[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Proposed Rules]
[Pages 26225-26232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11025]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2010-0630; FRL-8871-7]
RIN 2070-AJ71
Elemental Mercury Used in Barometers, Manometers, Hygrometers/
Psychrometers; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for
elemental mercury for use in barometers, manometers, and hygrometers/
psychrometers. This action would 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 proposed
rule to notify EPA at least 90 days before commencing that activity.
The required notification would provide EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit that
activity before it occurs. Not included in this proposed SNUR is
mercury use in barometers, manometers, and hygrometers/psychrometers
when they are in service as of the publication date of this proposed
rule and mercury use in portable battery-powered motor-aspirated
psychrometers that contain fewer than seven grams of elemental mercury
because they are currently manufactured. For this proposed rule, the
general SNUR exemption for persons that import or process chemical
substances as part of an article at Sec. 721.45(f) would not apply.
DATES: Comments must be received on or before July 5, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-0630, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-0630. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0630. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: 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., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically 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) 556-1973; e-mail 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; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process elemental mercury
used in barometers, manometers, or hygrometers/
[[Page 26226]]
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
(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. 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, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after June 6,
2011 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(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))).
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
This proposed SNUR would 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:
Barometers, manometers, and hygrometers/psychrometers. Not included in
this proposed rule are barometers, manometers, and hygrometers/
psychrometers when they are in service as of the publication date of
this proposed rule. Also not included in this proposal is the ongoing
use of mercury in the manufacture, import, or processing of portable
battery-powered motor-aspirated psychrometers that contain fewer than
seven grams of elemental mercury because they are currently
manufactured. Sphygmomanometers and other ``devices'' as defined under
section 201 of the Federal Food, Drug, and Cosmetics Act (FFDCA) would
not be affected by this proposed rule when manufactured, imported, or
processed for use as a device (see TSCA 3(2)(B)(vi)). Finally,
manometers used in the natural gas industry would not be affected by
this proposed rule because they were included in a previous SNUR (75 FR
42330, July 21, 2010) (FRL-8832-2).
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, and
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 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, 40 CFR 721.45(f) would not apply to this proposed SNUR.
As a result, persons subject to the provisions of this proposed rule
would not be 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 Sec. 707.60(b)) would remain in force. Thus, persons who
export elemental mercury as part of an
[[Page 26227]]
article would not be required to provide export notification.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA 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, the Agency 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, the Agency is required under TSCA
section 5(g) to explain in the Federal Register 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
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.
III. Summary of Proposed Rule
A. Overview of Mercury and Mercury Uses
1. Mercury. This proposed rule applies to elemental mercury (CAS
No. 7439-97-6), which 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 to methylmercury's neurological
effects than adults.
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 fifty states had issued fish consumption advisories for fish
from certain water bodies known to be contaminated by methylmercury
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 release 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 proposing this rule, please refer to
EPA's proposed SNUR for mercury switches in motor vehicles, issued in
the Federal Register of July 11, 2006 (71 FR 39035) (FRL-7733-9), or in
the docket for the 2006 proposal under docket identification 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 two decades, there has been a
dramatic drop in elemental mercury use by industries in the United
States. In response to 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 proposed rule, it does indicate that the
transition to cost-effective non-mercury containing alternatives is
already established (see http://www.epa.gov/epawaste/hazard/tsd/mercury/laws.htm).
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 (72
FR 56903, October 5, 2007) (FRL-8110-5). EPA promulgated another SNUR
for flow meters, natural gas manometers, and pyrometers on July 21,
2010 (75 FR 42330). 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, and hygrometers/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 three products subject to the proposed SNUR
currently have effective and economically feasible substitutes (Ref.
1). EPA requests comments on whether elemental mercury continues to be
used in manufacturing (including importing into the U.S.) barometers,
manometers, or hygrometers/psychrometers. EPA also requests comment on
whether elemental mercury is being used in the remanufacturing of any
of these articles that remain in use.
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
[[Page 26228]]
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.
1).
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. EPA found sufficient information to conclude that mercury-
containing barometers are no longer manufactured in or imported into
the U.S. (Ref. 1).
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
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. 1).
Alternatives to mercury 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 (Ref. 1). EPA found
sufficient information to conclude that mercury-containing manometers
are no longer manufactured in or imported into the U.S. (Ref. 1).
5. Hygrometers/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.
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.
Seven states have banned the sale and distribution of mercury-
containing hygrometers and psychrometers and three additional states
have general phase-outs of mercury-added products. EPA found sufficient
information to conclude that only one type of mercury-containing
hygrometer/psychrometer is manufactured in or imported into the U.S.
That one type is a portable battery-powered motor-aspirated
psychrometer containing fewer than seven grams of elemental mercury
(Ref. 1).
6. Potential exposure and release. The typical lifecycle of
barometers, manometers, and hygrometers/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, and
hygrometers/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, and hygrometers/psychrometers as
these devices are removed from equipment and facilities and handled
during waste management.
