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

2 03/18/2015 version – Reflects all changes made during EO 12866 Review. 

3 Filename: EO12866_Rin2070-AJ54_Nano 8(a) NPRM_FRdocument_Redlined.docx

4 

5 BILLING CODE 6560–50–P 

6 ENVIRONMENTAL PROTECTION AGENCY 

7 40 CFR Part 704 

8 [EPA–HQ–OPPT–2010-0572; FRL–XXXX–X9920-90] 

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 asat the nanoscale materials. as described in this 

16 rule. Specifically, EPA proposes to require persons that manufacture (defined by statute to include 

17 import) or process, or intend to manufacture or process these nanoscale materialschemical substances to 

18 electronically report to EPA certain information, which includes the specific chemical identity, production 

19 volume, methods of manufacture and processing, exposure and release information, and existing data 

20 concerning environmental and health effects. This proposal involves one-time reporting for existing 

21 nanoscale materials and one-time reporting for new discrete nanoscale materials before they are 

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

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

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

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

26 management, examination of the benefits and costs of further measures, and making future decisions 

27 based on available scientific evidence. 

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

29 Federal Register]. 

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

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

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

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

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

35 by statute. 

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

37 Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001. 
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38 • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed 

39 information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. 

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

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

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

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

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

45 (202) 564-8974; e-mail address: alwood.jim@epa.gov.

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

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

48 SUPPLEMENTARY INFORMATION: 

49 I. Executive Summary 

50 A. Does this Action Apply to Me? 

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

52 manufacture or process nanoscale materials.forms of certain chemical substances. However, persons that 

53 manufacture or process, or intend to manufacture or process nanoscale materialsthese chemical 

54 substances as part of articles, as impurities, or in small quantities solely for research and development 

55 would not be subject to this action. ConsultIn addition, the discussion in Unit III.A. describes in more 

56 detail which chemical substances would and would not be subject to reporting under the proposed rule. 

57 You may also consult 40 CFR 704.3 and 704.5, as well as the proposed regulatory text in this document,

58 for further information on the applicability of these and other exemptions to this proposed rule. 

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

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

61 appliesmay apply to them. Potentially affected entities may include: 

62 • ManufacturersChemical Manufacturing or processors of one or more subject chemical 

63 substancesProcessing (NAICS codes 325). 

64 • Synthetic Dye and 324110), e.g., chemical manufacturingPigment Manufacturing (NAICS code 

65 325130). 

66 • Other Basic Inorganic Chemical Manufacturing (NAICS code 325180). 

67 • Rolled Steel Shape Manufacturing (NAICS code 331221). 

68 • Semiconductor and petroleum refineries.Related Device Manufacturing (NAICS code 334413).

69 • Carbon and Graphite Product Manufacturing (NAICS code 335991). 

70 • Home Furnishing Merchant Wholesalers (NAICS code 423220). 

71 • Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330). 

72 • Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510). 
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73 • Research and Development in the Physical, Engineering, and Life Sciences (except 

74 Biotechnology) (NAICS code 541712). 

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

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

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

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

79 Unit II.A. 

80 C. What Action is the Agency Taking? 

81 EPA is proposing reporting and recordkeeping requirements for persons that manufacture 

82 (including import) or process certain chemical substances as nanoscale materials as described in Unit 

83 II.DIII.A. Persons who currently manufacture or process these chemical substances as discrete nanoscale 

84 materials would be required to notify EPA of certain information described in Unit II.DIII.C., including 

85 specific chemical identity, production volume, methods of manufacture and processing, use, exposure and 

86 release information, and available health and safety data. EPA is also proposing that any persons who 

87 intend to begin to manufacture or process chemical substances as discrete nanoscale materials after the 

88 effective date of this rule notify EPA of the same information at least 135 days before the intended date of 

89 commencement of manufacture or processing. The TSCA section 8(a) rule proposed here involves one90 time reporting for existing discrete nanoscale materialsforms of certain chemical substances and one-time 

91 reporting for new discrete nanoscale materials forms of certain chemical substances before they are 

92 manufactured or processed. A chemical substance as defined under TSCA section 3(2) does not include 

93 any food, food additive, drug, cosmetic, medical device, pesticide or other excluded materials. Such 

94 materials are not be subject to this rule.

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

96 2013, i.e., for other kinds of information: EPA is proposing to require submitters to use EPA’s Central 

97 Data Exchange (CDX), the Agency's electronic reporting siteportal, for all reporting under this rule. In the 

98 Federal Register of December 4, 2013 (78 FR 72818) (FRL 9394-6), EPA finalized a rule to require 

99 electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 

100 8(d). In proposing to require similar electronic reporting under this rule, EPA intends to save time, 

101 improve data quality and increase efficiencies for both the submitters and the Agency. (Ref. 1.)

102 This proposed rule and the discussion of the potential risks do not conclude and are not intended 

103 to conclude that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give 

104 rise to or are likely to cause harm to people or the environment. Rather, EPA would use information 

105 gathered through this reporting rule to determine if any further action under TSCA, including additional 

106 information collection, is needed. EPA intends to make conclusions on the basis of specific scientific 

107 evidence. As with current new chemical review of nanomaterials, each chemical substance manufactured 

108 at the nanoscale will be evaluated on a case-by-case basis and not with the presumption of either harm or 

109 safety, but rather its evaluation will be based on the specific nanoscale chemical substance’s own 

110 properties. If adequate data are not available for the properties of the nanoscale chemical substance, EPA 

111 will use data on structural analogues. Being nanoscale is not itself an indication of, or criterion for, 

112 hazard or exposure potential. Any potential future restrictions on chemical substances manufactured at the 

113 nanoscale would be tailored to protect against the specific harms identified for individual substances or 

114 categories. EPA would focus any toxicity concerns or data requirements based on available exposure or 

115 hazard data for specific nanoscale chemical substances. If the information provided indicates low risk, 
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116 EPA would not need to consider further review or regulation of that nanoscale chemical substance unless 

117 subsequent information raises risk concerns. For example during review of new chemical substances that 

118 are nanoscale materials, EPA typically does not request inhalation toxicity data for chemical substances 

119 that are manufactured in forms or handled by processes where no inhalation exposure occurs. 

120 EPA is not proposing to publish an inventory of chemical substances manufactured at the 

121 nanoscale based on the information that would be collected pursuant to these proposed TSCA section 8(a) 

122 reporting requirements. EPA will make non-confidential information reported under the proposed rule 

123 available in ChemView (see http://www.epa.gov/chemview/). 

124 D. Why Is the Agency Taking this Action?

125 D. Why Is the Agency Taking this Action?

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

127 chemical substances manufactured at the nanoscale materials, informed by available scientific, technical 

128 and economic evidence. This proposed rule is not intended to indicate restrictions or conclusions about 

129 the risks of chemical substances manufactured at the nanoscale materials in general. Rather, the 

130 requirements would facilitate EPA’s evaluation of the materials and its determination of whether any 

131 further action under TSCA, including additional information collection, is needed. 

132 Consistent with the June 9, 2011 memorandum on the Policy Principles for the U.S. Decision133 Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, 

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

135 specific nanoscale materials. (Ref. 28) In this proposal EPA takes a 2). These generally applicable 

136 principles are relevant to promoting a balanced, science-based approach and supportsto regulating 

137 chemical substances manufactured at the nanoscale and other applications of nanotechnology in a manner 

138 that protects human health, safety, and the environment without prejudging new technologies or creating 

139 unnecessary barriers to trade or hampering innovation. These principles build on the foundation provided 

140 by current regulatory statutes and do not supersede existing legal authorities. In this proposal, EPA’s 

141 approach seeks to support the policy principle to “[s]eek and develop adequate information with respect 

142 to the potential effects of nanomaterials on human health and the environment and take into account new 

143 knowledge when it becomes available”.” (Ref. 2). As with current new chemical reviews of chemical 

144 substances manufactured at the nanoscale materials, each nanoscale material would be evaluated on a 

145 case-by-case basis and not with the presumption of either harm or safety. Any evaluation will be based 

146 on the specific nanoscale material’s own properties and those of any structural analogs. 

