USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2011 Meeting

 

National Organic Standards Board Meeting

Hilton Savannah DeSoto Hotel | Savannah, Georgia

November 29 – December 2, 2011

Title Page

Agenda 3

Crops Committee | John Foster, Chairperson

Petitioned Materials Recommendations

Ammonium nonanoate 10

Indole-3 butyric acid 17

Propane (odorized) 24

Sunset 2013 Recommendations on § 205.601

Copper sulfate 32

Ozone 37

Peracetic acid 38

Sunset 2012 Recommendations on § 205.602

Calcium chloride 40

Discussion Document – EPA List 3 Inerts 42

Livestock Committee | Wendy Fulwider, Chairperson

Animal Welfare and Stocking Rates Regulatory Recommendation 50

Animal Welfare and Stocking Rates Guidance Recommendation 63

Animal Handling, Transit, and Slaughter Regulatory Recommendation 70

Animal Handling, Transit, and Slaughter Guidance Recommendation 75

Species-Specific Animal Welfare Scorecards Recommendation 79

Species-Specific Guidance Recommendation 84
Handling Committee | Steve DeMuri, Chairperson

Petitioned Materials Recommendations 

Annatto extract 130

Arachidonic acid (ARA) single-cell oil 136

Beta-carotene 148

Docosahexaenoic acid (DHA) algal oil 155

Potassium hydroxide 164

Silicon dioxide 173

Sulfur dioxide 182

Sunset 2013 Recommendations on § 205.605(a)

Animal Enzymes 187

Tartaric acid 188

Sunset 2012 Recommendations on § 205.605(b)

Tartaric acid 188

Chlorine Materials Annotation Recommendation 190

Materials Committee | Katrina Heinze, Chairperson

Aquaculture Materials Review Update Document 193

Research Priorities Framework Discussion Document 196

Compliance, Accreditation, and Certification Committee | Joe Dickson, Chairperson

Evaluation of Material Review Organizations Recommendation 200

Inspector Qualifications Recommendation 205

Unannounced Inspections Recommendation 212

Policy Development Committee | Barry Flamm, Chairperson

NOSB Policy and Procedure Manual Recommendations

Section IV: Administrative Team 219

Section I: Committee Transparency 221

Section I: Conflict of Interest 224

Section V: NOSB Membership and Leadership Transition 231

Public Comment Procedures Discussion Document 236
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       3

National Organic Standards Board Meeting

Hilton Savannah DeSoto | Savannah, Georgia

November 29 – December 2, 2011

November 29, 2011 | November 30, 2011 | December 1, 2011 | December 2, 2011

Tuesday, November 29, 2011

8:00 a.m. Call to Order

Tracy Miedema, Chairperson

 Approval of Agenda

 Announcements

 Introductions

 NOSB Mission

8:15 a.m. Secretary’s Report

Wendy Fulwider, Secretary

 Acceptance of April 2011 Meeting Transcripts and Voting Results as  

Official Record

8:30 a.m. NOSB Materials Review Process Update

Katrina Heinze, Materials Committee Chairperson

9:00 a.m. National Organic Program Report

Miles McEvoy, Deputy Administrator

National Organic Program

9:45 a.m. Inert Materials Working Group Report

National Organic Program

10:00 a.m. Break

10:15 a.m. Public Comments

12:30 p.m. Lunch

1:30 p.m. Public Comments (continued)

3:30 p.m. Break

3:45 p.m. Public Comments (continued)

5:30 p.m. Recess
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       4

Wednesday, November 30, 2011

8:00 a.m. NOSB Committee Presentations and Discussions

Crops Committee

John Foster, Chairperson

Tree Fruit Fire Blight Update (15 minutes)

Petitioned Materials Recommendations

 Ammonium nonanoate

 Ferric phosphate (to remove)

 Indole‐3‐butyric acid

 Propane (odorized)  

Sunset 2013 Recommendations on § 205.601  

 Copper sulfate

 Ozone  

 Peracetic acid  

Sunset 2013 Recommendations on § 205.602  

 Calcium chloride   

EPA List 3 Inerts – Discussion Document

9:45 a.m. Break

10:00 a.m. Livestock Committee

Wendy Fulwider, Chairperson

Animal Husbandry Presentation (15 minutes)

Animal Welfare & Stocking Rates Regulatory Language Recommendation  

Animal Welfare & Stocking Rates Guidance Recommendation  

Animal Handling, Transit, and Slaughter Regulatory Language Recommendation

Animal Handling, Transit, and Slaughter Guidance Recommendation

Species‐Specific Animal Welfare Scorecards Recommendation

Species‐Specific Guidance Recommendation

12:30 p.m. Lunch
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       5

Wednesday, November 30, 2011 (continued)

1:30 p.m. NOSB Committee Presentations and Discussions (continued)

Handling Committee

Steve DeMuri, Chairperson

Nutrient Vitamins and Minerals Presentation (15 minutes)

Petitioned Materials Recommendations  

 Annatto extract

 Arachidonic acid (ARA) single‐cell oil

 Beta‐carotene

 Choline

 Docosahexaenoic acid (DHA) algal oil  

 Potassium hydroxide

 Silicon dioxide

 Sulfur dioxide

Sunset 2013 Recommendations on § 205.605(a)

 Animal enzymes

 Tartaric acid

Sunset 2013 Recommendations on § 205.605(b)

 Tartaric acid   

Chlorine Materials Annotation Recommendation

3:00 p.m. Break

3:15 p.m. Materials Committee

Katrina Heinze, Chairperson

Aquaculture Materials Review Update

Research Priorities Framework Discussion Document

3:45 p.m. Compliance, Accreditation, and Certification Committee

Joe Dickson, Chairperson

Evaluation of Materials Review Organizations Recommendation

Inspector Qualifications Recommendation  

Unannounced Inspections Recommendation
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       6

Wednesday, November 30, 2011 (continued)

4:30 p.m. NOSB Committee Presentations and Discussions (continued)

Policy Development Committee

Barry Flamm, Chairperson

NOSB Policy and Procedure Manual Recommendations

 Administrative Team

 Committee Transparency

 Conflict of Interest  

 NOSB Member & Leadership Transition

Public Comment Procedures Discussion Paper

5:30 p.m. Recess

Thursday, December 1, 2011

8:00 a.m. Public Comments  

9:15 a.m. Break

9:30 a.m. Public Comments (continued)

10:45 a.m. Break

11:00 a.m. Public Comments (continued)

12:30 p.m. Lunch

1:30 p.m. Public Comments (continued)

3:15 p.m. Break

3:30 p.m. Public Comments (continued)

5:00 p.m. Recess
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       7

Friday, December 2, 2011

8:00 a.m. NOSB Consideration and Vote on Committee Action Items

Crops Committee

John Foster, Chairperson

Petitioned Materials Recommendations

 Ammonium nonanoate

 Ferric phosphate (to remove)

 Indole‐3‐butyric acid

 Propane (odorized)  

Sunset 2013 Recommendations on § 205.601  

 Copper sulfate

 Ozone  

 Peracetic acid  

Sunset 2013 Recommendations on § 205.602  

 Calcium chloride  

9:45 a.m. Break

10:00 a.m. Livestock Committee

Wendy Fulwider, Chairperson

Animal Welfare & Stocking Rates Regulatory Language Recommendation  

Animal Welfare & Stocking Rates Guidance Recommendation  

Animal Handling, Transit, and Slaughter Regulatory Language Recommendation

Animal Handling, Transit, and Slaughter Guidance Recommendation

Species‐Specific Animal Welfare Scorecards Recommendation

Species‐Specific Guidance Recommendation

12:00 p.m. Lunch

1:00 p.m. NOSB Consideration and Vote on Committee Action Items (continued)

Handling Committee

Steve DeMuri, Chairperson

Petitioned Materials Recommendations  

 Annatto extract

 Arachidonic acid (ARA) single‐cell oil

 Beta‐carotene

 Choline

 Docosahexaenoic acid (DHA) algal oil  

 Potassium hydroxide

 Silicon dioxide  

 Sulfur dioxide
USDA‐AMS | National Organic Program

National Organic Standards Board | Fall 2011 Meeting Agenda, Revised 9/30/2011

                                                       8

Friday, December 2, 2011 (continued)

NOSB Consideration and Vote on Committee Action Items (continued)

Handling Committee

Steve DeMuri, Chairperson

Sunset 2013 Recommendations on § 205.605(a)

 Animal enzymes

 Tartaric acid

Sunset 2013 Recommendations on § 205.605(b)

 Tartaric acid   

Chlorine Materials Annotation Recommendation

2:45 p.m. Break

3:00 p.m. Compliance, Accreditation, and Certification Committee

Joe Dickson, Chairperson

Evaluation of Materials Review Organizations Recommendation

Inspector Qualifications Recommendation  

Unannounced Inspections Recommendation

3:45 p.m. Break

4:00 p.m. Policy Development Committee

Barry Flamm, Chairperson

NOSB Policy and Procedure Manual Recommendations

 Administrative Team

 Committee Transparency

 Conflict of Interest  

 NOSB Member & Leadership Transition

4:30 p.m. NOSB Officer Elections

4:45 p.m. Committee Workplans

5:15 p.m. Other Business and Closing Remarks

5:30 p.m. Adjourn
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: __Fall, 2011______________ Substance: Ammonium Nonanoate

Committee: Crops X Livestock  Handling  Petition is for:___Ammonium nonanoate, as a synthetic substance 

for use in organic crop production as an herbicide __ on the National List § 205.601_________________________

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes  No X N/A 

3. Compatibility & Consistency Yes  No X N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A X 

Substance Fails Criteria Category: _[2 & 3]____ Comments: There are numerous weed control alternatives and it was the 

general consensus of the committee that although this material is fairly benign in the environment (the exception being its 

toxicity to aquatic invertebrates), a broad spectrum synthetic herbicide is not compatible or consistent with organic 

agriculture

B. Proposed Annotation (if any): _________________________________________________________________________ 

____________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

Classification Motion: Ammonium nonanoate The Crops Committee voted in Nov. 2008 that ammonium nonanoate is 

synthetic.

Classification of the material: Synthetic __X___ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _____

Recommended Committee Action & Vote The motion is to add ammonium nonanoate to the National List 205.601 as a synthetic 

substance for use as an herbicide in organic food production.

Motion by: _______________ Seconded:________________ Yes: _1____ No: __4___ Absent: ___0____ Abstain: _0____

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ____________________

____________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

____________________________________________________________________________________________________

 

3) Substance was rejected by vote for amending National List to § 205. _X_ why material was rejected: Ammonium nonanoate was 

rejected because of questions of necessity as there are several alternatives pointed out in the TR, because of issues of 

consistency and compatibility and because of concerns about toxicity to aquatic invertebrates. 

