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1 EO12866_NanoPests_FRN_DRAFT_2010-07-14.doc 

2 EO 12866 Review Draft as submitted. 

3 ENVIRONMENTAL PROTECTION AGENCY 

4 [EPA–HQ–OPP–2010-0197; FRL–XXXX–X]

5 Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for 

6 Public Comment

7 AGENCY: Environmental Protection Agency (EPA). 

8 ACTION: Notice.

9 SUMMARY: This document describes both an interpretation of a statutory requirement and a 

10 separate policy pertaining to pesticide products that contain a “nanoscale material.” In 

11 connection with the interpretation and policy discussed in this document, EPA is defining 

12 “nanoscale material” as an active or inert ingredient and any component parts thereof 

13 intentionally produced to have at least one dimension that measures between approximately 1 

14 and 100 nanometers. As explained more fully in this document, EPA believes that information 

15 regarding the presence of a nanoscale material in a registered pesticide product and its potential 

16 effects on humans or the environment is reportable under section 6(a)(2) of the Federal 

17 Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such information must also be included, 

18 pursuant to 40 CFR 152.50(f)(3), with any application for registration of a pesticide product that 

19 contains any nanoscale material. In addition, this document proposes a new approach for how 

20 EPA will determine on a case-by-case basis whether a nanoscale active or inert ingredient is a 

21 “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration 

22 Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale 

23 ingredient is already registered. Notwithstanding the fact that this document is announcing an 

24 interpretive rule of general applicability and a separate statement of general policy, both of 

25 which are exempt from the notice and comment requirements of the Administrative Procedure 

26 Act, EPA is soliciting public comment on the clarity of the reporting requirement as it pertains to 

27 the presence of nanoscale materials in pesticide products. EPA is also asking for specific input 

28 on the proposed policy for determining whether a nanoscale material is “new” under FIFRA and 

29 PRIA.

30 

31 DATES: Comments must be received on or before [45] days after the date of publication in the 

32 Federal Register. 

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

34 HQ–OPP–2010–0197, by one of the following methods: 

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

36 instructions for submitting comments. 

37 • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), 

38 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. 
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39 • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 

40 Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries 

41 are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., 

42 Monday through Friday, excluding legal holidays). Special arrangements should be made for 

43 deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. 

44 Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2010-0197. 

45 EPA's policy is that all comments received will be included in the docket without change and 

46 may be made available on-line at http://www.regulations.gov, including any personal 

47 information provided, unless the comment includes information claimed to be Confidential 

48 Business Information (CBI) or other information whose disclosure is restricted by statute. Do not 

49 submit information that you consider to be CBI or otherwise protected through regulations.gov 

50 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 

51 will not know your identity or contact information unless you provide it in the body of your 

52 comment. If you send an e-mail comment directly to EPA without going through 

53 regulations.gov, your e-mail address will be automatically captured and included as part of the 

54 comment that is placed in the docket and made available on the Internet. If you submit an 

55 electronic comment, EPA recommends that you include your name and other contact information 

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

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

58 be able to consider your comment. Electronic files should avoid the use of special characters, 

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

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

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

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

63 material, such as copyrighted material, is not placed on the Internet and will be publicly available 

64 only in hard copy form. Publicly available docket materials are available either in the electronic 

65 docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory 

66 Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 

67 VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through 

68 Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. 

69 

70 FOR FURTHER INFORMATION CONTACT: Demson Fuller, Antimicrobials Division 

71 (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 

72 Ave., NW., Washington, DC 20460–0001; telephone number: 703-308-8062; fax number: 703-

73 308-8005; e-mail address: fuller.demson@epa.gov. 

74 

75 SUPPLEMENTARY INFORMATION: 

76 I. General Information 

77 A. Does this Action Apply to Me? 

78 This action is directed to those persons who manufacture, distribute, sell, apply, or 

79 regulate pesticide products, including agricultural, commercial, and residential products (NAICS 

80 codes 32532 and 32561). This listing is not intended to be exhaustive, but rather provides a 
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81 guide for readers regarding entities likely to be affected by this action. Other types of entities not 

82 listed in this Unit could also be affected. The North American Industrial Classification System 

83 (NAICS) codes have been provided to assist you and others in determining whether this action 

84 might apply to certain entities. If you have any questions regarding the applicability of this 

85 action to a particular entity, consult the person listed under FOR FURTHER INFORMATION 

86 CONTACT. 

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

88 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e89 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

90 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD91 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 

92 information that is claimed as CBI. In addition to one complete version of the comment that 

93 includes information claimed as CBI, a copy of the comment that does not contain the 

94 information claimed as CBI must be submitted for inclusion in the public docket. Information so 

95 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 

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

97 

98 i. Identify the document by docket ID number and other identifying information (subject 

99 heading, Federal Register date and page number). 

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

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

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

103 your requested changes. 

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

105 used. 

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

107 sufficient detail to allow for it to be reproduced. 

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

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

110 threats. 

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

112 

113 II. Applicable Statutory and Regulatory Requirements 

114 As a general matter, pesticides may not be sold or distributed in the United States unless 

115 they are registered with the EPA. FIFRA section 3(a) (7 U.S.C. 136a(a)). In order to obtain a 

116 pesticide registration, an applicant must provide EPA with data (or cite existing data) 

117 demonstrating that the proposed registration complies with the requirement for registration. 
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118 FIFRA section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)). FIFRA contains two provisions under which 

119 EPA may register pesticides: section 3(c)(5) for “unconditional” registration and section 3(c)(7) 

120 for “conditional” registration (7 U.S.C. 136a(c)(5) and 7 U.S.C. 136a(c)(7)). Importantly, EPA 

121 must make statutorily required findings for each and every pesticide product for which 

122 registration is sought, regardless of whether another pesticide product with the same or similar 

123 composition and use patterns is already registered. 

