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Page 1 of 29 EO12866_MercurySNUR

- 3

- NPRM_2010

- 11

- 08.doc 1

BILLING CODE 6560

– 50

– P 2

ENVIRONMENTAL PROTECTION AGENCY 3

40 CFR Part 721 4

[EPA

– HQ

– OPPT

– 20 08

– 0483 ; FRL

– XXXX

– X ] 5

RIN 2070

- AJ71 6
Elemental Mercury Used in Barometers, Manometers, Hygrometers, and 7 Psychrometers; Significant New Use Rule 8

AGENCY: Environmental Protection Agency (EPA). 9

ACTION: Proposed rule. 10

SUMMARY : EPA is proposing a significant new use rule (SNUR) un der section 5(a)(2) 11
of the Toxic Substances Control Act (TSCA) for elemental mercury for use in 12

barometers, manometers, and hygro meters /psychrometers. This action would require 13
persons who intend to manufacture (including import ) or process elemental merc ury for 14
an activity that is designated as a significant new use by this proposed rule to notify EPA 15
at least 90 days b efore commencing that activity. The required notification would 16
provide EPA with the opportunity to evaluate the intended use and, if nec essary, to 17
prohibit or limit that activity before it occurs . Not included in this proposed SNUR is 18
mercury use in barometers, manometers, and hygro meters /psychrometers when they are 19

in service as of the publication date of this proposed rule ; and mercury use in portable, 20
battery

- powered, motor

- aspirated psychrometers that contain fewer than 7 grams of 21
elemental mercury because they are currently manufactured. For this proposed rule, the 22
general SNUR exemption for persons that import or process chemical su bstances as part 23
of an article at 40 CFR 721.45(f) would not apply. 24*** EO 12866 Review Draft

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Page 2 of 29 25 DATES: Comments must be received on or before [ insert date 60 days after date of 26
publication in the Federal Register ]. 27

ADDRESSES: Submit your comments, identified by docket identificati on ( ID ) number 28

EPA

– HQ

– OPPT

– 2008

- 0483
, by one of the following methods: 29

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on

- line 30
instructions for submitting comments. 31

• Mail : Document Control Office (7407M), Office of Pollution Preven tion and 32

Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 33
Washington, DC 20460

– 0001. 34

• Hand Delivery : OPPT Document Control Office (DCO ) , EPA East Bldg., Rm. 35
6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID N umber 36

EPA

– HQ

– OPPT

– 2008

- 0483 . The DCO is open from 8 a.m. to 4 p.m., Monday through 37
Friday, excluding legal holidays. The telephone number for the DCO is (202) 564

– 8930. 38
Such deliveries are only accepted during the DCO’s normal hours of operation, and 39
special arrangements should be made for deliveries of boxed information. 40

Instructions : Direct your comments to docket ID number EPA

– HQ

– OPP T

– 2008

- 41

0483 . EPA's policy is that all comments received will be included in the d ocket without 42
change and may be ma de available on

- line at http://www.regulations.gov
, including any 43
personal information provided, unless the comment includes information claimed to be 44

Confidential Business Information (CBI) or other information whose disclosure is 45
restricted by statute. D o not submit information that you consider to be CBI or otherwise 46
protected through regulations.gov or e

- mail. The regulations.gov website is an 47

“ anonymous access ” system, which means EPA will not know your identity or contact 48*** EO 12866 Review Draft

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Page 3 of 29 information unless you provi de it in the body of your comment. If you send an e

- mail 49
comment directly to EPA without going through regulations.gov
, your e

- mail address 50
will be automatically captured and included as part of th e comment that is placed in the 51

docket and made available on the Internet. If you submit an electronic comment, EPA 52
recommends that you include your name and other contact information in the body of 53
your comment and with any disk or CD

- ROM you submit. If EPA cannot read your 54

comment due to technical difficultie s and cannot contact you for clarification, EPA may 55
not be able to consider your comment. Electronic files should avoid the use of special 56
characters, any form of encryption, and be free of any defects or viruses

. 57

Docket : All documents in the docket are listed in the docket index available at 58
http://www.regulations.gov

. Although listed in the index, some information is not 59
publicly available, e.g., CBI or other information whose disclosure is restricted by stat ute. 60
Certain other material, such as copyrighted material, will be publicly available only in 61
hard copy. Publicly available docket materials are available electronically at 62
http://www.regulations.gov
, or, if onl y available in hard copy, at the OPPT Docket. The 63

OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 64
Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading 65
Room hours of operation are 8:30 a.m. to 4:30 p. m., Monday through Friday, excluding 66
legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 67

566

– 1744, and the telephone number for the OPPT Docket is (202) 566

– 0280. Docket 68
visitors are required to show photographic identification , pass through a metal detector
, 69

and sign the EPA visitor log. All visitor bags are processed through an X

- ray machine 70
and subject to search. Visitors will be provided an EPA/DC badge that must be visible at 71
all times in the building and returned upon de parture. 72*** EO 12866 Review Draft

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Page 4 of 29 FOR FURTHER INFORMATION CONTACT: For technical information contact : 73

Sue Slotnick , National Program Chemicals Division
, Office of Pollution Prevention and 74
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 75

DC 20460

– 0 001; telephone number: (202) 55 6

– 1973 ; e

- mail address: 76

slotnick.sue @epa.gov

. 77
For general information contact : The TSCA

- Hotline
, ABVI

- Goodwill, 422 South 78

Clinton Ave., Rochester, NY 14620 ; telephone number: (202) 554

– 1404; e

- mail address: 79

TSCA

- Hotline@epa .gov

. 80

SUPPLEMENTARY INFORMATION: 81

I. General Information 82
A. Does this Action Apply to Me? 83

Y ou may be potentially affected by this action if you manufacture (defined by 84
statute to include import) or process elemental mercury used in barometers, manometers, 85
or hygrometers/psychrometers