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops X Agricultural Allowed1

 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic X Rejected3 X

No restriction Commercially UnAvailable as Organic1

 

Deferred4

E. Approved by Committee Chair to transmit to NOSB:

__John Foster__________________ ______Oct. 07, 2011___________________

 Committee Chair Date

9
Decision Sheets 

December 2006 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

 

Category 1. Adverse impacts on humans or the environment? Substance ____Ammonium 

nonanoate________ 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on environment from 

manufacture, use, or disposal? [§205.600 

b.2] 

X

2011 TR pg. 6 “highly toxic to aquatic invertebrates”

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3] 

2011 TR pg. 6 Lines 300-320- product is rapidly 

biodegraded in the environment and it’s byproducts 

have value in food, pharmacy, and cosmetic 

applications. (paraphrased), although the TR states 

that “Specific information regarding the potential for 

environmental contamination associated with the

manufacture of ammonium nonanoate was not 

found.(lines 300-301) 

3. Is the substance harmful to the environment

and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 2011 TR pg. 3, lines 130-134 It is a “nonselective, 

broad-spectrum, contact” (TR line 117) synthetic 

herbicide and also is an EPA registered insecticide 

and fungicide. “Pesticide products containing 

ammonium nonanoate as the active ingredient were 

first registered with EPA in 2006 and several have 

been registered since then (PAN, 2010). All of these 

products are listed as herbicides. Pesticide products 

containing the active ingredient ammonium salts of 

fatty acids were first registered with EPA in 1982 

and many have been registered since that time (PAN, 

2010). The use types listed for these products 

include herbicides, deer repellents, fungicides, and 

insecticides

4. Does the substance contain List 1, 2, or 3 

inerts? [§6517 c (1 ) (B)(ii); 205.601(m)2] 

X 2011 TR pg. 4 Lines 190-196 “B). Ammonium 

nonanoate is not listed by EPA as an inert ingredient 

of toxicological concern. Soap is included on the list 

of EPA inert ingredients of minimal concern for food 

and nonfood uses, but it is defined as “the water 

soluble sodium or potassium salts of fatty acids 

produced by either the saponification of fats and oils, 

or the neutralization of fatty acid” (EPA, 2010). 

Ammonium nonanoate does not meet this definition 

because it is an ammonium salt of a fatty acid and 

not a sodium or potassium salt. However, 

ammonium nonanoate when used as an active or 

inert ingredient in pesticide products is exempt from 

the requirement of a tolerance per 40 CFR 180.1284 

and 180.910.” and lines 89-91 “According to 40 CFR 

180.910, ammonium salts of fatty acids, including 

ammonium nonanoate, may be used as inert 

ingredients (surfactants) in pesticides applied to preand post-harvest crops. No further information was 

found on this usage.”

5. Is there potential for detrimental chemical 

interaction with other materials used? 

[§6518 m.1] 

X 2011 TR pg. 7 lines 326-337 “No information could 

be found on known chemical interactions between 

ammonium nonanoate and other substances allowed 

for use in organic production or handling. The RED 

for soap salts states that ammonium soaps of higher 

fatty acids are not compatible with soluble metallic 

salts such as zinc, manganese, and iron sulfates 

(EPA, 1992), but does not provide any further details 

regarding the likelihood for these interactions. This 

is a potential issue in organic crop production 

because soluble metallic salts are permitted for use 

as soil micronutrients following documentation of a 

10
Decision Sheets 

December 2006 

soil deficiency. Specifically, sulfates, carbonates, 

oxides, or silicates of zinc, copper, manganese, iron, 

molybdenum, selenium, and cobalt are permitted by 

7 CFR 205.601(j)(6)(ii). The potential 

environmental or health effects resulting from the 

mixture of these incompatible materials in 

agricultural soil were not described. 

The MSDS for Racer® Concentrate (40% 

ammonium nonanoate) states that the product is 

incompatible with acids, strong bases, and any 

material incompatible with water (Smiley and Beste, 

2009).”

6. Are there adverse biological and chemical 

interactions in agro- ecosystem? [§6518 m.5] 

X 2011 TR pg. 7-8 lines 343-379

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5] 

2011 TR pg. 7 lines 343-379, specifically lines 370-

372 “No information could be found on the potential 

effects of ammonium nonanoate on soil organisms, 

soil temperature, water availability, pH levels, 

nutrient availability, salt concentration, solubility, or 

any other soil physicochemical and biological 

properties.” 

8. Is there a toxic or other adverse action of the 

material or its breakdown products? 

[§6518 m.2] 

X X 2011 TR pg. 6 lines 293-295 no:“As stated in the 

response to Evaluation Question #4, ammonium 

nonanoate is expected to rapidly degrade following 

contact with the soil. The breakdown products are 

compounds that naturally occur in the soil; therefore, 

no toxic effects are expected.” 

Yes: TR lines 276-279: “Soap salts of fatty acids are 

considered to be slightly toxic to birds on an acute 

basis, practically nontoxic to birds on a dietary basis, 

slightly toxic to warm and cold water fish, and 

highly toxic to aquatic invertebrates (EPA, 1992). 

Toxicity data for nontarget insects are not available 

for any soap salt (EPA, 2008). Some soap salts (e.g., 

potassium salts of fatty acids) are registered for use 

as insecticides (NPIRS, 2011).” 

Complete TR answer to this question lines 246-295

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment?[§6518 m.2] 

X 2011 TR pg. 5 lines 227-240 “Once released into the 

soil, ammonium salts of fatty acids, such as 

ammonium nonanoate, are expected to rapidly 

degrade primarily by microbial action (EPA, 1992). 

This is further supported by a draft environmental 

risk assessment of fatty acid salts prepared by 

HERA, which concludes that fatty acid salts with 

carbon chain lengths up to C18 can be considered 

readily biodegradable via aerobic metabolism 

(HERA, 2003). According to the RED for soap salts 

prepared by EPA, the half-life of the fatty acid 

components of ammonium soaps was demonstrated 

to be less than one day in soil (EPA, 1992). 

Regarding the potential degradation products of 

ammonium nonanoate in the environment, the RED 

states that microbial metabolism of fatty acids will 

result in the eventual formation of carbon dioxide 

and an ester, or that the carbon content of fatty acids 

will be converted into naturally-occurring organic 

substances normally produced by soil 

microorganisms (EPA, 1992). The BRAD for 

ammonium nonanoate concluded that this compound 

will not persist in the environment when used as an 

herbicide as directed (EPA, 2008). Environmental 

fate and groundwater data were waived for 

ammonium nonanoate due to EPA’s estimate of 

11
Decision Sheets 

December 2006 

minimal risk (EPA, 2008). No further information 

could be found on the persistence or concentration of

ammonium nonanoate and/or its byproducts in the 

environment.”

10. Is there any harmful effect on human health? 

[§6517 c (1)(A) (i) ; 6517 c(2)(A)I; §6518 

m.4] 

X 2011 TR pg. 8 lines 405-407 “EPA’s RED for soap 

salts concluded that products containing ammonium 

salts of fatty acids are not likely to cause 

unreasonable adverse effects on human health (EPA, 

1992). The toxicity of ammonium salts of fatty 

acids, including ammonium nonanoate, is generally 

low (E

11. Is there an adverse effect on human health as 

defined by applicable Federal regulations? 

[205.600 b.3] 

X

12. Is the substance GRAS when used according 

to FDA’s good manufacturing practices? 

[§205.600 b.5] 

X

13. Does the substance contain residues of heavy 

metals or other contaminants in excess of 

FDA tolerances? [§205.600 b.5] 

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

12
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance ____Ammonium 

nonanoate_______ 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical process? 

[6502 (21)]

X 2011 TR pg. 4-5 lines 203-215

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X 2011 TR pg. 4-5 lines 203-215

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

X 2011 TR pg. 4-5 lines 203-215

4. Is there a natural source of the 

substance? [§205.600 b.1]

X

5. Is there an organic substitute? 

[§205.600 b.1]

X

6. Is the substance essential for handling 

of organically produced agricultural 

products? [§205.600 b.6]

X

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X

8. Is the substance used in handling, 

not synthetic, but not organically 

produced? 

[§6517 c (1)(B)(iii)]

X

9. Are there any alternative substances? 

[§6518 m.6]

X 2011 TR pgs. 9-12 lines 436-602

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X 2011 TR pgs. 12-13 lines 607-711

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b)are N/A—not applicable. 

 

13
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? 

Substance __Ammonium nonanoate______

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2] 

X

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X Ammonium Nonanoate is a non-selective, broad-spectrum 

herbicide as well as being registered as an insecticide.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7] 

X X The nature of its non-selective and broad spectrum action 

on green plants as well as it’s insecticidal properties are not 

compatible with maintaining biodiversity which is integral 

to sustainability. It is relatively non-toxic and has low 

environmental impact

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3] 

X

5. Is the primary use as a preservative? 

[§205.600 b.4] 

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive values lost in processing 

(except when required by law, e.g., 

vitamin D in milk)? [205.600 b.4] 

X

7. Is the substance used in production, 

and does it contain an active 

synthetic ingredient in the following 

categories: 

a. copper and sulfur compounds; 

X

b. toxins derived from bacteria; X

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals? 

X The ammonium nonanoate is a soap 2011 TR lines 18, 95-

96,139-141, 157-159, 164-165, 171-172, 188

d. livestock parasiticides and 

medicines? 

X

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners? 

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

14
Decision Sheets 

December 2006 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance - __________Ammonium nonanoate____________________________ 

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

 X

2. Does the current and historical 

industry information, research, or

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling?

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quality to fulfill an essential function 

in a system of organic handling?

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quantity to fulfill an essential 

function in a system of organic 

handling?

X

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

15
Decision Sheets 

April 2010 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: November, 2011 Substance: Indole-3-butyric acid (IBA)__CAS#133-32-4___

Committee: Crops x Livestock  Handling  Petition is for:__IBA as a plant growth 

regulator___________________________________________

___________________________________________________ on the National List § 205.601_________________________

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes  No X N/A 

3. Compatibility & Consistency Yes  No X N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A  

B. Substance Fails Criteria Category: _2 and 3___Comments: __There has not been shown to be a demostrated need for IBA in organic 

production.__Synthetic materials to achieve propogation and to regulate plant growth is inconsistent with organic production._In addition, 

although #1 is checked yes, environmental__impacts my be greater than indicated in the review depending on the raw materials used and the 

manufacturing process. In addition, although the most common probable use of IBA would be point application_by dipping plant cuttings in 

powder dust or solution to promote rooting, the petition requests a broader use. Area application would present a different more complex 

risk.__________________________________________ 

___________________________________________________________________________________________________

C. Proposed Annotation (if any): _________________________________________________________________________ 

____________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

_________________________________________________________________________________________________

Classification of the material: Synthetic ____X____ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _Barry Flamm__ Seconded:__Tina Ellor______________ Yes: __6___ No: _____ Absent: ___1____ Abstain: _____

Recommended Committee Action & Vote ____Motion to list under 205.601(k)________________________________

____________________________________________________________________________________________________

 

Motion by: __Barry Flamm__________ Seconded:__Tina Ellor______________ Yes: __1___ No: ___4__ Absent: _______ Abstain: _____

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ____________________

____________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

____________________________________________________________________________________________________

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected: Failed Categories 2&3 and 

concerns under category 1_________ 

____________________________________________________________________________________________________

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops Agricultural Allowed

1

 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic X Rejected3 X

No restriction Commercially UnAvailable as Organic1

 

Deferred4

16
Decision Sheets 

April 2010 

E. Approved by Committee Chair to transmit to NOSB:

______________________________________ _________________________

 Committee Chair Date

17
Decision Sheets 

April 2010 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 1. Adverse impacts on humans or the environment? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on environment 

from manufacture, use, or disposal?