124 

125 The standard for determining whether an application should be granted unconditionally is 

126 found in FIFRA section 3(c)(5). This section provides that, in order to grant a registration, EPA 

127 must find that a product’s composition warrants the proposed claims for it; that the product’s 

128 labeling and other material required to be submitted comply with FIFRA; that the product will 

129 perform its intended function without causing unreasonable adverse effects on the environment; 

130 and that, when used in accordance with widespread and commonly recognized practice, the 

131 product will not cause unreasonable adverse effects on the environment. 

132 

133 FIFRA defines “unreasonable adverse effects on the environment” as including “any 

134 unreasonable risk to man or the environment, taking into account the economic, social, and 

135 environmental costs and benefits of the use of any pesticide.” FIFRA section 2(bb) (7 U.S.C. 

136 136(bb)). Thus, a critical aspect of determining whether or not a pesticide product should be 

137 granted a registration is an evaluation of whether the benefits associated with the use of a 

138 pesticide exceed the risks associated with such use. The burden of demonstrating that a product 

139 meets the standards for registration rests at all times on the registrant or applicant for registration. 

140 See, e.g. Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n. 61 (1980); 

141 Environmental Defense Fund v. EPA, 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975). 

142 

143 If an applicant cannot provide necessary data for EPA to make the determinations 

144 required to register a product unconditionally under FIFRA section 3(c)(5), EPA may still be 

145 able to register the product “conditionally” under FIFRA section 3(c)(7). FIFRA section 3(c)(7) 

146 authorizes EPA to register a pesticide product on the condition that the applicant provides 

147 additional data necessary to support a finding that the product meets the statutory standards in 

148 FIFRA section 3(c)(5). FIFRA section 3(c)(7) authorizes conditional registration in three 

149 circumstances. First, the Agency may conditionally register a product if EPA determines, among 

150 other things, that the product is identical or substantially similar to a currently registered 

151 pesticide or differs only in ways that would not significantly increase the risk of unreasonable 

152 adverse effects on the environment, and that approving the registration in the manner proposed 

153 would not significantly increase the risk of any unreasonable adverse effect on the environment. 

154 FIFRA section 3(c)(7)(A) (7 U.S.C. 136a(c)(7)(A)). Products approved under this authority are 

155 commonly called “me-too registrations.” Second, EPA may register a pesticide for an additional 

156 use, if the applicant provides data to evaluate the safety of the new use, and use of the product 

157 would not significantly increase the risk of unreasonable adverse effects on the environment 

158 compared to products already registered. FIFRA section 3(c)(7)(B) (7 U.S.C. 136a(c)(7)(B)). 

159 These product approvals are referred to as “new use” registrations. Finally, EPA may 

160 conditionally register a pesticide product that contains an active ingredient not present in any 

161 currently registered pesticide product, if the Administrator determines that: 

162 
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163 1. The applicant has provided all data necessary to evaluate the safety of the pesticide, 

164 with the exception of any data which are lacking because the applicant has not had enough time 

165 to generate the data since learning of the requirement; 

166 

167 2. Use of the pesticide during the time period needed to develop the additional data will 

168 not cause unreasonable adverse effects on the environment; and 

169 

170 3. Use of the pesticide is in the public interest. FIFRA section 3(c)(7)(C) (7 U.S.C. 

171 136a(c)(7)(C)). 

172 

173 As with applications for unconditional registrations, applicants for conditional 

174 registration bear the burden at all times of demonstrating that the statutory standards are met. 

175 

176 The Agency’s interest in data to evaluate the risks and benefits of a pesticide does not 

177 necessarily end once EPA has registered a pesticide product. Accordingly, other provisions of 

178 FIFRA allow the Agency to require pesticide registrants to develop and submit information the 

179 Agency believes it needs in order to maintain the registration of pesticide products. In addition, 

180 FIFRA section 6(a)(2) provides that registrants must inform the Agency of certain relevant 

181 information relating to their products, even though it was not specifically requested by EPA. 

182 Specifically, FIFRA section 6(a)(2) requires that, “[i]f at any time after the registration of a 

183 pesticide the registrant has additional factual information regarding unreasonable adverse effects 

184 on the environment of the pesticide, the registrant shall submit such information to the 

185 Administrator.” (7 U.S.C. 136d(a)(2)). 

186 

187 In 1997, EPA promulgated a final rule at 40 CFR part 159, subpart D in the Federal 

188 Register issue of September 19, 1997 (62 FR 49370)(FRL-5739-1), setting forth EPA’s 

189 interpretation and enforcement policy regarding FIFRA section 6(a)(2). The rule explains, 

190 among other things, what information EPA regards as “additional” and “factual,” as well as how 

191 quickly and to whom such information must be reported. 

192 

193 The regulation specifies many kinds of information, from varied scientific disciplines, 

194 that EPA requires registrants to submit pursuant to FIFRA section 6(a)(2). The types of 

195 information reflect the variety of scientific data used by EPA in making the statutorily required 

196 determinations – whether pesticides cause unreasonable adverse effects on the environment. 

197 Thus, for example, the regulations generally require registrants to report studies indicating that a 

198 pesticide causes new or a higher incidence of toxic effects than previously identified (see 40 

199 CFR 159.165) and to report incidents involving injury to humans, pets or wildlife resulting from 

200 exposure to a pesticide (40 CFR 159.184). But, EPA uses other types of information that do not 

201 directly demonstrate adverse effects in its risk assessments, and new factual information of this 

202 kind is also reportable under the regulation. For example, registrants must report studies that 

203 identify new metabolites, degradates, impurities, or contaminants of pesticides (40 CFR 

204 159.179); certain information on the detection of pesticide residues in water, food, and feed (40 

205 CFR 159.178); and new studies of human exposure (40 CFR 159.170). In sum, EPA’s 

206 regulation requires reporting of many types of information relevant to EPA’s assessment of the 

207 safety of a pesticide product – in the words of section 6(a)(2) “information regarding 

208 unreasonable adverse effects on the environment of the pesticide” – not merely information that 

209 directly concerns adverse effects. 
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210 

211 In promulgating that regulation, however, EPA also recognized it was impossible to 

212 establish rules addressing every type of factual information that might become relevant in the 

213 future to judging whether a registered pesticide product continued to meet the FIFRA statutory 

214 standards. Accordingly, 40 CFR 159.195(c) provides: 

215 

216 “The registrant shall submit to the Administrator information other than that described in 

217 §§159.165 through 159.188 if the registrant knows, or reasonably should know, that if the 

218 information should prove to be correct, EPA might regard the information alone or in 

219 conjunction with other information about the pesticide as raising concerns about the 

220 continued registration of a product or about the appropriate terms and conditions of 

221 registration of a product.” 

