*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 1 of 24

1 10/01/2014: As Submitted for EO 12866 Review. 

2 Filename: EO12866_RIN2070-AJ54_Nano-TSCA-8a-NPRM_FRdocument_2014-10-01.docx

3

4

5 BILLING CODE 6560–50–P

6 ENVIRONMENTAL PROTECTION AGENCY

7 40 CFR Part 704

8 [EPA–HQ–OPPT–2010-0572; FRL–XXXX–X]

9 RIN 2070–AJ54 

10 Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting 

11 and Recordkeeping Requirements

12 AGENCY: Environmental Protection Agency (EPA).

13 ACTION: Proposed rule.

14 SUMMARY: EPA is proposing reporting and recordkeeping requirements for certain chemical 

15 substances when they are manufactured or processed as nanoscale materials. Specifically, EPA proposes 

16 to require persons that manufacture or process, or intend to manufacture or process these nanoscale 

17 materials to electronically report to EPA certain information, which includes the specific chemical 

18 identity, production volume, methods of manufacture and processing, exposure and release information, 

19 and existing data concerning environmental and health effects. This proposal involves one-time reporting 

20 for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they 

21 are manufactured or processed. This information would facilitate EPA’s evaluation of the materials and a

22 determination of whether further action, including additional information collection, is needed. 

23 Consistent with the President’s memorandum for Executive Agencies regarding Principles for Regulation 

24 and Oversight of Emerging Technologies, this proposed rule would facilitate assessment of risks and risk 

25 management, examination of the benefits and costs of further measures, and making decisions on 

26 available scientific evidence. 

27 DATES: Comments must be received on or before [insert date 90 days after date of publication in the 

28 Federal Register].

29 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–

30 OPPT–2010-0572, by one of the following methods:

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

32 instructions for submitting comments. Do not submit electronically any information you consider 

33 to be Confidential Business Information (CBI) or other information whose disclosure is restricted 

34 by statute. 

35 • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), 

36 Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001.

37 • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed 

38 information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 2 of 24

39 Additional instructions on commenting or visiting the docket, along with more information about 

40 dockets generally, is available at http://www.epa.gov/dockets.

41 FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim Alwood, 

42 Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental 

43 Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 

44 202 564-8974; e-mail address: alwood.jim@epa.gov.

45 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 

46 Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA-Hotline@epa.gov.

47 SUPPLEMENTARY INFORMATION:

48 I. Executive Summary

49 A. Does this Action Apply to Me?

50 You may be potentially affected by this action if you manufacture or process or intend to 

51 manufacture or process nanoscale materials. However, persons that manufacture or process, or intend to 

52 manufacture or process nanoscale materials as part of articles, as impurities, or in small quantities solely 

53 for research and development would not be subject to this action. Consult 40 CFR 704.3 and 704.5 for 

54 further information on the applicability of these and other exemptions. 

55 The following list of North American Industrial Classification System (NAICS) codes is not 

56 intended to be exhaustive, but rather provides a guide to help readers determine whether this document 

57 applies to them. Potentially affected entities may include:

58 • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 

59 324110), e.g., chemical manufacturing and petroleum refineries.

60 B. What Is the Agency's Authority for Taking this Action?

61 The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., provides EPA with authority 

62 to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances 

63 and/or mixtures. EPA is proposing this rule under section 8(a) of TSCA, 15 U.S.C. 2607(a). See also 

64 Unit II.A. 

65 C. What Action is the Agency Taking? 

66 EPA is proposing reporting and recordkeeping requirements for persons that manufacture or 

67 process chemical substances as nanoscale materials as described in Unit II.D. Persons who currently 

68 manufacture or process these chemical substances as discrete nanoscale materials would be required to 

69 notify EPA of certain information described in Unit II.D., including specific chemical identity, production 

70 volume, methods of manufacture and processing, use, exposure and release information, and available 

71 health and safety data. EPA is also proposing that any persons who intend to begin to manufacture or 

72 process chemical substances as discrete nanoscale materials after the effective date of this rule notify EPA 

73 of the same information at least 135 days before the intended date of commencement of manufacture or 

74 processing. The TSCA section 8(a) rule proposed here involves one-time reporting for existing nanoscale 

75 materials and one-time reporting for new discrete nanoscale materials before they are manufactured or 

76 processed. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 3 of 24

77 Included in this proposal are electronic reporting requirements similar to those established in 

78 2013, i.e., EPA is proposing to require submitters to use EPA’s Central Data Exchange (CDX), the 

79 Agency's electronic reporting site, for all reporting under this rule. In the Federal Register of December 

80 4, 2013 (78 FR 72818) (FRL 9394-6), EPA finalized a rule to require electronic reporting of certain 

81 information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). In proposing to require 

82 similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase 

83 efficiencies for both the submitters and the Agency.

84 D. Why Is the Agency Taking this Action?

85 These reporting and recordkeeping requirements would assist EPA in its continuing evaluation of 

86 nanoscale materials, informed by available scientific, technical and economic evidence. This proposed 

87 rule is not intended to indicate restrictions or conclusions about the risks of nanoscale materials in 

88 general. Rather, the requirements would facilitate EPA’s evaluation of the materials and determination of 

89 whether any further action under TSCA, including additional information collection, is needed.

90 Consistent with the June 9, 2011 memorandum on the Policy Principles for the U.S. Decision91 Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, 

92 this proposal is not making any finding about the potential risks of nanoscale materials in general or any 

93 specific nanoscale materials. (Ref. 28) In this proposal EPA takes a science-based approach and supports 

94 the policy principle to “[s]eek and develop adequate information with respect to the potential effects of 

95 nanomaterials on human health and the environment and take into account new knowledge when it 

96 becomes available”. As with current new chemical reviews of nanoscale materials, each nanoscale 

97 material would be evaluated on a case-by-case basis and not with the presumption of either harm or 

98 safety. Any evaluation will be based on the specific nanoscale material’s own properties and those of any 

99 structural analogs. 

100 TSCA section 8(a) applies to a person “who manufactures or processes or proposes to 

101 manufacture or process a chemical substance”. A company proposes to manufacture or process a 

102 chemical substance by forming the intent to do so. Based on EPA’s experience, persons form the intent to 

103 manufacture or process chemical substances at least 135 days ahead of time. This belief is based on 

104 EPA's experience with Premanufacture Notice (PMN) submissions and subsequent notices of 

105 commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 40 CFR 720.22, PMNs are submitted 

106 by a person who intends to manufacture (including import) a chemical substance, at least 90 days before 

107 commencing manufacture. Under 40 CFR 720.102, a company that has submitted a PMN for which the 

108 statutory 90-day review period has expired and which has commenced manufacture of that substance 

109 must submit an NOC to EPA within 30 days following commencement. Over the past three fiscal years 

110 (i.e., FY 2009 - FY 2011), EPA received 1,723 PMNs. Based on EPA's review of NOC receipt date 

111 information, EPA determined that NOCs were received within 45 days of completion of the 90-day PMN 

112 review for only 16% of these submitted PMNs. Thus, for 84% of the submitted PMNs, the intent to 

113 manufacture was formed at least 135 days (i.e., the 90-day PMN review period plus 45 days) before 

114 commercialization. Because a company must by necessity form the intent to manufacture a chemical 

115 substance some period of time before the PMN is submitted to EPA, the intent to manufacture or process 

116 would be made at least 135 days in advance as a general matter. 

117 EPA is not proposing to publish an inventory of nanoscale materials based on the information that 

118 would be collected pursuant to these proposed TSCA section 8(a) reporting requirements. 

119 E. What are the Estimated Incremental Impacts of this Action? 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 4 of 24

120 EPA has evaluated the potential costs of establishing the proposed reporting and recordkeeping 

121 requirements for potential manufacturers (including importers) and processors. This analysis, which is 

122 available in the docket, is discussed in Unit VI., and is briefly summarized here. 