[§205.600 b.2]

N/A

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X X Petitioner stated IBA is a technical grade 

synthesized substance from many 

sources.186 products containing IBA are 

available in US. IBA is manufactured 

world wide. Thus, there might be different 

manufacturing procedures. (TR 227)

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X TR 282- IBA is biosynthesized in natural

plants and produced by soil bacteria. It is 

non-toxic to avian wildlife, plants, but 

slightly toxic to fish and aquatic, and 

invertebrates and should not cause 

adverse effects to mammalian wildlife.

EPA says IBA does not persist in the 

environment. TR 221 EPA also waved 

most tox requirements. TR 252-255 –

IBA has typical hormonal dose-response 

pattern. TR 287- PAN data base shows 

no evidence of harmful effects to 

environment, except slight toxicity to fish.

4. Does the substance contain List 1, 2 or 3 

inerts? [§6517 c (1)(B)(ii); 205.601(m)2]

X TR 238- Indole (CAS#120-72-9) 

butyrolactone(CAS# 96-48-0) and 

Sodium Hydroxide (CAS# 1310-73-2) 

was on list 4B.

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

X TR 246- potentially reacts with strong 

oxidizers. TR 249- 250 synergistic with 

other chemicals and bacteria

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5]

X X TR 44- There are two general groups of 

application methods in terms of toxic 

effect and environmental consequence. 

1) point application: dipping 

plant cuttings in 

powder,dust or solution.

2) Area appliction/ broad 

cast: foliar spray, turf, and 

adding to springler system.

The risks are greater under group 2.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X See # 3 above

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518 m.2]

X See # 3 above

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

X See # 3 above

18
Decision Sheets 

April 2010 

10. Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 c(2)(A)i; 

§6518 m.4]

X X EPA says no known risks to human 

health and has granted an exemption for 

tolerance of residue.

IBA is an ―acute health hazard‖ under 

Section 311/312 Hazard class of

SARA Title III Rules (MSDA-IBA,2007)

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

N/A

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5]

N/A

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

N/A

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

19
Decision Sheets 

April 2010 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 2. Is the Substance Essential for Organic Production? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or manufactured 

by a chemical process? [6502 (21)]

X Petitioner stated IBA is a technical grade 

synthesized substance

2. Is the substance formulated or manufactured 

by a process that chemically changes a 

substance extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X Petitioner/TR

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X However, IBA does occurTr naturally in a 

variety of plants.

4. Is there a natural source of the substance? 

[§205.600 b.1]

N/A

5. Is there an organic substitute? [§205.600 b.1] N/A

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

N/A

7. Is there a wholly natural substitute product?

[§6517 c (1)(A)(ii)]

X X IBA occurs naturally, but there is not any 

commercially available extraction 

process. The most commonly used auxin 

for inducing adventitious rooting is IAA, 

but the availability of natural sources is 

unclear.

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

N/A

9. Is there any alternative substances? 

[§6518 m.6]

X TR 392- 398 Researchers have 

evaluated the effects of several

alternative materials containing growth 

hormones.( Not clear if these would 

provide the same response as an auxin.)

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X TR 499 Successful rooting from stem 

cuttings depend on many factors: timing, 

types of cutting, light, temperature, 

moisture and 10 other factors including 

plant hormones.( which may be produced 

naturally by the plant tissues- BF)

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

20
Decision Sheets 

April 2010 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 3. Is the substance compatible with organic production practices? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

N/A

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

(1)(A)(iii); 6517 c (2)(A)(ii)]

X TR 381- European and N. American 

regulations do not allow synthetic 

products to obtain organic propogation. It 

does not fit any of the allowed categories 

for approving synthetic inputs: 6517c1(B)

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X X IBA is biosynthesized in natural plants 

and produced by soil bacteria. There is 

no evidence that chemical properties of 

synthetic IBA are different from natural

sources, but the manufactured IBA 

contains impurities.

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

N/A

5. Is the primary use as a preservative? 

[§205.600 b.4]

N/A

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law, e.g., vitamin D in milk)? 

[205.600 b.4]

N/A

7. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

a. copper and sulfur compounds;

X

b. toxins derived from bacteria; X

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

21
Decision Sheets 

April 2010 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance: Name 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description provided

as to why the non-organic form of the 

material /substance is necessary for use 

in organic handling? 

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system of 

organic handling? 

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system of 

organic handling? 

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quantity to 

fulfill an essential function in a system of 

organic handling?

5. Does the industry information provided 

on material / substance non-availability 

as organic, include ( but not limited to) 

the following:

a. Regions of production (including 

factors such as climate and number 

of regions);

b. Number of suppliers and amount 

produced;

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

22
NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: Fall 2012, Savannah, GA Substance: Odorized propane

Committee: Crops X Livestock  Handling  Petition is for: addition of odorized propane on the National List 

§ 205.601.

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes x No  N/A 

2. Essential & Availability Criteria Yes  No x N/A 

3. Compatibility & Consistency Yes x No  N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A x 

B. Substance Fails Criteria Category: 2 Comments: Majority of CC members believe adequate alternatives exist and questioned 

the materials efficacy.

C. Proposed Annotation (if any): _________________________________________________________________________ 

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote (State Actual Motion): To amend the National List, Synthetic substances allowed 

for use in organic crop production, § 205.601(g)(3) – Rodenticides, to include odorized propane as petitioned.

Motion by: John Foster Seconded: Tina Ellor Yes: 3 No: 4 Absent: _______ Abstain: _____ 

 

1) Substance voted to be added as ―allowed‖ on National List to § 205. with Annotation (if any) ____________________

____________________________________________________________________________________________________

2) Substance to be added as ―prohibited‖ on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

____________________________________________________________________________________________________

 

 3) Substance was rejected by vote for amending National List to § 205.601. Describe why material was rejected: Majority of 

 CC members believe adequate alternatives exist and did not believe the material to be effective.

4) Substance was recommended to be deferred because _________________________________________________________

If follow-up needed, who will follow up _____________________________________________________________________

Crops x Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic x Rejected3 x

No restriction Commercially UnAvailable as Organic1

 

Deferred4

E. Approved by Committee Chair to transmit to NOSB:

John Foster 10/7/11

Committee Chair Date

23
EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

 

Category 1. Adverse impacts on humans or the environment? Substance: Odorized Propane 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on environment 

from manufacture, use, or disposal? 

[§205.600 b.2] 

x

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3] 

x x Long term no, short term yes, and then 

when misused or mishandled. 

TR 250

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x See #2 above.

4. Does the substance contain List 1, 2, or 3 

inerts? [§6517 c (1 ) (B)(ii); 

205.601(m)2] 

x Given the EPA’s reclassification of inerts.

5. Is there potential for detrimental chemical 

interaction with other materials used? 

[§6518 m.1] 

x TR 265. Other than flammability with 

oxygen, no interactions between propane 

and other common substances used in 

agriculture were identified.

6. Are there adverse biological and chemical 

interactions in agro- ecosystem? [§6518 

m.5] 

x TR 276. These are highly localized and 

not persistent.

7. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518 m.5] 

x TR 276. These are highly localized and 

not persistent.

8. Is there a toxic or other adverse action of 

the material or its breakdown products? 

[§6518 m.2] 

x TR 276. These are highly localized and 

not persistent.

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

x TR 276. These are highly localized and 

not persistent.

10. Is there any harmful effect on human 

health? [§6517 c (1)(A) (i) ; 6517 

c(2)(A)I; §6518 m.4] 

x Not when used as directed. TR 276. 

These are highly localized and not 

persistent. 

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3] 

x

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5] 

x

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

24
Category 2. Is the Substance Essential for Organic Production? Substance Odorized propane 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is there a natural source of 

the substance? 

[§205.600 b.1] 

X

2. Is there an organic 

substitute? [§205.600 b.1] 

X

3. Is the substance essential for 

handling of organically 

produced agricultural 

products? [§205.600 b.6] 

X

4. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)] 

x

5. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)] 

x

6. Is there any alternative 

substances? [§6518 m.6] 

x However none of them have acceptable 

availability, applicability, functionality or efficacy. 

TR 316

Pet. pg. 7

7. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6] 

x Tillage, flooding, long-term fallow, smoke bombs, 

biological controls, removal of food, CO2, 

anticoagulants, trapping

TR 312, 338

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

x See #5 above

9. Is there any alternative 

substances? [§6518 m.6]

x See #6 above

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

x See #7 above

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b)are N/A—not applicable. 

 

25
Category 3. Is the substance compatible with organic production practices? 

Substance Odorized propane 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2] 

X

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)] 

x It is a physical control, consistent with preferred pest 

control methodologies; propane is currently in use as 

vertebrate deterrent and fuel for thermal weed control. 

The material was allowed by the majority of private 

certification standards pre-NOP and was allowed 

under the NOP until 2007, when the substance was 

summarily prohibited pending successful petition and 

inclusion on the National List. (Petition+TR)

3. Is the substance compatible with 

a system of sustainable 

agriculture? [§6518 m.7] 

x See above.

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3] 

X

5. Is the primary use as a 

preservative? [§205.600 b.4] 

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when

required by law, e.g., vitamin D 

in milk)? [205.600 b.4] 

X

7. Is the substance used in 

production, and does it contain 

an active synthetic ingredient in 

the following categories: 

a. copper and sulfur compounds; 

X

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals? 

X

d. livestock parasiticides and 

medicines? 

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners? 

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

26
Category 4. Is the commercial supply of an agricultural substance as organic, fragile or 

potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance: Odorized propane

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic form of the material 

/substance is necessary for use 

in organic handling? 

X

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate form to fulfill an 

essential function in a system of 

organic handling? 

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate quality to fulfill an 

essential function in a system of 

organic handling? 

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate quantity to fulfill an 

essential function in a system of 

organic handling?

X

5. Does the industry information 

provided on material / substance 

non-availability as organic, include ( 

but not limited to) the following:

a. Regions of production (including 

factors such as climate and number 

of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

 

27
National Organic Standards Board 

Crops Committee 

Proposed Recommendation 

Odorized Propane 

October 7, 2011 

List: § 205.601 Synthetic substances allowed for use in organic crop production 

 (g) As rodenticides. 

California Certified Organic Farmers, Inc. (CCOF) is petitioning to have odorized propane used 

in devices for control of burrowing pest animals added to the National List § 205.601, 

Synthetics for use in crop production. 

In its pure form, (C3H8) propane is an odorless gas, but may also be compressed into a liquid 

(often called LPG). It is a constituent of natural gas and of crude petroleum, is isolated from 

these sources by a “stabilization process” using fractional distillation under pressure, and is 

highly flammable. It is readily available for home, transportation, farm, commercial, and 

industrial uses. Propane is not currently listed as an allowed substance for organic crop 

production under 7 CFR § 205.601. However, heat methods (fueled with propane) are allowed 

to control weeds and propane is used to create above ground explosions to deter birds and 

other vertebrate pests from orchards, vineyards, and berry farms previous to and through 

harvest. It is a physical control, consistent with preferred pest control methodologies. Prior to 

NOP implementation, the substance was allowed by multiple private certification standards 

and was allowed under the NOP until 2007, when the substance was summarily prohibited 

unless and until successfully petitioned and included on the National List. 

The propane is mixed with oxygen and is exploded underground, causing a rapid expansion of 

gases that leads to concussive force that kills burrowing pest animals, with accompanying 

suffocation from consuming all the oxygen in the tunnel. The mixture is approximately 2% 

propane to 98% compressed oxygen, and the mixture is injected into the burrow for up to one 

minute before it is ignited. The Crops Committee has received a new Technical Report on this 

material and this has been posted by the Program for the Crops Committee, NOSB, and public 

review. 

