[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Rules and Regulations]
[Pages 17345-17360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08154]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2018-0159; FRL-9991-33]
RIN 2070-AK45
Restrictions on Discontinued Uses of Asbestos; Significant New
Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
promulgating a rule to ensure that any discontinued uses of asbestos
cannot re-enter the marketplace without EPA review, closing a loophole
in the regulatory regime for asbestos.
DATES: This final rule is effective June 24, 2019.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0159, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through
[[Page 17346]]
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Please review the visitor instructions and
additional information about the docket 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: This restrictive rule is called a
significant new use rule (SNUR) for asbestos, as the term asbestos is
defined under the Asbestos Hazard Emergency Response Act. The
restricted significant new uses of asbestos (including as part of an
article) is manufacturing (including importing) or processing for uses
that are neither ongoing nor already prohibited under TSCA. The Agency
has found no information indicating that the following uses are
ongoing, and therefore, the following uses are subject to this SNUR and
cannot return to the marketplace without EPA review: Adhesives,
sealants, and roof and non-roof coatings; arc chutes; beater-add
gaskets; cement products; extruded sealant tape and other tape; filler
for acetylene cylinders; friction materials (with certain exceptions
identified in Table 1); 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 is neither ongoing nor already prohibited under TSCA.
This action prohibits these discontinued uses of asbestos from
restarting without EPA having an opportunity to evaluate each intended
use (i.e., significant new use) for potential risks to health and the
environment and take any necessary regulatory action, which may include
a prohibition. This SNUR does not provide a means by which prohibited
uses under the 1989 partial ban under TSCA section 6 could return to
the marketplace. This SNUR keeps all prior asbestos prohibitions in
place and would not amend them in any way. EPA is focused on protecting
the public from exposure to asbestos, and as such persons subject to
the SNUR may not undertake any of these activities; they are 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. 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.
I. Executive Summary
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 it
is 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); and
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 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 makes
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 1, the Agency is not requiring export notification for articles
containing asbestos, as further explained in Unit III.B. of this
notice.
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 prohibits the 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)). Those actions could
include a prohibition on a use of that chemical substance. 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 promulgating a final 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 significant new use of
asbestos (including as part of an article) is manufacturing (including
importing) or processing for uses that are neither ongoing nor already
prohibited under TSCA. The Agency found no information indicating that
the following uses are ongoing, and
[[Page 17347]]
therefore, the following uses are subject to this SNUR: Adhesives,
sealants, and roof and non-roof coatings; arc chutes; beater-add
gaskets; cement products; extruded sealant tape and other tape; filler
for acetylene cylinders; friction materials (with certain exceptions
identified in Table 1); 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 is neither ongoing nor already prohibited under TSCA.
Table 1 below presents the significant new uses of asbestos
(including as part of an article) subject to this rule and lists
product categories of asbestos uses that are no longer ongoing (i.e.,
discontinued uses) in the United States that this SNUR will prohibit
from restarting under TSCA without EPA's prior notice, review, and, as
necessary, regulation by EPA. Unless otherwise noted, the product
category descriptions are based on those presented in the Regulatory
Impact Analysis of Controls on Asbestos and Asbestos Products for the
1989 final rule (Ref. 1).
Table 1--Restricted Product Categories of Significant New Uses of
Asbestos
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Product category Description of the product category
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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.
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.
Cement Products *................. Includes asbestos cement product
categories in the 1989 Regulatory
Impact Assessment: Asbestos-Cement
Pipe and Fittings, Asbestos-Cement
Flat Sheet, Corrugated Asbestos-
Cement Sheet, and Asbestos-Cement
Shingles.
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.
Friction Materials (except brake Friction materials were used as
blocks used in oil drilling braking and gear-changing (clutch)
equipment; aftermarket automotive components in a variety of
brakes/linings; and other vehicle industrial and commercial
friction products). machinery. Applications included
agricultural equipment such as
combines, mining and oil-well-
drilling equipment, construction
equipment such as cranes and
hoists, heavy equipment used in
various manufacturing industries
(e.g., machine tools and presses),
military equipment, marine engine
transmissions, elevators, chain
saws, and consumer appliances such
as lawn mowers, washing machines,
and vacuum cleaners.
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.
Packings.......................... Asbestos packings were dynamic or
mechanical (static packings are
gaskets) and used to seal fluids in
devices where motion was necessary.
The design of a packing is to
control the amount of leakage of
fluid at shafts, rods or valve
systems and other functional parts
or equipment requiring containment
of liquids or gases. Asbestos
packings were used in rotary,
centrifugal, and reciprocating
pumps, valves, expansion joints,
soot blowers, and many other types
of mechanical equipment.
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.
[[Page 17348]]
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
Woven Products *.................. Includes Protective Clothing and
Asbestos Textiles from the 1989
RIA.
Any Other Building Material....... Examples include insulation,
plasters, mastics, textured paints
(e.g., simulates stucco), and block
filler paints (e.g., for coating
masonry).
Any use of asbestos not otherwise Except those uses prohibited under
identified. Sec. 763.165 (i.e., Corrugated
Paper, Rollboard, Commercial Paper
Specialty Paper, Flooring Felt and
New Uses (the manufacture,
importation or processing of which
would be initiated for the first
time after August 25, 1989)) and
uses of imported chrysotile
(including as part of an article)
that are currently ongoing in the
United States (i.e., diaphragms;
sheet gaskets; oilfield brake
blocks; aftermarket automotive
brakes/linings; other vehicle
friction products; and other
gaskets).
