National Organic Standards Board

Materials/GMO Subcommittee

Proposal - Technical Review template update

February 13, 2024

Intro/Background:

The Materials Subcommittee (MS) is proposing updates to the Technical Review (TR) templates to better 

align with the petition process and OFPA criteria and to directly address excluded methods. 

The NOSB Policy and Procedures Manual defines a technical review as follows: “Technical Review - A 

report prepared by a third-party expert under contract addressing the environmental, human, and 

industrial impact of a petitioned material per the OFPA and regulatory evaluation criteria to aid in the 

thorough evaluation of that material by the NOSB.” According to the PPM, “A Subcommittee cannot 

proceed with a recommendation to list a material if it is determined that there is insufficient valid 

scientific information on that material’s impact on the environment, human health and its compatibility 

with organic principles.” The two revised TR templates, one for Handling and one for Crops/Livestock 

are included as Appendices to this proposal. Also included as appendices are the two versions with 

redlining. 

Discussion: 

The Materials Subcommittee submitted a discussion document on the TR updates for comment at the 

Spring 2023 meeting. Public commenters were supportive of the initiative to reorganize the flow of 

questions, reduce redundancy, and suggested additional questions for ancillary substances, 

nanoparticles, and excluded methods. The suggested changes were incorporated into the templates, 

and in January 2024, the MS voted unanimously in support of the versions of the TR templates included 

in the appendices. 

Questions to stakeholders: 

Do the proposed revisions to the technical report (TR) templates for Handling and Crops/Livestock raise 

any concerns or challenges for stakeholders that create and/or use TRs?

Subcommittee Vote: 

Motion to accept the technical Report template updates for Handling and Crops/Livestock. 

Motion by: Mindee Jeffery

Seconded by: Nate Lewis

Yes: 7 No: 1 Abstain: 0 Absent: 0 Recuse: 0

Appendix A1 - Redlined version of TR template: Handling

Appendix A2 - New version of TR template: Handling 

Appendix B1 - Redlined version of TR template: Livestock/Crops

Appendix B1 - New version of TR template: Livestock/Crops

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Name of Material 

Handling/Processing

___________________________________

[Insert date transmitted to NOP] Technical Evaluation Report Page 1 of 9 

Compiled by (Name of Contractor) for the USDA National Organic Program

1 

2 Identification of Petitioned Substance

3 Chemical Names:

4 List all chemical names

5 

6 Other Name:

7 List other names

8 

9 Trade Names:

10 List trade names

CAS Numbers: 

List CAS numbers

Other Codes:

List other codes (e.g., INS number, E number, 

etc.)

11

12 Summary of Petitioned Use

13

14 For petitions to add or amend a substance, describe the petitioned use of the substance. For substances currently 

15 on the National List, summarize the allowed uses under the USDA organic regulations (7 CFR Part 205). 

16

17 Characterization of Petitioned Substance

18

19 Composition of the Substance: 

20 Describe Composition of the Substance

21

22 Source or Origin of the Substance:

23 Briefly describe the source or origin of the substance (to be addressed in more detail below under 

24 Evaluation Questions 1 through 4).

25

26 Properties of the Substance: 

27 Describe Physical and Chemical Properties of the Substance

28

29 Specific Uses of the Substance: 

30 Describe Specific Uses of the Substance - primary focus should be given to describing the petitioned use of 

31 the substance as it relates to organic handling; secondary focus should be given to providing general 

32 information on other uses of the petitioned substance in agricultural handling/processing. 

33

34 Approved Legal Uses of the Substance:

35 Describe the Status of the Petitioned Substance under applicable Federal Regulations (i.e., EPA, FDA, 

36 USDA (including APHIS or FSIS), NIEHS, etc.)

37

38 Action of the Substance: 

39 Describe Action of the Substance – focus should be given to describing mode of action of the substance, 

40 when used as petitioned.

41

42 Combinations of the Substance:

43 Describe Combinations of the Substance – focus should be given to describing whether the petitioned 

44 substance is a precursor to, component of, or commonly used in combination with a substance(s) identified 

45 on the National List. Any known synergistic effects (either positive or negative) with other substances on 

46 the National List should be identified.

47

48 In addition, information should be provided on whether any additional ingredients (e.g., inert ingredients, 

49 stabilizers, preservatives, carriers, anti-caking agents, or other materials) are generally added to 

50 commercially available forms of the petitioned substance.

Appendix A1: TR Template with redlines - Handling/Processing

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51

52

53 Status 

54

55 Historic Use:

56 Describe historic use of the substance in organic agricultural production (if no historic use in organic 

57 agricultural production, please describe historic use in conventional agricultural production).

58

59 Organic Foods Production Act, USDA Final Rule: 

60 Describe whether the Petitioned Substance is Listed anywhere in the Organic Foods Production Act of 1990 

61 (OFPA) or the USDA organic regulations, 7 CFR Part 205.

62

63 International 

64

65 Describe the status of the substance among international organizations. Specifically, the report should 

66 address whether the petitioned substance is allowed or prohibited for use in other international organic 

67 standards such as: 

68

69 Canada, Canadian General Standards Board— 

70

71 CAN/CGSB-32.310- Organic production systems-General principles and management standards

72 CAN/CGSB-32.311-2015, Organic Production Systems Permitted Substances List

73 http://www.inspection.gc.ca/food/organic-products/standards/eng/1300368619837/1300368673172 

74

75 CODEX Alimentarius Commission—Guidelines for the Production, Processing, Labelling and 

76 Marketing of Organically Produced Foods (GL 32-1999)

77 http://www.fao.org/docrep/005/Y2772E/Y2772E00.HTM

78 Note: For Codex, the reference should be cited as “guidelines,” rather than as “standards”.

79

80 European Economic Community (EEC) Council Regulation—EC No. 834/2007 and 889/2008

81 http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008R0889 

82 

83 Japan Agricultural Standard (JAS) for Organic Production

84 http://www.maff.go.jp/e/jas/specific/criteria_o.html 

85

86 International Federation of Organic Agriculture Movements (IFOAM)

87 http://www.ifoam.bio/en/ifoam-norms 

88

89

90 Evaluation Questions for Substances to be used in Organic Handling

91

92 [combination of old #1, 2 &3 – word smithed and added D, E and F] 

93 Evaluation Question #1: Describe the most prevalent processes used to manufacture or formulate the 

94 petitioned substance. Further, describe any chemical change that may occur during manufacture or 

95 formulation of the petitioned substance when this substance is extracted from naturally occurring plant, 

96 animal, or mineral sources (7 U.S.C. § 6502 (21)). (A) Describe if the substance is extracted from naturally 

97 occurring plant, animal, or mineral sources. (B) Describe the most prevalent processes used to 

98 manufacture or formulate the petitioned substance. Include any chemical changes that may occur 

99 during manufacture or formulation of the substance. (C) Discuss whether the petitioned substance is 

100 agricultural or Non-agricultural. If the substance is Non-agricultural, is it synthetic or non-synthetic? [7 

101 U.S.C. §6502(21); NOP 5032-1; NOP 5033-2]. (D) Does the substance in its raw or formulated forms 

102 contain nanoparticles? (E) Does the substance in its raw or formulated forms contain ancillary 

103 substances (F) Is the substance created using Excluded Methods?

104

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105 Data Required: The response must describe the processes used to manufacture or formulate the substance, 

106 including a discussion of all precursors and/or feedstocks. A description of alternate manufacturing 

107 methods which are not included in the petition, if any, should be presented. The response must also 

108 describe, in detail, any chemical changes effected on any naturally occurring precursor or feedstock by all 

109 manufacturing or formulation processes. For the purposes of this response, a chemical change could be the 

110 addition or deletion of one atom to the substance’s molecular structure or other description of chemical 

111 modification.

112 (A) If the substance is extracted from a natural material, information should be provided on any 

113 materials and methods used to extract, separate, isolate, or withdraw the substance, including any 

114 solvents used, acid-base extraction methods, or mechanical or physical separation methods. If the 

115 substance is created by a naturally occurring biological process, those process(es) must be 

116 described in detail. 

117

118 For the purposes of this response, naturally occurring biological processes are processes that 

119 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, 

120 various metabolic processes, and photosynthesis.

121

122 (B) The response must describe the processes used to manufacture or formulate the substance, 

123 including a discussion of all precursors and/or feedstocks. A description of alternate 

124 manufacturing methods and the extent of their commercial use which are not included in the 

125 petition, if any, should be presented. The response must also describe, in detail, any chemical 

126 changes effected on any naturally occurring precursor or feedstock by all manufacturing or 

127 formulation processes. If any synthetic materials used in the production or extraction of a 

128 substance remain in the final product, describe them.

129

130 For the purposes of this response, a chemical change involves a process (i.e., chemical reaction) 

131 whereby a substance is transformed into one or more other distinct substances. This may include 

132 the addition or deletion of one atom to the substance’s molecular structure or other description of 

133 chemical modification. 

134

135 Chemical processes include, but are not limited to: acid base reactions, calcification, thermal or 

136 catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation137 reduction, polymerization, etc., obtained through process units such as compressors, cracking 

138 towers, heat exchangers, mixers, reactors, pumps, etc.

139

140 (C) Based on the information provided on (A) and (B), the definition of synthetic at 7 U.S.C. § 6502 (22) 

141 NOP Guidance 5033-1 and NOP Guidance 5033-2, describe if the substance can be classified as 

142 agricultural or non-agricultural.

143

144 (D) Nano Particles: Does the substance in its raw or formulated forms contain nanoparticles? If so, are 

145 they engineered nanomaterials or incidental nanomaterials as defined by the NOSB and NOP? 

146 (Policy Memo 15-2)

147

148 (E) Ancillary Substances: Does the substance in its raw or formulated forms contain ancillary 

149 substances as defined by the NOSB in the 2016 recommendation? 

