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### 10/01 /201 4 : A s Submitted for EO 12866 Review . 1 

### Filename: EO12866_RIN2070- AJ54_Nano - TSCA - 8a -NPRM_FRdocument_2014
- 10- 01.docx 2 3 4 BILLING CODE 6560

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–P 5 **ENVIRONMENTAL PROTECTION AGENCY** 6 **40 CFR Part 704** 7 **[EPA**

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**– 2010**  **- 0572; FRL** 
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**AJ54** 9 **Chemical Substances When Manufactured or Processed 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 as nanoscale materials. Specifically, EPA proposes 15 to require persons that manufacture or process , or intend to manufacture or process these nanoscale 16 materials to electronically report to EPA certain information, which includes the specific chemical 17 identity, production volume, methods of manufacture and processing, exposure and release information, 18 and existing data concerning environmental and health effects. This proposal involves one -time reporting 19 for existing nanoscale materials and one -time reporting for new discrete nanoscale materials before they 20 are manufactured or proc essed. This information would facilitate EPA’s evaluation of the materials and a 21 determination of whether further action , including additional information collection, is needed. 22 Consistent with the President’s memorandum for Executive Agencies regarding Principles for Regulation 23 and Oversight of Emerging Technologies, this proposed rule would facilitate assessment of risks and risk 24 management, examination of the benefits and costs of further measures, and making decisions on 25 available scientific evidence. 26 **DATES:** Comments must be received on or before [ insert date 90 days after date of publication in the 27 **Federal Register** ]. 28 **ADDRESSES:** Submit your comments, identified by docket identification (ID) number EPA

–HQ

– 29 OPPT

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



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

### instructions for submitting comments. Do not submit electronicall y any information you consider 32 

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

### by statute. 34

• Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), 35 Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460

–0001. 36

• Hand Delivery : To make special arrangements for hand delivery or delivery of boxed 37 information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. 38*** EO 12866 Deliberative Draft

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Page 2 of 24 Additional instructions on commenting or visiting the docket, along with more information about 39 dockets generally, is available at http://www.epa.gov/dockets. 40 **FOR FURTHER INFORMATION CONTACT:** For technical information contact : Jim Alwood, 41 Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental 42 Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

–0001; telephone number: 43 202 564 - 8974; e - mail address: alwood.jim @epa.gov . 44 For general information contact : The TSCA - Hotline , ABVI - Goodwill, 422 South Clinton Ave., 45 Rochester, NY 14620 ; telephone number: (202) 554

– 1404; e -mail address: TSCA -Hotline@epa.gov . 46 **SUPPLEMENTARY INFORMATION:** 47 **I. Executive Summary**  48 A. Does this Action Apply to Me? 49 You may be potentially affected by this action if you manufacture or process or intend to 50 manufacture or process nanoscale materials. However, p ersons that manufacture or process, or intend to 51 manufacture or process nanoscale materials as part of articles, as impurities, or in small quantities solely 52 for research and development would not be subject to this action. Consult 40 CFR 704. 3 and 704. 5 for 53 further information on the applicability of these and other exemptions . 54 The following list of North American Industrial Classification System (NAICS) codes is not 55 intended to be exhaustive, but rather provides a guide to help readers determine wheth er this document 56 applies to them. Potentially affected entities may include: 57 • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 58 324110), e.g., chemical manufacturing and petroleum refineries . 59 B. What Is the Agency's Authority for Taking this Action? 60 The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq ., provides EPA with authority 61 to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances 62 and/or mixtures . EPA is proposing this rule under s ection 8(a) of TSCA, 15 U.S.C. 260 7(a) . See also 63 Unit II. A . 64 C. What Action is the Agency Taking? 65 EPA is proposing reporting and recordkeeping requirements for persons that manufacture or 66 process chemical substances as nanoscale materials as described in Unit II.D. Persons who currently 67 manufacture or process these chemical substances as discrete nanoscale materials would be required to 68 notify EPA of certain information described in Unit II.D., including specific chemical identity, production 69 volume, methods of manufacture and processing, use, exposure and release information, and available 70 health and safety data. EPA is also proposing that any persons who intend to begin to manufacture or 71 process chemical substances as discrete nanoscale materials after the effective date of this rule notify EPA 72 of the same information at least 135 days before the intended date of commencement of manufacture or 73 processing. The TSCA section 8(a) rule proposed here involves one -time reporting for existing nanoscale 74 materials and one -time reporting for new discrete nanoscale materials before they are manufactured or 75 processed. 76*** EO 12866 Deliberative Draft

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Page 3 of 24 Included in this proposal are electronic reporting requirements similar to those established in 77 2013 , i.e., EPA is proposing to require s ubmitters to use EPA’s Central Data Exchange (CDX), the 78 Agency's electronic reporting site , for all reporting under this rule . In the **Federal Register** of December 79 4, 2013 (78 FR 72818) (FRL 9394 - 6), EPA finalized a rule to require electronic reporting of certain 80 information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). In proposing to require 81 similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase 82 effic ienc ies for both the submitters and the Agency . 83 D. Why Is the Agency Taking this Action? 84 These reporting and recordkeeping requirements would assist EPA in its continuing evaluation of 85 nanoscale materials, informed by available scientific, technical and e conomic evidence. This proposed 86 rule is not intended to indicate restrictions or conclusions about the risks of nanoscale materials in 87 general. Rather, the requirements would facilitate EPA’s evaluation of the materials and determination of 88 whether any fu

rther action under TSCA, including additional information collection, is needed. 89 Consistent with the June 9, 2011 memorandum on the Policy Principles for the U.S. Decision 90 Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, 91 this proposal is not making any finding about the potential risks of nanoscale materials in general or any 92 specific nanoscale materials. (Ref. 28) In this proposal EPA takes a science -based approach and supports 93 the policy principle to “[s]eek and develop adequate information with respect to the potential effects of 94 nanomaterials on human health and the environment and take into account new knowledge when it 95 becomes available”. As with current new chemical reviews of nanoscale materials, each nanoscale 96 material would be evaluated on a case -by - case basis and not with the p resumption of either harm or 97 safety. Any evaluation will be based on the specific nanoscale material’s own properties and those of any 98 structural analogs. 99 TSCA section 8(a) applies to a person “who manufactures or processes or proposes to 100 manufacture or process a chemical substance”. A company proposes to manufacture or process a 101 chemical substance by forming the intent to do so. Based on EPA’s experience, persons form the intent to 102 manufacture or process chemical substances at least 135 days ahead of time. This belief is based on 103 EPA's experience with Premanufacture Notice (PMN) submissions and subsequent notices of 104 commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 40 CFR 720.22, PMNs are submitted 105 by a person who intends to manufacture (including import) a chemical substance, at least 90 days before 106 commencing manufacture. Under 40 CFR 720.102, a company that has submitted a PMN for which the 107 statutory 90 - day review period has expired and which has commenced manufacture of that substance 108 must submit an NOC to EPA within 30 days following commencement. Over the past three fiscal years 109 (i.e., FY 2009 - FY 2011), EPA received 1,723 PMNs. Based on EPA's review of NOC receipt date 110 information, EPA determined that NOCs were received within 45 days of completion of the 90 - day PMN 111 review for only 16% of these submitted PMNs. Thus, for 84% of the submitted PMNs, the intent to 112 manufacture was formed at least 135 days (i.e., the 90 - day PMN review period plus 45 days) before 113 commercialization. Because a company must by necessity form the intent to manufacture a chemical 114 substance some period of time before the PMN is submitted to EPA, the intent to manufacture or process 115 would be made at least 135 days in advance as a general matter. 116 EPA is not proposing to publish an inventory of nanoscale materials based on the information that 117 would be collected pursuant to these proposed TSCA section 8(a) reporting requirements. 118 E. What are the Estimated Incremental Impacts of this Action? 119*** EO 12866 Deliberative Draft

