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1 EO12866_MercurySNURMercury-SNUR-3-NPRM_2010-11-08.docrevised_2011-04-07.docx

2

3 Revised to address Interagency Comments received under EO 12866 Review.

4 BILLING CODE 6560–50–P

5 ENVIRONMENTAL PROTECTION AGENCY

6 40 CFR Part 721

7 [EPA–HQ–OPPT–2008–0483; FRL–XXXX–X]

8 RIN 2070-AJ71

9 Elemental Mercury Used in Barometers, Manometers, Hygrometers, and 

10 Psychrometers; Significant New Use Rule

11 AGENCY: Environmental Protection Agency (EPA).

12 ACTION: Proposed rule.

13 SUMMARY: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) 

14 of the Toxic Substances Control Act (TSCA) for elemental mercury for use in 

15 barometers, manometers, and hygrometers/psychrometers. This action would require 

16 persons who intend to manufacture (including import) or process elemental mercury for

17 an activity that is designated as a significant new use by this proposed rule to notify EPA 

18 at least 90 days before commencing that activity. The required notification would 

19 provide EPA with the opportunity to evaluate the intended use and, if necessary, to 

20 prohibit or limit that activity before it occurs. Not included in this proposed SNUR is 

21 mercury use in barometers, manometers, and hygrometers/psychrometers when they are

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

23 battery-powered, motor-aspirated psychrometers that contain fewer than 7seven grams of 

24 elemental mercury because they are currently manufactured. For this proposed rule, the 

25 general SNUR exemption for persons that import or process chemical substances as part 
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26 of an article at 40 CFR 721.45(f) would not apply. 

27

28 DATES: Comments must be received on or before [insert date 60 days after date of 

29 publication in the Federal Register].

30 ADDRESSES: Submit your comments, identified by docket identification (ID) number 

31 EPA–HQ–OPPT–2008-0483, by one of the following methods:

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

33 instructions for submitting comments.

34 • Mail: Document Control Office (7407M), Office of Pollution Prevention and 

35 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

36 Washington, DC 20460–0001.

37 • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 

38 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 

39 EPA–HQ–OPPT–2008-0483. The DCO is open from 8 a.m. to 4 p.m., Monday through 

40 Friday, excluding legal holidays. The telephone number for the DCO is (202) 564–8930. 

41 Such deliveries are only accepted during the DCO’s normal hours of operation, and 

42 special arrangements should be made for deliveries of boxed information.

43 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–2008-

44 0483. EPA's policy is that all comments received will be included in the docket without 

45 change and may be made available on-line at http://www.regulations.gov, including any 

46 personal information provided, unless the comment includes information claimed to be 

47 Confidential Business Information (CBI) or other information whose disclosure is 

48 restricted by statute. Do not submit information that you consider to be CBI or otherwise 

49 protected through regulations.gov or e-mail. The regulations.gov website is an 
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50 “anonymous access” system, which means EPA will not know your identity or contact 

51 information unless you provide it in the body of your comment. If you send an e-mail 

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

53 will be automatically captured and included as part of the comment that is placed in the 

54 docket and made available on the Internet. If you submit an electronic comment, EPA 

55 recommends that you include your name and other contact information in the body of 

56 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 

57 comment due to technical difficulties and cannot contact you for clarification, EPA may 

58 not be able to consider your comment. Electronic files should avoid the use of special 

59 characters, any form of encryption, and be free of any defects or viruses.

60 Docket: All documents in the docket are listed in the docket index available at 

61 http://www.regulations.gov. Although listed in the index, some information is not 

62 publicly available, e.g., CBI or other information whose disclosure is restricted by statute. 

63 Certain other material, such as copyrighted material, will be publicly available only in 

64 hard copy. Publicly available docket materials are available electronically at 

65 http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The 

66 OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West

67 Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading 

68 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 

69 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202)

70 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket 

71 visitors are required to show photographic identification, pass through a metal detector,

72 and sign the EPA visitor log. All visitor bags are processed through an X-ray machine

73 and subject to search. Visitors will be provided an EPA/DC badge that must be visible at 
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74 all times in the building and returned upon departure.

75 FOR FURTHER INFORMATION CONTACT: For technical information contact:

76 Sue Slotnick, National Program Chemicals Division, Office of Pollution Prevention and 

77 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 

78 DC 20460–0001; telephone number: (202) 556–1973; e-mail address: 

79 slotnick.sue@epa.gov.

80 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South 

81 Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: 

82 TSCA-Hotline@epa.gov.

83 SUPPLEMENTARY INFORMATION:

84 I. General Information

85 A. Does this Action Apply to Me?

86 You may be potentially affected by this action if you manufacture (defined by 

87 statute to include import) or process elemental mercury used in barometers, manometers, 

88 or hygrometers/psychrometers. Potentially affected entities may include, but are not 

89 limited to:

90 • Manufacturers of instruments and related products for measuring, displaying, 

91 and controlling industrial process variables (North American Industrial Classification 

92 System (NAICS) code 334513)

93 This listing is not intended to be exhaustive, but rather provides a guide for 

94 readers regarding entities likely to be affected by this action. Other types of entities not 

95 listed in this unit could also be affected. The North American Industrial Classification 

96 System (NAICS) codes have been provided to assist you and others in determining 

97 whether this action might apply to certain entities. If you have any questions regarding 
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98 the applicability of this action to a particular entity, consult the technical person listed 

99 under FOR FURTHER INFORMATION CONTACT.

