*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

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

### 03/18/2015 version – Reflects all change s made during EO 12866 Review. 2 

### Filename: EO12866_Rin2070-AJ54_Nano 8(a) NPRM _FRdocument_Redlined.docx 3 4 BILLING CODE 6560–50–P 5

ENVIRONMENTAL PROTECTION AGENCY 6

40 CFR Part 704 7
[EPA–HQ–OPPT–2010-0572; FRL–XXXX–X9920-90 ] 8

RIN 2070–AJ54 9

Chemical Substances When Manufactured or Proc essed as Nanoscale Materials; TSCA Reporting 10 and Recordkeeping Requirements 11

AGENCY: Environmental Protection Agency (EPA). 12

ACTION: Proposed rule. 13

SUMMARY : EPA is proposing reporting and recordkeeping requirements for certain chemical 14 substances when they are manufactured or processed asat the nanoscale materials. as described in this 15 rule. Specifically, EPA proposes to re quire persons that manufacture (defined by statute to include 16 import) or process, or intend to manufacture or process these nanoscale materialschemical substances to 17 electronically report to EPA certain information, wh ich includes the specific chemical identity, production 18 volume, methods of manufacture and processing, expos ure and release information, and existing data 19 concerning environmental and health effects. Th is proposal involves one-time reporting for existing 20 nanoscale materials and one-time reporting for new discrete nanoscale materials before they are 21 manufactured or processed. This information would f acilitate EPA’s evaluation of the materials and a 22 determination of whether further action, including additional information collection, is needed. 23 Consistent with the President’s memorandum for Ex ecutive Agencies regarding Principles for Regulation 24 and Oversight of Emerging Technologies, this proposed rule would facilitate assessment of risks and risk 25 management, examination of the benefits and costs of further measures, and making future decisions 26 based on available scientific evidence. 27

DATES: Comments must be received on or before [ insert date 90 days after date of publication in the 28 Federal Register ]. 29

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ– 30 OPPT–2010-0572, by one of the following methods: 31



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

### instructions for submitting comments. Do not subm it electronically any information you consider 33 

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

### by statute. 35

• Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), 36 Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001. 37*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 2 of 33 • Hand Delivery : To make special arrangements for hand delivery or delivery of boxed 38 information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. 39
Additional instructions on commenting or visiting the docket, along with more information about 40 dockets generally, is availabl e at http://www.epa.gov/dockets. 41

FOR FURTHER INFORMATION CONTACT: For technical information contact : Jim Alwood, 42 Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental 43 Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 44 ( 202 ) 564-8974; e-mail address: alwood.jim@epa.gov

. 45
For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 46 Rochester, NY 14620; telephone number : (202) 554–1404; e-mail address: TSCA-Hotline@epa.gov

. 47

SUPPLEMENTARY INFORMATION: 48
I. Executive Summary 49
A. Does this Action Apply to Me? 50
You may be potentially affected by this ac tion if you manufacture or process or intend to 51 manufacture or process nanoscale materials.forms of certain chemical substances. However, persons that 52 manufacture or process, or intend to manufacture or process nanoscale materialsthese chemical 53 substances as part of articles, as impurities, or in sm all quantities solely for research and development 54 would not be subject to this action. ConsultIn addition, the discussion in Unit III.A. describes in more 55 detail which chemical substances w ould and would not be subject to reporting under the proposed rule

. 56 You may also consult 40 CFR 704.3 and 704.5 , as well as the proposed regulatory text in this document, 57 for further information on the appli cability of these and other exemptions to this proposed rule

. 58
The following list of North American Industria l Classification System (NAICS) codes is not 59 intended to be exhaustive, but rather provides a guideto help readers determine whether this document 60 appliesmay apply to them . Potentially affected entities may include : 61

• ManufacturersChemical Manufacturing or processors of one or more subject chemical 62 substancesProcessing (NAICS codes 325 ). 63
• Synthetic Dye and 324110), e.g., chemical manufacturingPigment Manufacturing (NAICS code 64 325130). 65
• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180). 66
• Rolled Steel Shape Manufacturing (NAICS code 331221). 67

• Semiconductor and petroleum refineries.Related Device Manufacturing (NAICS code 334413). 68
• Carbon and Graphite Product Manuf acturing (NAICS code 335991). 69
• Home Furnishing Merchant Wholesalers (NAICS code 423220). 70
• Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330). 71

• Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510). 72*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 3 of 33 • Research and Development in the Physical , Engineering, and Life Sciences (except 73 Biotechnology) (NAICS code 541712). 74
B. What Is the Agency's Authority for Taking this Action? 75
The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq ., provides EPA with authority 76 to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances 77 and/or mixtures. EPA is proposing this rule unde r section 8(a) of TSCA, 15 U.S.C. 2607(a). See also 78 Unit II.A. 79
C. What Action is the Agency Taking? 80
EPA is proposing reporting and recordkeeping requirements for persons that manufacture 81 (including import) or process certain chemical substances as nanoscale materials as described in Unit 82 II.DIII.A . Persons who currently manufacture or process these chemical substances as discrete nanoscale 83 materials would be required to notify EPA of certain information described in Unit II.DIII.C ., including 84 specific chemical identity, production volume, methods of manufacture and processing, use, exposure and 85 release information, and available health and safety data. EPA is also proposing that any persons who 86 intend to begin to manufacture or process chemical su bstances as discrete nanoscale materials after the 87 effective date of this rule notify EPA of the same in formation at least 135 days be fore the intended date of 88 commencement of manufacture or processing. The TSCAsection 8(a) rule proposed here involves one89 time reporting for existing discrete nanoscale materialsforms of certain chemical substances and one-time 90 reporting for new discrete nanoscale materials forms of certain chemical substances before they are 91 manufactured or processed. A chemical substance as defined under TSCA section 3(2) does not include 92 any food, food additive, drug, cosmetic, medical devi ce, pesticide or other excluded materials. Such 93 materials are not be subject to this rule. 94
Included in this proposal are electronic reporting requirements similar to those established in 95 2013 , i.e., for other kinds of information: EPA is proposing to require submitters to use EPA’s Central 96 Data Exchange (CDX), the Agency's electronic reporting siteportal , for all reporting under this rule. In the 97 Federal Registerof December 4, 2013 (78 FR 72818) (FRL 9394-6), EPA finalized a rule to require 98 electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 99 8(d). In proposing to require similar electronic re porting under this rule, EPA intends to save time, 100 improve data quality and increase efficienci es for both the submitters and the Agency. (Ref. 1.) 101
This proposed rule and the discussion of the pot ential risks do not conclude and are not intended 102 to conclude that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give 103 rise to or are likely to cause harm to people or the environment. Rather, EPA would use information 104 gathered through this reporting rule to determine if any further action under TSCA, including additional 105 information collection, is needed. EPA intends to make conclusions on the basis of specific scientific 106 evidence. As with current new chemical review of nanom aterials, each chemical substance manufactured 107 at the nanoscale will be evaluated on a case-by-case basis and not with the presumption of either harm or 108 safety, but rather its evaluation will be based on the specific nanoscale chemical substance’s own 109 properties. If adequate data are not available for th e properties of the nanoscale chemical substance, EPA 110 will use data on structural analogues. Being nanoscale is not itself an indication of, or criterion for, 111 hazard or exposure potential. Any potential future restrictions on chemical substances manufactured at the 112 nanoscale would be tailored to protect against the sp ecific harms identified for individual substances or 113 categories. EPA would focus any toxicity concerns or data requirements base d on available exposure or 114 hazard data for specific nanoscale chemical substanc es. If the information provided indicates low risk, 115*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 4 of 33 EPA would not need to consider further review or regulation of that nanoscale chemical substance unless 116 subsequent information raises risk concerns. For example during review of new chemical substances that 117 are nanoscale materials, EPA typically does not requestinhalation toxicity data for chemical substances 118 that are manufactured in forms or handled by processes where no inhalation exposure occurs. 119
EPA is not proposing to publish an inventory of chemical substances manufactured at the 120 nanoscale based on the information that would be co llected pursuant to these proposed TSCA section 8(a) 121 reporting requirements. EPA will make non-confidentia l information reported under the proposed rule 122 available in ChemView (see http://www.epa.gov/chemview/). 123
D. Why Is the Agency Taking this Action? 124
D. Why Is the Agency Taking this Action? 125
These reporting and recordkeeping requirements woul d assist EPA in its continuing evaluation of 126 chemical substances manufactured at the nanoscale materials , informed by available scientific, technical 127 and economic evidence. This proposed rule is not inte nded to indicate restrictions or conclusions about 128 the risks of chemical substances manufactured at the nanoscale materials in general. Rather, the 129 requirements would facilitate EPA’s evaluation of the materials and its determination of whether any 130 further action under TSCA, including additional information collection, is needed. 131
Consistent with the June 9, 2011 memorandum on the Policy Principles for the U.S. Decision132 Making Concerning Regulation and Oversight of Ap plications of Nanotechnology and Nanomaterials, 133 this proposal is not making any finding about the poten tial risks of nanoscale materials in general or any 134 specific nanoscale materials

. (Ref. 28) In this proposal EPA takes a 2). These generally applicable 135 principles are relevant to promoting a balanced, science-based approach and supportsto regulating 136 chemical substances manufactured at the nanoscale and other applications of nanotechnology in a manner 137 that protects human health, safety, and the environment without prejudging new technologies or creating 138 unnecessary barriers to trade or hampering innovation. These principles build on the foundation provided 139 by current regulatory statutes and do not supersede ex isting legal authorities. In this proposal, EPA’s 140 approach seeks to support the policy principle to “[s]eek and develop adequate information with respect 141 to the potential effects of nanomaterials on human he alth and the environment and take into account new 142 knowledge when it becomes available ”.” (Ref. 2). As with current new chemical reviews of chemical 143 substances manufactured at the nanoscale materials , each nanoscale material would be evaluated on a 144 case-by-case basis and not with the presumption of either harm or safety. Any evaluation will be based 145 on the specific nanoscale material’s own properties and those of any structural analogs. 146
E. What are the Estimated Incremental Impacts of this Action? 147
EPA has evaluated the potential costs of establishing the proposed reporting and 148 recordkeeping requirements for potential manufactur ers Any evaluation will be based on the specific 149 nanoscale material’s own properties and those of any structural analogs. TSCA section 8(a) applies to a 150 person “who manufactures or processes or proposes to manufacture or process a chemical substance”. A 151 company proposes to manufacture or process a chemical s ubstance by forming the intent to do so. Based 152 on EPA’s experience, persons form the intent to manufacture or process chemical substances at least 135 153 days ahead of time. This belief is based on EPA's experience with Premanufacture Notice (PMN) 154 submissions and subsequent notices of commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 155 40 CFR 720.22, PMNs are submitted by a person who intends to manufacture (including import) a 156 chemical substance, at least 90 days before commencing manufacture. Under 40 CFR 720.102, a 157*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 5 of 33 company that has submitted a PMN for which the statutory 90-day review period has expired and which 158 has commenced manufacture of that substance must submit an NOC to EPA within 30 days following 159
commencement. Over the past three fiscal years (i.e., FY 2009 - FY 2011), EPA received 1,723 PMNs. 160 Based on EPA's review of NOC receipt date information, EPA determined that NOCs were received 161 within 45 days of completion of the 90-day PMN re view for only 16% of these submitted PMNs. Thus, 162 for 84% of the submitted PMNs, the intent to manufac ture was formed at least 135 days (i.e., the 90-day 163 PMN review period plus 45 days) before commercialization. Because a company must by necessity form 164 the intent to manufacture a chemical substance some period of time before the PMN is submitted to EPA, 165 the intent to manufacture or process would be made at least 135 days in advance as a general matter. 166
EPA is not proposing to publish an inventory of nanoscale materials based on the information that 167 would be collected pursuant to these propo sed TSCA section 8(a) reporting requirements. 168
E. What are the Estimated Incremental Impacts of this Action? 169
EPA has evaluated the potential costs of estab lishing the proposed reporting and recordkeeping 170 requirements for potential manufacturers (including importers) and processors. This analysis , (Ref. 3), 171 which is available in the docket, is discussed in Unit VI., and is briefly summarized here. 172
Under the proposed rule, industry is conservativel y estimated to incur a burden of approximately 173 206,098 hours in the first year and 22,755 hours in sub sequent years, with costs of approximately $13.9 174 million and $1.5 million, respectively (see Chapter 3 in Ref. 3 ), while the Agency is expected to use 175 approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of 176 approximately $0.51 million and $0.06 million respectively (see Chapter 4 in Ref. 3). Discounted over a 177 10-year period at three and seven percent, total annualized costs are estimated to be approximately $2.80 178 million and $3.08 million, respectively. (Ref. ). Discounted over a 10-year period at three and seven 179 percent, total annualized costs are estimated to be approximately $2.80 million and $3.08 million, 180 respectively. (Ref. 25)3.) 181 182 F. What Should I Consider as I Prepare My Comments for EPA? 183