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* Not a product category described in the same terms in the Regulatory
Impact Analysis (Ref. 1); this broader product category is used
generally to describe a number of specific product categories
identified during the TSCA section 6 risk evaluation process.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act
(Pub. L. 114-182, 130 Stat. 448) amended TSCA in June 2016. As amended,
TSCA includes statutory requirements related to the risk evaluations of
existing chemicals under their conditions of use. In December of 2016
(81 FR 91927, December 19, 2019) (FRL-9956-47), EPA designated asbestos
as one of the first 10 chemical substances subject to the Agency's
chemical risk evaluation rule, pursuant to 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. However, through extensive research, review of public
comments, and stakeholder engagement, the conditions of use of asbestos
have been further refined since publication of the proposed Asbestos
SNUR (83 FR 26922, June 11, 2018) (FRL-9978-76), and Problem
Formulation of the Risk Evaluation for Asbestos (Ref. 2) in June 2018.
The conditions of use of asbestos currently undergoing risk evaluation
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 chemical production (e.g., titanium dioxide
production), brake blocks used in oil drilling equipment, aftermarket
automotive brakes/linings and other vehicle friction products, and
other gaskets. Cement products, woven products, and packings have been
removed from the scope of the risk evaluation since publication of the
problem formulation document because no information was found to
confirm they are conditions of use. Because additional EPA research
indicates that cement products, woven products, and packings are not
ongoing uses, this significant new use rule includes them as
significant new uses. This final SNUR does not affect those uses that
EPA believes are currently ongoing in the United States; again, those
uses are being evaluated in the context of EPA's asbestos risk
evaluation.
EPA requested public comment on the proposed SNUR for information
regarding any ongoing uses not identified by the Agency and additional
uses no longer ongoing (83 FR 26922, June 11, 2018) (FRL-9978-76). The
Agency did not receive any comments providing additional information
regarding the ongoing uses or discontinued uses of asbestos. EPA did
receive many comments (too numerous to cite individually) stating that
the Agency should not allow otherwise prohibited asbestos uses to
return to the marketplace. EPA's approach is consistent with these
comments, and this rulemaking does not bring previously prohibited uses
back to market. This SNUR regulates uses of asbestos that are no longer
ongoing (i.e., discontinued uses) in the United States but that are not
currently prohibited from restarting under TSCA (i.e., not subject to
the 1989 partial ban under TSCA section 6). In the absence of this
SNUR, manufacturing, importing, or processing of asbestos (including as
part of an article) for the significant new uses identified in Table 1
may begin at any time and without prior notice to and oversight by EPA.
EPA is committed to protecting the public from asbestos risks. As such,
EPA will ensure through this final rule that no former uses of asbestos
can be reintroduced into commerce in the U.S. without prior notice,
review, and, as necessary, regulation by EPA.
As explained in greater detail in the Response to Comments document
(Ref. 3), a significant new use rule can be promulgated to regulate new
chemicals or existing chemicals. For existing chemicals, such as
asbestos, a SNUR can be used to ensure that no company will be able to
manufacture, import, or process the chemical for uses the Agency
identifies as significant new uses without prior notification to EPA
and not before EPA has conducted a review of the notice, made an
appropriate determination on the notice based on information available
to EPA about the risk to health and the environment, and taken such
regulatory actions as are required in association with that
determination. This final SNUR requires persons who 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 listed in Table 1, consistent with the requirements
at 40 CFR 721.25, to notify EPA at least 90 days before commencing such
manufacturing (including importing) or processing. Furthermore, this
rule precludes 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.
EPA intends that the provisions of this rule be severable. In the
event that any individual provision or part of this rule is
invalidated, EPA intends that this would not render the entire rule
invalid, and that any individual provisions that can continue to
operate will be left in place.
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D. Why is the Agency taking this action?
This final SNUR will require timely advance notice to EPA of any
future manufacturing (including importing) or processing of asbestos
(including as part of an article) for the designated significant new
uses that may produce changes in human and environmental exposures and
to allow EPA to make an appropriate determination (relevant to the
risks associated with such manufacturing (including importing),
processing, and use) prior to the commencement of such manufacturing
(including importing) or processing. This action is 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 TSCA sections 5(e)
or 5(f) in the event that EPA determines any of the following: (1) That
the significant new use presents an unreasonable risk to health or the
environment 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 consideration of costs or other non-risk factors, and
including an unreasonable risk to potentially exposed or susceptible
subpopulations 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. 4; Ref. 5 Ref. 6; Ref. 7; Ref. 8; Ref. 9). In
addition, other cancers, as well as non-cancer effects, such as
respiratory and immune effects, have been associated with asbestos
exposure (Ref. 10).
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.
Nevertheless, EPA is concerned about the potential for adverse health
effects of asbestos and believes this action will prevent former uses
of asbestos from being reintroduced into commerce without the EPA being
aware and having the opportunity to review and, as necessary, restrict
those uses. EPA is taking action in this final rule to prohibit
manufacturing (including importing) or processing for a significant new
use of asbestos (including as part of an article) identified in Table 1
in the United States without prior notice, review, and, as necessary,
regulation by EPA. The rationale and objectives for this final SNUR are
explained in additional detail in Unit III. of the proposed rule (83 FR
26922, June 11, 2018) (FRL-9978-76).