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Page 4 of 24 EPA has evaluate d the potential costs of establishing the proposed reporting and recordkeeping 120 requirements for potential manufacturers (including importers) and processors. This analysis, which is 121 available in the docket, is discussed in Unit VI ., and is briefly summariz ed here. 122 Under the proposed rule, industry is conservatively estimated to incur a burden of approximately 123 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 124 million and $1.5 million, respectively (see Chapter 3), while the Agency is expected to use approximately 125 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million 126 and $0.06 million respectively (see Chapter 4). Discounted over a 10 -year period at three and seven 127 percent, total annualized costs are estimated to be approximately $2.80 million and $3.08 million, 128 respectively. (Ref. 25) 129 130 F . What Should I Consider as I Prepare My Comments for EPA? 131 1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e - mail. 132 Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or 133 CD - ROM that you mail to EPA, mark the outside of the disk or CD - ROM as CBI and then identify 134 electronically within the disk or CD - ROM the specific information that is claimed as CBI. In addition to 135 one complete version of the comment that includes information claimed as CBI, a copy of the comment 136 that does not contain the information claimed as CBI must be submitte d for inclusion in the public docket. 137 Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR 138 part 2. 139 2. Tips for preparing your comments . When submitting comments, remember to: 140 i. Identify the document by docket ID number and other identifying information (subject heading, 141 **Federal Register** date and page number). 142 ii. Follow directions. The Agency may ask you to respond to specific questions or organize 143 comments by referencing a Code of Federal Regulations ( CFR) part or section number. 144 iii. Explain why you agree or disagree; suggest alternatives and substitute language for your 145 requested changes. 146 iv. Describe any assumptions and provide any technical information and/or data that you used. 147 v. If you estimat e potential costs or burdens, explain how you arrived at your estimate in 148 sufficient detail to allow for it to be reproduced. 149 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 150 vii. Explain your views as clearly as possib le, avoiding the use of profanity or personal threats. 151 viii. Make sure to submit your comments by the comment period deadline identified. 152 **II. Background** 153 A . Overview of Applicable TSCA Authority 154 1. TSCA Section 8(a) Reporting. EPA is proposing reporting and recordkeeping requirements for 155 manufacturers (including importers ) and processors of nanoscale materials pursuant to TSCA section 156 8(a). Section 8(a) of TSCA authorizes the Administrator to promulgate rules which require each person 157*** EO 12866 Deliberative Draft

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Page 5 of 24 (other than a small manufacturer or processor) who manufactures **,** processes **,** or proposes to manufacture 158 or process a chemical substance, to maintain such records and submit such reports as the Administrator 159 may reasonably require. 160 Small manufacturers and processors, as defined by EPA, are exempt from TSCA section 8(a) 161 reporting requirements, unless the manufacture or processing is subject to a rule proposed or promulgated 162 under TSCA section 4, 5(b)(4), or 6, or an order under 5(e). For purposes of this rule, and in accordance 163 with TSCA section 8(a)(3)(B), EPA is proposing an alternative definition of small manufacturer or 164 processor from that typically used in TSCA section 8(a) rules. See, e.g., 40 CFR 704.3. For further 165 discussion see Unit II.D. 166 2. Exemption for Research a nd Development. Persons who manufacture or process chemical 167 substances that are nanoscale materials that would be subject to the TSCA section 8(a) rule in “ small 168 quantities solely for research and development” ( See 40 CFR 704.3) would be exempt from the 169 requirements of this proposed rule. Examples of research and development activity are the analysis of 170 the chemical or physical characteristics, the performance, or the production characteristics of a chemical 171 substance, a mixture containing the substance, or an article. It can include production of a chemical 172 substance for use by others in their R&D activities . R&D activity generally includes specific monitored 173 tests undertaken as part of a planned program of activity. 174 3. Electronic Reporting. The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) 175 provides that, when practicable, Federal organizations use electronic forms, electronic filings, and 176 electronic signatures to conduct official business with the public. EPA’s Cross - Media Electronic 177 Reporting Regulation (CROMERR) (40 CFR part 3) (Ref. 2 4 ), provides that any requirement in title 40 178 of the CFR to submit a report directly to EPA can be satisfied with an electronic submission that meets 179 certain conditions once the Agency publi shed a document in the **Federal Register** announcing that EPA 180 is prepared to receive certain documents in electronic form. For more information about CROMERR, go 181 to http://www.epa.gov/cromerr . 182 TSCA Section 8(a) gives EPA authority to determine the format of reporting under this section. 183 B . Why is EPA Interested in Nanoscale Materials? 184 As described in Unit II. A . , TSCA s ection 8(a) authorizes EPA to promulgate rules which require 185 manufacturers and processors to maintain records and submit information that EPA may reasonably 186 require. Unit II. C. includes discussion of why EPA is proposing to use this authority to gather more 187 information about proposed and existing nanoscale materials. 188 There is a growing body of scientific evidence showing the differences that exist between 189 nanoscale material(s) and their non -nanoscale counterpart(s) (Ref. 1 ) . Nanoscale materials may have 190 different or enhanced properties

– for example, electrical, chemi cal, magnetic, mechanical, thermal, or 191 optical properties

– or features, such as improved hardness or strength, that are highly desirable for 192 applications in commercial, medical, military, and environmental sectors (Ref. 3 ). These properties are a 193 direct consequence of small size, which results in a larger surface area per unit of volume and / or 194 quantum effects that occur at the scale of 1 x 10 - 9 meters. Small size itself can also be a desirable 195 property of nanoscale materials. The small size can be exp loited for miniaturization of 196 applications/processes and/or stabilization or delivery of payloads to diverse environments or 197 incorporation into diverse products. 198*** EO 12866 Deliberative Draft

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Page 6 of 24 Nanoscale materials have a range of potentially beneficial public and commercial applications , 199 including medicine and public health, clean energy through more efficient solar panels, pollution 200 reduction and environmental cleanup, and improved products such as stronger, lighter, and more durable 201 or conductive materials. These benefits arise from the distinctive properties of nanoscale materials, in that 202 they are potentially more interactive or durable than other chemicals as a result of their size and 203 composition. Altering the size of a material from conventional particle size can enhance or produce 204 unique properties that are desirable for a variety of commercial applications. However, these unique and 205 enhanced properties can raise new regulatory questions, such as whether the material in the smaller form 206 may present increased hazards to humans and the environment. 207 Government, academic, and private sector scientists in multiple countries are performing research 208 into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial 209 and rapidly growing body of scientific evidence. Research also indicates that , in biological systems or in 210 the environment , not all materials in the nanoscale size range behave differently from larger sized 211 materials of the same substance (Ref. 4 ). Recently , two governmental and exper t peer review 212 organizations have reviewed and summarized this evidence and offered views about the implications of 213 this evidence for environmental and human health and safety. These reviews are described below. 214 In 2009, the National Institute of Occupati onal Safety and Health (NIOSH) issued a report, 215 “Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with 216 Engineered Nanomaterials,” (Ref. 5 ) that summarized the available scientific information about nanoscale 217 materials a

nd identified the following potential health and safety properties: 218 • “Nanomateri als have the greatest potential to enter the body through the respiratory sys tem if 219 they are airborne and in the form of respirable - sized particles (nanopar ticles). They may also come into 220 contact with the skin or be ingested.” 221 • “Based on results from human and animal studies, airborne nanoparticles can be inhaled and 222 deposit in the respiratory tract; and based on animal studies, nanoparticles can enter the blood stream, and 223 translocate to other organs.” 224 • “Experimental studies in rats have shown that equivalent mass doses of insolu ble incidental 225 nanoparticles are more potent than large particles of similar composition in causing pulmonary in 226 flammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally 227 supportive of the biological responses observed in animals.” 228 • “Experimental studies in animals, cell cultures, and cell - free systems have shown that changes 229 in the chemical composition, crystal structure, and size of particles can influence their oxidant generation 230 properties and cytotoxicity.” 231 • “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) 232 and nanoscale (ultra fine) particles have reported adverse lung effects including lung function decrements 233 and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, 234 which may have different particle properties, are uncertain.” 235 • “Some nanomaterials may initiate catalytic reactions depending on their composition and 236 structure that would not otherwise be anticipated based on their chemical composition.” 237*** EO 12866 Deliberative Draft

