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1 EO12866_NanoPests_FRN_DRAFT_2010-07-14.doc-Revised-clean_2011-06-01.docx

2 EO 12866 Review Draft as submitted.

3 This is the final revised document as of today. Revised to address Interagency Comments received under EO 

4 12866 review.

5 BILLING CODE 6560–50–P

6 ENVIRONMENTAL PROTECTION AGENCY 

7 [EPA–HQ–OPP–2010-0197; FRL–XXXX–X]

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

9 Public Comment

10 AGENCY: Environmental Protection Agency (EPA). 

11 ACTION: Notice.

12 SUMMARY: This document describes both an interpretationseveral possible approaches for 

13 obtaining certain additional information on the composition of a statutory requirement and a 

14 separate policy pertaining to pesticide products that contain a “. The notice focuses particularly 

15 on information about what nanoscale material.”materials are present in registered pesticide 

16 products. In connection with the interpretation and policy discussed in this document, EPA is 

17 definingdescribes “nanoscale material” as an active or inert ingredient and any component parts 

18 thereof intentionally produced to have at least one dimension that measures between 

19 approximately 1 and 100 nanometers. As explained more fully in this document

20 

21 Under one approach, EPA believes thatwould use section 6(a)(2) of the Federal 

22 Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding the 

23 presence of awhat nanoscale material is present in a registered pesticide product and its potential 

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

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

26 pursuant to . If EPA adopts this approach, 40 CFR 152.50(f)(3),) would also require the 

27 inclusion of such information with any application for registration of a pesticide product that 

28 contains a nanoscale material. Under an alternative approach, EPA would obtain such 

29 information using data call-in notices (DCIs) under FIFRA section 3(c)(2)(B). If EPA adopts 

30 this alternate approach, EPA would also need to require the inclusion of this information with 

31 any application for registration of a pesticide product that contains any nanoscale material. In 

32 addition, this documenta nanoscale material. EPA is reviewing whether this could be done under 

33 existing regulations or whether EPA would need to amend existing regulations to clarify that the 

34 information is required with any application for registration. It is EPA’s view that FIFRA 

35 section 6(a)(2) is the most efficient and expedient administrative approach to obtaining 

36 information about nanoscale materials in pesticides and EPA would prefer to use this approach. 

37 This document also proposes a new approach for how EPA will determine on a case-by-case 

38 basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for 

39 purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an 
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40 identical, non-nanoscale form of the nanoscale ingredient is already registered. 

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

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

43 notice and comment requirements of the Administrative Procedure Act, EPA is soliciting public 

44 comment on the clarity of the reporting requirement as it pertains to the presence of nanoscale 

45 materials in pesticide products. EPA is also asking for specific input on the proposed policy for 

46 determining whether a nanoscale material is “new” under FIFRA and PRIA.

47 

48 After considering any public comments on the use of FIFRA section 6(a)(2) or DCIs 

49 under FIFRA section 3(c)(2)(B), as well as public comments submitted in response to other 

50 questions posed in this Notice, EPA plans to issue a subsequent Notice in the Federal Register 

51 announcing its approach to gather this information. EPA is also asking for specific input on the 

52 proposed approach for determining whether a nanoscale material is “new” under FIFRA and 

53 PRIA. 

54 

55 DATES: Comments must be received on or before [45]insert 30 days after the date of 

56 publication in the Federal Register.]. 

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

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

59 • Federal eRulemaking Portal: http://www.regulations.gov.http://www.regulations.gov.

60 Follow the on-line instructions for submitting comments. 

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

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

63 • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 

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

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

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

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

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

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

70 may be made available on-line at http://www.regulations.gov,http://www.regulations.gov,

71 including any personal information provided, unless the comment includes information claimed 

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

73 by statute. Do not submit information that you consider to be CBI or otherwise protected through 

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

75 means EPA will not know your identity or contact information unless you provide it in the body 

76 of your comment. If you send an e-mail comment directly to EPA without going through 

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

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

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

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

81 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 
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82 be able to consider your comment. Electronic files should avoid the use of special characters, 

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

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

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

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

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

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

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

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

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

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

93 FOR FURTHER INFORMATION CONTACT: Demson FullerJed Costanza, Antimicrobials 

94 Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 

95 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 703-308-8062347-

96 0204; fax number: 703-308-8005; e-mail address: 

97 fuller.demson@epa.gov.costanza.jed@epa.gov.

98 

99 SUPPLEMENTARY INFORMATION: 

100 

101 I. General Information 

102 

103 A. Does this Action Apply to Me? 

104 

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

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

107 codes 32532 and 32561). This listing is not intended to be exhaustive, but rather provides a 

108 guide for readers regarding entities likely to be affected by this action. Other types of entities not 

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

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

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

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

113 CONTACT. 

114 

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

116 

117 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e118 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

119 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD120 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 

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

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

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

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

125 

126 2. Tips for preparing your comments. When submitting comments, remember to: 
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127 

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

129 heading, Federal Register date and page number). 

130 

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

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

133 

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

135 your requested changes. 

136 

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

138 used. 

139 

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

141 sufficient detail to allow for it to be reproduced. 

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

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

144 threats. 

145 

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

147 

148 II. Applicable Statutory and Regulatory Requirements 

149 

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

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

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

153 demonstrating that the proposed registration complies with the requirement for registration. 

154 FIFRA section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)). FIFRA contains two provisions under which 

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

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

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

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

159 composition and use patterns is already registered. 

160 

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

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

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

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

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

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

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

168 

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

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

171 environmental costs and benefits of the use of any pesticide.” FIFRA section 2(bb) (7 U.S.C. 
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172 136(bb)). Thus, a critical aspect of determining whether or not a pesticide product should be 

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

174 pesticide exceedoutweigh the risks associated with such use. The burden of demonstrating that a 

175 product meets the standards for registration rests at all times on the registrant or applicant for 

176 registration. See, e.g. Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607, 653 

177 n. 61 (1980); Environmental Defense Fund v. EPA, 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975). 

178 

179 The Agency has promulgated regulations in 40 CFR parts 158 and 161 which identify the 

180 types of data EPA expects an applicant to provide to support an application for registration of a 

181 pesticide product. The Agency requires a wide variety of studies in order to evaluate whether a 

182 pesticide will cause unreasonable adverse effects on the environment. These required studies 

183 include both toxicity tests and data to characterize exposure to a pesticide, including extensive 

184 information on a product’s composition, and its fate in the environment and within the human 

185 body. For certain pesticides EPA also requires data on product efficacy.

186 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

206 

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

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

209 to generate the data since learning of the requirement; 

210 

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

212 not cause unreasonable adverse effects on the environment; and 

213 

214 3.). Use of the pesticide is in the public interest. 

215 

216 FIFRA section 3(c)(7)(C) (7 U.S.C. 136a(c)(7)(C)). 

217 
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218 As with applications for unconditional registrations, applicants for conditional 

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

220 

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

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

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

224 Agency believes it needs in order to maintain the registration of pesticide products.

225 

226 A. Data Call-in

227 

228 Under FIFRA section 3(c)(2)(B), EPA may send a data call-in notice (DCI) to a 

229 registrant requiring the registrant to provide additional data or other information, which the 

230 registrant may need to generate or compile. Specifically, “if the Administrator determines that 

231 additional data are required to maintain in effect an existing registration of a pesticide, the 

232 Administrator shall notify all existing registrants of the pesticide to which the determination 

233 relates and provide a list of such registrants to any interested person.” Failure to respond to the 

234 DCI can serve as the basis for suspending the registration of the product, thereby making it 

235 unlawful for the registrant to sell or distribute the pesticide. 

236 

237 Generally, EPA’s determination that additional data are needed is contemplated to occur 

238 for one of the following five reasons:

239 

240 1). The Re-registration Program. Section 4 of FIFRA requires EPA to re-assess the health 

241 and safety data for all pesticide active ingredients registered before November 1, 1984, to 

242 determine whether these “older” pesticides meet the criteria for registration that would be 

243 expected of a pesticide being registered today for the first time. Section 4 directs EPA to use 

244 Section 3(c)(2)(B) authority to obtain the required data. 

245 

246 2). The Registration Review Program. Section 3(g) of FIFRA contains provisions to help 

247 achieve the goal of reviewing each pesticide every 15 years to assure that the pesticide continues 

248 to pose no risk of unreasonable adverse effects on human health or the environment. Section 

249 3(g) instructs EPA to use the section 3(c)(2)(B) authority to obtain the required data.