100 This action may also affect certain entities through pre-existing import 

101 certification and export notification rules under TSCA. Persons who import any 

102 chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 

103 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 

104 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that 

105 the shipment of the chemical substance complies with all applicable rules and orders 

106 under TSCA, including any SNUR requirements. The EPA policy in support of import 

107 certification appears at 40 CFR part 707, subpart B. In addition, any persons who export 

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

109 after [insert date 30 days after the date of publication in the Federal Register] are subject 

110 to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 

111 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 

112 707, subpart D. Note that as of January 1, 2013, the Mercury Export Ban Act of 2008 

113 prohibits the export of elemental mercury from the United States (see TSCA section 

114 12(c) (15 U.S.C. 2611(c)).

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

116 1. Submitting CBI. Do not submit this information to EPA through

117 regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 

118 to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 

119 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 

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

121 version of the comment that includes information claimed as CBI, a copy of the comment 
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122 that does not contain the information claimed as CBI must be submitted for inclusion in 

123 the public docket. Information so marked will not be disclosed except in accordance with 

124 procedures set forth in 40 CFR part 2.

125 2. Tips for preparing your comments. When submitting comments, remember to:

126 i. Identify the document by docket ID number and other identifying information 

127 (subject heading, Federal Register date and page number).

128 ii. Follow directions. The Agency may ask you to respond to specific questions or 

129 organize comments by referencing a Code of Federal Regulations (CFR) part or section 

130 number.

131 iii. Explain why you agree or disagree; suggest alternatives and substitute 

132 language for your requested changes.

133 iv. Describe any assumptions and provide any technical information and/or data 

134 that you used.

135 v. If you estimate potential costs or burdens, explain how you arrived at your 

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

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

138 vii. Explain your views as clearly as possible, avoiding the use of profanity or 

139 personal threats.

140 viii. Make sure to submit your comments by the comment period deadline 

141 identified.

142 II. Background

143 A. What Action is the Agency Taking?

144 This proposed SNUR would require persons to notify EPA at least 90 days before 

145 commencing the manufacture, import, or processing of elemental mercury for any of the 
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146 following significant new uses: barometers, manometers, and 

147 hygrometers/psychrometers. Not included in this proposed rule are barometers,

148 manometers, and hygrometers/psychrometers when they are in service as of the 

149 publication date of this proposed rule. Also not included in this proposal is the ongoing 

150 use of mercury in the manufacture, import, or processing of portable battery-powered 

151 motor-aspirated psychrometers that contain fewer than 7seven grams of elemental 

152 mercury because they are currently manufactured. Sphygmomanometers and other 

153 “devices” as defined under section 201 of the Federal Food, Drug, and Cosmetics Act 

154 would not be affected by this proposed rule when manufactured, imported, or processed 

155 for use as a device. See TSCA 3(2)(B)(vi). Finally, manometers used in the natural gas 

156 industry would not be affected by this rule because they were included in a previous 

157 SNUR (75 FR 42330, July 21, 2010). 

158 B. What is the Agency's Authority for Taking this Action?

159 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that 

160 a use of a chemical substance is a "significant new use." EPA must make this 

161 determination by rule after considering “all relevant factors, including those listed in 

162 TSCA section 5(: 

163 • The projected volume of manufacturing and processing of a chemical 

164 substance,

165 • The extent to which a use changes the type or form of exposure of human 

166 beings or the environment to a chemical substance,

167 • The extent to which a use increases the magnitude and duration of exposure of

168 human beings or the environment to a chemical substance, and

169 • The reasonably anticipated manner and methods of manufacturing, processing,
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170 distribution in commerce, and disposal of a chemical substance.” 

171 In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes 

172 EPA to consider any other relevant factors.)(2).

173 . Once EPA determines that a use of a chemical substance is a significant new use, 

174 TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) 

175 to EPA at least 90 days before they manufacture or process the chemical substance for 

176 that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit II.C., the general SNUR 

177 provisions are found at 40 CFR Part 721, Subpart A. 

178 C. Applicability of General Provisions

179

180 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 

181 provisions describe persons subject to the rule, recordkeeping requirements, exemptions 

182 to reporting requirements, and applicability of the rule to uses occurring before the 

183 effective date of the final rule. However, 40 CFR 721.45(f) would not apply to this 

184 proposed SNUR. As a result, persons subject to the provisions of this proposed rule 

185 would not be exempt from significant new use reporting if they import or process 

186 elemental mercury as part of an article (see 40 CFR 721.5). Conversely, the exemption 

187 from notification requirements for exported articles (see 40 CFR 707.60(b)) would 

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

189 not be required to provide export notification.

190 Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 

191 721.1(c), persons subject to SNURs must comply with the same notice requirements and 

192 EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under 

193 TSCA section 5(a)(1)(A). In particular, these requirements include the information 

194 submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by 
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195 TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. 

196 Once EPA receives a SNUN, the Agency may take regulatory action under TSCA section 

197 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA 

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

199 Federal Register its reasons for not taking action.

200 Persons who export or intend to export a chemical substance identified in a 

201 proposed or final SNUR are subject to the export notification provisions of TSCA section 

202 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 

203 subpart D. Persons who import a chemical substance identified in a final SNUR are 

204 subject to the TSCA section 13 import certification requirements, codified at 19 CFR 

205 12.118 through 12.127; see also 19 CFR 127.28. Such persons must certify that the 

206 shipment of the chemical substance complies with all applicable rules and orders under 

207 TSCA, including any SNUR requirements. The EPA policy in support of import 

208 certification appears at 40 CFR part 707, subpart B.