147 E. What are the Estimated Incremental Impacts of this Action? 

148 EPA has evaluated the potential costs of establishing the proposed reporting and 

149 recordkeeping requirements for potential manufacturers Any evaluation will be based on the specific 

150 nanoscale material’s own properties and those of any structural analogs. TSCA section 8(a) applies to a 

151 person “who manufactures or processes or proposes to manufacture or process a chemical substance”. A 

152 company proposes to manufacture or process a chemical substance by forming the intent to do so. Based 

153 on EPA’s experience, persons form the intent to manufacture or process chemical substances at least 135 

154 days ahead of time. This belief is based on EPA's experience with Premanufacture Notice (PMN) 

155 submissions and subsequent notices of commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 

156 40 CFR 720.22, PMNs are submitted by a person who intends to manufacture (including import) a 

157 chemical substance, at least 90 days before commencing manufacture. Under 40 CFR 720.102, a 
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158 company that has submitted a PMN for which the statutory 90-day review period has expired and which 

159 has commenced manufacture of that substance must submit an NOC to EPA within 30 days following 

160 commencement. Over the past three fiscal years (i.e., FY 2009 - FY 2011), EPA received 1,723 PMNs. 

161 Based on EPA's review of NOC receipt date information, EPA determined that NOCs were received 

162 within 45 days of completion of the 90-day PMN review for only 16% of these submitted PMNs. Thus, 

163 for 84% of the submitted PMNs, the intent to manufacture was formed at least 135 days (i.e., the 90-day 

164 PMN review period plus 45 days) before commercialization. Because a company must by necessity form 

165 the intent to manufacture a chemical substance some period of time before the PMN is submitted to EPA, 

166 the intent to manufacture or process would be made at least 135 days in advance as a general matter. 

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

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

169 E. What are the Estimated Incremental Impacts of this Action? 

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

171 requirements for potential manufacturers (including importers) and processors. This analysis, (Ref. 3),

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

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

174 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 

175 million and $1.5 million, respectively (see Chapter 3 in Ref. 3), while the Agency is expected to use 

176 approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of 

177 approximately $0.51 million and $0.06 million respectively (see Chapter 4 in Ref. 3). Discounted over a 

178 10-year period at three and seven percent, total annualized costs are estimated to be approximately $2.80 

179 million and $3.08 million, respectively. (Ref. ). Discounted over a 10-year period at three and seven 

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

181 respectively. (Ref. 25)3.)

182 

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

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

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

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

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

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

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

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

191 part 2. 

192 2. Tips for preparing your comments. When preparing and submitting your comments, remember 

193 to:see the commenting tips at http://www.epa.gov/dockets/comments.html. 

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

195 Federal Register date and page number). 

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

197 comments by referencing a Code of Federal Regulations (CFR) part or section number. 
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198 iii. Explain why you agree or disagree; suggest alternatives and substitute language for your 

199 requested changes. 

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

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

202 sufficient detail to allow for it to be reproduced. 

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

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

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

206 II. Background 

207 A. Overview of Applicable TSCA Authority 

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

209 manufacturers (including importers) and processors of nanoscale materials pursuant to TSCA section 8(a).

210 ) reporting. Section 8(a) of TSCA authorizes the AdministratorEPA to promulgate rules which require 

211 each person (other than a small manufacturer or processor) who manufactures, processes, or proposes to 

212 manufacture or process a chemical substance, to maintain such records and submit such reports as the 

213 EPA Administrator may reasonably require. TSCA section 8(a) gives EPA authority to determine the 

214 format of reporting under this section.

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

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

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

218 in accordance with Under TSCA section 8(a)(3)(B), after consultation with the Administrator of the Small 

219 Business Administration (SBA), EPA is proposing an alternative definition ofmay prescribe standards for 

220 determining which manufacturers and processors qualify as small manufacturer or processor from that 

221 typically used infor purposes of reporting under a TSCA section 8(a) rules. See, e.g., 40 CFR 704.3. For 

222 further discussion see Unit II.Drule. 

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

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

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

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

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

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

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

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

231 General provisions for TSCA section 8(a) rules appear in 40 CFR part 704 Subpart A. These 

232 provisions describe definitions, exemptions (including for articles and research and development), 

233 confidential business information claims, and recordkeeping that apply to TSCA section 8(a) rules. For 

234 example in 40 CFR 704.3 the definition of known to or reasonably ascertainable by is defined to mean all 

235 information in a person’s possession or control, plus all information that a reasonable person similarly 

236 situated might be expected to possess, control, or know. 
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237 In addition, the definitions in TSCA section 3 apply to this rulemaking. 

238 2. Electronic Reporting. The reporting under the Government Paperwork Elimination Act 

239 (GPEA) (). GPEA, 44 U.S.C. 3504), provides that, when practicable, Federal organizations use electronic 

240 forms, electronic filings, and electronic signatures to conduct official business with the public. EPA’s 

241 Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3) (Ref. 244), provides that 

242 any requirement in title 40 of the CFR to submit a report directly to EPA can be satisfied with an 

243 electronic submission that meets certain conditions once the Agency published a document in the Federal 

244 Register announcing that EPA is prepared to receive certain documents in electronic form. For more 

245 information about CROMERR, go to http://www.epa.gov/cromerr. 

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

247 B. Why is EPA Interested in Nanoscale Materials? 

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

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

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

251 information about proposed and existing nanoscale materials.

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

253 substances and chemical substances manufactured in nanoscale forms (Ref. 5). Chemical substances 

254 manufactured at the nanoscale material(s) and their non-nanoscale counterpart(s) (Ref. 1). Nanoscale 

255 materials may have different or enhanced properties – for example, electrical, chemical, magnetic, 

256 mechanical, thermal, or optical properties – or features, such as improved hardness or strength, that are 

257 highly desirable for applications in commercial, medical, military, and environmental sectors (Ref. 36). 

258 These properties are a direct consequence of smalldecreasing size, which results in a largerwhere surface 

259 area per unit of volume increases exponentially and / or quantum effects that occur at may appear in the 

scalelow tens of 1 x 10-9 260 metersnanometers and below. Small size itself can also be a desirable property 

261 of nanoscale materials. The small size can be exploited for miniaturization of applications/processes 

262 and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse 

263 products. 

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

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

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

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

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

269 composition. chemical substances. Altering the size of a material from conventional particle size can 

270 enhance or produce unique properties that are desirable for a variety of commercial applications. 

271 However, these unique and enhanced properties can raise new regulatory questions, such as whether the 

272 material in the smaller form may present increased hazards to humans and the environment. 

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

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

275 and rapidly growing body of scientific evidence. ResearchThis research also indicates that, in biological 

276 systems or in the environment, not all materials in the nanoscale size range behave differently from larger 

277 sized materials of the same substance (Ref. 4). 7). Recently, twoa governmental organization and expert 

278 peer review organizationsan independent scientific committee have reviewed and summarized this 
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279 evidence and offered views about the implications of this evidence for environmental and human health 

280 and safety. These reviews are described below. 

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

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

283 Engineered Nanomaterials,” (Ref. 58) that summarized the available scientific information about 

284 nanoscale materials and identified the following potential health and safety properties: 

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

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

287 contact with the skin or be ingested.” 

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

289 depositdeposited in the respiratory tract; and based on animal studies, nanoparticles can enter the blood 

290 stream, and translocate to other organs.” 

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

292 nanoparticles are more potent than large particles of similar composition in causing pulmonary in293 flammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally 

294 supportive of the biological responses observed in animals.” 

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

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

297 properties and cytotoxicity.” 

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

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

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

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

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

303 structure that would not otherwise be anticipated based on their chemical composition.” 

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

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

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

307 SCENIHR report (Ref. 9) that identified properties similar to those identified in the NIOSH report: 

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

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

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

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

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

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

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

315 In another recent survey of scientific research on nanoscale materials (Ref. 710), the authors 

316 reported: 
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317 “Many studies have examined the pro-inflammatory effects of manufactured nanoparticles, 

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

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

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

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

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

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

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

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

326 placental barrier (in an ex-vivo human placental perfusion model (Ref.8 11). Another study found that 

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

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

329 and/or an inflammatory response, resulting in toxic effects (Ref. 912). 

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

331 exposure to nanoscale materials (Ref. 1013 and 1114). These include, for example, increased ventilation 

332 rates, mucus production, and pathologies, and related alteration of enzyme activities and indicators of 

333 oxidative stress in rainbow trout, Oncorhyncus mykiss (Ref. 1215) and ingestion and accumulation of 

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

335 in Daphnia magna (Ref. 13, 1416, 17, and 1518). Translocation of nanoscale materials from gill and gut 

336 surface to blood and other organs in exposed Medaka, Oryzius latipes, has also been reported (Ref. 1619) 

337 and carbon nanotubes, although unable to cross the egg surface, have been shown to delay hatching in 

338 zebra fish, Danio rerio (Ref. 1720). 