The Committee discussed the placement of this material on § 205.601, noting this is somewhat 

atypical given that the material’s efficacy is accomplished by physical action, either as an 

agent of concussive force or as an agent of oxygen displacement, either of which are physical 

control methods in common IPM parlance. The Committee discussed the possibility of creating 

a new subsection, § 205.601(o) – Pest control production aids, consistent with an option 

identified in the TR, line 171. The intent with that listing would be to provide a place on the 

National List for synthetic substances which are used up in their application and not present 

after the fact, somewhat analogous to processing aids used on food handling. While propane 

itself as applied is not a rodenticide, the Committee discussed the merits of classifying it under 

§ 205.601(g) - Rodenticides. One Committee member felt strongly that propane should not be 

identified as a rodenticide per se, but ultimately agreed in framing the recommendation to 

place the material under § 205.601(g) in the interests of collaboration and consensus and 

28
Page 2 of 3 

Odorized Propane on §205.601 

October 7, 2011 

recognized that in fact the intended use was to control, in the main, rodents. Standards in 

Canada, EU and Japan either a) allow or b) do not prohibit the use of propane in organic 

production systems. 

The Committee noted there are legitimate concerns over collateral damage from this method 

on endangered species. The Crops Committee wishes to make it clear to all concerned that 

use of the propane in a manner that violates the Endangered Species Act is a federal crime; 

the presumably provides adequate disincentive for such misuse. 

In discussions, some members thought that this material was preferable to chemical controls 

currently allowed for use in organic production since it leaves no residue and complies with the 

mandates of § 205.206 which require that physical or mechanical controls be attempted prior 

to use of chemical controls. Other members felt that its use was unnecessary given the 

alternatives available for use, with discussion as to the applicability, efficacy, and functionality 

of those alternative methods. Allowed alternative methods discussed included flooding with 

water, a vacuum, CO2, vitamin D3 baits, smoke bombs, and several cultural practices listed 

under § 205.206(a). Some members also questioned the efficacy of propane for the petitioned 

use. There was again discussion about the utility of these practices across the wide range of 

crops, conditions and environments where propane had been used under pre-NOP private 

certification standards and under the NOP, until 2007 and whether that was an appropriate 

criterion on which to base a decision. 

Another relevant discussion item was that propane is currently allowed in organic production 

as a physical control agent to kill weeds by heat and flame and is presently and widely used in 

many crops and conditions in that capacity. It is also used for fuel in so called “propane 

cannons” to generate loud explosions that deter wildlife from crops around harvest time, 

generally in and around perennial crops such as orchards, vineyards and cane berries. The 

Committee understands that both uses are allowed under the NOP as they are considered 

physical pest control methods. 

The Committee recognized that if this material is included on the National List, an organic 

operator would still have to demonstrate that cultural practices (repellants, rotations, irrigation 

management, etc.) and non-synthetic physical practices (trapping, etc.) have been determined 

to be inadequate prior to using this management method on organic farms. In other words, the 

inclusion of propane on the National List would not affect the obligation to abide by § 205.206. 

With those discussions had, the majority of the Crops Committee voted not to recommend 

odorized propane be included on the National List. 

Committee Recommendation 

The Crops Committee voted on the recommendation for propane to be added to the National 

List. The motion was as follows: To amend the National List, Synthetic substances allowed for 

use in organic crop production, § 205.601(g)(3) – Rodenticides, to include odorized propane 

as petitioned. 

29
Page 3 of 3 

Odorized Propane on §205.601 

October 7, 2011 

Committee Vote

Motion: John Foster Second: Tina Ellor 

Yes: 3 No: 4 Abstain: 0 Absent: 0 

30
National Organic Standards Board 

Crops Committee 

2013 Sunset Recommendation 

Copper Sulfate 

October 4, 2011 

List: §205.601 Synthetic substances allowed for use in organic crop production. 

 (a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

 systems. 

 (3) Copper sulfate—for use as an algicide in aquatic rice systems, is 

limited to one application per field during any 24-month period. Application 

rates are limited to those which do not increase baseline soil test values 

for copper over a timeframe agreed upon by the producer and accredited 

certifying agent. 

(e) As insecticides (including acaricides or mite control). 

(4) Copper sulfate—for use as tadpole shrimp control in aquatic rice 

production, is limited to one application per field during any 24-month 

period. Application rates are limited to levels which do not increase 

baseline soil test values for copper over a timeframe agreed upon by the 

producer and accredited certifying agent. 

Background 

History: 

Copper sulfate as algicide, invertebrate pest control in rice 

 Approved 10/16/01 

 Allowed synthetic: vote 10-3-1 

 3 TAP reviewers: 1 in favor of approval, 2 against 

 Annotation: one application per field per 24 month period, not to increase 

baseline soil test values for copper over a timeframe agreed upon by the 

producer and accredited certifying agent 

 205.601(a)(3), 205.601(e)(3) 

o Approval renewed 11-30-07 

o 11-3-1 vote 

o ―Material is still needed in organic aquatic rice systems. No compelling 

new information presented to warrant removal from the list.‖

The original petition by CCOF stated, ―In southeastern growing states there is a whole 

different set of rice pests and crop management issues and so the material is not widely 

used or needed.‖

31
Page 2 of 5 

Copper sulfate on §205.601 

October 4, 2011 

Summary

There have always been concerns over the use of copper, particularly in rice, because 

of its toxicity to aquatic organisms. Two out of three TAP reviewers opposed this use 

because of the toxicity to aquatic organisms and the fact that rice fields are attractive to 

animals like frogs. The TAP review also looked at alternatives to copper sulfate. 

Now the Crops Committee has additional information on the severity of the threat to 

aquatic organisms. The California Rice Commission lists 230 species known to use rice 

fields in California. These include birds, mammals, reptiles, and amphibians. 

Tadpoles—the larval form of frogs and toads, not the tadpole shrimp—eat algae, 

making them a candidate for controlling algae in rice paddies. But copper is highly toxic 

to amphibians (including mortality and sodium loss), with adverse effects in tadpoles 

and embryos at concentrations expected with the listed use. The California Rice 

Commission also points out that 95% of California’s wetlands are gone, so rice fields 

provide important habitat for aquatic and semi-aquatic species who have been 

displaced. 

ATSDR says that when copper sulfate is used in ponds, lakes, and reservoirs for 

controlling algae, the copper levels in the water column return to pretreatment levels 

within a few days. ―The reduction in dissolved copper during this period was 

accompanied by an increase in particulate copper (e.g., sorption to algae or other 

organic matter, which settles into the sediments of these bodies of water). The copper in 

the settled particulates is in equilibrium with the water column, which greatly favors 

copper in a bound state.‖ They also say that copper can enter surface water in 

agricultural runoff. ―The copper in the runoff water was found to be predominantly 

bound to drift material in the water (e.g., algae, vascular plants, invertebrates, 

vertebrates, and detritial material).‖1

Hundreds of studies document lethal and sublethal impacts of copper on aquatic food 

chains. These have been summarized by Carol Ann Woody as follows:2

Starting at the bottom the bottom of the food chain, at just 1.0 μg Cu/L green 

algae (Chlorella spp.) growth declined, at 5.0 μg Cu/L photosynthesis declined, 

and at 6.3 μg Cu/L photosynthesis was inhibited in a mixed algae culture 

(USEPA 1980). Zooplankton feed on algae and their growth and reproduction are 

affected by food availability. Declining algae production causes declining 

zooplankton production (Urabe 1991, Müller-Navarra and Lampert 1996), 

reducing food availability for species, such as sockeye salmon (Oncorhynchus 

nerka), that feed on zooplankton. 

 

1

 ATSDR, 2004. Toxicological Profile for Copper. http://www.atsdr.cdc.gov/toxprofiles/tp132.pdf P. 141. 

Accessed 8/30/2011. 

2

 Carol Ann Woody, 2007. Copper Effects on Freshwater Food Chains and Salmon: A review, Fisheries Research 

and Consulting. Pp 10-11.

32
Page 3 of 5 

Copper sulfate on §205.601 

October 4, 2011 

Thus, copper used in rice fields tends to concentrate in the ―particulate matter‖, which is 

composed of remains of algae, plankton, and invertebrates, and this ―particulate matter‖

is the food of tadpoles and forms the basis of aquatic food chains. The LC50 for 

tadpoles of Bufo boreas (one of the frogs found in California rice fields) is 47.49 parts 

per billion copper (0.04749 ppm).3

 According to the TAP review (lines 680-683): 

Typical application rates in paddies to control algae appear to range from 0.25 

ppm to 2.0 ppm. For treating tadpole shrimp, application rates appear to be ―less 

than 10 ppm‖. With aquatic organisms showing detrimental effects at levels of 

about 0.4 ppm and above, this means that the application of CuSO4 to rice 

paddies could kill mosquito fish, pond snails, and other organisms that could 

have beneficial properties. 

In California, rice growers describe a system of drill seeding or dry planting rice that 

does not rely on copper. In this system, the seed drilling/dry planting, described in 

Alternative Agriculture (National Research Council, National Academy of Sciences, 

1989) and currently in practice, allows the rice plant to be established to a stage that is 

not vulnerable to tadpole shrimp by the time the field is flooded. However, overly wet 

and warm weather in the spring is a factor that can prevent the use of this practice. 

The Washington State Department of Ecology describes below the action of an 

alternative material to copper sulfate for algae control, sodium carbonate peroxyhydrate 

products (http://www.ecy.wa.gov/programs/wq/plants/algae/lakes/ControlOptions.html). 

This alternative, which appears to make the use of copper sulfate as an algicide 

unnecessary, is approved under 205.601 with the following annotation: (a)(8) Sodium 

carbonate peroxyhydrate (CAS #–15630–89–4)—Federal law restricts the use of this 

substance in food crop production to approved food uses identified on the product label. 

These Environmental Protection Agency (EPA)-registered sodium carbonate 

peroxyhydrate products are fast acting algaecides (algae killer) or algaestats. 

Algaestats do not kill algae outright but instead inhibit their growth, preventing bloom 

formation. Lake managers apply these products to the water to prevent algal blooms 

or to treat existing algae. Lake managers use these products as an alternative to 

copper-based algaecides not allowed in most Washington water bodies. In some 

parts of the world, there are copper-resistant algae strains and these products 

provide an alternative to treat copper-resistant algae.

The EPA registered sodium carbonate peroxyhydrate products for use in ponds, 

lakes, reservoirs, and drinking water sources. Sodium carbonate peroxyhydrate acts 

as an oxidizing agent to kill algae. When applied to water, these granular products 

break down into sodium carbonate and hydrogen peroxide. . .

Comments were submitted by Wolf, DiMatteo and Associates (WD+A) and CCOF. 

WD+A supports the continuation of the listings with annotation similar to the terrestrial 

use, but did not give any reasoning for the continuation. CCOF supports the 

 

3

 EPA, 2007. Aquatic Life Ambient Freshwater Criteria—Copper, Office of Water. EPA-822-R-07-001

33
Page 4 of 5 

Copper sulfate on §205.601 

October 4, 2011 

continuation with annotation and change of ―algae‖ to ―scum‖ to match international 

usage. CCOF says most organic rice is exported, and none of the countries receiving 

CCOF certified exports recognize copper sulfate for shrimp control. However, since the 

methods for controlling shrimp without copper also seem to manage ―scum‖ when it is at 

a damaging stage (i.e., when rice is below the water level), there appears to be little 

justification for keeping either listing.4

The information received by the committee concerning the hazards to aquatic 

ecosystems and the availability of alternative practices leads us to the conclusion that 

the use of copper sulfate in rice production should be restricted as much as possible. 