209 III. Summary of Proposed Rule

210 A. Overview of Mercury and Mercury Uses

211 1. Mercury. This proposed rule applies to elemental mercury (CAS No. 7439–

212 97–6), which is a naturally occurring element. Because of its unique properties (e.g., 

213 exists as a liquid at room temperature and forms amalgams with many metals), elemental 

214 mercury has been used in many industrial processes and consumer products. In addition 

215 to its useful characteristics, mercury also is known to cause adverse health effects in 

216 humans and wildlife. These effects can vary depending on the form of mercury to which 

217 a person or animal is exposed, as well as the magnitude, duration, and frequency of 

218 exposure. 
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219 The most prevalent human and wildlife exposure to mercury results from 

220 ingesting fish contaminated with methylmercury. Methylmercury is an organo-metallic

221 compound that is formed via the conversion of elemental or inorganic mercury 

222 compounds by certain microorganisms and other natural processes. For example, 

223 elemental mercury may evaporate and be emitted into the atmosphere. Atmospheric 

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

225 washed into surface waters via overland run-off. Once deposited in sediments, certain 

226 microorganisms and other natural processes can convert elemental mercury into 

227 methylmercury. Methylmercury bioaccumulates, which means that it is taken up and 

228 concentrated in the tissues of aquatic, mammalian, avian, and other wildlife. 

229 Methylmercury is a highly toxic substance; a number of adverse health effects associated 

230 with exposure to it have been identified in humans and in animal studies. Most extensive 

231 are the data on neurotoxicity, particularly in developing organisms. Fetuses, infants, and 

232 young children generally are more sensitive to methylmercury’s neurological effects than 

233 adults.

234 In 2004, EPA and the Food and Drug Administration (FDA) issued a national 

235 consumption advisory concerning mercury in fish. The advisory contains recommended 

236 limits on the amount of certain types of fish and shellfish that pregnant women and young 

237 children can safely consume. By 2005, all fifty states had issued fish consumption 

238 advisories for fish from certain water bodies known to be contaminated by 

239 methylmercury http://www.epa.gov/mercury/advisories.htm.

240 In addition to methylmercury, exposure to elemental mercury can also pose health 

241 risks. Elemental mercury primarily causes health effects when it is breathed as a vapor

242 that can be absorbed through the lungs. These exposures can occur when elemental 
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243 mercury is spilled or products that contain elemental mercury break, resulting in release 

244 of mercury to the air, particularly in warm or poorly-ventilated indoor spaces. 

245 For a more detailed summary of background information (e.g., chemistry, 

246 environmental fate, exposure pathways, and health and environmental effects), as well as 

247 references pertaining to elemental mercury that EPA considered before proposing this 

248 rule, please refer to EPA’s proposed SNUR for mercury switches in motor vehicles, 

249 issued in the Federal Register of July 11, 2006, or in the docket for the 2006 proposal 

250 under docket identification number EPA-HQ-OPPT-2005-0036. All documents in the 

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

252 2. Mercury uses. Elemental mercury has been used in thousands of products and 

253 applications. Over the past two decades, there has been a dramatic drop in elemental 

254 mercury use by industries in the United States. In response to increased concerns about 

255 exposure to anthropogenic sources of mercury in the environment and also because of the 

256 availability of suitable mercury-free products, Federal and State governments have made 

257 efforts to limit the use of elemental mercury in certain products. Various states have 

258 banned or restricted the manufacture or sale of products containing mercury. While this 

259 is not the rationale for this proposed rule, it does indicate that the transition to cost260 effective non-mercury containing alternatives is already established. See

261 http://www.epa.gov/epawaste/hazard/tsd/mercury/laws.htm. 

262 On October 7, 2007, EPA issued a final SNUR for elemental mercury used in 

263 convenience light switches, anti-lock braking system switches, and active ride control 

264 system switches in certain motor vehicles (72 FR 56903, July 11, 2006). EPA 

265 promulgated another SNUR for flow meters, natural gas manometers, and pyrometers on 

266 July 21, 2010 (75 FR 42330). For more information on EPA is also considering 
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267 regulatory actionsactivities on mercury in products that are currently manufacturedand 

268 other areas, see www.epa.gov/hg. 

269 In the past, elemental mercury was used in the manufacture of barometers,

270 manometers, and hygrometers/psychrometers. The latest information available to EPA 

271 indicates that the manufacture (including import) of these mercury-containing articles has

272 ceased (with the exception of one psychrometer as described at Unit III.A.5.). EPA also 

273 has found that all three products subject to the proposed SNUR currently have effective 

274 and economically feasible substitutes (ref 1). EPA requests comments on whether 

275 elemental mercury continues to be used in manufacturing (including importing into the 

276 U.S.) barometers, manometers, or hygrometers/psychrometers. EPA also requests 

277 comment on whether elementary mercury is being used in the remanufacturing of any of 

278 these articles that remain in use. 

279 3. Barometers containing elemental mercury. Barometers are instruments which 

280 measure atmospheric pressure. Mercury barometers were manufactured as a long 

281 cylindrical tube, typically closed at one end, with a mercury-filled reservoir at the base. 

282 The weight of mercury created a vacuum at the top of the tube, and the mercury adjusted 

283 until the pressure inside the reservoir equaled the atmospheric pressure. Rising mercury 

284 indicated increasing air pressure while dropping mercury indicated decreasing air 

285 pressure. Historically, mercury barometers were used in applications where measuring 

286 and monitoring changes in air pressure are important, such as weather stations, airports, 

287 and ships. Additional uses include scientific demonstration in schools and non-mercury 

288 device calibration. A mercury barometer contains between 400 and 620 grams of 

289 mercury (Ref.1).