250 

251 3). Anticipated Residue/Percent Crop Treated Information. Under section 408 of the 

252 Federal Food, Drug and Cosmetic Act (FFDCA), before a pesticide may be used on food or feed 

253 crops, the Agency must establish a tolerance for the pesticide residues on that crop or establish

254 an exemption from the requirement to have a tolerance. Section 408(b)(2)(E) and (F) of FFDCA 

255 authorize the use of anticipated or actual residue (ARs) data and percent crop treated (PCT) data 

256 to establish, modify, maintain, or revoke a tolerance for a pesticide. The FFDCA requires that if 

257 AR data are used, data must be reviewed five years after a tolerance is initially established. 

258 

259 4). The Special Review Program. EPA may conduct a Special Review if EPA believes 

260 that a pesticide poses risks of unreasonable adverse effects on human health or the environment. 

261 In addition,the Special Review Program, EPA focuses on specific hazards or uses of a pesticide. 

262 Special Reviews are not intended to be comprehensive evaluations of the pesticide; instead the 

263 Special Review DCIs are to address the specific hazard or exposure concerns that are at issue. 

264 
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265 5). Enforcement and Unanticipated Circumstances. The need for a DCI may arise from 

266 the discovery of deficiencies in previously submitted data, or from the discovery of specific 

267 attributes of the pesticide or its ingredients. This may lead the agency to determine that 

268 additional information is necessary to reassess whether the pesticide will cause unreasonable 

269 adverse effects on the environment. This type of DCI is needed because the concern and 

270 therefore the need for data arise not from a mandated review program like Re-registration or 

271 Registration Review described above, but from unanticipated circumstances. Section 3(c)(2)(B) 

272 of FIFRA provides a means of obtaining any needed data. 

273 

274 B. FIFRA section 6(a)(2)

275 

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

277 relevant information relating to their products, even though it was not specifically requested by 

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

279 a pesticide the registrant has additional factual information regarding unreasonable adverse 

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

281 Administrator.” (7 U.S.C. 136d(a)(2)). For over thirty years, EPA has interpreted this provision 

282 expansively to include not only information relating directly to adverse effects caused by 

283 pesticides, but also to other types of information and studies that EPA would typically use in 

284 assessing whether a pesticide meets the statutory standard for registration (i.e., the “unreasonable 

285 adverse effects on the environment” risk/benefit standard). See 43 FR 37611 (August 23, 1978).

286 

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

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

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

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

291 quickly and to whom such information must be reported. The regulation specifies many kinds of 

292 information, from varied scientific disciplines, that EPA requires registrants to submit pursuant 

293 to FIFRA section 6(a)(2). The types of information reflect the variety of scientific data used by 

294 EPA in making the statutorily required determinations – whether pesticides cause unreasonable 

295 adverse effects on the environment. Thus, for example, the regulations generally require 

296 registrants to report studies indicating that a pesticide causes new or a higher incidence of toxic 

297 effects than previously identified (see 40 CFR 159.165) and to report incidents involving injury 

298 to humans, pets or wildlife resulting from exposure to a pesticide (40 CFR 159.184). But, EPA 

299 uses other types of information that do not directly demonstrate adverse effects in its risk 

300 assessments, and new factual information of this kind is also reportable under the regulation. For 

301 example, registrants must report studies that identify new metabolites, degradates, impurities, or 

302 contaminants of pesticides (40 CFR 159.179); certain information on the detection of pesticide 

303 residues in water, food, and feed (40 CFR 159.178); and new studies of human exposure (40 

304 CFR 159.170). In sum, EPA’s regulation requires reporting of many types of information 

305 relevant to EPA’s assessment of the safety of a pesticide product – in the words of section 

306 6(a)(2) “information regarding unreasonable adverse effects on the environment of the pesticide” 

307 – not merely information that directly concerns adverse effects. 

308 

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

310 establish rules addressing every type of factual information that might become relevant in the 
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311 future to judging whether a registered pesticide product continued to meet the FIFRA statutory 

312 standards. Accordingly, 40 CFR 159.195(ca) provides: 

313 

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

315 §§159.165 through 159.188 if the registrant knows, or reasonably should know, that if the 

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

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

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

319 registration of a product.” 

320 

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

322 

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

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

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

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

327 

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

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

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

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

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

333 section 6(a)(2) regulations.

334 

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

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

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

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

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

340 

341 Thus, once the Agency has informed registrants that EPA considers a particular type of 

342 information relevant to determining whether a pesticide has the potential to cause unreasonable 

343 adverse effects on the environment, that type of information becomes reportable under FIFRA 

344 section 6(a)(2). 

345 

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

347 15952)(FRL-3266-96) concerningat 40 CFR part 152 addressing the submission of applications 

348 for registration at 40 CFR part 152.(53 FR 15952, May 4, 1988) (FRL-3266-96). That rule 

349 specifies, among other things, certain types of information that an application for registration of a 

350 pesticide product must contain. The rule provides that the applicant must “furnish with his 

351 application any factual information of which he is aware regarding unreasonable adverse effects 

352 of the pesticide on man or the environment, which would be required to be reported under 

353 FIFRA section 6(a)(2), if the product were registered.” (40 CFR 152.50(f)(3). 

354 

355 Registrants’ compliance with section 6(a)(2) and EPA’s implementing regulations in 40 

356 CFR Parts 152 and 159 ensures that EPA has access to any additional factual information that 

357 could be important for determining whether a previous Agency decision to register a pesticide 
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358 remains a correct one, and whether a registered pesticide can in fact be used without posing 

359 unreasonable adverse effects to human health and the environment. This provision of FIFRA 

360 recognizes that registrants may come into the possession of important new information that was 

361 not anticipated by the Agency or of information the importance of which was not previously 

362 known, and that in the absence of registrants submitting such information, EPA might well 

363 remain unaware of the information. Thus, section 6(a)(2) and Part 159 serve to provide an 

364 important ongoing check on the correctness of the original decision to register a pesticide. 

365 Failures to report required information, or delays in reporting, are regarded by EPA as violations 

366 of FIFRA section 6(a)(2), which in turn makes them actionable under FIFRA sections 

367 12(a)(2)(B)(ii) and 12(a)(2)(N) (7 U.S.C. 136j(a)(2)(B)(ii) and 7 U.S.C. 136j(a)(2)(N)). 

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

369 A. Applicable Definition of “Nanoscale Material”

370 

371 With FIFRA section 6(a)(2) as a backdrop, the focus of this document turns next EPA believes 

372 that certain information concerning pesticide ingredients, which applicants and registrants have 

373 not routinely provided previously, is relevant to the topics of nanotechnology and Agency’s 

374 statutory obligation to determine whether the registration of a pesticide may cause unreasonable 

375 adverse effects on the presence of environment. For the reasons discussed below, EPA is 

376 particularly interested in nanoscale materials as either active ingredients or inert ingredientsin 

377 this context. Accordingly, EPA is considering how to collect information about what nanoscale 

378 materials are in pesticide products. At the outset, it and is therefore soliciting public comment on 

379 two possible approaches. It is important to first clarify some key terminology that how the term 

380 “nanoscale material” is being used for purposes of this document. 

381 

382 A. “Nanoscale Material”

383 

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

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

386 administered by the Agency. Broad definitions for the terms “nanotechnology” or “nanoscale 

387 materials” and discussions of nanotechnology generally reflect the same common elements, 

388 namely: 

389 

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

391 nanometers in at least one dimension; 

392 

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

394 same material; and 

395 

396 3.). Rather than occurring naturally, the material has been manufactured or engineered at 

397 the nanoscale to take advantage of these unique properties. See, for example, the definition from 

398 the National Nanotechnology Initiative at: http://www.nano.gov/html/facts/whatIsNano.html. 

399 

400 These elements do not readily work forin a regulatory definitioncontext because of the 

401 high degree of subjectivity involved with interpreting such phrases as “unique or novel 
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402 properties” or “manufactured or engineered to take advantage of these properties.” Moreover, 

403 the contribution of these subjective elements to risk has not been established. 