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

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

341 Nanofibers” (Ref. 2721), NIOSH summarized and evaluated the available published information on 

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

343 the potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT- and CNF344 product use (processing, use, disposal, recycling), the extent to which workers are exposed has not been 

345 completely characterized. “Comprehensive workplace exposure evaluations are needed to characterize 

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

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

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

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

350 exposures.”

351 There are many scientific questions about the impacts of chemical substances manufactured at the 

352 nanoscale materialss on human health and the environment. Part of EPA’s mission under TSCA is to 

353 understand potential risks in order to protect human health and the environment. As stated in EPA’s 

354 White Paper on Nanotechnology (Ref. 1822): 

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

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

357 conditions.” 

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

359 introduction of chemical substances manufactured at the nanoscale materials into commerce. 
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360 As described in the 2008 TSCA Inventory Status of Nanoscale Substances -- General Approach, 

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

362 1923). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are 

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

364 160170 of these nanoscale materials as new chemical substances and taken action to control exposures to 

365 prevent any potential unreasonable risks to human health or the environment pending development of 

366 information which will allow EPA to more fully assess those risks. Nanoscale materials based on 

367 chemical substances already on the TSCA Inventory are considered existing chemical substances. These 

368 nanoscale materials do not require reporting as new chemical substances because they are nanoscale 

369 forms of chemical substances already in commerce. 

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

371 program”) to complement and support its regulatory activities on chemical substances manufactured at 

372 the nanoscale materials. . EPA conducted the program from January 2008 to December 2009. Thirty one 

373 companies or associations submitted information to EPA for 132 chemical substances manufactured at the 

374 nanoscale materials with available information on how those nanoscale materials were manufactured, 

375 processed or used. For more details on the NMSP and to read, see the program’s interim report, consulta 

376 copy of which is in the EPA website at http://epa.gov/oppt/nano/stewardship.htmdocket (Ref. 2024). 

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

378 users of chemical substances manufactured at the nanoscale materials to expeditiously develop 

379 knowledge about commercially available nanoscale materials. In addition, the program was designed to 

380 identify and encourage use of risk management practices in developing and commercializing chemical 

381 substances manufactured at the nanoscale materials. EPA also participated in a series of National 

382 Nanotechnology Initiative public workshops, including co-Chairing a public Risk Management Methods 

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

384 management practices towards developing and commercializing chemical substances manufactured at the 

385 nanoscale materials of interest to EPA. In the NMSP interim report, which was based on the information 

386 EPA received prior to January 2009, EPA identified data gapsneeds for existing nanoscale material 

387 production, uses, and exposures. For example, in the report EPA estimated that companies provided 

388 information on only about 10 percent of the chemical substances manufactured at the nanoscale materials 

389 that may be commercially available in 2009. 

390 

391 To address some of the data needs identified in the NMSP interim report, EPA is proposing 

392 reporting requirements under TSCA section 8(a) for persons who are manufacturing, or processing 

393 chemical substances manufactured at the nanoscale materials or intend to manufacture or process these 

394 nanoscale materials for commercial purposes to address some of the data gaps identified in the NMSP 

395 interim report. This information would facilitate EPA’s evaluation of the materials and determination if 

396 any further action under TSCA, including additional information collection, is needed. By gathering data 

397 regarding the characteristics, uses, and exposure pertaining to chemical substances manufactured at the 

398 nanoscale, EPA will create a more robust database that will expand the Agency’s understanding of 

399 commercially available nanoscale substances including available environmental health and safety data 

400 and risk management practices. 

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

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

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

404 reporting rule to determine if any further action under TSCA, including additional information collection, 
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405 is needed. EPA intends to make conclusions on the basis of specific scientific evidence. Restrictions on 

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

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

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

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

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

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

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

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

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

415 EPA is proposing reporting and recordkeeping requirements for manufacturers and processors of 

416 certain chemical substances pursuant to TSCA section 8(a). 

417 A. What Chemical Substances willwould be Subject toReportable Under this Rule? 

418 1. Reportable chemical substances. This proposed rule would apply to chemical substances that 

419 are solids at 25 oC and atmospheric pressure and that are manufactured or processed in a form where at 

420 least 10% of the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm.

421 When proposing at least 10% of particlesnanometers (nm) and exhibit unique and novel 

422 characteristics or properties because of their size. The proposed rule would apply to chemical substances 

423 containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm as a threshold for 

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

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

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

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

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

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

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

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

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

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

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

435 100 nm within any given sample of particles would be of interest with respect to human health or 

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

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

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

439 proposed reporting. EPA does not want to exclude dimension. This proposed rule would not apply to 

440 chemical substances that are considered to be nanoscale materials by setting too high of a cut-off. 

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

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

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

444 threshold greater than 10% of particles less than 100 nm to require reporting begins to exclude nanoscale 

445 materials that are less than one standard deviation from the mean of a normal distribution curve of particle 

446 sizes. This would begin to exclude a large number of nanoscale materials with trace amounts of primary 
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447 particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance 

448 does not exhibit the unique and novel characteristics or properties of potential interest. EPA is seeking 

449 comment on this issue. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

470 materials created as a thin film because EPA believes that information collected on these materials would 

471 be of limited value because either they have been well-characterized or they present little exposure 

472 potential. EPA requests comment on these proposed exclusions and whether other nanoscale materials 

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

474 should be excludedof particle size. EPA is proposing these parameters for purposes of identifying 

475 chemical substances that are subject to the rule, not to establish a definition of what is a nanoscale 

476 material. 

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

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

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

480 i. Discrete forms. B. When would nanoscale materials be reported under the rule?

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

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

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

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

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

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

487 C. How would nanoscale materials be reported under the rule? 

488 Manufacturers and processors of multiple nanoscale forms of the same chemical substance 
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489 would, in some cases, need to know if reporting is requiredreport separately for each form. . discrete form 

490 of the reportable chemical substance. EPA is proposing to distinguish among nanoscale materials for 

491 purposes of this rule based on a combination of three factors: 1) a change in process to affect a change in 

492 size and/or a change in properties of the chemical substances manufactured at the nanoscale materials; 2) 

493 a change in mean particle size of 10% or greater; and 3) athe measured change in at least one of 10% or 

494 more in surface chargethe following properties, zeta potential, specific surface area, 

495 dispersibility/solubilitydispersion stability, or surface reactivity., is greater than 7 times the standard 

496 deviation of the measured values (+/- 7 times the standard deviation). For example if the specific surface 

area of one discrete form was measured to be 50 +/- 5 m2 497 /g, then a change resulting in a new average 

specific area of 85 m2 498 /g would be reportable if factors 1 and 2 were also met. EPA recommends using the 

499 same medium and method when measuring the change in these properties, as even minor changes in the 

500 medium and methods can result in large differences in the measured results. EPA’s intent for proposing 

501 these reporting requirements is to focus reporting on intentionally manufactured chemical substances at 

502 the nanoscale materials. . 

503 EPA is proposing the combination of these three factors rather than simply size to distinguish 

504 between different chemical substances manufactured at the nanoscale materials so that unintended 

505 variation in size range between production batches would not trigger TSCA section 8(a) reporting. Also, 

506 EPA is proposing not to rely solely on process changes because there may be process changes that are not 

507 intended to change the material produced but rather intended to improve the efficiency of the process or 

508 to use a cheaper reactant. EPA is focusing on the properties of surface chargezeta potential, specific 

509 surface area, dispersibility/solubilitydispersion stability, or surface reactivity because these are properties 

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

511 unique properties of chemical substances manufactured at the nanoscale materials (e.g., the wavelength at 

512 which light is emitted) may be important for how the nanoscale materialthat form of the chemical 

513 substance functions but are less likely to be important in a health and safety context. EPA believes that 

514 the combination of these three factors will provide a clear and transparent way for the regulated 

515 community to distinguish among different chemical substances manufactured at the nanoscale materials 

516 for purposes of TSCA section 8(a) reporting. 

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

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

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

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

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

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

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

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

525 inherent property should be included. 

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

527 nanoscale material to its mass or the area of the surface of the nanoscale material divided by volume. 

528 This is an important factor because chemical reactions take place at the surface of the material. Thus, the 

529 higher the surface area, the greater the chemical reactivity, which is an important consideration for human 

530 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 (m2 531 /kg) or the area of the surface of the nanoscale 

materialsmaterial divided by volume (m2

/m3 532 . ).
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533 Surface charge Zeta potential is the electric charge on a surface in contact with a continuous 

534 phase (Ref 23). Surface charge can be calculated by measuring the electrokinetic potential in colloidal 

535 systems known as the zeta potential. . It is measured as the net number of positive and negative charges 

per unit particle surface area in Coulomb/m2 536 (Ref 23. 25) and is typically measured by electrophoresis. 