290 Alternatives to mercury-containing barometers include aneroid, electronic, and 
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291 other liquid-based (water or eco-celli) barometers. At least eight states have banned the 

292 sale of mercury-containing barometers. EPA found sufficient information to conclude 

293 that mercury-containing barometers are no longer manufactured in or imported into the 

294 U.S. (Ref.1).

295 4. Manometers containing elemental mercury. A manometer is an instrument 

296 used to measure pressure of gases or liquids. Mercury-containing manometers were 

297 manufactured for use in sectors such as dairy farms, Heating Ventilationheating 

298 ventilation and Air Conditioning/Plumbing Installationair conditioning/plumbing 

299 installation and Repair, Auto/Motorcycle Industryrepair, auto/motorcycle industry, 

300 laboratories; and in general industrial uses. The amount of mercury used in a single 

301 manometer ranged between approximately 150 kg30 grams and 525 kggrams (Ref. 1).

302 Alternatives to mercury manometers include hydrostatic gauges using mercury303 free liquid, aneroid manometers, needle-bourdon gauges and digital manometers. At 

304 least five states have banned the sale of mercury-containing manometers, and four 

305 additional states have banned the sale of mercury-containing dairy manometers (Ref. 1 ). 

306 EPA found sufficient information to conclude that mercury-containing manometers are 

307 no longer manufactured in or imported into the U.S. (Ref. 1). 

308 5. Hygrometers/psychrometers containing elemental mercury. Hygrometers are 

309 instruments used to measure relative humidity (i.e., the moisture content of the air). 

310 Psychrometers, which are the most common type of hygrometer, use two mercury-added 

311 thermometers, one with a wetted base, and one with a dry base. Hygrometers and 

312 psychrometers function similarly; however, they are used in different applications. 

313 Historically, mercury-containing hygrometers were used for cigar and tobacco humidors, 

314 or in residential settings, while mercury-containing psychrometers were used by 
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315 atmospheric scientists and weather enthusiasts. The amount of mercury in a single 

316 hygrometer or psychrometer was between three and seven grams. 

317 There are two types of alternatives to mercury-added hygrometers that are readily 

318 available and widely used: spirit-filled devices, which use methyl alcohol or citrus oil 

319 thermometers and provide results with comparable accuracy to mercury-added 

320 thermometers; and digital devices, which use electronic sensors to measure humidity 

321 changes and, when calibrated properly, provide results that are as accurate results as 

322 mercury devices.

323 Seven states have banned the sale and distribution of mercury-containing hygrometers 

324 and psychrometers and three additional states have general phase-outs of mercury-added 

325 products. EPA found sufficient information to conclude that only one type of mercury326 containing hygrometer/psychrometer is manufactured in or imported into the U.S. 

327 Portable, battery-powered, motor-aspirated psychrometers containing fewer than 7seven

328 grams of elemental mercury continue to be manufactured in the U.S. (Ref. 1). EPA is 

329 considering whether risk management or other actions would be appropriate for the one 

330 type of psychrometer that is still in use.

331 6. Potential exposure and release. The typical lifecycle of barometers, 

332 manometers, and hygrometers/psychrometers includes several stages: manufacture, 

333 distribution in commerce, use, and waste management (landfilling or recycling). At any 

334 point in the lifecycle, there is potential for mercury to be released as liquid or vapor. 

335 Workers and others can be exposed to the mercury and it can be released into water, air, 

336 or onto land as the mercury is transported, stored, and handled during manufacturing. 

337 While the barometers, manometers, and hygrometers/psychrometers are in use, the 

338 mercury can vaporize or spill due to breakage during transport, installation, maintenance, 
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339 refilling, or repair. Other opportunities for release can occur at the end of the lifecycle of 

340 barometers, manometers, and hygrometers/psychrometers as these devices are removed 

341 from equipment and facilities, and handled during waste management.

342 B. Proposed Action 

343 EPA is proposing to designate as significant new uses the use of elemental 

344 mercury in barometers, manometers, and hygrometers/psychrometers. However, use of 

345 elemental mercury in these articles when they are in service as of the publication date of 

346 this proposed rule would not be covered as a significant new use under this proposed 

347 SNUR. Also, use of mercury in portable, battery-powered, motor-aspirated 

348 psychrometers that contain fewer than 7seven grams of mercury is an ongoing use and 

349 therefore would not be covered by this SNUR. Due to EPA’s concern about use of 

350 mercury in products, the Agency may take other action to facilitate the evaluation or 

351 control of ongoing uses, as appropriate. For the portable, battery-powered, motor352 aspirated psychrometers that contain fewer than 7seven grams of mercury, EPA is 

353 considering whether risk management or other actions would be appropriate. Use of 

354 mercury in manometers used in the natural gas industry would not be affected by this 

355 proposed SNUR because they are included in a previous SNUR. (75 FR 42330, July 21, 

356 2010). Proposed definitions of “barometer,” “manometer,” “hygrometer” and 

357 “psychrometer” can be found at 40 CFR 721.10068 of the regulatory text at the end of 

358 this proposed rule. 

359 This action would amend 40 CFR 721.10068 and require persons who intend to 

360 manufacture or process elemental mercury for a use designated by this proposed rule as a

361 significant new use to notify EPA at least 90 days before commencing the manufacturing 

362 or processing of elemental mercury for such significant new use. The required 
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363 notification would provide EPA with the opportunity to evaluate the intended use and, if 

364 necessary, to prohibit or limit that activity before it occurs. 