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Page 7 of 24 Earlier the same year, the Scientific Committee on Emerging and Newly Identif ied Health Risks 238 (SCENIHR), an independent scientific committee advising the European Commission’s Health and 239 Consumer Directorate, issued a report, “Risk assessment of products of nanotechnologies.” (Ref. 6 ). The 240 SCENIHR report identified properties simi lar to those identified in the NIOSH report: 241 • “Some specific hazards, discussed in the context of risk for human health, have been 242 identified. These include the possibility of some nanoparticles to induce protein fibrillation, the 243 possible pathological effects caused by specific types of carbon nanotubes, the induction of 244 genotoxicity, and size effects in terms of biodistribution.” 245 • “For some nanomaterials, toxic effects on environmental organisms have been 246 demonstrated, as well as the potential to tran sfer across environmental species, indicating a potential 247 for bioaccumulation in species at the end of that part of the food chain.” 248 In another recent survey of scientific research on nanoscale materials (Ref. 7 ), the authors 249 reported: 250 “Many studies have e xamined the pro - inflammatory effects of manufactured nanoparticles, 251 on the basis that their ability to cause inflammation is a major predictor of potential hazard 252 in such particles. The first important finding was that nanoparticles have a more pronounced 253 effect on inflammation, cell damage and cell stimulation than an equal mass of particles of 254 the same material of greater size. This appears to hold true for materials as varied as carbon 255 black, titanium dioxide, various metals and polystyrene. Surface are a is the metric driving 256 the pro - inflammatory effects and this is evident both in vitro and in vivo , particles of various 257 sizes producing inflammatory effects that are directly related to the surface area dose.” 258 A report in the scientific literature has indicated that nanoscale polystyrene beads may cross the 259 placental barrier (in an ex -vivo human placental perfusion model (Ref. 8 ). Another study found that 260 nanoparticles could translocate to diverse organs following oral exposure in rodents. Once in these 261 diverse sites and organs, the large surface area of nanoscale materials may facilitate increased reactivity 262 and/or an inflammatory response, resulting in toxic effects (Ref. 9 ). 263 Two literature surveys describe a broad range of effects in non - mammalian species following 264 exposure to nanoscale materials (Ref. 10 and 1 1 ). These include, for example, increased ventilation rates, 265 mucus production, and pathologies, and related alteration of enzyme activities and indicators of oxidative 266 stress in rainbow trout, Oncorhyncus mykiss (Ref. 1 2 ) and ingestion and accumulation of nanoscale 267 material in the digestive tract, as well as mortality, increased heart rates, and reduced fecundity in 268 Daphnia magna (Ref. 1 3 , 1 4 , and 1 5 ). Translocation of nanoscale materials from g ill and gut surface to 269 blood and other organs in exposed Medaka, Oryzius latipes , has also been reported (Ref. 1 6 ) and carbon 270 nanotubes, although unable to cross the egg surface, have been shown to delay hatching in zebra fish, 271 Danio rerio (Ref. 1 7 ). 272 Published reports of human and ecological exposure to nanomaterials are also limited. For 273 example, in its “Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and 274 Nanofibers” (Ref. 2 7 ), NIOSH summarized and evaluated the available published information on worker 275 exposures to carbon nanotubes (CNT) and nanofibers CNF). NIOSH determined that, although the 276 potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT - and CNF 277 product use (processing, use, disp osal, recycling), the extent to which workers are exposed has not been 278 completely characterized. “Comprehen sive workplace exposure evaluations are needed to characterize 279*** EO 12866 Deliberative Draft

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Page 8 of 24 and quantify worker exposure to CNT and CNF at various job tasks and operations, and to determine 280 what control measures are the most effective in reducing worker exposures.” “Data are particularly 281 needed on workplace exposures to CNT and CNF, as well as information on whether in -place exposure 282 control measures (e.g., engineering control s) and work practices are effective in reducing worker 283 exposures.” 284 There are many scientific questions about the impacts of nanoscale materials on human health 285 and the environment. Part of EPA’s mission under TSCA is to understand potential risks in order to 286 protect human health and the environment. As stated in EPA’s White Paper on Nanotechnology (Ref. 287 1 8 ): 288 “Some of the same special properties that make nanoscale materials useful are also properties that 289 may cause some nanoscale materials to pose risks to humans and the environment, under specific 290 conditions.” 291 EPA needs a sound scientific basis for assessing and managing potential impacts resulting from the 292 introduction of nanoscale materials into commerce. 293 As described in the 2008 TSCA Inventory St atus of Nanoscale Substances -- General Approach, 294 many nanoscale materials are considered chemical substances as defined under TSCA section 3(2) (Ref . 295 1 9 ). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are 296 considere d new chemical substances that require reporting under TSCA section 5. EPA has assessed over 297 1 6 0 of these nanoscale materials and taken action to control exposures to prevent any potential 298 unreasonable risks to human health or the environment pending deve lopment of information which will 299 allow EPA to more fully assess those risks. Nanoscale materials based on chemical substances already on 300 the TSCA Inventory are considered existing chemical substances. These nanoscale materials do not 301 require reporting a s new chemical substances because they are nanoscale forms of chemical substances 302 already in commerce. 303 EPA developed a voluntary Nanoscale Materials Stewardship Program (“NMSP” or “the 304 program”) to complement and support its regulatory activities on nanoscale materials. EPA conducted 305 the program from January 2008 to December 2009. Thirty one companies or associations submitted 306 information to EPA for 132 nanoscale materials with available information on how those nanoscale 307 materials were manufactured, processed or used. For more details on the NMSP and to read the 308 program’s interim report, consult the EPA website at http://epa.gov/oppt/nano/stewardship.htm (Ref. 20 ). 309 EPA solicit ed existing data and information , on a voluntary basis , from manufacturers, processors, and 310 users of nanoscale materials to expeditiously develop knowledge about commercially available nanoscale 311 material s. In addition, the program was designed to identify and encourage use of risk management 312 practices in developing and commercializing nanoscale materials. EPA also participated in a series of 313 N ational Nanotechnology Initiative public workshops, including co - Chairing a public Risk Management 314 Methods workshop . This workshop was also useful in further identifying additional considerations in risk 315 management practices towards developing and commercializing nanoscale materials of interest to EPA. 316 In the NMSP interim report which was based on the information EPA received prior to January 2009 , 317 EPA identified data gaps for existing nanoscale material production, uses, and exposures . For example, 318 in the report EPA estimated that companies provided information on only about 10 percent of the 319 nanoscale materials that may be commercially available 

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Page 9 of 24 EPA is proposing reporting requirements under TSCA section 8(a) for persons who are 322 manufacturing, or processing nanoscale materials or intend to manufacture or process nanoscale materials 323 for commercial purposes to address some of the data gaps identified in the NMSP interim report. This 324 information would facilitate EPA’s evaluation of the materials and determination if any further action 325 under TSCA, including additional information collection, is needed. 326 This proposed rule and the discussion of the potential risks are not intended to conclude that 327 nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely 328 to cause harm to people, or the environment. Rather, EPA would use information gathered through this 329 reporting rule to determine if any further action under TSCA, including additional information collection, 330 is needed . EPA intends to make conclusions on the basis of specific scientific evidence . Restrictions on 331 nanoscale materials would be tailored to protect against the specific harms identified for individual 332 substances. EPA would focus any toxicity concerns or data requirements based on available exposure or 333 hazard data for specific nanoscale materials. For example during review of new chemical substances that 334 are nanoscale materials, EPA typically does not request inhalation toxicity data for nanomaterials that are 335 manufactured in forms or handled by processes where no inhalation exposure occurs . 336 E PA is seeking public comment pertaining to several specific issues regarding the proposed rule 337 (see Unit II.D . ) . EPA anticipates conducting a public meeting during the comment period to further 338 discuss the se and any other issues concerning the proposed rule. 339 **III . Summary of Proposed**  **TSCA Section 8(a) Rule**  340 A. What Chemical Substances will be Subject to this Rule ? 341 This proposed rule would apply to chemical substances that are solids at 25 oC and atmospheric 342 pressure that are manufactured or processed in a form where at least 10% of the primary particles, 343 aggregates, or agglomerates are in the size range of 1 - 100 nm**.** 344 When proposing at least 10% of particles in the size range of 1 - 100 nm as a threshold for 345 reporting of chemical substances subject to this rule , EPA considered a number of factors. If a chemical 346 substance consists of particles solely within the 1 - 100 nm range there is general agreement among 347 scientists and policy makers that the substance is considered a nanoscale material. However, most 348 nanoscale materials or nanostructured materials contain a distribution of different - sized particles usually 349 with a fraction of that distribution greater than 100 nm and a fraction less than 100 nm. EPA does not 350 believe that reporting should be required for a chemical substance that contains less than 1 % particles 351 less than 100 nm. The Agency considered including materials in which at least one percent of particles 352 were less than 100 nm. One percent is use d in several environmental health and safety contexts as a 353 cutoff or exemption level such as the OSHA hazard communication standard and TSCA section 12(b) 354 export notification . EPA is also concerned that using one percent would encompass too broad a range of 355 chemicals, particularly because there is no scientific consensus on what percentage of particles less than 356 100 nm within any given sample of particles would be of interest with respect to human health or 357 ecological effects from exposure to the sample. EPA is seeking to strike a balance between including 358 what can reasonably be considered to be a nanoscale material while at the same time being practical in 359 determining what materials contain particles within the 1 - 100 nm range that should be considered for 360 proposed reporting . EPA does not w ant to exclude chemical substances that are considered to be 361 nanoscale materials by setting too high of a cut - off. 362*** EO 12866 Deliberative Draft