404 

405 Instead, OPP will focus on more objective criteria in its definition ofdescribing when 

406 information about a “nanoscale material.” In connection with” in a pesticide product may be 

407 relevant to determining whether the interpretation and policy discussedproduct has an 

408 unreasonable adverse environmental effect. Specifically, such information may be relevant in 

409 this document, OPP defines “nanoscale material” as ancontext when the active or inert ingredient 

410 and any component parts thereof is intentionally produced to have at least one dimension that 

411 measures between approximately 1 and 100 nanometers. , regardless of the aggregation or 

412 agglomeration state of the final material. 

413 

414 In determining whether an ingredient meets this defscriniption, EPA willmay review

415 particle size data and, among other things, the manufacturing process to determine whether it 

416 employs processes specifically to create or enhance the proportion of nanoscale materials in the 

417 product, as compared with other processes used to produce similar products. The Agency 

418 generally expects that these ingredients may comprise, but are not limited to, metal-based (e.g., 

419 silver) and carbon-based (e.g., carbon nanotubes) nanoscale materials. The Agency does not, 

420 however, intend this description to cover biological materials (e.g., DNA, RNA, proteins) or 

421 materials in their natural state (e.g., clays). To the extent that the application of this description 

422 to a particular product or ingredient is unclear, EPA would review information provided by a 

423 registrant or applicant concerning the composition of the pesticide product and to provide an

424 Agency view on whether the product did (or did not) contain a nanoscale material for purposes 

425 of this policy. 

426 

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

428 

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

430 between nanoscale material(s) and their non-nanoscale counterpart(s) (Ref. 141). Nanoscale 

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

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

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

434 environmental sectors (Ref. 132). These properties are a direct consequence of small size, which 

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

nanometer scale (i.e., 1 x 10-9 436 meters). Small size itself is also a desirable property of nanoscale 

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

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

439 

440 A Nanoscale materials have a range of potentially beneficial public and commercial 

441 applications, including medicine and public health, clean energy through more efficient solar panels, 

442 pollution reduction and environmental cleanup, and improved products such as stronger, lighter, and 

443 more durable or conductive materials. These benefits arise from the distinctive properties of 

444 nanoscale materials, in that they are potentially more interactive or durable than other chemicals as a 

445 result of their size and composition. EPA sees the emergence of nanoscale materials as offering 

446 potential benefits for society in many different fields, including pest control products. The use of 

447 nanoscale materials in pesticide products and treated articles may allow for more effective 

448 targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of 
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449 spray-applied surface disinfection. These could contribute to improved human and 

450 environmental safety and could lower pest control costs. For example, as a materials

451 preservative, nanosilver should maintain its efficacy longer and require smaller quantities than 

452 other silver preservatives due to an expected gradual and controlled release of silver as opposed 

453 to the rapid release of for example, silver from a zeolite structure or the immediate dissolution of 

454 a silver salt. Therefore EPA seeks to encourage innovative work in developing nanoscale 

455 materials to realize these benefits.

456 

457 However, a number of organizations have considered whether the small size of nanoscale 

458 materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, 

459 pose new or increased hazards to humans and the environment. Government, academic, and private 

460 sector scientists in multiple countries are performing research into the human health effects of 

461 diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific 

462 evidence. These research findings point generally to the possibility for nanoscale materials to 

463 adversely affect human health and the environment. Research also indicates, however, that not 

464 all materials in the nanoscale size range behave differently from larger sized materials of the 

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

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

467 environmental and human health and safety. 

468 

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

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

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

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

473 properties: 

474 

475  “Nanomaterials have the greatest potential to enter the body through the respiratory sys476 tem if they are airborne and in the form of respirable-sized particles (nanoparticles). They 

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

478 

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

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

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

482 

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

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

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

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

487 observed in animals.” 

488 

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

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

491 their oxidant generation properties and cytotoxicity.” 

492 

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

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

495 lung function decrements and obstructive and fibrotic lung diseases. The implications of 
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496 these studies to engineered nanoparticles, which may have different particle properties, 

497 are uncertain.” 

498 

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

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

501 

502 (Ref. 23). 

503 

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

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

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

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

508 the NIOSH report: 

509 

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

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

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

513 nanotubes, the induction of genotoxicity, and size effects in terms of 

514 biodistribution.” 

515 

516 and: 

517 

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

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

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

521 food chain.” 

522 

523 (Ref. 174). 

524 

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

526 reported: 

527 

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

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

530 predictor of potential hazard in such particles. The first important finding was that 

531 NPs have a more pronounced effect on inflammation, cell damage and cell 

532 stimulation than an equal mass of particles of the same material of greater size [(Ref. 

533 3)].[...]. This appears to hold true for materials as varied as carbon black, titanium 

534 dioxide, various metals and polystyrene [(Ref. 5)].[...]. Surface area is the metric 

535 driving the pro-inflammatory effects and this is evident both in vitro [(Ref. 4)][...]

536 and in vivo [(Ref. 5)],[...], particles of various sizes producing inflammatory effects 

537 that are directly related to the surface area dose.” 

538 

539 (Ref. 18).

540 

541 

542 (Ref. 5 [reference numbers in the original were omitted]).
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543 

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

545 cross the placental barrier (Ref. 206) or translocate to diverse organs following oral exposure 

546 (Ref. 107). Once in these diverse sites and organs, the large surface area of nanoscale materials 

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

548 

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

550 following exposure to nanoscale materials (Refs. 8 and 119). These include, for example, 

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

552 activities and indicators of oxidative stress in rainbow trout, Oncorhyncus mykiss (Refs. 610 and 

553 1911), and ingestion and accumulation of nanoscale material in the digestive tract, as well as 

554 mortality, increased heart rates, and reduced fecundity in Daphnia magna (Refs. 12, 1513, and 

555 1614). Translocation of nano-scale materials from gill and gut surface to blood and other organs 

556 in exposed Medaka, Oryzius latipes, has also been reported (Ref. 915) and carbon nanotubes, 

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

558 rerio (Ref. 1). 16). A recent review of lethal and effects concentrations determined for a wide 

559 variety of species showed that some nanoscale materials, including nano-titanium, nano-zinc 

560 oxide, nano-silver, nano-copper oxide, C60, and single- and multi-walled carbon nanotubes,

561 would be classified as harmful to extremely toxic to non-mammalian species (Ref. 17).

562 

563 While the reports and articles cited abovepreviously have focused primarily on 

564 differences between nanoscale material and conventionally sized material of the same substances, 

565 EPA has also consulted with the FIFRA Scientific Advisory Panel (SAP) on the extent to which 

566 different types of nanoscale materials may display different properties. (The SAP is a federal 

567 advisory committee consisting of external, independent, expert, scientific peer reviewers who 

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

569 to EPA questions on how size and other properties of nanoscale materials potentially affect risk 

570 and how to assess such risks, the SAP said: “Existing data clearly indicate that many properties 

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

572 catalytic efficiency, Plasmon resonance, and quantum effects. . . . The effect of particle size on 

573 biological responses to particle exposure is less well defined.” (Ref. 718). The SAP also noted 

574 that “[o]ther physicochemical properties, such as shape, charge and surface coating, are also 

575 likely to impact biological response and environmental fate [of nanoscale materials]. . . . The 

576 lack of a clear understanding of how particle size and other physical properties affect hazard 

577 profiles led most Panel members to be unsupportive of bridging among silver-based materials 

578 with different properties.” (Ref. 718). 

579 

580 It is important to emphasize that, while the conclusions described abovepreviously apply 

581 generally to the class of nanoscale materials, anspecific material(s) and or context in which the 

582 study was conducted, any individual type of nanomaterialnanoscale material may not display all 

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

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

585 of a pesticide, are essentially identical to larger sized materials (or particles) of the same 

586 substance. Furthermore, nanoscale materials may also have properties that make them less risky, 

587 or more beneficial in some other way, than larger sized materials (or particles) of the same 

588 substance. So, it appears increasingly likely that there are few, if any, universal “nanoscale” 

589 effects, and the distinctive effects seen at nanoscale are specific to the properties of each material 
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590 type under specific exposure scenarios. Thus, EPA does not regard the fact that an ingredient 

591 meets our defscriniption of a nanoscale material as evidence that a pesticide containing the 

592 ingredient would cause unreasonable adverse effects on the environmental and thus would no 

593 longer meets the statutory standards for registration. Rather, the presence of a nanoscale material 

594 in a pesticide is grounds for EPA to consider the possible need for data to characterize the 

595 potential of the ingredient to pose risks. However, the registration status of a product would not 

596 change merely as a result of providing information to EPA about the presence of a previously597 unreported nanoscale material. If, based on a science based assessment of the risks of the 

598 specific pesticide ingredients involved, EPA were to determine that the pesticide no longer met 

599 the criteria for registration, or that some change was needed in the conditions of use, EPA would 

600 conduct a separate action to notify the manufacturer of that determination, consistent with 

601 current FIFRA regulations.