Our conversations with rice growers leads us to believe that particular weather 

conditions in some years rule out the use of cultural practices (drill-seeding) that would 

eliminate the need for copper sulfate. Therefore, we are recommending an annotation to 

both uses. We hope that the uses of and alternatives to copper sulfate will become a 

research priority. 

Committee Recommendations 

1. The Crops Committee recommends adding an annotation to the listing of copper 

sulfate as an algicide in rice. The motion was to approve the listing with the following 

addition (in italics): 

List: §205.601 Synthetic substances allowed for use in organic crop 

production.

(a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. 

(3) Copper sulfate—for use as an algicide in aquatic rice systems when it is 

determined that weather conditions prevent the drill-seeding production practice, 

is limited to one application per field during any 24-month period. Application 

rates are limited to those which do not increase baseline soil test values for 

copper over a timeframe agreed upon by the producer and accredited certifying 

agent. 

2. The Crops Committee recommends adding an annotation to the listing of copper 

sulfate for control of tadpole shrimp in rice. The motion was to approve the listing with 

the following annotation (in italics): 

List: §205.601 Synthetic substances allowed for use in organic crop 

production.

 

4

TAP lines 591-594: If pre-germinated seed were drilled and allowed to grow for a short while before flooding the 

fields, the rice most likely would escape the impacts of the shrimp and algae that only bother seedlings or rice that 

have not emerged above the water level. Lundberg website: “Our dry planting technique helps protect the rice 

from shrimp. The rice plant is well established by the time we apply the permanent flood, so the shrimp cannot 

ruin the crop.”

34
Page 5 of 5 

Copper sulfate on §205.601 

October 4, 2011 

(e) As insecticides (including acaricides or mite control). 

(4) Copper sulfate—for use as tadpole shrimp control in aquatic rice production 

when it is determined that weather conditions prevent the drill-seeding production 

practice, is limited to one application per field during any 24-month period. 

Application rates are limited to levels which do not increase baseline soil test 

values for copper over a timeframe agreed upon by the producer and accredited 

certifying agent. 

Committee Vote on Annotation Changes 

Moved: Jay Feldman Second: Steve Demuri 

Yes__4___ No__0___ Abstain__0__ Absent__3___ 

Committee Vote to Relist

§205.601 Synthetic substances allowed for use in organic crop production. 

(a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems (3) Copper sulfate and (e) Copper sulfate. 

Moved: Jay Feldman Second: Steve Demuri 

Yes__4___ No__0___ Abstain__0__ Absent__3___

35
National Organic Standards Board 

Crops Committee 

2013 Sunset Recommendation 

Ozone 

October 7, 2011 

List: §205.601 Synthetic substances allowed for use in organic crop production. 

 

 (a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

 systems. 

(5) Ozone gas—for use as irrigation system cleaner only.

Committee Summary 

There was a broad consensus in the organic community at the last round of sunset for 

this use of ozone that it should be kept on the list. There has been no new information 

since that time and it was generally agreed within the committee that it is a good 

alternative to chlorine for this use. 

Committee Recommendation 

The Crops Committee recommends relisting Ozone gas on 205.601 (a) As algicide, 

disinfectants, and sanitizer, including irrigation system cleaning systems. (5) Ozone 

gas—for use as irrigation system cleaner only. 

Committee Vote 

Motion: Tina Ellor Second: John Foster 

Yes: 4 No: 0 Abstain: 0 Absent: 3 

36
National Organic Standards Board 

Crops Committee 

Sunset 2013 Proposed Recommendation 

Peracetic acid 

October 4, 2011 

List: §205.601 Synthetic substances allowed for use in organic crop production. 

(a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. 

 (6) Peracetic acid – for use in disinfecting equipment, seed, and asexually 

propagated planting material. 

(i) As plant disease control. 

 (7) Peracetic acid – for use to control fire blight bacteria. 

Committee Summary 

A petition was received on 8/12/08 to remove the annotations for the use of 

Peracetic acid, which would expand the use. The Crops Committee reviewed the 

petition in 2009 and finally arrived at a recommendation, which was approved by the 

Board on November 5 2009 ( 0 yes, 13 no) to deny the petition. 

At the same time, the Committee recommended a change in the annotation for both 

listings as follows:“Permitted in hydrogen peroxide formulations at concentrations of 

no more than 5%.” The crops committee did not wish to jeopardize the availability of 

the HP formulations currently used by many growers, knowing that these 

formulations all contain small, formerly allowed as inert concentrations of peracetic 

acid. The Board approved the recommendation on 11/5/09. 

The NOP concurred with the NOSB recommendation. (4/23/10). To date the NOP 

has not issued a proposed rule to implement the rule change. 

Comments submitted to regulations.gov are supportive of continued listing of 

Peracetic acid. 

Recommendation 

The Crops Committee recommends that the 2009 proposed annotation is adopted: 

§205.601(a)(6) Peracetic acid- for use in disinfecting equipment, seed, and 

asexually propagated planting material. Permitted in hydrogen peroxide formulations 

at concentration of no more than 5%. 

§205.601(i)(7) Peracetic acid for use to control fireblight bacteria. Permitted in 

hydrogen peroxide formulations at concentration of no more than 5%. 

37
Page 2 of 2 

Peracetic acid on §205.601(a) and (i) 

October 4, 2011 

Committee Votes 

Motion to relist peracetic acid under 205.601(a)(6) and 605(i)(8). 

Motion: Barry Flamm Second: Tina Ellor 

Yes: 5 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Motion to change annotation as written in 2009 recommendation (reaffirm 2009 rec). 

Motion: Barry Flamm Second: Tina Ellor 

Yes: 4 No: 1 Absent: 2 Abstain: 0 Recuse: 0 

38
National Organic Standards Board 

Crops Committee 

2013 Sunset Proposed Recommendation 

Calcium chloride 

October 7, 2011 

List: §205.602 Non-Synthetic substances prohibited for use in organic crop production. 

 (c) Calcium chloride, brine process is natural and prohibited for use except as a foliar 

 spray to treat a physiological disorder associated with calcium uptake. 

Committee Summary: 

Calcium chloride is currently on the National List of non-synthetic materials prohibited for crop 

production with the following annotation: ...“brine process is natural and prohibited for use 

except as a foliar spray to treat a physiological disorder associated with calcium uptake.” 

In considering crop materials as part of the sunset process, the Crops Committee reviews the 

previous NOSB work pertaining to the material, as well as any new information that has 

become available since the original board decision. 

An updated Technical Report (TR) on this material was requested, but not received prior to 

consideration. Review was made of the 2001 TR, as well as the other steps taken, including 

the 2007 NOSB Sunset Recommendation (as adopted). 

Brine process Calcium chloride would be classified as a mined substance of high solubility as 

mentioned in §205.203(d)(3), and as such its use is subject to the conditions established on 

the National List of non-synthetic materials prohibited for crop production. 

The foundational principle for placing high solubility materials such as Calcium chloride, 

Potassium chloride, etc. on a prohibited non-synthetic materials list is spelled out in 

§205.203(d) – Soil fertility and crop nutrient management practice standard; “A producer may 

manage crop nutrients...in a manner that does not contribute to contamination of crops, soil, or 

water by plant nutrients...” The current Crops Committee respects the intent of the earlier 

NOSB to annotate the prohibition on this material in such a way as to accomplish these 

nutrient management goals. 

Public comment on the previously considered annotation for Calcium chloride expressed 

concerns regarding; 

1) application rates applied with the proper methods in irrigation water which can supply 

calcium nutrient without significant soil or water contamination and with less salt burn to the 

crop foliage, particularly in sensitive vegetable and greenhouse crops, 

2) the fact that chloride is an essential plant nutrient and can be deficient in some situations. In 

addition, some irrigation waters have almost no dissolved minerals (including chlorides and 

calcium), which can cause poor soil infiltration rates. Small amounts of calcium chloride added 

to irrigation water would be a very appropriate management choice to provide nutrients and 

improve the infiltration rate, and, 

39
2013 Sunset Recommendation Calcium Chloride

September 6, 2011

Page 2 of 2

3) limitations on calcium chloride use are much more restrictive than the other mined natural 

chloride materials allowed in organic farming. The Potassium chloride annotation reads, 

“unless derived from a mined source and applied in a manner that minimizes chloride 

accumulation in the soil”. Magnesium and Sodium chloride, although high solubility mined 

substances, are not on the prohibited non-synthetic list at all. Some consistency is needed in 

how these materials are listed. Public comment suggested capturing the intent of the 

regulation in §205.203(d), and bringing consistency within §205.602 with the following 

annotation language: 

Generic chloride – unless derived from a non-synthetic mined and/or brined source, and 

applied in a manner that minimizes chloride accumulation in soils, sub-soils, surface waters or 

groundwater. 

It is worth recognizing that these comments still have merit, and that petitions are a viable 

strategy for change. Yet, the Crops Committee acknowledges that annotations cannot be 

changed during the sunset review process, and can only be changed through the petition 

process. 

Committee Recommendation 

Considering the fact that potential overuse of this natural substance, as well as resultant 

subsoil, surface water and ground water contamination warrant continued limitation of use, the 

recommendation is: 

To retain calcium chloride on §205.602(c) Non-synthetic substances prohibited for use in 

organic crop production, with (c) Calcium chloride, brine process is natural and prohibited for 

use except as a foliar spray to treat a physiological disorder associated with calcium uptake. 

Committee Vote 

Motion: Colehour Bondera Second: Barry Flamm 

Yes: 6 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

40
Inert Ingredients Discussion Document 

October 11, 2011 

Background 

Inert ingredients are defined in the National Organic Program (NOP) regulations, with 

reference to the Environmental Protection Agency (EPA) definition, to include any 

ingredient other than active ingredients used in pesticide products. The Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides that inert ingredients used 

in pesticides do not need to be disclosed on product labels. 

NOP 7 CFR §205.2 Terms Defined 

Inert ingredient. Any substance (or group of substances with similar chemical 

structures if designated by the Environmental Protection Agency) other than an 

active ingredient which is intentionally included in any pesticide product (40 CFR 

152.3(m)). 

EPA 40 CFR 152.3 Definitions 

Active ingredient means any substance (or group of structurally similar substances if 

specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that 

functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA 

sec. 2(a), except as provided in §174.3 of this chapter 

Section 6517(c)(1)(B)(ii) of the Organic Foods Production Act of 1990 (OFPA) 

authorizes the National Organic Standards Board (NOSB) to establish a National List of 

approved and prohibited substances that may include synthetic inert ingredients that are 

not classified by the Administrator of the EPA as ―inerts of toxicological concern.‖ 

OFPA 

7 USC 6517(c)(1) Exemption for Prohibited Substances. 

The National List may provide for the use of substances in an organic farming or 

handling operation that are otherwise prohibited under this chapter only if 

...(B) the substance 

NOTE

This Discussion Document is presented by the National Organic Standards 

Board Crops Committee on behalf of the NOSB-NOP-EPA Working Group 

on Inert Ingredients. This document has not been approved by the Crops 

Committee, but comments on this document are welcomed, and will be supplied 

to the Working Group as they develop a final recommendation. The Crops 

Committee also seeks comments in particular on the status of former List 3 inert

ingredients, which are currently permitted only in passive pheromone dispensers 

(§ 205.601(m)(2)). The allowance for former List 3 inert ingredients is scheduled 

to sunset on November 3, 2013; a vote to determine renewal is scheduled for 

the May 21-24, 2012 NOSB Meeting. 

