[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Rules and Regulations]
[Pages 31728-31734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13071]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2010-0630; FRL-9345-9]
RIN 2070-AJ71
Elemental Mercury Used in Barometers, Manometers, Hygrometers,
and Psychrometers; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is promulgating a significant new use rule (SNUR) under
the Toxic Substances Control Act (TSCA) for elemental mercury use in
barometers, manometers, hygrometers, and psychrometers. This action
will require persons who intend to manufacture (including import) or
process elemental mercury for an activity that is designated as a
significant new use by this final rule to notify EPA at least 90 days
before commencing that activity. The required notification will provide
EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.
DATES: This final rule is effective June 29, 2012.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2010-0630. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Sue
Slotnick, National Program Chemicals Division (7404T), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 566-1973; email address: slotnick.sue@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process elemental mercury
used in barometers, manometers, or hygrometers or psychrometers.
Potentially affected entities may include, but are not limited to:
Manufacturers, of instruments and related products for
measuring, displaying, and controlling industrial process variables
(North American Industrial Classification System NAICS code 334513).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import 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. Chemical importers must certify that
shipments of the chemical substance comply with all applicable rules
and orders under TSCA, including any SNURs. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, TSCA section 12(b) (15 U.S.C. 2611(b)) export notification
requirements are triggered by publication of a proposed SNUR.
Therefore, on or after June 6, 2011, any persons who export or intend
to export elemental mercury are subject to the export notification
provisions of TSCA section 12(b) (see Sec. 721.20) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D. Note that as of January 1, 2013, the Mercury Export Ban Act of 2008
prohibits the export of elemental mercury from the United States (see
TSCA section 12(c) (15 U.S.C. 2611(c)).
II. Background
A. What action is the agency taking?
EPA proposed a SNUR for elemental mercury used in barometers,
manometers, hygrometers, and pyrometers in the Federal Register of May
6, 2011 (Ref. 1). EPA's response to the public comment received on the
proposed rule appears in Unit III.C.
This final SNUR will require persons to notify EPA at least 90 days
before commencing the manufacture, import, or processing of elemental
mercury for any of the following significant new uses: Use in
barometers, manometers, hygrometers, and psychrometers, except for use
in barometers, manometers, hygrometers, and psychrometers that were in
service prior to May 6, 2011, the publication date of the proposed rule
(Ref. 1). Also not included, because the activity is ongoing, is the
use of elemental mercury in portable battery-powered motor-aspirated
psychrometers that contain fewer than seven grams of elemental mercury.
Sphygmomanometers, a type of manometer, as well as other ``devices'' as
defined under section 201 of the Federal Food, Drug, and Cosmetics Act
(FFDCA), will not be affected by this final rule when manufactured,
imported, or processed for use as a device, per TSCA section
3(2)(B)(vi). Finally, manometers used in the natural
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gas industry will not be affected by this final rule because they are
included in a previous SNUR (Ref. 2).
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:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
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.
Once EPA determines that a use of a chemical substance is a
significant new use, TSCA section 5(a)(1)(B) requires persons to submit
a significant new use notice (SNUN) to EPA at least 90 days before they
manufacture, import, or process the chemical substance for that use (15
U.S.C. 2604(a)(1)(B)). As described in Unit II.C., the general SNUR
provisions are found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. However, Sec. 721.45(f) does not apply to this SNUR. As a
result, persons subject to the provisions of this final rule are not
exempt from significant new use reporting if they import or process
elemental mercury as part of an article (see Sec. 721.5). Conversely,
the exemption from notification requirements for exported articles (see
40 CFR 707.60(b)) remains in force. Thus, persons who export elemental
mercury as part of an article are not required to provide export
notification.
Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 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 section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6,
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in a Federal Register document its reasons for not taking
action.
Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNURs. The EPA policy in support of import certification appears at 40
CFR part 707, subpart B.
