National Organic Standards Board

Materials/GMO Subcommittee

Discussion Document - Technical Report (TR) Template Update

Spring 2023

Intro/Background:

The Materials Subcommittee (MS) is seeking feedback on an update to the Technical Report (TR) 

template. The NOSB Policy and Procedures Manual (PPM)1 defines a Technical Report as: 

“... 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 (Appendix A), “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 NOSB is 

presenting this discussion document to provide the community of experts with an opportunity to 

comment on updates to the format and an opportunity to include relevant questions for materials that 

are at risk for Excluded Methods. The Materials Subcommittee, with technical assistance from the 

National Organic Program (NOP) and the Organic Materials Review Institute (OMRI), has included the 

existing TR template for Handling (Appendix B1) and Crops/Livestock (Appendix C1), along with 

proposed updated templates for Handling (Appendix B2) and Crops/Livestock (Appendix C2). 

Note: the NOSB has within its mandate to add specific questions to the TR template when necessary

Goals:

a. Harmonize the flow of information requested in the TR with the petition template (NOP 3011,

4.22

) and the Organic Foods Production Act (OFPA) criteria3, while reducing redundancy.

b. Add relevant questions/sections for Excluded Methods discovery.

Discussion:

The Materials Subcommittee requests help to try to solve a gap/problem with the scope and format of 

TRs. The intended use of TRs is for the evaluation of specific substances. However, the Materials 

Subcommittee would like to request a TR for breeding methods, like induced mutagenesis, which may 

fall in the class of Excluded Methods. In the course of this work, the Materials Subcommittee discussed 

the possibility of using the TR process to evaluate many kinds of methods and practices in addition to 

the evaluation of specific substances. Excluded Methods may include both unique methods and specific 

materials in the creation/manufacture of a technique that is being evaluated for use in an organic 

system. The Materials Subcommittee is not advocating for a change in the TR process, but instead has 

1National Organic Standards Board Policy and Procedures Manual https://www.ams.usda.gov/sites/default/files/media/NOSBPolicyManual.pdf 2NOP 3011 Procedure - National List Petition Guidelines, 4.2: Items to be Included in a Petition, 

https://www.ams.usda.gov/sites/default/files/media/NOP3011PetitionProcedures.pdf

3Organic Foods Production Act, 7 U.S.C. 6517(c)(1)(B)(i), https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-

section6517&num=0&edition=prelim

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framed several questions around the issue. The Materials Subcommittee asks the community’s

feedback/ideas on how best to proceed.

Questions to our Stakeholders: 

1. Are there other relevant sections of OFPA, or the NOSB PPM, that refer to the TRs that could 

provide further information on improving the TR process? Is the Materials Subcommittee 

missing resources outside of OFPA and the NOSB PPM?

2. Where in the TRs is the best places for questions? What questions should be included to help 

the NOSB identify excluded methods in the organic supply chain? 

3. Who uses TRs and for what purposes? 

4. Is the TR template functional for all types of materials, methods, and practices? If not, does the 

NOSB need to develop another report template for methods/practices? 

Subcommittee Vote

Motion to accept the discussion document on the TR template updates.

Motion by: Mindee Jeffery

Seconded by: Dilip Nandwani

Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 1

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Appendix A

Policy and Procedures Manual – Pages 23-284

1 

4 National Organic Standards Board Policy and Procedures Manual https://www.ams.usda.gov/sites/default/files/media/NOSBPolicyManual.pdf

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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 B1: Existing TR Template - 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—CAN/CGSB-32.311-2015, Organic Production Systems

70 Permitted Substances List

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

72

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

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

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

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

77

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

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

80

81 Japan Agricultural Standard (JAS) for Organic Production

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

83

84 International Federation of Organic Agriculture Movements (IFOAM)

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

86

87

88 Evaluation Questions for Substances to be used in Organic Handling

89

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

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

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

93 animal, or mineral sources (7 U.S.C. § 6502 (21)).

94

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

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

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

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

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

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

101 modification.

102

103 Evaluation Question #2: Discuss whether the petitioned substance is formulated or manufactured by a 

104 chemical process, or created by naturally occurring biological processes (7 U.S.C. § 6502 (21)). Discuss 

105 whether the petitioned substance is derived from an agricultural source.