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 asbestos, as defined in this rule. This
Economic Analysis (Ref. 11), 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
approximately $23,000 per SNUN submission for large business submitters
and about $10,000 for small business submitters. 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
requiring export notifications for articles containing asbestos.
Articles are generally excluded from the TSCA section 12(b) export
notification requirements and the Agency is not lifting the article
exemption for 12(b) export notification for asbestos articles for the
reasons discussed in Unit III.B. Therefore, EPA assumes no additional
costs under TSCA section 12(b) for this rule.
The 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 that they are not
undertaking a significant new use. In the accompanying Economic
Analysis for this final SNUR (Ref. 11), 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 Substance Subject to This Final Rule
A. What chemicals are included in the final SNUR?
This SNUR applies to 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.'' This SNUR applies to the manufacturing (including
importing) or processing of asbestos (including as part of an article)
for uses that are neither ongoing nor already prohibited under TSCA.
EPA found no information indicating that the following uses are
ongoing, and therefore, the following uses are subject to this final
SNUR: Adhesives, sealants, and roof and non-roof coatings; arc chutes;
beater-add gaskets; cement products; extruded sealant tape and other
tape; filler for acetylene cylinders; friction materials (with certain
exceptions identified in Table 1); 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 is neither ongoing nor already prohibited under
TSCA. This action enables the Agency to protect public health because
these significant new uses are not permitted to commence until EPA
conducts a review and evaluates risks, and, as necessary, restricts the
use(s).
Under this final 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. Asbestos-
containing articles subject to this SNUR are listed in Table 1.
[[Page 17350]]
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 750 metric tons of raw bulk asbestos was imported
into the United States in 2018 (Ref. 12). Chrysotile is the only form
of raw bulk asbestos currently imported, and the chlor-alkali industry
is the only known importer (Ref. 12). 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 being conducted 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 (Ref. 13). Based on this research, EPA published a
preliminary list of information and sources related to asbestos
conditions of use prior to a February 2017 public meeting on the
scoping efforts for the risk evaluation convened to solicit public
comment (see Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: Asbestos, Ref. 14). 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.
During the public comment period for the Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: Asbestos
(Ref. 14), 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 oil drilling
equipment by the oil industry. EPA believes that aftermarket automotive
brakes/linings and other vehicle friction products, and other gaskets
containing asbestos are also imported, as reported by USGS (Ref. 15)
and also appear in data from ACE; however, the volume of products and
the quantity of asbestos within imported products is not fully known.
These conditions of use along with the others listed in Table 3 will be
subject to the TSCA section 6 risk evaluation.
On June 22, 2017, EPA published the Scope of the Risk Evaluation
for Asbestos (Ref. 10), which was further refined by the June 2018,
Problem Formulation of the Risk Evaluation for Asbestos (Ref. 2) issued
in conjunction with the June 11, 2018 proposed Asbestos SNUR (83 FR
26922, June 11, 2018) (FRL-9978-76). Each of these three actions
provided 60-day comment periods and opportunity for the public and
private sector to identify conditions of use of asbestos in the United
States. The Agency did not receive additional information from the
public comments during the comment period regarding ongoing or
discontinued uses of asbestos.
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.
16). 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. 5). There is causal association between
asbestos and lung cancer and mesotheliomas (Ref. 4; Ref. 6; Ref. 7).
EPA also noted in the Scope of the Risk Evaluation for Asbestos (Ref.
10) that there is a causal association between exposure to asbestos and
cancer of the larynx and cancer of the ovary (Ref. 7). There is also
suggestive evidence of a positive association between asbestos and
cancer of the pharynx (Ref. 7; Ref. 17), stomach (Ref. 6; Ref. 7), and
colorectum (Ref. 4; Ref. 6; Ref. 7; Ref. 17; Ref. 18; Ref. 19). All
types of asbestos fibers have been reported to cause mesothelioma (Ref.
7).
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. 7). There is evidence in in-vitro, animal, and
human studies that asbestos is genotoxic, meaning asbestos can damage
an organism's genetic material (Ref. 6). There is also evidence that
asbestos exposure is associated with adverse respiratory system
effects, such as asbestosis and immunotoxicity (Ref. 6; Ref. 10).
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. 6). During use and
over time, non-friable asbestos has the potential to become friable
(Ref. 6). 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. 20). Similarly, non-friable
asbestos-containing building materials can release fibers if disturbed
during building repair or demolition (Ref. 21). 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. 10).
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. 6). 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. SNUR Rationale and Objectives
A. Rationale
As discussed in Unit II. and Unit III. of the proposed rule (83 FR
26922, June 11, 2018) (FRL-9978-76), 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.
16).
Asbestos, in particular chrysotile asbestos, has several useful
properties, including low electrical conductivity while maintaining
high tensile strength, high friction coefficient, and high resistance
to heat (Ref. 19). 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.,
[[Page 17351]]
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. 22), which has led to the
elimination of some exposure scenarios associated with such uses.
According to USGS, in 1973, national annual 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. 12).
Today, most manufactured products that historically contained asbestos
in the United States are now asbestos-free (Ref. 22).