41
Page 2 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

... (ii) is used in production and contains synthetic inert ingredients that are not 

classified by the Administrator of the Environmental Protection Agency as inerts 

of toxicological concern; 

The NOSB, in conjunction with USDA, consulted with EPA during the development and 

subsequent amendments of the National List. The NOSB recommended in 1999 

prohibiting List 1 and 2 inerts, and List 3 inerts that are not specifically approved by the 

NOSB. In 1999, the NOSB recommended that ―inerts on List 4 generally be allowed 

unless explicitly recommended for prohibition.‖

1

 in spite of the fact that the EPA had by 

that time distinguished Lists 4A and 4B as those ingredients that were not of 

toxicological concern (4A), and those regarded as not causing adverse effects based on 

their use patterns (4B)2. In 2002, the NOSB recommended that the Secretary of 

Agriculture allow the use of certain EPA List 3 inert pesticide ingredients in certain 

pheromone products.3 The Secretary accepted and codified the NOSB 

recommendations accordingly. 

NOP regulation 

§ 205.601 Synthetic substances allowed for use in organic crop production. 

In accordance with restrictions specified in this section, the following synthetic 

substances may be used in organic crop production...:

(m) As synthetic inert ingredients as classified by the Environmental Protection 

Agency (EPA), for use with nonsynthetic substances or synthetic substances 

listed in this section and used as an active pesticide ingredient in accordance 

with any limitations on the use of such substances. 

(1) EPA List 4—Inerts of Minimal Concern. 

(2) EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone 

dispensers. 

In 2006, EPA reassessed all inert ingredients used in pesticide formulations allowed on 

food crops, including former Lists 3, 4A, and 4B inerts, to ensure that they met the 

requirements of the Food Quality Protection Act. Inerts allowed for use in EPA 

registered pesticides applied to food now must either have a residue tolerance level or 

an exemption from tolerance level codified at 40 CFR Part 180. As a result of this 

 

1

 1999 NOSB Recommendation available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058968 

2

In the notice 54 FR 48314 (11/22/89), EPA said (emphasis added), 

“To accommodate revision of the lists, EPA has decided to subdivide List 4 into two parts. The previous list 4, representing 

inerts generally recorded as safe, has become List 4A, and a new List 4B has been created. List 4B is composed of inerts 

for which EPA has sufficient information to reasonably conclude that the current use patterns in pesticide products will not 

adversely affect public health and the environment. List 4B inerts in formulations proposed for new use patterns which 

cause significant increases in exposure will receive further scrutiny.” In notice 59 FR 49400 (6/28/94), EPA said, “In 

reviewing List 4 inert ingredients for the proposed section 25(b) rule, many inerts on the original List 4 were moved from 

List 4A to List 4B. In particular, acutely toxic inerts were moved to 4B because, although the testing of products for acute 

toxicity ensures low concern for these inerts in registered products, without such regulatory oversight there may be 

unacceptable acute risks.”

3

 October 19–20, 2002 NOSB Meeting minutes available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057498

42
Page 3 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

reclassification, the NOP regulations concerning allowed inert ingredients are out of 

date when compared with current EPA regulations. The NOSB recommended in April 

2010 that NOP establish a task force in collaboration with EPA to examine this problem 

and provide a recommendation to the board for re-evaluation of former List 3 and List 4 

inerts. In October 2010, the NOSB recommended that the current exemption on the 

National List that permits former List 4 inerts through October 2012 should be renewed 

―pending review by the program of inerts individually and as a class of materials‖.

4

 The 

current exemption that permits former List 3 inerts in passive pheromone dispensers 

only is scheduled to sunset November 3, 2013 and will be voted on at the May 21-24, 

2012 NOSB meeting. 

A NOSB-NOP-EPA working group was established in June 2010. Members include: Jay 

Feldman (NOSB), Tracy Miedema (NOSB), Jeff Moyers (former NOSB), Chris Pfeifer 

(EPA Biopesticides and Pollution Prevention Division), Kerry Leifer (EPA Registration 

Division), Emily Brown Rosen (NOP), Lisa Brines (NOP), and John Punzi (NOP, on 

detail from AMS Pesticide Data Program). The group has collected information 

regarding current classification of the former List 3 and 4 inerts and gave a brief 

presentation at the April 2011 NOSB meeting.5 

At this point, the Working Group has developed a few options for consideration and is 

requesting public comment. 

I. Some initial considerations for review of inert ingredients 

a. NOSB must be able to review any substance recommended for the National List 

according to OFPA criteria, section 6518 (m): 

―Evaluation. In evaluating substances considered for inclusion in the 

proposed National List or proposed amendment to the National List, the 

Board shall consider:

1. The potential of such substances for detrimental chemical interactions with 

other materials used in organic farming systems; 

2. The toxicity and mode of action of the substance and of its breakdown products 

or any contaminants, and their persistence and areas of concentration in the 

environment; 

3. The probability of environmental contamination during manufacture, use, 

misuse or disposal of such substance; 

4. The effect of the substance on human health; 

5. The effects of the substance on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil 

organisms (including the salt index and solubility of the soil), crops and 

livestock; 

6. The alternatives to using the substance in terms of practices or other available 

materials; and 

7. Its compatibility with a system of sustainable agriculture.‖

 

4

 October 28, 2010 recommendation available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087999&acct=nosb 

5

 Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090591&acct=nosb 

43
Page 4 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

b. This means that any EPA permitted category of ―inerts‖ used in organic 

formulations would need to be reviewed. The OFPA criteria include need for use 

(i.e. the absence of natural alternatives) and cradle-to-grave considerations, 

which are not FIFRA criteria, so no list adopted under FIFRA would be 

satisfactory without additional consideration. 

c. In the interim, the NOSB could accept an EPA list (or lists) aligned with some of 

the OFPA criteria related to the potential for hazardous effects associated with 

use. The working group notes that the EPA’s criteria do not include need, 

manufacture, misuse, or disposal issues. 

d. If a baseline EPA category is accepted, the NOSB will need to provide other 

options for substances not covered by this list (e.g., applying OFPA criteria for 

review of petitioned inert ingredients). 

e. The NOSB may need to separately consider the few former List 3 chemicals that 

are currently in use. 

f. The WG on Inerts believes there are at least 120 substances in current use in 

organic production as inert ingredients that are not included in EPA’s current 

25(b) list (Inerts of Minimal Concern). Most of these substances would be 

classified as synthetic and appear on the former EPA List 4B. 

II. Proposals Under Consideration by WG-Inerts 

1. Relist the allowance for former List 3 inerts “as is” for use in passive 

pheromone dispensers only during the 2013 Sunset review 

The NOSB could renew the current exemption for former List 3 inerts for the next 

sunset period (i.e. through 2018). In the interim, the Working Group will continue to 

determine how to apply the OFPA criteria for evaluation of individual inert 

ingredients or categories of inerts, and provide a recommendation to NOSB for 

implementation by 2017, when the exemption (allowance) for former List 4 inert 

ingredients expires. 

2. Allow the List 3 listing to sunset; former List 3 inert ingredients would need 

to be individually petitioned to be allowed for continued use 

Guidelines for applying OFPA criteria for review of inert ingredients are still in 

development within the working group. 

The WGI is unclear of essentiality of the approximately four former List 3 materials 

known to be in use. There may be alternatives to the use of these substances. This 

option would mean that manufacturers would need to bring forward information on 

lack of alternatives, safety, and environmental impacts. 

The working group notes that it would be difficult for the board to review petitions in 

time for them to be reviewed before the November 3, 2013 sunset date for List 3 

inerts. At a minimum, the NOSB may need to extend expiration date to allow 

44
Page 5 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

additional time for petitions and rulemaking. A channel of trade provision would also 

be needed. 

3. Replace/amend the current listing for former List 3 inert ingredients, 

limiting to pheromone products. 

Replacement options under consideration include the following: 

a) Inert ingredients of semiochemical dispenser products that are exempt from the 

requirement of a tolerance under 40 CFR 180.1122.6

b) Inert ingredients for use in retrievable polymeric pheromone dispensers:7

a. Butylated hydroxytoluene (CAS # 128-37-0)

b. 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 1843-05-6)

c. 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-chlorobenzotriazole (CAS 

#3896-11-5) 

c) Inert ingredients for use in passive pheromone dispensers 

d) Inert ingredients for use in retrievable polymeric pheromone dispensers8. 

4. Replace both former List 4 and List 3 references:9

a) Inert ingredients eligible for FIFRA 25(b) Pesticide Products.10,11

 

6

 eCFR available at http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=8e1e539122b1034803f22bdbdc391ecc&rgn=div8&view=text&node=40:24.0.1.1.28.4.19.70&idno

=40 

7 Or, alternatively, “Inert ingredients for use in for use in passive pheromone dispensers.”

8 Defined as a “solid matrix dispenser” delivering pheromones “at rates less than or equal to 150 grams active 

ingredient (AI)/acre/year” that is “placed by hand in the field and is of such size and construction that it is readily 

recognized and retrievable.” 59 FR 7368, March 30, 1994. (http://frwebgate2.access.gpo.gov/cgibin/TEXTgate.cgi?WAISdocID=9xi50t/3/1/0&WAISaction=retrieve) The notice says, “First, the proposal 

incorporates features that would limit the direct dietary exposure to the arthropod pheromones used as pesticides by 

requiring the formulation to be restricted to larger dispensers. This formulation restriction will limit exposure to an 

active ingredient resulting from the small amount that volatilizes from the dispenser and subsequently may deposit 

on food crops. Due to its size, the dispenser itself, with or without any remaining active ingredient, is not likely to 

become incorporated into food. Second, the Agency believes that an annual rate limitation of 150 grams AI/acre and 

a restriction to retrievably sized dispensers are likely to limit the dietary exposure to what is no greater than that 

found naturally in food as a result of heavy infestations of the pest arthropods. An arthropod species becomes a pest 

only if its populations reach levels that impede economic returns. The Agency believes there already has been 

dietary exposure to the arthropod pheromones deposited after volatilization from natural heavy pest infestations that 

could be shown to control such pest species.”

9

 Inert ingredients not included would need to be individual petitioned, pending additional criteria adopted by 

NOSB. 

10 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf 

11 Does not include synthetic former List 3 inerts known to be in use in pheromone products. 

45
Page 6 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

b) Inert ingredients exempt from the requirement of a tolerance under 40 CFR 

180.910, 180.920, 180.930, 180.940, 180.950, 180.960 and/or 180.1122.12

c) Individual listings of inerts. 

d) Inert ingredients as permitted by the Environmental Protection Agency.13

e) Hybrid approach – Class(es) of inerts plus individual listings. 

f) Classes of inerts, minus specific ones. 