365 For this SNUR, EPA is proposing not to include the general “article” exemption 

366 at 40 CFR 721.45(f). Thus, persons importing or processing elemental mercury 

367 (including when part of an article) for a significant new use would be subject to the 

368 notification requirements of 40 CFR 721.25. EPA proposes not to include this exemption 

369 because barometers, manometers, and hygrometers/psychrometers are articles, and a 

370 primary concern associated with this SNUR is potential exposures associated with the 

371 lifecycle of these uses. Further, it is possible to reclaim elemental mercury from certain 

372 articles, which could be used to produce barometers, manometers, or 

373 hygrometers/psychrometers. EPA notes that, in accordance with TSCA section 12(a) and 

374 40 CFR 721.45(g), persons who manufacture or process elemental mercury solely for 

375 export would be exempt from the notification requirements of 40 CFR 721.25, if when 

376 distributing the substance in commerce, it is labeled in accordance with TSCA section 

377 12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b) 

378 notification requirements for exported articles (see 40 CFR 707.60(b)) would remain in 

379 force. Thus, persons who export elemental mercury as part of an article would not be 

380 required to provide export notification.

381 EPA believes elemental mercury is no longer used to manufacture barometers, 

382 manometers, and hygrometers/psychrometers (with one exception as discussed), but 

383 some of these articles may remain in service in the United States. The ongoing use of 

384 such articles, including some maintenance and servicing activities, falls outside of the 

385 scope of this significant new use rule. Thus, the manufacturing and processing of 

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

388 an article that is in service as of the publication date of this proposed rule is removed 

389 from service for maintenance or servicing, including the addition of new mercury, and 

390 then placed back into service, any manufacturing or processing of mercury associated 

391 with that maintenance or servicing would not be covered by the rule. Otherwise, the 

392 addition of new mercury to these existing articles after the effective date of this proposed 

393 rule could potentially trigger a significant new use notice under this proposed rule (e.g., if 

394 it involved processing of the mercury), which is not EPA's intent. 

395 IV. Significant New Use DeterminationRationale and Objectives

396 A. Rationale

397 As summarized in Unit III.A., EPA has concerns regarding the environmental fate 

398 and the exposure pathways of elemental mercury that lead to the presence of 

399 methylmercury in fish and the consumption of mercury-contaminated fish by humans and 

400 wildlife. EPA is encouraged by the general discontinuation of the use of elemental 

401 mercury in the manufacturing of barometers, manometers, and 

402 hygrometers/psychrometers. However, EPA is concerned that the manufacturing or 

403 processing of elemental mercury for the proposed significant new uses could be 

404 reinitiated in the future. Accordingly, EPA wants the opportunity to evaluate and control, 

405 where appropriate, activities associated with those uses, if such manufacturing or 

406 remanufacturing were to occur again. The required notification provided by a SNUN 

407 would provide EPA with the opportunity to evaluate activities associated with a 

408 significant new use and an opportunity to protect against unreasonable risks, if any, from 

409 exposure to mercury.

410 Consistent with EPA’s past practice for issuing SNURs under TSCA Section 
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411 5(a)(2), EPA’s decision to propose a SNUR for a particular chemical use need not be 

412 based on an extensive evaluation of the hazard, exposure, or potential risk associated with 

413 that use. Rather, the Agency’s action is based on EPA’s determination that if the use 

414 begins or resumes, it may present a risk that EPA should evaluate under TSCA before the 

415 manufacturing or processing for that use begins. Since the new use does not currently 

416 exist, deferring a detailed consideration of potential risks or hazards related to that use is 

417 an effective use of resources. If a person decides to begin manufacturing or processing 

418 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 

419 the specific parameters and circumstances surrounding that intended use.

420 B. Objectives

421 Based on the considerations in Unit IV.A., EPA has the following objectives with 

422 regard to the significant new uses that are designated in this proposed rule:

423 1. EPA would receive notice of any person’s intent to manufacture or process 

424 elemental mercury for any of the described significant new uses before that activity 

425 begins.

426 2. EPA would have an opportunity to review and evaluate data submitted in a

427 SNUN before the notice submitter begins manufacturing or processing of elemental

428 mercury for any of the described significant new uses.

429 3. EPA would be able to regulate prospective manufacturers or processors of 

430 elemental mercury before the described significant new uses of the chemical substance 

431 occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.

432 V. C. Relevant Factors Considered for this SNUR

433 Significant New Use Determination

434 Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 
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435 substance is a significant new use must be made after consideration of all relevant factors

436 including:(see further detail at Unit II. B.).

437 • The projected volume ofEPA has preliminarily determined that manufacturing 

438 andor processing of a chemical substance

439 • The elemental mercury for use in barometers, manometers, or 

440 hygrometers/psychrometers is a significant new use. This determination is based on the 

441 following factor in TSCA section 5(a)(2): “the extent to which a use changesincreases the 

442 type or formmagnitude and duration of exposure of human beings or the environment to a 

443 chemical substance

444 • The extent to which a use increases the magnitude and duration of exposure of

445 human beings or the environment to a chemical substance

446 • The reasonably anticipated manner and methods of manufacturing, processing,

447 distribution in commerce, and disposal of a chemical substance 

448 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 

449 authorizes EPA to consider any other relevant factors.

450 To determine what would constitute a.” Increased exposure to mercury is

451 significant new usebecause of elemental mercury, EPA considered the four factors listed 

452 in section 5(a)(2) of TSCA.adverse health effects described at Unit III.A.1. The latest 

453 information available to EPA indicates that there is no ongoing use of elemental mercury 

454 in the manufacture or remanufacture of barometers, manometers, hygrometers, and all but 

455 one type of psychrometer. Resumption of these uses of elemental mercury could result in 

456 a significant increase in the magnitude and duration of exposure to workers and the 

457 surrounding environment at facilities of all types involved in the lifecycle of the products, 

458 as well as an increasedescribed in greater detail in Unit III. A. 6. Increase in releases
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459 which could contribute additional mercury to the atmosphere for long-range transport. 