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 (Ref. 1),
which was conducted in support of the rule. However, the ban against
most of the asbestos product categories was partially vacated and
remanded to EPA 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 2 below, any new use of asbestos
was also banned. This prohibition on any new uses of asbestos is for
uses initiated for the first time after August 25, 1989. The purpose of
this SNUR is to address the uses of asbestos that began prior to August
25, 1989, for which manufacturing (including importing) and processing
are no longer ongoing in the United States but are not prohibited under
the 1989 partial ban under TSCA section 6.
Table 2--Asbestos Containing Product Categories Banned Under TSCA
Section 6
------------------------------------------------------------------------
Product category Definition (40 CFR 763.163)
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
* 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 final rule in Table 1.
After the court's ruling in Corrosion Proof Fittings v. EPA, 947
F.2d 1201 (5th Cir. 1991), only the specific asbestos products
identified in Table 2 and new uses of asbestos initiated for the first
time after August 25, 1989, remained banned under TSCA. This SNUR keeps
these prohibitions in place and would not amend them in any way. In
other words, this SNUR does not provide a means by which these
prohibited uses under the 1989 partial ban under TSCA section 6 could
return to the marketplace.
A significant new use of asbestos includes all uses that were
initiated on or before August 25, 1989 (and were not covered by the
1989 partial ban under TSCA section 6) for which manufacturing
(including importing) and processing are no longer ongoing in the
United States. This SNUR is designed to complement the existing
prohibitions on asbestos and does not alter or displace those
prohibitions.
As part of the current asbestos risk evaluation process, the Agency
identified conditions of use to be considered under the TSCA risk
evaluation. In the proposed Asbestos SNUR (83 FR 26922, June 11, 2018)
(FRL-9978-76) and the Problem Formulation of the Risk Evaluation for
Asbestos (Ref. 2), the Agency identified the following conditions of
use to be considered under the TSCA section 6 risk evaluation: 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 chemical production (e.g., 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. However,
since the problem formulation document and proposed SNUR were published
in June 2018, EPA has further refined the conditions of use of asbestos
for the TSCA section 6 risk evaluation. Three uses of asbestos--cement
products, packings, and woven products--were believed to be possibly
ongoing based on import data reported in USGS's 2016 Mineral Yearbook
(Ref. 16). EPA further investigated the import data and determined that
there is no evidence to support that asbestos-containing cement
products, packings, and woven products are ongoing uses of asbestos,
and therefore, these three uses are subject to this final rulemaking.
[[Page 17352]]
In an effort to obtain confirmation that asbestos-containing cement
products are imported into the U.S., EPA contacted the last known
foreign supplier to North America. After contacting them, the supplier
informed the Agency that they do not export asbestos-containing cement
to the United States (Ref. 23). The Agency also discussed the use of
asbestos cement pipe in the U.S. with the trade organization American
Water Works, who provided a written statement that, to their knowledge,
asbestos cement pipe is no longer an ongoing use (Ref. 24).
Upon further review of import data, EPA determined that packings
and ``woven and knitted fabrics,'' which are reported in USGS's 2016
Minerals Yearbook (Ref. 16) under Harmonized Tariff Schedule (HTS)
codes 6812.99.0020 and 6812.99.0004 respectively, were misreported. EPA
also determined that the import data suggesting that imported packings
contain asbestos pertained to gaskets, not packings. The Agency
contacted a potential exporter of asbestos-containing woven products,
but the company stated that they do not have customers in the United
States (Ref. 25). EPA has included woven products in this SNUR because
there is no evidence of ongoing use of woven products.
Based on further outreach and investigation since June 2018, the
refined conditions of use of asbestos currently undergoing risk
evaluation 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 chemical products (e.g.,
titanium dioxide chemical production), brake blocks used in oil
drilling equipment, aftermarket automotive brakes/linings and other
vehicle friction products, and other gaskets. Cement products,
packings, and woven products have been removed from the risk evaluation
since publication of the problem formulation document because no
information was found to confirm they are conditions of use. Because
additional EPA research indicates that cement products, woven products
and packings are not ongoing uses, this SNUR includes them as
significant new uses. This SNUR does not identify as significant new
uses those uses that EPA believes are currently ongoing in the United
States. The conditions of use of asbestos that are undergoing risk
evaluation are specific to the chrysotile form only, which is the only
known form of asbestos that is still manufactured or imported into the
United States. Therefore, manufacturing, importing, mining, or
processing crocidolite (riebeckite), amosite (cummingtonite-grunerite),
anthophyllite, tremolite or actinolite for a significant new use of
asbestos (including as part of an article) or any use whatsoever
requires a significant new use notification to EPA.