602 

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

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

605 concerns.be of interest in assessing whether a pesticide product has the potential to cause 

606 unreasonable adverse effects on the environment. Therefore, the precise size range in 

607 nanometers addressed by the policies announcedproposed in this document are subject to 

608 changemight be revised in the future as new information becomes available. 

609 

610 C. Nanoscale Materials and Pesticides 

611 

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

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

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

615 products containing ingredients identified as nanosilver or nanosilver composite structures 

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

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

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

619 nanosilver as an active ingredient. 

620 

621 As already summarized above, inIn order for EPA to fulfill its responsibilities to regulate 

622 pesticides under FIFRA, EPAit needs to determine whether pesticidal products containing

623 anmeet the statutory standards for registration. As summarized previously EPA believes that

624 what intentionally-produced nanoscale materialmaterials are in a pesticide product, whether as an 

625 active or inert ingredient, meet the statutory standards for registration. is relevant to that 

626 determination. Accordingly, EPA needs is considering how to collect information not only to 

627 know about the presence ofwhat nanoscale materials are in pesticide products, but also to have 

628 available allother information that may be relevant to the assessment of the potential of such 

629 pesticide products to cause unreasonable adverse effects on the environment, and/or. Such 

630 information may be important for EPA to determine whether EPA should continue the 

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

632 product. EPA is therefore soliciting public comment on two possible approaches for obtaining 

633 this information, as discussed in this document.

634 

635 IV. Reporting Information Relevant to Assessing the Presence of Nanoscale Materials in 

636 a Pesticide Products
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637 As mentioned above, FIFRA section 6(a)(2) and implementing regulations in 40 CFR 

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

639 

640 1) Is additional; 

641 

642 2) Is factual; and 

643 

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

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

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

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

648 appropriate terms and conditions of registration of a product. 

649 

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

651 D, once the Agency has informed registrants that EPA considers a particular type of information 

652 relevant to determining whether a pesticide has the potential to cause unreasonable adverse 

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

654 6(a)(2). The failure to report required information, or delays in reporting, are regarded by EPA 

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

656 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. 

657 136j(a)(2)(N). 

658 

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

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

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

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

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

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

665 

666  any information concerning or indicating the presence ofwhat nanoscale 

667 materialmaterials are present in pesticides, whether as an active ingredient or as an inert 

668 ingredient; 

669 

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

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

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

673 

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

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

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

677 produced; 

678 

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

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

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

682 combination with a carrier, such as silica or sulfur), any existing information not 
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683 previously provided to the Agency that characterizes the size and size distribution of the 

684 composite; and 

685 

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

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

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

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

690 and environmental exposure. 

691 

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

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

694 existing information not captured in the previous list above that pertains to, concerns, or 

695 otherwise relates to the nanoscale material and has the potential to raise questions about the 

696 continued registration of a product or the appropriate terms and conditions of a product 

697 registration, itEPA is EPA’s position that italso considering whether this too mustshould be 

698 submitted to the Agency under FIFRA section 6(a)(2).. 

699 

700 In addition, since the types of information described above are reportable under 

701 FIFRA section 6(a)(2), these types of information also are reportableEPA will review 

702 information submitted concerning what nanoscale materials are present, including any existing 

703 information not previously provided to the Agency on size and size distribution, manufacturing 

704 process, and adverse effects. EPA will use this and product use information to determine if it 

705 raises any issues, not previously considered, regarding the product’s potential to cause 

706 unreasonable adverse effects on the environment. In some cases, EPA may determine that 

707 additional information is needed to assess such potential; in this case, additional data may be 

708 required including data on physical and chemical properties, rate of nanoscale material release, 

709 and acute, subchronic, and chronic toxicity to human and ecological receptors.

710 

711 V. Reporting the Presence of Nanoscale Materials in Pesticide Products

712 

713 As discussed in Units III and IV of this document, EPA believes that information about what 

714 nanoscale materials are in pesticide products is important to its assessment of whether pesticides 

715 meet the statutory standard for registration. EPA may require such information under either 

716 FIFRA section 6(a)(2) or section 3(c)(2)(B). The Agency believes that announcing the 

717 applicability of FIFRA section 6(a)(2) to this type of information would be the most efficient and 

718 expedient administrative approach to obtaining existing information about nanoscale materials in 

719 pesticides, in which case any registrants with this type of information would be required to report 

720 it to EPA. The Agency is considering, however, an alternative approach under which it would

721 issue DCIs under FIFRA section 3(c)(2)(B) to obtain this information, in which case registrants 

722 that received the DCI would be required to respond. This Unit of the document discusses the

723 two possible approaches and related procedures for obtaining information concerning nanoscale 

724 materials in pesticides.

725 

726 A. FIFRA section 6(a)(2)

727 

728 As mentioned previously, FIFRA section 6(a)(2) and implementing regulations in 40 

729 CFR part 159 require pesticide registrants to report certain information if that information: 
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730 

731 1). Is additional; 

732 

733 2). Is factual; and 

734 

735 3). Regards unreasonable adverse effects on the environment of the pesticide. 

736 

737 Per 40 CFR 159.195, this includes information that, if correct, a registrant knows, or 

738 reasonably should know, would be regarded by EPA, either alone or in conjunction with other 

739 information about the pesticide, as raising concerns about the continued registration of a product 

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

741 

742 Announcing the applicability of FIFRA section 6(a)(2) to information about nanoscale 

743 materials in pesticides would not mean that EPA is expanding its interpretation of FIFRA section 

744 6(a)(2) or changing its regulations. Rather, consistent with EPA’s section 6(a)(2) regulations, 

745 EPA would be merely identifying a set of information that adds to the subset of reportable 

746 section 6(a)(2) data explicitly identified at present under the section 6(a)(2) regulations. 

747 

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

749 FIFRA section 6(a)(2) does not mean that any particular pesticide or group of pesticides, to 

750 which such information pertains, poses a risk. Rather, the requirement merely indicates that 

751 EPA has determined that a particular type of information is relevant to, and may improve the 

752 Agency’s ability to assess, whether the pesticide would cause an unreasonable adverse 

753 environmental effect.

754 

755 As part of this approach, EPA would also require that any such information be reported in 

756 connection with any application to register a pesticide product containing any nanoscale material 

757 (40 CFR 152.50(f)(3)). As with the reporting obligation under FIFRA section 6(a)(2), EPA 

758 would consider the failure to provide these types of information with an application for a product 

759 containing nanoscale material to be a violation of FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). 

760 

761 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 762 calendar 

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

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

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

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

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

768 159.195). The Agency will begin to apply the interpretation announced herein that pertains to 

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

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

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

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

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

774 of this document. 

775 
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776 Finally, although this announcement currently limits this reporting requirement only to 

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

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

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

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

781 announced herein if necessary. 

782 

783 V. After learning that EPA was considering relying on FIFRA 6(a)(2) to require 

784 reporting, some stakeholders raised questions about the use of FIFRA section 6(a)(2) to obtain 

785 this information. Even though, as stated above, EPA is not making a judgment that the presence 

786 of any particular nanoscale material poses a risk, it has been argued that use of the “adverse 

787 effects” reporting authority in FIFRA section 6(a)(2) could create a “stigma” for the 

788 nanotechnology industry.