III. Issues and Discussion 

1. Consider inert ingredients eligible for use in minimal risk pesticide products 

under FIFRA Section 25(b) 

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 25(b)(2), 

EPA may exempt from the requirements of FIFRA any pesticide that is ―of a 

character unnecessary to be subject to [FIFRA]‖. Regulations at §152.25(f) 

implement 25(b). 

Restrictions on which ingredients may be used in minimum risk pesticide 

products are key aspects of the exemption, since the properties of these specific 

ingredients are the reason EPA exempted minimum risk pesticide products from 

FIFRA regulatory requirements. 

The federal register notice establishing this list (61 FR 8876; Mar. 6, 1996) also 

noted the following: 

In developing its list of exempted substances, EPA applied certain factors. 

Consideration was given to such factors as, (1) whether the pesticidal 

substance is widely available to the general public for other uses; (2) if it is 

a common food or constituent of a common food; (3) if it has a nontoxic 

mode of action; (4) if it is recognized by the Food and Drug Administration 

(FDA) as safe; (5) if there is no information showing significant adverse 

effects; (6) if its use pattern will result in significant exposure, and (7) if it is 

likely to be persistent in the environment. 

In 2006, EPA classified 13 additional substances having tolerance exemptions 

under 40 CFR 180.910 and/or 180.920 as minimal risk under 40 CFR 

180.950(e). The proposed rule also clarified that EPA was shifting existing 

tolerance exemptions for the ―inert‖ ingredients that appear on former List 4A 

 

12 Includes all inert ingredients allowed for food use which are exempt from tolerance by EPA. 

13 Would include inert ingredients for both food use and non-food use. 

46
Page 7 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

from that list to 40 CFR 180.950(e). 40 CFR 180.950 also includes exemptions 

from tolerance for certain foods, animal foods, and edible fats and oils. The 

current compiled list of all inerts that qualify for 25(b) exemption may be found at: 

http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf. 

The working group is aware of at least 120 inerts allowed for use in organic 

products that are former EPA List 4B substances that are currently in use and 

are not included on the 25(b) list. The majority of these substances would be 

classified as synthetic. If the baseline for allowance in organic products is limited 

to 25(b) substances, there will need to be development of an approach to apply 

the OFPA criteria to inert ingredients, and a phase in time to allow for 

reformulation and for review of petitions for substances currently allowed under 

the exemption for former EPA List 3 and List 4 inert ingredients. 

2. Other lists of substances exempt from tolerance have been considered. 

a. EPA residue tolerance exemptions under 40 CFR 180.910 and 180.920 are 

established for ―inert‖ ingredients used pre-harvest or post-harvest on crops. 

Exemptions under 180.930 are established for inert ingredients applied to 

animals. Exemptions provided under 180.940 are established for active and 

inert ingredients used in food-contact surface sanitizing for processing 

equipment solutions. 

b. 40 CFR 180.950 lists the pesticide chemicals that are exempted from the 

requirement of a tolerance based on the Agency's determination that these 

chemicals are of ―minimal risk.'' The pesticide chemicals listed include both 

active and inert ingredients. 

c. 40 CFR 180.960 lists the pesticide chemicals that are exempt from the 

requirement of a tolerance because they meet the criteria established by the 

Agency to identify certain polymers that are of low risk. This section contains 

those polymers whose tolerance exemptions were established post-Food 

Quality Protection Act (FQPA) of 1996 and are based on the polymer’s 

meeting the criteria described in 40 CFR 723.250.These compounds have 

been determined to present little risk to the environment because of their size, 

they are too large to be active in biological systems. 

d. Inerts used in Pheromones – 40 CFR 180.1122 indicates the following: 

i. All inert ingredients of semiochemical dispenser products formulated 

with, and/or contained in, dispensers made of polymeric matrix 

materials (the monomers, plasticizers, dispersing agents, antioxidants, 

UV protectants, stabilizers, and other inert ingredients) are exempted 

from the requirement of a tolerance when used as carriers in pesticide 

formulations for application to growing crops only. 

47
Page 8 of 8 

Inert Ingredients Discussion Document 

October 11, 2010 

3. List 3 Inerts permitted for use in passive pheromone products. 

NOP regulation: 

§ 205.601(m)(2) EPA List 3—Inerts of unknown toxicity—for use only in passive 

pheromone dispensers. 

The NOSB received petitions for several List 3 specific inerts for use in 

pheromones and voted in 2002 to add a general allowance for List 3 substances, 

only in passive dispensers, rather than add these specific chemicals to the 

National List. At this time the Working Group (including EPA) is only aware of 4 

List inerts that are currently in use in pheromone dispensers used in organic 

production, three of them have been disclosed via petition to the NOSB: 

 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-5-chlorobenzotriazole 14

(CAS # 3896-11-5)

 2, 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 1843-05-6)

 Butylated hydroxytoluene (BHT)15 (CAS # 128-37-0)

 one other surfactant 

At this time the Working Group invites manufacturers to provide information on 

additional substances that may be used in passive pheromone dispensers, 

particularly any inert ingredients that are not specifically listed above, or that are 

not included on the EPA 25(b) list for inerts of minimal risk. 

IV. Comments Requested 

The NOSB Crops Committee and NOSB-NOP-EPA Working Group on Inerts 

specifically invite comments on the following topics at this time: 

 What are the preferred options for replacing / amending the current allowance for 

List 3 inert ingredients in pheromone products? 

 Is the list of former List 3 inert ingredients that are currently used in NOPcompliant pheromone products accurate, or are there others in use? 

 The NOP regulation uses the term ―passive pheromone dispensers.‖ Has this 

terminology been problematic? Is the term ―retrievable polymeric pheromone 

dispensers‖ a better fit? 

 Provide suggestions regarding the process by which alternatives to the use of 

synthetic inert ingredients may be considered and implemented. 

 What are the barriers to the development or use of alternative natural inert 

ingredients for use in pesticide formulations? 

 What timelines for implementation are appropriate? 

 What are preferred replacement options for both List 3 and List 4 references? 

Include any that may not have been discussed above. 

 

14 TAP review available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094039 

15 TAP review available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057586 

48
National Organic Standards Board

Livestock Committee

Proposed Regulatory Recommendation

Animal Welfare and Stocking Rates

October 14, 2011 

Introduction

Animal welfare is a basic principle of organic production. The Livestock Committee of 

the NOSB considers that a focus on animal welfare warrants appropriate and effective 

regulation. It is important to consider the social and ethical implications as well as 

scientific research with regard to animal welfare. This proposal involves the following 

sections: 

Language changes to existing sections: 

 § 205.2: Terms defined 

 § 205.238: Livestock health care practice standard 

 § 205.239: Livestock living conditions 

This proposal is intended to refine—not replace— previous NOSB Animal Welfare 

Recommendations. The combination of the 2009, 2010 and this recommendation aim 

to more clearly identify the parameters that define animal welfare on certified organic 

operations. As requested by the National Organic Program, it is our intention to create a 

comprehensive animal welfare program that benefits both livestock and farmers. 

Except for the specific sections whose proposed changes or additions are detailed in 

this recommendation, the November 2009 recommendation is still current. 

Background

At the May 2009 NOSB meeting, the Livestock Committee presented a Discussion 

Document on Animal Health and Living Conditions. This document proposed that 

numerical scoring be used to assess body condition, lameness, coat/feather conditions 

and cleanliness. Please note that, as described in the discussion section, the 

Committee has begun and will continue to work on assessment measures that will be 

outlined in species-specific Guidance Documents for each species addressed in the 

livestock charts. 

At the November 2009 NOSB meeting, the NOSB approved an Animal Welfare 

recommendation that proposed changes to §205.238 Livestock health care practice 

standard and §205.239 Livestock living conditions (including the separation into 

mammalian and avian sections) to give more detail to requirements to ensure animal 

welfare. This 2009 recommendation also noted the need for the establishment of indoor 

and outdoor space provision minimums. 

49
Page 2 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

At the fall 2010 NOSB meeting, the Livestock Committee presented Discussion 

Documents on Stocking Density and Handling, Transport and Slaughter, receiving 

public comment on both documents. This recommendation aims to refine the 2009 

recommendation and consolidate it with the Livestock Committee’s current 

recommendations on animal welfare and handling, transport and slaughter. In 

completing the current proposal, the Livestock Committee considered public comment 

and existing animal welfare standards, reviewed studies presented on animal welfare, 

and considered existing legislation from other countries and input from the Livestock 

Issues Working Group. 

Relevant Areas in the Rule

The areas of the Rule currently addressing animal welfare include 205.2. Terms 

defined, §205.237 Livestock feed, §205.238 Livestock health care practice 

standard, §205.239 Livestock living conditions, and §205.240 Pasture 

practice standard. This recommendation includes and builds upon changes 

recommended by the NOSB in November of 2009.

Discussion 

The Livestock Committee has proposed a number of additions to § 205.2: Terms 

defined. Several of these are physical alterations that are prohibited or allowed within 

limits. Soil, outdoor access, perches, and roosts are defined as they relate to § 205.238 

(a) (5) Livestock Health Care Practice Standard. 

Market considerations. Increasingly, consumers are demanding that livestock be treated 

with respect. This market trend has led to several different product labels with animal 

welfare certification; this standard details specific quantitative requirements for animal 

stocking rates,. This recommendation intends to match the numbers currently used by 

the various animal welfare certification labels. Ultimately, the Livestock Committee 

would like the organic seal to continue to be the gold standard, indicating the most 

nutritious food produced in the safest and most respectful manner. 

Physical alterations. A major concern when managing and working with livestock is the 

health and safety of animals and the people who come in contact with them. Alterations 

performed at the recommended age with appropriate equipment are beneficial and 

allowed. Dehorning may prevent serious injuries and fatalities. Castration allows males 

and females to be housed together with no worry of females being impregnated when 

they are too small or young. When teeth or hooves are injured or not wearing evenly or 

properly, filing or trimming is indicated. Beak trimming or toe trimming performed at the 

hatchery on the first day of life ensures best practices for poultry when deemed 

necessary. 

The alterations defined are prohibited or allowed with specific limits. 

50
Page 3 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

Effective pain relief for dehorning or disbudding is readily available, inexpensive, and 

has been well-documented in University studies. Species specific guidance documents 

will address alterations and best practices. Pain relief for dairy and other species 

continues to be the subject of research since practical methods for on farm use are not 

yet available in many instances. 

Ammonia levels in housing must be monitored as high levels may be damaging to eyes 

and lungs of livestock and human caretakers. Diet composition, manure management, 

and ventilation must be managed in a manner that maintains ammonia at a level that 

will not cause injury or discomfort. 

Outdoor access. This is a basic tenet of organic production. Livestock must have 

access to fresh air and sunshine whenever possible. Exceptions may be necessary for 

environmental concerns or disease prevention. Concrete outdoor areas should be 

scraped daily or as necessary to prevent slurry accumulation. The area must be bedded 

if necessary to keep animals clean and dry. Housing with or without curtains does not 

count as outdoor access. Access to the soil should be provided when the land or 

pasture is dry enough that vegetation will not be destroyed if present and animals will 

not be in mud. 

Dairy cattle housing. Tie-stalls are a traditional housing system used on family farms in 

many areas of the country. Larger farms may have free-stalls. Farms with bedded 

packs, compost packs, or no barn at all are less common. These different types of 

facilities all work well when managed properly. This is where outcome based standards 

are important to monitor the general health, cleanliness, and well-being of livestock. 