150 (https://www.ams.usda.gov/sites/default/files/media/HS%20Ancillary%20Substance%20Propo

151 sal%20NOP.pdf) 

152

153 (F) Excluded Methods:

154 i. Is the substance created using excluded methods? This includes but is not limited 

155 to the following list of techniques found to be “excluded methods” by the NOSB: 

156 Targeted genetic modification (TagMo), Synthetic gene technologies, Genome 

157 engineering, Gene editing, Gene targeting, Gene Silencing, Accelerated plant 

158 breeding techniques, Synthetic Biology, cloned animals and offspring, plastid 

159 transformation, cisgenesis, intragenesis, agro-infiltration, transposons developed 

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160 using invitro nucleic acid techniques, induced mutagenesis developed through in 

161 vitro nucleic acid techniques, cell and protoplast fusion (NOP policy Memo 13-1).

162 ii. If the substance is manufactured from agricultural raw materials, are those 

163 materials derived from genetically engineered crop, or crops resulting from 

164 excluded methods?

165 iii. If the substance is manufactured from other biological raw materials—such as 

166 those produced by fermentation or enzymatic action—are those biological 

167 materials, derived from genetically engineered organisms, or crops organisms 

168 resulting from excluded methods? 

169

170

171 [old #4] Evaluation Question #2: Discuss whether the petitioned substance is formulated or 

172 manufactured by a chemical process, or created by naturally occurring biological processes (7 U.S.C. § 

173 6502 (21)). Discuss whether the petitioned substance is derived from an agricultural source. Specify 

174 whether the petitioned substance is categorized as generally recognized as safe (GRAS) when used 

175 according to FDA’s good manufacturing practices (7 CFR 205.600(b)(5)). If not categorized as GRAS, 

176 describe the regulatory status.

177

178 Data Required: For the purposes of this response, chemical processes are processes include, but are not 

179 limited to, acid base reactions, calcification, thermal or catalytic cracking, esterification, hydrogenation, 

180 mixing of substances or elements, oxidation-reduction, polymerization, etc., obtained through process units 

181 such as compressors, cracking towers, heat exchangers, mixers, reactors, pumps, etc.

182

183 If the substance is extracted from a natural material, information should be provided on any materials and 

184 methods used to extract, separate, isolate, or withdraw the substance, including any solvents used, acid185 base extraction methods, or mechanical or physical separation methods.

186

187 If the substance is created by a naturally occurring biological process, those process(es) must be described 

188 in detail. For the purposes of this response, naturally occurring biological processes are processes that 

189 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various 

190 metabolic processes, and photosynthesis.

191

192 Information should be provided on whether the substance has been chemically modified from the source 

193 or origin of the substance, including whether the substance has been isolated from a natural source in a 

194 form that does not occur in nature, and whether any synthetic materials used in the production or 

195 extraction of a substance may remain in the final product.

196

197 For the purposes of this response, an agricultural source is any agricultural commodity or product, 

198 whether raw or processed, including any commodity or product derived from livestock that is marketed in 

199 the United States for human or livestock consumption.

200 

201 Purpose and necessity of the substance

202

203 [old #5] Evaluation Question #3: If the substance is a synthetic substance, provide a list of nonsynthetic 

204 or natural source(s) of the petitioned substance (7 CFR 205.600(b)(1)). Describe whether the primary 

205 technical function or purpose of the petitioned substance is a preservative (7 CFR 205.600(b)(4)).

206

207 Data Required: The response must discuss whether non-synthetic or natural sources of the petitioned 

208 substance exist and are available. The report contractor should examine the effect, form, function, quality, 

209 and quantity of the naturally sourced version of the petitioned substance, in comparison to manufactured 

210 versions. The following information on any naturally sourced versions should be provided in the report: 

211

212 • literature, including product or practice description, on performance and test data; 

213 • name and address of the manufacturer(s), if applicable; and,

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214 • types of products the substance is currently used in. 

215 The response must explain why the primary function of the substance is or is not as a preservative.

216

217 [old #6] Evaluation Question #4: Specify whether the petitioned substance is categorized as generally 

218 recognized as safe (GRAS) when used according to FDA’s good manufacturing practices (7 CFR 

219 205.600(b)(5)). If not categorized as GRAS, describe the regulatory status. Describe whether the 

220 petitioned substance will be used primarily to recreate or improve flavors, colors, textures, or nutritive 

221 values lost in processing (except when required by law). If so, how? (7 CFR 205.600(b)(4)).

222

223 Date Required: The response must indicate whether or not the substance has been determined to be GRAS 

224 by FDA. This information may be found in 21 CFR Parts 182, 184, and 186. If not determined to be GRAS 

225 by FDA, indicate whether it appears on FDA’s "GRAS Notice Inventory" available at 

226 http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing. 

227

228 The response should cite the FDA regulatory citation confirming GRAS status or whether FDA has 

229 provided a response letter of no objection to a manufacturer’s notification of GRAS status. When 

230 replacement or improvement of nutrients is required or allowed by regulation, the report evaluators 

231 should cite the appropriate regulations.

232

233 [old #7] Evaluation Question #5: Describe whether the primary technical function or purpose of the 

234 petitioned substance is a preservative. If so, provide a detailed description of its mechanism as a 

235 preservative (7 CFR 205.600(b)(4)). Describe any effect or potential effect on the nutritional quality of 

236 the food or feed when the petitioned substance is used (7 CFR 205.600(b)(3)).

237

238 Data Required: The response must explain why the primary function of the substance is or is not as a 

239 preservative. The response must indicate whether the use of the petitioned substance affects the levels of 

240 nutrients (e.g., proteins, carbohydrates, fats, vitamins, and minerals) commonly found in the food product. 

241 Effects may include increasing or decreasing the amount and/or bioavailability of the nutrients.

242

243 Environment and human health effects

244

245 [old #8] Evaluation Question #6: Describe whether the petitioned substance will be used primarily to 

246 recreate or improve flavors, colors, textures, or nutritive values lost in processing (except when required 

247 by law) and how the substance recreates or improves any of these food/feed characteristics (7 CFR 

248 205.600(b)(4)). List any reported residues of heavy metals or other contaminants in excess of FDA 

249 tolerances that are present or have been reported in the petitioned substance (7 CFR 205.600(b)(5)).

250

251 Data Required: When replacement or improvement of nutrients is required or allowed by regulation, the 

252 report evaluators should cite the appropriate regulations. The response must indicate whether the 

253 petitioned substance may contain residues of substances that exceed FDA’s Action Levels for Poisonous or 

254 Deleterious Substances in Human Food. For the most part, these action levels will relate to residues found 

255 in agricultural products. Heavy metals or contaminants are addressed through FDA’s action levels. 

256 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-action-levels257 poisonous-or-deleterious-substances-human-food-and-animal-feed See the latest edition of Food Chemicals 

258 Codex (National Research Council) for accepted reference standards for metals and other contaminants in 

259 food ingredients in the U.S.

260

261 [old #9] Evaluation Question #7: Describe any effect or potential effect on the nutritional quality of the 

262 food or feed when the petitioned substance is used (7 CFR 205.600(b)(3)). Discuss and summarize 

263 findings on whether the manufacture and use of the petitioned substance may be harmful to the 

264 environment or biodiversity (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i)).

265

266 Data Required: The response must indicate whether the use of the petitioned substance affects the levels of 

267 nutrients (e.g., proteins, carbohydrates, fats, vitamins, and minerals) commonly found in the food product. 

268 Effects may include increasing or decreasing the amount and/or bioavailability of the nutrients. In 

269 consideration of the petitioned substance, its manufacturing process, and its breakdown products, describe 

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270 the mode of action of the substance with respect to its effects on biological, chemical and physical effects on 

271 the environment or biodiversity. The analysis must include consideration of potential effects on both 

272 terrestrial and aquatic systems and effects on arthropod natural enemies (e.g., predators and parasitic 

273 hymenoptera), pollinators, bats and birds.

274

275 [old #10] Evaluation Question #8: List any reported residues of heavy metals or other contaminants in 

276 excess of FDA tolerances that are present or have been reported in the petitioned substance (7 CFR 

277 205.600(b)(5)). Describe and summarize any reported effects upon human health from use of the 

278 petitioned substance (7 U.S.C. § 6517(c)(1)(A)(i), 7 U.S.C. § 6517(c)(2)(A)(i)) and 7 U.S.C. § 6518(m)(4)).

279

280 Data Required: The response must indicate whether the petitioned substance may contain residues of 

281 substances that exceed FDA’s Action Levels for Poisonous or Deleterious Substances in Human Food. For 

282 the most part, these action levels will relate to residues found in agricultural products. Heavy metals or 

283 contaminants are addressed through FDA’s action levels. These action levels can be found at 

284 https://www.fda.gov/food/guidanceregulation/ucm077969. See the latest edition of Food Chemicals 

285 Codex (National Research Council) for accepted reference standards for metals and other contaminants in 

286 food ingredients in the U.S. Describe reported health effects and causation that may be attributed to the use 

287 of the petitioned substance and/or its breakdown products. 

288

289 Alternatives

290

291 [old #3] Evaluation Question #9: Discuss and summarize findings on whether the manufacture and use 

292 of the petitioned substance may be harmful to the environment or biodiversity (7 U.S.C. § 6517 (c) (1) 

293 (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i)). Are there alternative natural (nonsynthetic) source(s) of the 

294 substance? (7 CFR 205.600(b)(1)). 

295

296 Data Required: In consideration of the petitioned substance, its manufacturing process, and its breakdown 

297 products, describe the mode of action of the substance with respect to its effects on biological, chemical and 

298 physical effects on the environment or biodiversity. The analysis must include consideration of potential 

299 effects on both terrestrial and aquatic systems and effects on arthropod natural enemies (e.g., predators and 

300 parasitic hymenoptera), pollinators, bats and birds. 

301 The response must discuss whether natural (nonsynthetic) sources of the petitioned substance exist and are 

302 available. The report contractor should examine the effect, form, function, quality, and quantity of the 

303 naturally sourced version of the petitioned substance, in comparison to manufactured versions. Briefly 

304 describe any naturally sourced alternatives by summarizing: 

305

306 • literature, including product or practice description, on performance and test data; 

307 • name and address of the manufacturer(s), if applicable; and,

308 • types of products the substance is currently used in. 