123 Under the proposed rule, industry is conservatively estimated to incur a burden of approximately 

124 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 

125 million and $1.5 million, respectively (see Chapter 3), while the Agency is expected to use approximately 

126 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million 

127 and $0.06 million respectively (see Chapter 4). Discounted over a 10-year period at three and seven 

128 percent, total annualized costs are estimated to be approximately $2.80 million and $3.08 million, 

129 respectively. (Ref. 25)

130

131 F. What Should I Consider as I Prepare My Comments for EPA?

132 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. 

133 Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or 

134 CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify 

135 electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to 

136 one complete version of the comment that includes information claimed as CBI, a copy of the comment 

137 that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. 

138 Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR 

139 part 2.

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

141 i. Identify the document by docket ID number and other identifying information (subject heading, 

142 Federal Register date and page number).

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

144 comments by referencing a Code of Federal Regulations (CFR) part or section number.

145 iii. Explain why you agree or disagree; suggest alternatives and substitute language for your 

146 requested changes.

147 iv. Describe any assumptions and provide any technical information and/or data that you used.

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

149 sufficient detail to allow for it to be reproduced.

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

151 vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

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

153 II. Background

154 A. Overview of Applicable TSCA Authority 

155 1. TSCA Section 8(a) Reporting. EPA is proposing reporting and recordkeeping requirements for 

156 manufacturers (including importers) and processors of nanoscale materials pursuant to TSCA section 

157 8(a). Section 8(a) of TSCA authorizes the Administrator to promulgate rules which require each person 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 5 of 24

158 (other than a small manufacturer or processor) who manufactures, processes, or proposes to manufacture 

159 or process a chemical substance, to maintain such records and submit such reports as the Administrator 

160 may reasonably require. 

161 Small manufacturers and processors, as defined by EPA, are exempt from TSCA section 8(a) 

162 reporting requirements, unless the manufacture or processing is subject to a rule proposed or promulgated 

163 under TSCA section 4, 5(b)(4), or 6, or an order under 5(e). For purposes of this rule, and in accordance 

164 with TSCA section 8(a)(3)(B), EPA is proposing an alternative definition of small manufacturer or 

165 processor from that typically used in TSCA section 8(a) rules. See, e.g., 40 CFR 704.3. For further 

166 discussion see Unit II.D.

167 2. Exemption for Research and Development. Persons who manufacture or process chemical 

168 substances that are nanoscale materials that would be subject to the TSCA section 8(a) rule in “small 

169 quantities solely for research and development” (See 40 CFR 704.3) would be exempt from the 

170 requirements of this proposed rule. Examples of research and development activity are the analysis of 

171 the chemical or physical characteristics, the performance, or the production characteristics of a chemical 

172 substance, a mixture containing the substance, or an article. It can include production of a chemical 

173 substance for use by others in their R&D activities. R&D activity generally includes specific monitored 

174 tests undertaken as part of a planned program of activity.

175 3. Electronic Reporting. The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) 

176 provides that, when practicable, Federal organizations use electronic forms, electronic filings, and 

177 electronic signatures to conduct official business with the public. EPA’s Cross-Media Electronic 

178 Reporting Regulation (CROMERR) (40 CFR part 3) (Ref. 24), provides that any requirement in title 40 

179 of the CFR to submit a report directly to EPA can be satisfied with an electronic submission that meets 

180 certain conditions once the Agency published a document in the Federal Register announcing that EPA 

181 is prepared to receive certain documents in electronic form. For more information about CROMERR, go 

182 to http://www.epa.gov/cromerr.

183 TSCA Section 8(a) gives EPA authority to determine the format of reporting under this section.

184 B. Why is EPA Interested in Nanoscale Materials? 

185 As described in Unit II.A., TSCA section 8(a) authorizes EPA to promulgate rules which require 

186 manufacturers and processors to maintain records and submit information that EPA may reasonably 

187 require. Unit II.C. includes discussion of why EPA is proposing to use this authority to gather more 

188 information about proposed and existing nanoscale materials.

189 There is a growing body of scientific evidence showing the differences that exist between 

190 nanoscale material(s) and their non-nanoscale counterpart(s) (Ref. 1). Nanoscale materials may have 

191 different or enhanced properties – for example, electrical, chemical, magnetic, mechanical, thermal, or 

192 optical properties – or features, such as improved hardness or strength, that are highly desirable for 

193 applications in commercial, medical, military, and environmental sectors (Ref. 3). These properties are a 

194 direct consequence of small size, which results in a larger surface area per unit of volume and / or 

quantum effects that occur at the scale of 1 x 10-9195 meters. Small size itself can also be a desirable 

196 property of nanoscale materials. The small size can be exploited for miniaturization of 

197 applications/processes and/or stabilization or delivery of payloads to diverse environments or 

198 incorporation into diverse products.
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 6 of 24

199 Nanoscale materials have a range of potentially beneficial public and commercial applications, 

200 including medicine and public health, clean energy through more efficient solar panels, pollution 

201 reduction and environmental cleanup, and improved products such as stronger, lighter, and more durable 

202 or conductive materials. These benefits arise from the distinctive properties of nanoscale materials, in that 

203 they are potentially more interactive or durable than other chemicals as a result of their size and 

204 composition. Altering the size of a material from conventional particle size can enhance or produce 

205 unique properties that are desirable for a variety of commercial applications. However, these unique and 

206 enhanced properties can raise new regulatory questions, such as whether the material in the smaller form 

207 may present increased hazards to humans and the environment.

208 Government, academic, and private sector scientists in multiple countries are performing research 

209 into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial 

210 and rapidly growing body of scientific evidence. Research also indicates that, in biological systems or in 

211 the environment, not all materials in the nanoscale size range behave differently from larger sized 

212 materials of the same substance (Ref. 4). Recently, two governmental and expert peer review 

213 organizations have reviewed and summarized this evidence and offered views about the implications of 

214 this evidence for environmental and human health and safety. These reviews are described below. 

215 In 2009, the National Institute of Occupational Safety and Health (NIOSH) issued a report, 

216 “Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with 

217 Engineered Nanomaterials,” (Ref. 5) that summarized the available scientific information about nanoscale 

218 materials and identified the following potential health and safety properties: 

219 • “Nanomaterials have the greatest potential to enter the body through the respiratory system if 

220 they are airborne and in the form of respirable-sized particles (nanoparticles). They may also come into 

221 contact with the skin or be ingested.” 

222 • “Based on results from human and animal studies, airborne nanoparticles can be inhaled and 

223 deposit in the respiratory tract; and based on animal studies, nanoparticles can enter the blood stream, and 

224 translocate to other organs.”

225 • “Experimental studies in rats have shown that equivalent mass doses of insoluble incidental 

226 nanoparticles are more potent than large particles of similar composition in causing pulmonary in227 flammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally 

228 supportive of the biological responses observed in animals.”

229 • “Experimental studies in animals, cell cultures, and cell-free systems have shown that changes 

230 in the chemical composition, crystal structure, and size of particles can influence their oxidant generation 

231 properties and cytotoxicity.”

232 • “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) 

233 and nanoscale (ultrafine) particles have reported adverse lung effects including lung function decrements 

234 and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, 

235 which may have different particle properties, are uncertain.” 

236 • “Some nanomaterials may initiate catalytic reactions depending on their composition and 

237 structure that would not otherwise be anticipated based on their chemical composition.”
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 7 of 24

238 Earlier the same year, the Scientific Committee on Emerging and Newly Identified Health Risks 

239 (SCENIHR), an independent scientific committee advising the European Commission’s Health and 

240 Consumer Directorate, issued a report, “Risk assessment of products of nanotechnologies.” (Ref. 6). The 

241 SCENIHR report identified properties similar to those identified in the NIOSH report: 

242 • “Some specific hazards, discussed in the context of risk for human health, have been 

243 identified. These include the possibility of some nanoparticles to induce protein fibrillation, the 

244 possible pathological effects caused by specific types of carbon nanotubes, the induction of 

245 genotoxicity, and size effects in terms of biodistribution.”

246 • “For some nanomaterials, toxic effects on environmental organisms have been 

247 demonstrated, as well as the potential to transfer across environmental species, indicating a potential 

248 for bioaccumulation in species at the end of that part of the food chain.”

