chrysotile (serpentine), crocidolite
(riebeckite), amosite (cummingtonite-grunerite), anthophyllite,
tremolite or actinolite.'' The proposed significant new use of asbestos
(including as part of an article) is manufacturing (including
importing) or processing for certain uses no longer ongoing. The Agency
found no information indicating that the following uses are ongoing,
and therefore, the following uses are subject to this proposed SNUR:
Adhesives, sealants, and roof and non-roof coatings; arc chutes;
beater-add gaskets; extruded sealant tape and other tape; filler for
acetylene cylinders; high-grade electrical paper; millboard; missile
liner; pipeline wrap; reinforced plastics; roofing felt; separators in
fuel cells and batteries; vinyl-asbestos floor tile; and any other
building material (other than cement).
The Frank R. Lautenberg Chemical Safety for the 21st Century Act
(Pub. L. 114-182, 130 Stat. 448) amended TSCA in June 2016. The new law
includes statutory requirements related to the risk evaluations of
conditions of use for existing chemicals. Based on the 2014 update of
EPA's TSCA Work Plan for Chemical Assessments, in December of 2016, EPA
designated asbestos as one of the first 10 chemical substances subject
to the Agency's initial chemical risk evaluations (81 FR 91927), as
required by TSCA section 6(b)(2)(A) (15 U.S.C. 2605(b)(2)(A)).
EPA is separately conducting a risk evaluation of asbestos under
its conditions of use, pursuant to TSCA section 6(b)(4)(A). Through
scoping and subsequent research for the asbestos risk evaluation, EPA
identified several conditions of use of asbestos to include in the risk
evaluation. Those include imported raw bulk chrysotile asbestos for the
fabrication of diaphragms for use in chlorine and sodium hydroxide
production and several imported chrysotile asbestos-containing
materials, including sheet gaskets for use in titanium dioxide chemical
production, brake blocks for use in oil drilling, aftermarket
automotive brakes/linings and other vehicle friction products, other
gaskets and packing, cement products, and woven products. This proposed
significant new rule would not identify as significant new uses those
uses that EPA believes are currently ongoing. EPA is requesting public
comment on this proposal and welcomes specific and verifiable
documentation of any ongoing uses not identified by the Agency as well
as additional uses not identified as no longer ongoing. This proposed
SNUR would require persons that intend to manufacture (including
import) or process any form of asbestos as defined under Title II of
TSCA (including as part of an article) for a significant new use,
consistent with the requirements at 40 CFR 721.25, to notify EPA at
least 90 days before commencing such manufacturing (including
importing) or processing. This proposed SNUR would preclude the
commencement of such manufacturing (including importing) or processing
until EPA has conducted a review of the notice, made an appropriate
determination on the notice, and taken such actions as are required in
association with that determination.
D. Why is the Agency taking this action?
This proposed SNUR is necessary to ensure that EPA receives timely
advance notice of any future manufacturing (including importing) or
processing of asbestos (including as part of an article) for new uses
that may produce changes in human and environmental exposures, and to
ensure that an appropriate determination (relevant to the risks
associated with such manufacturing (including importing), processing,
and use) has been issued prior to the commencement of such
manufacturing (including importing) or processing. Today's action is
furthermore necessary to ensure that manufacturing (including
importing) or processing for the significant new use cannot proceed
until EPA has responded to the circumstances by taking the required
actions under Sections 5(e) or 5(f) of TSCA in the event that EPA
determines any of the following: (1) That the significant new use
presents an unreasonable risk under the conditions of use (without
consideration of costs or other non-risk factors, and including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by EPA); (2) that the information available to
EPA is insufficient to permit a reasoned evaluation of the health and
environmental effects of the significant new use; (3) that, in the
absence of sufficient information, the manufacturing (including
importing), processing, distribution in commerce, use, or disposal of
the substance, or any combination of such activities, may present an
unreasonable risk (without
[[Page 26924]]
consideration of costs or other non-risk factors, and including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by EPA); or (4) that there is substantial
production and sufficient potential for environmental release or human
exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)).
There is a strong causal association between asbestos exposure and
lung cancer and mesotheliomas (tumors arising from the thin membranes
that line the chest (thoracic) and abdominal cavities and surround
internal organs) (Ref. 1; Ref. 2; Ref. 3; Ref. 4; Ref. 5; Ref. 6). In
addition, other cancers, as well as non-cancer effects, such as
respiratory and immune effects, have been associated with asbestos
exposure (Ref. 7).
Agency research conducted in support of the TSCA risk evaluation of
asbestos revealed that the use of asbestos has declined dramatically in
the United States since the 1970s when asbestos use was at its peak.
EPA is taking action in this proposed rule to ensure that EPA receives
timely advance notice and makes an appropriate determination prior to
the commencement of manufacturing (including importing) or processing
for any significant new use of asbestos (including as part of an
article) as identified in Table 2. The rationale and objectives for
this proposed SNUR are explained in detail in Unit III.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substance included in this
proposed rule. This Economic Analysis (Ref. 8), which is available in
the docket, is discussed in Unit IX. and is briefly summarized here.
In the event that a SNUN is submitted, costs are estimated to be
less than $10,000 per SNUN submission for large business submitters and
$8,000 for small business submitters. In addition, for persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country, which is estimated to be approximately $96 per
notification. However, asbestos is already subject to TSCA section 6(a)
rules (40 CFR part 763, subparts G and I) that trigger the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b); see
also 40 CFR 721.20), and the Agency is not proposing to require export
notifications for articles containing asbestos as articles are
generally excluded from the TSCA section 12(b) export notification
requirements. Therefore, EPA assumes no additional costs under TSCA
section 12(b) for this proposed rule.
The proposed rule may also affect firms that plan to import or
process articles that may be subject to the SNUR. Although there are no
specific requirements in the rule for these firms, they may choose to
undertake some activity to assure themselves they are not undertaking a
new use. In the accompanying Economic Analysis for this proposed SNUR
(Ref. 8), example steps (and their respective costs) that an importer
or processor might take to identify asbestos in articles are provided.
These steps can include gathering information through agreements with
suppliers, declarations through databases or surveys, or use of a
third-party certification system. Additionally, importers may require
suppliers to provide certificates of testing analysis of the products
or perform their own laboratory testing of certain articles. EPA is
unable to predict, however, what, if any, particular steps an importer
might take; thus, potential total costs were not estimated.