537 For purposes of this proposed rule the differential of 10% in the surface charge would be measured for the 

538 same medium.

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

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

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

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

543 rather than solubility would be observed. 

544 Dispersion stability is the ability of a dispersion to resist changes in properties over time and can 

545 be defined in terms of the change in one or more physical properties over a given time period. See 

546 ISO/TR 13097:2013 “Guidelines for characterization of dispersion stability” (Ref. 26) as an example. 

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

548 biological systems. The surface reactivity of the nanoscale materialform of a chemical substance is 

549 dependent upon factors such as redox potential which is a measure of the tendency of an entity to lose or 

550 acquire electrons, and photocatalytic activity, including the potential to generate free radicals. Reactive 

551 oxygen species (ROS) and free radicals are important in considering toxicity for these materials. 

552 EachA nanoscale form of a particular chemical substance with a different morphology or shapes 

553 thatshape would also qualify as a discrete form. Examples include but are not limited to spheres, rods, 

554 ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, orand

555 sheets would also be a discrete form. Nanoscale forms of a particular chemical substance that are coated 

556 with different chemical substances would be considered discrete forms for each chemical coating. 

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

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

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

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

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

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

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

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

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

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

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

568 such distinctions. 

569 Chemical mixtures. Chemical substances that are manufactured (including imported), or 

570 processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite 

571 would also have to be reported. Nanoscale materialsChemical substances at the nanoscale that are 

572 manufactured but are then incorporated into mixtures, encapsulated materials or composites by that 

573 manufacturer would not require separate reporting for their incorporation. However, the person reporting 

574 the nanoscale material would have to report each step of the manufacture, processing, and use of the 

575 nanoscale material to the extent it is known or reasonably ascertainable. However, the person reporting 
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576 the chemical substance would have to report each step of its manufacture, processing and use to the extent 

577 it is known or reasonably ascertainable.The proposed rule would not require manufacturers or processors 

578 to report certain information that has already been submitted to EPA. A person who submitted a new 

579 chemical notice for a nanoscale material under TSCA section 5 to EPA on or after January 1, 2005 would 

580 not be required to report regarding the same substance under this proposed TSCA section 8(a) rule. In 

581 addition, any person who has already reported part of or all of the information that would be required 

582 under this proposed TSCA section 8(a) rule under the NMSP would not need to report that information 

583 again. See http://www.epa.gov/oppt/nano/stewardship.html for more information on that program. If, 

584 however, information required by this proposed rule was not reported under the NMSP (including 

585 information for each discrete form of a nanoscale material), then reporting of that information would be 

586 required. 

587 2. Substances excluded from reporting. EPA is proposing to exclude from the requirements of this 

588 rule certain biological materials (e.g., DNA, RNA, and proteins). EPA is seeking comment to identify 

589 other specific biological materials that should be excluded from reporting and the reasons for excluding 

590 them, including microorganisms and viral based products (or other combinations of RNA, DNA and 

591 protein), lipids, carbohydrates, enzymes, and peptides. However, the properties of biological materials 

592 such as DNA, RNA and proteins are not a function of the size range per se but rather the precise 

593 nucleotide sequence (in the case of DNA and RNA), shape, and other features. 

594 EPA is proposing to exclude chemical substances which dissociate completely in water to form 

595 ions that are less than 1 nanometer. This exclusion would not apply to chemical substances manufactured 

596 at the nanoscale materials that release ions but do not dissociate in water to form those ions. EPA 

597 believes that the chemical substances that would be excluded do not exhibit new properties when their 

598 size falls in the range of 1-100 nanometers and manufacture or processing such substances at the 

599 nanoscale should therefore not be subject to the reporting requirements of the proposed rule. EPA is 

600 seeking comment to identify other water soluble compounds that should be excluded from reporting and 

601 the reasons for excluding them.

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

603 chemical substances manufactured at the nanoscale as part of a film on a surface. The Agency believes 

604 that information collected on these materials would be of limited value because either they have been 

605 well-characterized or they present little exposure potential. EPA requests comment on these proposed 

606 exclusions and whether other chemical substances manufactured at the nanoscale should be excluded. 

607 EPA requests that commenters explain why they believe the chemical substances manufactured at the 

608 nanoscale should be excluded. 

609 3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 

610 8(a) reporting at 40 CFR 704.5 would be applicable to this proposed rule, including the . This includes, 

611 among other exemptions, the exemption for research and development and small manufacturers. Aunder 

612 which a person who manufactures or processes, a chemical substance only in small quantities for research 

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

614 manufacturers would be exempt from Examples of research and development (R&D) activity are the 

615 reporting requirements of this proposed rule. analysis of the chemical or physical characteristics, the 

616 performance, or the production characteristics of a chemical substance, a mixture containing the 

617 substance, or an article. It can include production of a chemical substance for use by others in their R&D 

618 activities. R&D activity generally includes specific monitored tests undertaken as part of a planned 

619 program of activity. 
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620 EPA is proposing an alternate exemption for the existing small manufacturer exemption. Under 

621 other TSCA section 8(a) rules, a company may qualifyqualifies as a small manufacturer in 40 CFR 704.3 

622 it if meetsby meeting either of the following two standards. The first is that sales of the company are less 

623 than $40 million dollars per year and the company does not manufacture or import more than 100,000 

624 pounds annually of an individual substance at any individual site owned or controlled by the company. 

625 The second is that any company with sales ofare less than $4 million dollars is considered a small 

626 business regardless of the quantity manufactured or imported. 

627 However, EPA is proposing a different definition of a small manufacturer or processorexemption

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

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

630 exemption did not contemplate typical production volumes for chemical substances manufactured at the 

631 nanoscale materials. EPA has reviewed over 200 chemical substances manufactured at the nanoscale 

632 materials in the NMSP and the new chemicals program under TSCA. At least 170 of those chemical 

633 substances manufactured at the nanoscale materials had reported or estimated production volumes less 

634 than 22,000 pounds. Based on this experience, exempting manufacturers or processors from reporting 

635 annual production volumes of nanoscale materials up to 100,000 pounds would exclude a large proportion 

636 of companies that characteristically manufacture chemical substances manufactured at the nanoscale 

637 materials in small amounts but would not otherwise be considered small. Given that chemical substances 

638 manufactured at the nanoscale materials tend to be produced in small volumes, EPA does not believe 

639 production volume should be a relevant consideration in determining whether a nanotechnology company 

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

641 manufacturer or processor exemption that would apply for this proposed rule. 

642 4. Proposed exceptions to reporting. The proposed rule would not require manufacturers or 

643 processors to report certain information that has already been submitted to EPA. A person who submitted 

644 a TSCA chemical notice under section 5 to EPA on or after January 1, 2005 would not be required to 

645 report regarding the same substance under this proposed TSCA section 8(a) rule except where the person 

646 manufactured or processed a new discrete form of the reportable chemical substance. In addition, any 

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

648 proposed TSCA section 8(a) rule under the NMSP would not need to report that information again under 

649 this proposed TSCA section 8(a) rule. If, however, information required by this proposed rule was not 

650 reported under section 5 or the NMSP (including information for each discrete form of a reportable 

651 chemical substance), then reporting of that information would be required under this proposed TSCA 

652 section 8(a) rule. The purpose of these exemptions is to avoid duplicative reporting. For example new 

653 chemical notices that have been reviewed as nanoscale materials would not be subject to reporting the 

654 same information under this rule. 

655 B. When would Reporting be Required?

656 EPA proposes that persons who manufacture or process a discrete form of a reportable chemical 

657 substance at any time during the three years prior to the final effective date of the rule would report to 

658 EPA six months after the final effective date of the rule. EPA also proposes a continuing requirement that 

659 persons who intend to manufacture or process a discrete form of a reportable chemical substance on or 

660 after the effective date of the rule would report to EPA at least 135 days before commencement of 

661 manufacture or processing. 
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662 The 135-day period is based on EPA’s experience with PMN submissions. TSCA section 8(a) 

663 applies to a person “who manufactures or processes or proposes to manufacture or process a chemical 

664 substance”. A company proposes to manufacture or process a chemical substance by forming the intent 

665 to do so. Based on EPA’s experience, persons form the intent to manufacture or process chemical 

666 substances at least 135 days ahead of time. This belief is based on EPA's experience with Premanufacture 

667 Notice (PMN) submissions and subsequent notices of commencement (NOCs). Pursuant to section 

668 5(a)(1) of TSCA and 40 CFR 720.22, PMNs are submitted by a person who intends to manufacture a 

669 chemical substance, at least 90 days before commencing manufacture. Under 40 CFR 720.102, a 

670 company that has submitted a PMN for which the statutory 90-day review period has expired and which 

671 has commenced manufacture of that substance must submit an NOC to EPA within 30 days following 

672 commencement. For fiscal years 2009-2011, EPA received 1,723 PMNs. Based on EPA's review of 

673 NOC receipt date information, EPA determined that NOCs were received within 45 days of completion of 

674 the 90-day PMN review for only 16% of these submitted PMNs. Thus, for 84% of the submitted PMNs, 

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

676 before commercialization. Because a company must by necessity form the intent to manufacture a 

677 chemical substance some period of time before the PMN is submitted to EPA, the intent to manufacture 

678 or process would be made at least 135 days in advance as a general matter.