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Page 10 of 24 EPA is proposing a threshold of 10% of particles in the size range of 1 - 100 nm to include those 363 nanoscale materials potentially demonstrating novel properties of interest without including large 364 numbers of chemical substances that have a just a “tail” of particles below 100 nm. Using a threshold 365 greater than 10% of particles less than 100 nm to require reporting begins to exclude nanoscale materials 366 that are less than one standard deviation from the mean of a normal distribution curve of particle sizes. 367 This would begin to exclude a large number of nanoscale materials with properties of potential interest. 368 EPA is seeking comment on this issue. 369 EPA has placed in the public docket a list of 2400 chemical substances found on the TSCA 370 Inventory that EPA believes could be manufactured or processed in a form that would be subject to 371 reporting under this proposed rule (Ref. 2 1 ). This list does not limit the substances that would be subject 372 to the proposed rule, as other solid chemical substances may also be manufactured or processed in a form 373 that would be subject to reporting under this proposed rule. EPA is proposing to exclude from the 374 requirements of this rule certain biological materials (e.g., DNA, RNA, and proteins). EPA is seeking 375 comment to identify other specific biological materials that should be excluded from reporting and the 376 reasons for excluding them , including microorganisms and viral based products (or other combinations of 377 RNA, DNA & protein), lipids, carbohydrates, enzymes, and peptides . Although DNA is typically larger 378 than 1 - 100 nanometers, RNA and proteins may fall within this size range. However, the properties of 379 biological materials such as DNA, RNA and proteins are not a function of the size range per se but rather 380 the precise nucle otide sequence (in the case of DNA and RNA), shape, and other features. EPA is also 381 proposing to exclude chemical substances which dissociate completely in water to form ions that are less 382 than 1 nanometer. EPA is seeking comment to identify other water soluble compounds that should be 383 excluded from reporting and the reasons for excluding them. T his exclusion would not apply to 384 nanoscale materials that release ions but do not dissociate in water to form those ions. EPA believes that 385 the chemical substances that would be excluded do not exhibit new properties when their size falls in the 386 range of 1 - 100 nanometers and manufacture or processing such substances at the nanoscale should 387 therefore not be subject to the reporting requirements of the proposed rul e. 388 EPA is proposing to exclude from the requirements of this rule nanoclays, zinc oxide and 389 nanoscale materials created as a thin film because EPA believes that information collected on these 390 materials would be of limited value because either they have be en well - characterized or they present little 391 exposure potential. EPA requests comment on these proposed exclusions and whether other nanoscale 392 materials should be excluded. EPA requests that commenters identify why they believe the nanoscale 393 materials sh ould be excluded. 394 EPA is also requesting comment on whether any information proposed to be collected requested 395 in this proposed rule is duplicative of information collected under other federal statutes and, thus should 396 be excluded. Please identify the sta tute and the information that you believe is duplicative . 397 B . When would nanoscale materials be reported under the rule? 398 This notice proposes that persons who manufacture (including import) or process a discrete form 399 of a solid nanoscale material at any time during the three years prior to the final effective date of the rule 400 would report to EPA six months after the final effective date of the rule. This notice also proposes a 401 continuing requirement that persons who intend to manufacture (including import) or process a discrete 402 form of a solid nanoscale material on or after the effective date of th e rule report to EPA at least 135 days 403 before commencement of manufacture (including import) or processing. 404 C . How would nanoscale materials be reported under the rule? 405*** EO 12866 Deliberative Draft

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Page 11 of 24 Manufacturers and processors of multiple nanoscale forms of the same chemical substance would 406 need to know if reporting is required for each form. . EPA is proposing to distinguish among nanoscale 407 materials for purposes of this rule based on a combination of three factors: 1) a change in process to 408 affect a change in size and/or a change in properties of the nanoscale materials; 2) a change in mean 409 particle size of 10% or greater; and 3) a change of 10% or more in surface charge, specific surface area, 410 dispers ibility

/solubility, or surface reactivity. EPA’s intent for proposing these reporting requirements is 411 to focus reporting on intentionally manufac tured nanoscale materials. EPA is proposing the combination 412 of these three factors rather than simply size to distinguish between different nanoscale materials so that 413 unintended variation in size range between production batches would not trigger TSCA s ection 8(a) 414 reporting. Also, EPA is proposing not to rely solely on process changes because there may be process 415 changes that are not intended to change the material produced but rather intended to improve the 416 efficiency of the process or to use a cheaper reactant. EPA is focusing on the properties of surface 417 charge, specific surface area, dispers ibility /solubility, or surface reactivity because these are properties of 418 manufactured nanomaterials that are of particular interest in a health and safety context, whereas other 419 unique properties of nanoscale materials (e.g., the wavelength at which light is emitted) may be important 420 for how the nanoscale material functions but are less important in a health and safety context. EPA 421 believes that the combinatio n of these three factors will provide a clear and transparent way for the 422 regulated community to distinguish among different nanoscale materials for purposes of TSCA section 423 8(a) reporting . 424 While EPA realizes that the percentage cut - off of 10% is arbitrary, as would be any percentage 425 cut - off, EPA believes the number is high enough so that small variations in size and/or properties would 426 not be considered a change in nanoscale material. EPA also believes adopting a higher number may 427 exclude reporting on nanoscale materials that have been modified to exhibit different properties. EPA is 428 requesting comment on whether 10% is an appropriate threshold both for mean particle size differences 429 and for changes in surface charge, specific surface area, dispers ibility /solubility, or surface reactivity. 430 EPA is also requesting comment on whether other inherent properties that are important for health and 431 safety assessments should be included. These comments should include a rationale of why the specific 432 inherent property should be included. 433 For the purposes of this proposed rule specific surface area is the ratio of the surface area of the 434 nanoscale material to its mass. This is an important factor because chemical reactions take place at the 435 surface of the material. Thus, the higher the surface area , the greater the chemical reactivity which is an 436 important consideration for human health toxicity and environmental toxicity assessments. Specific 437 surface area is the ratio of the area of the surface of a nanoscal e material divided by the mass (m 2/kg) or 438 the area of the surface of the nanoscale materials divided by volume m 2/m3

. 439 Surface charge is the electric charge on a surface in contact with a continuous phase (Ref 23 ). 440 Surface charge can be calculated by me asuring the electrokinetic potential in colloidal systems known as 441 the zeta potential. It is measured as the net number of positive and negative charges per unit particl e 442 surface area in Coulomb/m2 (Ref 23 ) and is typically measured by electrophoresis. F or purposes of this 443 proposed rule the differential of 10% in the surface charge would be measure d for the same medium. 444 Dispers ibility is the extent to which the particulate n anoscale material can be distributed in 445 another material such as liquid. Solubility is the degree to which the nanoscale material can be dissolved 446 in another material, such as liquid. This is an important factor in assessing toxicity and exposure. These 447 are typically measured in mass per volume, e.g., grams/liter. For mos t nanosc ale materials, dispersibility 448 rather than solubility would be observed. 449*** EO 12866 Deliberative Draft