II. Chemical Substances Subject to This Proposed Rule and Associated
Background Information
A. What chemicals are included in the proposed SNUR?
This proposed SNUR applies to asbestos, using the definition in
TSCA Title II (added to TSCA in 1986), Section 202, which defines
asbestos as the ``asbestiform varieties of six fiber types--chrysotile
(serpentine), crocidolite (riebeckite), amosite (cummingtonite-
grunerite), anthophyllite, tremolite or actinolite.'' This proposed
SNUR Applies to the manufacturing (including importing) or processing
of asbestos (including as part of an article) for certain uses no
longer ongoing. EPA found no information indicating that the following
uses are ongoing, and therefore, the following uses are subject to this
proposed SNUR: Adhesives, sealants, and roof and non-roof coatings; arc
chutes; beater-add gaskets; extruded sealant tape and other tape;
filler for acetylene cylinders; high-grade electrical paper; millboard;
missile liner; pipeline wrap; reinforced plastics; roofing felt;
separators in fuel cells and batteries; vinyl-asbestos floor tile; and
any other building material (other than cement). Under this proposed
SNUR, the exemption at 40 CFR 721.45(f) would not apply to persons who
import or process asbestos as part of an article (which includes as a
component of an article) because there is reasonable potential for
exposure to asbestos if the substance is incorporated into articles and
then imported or processed. However, in accordance with the impurity
exclusion at 40 CFR 721.45(d), this proposed significant new use rule
would not apply to persons who manufacture (including import) or
process asbestos (including as part of an article) only as an impurity.
B. What are the production volumes and uses of asbestos?
Asbestos has not been mined or otherwise produced in the United
States since 2002; therefore, any new raw bulk asbestos used in the
United States is imported. According to the U.S. Geological Survey
(USGS), approximately 300 metric tons of raw bulk asbestos was imported
into the United States in 2017 (Ref. 9). Chrysotile is the only form of
raw bulk asbestos currently imported, and the chlor-alkali industry is
the only known importer (Ref. 9). EPA did not identify any domestic
entity that uses raw bulk asbestos other than the chlor-alkali
industry, which uses chrysotile asbestos to fabricate diaphragms for
use in chlorine and sodium hydroxide production.
In an effort to identify national import volumes and conditions of
use for the asbestos risk evaluation under TSCA section 6(b)(4)(A), EPA
searched a number of available data sources including EPA's Chemical
Data Reporting (CDR) database, USGS's Mineral Commodities Summary and
the Minerals Yearbook, the U.S. International Trade Commission's
Dataweb, the U.S. Customs and Border Protection's Automated Commercial
Environment (ACE) System, and the Use and Market Profile for Asbestos
(EPA-HQ-OPPT-2016-0736-0085). Based on this search, EPA published a
preliminary list of information and sources related to asbestos
conditions of use (see Preliminary Information on Manufacturing,
Processing, Distribution, Use, and Disposal: Asbestos, EPA-HQ-OPPT-
2016-0736-0005) prior to a February 2017 public meeting on the scoping
efforts for the risk evaluation convened to solicit public comment. EPA
also convened meetings with companies, associated industry groups,
chemical users and other stakeholders to aid in identifying conditions
of use and verifying conditions of use identified by EPA. On June 22,
2017, EPA published the Scope of the Risk Evaluation for Asbestos (EPA-
HQ-OPPT-2016-0736-0086), which further
[[Page 26925]]
provided opportunity for the public and private sector to identify
conditions of use of asbestos in the United States.
During the public comment period for the Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: Asbestos
(EPA-HQ-OPPT-2016-0736-0005), one company identified the use of
asbestos-containing gaskets, which are imported, for use during the
production of titanium dioxide. During stakeholder discussions another
company confirmed importing and distributing brake blocks for use in
drawworks by the oil industry. EPA believes that aftermarket automotive
brakes/linings and other vehicle friction products, other gaskets and
packing, cement products, and woven products containing asbestos could
also be imported, as reported by USGS (Ref. 10) and also appear in data
from ACE (Ref. 11); however, the volume of products and the quantity of
asbestos within imported products is unknown. ACE is not a publicly
accessible database because it contains information that is protected
under the provisions of Freedom of Information Act (5 U.S.C. 552), the
Privacy Act (5 U.S.C. 552a), and the Trade Secrets Act (18 U.S.C.
1905), and the information in ACE related to importer identity cannot
be released.
C. What are the potential health effects of asbestos?
Asbestos was listed as a known human carcinogen in the National
Toxicology Program's First Annual Report on Carcinogens in 1980 (Ref.
1). In 1988, EPA assessed the health hazards and effects caused by
exposure to asbestos under the Integrated Risk Information System
(IRIS) program, and determined that asbestos exposure can lead to lung
cancer and mesotheliomas (tumors arising from the thin membranes that
line internal organs) (Ref. 2). Many authorities have established that
there is causal association between asbestos and lung cancer and
mesotheliomas (Ref. 1; Ref. 3; Ref. 4). EPA also noted in the Scope of
the Risk Evaluation for Asbestos that there is a causal association
between exposure to asbestos and cancer of the larynx and cancer of the
ovary (Ref. 4). There is also suggestive evidence of a positive
association between asbestos and cancer of the pharynx (Ref. 4; Ref.
12), stomach (Ref. 3; Ref. 4), and colorectum (Ref. 1; Ref. 3; Ref. 4;
Ref. 12; Ref. 13; Ref. 14). All types of asbestos fibers have been
reported to cause mesothelioma. (Ref. 4).
Increases in lung cancer mortality have been reported in both
workers and residents exposed to various asbestos fiber types as well
as fiber mixtures (Ref. 4). There is evidence in in-vitro, animal, and
human studies that asbestos is genotoxic, meaning asbestos can damage
an organism's genetic material (Ref. 3). There is also evidence that
asbestos exposure is associated with adverse respiratory system
effects, such as asbestosis and immunotoxicity (Ref. 3; Ref. 7).