222 

223 In addition, 40 CFR 159.195(c) provides that: 

224 

225 “[t]he registrant shall submit . . . information other than that described in §§159.165 

226 through 159.188 if the registrant has been informed by EPA that such additional 

227 information has the potential to raise questions about the continued registration of a 

228 product or about the appropriate terms and conditions of registration of a product.” 

229 

230 In light of the preceding, it must be emphasized that EPA is not expanding its 

231 interpretation of FIFRA section 6(a)(2) or changing its regulations through this document. 

232 Rather, consistent with EPA’s section 6(a)(2) regulations, EPA is merely identifying a set of 

233 information, to which the FIFRA section 6(a)(2) reporting requirement already applies, that is 

234 broader than the subset of reportable section 6(a)(2) data explicitly identified at present under the 

235 section 6(a)(2) regulations. 

236 

237 Further, the Agency notes that the identification of information as reportable under 

238 FIFRA section 6(a)(2) does not necessarily mean that any particular pesticide or group of 

239 pesticides, to which such information pertains, poses a risk. Rather, the requirement merely 

240 indicates that EPA has determined that a particular type of information is relevant to, and may 

241 improve the Agency’s ability to assess, the safety of a pesticide. 

242 

243 Finally, EPA promulgated a regulation in the Federal Register of May 4, 1988 (53 FR 

244 15952)(FRL-3266-96) concerning the submission of applications for registration at 40 CFR part 

245 152. That rule specifies, among other things, certain types of information that an application for 

246 registration of a pesticide product must contain. The rule provides that the applicant must 

247 “furnish with his application any factual information of which he is aware regarding 

248 unreasonable adverse effects of the pesticide on man or the environment, which would be 

249 required to be reported under FIFRA section 6(a)(2), if the product were registered.” (40 CFR 

250 152.50(f)(3). 

251 

252 Registrants’ compliance with section 6(a)(2) and EPA’s implementing regulations in 

253 Parts 152 and 159 ensures that EPA has access to any additional factual information that could 

254 be important for determining whether a previous Agency decision to register a pesticide remains 

255 a correct one, and whether a registered pesticide can in fact be used without posing unreasonable 

256 adverse effects to human health and the environment. This provision of FIFRA recognizes that 
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257 registrants may come into the possession of important new information that was not anticipated 

258 by the Agency or of information the importance of which was not previously known, and that in 

259 the absence of registrants submitting such information, EPA might well remain unaware of the 

260 information. Thus, section 6(a)(2) and Part 159 serve to provide an important ongoing check on 

261 the correctness of the original decision to register a pesticide. Failures to report required 

262 information, or delays in reporting, are regarded by EPA as violations of FIFRA section 6(a)(2), 

263 which in turn makes them actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N) (7 

264 U.S.C. 136j(a)(2)(B)(ii) and 7 U.S.C. 136j(a)(2)(N)). 

265 

266 III. EPA’s Interest in Nanoscale Materials as Pesticide Ingredients 

267 A. Applicable Definition of “Nanoscale Material” 

268 

269 With FIFRA section 6(a)(2) as a backdrop, the focus of this document turns next to the 

270 topics of nanotechnology and the presence of nanoscale materials as either active ingredients or 

271 inert ingredients in pesticide products. At the outset, it is important to clarify some key 

272 terminology that is being used for purposes of this document. 

273 

274 To date, EPA has not developed formal definitions for the terms “nanotechnology” or 

275 “nanoscale materials” or any similar terms for regulatory purposes under any statute 

276 administered by the Agency. Broad definitions and discussions of nanotechnology generally 

277 reflect the same common elements, namely: 

278 

279 1. The material’s particle size measures typically between approximately 1 and 100 

280 nanometers in at least one dimension; 

281 

282 2. The material exhibits unique or novel properties compared to larger particles of the 

283 same material; and 

284 

285 3. Rather than occurring naturally, the material has been manufactured or engineered to 

286 take advantage of these unique properties. See, for example, the definition from the National 

287 Nanotechnology Initiative at: http://www.nano.gov/html/facts/whatIsNano.html. 

288 

289 These elements do not readily work for a regulatory definition because of the high degree 

290 of subjectivity involved with interpreting such phrases as “unique or novel properties” or 

291 “manufactured or engineered to take advantage of these properties.” Moreover, the contribution 

292 of these subjective elements to risk has not been established. 

293 

294 Instead, OPP will focus on more objective criteria in its definition of “nanoscale material.” 

295 In connection with the interpretation and policy discussed in this document, OPP defines 

296 “nanoscale material” as an active or inert ingredient and any component parts thereof 

297 intentionally produced to have at least one dimension that measures between approximately 1 

298 and 100 nanometers. In determining whether an ingredient meets this definition, EPA will 

299 review, among other things, the manufacturing process to determine whether it employs 

300 processes to create or enhance the proportion of nanoscale materials in the product, as compared 

301 with other processes used to produce similar products. 
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302 

303 B. Potential of Nanoscale Materials to Affect Human Health and the Environment Adversely 

304 

305 There is a growing body of scientific evidence showing that differences can exist 

306 between nanoscale material(s) and their non-nanoscale counterpart(s) (Ref. 14). Nanoscale 

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

308 magnetic, mechanical, thermal, or optical properties – or features, such as improved hardness or 

309 strength, that are highly desirable for applications in commercial, medical, military, and 

310 environmental sectors (Ref. 13). These properties are a direct consequence of small size, which 

311 results in a larger surface area per unit of volume and/or quantum effects that occur at the 

nanometer scale (i.e., 1 x 10-9 312 meters). Small size itself is also a desirable property of nanoscale 

313 materials that is exploited for miniaturization of applications/processes and/or stabilization or 

314 delivery of payloads to diverse environments or incorporation into diverse products. 