249 In another recent survey of scientific research on nanoscale materials (Ref. 7), the authors 

250 reported:

251 “Many studies have examined the pro-inflammatory effects of manufactured nanoparticles, 

252 on the basis that their ability to cause inflammation is a major predictor of potential hazard 

253 in such particles. The first important finding was that nanoparticles have a more pronounced 

254 effect on inflammation, cell damage and cell stimulation than an equal mass of particles of 

255 the same material of greater size. This appears to hold true for materials as varied as carbon 

256 black, titanium dioxide, various metals and polystyrene. Surface area is the metric driving 

257 the pro-inflammatory effects and this is evident both in vitro and in vivo, particles of various 

258 sizes producing inflammatory effects that are directly related to the surface area dose.” 

259 A report in the scientific literature has indicated that nanoscale polystyrene beads may cross the 

260 placental barrier (in an ex-vivo human placental perfusion model (Ref.8). Another study found that 

261 nanoparticles could translocate to diverse organs following oral exposure in rodents. Once in these

262 diverse sites and organs, the large surface area of nanoscale materials may facilitate increased reactivity 

263 and/or an inflammatory response, resulting in toxic effects (Ref. 9). 

264 Two literature surveys describe a broad range of effects in non-mammalian species following 

265 exposure to nanoscale materials (Ref. 10 and 11). These include, for example, increased ventilation rates, 

266 mucus production, and pathologies, and related alteration of enzyme activities and indicators of oxidative 

267 stress in rainbow trout, Oncorhyncus mykiss (Ref. 12) and ingestion and accumulation of nanoscale 

268 material in the digestive tract, as well as mortality, increased heart rates, and reduced fecundity in 

269 Daphnia magna (Ref. 13, 14, and 15). Translocation of nanoscale materials from gill and gut surface to 

270 blood and other organs in exposed Medaka, Oryzius latipes, has also been reported (Ref. 16) and carbon 

271 nanotubes, although unable to cross the egg surface, have been shown to delay hatching in zebra fish, 

272 Danio rerio (Ref. 17). 

273 Published reports of human and ecological exposure to nanomaterials are also limited. For 

274 example, in its “Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and 

275 Nanofibers” (Ref. 27), NIOSH summarized and evaluated the available published information on worker 

276 exposures to carbon nanotubes (CNT) and nanofibers CNF). NIOSH determined that, although the 

277 potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT- and CNF278 product use (processing, use, disposal, recycling), the extent to which workers are exposed has not been 

279 completely characterized. “Comprehensive workplace exposure evaluations are needed to characterize 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 8 of 24

280 and quantify worker exposure to CNT and CNF at various job tasks and operations, and to determine 

281 what control measures are the most effective in reducing worker exposures.” “Data are particularly 

282 needed on workplace exposures to CNT and CNF, as well as information on whether in-place exposure 

283 control measures (e.g., engineering controls) and work practices are effective in reducing worker 

284 exposures.”

285 There are many scientific questions about the impacts of nanoscale materials on human health 

286 and the environment. Part of EPA’s mission under TSCA is to understand potential risks in order to 

287 protect human health and the environment. As stated in EPA’s White Paper on Nanotechnology (Ref. 

288 18): 

289 “Some of the same special properties that make nanoscale materials useful are also properties that 

290 may cause some nanoscale materials to pose risks to humans and the environment, under specific 

291 conditions.”

292 EPA needs a sound scientific basis for assessing and managing potential impacts resulting from the 

293 introduction of nanoscale materials into commerce. 

294 As described in the 2008 TSCA Inventory Status of Nanoscale Substances -- General Approach,

295 many nanoscale materials are considered chemical substances as defined under TSCA section 3(2) (Ref.

296 19). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are 

297 considered new chemical substances that require reporting under TSCA section 5. EPA has assessed over 

298 160 of these nanoscale materials and taken action to control exposures to prevent any potential 

299 unreasonable risks to human health or the environment pending development of information which will 

300 allow EPA to more fully assess those risks. Nanoscale materials based on chemical substances already on 

301 the TSCA Inventory are considered existing chemical substances. These nanoscale materials do not 

302 require reporting as new chemical substances because they are nanoscale forms of chemical substances 

303 already in commerce. 

304 EPA developed a voluntary Nanoscale Materials Stewardship Program (“NMSP” or “the 

305 program”) to complement and support its regulatory activities on nanoscale materials. EPA conducted 

306 the program from January 2008 to December 2009. Thirty one companies or associations submitted 

307 information to EPA for 132 nanoscale materials with available information on how those nanoscale 

308 materials were manufactured, processed or used. For more details on the NMSP and to read the 

309 program’s interim report, consult the EPA website at http://epa.gov/oppt/nano/stewardship.htm (Ref. 20). 

310 EPA solicited existing data and information, on a voluntary basis, from manufacturers, processors, and 

311 users of nanoscale materials to expeditiously develop knowledge about commercially available nanoscale 

312 materials. In addition, the program was designed to identify and encourage use of risk management 

313 practices in developing and commercializing nanoscale materials. EPA also participated in a series of 

314 National Nanotechnology Initiative public workshops, including co-Chairing a public Risk Management 

315 Methods workshop. This workshop was also useful in further identifying additional considerations in risk 

316 management practices towards developing and commercializing nanoscale materials of interest to EPA. 

317 In the NMSP interim report which was based on the information EPA received prior to January 2009, 

318 EPA identified data gaps for existing nanoscale material production, uses, and exposures. For example, 

319 in the report EPA estimated that companies provided information on only about 10 percent of the 

320 nanoscale materials that may be commercially available. 

321
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 9 of 24

322 EPA is proposing reporting requirements under TSCA section 8(a) for persons who are 

323 manufacturing, or processing nanoscale materials or intend to manufacture or process nanoscale materials

324 for commercial purposes to address some of the data gaps identified in the NMSP interim report. This 

325 information would facilitate EPA’s evaluation of the materials and determination if any further action 

326 under TSCA, including additional information collection, is needed. 

327 This proposed rule and the discussion of the potential risks are not intended to conclude that 

328 nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely 

329 to cause harm to people, or the environment. Rather, EPA would use information gathered through this 

330 reporting rule to determine if any further action under TSCA, including additional information collection, 

331 is needed. EPA intends to make conclusions on the basis of specific scientific evidence. Restrictions on 

332 nanoscale materials would be tailored to protect against the specific harms identified for individual 

333 substances. EPA would focus any toxicity concerns or data requirements based on available exposure or 

334 hazard data for specific nanoscale materials. For example during review of new chemical substances that 

335 are nanoscale materials, EPA typically does not request inhalation toxicity data for nanomaterials that are 

336 manufactured in forms or handled by processes where no inhalation exposure occurs. 

337 EPA is seeking public comment pertaining to several specific issues regarding the proposed rule

338 (see Unit II.D.). EPA anticipates conducting a public meeting during the comment period to further 

339 discuss these and any other issues concerning the proposed rule. 

340 III. Summary of Proposed TSCA Section 8(a) Rule 

341 A. What Chemical Substances will be Subject to this Rule?

342 This proposed rule would apply to chemical substances that are solids at 25 oC and atmospheric 

343 pressure that are manufactured or processed in a form where at least 10% of the primary particles, 

344 aggregates, or agglomerates are in the size range of 1-100 nm.