. Potentially affected entities may include, but are not 86

limited to: 87

• M anufacturers of instruments and related products for measuring, displaying, 88
and controlling industrial process variables (North American Industrial Classi fication 89
System (NAICS) code 334513) 90

T his listing is not intended to be exhaustive, but rather provides a guide for 91
readers regarding entities likely to be affected by this action. Other types of entities not 92

listed in this unit could also be affected. The North American Industrial Classification 93
System (NAICS) codes have been provided to assist you and others in determining 94
whether this action might apply to certain entities

. If you have any questions regarding 95
the applicability of this action to a par ticular entity, consult the technical person listed 96*** EO 12866 Review Draft

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Page 5 of 29 under FOR FURTHER INFORMATION CONTACT

. 97
This action may also affect certain entities through pre

- existing import 98
certification and export notification rules under TSCA. Persons who import any 99

chemical su bstance governed by a final SNUR are subject to the TSCA section 13 (15 100
U.S.C. 2612) import certification requirements and the corresponding regulations at 19 101
CFR 12.118 through 12.127 ; see also 19 CFR 127.28. Those persons must certify that 102
the shipment of the chemical substance complies with all applicable rules and orders 103
under TSCA, including any SNUR requirements. The EPA policy in support of import 104
certification appears at 40 CFR part 707, subpart B. In addition, any persons who export 105

or intend to export a chemical substance that is the subject of this proposed rule on or 106

after [ insert date 30 days after the date of publication in the Federal Register ] are subject 107
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 108
CFR 721.20), and must comply with the export notification requirements in 40 CFR part 109
707, subpart D. Note that as of January 1, 2013, the Mercury Export Ban Act of 2008 110
prohibits the export of elemental mercury from the United States (see TSCA section 111

12(c) (15 U.S.C. 2611(c)). 112

B . What Should I Consider as I Prepare My Comments for EPA? 113

1

. Submitting CBI . Do not submit this information to EPA through 114
regulations.gov or e

- mail. Clearly mark the part or all of the information that you claim 115

to be CBI. For CBI information in a disk or CD

- ROM that you mail to EPA, m ark the 116

outside of the disk or CD

- ROM as CBI and then identify electronically within the disk or 117

CD

- ROM the specific information that is claimed as CBI. In addition to one complete 118

version of the comment that includes information claimed as CBI, a copy of the comment 119

that does not contain the information claimed as CBI must be submitted for inclusion in 120*** EO 12866 Review Draft

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Page 6 of 29 the public docket. Information so marked will not be disclosed except in accordance with 121

p rocedures set forth in 40 CFR part 2. 122

2. Tips for preparing your comments . When submitting comments, remember to: 123
i. Identify the document by docket ID number and other identifying information 124
(subject heading, Federal Register date and page number). 125

i i. Follow directions. The Agency may ask you to respond to specific questions or 126
organize comments by referencing a Code of Federal Regulations (CFR) part or section 127

number. 128
iii. Explain why you agree or disagree; suggest alternatives and substitute 129
lang uage for your requested changes. 130
iv. Describe any assumptions and provide any technical information and/or data 131
that you used. 132
v. If you estimate potential costs or burdens, explain how you arrived at your 133

estimate in sufficient detail to allow for it to be reproduced. 134

vi. Provide specific examples to illustrate your concerns and suggest alternatives. 135

vii. Explain your views as clearly as possible, avoiding the use of profanity or 136
personal threats. 137
viii. Make sure to submit your comments by the comment period deadline 138

identified. 139

II. Background 140
A. What Action is the Agency Taking? 141
This proposed SNUR would require persons to notify EPA at least 90 days before 142
commencing the manufacture , import, or processing of elemental mercury f or any of the 143
following significant new uses: barometers, manometers, and 144*** EO 12866 Review Draft

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Page 7 of 29 hygro meters /psychrometers

. Not included in this proposed rule are barometers, 145

manometers, and hygro meters /psychrometers when they are in service as of the 146
publication date of this pr oposed rule . Also not included in this proposal is the ongoing 147
use of mercury in the manufacture, import, or processing of portable battery

- powered 148

motor

- aspirated psychrometers that contain fewer than 7 grams of elemental mercury 149
because they are current ly manufactured. Finally, m anometers used in the natural gas 150
industry would not be affected by this rule because they were included in a previous 151

SNUR ( 75 F R 4 2330, July 21, 2010). 152
B. What is the Agency's Authority for Taking this Action? 153

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that 154
a use of a chemical substance is a "significant new use." EPA must make this 155
determination by rule after considering all relevant factors, including those listed in 156

TSCA section 5(a)(2) . Once EPA determines that a use of a chemical substance is a 157
significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant 158
new use notice (SNUN) to EPA at least 90 days before they manufacture or process the 159

chemi cal substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit II.C., 160
the general SNUR provisions are found at 40 CFR Part 721, Subpart A. 161
C. Applicability of General Provisions 162 163 General provisions for SNURs appear under 40 CFR part 721, su bpart A. These 164
provisions describe persons subject to the rule, recordkeeping requirements , exemptions 165
to reporting requirements, and applicability of the rule to uses occurring before the 166

effective date of the final rule

. However, 40 CFR 721.45(f) would not apply to this 167
proposed SNUR. As a result, persons subject to the provisions of this proposed rule 168
would not be exempt from significant new use reporting if they import or process 169*** EO 12866 Review Draft

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Page 8 of 29 elemental mercury as part of an article ( see 40 CFR 721.5). Conversely, the exemption 170
from notification requirements for exported articles (see 40 CFR 707.60(b)) would 171

remain in force. Thus, persons who export elemental mercury as part of an article would 172

not be required to provide export noti fication. 173
Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 174
721.1(c), persons subject to SNURs must comply with the same notice requirements and 175
EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under 176