789 

790 EPA does not believe that using FIFRA Section 6(a)(2) to gather information on the 

791 presence of nanoscale materials in pesticide products would create a stigma for the 

792 nanotechnology industry. EPA’s longstanding interpretation of Section 6(a)(2) is that it is not 

793 limited to requiring reporting only of actual “adverse effects” of pesticides, and its use does not 

794 imply that “adverse effects” actually have occurred, or even could occur, in connection with the 

795 pesticide or pesticide ingredient on which the information is being obtained. FIFRA section 

796 6(a)(2) requires reporting of “additional factual information regarding unreasonable adverse 

797 effects on the environment,” where “unreasonable adverse effects on the environment” is 

798 specifically defined as a risk/benefit standard. EPA’s implementing regulations require reporting 

799 of a wide range of data, which – like information on nanoscale materials – are relevant to EPA’s 

800 risk/benefit evaluations, but which do not indicate the pesticide causes any adverse effects. Any 

801 suggestion that this information gathering proposal implied an EPA position on the adverse 

802 effects of pesticides containing nanoscale materials would be a misinterpretation of EPA’s intent.

803 

804 It is further EPA’s position that merely filing an additional report under FIFRA section 

805 6(a)(2) does not stigmatize pesticides and would not stigmatize any nanomaterials in pesticides, 

806 since filing such reports is quite common. On average, EPA receives 200 studies and 56,000 

807 incident reports per year under this authority. In fact, over the last ten years, pesticide registrants 

808 have filed section 6(a)(2) reports on more than two-thirds of all pesticide active ingredients. 

809 

810 Use of FIFRA section 6(a)(2) also would have only a minimal overall administrative 

811 burden for both EPA and industry. Under section 6(a)(2), only registrants who know that their 

812 products contain nanoscale materials would be required to report to EPA. Further, they would be 

813 required to report only the information they know about. Section 6(a)(2) does not require a 

814 registrant to generate new data or to seek out additional information. Further, registrants and 

815 applicants whose products do not contain nanoscale materials (or who do not know that their 

816 products contain nanoscale materials) would have no reporting obligation under FIFRA section 

817 6(a)(2). Under this approach, EPA would be required to keep track of each response received 

818 under 6(a)(2), but would not otherwise need to prepare or track individual requests for the 

819 information. 

820 

821 B. DCIs under FIFRA section 3(c)(2)(B)

822 
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823 As an alternative to relying on FIFRA section 6(a)(2) to obtain information concerning 

824 nanoscale materials in pesticides, EPA is also considering issuing DCIs under FIFRA section 

825 3(c)(2)(B). The Agency has authority under FIFRA section 3(c)(2)(B) to issue a DCI notice to a 

826 pesticide registrant directing them to provide data “required to maintain in effect an existing 

827 registration of a pesticide . . .” The DCI notice is addressed to an individual registrant, 

828 specifically identifies the information or data that the registrant must provide, prescribes an 

829 initial response deadline of 90 days, and, if data are to be generated, it may prescribe a timeframe 

830 for generating and providing that data. Under FIFRA, EPA can suspend the registration of a 

831 pesticide if the registrant fails to respond to a DCI.

832 

833 As part of this alternate approach, EPA would also need to require the inclusion of this 

834 information with any application for registration of a pesticide product that contains a nanoscale 

835 material. EPA is reviewing whether this could be done under existing regulations or whether 

836 EPA would need to amend existing regulations to clarify that this information is required with 

837 any application for registration. As with the reporting obligation under FIFRA section 6(a)(2), 

838 EPA would consider the failure to provide these types of information with an application for a 

839 product containing nanoscale material to be a violation of FIFRA sections 12(a)(2)(B)(ii) and 

840 12(a)(2)(N).

841 

842 

843 Since EPA's goal is to identify what nanoscale materials are contained in products (and 

844 the products that contain them) and to gather existing information not previously provided to 

845 assess their safety, the DCI would need to require the kinds of information specified in Unit IV 

846 of this document. Because such a request is not consistent with the Re-registration or 

847 Registration Review programs, the Agency would use the Enforcement and Unanticipated

848 Circumstances category available in the currently approved Information Collection Request (73 

849 FR 55072). 

850 

851 Unless a registrant has already disclosed the presence of nanoscale material in all of its 

852 products, there currently is no way to identify with certainty what nanoscale materials are in 

853 products (and the products that contain them). Therefore, in order to identify what nanoscale 

854 materials are in products, EPA could initially send an individual Enforcement and Unanticipated

855 Circumstances DCI order to each of the 1,716 currently registered pesticide producers. Under 

856 this approach each of these pesticide registrants would then be required to respond within 90 

857 days by either providing the requested information about the nanoscale materials in their 

858 product(s) or certifying that their product(s) do not contain nanoscale materials. In addition to 

859 keeping track of each response like under 6(a)(2), the approach under 3(c)(2)(B) could require 

860 EPA to also prepare and track the issuance of individual DCIs for each pesticide registrant, as 

861 well as determine and take any necessary enforcement actions for non-responders. EPA notes 

862 that only pesticide registrants receive DCIs; EPA would need to employ additional 

863 administrative procedures to ensure that applicants also provided such information.

864 

865 A variation on this approach would be for EPA to craft a DCI that would be more 

866 targeted and place less burden on industry and the Agency, possibly by not requiring a response 

867 from recipients of the DCI who do not have (or who do not know that they have) nanoscale 

868 material in their registered pesticide products. The Agency has not used such an approach with 

869 any DCI in the past, however, and a number of issues, including enforcement, would need to be 
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870 addressed if it were to seek to do so here. EPA could also focus its initial data gathering on 

871 certain classes of pesticides that might be most likely to contain a nanoscale material that EPA 

872 would be interested in knowing about. EPA is interested in receiving comments on these 

873 variations.

874 

875 It is useful to note that while FIFRA section 6(a)(2) can be used to obtain existing 

876 information, the DCI approach under FIFRA section 3(c)(2)(B) allows the Agency to request that 

877 data be generated. If EPA uses FIFRA section 6(a)(2) authority and the Agency learns, for 

878 instance, the identity of a nanoscale material present in a product, and subsequently determines 

879 that sufficient data are not available to support the continued registration of the pesticide, EPA 

880 could then use the DCI approach under FIFRA section 3(c)(2)(B) to gather such information. 

881 EPA must use the DCI approach if EPA intends to require a registrant to provide information 

882 which the registrant does not already possess.

883 

884 It is anticipated that some registrants will request that EPA review information to 

885 determine if their product contains nanoscale materials. To the extent that the description of 

886 nanoscale material to a particular product or ingredient is unclear, EPA will review information 

887 concerning the composition and manufacturing process of the pesticide product and, based on 

888 that information, the Agency will determine whether the product does (or does not) contain 

889 nanoscale material.

890 

891 It has been suggested that the use of a 3(c)(2)(B) approach would result in submission of 

892 information that only reflected the composition of registrants’ products at the time of their 

893 responses, but that EPA would need periodically to issue DCIs to insure that registrants did not 

894 alter the composition of the products to add nanoscale materials after submitting their responses. 

895 EPA is interested in receiving comments on options whereby it can ensure registrants report what 

896 nanoscale materials are in products, regardless of when they are added to the pesticide.

897 

898 Under either the 6(a)(2) or the 3(c)(2)(B) approach, DCIs targeted to individual pesticide 

899 products that contain specific nanoscale materials would likely be used in the future to collect 

900 more specific information or data about particular products. EPA would consider doing so on a 

901 case-by-case basis and would tailor any request for information accordingly. 

902 

903 C. Amending the Pesticide Data Requirement Regulations

904 

905 Some stakeholders have suggested, as an alternative to relying on either FIFRA section 

906 6(a)(2) or 3(c)(2)(B) DCIs to obtain information concerning nanoscale materials in pesticides, 

907 that EPA instead promulgate a regulation amending the data requirements in 40 CFR parts 158 

908 and 161. The Agency could amend the data requirements to include disclosure of what nanoscale 

909 materials are present as part of the pesticide registration process. However, completing this 

910 action would not provide information on currently registered pesticide products.

911 

912 The Agency sees such proposed rulemaking with a broader scope in that it would address 

913 not only the basic information such as identifying what nanoscale materials are in products, but 

914 also many other types of data required for making safety evaluations. The Agency is currently 

915 making data need decisions on a case-by-case basis, and EPA is trying to tailor data requirements 

916 to the particular characteristics of each product. The Agency does not yet have the knowledge 
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917 base typically gained through the registration process to support the development of specific data 

918 requirements that would be imposed broadly for the registration of pesticides containing 

919 nanoscale materials across all the application and use scenarios, as required for such a 

920 rulemaking. 