1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e-mail. 184 Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or 185 CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify 186 electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to 187 one complete version of the comment that includes information claimed as CBI, a copy of the comment 188 that does not contain the information claimed as CBI mustbe submitted for inclusion in the public docket. 189 Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR 190 part 2. 191

2. Tips for preparing your comments . When preparing and submitting your comments, remember 192 to:see the commenting tips at http://www.epa.gov/dockets/comments.html

. 193
i. Identify the document by docket ID number and other identifying information (subject heading, 194 Federal Registerdate and page number). 195

ii. Follow directions. The Agency may ask you to respond to specific questions or organize 196 comments by referencing a Code of Federal Regulations (CFR) part or section number. 197*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 6 of 33 iii. Explain why you agree or disagree; suggest alternatives and substitute language for your 198 requested changes. 199
iv. Describe any assumptions and provide any tec hnical information and/or data that you used. 200
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 201 sufficient detail to allow for it to be reproduced. 202
vi. Provide specific examples to illustrate your concerns and suggest alternatives. 203
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. 204
viii. Make sure to submit your comments by the comment period deadline identified. 205
II. Background 206
A. Overview of Applicable TSCA Authority 207

1. TSCA Section 8(a) Reporting. EPA is proposing reporting and recordkeeping requirements for 208 manufacturers (including importers) and processors of nanoscale materials pursuant to TSCA section 8(a ). 209 ) reporting. Section 8(a) of TSCA authorizes the AdministratorEPA to promulgate rules which require 210 each person (other than a small manufacturer or processor) who manufactures , processes , or proposes to 211 manufacture or process a chemical substance, to main tain such records and submit such reports as the 212 EPA Administrator may reasonably require. TSCA section 8(a) gives EPA authority to determine the 213 format of reporting under this section. 214
Small manufacturers and processors, as defined by EPA, are exempt from TSCA section 8(a) 215 reporting requirements, unless the manufacture or processi ng is subject to a rule proposed or promulgated 216 under TSCA sectionsections 4, 5(b)(4), or 6, or an order under section 5(e). For purposes of this rule, and 217 in accordance with Under TSCA section 8(a)(3)(B), after consultation with the Administrator of the Small 218 Business Administration (SBA), EPA is proposing an alternative defin ition ofmay prescribe standards for 219 determining which manufacturers and processors qualify as small manufacturer or processor from that 220 typically used infor purposes of reporting under a TSCA section 8(a) rules. See, e.g., 40 CFR 704.3. For 221 further discussion see Unit II.Drule

. 222
2. Exemption for Research and Development. Persons who manufacture or process chemical 223 substances that are nanoscale materials that would be subject to the TSCA section 8(a) rule in “small 224 quantities solely for research and development” (See 40 CFR 704.3) would be exempt from the 225 requirements of this proposed rule. Examples of r esearch and development activity are the analysis of 226 the chemical or physical characteristics, the performance, or the produc tion characteristics of a chemical 227 substance, a mixture containing the substance, or an article. It can include production of a chemical 228 substance for use by others in their R&D activities. R&D activity generally includes specific monitored 229 tests undertaken as part of a planned program of activity. 230
General provisions for TSCA section 8(a) rules appear in 40 CFR part 704 Subpart A. These 231 provisions describe definitions, exemptions (incl uding for articles and research and development), 232 confidential business information claims, and recordk eeping that apply to TSCA section 8(a) rules. For 233 example in 40 CFR 704.3 the definition of known to or reasonably ascertainable by is defined to mean all 234 information in a person’s possession or control, plus all information that a reasonable person similarly 235 situated might be expected to possess, control, or know. 236*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 7 of 33 In addition, the definitions in TSCA section 3 apply to this rulemaking. 237

2 . Electronic Reporting. The reporting under the Government Paperwork Elimination Act 238 (GPEA ) ( ). GPEA, 44 U.S.C. 3504 ), provides that, when practicable, Federal organizations use electronic 239 forms, electronic filings, and electronic signatures to conduct official business with the public. EPA’s 240 Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3) (Ref. 244 ), provides that 241 any requirement in title 40 of the CFR to submit a re port directly to EPA can be satisfied with an 242 electronic submission that meets certain conditions once the Agency published a document in the Federal 243 Register announcing that EPA is prepared to receive certain documents in electronic form. For more 244 information about CROMERR, go to http://www.epa.gov/cromerr

. 245
TSCA Section 8(a) gives EPA authority to determine the format of reporting under this section. 246
B. Why is EPA Interested in Nanoscale Materials? 247
As described in Unit II.A., TSCA section 8(a) au thorizes EPA to promulgate rules which require 248 manufacturers and processors to maintain records and submit information that EPA may reasonably 249 require. Unit II.C. includes discussion of why EPA is proposing to use this authority to gather more 250 information about proposed and existing nanoscale materials. 251
There is a growing body of scientific eviden ce showing the differences that exist between chemical 252 substances and chemical substances manufactured innanoscale forms (Ref. 5). Chemical substances 253 manufactured at the nanoscale material(s) and their non-nanoscale counterpart(s) (Ref. 1). Nanoscale 254 materials may have different or enhanced properties – for example, electrical, chemical, magnetic, 255 mechanical, thermal, or optical properties – or features, such as improved hardness or strength, that are 256 highly desirable for applications in commercial, medical, military, and environmental sectors (Ref. 36 ). 257 These properties are a direct consequence of smalldecreasing size, which results in a largerwhere surface 258 area per unit of volume increases exponentially and / or quantum effects that occur at may appear in the 259 scalelow tens of 1 x 10 -9 metersnanometers and below . Small size itself can also be a desirable property 260 of nanoscale materials. The small size can be exploited for miniaturization of applications/processes 261 and/or stabilization or delivery of payloads to di verse environments or incorporation into diverse 262 products. 263
Nanoscale materials have a range of potentially beneficial public and commercial applications, 264 including medicine and public health, clean energy through more efficient solar panels , pollution 265 reduction and environmental cleanup, and improved products such as str onger, lighter, and more durable 266 or conductive materials. These benefits arise from the di stinctive properties of nanoscale materials, in that 267 they are potentially more interactive or durable than other chemicals as a result of their size and 268 composition. chemical substances. Altering the size of a material fr om conventional particle size can 269 enhance or produce unique properties that are desirable for a variety of commercial applications. 270 However, these unique and enhanced properties can raise new regulatory questions, such as whether the 271 material in the smaller form may present in creased hazards to humans and the environment. 272
Government, academic, and private sector scientists in multiple countries are performing research 273 into the environmental and human health effects of di verse nanoscale materials, resulting in a substantial 274 and rapidly growing body of scientific evidence. ResearchThis researchalso indicates that, in biological 275 systems or in the environment, not all materials in th e nanoscale size range behave differently from larger 276 sized materials of the same substance (Ref. 4). 7). Recently, twoa governmental organization and expert 277 peer review organizationsan independent scientific committeehave reviewed and summarized this 278*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 8 of 33 evidence and offered views about the implications of this evidence for environmental and human health 279 and safety. These reviews are described below. 280
In 2009, the National Institute of Occupationa l Safety and Health (NIOSH) issued a report
, 281 “Approaches to Safe Nanotechnology: Managing the H ealth and Safety Concerns Associated with 282 Engineered Nanomaterials,” (Ref. 58 ) that summarized the available scientific information about 283 nanoscale materials and identified the following potential health and safety properties: 284
• “Nanomaterials have the greatest potential to en ter the body through the respiratory system if 285 they are airborne and in the form of respirable-sizedparticles (nanoparticles). They may also come into 286 contact with the skin or be ingested.” 287
• “Based on results from human and animal studies, airborne nanoparticles can be inhaled and 288 depositdepositedin the respiratory tract; and based on anim al studies, nanoparticles can enter the blood 289 stream, and translocate to other organs.” 290
• “Experimental studies in rats have shown that equivalent mass doses of insoluble incidental 291 nanoparticles are more potent than large particl es of similar composition in causing pulmonary in292 flammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally 293 supportive of the biological responses observed in animals.” 294
• “Experimental studies in animals, cell cultures, and cell-free systems have shown that changes 295 in the chemical composition, crystal structure, and si ze of particles can influence their oxidant generation 296 properties and cytotoxicity.” 297
• “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) 298 and nanoscale (ultrafine) particles have reported adve rse lung effects including lung function decrements 299 and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, 300 which may have different particleproperties, are uncertain.” 301
• “Some nanomaterials may initiate catalytic reactions depending on their composition and 302 structure that would not otherwise be antic ipated based on their chemical composition.” 303
Earlier the same year, the Scientific Committe e on Emerging and Newly Identified Health Risks 304 (SCENIHR), an independent scientific committee advising the European Commission’s Health and 305 Consumer Directorate, issued a report , “Risk assessment of products of nanotechnologies.” (Ref. 6). The 306 SCENIHR report (Ref. 9) thatidentified properties similar to tho se identified in the NIOSH report: 307
• “Some specific hazards, discussed in the cont ext of risk for human health, have been 308 identified. These include the possibility of some nanoparticles to induce protein fibrillation, the 309 possible pathological effects caused by specific types of carbon nanotubes, the induction of 310 genotoxicity, and size effects in terms of biodistribution.” 311
• “For some nanomaterials, toxic effect s on environmental organisms have been 312 demonstrated, as well as the potential to transfer across environmental species, indicating a potential 313 for bioaccumulation in species at the end of that part of the food chain.” 314