TSCA section 5(a)(1)(A). In particular, these requirements include the information 177
submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by 178
TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. 179

Once E PA receives a SNUN, the Agency may take regulatory action under TSCA section 180

5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA 181

does not take action, the Agency is required under TSCA section 5(g) to explain in the 182

Fed eral Register its reasons for not taking action. 183
Persons who export or intend to export a chemical substance identified in a 184
proposed or final SNUR are subject to the export notification provisions of TSCA section 185
12(b). The regulations that interpret TS CA section 12(b) appear at 40 CFR part 707, 186
subpart D. Persons who import a chemical substance identified in a final SNUR are 187
subject to the TSCA section 13 import certification requirements, codified at 19 CFR 188
12.118 through 12.127 ; see also 19 CFR 127.2 8. Such persons must certify that the 189
shipment of the chemical substance complies with all applicable rules and orders under 190
TSCA, including any SNUR requirements. The EPA policy in support of import 191
certification appears at 40 CFR part 707, subpart B. 192
III. Summary of Proposed Rule 193*** EO 12866 Review Draft

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Page 9 of 29 A. Overview of M

ercury and M

ercury U ses 194

1. Mercury

. This proposed rule applies to elemental mercury (CAS No. 7439

– 195

97

– 6), which is a naturally occurring element. Because of its unique properties (e.g., 196

e xists as a liquid at room temperature and forms amalgams with many metals), elemental 197
mercury has been used in many industrial processes and consumer products. In addition 198
to its useful characteristics, mercury also is known to cause adverse health effect s in 199
humans and wildlife. These effects can vary depending on the form of mercury to which 200
a person or animal is exposed, as well as the magnitude, duration , and frequency of 201

exposure. 202
The most prevalent human and wildlife exposure to mercury results from 203
ingesting fish contaminated with methylmercury. Methylmercury is an organ o

- metallic 204
compound that is formed via the conversion of elemental or inorganic mercury 205
compounds by certain microorganisms and other natural processes. For example, 206

elemental mercu ry may evaporate and be emitted into the atmosphere. Atmospheric 207

mercury can then be deposited directly into water bodies or watersheds, where it can be 208

washed into surface waters via overland run

- off. Once deposited in sediments, certain 209
microorganisms an d other natural processes can convert elemental mercury into 210
methylmercury. Methylmercury bioaccumulates, which means that it is taken up and 211
concentrated in the tissues of aquatic, mammalian, avian, and other wildlife. 212
Methylmercury is a highly toxic subs tance; a number of adverse health effects associated 213
with exposure to it have been identified in humans and in animal studies. Most extensive 214
are the data on neurotoxicity, particularly in developing organisms. Fetuses, infants, and 215
young children generall y are more sensitive to methylmercury’s neurological effects than 216

adults. 217*** EO 12866 Review Draft

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Page 10 of 29 I n 2004, EPA and the Food and Drug Administration (FDA) issued a national 218
consumption advisory concerning mercury in fish. The advisory contains recommended 219

limits on the amount of certain types of fish and shellfish that pregnant women and young 220
children can safely consume. By 2005, all fifty states had issued fish consumption 221

advisories for fish from certain water bodies known to be contaminated by 222
methylmercury http://www.epa.gov /mercury/advisories.htm

. 223
In addition to methylmercury, exposure to elemental mercury can also pose health 224
risks. Elemental mercury primarily causes health effects when it is breathed as a vapor 225

that can be absorbed through the lungs. These exposures can oc cur when elemental 226
mercury is spilled or products that contain elemental mercury break, resulting in release 227
of mercury to the air, particularly in warm or poorly

- ventilated indoor spaces. 228
For a more detailed summary of background information (e.g., chemi stry, 229
environmental fate, exposure pathways, and health and environmental effects), as well as 230
references pertaining to elemental mercury that EPA considered before proposing this 231
rule, please refer to EPA’s proposed SNUR for mercury switches in motor vehi cles, 232
issued in the Federal Register of July 11, 2006, or in the docket for the 2006 proposal 233

under docket identification number EPA

- HQ

- OPPT

- 2005

- 0036. All documents in the 234

docket are listed in the docket's index
, which is available at http://www.regulatio ns.gov

. 235

2. Mercury u ses

. Elemental mercury has been used in thousands of products and 236
applications. Over the past two decades, there has been a dramatic drop in elemental 237
mercury use by i ndustries in the United States. In response to increased concerns about 238
exposure to anthropogenic sources of mercury in the environment and also because of the 239
availability of suitable mercury

- free products, Federal and State governments have made 240

efforts to limit the use of elemental mercur y in certain products. Variou s s tates have 241*** EO 12866 Review Draft

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Page 11 of 29 banned or restricted the manufacture or sale of products containing mercury. See 242
http://www.epa.gov/epawaste/hazard/tsd/mercury/laws.htm

. 243

On October 7, 2007, EPA issued a final SNUR for elemental mercury used in 244
convenience light switches, anti

- lock braking system switches, and active ride control 245
system switches in certain motor vehicles (72 FR 56903
, July 11, 2006 ). EPA 246
promulgated another SNUR for flow meters, natural gas manometers, and pyrometers on 247
July 21, 2010 ( 75 F R 4 2330 ). EPA is also considering regulatory actions on mercury 248
products that are currently manufactured. 249
In the past, elemental mercury was used in the manufacture of barometers, 250

manometers, and hygro meters /psychrometers

. The latest information available to EPA 251

indicates that the manufacture (including import) of these mercury

- containing articles has 252
ceased (with the exception of one ps y chrometer as described at Unit III.A.5.). EPA 253
requests comments on whether elemental mercury continues to be used in manufa cturing 254
(including importing into the U.S.) barometers, manometers, or 255
hygrometers/psychrometers. EPA also requests comment on whether elementary mercury 256
is being used in the remanufacturing of any of these articles that remain in use. 257