In the proposed SNUR, the Agency requested comment on the ongoing
uses of asbestos as well as uses that are no longer ongoing (83 FR
26922, June 11, 2018) (FRL-9978-76). EPA received several comments
suggesting that the SNUR be revised to include all product uses of
asbestos that are no longer ongoing, and some commenters suggested
targeting all uses of asbestos except ongoing uses currently under
consideration for the asbestos TSCA section 6 risk evaluation (EPA-HQ-
OPPT-2018-0159-1269; EPA-HQ-OPPT-2018-0159-1271; EPA-HQ-OPPT-2018-0159-
5755; EPA-HQ-OPPT-2018-0159-5886). Considering that asbestos has been
used in thousands of applications, EPA recognizes the public's comments
on the significant new use rule as originally proposed and whether it
covered all uses of asbestos that are no longer ongoing in the United
States. The Agency's intent in this final SNUR is to cover all uses of
asbestos that are neither ongoing in the United States nor already
banned under TSCA. In response to public comment since proposal, the
Agency is revising the regulatory text to add another broad use
category to ensure all other uses of asbestos that are no longer
ongoing and not already prohibited under TSCA are captured in this
rulemaking. EPA is explicitly excluding from this rulemaking uses of
asbestos that are already prohibited under TSCA through the 1989
partial ban under TSCA section 6 or are currently ongoing. Ongoing uses
identified by EPA as conditions of use under consideration for the TSCA
section 6 risk evaluation (i.e., imported chrysotile for the
fabrication of asbestos diaphragms and the following imported
chrysotile products: Sheet gaskets, oilfield brake blocks, aftermarket
automotive brakes/linings, other vehicle friction products, and other
gaskets) are not significant new uses of asbestos and therefore would
not require a significant new use notice submission to the Agency.
As explained in the proposed rule (83 FR 26922, June 11, 2018)
(FRL-9978-76), as part of the information gathering activity associated
with the current asbestos TSCA section 6 risk evaluation, the Agency
researched market availability for the asbestos product categories
subject to the 1989 TSCA section 6 ban that was later partially vacated
and remanded to EPA. In addition to the asbestos product categories
that EPA identified in the proposed SNUR where manufacturing (including
importing) and processing for the use is no longer ongoing, the Agency
has determined that the product category ``friction materials'' as
defined in Table 1 (and with the exceptions noted in Table 1) is also a
significant new use of asbestos. While this product category was in the
1989 Regulatory Impacts Analysis (Ref. 1), it was not included in the
proposed SNUR because the broad category definition could be viewed as
contradictory to uses not subject to the rule--brake blocks in
particular. However, in response to public comments, the Agency is
including friction materials as defined in Table 1 within the
significant new use for asbestos, to encompass all uses that the Agency
has determined to be neither ongoing in the United States nor already
prohibited under TSCA. The Agency believes it is appropriate to include
the product category of ``friction materials'' in the scope of this
SNUR and doing so will not create confusion or potentially overlapping
definitions.
Table 3 represents the conditions of use for asbestos which are
undergoing risk evaluation under TSCA section 6. These uses are ongoing
uses that are not covered under the 1989 partial ban under TSCA section
6 nor in this final SNUR. All of the remaining ongoing uses of asbestos
are solely for chrysotile asbestos. Ongoing uses identified by EPA as
conditions of use under consideration for the TSCA section 6 risk
evaluation are not significant new uses of asbestos and therefore are
not subject to this rulemaking and would not require a significant new
use notice submission to the Agency.
Table 3--Conditions of Use of Asbestos That Are Not Significant New Uses
of Asbestos
------------------------------------------------------------------------
Product category Example
------------------------------------------------------------------------
Asbestos Diaphragms....................... Chlor-alkali Industry.
Sheet Gaskets............................. Chemical Manufacturing
Industry.
Oilfield Brake Blocks..................... Oil Industry.
Aftermarket Automotive Brakes/Linings..... Automotive Industry.
Other Vehicle Friction Products........... Automotive Industry.
Other Gaskets............................. Non-automotive Vehicle
Industry.
------------------------------------------------------------------------
As discussed in Unit 1.C., EPA is conducting a TSCA section 6 risk
evaluation for the ongoing uses of
[[Page 17353]]
asbestos. If a finding of unreasonable risk of injury to health or the
environment is determined for any of those ongoing uses listed in Table
3, the Agency is required by statute to pursue risk management action
options, including prohibitions on use. Risk management action by the
Agency must be proposed within 1 year and finalized within 2 years of
publication of the final asbestos risk evaluation document. For more
information on the TSCA chemical risk evaluation process, read the
Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act final rule (40 CFR 702, subpart B) (82 FR 33726,
July 20, 2017) (FRL-9964-38).
In the absence of this rule, the manufacturing (including
importing) or processing of asbestos (including as part of an article)
for the significant new uses identified in this rule may begin at any
time and without prior notice to EPA. EPA is committed to protecting
the public from asbestos risks and is concerned that the commencement
of the manufacturing (including importing) or processing for the
significant new uses of asbestos identified in Table 1 could 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 concluded that
action on this chemical substance is warranted and therefore determined
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 1 is a significant new use.
The Agency received several public comments on the proposed rule
requesting that disposal and recycling of asbestos-containing products
(EPA-HQ-OPPT-2018-0159-0437; EPA-HQ-OPPT-2018-0159-4066) as well as
asbestos mining (EPA-HQ-OPPT-2018-0159-4023; EPA-HQ-OPPT-2018-0159-
5886) be addressed. The Agency does not interpret the disposal of
asbestos-containing materials to be processing for a significant new
use; therefore, such activity does not require a significant new use
notice under this final rule. Disposal is considered to be the end of
life for a product. By contrast, however, the Agency does interpret
recyling to be processing under TSCA, and recycling of any asbestos-
containing material for a significant new use of asbestos subject to
this rulemaking requires a SNUN. For example, recycling asbestos
building material, such as roofing tiles, for reuse is prohibited
without notification, review, and, as necessary, regulation by EPA.