315 

316 A number of organizations have considered whether the small size of nanoscale materials or 

317 the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or 

318 increased hazards to humans and the environment. Government, academic, and private sector 

319 scientists in multiple countries are performing research into the human health effects of diverse 

320 nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. 

321 These research findings point generally to the possibility for nanoscale materials to adversely 

322 affect human health and the environment. Research also indicates, however, that not all 

323 materials in the nanoscale size range behave differently from larger sized materials of the same 

324 substance. Recently, governmental and expert peer review organizations have reviewed and 

325 summarized this evidence and offered views about the implications of this evidence for 

326 environmental and human health and safety. 

327 

328 For instance, in 2009, the National Institute of Occupational Safety and Health (NIOSH) 

329 issued a report, “Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns 

330 Associated with Engineered Nanomaterials,” which summarized the available scientific 

331 information about nanoscale materials and identified the following potential health and safety 

332 properties: 

333 

334  “Nanomaterials have the greatest potential to enter the body through the respiratory sys335 tem if they are airborne and in the form of respirable-sized particles (nanoparticles). They 

336 may also come into contact with the skin or be ingested.” 

337 

338  “Based on results from human and animal studies, airborne nanoparticles can be inhaled 

339 and deposit in the respiratory tract; and based on animal studies, nanoparticles can enter 

340 the blood stream, and translocate to other organs.” 

341 

342  “Experimental studies in rats have shown that equivalent mass doses of insoluble 

343 incidental nanoparticles are more potent than large particles of similar composition in 

344 causing pulmonary inflammation and lung tumors. Results from in vitro cell culture 

345 studies with similar materials are generally supportive of the biological responses 

346 observed in animals.” 

347 
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348  “Experimental studies in animals, cell cultures, and cell-free systems have shown that 

349 changes in the chemical composition, crystal structure, and size of particles can influence 

350 their oxidant generation properties and cytotoxicity.” 

351 

352  “Studies in workers exposed to aerosols of some manufactured or incidental microscopic 

353 (fine) and nanoscale (ultrafine) particles have reported adverse lung effects including 

354 lung function decrements and obstructive and fibrotic lung diseases. The implications of 

355 these studies to engineered nanoparticles, which may have different particle properties, 

356 are uncertain.” 

357 

358  “Some nanomaterials may initiate catalytic reactions depending on their composition and 

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

360 

361 (Ref. 2). 

362 

363 Earlier the same year, the Scientific Committee on Emerging and Newly Identified 

364 Health Risks (SCENIHR), an independent scientific committee advising the European 

365 Commission’s Health and Consumer Directorate, issued a report, “Risk assessment of products 

366 of nanotechnologies.” The SCENIHR report identified properties similar to those identified in 

367 the NIOSH report: 

368 

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

370 identified. These include the possibility of some nanoparticles to induce protein 

371 fibrillation, the possible pathological effects caused by specific types of carbon 

372 nanotubes, the induction of genotoxicity, and size effects in terms of biodistribution.” 

373 

374 and: 

375 

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

377 demonstrated, as well as the potential to transfer across environmental species, 

378 indicating a potential for bioaccumulation in species at the end of that part of the food 

379 chain.” 

380 

381 (Ref. 17). 

382 

383 In another recent survey of scientific research on nanoscale materials, the authors 

384 reported: 

385 

386 “Many studies have examined the pro-inflammatory effects of manufactured NPs 

387 [nanoparticles], on the basis that their ability to cause inflammation is a major predictor 

388 of potential hazard in such particles. The first important finding was that NPs have a 

389 more pronounced effect on inflammation, cell damage and cell stimulation than an 

390 equal mass of particles of the same material of greater size [(Ref. 3)]. This appears to 

391 hold true for materials as varied as carbon black, titanium dioxide, various metals and 

392 polystyrene [(Ref. 5)]. Surface area is the metric driving the pro-inflammatory effects 

393 and this is evident both in vitro [(Ref. 4)] and in vivo [(Ref. 5)], particles of various 

394 sizes producing inflammatory effects that are directly related to the surface area dose.” 
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395 

396 (Ref. 18). 

397 

398 Other reports in the scientific literature have indicated that some nanoscale materials may 

399 cross the placental barrier (Ref. 20) or translocate to diverse organs following oral exposure (Ref. 

400 10). Once in these diverse sites and organs, the large surface area of nanoscale materials may 

401 facilitate increased reactivity and/or an inflammatory response, resulting in toxic effects. 

402 

403 Two recent literature surveys describe a broad range of effects in non-mammalian species 

404 following exposure to nanoscale materials (Refs. 8 and 11). These include, for example, 

405 increased ventilation rates, mucus production, and pathologies, and related alteration of enzyme 

406 activities and indicators of oxidative stress in rainbow trout, Oncorhyncus mykiss (Refs. 6 and 

407 19), and ingestion and accumulation of nanoscale material in the digestive tract, as well as 

408 mortality, increased heart rates, and reduced fecundity in Daphnia magna (Refs. 12, 15, and 16). 

409 Translocation of nano-scale materials from gill and gut surface to blood and other organs in 

410 exposed Medaka, Oryzius latipes, has also been reported (Ref. 9) and carbon nanotubes, 

411 although unable to cross the egg surface, have been shown to delay hatching in zebrafish, Danio 

412 rerio (Ref. 1). 