3. Baro meters c ont aining e lemental m ercury

. Barometers are instruments which 258

measure atmospheric pressure. Mercury barometers were manufactured as a long 259
cylindrical tube, typically closed at one end, with a mercury

- filled reservoir at the base. 260
The weight of mercury crea ted a vacuum at the top of the tube, and the mercury adjusted 261
until the pressure inside the reservoir equaled the atmospheric pressure. Rising mercury 262
indicated increasing air pressure while dropping mercury indicated decreasing air 263

pressure . Historically, mercury barometers were used in applications where measuring 264
and monitoring changes in air pressure are important, such as weather stations, airports, 265*** EO 12866 Review Draft

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Page 12 of 29 and ships. Additional uses include scientific demonstration in schools and non

- mercury 266

device calibratio n. A mercury barometer contains between 400 and 620 grams of 267

mercury (Ref. 1 ). 268

A lternatives to mercury

- containing barometers include aneroid, electronic, and 269
other liquid

- based (water or eco

- celli) barometers. At least eight states have banned the 270

sale o f mercury

- containing barometers. EPA found sufficient information to conclude 271
that mercury

- containing baro me ters are no longer manufactured in or imported into the 272

U.S. (Ref. 1 )

. 273

4. M

anometers containing elemental mercury

. A manometer is an instrument 274

use d to measure pressure of gases or liquids. Mercury

- containing manometers were 275

manufactured for u se in sectors such as dairy farms, Heating Ventilation and Air 276
Conditioning/Plumbing Installation and Repair, Auto/Motorcycle Industry, laboratories 277
and in gen eral industrial uses. The amount of mercury used in a single manometer 278

rang ed between approximately 150 kg and 525 kg (Ref. 1 )

. 279
Alternatives to mercury manometers include hydrostatic gauges using mercury

- free 280
liquid, aneroid manometers, needle

- bourdon gau ges and digital manometers. At least 281

f ive states have banned the sale of mercury

- containing manometers , and four additional 282

state s have banned the sale of mercury

- containing dairy manometers (Ref. 1 ). EPA 283

found sufficient information to conclude that m ercury

- containing manometers are n o 284
longer manufactured in or imported into the U.S. (Ref

. 1). 285

5. Hygrometers/psychrometers containing elemental mercury

. Hygrometers are 286
instruments used to measure relative humidity (i.e., the moisture content of the a ir). 287
Psychrometers, which are the most common type of hygrometer, use two mercury

- added 288
thermometers, one with a wetted base, and one with a dry base. Hygrometers and 289*** EO 12866 Review Draft

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Page 13 of 29 psychrometers function similarly; however
, they are used in different applications

. 290

Hist orically, mercury

- containing hygrometers were used for cigar and tobacco humidors, 291
or in residential settings, while mercury

- containing psychrometers were used by 292
atmospheric scientists and weather enthusiasts. The amount of mercury in a single 293
hygrometer or psychrometer was between three and seven grams. 294
There are two types of alternatives to mercury

- added hygrometers that are readily 295
available and widely used: spirit

- filled devices, which use methyl alcohol or citrus oil 296

thermometers and provide results with comparable accuracy to mercury

- added 297

thermometers ; and digital devices, which use electronic sensors to measure humidity 298
changes and, when calibrated properly, provide as accurate r esults as mercury devices. 299

Seven states have banned the sale and distr ibution of mercury

- containing hygrometers 300
and psychrometers and three additional states have general phase

- outs of mercury

- added 301
products. EPA found sufficient information to conclude that only one type of mercury

302
containing hygrometer/psychrometer is man ufactured in or imported into the U.S. 303

P ortable, battery

- powered, motor

- aspirated psychrometers containing fewer than 7 grams 304
of elemental mercury continue to be manufactured in the U.S. (Ref. 1 )

. EPA is 305
considering whether risk management or other actio ns would be appropriate for the one 306
type of psychrometer that is still in use. 307

6 . Potential exposure and release

. The typical lifecycle of barometers, 308
manometers, and hygrometers/psychrometers includes several stages: manufacture, 309

distribution in commerc e, use, and waste management (landfilling or recycling). At any 310
point in the lifecycle, there is potential for mercury to be released as liquid or vapor. 311
Workers and others can be exposed to the mercury and it can be released into water, air, 312

or onto land as the mercury is transported, stored, and handled during manufacturing. 313*** EO 12866 Review Draft

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Page 14 of 29 While the baro met ers, manometers, and hygrometers/psychro meters are in use, the 314
mercury can vaporize or spill due to breakage during transport, installation, maintenance, 315
refilling, or repair. Other opportunities for release can occur at the end of the lifecycle of 316

baro met ers, manometers, and hygrometers/psychro meters as the se devices are removed 317
from equipment and facilities, and handled during waste management. 318
B. Proposed Action 319
EPA is proposing to designate as significant new uses the use of elemental 320
mercury in barometers, manometers, and hygrometers / psychrometers. However, use of 321
elemental mercury in these articles when they are in service as of the publication date of 322

this proposed rule would not be covered as a significant new use under this proposed 323
SNUR. Also, use of mercury in portable, battery

- powered, motor

- aspirated 324
psychrometers that contain fewer than 7 grams of mercury is an ongoing use and 325

therefore would not be covered by this SNUR. Due to EPA’s concern about use of 326
mercury in products, the Agency may take other action to facilitate the evaluation or 327
control of ongoing uses, as appropriate. For the portable, battery

- powered, motor

328
aspirated psychrometers that co ntain fewer than 7 grams of mercury, EPA is considering 329
whether risk management or other actions would be appropriate. Use of mercury in 330
manometers used in the natural gas industry would not be affected by this proposed 331
SNUR because they are included in a previous SNUR. ( 75 F R 4 2330, July 21, 2010). 332
Proposed definitions of “barometer,” “manometer,” “hygrometer” and “psychrometer” 333

can be found at 40 CFR 721.10068 of the regulatory text at the end of this proposed rule. 334