921 

922 Although it could take considerable time to finalize and implement a rule establishing 

923 standard data requirements for pesticides containing nanoscale materials, and the Agency thus 

924 believes that this approach by itself would not generate information on nanoscale ingredients in 

925 pesticides in a timely manner, EPA also seeks comment on this approach. 

926 

927 VI. Proposed Policy Regarding Classification of Applications under FIFRA and PRIA for 

928 Products Containing Nanoscale Active and Inert Ingredients 

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

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

931 FIFRA and PRIA. As discussed in more detail above

932 As discussed in more detail earlier in this document, under FIFRA, all pesticides must 

933 meet stringent statutory and regulatory standards before they are registered by the Agency and 

934 allowed to be marketed and sold. Pesticides containing nanoscale materials, whether as active or 

935 inert ingredients, must meet the same safety standards as other pesticides. Because of the large 

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

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

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

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

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

941 conventionally-sized counterparts. For the same reasons Because the size, shape, and other 

942 characteristics of nanoscale ingredients are likely to vary widely, EPA also proposes to apply an 

943 initial presumption that nanoscale active and inert ingredients are potentially different even from 

944 other, already-registered nanoscale versions of the same ingredients. As explained belowlater in 

945 this document, however, applicants can overcome this presumption on a case-by-case basis. 

946 

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

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

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

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

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

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

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

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

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

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

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

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

959 making the determinations under section 3(c)(7)(A). 

960 

961 As noted abovepreviously, however, once the size of an ingredient is reduced below 

962 approximately 100 nm, a substance can exhibit different properties, and therefore it may also 

963 have different potential environmental health and safety properties. Accordingly, for a product 
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964 containing an ingredient that is a nanoscale version of a conventionally-sized active or inert 

965 ingredient contained in an already- registered product, EPA necessarily willmay require 

966 adequateadditional data in order to determine that the nanoscale material differs only in ways 

967 that do not significantly increase the risk of unreasonable adverse effects on the environment and 

968 that approving the registration in the manner proposed would not significantly increase the risk 

969 of any unreasonable adverse effect on the environment, and/or require different terms and 

970 conditions for the registration. The implication of this thinking, therefore, is that EPA cannot 

971 automatically EPA is thus proposing that it not make the requisite findings absent specific 

972 information on the nanoscale material included in a pesticide product when the application relies 

973 on a comparison to a currently registered pesticide product containing either a non-nanoscale 

974 version of the same ingredient or another nanoscale version of the ingredient that has different 

975 characteristics. TheUnder this approach, the Agency willwould follow the same thinking in 

976 making the statutorily required determinations under FIFRA section 3(c)(7)(B) and 3(c)(7)(C), as 

977 well as FIFRA section 3(c)(5). 

978 

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

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

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

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

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

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

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

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

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

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

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

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

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

992 the environment. 

993 

994 If an applicant cancould make this showing to EPA’s satisfaction, then the application 

995 cwould be processed as a me-too application within the timeframes prescribed for such 

996 applications. However, if an applicant cannotcould not make this showing to EPA’s satisfaction, 

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

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

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

1000 typically required for an assessment of the potential hazards and exposure to a new active or inert 

1001 ingredient. Under this proposed policy, it would also follow that if a registrant wished to change 

1002 the composition of its product to include a nanoscale version of a material that EPA had 

1003 previously approved in non-nanoscale form, the registrant would need to notify EPA and obtain 

1004 EPA approval before making such a change in the composition of its product. However, as 

1005 noted earlier, the registration status of a product would not change merely as a result of

1006 providing information to EPA about the presence of a previously-unreported nanoscale material. 

1007 If EPA made an affirmative finding that a change in status or conditions of use was necessary, 

1008 EPA would notify the registrant in accordance with applicable regulations and procedures.

1009 
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1010 VII. Does This Document Contain Binding Requirements and When Do They Take 

1011 Effect??

1012 

1013 This document announces how FIFRA section 6(a)(2) applies in a particular circumstance. This 

1014 announcement informs registrants that certain information is reportable pursuant to FIFRA section 6(a)(2) and 40 

1015 CFR 159.195. As such, the document explains the applicability of the statute and regulation and makes clear the

1016 requirement also applies to applicants through 40 CFR 152.50(f)(3). As already discussed above, the Agency will 

1017 begin to apply this interpretation 90 days after publication of this document in the Federal Register. seeks 

1018 comments on how the Agency could use FIFRA section 6(a)(2) or FIFRA section 3(c)(2)(B) to 

1019 gain information on what nanoscale materials are in pesticides. Given that the Agency is seeking 

1020 comment before determining its approach to obtaining information on what nanoscale materials 

1021 are in pesticides, there are no binding requirements in this document.

1022 

1023 The Once this document is finalized, the Agency’s proposed policy for determining 

1024 whether a nanoscale material is a new active or inert ingredient for purposes of both FIFRA and 

1025 PRIA iswould be intended only as guidance to EPA personnel and decision-makers and to 

1026 pesticide applicants. While the requirements in the statute and Agency regulations are binding 

1027 on EPA and the applicants, the proposed policy described in this document would not be binding 

1028 on EPA personnel, pesticide applicants, or the public. Accordingly, EPA may depart from the 

1029 policy proposed herein if and when circumstances warrant. Likewise, pesticide applicants may 

1030 assert that the proposed policy is not applicable to a specific pesticide or situation in which EPA 

1031 may be expected to apply it. 

1032 

1033 VIII. Questions for Comment

1034 Notwithstanding the fact that this document 

1035 The Agency is announcing an interpretive rule of general applicability and a separate statement 

1036 of general policy, both of which are exempt from the notice and comment requirements of the 

1037 Administrative Procedure Act, EPA is inviting seeking public comment. 

1038 

1039 With respect to the interpretation, EPA is not seeking comment on several questions, including 

1040 whether information concerning the presence of a nanoscale material in a pesticide product is or it should be 

1041 reportable underuse the FIFRA section 6(a)(2), but we are interested) reporting obligation to obtain 

1042 information on what nanoscale material are in pesticide products or use FIFRA section 

1043 3(c)(2)(B) as described in comment on the clarity of the interpretation and whether the this document to 

1044 obtain such information. 

1045 

1046 With respect to the scope of reportable information should be expanded. EPA 

1047 specifically invites comments on the following issues: 

1048 

1049 1. In view of the Agency’s goal of identifying what nanoscale materials are in products so 

1050 that EPA can determine whether it needs additional data to evaluate the products’ safety 

1051 under FIFRA, should EPA change the description of a “nanoscale material”? For 

1052 example, should the size range remain “between approximately 1 and 100 nm in one 

1053 dimension”? Are there other characteristics that EPA should consider, e.g., morphology, 

1054 including shape and crystal structure; surface chemistry and reactivity; specific surface 

1055 area, charge; solubility; conductive, magnetic, and optical properties?

1056 
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1057 1.2.Should the reporting requirement apply only to nanoscale material that is “intentionally 

1058 produced to have at least one dimension that measures between approximately 1 and 100 

1059 nanometers,” or should it also apply to naturally occurring materials? Why? 

1060 

1061 3. Is the meaning of “intentionally produced” sufficiently clear? If not, in what 

1062 circumstances would the term be unclear and how might it be clarified? Would offering 

1063 a consultation procedure – by which a registrant or applicant describes to EPA the 

1064 production process that results in the presence of a material in the nanoscale size range, 

1065 and EPA responds with a determination regarding whether reporting is required – be an 

1066 acceptable approach to providing clarity?

1067 

1068 2.4.Should the reporting requirement apply to ingredients in pesticides that contain any 

1069 amount of a nanoscale material, or should the requirement apply only if an ingredient 

1070 contains more than a specified percentage (e.g., 10%) of nanoscale material? If the latter, 

1071 what should the specified percentage be and why? 

1072 

1073 3.5.How should the reporting requirement apply to a pesticide manufacturer who purchases 

1074 ingredients that may contain nanoscale material? 