D. What are the potential routes and sources of exposure to asbestos?
The greatest risk of exposure to asbestos occurs when the substance
is in a friable state, meaning the fibers can be crumbled, pulverized
or reduced to a powder under hand pressure (Ref. 3). During use and
over time, non-friable asbestos has the potential to become friable
(Ref. 3). For example, testing has shown that non-friable asbestos-
containing material can become friable during use such as cutting,
crumbling, and tearing, and as a result of such use, asbestos fibers
can be released into the air (Ref. 15). Similarly, non-friable
asbestos-containing building materials can release fibers if disturbed
during building repair or demolition (Ref. 16). Exposures to workers,
consumers and the general population, as well as environmental
receptors, may occur from industrial releases and use of asbestos-
containing products. Based on EPA's research conducted during the early
stages of the TSCA risk evaluation, most of the ongoing uses of
asbestos pertain to industrial and commercial uses (Ref. 7).
The primary exposure route for asbestos is inhalation. Asbestos
fibers can be released into the air during processing of raw bulk
asbestos and asbestos-containing products. Weathering and the
disturbance and/or degradation of asbestos-containing products can also
cause asbestos fibers to be suspended in air (Ref. 3). Fibers can then
enter the lungs through inhalation. Exposures to asbestos can
potentially occur via oral and dermal routes; however, EPA anticipates
that the most likely exposure route is inhalation.
III. Rationale and Objectives
A. Rationale
EPA is concerned about the potential for adverse health effects of
asbestos based on established sound scientific data indicating that
asbestos is a known human carcinogen. Asbestos was listed as a human
carcinogen in the National Toxicology Program's First Annual Report on
Carcinogens in 1980 (Ref. 1).
Asbestos, in particular chrysotile asbestos, has several unique
properties, including low electrical conductivity while maintaining
high tensile strength, high friction coefficient, and high resistance
to heat (Ref. 17). These properties made asbestos ideal for use in
friction materials (e.g., brakes), insulation (e.g., sound, heat, and
electrical), and building materials (e.g., cement pipes, roofing
compounds, flooring) over the past century. However, the use of
asbestos has declined dramatically due to health concerns and consumer
preference (Ref. 17), which has led to the elimination of some exposure
scenarios associated with such uses. According to USGS, in 1973,
national consumption, including manufacturing/importing and processing,
of raw bulk asbestos peaked around 800,000 metric tons and has since
fallen approximately 99 percent to between 300 and 800 metric tons in
recent years (Ref. 9). Today, most manufactured products in the United
States are now asbestos-free (Ref. 17).
In 1989, EPA published a final rule Asbestos: Manufacture,
Importation, Processing, and Distribution in Commerce Prohibitions (54
FR 29460, July 12, 1989) (FRL-3476-2), which was intended ``to
prohibit, at staged intervals, the future manufacture, importation,
processing and distribution in commerce of asbestos in almost all
products, as identified in the rule . . .'' and to ``reduce the
unreasonable risks presented to human health by exposure to asbestos
during activities involving these products.'' The 1989 final rule
applied to the asbestos product categories identified in the Regulatory
Impact Analysis of Controls on Asbestos and Asbestos Products, which
was conducted in support of the rule (Ref. 20). However, the ban
against most of the asbestos product categories was overturned by the
Fifth Circuit Court of Appeals in 1991. In addition to the asbestos
products that remain banned after the court ruling, which are
identified in Table 1 below, any new use of asbestos was also banned.
The prohibition on any new uses of asbestos is for uses initiated for
the first time after August 25, 1989. As a point of clarification, in
this proposed rulemaking, a significant new use of asbestos addresses
multiple uses that were initiated prior to August 25, 1989, for which
manufacturing and processing are no longer ongoing in the United
States.
[[Page 26926]]
Table 1--Asbestos Containing Product Categories Banned Under TSCA
Section 6
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Product category Definition (40 CFR 763.163)
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Corrugated Paper.................. Corrugated paper means an asbestos-
containing product made of
corrugated paper, which is often
cemented to a flat backing, may be
laminated with foils or other
materials, and has a corrugated
surface. Major applications of
asbestos corrugated paper include:
Thermal insulation for pipe
coverings; block insulation; panel
insulation in elevators; insulation
in appliances; and insulation in
low-pressure steam, hot water, and
process lines.
Rollboard......................... Rollboard means an asbestos-
containing product made of paper
that is produced in a continuous
sheet, is flexible, and is rolled
to achieve a desired thickness.
Asbestos rollboard consists of two
sheets of asbestos paper laminated
together. Major applications of
this product include: Office
partitioning; garage paneling;
linings for stoves and electric
switch boxes; and fire-proofing
agent for security boxes, safes,
and files.
Commercial Paper.................. Commercial paper means an asbestos-
containing product that is made of
paper intended for use as general
insulation paper or muffler paper.
Major applications of commercial
papers are insulation against fire,
heat transfer, and corrosion in
circumstances that require a thin,
but durable, barrier.
Specialty Paper................... Specialty paper means an asbestos-
containing product that is made of
paper intended for use as filters
for beverages or other fluids or as
paper fill for cooling towers.
Cooling tower fill consists of
asbestos paper that is used as a
cooling agent for liquids from
industrial processes and air
conditioning systems.
Flooring Felt..................... Flooring felt means an asbestos-
containing product that is made of
paper felt intended for use as an
underlayer for floor coverings, or
to be bonded to the underside of
vinyl sheet flooring.
New Uses *........................ The commercial uses of asbestos not
identified in Sec. 763.165 the
manufacture, importation or
processing of which would be
initiated for the first time after
August 25, 1989.
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* Note: A ``new use'' as defined in 40 CFR 763.163 is distinct from a
significant new use per TSCA section 5(a)(2), which is explained for
the purposes of this proposed rule in Table 2.
As part of the information gathering activity associated with the
current asbestos risk evaluation, the Agency researched market
availability for the asbestos product categories subject to the 1989
asbestos ban and phase-out rule that was later overturned. EPA
identified several asbestos product categories where manufacturing
(including importing) and processing for the use is no longer ongoing.
Through further refinement of the Scope of the Risk Evaluation for
Asbestos, the Agency determined that asbestos-containing cement
products (e.g., pipe, shingles and replacement parts) are the only
condition of use of asbestos in building materials; therefore, this
proposed SNUR also applies to all asbestos-containing building
materials other than asbestos cement products. These product categories
and descriptions are listed in Table 2, and manufacturing and
processing for these product categories are significant new uses
subject to this proposed rulemaking. The product category descriptions
are based on the product category descriptions presented in the
Regulatory Impact Analysis of Controls on Asbestos and Asbestos
Products for the 1989 final rule (Ref. 20) and may not be all-
encompassing.