In another recent survey of scientific research on nanoscale materials (Ref. 710 ), the authors 315 reported: 316*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 9 of 33 “Many studies have examined the pro-inflammatory effects of manufactured nanoparticles, 317 on the basis that their ability to cause inflammation is a major predictor of potential hazard 318 in such particles. The first important finding was that nanoparticles have a more pronounced 319 effect on inflammation, cell damage and cell stim ulation than an equal mass of particles of 320 the same material of greater size. This appear s to hold true for materials as varied as carbon 321 black, titanium dioxide, various metals and poly styrene. Surface area is the metric driving 322 the pro-inflammatory effects and this is evident both in vitro and in vivo , particles of various 323 sizes producing inflammatory effects that are directly related to the surface area dose.” 324
A report in the scientific literature has indicatedthat nanoscale polystyrene beads may cross the 325 placental barrier (in an ex-vivo human placental perfusion model (Ref. 8 11 ). Another study found that 326 nanoparticles could translocate to diverse organs fo llowing oral exposure in rodents. Once in these 327 diverse sites and organs, the large surface area of nanoscale materials may facilitate increased reactivity 328 and/or an inflammatory response, resulting in toxic effects (Ref. 912 ). 329
Two literature surveys describe a broad range of effects in non-mammalian species following 330 exposure to nanoscale materials (Ref. 1013 and 1114 ). These include, for example, increased ventilation 331 rates, mucus production, and pathologies, and related alteration of enzyme activities and indicators of 332 oxidative stress in rainbow trout, Oncorhyncus mykiss (Ref. 1215 ) and ingestion and accumulation of 333 nanoscale material in the digestive tract, as well as mo rtality, increased heart rates, and reduced fecundity 334 in Daphnia magna (Ref. 13, 1416, 17 , and 1518 ). Translocation of nanoscale materials from gill and gut 335 surface to blood and other organs in exposed Medaka, Oryzius latipes , has also been reported (Ref. 1619 ) 336 and carbon nanotubes, although unable to cross the egg surface, have been shown to delay hatching in 337 zebra fish, Danio rerio (Ref. 1720 ). 338
Published reports of human and ecological expos ure to nanomaterials are also limited. For 339 example, in its “Current Intelligence Bulletin 65: Occ upational Exposure to Carbon Nanotubes and 340 Nanofibers” (Ref. 2721 ), NIOSH summarized and evaluated the available published information on 341 worker exposures to carbon nanotubes (CNT) and nanofibers ( CNF). NIOSH determined that, although 342
the potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT- and CNF343 product use (processing, use, disposal, recycling), the extent to which workers are exposed has not been 344 completely characterized. “Comprehensive workpl ace exposure evaluations are needed to characterize 345 and quantify worker exposure to CNT and CNF at va rious job tasks and operations, and to determine 346 what control measures are the most effective in re ducing worker exposures.” “Data are particularly 347 needed on workplace exposures to CNT and CNF, as well as information on whether in-place exposure 348 control measures (e.g., engineering controls) and work practices are effective in reducing worker 349 exposures.” 350
There are many scientific questions about the impacts of chemical substances manufactured at the 351 nanoscale materialss on human health and the environment. Part of EPA’s mission under TSCA is to 352 understand potential risks in order to protect human h ealth and the environment. As stated in EPA’s 353 White Paper on Nanotechnology (Ref. 1822 ): 354
“Some of the same special properties that make nanoscale materials useful are also properties that 355 may cause some nanoscale materials to pose risks to humans and the environment, under specific 356 conditions.” 357
EPA needs a sound scientific basis for assessing a nd managing potential impacts resulting from the 358 introduction of chemical substances manufactured at the nanoscale materials into commerce. 359*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 10 of 33 As described in the 2008 TSCA Inventory Status of Nanoscale Substances -- General Approach, 360 many nanoscale materials are considered chemical substances as defined under TSCA section 3(2) (Ref. 361 1923 ). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are 362 considered new chemical substances that require re porting under TSCA section 5. EPA has assessed over 363 160170 of these nanoscale materials as new chemical substances and taken action to control exposures to 364 prevent any potential unreasonable risks to human he alth or the environment pending development of 365 information which will allow EPA to more full y assess those risks. Nanoscale materials based on 366 chemical substances already on the TSCA Inventory ar e considered existing chemical substances. These 367 nanoscale materials do not require reporting as new chemical substances because they are nanoscale 368 forms of chemical substances already in commerce. 369
EPA developed a voluntary Nanoscale Materials Stewardship Program (“( NMSP ” or “the 370 program”) to complement and support its regulatory activities on chemical substances manufactured at 371 the nanoscale materials. . EPA conducted the program from January 2008 to December 2009. Thirty one 372 companies or associations submitted information to EPA for 132 chemical substances manufactured at the 373 nanoscale materials with available information on how those nanoscale materials were manufactured, 374 processed or used. For more details on the NMSPand to read, see the program’s interim report, consulta 375 copy of which is in the EPA website at http://epa.gov/oppt/nano/stewardship.htm docket (Ref. 2024 ). 376 EPA solicited existing data and information, on a vol untary basis, from manufacturers, processors, and 377 users of chemical substances manufactured at the nanoscale materials to expeditiously develop 378 knowledge about commercially available nanoscale materi als. In addition, the program was designed to 379 identify and encourage use of risk manageme nt practices in developing and commercializing chemical 380 substances manufactured at the nanoscale materials . EPA also participated in a series of National 381 Nanotechnology Initiative public workshops, including co-Chairing a public Risk Management Methods 382 workshop. This workshop was also useful in further identifying additional considerations in risk 383 management practices towards developing and commercializing chemical substances manufactured at the 384

nanosca 

### le materials of interest to EPA. In the NMSP interim report
, which was based on the information 385 EPA received prior to January 2009, EPA identified data gapsneeds for existing nanoscale material 386 production, uses, and exposures. For example, in the report EPA estimated that companies provided 387 information on only about 10 percent of the chemical substances manufactured at the nanoscale materials 388 that may be commercially available in 2009



### . 389 390 To address some of the data needs identified in the NMSP interim report, EPA is proposing 391 reporting requirements under TSCA section 8(a) fo r persons who are manufacturing, or processing 392 chemical substances manufactured at the nanoscale materials or intend to manufacture or process these 393 nanoscale materials for commercial purposes to address some of the data gaps identified in the NMSP 394 interim report . This information would facilitate EPA’s eval uation of the materials and determination if 395 any further action under TSCA, including add itional information collection, is needed. By gathering data 396 regarding the characteristics, uses, and exposure pert aining to chemical substances manufactured at the 397 nanoscale, EPA will create a more robust database that will expand the Agency’s understanding of 398 commercially available nanoscale substances including available environmental health and safety data 399 and risk management practices. 400
This proposed rule and the discussion of the potential risks are not intended to conclude that 401 nanoscale materials as a class, or specific uses of nanoscal e materials, necessarily give rise to or are likely 402 to cause harm to people, or the environment. Rather, EPA would use information gathered through this 403 reporting rule to determine if any further action unde r TSCA, including additional information collection, 404*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 11 of 33 is needed. EPA intends to make conclusions on the basis of specific scientific evidence. Restrictions on 405 nanoscale materials would be tailored to protect ag ainst the specific harms identified for individual 406 substances. EPA would focus any toxicity concerns or data requirements base d on available exposure or 407 hazard data for specific nanoscale materials. For exam ple during review of new chemical substances that 408 are nanoscale materials, EPA typically does not request inhalation toxicity data for nanomaterials that are 409 manufactured in forms or handled by processes where no inhalation exposure occurs. 410
EPA is seeking public comment pertaining to sever al specific issues regarding the proposed rule 411 (see Unit II.D.). EPA anticipates conducting a public meeting during the comment period to further 412 discuss these and any other issues c oncerning the proposed rule. 413
III. Summary of Proposed TSCA Section 8(a) Rule 414
EPA is proposing reporting and recordkeeping requirements for manufacturers and processors of 415 certain chemical substances pursuant to TSCA section 8(a). 416

A. What Chemical Substances willwould be Subject toReportable Under this Rule? 417
1. Reportable chemical substances. This proposed rule would apply to chemical substances that 418 are solids at 25 oC and atmospheric pressure and that are manufactured or processed in a form where at 419 least 10% of the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm . 420
When proposing at least 10% of particlesn anometers (nm) and e xhibit unique and novel 421 characteristics or properties because of their size. The proposed rule would apply to chemical substances 422 containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm as a threshold for 423 reporting of chemical substances subject to this rule, EPA considered a number of factors. If a chemical 424 substance consists of particles solely within th e 1-100 nm range there is general agreement among 425 scientists and policy makers that the substance is considered a nanoscale material. However, most 426 nanoscale materials or nanostructured materials contain a distribution of different-sized particles usually 427 with a fraction of that distribution greater than 10 0 nm and a fraction less than 100 nm. EPA does not 428 believe that reporting should be required for a chemic al substance that contains less than 1 % particles 429 less than 100 nm. The Agency considered including materials in which in at least one percent of particles 430 were less than 100 nm. One percent is used in sev eral environmental health and safety contexts as a 431 cutoff or exemption level such as the OSHA hazar d communication standard and TSCA section 12(b) 432 export notification. EPA is also concerned that us ing one percent would encompass too broad a range of 433 chemicals, particularly because there is no scientific consensus on what percentage of particles less than 434 100 nm within any given sample of particles would beof interest with respect to human health or 435 ecological effects from exposure to the sample. EPA is seeking to strike a balance between including 436 what can reasonably be considered to be a nanoscale material while at the same time being practical in 437 determining what materials contain particles within the 1-100 nm range that should be considered for 438 proposed reporting. EPA does not want to exclude dimension. This proposed rule would not apply to 439 chemical substances that are considered to be nanoscale material s by setting too high of a cut-off. 440
EPA is proposing a threshold of 10% of particles in the size range of 1- 100 nm to include those 441 nanoscale materials potentially demonstrating novel properties of interest without including large 442 numbers of chemical substances that only have a just a “tail” of particles below 100 nm. Using a 443 threshold greater than 10% of particles less than 100 nm to require reporting begins to exclude nanoscale 444 materials that are less than one standard deviation fro m the mean of a normal distribution curve of particle 445 sizes. This would begin to exclude a large number of nanoscale materials with trace amounts of primary 446*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 12 of 33 particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance 447 does not exhibit the unique and novel characteristics or properties of potential interest. EPA is seeking 448 comment on this issue. 449
EPA has placed in the public docket a list of 2400 chemical substances found on the TSCA 450 Inventory that EPA believes could be manufactured or processed in a form that would be subject to 451 reporting under this proposed rule (R ef. 21). This list does not limit the substances that would be subject 452 to the proposed rule, as other solid chemical substances may also be manufactured or processed in a form 453 that would be subject to reporting under this proposed rule. EPA is proposing to exclude from the 454 requirements of this rule certain biological materi als (e.g., DNA, RNA, and proteins). EPA is seeking 455 comment to identify other specific biological materi als that should be excluded from reporting and the 456 reasons for excluding them, including microorganisms a nd viral based products (or other combinations of 457 RNA, DNA & protein), lipids, carbohydrates, enzymes, and peptides. Although DNA is typically larger 458 than 1-100 nanometers, RNA and proteins may fall within this size range. However, the properties of 459 biological materials such as DNA, RNA and proteins are not a function of the size range per se but rather 460 the precise nucleotide sequence (in the case of DNA and RNA), shape, and other features. EPA is also 461 proposing to exclude chemical substanc es which dissociate completely in water to form ions that are less 462 than 1 nanometer. EPA is seeking comment to identify other water soluble compounds that should be 463 excluded from reporting and the reasons for excluding them. This exclusion would not apply to 464 nanoscale materials that release ions but do not dissociat e in water to form those ions. EPA believes that 465 the chemical substances that would be excluded do no t exhibit new properties when their size falls in the 466 range of 1-100 nanometers and manufacture or processing such su bstances at the nanoscale should 467 therefore not be subject to the reporting requirements of the proposed rule. 468
EPA is proposing to exclude from the requirements of this rule nanoclays, zinc oxide and nanoscale 469 materials created as a thin film because EPA believes that information collected on these materials would 470 be of limited value because either they have beenwell-characterized or they present little exposure 471 potential. EPA requests comment on these proposed ex clusions and whether other nanoscale materials 472 should be excluded. EPA requests that commenters identify why they believe the nanoscale materials 473 should be excludedof particle size. EPA is pr oposing these parameters for purposes of identifying 474 chemical substances that are subject to the rule, not to establish a definition of what is a nanoscale 475 material