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Page 12 of 24 Surface reactivity is indicative of the degree to which the nanoscale material will react with 450 biological systems. The surface reactivity of the nanoscale material is dependent upon f actors such as 451 redox potential which is a measure of the tendency of an entity to lose or acquire electrons, photocatalytic 452 activity, including the potential to generate free radicals. Reactive oxygen species (ROS) and free 453 radicals are important in consi dering toxicity for these materials. 454 Each nanoscale form of a particular chemical substance with different morphology or shapes that 455 include but are not limited to spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow 456 shells, trees, flowers, rings, tori, cones, or sheets would also be a discrete form. Nanoscale forms of a 457 particular chemical substance that are coated with different chemical substances would be considered 458 discrete forms for each chemical coating. 459 EPA has developed thi s proposed approach based on the approximate size range of 1 - 100 nm as 460 defined by the National Nanotechnology Initiative (NNI) (Ref. 3 ), experience in conducting assessments 461 of new chemical nanoscale materials by EPA under TSCA, and data submitted to EPA under the NMS P . 462 EPA is soliciting comment on each aspect of the proposed approach to identifying the chemical 463 substances that would be subject to the reporting requirements of the rule. The Agency is seeking 464 comment on these approaches and alternative approaches for reporting requirements. EPA is especially 465 interested in comments on whether these approaches would require reporting of sufficiently distinct 466 nanoscale forms of a chemical substance so that reporting would be focused on those nanoscale forms 467 with potential for significantly different physical or chemical characteristics or properties . EPA also 468 seeks comment on each aspect of its proposed reporting such as size increments, morphology, the specific 469 physical - chemical properties identified above , and whether companies have the analytical tools to make 470 such distinctions. 471 Chemical substances that are manufactured (including imported) , or processed in a nanoscale 472 form solely as a component of a mixture, encapsulated material, or composite would also have to be 473 reported. Nanoscale materials that are manufactured but are then incorporated into mixtures, 474 encapsulated materials or composites by that manufacturer would not require separate reporting for their 475 incorporation. However, the person reporting the nanoscale material would have to report each step of 476 the manufacture, processing, and use of the nanoscale material to the extent it is known or reasonably 477 ascertainable. The proposed rule would not require manufacturers or processors to report certain 478 informati on that has already been submitted to EPA. A person who submitted a new chemical notice for 479 a nanoscale material under TSCA section 5 to EPA on or after January 1, 2005 would not be required to 480 report regarding the same substance under this proposed TSCA section 8(a) rule. In addition, any person 481 who has already reported part of or all of the information that would be required under this proposed 482 TSCA section 8(a) rule under the NMSP would not need to report that information again. See 483 http://www.epa.gov/oppt/nano/stewardship.html for more information on that program. If, however, 484 information required by this proposed rule was not reported under the NMSP (including information for 485 each discrete form of a nanoscale material) **,** then reporting of that information would be required. 486 The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 would be applicable to 487 this proposed rule , including the exemptions for research and development and small manufacturers . A 488 person who manufactures or processes, a chemical substance only in small quantities for research and 489 development would be exempt from the reporting requirements of this proposed rule. Small 490 manufacturers would be exempt from the reporting requirements of this proposed rule. Under other 491 TSCA section 8(a) rules, a company may qualify as a small manufacturer in 40 CFR 704.3 it if meets 492 either of the following two standards. The first is that sales of the company are less than $40 million 493*** EO 12866 Deliberative Draft

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Page 13 of 24 dollars per year and the company does not manufacture or import more than 100,000 pounds annually of 494 an individual substance at any individual site owned or controlled by the company. The second is that 495 any company with sales of less than $4 million dollars is considered a small business regardless of the 496 quantity manufactured or imported . 497 However, EPA is proposing a different definition of a small manufacturer or processor for 498 purposes of this rule by eliminating the first standard and defining a small manufacturer or processor as 499 any company with sales of less than $4 million dollars. The 100,000 -pound threshold in the existing 500 exemption did not contemplate typical production volumes for nanoscale materials. EPA has reviewed 501 over 200 nanoscale materials in the NMSP and the new chemicals program under TSCA. At least 170 of 502 those nanoscale materials had reported or estimated production volumes less than 22,000 pounds. Based 503 on this experience, exempting manufacturers or processors from reporting annual production volumes of 504 nanoscal e materials up to 100,000 pounds would exclude a large proportion of companies that 505 characteristically manufacture nanoscale materials in small amounts but would not otherwise be 506 considered small . Given that nanoscale materials tend to be produced in small volumes, EPA does not 507 believe production volume should be a relevant consideration in determining whether a nanotechnology 508 company is a small manufacturer or processor . EPA requests comment on the proposed modification of 509 th e small manufacturer or processor exemption for this proposed rule. 510 EPA developed an information reporting form for the NMSP which has been slightly modified 511 for purposes of this proposed rule. The same information that was requested in the NMSP would be 512 required by this proposed rule including information on specific chemical identity, material 513 characterization, physical chemical properties, production volume, use, methods of manufacturing and 514 processing, exposure and release information, and existing data concerning the environmental and health 515 effects. The information would be reported on a form similar to that used in the NMSP. Any person 516 required to report under this proposed rule would supply the information identified in the form to the 517 extent i t is known or reasonably ascertainable to them. 518 D . How would information be submitted under the rule? 519 Electronic reporting requirements for Form No. 7710 - xx would be included in 40 CFR 520 704.xxx( e ) . EPA is proposing electronic reporting similar to the requirements established in 2013, i.e., 521 EPA is proposing to require submitters to use EPA’s CDX, the Agency's electronic reporting site , for all 522 reporting under this rule. In the **Federal Register** of Dece mber 4, 2013 (78 FR 72818) (FRL 9394 - 6), 523 EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under 524 TSCA sections 4, 5, 8(a) and 8(d). The final rule follows two previous rules requiring similar electronic 525 rep orting of information submitted to EPA (for TSCA Chemical Data Reporting and for Pre - Manufacture 526 Notifications . In proposing to require similar electronic reporting under this rule, EPA intends to save 527 time, improve data quality and increase efficienc ies f or both the submitters and the Agenc y . 528 EPA developed the Chemical Information Submission System ( CI SS ) for use in submitting data 529 for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The tool is available for use with 530 Windows, Macs, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) 531 specifications for efficient data transmission across the Internet. CISS, a web -based reporting tool, 532 provides user - friendly navigation, works with CDX to secure online communication, creates a completed 533 Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other 534 information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. 535*** EO 12866 Deliberative Draft

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Page 14 of 24 EPA is proposing to require submitters to register with EPA’s CDX and use CISS to prepare a 536 data file for submission. Registration enables CDX to authenticat e identity and verif y authorization. To 537 submit electronically to EPA via CDX, individuals must first register with that system at 538 http://cdx.epa.gov/epa_home.asp . To register in CDX, the CDX registrant (also referred to as “Electronic 539 Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides 540 information about the submitter and organization, selects a user name and password, and follows the 541 procedures outlined in the guidance document for CDX available at 542 http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. 543 User s who have previously registered with CDX for other TSCA submissions, Chemical Data 544 Reporting, or the Toxic Release Inventory TRI - ME web reporting flow , would be able to add the 545 “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, 546 and use the CISS web -based reporting tool. 547 All submitt ers would be required to use CISS to prepare their submissions. CISS guides users 548 through a “hands - on” process of creating an electronic submission. Once a user completes the relevant 549 data fields, attaches appropriate PDF files, or other file types, such a s XML files, and completes metadata 550 information, the web -based tool validates the submission by performing a basic error check and makes 551 sure all the required fields and attachments are provided and complete. Further instructions on submitting 552 voluntary submissions, such as under MOUs, are available, and instructions for uploading PDF 553 attachments or other file types, such as XML, and completing metadata information would be available 554 through CISS reporting guidance. 555 CI SS, a web -based reporting tool, also al lows the user to choose “Print,” “Save,” or “Transmit 556 through CDX.” When “Transmission through CDX” is selected, the user is asked to provide the user 557 name and password that was created during the CDX registration process. CISS then encrypts the file and 558 s ubmits it via CDX. The user will login to the application and check the status of their submissions. 559 Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as 560 “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user 561 registration. Information on accessing the CDX user inbox is provided in the guidance document for CDX 562 at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf . To access CISS go to 563 https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and 564 for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html . Procedures for 565 reporting nanoscale materials under this proposed rule would be similar. EPA will s ubsequently put a 566 version of the tool for reporting nanoscale materials in the docket for comment , including comments on 567 the extent of and burden associated with training for using CDX. 568 EPA believes that electronic reporting reduces the reporting burden for submitters by reducing 569 the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to 570 share a draft submission within their organization, and more easily save a copy for their records or future 571 use. The resource and time requirements to review and process data by the Agency will also be reduced 572 and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving 573 electronic submissions and communicating back electronically with submitters. 574 EPA would also consider electronic reporting of this form similar to procedures for Significant 575 New Use Notices and PMNs set forth in §§ 721.25 and 720.40 . EPA is seeking comment on these 576 approach es . 577*** EO 12866 Deliberative Draft