309

310 [old #12] Evaluation Question #10: Describe and summarize any reported effects upon human health 

311 from use of the petitioned substance (7 U.S.C. § 6517(c)(1)(A)(i), 7 U.S.C. § 6517(c)(2)(A)(i)) and 7 U.S.C. § 

312 6518(m)(4)). Describe all nonagricultural non-synthetic substances or products which may be used in 

313 place of the petitioned substance (7 U.S.C. § 6517(c)(1)(A)(ii)). Additionally, identify which of those are 

314 currently allowed under the NOP regulations.

315 

316 Data Required: Describe reported health effects and causation that may be attributed to the use of the 

317 petitioned substance and/or its breakdown products. 

318 The response must describe the availability of a nonagricultural non-synthetic or natural substance(s) 

319 which could be substituted for petitioned substance. Briefly describe any nonagricultural nonsynthetically 

320 sourced alternatives by summarizing:

321 • A comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic 

322 (natural) product with the petitioned substance; 

323 • Commercial availability of substitute non-synthetic (natural) products, both domestically and 

324 globally.

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325 • A comparison of reported risks to human health associated with the substitute non-synthetic 

326 (natural) product to the petitioned substance;

327 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

328 substitute non-synthetic (natural) product to the petitioned substance;

329 • Literature, including product or practice description, on performance and test data; and

330 • Types of products and range of uses for the alternative substance

331

332

333

334 [old #13] Evaluation Question #11: Describe any alternative practices that would make the use of the 

335 petitioned substance unnecessary (7 U.S.C. § 6518(m)(6)). Provide a list of organic agricultural products 

336 that could be alternatives for the petitioned substance (7 CFR 205.600(b)(1)). 

337

338

339 Data Required: The response to this request for development of technical information must describe the 

340 availability of an alternative practice(s) to the use of the petitioned substance. Many research-based 

341 alternative practices may be found at: http://eorganic.info/, https://www.sare.org/, and 

342 https://attra.ncat.org/; these resources should be consulted before exhausting search for alternative 

343 practices. When assessing alternative practices, the report should address:

344 • Literature, including practice description, on performance and test data; 

345 • A comparison of the function and effectiveness of the proposed alternative practice to the 

346 petitioned substance; and,

347 • Types of products produced and scope of use of alternative practices.

348 The list should be based upon a comparison of the effect, form, function, quality, and quantity of the 

349 recommended organic agricultural product with the petitioned substance. Many organic products may be 

350 found at: https://organic.ams.usda.gov/Integrity/default.aspx, http://eorganic.info/, 

351 https://www.sare.org/, https://www.omri.org/, www.606organic.com, and https://attra.ncat.org/;

352 these resources should be consulted before exhausting search for alternative practices. Briefly describe the 

353 organic agriculturally derived alternatives by summarizing: 

354

355 • A comparison of the effect, form, function, quality, and quantity of the substitute organic 

356 agricultural product to the petitioned substance; 

357 • Commercial availability of substitute organic products, both domestically and globally

358 • A comparison of reported risks to human health associated with the substitute organic agricultural 

359 product to the petitioned substance;

360 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

361 substitute organic agricultural product to the petitioned substance;

362 • Any literature, including product description, on performance and test data; 

363 • The name and address of the supplier/manufacturer, if applicable; and

364 • Types of products and range of uses for the alternative substance.

365 

366

367 [old #11] Evaluation Question #12: Describe all natural (non-synthetic) substances or products which 

368 may be used in place of a petitioned substance (7 U.S.C. § 6517(c)(1)(A)(ii)). Provide a list of allowed 

369 substances that may be used in place of the petitioned substance (7 U.S.C. § 6518(m)(6)). Describe if 

370 there are any alternative practices that would make the use of the petitioned substance unnecessary (7 

371 U.S.C. § 6518(m)(6)).

372

373 Data Required: The response must describe the availability of a non-synthetic or natural substance(s) 

374 which could be substituted for petitioned substance. Many natural substances may be found at: 

375 https://organic.ams.usda.gov/Integrity/default.aspx, http://eorganic.info/, https://www.sare.org/, 

376 https://www.omri.org/, www.606organic.com, and https://attra.ncat.org/; these resources should be 

377 consulted before exhausting search for alternative practices. The examination should address:

378 • A comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic 

379 (natural) product with the petitioned substance; 

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380 • Commercial availability of substitute non-synthetic (natural) products, both domestically and 

381 globally.

382 • A comparison of reported risks to human health associated with the substitute non-synthetic 

383 (natural) product to the petitioned substance;

384 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

385 substitute non-synthetic (natural) product to the petitioned substance;

386 • Literature, including product or practice description, on performance and test data; and

387 • Types of products and range of uses for the alternative substance; and,

388 The response to this request for development of technical information must describe the availability of an 

389 alternative practice(s) to the use of the petitioned substance. Many research-based alternative practices 

390 may be found at: http://eorganic.info/, https://www.sare.org/, and https://attra.ncat.org/; these 

391 resources should be consulted before exhausting search for alternative practices. Briefly describe 

392 alternative practices by summarizing: 

393 • Literature, including practice description, on performance and test data; 

394 • A comparison of the function and effectiveness of the proposed alternative practice to the 

395 petitioned substance; and,

396 • Types of products produced and scope of use of alternative practices. 

397

398 Evaluation Information #13: Provide a list of organic agricultural products that could be alternatives for 

399 the petitioned substance (7 CFR 205.600(b)(1)). 

400

401 Data Required: The list should be based upon a comparison of the effect, form, function, quality, and 

402 quantity of the recommended organic agricultural product with the petitioned substance. Many organic 

403 products may be found at: https://organic.ams.usda.gov/Integrity/default.aspx, http://eorganic.info/, 

404 https://www.sare.org/, https://www.omri.org/, www.606organic.com, and https://attra.ncat.org/;

405 these resources should be consulted before exhausting search for alternative practices. In developing the 

406 list, the following should be considered: 

407

408 • A comparison of the effect, form, function, quality, and quantity of the substitute organic 

409 agricultural product to the petitioned substance; 

410 • Commercial availability of substitute organic products, both domestically and globally

411 • A comparison of reported risks to human health associated with the substitute organic agricultural 

412 product to the petitioned substance;

413 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

414 substitute organic agricultural product to the petitioned substance;

415 • Any literature, including product description, on performance and test data; 

416 • The name and address of the supplier/manufacturer, if applicable; and

417 • Types of products and range of uses for the alternative substance. 

418

419 Report Authorship

420

421 The following individuals were involved in research, data collection, writing, editing, and/or final 

422 approval of this report: 

423

424 • Name, Title, Organization

425 • Name, Title, Organization

426 • Name, Title, Organization

427

428 All individuals are in compliance with Federal Acquisition Regulations (FAR) Subpart 3.11—Preventing 

429 Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

430

431

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432 References

433

434 All citations listed in the report must be included in references section using MLA format. 

435 A minimum of 20 current scientific references must be cited in the report to provide adequate scientific 

436 credibility and thorough review. Citation using MLA format must be included appropriately within the 

437 text to avoid plagiarism.

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Name of Material 

Handling/Processing

___________________________________

[Insert date transmitted to NOP] Technical Evaluation Report Page 1 of 6 

Compiled by (Name of Contractor) for the USDA National Organic Program

1 

2 Identification of Petitioned Substance

3 Chemical Names:

4 List all chemical names

5 

6 Other Name:

7 List other names

8 

9 Trade Names:

10 List trade names

CAS Numbers: 

List CAS numbers

Other Codes:

List other codes (e.g., INS number, E number, 

etc.)

11

12 Summary of Petitioned Use

13

14 For petitions to add or amend a substance, describe the petitioned use of the substance. For substances currently 

15 on the National List, summarize the allowed uses under the USDA organic regulations (7 CFR Part 205). 

16

17 Characterization of Petitioned Substance

18

19 Composition of the Substance: 

20 Describe Composition of the Substance

21

22 Source or Origin of the Substance:

23 Briefly describe the source or origin of the substance (to be addressed in more detail below under 

24 Evaluation Questions 1 through 4).

25

26 Properties of the Substance: 

27 Describe Physical and Chemical Properties of the Substance

28

29 Specific Uses of the Substance:

30 Describe Specific Uses of the Substance - primary focus should be given to describing the petitioned use of 

31 the substance as it relates to organic handling; secondary focus should be given to providing general 

32 information on other uses of the petitioned substance in agricultural handling/processing. 

33

34 Approved Legal Uses of the Substance:

35 Describe the Status of the Petitioned Substance under applicable Federal Regulations (i.e., EPA, FDA, 

36 USDA (including APHIS or FSIS), NIEHS, etc.)

37

38 Action of the Substance: 

39 Describe Action of the Substance – focus should be given to describing mode of action of the substance, 

40 when used as petitioned.

41

42 Combinations of the Substance:

43 Describe Combinations of the Substance – focus should be given to describing whether the petitioned 

44 substance is a precursor to, component of, or commonly used in combination with a substance(s) identified 

45 on the National List. Any known synergistic effects (either positive or negative) with other substances on 

46 the National List should be identified.

47

48 In addition, information should be provided on whether any additional ingredients (e.g., inert ingredients, 

49 stabilizers, preservatives, carriers, anti-caking agents, or other materials) are generally added to 

50 commercially available forms of the petitioned substance.

Appendix A2: TR Template updated - Handling/Processing

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51

52

53 Status 

54

55 Historic Use:

56 Describe historic use of the substance in organic agricultural production (if no historic use in organic 

57 agricultural production, please describe historic use in conventional agricultural production).

58

59 Organic Foods Production Act, USDA Final Rule: 

60 Describe whether the Petitioned Substance is Listed anywhere in the Organic Foods Production Act of 1990 

61 (OFPA) or the USDA organic regulations, 7 CFR Part 205.