413 

414 While the reports and articles cited above have focused primarily on differences between 

415 nanoscale material and conventionally sized material of the same substances, EPA has also 

416 consulted with the FIFRA Scientific Advisory Panel (SAP) on the extent to which different types 

417 of nanoscale materials may display different properties. (The SAP is a federal advisory 

418 committee consisting of external, independent, expert, scientific peer reviewers who provide 

419 advice to EPA on scientific issues involved in the regulation of pesticides.) In response to EPA 

420 questions on how size and other properties of nanoscale materials potentially affect risk and how 

421 to assess such risks, the SAP said: “Existing data clearly indicate that many properties of 

422 particles change with size, including rate of release of ionic forms of metal, reactivity or catalytic 

423 efficiency, Plasmon resonance, and quantum effects. . . . The effect of particle size on biological 

424 responses to particle exposure is less well defined.” (Ref. 7). The SAP also noted that “[o]ther 

425 physicochemical properties, such as shape, charge and surface coating, are also likely to impact 

426 biological response and environmental fate [of nanoscale materials]. . . . The lack of a clear 

427 understanding of how particle size and other physical properties affect hazard profiles led most 

428 Panel members to be unsupportive of bridging among silver-based materials with different 

429 properties.” (Ref. 7). 

430 

431 It is important to emphasize that, while the conclusions described above apply generally 

432 to the class of nanoscale materials, an individual type of nanomaterial may not display all or 

433 even any of the characteristics observed and reported for other nanoscale materials. In other 

434 words, some nanoscale materials may have properties which, for purposes of assessing the risk 

435 of a pesticide, are essentially identical to larger sized materials of the same substance. So, it 

436 appears increasingly likely that there are few, if any, universal “nanoscale” effects, and the 

437 distinctive effects seen at nanoscale are specific to the properties of each material type under 

438 specific exposure scenarios. Thus, EPA does not regard the fact that an ingredient meets our 

439 definition of a nanoscale material as evidence that a pesticide containing the ingredient no longer 

440 meets the statutory standards for registration. Rather, the presence of a nanoscale material in a 
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441 pesticide is grounds for EPA to consider the possible need for data to characterize the potential 

442 of the ingredient to pose risks. 

443 

444 Finally, scientifically speaking, there currently is no bright line with respect to a size 

445 below (or above) which nanoscale materials do (or do not) exhibit properties that might raise risk 

446 concerns. Therefore, the precise size range in nanometers addressed by the policies announced 

447 in this document are subject to change in the future as new information becomes available. 

448 

449 C. Nanoscale Materials and Pesticides 

450 

451 The Agency has information indicating that the use of nanotechnology has started to 

452 expand into pesticide products, as it already has in many other fields. For instance, a number of 

453 companies have contacted EPA expressing an interest in obtaining registrations for pesticide 

454 products containing ingredients identified as nanosilver or nanosilver composite structures 

455 (jointly referred to as “nanosilver”) and several companies have submitted applications to 

456 register pesticides containing nanosilver. In addition, EPA now has information suggesting that 

457 there are other pesticide products currently registered and in the marketplace that contain 

458 nanosilver as an active ingredient. 

459 

460 As already summarized above, in order for EPA to fulfill its responsibilities to regulate 

461 pesticides under FIFRA, EPA needs to determine whether pesticidal products containing an 

462 intentionally-produced nanoscale material, whether as an active or inert ingredient, meet the 

463 statutory standards for registration. Accordingly, EPA needs not only to know about the 

464 presence of nanoscale materials in pesticide products, but also to have available all information 

465 relevant to the assessment of the potential of such pesticide products to cause unreasonable 

466 adverse effects on the environment, and/or to determine whether EPA should continue the 

467 registration of a product, or amend, as appropriate, the terms and conditions of registration of a 

468 product. 

469 

470 IV. Reporting the Presence of Nanoscale Materials in Pesticide Products 

471 As mentioned above, FIFRA section 6(a)(2) and implementing regulations in 40 CFR 

472 part 159 require pesticide registrants to report certain information if that information: 

473 

474 1) Is additional; 

475 

476 2) Is factual; and 

477 

478 3) Regards unreasonable adverse effects on the environment of the pesticide. Per 40 

479 CFR 159.195, this includes information that, if correct, a registrant knows, or reasonably should 

480 know, would be regarded by EPA, either alone or in conjunction with other information about 

481 the pesticide, as raising concerns about the continued registration of a product or about the 

482 appropriate terms and conditions of registration of a product. 

483 

484 Under EPA’s section 6(a)(2) regulations, which are codified at 40 CFR Part 159, Subpart 

485 D, once the Agency has informed registrants that EPA considers a particular type of information 
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486 relevant to determining whether a pesticide has the potential to cause unreasonable adverse 

487 effects on the environment, that type of information becomes reportable under FIFRA section 

488 6(a)(2). The failure to report required information, or delays in reporting, are regarded by EPA 

489 as violations of FIFRA section 6(a)(2), which in turn makes them subject to enforcement action 

490 under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N) (7 U.S.C. 136j(a)(2)(B)(ii) and 7 U.S.C. 

491 136j(a)(2)(N). 

492 

493 In light of the foregoing and in consideration of the potential for nanoscale material to 

494 cause different effects and to behave differently in the environment and within organisms from 

495 larger particles of the same substance, as well as from nanoscale materials with different 

496 characteristics (see Unit III. B.), it is EPA’s position that any of the following types of 

497 information are relevant to assessing the potential of a pesticide to cause unreasonable adverse 

498 effects on the environment and are thus reportable under FIFRA section 6(a)(2): 

499 

500  any information concerning or indicating the presence of nanoscale material, whether as 

501 an active ingredient or as an inert ingredient; 

502 

503  for any pesticide product that contains nanoscale material, whether active or inert, any 

504 existing information not previously provided to the Agency that characterizes the size and 

505 size distribution of the nanoscale material as measured in nanometers; 

506 

507  for any pesticide product that contains nanoscale materials, whether active or inert, any 

508 existing information not previously provided to the Agency that describes the 

509 manufacturing process used to produce the nanoscale material in whatever size range it is 

510 produced; 

511 

512  for any pesticide product that contains nanoscale materials, whether active or inert, and 

513 that also is or will be used for an end-use formulation that contain(s) a composite (e.g., 

514 the active ingredient is a matrix complex comprised of the nanoscale material(s) in 

515 combination with a carrier, such as silica or sulfur), any existing information not 

516 previously provided to the Agency that characterizes the size and size distribution of the 

517 composite; and 

518 

519  for any pesticide product that contains nanoscale materials, whether active or inert, any 

520 existing information not previously provided to the Agency that shows adverse effects at 

521 any level of exposure to the nanoscale material on humans or nontarget species, and/or 

522 that shows the levels or nature (e.g. routes, frequency, or life stage) of potential human 

523 and environmental exposure. 