Table 2--Product Categories of Proposed Significant New Uses of Asbestos
------------------------------------------------------------------------
Product category Description of the product category
------------------------------------------------------------------------
Arc Chutes........................ Ceramic arc chutes containing
asbestos were used to guide
electric arcs in motor starter
units in electric generating
plants.
Beater-Add Gaskets................ Asbestos fibers were incorporated
within various elastomeric binders
and other fillers to form the
beater-add paper. These products
were used extensively for internal
combustion applications and for the
sealing component of spiral wound
gaskets. Gaskets were used to seal
one compartment of a device from
another in non-dynamic applications
such as engine and exhaust
manifolds.
Extruded Sealant Tape and Other Sealant tape was made from a semi-
Tape. liquid mixture of butyl rubber and
asbestos. On exposure to air, the
sealant solidified forming a rubber
tape about an inch wide and an
eighth of an inch thick. The tape
acted as a gasket for sealing
building windows, automotive
windshields, and mobile home
windows. It was also used in the
manufacture of parts for the
aerospace industry and in the
manufacture of insulated glass.
Filler for Acetylene Cylinders.... Asbestos was used to produce a
sponge-like filler, which held the
liquefied acetylene gas (acetone)
in suspension in the steel cylinder
and puled the acetone up through
the tank as the gas was released
through the oxyacetylene torch. The
torch was used to weld or cut metal
and sometimes used as an illuminant
gas. The filler also acted as an
insulator that offered fire
protection in case the oxidation of
the acetylene became
uncontrollable.
High-Grade Electrical Paper....... The major use of asbestos electrical
paper was insulation for high
temperature, low voltage
applications such as in motors,
generators, transformers, switch
gears, and other heavy electrical
apparatuses.
Millboard......................... Asbestos millboard was essentially a
heavy cardboard product that was
used for gasketing, insulation,
fireproofing, and resistance
against corrosion and rot.
Millboard was used in many
industrial applications to include
linings in boilers, kilns, and
foundries; insulation in glass tank
crowns, melters, refiners, and
sidewalls in the glass industry;
linings for troughs and covers in
the aluminum, marine, and aircraft
industries; and thermal protection
in circuit breakers in the
electrical industry. In addition,
thin millboard was inserted between
metal to produce gaskets.
Commercial applications for
millboard included fireproof
linings for safes, dry-cleaning
machines, and incinerators.
Missile Liner..................... A missile liner was an asbestos and
rubber compound used to insulate
the outer casing of the rocket from
the intense heat generated in the
rocket motor while the rocket fuel
was burned. Rockets and rocket
boosters were used to propel a
number of objects including
military weapons and the space
shuttle.
[[Page 26927]]
Adhesives, Sealants, and Roof and The automobile industry historically
Non-Roof Coatings. used asbestos in a wide variety of
adhesive, sealant, and coating
applications. The aerospace
industry used asbestos in extremely
specialized applications such as
firewall sealants and epoxy
adhesives. Non-roof coatings were
used to prevent corrosion (e.g., as
vehicle undercoatings and
underground pipe coatings). Roof
coatings were used to repair and
patch roofs, seal around
projections such as chimneys and
vent pipes, and bond horizontal and
vertical surfaces.
Pipeline Wrap..................... Pipeline wrap was an asbestos felt
product primarily used by the oil
and gas industry for coating its
pipelines. Asbestos pipeline wrap
was also used in the coal tar
enamel method of coating pipes,
some above-ground applications
(such as for special piping in
cooling towers), and was also used
by the chemical industry for
underground hot water and steam
piping.
Reinforced Plastics............... Asbestos-reinforced plastics were
used for electro-mechanical parts
in the automotive and appliance
industries and as high-performance
plastics for the aerospace
industry. Asbestos-reinforced
plastic was typically a mixture of
some type of plastic resin (usually
phenolic or epoxy), a general
filler (often chalk or limestone),
and raw asbestos fiber.
Roofing Felt...................... Asbestos roofing felt was single or
multi-layered grade and used for
built-up roofing. Asbestos was used
in roofing felts because of its
dimensional stability and
resistance to rot, fire, and heat.
Separators in Fuel Cells and In very specialized aerospace
Batteries. applications, asbestos functioned
as an insulator and separator
between the negative and positive
terminals of a fuel cell/battery.
Vinyl-Asbestos Floor Tile......... Vinyl-asbestos floor tile was used
in commercial, residential, and
institutional buildings in heavy
traffic areas such as supermarkets,
department stores, commercial
plants, kitchens, and ``pivot
points''--entry ways and areas
around elevators
Any Other Building Materials Examples include insulation,
(other than cement) *. plasters, mastics, textured paints
(e.g., simulates stucco), and block
filler paints (e.g., for coating
masonry).
------------------------------------------------------------------------
* Note: Not a product category described in the same terms in the
Regulatory Impact Analysis; this broader product category is used
generally to describe a number of specific product categories
identified during the TSCA section 6 risk evaluation process.
As part of the current asbestos risk evaluation process, the Agency
identified conditions of use to be considered under the TSCA risk
evaluation. Those include: Imported raw bulk chrysotile asbestos for
the fabrication of diaphragms for use in chlorine and sodium hydroxide
production and several imported chrysotile asbestos-containing
materials including sheet gaskets for use in titanium dioxide chemical
production, brake blocks for use in oil drilling, aftermarket
automotive brakes/linings and other vehicle friction products, other
gaskets and packing, cement products, and woven products. These ongoing
uses identified by EPA are not among the significant new uses
identified in this proposal and therefore would not require a
significant new use notification submission to the Agency. EPA requests
comment regarding any ongoing uses not identified by the Agency and
welcomes specific and verifiable documentation. EPA also requests
comment on additional uses not identified as no longer ongoing.