679 C. What Information would be Reported? 

680 This TSCA section 8(a) rule proposes one-time reporting of certain information, including 

681 specific chemical identity, production volume, methods of manufacture and processing, use, exposure and 

682 release information, and available health and safety data. 

683 EPA developed an information reporting form for the NMSP (Ref. 27) which has been slightly 

684 modified for purposes of this proposed rule. The same information that was requested in the NMSP 

685 would be required by this proposed rule, including information on specific chemical identity, material 

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

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

688 effects. The information would be reported on a form similar to that used in the NMSP. (Ref. 27). Any 

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

690 the extent it is known to or reasonably ascertainable toby them. A draft of the proposed reporting form 

691 (EPA Form No. 7710-[tbd]) is available in the docket for public review (Ref. 28).

692 EPA is requesting comment on whether any information proposed to be collected requested in 

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

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

695 D. How would information be submitted under the ruleInformation be Submitted to EPA? 

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

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

698 for submitting other information under TSCA (see proposed 704.20(e)). EPA is proposing to require 

699 submitters to use EPA’s CDX, the Agency's electronic reporting siteportal, for all reporting under this 

700 rule. In the Federal Register of December 4, 2013 (78 FR 72818) (FRL 9394-6Ref. 1), EPA finalized a 

701 rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 

702 4, 5, 8(a) and 8(d). The final rule follows two previous rules requiring similar electronic reporting of 

703 information submitted to EPA (for TSCA Chemical Data Reporting and for Pre-Manufacture 
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704 Notifications. In proposing to require similar electronic reporting under this rule, EPA intends to save 

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

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

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

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

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

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

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

712 information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. 

713 EPA is proposing to require submitters to follow the same submission procedures used for other 

714 TSCA submissions, i.e., to register with EPA’s CDX and use CISS to prepare a data file for submission. 

715 Registration enables CDX to authenticate identity and verify authorization. To submit electronically to 

716 EPA via CDX, individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To 

717 register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private 

718 Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and 

719 organization, selects a user name and password, and follows the procedures outlined in the guidance 

720 document for CDX available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. 

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

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

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

724 and use the CISS web-based reporting tool. 

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

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

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

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

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

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

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

732 through CISS reporting guidance. 

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

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

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

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

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

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

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

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

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

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

743 reporting nanoscale materialschemical substances under this proposed rule would be similar. EPA will 

744 subsequently put a version of the tool for reporting nanoscale materialsunder this rule in the docket for 

745 comment, including comments on the extent of and burden associated with training for using CDX. 
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746 EPA believes that electronic reporting reduces the reporting burden for submitters by reducing 

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

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

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

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

751 electronic submissions and communicating back electronically with submitters.

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

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

754 approaches. 

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

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

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

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

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

760 processed. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

776 of information regarding chemical substances manufactured at the nanoscale materials, EPA would 

777 encourage respondents to this proposed rule to provide the Agency with any relevant data on chemical 

778 substances manufactured at the nanoscale materials they may wishdecide to develop. 

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

780 Practice Standards, which are codified at 40 CFR part 792. There are also standard test methods available 

781 for properties and information identified in the proposed rule from a number of sources. Some of these 

782 sources include but are not limited to ASTM International, the International Organization for 

783 Standardization, the National Institute of Standards and Technology, and the Organization for Economic 

784 Cooperation and Development. EPA encourages persons who intend to conduct testing to consult with 

785 the Agency before selecting a protocol for testing a chemical substance manufactured at the nanoscale

786 material. EPA would also encourage persons that would be required to submit TSCA section 8(a) data 
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787 under this proposed rule to provide information on the potential benefits regarding the nanoscale 

788 materialreportable chemical substance. 

789 V.V. Request for Comments

790 EPA is seeking public comment on all aspects of this proposed rule. In addition to specific 

791 requests for comment included throughout this document, EPA is interested in comments pertaining to the 

792 specific issues discussed in this unit. EPA also anticipates conducting a public meeting during the 

793 comment period to further discuss these and any other issues concerning the proposed rule. 

794 1. Identifying the chemical substances that would be subject to reporting. EPA has developed the 

795 proposed approach based on the approximate size range of 1-100 nm as used by the NNI for defining 

796 nanotechnology (Ref. 6), experience in conducting assessments of new chemicals manufactured at the 

797 nanoscale by EPA under TSCA, and data submitted to EPA under the NMSP. EPA is soliciting comment 

798 on each aspect of the proposed approach to identifying the chemical substances that would be subject to 

799 the reporting requirements of the rule. The Agency is seeking comment on these approaches and 

800 alternative approaches for reporting requirements. For example the proposed rule would apply to 

801 reportable chemical substances that contain primary particles, aggregates, or agglomerates in the size 

802 range of 1-100 nm in at least one dimension. EPA is seeking comments on that aspect of reportable 

803 chemical substances. EPA is asking commenters if the current proposal sufficiently encompasses these 

804 types of reportable chemical substances. 

805 2. Distinguishing between nanoscale forms of a reportable chemical substance. EPA considered 

806 several different approaches to distinguish between nanoscale forms of a reportable chemical substance 

807 including a percentage or numerical change in measured properties. The agency is also seeking comment 

808 on an approach based solely on the behavior of the reportable chemical substance. For example, if a 

809 manufacturer or processor knows about or engineers a reportable chemical substance with multiple 

810 nanoscale forms with different performance characteristics then each nanoscale form would be reported. 

811 If multiple nanoscale forms of a reportable chemical substance do not perform differently then only a 

812 single report of the entire range would be reported. EPA is seeking comment on these and other 

813 alternative approaches. EPA is especially interested in comments on whether these approaches would 

814 require reporting of sufficiently distinct nanoscale forms of a chemical substance so that reporting would 

815 be focused on those nanoscale forms with potential for significantly different physical or chemical 

816 characteristics or properties. EPA also seeks comment on each aspect of its proposed reporting such as 

817 size increments, the number of standard deviations, morphology, the specific physical-chemical properties 

818 identified, exclusions to reporting, and whether companies have the analytical tools to make such 

819 distinctions. 

820 3. Reporting discrete forms at least 135 days before commencement of manufacture or 

821 processing. As discussed in Unit III.B., EPA proposed the 135-day period based on EPA’s experience 

822 with PMN submissions, and the determination that the intent to manufacture was formed at least 135 days 

823 before commercialization (i.e., the 90-day PMN review period plus 45 days). EPA is specifically seeking 

824 comment on whether this time-period should be 135 days as proposed, 90 days to be similar to the PMN 

825 review period, or some other time period. It would be most helpful if commenters explain why the time 

826 period they suggest is appropriate. 

827 4. Considerations for the Agency’s economic analysis. EPA has evaluated the potential costs for 

828 manufacturers and processors of reportable chemical substances for this proposed rule (Ref. 3). EPA is 

829 specifically seeking additional information and data that EPA could consider in developing the final 
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830 economic analysis. In particular, data that could facilitate the Agency’s further evaluation of the 

831 potentially affected industry and firms, including data related to potential impacts for those small 

832 businesses that would be subject to reporting. EPA is especially interested in available data or other 

833 measures of the number of and potential growth in the number of commercial nanoscale materials or 

834 firms that might manufacture or process such materials. 

835 5. Electronic reporting. In proposing to require electronic reporting under this rule that is similar 

836 to those established in 2013 for other TSCA reporting, EPA intends to save time, improve data quality 

837 and increase efficiencies for both the submitters and the Agency. EPA is specifically interested in 

838 comments related to the adoption of the existing mechanisms and related procedures for use in 

839 transmitting the reports proposed in this rule, including comments related to the extent to which 

840 potentially reporting entities are already familiar with those mechanisms given their existing use for other 

841 TSCA reporting. EPA is also interested in feedback on how electronic reporting mechanisms affect 

842 reporting entities in terms of reporting time, added efficiencies, and potential burden associated with 

843 training to use the electronic systems (i.e., CDX and CISS). 