524 

525 Importantly, the foregoing is not intended to be an exclusive list. To the extent that a 

526 registrant has a pesticide product that contains a nanoscale material, and in addition has any other 

527 existing information not captured in the list above that pertains to, concerns, or otherwise relates 

528 to the nanoscale material and has the potential to raise questions about the continued registration 

529 of a product or the appropriate terms and conditions of a product registration, it is EPA’s position 

530 that it too must be submitted to the Agency under FIFRA section 6(a)(2). 

531 
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532 In addition, since the types of information described above are reportable under FIFRA 

533 section 6(a)(2), these types of information also are reportable in connection with any application 

534 to register a pesticide product containing any nanoscale material (40 CFR 152.50(f)(3)). As with 

535 the reporting obligation under FIFRA section 6(a)(2), EPA would consider the failure to provide 

536 these types of information with an application for a product containing nanoscale material to be a 

537 violation of FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). 

538 

539 Agency regulations implementing FIFRA section 6(a)(2) provide that a registrant must 

submit information to EPA that is reportable under section 6(a)(2) no later than the 30th 540 calendar 

541 day after the registrant first possesses or becomes aware of the information (40 CFR 159.155). 

542 In addition, a registrant is required to submit to EPA any section 6(a)(2) information not 

543 explicitly covered under the section 6(a)(2) regulations if EPA has informed the registrant that 

544 such additional information has the potential to raise questions about the continued registration 

545 of a product or the appropriate terms and conditions of registration of a product (40 CFR 

546 159.195). The Agency will begin to apply the interpretation announced herein that pertains to 

547 nanoscale materials and FIFRA section 6(a)(2) 90 days after publication of this document. 

548 Absent specific, earlier notice to a registrant, therefore, EPA will view that date as the date on 

549 which a registrant first became aware that such information is reportable under section 6(a)(2). 

550 Thus, absent a specific notice, a registrant will comply with its FIFRA section 6(a)(2) obligations 

551 in this area as long as EPA receives the reportable information within 120 days after publication 

552 of this document. 

553 

554 Finally, although this announcement currently limits this reporting requirement only to 

555 nanoscale materials that are “intentionally produced” such that any dimension falls within the 

556 specific size range currently under scrutiny (i.e., between approximately 1 and 100 nanometers), 

557 it is subject to change in the future as new information becomes available that warrants change. 

558 Accordingly, the Agency reserves the right to revisit and change the reporting requirement 

559 announced herein if necessary. 

560 

561 V. Proposed Policy Regarding Classification of Applications under FIFRA and PRIA 

562 for Products Containing Nanoscale Active and Inert Ingredients 

563 Through this document, EPA also is more broadly announcing how it proposes to address 

564 the status of nanoscale materials as new active or inert ingredients for purposes of both FIFRA 

565 and PRIA. As discussed in more detail above, under FIFRA, all pesticides must meet stringent 

566 statutory and regulatory standards before they are registered by the Agency and allowed to be 

567 marketed and sold. Pesticides containing nanoscale materials, whether as active or inert 

568 ingredients, must meet the same safety standards as other pesticides. Because of the large and 

569 increasing body of data described in Unit III B. of this document demonstrating that size can 

570 alter the manner in which materials behave and, in turn, the potential risk to human health and 

571 the environment associated such materials, EPA proposes to apply an initial presumption that 

572 active and inert ingredients, which are the nanoscale versions of non-nanoscale active and inert 

573 ingredients already present in registered pesticide products, are potentially different from those 

574 conventionally-sized counterparts. For the same reasons, EPA also proposes to apply an initial 

575 presumption that nanoscale active and inert ingredients are potentially different even from other, 
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576 already-registered nanoscale versions of the same ingredients. As explained below, however, 

577 applicants can overcome this presumption on a case-by-case basis. 

578 

579 Historically, EPA has evaluated an application for registration of a pesticide product that 

580 claims to have the same composition and uses as a currently registered pesticide – a so-called 

581 “me-too” application – under either the “conditional” registration or “unconditional” registration 

582 authorities in FIFRA section 3(c)(7) and section 3(c)(5), respectively. In making the statutory 

583 determinations under section 3(c)(7)(A) – whether the applicant’s product is identical or 

584 substantially similar to a currently registered pesticide or differs only in ways that would not 

585 significantly increase the risk of unreasonable adverse effects on the environment, and that 

586 approving the registration in the manner proposed would not significantly increase the risk of 

587 any unreasonable adverse effect on the environment – EPA has focused on whether the use 

588 patterns of the products are identical or similar and whether the ingredients present in the 

589 products have the same chemical structure and are present in about the same percentages. Until 

590 recently, EPA generally has not focused on the size of an ingredient as an attribute relevant to 

591 making the determinations under section 3(c)(7)(A). As noted above, however, once the size of 

592 an ingredient is reduced below approximately 100 nm, a substance can exhibit different 

593 properties, and therefore it may also have different potential environmental health and safety 

594 properties. Accordingly, for a product containing an ingredient that is a nanoscale version of a 

595 conventionally-sized active or inert ingredient contained in an already- registered product, EPA 

596 necessarily will require adequate data in order to determine that the nanoscale material differs 

597 only in ways that do not significantly increase the risk of unreasonable adverse effects on the 

598 environment and that approving the registration in the manner proposed would not significantly 

599 increase the risk of any unreasonable adverse effect on the environment, and/or require different 

600 terms and conditions for the registration. The implication of this thinking, therefore, is that EPA 

601 cannot automatically make the requisite findings absent specific information on the nanoscale 

602 material included in a pesticide product when the application relies on a comparison to a 

603 currently registered pesticide product containing either a non-nanoscale version of the same 

604 ingredient or another nanoscale version of the ingredient that has different characteristics. The 