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Page 15 of 24 Any person submitting a reporting form could claim any part or all of the form as CBI. Any 578 information which is claimed as confidential will be disclosed by EPA only to the extent and by the 579 means of the procedures set forth in 40 CFR part 2. 580 Th e TSCA section 8(a) rule proposed here involves one -time reporting for existing nanoscale 581 materials and one -time reporting for new discrete nanoscale materials before they are manufactured or 582 processed . 583 EPA is also seeking comment on the possibility of a future rule that would require periodic 584 reporting of nanoscale materials similar to reporting that occurs under the Chemical Data Reporting Rule 585 ( CD R) at 40 CFR part 71 1 . Such a rule c ould require manufacturers and processors of nanoscale materials 586 to report the type of information collected under the CDR rule to EPA at the same reporting interval as 587 currently required by CDR reporting (every four years) . That reporting c ould occur at lower thresholds 588 for criteria such as production volume . The CDR is a program designed to collect screening - level, 589 exposure -related information on chemical substances and to make that information available for use by 590 EPA and to the public consistent with requirements for handling information claimed as confidential. The 591 CD R rule data are used by EPA to support risk screening, assessment, priority setting and management 592 activities and constitute the most comprehensive source of b asic screening - level, exposure -related 593 information on chemicals available to EPA. For further information see http://www.epa.gov/iur/ . 594 **I V**  **. Development of**  **Additional Data in Connection with the**  **TSCA Section 8(a) Rule**  595 A TSCA section 8(a) rule may require persons subject to the rule to submit test data in their 596 possession or control and to describe any other data known to or reasonably ascertainable by them, but 597 may not require persons to develop test data for submission to the Agency. However, in view of the lack 598 of information regarding nanoscale materials, EPA would encourage respondents to this proposed rule to 599 provide the Agency with any relevant data on nanoscale materials they may wish to develop. 600 Persons choosing to develop test data should provide data that conform to the Good Laboratory 601 Practice Standards, which are codified at 40 CFR part 792. EPA encourages persons who intend to 602 conduct testing to consult with the Agency before selecting a protocol for testing a nanoscale material. 603 EPA would also encourage persons that would be required to submit TSCA section 8(a) data under this 604 proposed rule to provide information on the potential benefits regarding the nanoscale material. 605 **V. References** 606 The following is a listing of the documents that are specifically referenced in this document. The 607 docket includes these references and other information considered by EPA. For assistance in locating 608 these other documents, please consult the technical contact listed under **FOR FURTHER** 609 **INFORMATION CONTACT** . 610 1. 2014. National Nanotechnology Initiative . “Supplement tot eh President’s 2015 Budget,” p. 611 3. http://www.nano.gov/sites/default/files/pub_resource/nni_fy15_budget_supplement.pdf . 612 2. 2005. Oberdörster, Gunter, Oberdörster, Eva, and Oberdörster, Jan. Nanotoxicology: an 613 emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives. 614 (113): 823 - 839. 615 3. 2004. National Nanotechnology Initiative. The National Nanotechnology Initiative Strategic 616 Plan. Available on - line at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf . 617*** EO 12866 Deliberative Draft

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Page 16 of 24 4. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean -Yves, Lowry, Gregory V Jolivet Jean 618 Pierre, and Wiesner, Mark R. Towards a definition of inorganic nanoparticles from an environmental, 619 health and safety perspective. Nature Nanotechnology 4, 634

– 641. Published online: 13 September 620 2009 | doi:10.1038/nnano .2009.242 . 621 5. 2009. National Institute of Occupational Safety and Health. Approaches to Safe 622 Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials. 623 Available on - line at http://www.cdc.gov/niosh/docs/2009
- 125/pdfs/2 009- 125.pdf. 624 6. 2009. European Commission, Directorate - General for Health and Consumers. Scientific 625 Committee on Emerging and Newly Identified Risks, Risk Assessment of Products of Nanotechnologies. 626 Available on - line at http://ec.europa.eu/health/ph_risk/co mmittees/04_scenihr/docs/scenihr_s_01.pdf. 627 7. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and Donaldson, Kenneth. 628 Nanoparticles, human health hazard and regulation. Journal of the Royal Society, Available on- line at 629 http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#ref
- 14 . 630 8. 2010. Wick, Peter, Malek, Antoine, Manser, Pius, Meili, Danielle, Maeder-Althaus, Xenia, 631 Diener, Liliane, Diener, Pierre -Andre, Zisch, Andreas, Krug, Harold F, and Mandach, Ursula von. Barrier 632 Capacity of Human Placenta for Nanosized Materials. Environmental Health Perspectives. (118):432 - 633 436 . 634 9. 2008. Kim, Yong Soon, Kim, Jin Sik, Cho, Hyun Sun, Rha, Dae Sik, Kim, Jae Min, Park, 635 Ju ng Duck, Choi, Byung Sun, Lim, Ruth, Chang, Hee Kyung, Chung, Yong Hyun, Kwon, Il Hoon, Jeong, 636 Jayoung, Han, Beom Seok, and Yu, Il Je. Twenty - Eight Day Oral Toxicity, Genotoxicity, and Gender637 Related Tissue Distribution of Silver Nanoparticles in Sprague - Dawley Rats. Inhalation Toxicology. 20 638 (6): 575 - 583. 639 10. 2008. Handy, Richard D., Von der Kammer, Frank, Lead, Jamie R., Hassello, Martin, Owen, 640 Richard, and Crane, Mark. The ecotoxicology and chemistry of manufactured nanoparticles. 641 Ecotoxicology 17:287 - 314. 642 11. 2008. Klaine, Stephen J., Alvarez, Pedro J., Batley, Graeme E., Fernandes, Teresa F., Handy, 643 Richard D., Lyon, Delina Y., Mahendra, Shaily, McLaughlin, Michael J., and Lead, Jamie R. 644 Nanomaterials in the Environment: Behavior, Fate, Bioavailability, and Effects . Environmental 645 Toxicology and Chemistry . 27: 1825 - 1851. 646 12. 2007. Federici, Gillian, Shaw, Benjamin J., and Handy, Richard D. Toxicity of titanium 647 dioxide to rainbow trout ( Oncorhynchus mykiss ): Gill injury, oxidative stress, and other physiological 648 effects. Aquatic Toxicology. 84: 415

–430. 649 13. 2007. Roberts, Aaron P., Mount, Andrew S., Seda, Brandon, Souther, Justin, Qiao, Rui, Lin, 650 Sijie, Ke, Pu Chun, Rao, Apparao M., and Klaine, Stephen J. In vivo biomodification of lipid coated 651 carbon nanotubes by Daphnia magna . Environmental Science and Technology. 41 : 3025

–3029 652 14. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna mortality when exposed to 653 titanium nanoparticles and fullerene (C60) nanoparticles. Environmental Toxicology and Chemistry. 25: 654 1132

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Page 17 of 24 15. 2006. Oberdörster, Eva, Zhu, Shiqian, Zhu, Blickley, T. Michelle, McClellan - Green, Patricia, 656 and Haasch, Mary L. Ecotoxicology of carbon -based engineered nanoparticles: effects of fullerene (C 657 60) on aquatic organisms. Carbon. 44: 1112 - 1120. 658 16. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the see -through Medaka ( Oryzias 659 latipes ). Environmental Health Perspectives. 114: 1697

– 1702 . 660 17. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. Effect of carbon nanotubes 661 on developing zebra fish ( Danio rerio ) embryos. Environmental Toxicology and Chemistry. 26:708

–716. 662 18. 2007. EPA. EPA Nanotechnology White Paper. Available online at 663 http://www.epa.gov/osa/pdfs/nanotech/epa
- nanotechnology
- whitepaper
- 0207.pdf . 664 19. 2008. EPA. TSCA Inventory Status of Nanoscale Subst ances -- General Approach. Available 665 online at http://www.epa.gov/oppt/nano/nmsp
- inventorypaper2008.pdf . 666 20. 2009. EPA. EPA interim report on the Nanoscale Materials Stewardship Program . Available 667 online at http://www.epa.gov/oppt/nano/nmsp
- interim - report - final.pdf . 668 21. 2010. EPA. List of Chemical Substances on the TSCA Inventory that EPA believes can be solid 669 chemical substances manufactured or processed in the range of 1 - 100 nanomet ers at ambient 670 conditions. 671 22. 2010. Joint Research Centre of the European Commission. Considerations on a Definition of 672 Nanomaterial for Regulatory Purposes. Available online at 673 http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf . 674 23. 2011. International Organization for Standardization. Nanotechnolo gies