B. Proposed Action
EPA is proposing to designate as significant new uses the use of
elemental mercury in barometers, manometers, and hygrometers/
psychrometers. However, use of elemental mercury in these articles when
they are in service as of the publication date of this proposed rule
would not be covered as a significant new use under this proposed 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 would 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 is
considering whether risk management or other actions would be
appropriate. Use of mercury in manometers used in the natural gas
industry would not be affected by this proposed SNUR because they are
included in a previous SNUR (75 FR 42330, July 21, 2010). Proposed
definitions of barometer, manometer, hygrometer and psychrometer can be
found in Sec. 721.10068 of the regulatory text in this proposed rule.
This action would amend Sec. 721.10068 and require persons who
intend to manufacture or process elemental mercury for a use designated
by this proposed 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 would
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 proposing not to include 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 would be subject to the notification requirements
of Sec. 721.25. EPA proposes not to include this exemption because
barometers, manometers, and hygrometers/psychrometers are articles, and
a primary concern associated with this SNUR is potential exposures
associated with the lifecycle of these uses. Further, it is possible to
reclaim elemental mercury from certain articles, which could be used to
produce barometers, manometers, or hygrometers/psychrometers. 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
would 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 Sec. 707.60(b)) would remain in force. Thus,
persons who export elemental mercury as part of an article would not be
required to provide export notification.
[[Page 26229]]
EPA believes elemental mercury is no longer used to manufacture
barometers, manometers, and hygrometers/psychrometers (with one
exception as discussed), but some of these articles may remain in
service in the U.S. The ongoing use of such articles, including some
maintenance and servicing activities, falls outside of the scope of
this significant new use rule. Thus, the manufacturing and processing
of elemental mercury for use in these articles, provided they are in
service as of the publication date of this proposed rule, would not be
covered by the rule. For example, if an article that is in service as
of the publication date of this proposed rule 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 would not be
covered by the rule. Otherwise, the addition of new mercury to these
existing articles after the effective date of this proposed rule could
potentially trigger a significant new use notice under this proposed
rule (e.g., if it involved processing of the mercury), which is not
EPA's intent.
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, and hygrometers/psychrometers.
However, EPA is concerned that the manufacturing or processing of
elemental mercury for the proposed 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 remanufacturing were to occur
again. The required notification provided by a SNUN would 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 propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. 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 under
TSCA 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 EPA 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 proposed rule:
1. EPA would 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 would 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 would be able to regulate prospective manufacturers or
processors of elemental mercury before the described significant new
uses of the chemical substance occur, provided that 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 preliminarily determined that manufacturing or processing
of elemental mercury for use in barometers, manometers, or hygrometers/
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, or hygrometers/
psychrometers. Increases in mercury releases could lead to increases in
mercury concentrations in the environment and reduction in overall
ecosystem and human health from consumption of mercury-contaminated
fish.
EPA believes that any of these renewed uses of elemental mercury
would increase the magnitude and duration of exposure to humans and the
environment over that which would otherwise exist. Thus, EPA has
preliminarily determined that any manufacturing or processing of
elemental mercury for use in barometers, manometers, or hygrometers/
psychrometers is a significant new use, except for mercury use in
barometers, manometers, and hygrometers/psychrometers when they are in
service as of the effective date of this proposed rule; and in portable
battery-powered motor-aspirated psychrometers that contain less than
seven grams of elemental mercury.
D. Request for Comment
EPA welcomes comment on all aspects of this proposed rule,
including comments on the basis for the significant new use
determinations presented for this proposed rule.
V. Alternatives
Before proposing this SNUR, EPA considered the following
alternative regulatory actions.
A. Promulgate a TSCA Section 8(a) Reporting Rule
Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture or process a listed chemical for a specific use
or any use. However, for elemental mercury used in barometers,
manometers, and
[[Page 26230]]
hygrometers/psychrometers, 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),
EPA would not have the opportunity to review human and environmental
hazards and exposures associated with the proposed significant new use
and, if necessary, take immediate follow-up regulatory action under
TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it
begins. In addition, EPA may not receive important information from
small businesses, because such firms generally are exempt from TSCA
section 8(a) reporting requirements. In view of the level of health and
environmental concerns about elemental mercury, if used for the
proposed significant new uses, EPA believes that a TSCA section 8(a)
rule for this substance would not meet EPA's regulatory objectives.
B. Regulate Elemental Mercury for Use in Barometers, Manometers, and
Hygrometers/Psychrometers Under TSCA Section 6
EPA may regulate under TSCA section 6 if ``the Administrator finds
that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or disposal of a chemical
substance or mixture * * * presents or will present an unreasonable
risk of injury to health or the environment'' (TSCA section 6(a)).
Given that elemental mercury is no longer being used in the manufacture
of barometers, manometers, or hygrometers/psychrometers (with the
exception of one psychrometer), EPA concluded that risk management
action under TSCA section 6 is not necessary at this time. This
proposed SNUR would allow the Agency to address the potential risks
associated with the proposed significant new use. Note that EPA is also
considering whether risk management or other regulatory action may be
appropriate for the one remaining psychrometer use.