III. Summary of Final Rule
A. Overview of Mercury and Mercury Uses
1. Mercury. This final rule applies to elemental mercury (CAS No.
7439-97-6). Mercury is a naturally occurring element. Because of its
unique properties (e.g., exists as a liquid at room temperature and
forms amalgams with many metals), elemental mercury has been used in
many industrial processes and consumer products. In addition to its
useful characteristics, mercury also is known to cause adverse health
effects in humans and wildlife. These effects can vary depending on the
form of mercury to which a person or animal is exposed, as well as the
magnitude, duration, and frequency of exposure. The most prevalent
human and wildlife exposure to mercury results from ingesting fish
contaminated with methylmercury. Methylmercury is an organo-metallic
compound that is formed via the conversion of elemental or inorganic
mercury compounds by certain microorganisms and other natural
processes. For example, elemental mercury may evaporate and be emitted
into the atmosphere. Atmospheric mercury can then be deposited directly
into water bodies or watersheds, where it can be washed into surface
waters via overland run-off. Once deposited in sediments, certain
microorganisms and other natural processes can convert elemental
mercury into methylmercury.
Methylmercury bioaccumulates, which means that it is taken up and
concentrated in the tissues of aquatic, mammalian, avian, and other
wildlife. Methylmercury is a highly toxic substance; a number of
adverse health effects associated with exposure to it have been
identified in humans and in animal studies. Most extensive are the data
on neurotoxicity, particularly in developing organisms. Fetuses,
infants, and young children generally are more sensitive than adults to
the neurological effects of methylmercury.
In 2004, EPA and the Food and Drug Administration (FDA) issued a
national consumption advisory concerning mercury in fish. The advisory
contains recommended limits on the amount of certain types of fish and
shellfish that pregnant women and young children can safely consume. By
2005, all 50 States had issued fish consumption advisories for fish
from certain water bodies known to be contaminated by methylmercury.
See http://www.epa.gov/mercury/advisories.htm.
In addition to methylmercury, exposure to elemental mercury can
also pose health risks. Elemental mercury primarily causes health
effects when it is breathed as a vapor that can be absorbed through the
lungs. These exposures can occur when elemental mercury is spilled, or
products that contain elemental mercury break, resulting in releases of
mercury to the air, particularly in warm or poorly ventilated indoor
spaces.
For a more detailed summary of background information (e.g.,
chemistry, environmental fate, exposure pathways, and health and
environmental effects), as well as references pertaining to elemental
mercury that EPA considered before promulgating this final rule, please
refer to EPA's proposed SNUR for mercury switches in motor vehicles
(Ref. 3), or see the docket for that proposed rule under docket ID
number EPA-HQ-OPPT-2005-0036. All documents in the docket are listed in
the docket's index, which is available at http://www.regulations.gov.
2. Mercury uses. Elemental mercury has been used in thousands of
products and applications. Over the past 2 decades, there has been a
dramatic drop in elemental mercury use by industries in the United
States. In response to
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increased concerns about exposure to anthropogenic sources of mercury
in the environment and also because of the availability of suitable
mercury-free products, Federal and State governments have made efforts
to limit the use of elemental mercury in certain products. Various
States have banned or restricted the manufacture or sale of products
containing mercury. While this is not the rationale for this final
rule, it does indicate that the transition to cost-effective non-
mercury alternatives is already established. See http://www.epa.gov/mercury/regs.htm#states.
On October 5, 2007, EPA issued a final SNUR for elemental mercury
used in convenience light switches, anti-lock braking system switches,
and active ride control system switches in certain motor vehicles (Ref.
4). EPA promulgated another SNUR for flow meters, natural gas
manometers, and pyrometers on July 21, 2010 (Ref. 2). For more
information on EPA activities on mercury in products and other areas;
see http://www.epa.gov/hg.
In the past, elemental mercury was used in the manufacture of
barometers, manometers, hygrometers, and psychrometers. The latest
information available to EPA indicates that the manufacture (including
import) of these mercury-containing articles has ceased (with the
exception of one psychrometer as described at Unit III.A.5.). EPA also
has found that all four products subject to this SNUR currently have
effective and economically feasible substitutes (Ref. 5).