The Agency interprets mining to be production under the TSCA
definition of manufacture. Therefore, mining asbestos for a significant
new use as identified in this rule would require a SNUN. Mining for the
ongoing uses of asbestos, however, would not require a significant new
use notice.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), 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. If a
person decides to begin manufacturing (including importing) or
processing asbestos (including as part of an article) for a use
identified in Table 1, 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. 6; Ref. 20; Ref. 21). During use and
over time, non-friable asbestos has the potential to become friable
(Ref. 6). 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. 20). Similarly, non-friable
asbestos-containing building materials can release fibers if disturbed
during building repair or demolition (Ref. 21). Therefore, EPA is
making inapplicable the exemption at 40 CFR 721.45(f) for persons who
import or process any asbestos as part of an article for the
significant new uses of asbestos identified in Table 1. A person who
imports or processes asbestos (including as part of an article) for a
significant new use would be subject to the SNUN requirements in this
rule. No person would be able to begin importing or processing asbestos
(including as part of an article) for a significant new use without
first submitting a SNUN to EPA and not before 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, including a prohibition on use.
The Agency received several comments suggesting that exported
asbestos-containing articles be subject to the notification requirement
at TSCA section 12(b) (15 U.S.C. 2611(b)). Considering that this
rulemaking addresses uses of asbestos (including as part of an article)
that are no longer ongoing, the Agency sees no value in requiring
export notification for the uses subject to this rule because such
articles of asbestos are neither manufactured, imported, nor processed
in the United States. Therefore, the Agency assumes that such articles
are not exported. In the event EPA receives a notice for a significant
new use of asbestos, the Agency will consider an export notification
requirement for that significant new use at that time.
As for the ongoing uses of asbestos that are currently undergoing
risk evaluation under TSCA section 6, the Agency feels it is
appropriate to consider a TSCA section 12(b) export notification
requirement as part of any risk management pursued after completion of
the risk evaluation, if an unreasonable risk is determined.
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 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
According to TSCA section 5(a)(2), 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:
[[Page 17354]]
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 1 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 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 1 and be provided the opportunity to
evaluate such intended new use. Once a SNUR is finalized, failure to
notify EPA and file a SNUN prior to manufacturing (including importing)
or processing for a significant new use would constitute a violation of
TSCA and would be subject to TSCA section 16 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 TSCA section 5(a)(2). In addition to the
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. 26). However, even when contained
in an article, asbestos can become friable over time with use (Ref. 6;
Ref. 20; Ref. 21). Based on this understanding, upon receipt of a SNUN,
EPA intends to evaluate the potential risk of exposure to human health
and the environment for any intended significant new use of asbestos
(including as part of an article). This understanding warrants making
the article exemption for submitting a SNUN 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 affirmatively finds 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,
for any associated risks or hazards that might exist before those uses
would begin. 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.
V. Applicability of General Provisions
General provisions for SNURs appear in 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 in 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 the
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 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 began commercial manufacturing (including importing) or
processing of the chemical substance (to include importing or
processing articles and components thereof containing the chemical
substance) for a significant new use 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 55 FR 17376, April
24, 1990 (FRL-3658-5) and 81 FR 85472, November 28, 2016 (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
[[Page 17355]]
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 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.
The Agency received several public comments on the proposed
asbestos SNUR requesting more explanation regarding the review process
of a significant new use notice (EPA-HQ-OPPT-2018-0159-0437; EPA-HQ-
OPPT-2018-0159-3224) and the opportunity for public comment on
submitted SNUN applications, if any, as well as the Agency's
significant new use determinations, if any, for asbestos (EPA-HQ-OPPT-
2018-0159-4021; EPA-HQ-OPPT-2018-0159-1270; EPA-HQ-OPPT-2018-0159-
5889). The SNUN submission and review process is explained in detail in
the Response to Comments document (Ref. 3) and in this unit.
Anyone who plans to manufacture, import, or process asbestos
(including as part of an article) for a significant new use identified
in the rule is required by TSCA section 5 to provide EPA with notice at
least 90 days before initiating the activity. A SNUN submission follows
the same process as a PMN for new chemicals. Upon receipt of a
significant new use notice, EPA is required by TSCA section 5(d)(2) to
publish notification of the intended significant new use in the Federal
Register. For transparency purposes, in addition, EPA intends to take
public comment on any intended significant new use following that
public notification.
In general, TSCA section 5 notices require that all reasonably
ascertainable information on chemical identity, production volume,
byproducts, use, environmental release, disposal practices, and human
exposure be included in the notice. In addition, EPA requires that the
following information be submitted with the notice: Any health and
environmental information in the possession or control of the
submitter, parent company or affiliates, and a description of any other
applicable information known to or reasonably ascertainable by the
submitter (see 40 CFR 720.45 and 40 CFR 720.50 for specific
requirements).
EPA risk assessors consider all of this information during the EPA
significant new use review process and conduct a detailed analysis with
the ultimate goal of identifying and controlling unreasonable risks.
EPA uses an integrated approach that draws on knowledge and experience
across disciplines to identify and evaluate concerns regarding human
health and environmental effects, exposures and releases and impacts.
EPA has developed assessment methods, databases, and predictive tools
to evaluate what happens to chemicals when they are used and released
to the environment and how workers, citizens, and the environment might
be exposed to and affected by these chemicals. These tools are helpful
when laboratory studies or monitoring data are not available or need to
be supplemented. The Agency can take a range of actions, including
prohibition, to ensure the use of the chemical does not present an
unreasonable risk to human health or the environment.