605 Agency will follow the same thinking in making the statutorily required determinations under 

606 FIFRA section 3(c)(7)(B) and 3(c)(7)(C), as well as FIFRA section 3(c)(5). 

607 

608 For purposes of registration under FIFRA section 3(c)(5) or 3(c)(7), therefore, EPA 

609 would initially classify any application for registration of a pesticide product containing an active 

610 or inert ingredient that is a nanoscale material as an application for a “new” active or inert 

611 ingredient, even when another registered pesticide product contains a non-nanoscale form of the 

612 ingredient or a nanoscale form of the ingredient with different size dimensions or other 

613 properties. This initial presumption, however, could be rebutted on a case-by-case basis through 

614 the submission of, among other possibilities, bridging data or other information demonstrating to 

615 EPA’s satisfaction that the nanoscale material’s properties, which are relevant to assessing the 

616 potential risks to human health and the environment, are substantially similar to the properties of 

617 the already-registered non-nanoscale or already-registered nanoscale form of the material, or that 

618 the nanoscale material differs only in ways that do not significantly increase the risk of 

619 unreasonable adverse effects on the environment, and that approving the registration in the 

620 manner proposed would not significantly increase the risk of any unreasonable adverse effect on 

621 the environment. If an applicant can make this showing to EPA’s satisfaction, then the 

622 application could be processed as a me-too application within the timeframes prescribed for such 
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623 applications. However, if an applicant cannot make this showing to EPA’s satisfaction, then 

624 EPA would process such products as new active ingredients or new inert ingredients and would 

625 complete its review within the timeframes prescribed for such applications. In those 

626 circumstances, the Agency would likely require the applicant to provide the types of data 

627 typically required for an assessment of the potential hazards and exposure to a new active or inert 

628 ingredient. Under this proposed policy, it would also follow that if a registrant wished to change 

629 the composition of its product to include a nanoscale version of a material that EPA had 

630 previously approved in non-nanoscale form, the registrant would need to notify EPA and obtain 

631 EPA approval before making such a change in the composition of its product. 

632 

633 VI. Does This Document Contain Binding Requirements and When Do They Take Effect? 

634 This document announces how FIFRA section 6(a)(2) applies in a particular 

635 circumstance. This announcement informs registrants that certain information is reportable 

636 pursuant to FIFRA section 6(a)(2) and 40 CFR 159.195. As such, the document explains the 

637 applicability of the statute and regulation and makes clear the requirement also applies to 

638 applicants through 40 CFR 152.50(f)(3). As already discussed above, the Agency will begin to 

639 apply this interpretation 90 days after publication of this document in the Federal Register. 

640 

641 The Agency’s proposed policy for determining whether a nanoscale material is a new 

642 active or inert ingredient for purposes of both FIFRA and PRIA is intended only as guidance to 

643 EPA personnel and decision-makers and to pesticide applicants. While the requirements in the 

644 statute and Agency regulations are binding on EPA and the applicants, the proposed policy 

645 described in this document would not be binding on EPA personnel, pesticide applicants, or the 

646 public. Accordingly, EPA may depart from the policy proposed herein if and when 

647 circumstances warrant. Likewise, pesticide applicants may assert that the proposed policy is not 

648 applicable to a specific pesticide or situation in which EPA may be expected to apply it. 

649 

650 VII. Questions for Comment

651 Notwithstanding the fact that this document is announcing an interpretive rule of general 

652 applicability and a separate statement of general policy, both of which are exempt from the 

653 notice and comment requirements of the Administrative Procedure Act, EPA is inviting public 

654 comment. 

655 

656 With respect to the interpretation, EPA is not seeking comment on whether information 

657 concerning the presence of a nanoscale material in a pesticide product is or should be reportable 

658 under FIFRA section 6(a)(2), but we are interested in comment on the clarity of the interpretation 

659 and whether the scope of reportable information should be expanded. EPA specifically invites 

660 comments on the following issues: 

661 

662 1. Should the reporting requirement apply only to nanoscale material that is “intentionally 

663 produced to have at least one dimension that measures between approximately 1 and 100 

664 nanometers,” or should it also apply to naturally occurring materials? Why? 

665 
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666 2. Should the reporting requirement apply to ingredients in pesticides that contain any 

667 amount of a nanoscale material, or should the requirement apply only if an ingredient 

668 contains more than a specified percentage (e.g., 10%) of nanoscale material? If the 

669 latter, what should the specified percentage be and why? 

670 

671 3. How should the reporting requirement apply to a pesticide manufacturer who purchases 

672 ingredients that may contain nanoscale material? 

673 

674 With respect to the proposed policy, EPA is seeking comment on how to implement it to 

675 ensure efficient, effective, and timely review of applications. EPA specifically invites comments 

676 on the following issues: 

677 

678 1. Is there a way to determine, in advance of receiving an application for registration of a 

679 product containing a nanoscale material, whether a particular kind of nanoscale 

680 material has properties that, for purposes of risk assessment, are essentially the same as 

681 larger sized materials of the same substance? If so, how would such determinations be 

682 made and on what would they be based? 

683 

684 2. What kinds of information should EPA accept as demonstrating that a pesticide product 

685 containing a nanoscale ingredient is identical or substantially similar to a currently 

686 registered pesticide or differs only in ways that would not significantly increase the risk 

687 of unreasonable adverse effects on the environment, and that approving the registration 

688 in the manner proposed would not significantly increase the risk of any unreasonable 

689 adverse effect on the environment? 

690 

691 3. Can you suggest any alternative(s) to the proposed policy that would be equally or even 

692 more effective in addressing the status of nanoscale materials as new active or inert 

693 ingredients for purposes of both FIFRA and PRIA, keeping in mind the growing body of 

694 data showing that size, especially when reduced below approximately 100 nm, may alter 

695 the manner in which materials behave and, in turn, the potential risk to human health 

696 and the environment associated with such materials? 