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106

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

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

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

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

111

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

113 methods used to extract, separate, isolate, or withdraw the substance, including any solvents used, acid114 base extraction methods, or mechanical or physical separation methods.

115

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

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

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

119 metabolic processes, and photosynthesis.

120

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

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

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

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

125

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

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

128 the United States for human or livestock consumption.

129

130 Evaluation Question #3: If the substance is a synthetic substance, provide a list of nonsynthetic or 

131 natural source(s) of the petitioned substance (7 CFR 205.600(b)(1)). 

132

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

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

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

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

137

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

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

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

141

142 Evaluation Question #4: Specify whether the petitioned substance is categorized as generally 

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

144 205.600(b)(5)). If not categorized as GRAS, describe the regulatory status. 

145

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

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

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

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

150

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

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

153

154 Evaluation Question #5: Describe whether the primary technical function or purpose of the petitioned 

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

156 (7 CFR 205.600(b)(4)).

157

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

159 preservative.

160

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161 Evaluation Question #6: Describe whether the petitioned substance will be used primarily to recreate 

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

163 and how the substance recreates or improves any of these food/feed characteristics (7 CFR 205.600(b)(4)).

164

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

166 report evaluators should cite the appropriate regulations. 

167

168 Evaluation Question #7: Describe any effect or potential effect on the nutritional quality of the food or 

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

170

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

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

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

174

175 Evaluation Question #8: List any reported residues of heavy metals or other contaminants in excess of 

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

177

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

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

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

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

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

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

184 food ingredients in the U.S. 

185

186 Evaluation Question #9: Discuss and summarize findings on whether the manufacture and use of the 

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

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

189

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

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

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

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

194 parasitic hymenoptera), pollinators, bats and birds 

195

196 Evaluation Question #10: Describe and summarize any reported effects upon human health from use of

197 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)).

198

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

200 petitioned substance and/or its breakdown products. 

201

202 Evaluation Question #11: Describe any alternative practices that would make the use of the petitioned 

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

204

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

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

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

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

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

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

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

212 petitioned substance; and,

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

214

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215 Evaluation Question #12: Describe all natural (non-synthetic) substances or products which may be 

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

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

218

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

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

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

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

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

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

225 (natural) product with the petitioned substance;

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

227 globally.

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

229 (natural) product to the petitioned substance;

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

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

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

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

234

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

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

237

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

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

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

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

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

243 list, the following should be considered: 

244

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

246 agricultural product to the petitioned substance;

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

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

249 product to the petitioned substance;

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

251 substitute organic agricultural product to the petitioned substance;

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

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

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

255

256 Report Authorship

257

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

259 approval of this report: 

260

261 • Name, Title, Organization

262 • Name, Title, Organization

263 • Name, Title, Organization

264

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

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

267

268

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269 References

270

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

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

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

274 text to avoid plagiarism.

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Name of Material

Handling/Processing

[Insert date transmitted to NOP] Technical Evaluation Report Page 1 of 5 

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

12 CAS Numbers: 

13 List CAS numbers

14

15

16 Other Codes:

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

18 etc.)

19

20 Summary of Petitioned Use

21

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

23 currently on the National List, summarize the allowed uses under the USDA organic regulations

24 (7 CFR part 205). 

25

26 Characterization of Petitioned Substance 

27

28 Composition of the Substance: 

29 Describe Composition of the Substance

30

31 Source or Origin of the Substance:

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

33 Evaluation Questions 1 through 4).

34

35 Properties of the Substance: 

36 Describe Physical and Chemical Properties of the Substance

37

38 Specific Uses of the Substance:

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

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

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

42

43 Approved Legal Uses of the Substance:

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

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

46

47 Action of the Substance:

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

49 when used as petitioned.

50

51 Combinations of the Substance:

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

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

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

55 substances on the National List should be identified.

56

Appendix B2: Proposed TR Template - Handling/Processing

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

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

59 commercially available forms of the petitioned substance.

60

61 Status

62

63 Historic Use:

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

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

66

67 Organic Foods Production Act, USDA Final Rule: 

68 Describe whether the Petitioned Substance is listed anywhere in the Organic Foods Production Act of 1990 

69 (OFPA) https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title7-

70 chapter94&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU3LWNoYXB0ZXI5NC1mcm9udA%

71 3D%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim or the USDA organic regulations, 

72 7 CFR part 205 https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205. 