1075 

1076 6. Are there ways in which the description of “nanoscale materials” can be refined and 

1077 clarified, including ways in which agglomeration and aggregation could be considered as 

1078 well as suggestions for ways in which more subjective criteria, such as “unique or novel 

1079 properties” can be incorporated into the screening criteria?

1080 7. Is EPA’s description of “nanoscale material” inconsistent with other definitions of 

1081 nanoscale material or similar terms? If so, please comment on whether such differences 

1082 create any regulatory issues. In particular, does the focus on “intentionally produced” 

1083 materials create any such inconsistency with other definitions of nanoscale materials or 

1084 similar terms?

1085 

1086 8. If a pesticide is identified as containing a particular nanoscale material, what would be 

1087 the most useful next steps to inform EPA’s understanding of potential risks associated 

1088 with the pesticide? Are there tests that could provide useful information toward an 

1089 understanding of risk that would be common to all nanoscale materials, or should the data 

1090 requirements necessarily be compound- and situation- specific? How should 

1091 bioavailability be considered in determining testing requirements (e.g., are nano-particles 

1092 respirable or bound to other components)? 

1093 

1094 With respect to the proposed policyapproaches, EPA is seeking comment on how to 

1095 implement itthem to ensure efficient, effective, and timely review of applications. EPA 

1096 specifically invites comments on the following issues: 

1097 

1098 1. Is there a way to determine, in advance of receiving an application for registration of a 

1099 product containing a nanoscale material, whether a particular kind of nanoscale material 

1100 has properties that, for purposes of risk assessment, are essentially the same as larger 

1101 sized materials of the same substance? If so, how would such determinations be made 

1102 and on what would they be based? 
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1103 

1104 2. What kinds of information should EPA accept as demonstrating that a pesticide product 

1105 containing a nanoscale ingredient is identical or substantially similar to a currently 

1106 registered pesticide or differs only in ways that would not significantly increase the risk 

1107 of unreasonable adverse effects on the environment, and that approving the registration in 

1108 the manner proposed would not significantly increase the risk of any unreasonable 

1109 adverse effect on the environment? 

1110 

1111 3. Can you suggest any alternative(s) to the proposed policyapproaches that would be 

1112 equally or even more effective in addressing the status of nanoscale materials as new 

1113 active or inert ingredients for purposes of both FIFRA and PRIA, keeping in mind the 

1114 growing body of data showing that size, especially when reduced below approximately 

1115 100 nm, may alter the manner in which materials behave and, in turn, the potential risk to 

1116 human health and the environment associated with such materials? 

1117 

1118 VIII. With respect to the potential alternative ways of obtaining the needed information

1119 on what nanoscale materials are in pesticide products, EPA specifically invites comments on the 

1120 following issues:

1121 

1122 1. Has EPA appropriately characterized in this document the current scientific 

1123 understanding of the potential risks of nanoscale materials? If not, please comment on 

1124 how to characterize the potential risks of nanoscale materials. How would the perception 

1125 of the risks of nanoscale materials differ depending on the approach used by EPA to 

1126 require needed data on nanoscale materials in pesticide? How could EPA lessen the 

1127 possibility that issuance of a final requirement to report what nanoscale materials are in 

1128 pesticides will result in a public misunderstanding of the potential risks of 

1129 nanotechnology more generally? 

1130 

1131 2. Do commenters believe that identification of the nanoscale materials in pesticide 

1132 products is relevant to EPA’s statutory determination regarding the potential for 

1133 unreasonable adverse effects on the environment? Please provide the scientific or legal 

1134 basis for your view.

1135 

1136 3. Has EPA characterized the alternative approaches with respect to which they would: a) 

1137 result in a misunderstanding of the potential risks posed by nanoscale materials; b) result 

1138 in the timely submission of needed information; and c) impose burdens on pesticide 

1139 companies, those whose products do, and do not, contain nanoscale materials? If not, 

1140 please comment on those issues.

1141 

1142 4. If EPA uses FIFRA section 6(a)(2) to obtain the needed information on nanoscale 

1143 materials in pesticides, how could the Agency ensure that its action is not 

1144 mischaracterized or misunderstood as a determination that the mere fact that a pesticide 

1145 contains nanoscale materials causes unreasonable adverse environmental effects?

1146 

1147 5. If EPA were to use DCIs to obtain the needed information on nanoscale materials in 

1148 pesticides, how could EPA reduce both the burdens on registrants and on EPA, as well as 

1149 the time required to complete such a process? For example, is it possible to reduce the 
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Page 26 of 30 

1150 burdens on registrants by targeting only certain types of products? If so, how would EPA 

1151 determine which products should receive DCIs?

1152 

1153 6. What are the advantages and disadvantages of requesting information on nanoscale 

1154 materials specifically versus requesting information on size distribution generally? (Note 

1155 that either type of information could be collected under either the 6(a)(2) or the 

1156 3(c)(2)(B) approach, except that 6(a)(2) cannot be used to require the production of new 

1157 information that does not already exist, while a collection under 3(c)(2)(B) must be 

1158 directed to an individual registrant and requires a response.) Is identifying what 

1159 nanoscale materials are in products a useful first step, or should EPA move towards 

1160 immediate collection of more specific information, such as particle size distribution, on 

1161 products that might contain nanoscale materials? Are there other physical and/or 

1162 chemical properties that might be equally or more important for assessing the potential of 

1163 a pesticide to cause unreasonable adverse effects on the environment (e.g., morphology, 

1164 including shape and crystal structure; surface chemistry and reactivity; specific surface 

1165 area, charge; solubility; conductive, magnetic, and optical properties)? Should 

1166 information on these properties be separately requested? What would be the value and 

1167 burden of obtaining such information?

1168 7. If EPA were to use rulemaking to establish data requirements for pesticides containing 

1169 nanoscale materials, what types of information should EPA use to determine appropriate 

1170 data requirements? What types of studies should EPA require to evaluate a nanoscale 

1171 material?

1172 

1173 8. When choosing an approach for obtaining needed data, how should EPA weigh 

1174 considerations relating to the need to update its safety evaluations of currently marketed 

1175 pesticides in a timely manner, the goal of ensuring marketplace equity, and the interest in 

1176 minimizing the burdens on regulated entities?

1177 

1178 IX. References 

1179 

1180 As indicated under ADDRESSES, a docket has been established for this document under 

1181 docket ID number EPA-HQ-OPP-2010-0197. The following is a listing of the documents that 

1182 are specifically referenced in this document. The docket includes these documents and other 

1183 information considered by EPA, including documents that are referenced within the documents 

1184 that are included in the docket, even if the referenced document is not physically located in the 

1185 docket. For assistance in locating these other documents, please consult the technical contact 

1186 listed under FOR FURTHER INFORMATION CONTACT.

1187 

1188 1. Oberdörster, G. et al., 2005. Nanotoxicology: an emerging discipline evolving from 

1189 studies of ultrafine particles. Environmental Health Perspectives. (113): 823-839.

1190 

1191 1.2.National Nanotechnology Initiative. 2004. Strategic Plan. 

1192 http://www.nano.gov/NNI_Strategic_Plan_2004.pdf.

1193 Cheng et al. 2007. Effect of carbon nanotubes on developing zebrafish (Danio rerio) 

1194 embryos. Environ. Toxicol. Chem. 26:708–716.
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Page 27 of 30 

1195 2.3.Department of Health and Human Services. Centers for Disease Control and Prevention. 

1196 National Institute for Occupational Safety and Health. Approaches to Safe 

1197 Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered 

1198 Nanomaterials. November 2009. http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-

1199 125.pdf (November 2009)..

1200 

1201 3. Donaldson, K. et al., 2000. Ultrafine Particles: Mechanisms of Lung Injury. Philosophical 

1202 Transactions: Mathematical, Physical and Engineering Sciences. 358 (1775): 2741-2749.

1203 

1204 4. Donaldson, K. et al., 2002. Inflammation Caused by Particles and Fibers. Inhalation 

1205 Toxicology. 14 (1): 5-27. 

1206 

1207 5. Duffin, R. et al., 2002. The Importance of Surface Area and Specific Reactivity in the 

1208 Acute Pulmonary Inflammatory Response to Particles. Annals of Occupational Hygiene. 

1209 46 (1): 242-245. 