This action would amend 40 CFR 721.10 068 and require persons who intend to 335
manufacture or process elemental mercury for a use designated by this proposed rule as a 336
significant new use to notify EPA at least 90 days before commencing the manufacturing 337*** EO 12866 Review Draft

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Page 15 of 29 or processing of elemental mercury for suc h significant new use. The required 338
notification would provide EPA with the opportunity to evaluate the intended use and, if 339
necessary, to prohibit or limit that activity before it occurs. 340
For this SNUR, EPA is proposing not to include the general “arti cle” exemption 341
at 40 CFR 721.45(f). Thus, persons importing or processing elemental mercury 342
(including when part of an article) for a significant new use would be subject to the 343
notification requirements of 40 CFR 721.25. EPA proposes not to include this exemption 344

because barometers, manometers, and hygrometers/psychrometers are articles, and a 345
primary concern associated with this SNUR is potential exposures associated with the 346
lifecycle of these uses. Further, it is possible to reclaim elemental mercury f rom certain 347
articles, which could be used to produce baro meters, manometers, or 348
hygrometers/

p s y ch rometers. EPA notes that, in accordance with TSCA section 12(a) and 349
40 CFR 721.45(g), persons who manufacture or process elemental mercury solely for 350

export w ould be exempt from the notification requirements of 40 CFR 721.25, if when 351
distributing the substance in commerce, it is labeled in accordance with TSCA section 352

12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b) 353

notification r equirements for exported articles ( see 40 CFR 707.60(b)) would remain in 354

force. Thus
, persons who export elemental mercury as part of an article would not be 355
required to provide export noti fication

. 356
EPA believes elemental mercury is no longer used to man ufacture barometers, 357
manometers, and hygrometers/psychrometers (with one exception as discussed) , but 358
some of these articles may remain in service in the United States. T he ongoing use of 359
such articles, including some maintenance and servicing activities, falls outside of the 360
scope of this significant new use rule . Thus, the manufacturing and processing of 361*** EO 12866 Review Draft

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Page 16 of 29 elemental mercury for use in these articles, provided they are in service as of the 362
publication date of this proposed rule, would not be covered by the rule. For example, if 363

an article that is in service as of the publication date of this proposed rule is removed 364
from service for maintenance or servicing, including the addition of new mercury, and 365
then placed back into service, any manufacturing or proc essing of mercury associated 366
with that maintenance or servicing would not be covered by the rule. Otherwise, the 367
addition of new mercury to these existing articles after the effective date of this proposed 368
rule could potentially trigger a significant new use notice under this proposed rule (e.g., if 369
it involved processing of the mercury ) , which is not EPA's intent. 370
IV. Rationale and Objectives 371

A. Rationale 372
As summarized in Unit III.A., EPA has concerns regarding the environmental fate 373
and the exposure pathways of elemental mercury that lead to the presence of 374
methylmercury in fish and the consumption of mercury

- contaminated fish by humans and 375

wildlife. EPA is encouraged by the general discontinuation of the use of elemental 376
mercury in the manufacturing of barometers, manometers, and 377
hygrometers/

p s y chr ometers. However, EPA is concerned that the manufacturing or 378
processing of elemental mercury for the proposed significant new use s could be 379
reinitiated in the future. Accordingly, EPA wants the opportunity to evaluate and control, 380
where appropriate, activities associated with those uses, if such manufacturing or 381
remanufacturing were to occur again. The required notification provided by a SNUN 382
would provide EPA with the opportunity to evaluate activities as sociated with a 383
significant new use and an opportunity to protect against unreasonable risks, if any, from 384

exposure to mercury. 385*** EO 12866 Review Draft

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Page 17 of 29 B. Objectives 386
Based on the considerations in Unit IV.A., EPA has the following objectives with 387
regard to the significant new us es that are designated in this proposed rule: 388
1. EPA would receive notice of any person’s intent to manufacture or process 389
elemental mercury for any of the described significant new uses before that activity 390
begins. 391
2. EPA would have an opportunity to review and evaluate data submitted in a 392

SNUN before the notice submitter begins manufacturing or processing of elemental 393
mercury for any of the described significant new uses. 394
3. EPA would be able to regulate prospective manufacturers or processors of 395

el emental mercury before the described significant new uses of the chemical substance 396
occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. 397
V. Significant New Use Determination 398

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 399
substance is a significant new use must be made after consideration of all relevant factors 400
including: 401
• The projected volume of manufacturing and processing of a chemical substance 402

• The extent to which a use cha nges the type or form of exposure of human 403
beings or the environment to a chemical substance 404

• The extent to which a use increases the magnitude and duration of exposure of 405
human beings or the environment to a chemical substance 406
• The reasonably antici pated manner and methods of manufacturing, processing, 407
distribution in commerce, and disposal of a chemical substance 408

In addition to these factors enumerated in TSCA section 5(a)(2), the statute 409*** EO 12866 Review Draft

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Page 18 of 29 authorizes EPA to consider any other relevant factors. 410

To determine what would constitute a significant new use of elemental mercury
, 411

EPA considered the four factors listed in section 5(a)(2) of TSCA. The latest information 412
available to EPA indicates that there is no ongoing use of elemental mercury in the 413

manuf

acture or remanufacture of barometers, manometers, hygrometers, and all but one 414
type of psychrometer

. Resumption of these uses of elemental mercury could result in a 415
significant increase in the magnitude and duration of exposure to workers and the 416

surroun ding environment at facilities of all types in the lifecycle, as well as an increase in 417
releases which could contribute additional mercury to the atmosphere for long