62

63 International 

64

65 Describe the status of the substance among international organizations. Specifically, the report should 

66 address whether the petitioned substance is allowed or prohibited for use in other international organic 

67 standards such as: 

68

69 Canada

70

71 CAN/CGSB-32.310- Organic production systems-General principles and management standards

72

73 CAN/CGSB-32.311, Organic Production Systems-Permitted Substances List

74 http://www.inspection.gc.ca/food/organic-products/standards/eng/1300368619837/1300368673172 

75

76 CODEX Alimentarius Commission—Guidelines for the Production, Processing, Labelling and 

77 Marketing of Organically Produced Foods (GL 32-1999)

78 http://www.fao.org/docrep/005/Y2772E/Y2772E00.HTM

79 Note: For Codex, the reference should be cited as “guidelines,” rather than as “standards”.

80

81 European Economic Community (EEC) Council Regulation—EC No. 834/2007 and 889/2008

82 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R1165&from=EN#d1e32-48-1

83 

84 Japan Agricultural Standard (JAS) for Organic Production

85 http://www.maff.go.jp/e/jas/specific/criteria_o.html 

86

87 IFOAM-Organics International 

88 http://www.ifoam.bio/en/ifoam-norms 

89

90

91 Evaluation Questions for Substances to be used in Organic Handling

92

93 Classification of the substance

94 Evaluation Question #1: (A) Describe if the substance is extracted from naturally occurring plant, 

95 animal, or mineral sources. (B) Describe the most prevalent processes used to manufacture or formulate 

96 the petitioned substance. Include any chemical changes that may occur during manufacture or 

97 formulation of the substance. (C) Discuss whether the petitioned substance is agricultural or Non98 agricultural. If the substance is Non-agricultural, is it synthetic or non-synthetic? [7 U.S.C. §6502(21); 

99 NOP 5032-1; NOP 5033-2]. (D) Does the substance in its raw or formulated forms contain nanoparticles?

100 (E) Does the substance in its raw or formulated forms contain ancillary substances (F) Is the substance 

101 created using Excluded Methods?

102

103

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104

105

106

107

108 Data Required: 

109

110 (A) If the substance is extracted from a natural material, information should be provided on any 

111 materials and methods used to extract, separate, isolate, or withdraw the substance, including any 

112 solvents used, acid-base extraction methods, or mechanical or physical separation methods. If the 

113 substance is created by a naturally occurring biological process, those process(es) must be 

114 described in detail. 

115

116 For the purposes of this response, naturally occurring biological processes are processes that 

117 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, 

118 various metabolic processes, and photosynthesis.

119

120 (B) The response must describe the processes used to manufacture or formulate the substance, 

121 including a discussion of all precursors and/or feedstocks. A description of alternate 

122 manufacturing methods and the extent of their commercial use which are not included in the 

123 petition, if any, should be presented. The response must also describe, in detail, any chemical 

124 changes effected on any naturally occurring precursor or feedstock by all manufacturing or 

125 formulation processes. If any synthetic materials used in the production or extraction of a 

126 substance remain in the final product, describe them. 

127

128 For the purposes of this response, a chemical change involves a process (i.e., chemical reaction) 

129 whereby a substance is transformed into one or more other distinct substances. This may include 

130 the addition or deletion of one atom to the substance’s molecular structure or other description of 

131 chemical modification. 

132

133 Chemical processes include, but are not limited to: acid base reactions, calcification, thermal or 

134 catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation135 reduction, polymerization, etc., obtained through process units such as compressors, cracking 

136 towers, heat exchangers, mixers, reactors, pumps, etc.

137

138 (C) Based on the information provided on (A) and (B), the definition of synthetic at 7 U.S.C. § 6502 (22) 

139 NOP Guidance 5033-1 and NOP Guidance 5033-2, describe if the substance can be classified as

140 agricultural or non-agricultural.

141

142 (D) Nano Particles: Does the substance in its raw or formulated forms contain nanoparticles? If so, are 

143 they engineered nanomaterials or incidental nanomaterials as defined by the NOSB and NOP? 

144 (Policy Memo 15-2) 

145

146 (E) Ancillary Substances: Does the substance in its raw or formulated forms contain ancillary 

147 substances as defined by the NOSB in the 2016 recommendation? 

148 (https://www.ams.usda.gov/sites/default/files/media/HS%20Ancillary%20Substance%20Propo

149 sal%20NOP.pdf) 

150

151 (F) Excluded Methods: 

152 i. Is the substance created using excluded methods? This includes but is not limited 

153 to the following list of techniques found to be “excluded methods” by the NOSB: 

154 Targeted genetic modification (TagMo), Synthetic gene technologies, Genome 

155 engineering, Gene editing, Gene targeting, Gene Silencing, Accelerated plant 

156 breeding techniques, Synthetic Biology, cloned animals and offspring, plastid 

157 transformation, cisgenesis, intragenesis, agro-infiltration, transposons developed 

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158 using invitro nucleic acid techniques, induced mutagenesis developed through in 

159 vitro nucleic acid techniques, cell and protoplast fusion (NOP policy Memo 13-1). 

160 ii. If the substance is manufactured from agricultural raw materials, are those 

161 materials derived from genetically engineered crop, or crops resulting from 

162 excluded methods?

163 iii. If the substance is manufactured from other biological raw materials—such as 

164 those produced by fermentation or enzymatic action—are those biological 

165 materials, derived from genetically engineered organisms, or crops organisms 

166 resulting from excluded methods? 

167

168 Evaluation Question #2: Specify whether the petitioned substance is categorized as generally 

169 recognized as safe (GRAS) when used according to FDA’s good manufacturing practices (7 CFR 

170 205.600(b)(5)). If not categorized as GRAS, describe the regulatory status. 

171 Purpose and necessity of the substance

172

173 Evaluation Question #3: Describe whether the primary technical function or purpose of the petitioned 

174 substance is a preservative (7 CFR 205.600(b)(4)).

175

176 Data Required: The response must explain why the primary function of the substance is or is not as a 

177 preservative. 

178

179 Evaluation Question #4: Describe whether the petitioned substance will be used primarily to recreate 

180 or improve flavors, colors, textures, or nutritive values lost in processing (except when required by law). 

181 If so, how? (7 CFR 205.600(b)(4)).

182

183 Data Required: When replacement or improvement of nutrients is required or allowed by regulation, the 

184 report evaluators should cite the appropriate regulations. 

185

186 Evaluation Question #5: Describe any effect or potential effect on the nutritional quality of the food or 

187 feed when the petitioned substance is used (7 CFR 205.600(b)(3)).

188

189

190

191 Data Required: The response must indicate whether the use of the petitioned substance affects the levels of 

192 nutrients (e.g., proteins, carbohydrates, fats, vitamins, and minerals) commonly found in the food product. 

193 Effects may include increasing or decreasing the amount and/or bioavailability of the nutrients.

194

195

196 Environment and human health effects

197

198 Evaluation Question #6: List any reported residues of heavy metals or other contaminants in excess of 

199 FDA tolerances that are present or have been reported in the petitioned substance (7 CFR 205.600(b)(5)).

200

201 Data Required: The response must indicate whether the petitioned substance may contain residues of 

202 substances that exceed FDA’s Action Levels for Poisonous or Deleterious Substances in Human Food. For 

203 the most part, these action levels will relate to residues found in agricultural products. Heavy metals or 

204 contaminants are addressed through FDA’s action levels. https://www.fda.gov/regulatory-information/search205 fda-guidance-documents/guidance-industry-action-levels-poisonous-or-deleterious-substances-human-food-and206 animal-feed See the latest edition of Food Chemicals Codex (National Research Council) for accepted 

207 reference standards for metals and other contaminants in food ingredients in the U.S. 

208

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209 Evaluation Question #7: Discuss and summarize findings on whether the manufacture and use of the 

210 petitioned substance may be harmful to the environment or biodiversity (7 U.S.C. § 6517 (c) (1) (A) (i) 

211 and 7 U.S.C. § 6517 (c) (2) (A) (i)).

212

213 Data Required: In consideration of the petitioned substance, its manufacturing process, and its breakdown 

214 products, describe the mode of action of the substance with respect to its effects on biological, chemical and 

215 physical effects on the environment or biodiversity. The analysis must include consideration of potential 

216 effects on both terrestrial and aquatic systems and effects on arthropod natural enemies (e.g., predators and 

217 parasitic hymenoptera), pollinators, bats and birds 

218

219 Evaluation Question #8: Describe and summarize any reported effects upon human health from use of 

220 the petitioned substance (7 U.S.C. § 6517(c)(1)(A)(i), 7 U.S.C. § 6517(c)(2)(A)(i)) and 7 U.S.C. § 6518(m)(4)).

221 

222 Data Required: Describe reported health effects and causation that may be attributed to the use of the 

223 petitioned substance and/or its breakdown products. 

224

225

226 Alternatives

227 

228 Evaluation Question #9: Are there alternative natural (nonsynthetic) source(s) of the substance? (7 CFR 

229 205.600(b)(1)). 

230

231 Data Required: The response must discuss whether natural (nonsynthetic) sources of the petitioned 

232 substance exist and are available. The report contractor should examine the effect, form, function, quality, 

233 and quantity of the naturally sourced version of the petitioned substance, in comparison to manufactured 

234 versions. Briefly describe any naturally sourced alternatives by summarizing: 

235

236 • literature, including product or practice description, on performance and test data; 

237 • name and address of the manufacturer(s), if applicable; and,

238 • types of products the substance is currently used in. 

239

240 Evaluation Question #10: Describe all nonagricultural non-synthetic substances or products which may 

241 be used in place of the petitioned substance (7 U.S.C. § 6517(c)(1)(A)(ii)). Additionally, identify which of 

242 those are currently allowed under the NOP regulations. 