C. Allow the Exemption for Persons That Import or Process Elemental
Mercury as Part of Articles That Could Be Subject to the SNUR
Under the SNUR exemption provision at Sec. 721.45(f), a person who
imports or processes a substance covered by a SNUR identified in
subpart E of part 721 as part of an article is not generally subject to
the notification requirements of Sec. 721.25 for that substance.
However, EPA is concerned that exempting articles would render the SNUR
less effective because of the possibility that barometers, manometers,
and hygrometers/psychrometers containing elemental mercury could be
imported or processed for uses subject to this proposed SNUR without
the submission of a SNUN. Because mercury-containing barometers,
manometers, and hygrometers/psychrometers are the primary concerns in
this SNUR, EPA wishes to include not only bulk elemental mercury but
also these and other articles when they contain elemental mercury
imported or processed for a significant new use. Thus, EPA is proposing
to promulgate this rule without the exemption generally provided for in
Sec. 721.45(f).
VI. 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 section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new use as of the
date of publication of this 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
begin commercial manufacture or processing of the chemical substance
for a use that would be regulated through this proposed rule, if
finalized, would have to cease any such activity before the effective
date of the rule if and when finalized. To resume their activities,
these persons would have to 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 were to
meet the conditions of advance compliance under Sec. 721.45(h), that
person would be considered to have met the requirements of the final
SNUR for those activities.
VII. 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)); and (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
section 4 test rule or a 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 (TSCA section 5(d); Sec. 721.25 and
Sec. 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:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
2. Potential benefits of the chemical substance.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
VIII. 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 Sec. 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 Sec. Sec.
721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
IX. 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 proposed rule. EPA's economic
analysis (Ref. 1), which is briefly summarized
[[Page 26231]]
here, is available in the docket for this proposed rule.
Because the use of elemental mercury for manufacturing the
specified mercury-containing products in the U.S. appears to have
ceased, EPA expects very few, if any, entities will submit a SNUN. As a
result, the economic impact of this rule is anticipated to be either
zero or very low.
The costs of submission of a SNUN would not be incurred by any
company until a company decides to pursue a significant new use as
defined in this proposed SNUR. In the event that a SNUN is submitted,
costs are estimated at approximately $8,100 per SNUN submission, and
include the cost to prepare and submit the SNUN, and the payment of a
user fee. Businesses that submit a SNUN would be subject to either a
$2,500 user fee required by Sec. 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
(Sec. 700.45(b)(1)). In its evaluation of this 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.
X. References
The following document is specifically referenced in the preamble
for this rulemaking. In addition to this document, other materials may
be available in the docket established for this rulemaking 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 proposed 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, 2010. Economic Analysis of the Proposed Significant New Use
Rule for Mercury-Containing Barometers, Manometers, Hygrometers, and
Psychrometers, Washington, DC OPPT/EETD/EPAB, July 16, 2010.
XI. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this action is a ``significant
regulatory action.'' Accordingly, EPA submitted this action to OMB for
review under Executive Order 12866 and any changes made in response to
OMB recommendations have been documented in the docket for this action
as required by section 6(a)(3)(E) of the Executive Order.
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 the 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 the 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.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden to the Director,
Collection Strategies Division, Office of Environmental Information
(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 submit any completed forms to
this address.
C. Small Entity Impacts
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 would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows.
Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. Small entity is
defined in accordance with section 601 of the RFA as: A small business
as defined by the Small Business Administration's (SBA) regulations at
13 CFR 121.201; A small governmental jurisdiction that 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 that 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 proposed rule on small entities, EPA has determined that this
proposed rule is not expected to impact any small not-for-profit
organizations or small governmental jurisdictions. As such, the Agency
estimated potential impacts on small business.
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 activity. Since this
proposed SNUR would 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 over 1,000 SNURs, the
Agency receives on average only five notices per year. Of those SNUNs
submitted, only one appears to be from a small entity in response to
any SNUR. 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 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, which was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
[[Page 26232]]
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538).
E. Federalism
This action would not have federalism implications 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, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999).
F. Indian Tribal Governments
This action would 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,
would not significantly or uniquely affect the communities of Indian
Tribal governments, and would not involve or impose any requirements
that affect Indian Tribes. Thus, Executive Order 13175 does not apply
to this action.
G. Protection of Children
EPA interprets Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997), as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of the Executive Order has the potential to influence the
regulation. This action is not subject to Executive Order 13045 because
it would not establish an environmental standard intended to mitigate
health or safety risks.
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 would not involve any technical standards,
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), does not apply to this action.
J. Environmental Justice
This action would 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).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: April 29, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. In Sec. 721.10068, add the following definitions in
alphabetical order to paragraph (a) and add a new paragraph
(b)(2)(viii) to read as follows:
Sec. 721.10068 Elemental mercury.
(a) * * *
Barometer means an instrument used in various applications to
measure atmospheric pressure.
Hygrometer or psychrometer 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.
(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 when
these articles are in service as of May 6, 2011; and portable battery
powered and motor-aspirated psychrometers that contain fewer than seven
grams of elemental mercury.
[FR Doc. 2011-11025 Filed 5-5-11; 8:45 am]
BILLING CODE 6560-50-P