3. Barometers containing elemental mercury. Barometers are
instruments which measure atmospheric pressure. Mercury barometers were
manufactured as a long cylindrical tube, typically closed at one end,
with a mercury-filled reservoir at the base. The weight of mercury
created a vacuum at the top of the tube, and the mercury adjusted until
the pressure inside the reservoir equaled the atmospheric pressure.
Rising mercury indicated increasing air pressure while dropping mercury
indicated decreasing air pressure. Historically, mercury barometers
were used in applications where measuring and monitoring changes in air
pressure are important, such as weather stations, airports, and ships.
Additional uses include scientific demonstration in schools and non-
mercury device calibration. A mercury barometer contains between 400
and 620 grams of mercury (Ref. 5).
Alternatives to mercury-containing barometers include aneroid,
electronic, and other liquid-based (water or eco-celli) barometers. At
least eight States have banned the sale of mercury-containing
barometers. Three additional States have general phase-outs of mercury-
added products. EPA found sufficient information to conclude that
mercury-containing barometers are no longer manufactured in or imported
into the United States (Ref. 5).
4. Manometers containing elemental mercury. A manometer is an
instrument used to measure pressure of gases or liquids. Mercury-
containing manometers were manufactured for use in sectors such as
dairy farms; heating, ventilation, and air conditioning/plumbing (HVAC)
installation and repair; auto/motorcycle industry; laboratories; and in
general industrial uses. The amount of mercury used in a single
manometer ranged between approximately 30 grams and 525 grams (Ref. 5).
Alternatives to mercury-containing manometers include hydrostatic
gauges using mercury-free liquid, aneroid manometers, needle-bourdon
gauges, and digital manometers. At least five States have banned the
sale of mercury-containing manometers, and four additional States have
banned the sale of mercury-containing dairy manometers. The general
phase-outs of mercury products in three States apply to manometers. EPA
found sufficient information to conclude that mercury-containing
manometers are no longer manufactured in or imported into the United
States (Ref. 5).
5. Hygrometers and psychrometers containing elemental mercury.
Hygrometers are instruments used to measure relative humidity (i.e.,
the moisture content of the air). Psychrometers, which are the most
common type of hygrometer, use two mercury-added thermometers, one with
a wetted base, and one with a dry base. Hygrometers and psychrometers
function similarly; however, they are used in different applications.
Historically, mercury-containing hygrometers were used for cigar and
tobacco humidors, or in residential settings, while mercury-containing
psychrometers were used by atmospheric scientists and weather
enthusiasts. The amount of mercury in a single hygrometer or
psychrometer was between three and seven grams (Ref. 5).
There are two types of alternatives to mercury-added hygrometers
that are readily available and widely used: Spirit-filled devices,
which use methyl alcohol or citrus oil thermometers and provide results
with comparable accuracy to mercury-added thermometers; and digital
devices, which use electronic sensors to measure humidity changes and,
when calibrated properly, provide results that are as accurate as
mercury devices (Ref. 5).
Seven States have banned the sale and distribution of mercury-
containing hygrometers and psychrometers and the devices are subject to
the general phase-outs of mercury products in three States. EPA found
sufficient information to conclude that only one type of mercury-
containing psychrometer is manufactured in or imported into the United
States. That one type is a portable, battery-powered, motor-aspirated
psychrometer containing less than seven grams of elemental mercury
(Ref. 5).
6. Potential exposure and release. The typical lifecycle of
barometers, manometers, hygrometers, and psychrometers includes several
stages: Manufacture, distribution in commerce, use, and waste
management (landfilling or recycling). At any point in the lifecycle,
there is potential for mercury to be released as liquid or vapor.