- range 418

transport . Resumption of these uses could also result in exposures to workers who h ad 419
not previously worked in these facilities when elemental mercury was commonly used, as 420
well as exposures to workers who are not currently being exposed to mercury in the 421

manufacture of barometers, manometers, or hygrometers/psychrometers . Increases in 422
mercury releases could lead to increases in mercury concentrations in the environment 423
and reduction in overall ecosystem and human health from consumption of mercury

424

contaminated fish. 425
EPA believes that any of these renewed uses of elemental mercury would increase 426
the magnitude and duration of exposure to humans and the environment over that which 427

would otherwise exist. Based upon the relevant factors as discussed in this Unit, EPA has 428
preliminarily determined that any manufacturing or processing of elemen tal mercury for 429

use in barometers, manometers, or hygrometers/psychrometers is a significant new use
, 430
except for mercury use in barometers, manometers, and hygro meters /psychrometers 431

when they are in service as of the effective date of this proposed rule ; a nd in portable, 432
battery

- powered, motor

- aspirated psychrometers that contain less than 7 grams of 433*** EO 12866 Review Draft

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Page 19 of 29 elemental mercury. 434

VI. Alternatives 435
Before proposing this SNUR, EPA considered the following alternative regulatory 436

actions: 437
A. Promulgate a TSCA sectio n 8(a) reporting rule

. 438
Under a TSCA section 8(a) rule, EPA could, among other things, generally 439
require persons to report information to the Agency when they intend to manufacture or 440
process a listed chemical for a specific use or any use. However, for elemental mercury 441

used in barom eters, manometers, and hygrometers/ p s y chro meters, the use of TSCA 442
section 8(a) rather than SNUR authority would have several limitations. First, if EPA 443

w ere to require reporting under TSCA section 8(a) instead of TSCA secti on 5(a), EPA 444
would not have the opportunity to review human and environmental hazards and 445
exposures associated with the proposed significant new use and, if necessary, take 446

immediate follow

- up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or 447
limit the activity before it begins. In addition, EPA may not receive important 448
information from small businesses, because such firms generally are exempt from TSCA 449
section 8(a) reporting requirements. In view of the level of health and environmental 450

concerns about elemental mercury, if used for the proposed significant new use, EPA 451

believes that a TSCA section 8(a) rule for this substance would not meet EPA's 452
regulatory objectives. 453
B. Regulate elemental mercury for use in baro meters, manometers, and 454
hygrometers/psychrometers under TSCA section 6. 455
EPA may regulate under TSCA section 6 if "the Administrator finds that there is a 456
reasonable basis to conclude that the manufacture, processing, distribution in commerce, 457*** EO 12866 Review Draft

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Page 20 of 29 use or dis posal of a chemical substance or mixture . . . presents or will present an 458
unreasonable risk of injury to health or the environment." (TSCA section 6(a)). Given 459

that elemental mercury is no longer being used in the manufacture of barometers, 460

manometers, or hygrometers/psychrometers (with the exception of one p s ychrometer)
, 461
EPA concluded that risk management action under TSCA section 6 is not necessary at 462
this time. This proposed SNUR would allow the Agency to address the potential risks 463

associated with t he proposed significant new use

. Note that EPA is also considering 464
whether risk management or other regulatory action may be appropriate for the one 465
remaining psychrometer use. 466

C . Allow the Exemption for Persons that Import or Process Elemental Mercury as Part 467
of Articles that Could be Subject to the SNUR. 468
Under the SNUR exemption provision at 40 CFR 721.45(f), a person who imports 469
or processes a substance covered by a SNUR identified in subpart E of part 721 as part of 470
an article is not generally subjec t to the notification requirements of § 721.25 for that 471
substance. However, EPA is concerned that exempting articles would render the SNUR 472
less effective because of the possibility that barometers, manometers, and 473
hygrometers/psychrometers containing elemen tal mercury could be imported or 474
processed for uses subject to this proposed SNUR without the submission of a SNUN. 475

Because mercury

- containing barom eters, manometers , and hygrometers/ p s y ch rometers 476
are the primary concerns in this SNUR, EPA wishes to includ e not only bulk elemental 477
mercury but also these and other articles when they contain elemental mercury imported 478
or processed for a significant new use . Thus, EPA is proposing to promulgate this rule 479
without the exemption generally provided for in §721.45( f). 480

481*** EO 12866 Review Draft

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Page 21 of 29 VII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 482
As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 483
decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use 484
as a significant new use as of the date of publication of this proposed rule rather than as 485
of the effective date of the final rule. If uses begun after publication of the proposed rule 486
were considered ongoing rather than new, it would be difficult for EPA to establish 487
SNUR notice requirements, because a person could defeat the SNUR by initiating the 488
proposed significant new use before the rule became final, and then argue that the use 489
was ongoing as of the effective date of the final rule. Thus, perso ns who begin 490
commercial manufacture or processing of the chemical substance that would be regulated 491
through this proposed rule
, if finalized
, would have to cease any such activity before the 492

effective date of the rule if and when finalized. To resume thei r activities, these persons 493
would have to comply with all applicable SNUR notice requirements and wait until the 494
notice review period, including all extensions, expires. EPA has promulgated provisions 495
to allow persons to comply with this SNUR before the e ffective date. If a person were to 496
meet the conditions of advance compliance under section 721.45(h), that person would be 497
considered to have met the requirements of the final SNUR for those activities. 498

VIII. Test Data and Other Information 499

EPA reco gnizes that TSCA section 5 does not require the development of any 500
particular test data before submission of a SNUN . There are two exceptions: 1) 501
development of test data is required where the chemical substance subject to the SNUR is 502
also subject to a te st rule under TSCA section 4 (see TSCA section 5(b )(1)); and 2) 503
development of test data may be necessary where the chemical substance has been listed 504

under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 505*** EO 12866 Review Draft

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Page 22 of 29 test rule or a sect ion 5(b)(4) listing covering the chemical substance, p ersons are required 506
only to submit test data in their possession or control and to describe any other data 507
known to or reasonably ascertainable by them (TSCA section 5(d); 40 CFR 721.25 and 508