243

244 Data Required: The response must describe the availability of a nonagricultural non-synthetic or natural 

245 substance(s) which could be substituted for petitioned substance. . Briefly describe any nonagricultural 

246 nonsynthetically sourced alternatives by summarizing: 

247 • A comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic 

248 (natural) product with the petitioned substance; 

249 • Commercial availability of substitute non-synthetic (natural) products, both domestically and 

250 globally.

251 • A comparison of reported risks to human health associated with the substitute non-synthetic 

252 (natural) product to the petitioned substance;

253 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

254 substitute non-synthetic (natural) product to the petitioned substance;

255 • Literature, including product or practice description, on performance and test data; and

256 • Types of products and range of uses for the alternative substance

257

258 Evaluation Information #11: Provide a list of organic agricultural products that could be alternatives for 

259 the petitioned substance (7 CFR 205.600(b)(1)). 

260

261 Data Required: The list should be based upon a comparison of the effect, form, function, quality, and 

262 quantity of the recommended organic agricultural product with the petitioned substance. Many organic 

263 products may be found at: https://organic.ams.usda.gov/Integrity/default.aspx, http://eorganic.info/, 

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264 https://www.sare.org/, https://www.omri.org/, www.606organic.com, and https://attra.ncat.org/;

265 these resources should be consulted before exhausting search for alternative practices. Briefly describe the 

266 organic agriculturally derived alternatives by summarizing: 

267

268 • A comparison of the effect, form, function, quality, and quantity of the substitute organic 

269 agricultural product to the petitioned substance; 

270 • Commercial availability of substitute organic products, both domestically and globally

271 • A comparison of reported risks to human health associated with the substitute organic agricultural 

272 product to the petitioned substance;

273 • A comparison of reported environmental effects (both aquatic and terrestrial) associated with the 

274 substitute organic agricultural product to the petitioned substance;

275 • Any literature, including product description, on performance and test data; 

276 • The name and address of the supplier/manufacturer, if applicable; and

277 • Types of products and range of uses for the alternative substance. 

278

279

280 Evaluation Question #12: Describe if there are any alternative practices that would make the use of the 

281 petitioned substance unnecessary (7 U.S.C. § 6518(m)(6)). 

282

283 Data Required: The response to this request for development of technical information must describe the 

284 availability of an alternative practice(s) to the use of the petitioned substance. Many research-based 

285 alternative practices may be found at: http://eorganic.info/, https://www.sare.org/, and 

286 https://attra.ncat.org/; these resources should be consulted before exhausting search for alternative 

287 practices. Briefly describe alternative practices by summarizing: 

288 • Literature, including practice description, on performance and test data; 

289 • A comparison of the function and effectiveness of the proposed alternative practice to the 

290 petitioned substance; and,

291 • Types of products produced and scope of use of alternative practices. 

292

293

294 Report Authorship

295

296 The following individuals were involved in research, data collection, writing, editing, and/or final 

297 approval of this report: 

298

299 • Name, Title, Organization

300 • Name, Title, Organization

301 • Name, Title, Organization

302

303 All individuals are in compliance with Federal Acquisition Regulations (FAR) Subpart 3.11—Preventing 

304 Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

305

306

307 References

308

309 All citations listed in the report must be included in references section using MLA format. 

310 A minimum of 20 current scientific references must be cited in the report to provide adequate scientific 

311 credibility and thorough review. Citation using MLA format must be included appropriately within the text 

312 to avoid plagiarism. 

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Name of Material 

Crops or Livestock

___________________________________

[Insert date report is transmitted to NOP] Technical Evaluation Report Page 1 of 8 

Compiled by (Name of Contractor) for the USDA National Organic Program

1 

2 Identification of Petitioned Substance

3 

4 Chemical Names:

5 List all chemical names

6 

7 Other Name:

8 List other names

9 

10 Trade Names:

11 List Trade Names

CAS Numbers: 

List CAS numbers

Other Codes:

List other codes

12

13 Summary of Petitioned Use

14

15 For petitions to add or amend a substance, describe the petitioned use of the substance. For substances currently 

16 on the National List, summarize the allowed uses under the USDA organic regulations. 

17

18 Characterization of Petitioned Substance

19

20 Composition of the Substance: 

21 Describe Composition of the Substance

22

23 Source or Origin of the Substance:

24 Briefly describe the source or origin of the substance (to be addressed in more detail below under 

25 Evaluation Questions 2 and 3).

26

27 Properties of the Substance: 

28 Describe Physical and Chemical Properties of the Substance

29

30 Specific Uses of the Substance: 

31 Describe Specific Uses of the Substance - primary focus should be given to describing the petitioned use of 

32 the substance; secondary focus should be given to providing general information on other uses of the

33 petitioned substance in agricultural crop or livestock production. 

34

35 Approved Legal Uses of the Substance:

36 Describe the Status of the Petitioned Substance under applicable Federal Regulations (i.e., EPA, FDA, 

37 USDA (including APHIS or FSIS), NIEHS, etc.)

38

39 Action of the Substance:

40 Describe the Mode Action of the Substance – focus should be given to describing the mode of action of the 

41 substance, when used as petitioned.

42

43 Combinations of the Substance: 

44 Describe Combinations of the Substance – focus should be given to describing whether the petitioned 

45 substance is a precursor to, component of, or commonly used in combination with a substance(s) identified 

46 on the National List.

47

48 In addition, information should be provided on whether any additional ingredients (e.g., inert ingredients, 

49 stabilizers, preservatives, carriers, anti-caking agents, or other materials) are generally added to 

50 commercially available forms of the petitioned substance.

51

Appendix B1: TR Template with redlines - Crops

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52 Status 

53

54 Historic Use:

55 Describe historic use of the substance in organic agricultural production (if no historic use in organic 

56 agricultural production, please describe historic use in conventional agricultural production). 

57

58 Organic Foods Production Act, USDA Final Rule: 

59 Describe whether the Petitioned Substance is Listed anywhere in the Organic Foods Production Act of 1990 

60 (OFPA) or the USDA organic regulations, 7 CFR Part 205.

61

62 International 

63

64 Describe the status of the substance among international organizations. Specifically, the report should 

65 address whether the petitioned substance is allowed or prohibited for use in other international organic 

66 standards such as: 

67

68 Canada - Canadian General Standards Board Permitted Substances List. This list was updated in 

69 November 2015.

70 CAN/CGSB-32.310- Organic production systems-General principles and management standards 

71 CAN/CGSB-32.311-2015 — Organic production systems - Permitted substances lists

72 http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/programme-program/normes-standards/internet/bio73 org/lsp-psl-eng.html 

74

75 CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing 

76 of Organically Produced Foods (GL 32-1999) - 

77

78 Note: For Codex, the reference should be cited as “guidelines,” rather than as “standards”.

79

80 http://www.codexalimentarius.org/standards/list-standards/en/?no_cache=1 

81 http://www.codexalimentarius.org/download/standards/360/cxg_032e.pdf 

82

83 European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

84

85 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:250:0001:0084:EN:PDF

86 

87 Japan Agricultural Standard (JAS) for Organic Production— 

88 http://www.maff.go.jp/e/jas/specific/criteria_o.html 

89

90 International Federation of Organic Agriculture Movements (IFOAM) – 

91 http://www.ifoam.bio/en/ifoam-norms 

92

93

94 Evaluation Questions for Substances to be used in Organic Crop or Livestock Production

95

96 Classification of the substance

97

98 [combination of old #2 & 3 – word smithed and added D and E] 

99 Evaluation Question #1: Indicate which category in OFPA that the substance falls under: (A) Does the 

100 substance contain an active ingredient in any of the following categories: copper and sulfur 

101 compounds, toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated 

102 seed, vitamins and minerals; livestock parasiticides and medicines and production aids including 

103 netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers? (A)

104 Describe if the substance is extracted from naturally occurring plant, animal, or mineral sources. (B) Is 

105 the substance a synthetic inert ingredient that is not classified by the EPA as inerts of toxicological 

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106 concern (i.e., EPA List 4 inerts) (7 U.S.C. § 6517(c)(1)(B)(ii))? Is the synthetic substance an inert 

107 ingredient which is not on EPA List 4, but is exempt from a requirement of a tolerance, per 40 CFR part 

108 180? (B) Describe the most prevalent processes used to manufacture or formulate the petitioned 

109 substance. Include any chemical changes that may occur during manufacture or formulation of the 

110 substance. (C) Based on the manufacturing process description, discuss if the substance is classified as 

111 synthetic or a nonsynthetic. [7 U.S.C. §6502(21)]; NOP 5033-1]. (D) Does the substance in its raw or 

112 formulated forms contain nanoparticles? (E) Is the substance created using Excluded Methods?

113 Data Required:

114

115 (A) If the substance is extracted from a natural material, information should be provided on any 

116 materials and methods used to extract, separate, isolate, or withdraw the substance, including any 

117 solvents used, acid-base extraction methods, or mechanical or physical separation methods.If the 

118 substance is created by a naturally occurring biological process, those process(es) must be 

119 described in detail. 

120

121 For the purposes of this response, naturally occurring biological processes are processes that 

122 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, 

123 various metabolic processes, and photosynthesis.

124

125 (B) The response must describe the processes used to manufacture or formulate the substance, 

126 including a discussion of all precursors and/or feedstocks. A description of alternate 

127 manufacturing methods and the extent of their commercial use which are not included in the 

128 petition, if any, should be presented. The response must also describe, in detail, any chemical 

129 changes effected on any naturally occurring precursor or feedstock by all manufacturing or 

130 formulation processes. If any synthetic materials used in the production or extraction of a 

131 substance remain in the final product, describe them.

132

133 For the purposes of this response, a chemical change involves a process (i.e., chemical reaction) 

134 whereby a substance is transformed into one or more other distinct substances. This may include 

135 the addition or deletion of one atom to the substance’s molecular structure or other description of 

136 chemical modification. 

137

138 Chemical processes include, but are not limited to: acid base reactions, calcification, thermal or 

139 catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation140 reduction, polymerization, etc., obtained through process units such as compressors, cracking 

141 towers, heat exchangers, mixers, reactors, pumps, etc.