460 Resumption of these uses could also result in exposures to workers who had not 

461 previously worked in these facilities when elemental mercury was commonly used, as 

462 well as exposures to workers who are not currently being exposed to mercury in the 

463 manufacture of barometers, manometers, or hygrometers/psychrometers. Increases in 

464 mercury releases could lead to increases in mercury concentrations in the environment 

465 and reduction in overall ecosystem and human health from consumption of mercury466 contaminated fish. 

467 EPA believes that any of these renewed uses of elemental mercury would increase 

468 the magnitude and duration of exposure to humans and the environment over that which 

469 would otherwise exist. Based upon the relevant factors as discussed in this Unit Thus,

470 EPA has preliminarily determined that any manufacturing or processing of elemental 

471 mercury for use in barometers, manometers, or hygrometers/psychrometers is a 

472 significant new use, except for mercury use in barometers, manometers, and 

473 hygrometers/psychrometers when they are in service as of the effective date of this 

474 proposed rule; and in portable, battery-powered, motor-aspirated psychrometers that 

475 contain less than 7seven grams of elemental mercury. 

476 VID. Request for Comment

477 EPA welcomes comment on all aspects of this proposed rule, including comments 

478 on the basis for the significant new use determinations presented for this proposed rule.

479 V. Alternatives

480 Before proposing this SNUR, EPA considered the following alternative regulatory 

481 actions:. 

482 A. Promulgate a TSCA section 8(a) reporting rule. 
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483 Under a TSCA section 8(a) rule, EPA could, among other things, generally 

484 require persons to report information to the Agency when they intend to manufacture or 

485 process a listed chemical for a specific use or any use. However, for elemental mercury 

486 used in barometers, manometers, and hygrometers/psychrometers, the use of TSCA 

487 section 8(a) rather than SNUR authority would have several limitations. First, if EPA 

488 were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA 

489 would not have the opportunity to review human and environmental hazards and 

490 exposures associated with the proposed significant new use and, if necessary, take 

491 immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or 

492 limit the activity before it begins. In addition, EPA may not receive important 

493 information from small businesses, because such firms generally are exempt from TSCA 

494 section 8(a) reporting requirements. In view of the level of health and environmental 

495 concerns about elemental mercury, if used for the proposed significant new useuses, EPA 

496 believes that a TSCA section 8(a) rule for this substance would not meet EPA's 

497 regulatory objectives. 

498 B. Regulate elemental mercury for use in barometers, manometers, and 

499 hygrometers/psychrometers under TSCA section 6. 

500 EPA may regulate under TSCA section 6 if "the Administrator finds that there is a 

501 reasonable basis to conclude that the manufacture, processing, distribution in commerce, 

502 use or disposal of a chemical substance or mixture . . . presents or will present an 

503 unreasonable risk of injury to health or the environment." (TSCA section 6(a)). Given 

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

505 manometers, or hygrometers/psychrometers (with the exception of one psychrometer), 

506 EPA concluded that risk management action under TSCA section 6 is not necessary at 
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507 this time. This proposed SNUR would allow the Agency to address the potential risks 

508 associated with the proposed significant new use. Note that EPA is also considering 

509 whether risk management or other regulatory action may be appropriate for the one 

510 remaining psychrometer use.

511 C. Allow the Exemption for Persons that Import or Process Elemental Mercury as Part 

512 of Articles that Could be Subject to the SNUR. 

513 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who imports 

514 or processes a substance covered by a SNUR identified in subpart E of part 721 as part of 

515 an article is not generally subject to the notification requirements of §721.25 for that 

516 substance. However, EPA is concerned that exempting articles would render the SNUR 

517 less effective because of the possibility that barometers, manometers, and 

518 hygrometers/psychrometers containing elemental mercury could be imported or 

519 processed for uses subject to this proposed SNUR without the submission of a SNUN. 

520 Because mercury-containing barometers, manometers, and hygrometers/psychrometers

521 are the primary concerns in this SNUR, EPA wishes to include not only bulk elemental 

522 mercury but also these and other articles when they contain elemental mercury imported 

523 or processed for a significant new use. Thus, EPA is proposing to promulgate this rule 

524 without the exemption generally provided for in §721.45(f).

525

526 VIIVI. Applicability of Rule to Uses Occurring Before Effective Date of the Final 

527 Rule

528 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 

529 decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use 

530 as a significant new use as of the date of publication of this proposed rule rather than as 
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531 of the effective date of the final rule. If uses begun after publication of the proposed rule 

532 were considered ongoing rather than new, it would be difficult for EPA to establish 

533 SNUR notice requirements, because a person could defeat the SNUR by initiating the 

534 proposed significant new use before the rule became final, and then argue that the use 

535 was ongoing as of the effective date of the final rule. Thus, persons who begin 

536 commercial manufacture or processing of the chemical substance that would be regulated 

537 through this proposed rule, if finalized, would have to cease any such activity before the 

538 effective date of the rule if and when finalized. To resume their activities, these persons 

539 would have to comply with all applicable SNUR notice requirements and wait until the 

540 notice review period, including all extensions, expires. EPA has promulgated provisions 

541 to allow persons to comply with this SNUR before the effective date. If a person were to 

542 meet the conditions of advance compliance under section 721.45(h), that person would be 

543 considered to have met the requirements of the final SNUR for those activities.

544 VIIIVII. Test Data and Other Information

545 EPA recognizes that TSCA section 5 does not require the development of any 

546 particular test data before submission of a SNUN. There are two exceptions: 1) 

547 development of test data is required where the chemical substance subject to the SNUR is 

548 also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and 2) 

549 development of test data may be necessary where the chemical substance has been listed 

550 under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 

551 test rule or a section 5(b)(4) listing covering the chemical substance, persons are required 

552 only to submit test data in their possession or control and to describe any other data 

553 known to or reasonably ascertainable by them (TSCA section 5(d); 40 CFR 721.25 and 

554 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters 
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555 include data that would permit a reasoned evaluation of risks posed by the chemical 

556 substance during its manufacture, processing, use, distribution in commerce, or disposal. 