Workers and others can be exposed to the mercury and it can be released
into water, air, or onto land as the mercury is transported, stored,
and handled during manufacturing. While the barometers, manometers,
hygrometers, and psychrometers are in use, the mercury can vaporize or
spill due to breakage during transport, installation, maintenance,
refilling, or repair. Other opportunities for release can occur at the
end of the lifecycle of barometers, manometers, hygrometers, and
psychrometers as these devices are removed from equipment and
facilities, and handled during waste management.
B. This Action
EPA is designating as significant new uses the use of elemental
mercury in barometers, manometers, hygrometers, and psychrometers.
However, use of elemental mercury in these articles that were in
service prior to May 6, 2011, will not be covered as a significant new
use under this SNUR. Also, use of mercury in portable, battery-powered,
motor-aspirated psychrometers that contain fewer than seven grams of
mercury is an ongoing use and therefore will not be covered by this
SNUR. Due to EPA's concern about use of mercury in products, the Agency
may take other action to facilitate the evaluation or control of
ongoing uses, as appropriate. For the portable, battery-powered, motor-
aspirated psychrometers that contain fewer than seven grams of mercury,
EPA may consider whether risk management or other actions will be
appropriate. Use of mercury in manometers used in the natural gas
industry will not be affected by this SNUR because they are included in
a
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previous SNUR (Ref 2). Definitions of ``barometer,'' ``manometer,''
``hygrometer'' and ``psychrometer'' can be found at Sec. 721.10068 of
the regulatory text.
This action will amend Sec. 721.10068 and require persons who
intend to manufacture or process elemental mercury for a use designated
by this final rule as a significant new use to notify EPA at least 90
days before commencing the manufacturing or processing of elemental
mercury for such significant new use. The required notification will
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.
For this SNUR, EPA is not including the general ``article''
exemption at Sec. 721.45(f). Thus, persons importing or processing
elemental mercury (including when part of an article) for a significant
new use will be subject to the notification requirements of Sec.
721.25. EPA is not including this exemption because barometers,
manometers, hygrometers, and psychrometers are articles, and a primary
concern associated with this SNUR is potential exposures associated
with the lifecycle of these uses. EPA notes that, in accordance with
TSCA section 12(a) and Sec. 721.45(g), persons who manufacture or
process elemental mercury solely for export will be exempt from the
notification requirements of Sec. 721.25, if when distributing the
substance in commerce, it is labeled in accordance with TSCA section
12(a)(1)(B). Further, EPA notes that the exemption from the TSCA
section 12(b) notification requirements for exported articles (see 40
CFR 707.60(b)) will remain in force. Thus, persons who export elemental
mercury as part of an article will not be required to provide export
notification.
EPA believes elemental mercury is no longer used to manufacture
barometers, manometers, hygrometers, and psychrometers (with one
exception as discussed), but some of these articles may remain in
service in the United States. The ongoing use of such articles,
including some maintenance and servicing activities, falls outside of
the scope of this SNUR. Thus, the manufacturing and processing of
elemental mercury for use in these articles, provided that they were in
service prior to the May 6, 2011 proposed rule (Ref. 1), will not be
covered by the final rule. For example, if an article that was in
service prior to May 6, 2011, is removed from service for maintenance
or servicing, including the addition of new mercury, and then placed
back into service, any manufacturing or processing of mercury
associated with that maintenance or servicing is not covered by the
final rule. Otherwise, the addition of mercury to these existing
articles could potentially trigger a SNUN under this final rule (i.e.,
if it involved processing of the mercury), which is not EPA's intent.
C. Response to Public Comment
EPA received one comment on the May 6, 2011 proposed rule (Ref. 1).
A copy of the comment is in the docket for this final rule. The comment
did not provide any data or make any assertions that manufacture,
import, processing, distribution, or use of elemental mercury in
barometers, manometers, or hygrometers, and pyrometers is ongoing. A
summary of the comment and EPA's response follow.
The commenter suggested that the Federal Government take some form
of regulatory action to address the mercury products excluded from the
final rule. The products are portable, battery-powered, motor-aspirated
psychrometers that contain fewer than seven grams of elemental mercury.