345 When proposing at least 10% of particles in the size range of 1-100 nm as a threshold for

346 reporting of chemical substances subject to this rule, EPA considered a number of factors. If a chemical 

347 substance consists of particles solely within the 1-100 nm range there is general agreement among 

348 scientists and policy makers that the substance is considered a nanoscale material. However, most 

349 nanoscale materials or nanostructured materials contain a distribution of different-sized particles usually 

350 with a fraction of that distribution greater than 100 nm and a fraction less than 100 nm. EPA does not 

351 believe that reporting should be required for a chemical substance that contains less than 1 % particles 

352 less than 100 nm. The Agency considered including materials in which at least one percent of particles 

353 were less than 100 nm. One percent is used in several environmental health and safety contexts as a 

354 cutoff or exemption level such as the OSHA hazard communication standard and TSCA section 12(b) 

355 export notification. EPA is also concerned that using one percent would encompass too broad a range of 

356 chemicals, particularly because there is no scientific consensus on what percentage of particles less than 

357 100 nm within any given sample of particles would be of interest with respect to human health or 

358 ecological effects from exposure to the sample. EPA is seeking to strike a balance between including 

359 what can reasonably be considered to be a nanoscale material while at the same time being practical in 

360 determining what materials contain particles within the 1-100 nm range that should be considered for 

361 proposed reporting. EPA does not want to exclude chemical substances that are considered to be 

362 nanoscale materials by setting too high of a cut-off. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 10 of 24

363 EPA is proposing a threshold of 10% of particles in the size range of 1- 100 nm to include those 

364 nanoscale materials potentially demonstrating novel properties of interest without including large 

365 numbers of chemical substances that have a just a “tail” of particles below 100 nm. Using a threshold 

366 greater than 10% of particles less than 100 nm to require reporting begins to exclude nanoscale materials 

367 that are less than one standard deviation from the mean of a normal distribution curve of particle sizes. 

368 This would begin to exclude a large number of nanoscale materials with properties of potential interest. 

369 EPA is seeking comment on this issue. 

370 EPA has placed in the public docket a list of 2400 chemical substances found on the TSCA 

371 Inventory that EPA believes could be manufactured or processed in a form that would be subject to 

372 reporting under this proposed rule (Ref. 21). This list does not limit the substances that would be subject 

373 to the proposed rule, as other solid chemical substances may also be manufactured or processed in a form 

374 that would be subject to reporting under this proposed rule. EPA is proposing to exclude from the 

375 requirements of this rule certain biological materials (e.g., DNA, RNA, and proteins). EPA is seeking 

376 comment to identify other specific biological materials that should be excluded from reporting and the 

377 reasons for excluding them, including microorganisms and viral based products (or other combinations of 

378 RNA, DNA & protein), lipids, carbohydrates, enzymes, and peptides. Although DNA is typically larger 

379 than 1-100 nanometers, RNA and proteins may fall within this size range. However, the properties of 

380 biological materials such as DNA, RNA and proteins are not a function of the size range per se but rather 

381 the precise nucleotide sequence (in the case of DNA and RNA), shape, and other features. EPA is also 

382 proposing to exclude chemical substances which dissociate completely in water to form ions that are less 

383 than 1 nanometer. EPA is seeking comment to identify other water soluble compounds that should be 

384 excluded from reporting and the reasons for excluding them. This exclusion would not apply to 

385 nanoscale materials that release ions but do not dissociate in water to form those ions. EPA believes that 

386 the chemical substances that would be excluded do not exhibit new properties when their size falls in the 

387 range of 1-100 nanometers and manufacture or processing such substances at the nanoscale should 

388 therefore not be subject to the reporting requirements of the proposed rule.

389 EPA is proposing to exclude from the requirements of this rule nanoclays, zinc oxide and 

390 nanoscale materials created as a thin film because EPA believes that information collected on these 

391 materials would be of limited value because either they have been well-characterized or they present little 

392 exposure potential. EPA requests comment on these proposed exclusions and whether other nanoscale 

393 materials should be excluded. EPA requests that commenters identify why they believe the nanoscale 

394 materials should be excluded.

395 EPA is also requesting comment on whether any information proposed to be collected requested 

396 in this proposed rule is duplicative of information collected under other federal statutes and, thus should 

397 be excluded. Please identify the statute and the information that you believe is duplicative.

398 B. When would nanoscale materials be reported under the rule?

399 This notice proposes that persons who manufacture (including import) or process a discrete form 

400 of a solid nanoscale material at any time during the three years prior to the final effective date of the rule

401 would report to EPA six months after the final effective date of the rule. This notice also proposes a 

402 continuing requirement that persons who intend to manufacture (including import) or process a discrete 

403 form of a solid nanoscale material on or after the effective date of the rule report to EPA at least 135 days 

404 before commencement of manufacture (including import) or processing. 

405 C. How would nanoscale materials be reported under the rule?
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 11 of 24

406 Manufacturers and processors of multiple nanoscale forms of the same chemical substance would 

407 need to know if reporting is required for each form. . EPA is proposing to distinguish among nanoscale 

408 materials for purposes of this rule based on a combination of three factors: 1) a change in process to 

409 affect a change in size and/or a change in properties of the nanoscale materials; 2) a change in mean 

410 particle size of 10% or greater; and 3) a change of 10% or more in surface charge, specific surface area, 

411 dispersibility/solubility, or surface reactivity. EPA’s intent for proposing these reporting requirements is 

412 to focus reporting on intentionally manufactured nanoscale materials. EPA is proposing the combination 

413 of these three factors rather than simply size to distinguish between different nanoscale materials so that 

414 unintended variation in size range between production batches would not trigger TSCA section 8(a) 

415 reporting. Also, EPA is proposing not to rely solely on process changes because there may be process 

416 changes that are not intended to change the material produced but rather intended to improve the 

417 efficiency of the process or to use a cheaper reactant. EPA is focusing on the properties of surface 

418 charge, specific surface area, dispersibility/solubility, or surface reactivity because these are properties of 

419 manufactured nanomaterials that are of particular interest in a health and safety context, whereas other 

420 unique properties of nanoscale materials (e.g., the wavelength at which light is emitted) may be important 

421 for how the nanoscale material functions but are less important in a health and safety context. EPA 

422 believes that the combination of these three factors will provide a clear and transparent way for the 

423 regulated community to distinguish among different nanoscale materials for purposes of TSCA section 

424 8(a) reporting. 

425 While EPA realizes that the percentage cut-off of 10% is arbitrary, as would be any percentage 

426 cut-off, EPA believes the number is high enough so that small variations in size and/or properties would 

427 not be considered a change in nanoscale material. EPA also believes adopting a higher number may 

428 exclude reporting on nanoscale materials that have been modified to exhibit different properties. EPA is 

429 requesting comment on whether 10% is an appropriate threshold both for mean particle size differences 

430 and for changes in surface charge, specific surface area, dispersibility/solubility, or surface reactivity. 

431 EPA is also requesting comment on whether other inherent properties that are important for health and 

432 safety assessments should be included. These comments should include a rationale of why the specific 

433 inherent property should be included.

434 For the purposes of this proposed rule specific surface area is the ratio of the surface area of the 

435 nanoscale material to its mass. This is an important factor because chemical reactions take place at the 

436 surface of the material. Thus, the higher the surface area, the greater the chemical reactivity which is an 

437 important consideration for human health toxicity and environmental toxicity assessments. Specific 

surface area is the ratio of the area of the surface of a nanoscale material divided by the mass (m2438 /kg) or 

the area of the surface of the nanoscale materials divided by volume m2/m3439 . 

440 Surface charge is the electric charge on a surface in contact with a continuous phase (Ref 23). 

441 Surface charge can be calculated by measuring the electrokinetic potential in colloidal systems known as 

442 the zeta potential. It is measured as the net number of positive and negative charges per unit particle

surface area in Coulomb/m2443 (Ref 23) and is typically measured by electrophoresis. For purposes of this 

444 proposed rule the differential of 10% in the surface charge would be measured for the same medium.

445 Dispersibility is the extent to which the particulate nanoscale material can be distributed in 

446 another material such as liquid. Solubility is the degree to which the nanoscale material can be dissolved 

447 in another material, such as liquid. This is an important factor in assessing toxicity and exposure. These 

448 are typically measured in mass per volume, e.g., grams/liter. For most nanoscale materials, dispersibility 

449 rather than solubility would be observed.
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 12 of 24

450 Surface reactivity is indicative of the degree to which the nanoscale material will react with 

451 biological systems. The surface reactivity of the nanoscale material is dependent upon factors such as 

452 redox potential which is a measure of the tendency of an entity to lose or acquire electrons, photocatalytic 

453 activity, including the potential to generate free radicals. Reactive oxygen species (ROS) and free 

454 radicals are important in considering toxicity for these materials. 