557 EPA encourages persons to consult with the Agency before submitting a SNUN. As part 

558 of this optional pre-notice consultation, EPA would discuss specific data it believes may 

559 be useful in evaluating a significant new use. SNUNs submitted for significant new uses 

560 without any test data may increase the likelihood that EPA will take action under TSCA 

561 section 5(e) to prohibit or limit activities associated with this chemical. 

562 SNUN submitters should be aware that EPA will be better able to evaluate 

563 SNUNs that provide detailed information on: 

564 1. Human exposure and environmental releases that may result from the 

565 significant new uses of the chemical substance.

566 2. Potential benefits of the chemical substance.

567 3. Information on risks posed by the chemical substances compared to risks 

568 posed by potential substitutes. 

569 IXVIII. SNUN Submissions 

570 SNUNs must be submitted to EPA on EPA Form No. 7710-25 in accordance with 

571 the procedures set forth in §§ 721.25 and 720.40. This form is available from the 

572 Environmental Assistance Division, (7408M), 1200 Pennsylvania Ave., NW., 

573 Washington, DC 20460-0001. Forms and information are also available electronically at 

574 http://www.epa.gov/opptintr/newchems.

575 XIX. Economic Analysis

576 EPA has evaluated the potential costs of establishing SNUR reporting 

577 requirements for potential manufacturers and processors of the chemical substance 

578 included in this proposed rule (Ref. 1).. EPA’s economic analysis (Ref. 1), which is 
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579 briefly summarized here, is available in the docket for this proposed rule. 

580 Because the use of elemental mercury for manufacturing the specified mercury581 containing products in the United States appears to have ceased, EPA expects very few, if 

582 any, entities will submit a SNUN. As a result, the economic impact of this rule is 

583 anticipated to be either zero or very low.

584 The costs of submission of a SNUN would not be incurred by any company until 

585 a company decides to pursue a significant new use as defined in this proposed SNUR. In 

586 the event that a SNUN is submitted, costs are estimated at approximately $8,100 per 

587 SNUN submission, and include the cost to prepare and submit the SNUN, and the 

588 payment of a user fee. Businesses that submit a SNUN would be subject to either a 

589 $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with 

590 annual sales of less than $40 million when combined with those of the parent company (if 

591 any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its evaluation of this rule, 

592 EPA also considered the potential costs a company might incur by avoiding or delaying 

593 the significant new use in the future, but these costs have not been quantified. 

594 XIX. References

595 The following document is specifically referenced in the preamble for this 

596 rulemaking. In addition to this document, other materials may be available in the docket 

597 established for this rulemaking under Docket ID No. EPA-HQ-OPPT-2008-0483, which 

598 you can access through www.regulations.gov. Those interested in the information 

599 considered by EPA in developing this proposed rule, should also consult documents that 

600 are referenced in the documents that EPA has placed in the docket, regardless of whether 

601 the other documents are physically located in the docket.

602 1. EPA, 2010. Economic Analysis of the Proposed Significant New Use Rule for 
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603 Mercury-Containing Barometers, Manometers, Hygrometers, and Psychrometers,

604 Washington, D.C. OPPT/EETD/EPAB, July 16, 2010.

605

606

607 IIIXI. Statutory and Executive Order Reviews

608 A. Regulatory Planning and Review

609

610 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 

611 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined 

612 that this action is a "significant regulatory action." Accordingly, EPA submitted this 

613 action to OMB for review under Executive Order 12866 and any changes made in 

614 response to OMB recommendations have been documented in the docket for this action 

615 as required by section 6(a)(3)(E) of the Executive Order. 

616 B. Paperwork Reduction Act

617 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an 

618 Agency may not conduct or sponsor, and a person is not required to respond to a 

619 collection of information that requires OMB approval under the PRA, unless it has been 

620 approved by OMB and displays a currently valid OMB control number. The OMB 

621 control numbers for certain EPA regulations in title 40 of the CFR, after appearing in the 

622 Federal Register, are listed in 40 CFR part 9, and included on the related collection 

623 instrument, or form, if applicable. 

624 The information collection requirements related to this action have already been 

625 approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA 

626 ICR No. 1188). This action does not impose any burden requiring additional OMB 

627 approval. If an entity were to submit a SNUN to the Agency, the annual burden is 
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628 estimated to average 97 hours per response. This burden estimate includes the time 

629 needed to review instructions, search existing data sources, gather and maintain the data 

630 needed, and complete, review, and submit the required SNUN. 

631 Send any comments about the accuracy of the burden estimate, and any suggested 

632 methods for minimizing respondent burden to the Director, Collection Strategies 

633 Division, Office of Environmental Information (2822T), Environmental Protection 

634 Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460-0001. Please 

635 remember to include the OMB control number in any correspondence, but do not submit 

636 any completed forms to this address. 

637 C. Small Entity Impacts

638 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 

639 et seq.), the Agency hereby certifies that promulgation of this SNUR would not have a 

640 significant adverse economic impact on a substantial number of small entities. The 

641 rationale supporting this conclusion is as follows. 