The comment also expressed concern that issuance of the SNUR would
still allow for future production of mercury-containing barometers,
manometers, hygrometers, and psychrometers, which could lead to
``detrimental environmental impact and exposure.'' The comment
continues: ``If any resurgence in interest in the production of such
products occurs, the EPA should consider regulation under TSCA Section
6.'' EPA's response is that the psychrometers were excluded because the
use of mercury in such articles is an ongoing use and therefore not a
new use that can be subject to a SNUR. As stated in Unit III.B., the
Agency may take other action to facilitate the evaluation or control of
ongoing uses of mercury, and may consider risk management actions for
them, as appropriate. Second, the purpose of the SNUR is to provide an
opportunity for EPA to evaluate and control, where appropriate, use of
mercury in the four types of mercury products, if needed, before any of
those uses occurs. The SNUR provides this opportunity by requiring that
manufacturers and importers notify EPA 90 days before commencing use of
mercury in the products.
IV. Significant New Use Determination
A. Rationale
As summarized in Unit III.A., EPA has concerns regarding the
environmental fate and the exposure pathways of elemental mercury that
lead to the presence of methylmercury in fish and the consumption of
mercury-contaminated fish by humans and wildlife. EPA is encouraged by
the general discontinuation of the use of elemental mercury in the
manufacturing of barometers, manometers, hygrometers, and
psychrometers. However, EPA is concerned that the manufacturing or
processing of elemental mercury for these significant new uses could be
reinitiated in the future. Accordingly, EPA wants the opportunity to
evaluate and control, where appropriate, activities associated with
those uses, if such manufacturing or processing were to occur again.
The required notification provided by a SNUN will provide EPA with the
opportunity to evaluate activities associated with a significant new
use and an opportunity to protect against unreasonable risks, if any,
from exposure to mercury.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to issue 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. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate
before the manufacturing or processing for that use begins. Since the
new use does not currently exist, deferring a detailed consideration of
potential risks or hazards related to that use is an effective use of
resources. If a person decides to begin manufacturing or processing the
chemical for the use, the notice to EPA allows the Agency to evaluate
the use according to the specific parameters and circumstances
surrounding that intended use.
B. Objectives
Based on the considerations in Unit IV.A., EPA has the following
objectives with regard to the significant new uses that are designated
in this final rule:
1. EPA will receive notice of any person's intent to manufacture or
process elemental mercury for any of the described significant new uses
before that activity begins.
2. EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing of elemental mercury for any of the described significant
new uses.
3. EPA will be able to regulate prospective manufacturers or
processors of elemental mercury before the described significant new
uses of the chemical substance occur, provided that
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regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
C. Relevant Factors Considered for This SNUR
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors (see further detail at Unit
II.B.).
EPA has determined that manufacturing or processing of elemental
mercury for use in barometers, manometers, or hygrometers or
psychrometers is a significant new use. This determination is based on
the following factor in TSCA section 5(a)(2): ``the extent to which a
use increases the magnitude and duration of exposure of human beings or
the environment to a chemical substance.'' Increased exposure to
mercury is significant because of the adverse health effects described
at Unit III.A.1. The latest information available to EPA indicates that
there is no ongoing use of elemental mercury in the manufacture or
remanufacture of barometers, manometers, hygrometers, and all but one
type of psychrometer. Resumption of these uses of elemental mercury
could increase the magnitude and duration of exposure to workers and
the surrounding environment at facilities of all types involved in the
lifecycle of the products, as described in greater detail in Unit
III.A.6. Increase in releases could contribute additional mercury to
the atmosphere for long-range transport. Resumption of these uses could
also result in exposures to workers who had not previously worked in
these facilities when elemental mercury was commonly used, as well as
exposures to workers who are not currently being exposed to mercury in
the manufacture of barometers, manometers, hygrometers, or
psychrometers. Increases in mercury releases could lead to increases in
mercury concentrations in the environment and reduction in overall
human health from consumption of mercury-contaminated fish.