40 CFR 720.5 0). However, as a general matter, EPA recommends that SNUN submitters 509
include data that would permit a reasoned evaluation of risks posed by the chemical 510
substance during its manufacture
, processing, use, distribution in commerce, or disposal. 511

EPA encour ages persons to consult with the Agency before submitting a SNUN. As part 512
of this optional pre

- notice consultation, EPA would discuss specific data it believes may 513
be useful in evaluating a significant new use. SNUNs submitted for significant new uses 514

wi thout any test data may increase the likelihood that EPA will take action under TSCA 515
section 5(e) to prohibit or limit activities associated with this chemical. 516

SNUN submitters should be aware that EPA will be better able to evaluate 517
SNUNs that provide detailed information on: 518
1. Human exposure and environmental releases that may result from the 519
significant new uses of the chemical substance. 520

2. Potential benefits of the chemical substance. 521

3. Information on risks posed by the chemical substances compared to risks 522
posed by potential substitutes. 523

IX. SNUN Submission s 524

SNUNs must be submitted to EPA on EPA Form No. 7710

- 25 in accordance with 525
the procedures set forth in §§ 721.25 and 720.40

. This form is available from the 526

Environmental Assistance Division, (7408M), 1200 Pennsylvania Ave., NW., 527
Washington, DC 20460

- 0001. Forms and information are also available electronically at 528
http://www.epa.gov/opptintr/newchems. 529*** EO 12866 Review Draft

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Page 23 of 29 X. Economic Analysis 530
EPA has evaluated the potential costs of establishing SNUR r eporting 531
requirements for potential manufacturers and processors of the chemical substance 532
included in this proposed rule (Ref. 1). EPA’s economic analysis (Ref. 1), which is 533
briefly summarized here, is available in the docket for this proposed rule. 534

The costs of submission of a SNUN would not be incurred by any company until 535
a company decides to pursue a significant new use as defined in this proposed SNUR. In 536
the event that a SNUN is submitted, costs are estimated at approximately $8,1 00 p er 537

SNUN submi ssion, and include the cost to prepar e and submit the SNUN , and the 538
payment of a user fee. Businesses that submit a SNUN would be subject to either a 539
$2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with 540

annual sales of less than $40 million when combined with those of the parent company (if 541
any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its evaluation of this rule, 542
EPA also considered the potential costs a company might incur by avoiding or delaying 543

the s ignificant new use in the future, but these costs have not been quantified. 544

XI. References 545
The following document is specifically referenced in the preamble for this 546
rulemaking. In addition to this document, other materials may be available in the doc ket 547
established for this rulemaking under Docket ID No. EPA

- HQ

- OPPT

- 2008

- 0483, which 548
you can access through www.regulations.gov . Those interested in the information 549
considered by EPA in developing this proposed rule, should also consult documents that 550
are referenced in the documents that EPA has placed in the docket, regardless of whether 551
the other documents are physically located in the docket. 552

1. EPA, 20 10

. Economic Analysis of the Proposed Significant New Use Rule for 553*** EO 12866 Review Draft

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Page 24 of 29 Mercury

- Containing Barometers, Manometers, Hygrometers , and Psychrometers, 554
Washington, D.C. OPPT/EETD/EPAB, July 16, 2010

. 555

556

557
III. Statutory and Executive Order Reviews 558
A. Regulatory Planning and Review 559 560 Under Executive Order 12866, entitled Re gulatory Planning and Review (58 FR 561
51735, October 4, 1993), the Office of Management and Budget (OMB) has determined 562
that this action is a "significant regulatory action

. " Accordingly, EPA submitted this 563

action to OMB for review under Executive Order 1286 6 and any changes made in 564
response to OMB recommendations have been documented in the docket for this action 565
as required by section 6(a)(3)(E) of the Executive Order. 566
B. Paperwork Reduction Act 567
According to the Paperwork Reduction Act (PRA), 44 U.S.C . 3501 et seq ., an 568
Agency may not conduct or sponsor, and a person is not required to respond to a 569
collection of information that requires OMB approval under the PRA, unless it has been 570
approved by OMB and displays a currently valid OMB control number. Th e OMB 571
control numbers for certain EPA regulations in title 40 of the CFR, after appearing in the 572
Federal Register , are listed in 40 CFR part 9, and included on the related collection 573
instrument, or form, if applicable. 574
The information collection require ments related to this action have already been 575
approved by OMB pursuant to the PRA under OMB control number 2070

- 0038 (EPA 576
ICR No. 1188). This action does not impose any burden requiring additional OMB 577
approval. If an entity were to submit a SNUN to the Agency, the annual burden is 578*** EO 12866 Review Draft

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Page 25 of 29 estimated to average 97 hours per response. This burden estimate includes the time 579
needed to review instructions, search existing data sources, gather and maintain the data 580
needed, and complete, review, and submit the required SNUN. 581
Send any comments about the accuracy of the burden estimate, and any suggested 582
methods for minimizing respondent burden to the Director, Collection Strategies 583

Division, Office of Environmental Information (2822T), Environmental Protection 584
Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460

- 0001. Please 585
remember to include the OMB control number in any correspondence, but do not submit 586
any completed forms to this address. 587
C. Small Entity Impacts 588
Pursuant to section 605(b) of the Regulat ory Flexibility Act (RFA) (5 U.S.C. 601 589

et seq .), the Agency hereby certifies that promulgation of this SNUR would not have a 590
significant adverse economic impact on a substantial number of small entities. The 591
rationale supporting this conclusion is as fol lows. 592
Under the RFA, small entities include small businesses, small organizations, and 593
small governmental jurisdictions. S mall entity is defined in accordance with section 601 594

of the RFA as: A small business as defined by the Small Business Administra tion’s 595
(SBA) regulations at 13 CFR 121.201 ; A small governmental jurisdiction that is a 596
government of a city, county, town, school district or special district with a population of 597

les s than 50,000; and A small organization that is any not

- for

- profit enterprise which is 598
independently owned and operated and is not dominant in its field. For purposes of 599
assessing the impacts of this proposed rule on small entities, EPA has determined that 600
this proposed rule is not expected to impact any small not