697 

698 VIII. References 

699 As indicated under ADDRESSES, a docket has been established for this document under 

700 docket ID number EPA-HQ-OPP-2010-0197. The following is a listing of the documents that 

701 are specifically referenced in this document. The docket includes these documents and other 

702 information considered by EPA, including documents that are referenced within the documents 

703 that are included in the docket, even if the referenced document is not physically located in the 

704 docket. For assistance in locating these other documents, please consult the technical contact 

705 listed under FOR FURTHER INFORMATION CONTACT.

706 

707 1. Cheng et al. 2007. Effect of carbon nanotubes on developing zebrafish (Danio rerio) 

708 embryos. Environ. Toxicol. Chem. 26:708–716. 

709 
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710 2. Department of Health and Human Services. Centers for Disease Control and Prevention. 

711 National Institute for Occupational Safety and Health. Approaches to Safe 

712 Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered 

713 Nanomaterials. http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf (November 

714 2009). 

715 

716 3. Donaldson, K. et al., 2000. Ultrafine Particles: Mechanisms of Lung Injury. Philosophical 

717 Transactions: Mathematical, Physical and Engineering Sciences. 358 (1775): 2741-2749. 

718 

719 4. Donaldson, K. et al., 2002. Inflammation Caused by Particles and Fibers. Inhalation 

720 Toxicology. 14 (1): 5-27. 

721 

722 5. Duffin, R. et al., 2002. The Importance of Surface Area and Specific Reactivity in the 

723 Acute Pulmonary Inflammatory Response to Particles. Annals of Occupational Hygiene. 

724 46 (1): 242-245. 

725 

726 6. Federici et al. 2007, Toxicity of titanium dioxide to rainbow trout (Oncorhynchus 

727 mykiss): Gill injury, oxidative stress, and other physiological effects. Aquat. Toxicol. 84: 

728 415–430. 

729 

730 7. FIFRA Science Advisory Panel (SAP). 2010. “Evaluation of Hazard and Exposure 

731 Associated with Nanosilver and Other Nanometal Pesticide Products.” Report from the 

732 FIFRA Scientific Advisory Panel Meeting of November, 2009. FIFRA Scientific 

733 Advisory Panel, Office of Science Coordination and Policy, Office of Prevention, 

734 Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Washington, 

735 DC. Available: http://www.epa.gov/scipoly/sap/2009. 

736 

737 8. Handy et al. 2008, The ecotoxicology and chemistry of manufactured nanoparticles. 2008. 

738 Ecotoxicology 17:287-314. 

739 

740 9. Kashiwada et al. 2006. Distribution of nanoparticles in the see-through Medaka (Oryzias 

741 latipes). Environ. Health Perspect. 114: 1697–1702. 

742 

743 10. Kim, Y.S. et al., 2008. Twenty-Eight Day Oral Toxicity, Genotoxicity, and Gender744 Related Tissue Distribution of Silver Nanoparticles in Sprague-Dawley Rats. Inhalation 

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

746 

747 11. Klaine et al. 2008. Nanomaterials in the Environment: Behavior, Fate, Bioavailability, 

748 and Effects. Environ..Toxicol..Chem.. 27: 1825-1851. 

749 

750 12. Lovern and Klaper 2006. Daphnia magna mortality when exposed to titanium 

751 nanoparticles and fullerene (C60) nanoparticles. Environ. Toxicol. Chem. 25: 1132–1137. 

752 

753 13. National Nanotechnology Initiative. 2004. Strategic Plan. 

754 http://www.nano.gov/NNI_Strategic_Plan_2004.pdf. 

755 
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756 14. Oberdörster, G. et al., 2005. Nanotoxicology: an emerging discipline evolving from 

757 studies of ultrafine particles. Environmental Health Perspectives. (113): 823-839. 

758 

759 15. Oberdorster et al. 2006. Ecotoxicology of carbon-based engineered nanoparticles: 

760 effects of fullerene (C-60) on aquatic organisms. Carbon 44: 1112-1120. 

761 

762 16. Roberts et al. 2007. In vivo biomodification of lipidcoated carbon nanotubes by Daphnia 

763 magna. Environ. Sci. Technol. 41: 3025–3029 

764 

765 17. SCENIHR, 2009. Risk Assessment of Products of Nanotechnologies. European 

766 Commission. Directorate-General for Health and Consumers. Scientific Committee on 

Emerging and Newly Identified Risks, Brussels: 28th 767 Plenary Meeting. January 19, 2009. 

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

769 

770 18. Seaton, A. et al., 2009. Nanoparticles, human health hazard and regulation. Journal of the 

771 Royal Society, published online at: 

772 http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#r

773 ef-14. 

774 

775 19. Smith et al. 2007. Toxicity of single walled carbon nanotubes on rainbow trout 

776 (Oncorhyncos mykiss): Respiratory toxicity, organ pathologies, and other physiological 

777 effects. Aquat. Toxicol. 84: 415–430. 

778 

779 20. Wick, P. et al., U.S. Department of Health and Human Services, National Institutes of 

780 Health. http://ehp.niehs.nih.gov/members/2009/0901200/0901200.pdf. 

781 

782 VIII. Applicable Statutory and Executive Order Reviews 

783 EPA submitted this document to the Office of Management and Budget (OMB) for 

784 review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

785 October 4, 1993). Any changes made in response to OMB recommendations have been 

786 documented in the docket for this action as required by section 6(a)(3)(E) of the Executive Order. 

787 The various other statutory and Executive Order review requirements that apply to a 

788 regulatory action do not apply to this action because this document is not a regulatory action and 

789 does not otherwise impose new requirements. As indicated previously this document clarifies 

790 the applicability of the statute and existing regulation regarding reporting under FIFRA section 

791 6(a)(2) and presents the Agency’s proposed policy for determining whether a nanoscale material 

792 is a new active or inert ingredient for purposes of both FIFRA and PRIA. 

793 List of Subjects 

794 Environmental protection, administrative practice and procedure, pesticides, 

795 nanotechnology. 

796 

797 Dated: ________ 
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798 ________________ 

799 Assistant Administrator for Chemical Safety and Pollution Prevention. 

800 

801 [FR Doc. 10–???? Filed ??–??–10; 8:45 am] 

802 BILLING CODE 6560–50–S