142

143 (C) Based on the information provided on (A) and (B), the definition of synthetic at 7 U.S.C. § 6502 (22) 

144 and NOP Guidance 5033-1, describe if the substance can be classified as synthetic or as a 

145 nonsynthetic. Synthetic substances have been chemically modified from the source or origin or 

146 have been isolated from a natural source in a form that does not occur in nature. 

147

148 (D) Nano Particles: Does the substance in its raw or formulated forms contain nanoparticles? If so, are 

149 they engineered nanomaterials or incidental nanomaterials as defined by the NOSB and NOP? 

150 (Policy Memo 15-2)

151

152 (E) Excluded Methods:

153 i. Is the substance created using excluded methods? This includes but is not limited 

154 to the following list of techniques found to be “excluded methods” by the NOSB: 

155 Targeted genetic modification (TagMo), Synthetic gene technologies, Genome 

156 engineering, Gene editing, Gene targeting, Gene Silencing, Accelerated plant 

157 breeding techniques, Synthetic Biology, cloned animals and offspring, plastid 

158 transformation, cisgenesis, intragenesis, agro-infiltration, transposons developed 

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159 using invitro nucleic acid techniques, induced mutagenesis developed through in 

160 vitro nucleic acid techniques, cell and protoplast fusion (NOP policy Memo 13-1).

161 ii. If the substance is manufactured from agricultural raw materials, are those 

162 materials derived from genetically engineered crop, or crops resulting from 

163 excluded methods?

164 iii. If the substance is manufactured from other biological raw materials—such as 

165 those produced by fermentation or enzymatic action—are those biological 

166 materials derived from genetically engineered organisms, or crops organisms 

167 resulting from excluded methods?

168

169

170 [old #1] Evaluation Question #2: Describe the most prevalent processes used to manufacture or 

171 formulate the petitioned substance. Further, describe any chemical change that may occur during 

172 manufacture or formulation of the petitioned substance when this substance is extracted from naturally 

173 occurring plant, animal, or mineral sources (7 U.S.C. § 6502 (21)). For substances classified as synthetic: 

174 Is the substance used in production, and does it contain an active synthetic ingredient in the following 

175 categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from bacteria; pheromones, 

176 soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and 

177 medicines and production aids including netting, tree wraps and seals, insect traps, sticky barriers, row 

178 covers, and equipment cleansers; or (ii) is used in production and contains synthetic inert ingredients 

179 that are not classified by the Administrator of the Environmental Protection Agency as inerts of 

180 toxicological concern?

181

182 Data Required: The response must describe the processes used to manufacture or formulate the substance, 

183 including a discussion of all precursors and/or feedstocks. A description of alternate manufacturing 

184 methods and the extent of their commercial use which are not included in the petition, if any, should be 

185 presented. The response must also describe, in detail, any chemical changes effected on any naturally 

186 occurring precursor or feedstock by all manufacturing or formulation processes. For the purposes of this 

187 response, a chemical change involves a process (i.e., chemical reaction) whereby a substance is transformed 

188 into one or more other distinct substances. This may include the addition or deletion of one atom to the 

189 substance’s molecular structure or other description of chemical modification. 

190

191 [old #7] Evaluation Question #3: Discuss whether the petitioned substance is formulated or 

192 manufactured by a chemical process, or created by naturally occurring biological processes (7 U.S.C. § 

193 6502 (21)). Describe any known chemical interactions between the petitioned substance and other 

194 substances used in organic crop or livestock production or handling. (7 U.S.C. § 6518(m)(1)).

195

196 Data Required: For the purposes of this response, chemical processes are processes include, but are not 

197 limited to, acid base reactions, calcification, thermal or catalytic cracking, esterification, hydrogenation, 

198 mixing of substances or elements, oxidation-reduction, polymerization, etc., obtained through process units 

199 such as compressors, cracking towers, heat exchangers, mixers, reactors, pumps, etc.

200

201 If the substance is extracted from a natural material, information should be provided on any materials and 

202 methods used to extract, separate, isolate, or withdraw the substance, including any solvents used, acid203 base extraction methods, or mechanical or physical separation methods.

204

205 If the substance is created by a naturally occurring biological process, those process(es) must be described 

206 in detail. For the purposes of this response, naturally occurring biological processes are processes that 

207 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various 

208 metabolic processes, and photosynthesis.

209

210 Information should be provided on whether the substance has been chemically modified from the source 

211 or origin of the substance, including whether the substance has been isolated from a natural source in a 

212 form that does not occur in nature, and whether any synthetic materials used in the production or 

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213 extraction of a substance may remain in the final product. The response to this request for development of 

214 technical information must describe any known chemical interactions between the petitioned substance 

215 and other substances allowed for use in organic production or handling as applicable. Describe any 

216 common combinations of materials used with the petitioned substance. Describe any substances resulting 

217 from these interactions. 

218

219 [combination of old #4 & 5] Evaluation Question #4: Describe the persistence or concentration of the 

220 petitioned substance and/or its by-products in the environment (7 U.S.C. § 6518 (m) (2)). Discuss (A) the 

221 toxicity and mode of action of the substance; (B) the toxicity and mode of action of its breakdown 

222 products or any contaminants; and (C) their persistence and areas of concentration in the environment (7 

223 U.S.C. §6518(m)(2)).

224

225 Data Required: The response must describe whether and how the petitioned substance and/or the 

226 breakdown products are persistent or cumulative when used in organic crop or livestock production as 

227 petitioned.

228 (A) Describe whether the petitioned substance has been reported to have toxic effects and if its mode of 

229 action can cause adverse health and/or environmental effects.

230 (B) Describe whether the petitioned substance contaminants, or any of its breakdown products have 

231 been reported to have toxic effects and are capable of causing adverse health and/or 

232 environmental effects either present in the substance or arising from the degradation of the 

233 substance over time. 

234 (C) Describe whether and how the petitioned substance and/or the breakdown products are persistent 

235 or cumulative when used in organic crop or livestock production as petitioned. 

236

237 [old #6] Evaluation Question #5: Describe the toxicity and mode of action of the substance and of its 

238 breakdown products and any contaminants. Describe the persistence and areas of concentration in the 

239 environment of the substance and its breakdown products (7 U.S.C. § 6518 (m) (2)). Discuss the 

240 probability of environmental contamination during manufacture, use, misuse or disposal of the 

241 substance (7 U.S.C. §6518(m)(3)). 

242

243 Data Required: The response must describe whether the petitioned substance, its contaminants, or any of 

244 its breakdown products have been reported to have toxic effects and are capable of causing adverse health 

245 and/or environmental effects either present in the substance or arising from the degradation of the 

246 substance over time. The response must describe the occurrence and severity of environmental 

247 contamination during the manufacture, use, misuse, or disposal of the petitioned substance. Data or 

248 reports from U.S. or International universities, agencies, independent groups, or other news reports should 

249 be included in this response when available. This data may also be available through review of assessments 

250 performed per EPA, FDA, and/or NIEHS review.

251

252 [old #8] Evaluation Question #6: Describe any environmental contamination that could result from the 

253 petitioned substance’s manufacture, use, misuse, or disposal (7 U.S.C. § 6518 (m) (3)). Discuss the effects 

254 of the substance on biological and chemical interactions in the agroecosystem. Include the physiological 

255 effects of the substance on soil, crops, livestock or other organisms (such as aquatic) that could be 

256 affected by the substance when used as petitioned. (7 U.S.C. §6518(m)(5))

257 

258 Data Required: The response must describe the occurrence and severity of environmental contamination 

259 during the manufacture, use, misuse, or disposal of the petitioned substance. This data may be available 

260 through review of assessments performed per EPA, FDA, and/or NIEHS review. Data or reports from 

261 other U.S. or International universities, agencies, independent groups, or other news reports should be 

262 included in this response when available. The response must describe the substances (the petitioned 

263 substance and/or its byproducts in combination with naturally occurring substances over time) that are 

264 capable of affecting the agro-ecosystem. 

265

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266 The response should describe whether and how the petitioned substance affects the survival and/ or 

267 function of soil organisms, such as, but not limited to earthworms, mites, grubs, bacteria, nematodes, algae, 

268 and protozoa by changing soil temperature, water availability, pH levels, nutrient availability, salt 

269 concentration, solubility or other parameter. For crops, the response should also describe whether and 

270 how the substance affects plant physiology by creating changes in plant pH, nutrient or water utilization, 

271 or other parameters when used as petitioned. For livestock production, the response should also describe 

272 whether and how the substance affects animal physiology by creating changes in behavior, fertility, 

273 metabolism or other parameters. 

274

275 In addition, the response should describe the potential or actual impacts of the substances upon 

276 endangered species, population, viability or reproduction of non-target organisms and the potential for 

277 measurable reductions in genetic, species or eco-system biodiversity, if possible.

278 

279 [old #9] Evaluation Question #7: Describe any known chemical interactions between the petitioned 

280 substance and other substances used in organic crop or livestock production or handling. Describe any 

281 environmental or human health effects from these chemical interactions (7 U.S.C. § 6518 (m) (1)).

282 Discuss and summarize findings on whether the use of the petitioned substance may be harmful to the 

283 environment (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i)).

284 

285 Data Required: The response to this request for development of technical information must describe any 

286 known chemical interactions between the petitioned substance and other substances allowed for use in 

287 organic production or handling as applicable. Describe any common combinations of materials used with 

288 the petitioned substance. Describe any substances resulting from these interactions and whether they may 

289 cause adverse health and/or environmental effects either present in the substance or arising from the 

290 degradation of the substance over time. Toxicity, mode of action, and persistence of the substance and its 

291 breakdown products should be explained. Considering the information described in questions #1-6 and 

292 any other relevant information, discuss if the petitioned substance and/ or its breakdown products can 

293 cause harmful effects on the environment. Describe the biological, chemical and physical factors that may 

294 be affected by the use of the substance and/ or its breakdown products.