73

74 International

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

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

77 standards such as:

78

79 Canada

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

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

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

83

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

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

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

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

88

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

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

91 48-1

92

93 Japan Agricultural Standard (JAS) for Organic Production

94 https://www.maff.go.jp/e/policies/standard/specific/organic_JAS.html

95

96 IFOAM-Organics International

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

98

99 Evaluation Questions for Substances to be used in Organic Handling

100

101 Classification of the substance

102

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

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

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

106 formulation of the substance. (C) Discuss whether the petitioned substance is agricultural or non107 agricultural. If the substance is non-agricultural, is it synthetic or non-synthetic? [7 U.S.C. 6502(22); 

108 NOP 5032-1; NOP 5033-2] 

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

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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 include but 

116 are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various metabolic 

117 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) whereby a 

128 substance is transformed into one or more other distinct substances. This may include the addition or 

129 deletion of one atom to the substance’s molecular structure or other description of chemical modification.

130

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

132 cracking, esterification, hydrogenation, mixing of substances or elements, oxidation-reduction, 

133 polymerization, etc., obtained through process units such as compressors, cracking towers, heat 

134 exchangers, mixers, reactors, pumps, etc.

135

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

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

138 agricultural or non-agricultural.

139

140 Evaluation Question #2: Specify whether the petitioned substance is categorized as Generally 

141 Recognized as Safe (GRAS) when used according to FDA’s good manufacturing practices 

142 (7 CFR 205.600(b)(5)). If not categorized as GRAS, describe the regulatory status.

143 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

144

145 Purpose and necessity of the substance

146

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

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

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

150

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

152 or improve flavors, colors, textures, or nutritive values lost in processing (except when required by 

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

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

155 should cite the appropriate regulations.

156

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

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

159 The response must indicate whether the use of the petitioned substance affects the levels of nutrients (e.g., 

160 proteins, carbohydrates, fats, vitamins, and minerals) commonly found in the food product. Effects may 

161 include increasing or decreasing the amount and/or bioavailability of the nutrients.

162

163 Environment and human health effects

164

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

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

167 The response must indicate whether the petitioned substance may contain residues of substances that 

168 exceed FDA’s Action Levels for Poisonous or Deleterious Substances in Human Food. For the most part, 

169 these action levels will relate to residues found in agricultural products. Heavy metals or contaminants are 

170 addressed through FDA’s action levels. https://www.fda.gov/regulatory-information/search-fda171 guidance-documents/guidance-industry-action-levels-poisonous-or-deleterious-substances-human-food172 and-animal-feed See the latest edition of Food Chemicals Codex (National Research Council) for accepted 

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

174

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

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

177 7 U.S.C. 6517(c)(2)(A)(i)).

178 In consideration of the petitioned substance, its manufacturing process, and its breakdown products, 

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

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

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

182 hymenoptera), pollinators, bats, and birds. 

183

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

185 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. 518(m)(4)).

186 Describe reported health effects and causation that may be attributed to the use of the petitioned substance 

187 and/or its breakdown products.

188

189 Alternatives

190

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

192 (7 CFR 205.600(b)(1)).

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

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

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

196 describe any naturally sourced alternatives by summarizing:

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

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

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

200

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

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

203 those are currently allowed under the USDA organic regulations (7 CFR 205.605(a)). 

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

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

206 sourced alternatives by summarizing: 

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

208 (natural) product with the petitioned substance.

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

210 globally.

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

212 (natural) product to the petitioned substance.

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

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

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

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

217

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

219 the petitioned substance.

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

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

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

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

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

225 organic agriculturally derived alternatives by summarizing:

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

227 agricultural product to the petitioned substance;

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

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

230 agricultural product to the petitioned substance.

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

232 substitute organic agricultural product to the petitioned substance;

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

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

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

236

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

238 the petitioned substance unnecessary (7 U.S.C. 6518(m)(6)).

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

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

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

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

243 alternative practices by summarizing:

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

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

246 petitioned substance; and,

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

248

249 Report Authorship

250

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

252 approval of this report:

253 • Name, Title, Organization

254 • Name, Title, Organization

255 • Name, Title, Organization

256

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

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

259

260 References

261

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

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

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

265 text 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 6 

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 C1: Existing TR Template - Crops/Livestock

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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

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

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

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

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

100 netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers? (B) Is 

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

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

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

104 180? 