. 476

EPA is also requesting comment on whether any information proposed to be collected requested 477 in this proposed rule is duplicative of information collected under other federal statutes and, thus should 478 be excluded. Please identify the statute and the information that you believe is duplicative. 479
i. Discrete forms. B. When would nanoscale materials be reported under the rule? 480
This notice proposes that persons who manufacture (including import) or process a discrete form 481 of a solid nanoscale material at any time during the three years prior to the final effective date of the rule 482 would report to EPA six months after the final effective date of the rule. This notice also proposes a 483 continuing requirement that persons who intend to manufacture (including import) or process a discrete 484 form of a solid nanoscale material on or after the effec tive date of the rule report to EPA at least 135 days 485 before commencement of manufacture (including import) or processing. 486
C. How would nanoscale materials be reported under the rule? 487
Manufacturers and processors of multiple nanoscal e forms of the same chemical substance 488*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 13 of 33 would , in some cases, need to know if reporting is requiredreport separately for each form. . discrete form 489 of the reportable chemical substance. EPA is proposing to distinguish among nanoscale materials for 490 purposes of this rule based on a combination of three factors: 1) a change in process to affect a change in 491 size and/or a change in properties of the chemical substances manufactured at the nanoscale materials ; 2) 492 a change in mean particle size of 10% or greater; and 3) athe measuredchange in at least one of 10% or 493 more in surface chargethe following properties, zeta potential , specific surface area, 494 dispersibility/solubilitydispersion stability , or surface reactivity ., is greater than 7 times the standard 495 deviation of the measured values (+/- 7 times the stan dard deviation). For example if the specific surface 496 area of one discrete form was measured to be 50 +/- 5 m2/g, then a change resulting in a new average 497 specific area of 85 m 2/g would be reportable if factors 1 and 2 were also met. EPA recommends using the 498 same medium and method when measuring the change in these properties, as even minor changes in the 499 medium and methods can result in larg e differences in the measured results. EPA’s intent for proposing 500 these reporting requirements is to focus reporting on intentionally manufactured chemical substances at 501 the nanoscale materials. . 502
EPA is proposing the combination of these three f actors rather than simply size to distinguish 503 between different chemical substances manufactured at the nanoscale materials so that unintended 504 variation in size range between production batches w ould not trigger TSCA section 8(a) reporting. Also, 505 EPA is proposing not to rely solely on process cha nges because there may be process changes that are not 506 intended to change the material produced but rather intended to improve the efficiency of the process or 507 to use a cheaper reactant. EPA is focusing on the properties of surface charge zeta potential , specific 508 surface area, dispersibility/solubilitydispersion stability , or surface reactivity because these are properties 509 of manufactured nanomaterials that are of particular interest in a health and safety context, whereas other 510 unique properties of chemical substances manufactured at the nanoscale materials (e.g., the wavelength at 511 which light is emitted) may be important for how the nanoscale materialthat form of the chemical 512 substance functions but are less likely to be important in a health and safety context. EPA believes that 513 the combination of these three factors will provide a clear and transparent way for the regulated 514 community to distinguish among different chemical substances manufactured at the nanoscale materials 515 for purposes of TSCA section 8(a) reporting. 516
While EPA realizes that the percentage cut-off of 10% is arbitrary, as would be any percentage 517 cut-off, EPA believes the number is high enough so that small variations in size and/or properties would 518 not be considered a change in nanoscale material . EPA also believes adopting a higher number may 519 exclude reporting on nanoscale materials that have been modified to exhibit different properties. EPA is 520 requesting comment on whether 10% is an appropriate threshold both for mean particle size differences 521 and for changes in surface charge, specific surface area , dispersibility/solubility, or surface reactivity. 522 EPA is also requesting comment on whether other inhe rent properties that are important for health and 523 safety assessments should be included. These comment s should include a rationale of why the specific 524 inherent property should be included. 525
For the purposes of this proposed rule
, specific surface area is the ratio of the surface area of the 526 nanoscale material to its mass or the area of the surface of the nanoscale material divided by volume

. 527 This is an important factor because chemical reactions take place at the surface of the material. Thus, the 528 higher the surface area, the greater the chemical reactivity
, which is an important consideration for human 529 health toxicity and environmental toxicity assessments. Specific surface area is the ratio of the area of the 530 surface of a nanoscale material divided by the mass (m 2/kg) or the area of the surface of the nanoscale 531 materialsmaterial divided by volume ( m 2/m 3 . ). 532*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 14 of 33 Surface charge Zeta potential is the electric charge on a surface in contact with a continuous 533 phase (Ref 23). Surface charge can be calculated by measuring the electrokinetic potential in colloidal 534 systems known as the zeta potential. . It is measured as the net number of positive and negative charges 535 per unit particle surface area in Coulomb/m 2 (Ref 23. 25 ) and is typically measured by electrophoresis. 536 For purposes of this proposed rule the differential of 10% in the surface charge would be measured for the 537 same medium. 538
Dispersibility is the extent to which the partic ulate nanoscale material can be distributed in 539 another material such as liquid. Solubility is the degree to which the nanoscale material can be dissolved 540 in another material, such as liquid. This is an important factor in assessing toxicity and exposure. These 541 are typically measured in mass per volume, e.g., grams /liter. For most nanoscale materials, dispersibility 542 rather than solubility would be observed. 543
Dispersion stability is the ability of a dispersion to resist changes in properties over time and can 544 be defined in terms of the change in one or mo re physical properties over a given time period. See 545 ISO/TR 13097:2013 “Guidelines for characterization of dispersion stability” (Ref. 26) as an example. 546
Surface reactivity is indicative of the degree to which the nanoscale material will react with 547 biological systems. The surface reactivity of the nanoscale materialform of a chemical substance is 548 dependent upon factors such as redox potential which is a measure of the tendency of an entity to lose or 549 acquire electrons, and photocatalytic activity, including the poten tial to generate free radicals. Reactive 550 oxygen species (ROS) and free radicals are important in considering toxicity for these materials. 551

EachAnanoscale form of a particular chemical substance with a different morphology or shapes 552 thatshape would also qualify as a discrete form. Examples include but are not limited to spheres, rods, 553 ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, orand 554 sheets would also be a discrete form . Nanoscale forms of a particular chemical substance that are coated 555 with different chemical substances would be consid ered discrete forms for each chemical coating. 556
EPA has developed this proposed approach based on the approximate size range of 1-100 nm as 557 defined by the National Nanotechnology Initiative ( NNI) (Ref. 3), experience in conducting assessments 558 of new chemical nanoscale materials by EPA under TSCA, and data submitted to EPA under the NMSP. 559 EPA is soliciting comment on each aspect of the proposed approach to identifying the chemical 560 substances that would be subject to the reporting re quirements of the rule. The Agency is seeking 561 comment on these approaches and alternative approach es for reporting requirements. EPA is especially 562 interested in comments on whether these approaches would require reporting of sufficiently distinct 563 nanoscale forms of a chemical substance so that reporting would be focused on those nanoscale forms 564 with potential for significantly different physical or chemical characteristics or properties. ii. EPA also 565 seeks comment on each aspect of its proposed reporting such as size increments, morphology, the specific 566 physical-chemical properties identified above, and whether companies have the analytical tools to make 567 such distinctions. 568

Chemical mixtures. Chemical substances that are manufactured(including imported), or 569 processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite 570 would also have to be reported. Nanoscale materialsChemical substances at the nanoscalethat are 571 manufactured but are then incorporated into mixtures, encapsulated materials or composites by that 572 manufacturer would not require separate reporting for their incorporation. However, the person reporting 573 the nanoscale material would have to report each step of the manufacture, processing, and use of the 574 nanoscale material to the extent it is known or r easonably ascertainable. However, the person reporting 575*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 15 of 33 the chemical substance would have to report each step of its manufacture, processing and use to the extent 576 it is known or reasonably ascertainable. The proposed rule would not require manufacturers or processors 577 to report certain information that has already been submitted to EPA. A person who submitted a new 578 chemical notice for a nanoscale material under TSCA sec tion 5 to EPA on or after January 1, 2005 would 579 not be required to report regarding the same substa nce under this proposed TSCA section 8(a) rule. In 580 addition, any person who has already reported part of or all of the information that would be required 581 under this proposed TSCA section 8(a) rule under the NMSP would not need to report that information 582 again. See http://www.epa.gov/oppt/n ano/stewardship.html for more information on that program. If, 583 however, information required by this proposed rule was not reported under the NMSP (including 584 information for each discrete form of a nanoscale material) , then reporting of that information would be 585 required. 586
2. Substances excluded from reporting. EPA is proposing to exclude from the requirements of this 587 rule certain biological materials (e.g., DNA, RNA, and proteins). EPA is seeking comment to identify 588 other specific biological materials that should beexcluded from reporting and the reasons for excluding 589 them, including microorganisms and viral based pr oducts (or other combinations of RNA, DNA and 590 protein), lipids, carbohydrates, enzymes, and peptides. However, the properties of biological materials 591 such as DNA, RNA and proteins are not a function of the size range per se but rather the precise 592 nucleotide sequence (in the case of DNA and RNA), shape, and other features. 593
EPA is proposing to exclude chemical substances which dissociate completely in water to form 594 ions that are less than 1 nanometer. This exclusi on would not apply to chemical substances manufactured 595 at the nanoscale materials that release ions but do no t dissociate in water to form those ions. EPA 596 believes that the chemical substances that would beexcluded do not exhibit new properties when their 597 size falls in the range of 1-100 nanometers and manufacture or processing such substances at the 598 nanoscale should therefore not be subject to the re porting requirements of the proposed rule. EPA is 599 seeking comment to identify other water soluble co mpounds that should be excluded from reporting and 600 the reasons for excluding them. 601
EPA is proposing to exclude from the requirement s of this rule nanoclays, zinc oxide and 602 chemical substances manufactured at the nanoscale as part of a film on a surface. The Agency believes 603 that information collected on these materials would be of limited value because either they have been 604 well-characterized or they present little exposure potential. EPA requests comment on these proposed 605 exclusions and whether other chemical substances manufactured at the nanoscale should be excluded. 606 EPA requests that commenters explain why they beli eve the chemical substances manufactured at the 607 nanoscale should be excluded. 608
3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 609 8(a) reporting at 40 CFR 704.5 would be applicable to this proposed rule , including the . This includes, 610 among other exemptions , the exemption for research and development and small manufacturers. Aunder 611 which a person who manufactures or processes, a chemical substance only in small quantities for research 612 and development would be exempt from the reporting requirements of this proposed rule. Small 613 manufacturers would be exempt from Examples of research and development (R&D) activity are the 614 reporting requirements of this proposed rule. analys is of the chemical or physical characteristics, the 615 performance, or the production characteristics of a chemical substance, a mixture containing the 616 substance, or an article. It can in clude production of a chemical substan ce for use by others in their R&D 617 activities. R&D activity generally includes specific m onitored tests undertaken as part of a planned 618 program of activity. 619*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 16 of 33 EPA is proposing an alternate exemption for the existing small manufacturer exemption. Under 620 other TSCA section 8(a) rules, a company may qualifyqualifies as a small manufacturer in 40 CFR 704.3 621 it if meetsby meeting either of the following two standards. The first is that sales of the company are less 622 than $40 million dollars per year and the company does not manufactureor import more than 100,000 623 pounds annually of an individual substance at any indi vidual site owned or controlled by the company. 624 The second is that any company with sales ofare less than $4 million dollars is considered a small 625 business regardless of the quantity manufacturedor imported