844 6. Consideration of potential future rulemaking regarding periodic reporting. EPA is also 

845 seeking comment on the possibility of a future rule that would require periodic reporting of chemical 

846 substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data 

847 Reporting (CDR) rule at 40 CFR part 711. Such a rule could require manufacturers and processors of 

848 chemical substances manufactured at the nanoscale to report the type of information collected under the 

849 CDR rule to EPA at the same reporting interval as currently required by CDR reporting (every four 

850 years). That reporting could occur at lower thresholds for criteria such as production volume. The CDR 

851 is a program designed to collect screening-level, exposure-related information on chemical substances 

852 and to make that information available for use by EPA and to the public consistent with confidentiality 

853 under TSCA Section 14 and EPA regulations in 40 CFR Part 2. The CDR rule data are used by EPA to 

854 support risk screening, assessment, priority setting and management activities and constitute the most 

855 comprehensive source of basic screening-level, exposure-related information on chemicals available to 

856 EPA. For further information see http://www.epa.gov/oppt/cdr. 

857 VI. References 

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

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

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

861 INFORMATION CONTACT.

862 1. 2014. National Nanotechnology Initiative. “Supplement tot eh President’s 2015 Budget,” p. 

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

864 1. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. 

865 Federal Register (78 FR 72818, December 4, 2013) (FRL 9394-6). 

866 2. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making 

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

868 http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and869 oversight-principles.pdf. 
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870 3. 2015. EPA. Economic Analysis for the TSCA Section 8(a) Proposed Reporting 

871 Requirements for Certain Nanoscale Materials (RIN 2070-AJ54). March 12, 2015. 

872 2.4. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final Rule. Federal 

873 Register (70 FR 59848, October 13, 2005) (FRL-7977-1).

874 3.5. 2005. Oberdörster, Gunter, Oberdörster, Eva, and Oberdörster, Jan. Nanotoxicology: an 

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

876 (113): 823-839. 

877 4. 2004. National Nanotechnology Initiative. The National Nanotechnology Initiative Strategic 

878 Plan. Available on-line at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf. 

879 6. 2014. National Nanotechnology Initiative (NNI). “Supplement to the President’s 2015 

880 Budget,” p. 3. http://www.nano.gov/sites/default/files/pub_resource/nni_fy15_budget_supplement.pdf.. 

881 5.7. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean-Yves, Lowry, Gregory V Jolivet Jean882 Pierre, and Wiesner, Mark R. Towards a definition of inorganic nanoparticles from an environmental, 

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

884 2009 | doi:10.1038/nnano.2009.242. 

885 6.8. 2009. National Institute of Occupational Safety and Health.NIOSH. Approaches to Safe 

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

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

888 7.9. 2009. European Commission, Directorate-General for Health and Consumers. Scientific 

889 Committee on Emerging and Newly Identified Risks, (SCENIR), Report: Risk Assessment of Products of 

890 Nanotechnologies. Available on-line at 

891 http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf.http://ec.europa.eu/heal

892 th/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf.

893 8.10. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and Donaldson, Kenneth. 

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

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

896 9.11. 2010. Wick, Peter, Malek, Antoine, Manser, Pius, Meili, Danielle, Maeder-Althaus, 

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

898 Barrier Capacity of Human Placenta for Nanosized Materials. Environmental Health Perspectives. 

899 (118):432-436. 

900 10.12. 2008. Kim, Yong Soon, Kim, Jin Sik, Cho, Hyun Sun, Rha, Dae Sik, Kim, Jae Min, 

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

902 Jeong, Jayoung, Han, Beom Seok, and Yu, Il Je. Twenty-Eight Day Oral Toxicity, Genotoxicity, and 

903 Gender-Related Tissue Distribution of Silver Nanoparticles in Sprague-Dawley Rats. Inhalation 

904 Toxicology. 20 (6): 575-583. 

905 11.13. 2008. Handy, Richard D., Von der Kammer, Frank, Lead, Jamie R., Hassello, Martin, 

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

907 Ecotoxicology 17:287-314. 
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908 12.14. 2008. Klaine, Stephen J., Alvarez, Pedro J., Batley, Graeme E., Fernandes, Teresa F., 

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

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

911 Toxicology and Chemistry. 27: 1825-1851. 

912 13.15. 2007. Federici, Gillian, Shaw, Benjamin J., and Handy, Richard D. Toxicity of titanium 

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

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

915 14.16. 2007. Roberts, Aaron P., Mount, Andrew S., Seda, Brandon, Souther, Justin, Qiao, Rui, 

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

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

918 15.17. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna mortality when exposed to 

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

920 1132–1137. 

921 16.18. 2006. Oberdörster, Eva, Zhu, Shiqian, Zhu, Blickley, T. Michelle, McClellan-Green, 

922 Patricia, and Haasch, Mary L. Ecotoxicology of carbon-based engineered nanoparticles: effects of 

923 fullerene (C-60) on aquatic organisms. Carbon. 44: 1112-1120. 

924 17.19. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the see-through Medaka 

925 (Oryzias latipes). Environmental Health Perspectives. 114: 1697–1702. 

926 18.20. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. Effect of carbon 

927 nanotubes on developing zebra fish (Danio rerio) embryos. Environmental Toxicology and Chemistry.

928 26:708–716. 

929 19.21. 2013. NIOSH. Current Intelligence Bulletin 65: Occupational Exposure to Carbon 

930 Nanotubes and Nanofibers at http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf.

931 20.22. 2007. EPA. EPA Nanotechnology White Paper. Available online at 

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

933 21.23. 2008. EPA. TSCA Inventory Status of Nanoscale Substances -- General Approach. 

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

935 22.24. 2009. EPA. EPA interim reportInterim Report on the Nanoscale Materials Stewardship 

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

937 21. 2010. EPA. List of Chemical Substances on the TSCA Inventory that EPA believes can be solid 

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

939 conditions. 

940 22. 2010. Joint Research Centre of the European Commission. Considerations on a Definition of 

941 Nanomaterial for Regulatory Purposes. Available online at 

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

943 23.25. 23. 20112012. International Organization for Standardization. (ISO). Nanotechnologies 

944 – Guidance on Physicochemical Characterization for Manufactured Nano-objects submittedSubmitted for 

945 Toxicological Testing. ISO/TR (Technical Report) ISO/TR 13014:2012.
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946 24.26. 2013. 24. EPA. Cross-Media Electronic Reporting; Final Rule. Federal Register (70 

947 FR 59848, October 13, 2005) (FRL-7977-1).

948 27. 25. 2010. EPA. Economic AnalysisISO/TR. Guidelines for Characterization of Dispersion 

949 Stability. ISO/TR 13097:2013. 

950 25.28. 2008. EPA. the TSCA Section 8(a) Proposed Reporting Requirements for Certain 

951 Nanoscale Materials. Stewardship Program Data Submission Form. EPA Form No. 7710-25-NMSP; 

952 EPA ICR No. 2550.01; OMB Control No. 2070-0170.

953 29. 2015. EPA. 26. 2010. Proposed Data Submission Form. "TSCA 8(a) Data Reporting for 

954 Nanoscale Materials.” EPA Form No. 7710[tbd]; EPA ICR No. ####.01; OMB Control No. 2070-[new]. 

955 26.30. 2015. EPA. Proposed Addendum to an Existing EPA ICR Entitled: Chemical-Specific 

956 Rules, Toxic Substances Control Act Section 8(a). EPA ICR No. ####.01; OMB Control No. 2070-

957 [new].

958 27.31. 27. VII2013. National Institute of Occupational Safety and Health. Current Intelligence 

959 Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers at 

960 http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf.

961 28. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making 

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

963 http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation964 and-oversight-principles.pdf 

965 VI. Statutory and Executive Order Reviews 

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

967 Regulation and Regulatory Review 

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

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

970 1993). Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 

971 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes made in response to 

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

973 6(a)(3)(E) of Executive Order 12866.

974 B. Paperwork Reduction Act (PRA) 

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

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

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

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

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

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

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

982 proposed rule would involve revised information collection activities that require additional OMB 
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983 approval, EPA has prepared an addendum to the currently approved ICR (Ref. 26, and is identified under 

984 EPA ICR No. 1198.11 (Ref. 29). 

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

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

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

988 incremental industry burden of 228,853 hours. 