- for

- profit organizations or 601
small governmental jurisdictions. As such, the Agency estimated potential impacts on 602*** EO 12866 Review Draft

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Page 26 of 29 small business. 603
A SNUR applies to any person (including small or large entities) who intends to 604
engage in any activity described in the rule as a "signi ficant new use." By definition of 605
the word "new," and based on all information currently available to EPA, it appears that 606
no small or large entities presently engage in such activity. Since this proposed SNUR 607
would require a person who intends to engage in such activity in the future to first notify 608
EPA by submitting a SNUN, no economic impact will occur unless someone files a 609
SNUN to pursue a significant new use in the future or forgoes profits by avoiding or 610
delaying the significant new use. Although some small entities may decide to conduct 611
such activities in the future, EPA cannot presently determine how many, if any, there 612
may be. However, EPA's experience to date is that, in response to the promulgation of 613
over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those 614
SNUNs submitted, only one appears to be from a small entity in response to any SNUR. 615
Therefore, EPA believes that the potential economic impact of complying with a SNUR 616
is not expected to be significant or advers ely impact a substantial number of small 617
entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690)(FRL

618

5735

- 4), the Agency presented its general determination that proposed and final SNURs 619
are not expected to have a significant ec onomic impact on a substantial number of small 620
entities, which was provided to the Chief Counsel for Advocacy of the Small Business 621

Administration. 622
D. Unfunded Mandates 623
Based on EPA's experience with proposing and finalizing SNURs, State, local, 624

and Tri bal governments have not been impacted by these rulemakings, and EPA does not 625
have any reason to believe that any State, local, or Tribal government would be impacted 626*** EO 12866 Review Draft

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Page 27 of 29 by this rulemaking. As such, EPA has determined that this regulatory action would not 627
imp ose any enforceable duty, contain any unfunded mandate, or otherwise have any 628
effect on small governments subject to the requirements of sections 202, 203, 204, or 205 629

of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531

- 1538). 630

E. Federalism 631
This action would not have federalism implications because it is not expected to 632
have a substantial direct effect on States, on the relationship between the national 633
government and the States, or on the distribution of power and responsibilities among the 634
various levels of government, as specified in Executive Order 13132, entitled Federalism 635
(64 FR 43255, August 10, 1999). 636

F. Indian Tribal Governments 637
This action would not have tribal implications as specified in Executive Order 638

13175, entitled Consulta tion and Coordination with Indian Tribal Governments (65 FR 639
67249, November 9, 2000). This action is not expected to have substantial direct effects 640
on Indian Tribes, would not significantly or uniquely affect the communities of Indian 641
Tribal governments, and would not involve or impose any requirements that affect Indian 642
Tribes. Thus, Executive Order 13175 does not apply to this action. 643
G. Protection of Children 644
EPA interprets Executive Order 13045, entitled Protection of Children from 645

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 646
only to those regulatory actions that concern health or safety risks, such that the analysis 647
required under section 5

- 501 of the Executive Order has the potential to influence the 648

re gulation. This action is not subject to Executive Order 13045 because it would not 649
establish an environmental standard intended to mitigate health or safety risks. 650*** EO 12866 Review Draft

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Page 28 of 29 H. Effect on Energy Supply, Distribution, or Use 651
This action is not a “significant energy action” as defined in Executive Order 652

13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, 653

Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not likely to 654
have a significant adverse effect on the s upply, distribution, or use of energy. 655

I. Technical Standards 656
Because this action would not involve any technical standards, section 12(d) of 657
the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 658

104

- 113, Section 12(d) (15 U.S. C. 272 note), does not apply to this action. 659

J. Environmental Justice 660
This action would not entail special considerations of environmental justice 661
related issues as delineated by Executive Order 12898, entitled Federal Actions to 662

Address Environmental J ustice in Minority Populations and Low

- Income Populations (59 663
FR 7629, February 16, 1994). 664
List of Subjects in 40 CFR Part 721 665
Environmental protection, Chemicals, Hazardous substances, Reporting and 666
recordkeeping requirements. 667

668

Dated: ________

___________ _ 669

_______________ ___________________________ 670

Director, Office of Pollution Prevention and Toxics 671 672 673

674*** EO 12866 Review Draft

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Page 29 of 29 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 675
1. The authority citation for part 721 continue s to read as follows: 676
Authority: 1 5 U.S.C. 2604, 2607, and 2625(c)

. 677

2. By amending § 721.10068 by adding additional definitions to paragraph (a) and 678
adding a new paragraph (b)(2)(viii) to read as follows : 679
§ 721.10068 Elemental mercury. 680

( a) * * * 681

Barometer means an instrument used in various applications to measure 682
atmospheric pressure. 683

Manometer means an instrument used in various applications to measure pressure 684
of gases or liquids. 685
Hygrometer or psychrometer means an instrument used in various applications to 686
measure humidity of gases. 687

(b) * * * 688

(2 ) * * * 689

(viii) Manufacturing or processing of elemental mercury for use in barometers, 690
manometers, hygrometers, and psychrometers except for: natural gas manometers 691
covered by paragraph (b)(2)(vii) of this section ; barometers, manometers, hygrometers, 692
and psychrometers when these articles are in service as of [ insert date of publication of 693
the proposed rule ]; and portable battery powered and motor

- aspirated psychrometers that 694
contain fewer than 7 grams of elemental mercury. 695

[FR Doc. ??

– ????? Filed ??

– ??

– ??; ?:?? a.m.] 696