295

296 Harm to Human Health

297

298 [old #10] Evaluation Question #8: Describe any effects of the petitioned substance on biological or 

299 chemical interactions in the agro-ecosystem, including physiological effects on soil organisms 

300 (including the salt index and solubility of the soil), crops, and livestock (7 U.S.C. § 6518 (m) (5)). 

301 Describe and summarize any reported effects upon human health from use of the petitioned substance 

302 (7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i)) and 7 U.S.C. § 6518 (m) (4)).

303

304 Data Required: The response must describe the substances (the petitioned substance and/or its 

305 byproducts in combination with naturally occurring substances over time) that are capable of affecting the 

306 agro-ecosystem. The effects of these substances, including toxicity, mode of action and environmental 

307 persistence of the substance and its breakdown products should be explained. 

308

309 The response should describe whether and how the petitioned substance affects the survival and/ or 

310 function of soil organisms, such as, but not limited to earthworms, mites, grubs, bacteria, nematodes, algae, 

311 and protozoa by changing soil temperature, water availability, pH levels, nutrient availability, salt 

312 concentration, solubility or other parameter. For crops, the response should also describe whether and 

313 how the substance affects plant physiology by creating changes in plant pH, nutrient or water utilization, 

314 or other parameters when used as petitioned. For livestock production, the response should also describe 

315 whether and how the substance affects animal physiology by creating changes in behavior, fertility, 

316 metabolism or other parameters. 

317

318 In addition, the response should describe the potential or actual impacts of the substances upon 

319 endangered species, population, viability or reproduction of non-target organisms and the potential for 

320 measurable reductions in genetic, species or eco-system biodiversity, if possible. Drawing upon responses 

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321 to above questions #1-7 and any other relevant information, describe the reported health effects that may 

322 be attributed to the petitioned substance and/or its breakdown products.

323

324 Necessity and Alternatives

325

326 [old #11] Evaluation Question #9: Discuss and summarize findings on whether the use of the 

327 petitioned substance may be harmful to the environment (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 

328 6517 (c) (2) (A) (i)). Describe all natural (non-synthetic) substances or products which may be used in 

329 place of a petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (ii)). Provide a list of allowed substances that 

330 may be used in place of the petitioned substance (7 U.S.C. § 6518 (m) (6)).

331

332 Data Required: Drawing upon responses to above questions #2-8, and any other relevant information, 

333 describe the biological, chemical and physical agents capable of causing harmful environmental effects and 

334 the causation, that may be attributed to the use of the petitioned substance and/or its breakdown products. 

335 The response must describe the availability of non-synthetic or natural substance(s), including organic 

336 agricultural products, which could be substituted for petitioned substance. The examination should 

337 address: 

338 • a comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic or 

339 natural product with the petitioned substance; 

340 • literature, including product or practice description, on performance and test data;

341 • name and address of the manufacturer(s), if applicable; and 

342 • For livestock (and pet food) feed substances, information on technical barriers to production of 

343 organic agricultural products that may serve as alternatives. 

344

345 [old #12] Evaluation Question #10: Describe and summarize any reported effects upon human health 

346 from use of the petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i)) and 7 

347 U.S.C. § 6518 (m) (4)). Describe any alternative practices that would make the use of the petitioned 

348 substance unnecessary (7 U.S.C. § 6518 (m) (6)).

349 

350 Data Required: Drawing upon responses to above questions #2-8 and any other relevant information, 

351 describe the reported health effects and causation that may be attributed to the petitioned substance 

352 and/or its breakdown products.

353 The response to this request for development of technical information must describe the availability of 

354 specific alternative practices, such as cultural, biological, and mechanical controls, to the use of the 

355 petitioned substance. 

356

357 When assessing alternative practices, the report should address:

358 • Literature, including specific practice description, on performance and test data; 

359 • A comparison of the function and effectiveness of the proposed alternative practice with the 

360 petitioned substance; and,

361 • Frequency or prevalence of use of alternatives, if known.

362

363 Evaluation Question #11: Describe all natural (non-synthetic) substances or products which may be 

364 used in place of a petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (ii)). Provide a list of allowed 

365 substances that may be used in place of the petitioned substance (7 U.S.C. § 6518 (m) (6)). 

366

367 Data Required: The response must describe the availability of non-synthetic or natural substance(s), 

368 including organic agricultural products, which could be substituted for petitioned substance. The 

369 examination should address:

370 • a comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic or 

371 natural product with the petitioned substance; 

372 • literature, including product or practice description, on performance and test data;

373 • name and address of the manufacturer(s), if applicable; and 

374 • For livestock (and pet food) feed substances, information on technical barriers to production of

375 organic agricultural products that may serve as alternatives. 

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376

377 Evaluation Question #12: Describe any alternative practices that would make the use of the petitioned 

378 substance unnecessary (7 U.S.C. § 6518 (m) (6)). 

379

380 Data Required: The response to this request for development of technical information must describe the 

381 availability of alternative practices, such as cultural, biological, and mechanical controls, to the use of the 

382 petitioned substance. 

383

384 Alternative cultural methods including methods used to enhance crop health and prevent weed, pest, or 

385 disease problems without the use of substances. Examples include the selection of appropriate varieties 

386 and planting sites; proper timing and density of plantings; irrigation; and extending a growing season by 

387 manipulating the microclimate with green houses, cold frames; or wind breaks.

388

389 Other alternative practices may include, but are not limited to, crop rotation, mulching with fully 

390 biodegradable materials, mechanical cultivation, augmentation or introduction of predators or parasites of 

391 the pest species; development of habitat for natural enemies of pests; nonsynthetic controls such as lures, 

392 traps, and repellents; sanitation measures and management practices which suppress the spread of disease 

393 organisms.

394

395 Alternative practices used in livestock production may include, but are not limited to, selection of species 

396 and types of livestock with regard to suitability for site-specific conditions, resistance to diseases and 

397 parasites; site selection , housing, pasture and sanitation practices that minimize occurrence and spread of 

398 disease and parasites; stocking density; and seasonal production practices. 

399

400 When assessing alternative practices, the report should address:

401 • Literature, including practice description, on performance and test data; 

402 • A comparison of the function and effectiveness of the proposed alternative practice with the 

403 petitioned substance; and,

404 • Frequency or prevalence of use of alternatives, if known.

405

406 Report Authorship

407

408 The following individuals were involved in research, data collection, writing, editing, and/or final 

409 approval of this report: 

410

411 • Name, Title, Organization

412 • Name, Title, Organization

413 • Name, Title, Organization

414

415 All individuals are in compliance with Federal Acquisition Regulations (FAR) Subpart 3.11—Preventing 

416 Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

417

418 References

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 Name of Material 

Crops or Livestock

___________________________________

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Compiled by (Name of Contractor) for the USDA National Organic Program

1 Identification of Petitioned Substance

2 

3 Chemical Names:

4 List all chemical names

5 

6 Other Name:

7 List other names

8 

9 Trade Names:

10 List Trade Names

CAS Numbers: 

List CAS numbers

Other Codes:

List other codes

11

12 Summary of Petitioned Use

13

14 For petitions to add or amend a substance, describe the petitioned use of the substance. For substances currently 

15 on the National List, summarize the allowed uses under the USDA organic regulations. 

16

17 Characterization of Petitioned Substance

18

19 Composition of the Substance: 

20 Describe Composition of the Substance

21

22 Source or Origin of the Substance:

23 Briefly describe the source or origin of the substance (to be addressed in more detail below under 

24 Evaluation Questions 2 and 3).

25

26 Properties of the Substance: 

27 Describe Physical and Chemical Properties of the Substance

28

29 Specific Uses of the Substance: 

30 Describe Specific Uses of the Substance - primary focus should be given to describing the petitioned use of 

31 the substance; secondary focus should be given to providing general information on other uses of the

32 petitioned substance in agricultural crop or livestock production. 

33

34 Approved Legal Uses of the Substance:

35 Describe the Status of the Petitioned Substance under applicable Federal Regulations (i.e., EPA, FDA, 

36 USDA (including APHIS or FSIS), NIEHS, etc.)

37

38 Action of the Substance: 

39 Describe the Mode Action of the Substance – focus should be given to describing the mode of action of the 

40 substance, when used as petitioned.

41

42 Combinations of the Substance: 

43 Describe Combinations of the Substance – focus should be given to describing whether the petitioned 

44 substance is a precursor to, component of, or commonly used in combination with a substance(s) identified 

45 on the National List.

46

47 In addition, information should be provided on whether any additional ingredients (e.g., inert ingredients, 

48 stabilizers, preservatives, carriers, anti-caking agents, or other materials) are generally added to 

49 commercially available forms of the petitioned substance.

50

Appendix B2: TR Template updated - Crops/Livestock

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51 Status 

52

53 Historic Use:

54 Describe historic use of the substance in organic agricultural production (if no historic use in organic 

55 agricultural production, please describe historic use in conventional agricultural production). 

56

57 Organic Foods Production Act, USDA Final Rule: 

58 Describe whether the Petitioned Substance is Listed anywhere in the Organic Foods Production Act of 1990 

59 (OFPA) or the USDA organic regulations, 7 CFR Part 205.