455 Each nanoscale form of a particular chemical substance with different morphology or shapes that 

456 include but are not limited to spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow 

457 shells, trees, flowers, rings, tori, cones, or sheets would also be a discrete form. Nanoscale forms of a 

458 particular chemical substance that are coated with different chemical substances would be considered 

459 discrete forms for each chemical coating.

460 EPA has developed this proposed approach based on the approximate size range of 1-100 nm as 

461 defined by the National Nanotechnology Initiative (NNI) (Ref. 3), experience in conducting assessments 

462 of new chemical nanoscale materials by EPA under TSCA, and data submitted to EPA under the NMSP. 

463 EPA is soliciting comment on each aspect of the proposed approach to identifying the chemical 

464 substances that would be subject to the reporting requirements of the rule. The Agency is seeking 

465 comment on these approaches and alternative approaches for reporting requirements. EPA is especially 

466 interested in comments on whether these approaches would require reporting of sufficiently distinct 

467 nanoscale forms of a chemical substance so that reporting would be focused on those nanoscale forms 

468 with potential for significantly different physical or chemical characteristics or properties. EPA also 

469 seeks comment on each aspect of its proposed reporting such as size increments, morphology, the specific 

470 physical-chemical properties identified above, and whether companies have the analytical tools to make 

471 such distinctions. 

472 Chemical substances that are manufactured (including imported), or processed in a nanoscale 

473 form solely as a component of a mixture, encapsulated material, or composite would also have to be 

474 reported. Nanoscale materials that are manufactured but are then incorporated into mixtures, 

475 encapsulated materials or composites by that manufacturer would not require separate reporting for their 

476 incorporation. However, the person reporting the nanoscale material would have to report each step of 

477 the manufacture, processing, and use of the nanoscale material to the extent it is known or reasonably 

478 ascertainable. The proposed rule would not require manufacturers or processors to report certain 

479 information that has already been submitted to EPA. A person who submitted a new chemical notice for 

480 a nanoscale material under TSCA section 5 to EPA on or after January 1, 2005 would not be required to 

481 report regarding the same substance under this proposed TSCA section 8(a) rule. In addition, any person 

482 who has already reported part of or all of the information that would be required under this proposed

483 TSCA section 8(a) rule under the NMSP would not need to report that information again. See 

484 http://www.epa.gov/oppt/nano/stewardship.html for more information on that program. If, however, 

485 information required by this proposed rule was not reported under the NMSP (including information for 

486 each discrete form of a nanoscale material), then reporting of that information would be required. 

487 The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 would be applicable to 

488 this proposed rule, including the exemptions for research and development and small manufacturers. A 

489 person who manufactures or processes, a chemical substance only in small quantities for research and 

490 development would be exempt from the reporting requirements of this proposed rule. Small 

491 manufacturers would be exempt from the reporting requirements of this proposed rule. Under other 

492 TSCA section 8(a) rules, a company may qualify as a small manufacturer in 40 CFR 704.3 it if meets 

493 either of the following two standards. The first is that sales of the company are less than $40 million 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 13 of 24

494 dollars per year and the company does not manufacture or import more than 100,000 pounds annually of 

495 an individual substance at any individual site owned or controlled by the company. The second is that 

496 any company with sales of less than $4 million dollars is considered a small business regardless of the 

497 quantity manufactured or imported. 

498 However, EPA is proposing a different definition of a small manufacturer or processor for 

499 purposes of this rule by eliminating the first standard and defining a small manufacturer or processor as 

500 any company with sales of less than $4 million dollars. The 100,000-pound threshold in the existing 

501 exemption did not contemplate typical production volumes for nanoscale materials. EPA has reviewed 

502 over 200 nanoscale materials in the NMSP and the new chemicals program under TSCA. At least 170 of 

503 those nanoscale materials had reported or estimated production volumes less than 22,000 pounds. Based 

504 on this experience, exempting manufacturers or processors from reporting annual production volumes of 

505 nanoscale materials up to 100,000 pounds would exclude a large proportion of companies that 

506 characteristically manufacture nanoscale materials in small amounts but would not otherwise be 

507 considered small. Given that nanoscale materials tend to be produced in small volumes, EPA does not 

508 believe production volume should be a relevant consideration in determining whether a nanotechnology 

509 company is a small manufacturer or processor. EPA requests comment on the proposed modification of 

510 the small manufacturer or processor exemption for this proposed rule.

511 EPA developed an information reporting form for the NMSP which has been slightly modified 

512 for purposes of this proposed rule. The same information that was requested in the NMSP would be

513 required by this proposed rule including information on specific chemical identity, material 

514 characterization, physical chemical properties, production volume, use, methods of manufacturing and 

515 processing, exposure and release information, and existing data concerning the environmental and health 

516 effects. The information would be reported on a form similar to that used in the NMSP. Any person 

517 required to report under this proposed rule would supply the information identified in the form to the 

518 extent it is known or reasonably ascertainable to them.

519 D. How would information be submitted under the rule?

520 Electronic reporting requirements for Form No. 7710-xx would be included in 40 CFR 

521 704.xxx(e). EPA is proposing electronic reporting similar to the requirements established in 2013, i.e., 

522 EPA is proposing to require submitters to use EPA’s CDX, the Agency's electronic reporting site, for all 

523 reporting under this rule. In the Federal Register of December 4, 2013 (78 FR 72818) (FRL 9394-6),

524 EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under 

525 TSCA sections 4, 5, 8(a) and 8(d). The final rule follows two previous rules requiring similar electronic 

526 reporting of information submitted to EPA (for TSCA Chemical Data Reporting and for Pre-Manufacture 

527 Notifications. In proposing to require similar electronic reporting under this rule, EPA intends to save 

528 time, improve data quality and increase efficiencies for both the submitters and the Agency.

529 EPA developed the Chemical Information Submission System (CISS) for use in submitting data 

530 for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The tool is available for use with 

531 Windows, Macs, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) 

532 specifications for efficient data transmission across the Internet. CISS, a web-based reporting tool, 

533 provides user-friendly navigation, works with CDX to secure online communication, creates a completed 

534 Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other

535 information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 14 of 24

536 EPA is proposing to require submitters to register with EPA’s CDX and use CISS to prepare a 

537 data file for submission. Registration enables CDX to authenticate identity and verify authorization. To 

538 submit electronically to EPA via CDX, individuals must first register with that system at 

539 http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant (also referred to as “Electronic 

540 Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides 

541 information about the submitter and organization, selects a user name and password, and follows the 

542 procedures outlined in the guidance document for CDX available at

543 http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.

544 Users who have previously registered with CDX for other TSCA submissions, Chemical Data 

545 Reporting, or the Toxic Release Inventory TRI-ME web reporting flow, would be able to add the 

546 “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, 

547 and use the CISS web-based reporting tool.

548 All submitters would be required to use CISS to prepare their submissions. CISS guides users 

549 through a “hands-on” process of creating an electronic submission. Once a user completes the relevant 

550 data fields, attaches appropriate PDF files, or other file types, such as XML files, and completes metadata 

551 information, the web-based tool validates the submission by performing a basic error check and makes 

552 sure all the required fields and attachments are provided and complete. Further instructions on submitting 

553 voluntary submissions, such as under MOUs, are available, and instructions for uploading PDF

554 attachments or other file types, such as XML, and completing metadata information would be available 

555 through CISS reporting guidance.

556 CISS, a web-based reporting tool, also allows the user to choose “Print,” “Save,” or “Transmit 

557 through CDX.” When “Transmission through CDX” is selected, the user is asked to provide the user 

558 name and password that was created during the CDX registration process. CISS then encrypts the file and 

559 submits it via CDX. The user will login to the application and check the status of their submissions. 

560 Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as 

561 “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user 

562 registration. Information on accessing the CDX user inbox is provided in the guidance document for CDX 

563 at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS go to 

564 https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and 

565 for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for 

566 reporting nanoscale materials under this proposed rule would be similar. EPA will subsequently put a 

567 version of the tool for reporting nanoscale materials in the docket for comment, including comments on 

568 the extent of and burden associated with training for using CDX.