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

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

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

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

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

994 comments to OMB Desk Officer for EPA. 

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

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

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

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

999 this proposed rule. 

1000 C. Regulatory Flexibility Act (RFA) 

1001 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certifiescertify that this 

1002 action would not have a significant adverse economic impact on a substantial number of small entities. 

1003 The rationale supporting this conclusion is summarized here, and is presented in a small entity impact 

1004 analysis that EPA prepared for this proposed action that is part of the Agency’s economic analysis (Ref. 

1005 25). in the public docket for this proposed rule. (Ref. 3). 

1006 Under the RFA, small entities include small businesses, small organizations, and small 

1007 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, 

1008 small entity is defined as: (1) a small business, as defined by the Small Business Administration’s (SBA) 

1009 regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, 

1010 county, town, school district or special district with a population of less than 50,000; and (3) a small 

1011 organization that is any not-for-profit enterprise which is independently owned and operated and is not 

1012 dominant in its field. Since the regulated community is not expected to include small governmental 

1013 jurisdictions or small not-for-profit organizations, the analysis focuses on small businesses. 

1014 A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). 

1015 For this action, EPA is proposing to modify the exemption. For more details see Unit II.D. EPA analyzed 

1016 potential small business impacts from this proposed rule using both the SBA employee size standards and 

1017 the TSCA sales-based definition of small business. EPA estimates that up to 174 small businesses may 

1018 be impacted by the proposed TSCA section 8(a) reporting rule but estimates no adverse economic impact 

1019 greater than three percent of sales for any of those companies.and evaluated the number that may incur 

1020 costs at below 1%, between 1% and 3%, and above 3% of sales. EPA estimates that all 174 small 

1021 businesses would identified would incur costs below 1% of sales. 

1022 

1023 EPA continues to be interested in the potential impacts of this proposed rule on small entities that 

1024 are not exempt from reporting and welcomes comments on issues related to such impacts. 
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1025 D. Unfunded Mandates Reform Act (UMRA) 

1026 Based on EPA’s experience with proposing and finalizing rules under TSCA section 8(a), State, 

1027 local and Tribal governments have not been impacted by these rulemakings, and EPA does not have any 

1028 reason to believe that any State, local or Tribal government would be impacted by this rulemaking. In 

1029 addition, this action will not result in annual expenditures of $100 million or more for the private sector. 

1030 As such, EPA has determined that this action does not impose any enforceable duty, contain any 

1031 unfunded mandate, or otherwise have any effect on small governments, and that the requirements of 

1032 sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action. 

1033 E. Executive Order 13132: Federalism 

1034 This action does not have substantial direct effects on the states, on the relationship between the 

1035 national government and the states, or on the distribution of power and responsibilities among the 

1036 various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 

1037 1999). 

1038 

1039 F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments 

1040 This action does not have tribal implications because it will not have any effect on tribal 

1041 governments, on the relationship between the Federal government and the Indian tribes, or on the 

1042 distribution of power and responsibilities between the Federal government and Indian tribes, as specified 

1043 in Executive Order 13175 (65 FR 67249, November 9, 2000). 

1044 

1045 G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks 

1046 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those 

1047 regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 

1048 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to 

1049 Executive Order 13045 because it does not establish an environmental standard intended to mitigate 

1050 health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed 

1051 rule will be used to inform the Agency’s decision-making process regarding chemicalschemical 

1052 substances to which children may be disproportionately exposed. This information will also assist the 

1053 Agency and others in determining whether the chemicalschemical substances addressed in this proposed 

1054 rule present potential risks, allowing the Agency and others to take appropriate action to investigate and 

1055 mitigate those risks. 

1056 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, 

1057 Distribution, or Use

1058 This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 

1059 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, 

1060 distribution, or use. 

1061 

1062 I. National Technology Transfer and Advancement Act (NTTAA) 

1063 Since this action does not involve any technical standards, NTTAA section 12(d) , 15 U.S.C. 272 

1064 note, does not apply to this action. 

1065 
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1066 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations 

1067 and Low -Income Populations 

1068 This action does not entail special considerations of environmental justice related issues as 

1069 delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that 

1070 this action will not have disproportionately high and adverse human health or environmental effects on 

1071 minority or low-income populations. This action does not affect the level of protection provided to human 

1072 health or the environment. 

1073 

1074 This action does not affect the level of protection provided to human health or the environment. 

1075 However, the Agency believes that the information collected under this proposed rule, if finalized, will 

1076 assist EPA and others in determining the potential hazards and risks associated with various chemicals 

1077 manufactured processed, and used at the nanoscale. Although not directly impacting environmental 

1078 justice-related concerns, this information will enable the Agency to better protect human health and the 

1079 environment, including in low-income and minority communities. 

1080 

1081 List of Subjects in 40 CFR Part 704

1082 Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting 

1083 Requirements. 

1084 Dated: ____________________ 

1085 __________________________________________ 

1086 Assistant Administrator, Office of Chemical Safety and Pollution Prevention. 
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1087 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

1088 1. The authority citation for part 704 continues to read as follows: 

1089 Authority: 15 U.S.C. 2607(a) 

1090 2. By adding § 704.xxxx20 to Subpart B, to read as follows 

1091 §704.xxx Nanoscale materials. 

1092 §704.20 Chemical substances manufactured or processed at the nanoscale.

1093 (a) Definitions. For purposes of this section the terms below are defined as follows:

1094 An agglomerate is a collection of weakly bound particles or aggregates or mixtures of the two 

1095 where the resulting external surface area is similar to the sum of the surface areas of the individual 

1096 components. 

1097 An aggregate is a particle comprising strongly bonded or fused particles where the resulting 

1098 external surface area may be significantly smaller than the sum of calculated surface areas of the 

1099 individual components. 

1100 Central Data Exchange or CDX means EPA's centralized electronic submission receiving system. 

1101 Chemical Information Submission System or CISS means EPA's electronic, web-based reporting 

1102 tool for the completion and submission of data, reports, and other information, or its successors. 

1103 A discrete form of a reportable chemical substance differs from another form of the same 

1104 reportable chemical substance in that either: 

1105 (1) The change in the reportable chemical substance is due to all of the following: 

1106 (i) There is a change in process to affect a change in size and/or a change in one or more of the 

1107 properties of the reportable chemical substances identified in (iii); 

1108 (ii) There is a size variation in the mean particle size that is greater than 7 times the standard 

1109 deviation of the mean particle size (+/- 7 times the standard deviation); and 

1110 (iii) There is a measured change in at least one of the following properties, zeta potential, specific 

1111 surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of 

1112 the measured value (+/- 7 times the standard deviation); 

1113 (2) The reportable chemical substance has a different morphology. Examples of morphologies 

1114 include but are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, 

1115 flower, ring, torus, cone, and sheet; or 

1116 (3) A reportable chemical substance that is coated with another chemical substance or mixture at 

1117 the end of manufacturing or processing has a coating that consists of a different chemical substance or 

1118 mixture. 

1119 The Nanoscale Materials Stewardship Program was a program conducted by EPA from January 

1120 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily 
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1121 provided EPA available information on engineered nanoscale materials that were manufactured processed 

1122 or used. 

1123 Primary particles are particles or droplets that form during manufacture of a chemical substance 

1124 before aggregation or agglomerization occurs. 

1125 An aggregate is a heterogeneous particle in which the various components are held together by 

1126 relatively strong forces, and thus not easily broken apart. Aggregated nanoparticles would be an example 

1127 of a nanostructured material which means a material having an internal or surface structure at the 

1128 nanoscale. 

1129 An agglomerate is a group of nanoparticles held together by relatively weak forces, including van 

1130 der Waals forces, electrostatic forces, and surface tension. 

1131 A solid nanoscale material reportable chemical substance is a chemical substance that is a solid 

1132 at 25 oC and atmospheric pressure that is manufactured or processed in a form where at least 10 % of the 

1133 primary particles, aggregates, or agglomerates, or aggregates are manufactured or processed in the size 

1134 range of 1-100 nanometers. 

1135 . 