60

61 International 

62

63 Describe the status of the substance among international organizations. Specifically, the report should 

64 address whether the petitioned substance is allowed or prohibited for use in other international organic 

65 standards such as: 

66

67 Canada – 

68

69 CAN/CGSB-32.310- Organic production systems-General principles and management standards 

70

71 CAN/CGSB-32.311— Organic production systems - Permitted substances lists

72

73 CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing 

74 of Organically Produced Foods (GL 32-1999) - 

75

76 Note: For Codex, the reference should be cited as “guidelines,” rather than as “standards”.

77

78 

79

80 European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

81

82

83 

84 Japan Agricultural Standard (JAS) for Organic Production— 

85

86 IFOAM – Organics International

87

88

89 Evaluation Questions for Substances to be used in Organic Crop or Livestock Production

90

91

92 Classification of the substance

93 Evaluation Question #1: (A) Describe if the substance is extracted from naturally occurring plant, 

94 animal, or mineral sources. (B) Describe the most prevalent processes used to manufacture or formulate 

95 the petitioned substance. Include any chemical changes that may occur during manufacture or 

96 formulation of the substance. (C) Based on the manufacturing process description, discuss if the 

97 substance is classified as synthetic or a nonsynthetic. [7 U.S.C. §6502(21)]; NOP 5033-1]. (D) Does the 

98 substance in its raw or formulated forms contain nanoparticles? (E) Is the substance created using 

99 Excluded Methods?

100

101

102

103

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104

105

106

107 Data Required: 

108

109 (A) If the substance is extracted from a natural material, information should be provided on any 

110 materials and methods used to extract, separate, isolate, or withdraw the substance, including any 

111 solvents used, acid-base extraction methods, or mechanical or physical separation methods.If the 

112 substance is created by a naturally occurring biological process, those process(es) must be 

113 described in detail. 

114

115 For the purposes of this response, naturally occurring biological processes are processes that 

116 include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, 

117 various metabolic processes, and photosynthesis.

118

119 (B) The response must describe the processes used to manufacture or formulate the substance, 

120 including a discussion of all precursors and/or feedstocks. A description of alternate 

121 manufacturing methods and the extent of their commercial use which are not included in the 

122 petition, if any, should be presented. The response must also describe, in detail, any chemical 

123 changes effected on any naturally occurring precursor or feedstock by all manufacturing or 

124 formulation processes. If any synthetic materials used in the production or extraction of a 

125 substance remain in the final product, describe them. 

126

127 For the purposes of this response, a chemical change involves a process (i.e., chemical reaction) 

128 whereby a substance is transformed into one or more other distinct substances. This may include 

129 the addition or deletion of one atom to the substance’s molecular structure or other description of 

130 chemical modification. 

131

132 Chemical processes include, but are not limited to: acid base reactions, calcification, thermal or 

133 catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation134 reduction, polymerization, etc., obtained through process units such as compressors, cracking 

135 towers, heat exchangers, mixers, reactors, pumps, etc.

136

137 (C) Based on the information provided on (A) and (B), the definition of synthetic at 7 U.S.C. § 6502 (22) 

138 and NOP Guidance 5033-1, describe if the substance can be classified as synthetic or as a 

139 nonsynthetic. Synthetic substances have been chemically modified from the source or origin or 

140 have been isolated from a natural source in a form that does not occur in nature. 

141

142 (D) Nano Particles: Does the substance in its raw or formulated forms contain nanoparticles? If so, are 

143 they engineered nanomaterials or incidental nanomaterials as defined by the NOSB and NOP? 

144 (Policy Memo 15-2) 

145

146 (E) Excluded Methods: 

147 i. Is the substance created using excluded methods? This includes but is not limited 

148 to the following list of techniques found to be “excluded methods” by the NOSB: 

149 Targeted genetic modification (TagMo), Synthetic gene technologies, Genome 

150 engineering, Gene editing, Gene targeting, Gene Silencing, Accelerated plant 

151 breeding techniques, Synthetic Biology, cloned animals and offspring, plastid 

152 transformation, cisgenesis, intragenesis, agro-infiltration, transposons developed 

153 using invitro nucleic acid techniques, induced mutagenesis developed through in 

154 vitro nucleic acid techniques, cell and protoplast fusion (NOP policy Memo 13-1).

155 ii. If the substance is manufactured from agricultural raw materials, are those 

156 materials derived from genetically engineered crop, or crops resulting from 

157 excluded methods?

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158 iii. If the substance is manufactured from other biological raw materials—such as 

159 those produced by fermentation or enzymatic action—are those biological 

160 materials derived from genetically engineered organisms, or crops organisms 

161 resulting from excluded methods?

162

163

164

165 Evaluation Question #2: For substances classified as synthetic: Is the substance used in production, and 

166 does it contain an active synthetic ingredient in the following categories: [§6517(c)(1)(B)(i)]; copper and 

167 sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, 

168 treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids 

169 including netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment 

170 cleansers; or (ii) is used in production and contains synthetic inert ingredients that are not classified by 

171 the Administrator of the Environmental Protection Agency as inerts of toxicological concern? 

172

173

174 Evaluation Question #3: Describe any known chemical interactions between the petitioned substance 

175 and other substances used in organic crop or livestock production or handling. (7 U.S.C. § 6518(m)(1)).

176 

177 Data Required: The response to this request for development of technical information must describe any 

178 known chemical interactions between the petitioned substance and other substances allowed for use in 

179 organic production or handling as applicable. Describe any common combinations of materials used with 

180 the petitioned substance. Describe any substances resulting from these interactions. 

181

182 Evaluation Question #4: Discuss (A) the toxicity and mode of action of the substance; (B) the toxicity 

183 and mode of action of its breakdown products or any contaminants; and (C) their persistence and areas 

184 of concentration in the environment (7 U.S.C. §6518(m)(2)).

185 Data Required: 

186

187

188 (A) Describe whether the petitioned substance has been reported to have toxic effects and if its mode of 

189 action can cause adverse health and/or environmental effects.

190 (B) Describe whether the petitioned substance contaminants, or any of its breakdown products have 

191 been reported to have toxic effects and are capable of causing adverse health and/or 

192 environmental effects either present in the substance or arising from the degradation of the 

193 substance over time. 

194 (C) Describe whether and how the petitioned substance and/or the breakdown products are persistent 

195 or cumulative when used in organic crop or livestock production as petitioned. 

196

197 Evaluation Question #5: Discuss the probability of environmental contamination during manufacture, 

198 use, misuse or disposal of the substance (7 U.S.C. §6518(m)(3)).

199

200 Data Required: The response must describe the occurrence and severity of environmental contamination 

201 during the manufacture, use, misuse, or disposal of the petitioned substance. Data or reports from U.S. or 

202 International universities, agencies, independent groups, or other news reports should be included in this 

203 response when available. This data may also be available through review of assessments performed per 

204 EPA, FDA, and/or NIEHS review. 

205

206

207 Evaluation Question #6: Discuss the effects of the substance on biological and chemical interactions in 

208 the agroecosystem. Include the physiological effects of the substance on soil, crops, livestock or other 

209 organisms (such as aquatic) that could be affected by the substance when used as petitioned. (7 U.S.C. 

210 §6518(m)(5)) 

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211 Data Required: The response must describe the substances (the petitioned substance and/or its 

212 byproducts in combination with naturally occurring substances over time) that are capable of affecting the 

213 agro-ecosystem. 

214

215 The response should describe whether and how the petitioned substance affects the survival and/ or 

216 function of soil organisms, such as, but not limited to earthworms, mites, grubs, bacteria, nematodes, algae, 

217 and protozoa by changing soil temperature, water availability, pH levels, nutrient availability, salt 

218 concentration, solubility or other parameter. For crops, the response should also describe whether and 

219 how the substance affects plant physiology by creating changes in plant pH, nutrient or water utilization, 

220 or other parameters when used as petitioned. For livestock production, the response should also describe 

221 whether and how the substance affects animal physiology by creating changes in behavior, fertility, 

222 metabolism or other parameters. 

223

224 In addition, the response should describe the potential or actual impacts of the substances upon 

225 endangered species, population, viability or reproduction of non-target organisms and the potential for 

226 measurable reductions in genetic, species or eco-system biodiversity, if possible.

227 

228

229 Evaluation Question #7: Discuss and summarize findings on whether the use of the petitioned 

230 substance may be harmful to the environment (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) 

231 (i)).

232

233 Data Required: Considering the information described in questions #1-6 and any other relevant 

234 information, discuss if the petitioned substance and/ or its breakdown products can cause harmful effects 

235 on the environment. Describe the biological, chemical and physical factors that may be affected by the use 

236 of the substance and/ or its breakdown products. 

237

238

239 Harm to Human Health

240 Evaluation Question #8: Describe and summarize any reported effects upon human health from use of 

241 the petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i)) and 7 U.S.C. § 6518 

242 (m) (4)).

243

244 Data Required: Drawing upon responses to above questions #1-7 and any other relevant information, 

245 describe the reported health effects that may be attributed to the petitioned substance and/or its 

246 breakdown products.

247

248

249 

250 Necessity and Alternatives

251

252 Evaluation Question #9: Describe all natural (non-synthetic) substances or products which may be used 

253 in place of a petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (ii)). Provide a list of allowed substances 

254 that may be used in place of the petitioned substance (7 U.S.C. § 6518 (m) (6)).

255 Data Required: The response must describe the availability of non-synthetic or natural substance(s), 

256 including organic agricultural products, which could be substituted for petitioned substance. The 

257 examination should address:

258 • a comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic or 

259 natural product with the petitioned substance; 

260 • literature, including product or practice description, on performance and test data;

261 • name and address of the manufacturer(s), if applicable; and 

262 • For livestock (and pet food) feed substances, information on technical barriers to production of 

263 organic agricultural products that may serve as alternatives. 

264

265

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266 Evaluation Question #10: Describe any alternative practices that would make the use of the petitioned 

267 substance unnecessary (7 U.S.C. § 6518 (m) (6)).

268

269 Data Required: The response to this request for development of technical information must describe the 

270 availability of specific alternative practices, such as cultural, biological, and mechanical controls, to the use 

271 of the petitioned substance. 

272

273 When assessing alternative practices, the report should address:

274 • Literature, including specific practice description, on performance and test data; 

275 • A comparison of the function and effectiveness of the proposed alternative practice with the 

276 petitioned substance; and,

277 • Frequency or prevalence of use of alternatives, if known.

278

279

280

281

282 Report Authorship

283

284 The following individuals were involved in research, data collection, writing, editing, and/or final 

285 approval of this report: 

286

287 • Name, Title, Organization

288 • Name, Title, Organization

289 • Name, Title, Organization

290

291 All individuals are in compliance with Federal Acquisition Regulations (FAR) Subpart 3.11—Preventing 

292 Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

293

294 References

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 66 of 267