569 EPA believes that electronic reporting reduces the reporting burden for submitters by reducing 

570 the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to 

571 share a draft submission within their organization, and more easily save a copy for their records or future 

572 use. The resource and time requirements to review and process data by the Agency will also be reduced 

573 and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving 

574 electronic submissions and communicating back electronically with submitters.

575 EPA would also consider electronic reporting of this form similar to procedures for Significant 

576 New Use Notices and PMNs set forth in §§721.25 and 720.40. EPA is seeking comment on these 

577 approaches. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 15 of 24

578 Any person submitting a reporting form could claim any part or all of the form as CBI. Any 

579 information which is claimed as confidential will be disclosed by EPA only to the extent and by the 

580 means of the procedures set forth in 40 CFR part 2. 

581 The TSCA section 8(a) rule proposed here involves one-time reporting for existing nanoscale 

582 materials and one-time reporting for new discrete nanoscale materials before they are manufactured or 

583 processed. 

584 EPA is also seeking comment on the possibility of a future rule that would require periodic 

585 reporting of nanoscale materials similar to reporting that occurs under the Chemical Data Reporting Rule 

586 (CDR) at 40 CFR part 711. Such a rule could require manufacturers and processors of nanoscale materials 

587 to report the type of information collected under the CDR rule to EPA at the same reporting interval as 

588 currently required by CDR reporting (every four years). That reporting could occur at lower thresholds

589 for criteria such as production volume. The CDR is a program designed to collect screening-level, 

590 exposure-related information on chemical substances and to make that information available for use by 

591 EPA and to the public consistent with requirements for handling information claimed as confidential. The 

592 CDR rule data are used by EPA to support risk screening, assessment, priority setting and management 

593 activities and constitute the most comprehensive source of basic screening-level, exposure-related 

594 information on chemicals available to EPA. For further information see http://www.epa.gov/iur/. 

595 IV. Development of Additional Data in Connection with the TSCA Section 8(a) Rule 

596 A TSCA section 8(a) rule may require persons subject to the rule to submit test data in their 

597 possession or control and to describe any other data known to or reasonably ascertainable by them, but 

598 may not require persons to develop test data for submission to the Agency. However, in view of the lack 

599 of information regarding nanoscale materials, EPA would encourage respondents to this proposed rule to 

600 provide the Agency with any relevant data on nanoscale materials they may wish to develop. 

601 Persons choosing to develop test data should provide data that conform to the Good Laboratory 

602 Practice Standards, which are codified at 40 CFR part 792. EPA encourages persons who intend to 

603 conduct testing to consult with the Agency before selecting a protocol for testing a nanoscale material. 

604 EPA would also encourage persons that would be required to submit TSCA section 8(a) data under this 

605 proposed rule to provide information on the potential benefits regarding the nanoscale material. 

606 V. References 

607 The following is a listing of the documents that are specifically referenced in this document. The 

608 docket includes these references and other information considered by EPA. For assistance in locating 

609 these other documents, please consult the technical contact listed under FOR FURTHER 

610 INFORMATION CONTACT.

611 1. 2014. National Nanotechnology Initiative. “Supplement tot eh President’s 2015 Budget,” p. 

612 3. http://www.nano.gov/sites/default/files/pub_resource/nni_fy15_budget_supplement.pdf. 

613 2. 2005. Oberdörster, Gunter, Oberdörster, Eva, and Oberdörster, Jan. Nanotoxicology: an 

614 emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives.

615 (113): 823-839.

616 3. 2004. National Nanotechnology Initiative. The National Nanotechnology Initiative Strategic 

617 Plan. Available on-line at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 16 of 24

618 4. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean-Yves, Lowry, Gregory V Jolivet Jean619 Pierre, and Wiesner, Mark R. Towards a definition of inorganic nanoparticles from an environmental, 

620 health and safety perspective. Nature Nanotechnology 4, 634 – 641. Published online: 13 September 

621 2009 | doi:10.1038/nnano.2009.242.

622 5. 2009. National Institute of Occupational Safety and Health. Approaches to Safe 

623 Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials. 

624 Available on-line at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.

625 6. 2009. European Commission, Directorate-General for Health and Consumers. Scientific 

626 Committee on Emerging and Newly Identified Risks, Risk Assessment of Products of Nanotechnologies. 

627 Available on-line at http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf.

628 7. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and Donaldson, Kenneth. 

629 Nanoparticles, human health hazard and regulation. Journal of the Royal Society, Available on-line at 

630 http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#ref-14 .

631 8. 2010. Wick, Peter, Malek, Antoine, Manser, Pius, Meili, Danielle, Maeder-Althaus, Xenia, 

632 Diener, Liliane, Diener, Pierre-Andre, Zisch, Andreas, Krug, Harold F, and Mandach, Ursula von. Barrier 

633 Capacity of Human Placenta for Nanosized Materials. Environmental Health Perspectives. (118):432-

634 436.

635 9. 2008. Kim, Yong Soon, Kim, Jin Sik, Cho, Hyun Sun, Rha, Dae Sik, Kim, Jae Min, Park, 

636 Jung Duck, Choi, Byung Sun, Lim, Ruth, Chang, Hee Kyung, Chung, Yong Hyun, Kwon, Il Hoon, Jeong, 

637 Jayoung, Han, Beom Seok, and Yu, Il Je. Twenty-Eight Day Oral Toxicity, Genotoxicity, and Gender638 Related Tissue Distribution of Silver Nanoparticles in Sprague-Dawley Rats. Inhalation Toxicology. 20 

639 (6): 575-583.

640 10. 2008. Handy, Richard D., Von der Kammer, Frank, Lead, Jamie R., Hassello, Martin, Owen, 

641 Richard, and Crane, Mark. The ecotoxicology and chemistry of manufactured nanoparticles. 

642 Ecotoxicology 17:287-314. 

643 11. 2008. Klaine, Stephen J., Alvarez, Pedro J., Batley, Graeme E., Fernandes, Teresa F., Handy, 

644 Richard D., Lyon, Delina Y., Mahendra, Shaily, McLaughlin, Michael J., and Lead, Jamie R. 

645 Nanomaterials in the Environment: Behavior, Fate, Bioavailability, and Effects. Environmental 

646 Toxicology and Chemistry. 27: 1825-1851.

647 12. 2007. Federici, Gillian, Shaw, Benjamin J., and Handy, Richard D. Toxicity of titanium 

648 dioxide to rainbow trout (Oncorhynchus mykiss): Gill injury, oxidative stress, and other physiological 

649 effects. Aquatic Toxicology. 84: 415–430. 

650 13. 2007. Roberts, Aaron P., Mount, Andrew S., Seda, Brandon, Souther, Justin, Qiao, Rui, Lin, 

651 Sijie, Ke, Pu Chun, Rao, Apparao M., and Klaine, Stephen J. In vivo biomodification of lipid coated 

652 carbon nanotubes by Daphnia magna. Environmental Science and Technology. 41: 3025–3029

653 14. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna mortality when exposed to 

654 titanium nanoparticles and fullerene (C60) nanoparticles. Environmental Toxicology and Chemistry. 25: 

655 1132–1137.
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 17 of 24

656 15. 2006. Oberdörster, Eva, Zhu, Shiqian, Zhu, Blickley, T. Michelle, McClellan-Green, Patricia, 

657 and Haasch, Mary L. Ecotoxicology of carbon-based engineered nanoparticles: effects of fullerene (C658 60) on aquatic organisms. Carbon. 44: 1112-1120. 

659 16. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the see-through Medaka (Oryzias 

660 latipes). Environmental Health Perspectives. 114: 1697–1702.

661 17. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. Effect of carbon nanotubes 

662 on developing zebra fish (Danio rerio) embryos. Environmental Toxicology and Chemistry. 26:708–716.

663 18. 2007. EPA. EPA Nanotechnology White Paper. Available online at 

664 http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf.

665 19. 2008. EPA. TSCA Inventory Status of Nanoscale Substances -- General Approach. Available 

666 online at http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf.