. 626
However, EPA is proposing a different definition of a small manufacturer or processorexemption 627 for purposes of this rule by eliminating the first st andard and defining a small manufacturer or processor 628 as any company with sales of less than $4 million dollars . The 100,000-pound threshold in the existing 629 exemption did not contemplate typical production volumes for chemical substances manufactured at the 630 nanoscale materials . EPA has reviewed over 200 chemical substances manufactured at the nanoscale 631 materials in the NMSP and the new chemicals program under TSCA. At least 170 of those chemical 632 substances manufactured at the nanoscale materials had reported or estimated production volumes less 633 than 22,000 pounds. Based on this experience, exempting manufacturers or processors from reporting 634 annual production volumes of nanoscale materials up to 100,000 pounds would exclude a large proportion 635 of companies that characteristically manufacture chemical substances manufactured at the nanoscale 636 materials in small amounts but would not otherwi se be considered small. Given that chemical substances 637 manufactured at the nanoscale materials tend to be produced in small volumes, EPA does not believe 638 production volume should be a releva nt consideration in determini ng whether a nanotechnology company 639 is a small manufacturer or processor. EPA requests comment on the proposed modification of the small 640 manufacturer or processor exemption that would apply for this proposed rule. 641
4. Proposed exceptions to reporting. The proposed rule would not require manufacturers or 642 processors to report certain information th at has already been submitted to EPA. A person who submitted 643 a TSCA chemical notice under section 5 to EPA on or af ter January 1, 2005 would not be required to 644 report regarding the same substance under this propos ed TSCA section 8(a) rule except where the person 645 manufactured or processed a new discrete form of the reportable chemical substance. In addition, any 646 person who has already reported part of or all of the information that would be required under this 647 proposed TSCA section 8(a) rule under the NMSP woul d not need to report that information again under 648 this proposed TSCA section 8(a) rule. If, however, information required by this proposed rule was not 649 reported under section 5 or the NMSP (including information for each discrete form of a reportable 650 chemical substance), then reporting of that info rmation would be required under this proposed TSCA 651 section 8(a) rule. The purpose of these exemptions is to avoi d duplicative reporting. For example new 652 chemical notices that have been reviewed as nanoscale materials would not be subject to reporting the 653 same information under this rule. 654

B. When would Reporting be Required? 655
EPA proposes that persons who manufacture or process a discrete form of a reportable chemical 656 substance at any time during the three years prior to th e final effective date of the rule would report to 657 EPA six months after the final effective date of the rule. EPA also proposes a continuing requirement that 658 persons who intend to manufacture or process a discrete form of a reportable chemical substance on or 659 after the effective date of the rule would report to EPA at least 135 days before commencement of 660 manufacture or processing. 661*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 17 of 33 The 135-day period is based on EPA’s experience with PMN submissions. TSCA section 8(a) 662 applies to a person “who manufactures or processes or proposes to manufacture or process a chemical 663 substance”. A company proposes to manufacture or pr ocess a chemical substance by forming the intent 664 to do so. Based on EPA’s experience, persons form the intent to manufacture or process chemical 665 substances at least 135 days ahead of time. This be lief is based on EPA's experience with Premanufacture 666 Notice (PMN) submissions and subsequent notices of commencement (NOCs). Pursuant to section 667 5(a)(1) of TSCA and 40 CFR 720.22, PMNs are submitted by a person who intends to manufacture a 668 chemical substance, at least 90 days before commencing manufacture. Under 40 CFR 720.102, a 669 company that has submitted a PMN for which the statutory 90-day review period has expired and which 670 has commenced manufacture of that substance must submit an NOC to EPA within 30 days following 671
commencement. For fiscal years 2009-2011, EPA received 1,723 PMNs. Based on EPA's review of 672 NOC receipt date information, EPA determined that NOCs were received within 45 days of completion of 673 the 90-day PMN review for only 16% of these submitte d PMNs. Thus, for 84% of the submitted PMNs, 674 the intent to manufacture was formed at least 135 days (i.e., the 90-day PMN review period plus 45 days) 675 before commercialization. Because a company must by necessity form the intent to manufacture a 676 chemical substance some period of time before the PMN is submitted to EPA, the intent to manufacture 677 or process would be made at least 135 days in advance as a general matter. 678
C. What Information would be Reported? 679
This TSCA section 8(a) rule proposes one-time reporting of certain information, including 680 specific chemical identity, production volume, methods of manufacture and processing, use, exposure and 681 release information, and available health and safety data. 682
EPA developed an information reporting form for the NMSP(Ref. 27) which has been slightly 683 modified for purposes of this proposed rule. Th e same information that was requested in the NMSP 684 would be required by this proposed rule
, including information on specific chemical identity, material 685 characterization, physical chemical properties, pr oduction volume, use, methods of manufacturing and 686 processing, exposure and release information, and exis ting data concerning the environmental and health 687 effects. The information would be reported on a form similar to that used in the NMSP . (Ref. 27). Any 688 person required to report under this proposed rule would supply the info rmation identified in the form to 689 the extent it is known to or reasonably ascertainable toby them. A draft of the proposed reporting form 690 (EPA Form No. 7710-[tbd]) is available inthe docket for public review (Ref. 28). 691

EPA is requesting comment on whether any informati on proposed to be collected requested in 692 this proposed rule is duplicative of information colle cted under other federal statutes and, thus should be 693 excluded. Please identify the statute and the information that you believe is duplicative. 694

D. How would information be submitted under the ruleInformation be Submitted to EPA ? 695
Electronic reporting requirements for Form No. 7710-xx would be included in 40 CFR 696 704.xxx(e). EPA is proposing electronic reporting similar to the requirements established in 2013 , i.e., 697 for submitting other information unde r TSCA (see proposed 704.20(e)). EPA is proposing to require 698 submitters to use EPA’s CDX, the Agency's electronic reporting siteportal , for all reporting under this 699 rule. In the Federal Registerof December 4, 2013 ( 78 FR 72818) (FRL 9394-6Ref. 1 ), EPA finalized a 700 rule to require electronic reporting of certain info rmation submitted to the Agency under TSCA sections 701 4, 5, 8(a) and 8(d). The final rule follows two pr evious rules requiring similar electronic reporting of 702 information submitted to EPA ( for TSCA Chemical Data Reporting and for Pre-Manufacture 703*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 18 of 33 Notifications. In proposing to require similar elec tronic reporting under this rule, EPA intends to save 704 time, improve data quality and increase efficien cies for both the submitters and the Agency. 705
EPA developed the Chemical Information Submis sion System (CISS) for use in submitting data 706 for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The tool is available for use with 707 Windows, Macs, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) 708 specifications for efficient data transmission acro ss the Internet. CISS, a web-based reporting tool, 709 provides user-friendly navigation, works with CDX to secure online communication, creates a completed 710 Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other 711 information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. 712
EPA is proposing to require submitters to follow the same submission procedures used for other 713 TSCA submissions, i.e., to register with EPA’s CDX and use CISS to prepare a data file for submission. 714 Registration enables CDX to authenticate identity and verify authorization. To submit electronically to 715 EPA via CDX, individuals must first register with that system at http://cdx.epa.gov/epa_home.asp . To 716 register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private 717 Key Holder”) agrees to the Terms and Conditions , provides information about the submitter and 718 organization, selects a user name and password, a nd follows the procedures outlined in the guidance 719 document for CDX available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. 720
Users who have previously registered with CDX for other TSCA submissions, Chemical Data 721 Reporting, or the Toxic Release Inventory TRI-ME web reporting flow, would be able to add the 722 “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, 723 and use the CISS web-based reporting tool. 724
All submitters would be required to use CISS to prepare their submissions. CISS guides users 725 through a “hands-on” process of creating an electronic submission. Once a user completes the relevant 726 data fields, attaches appropriate PDF files, or other fi le types, such as XML files, and completes metadata 727 information, the web-based tool validates the submission by performing a basic error check and makes 728 sure all the required fields and attachments are provi ded and complete. Further instructions on submitting 729 voluntary submissions, such as under MOUs, are avai lable, and instructions for uploading PDF 730 attachments or other file types, such as XML, and completing metadata inform ation would be available 731 through CISS reporting guidance. 732
CISS, a web-based reporting tool, also allows the user to choose “Print,” “Save,” or “Transmit 733 through CDX.” When “Transmission through CDX” is sel ected, the user is asked to provide the user 734 name and password that was created during the CDX registration process. CISS then encrypts the file and 735 submits it via CDX. The user will login to the app lication and check the status of their submissions. 736 Upon successful receipt of the submission by EPA, th e status of the submissions will be flagged as 737 “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user 738 registration. Information on accessing the CDX user i nbox is provided in the guidance document for CDX 739
at http://www.epa.gov/cdr/tools/CD X_Registration_Guide_v0_02.pdf . To access CISS go to 740 https://cdx.epa.gov/ssl/CSPP/Prim aryAuthorizedOfficial/Home.aspx and follow the appropriate links and 741 for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html . Procedures for 742 reporting nanoscale materialschemical substances under this proposed rule would be similar. EPA will 743 subsequently put a version of the tool for reporting nanoscale materialsunder this rule in the docket for 744 comment, including comments on the extent of and burden associated with training for using CDX. 745*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 19 of 33 EPA believes that electronic reporting reduces the reporting burden for submitters by reducing 746 the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to 747 share a draft submission within their organization, and more easily save a copy for their records or future 748 use. The resource and time requirements to review and process data by the Agency will also be reduced 749 and document storage and retrieval will require fewe r resources. EPA expects to benefit from receiving 750 electronic submissions and communicating back electronically with submitters. 751
EPA would also consider electronic reporting of this form similar to procedures for Significant 752 New Use Notices and PMNs set forth in §§721.25 and 720.40. EPA is seeking comment on these 753 approaches. 754
Any person submitting a reporting form could claim any part or all of the form as CBI. Any 755 information which is claimed as confidential will be disclosed by EPA only to the extent and by the 756 means of the procedures set forth in 40 CFR part 2. 757
The TSCA section 8(a) rule proposed here involves one-time reporting for existing nanoscale 758 materials and one-time reporting for new discrete nanoscale materials before they are manufactured or 759 processed. 760
EPA is also seeking comment on the possibility of a future rule that would require periodic 761 reporting of nanoscale materials similar to reporting that occurs under the Chemical Data Reporting Rule 762 (CDR) at 40 CFR part 711. Such a rule could require manufacturers and processors of nanoscale materials 763 to report the type of information collected under th e CDR rule to EPA at the same reporting interval as 764 currently required by CDR reporting (every four year s). That reporting could occur at lower thresholds 765 for criteria such as production volume. The CDR is a program designed to collect screening-level, 766 exposure-related information on chemical substances and to make that information available for use by 767 EPA and to the public consistent with requirements for handling information claimed as confidential. The 768 CDR rule data are used by EPA to support risk screening, assessment, priority setting and management 769 activities and constitute the most comprehensive s ource of basic screening-level, exposure-related 770 information on chemicals available to EPA. For further information see http://www.epa.gov/ iur/

. 771
IV. Development of Additional Data in Co nnection with the TSCA Section 8(a) Rule 772
A TSCA section 8(a) rule may require persons subj ect to the rule to submit test data in their 773 possession or control and to describe any other data known to or reasonably ascertainable by them, but 774 may not require persons to develop test data for submi ssion to the Agency. However, in view of the lack 775 of information regarding chemical substances manufactured at the nanoscale materials , EPA would 776 encourage respondents to this proposed rule to provide the Agency with any relevant data on chemical 777 substances manufactured at the nanoscale materials they may wishdecide to develop. 778
Persons choosing to develop test data should provide data that conform to the Good Laboratory 779 Practice Standards, which are codified at 40 CFR part 792. There are also standard test methods available 780 for properties and information identified in the propos ed rule from a number of sources. Some of these 781 sources include but are not limited to ASTM Inte rnational, the International Organization for 782 Standardization, the National Institute of Standard s and Technology, and the Organization for Economic 783 Cooperation and Development. EPA encourages persons who intend to conduct testing to consult with 784 the Agency before selecting a protocol for testing a chemical substance manufactured at the nanoscale 785 material . EPA would also encourage persons that woul d be required to submit TSCA section 8(a) data 786*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 20 of 33 under this proposed rule to provide inform ation on the potential benefits regarding the nanoscale 787 materialreportable chemical substance