– Guidance on 675 Physicochemical Characterization for Manufactured Nano - objects submitted for Toxicological 676 Testing. 677 24. EPA. Cross - Media Electronic Reporting; Final Rule. **Federal Register** (70 FR 59848, October 678 13, 2005) (FRL - 7977 - 1). 679 25. 2010. E PA. Economic Analysis for the TSCA Section 8(a) Proposed Reporting 680 Requirements for Certain Nanoscale Materials . 681 26. 2010. EPA. Proposed Addendum to an Existing EPA ICR Entitled: Chemical - Specific Rules, 682 Toxic Substances Control Act Section 8(a). 683 27. 2013. National Institute of Occupational Safety and Health. Current Intelligence Bulletin 65: 684 Occupational Exposure to Carbon Nanotubes and Nanofibers at http://www.cdc.gov/niosh/docs/2013 - 685 145/pdfs/2013 - 145.pdf . 686 28. 2011. Executive Office of the President. Policy Principles for the U.S. Decision - Making 687 Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials. 688 http://www.whi tehouse.gov/sites/default/files/omb/inforeg/for- agencies/nanotechnology -regulation 689 and - oversight -principles.pdf 690 **VI. Statutory and Executive Order Reviews** 691*** EO 12866 Deliberative Draft

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Page 18 of 24 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563 : Improving 692 Regulation and Regulatory Review 693 T he Office of Management and Budget (OMB) has designated this proposed rule as a 694 ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 695 1993) . Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 696 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011) , and any changes made in response to 697 OMB comments have been documented in the public docket for this rulemaking as required by section 698 6(a)(3)(E) of Executive Order 12866 . 699 B. Paperwork Reduction Act (PRA) 700 An agency may not conduct or sponsor, and a person is not required to respond to an information 701 collection request subject to the PRA 

### , 44 U.S.C. 3501 et seq. , unless it displays a currently valid OMB 702 control number. The OMB control numbers for EPA’s regulations are listed in 40 CFR part 9 and 703 included on any related collection instrument (e.g., on the form or survey). 704 The information collection requirements in 40 CFR part 704 related to TSCA section 8(a) 705 reporting rules have already been approved by OMB under the PRA. That information collection request 706 ( ICR) has been assigned EPA ICR No. 1198 and OMB control number 20 70 - 0067. Because this 707 proposed rule would involve revised information collection activities that require additional OMB 708 approval, EPA has prepared an addendum to the currently approved ICR (Ref. 2 6 ). 709 If an entity were to submit a report to the Agency, the annual burden is estimated to average 1 37 710 hours per response. 

### Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and 711 the ICR addenda, EPA estimates that the proposed TSCA section 8(a) rule would create a total 712 incremental indu stry burden of 2 28,853 hours. 713 To comment on the Agency's need for this information, the accuracy of the provided burden 714 estimates, and any suggested methods for minimizing respondent burden, EPA has established a docket 715 for this proposed rule, which includes this ICR, under docket ID number EPA - HQ - OPPT - 2010 - 0572. 716 Submit any comments related to the ICR to EPA and OMB. See **ADDRESSES** for where to submit 717 comments to EPA. Send comments to OMB via email to oira_submission@omb.eop.gov. Address 718 comments to OMB De sk Officer for EPA. 719 Since OMB is required to make a decision concerning the ICR between 30 and 60 days after 720 [ insert date of publication in the **Federal Register** ], a comment to OMB is best assured of having its full 721 effect if OMB receives it by [Insert date 30 days after publication in the **Federal Register** ]. The final rule 722 will respond to any OMB or public comments on the information collection requirements contained in 723 this proposed rule. 724 C. Regulatory Flexibility Act (RFA) 725 Pursuant to section 605(b) of the RFA , 5 U.S.C. 601 et seq ., I hereby certifies that this action 726 would not have a significant adverse economic impact on a substantial number of small entities. 

### The 727 

### rationale supporting this conclusion is summarized here, and is presented in a small entity impact 728 analysis that EPA prepared for this proposed action that is part of the Agency’s economic analysis (Ref. 729 25). in the public docket for this proposed rule . 730*** EO 12866 Deliberative Draft

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Page 19 of 24 Under the RFA, small entities include small businesses, small organizations, and small 731 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, 732 small entity is defined as: (1) a small business, as defined by the Small Business Administration’s (SBA) 733 regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, 734 county, town, school district or special district with a population of less than 50,000; and (3) a small 735 organization that is any not- for -profit enterprise which is independently owned and operated and is not 736 dominant in its field. Since the regulated community is not expected to include small governmental 737 jurisdictions or small not - for -profit organizations, the analysis focuses on small businesses. 738 A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 7 04 . 5(f). 739 For this action , EPA is proposing to modify the exemption. For more details see Unit II.D. EPA analyzed 740 potential small business impacts from this proposed rule using both the SBA employee size standards and 741 the TSCA sales -based definition of small business. EPA estimates that up to 174 small businesses may 742 be impacted by the proposed TSCA section 8(a) reporting rule but es timates no adverse economic impact 743 greater than three percent of sales for any of those companies. 744 745 EPA continues to be interested in the potential impacts of this proposed rule on small entities that 746 are not exempt from reporting and welcomes comments on issues related to such impacts. 747 D. Unfunded Mandates Reform Act (UMRA) 748 

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

### State, local and Tribal governments have not been impacted b y these rulemakings, and EPA does 750 

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

### this rulemaking . In addition, this action will not result in annual expenditures of $100 million or more 752 for the private sector. As such, EPA has determine d that this action does not impose any enforceable 753 duty, contain any unfunded mandate, or otherwise have any effect on small governments , and that the 754 

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

### this action . 756 E. Executive Order 13132 : Federalism 757 This action does not have substantial direct effects on the states, on the relationship between the 758 national government and the states, or on the distribution of power and 

### responsibilities among the 759 

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

### 1999) . 761 762 F. Executive Order 13175 : Consultation and Coordination with Indian Tribal Governments 763 This action do es not have tribal implic ations because it will not have any effect on tribal 764 governments, on the relationship between the Federal government and the Indian tribes, or on the 765 distribution of power and responsibilities between the Federal government and Indian tribes, as specified 766 in Executive Order 13175 (65 FR 67249, November 9, 2000) . 767 768 G. Executive Order 13045 : Protection of Children from Environmental Health Risks and Safety Risks 769 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those 770 regulatory actions that concern health or safety risks, such that the analysis required under section 5 - 501 771*** EO 12866 Deliberative Draft

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Page 20 of 24 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to 772 Executive Order 13045 because it does not establish an environmental standard intended to mitigate 773 health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed 774 rule will be used to inform the Agency’s decision - making process regarding chemicals to which children 775 may be disproportionately exposed. This information will also assist the Agency and others in 776 determining whether the chemicals in this proposed rule present potential risks, allowing the Agency and 777 others to take appropriate action to investigate and mitigate those risks. 778 H. Executive Order 13211 : Actions Concerning Regulations that Significantly Affect Energy Supply, 779 Distribution, or Use 780 T his action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 781 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, 782 distribution, or use. 783 784 I. National Technology Transfer and Advancement Act (NTTAA) 785 Since this action do es not involve any technical standards, NTTAA section 12(d) , 15 U.S.C. 272 786 note, does not apply to this action. 787 788 J. Executive Order 12898 : Federal Actions to Address Environmental Justice in Minority Populations 789 and Low
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Inc ome Populations 790 This action does not entail special considerations of environmental justice related issues as 791 delineated by Executive Order 12898 (59 FR 7629, February 16, 1994) , because EPA has determined that 792 this action will not have disproportionately high and adverse human health or environmental effects on 793 minority or low - income populations. This action does not affect the level of protection provided to human 794 health or the environment. 795 This action does not affect the level of protection provided to human health or the environment . 796 However, the Agency believes that the information collected under this proposed rule, if finalized, will 797 assist EPA and others in determining the potential hazards and risks associated with various chemicals 798 manufactured processed, and used at the nanoscale. Although not directly impacting environmental 799 justice -related concerns, this information will enable the Agency to better protect human health and the 800 environment, including in low - income and minority communities. 801 802 **List of Subjects in 40 CFR Part 704** 803 Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting 804 Requirements. 805 Dated: ____________________ 806

