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[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

[[Page 31729]]

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

[[Page 31730]]

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

[[Page 31731]]

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

[[Page 31732]]

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

[[Page 31733]]

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]
BILLING CODE 6560-50-P
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