In the absence of this proposed rule, the importing or processing
of asbestos (including as part of an article) for the significant new
uses proposed in this rule may begin at any time, without prior notice
to EPA. Thus, EPA is concerned that commencement of the manufacturing
(including importing) or processing for the significant new uses of
asbestos identified in Table 2 could significantly increase the volume
of manufacturing (including importing) and processing of asbestos as
well as the magnitude and duration of exposure to humans over that
which would otherwise exist currently. EPA has preliminarily concluded
that action on this chemical substance is warranted and therefore
proposes that any manufacturing (including importing) or processing of
asbestos (including as part of an article), using the definition under
Title II of TSCA, for any use identified in Table 2 would be a
significant new use.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. If a
person decides to begin manufacturing (including importing) or
processing asbestos (including as part of an article) for a use
identified in Table 2, the notice to EPA allows the Agency to evaluate
the use according to the specific parameters and circumstances
surrounding the conditions of use.
B. Rationale for Making Inapplicable the Exemption at 40 CFR 721.45(f)
for Persons Who Import or Process Asbestos
Chemical substances that are part of an article may still result in
exposure if the chemical substance has certain physical-chemical
properties--as in the case of asbestos, fibers can degrade with use and
become friable over time where human exposures can occur leading to
increased risks for disease (Ref. 3; Ref. 15; Ref. 16). During use and
over time, non-friable asbestos has the potential to become friable
(Ref. 3). For example, testing has shown that non-friable asbestos-
containing material can become friable during use such as cutting,
crumbling, and tearing, and as a result of such use, asbestos fibers
can be released into the air (Ref. 15). Similarly, non-friable
asbestos-containing building materials can release fibers if disturbed
during building repair or demolition (Ref. 16). Therefore, EPA is
proposing to make inapplicable the exemption at 40 CFR 721.45(f) for
persons who import or process any asbestos as part of an article for
the proposed significant new uses, which are identified in Table 2. A
person who imports or processes asbestos (including as part of an
article) for a proposed significant new use identified in Table 2 would
be subject to the significant new use notification requirements in this
proposed rule. No person would be able to begin importing or processing
asbestos (including as part of an article) for a proposed significant
new use without first submitting a SNUN to EPA and until the Agency has
conducted a review of the notice, made an appropriate determination on
the notice, and taken such actions as are required in association with
that determination.
As requested in Unit XII., EPA asks for comment on the Agency's
understanding of ongoing uses. When submitting a comment to the Agency,
EPA requests specific and verifiable information that provides evidence
of ongoing uses beyond those identified in this proposed rule.
[[Page 26928]]
C. Objectives
Based on the considerations in Unit III.A., EPA wants to achieve
the following objectives with regard to the significant new use of
asbestos (including as part of an article) as designated in this
proposed rule:
1. EPA would receive notice of any person's intent to manufacture
(including import) or process asbestos (including as part of an
article) for the described significant new use before that activity
begins.
2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing
(including importing) or processing asbestos (including as part of an
article) for the described significant new use.
3. EPA would be able to either determine that the significant new
use is not likely to present an unreasonable risk, or take necessary
regulatory action associated with any other determination before the
described significant new use of asbestos (including as part of an
article) occurs.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
1. The projected volume of manufacturing and processing of a
chemical substance.
2. The extent to which a use changes the type or form of exposure
of human beings or the environment to a chemical substance.
3. The extent to which a use increases the magnitude and duration
of exposure of human beings or the environment to a chemical substance.
4. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
Both federal and state environmental protection agencies and
occupational safety and health organizations provide existing
regulation pertaining to certain aspects of the manufacturing
(including importing), processing, use, and/or disposal of asbestos in
order to protect consumers, workers, and the environment. EPA believes
the significant new uses of asbestos identified in Table 2 could
increase the volume of manufacturing (including importing) and
processing of asbestos, as well as the duration and magnitude of human
and environmental exposure to the substance, reverse the declining
trend of national import volumes of the substance, and reintroduce
exposure scenarios that have become obsolete over the past several
decades. It is imperative that EPA be notified of any intended
significant new use of asbestos identified in Table 2 and be provided
the opportunity to evaluate such proposed new use. Once a SNUR is
finalized, failure to notify EPA and file a SNUN prior to manufacturing
or processing for the significant new uses would constitute a violation
of TSCA and would be subject to penalties, accordingly.
To determine what would constitute a significant new use of
asbestos as discussed in this unit, EPA considered relevant information
about the toxicity or expected toxicity of the substance, likely human
exposures and environmental releases associated with possible uses, and
the four factors listed in Section 5(a)(2) of TSCA. In addition to
these factors enumerated in TSCA section 5(a)(2), the statute
authorizes EPA to consider any other relevant factors.
The article exemption at 40 CFR 721.45(f) is based on an assumption
that people and the environment will generally not be exposed to
chemical substances in articles (Ref. 18). However, even when contained
in an article, asbestos can become friable over time with use (Ref. 3;
Ref. 15; Ref. 16). Based on this understanding, upon submission of a
SNUN, EPA intends to evaluate the potential risk of exposure to human
health and the environment for any proposed significant new use of
asbestos (including as part of an article). This understanding warrants
making the exemption at 40 CFR 721.45(f) inapplicable to importers or
processors of articles containing asbestos. Considering the potential
friability of asbestos, even when incorporated in articles, and the
health risks associated with exposure to asbestos, EPA proposes to
affirmatively find under TSCA section 5(a)(5) that notification is
justified by the reasonable potential for exposure to asbestos through
the articles subject to this SNUR. EPA intends to evaluate such
potential uses whether in the form of an article or not before those
uses would begin for any associated risks or hazards that might exist.
EPA has reason to anticipate that importing or processing asbestos as
part of an article would create the potential for exposure to asbestos,
and that EPA should have an opportunity to review the intended use
before such use could occur. Persons subject to this proposed SNUR are
required to notify EPA at least 90 days prior to commencing
manufacturing (including importing) or processing of the substance for
the new use. This required notification provides EPA with the
opportunity to evaluate an intended significant new use of the
regulated chemical substance and, if necessary, an opportunity to
protect against potential unreasonable risks.
V. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, and exemptions to reporting requirements.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the significant new use is not
likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
before the manufacturing (including importing) or processing for the
significant new use can commence. If EPA determines that the
significant new use is not likely to present an unreasonable risk, EPA
is required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's finding.