105

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106 Evaluation Question #2: Describe the most prevalent processes used to manufacture or formulate the 

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

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

109 animal, or mineral sources (7 U.S.C. § 6502 (21)).

110

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

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

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

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

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

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

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

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

119

120 Evaluation Question #3: Discuss whether the petitioned substance is formulated or manufactured by a 

121 chemical process, or created by naturally occurring biological processes (7 U.S.C. § 6502 (21)). 

122

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

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

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

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

127

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

129 methods used to extract, separate, isolate, or withdraw the substance, including any solvents used, acid130 base extraction methods, or mechanical or physical separation methods.

131

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

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

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

135 metabolic processes, and photosynthesis.

136

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

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

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

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

141

142

143 Evaluation Question #4: Describe the persistence or concentration of the petitioned substance and/or its 

144 by-products in the environment (7 U.S.C. § 6518 (m) (2)). 

145

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

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

148 petitioned.

149

150 Evaluation Question #5: Describe the toxicity and mode of action of the substance and of its 

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

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

153

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

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

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

157 substance over time. 

158

159 Evaluation Question #6: Describe any environmental contamination that could result from the 

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

161

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

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

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

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

166 included in this response when available. 

167

168

169 Evaluation Question #7: Describe any known chemical interactions between the petitioned substance 

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

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

172

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

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

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

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

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

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

179 breakdown products should be explained. 

180

181 Evaluation Question #8: Describe any effects of the petitioned substance on biological or chemical 

182 interactions in the agro-ecosystem, including physiological effects on soil organisms (including the salt 

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

184

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

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

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

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

189

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

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

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

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

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

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

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

197 metabolism or other parameters. 

198

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

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

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

202

203 Evaluation Question #9: Discuss and summarize findings on whether the use of the petitioned 

204 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) 

205 (i)). 

206

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

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

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

210

211 Evaluation Question #10: Describe and summarize any reported effects upon human health from use of 

212 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 

213 (m) (4)).

214

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

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

217 and/or its breakdown products.

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218

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

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

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

222

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

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

225 examination should address:

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

227 natural product with the petitioned substance;

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

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

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

231 organic agricultural products that may serve as alternatives.

232

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

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

235

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

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

238 petitioned substance. 

239

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

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

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

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

244

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

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

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

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

249 organisms.

250

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

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

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

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

255

256 When assessing alternative practices, the report should address:

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

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

259 petitioned substance; and,

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

261

262 Report Authorship

263

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

265 approval of this report: 

266

267 • Name, Title, Organization

268 • Name, Title, Organization

269 • Name, Title, Organization

270

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

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

273

274 References

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Name of Material

Crops or Livestock

[Insert date report is transmitted to NOP] Technical Evaluation Report Page 1 of 5 

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

12

13 CAS Numbers:

14 List CAS numbers

15

16 Other Codes:

17 List other codes

18

19 Summary of Petitioned Use

20

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

22 currently on the National List, summarize the allowed uses under the USDA organic regulations

23 7 CFR part 205. 

24

25 Characterization of Petitioned Substance

26

27 Composition of the Substance: 

28 Describe Composition of the Substance

29

30 Source or Origin of the Substance:

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

32 Evaluation Questions 2 and 3).

33

34 Properties of the Substance: 

35 Describe Physical and Chemical Properties of the Substance

36

37 Specific Uses of the Substance: 

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

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

40 petitioned substance in agricultural crop or livestock production. 

41

42 Approved Legal Uses of the Substance:

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

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

45

46 Action of the Substance: 

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

48 substance, when used as petitioned.

49

50 Combinations of the Substance: 

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

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

53 on the National List.

54

Appendix C2: Proposed TR Template - Crops/Livestock

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

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

57 commercially available forms of the petitioned substance.

58

59 Status

60

61 Historic Use:

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

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

64

65 Organic Foods Production Act (OFPA), USDA Final Rule: 

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

67 (OFPA) or the USDA organic regulations, 7 CFR part 205.