. 788
V.V. Request for Comments 789
EPA is seeking public comment on all aspects of this proposed rule. In addition to specific 790 requests for comment included throughout this document , EPA is interested in comments pertaining to the 791 specific issues discussed in this unit. EPA also anticipates conducting a pu blic meeting during the 792 comment period to further discuss these and any other issues concerning the proposed rule. 793

1. Identifying the chemical substances that would be subject to reporting. EPA has developed the 794 proposed approach based on the appr oximate size range of 1-100 nm as used by the NNI for defining 795 nanotechnology (Ref. 6), experience in conducting assessments of new chemicals manufactured at the 796 nanoscale by EPA under TSCA, and datasubmitted to EPA under the NMSP. EPA is soliciting comment 797 on each aspect of the proposed approachto identifying the chemical substances that would be subject to 798 the reporting requirements of the rule. The Ag ency is seeking comment on these approaches and 799 alternative approaches for reporting requirements. For example the proposed rule would apply to 800 reportable chemical substances that contain primary particles, aggregates, or agglomerates in the size 801 range of 1-100 nm in at least one dimension. EPAis seeking comments on that aspect of reportable 802 chemical substances. EPA is asking commenters if the current proposal su fficiently encompasses these 803 types of reportable chemical substances. 804

2. Distinguishing between nanoscale forms of a reportable chemical substance. EPA considered 805 several different approaches to distinguish between nanoscale forms of a reportable chemical substance 806 including a percentage or numerical change in measur ed properties. The agency is also seeking comment 807 on an approach based solely on the behavior of the reportable chemical substance. For example, if a 808 manufacturer or processor knows about or engineers a reportable chemical substance with multiple 809 nanoscale forms with different performance characteris tics then each nanoscale form would be reported. 810 If multiple nanoscale forms of a reportable chemical substance do not perform differently then only a 811 single report of the entire range would be reported. EPA is seeking comment on these and other 812 alternative approaches. EPA is especially interested in comments on whether these approaches would 813 require reporting of sufficiently distinct nanoscale form s of a chemical substance so that reporting would 814 be focused on those nanoscale forms with potential for significantly different physical or chemical 815 characteristics or properties. EPA also seeks comment on each aspect of its proposed reporting such as 816 size increments, the number of standard deviations, morphology, the specific physical-chemical properties 817 identified, exclusions to reporting, and whether co mpanies have the analytical tools to make such 818 distinctions. 819

3. Reporting discrete forms at least 135 days before commencement of manufacture or 820 processing . As discussed in Unit III.B., EPA proposed th e 135-day period based on EPA’s experience 821 with PMN submissions, and the determination that the intent to manufacture was formed at least 135 days 822 before commercialization (i.e., the 90-day PMN review period plus 45 days). EPA is specifically seeking 823 comment on whether this time-period should be 135 days as proposed, 90 days to be similar to the PMN 824 review period, or some other time period. It woul d be most helpful if commenters explain why the time 825 period they suggest is appropriate. 826

4. Considerations for the Agency’s economic analysis. EPA has evaluated the potential costs for 827 manufacturers and processors of reportable chemical s ubstances for this proposed rule (Ref. 3). EPA is 828 specifically seeking additional information and data th at EPA could consider indeveloping the final 829*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 21 of 33 economic analysis. In particular, data that could facilitate the Agency’s further evaluation of the 830 potentially affected industry and firms, including data related to potential impacts for those small 831 businesses that would be subject to reporting. EPA is especially interested in available data or other 832 measures of the number of and potential growth in the number of commercial nanoscale materials or 833 firms that might manufacture or process such materials. 834

5. Electronic reporting. In proposing to require electronic reporting under this rule that is similar 835 to those established in 2013 for other TSCA reporti ng, EPA intends to save time, improve data quality 836 and increase efficiencies for both the submitters and the Agency. EPA is specifically interested in 837 comments related to the adoption of the existing mechanisms and related procedures for use in 838 transmitting the reports proposed in this rule, in cluding comments related to the extent to which 839 potentially reporting entities are already familiar with those mechanisms given their existing use for other 840 TSCA reporting. EPA is also interested in feedb ack on how electronic reporting mechanisms affect 841 reporting entities in terms of reporting time, added efficiencies, and potential burden associated with 842 training to use the electronic systems (i.e., CDX and CISS). 843

6. Consideration of potential future rulemaking regarding periodic reporting. EPA is also 844 seeking comment on the possibility of a future rule that would require periodic reporting of chemical 845 substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data 846 Reporting (CDR) rule at 40 CFR part 711. Such a rule could require manufacturers and processors of 847 chemical substances manufactured at the nanoscaleto report the type of information collected under the 848 CDR rule to EPA at the same reporting interval as currently required by CDR reporting (every four 849 years). That reporting could occur at lower thresholds for criteria such as production volume. The CDR 850 is a program designed to collect screening-level, exposure-related information on chemical substances 851 and to make that information available for u se by EPA and to the public consistent with confidentiality 852 under TSCA Section 14 and EPA regulations in 40 CFR Part 2. The CDR rule data are used by EPA to 853 support risk screening, assessment, priority setting and management activities and constitute the most 854 comprehensive source of basic screening-level, expo sure-related information on chemicals available to 855 EPA. For further information see http://www.epa.gov/ oppt/cdr

. 856

VI. References 857
The following is a listing of the documents that ar e specifically referenced in this document. The 858 docket includes these references and other informati on considered by EPA. For assistance in locating 859 these other documents, please consult the technical contact listed under FOR FURTHER 860 INFORMATION CONTACT

. 861

1. 2014. National Nanotechnology Initiative. “Supplement tot eh President’s 2015 Budget,” p. 862 3. http://www.nano.gov/sites/default/files/ pub_resource/nni_fy15_budget_supplement.pdf. 863

1. 2013. EPA. Electronic Reporting Under the T oxic Substances Control Act; Final Rule. 864 Federal Register(78 FR 72818, December 4, 2013) (FRL 9394-6). 865

2. 2011. Executive Office of the President. Polic y Principles for the U.S. Decision-Making 866 Concerning Regulation and Oversight of Appli cations of Nanotechnolog y and Nanomaterials. 867 http://www.whitehouse.gov/sites/default/files/omb/in foreg/for-agencies/nanot echnology-regulation-and868 oversight-principles.pdf. 869*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 22 of 33 3. 2015. EPA. Economic Analysis for the TSCA Section 8(a) Proposed Reporting 870 Requirements for Certain Nanoscale Materi als (RIN 2070-AJ54). March 12, 2015. 871

2.4. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final Rule. Federal 872 Register (70 FR 59848, October 13, 2005) (FRL-7977-1). 873

3.5. 2005. Oberdörster, Gunter, Oberdörster, Eva, and Oberdörster, Jan. Nanotoxicology: an 874 emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives. 875 (113): 823-839. 876

4. 2004. National Nanotechnology Initiative. The National Nanotechnology Initiative Strategic 877 Plan. Available on-line at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf

. 878

6. 2014. National Nanotechnology Initiative (NN I). “Supplement to the President’s 2015 879 Budget,” p. 3. http://www.nano.gov/sites/defau lt/files/pub_resource/nni_fy15_bu dget_supplement.pdf.. 880

5.7. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean-Yves, Lowry, Gregory V Jolivet Jean881 Pierre, and Wiesner, Mark R. Towards a definition of inorganic nanoparticles from an environmental, 882 health and safety perspective. Nature Nanotechnology 4, 634 – 641. Published online: 13 September 883 2009 | doi:10.1038/nnano.2009.242. 884

6.8. 2009. National Institute of Occupati onal Safety and Health.NIOSH. Approaches to Safe 885 Nanotechnology: Managing the Health and Safety Con cerns Associated with Engineered Nanomaterials. 886 Available on-line at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf. 887

7.9. 2009. European Commission, Directorate-Gene ral for Health and C onsumers. Scientific 888 Committee on Emerging and Newly Identified Risks , (SCENIR), Report: Risk Assessment of Products of 889 Nanotechnologies. Available on-line at 890 http://ec.europa.eu/health/ph_risk/committees/04_scenihr /docs/scenihr_s_01.pdf.h ttp://ec.europa.eu/heal 891 th/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf. 892

8.10. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and Donaldson, Kenneth. 893 Nanoparticles, human health hazard and regulation. Jo urnal of the Royal Society, Available on-line at 894 http://rsif.royalsocietypublishing.org/content/e arly/2009/08/31/rsif.2009.0252.focus.full#ref-14

. 895

9.11. 2010. Wick, Peter, Malek, Antoine, Manser , Pius, Meili, Danielle, Maeder-Althaus, 896 Xenia, Diener, Liliane, Diener, Pierre-Andre, Zisch, Andreas, Krug, Harold F, and Mandach, Ursula von. 897 Barrier Capacity of Human Placenta for Nanosized Materials. Environmental Health Perspectives. 898 (118):432-436. 899

10.12. 2008. Kim, Yong Soon, Kim, Jin Sik, Cho, Hyun Sun, Rha, Dae Sik, Kim, Jae Min, 900 Park, Jung Duck, Choi, Byung Sun, Lim, Ruth, Chang, Hee Kyung, Chung, Yong Hyun, Kwon, Il Hoon, 901 Jeong, Jayoung, Han, Beom Seok, and Yu, Il Je. Tw enty-Eight Day Oral Toxicity, Genotoxicity, and 902 Gender-Related Tissue Distribution of Silv er Nanoparticles in Sprague-Dawley Rats. Inhalation 903 Toxicology. 20 (6): 575-583. 904

11.13. 2008. Handy, Richard D., Von der Kammer, Frank, Lead, Jamie R., Hassello, Martin, 905 Owen, Richard, and Crane, Mark. The ecotoxico logy and chemistry of manufactured nanoparticles. 906 Ecotoxicology 17:287-314. 907*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 23 of 33 12.14. 2008. Klaine, Stephen J., Alvarez, Pedro J ., Batley, Graeme E., Fernandes, Teresa F., 908 Handy, Richard D., Lyon, Delina Y., Mahendra, Shaily, McLaughlin, Michael J., and Lead, Jamie R. 909 Nanomaterials in the Environment: Behavior, Fate, Bioavailability, and Effects . Environmental 910 Toxicology and Chemistry . 27: 1825-1851. 911

13.15. 2007. Federici, Gillian, Shaw, Be njamin J., and Handy, Richard D. Toxicity of titanium 912 dioxide to rainbow trout ( Oncorhynchus mykiss ): Gill injury, oxidative stress, and other physiological 913 effects. Aquatic Toxicology. 84: 415–430. 914

14.16. 2007. Roberts, Aaron P., Mount, Andrew S., Seda, Brandon, Souther, Justin, Qiao, Rui, 915 Lin, Sijie, Ke, Pu Chun, Rao, Apparao M., and Klaine, Stephen J. In vivo biomodification of lipid coated 916 carbon nanotubes by Daphnia magna

. Environmental Science and Technology. 41: 3025–3029

. 917

15.17. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna mortality when exposed to 918 titanium nanoparticles and fulle rene (C60) nanoparticles. Environmental Toxicology and Chemistry. 25: 919 1132–1137. 920

16.18. 2006. Oberdörster, Eva, Zhu, Shiqian, Zhu, Blickley, T. Michelle, McClellan-Green, 921 Patricia, and Haasch, Mary L. Ecotoxicology of car bon-based engineered nanoparticles: effects of 922 fullerene (C-60) on aquatic organisms. Carbon. 44: 1112-1120. 923