1136 A discrete form of a solid nanoscale material differs from another form ofnm and exhibit unique 

1137 and novel characteristics or properties because of their size. A reportable chemical substance does not 

1138 include a chemical substance that only has trace amounts of primary particles, aggregates, or 

1139 agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the same 

1140 nanoscale material as follows in that either: 

1141 (1) The change in the nanoscale material is due to a combination of (i), (ii)unique and (iii) 

1142 (i) there is a change in process to affect a change in size and/or a change in onenovel 

1143 characteristics or more of the properties of the nanoscale materials identified in (iii) 

1144 (ii) there is a size variation in the mean because of particle size of 10% or greater; and 

1145 (iii) there is a change in one or more of the following properties of 10% or more: surface 

1146 charge, specific surface area, dispersibility/solubility, or surface reactivity; 

1147 (2) The nanoscale material has a different morphology. Examples of morphologies include but 

1148 are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, 

1149 torus, cone, and sheet. 

1150 (3) A nanoscale material that is coated with another chemical substance or mixture at the 

1151 end of manufacturing or processing has a coating that consists of a different chemical substance or 

1152 mixture. 

1153 A small manufacturer or processor means any manufacturer or processor whose total annual 

1154 sales, when combined with those of its parent company (if any), are less than $ 4 million. The definition 

1155 of small manufacturer in section 704.3 of this title does not apply to reporting under this section (40 CFR 

1156 704.xxx.20). 
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1157 Dispersibility means the extent to which the particulate nanoscale material can be distributed in 

1158 another material such as a liquid. 

1159 Solubility means the degree to which the nanoscale material can be dissolved in another material 

1160 such as a liquid. 

1161 Specific surface area means the ratio of the area of the surface of the nanoscale 

1162 materialreportable chemical substance to its mass. or volume. Specific surface area by mass is the ratio 

of the area of the surface of a nanoscale material divided by the mass (m2 1163 /kg) orand the specific surface 

1164 area by volume is the area of the surface of the nanoscale materialsreportable chemical substance divided 

by its volume m2

/m3 1165 . 

1166 Surface charge means the electric charge on a surface in contact with a continuous phase. 

1167 Surface charge can be calculated by measuringZeta Potential is the electrokinetic potential in colloidal 

1168 systems known as the zeta potential. . It is measured as the net number of positive and negative charges 

per unit particle surface area in Coulomb/m2 1169 . The differential of 10% in the surface charge would be 

1170 measured for the same medium.

1171 Surface reactivity means the reactivity at the surface of a nanoscale material.reportable chemical 

1172 substance. It is dependent upon factors such as redox potential, which is a measure of the tendency of a 

1173 substance to lose or acquire electrons, photocatalytic activity, including the potential to generate free 

1174 radicals. 

1175 Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, 

1176 or its successors. 

1177 Chemical Information Submission System or CISS means EPA’s electronic, web-based reporting 

1178 tool for the completion and submission of data, reports, and other information associated with TSCA 

1179 sections 4 and 8. 

1180 (b) Persons who must report. 

1181 (1) Manufacturers and processors of a discrete form of a solid nanoscale materialreportable 

1182 chemical substance during the three years prior to the final effective date of the rule must report except as 

1183 provided in paragraph (c) of this section. 

1184 (2) Persons who propose to manufacture or process a discrete form of a solid nanoscale 

1185 materialreportable chemical substance after the final effective date of the rule which was not reported 

1186 under paragraph (b)(1) must report except as provided in paragraph (c) of this section. 

1187 (c) When reporting is not required. 

1188 (1) The following chemical substances are not subject to reporting under this section: 

1189 (i) Zinc oxide 

1190 (ii) Nanoclays 

1191 (iii)Nanoscale materials created as a thin film 

1192 (iii) Chemical substances manufactured at the nanoscale as part of a film on a surface 

1193 (iv) DNA 

1194 (v) RNA 

1195 (vi) Proteins 
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1196 (vii) Chemical substances which dissociate completely in water to form ions that are lesssmaller

1197 than 1 nanometer.

1198 

1199 (2) Persons who submitted a TSCA chemical notice under 40 CFR part 720, 721, or 723 of this 

1200 title for a solid nanoscale material reportable chemical substance on or after January 1, 2005 are not 

1201 required to submit a report for the solid nanoscale materialreportable chemical substance submitted 

1202 except where the person manufactured or processed a discrete form of the solid nanoscale 

1203 material.reportable chemical substance. 

1204 (3) Section 704.5 (a) through (e) of this part 704 appliesapply to reporting under this section

1205 704.xxx. Small manufacturers and processors as defined in paragraph (a) of this section 704.xxx are 

1206 exempt from the reporting requirements ofunder this rulesection. 

1207 (4) Any personPersons who has already submitted some or all of the required information for a 

1208 reportable chemical substance described in paragraph (a) as part of the Nanoscale Materials Stewardship 

1209 Program isare not required to report thatthe information previously submitted except where the person 

1210 manufacturersmanufactures or processes a discrete form of the solid nanoscale material.reportable 

1211 chemical substance. 

1212 (d) What information to report. The following information must be reported for each discrete 

1213 form of a reportable chemical substance to the extent that it is known to or reasonably ascertainable for 

1214 each discrete form of a solid nanoscale material manufactured or processed during the three years prior to 

1215 the final effective date of the rule:by the person reporting: 

1216 (1) theThe common or trade name, the specific chemical identity including the correct Chemical 

1217 Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the 

1218 molecular structure of each chemical substance or mixture. Information must be reported as specified in 

1219 § 720.45. 

1220 (2) material characterizationMaterial characteristics including particle size, morphology, and 

1221 surface modifications;. 

1222 (3) physicalPhysical/chemical properties;. 

1223 (4) theThe maximum weight percentage of impurities and byproducts resulting from the 

1224 manufacture, processing, use, or disposal of each chemical substance;. 

1225 (5))(i) Persons described in paragraph (b)(1) of this section must report the annual production 

1226 volume for the previous three years before the effective date of the final rule and an estimate of the 

1227 maximum production volume for any consecutive 12-month period during the next two years of 

1228 production after the final effective date of this rule. Estimates must be on 100% chemical basis of the 

1229 discrete form of the solid nanoscale material;

1230 (ii) Persons described in paragraph (b)(2) of this section must report the estimated maximum 12 

1231 month production volume and the estimated maximum production volume for any consecutive 12 month 

1232 period during the first three years of production. 

1233 (iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section must be on 100% chemical basis of 

1234 the discrete form of the solid nanoscale material. 
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1235 (6) useUse information describing the category of each use by function and application, estimates 

1236 of the amount manufactured or processed for each category of use, and estimates of the percentage in the 

1237 formulation for each use;. 

1238 (7) detailedDetailed methods of manufacturing or processing;.

1239 (8) exposureExposure information with estimates of the number of individuals exposed in their 

1240 places of employment, descriptions and duration of the occupational tasks that cause such exposure, 

1241 descriptions and estimates of any general population or consumer exposures;. 

1242 (9) releaseRelease information with estimates of the amounts released, descriptions and duration 

1243 of the activities that cause such releases, and whether releases are directly to the environment or to control 

1244 technology;.

1245 (10) riskRisk management practices describing protective equipment for individuals, engineering 

1246 controls, control technologies used, any hazard warning statement, label, material safety data sheet, 

1247 customer training, or other information which is provided to any person who is reasonably likely to be 

1248 exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, 

1249 or disposal of the substance; and.

1250 (11) existingExisting data concerning the environmental and health effects. 

1251 (e) How to report.

1252 (1) Persons You must use CDX and the CISS tool to complete and submit the information required under 

1253 this part to EPA electronically. 

1254 (1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA §8(a) Data Reporting for 

1255 Nanoscale Materials: Data Submission Form and any attachments,. 

1256 (2) Electronic submission. You must submit the required information to EPA electronically via 

1257 CDX. Submission requires registration with CDX, and must be made only as set forth in this 

1258 section.using the CISS tool.

1259 (2) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx 

1260 and follow the appropriate links and for further instructions to go 

1261 http://www.epa.gov/oppt/chemtest/ereporting/index.html.

1262 (i) To access the CDX portal, go to https://cdx.epa.gov. 

1263 (ii) The CISS tool is accessible in CDX.

1264 (f) When to report. 

1265 (1) Persons specified in paragraph (b)(1) of this section must report the information specified in 

1266 paragraph (d) of this section within six months after the final effective date of the rule. 

1267 (2) Persons specified in paragraph (b)(2) of this section must report the information specified in 

1268 paragraph (d) of this section at least 135 days before commencing manufacture or processing of the 

1269 chemical substance. 
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1270 (g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to 

1271 the recordkeeping requirements in §704.11 (a) and (b). 

1272 (h) Confidential business information. Persons submitting a notice under this rule are subject to 

1273 the requirements for confidential business information claims in §704.7.

1274 [FR Doc. ??–????? Filed ??–??–??; 8:45 am]