68

69 International

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

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

72 standards such as: 

73

74 Canada

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

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

77 https://inspection.canada.ca/organic-products/standards/eng/1300368619837/1300368673172

78

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

80 of Organically Produced Foods (GL 32-1999)

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

82 http://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en/

83

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

85 834/2007: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007R0834&from=EN

86 889/2008: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R0889&from=EN

87

88 Japan Agricultural Standard (JAS) for Organic Production— 

89 https://www.maff.go.jp/e/policies/standard/specific/organic_JAS.html

90

91 IFOAM – Organics International

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

93

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

95

96 Classification of the substance

97

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

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

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

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

102 substance is classified as synthetic or a nonsynthetic. [7 U.S.C. 6502(22); NOP 5033-1]

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

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

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

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

107 described in detail.

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108 For the purposes of this response, naturally occurring biological processes are processes that include but 

109 are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various metabolic 

110 processes, and photosynthesis.

111

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

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

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

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

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

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

118 substance remain in the final product, describe them.

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

120 substance is transformed into one or more other distinct substances. This may include the addition or 

121 deletion of one atom to the substance’s molecular structure or other description of chemical modification.

122

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

124 cracking, esterification, hydrogenation, mixing of substances or elements, oxidation-reduction, 

125 polymerization, etc., obtained through process units such as compressors, cracking towers, heat 

126 exchangers, mixers, reactors, pumps, etc.

127

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

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

130 nonsynthetic.

131 Synthetic substances have been chemically modified from the source or origin or have been isolated from a 

132 natural source in a form that does not occur in nature.

133

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

135 does it contain an active synthetic ingredient in the following categories (7 U.S.C. 6517(c)(1)(B)(i)); 

136 copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish 

137 emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production 

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

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

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

141

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

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

144 The response to this request for development of technical information must describe any known chemical 

145 interactions between the petitioned substance and other substances allowed for use in organic production 

146 or handling as applicable. Describe any common combinations of materials used with the petitioned 

147 substance. Describe any substances resulting from these interactions.

148

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

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

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

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

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

154

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

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

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

158 substance over time.

159

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

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

162

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163 Evaluation Question #5: Discuss the probability of environmental contamination during manufacture, 

164 use, misuse or disposal of the substance (7 U.S.C. 6518(m)(3)).

165 The response must describe the occurrence and severity of environmental contamination during the 

166 manufacture, use, misuse, or disposal of the petitioned substance. Data or reports from U.S. or 

167 International universities, agencies, independent groups, or other news reports should be included in this 

168 response when available. This data may also be available through review of assessments performed per 

169 EPA, FDA, and/or NIEHS review.

170

171 Evaluation Question #6: Discuss the effects of the substance on biological and chemical interactions in 

172 the agroecosystem. Include the physiological effects of the substance on soil, crops, livestock or other 

173 organisms (such as aquatic) that could be affected by the substance when used as petitioned. 

174 (7 U.S.C. 6518(m)(5)) 

175 The response must describe the substances (the petitioned substance and/or its byproducts in combination 

176 with naturally occurring substances over time) that are capable of affecting the agro-ecosystem.

177

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

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

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

181 concentration, solubility or other parameters. For crops, the response should also describe whether and 

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

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

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

185 metabolism or other parameters.

186

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

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

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

190

191 Evaluation Question #7: Discuss and summarize findings on whether the use of the petitioned 

192 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)(i)).

193 Considering the information described in questions #1-6 and any other relevant information, discuss if the 

194 petitioned substance and/ or its breakdown products can cause harmful effects on the environment. 

195 Describe the biological, chemical and physical factors that may be affected by the use of the substance and/ 

196 or its breakdown products.

197

198 Harm to Human Health

199

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

201 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)).

202 Drawing upon responses to above questions #1-7 and any other relevant information, describe the reported 

203 health effects that may be attributed to the petitioned substance and/or its breakdown products.

204

205 Necessity and Alternatives

206

207 Evaluation Question #9: Describe all natural (non-synthetic) substances or products which may be used 

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

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

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

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

212 address:

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

214 natural product with the petitioned substance;

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

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

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

218 organic agricultural products that may serve as alternatives.

219

220 Evaluation Question #10: Describe any alternative practices that would make the use of the petitioned 

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

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

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

224 petitioned substance.

225

226 When assessing alternative practices, the report should address:

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

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

229 petitioned substance; and,

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

231

232 Report Authorship

233

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

235 approval of this report:

236 • Name, Title, Organization

237 • Name, Title, Organization

238 • Name, Title, Organization

239

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

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

242

243 References

244

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

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

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

248 text to avoid plagiarism.

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