642 Under the RFA, small entities include small businesses, small organizations, and 

643 small governmental jurisdictions. Small entity is defined in accordance with section 601 

644 of the RFA as: A small business as defined by the Small Business Administration’s 

645 (SBA) regulations at 13 CFR 121.201; A small governmental jurisdiction that is a 

646 government of a city, county, town, school district or special district with a population of 

647 less than 50,000; and A small organization that is any not-for-profit enterprise which is 

648 independently owned and operated and is not dominant in its field. For purposes of 

649 assessing the impacts of this proposed rule on small entities, EPA has determined that 

650 this proposed rule is not expected to impact any small not-for-profit organizations or 

651 small governmental jurisdictions. As such, the Agency estimated potential impacts on 
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652 small business.

653 A SNUR applies to any person (including small or large entities) who intends to 

654 engage in any activity described in the rule as a "significant new use." By definition of 

655 the word "new," and based on all information currently available to EPA, it appears that 

656 no small or large entities presently engage in such activity. Since this proposed SNUR 

657 would require a person who intends to engage in such activity in the future to first notify 

658 EPA by submitting a SNUN, no economic impact will occur unless someone files a 

659 SNUN to pursue a significant new use in the future or forgoes profits by avoiding or 

660 delaying the significant new use. Although some small entities may decide to conduct 

661 such activities in the future, EPA cannot presently determine how many, if any, there 

662 may be. However, EPA's experience to date is that, in response to the promulgation of 

663 over 1,000 SNURs, the Agency receives on average only 5five notices per year. Of those 

664 SNUNs submitted, only one appears to be from a small entity in response to any SNUR. 

665 Therefore, EPA believes that the potential economic impact of complying with a SNUR 

666 is not expected to be significant or adversely impact a substantial number of small 

667 entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690)(FRL668 5735-4), the Agency presented its general determination that proposed and final SNURs 

669 are not expected to have a significant economic impact on a substantial number of small 

670 entities, which was provided to the Chief Counsel for Advocacy of the Small Business 

671 Administration.

672 D. Unfunded Mandates 

673 Based on EPA's experience with proposing and finalizing SNURs, State, local, 

674 and Tribal governments have not been impacted by these rulemakings, and EPA does not 

675 have any reason to believe that any State, local, or Tribal government would be impacted 
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676 by this rulemaking. As such, EPA has determined that this regulatory action would not 

677 impose any enforceable duty, contain any unfunded mandate, or otherwise have any 

678 effect on small governments subject to the requirements of sections 202, 203, 204, or 205 

679 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538).

680 E. Federalism

681 This action would not have federalism implications because it is not expected to 

682 have a substantial direct effect on States, on the relationship between the national 

683 government and the States, or on the distribution of power and responsibilities among the 

684 various levels of government, as specified in Executive Order 13132, entitled Federalism

685 (64 FR 43255, August 10, 1999).

686 F. Indian Tribal Governments

687 This action would not have tribal implications as specified in Executive Order 

688 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 

689 67249, November 9, 2000). This action is not expected to have substantial direct effects 

690 on Indian Tribes, would not significantly or uniquely affect the communities of Indian 

691 Tribal governments, and would not involve or impose any requirements that affect Indian 

692 Tribes. Thus, Executive Order 13175 does not apply to this action. 

693 G. Protection of Children

694 EPA interprets Executive Order 13045, entitled Protection of Children from 

695 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 

696 only to those regulatory actions that concern health or safety risks, such that the analysis 

697 required under section 5-501 of the Executive Order has the potential to influence the 

698 regulation. This action is not subject to Executive Order 13045 because it would not 

699 establish an environmental standard intended to mitigate health or safety risks.
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700 H. Effect on Energy Supply, Distribution, or Use

701 This action is not a “significant energy action” as defined in Executive Order 

702 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, 

703 Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not likely to 

704 have a significant adverse effect on the supply, distribution, or use of energy.

705 I. Technical Standards

706 Because this action would not involve any technical standards, section 12(d) of 

707 the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 

708 104-113, Section 12(d) (15 U.S.C. 272 note), does not apply to this action.

709 J. Environmental Justice 

710 This action would not entail special considerations of environmental justice 

711 related issues as delineated by Executive Order 12898, entitled Federal Actions to 

712 Address Environmental Justice in Minority Populations and Low-Income Populations (59 

713 FR 7629, February 16, 1994).

714 List of Subjects in 40 CFR Part 721

715 Environmental protection, Chemicals, Hazardous substances, Reporting and 

716 recordkeeping requirements.

717

718 Dated: ____________________

719 __________________________________________

720 Director, Office of Pollution Prevention and Toxics

721

722

723
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724 Therefore, it is proposed that 40 CFR chapter I be amended as follows:

725 1. The authority citation for part 721 continues to read as follows:

726 Authority: 15 U.S.C. 2604, 2607, and 2625(c).

727 2. By amending § 721.10068 by adding additional definitions to paragraph (a) and 

728 adding a new paragraph (b)(2)(viii) to read as follows:

729 § 721.10068 Elemental mercury.

730 (a) * * *

731 Barometer means an instrument used in various applications to measure 

732 atmospheric pressure. 

733 Manometer means an instrument used in various applications to measure pressure 

734 of gases or liquids.

735 Hygrometer or psychrometer means an instrument used in various applications to 

736 measure humidity of gases.

737 (b) * * * 

738 (2) * * *

739 (viii) Manufacturing or processing of elemental mercury for use in barometers, 

740 manometers, hygrometers, and psychrometers except for: natural gas manometers 

741 covered by paragraph (b)(2)(vii) of this section; barometers, manometers, hygrometers, 

742 and psychrometers when these articles are in service as of [insert date of publication of 

743 the proposed rule]; and portable battery powered and motor-aspirated psychrometers that 

744 contain fewer than 7seven grams of elemental mercury.

745 [FR Doc. ??–????? Filed ??–??–??; ?:?? a.m.]