667 20. 2009. EPA. EPA interim report on the Nanoscale Materials Stewardship Program. Available 

668 online at http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf .

669 21. 2010. EPA. List of Chemical Substances on the TSCA Inventory that EPA believes can be solid 

670 chemical substances manufactured or processed in the range of 1-100 nanometers at ambient 

671 conditions.

672 22. 2010. Joint Research Centre of the European Commission. Considerations on a Definition of 

673 Nanomaterial for Regulatory Purposes. Available online at 

674 http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf.

675 23. 2011. International Organization for Standardization. Nanotechnologies – Guidance on 

676 Physicochemical Characterization for Manufactured Nano-objects submitted for Toxicological 

677 Testing. 

678 24. EPA. Cross-Media Electronic Reporting; Final Rule. Federal Register (70 FR 59848, October 

679 13, 2005) (FRL-7977-1).

680 25. 2010. EPA. Economic Analysis for the TSCA Section 8(a) Proposed Reporting 

681 Requirements for Certain Nanoscale Materials. 

682 26. 2010. EPA. Proposed Addendum to an Existing EPA ICR Entitled: Chemical-Specific Rules, 

683 Toxic Substances Control Act Section 8(a).

684 27. 2013. National Institute of Occupational Safety and Health. Current Intelligence Bulletin 65: 

685 Occupational Exposure to Carbon Nanotubes and Nanofibers at http://www.cdc.gov/niosh/docs/2013-

686 145/pdfs/2013-145.pdf.

687 28. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making 

688 Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials. 

689 http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation690 and-oversight-principles.pdf

691 VI. Statutory and Executive Order Reviews
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 18 of 24

692 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving 

693 Regulation and Regulatory Review

694 The Office of Management and Budget (OMB) has designated this proposed rule as a 

695 ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 

696 1993). Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 

697 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes made in response to 

698 OMB comments have been documented in the public docket for this rulemaking as required by section 

699 6(a)(3)(E) of Executive Order 12866.

700 B. Paperwork Reduction Act (PRA)

701 An agency may not conduct or sponsor, and a person is not required to respond to an information 

702 collection request subject to the PRA, 44 U.S.C. 3501 et seq., unless it displays a currently valid OMB 

703 control number. The OMB control numbers for EPA’s regulations are listed in 40 CFR part 9 and 

704 included on any related collection instrument (e.g., on the form or survey). 

705 The information collection requirements in 40 CFR part 704 related to TSCA section 8(a) 

706 reporting rules have already been approved by OMB under the PRA. That information collection request 

707 (ICR) has been assigned EPA ICR No. 1198 and OMB control number 2070-0067. Because this 

708 proposed rule would involve revised information collection activities that require additional OMB 

709 approval, EPA has prepared an addendum to the currently approved ICR (Ref. 26). 

710 If an entity were to submit a report to the Agency, the annual burden is estimated to average 137

711 hours per response. Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and 

712 the ICR addenda, EPA estimates that the proposed TSCA section 8(a) rule would create a total 

713 incremental industry burden of 228,853 hours. 

714 To comment on the Agency's need for this information, the accuracy of the provided burden 

715 estimates, and any suggested methods for minimizing respondent burden, EPA has established a docket 

716 for this proposed rule, which includes this ICR, under docket ID number EPA-HQ-OPPT-2010-0572. 

717 Submit any comments related to the ICR to EPA and OMB. See ADDRESSES for where to submit 

718 comments to EPA. Send comments to OMB via email to oira_submission@omb.eop.gov. Address 

719 comments to OMB Desk Officer for EPA.

720 Since OMB is required to make a decision concerning the ICR between 30 and 60 days after 

721 [insert date of publication in the Federal Register], a comment to OMB is best assured of having its full 

722 effect if OMB receives it by [Insert date 30 days after publication in the Federal Register]. The final rule 

723 will respond to any OMB or public comments on the information collection requirements contained in 

724 this proposed rule.

725 C. Regulatory Flexibility Act (RFA) 

726 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certifies that this action 

727 would not have a significant adverse economic impact on a substantial number of small entities. The 

728 rationale supporting this conclusion is summarized here, and is presented in a small entity impact 

729 analysis that EPA prepared for this proposed action that is part of the Agency’s economic analysis (Ref. 

730 25). in the public docket for this proposed rule. 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 19 of 24

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

732 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, 

733 small entity is defined as: (1) a small business, as defined by the Small Business Administration’s (SBA) 

734 regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, 

735 county, town, school district or special district with a population of less than 50,000; and (3) a small 

736 organization that is any not-for-profit enterprise which is independently owned and operated and is not 

737 dominant in its field. Since the regulated community is not expected to include small governmental 

738 jurisdictions or small not-for-profit organizations, the analysis focuses on small businesses.

739 A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). 

740 For this action, EPA is proposing to modify the exemption. For more details see Unit II.D. EPA analyzed 

741 potential small business impacts from this proposed rule using both the SBA employee size standards and 

742 the TSCA sales-based definition of small business. EPA estimates that up to 174 small businesses may 

743 be impacted by the proposed TSCA section 8(a) reporting rule but estimates no adverse economic impact 

744 greater than three percent of sales for any of those companies. 

745

746 EPA continues to be interested in the potential impacts of this proposed rule on small entities that 

747 are not exempt from reporting and welcomes comments on issues related to such impacts.

748 D. Unfunded Mandates Reform Act (UMRA)

749 Based on EPA’s experience with proposing and finalizing rules under TSCA section 8(a), 

750 State, local and Tribal governments have not been impacted by these rulemakings, and EPA does 

751 not have any reason to believe that any State, local or Tribal government would be impacted by 

752 this rulemaking. In addition, this action will not result in annual expenditures of $100 million or more 

753 for the private sector. As such, EPA has determined that this action does not impose any enforceable 

754 duty, contain any unfunded mandate, or otherwise have any effect on small governments, and that the 

755 requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to 

756 this action. 

757 E. Executive Order 13132: Federalism

758 This action does not have substantial direct effects on the states, on the relationship between the 

759 national government and the states, or on the distribution of power and responsibilities among the 

760 various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 

761 1999).

762

763 F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

764 This action does not have tribal implications because it will not have any effect on tribal 

765 governments, on the relationship between the Federal government and the Indian tribes, or on the 

766 distribution of power and responsibilities between the Federal government and Indian tribes, as specified 

767 in Executive Order 13175 (65 FR 67249, November 9, 2000).

768

769 G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

770 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those 

771 regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 20 of 24

772 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to 

773 Executive Order 13045 because it does not establish an environmental standard intended to mitigate 

774 health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed 

775 rule will be used to inform the Agency’s decision-making process regarding chemicals to which children 

776 may be disproportionately exposed. This information will also assist the Agency and others in 

777 determining whether the chemicals in this proposed rule present potential risks, allowing the Agency and 

778 others to take appropriate action to investigate and mitigate those risks.

779 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, 

780 Distribution, or Use

781 This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 

782 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, 

783 distribution, or use. 

784

785 I. National Technology Transfer and Advancement Act (NTTAA) 

786 Since this action does not involve any technical standards, NTTAA section 12(d) , 15 U.S.C. 272 

787 note, does not apply to this action.

788

789 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations 

790 and Low -Income Populations

791 This action does not entail special considerations of environmental justice related issues as 

792 delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that 

793 this action will not have disproportionately high and adverse human health or environmental effects on 

794 minority or low-income populations. This action does not affect the level of protection provided to human 

795 health or the environment. 

796 This action does not affect the level of protection provided to human health or the environment. 

797 However, the Agency believes that the information collected under this proposed rule, if finalized, will 

798 assist EPA and others in determining the potential hazards and risks associated with various chemicals 

799 manufactured processed, and used at the nanoscale. Although not directly impacting environmental 

800 justice-related concerns, this information will enable the Agency to better protect human health and the 

801 environment, including in low-income and minority communities.

802

803 List of Subjects in 40 CFR Part 704

804 Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting 

805 Requirements. 

806 Dated: ____________________

807 __________________________________________

808 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 21 of 24

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

810 1. The authority citation for part 704 continues to read as follows:

811 Authority: 15 U.S.C. 2607(a)

812 2. By adding § 704.xxxx to Subpart B, to read as follows 

813 §704.xxx Nanoscale materials. 