1210 

1211 6. Federici et al. 2007, Toxicity of titanium dioxide to rainbow trout (Oncorhynchus 

1212 mykiss): Gill injury, oxidative stress, and other physiological effects. Aquat. Toxicol. 84:

1213 415–430.

1214 

1215 7. FIFRA Science Advisory Panel (SAP). 2010. “Evaluation of Hazard and Exposure 

1216 Associated with Nanosilver and Other Nanometal Pesticide Products.” Report from the 

1217 FIFRA Scientific Advisory Panel Meeting of November, 2009. FIFRA Scientific 

1218 Advisory Panel, Office of Science Coordination and Policy, Office of Prevention, 

1219 Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Washington, 

1220 DC. Available: http://www.epa.gov/scipoly/sap/2009. 

1221 

1222 8.1.Handy et al. 2008, The ecotoxicology and chemistry of manufactured nanoparticles. 2008.

1223 Ecotoxicology 17:287-314.

1224 9.1.Kashiwada et al. 2006. Distribution of nanoparticles in the see-through Medaka (Oryzias 

1225 latipes). Environ. Health Perspect. 114: 1697–1702.

1226 

1227 10. Kim, Y.S. et al., 2008. Twenty-Eight Day Oral Toxicity, Genotoxicity, and Gender1228 Related Tissue Distribution of Silver Nanoparticles in Sprague-Dawley Rats. Inhalation 

1229 Toxicology. 20 (6): 575-583.Klaine et al. 2008. Nanomaterials in the Environment: 

1230 Behavior, Fate, Bioavailability, and Effects. Environ..Toxicol..Chem.. 27: 1825-1851.

1231 

1232 11.1. Lovern and Klaper 2006. Daphnia magna mortality when exposed to titanium 

1233 nanoparticles and fullerene (C60) nanoparticles. Environ. Toxicol. Chem. 25: 1132–1137.

1234 

1235 12.1. National Nanotechnology Initiative. 2004. Strategic Plan. 

1236 http://www.nano.gov/NNI_Strategic_Plan_2004.pdf.Oberdörster, G. et al., 2005. 

1237 Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. 

1238 Environmental Health Perspectives. (113): 823-839.

1239 
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Page 28 of 30 

1240 13.1. Oberdorster et al. 2006. Ecotoxicology of carbon-based engineered nanoparticles: 

1241 effects of fullerene (C-60) on aquatic organisms. Carbon 44: 1112-1120.

1242 

1243 14.1. Roberts et al. 2007. In vivo biomodification of lipidcoated carbon nanotubes by 

1244 Daphnia magna. Environ. Sci. Technol. 41: 3025–3029

1245 

1246 15.4. SCENIHR, 2009. Risk Assessment of Products of Nanotechnologies. European 

1247 Commission. Directorate-General for Health and Consumers. Scientific Committee on 

Emerging and Newly Identified Risks, Brussels: 28th 1248 Plenary Meeting. January 19, 2009. 

1249 http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf. 

1250 

1251 16.5. Seaton, A. et al., 2009. Nanoparticles, human health hazard and regulation. 

1252 Journal of the Royal Society, published online at:. August 31, 2009. 

1253 http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#

1254 ref-14. 

1255 

1256 6. Wick, P. et al., U.S. Department of Health and Human Services, National Institutes of 

1257 Health. 2009. http://ehp.niehs.nih.gov/members/2009/0901200/0901200.pdf.

1258 

1259 17.7. Kim, Y.S. et al., 2008. Twenty-Eight Day Oral Toxicity, Genotoxicity, and 

1260 Gender-Related Tissue Distribution of Silver Nanoparticles in Sprague-Dawley Rats. 

1261 Inhalation Toxicology. 20 (6): 575-583.

1262 8. Handy et al. 2008, The ecotoxicology and chemistry of manufactured nanoparticles. 2008.

1263 Ecotoxicology 17:287-314.

1264 9. Klaine et al. 2008. Nanomaterials in the Environment: Behavior, Fate, Bioavailability, 

1265 and Effects. Environ. Toxicol. Chem. 27: 1825-1851.

1266 

1267 18.10. Federici et al. 2007, Toxicity of titanium dioxide to rainbow trout (Oncorhynchus 

1268 mykiss): Gill injury, oxidative stress, and other physiological effects. Aquat. Toxicol. 84:

1269 415–430.

1270 19.11. Smith et al. 2007. Toxicity of single walled carbon nanotubes on rainbow trout 

1271 (Oncorhyncos mykiss): Respiratory toxicity, organ pathologies, and other physiological 

1272 effects. Aquat. Toxicol. 84: 415–430. 

1273 12. Lovern and Klaper 2006. Daphnia magna mortality when exposed to titanium 

1274 nanoparticles and fullerene (C60) nanoparticles. Environ. Toxicol. Chem. 25: 1132–1137.

1275 

1276 13. Oberdorster et al. 2006. Ecotoxicology of carbon-based engineered nanoparticles: 

1277 effects of fullerene (C-60) on aquatic organisms. Carbon 44: 1112-1120.

1278 

1279 14. Roberts et al. 2007. In vivo biomodification of lipidcoated carbon nanotubes by Daphnia 

1280 magna. Environ. Sci. Technol. 41: 3025–3029

1281 

1282 15. Kashiwada et al. 2006. Distribution of nanoparticles in the see-through Medaka (Oryzias 

1283 latipes). Environ. Health Perspect. 114: 1697–1702.
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1284 

1285 16. Cheng et al. 2007. Effect of carbon nanotubes on developing zebrafish (Danio rerio) 

1286 embryos. Environ. Toxicol. Chem. 26:708–716.

1287 

1288 17. Kahru and Dubourguier 2010. Review: From ecotoxicology to nanoecotoxicology. 

1289 Toxicology 269:105-119.

1290 

1291 20.18. FIFRA Science Advisory Panel (SAP). 2010. “Evaluation of Hazard and 

1292 Exposure Associated with Nanosilver and Other Nanometal Pesticide Products.” Report 

1293 from the FIFRA Scientific Advisory Panel Meeting of November, 2009. Wick, P. et al., 

1294 U.S. Department of Health and Human Services, National Institutes of Health. 

1295 http://ehp.niehs.nihwww.epa.gov/membersscipoly/sap/2009/0901200/0901200.pdf.

1296 

1297 VIIIX. Applicable Statutory and Executive Order Reviews 

1298 EPA submitted this document to the Office of Management and Budget (OMB) for 

1299 review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

1300 October 4, 1993). Any changes made in response to OMB recommendations have been 

1301 documented in the docket for this action as required by section 6(a)(3)(E) of the Executive Order. 

1302 The information collection requirements associated with reporting under FIFRA section 

1303 6(a)(2) as prescribed in 40 CFR part 159, subpart D are approved under the Paperwork 

1304 Reduction Act (PRA), 44 U.S.C. 3501 et seq. The approval is identified under OMB Control No. 

1305 2070-0039 and EPA ICR No. 1204. The information collection requirements associated with 

1306 DCIs is approved under OMB Control No. 2070-0174 and identified by EPA ICR No. 2288. If 

1307 EPA were to finalize a policy that required additional reporting of information not currently 

1308 collected, or that substantively changed the burden for such reporting (for example if it resulted 

1309 in a larger number of such reports than covered in current burden estimates), EPA would submit 

1310 a request for revised PRA approval to OMB. 

1311 The various other statutory and Executive Order review requirements that apply to a 

1312 regulatory action do not apply to this action because this document is not a regulatory action and 

1313 does not otherwise impose new requirements. As indicated previously this document clarifies 

1314 the applicability of the statute and existing regulation regarding reporting under FIFRA section 

1315 6(a)(2)requests comment on several approaches for applying existing requirements in order to 

1316 obtain information on nanoscale materials in pesticide products and presents the Agency’s 

1317 proposed policy for determining whether a nanoscale material is a new active or inert ingredient 

1318 for purposes of both FIFRA and PRIA. 

1319 List of Subjects 

1320 Environmental protection, administrative practice and procedure, pesticides, 

1321 nanotechnology. 

1322 

1323 Dated: ________ 
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1324 ________________ 

1325 Assistant Administrator for Chemical Safety and Pollution Prevention. 

1326 [FR Doc. 10–???? Filed ??–??–10; 8:45 am]

1327 BILLING CODE 6560–50–S