17.19. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the see-through Medaka 924 ( Oryzias latipes ). Environmental Health Perspectives. 114: 1697–1702. 925

18.20. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. Effect of carbon 926 nanotubes on developing zebra fish ( Danio rerio ) embryos. Environmental Toxicology and Chemistry. 927 26:708–716. 928

19.21. 2013. NIOSH. Current Intelligence Bulletin 65: Occupational Exposure to Carbon 929 Nanotubes and Nanofibers at http://www.cd c.gov/niosh/docs/2013- 145/pdfs/2013-145.pdf. 930

20.22. 2007. EPA. EPA Nanotechnology White Paper. Available online at 931 http://www.epa.gov/osa/pdfs/nanotech /epa-nanotechnology-whitepaper-0207.pdf

. 932

21.23. 2008. EPA. TSCA Inventory Status of Na noscale Substances -- General Approach. 933 Available online at http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf

. 934

22.24. 2009. EPA. EPA interim reportInterim Report on the Nanoscale Materials Stewardship 935 Program. Available online at http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf

. 936

21. 2010. EPA. List of Chemical Substances on the TSCA Inventory that EPA believes can be solid 937 chemical substances manufactured or processed in the range of 1-100 nanometers at ambient 938 conditions. 939
22. 2010. Joint Research Centre of the European Commission. Considerations on a Definition of 940 Nanomaterial for Regulatory Purposes. Available online at 941 http://ec.europa.eu/dgs/jrc/downloads/jrc_re ference_report_201007_nanomaterials.pdf. 942

23.25. 23. 20112012 . International Organization for Standardization . (ISO). Nanotechnologies 943 – Guidance on Physicochemical Characterization for Manufactured Nano-objects submittedSubmittedfor 944 Toxicological Testing. ISO/TR (Technical Report) ISO/TR 13014:2012. 945*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 24 of 33 24.26. 2013. 24. EPA. Cross-Media Electronic Reporting; Final Rule. Federal Register (70 946 FR 59848, October 13, 2005) (FRL-7977-1). 947

27. 25. 2010. EPA. Economic AnalysisISO/TR. Guidelines for Characterization of Dispersion 948 Stability. ISO/TR 13097:2013. 949

25.28. 2008. EPA. the TSCA Section 8(a) Proposed Reporting Requirements for Certain 950 Nanoscale Materials . Stewardship Program Data Submission Form. EPA Form No. 7710-25-NMSP; 951 EPA ICR No. 2550.01; OMB Control No. 2070-0170. 952

29. 2015. EPA. 26. 2010. Proposed Data Submission Form. "TSCA 8(a) Data Reporting for 953 Nanoscale Materials.” EPA Form No. 7710[tbd]; EPA ICR No. ####.01; OMB Control No. 2070-[new]. 954

26.30. 2015. EPA . Proposed Addendum to an Existing EPA ICR Entitled: Chemical-Specific 955 Rules, Toxic Substances Control Act Section 8(a). EPA ICR No. ####.01; OMB Control No. 2070- 956 [new]. 957

27.31. 27. VII 2013. National Institute of Occupational Safety and Health. Current Intelligence 958 Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers at 959 http://www.cdc.gov/niosh/do cs/2013-145/pdfs/2013-145.pdf. 960

28. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making 961 Concerning Regulation and Oversight of Appli cations of Nanotechnolog y and Nanomaterials. 962 http://www.whitehouse.gov/sites/default/files/omb /inforeg/for-agencies/nanotechnology-regulation963 and-oversight-principles.pdf 964

VI . Statutory and Executive Order Reviews 965
A. Executive Order 12866: Regulatory Planning a nd Review and Executive Order 13563: Improving 966 Regulation and Regulatory Review 967
The Office of Management and Budget (OMB ) has designated this proposed rule as a 968 ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 969 1993). Accordingly, EPA submitted this proposed ru lemaking to OMB for review under Executive Order 970 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes made in response to 971 OMB comments have been documented in the public docket for this rulemaking as required by section 972 6(a)(3)(E) of Executive Order 12866. 973
B. Paperwork Reduction Act (PRA) 974
An agency may not conduct or sponsor, and a pers on is not required to respond to an information 975 collection request subject to the PRA 

### , 44 U.S.C. 3501 et seq. , unless it displays a currently valid OMB 976 control number. The OMB control numbers for EPA ’s regulations are listed in 40 CFR part 9 and 977 included on any related collection instrument (e.g., on the form or survey). 978
The information collection requirements in 40 CFR part 704 related to TSCA section 8(a) 979 reporting rules have already been approved by OMB under the PRA. That information collection request 980 (ICR) has been assigned EPA ICR No. 1198 and OM B control number 2070-0067. Because this 981 proposed rule would involve revised information collection activities that require additional OMB 982*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 25 of 33 approval, EPA has prepared an addendum to the currently approved ICR(Ref. 26, and is identified under 983 EPA ICR No. 1198.11 (Ref. 29 ). 984
If an entity were to submit a report to the Agency, the annual burden is estimated to average 137 985 hours per response. 

### Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and 986 the ICR addenda, EPA estimates that the proposed TSCA section 8(a) rule would create a total 987 incremental industry burden of 228,853 hours. 988
To comment on the Agency's needfor this information, the accuracy of the provided burden 989 estimates, and any suggested methods for minimizi ng respondent burden, EPA has established a docket 990 for this proposed rule, which includes this ICR, under docket ID numb er EPA-HQ-OPPT-2010-0572. 991 Submit any comments related to the ICR to EPA and OMB. See ADDRESSES for where to submit 992 comments to EPA. Send comments to OMB via email to oira_submission@omb.eop.gov. Address 993 comments to OMB Desk Officer for EPA. 994
Since OMB is required to make a decision con cerning the ICR between 30 and 60 days after 995 [ insert date of publication in the Federal Register ], a comment to OMB is best assured of having its full 996 effect if OMB receives it by [ Insert date 30 days after publication in the Federal Register ]. The final rule 997 will respond to any OMB or public comments on the in formation collection requ irements contained in 998 this proposed rule. 999

C. Regulatory Flexibility Act (RFA) 1000
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq ., I hereby certifiescertify that this 1001 action would not have a significant adverse economi c impact on a substantial number of small entities. 1002 The rationale supporting this conclusion is summarized here, and is presented in a small entity impact 1003 analysis that EPA prepared for this proposed acti on that is part of the Agency’s economic analysis (Ref. 1004 25). in the public docket for this proposed rule . (Ref. 3). 1005
Under the RFA, small entities include small businesses, small organizations, and small 1006 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, 1007 small entity is defined as: (1) a small business, as defi ned by the Small Business Administration’s (SBA) 1008 regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, 1009 county, town, school district or special district with a population of less than 50,000; and (3) a small 1010 organization that is any not-for-profit enterprise whic h is independently owned and operated and is not 1011 dominant in its field. Since the regulated commun ity is not expected to include small governmental 1012 jurisdictions or small not-for-profit organizations, the analysis focuses on small businesses. 1013
A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). 1014 For this action, EPA is proposing to modify the exemption. For more details see Unit II.D. EPA analyzed 1015 potential small business impacts from this proposed rule using both the SBA employee size standards and 1016 the TSCA sales-based definition of small business. EPA estimates that up to 174 small businesses may 1017 be impacted by the proposed TSCA section 8(a) reporting rule but estimates no adverse economic impact 1018 greater than three percent of sales for any of tho se companies.and evaluated the number that may incur 1019 costs at below 1%, between 1% and 3%, and above3% of sales. EPA estimates that all 174 small 1020 businesses would identified would incur costs below 1% of sales. 1021 1022 EPA continues to be interested in the potential impacts of this proposed rule on small entities that 1023 are not exempt from reporting and welcomes comments on issues related to such impacts. 1024*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 26 of 33 D. Unfunded Mandates Reform Act (UMRA) 1025
Based on EPA’s experience with proposing and fi nalizing rules under TSCA section 8(a), State, 1026 local and Tribal governments have not been impact ed by these rulemakings, and EPA does not have any 1027 reason to believe that any State, local or Tribal government would be impacted by this rulemaking. In 1028 addition, this action will not result in annual expenditures of $100 million or more for the private sector. 1029 As such, EPA has determined that this action does not impose any enforceable duty, contain any 1030 unfunded mandate, or otherwise have any e ffect on small governments, and that the 

### requirements of 1031 

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

. 1032

E. Executive Order 13132: Federalism 1033

This action does not have substantial direct effe cts on the states, on the relationship between the 1034 national government and the states, or on the distribution of power and 

### responsibilities among the 1035 

### various levels of government, as specifiedin Executive Order 13132 (64 FR 43255, August 10, 1036 

### 1999)

. 1037 1038 F. Executive Order 13175: Consulta tion and Coordination with Indian Tribal Governments 1039
This action does not have tribal implications because it will not have any effect on tribal 1040 governments, on the relationship between the Federa l government and the Indian tribes, or on the 1041 distribution of power and responsibilities between the Federal government and Indian tribes, as specified 1042 in Executive Order 13175 (65 FR 67249, November 9, 2000). 1043 1044 G. Executive Order 13045: Protection of Children fromEnvironmental Health Risks and Safety Risks 1045
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those 1046 regulatory actions that concern health or safety risk s, such that the analysis required under section 5-501 1047 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to 1048 Executive Order 13045 because it does not establish an environmental standard intended to mitigate 1049 health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed 1050 rule will be used to inform the Ag ency’s decision-making process regarding chemicalschemical 1051 substances to which children may be disproportionately exposed. This information will also assist the 1052 Agency and others in determining whether the chemicalschemical substances addressedin this proposed 1053 rule present potential risks, allowing the Agency and others to take appropriate action to investigate and 1054 mitigate those risks. 1055

H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, 1056 Distribution, or Use 1057
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 1058 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, 1059 distribution, or use. 1060 1061 I. National Technology Transfer and Advancement Act (NTTAA) 1062
Since this action does not involve any technical standards, NTTAA section 12(d) , 15 U.S.C. 272 1063 note, does not apply to this action. 1064 1065*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 27 of 33 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations 1066 and Low -Income Populations 1067
This action does not entail special considerati ons of environmental justice related issues as 1068 delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that 1069 this action will not have disproportionately high and adverse human h ealth or environmental effects on 1070 minority or low-income populations. This action does not affect the level of protection provided to human 1071 health or the environment. 1072 1073 This action does not affect the level of protection provided to human health or the environment. 1074 However, the Agency believes that the information co llected under this proposed rule, if finalized, will 1075 assist EPA and others in determining the potential h azards and risks associated with various chemicals 1076 manufactured processed, and used at the nanoscale. Although not directly impacting environmental 1077 justice-related concerns, this information will enablethe Agency to better protect human health and the 1078 environment, including in low-income and minority communities. 1079 1080 List of Subjects in 40 CFR Part 704 1081
Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting 1082 Requirements. 1083
Dated: ____________________ 1084

__________________________________________ 1085
Assistant Administrator, Office of Chemi cal Safety and Pollution Prevention. 1086*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 28 of 33 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 1087
1. The authority citation for part 704 continues to read as follows: 1088
Authority: 15 U.S.C. 2607(a) 1089
2. By adding § 704. xxxx20 to Subpart B, to read as follows 1090
§704.xxx Nanoscale materials. 1091
§704.20 Chemical substances manufactured or processed at the nanoscale. 1092
(a) Definitions. For purposes of this section the terms below are defined as follows: 1093

An agglomerate is a collection of weakly bound particl es or aggregates or mixtures of the two 1094 where the resulting external surface area is similar to the sum of the surface areas of the individual 1095 components. 1096