SNUNs are reported using the standard electronic PMN form, which
allows manufacturers of TSCA chemical substances to use the internet
through EPA's Central Data Exchange (CDX), to submit TSCA section 5
notices to EPA (instructions available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn). SNUNs are subject to a 90-day review process similar to
that for a PMN. When submitting a SNUN, the submitter should include a
cover letter that provides the Code of Federal Regulations citation of
the SNUR and identifies the specific significant new use(s) for which
the SNUN is being submitted. The fee for each SNUN is $16,000, except
for small businesses the fee is $2,800 (see 40 CFR 700.45).
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
rule (Ref. 11). In the event that a SNUN is submitted, average costs
are estimated at approximately $23,000 per SNUN submission for large
business submitters and about $10,000 for small business submitters.
These estimates include the cost to prepare and submit the SNUN
(averaging about $7,300), and the payment of a user fee. Businesses
that submit a SNUN would be subject to either a $16,000 user fee
required by 40 CFR 700.45(c)(2)(ii), or, if they are a small business,
a reduced user fee of $2,800 (40 CFR 700.45(c)(1)(ii)). Businesses that
submit a SNUN are also estimated to incur average costs of $65 for rule
familiarization. First time submitters will incur an average cost of
$123 for CDX registration and associated activities. Companies
manufacturing, importing, or processing asbestos or articles containing
asbestos will incur an average cost of $79 for notifying their
customers of SNUR regulatory activities. EPA's complete economic
analysis is
[[Page 17356]]
available in the public docket for this rule (Ref. 11).
B. Export Notification
Under TSCA section 12(b) 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. and Unit III.B., export notifications are
required for asbestos, but not for articles containing asbestos.
Asbestos-containing articles are not subject to the export notification
requirements; therefore, EPA assumes no additional costs under TSCA
section 12(b) for this rule.
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 document entitled Understanding the Costs Associated
with Eliminating Exemptions for Articles in SNURs (Ref. 27). 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 rulemaking
(identified in Table 1) and the resources it has available. Example
activities and their costs are provided in the accompanying Economic
Analysis of this rule (Ref. 11).
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
manufacture (including import) or process a chemical substance 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 article 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 TSCA sections 5(e) or 5(f) 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 view of the level of health concerns about asbestos if used for
a 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 science standards required under TSCA section 26(h), as applicable,
to determine 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 significant new use rule, in Unit II. and in the references cited
throughout the preamble of this 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. Response to Public Comment
The Agency received a total of 17,912 comments in response to the
proposed rule under docket ID number EPA-HQ-OPPT-2018-0159. The public
comment period began on June 11, 2018 and ended August 10, 2018. Of the
17,912 public comments received, 11,732 are part of a mass mail
campaign, 240 are from a second mass mail campaign, 67 are not posted
in the public docket due to inappropriate language, and 5,873
individual comments are identified by
[[Page 17357]]
ID number, posted in the docket, and available to view on
regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2018-0159.
Over 90% (5,386) of the individual comments received on the
proposed Asbestos SNUR are anonymous. The majority of comments are
generally considered not germane to the proposed rule considering the
purpose and effect of the action, but, where appropriate, they are
associated with one of the comment topics and addressed in EPA's
Response to Comments document (Ref. 3). Upon careful review, EPA has
identified the following seven general themes throughout the public
comments:
1. The purpose of the proposed Asbestos SNUR.
2. Extend the comment period.
3. Ban asbestos.
4. Explain EPA's review process of Significant New Use Notices.
5. Provide clarification: Recycling and disposal.
6. Broaden the scope of the SNUR.
7. Economic Analysis.
EPA received thousands of comments pertaining to the purpose of the
proposed Asbestos SNUR as well as the request that EPA ban the use of
asbestos in the United States. Due to the overwhelming number of
comments on these two topics, the Agency does not cite each relevant
comment by ID number in the Response to Comments document. As for the
other public comment topics of the proposed rule listed earlier in this
unit, the Agency specifically cites in the Response to Comments
document 17 substantive public comments, which may address multiple
aspects of the proposed rule.
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. 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.
2. U.S. Environmental Protection Agency. (EPA, 2018). Problem
Formulation of the Risk Evaluation for Asbestos. Retrieved from
https://www.epa.gov/sites/production/files/2018-06/documents/asbestos_problem_formulation_05-31-18.pdf.
3. U.S. Environmental Protection Agency. (EPA, 2019). Response to
Comments on the Proposed Asbestos Significant New Use Rule.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. U.S. Environmental Protection Agency. (EPA, 2019). Economic
Analysis for the Significant New Use Rule for Asbestos--Final Rule.
12. U.S. Geological Survey. (USGS, 2018). Mineral Commodity
Summaries 2019. Washington, DC: U.S. Department of the Interior.
Retrieved from https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/mcs-2019-asbes.pdf.
13. U.S. Environmental Protection Agency. (EPA, 2017). Use and
Market Profile for Asbestos. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0736-0085.
14. U.S. Environmental Protection Agency. (EPA, 2017). Preliminary
Information on Manufacturing, Processing, Distribution, Use, and
Disposal: Asbestos. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0736-0005.
15. U.S. Geological Survey. (USGS, 2017). Mineral Commodity
Summaries: Asbestos. Retrieved from https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/mcs-2017-asbes.pdf.