VI. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
EPA designates June 1, 2018 (the date of web posting of this
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach is to ensure that a person
cannot defeat a SNUR by initiating a significant new use before the
effective date of the final rule. In developing this proposed rule, EPA
has recognized that, given EPA's general practice of posting proposed
and final SNURs on its website a week or more in advance of Federal
Register publication, this objective could be thwarted even before that
publication.
Persons who begin commercial manufacturing (including importing) or
processing of the chemical substance (to include importing or
processing articles
[[Page 26929]]
and components thereof containing the chemical substance) for a
significant new use identified as of June 1, 2018 would have to cease
any such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until all TSCA
prerequisites for the commencement of manufacturing (including
importing) or processing have been satisfied (see Federal Register
documents of April 24, 1990 (55 FR 17376) (FRL-3658-5) and November 28,
2016 (81 FR 85472) (FRL-9945-53) for additional information).
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not usually require
developing new information (e.g., generating test data) before
submission of a SNUN; however, there is an exception: Development of
information is required where the chemical substance subject to the
SNUR is also subject to a rule, order, or consent agreement under TSCA
section 4 (see TSCA section 5(b)(1)). Also pursuant to TSCA section
4(h), which pertains to reduction of testing of vertebrate animals, EPA
encourages consultation with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies or
NAMs), if available, to generate any recommended test data. EPA
encourages dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required to submit only information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and
40 CFR 720.50). However, as a general matter, EPA recommends that SNUN
submitters include information that would permit a reasoned evaluation
of risks posed by the chemical substance during its manufacturing
(including importing), processing, use, distribution in commerce, or
disposal. EPA encourages persons to consult with the Agency before
submitting a SNUN. As part of this optional pre-notice consultation,
EPA would discuss specific information it believes may be useful in
evaluating a significant new use.
Submitting a SNUN that does not itself include information
sufficient to permit a reasoned evaluation may increase the likelihood
that EPA will either respond with a determination that the information
available to the Agency is insufficient to permit a reasoned evaluation
of the health and environmental effects of the significant new use or,
alternatively, that in the absence of sufficient information, the
manufacturing (including importing), processing, distribution in
commerce, use, or disposal of the chemical substance may present an
unreasonable risk of injury.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs and define the terms of any potentially necessary
controls if the submitter provides detailed information on human
exposure and environmental releases that may result from the
significant new uses of the chemical substance.
VIII. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what information may be useful in
evaluating a significant new use. Discussions with the Agency prior to
submission can afford ample time to conduct any tests that might be
helpful in evaluating risks posed by the substance. According
to[emsp14]40 CFR 721.1(c), persons submitting a SNUN must comply with
the same notice requirements and EPA regulatory procedures as persons
submitting a PMN, including submission of test data on health and
environmental effects as described in 40 CFR 720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substance included in this
proposed rule (Ref. 8). In the event that a SNUN is submitted, average
costs are estimated at approximately $9,937 per SNUN submission for
large business submitters and $7,537 for small business submitters.
These estimates include the cost to prepare and submit the SNUN, and
the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $2,500 user fee required by 40 CFR
700.45(b)(2)(iii), or, if they are a small business with annual sales
of less than $40 million when combined with those of the parent company
(if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). On February
26, 2018, EPA proposed raising the fee for SNUNs to $2,800 for small
businesses and $16,000 for other businesses (83 FR 8212). Further, on
November 30, 2017, EPA determined that revisions to the current small
business size standards for TSCA reporting and recordkeeping
requirements are warranted (82 FR 56824). Businesses that submit a SNUN
are also estimated to incur average costs of $67 for rule
familiarization. First time submitters will incur an average cost of
$128 for Central Data Exchange (CDX) registration and associated
activities. Companies manufacturing, importing, or processing asbestos
or articles containing asbestos will incur an average cost of $80 for
notifying their customers of SNUR regulatory activities.
The costs of submitting a SNUN will not be incurred by any company
unless a company decides to pursue a significant new use as defined in
this proposed SNUR. Additionally, these estimates reflect the costs and
fees as they are known at the time this rule is promulgated. EPA's
complete economic analysis is available in the public docket for this
proposed rule (Ref. 8).
B. Export Notification
Under Section 12(b) of TSCA and the implementing regulations at 40
CFR part 707, subpart D, exporters must notify EPA if they export or
intend to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under TSCA section 5.
As explained in Unit I., export notifications are required for
asbestos, but not for articles containing asbestos. EPA is not
proposing that asbestos-containing articles be subject to the export
notification requirements; therefore, EPA assumes no additional costs
under TSCA section 12(b) for this proposed rule.
In general, for persons exporting a substance that is the subject
of a SNUR, a one-time notice to EPA must be provided for the first
export or intended export to a particular country. The total costs of
export notification will vary by chemical, depending on the number of
required notifications (i.e., the number of countries to which the
chemical is exported). While EPA is unable to make any estimate of the
likely number of export notifications for the chemical covered in this
proposed SNUR, as stated in the accompanying economic analysis of this
proposed SNUR, the estimated cost of the export notification
[[Page 26930]]
requirement on a per unit basis is approximately $96.
C. Import or Processing Chemical Substances as Part of an Article
In making inapplicable the exemption relating to persons that
import or process certain chemical substances as part of an article,
this action may affect firms that plan to import or process types of
articles that may contain the asbestos. Some firms have an
understanding of the contents of the articles they import or process.
However, EPA acknowledges that importers and processors of articles may
have varying levels of knowledge about the chemical content of the
articles that they import or process. These parties may need to become
familiar with the requirements of the rule. And, while not required by
the SNUR, these parties may take additional steps to determine whether
the subject chemical substance is part of the articles they are
considering for importing or processing. This determination may involve
activities such as gathering information from suppliers along the
supply chain and/or testing samples of the article itself. Costs vary
across the activities chosen and the extent of familiarity a firm has
regarding the articles it imports or processes. Cost ranges are
presented in the Understanding the Costs Associated with Eliminating
Exemptions for Articles in SNURs (Ref. 19). Based on available
information, EPA believes that article importers or processors that
choose to investigate their products would incur costs at the lower end
of the ranges presented in the Economic Analysis. For those companies
choosing to undertake actions to assess the composition of the articles
they import or process, EPA expects that importers or processors would
take actions that are commensurate with the company's perceived
likelihood that a chemical substance might be a part of an article for
the significant new uses subject to this proposed rulemaking
(identified in Table 2) and the resources it has available. Example
activities and their costs are provided in the accompanying Economic
Analysis of this proposed rule (Ref. 8).