814 (a) Definitions. For purposes of this section the terms below are defined as follows:

815 The Nanoscale Materials Stewardship Program was a program conducted by EPA from January 

816 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily 

817 provided EPA available information on engineered nanoscale materials that were manufactured processed 

818 or used. 

819 Primary particles are particles or droplets that form during manufacture of a chemical substance 

820 before aggregation or agglomerization occurs. 

821 An aggregate is a heterogeneous particle in which the various components are held together by 

822 relatively strong forces, and thus not easily broken apart. Aggregated nanoparticles would be an example 

823 of a nanostructured material which means a material having an internal or surface structure at the 

824 nanoscale.

825 An agglomerate is a group of nanoparticles held together by relatively weak forces, including van 

826 der Waals forces, electrostatic forces, and surface tension.

827 A solid nanoscale material is a chemical substance that is a solid at 25 oC and atmospheric 

828 pressure where at least 10 % of the primary particles, agglomerates, or aggregates are manufactured or 

829 processed in the size range of 1-100 nanometers.

830 . 

831 A discrete form of a solid nanoscale material differs from another form of the same nanoscale 

832 material as follows in that either:

833 (1) The change in the nanoscale material is due to a combination of (i), (ii) and (iii)

834 (i) there is a change in process to affect a change in size and/or a change in one or more 

835 of the properties of the nanoscale materials identified in (iii)

836 (ii) there is a size variation in the mean particle size of 10% or greater; and 

837 (iii) there is a change in one or more of the following properties of 10% or more: surface 

838 charge, specific surface area, dispersibility/solubility, or surface reactivity;

839 (2) The nanoscale material has a different morphology. Examples of morphologies include but 

840 are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, 

841 torus, cone, and sheet.
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 22 of 24

842 (3) A nanoscale material that is coated with another chemical substance or mixture at the end of 

843 manufacturing or processing has a coating that consists of a different chemical substance or mixture.

844 A small manufacturer or processor means any manufacturer or processor whose total annual 

845 sales, when combined with those of its parent company (if any), are less than $ 4 million. The definition 

846 of small manufacturer in section 704.3 of this title does not apply to reporting under this section 704.xxx. 

847 Dispersibility means the extent to which the particulate nanoscale material can be distributed in 

848 another material such as a liquid. 

849 Solubility means the degree to which the nanoscale material can be dissolved in another material 

850 such as a liquid.

851 Specific surface area means the ratio of the area of the surface of the nanoscale material to its 

852 mass. Specific surface area is the ratio of the area of the surface of a nanoscale material divided by the 

mass (m2/kg) or the area of the surface of the nanoscale materials divided by its volume m2/m3853 .

854 Surface charge means the electric charge on a surface in contact with a continuous phase. 

855 Surface charge can be calculated by measuring the electrokinetic potential in colloidal systems known as 

856 the zeta potential. It is measured as the net number of positive and negative charges per unit particle 

surface area in Coulomb/m2857 . The differential of 10% in the surface charge would be measured for the 

858 same medium.

859 Surface reactivity means the reactivity at the surface of a nanoscale material. It is dependent 

860 upon factors such as redox potential which is a measure of the tendency of a substance to lose or acquire 

861 electrons, photocatalytic activity, including the potential to generate free radicals. 

862 Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, 

863 or its successors.

864 Chemical Information Submission System or CISS means EPA’s electronic, web-based reporting 

865 tool for the completion and submission of data, reports, and other information associated with TSCA 

866 sections 4 and 8.

867 (b) Persons who must report. 

868 (1) Manufacturers and processors of a discrete form of a solid nanoscale material during the three 

869 years prior to the final effective date of the rule must report except as provided in paragraph (c) of this 

870 section. 

871 (2) Persons who propose to manufacture or process a discrete form of a solid nanoscale material 

872 after the final effective date of the rule which was not reported under paragraph (b)(1) must report except 

873 as provided in paragraph (c) of this section.

874 (c) When reporting is not required. 

875 (1) The following chemical substances are not subject to reporting:

876 (i) Zinc oxide

877 (ii) Nanoclays

878 (iii)Nanoscale materials created as a thin film
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 23 of 24

879 (iv) DNA

880 (v) RNA

881 (vi) Proteins

882 (vii) Chemical substances which dissociate completely in water to form ions that are less than 

883 1 nanometer

884 (2) Persons who submitted a TSCA chemical notice under part 720, 721, or 723 of this title for a 

885 solid nanoscale material on or after January 1, 2005 are not required to submit a report for the solid 

886 nanoscale material submitted except where the person manufactured or processed a discrete form of the 

887 solid nanoscale material. 

888 (3) Section 704.5 (a) through (e) of this part 704 applies to reporting under this section 704.xxx. 

889 Small manufacturers and processors as defined in section 704.xxx are exempt from the reporting

890 requirements of this rule. 

891 (4) Any person who has already submitted some or all of the required information for a substance 

892 described in paragraph (a) as part of the Nanoscale Materials Stewardship Program is not required to 

893 report that information previously submitted except where the person manufacturers or processes a 

894 discrete form of the solid nanoscale material. 

895 (d) What information to report. The following information must be reported to the extent that is 

896 known or reasonably ascertainable for each discrete form of a solid nanoscale material manufactured or 

897 processed during the three years prior to the final effective date of the rule: 

898 (1) the common or trade name, the specific chemical identity including the correct Chemical 

899 Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the 

900 molecular structure of each chemical substance or mixture. Information must be reported as specified in 

901 § 720.45. 

902 (2) material characterization including particle size, morphology, and surface modifications; 

903 (3) physical/chemical properties; 

904 (4) the maximum weight percentage of impurities and byproducts resulting from the manufacture, 

905 processing, use, or disposal of each chemical substance; 

906 (5) annual production volume and an estimate of the maximum production volume for any 

907 consecutive 12-month period during the next two years of production after the final effective date of this 

908 rule. Estimates must be on 100% chemical basis of the discrete form of the solid nanoscale material;

909 (6) use information describing the category of each use by function and application, estimates of 

910 the amount manufactured or processed for each category of use, and estimates of the percentage in the 

911 formulation for each use; 

912 (7) detailed methods of manufacturing or processing;

913 (8) exposure information with estimates of the number of individuals exposed in their places of 

914 employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions 

915 and estimates of any general population or consumer exposures; 
*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review ***

RIN 2070-AJ54

Page 24 of 24

916 (9) release information with estimates of the amounts released, descriptions and duration of the 

917 activities that cause such releases, and whether releases are directly to the environment or to control 

918 technology;

919 (10) risk management practices describing protective equipment for individuals, engineering 

920 controls, control technologies used, any hazard warning statement, label, material safety data sheet, 

921 customer training, or other information which is provided to any person who is reasonably likely to be 

922 exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, 

923 or disposal of the substance; and

924 (11) existing data concerning the environmental and health effects. 

925 (e) How to report.

926 (1) Persons must use CISS to complete and submit Form 7710-xx, 8(a) Data Reporting for 

927 Nanoscale Materials Data Submission Form and any attachments, via CDX. Submission requires 

928 registration with CDX, and must be made only as set forth in this section.

929 (2) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx 

930 and follow the appropriate links and for further instructions to go 

931 http://www.epa.gov/oppt/chemtest/ereporting/index.html.

932 (f) When to report.

933 (1) Persons specified in paragraph (b)(1) must report the information specified in paragraph (d) 

934 within six months after the final effective date of the rule. 

935 (2) Persons specified in paragraph (b)(2) must report the information specified in paragraph (d) at 

936 least 135 days before commencing manufacture or processing of the chemical substance. 

937 (g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to 

938 the recordkeeping requirements in §704.11 (a) and (b).

939 (h) Confidential business information. Persons submitting a notice under this rule are subject to 

940 the requirements for confidential business information claims in §704.7.

941 [FR Doc. ??–????? Filed ??–??–??; 8:45 am]