EPA believes that any of these renewed uses of elemental mercury
will increase the magnitude and duration of exposure to humans and the
environment over that which will otherwise exist. Thus, EPA has
determined that any manufacturing or processing of elemental mercury
for use in barometers, manometers, or hygrometers or psychrometers is a
significant new use, except for mercury use in barometers, manometers,
hygrometers, and psychrometers that were in service prior to May 6,
2011; and in portable, battery-powered, motor-aspirated psychrometers
that contain less than seven grams of elemental mercury.
V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
began or begin commercial manufacture or processing of the elemental
mercury for a significant new use designated in this rule must cease
any such activity before the effective date of the final rule. To
resume their activities, these persons must comply with all applicable
SNUR notice requirements and wait until the notice review period,
including all extensions, expires. EPA has promulgated provisions to
allow persons to comply with this SNUR before the effective date. If a
person meets the conditions of advance compliance under Sec.
721.45(h), that person is considered to have met the requirements of
the final SNUR for those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (15 U.S.C.
2604(d); Sec. 721.25, and 40 CFR 720.50). However, as a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, 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 data it believes may be useful in evaluating
a significant new use. SNUNs submitted for significant new uses without
any test data may increase the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or limit activities associated with
this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
Human exposure and environmental releases that may result
from the significant new uses of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VII. SNUN Submissions
According to Sec. 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
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
720.40 and 721.25. The e-PMN software is available electronically at
http://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this final rule. EPA's economic
analysis (Ref. 5), which is briefly summarized here, is available in
the docket for this final rule.
The use of elemental mercury for manufacturing the specified
mercury-containing products in the United States appears to have ceased
and EPA expects very few, if any, entities will submit a SNUN. As a
result, the economic impact of this final rule is anticipated to be
either zero or very low.
In the event that a SNUN is submitted, costs are estimated at
approximately $8,300 per SNUN submission, and include the cost to
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prepare and submit the SNUN, and the payment of a user fee. Businesses
that submit a SNUN are subject to either a $2,500 user fee required by
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual
sales of less than $40 million when combined with those of the parent
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In
its evaluation of this final rule, EPA also considered the potential
costs a company might incur by avoiding or delaying the significant new
use in the future, but these costs have not been quantified.
IX. References
The following documents are specifically referenced in the preamble
for this final rule. In addition to these documents, other materials
may be available in the docket established for this final rule under
Docket ID number EPA-HQ-OPPT-2010-0630, which you can access through
http://www.regulations.gov. Those interested in the information
considered by EPA in developing this final rule should also consult
documents that are referenced in the documents that EPA has placed in
the docket, regardless of whether the other documents are physically
located in the docket.
1. EPA. Elemental Mercury Used in Barometers, Manometers,
Hygrometers/Psychrometers; Significant New Use Rule; Proposed Rule.
Federal Register (76 FR 26225, May 6, 2011) (FRL-8871-7).
2. EPA. Elemental Mercury Used in Flow Meters, Natural Gas
Manometers, and Pyrometers; Significant New Use Rule; Final Rule.
Federal Register (75 FR 42330, July 21, 2010) (FRL-8832-2).
3. EPA. Mercury Switches in Motor Vehicles; Proposed Significant New
Use Rule; Proposed Rule. Federal Register (71 FR 39035, July 11,
2006) (FRL-7733-9).
4. EPA. Mercury Switches in Motor Vehicles; Significant New Use
Rule; Final Rule. Federal Register (72 FR 56903, October 5, 2007)
(FRL-8110-5).
5. EPA. 2012. Economic Analysis of the Final Significant New Use
Rule for Mercury-Containing Barometers, Manometers, Hygrometers, and
Psychrometers. Washington, DC. OPPT/Economics, Exposure and
Technology Division (EETD)/Economic and Policy Analysis Branch
(EPAB). March 26, 2012.
X. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51783, October 4, 1993), this action is not a
``significant regulatory action,'' and was not reviewed by the Office
of Management and Budget (OMB) under Executive Orders 12866 and 13563,
entitled ``Improving Regulation and Regulatory Review'' (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (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 PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for certain
EPA 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, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average 97 hours per
response. 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 SNUN.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of
this SNUR will not have a significant economic impact on a substantial
number of small entities. The rationale supporting this conclusion is
as follows.
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. Small entity is
defined in accordance with section 601 of RFA as: A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; a small governmental jurisdiction is a government of a
city, county, town, school district or special district with a
population of less than 50,000; and a small organization is any not-
for-profit enterprise which is independently owned and operated and is
not dominant in its field. For purposes of assessing the impacts of
this rule on small entities, EPA has determined that this final rule is
not expected to impact any small not-for-profit organizations or small
governmental jurisdictions. As such, the Agency estimated potential
impacts are focused on small business.
A SNUR applies to any person (including small or large entities)
who intends to manufacture, import, or process a chemical substance for
a use the EPA has designated as a ``significant new use.'' By
definition of the word ``new,'' and based on information currently
available to EPA, it appears that no small or large entities presently
engage in such activity. 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. For example, the number of SNUNs was
four in Federal fiscal year (FY) 2005, eight in FY2006, six in FY2007,
eight in FY2008, and seven in FY2009. During this 5-year period, three
small entities submitted a SNUN. Therefore, EPA believes that the
potential economic impact of complying with a 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 in the Federal
Register of 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, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of SNUR rulemakings on small entities.
Businesses that submit a SNUN are subject to either a $2,500 user fee
required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business
with annual sales of less than $40 million when combined with those of
the parent company (if any), a reduced user fee of $100 (40 CFR
700.45(b)(1)).
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal
[[Page 31734]]
government will be impacted by this rulemaking. As such, EPA has
determined that this regulatory action will not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
these governments or small governments such that it is subject to the
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates
Reform Act (UMRA), 2 U.S.C. 1531-1538.
E. Federalism
This action will not have federalism implications as specified in
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999) because it is not expected to have a 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.
F. Indian Tribal Governments
This action will not have tribal implications as specified in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). This
action is not expected to have substantial direct effects on Indian
Tribes, will not significantly or uniquely affect the communities of
Indian Tribal governments, and will not involve or impose any
requirements that affect Indian Tribes.
G. Protection of Children
This action is not subject to Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Effect on Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because this action is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.
I. Technical Standards
Because this action will not involve any technical standards,
section 12(d) of the National Technology Transfer and Advancement Act
(NTTAA), 15 U.S.C. 272 note, does not apply to this action.
J. Environmental Justice
This action will not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XI. Congressional Review Act
Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., EPA
will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Barometers, Chemicals, Elemental mercury,
Hazardous substances, Hygrometers, Manometers, Psychrometers, Reporting
and recordkeeping requirements.
Dated: May 3, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR chapter I is amended as follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. In Sec. 721.10068:
0
a. Add the following definitions in alphabetical order to paragraph
(a).
0
b. Add paragraph (b)(2)(viii).
The additions read as follows:
Sec. 721.10068 Elemental mercury.
(a) * * *
Barometer means an instrument used in various applications to
measure atmospheric pressure.
* * * * *
Hygrometer means an instrument used in various applications to
measure humidity of gases.
Manometer means an instrument used in various applications to
measure pressure of gases or liquids.
* * * * *
Psychrometer means an instrument used in various applications to
measure humidity of gases.
* * * * *
(b) * * *
(2) * * *
(viii) Manufacturing or processing of elemental mercury for use in
barometers, manometers, hygrometers, and psychrometers except for:
Natural gas manometers covered by paragraph (b)(2)(vii) of this
section; barometers, manometers, hygrometers, and psychrometers that
were in service prior to May 6, 2011; and portable battery powered and
motor-aspirated psychrometers that contain fewer than seven grams of
elemental mercury.
* * * * *
[FR Doc. 2012-13071 Filed 5-29-12; 8:45 am]
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