An aggregate is a particle comprising strongly bonded or fused particles where the resulting 1097 external surface area may be significantly smalle r than the sum of calculated surface areas of the 1098 individual components. 1099
Central Data Exchange or CDX means EPA's centralized electronic submission receiving system. 1100
Chemical Information Submission Systemor CISS means EPA's electronic, web-based reporting 1101 tool for the completion and submission of data, re ports, and other information, or its successors. 1102

A discrete form of a reportable chemical substance differs from another form of the same 1103 reportable chemical substance in that either: 1104
(1) The change in the reportable chemical substance is due to all of the following: 1105
(i) There is a change in process to affect a change in size and/or a change in one or more of the 1106 properties of the reportable chemical substances identified in (iii); 1107
(ii) There is a size variation in the mean particle size that is greater than 7 times the standard 1108 deviation of the mean particle size (+ /- 7 times the standard deviation); and 1109
(iii) There is a measured change in at least one of the following properties, zeta potential, specific 1110 surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of 1111 the measured value (+/- 7 tim es the standard deviation); 1112
(2) The reportable chemical substance has a di fferent morphology. Examples of morphologies 1113 include but are not limited to sphere, rod, ellipsoid, cy linder, needle, wire, fiber, cage, hollow shell, tree, 1114 flower, ring, torus, cone, and sheet; or 1115
(3) A reportable chemical substance that is coatedwith another chemical substance or mixture at 1116 the end of manufacturing or processing has a coating that consists of a different chemical substance or 1117 mixture. 1118

The Nanoscale Materials Stewardship Program was a program conducted by EPA from January 1119 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily 1120*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 29 of 33 provided EPA available information on engineered na noscale materials that were manufactured processed 1121 or used. 1122
Primary particles are particles or droplets that form during manufacture of a chemical substance 1123 before aggregation or agglomerization occurs. 1124

An aggregate is a heterogeneous particle in which the various components are held together by 1125 relatively strong forces, and thus not easily broken ap art. Aggregated nanoparticles would be an example 1126 of a nanostructured material which means a material having an internal or surface structure at the 1127 nanoscale. 1128

An agglomerate is a group of nanoparticles held togeth er by relatively weak forces, including van 1129 der Waals forces, electrostatic forces, and surface tension. 1130

A solid nanoscale material reportable chemical substance is a chemical substance that is a solid 1131 at 25 oC and atmospheric pressure that is manufactured or processed in a form where at least 10 % of the 1132 primary particles, aggregates, or agglomerates , or aggregates are manufactured or processed in the size 1133 range of 1-100 nanometers. 1134

. 1135

A discrete form of a solid nanoscale materialdiffers from another form ofnm and exhibit unique 1136 and novel characteristics or properties because of their size. A reportable chemical substance does not 1137 include a chemical substance that only has trace amounts of primary particles, aggregates, or 1138 agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the same 1139 nanoscale material as follows in that either: 1140
(1) The change in the nanoscale material is due to a combination of (i), (ii)uniqueand (iii) 1141
(i) there is a change in process to affect a change in size and/or a change in onenovel 1142 characteristics or more of the properties of the nanoscale materials identified in (iii) 1143
(ii) there is a size variation in the mean because of particle size of 10% or greater; and 1144
(iii) there is a change in one or more of the following properties of 10% or more: surface 1145 charge, specific surface area, dispersib ility/solubility, or surface reactivity; 1146
(2) The nanoscale material has a different morphology. Examples of morphologies include but 1147 are not limited to sphere, rod, ellipsoid, cylinder, needle , wire, fiber, cage, hollow shell, tree, flower, ring, 1148 torus, cone, and sheet. 1149
(3) A nanoscale material that is coated with another chemical substance or mixture at the 1150 end of manufacturing or processing has a coating that consists of a different chemical substance or 1151 mixture

. 1152

A small manufacturer or processor means any manufacturer or processor whose total annual 1153 sales, when combined with those of its parent compan y (if any), are less than $ 4 million. The definition 1154 of small manufacturer in section 704.3 of this title does not apply to reporting under this section (40 CFR 1155 704. xxx.20). 1156*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 30 of 33 Dispersibility means the extent to which the particulate nanoscale material can be distributed in 1157 another material such as a liquid. 1158
Solubility means the degree to which the nanoscale materi al can be dissolved in another material 1159 such as a liquid. 1160
Specific surface area means the ratio of the area of the surface of the nanoscale 1161 materialreportable chemical substanceto its mass . or volume. Specific surface area by mass is the ratio 1162 of the area of the surface of a nanoscale material divided by the mass (m 2/kg) orand the specific surface 1163 area by volume is the area of the surface of the nanoscale materialsreportable chemical substance divided 1164 by its volume m 2/m 3

. 1165
Surface charge means the electric charge on a surface in contact with a continuous phase. 1166 Surface charge can be calculated by measuring Zeta Potential is the electrokinetic potential in colloidal 1167 systems known as the zeta potential. . It is measured as the net number of positive and negative charges 1168 per unit particle surface area in Coulomb/m 2

. The differential of 10% in the surface charge would be 1169 measured for the same medium. 1170
Surface reactivity means the reactivity at the surface of a nanoscale material.reportable chemical 1171 substance. It is dependent upon factors such as redox potential
, which is a measure of the tendency of a 1172 substance to lose or acquire electrons, photocatalytic activity, including the potential to generate free 1173 radicals. 1174
Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, 1175 or its successors. 1176
Chemical Information Submission System or CISS means EPA’s electronic, web-based reporting 1177 tool for the completion and submission of data, re ports, and other information associated with TSCA 1178 sections 4 and 8. 1179
(b) Persons who must report. 1180
(1) Manufacturers and processors of a discrete form of a solid nanoscale materialreportable 1181 chemical substance during the three years prior to the final eff ective date of the rule must report except as 1182 provided in paragraph (c) of this section. 1183
(2) Persons who propose to manufacture or process a discrete form of a solid nanoscale 1184 materialreportable chemical substanceafter the final effective date of the rule which was not reported 1185 under paragraph (b)(1) must report except as pr ovided in paragraph (c) of this section. 1186
(c) When reporting is not required

. 1187
(1) The following chemical substances are not subject to reporting under this section : 1188
(i) Zinc oxide 1189 (ii) Nanoclays 1190 (iii) Nanoscale materials created as a thin film 1191 (iii) Chemical substances manufactured at the nanoscale as part of a film on a surface 1192 (iv) DNA 1193 (v) RNA 1194 (vi) Proteins 1195*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 31 of 33 (vii) Chemical substances which dissociate completely in water to form ions that are less smaller 1196 than 1 nanometer

. 1197 1198 (2) Persons who submitted a TSCA chemical notice under 40 CFR part 720, 721, or 723 of this 1199 title for a solid nanoscale material reportable chemical substance on or after January 1, 2005 are not 1200 required to submit a report for the solid nanoscale materialreportable chemical substance submitted 1201 except where the person manufactured or processed a discrete form of the solid nanoscale 1202 material.reportable chemical substance. 1203
(3) Section 704.5 (a) through (e) of this part 704 appliesapply to reporting under this section 1204 704.xxx . Small manufacturers and processors as defined in paragraph (a) of this section 704.xxx are 1205 exempt from the reporting requirements ofunderthis rulesection

. 1206
(4) Any personPersons who has already submitted some or all of the required information for a 1207 reportable chemical substance described in paragraph (a) as part of the Nanoscale Materials Stewardship 1208 Program isare not required to report thatthe information previously submitted except where the person 1209 manufacturersmanufactures or processes a discrete form of the solid nanoscale material.reportable 1210 chemical substance. 1211
(d) What information to report. The following information must be reported for each discrete 1212 form of a reportable chemical substance to the extent that it is known to or reasonably ascertainable for 1213 each discrete form of a solid nanoscale material manuf actured or processed during the three years prior to 1214 the final effective date of the rule:by the person reporting: 1215
(1) theThe common or trade name, the specific chemical identity including the correct Chemical 1216 Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number , and the 1217 molecular structure of each chemical substance or mixture. Information must be reported as specified in 1218 § 720.45. 1219
(2) material characterizationMaterial characteristics including particle size, morphology, and 1220 surface modifications ;. 1221
(3) physicalPhysical/chemical properties ;. 1222
(4) theThe maximum weight percentage of impurities and byproducts resulting from the 1223 manufacture, processing, use, or disposal of each chemical substance ;. 1224
(5 ))(i) Persons described in paragraph (b)(1) of this section must report the annual production 1225 volume for the previous three years before the effective date of the final rule and an estimate of the 1226 maximum production volume for any consecutive 12- month period during the next two years of 1227 production after the final effective date of this rule. Estimates must be on 100% chemical basis of the 1228 discrete form of the solid nanoscale material; 1229
(ii) Persons described in paragraph (b)(2) of this section must report the estimated maximum 12 1230 month production volume and the estimated maximum production volume for any consecutive 12 month 1231 period during the first three years of production. 1232
(iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section must be on 100% chemical basis of 1233 the discrete form of the solid nanoscale material. 1234*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 32 of 33 (6) useUse information describing the category of each use by function and application, estimates 1235 of the amount manufactured or processed for each category of use, and estimates of the percentage in the 1236 formulation for each use ;. 1237
(7) detailedDetailedmethods of manufacturing or processing ;. 1238
(8) exposureExposure information with estimates of the num ber of individuals exposed in their 1239 places of employment, descriptions and duration of the occupational tasks that cause such exposure, 1240 descriptions and estimates of any gene ral population or consumer exposures ;. 1241
(9) releaseRelease information with estimates of the amounts released, descriptions and duration 1242 of the activities that cause such releases, and whether re leases are directly to the environment or to control 1243 technology ;. 1244
(10) riskRisk management practices describing protectiv e equipment for individuals, engineering 1245 controls, control technologies used, any hazard warning statement, label, material safety data sheet, 1246 customer training, or other information which is prov ided to any person who is reasonably likely to be 1247 exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, 1248 or disposal of the substance ; and. 1249
(11) existingExisting data concerning the environmental and health effects. 1250
(e) How to report. 1251
(1) Persons You must use CDX and the CISS tool to complete and submit the information required under 1252 this part to EPA electronically. 1253
(1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA § 8(a) Data Reporting for 1254 Nanoscale Materials : Data Submission Form and any attachments,. 1255
(2) Electronic submission. You must submit the required information to EPA electronically via 1256 CDX . Submission requires registration with CDX, and must be made only as set forth in this 1257 section.using the CISS tool. 1258
(2) To access CISS go to https://cdx.epa.gov/ssl/CSPP/Prim aryAuthorizedOfficial/Home.aspx 1259 and follow the appropriate links and for further instructions to go 1260 http://www.epa.gov/oppt/chemtest/ereporting/index.html

. 1261
(i) To access the CDX portal, go to https://cdx.epa.gov. 1262
(ii) The CISS tool is accessible in CDX. 1263
(f) When to report. 1264
(1) Persons specified in paragraph (b)(1) of this section must report the information specified in 1265 paragraph (d) of this section within six months after the final effective date of the rule. 1266
(2) Persons specified in paragraph (b)(2) of this section must report the information specified in 1267 paragraph (d) of this section at least 135 days before commencing manufacture or processing of the 1268 chemical substance. 1269*** EO 12866 Deliberative Draft – Do not Cite, Quote or Release During the Review *** RIN 2070-AJ54

Page 33 of 33 (g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to 1270 the recordkeeping requirements in §704.11 (a) and (b). 1271
(h) Confidential business information. Persons submitting a notice under this rule are subject to 1272 the requirements for confidential business information claims in §704.7. 1273
[FR Doc. ??–????? Filed ??–??–??; 8:45 am] 1274