X. Alternatives
Before proposing this SNUR, EPA considered the following
alternative regulatory action: Promulgate a TSCA section 8(a) Reporting
Rule.
Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture (including import) or process a listed chemical
for a specific use or any use. However, for asbestos, the use of TSCA
section 8(a) rather than SNUR authority would have several limitations.
First, if EPA were to require reporting under TSCA section 8(a) instead
of TSCA section 5(a), that action would not ensure that EPA receives
timely advance notice of future manufacturing (including importing) or
processing of asbestos (including as part of an articles and components
thereof) for new uses that may produce changes in human and
environmental exposures. Nor would action under 8(a) ensure that an
appropriate determination (relevant to the risks of such manufacturing
(including importing) or processing) has been issued prior to the
commencement of such manufacturing (including importing) or processing.
Furthermore, a TSCA section 8(a) rule would not ensure that
manufacturing (including importing) or processing for the significant
new use cannot proceed until EPA has responded to the circumstances by
taking the required actions under Sections 5(e) or 5(f) of TSCA in the
event that EPA determines any of the following: (1) That the
significant new use presents an unreasonable risk under the conditions
of use (without consideration of costs or other non-risk factors, and
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by EPA); (2) that the information
available to EPA is insufficient to permit a reasoned evaluation of the
health and environmental effects of the significant new use; (3) that
in the absence of sufficient information, the manufacture (including
import), processing, distribution in commerce, use, or disposal of the
substance, or any combination of such activities, may present an
unreasonable risk (without consideration of costs or other non-risk
factors, and including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by EPA); or (4) that
there is substantial production and sufficient potential for
environmental release or human exposure (as defined in TSCA section
5(a)(3)(B)(ii)(II)).
In addition, EPA may not receive important information from small
businesses, because such firms generally are exempt from TSCA section
8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and
8(a)(1)(B)). In view of the level of health concerns about asbestos if
used for a proposed significant new use, EPA believes that a TSCA
section 8(a) rule for this substance would not meet EPA's regulatory
objectives.
XI. Scientific Standards, Evidence, and Available Information
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science, as applicable. These sources supply
information relevant to whether a particular use would be a significant
new use, based on relevant factors including those listed under TSCA
section 5(a)(2). As noted in Unit III., EPA's decision to promulgate a
SNUR for a particular chemical use need not be based on an extensive
evaluation of the hazard, exposure, or potential risk associated with
that use.
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this proposed significant new use rule, in Unit II. and in the
references cited throughout the preamble of this proposed rule. EPA
recognizes, based on the available information, that there is
variability and uncertainty in whether any particular significant new
use would actually present an unreasonable risk. For precisely this
reason, it is appropriate to secure a future notice and review process
for these uses, at such time as they are known more definitively. The
extent to which the various information, procedures, measures, methods,
protocols, methodologies or models used in EPA's decision have been
subject to independent verification or peer review is adequate to
justify their use, collectively, in the record for a significant new
use rule.
XII. Request for Comment
A. Do you have comments or information about ongoing uses?
EPA welcomes comment on all aspects of this proposed rule. EPA
based its understanding of the use profile of this chemical on the
published literature, the 2016 Chemical Data Reporting submissions,
market research, review of Safety Data Sheets, and extensive research
conducted during the early stages of the TSCA risk evaluation for
asbestos. To confirm EPA's understanding, the Agency is requesting
public comment on all aspects of this proposed rule. In providing
comments on an ongoing use of asbestos, it would be helpful to provide
specific information and documentation sufficient for EPA to
substantiate any assertions of use.
[[Page 26931]]
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. It is EPA's policy to include all comments
received in the public docket without change or further notice to the
commenter and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be CBI or other
information whose disclosure is restricted by statute. Do not submit
this information to EPA through regulations.gov or email. Clearly mark
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD ROM that you mail to EPA, mark the outside
of the disk or CD ROM that you mail to EPA as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2, subpart B.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www2.epa.gov/dockets/commenting-epa-dockets#tips.
XIII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket, EPA-HQ-OPPT-2018-0159,
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. National Toxicology Program. (NTP, 2016). Report on Carcinogens,
Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of
Health and Human Services, Public Health Service. Retrieved from
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf.
2. U.S. Environmental Protection Agency. (EPA, 1988). IRIS summary
for asbestos (CASRN 1332-21-4). Washington, DC: Integrated Risk
Information System. Retrieved from http://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0371_summary.pdf.
3. Agency for Toxic Substances and Disease Registry. (ATSDR, 2001).
Toxicological profile for asbestos (update). Retrieved from https://www.atsdr.cdc.gov/ToxProfiles/tp.asp?id=30&tid=4.
4. International Agency for Research on Cancer. (IARC, 2012). A
review of human carcinogens. Part C: Arsenic, metals, fibres, and
dusts [IARC Monograph]. Lyon, France: World Health Organization.
Retrieved from http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C.pdf.
5. International Agency for Research on Cancer. (IARC, 1977). IARC
monographs on the evaluation of carcinogenic risk of chemicals to
man: Asbestos. Lyon, France: World Health Organization. Retrieved
from http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono14.pdf.
6. International Agency for Research on Cancer. (IARC, 1987).
Asbestos and certain asbestos compounds [IARC Monograph]. In IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans (pp.
106-116). Lyon, France. Retrieved from http://monographs.iarc.fr/ENG/Monographs/suppl7/index.php.
7. U.S. Environmental Protection Agency. (EPA, 2017). Scope of the
Risk Evaluation for Asbestos. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0736-0086.
8. U.S. Environmental Protection Agency. (EPA, 2018). Economic
Analysis for the Proposed Significant New Use Rule for Asbestos.
9. U.S. Geological Survey. (USGS, 2018). Mineral Commodity Summaries
2018. Washington, DC: U.S. Department of the Interior. Retrieved
from https://minerals.usgs.gov/minerals/pubs/mcs/2018/mcs2018.pdf.
10. U.S. Geological Survey. (USGS, 2017). Mineral Commodity
Summaries: Asbestos. Retrieved from https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/mcs-2017-asbes.pdf.