16. National Toxicology Program. (NTP, 1980). First Annual Report on
Carcinogens. Retrieved from https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB84122852.xhtml.
17. National Research Council. (NRC, 2006). Asbestos: Selected
cancers. Institute of Medicine (US) Committee on Asbestos: Selected
Health Effects. Washington, DC: The National Academies Press.
18. 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.
19. U.S. Environmental Protection Agency. (EPA, 1980). Ambient water
quality criteria for asbestos EPA Report. (EPA/440/5-80/022).
Washington, DC.
20. 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.
21. 40 CFR part 61, subpart M, Asbestos National Emission Standards
for Hazardous Air Pollutants (NESHAP). Retrieved from https://www.govinfo.gov/content/pkg/CFR-2015-title40-vol9/pdf/CFR-2015-title40-vol9-part61-subpartM.pdf.
22. Virta, R. (2011). Asbestos. Kirk-Othmer Encyclopedia of Chemical
Technology. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/0471238961.0119020510151209.a01.pub3/pdf.
23. U.S. Environmental Protection Agency. (EPA, 2018). Chemical Use
Outreach Phone Call with Mexalit and EPA to Discuss Asbestos in
Products Exported to the United States.
24. American Water Works Association. (AWWA, March 21, 2019). Letter
regarding Asbestos; Significant New Use Rule, Docket No. EPA-HQ-
OPPT-2018-0159.
25. U.S. Environmental Protection Agency. (EPA, 2018). Chemical Use
Outreach Phone Call with Textiles T[eacute]cnicos and EPA to Discuss
Asbestos in Products Exported to the United States.
26. U.S. Environmental Protection Agency. (EPA, 1984). Significant
New Uses of Chemical Substances; Certain Chemicals. 49 FR 35014,
September 5, 1984 (FRL-2541-8).
27. U.S. Environmental Protection Agency. (EPA, 2013). Understanding
the Costs Associated with Eliminating Exemptions for Articles in
SNURs. May 1, 2013.
[[Page 17358]]
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 under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011, and was therefore not submitted to the Office of
Management and Budget (OMB) for review.
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)
According to PRA, 44 U.S.C. 3501 et seq., 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
This action does not impose any burden requiring additional OMB
approval. 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
(slightly less for submitters who have already registered to use the
electronic submission system). This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
information.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not send any completed regulatory submissions to
this address.
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 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. 11). 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 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 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 it is not economically significant as defined
in Executive Order 12866, and because EPA does not
[[Page 17359]]
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children. 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.
This SNUR will prohibit the discontinued uses of asbestos from
restarting without EPA having an opportunity to evaluate each intended
use (i.e., significant new use) for potential risks to health and the
environment and take any necessary regulatory action, as appropriate.
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.
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801-808, 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
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Imports,
Labeling, Occupational safety and health, Reporting and recordkeeping
requirements.
Dated: April 17, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add in numerical order under the undesignated center
heading ``Significant New Uses of Chemical Substances'' and entry for
``721.11095'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11095............................................ 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.11095 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 described in
paragraph (a)(2) of this section except as provided by paragraph (a)(3)
of this section.
(2) Except as provided by paragraph (a)(3) of this section, the
significant new use of the chemical substance identified in paragraph
(a)(1) of this section is: Manufacturing (including importing) or
processing for any of the following uses:
(i) Adhesives, sealants, roof and non-roof coatings;
(ii) Arc chutes;
(iii) Beater-add gaskets;
(iv) Cement products;
(v) Extruded sealant tape and other tape;
(vi) Filler for acetylene cylinders;
(vii) Friction materials;
(viii) High grade electrical paper;
(ix) Millboard;
(x) Missile liner;
(xi) Packings;
(xii) Pipeline wrap;
(xiii) Reinforced plastics;
(xiv) Roofing felt;
(xv) Separators in fuel cells and batteries;
(xvi) Vinyl-asbestos floor tile;
(xvii) Woven products;
(xviii) Other building products; or
(xix) Any other use of asbestos.
(3) Exceptions. (i) The significant new use identified in (a)(2) of
this section does not include manufacturing (including importing) or
processing for the following uses of the asbestiform variety of
chrysotile (serpentine) asbestos:
(A) Diaphragms for use in chorine and sodium hydroxide production;
(B) Sheet gaskets for use in chemical manufacturing;
(C) Brake blocks in oil drilling equipment;
(D) Aftermarket automotive brakes/linings;
(E) Other vehicle friction products; or
(F) Other gaskets.
(ii) The significant new use does not include the manufacture
(including importation) or processing of the asbestos-containing
products identified in Sec. 763.165, which continue to be prohibited
pursuant to 40 CFR part 763, subpart I.
(b) Specific requirements. (1) 40 CFR 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 paragraph (a)(2) of this
section as part of an article is subject to the notification provisions
of Sec. 721.25.
(2) Any person who submits a significant new use notice for the
substance identified in paragraph (a)(1) of this section for the
significant new
[[Page 17360]]
use identified in paragraph (a)(2) of this section must include with
the notice adequate documentation or supporting information in the
submitter's possession or control that the intended use is not subject
to the prohibitions identified in 40 CFR part 763, subpart I.
[FR Doc. 2019-08154 Filed 4-24-19; 8:45 am]
BILLING CODE 6560-50-P