_________________________ _________________ 807 Assistant Administrator, Office of Chemical Safety and Pollution Prevention. 808*** EO 12866 Deliberative Draft

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Page 21 of 24 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 809 1. The authority citation for part 704 continues to read as follows: 810 **Authority:** 15 U.S .C. 2607(a) 811 2. By adding § 704.xxxx to Subpart B, to read as follows 812 **§704.xxx Nanoscale materials.** 813 (a) Definitions. For purposes of this section the terms below are defined as follows: 814 The Nanoscale Materials Stewardship Program was a program conducted by EPA from January 815 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily 816 provided EPA available information on engineered nanoscale materials that were manufactured processed 817 or used. 818 Primary particles are particles or droplets that form during manufacture of a chemical substance 819 before aggregation or agglomerization occurs. 820 An aggregate is a heterogeneous particle in which the various components are held together by 821 relatively strong forces, and thus not easily broken apart. Aggregated nanoparticles would be an example 822 of a nanostructured material which means a material having an internal or surface structure at the 823 nanoscale. 824 An agglomerate is a group of nanoparticles held together by relatively weak forces, including van 825 der Waals forces, electrostatic forces, and surface tension. 826 A solid nanoscale material is a c hemical substance that is a solid at 25 oC and atmospheric 827 pressure where at least 10 % of the primary particles, agglomerates, or aggregates are manufactured or 828 processed in the size range of 1 - 100 nanometers . 829

. 830 A discrete form of a solid nanoscale material differs from another f orm of the same nanoscale 831 material as follows in that either: 832 ( 1) The change in the nanoscale material is due to a combination of (i), (ii) and (iii) 833 (i) there is a change in process to affect a change in size and/or a change in one or more 834 of the properties of the nanoscale materials identified in (iii) 835 (ii) there is a size variation in the mean particle size of 10% or greater; and 836 (iii) there is a change in one or more of the following properties of 10% or more: surface 837 charge, specific surface area, dispersibility /solubility, or surface reactivity; 838 ( 2 ) The nanoscale material has a different morphology. Examples of morphologies include but 839 are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, 840 torus, cone, and sheet. 841*** EO 12866 Deliberative Draft

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Page 22 of 24 (3) A nanoscale material that is coated with another chemical substance or mixture at the end of 842 manufacturing or processing has a coating that consists of a different chemical substance or mixture. 843 A small manufacturer or p rocessor means any manufacturer or processor whose total annual 844 sales, when combined with those of its parent company (if any), are less than $ 4 million. The definition 845 of small manufacturer in section 704.3 of this title does not apply to reporting under this section 704.xxx. 846 Dispers ibility means the extent to which the particulate nanoscale material can be distributed in 847 an other material such as a liquid. 848 Solubility means the degree to which the nanoscale material can be dissolved in another material 849 such as a liquid. 850 Specific s urface area means the ratio of the area of the surface of the nanoscale material to its 851 mass. Specific surface area is the ratio of the area of th e surface of a nanoscale material divided by the 852 mass (m2/kg) or the area of the surface of the nanoscale materials divided by its volume m2/m3

. 853 Surface charge means the electric charge on a surface in contact with a continuous phase . 854 Surface charge can b e calculated by measuring the electrokinetic potential in colloidal systems known as 855 the zeta potential. It is measured as the net number of positive and negative charges per unit particle 856 surface area in Coulomb/m2 . T he differential of 10% in the surfac e charge would be measured for the 857 same medium. 858 Surface reactivity means the reactivity at the surface of a nanoscale material. It is dependent 859 upon factors such as redox potential which is a measure of the tendency of a substance to lose or acquire 860 electrons, photocatalytic activity, including the potential to generate free radicals. 861 Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, 862 or its successors. 863 Chemical Information Submission System or CISS means EPA’s electronic, web -based reporting 864 tool for the completion and submission of data, reports, and other information associated with TSCA 865 sections 4 and 8. 866 (b) Persons who must report. 867 (1) Manufacturers and processors of a discrete form of a solid nanoscale material during the three 868 years prior to the final effective date of the rule must report except as provided in paragraph (c) of this 869 section. 870 (2) Persons who propose to manufacture or process a discrete form of a solid nanoscale material 871 after the final effective date of the rule which was not reported under paragraph (b)(1) must report except 872 as provided in paragraph (c) of this section. 873 (c) When reporting is not required. 874 (1) The following chemical substances are not subject to reporting: 875 (i) Zinc oxide 876 (ii) Nanoclays 877 (iii) N anoscale materials created as a thin film 878*** EO 12866 Deliberative Draft

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Page 23 of 24 (iv) DNA 879 (v) RNA 880 (vi) Proteins 881 (vii) Chemical substances which dissociate completely in water to form ions that are less than 882 1 nanometer 883 (2) Persons who submitted a TSCA chemical notice under part 720 , 721, or 723 of this title for a 884 solid nanoscale material on or after January 1, 2005 are not required to submit a report for the solid 885 nanoscale material submitted except where the person manufactured or processed a discrete form of the 886 solid nanoscale material. 887 (3) Section 704.5 (a) through (e) of this part 704 applies to reporting under this section 704.xxx. 888 Small manufacturers and processors as defined in section 704.xxx are exempt from the reporting 889 requirements of this rule. 890 (4) Any person who has already submitted some or all of the required information for a substance 891 described in paragraph (a) as part of the Nanoscale Materials Stewardship Program is not required to 892 report that information previously submitted except where the person manufacturer s or processes a 893 discrete form of the solid nanoscale material. 894 (d) What information to report. The following information must be reported to the extent that is 895 known or reasonably ascertainable for each discrete form of a solid nanoscale material manufactured or 896 processed during the three years prior to the final effective date of the rule: 897 (1) the common or trade name, the specific chemical identity including the correct Chemical 898 Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number**,** and the 899 molecular structure of each chemical substance or mixture. Information must be reported as specified in 900 § 720.45. 901 (2) material characterization including particle size, morphology, and surface modifications; 902 (3) physical/chemical properties; 903 (4) the maximum weight percentage of impurities and byproducts resulting from the manufacture, 904 processing, use, or disposal of each chemical substance; 905 (5) annual production volume and an estimate of the maximum production volume for any 906 consecutive 12 - month period during the next two years of production after the final effective date of this 907 rule . Estimates must be on 100% chemical basis of the discrete form of the solid nanoscale material; 908 (6) use information describing the category of each use by function and application, estimates of 909 the amount manufactured or processed for each category of use, and estimates of the percentage in the 910 f ormulation for each use; 911 (7) detailed methods of manufacturing or processing; 912 (8) exposure information with estimates of the number of individuals exposed in their places of 913 employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions 914 and estimates of any general population or consumer exposures; 915*** EO 12866 Deliberative Draft

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Page 24 of 24 (9) release information with estimates of the amounts released, descriptions and duration of the 916 activities that cause such releases, and whether releases are directly to the environment or to control 917 technology ; 918 (10) risk management practices describing protective equipment for individuals, engineering 919 controls, control technologies used, any hazard warning statement, label, material safety data sheet, 920 customer training, or other information which is provided to any person who is reasonably likely to be 921 exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, 922 or disposal of the substance; and 923 (11) existing data concerning the environmental and health effects. 924 (e) How to report. 925 (1) Persons must use CISS to complete and submit Form 7710 -xx, 8(a) Data Reporting for 926 Nanoscale Materials Data Submission Form and any attachment s , via CDX. Submission requires 927 registration with C DX, and must be made only as set forth in this section. 928 (2) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx 929 and follow the appropriate links and for further instructions to go 930 http://www.epa.gov/oppt/chemtest/ereporting/index.html . 931 (f) When to report. 932 (1) Persons specified in paragraph (b)(1) must report the information specified in paragraph (d) 933 within six months after the final effective date of the rule . 934 (2) Persons specified in paragraph (b)(2) must report the information specified in paragraph (d) at 935 least 1 35 days before commencing manufacture or processing of the chemical substance. 936 (g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to 937 the recordkeeping requirements in § 704.11 (a) and (b) . 938 (h) Confidential business information . Persons submitting a notice under this rule are subject to 939 the requirements for confidential business information claims in § 704.7. 940 [FR Doc. ??

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