11. U.S. Customs and Border Protection. (2017). Automated Commercial
Environment System (ACE).
12. National Research Council. (NRC, 2006). Asbestos: Selected
cancers. Institute of Medicine (US) Committee on Asbestos: Selected
Health Effects. Washington, DC: The National Academies Press.
13. National Research Council. (NRC, 1983). Drinking Water and
Health. Washington, DC: Safe Drinking Water Committee, Board on
Toxicology and Environmental Health Hazards. Retrieved from http://dx.doi.org/10.17226/326.
14. U.S. Environmental Protection Agency. (EPA, 1980). Ambient water
quality criteria for asbestos [EPA Report]. (EPA/440/5-80/022).
Washington, DC.
15. Anderson, P.H. and Farino, W.J. (1982). Analysis of Fiber
Release from Certain Asbestos Products. Draft Final Report. Prepared
by GCA Corporation for the U.S. Environmental Protection Agency.
Retrieved from https://nepis.epa.gov/Exe/ZyPDF.cgi/9101PBZ6.PDF?Dockey=9101PBZ6.PDF.
16. 40 CFR part 61, subpart M, Asbestos National Emission Standards
for Hazardous Air Pollutants (NESHAP).
17. Virta, R. (2011). Asbestos. Kirk-Othmer Encyclopedia of Chemical
Technology. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/0471238961.0119020510151209.a01.pub3/pdf.
18. U.S. Environmental Protection Agency. (EPA, 1984). Significant
New Uses of Chemical Substances; Certain Chemicals. 49 FR 35014,
September 5, 1984 (FRL-2541-8).
19. U.S. Environmental Protection Agency. (EPA, 2013). Understanding
the Costs Associated with Eliminating Exemptions for Articles in
SNURs. May 1, 2013.
20. U.S. Environmental Protection Agency. (EPA, 1989). Regulatory
Impact Analysis of Controls on Asbestos and Asbestos Products: Final
Report: Volume III. (5601989ICF001). Washington, DC: Office of Toxic
Substances, U.S. Environmental Protection Agency.
XIV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not expected to be a regulatory action subject to
Executive Order 13771 (82 FR 9339, February 3, 2017), because this
action is not a significant regulatory action under Executive Order
12866.
C. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with
existing chemical SNURs are already approved under OMB control number
2070-0038 (EPA ICR No. 1188); and the information collection activities
associated with export notifications are already approved under OMB
control number 2070-0030 (EPA ICR No. 0795). If an entity were to
submit a SNUN to the Agency, the burden is estimated to be
approximately 100 hours per response
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(slightly less for submitters who have already registered to use the
electronic submission system).
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information that requires OMB approval
under the PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in Title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR, part 9, and included on the related
collection instrument, or form, as applicable.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that promulgation of this SNUR would not have a significant
economic impact on a substantial number of small entities. The
rationale supporting this conclusion is as follows.
A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the rule as a
``significant new use.'' By definition of the word ``new'' and based on
all information currently available to EPA, it appears that no small or
large entities presently engage in such activities. Since this proposed
SNUR will require a person who intends to engage in such activity in
the future to first notify EPA by submitting a SNUN, no economic impact
will occur unless someone files a SNUN to pursue a significant new use
in the future or forgoes profits by avoiding or delaying the
significant new use. Although some small entities may decide to conduct
such activities in the future, EPA cannot presently determine how many,
if any, there may be. However, EPA's experience to date is that, in
response to the promulgation of SNURs covering over 1,000 chemical
substances, the Agency receives only a handful of notices per year.
During the six-year period from 2005-2010, only three submitters self-
identified as small in their SNUN submissions (Ref. 8). EPA believes
the cost of submitting a SNUN is relatively small compared to the cost
of developing and marketing a chemical new to a firm or marketing a new
use of the chemical and that the requirement to submit a SNUN generally
does not have a significant economic impact.
Therefore, EPA believes that the potential economic impact of
complying with this proposed SNUR is not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4),
the Agency presented its general determination that proposed and final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities.
E. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, the requirements of sections 202, 203, 204, or 205
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effect 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.
G. 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 any effect 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.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action does not address environmental
health or safety risks, and EPA interprets Executive Order 13045 as
applying only to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have any effect on energy supply, distribution, or use.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve any technical standards, and is
therefore not subject to considerations under section 12(d) of NTTAA,
15 U.S.C. 272 note.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does not affect the level of protection provided to human
health or the environment.
List of Subjects in 40 CFR Part 721
Environmental protection, Asbestos, Chemicals, Hazardous
substances, Reporting and recordkeeping requirements.
Dated: May 31, 2018.
Tala R. Henry,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, the
Environmental Protection Agency proposes that 40 CFR chapter I be
amended as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.11095 to subpart E to read as follows:
Sec. 721.11095 Asbestos.
(a) Chemical substance and significant new use subject to
reporting. (1) The chemical substance identified as asbestos (as
defined by 15 U.S.C. 2642(3) as the asbestiform varieties of chrysotile
(serpentine), crocidolite (riebeckite), amosite (cummingtonite-
grunerite), anthophyllite, tremolite or actinolite) is subject to
reporting under this section for the significant new use
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described in paragraph (a)(2) of this section.
(2) The significant new use is: Manufacturing (including importing)
or processing for any of the following uses:
(i) Arc chutes;
(ii) Beater-add gaskets;
(iii) Extruded sealant tape and other tape;
(iv) Filler for acetylene cylinders;
(v) High grade electrical paper;
(vi) Millboard;
(vii) Missile liner;
(viii) Adhesives, sealants, roof and non-roof coatings;
(ix) Pipeline wrap;
(x) Reinforced plastics;
(xi) Roofing felt;
(xii) Separators in fuel cells and batteries;
(xiii) Vinyl-asbestos floor tile; or
(xiv) Other building products (other than cement products).
(b) Specific requirements. (1) Section 721.45(f) does not apply to
this section. A person who intends to manufacture (including import) or
process the substance identified in paragraph (a)(1) of this section
for the significant new use identified in (a)(2) of this section as
part of an article is subject to the notification provisions of Sec.
721.25.
(2) [Reserved]
[FR Doc. 2018-12513 Filed 6-8-18; 8:45 am]
BILLING CODE 6560-50-P