Cattle require a clean dry place to lie down. There must be adequate space for all 

animals to lie down at the same time whether it is a pack area or a stall barn. In loose 

housing confinement there must be adequate space for all dairy cows to eat at the 

same time. If not, submissive animals tend to lose body condition and may need to be 

placed in a separate pen for feeding. 

Bulls are commonly found on dairy farms and require special attention. For human 

safety reasons it is acceptable to maintain a bull in a pen or paddock separate from the 

milking herd. Bull calves should always be raised by their dam, or with a group of 

animals whether that is steers, older heifers, or dry cows so that they are less inclined to 

identify with humans. 

Outcome-based standards. Scorecards and documents will be designed for each 

species to address hygiene, locomotion, body condition, lesions and injury, and 

anything else pertinent to a particular species. The Livestock Committee will continue to 

work on these documents with the organic community to develop a system that is 

reasonable, accurate, and enforceable. These guidance documents are intended to 

both provide producers with information on best management practices for proper 

animal care and to provide inspectors with assessment tools and the means to 

51
Page 4 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

consistently apply them. A farm plan approach with agreed upon corrective actions will 

be utilized to document improvement when problems are identified. The guidance 

documents will help the program, the certifiers, and producers to understand and meet 

the regulations. These documents will enhance the regulations and we recommend the 

NOP move forward with these completed recommendations for animal welfare. 

Bison. Bison are not domesticated animals and therefore indoor bedded space would 

be an added stressor. Bison should not be confined indoors except for medical 

treatment. 

Swine. During periods of temporary confinement provision of deep rooting materials 

such as straw is required to allow natural behaviors and prevent boredom. Outdoor 

space must allow all animals to lie down and apart from one another simultaneously. 

Poultry. Poultry must be provided with the amount of space listed in the chart at the end 

of this document at minimum. Laying hens must be provided at least one and a half 

square feet inside the house as indicated in the Avian Minimum Space Requirements 

Chart at the end of this document. Poultry house areas with floors and solid roofs will 

count toward indoor space if birds have unlimited access to that space. A combination 

of perches and flat roosts must be in the house to encourage natural behaviors, 

strengthen bones via exercise, allow submissive birds to escape, reduce aggression 

and mortality rates. Perches allow for maximum use of vertical space within the house. 

Houses must provide both flat roost space and perches to allow all birds to get up off 

the floor at any given time. Exit areas should be large enough to allow more than one 

bird to go out at the same time. 

Poultry outdoor areas must be managed in a manner that allows birds to perform 

natural behaviors which minimize stress and aggressive acts. It is the intent of the 

livestock committee that outdoor areas provide birds with access to the soil. 

A minimum of two square feet of outdoor space is required to protect the soil and to 

minimize parasite loads. Five or more feet of outdoor area would ensure that some 

vegetation would be available to birds during the growing season and producers are 

encouraged to provide a high quality outdoor area with vegetation that will be used and 

occupied by all birds listed in the chart. The farm plan should include detail as to how 

the time birds spend outdoors will be maximized. Producers who do not have two 

square feet per laying hen of certified land around houses may require transition time. 

Pullets must be raised with perches or roosts and have outdoor access by 12 weeks of 

age. It is well documented that birds instinctively use when they are young. This 

practice should result in less stress and an easier transition to the layer house. Nest 

training may require a few weeks but shall be limited to no more than five. Broilers must 

have outdoor access by 4 weeks of age. 

52
Page 5 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

Recommendation 

The language shown in the following pages is recommended for rulemaking. 

§ 205.2 Terms defined. 

Caponization. Castration of chickens, turkeys, pheasants, etc. 

De-snooding. The removal of the turkey snood. 

Toe clipping. The removal of the nail and distal joint of the back two toes of a male 

bird. 

Dubbing. The removal of poultry combs and wattles. 

Beak trimming. The removal of the curved tip of the beak. 

De-beaking. Removal of more than the beak tip. 

Cattle wattles. Created for ownership identification, wattles are made by surgically 

separating both layers of skin from the connective tissue for 2 to 4 inches on the 

dewlap, neck or shoulder. 

Outdoor access. Animals have contact with soil when seasonally appropriate and 

the sky overhead and without a solid roof or walls. Fencing that does not block 

sunlight may be used as necessary. 

Perches. A rod or branch type structure that serves as a roost and allows birds to 

utilize vertical space in the house. 

Roost. A flat structure over a manure pit that allows birds to grip with their toes as 

they would on a perch. 

Soil. The outermost layer of the earth comprised of minerals, water, air, and organic 

matter, fungi, and bacteria in which plants may grow roots. 

Mulesing. Removal of skin from the buttocks of wool sheep, approximately 5 - 7cm 

wide and running half way from the anus to the hock to prevent flystrike. 

§ 205.238 Livestock health care practice standard. 

(a) The producer must establish, maintain and describe in the organic system plan 

practices or procedures designed to improve health care of the livestock 

53
Page 6 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

operation, including: 

(5) Performance of physical alterations as needed to promote the health, welfare 

or hygiene of animals; identify animals; or provide increased safety to farm 

personnel. Allowed physical alterations must be performed at the youngest 

possible age by trained persons in a manner that minimizes pain and stress 

and shall be recorded in individual (or flock) animal health records with dates, 

reason needed, and methods used. The following practices are prohibited: 

(i) De-beaking, de-snooding, caponization, dubbing and toe trimming 

(ii) Toe trimming turkeys unless performed with infra-red at the hatchery 

 (iii) Beak trimming unless performed with infrared at the hatchery 

(iv)Tail docking of pigs and cattle. 

(v) Wattling of cattle. 

(vi) Face branding cattle. 

(vii) Tail docking of sheep shorter than the distal end of the caudal fold. 

(viii) Mulesing of sheep. 

(ix) Routine tooth clipping of piglets. 

(6) Effective pain relief must be provided when dehorning or disbudding livestock. 

(7) Ammonia levels should be less than 10 ppm and must be less than 25 ppm 

indoors. 

(d) Organic livestock producers must provide their certifier with the following lists 

each year: 

 (2) All animals that have left the operation during the past year due to sale or 

mortality, and the reason for their departure 

§ 205.239 Livestock living conditions. (Mammal section) 

(a) The producer of an organic livestock operation must establish and maintain yearround livestock living conditions, which accommodate the health and natural 

behavior of animals, including: 

(1) Year-round access for all animals to the outdoors, shade, shelter, exercise 

areas, fresh air, clean water for drinking, and direct sunlight, suitable to the 

species, its stage of life, the climate, and the environment: Except, that, 

animals may be temporarily denied access to the outdoors in accordance with 

§§ 205.239(b) and (c). 

(i) Livestock must be bedded or kept clean and dry per the hygiene outcome 

score when animals are temporarily denied access to the outdoors. 

54
Page 7 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

(ii) Yards, feeding pads, and feedlots may be used to provide ruminants with 

access to the outdoors during the non-grazing season and supplemental 

feeding during the grazing season, but shall be large enough to allow all 

ruminant livestock occupying these spaces to feed in a manner that maintains 

all animals in good body condition. (iii) Continuous total confinement of any 

animal indoors is prohibited. 

(4) Shelter designed to allow for: 

(iv) At least one feeding space per animal in loose housing. 

 (5) During the non-grazing season or during times of temporary confinement, the 

following will be provided. 

(i) In confined housing (free stalls, tie-stalls, etc.) at least one stall must be 

provided for each animal in the facility at any given time, except that: 

(A) The confinement of animals in cages is not permitted under any 

circumstance. 

(6) Deep bedded straw or rooting materials must be provided for pigs to allow 

them to forage, explore, and otherwise prevent behavior problems associated 

with the lack of natural conditions during temporary confinement. 

§ 205.239 Livestock living conditions. (Avian section) 

(f) The operator of an organic poultry operation shall establish and maintain poultry 

living conditions that accommodate health and natural behavior including: 

(1) Access to the outdoors. 

(i) Laying hens must be provided with no less than 2 square feet of outdoor 

access per bird. 

(ii) Enclosed spaces that have solid roofs overhead do not meet the definition 

of outdoor access and cannot be included in the space calculation of 

outdoor access. 

(iii) Pullets must be provided outdoor access by 12 weeks of age when 

weather permits. 

(iv) Broilers must be provided outdoor access by 4 weeks of age, provided 

that they are fully feathered and weather permits. 

(v) Once layers are accustomed to going outdoors, a brief confinement period 

of no more than 5 weeks to allow for nest box training is permitted. 

(vi) Outdoor access must provide birds with the opportunity to scratch and 

dust bathe in soil, turn around, and perform their natural behaviors. 

(vii) Access to outdoor areas with direct sunlight must be provided during 

daylight hours when temperatures exceed 50oF

55
Page 8 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

(3) Suitable Flooring 

(ii) Houses with slatted floors must have enough solid floor area available that 

birds may freely dust bathe without crowding 

(4) Birds must have sufficient exit areas to ensure that all birds have ready outdoor 

access. Exit areas must allow the passage of more than one bird at a time. 

 (5) Space Allowance. Poultry housing must allow: 

(i) All birds to move freely, and engage in natural behaviors. 

(ii) All birds to perch at one time whether on a flat roost surface or perch. 

(iii) Flat roosting areas where birds may grip with their feet 

(iv) A combination of flat roost and perches must be provided to allow 

submissive birds to escape aggressors. 

(v) The indoor space requirement must be met by the buildings interior 

ground floor perimeter. Perching areas and nest boxes will not be used in 

the calculation of floor space. 

(vi) Indoor space allowance will not be less than1.5 square feet per laying 

hen.

Avian Minimum Space Requirements Chart 

Livestock Species Indoor Space Outdoor Runs and Pens 

Chickens

Laying hens and breeders 1.5 sq ft / bird 2.0 sq ft / bird 

Pullets 5 lbs / sq ft 5 lbs / sq ft

Broilers 5 lbs / sq ft 5 lbs / sq ft

Other poultry

Turkeys and Geese—

breeding, laying, or meat 

birds (pounds)

7.5 lbs / sq ft 2 lbs / sq ft

 

Ducks-meat 5 lbs / sq ft 2 lbs / sq ft

Ducks-laying hen 2 lbs / sq ft 1 lbs / sq ft

Ducks—breeder 3.3 lbs / sq ft 1 lbs / sq ft

Reserved for additional 

species

Committee Vote 

Motion: Wendy Fulwider Second: Mac Stone

Yes: 4 No: 2 Absent: 1 Abstain: 0 Recuse: 0

56
Page 9 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

Minority Opinion 

Sir Albert Howard (the father of the organic movement), his wife Madam Louis E. 

Howard, and the Organic Foods Production Act of 1990 (OFPA) focused on the whole 

farm system approach to organic production. Organic livestock production must be 

viewed as a part of a whole farm system and not in isolation from the issue of being 

good stewards to the environment. The Minority Opinion is consistent with section 

205.200 of the regulation as it pertains to maintaining or improving the natural resources 

of the operation, including soil and water quality. 

The Minority Opinion is intended to help move the issue of minimum space 

requirements for poultry and pigs alone in conjunction with meaningful practices that 

address natural behavior, outdoor access, and the environmental protection. The 

April, 2010 NOSB Livestock Committee Minority Opinion stated that “economic or 

management challenges should not be a valid argument to weaken organic standards. 

Organic certification is not a right; it is a privilege that must be earned by meeting strict, 

sustainable, humane, and enforceable standards.” The 2011 NOSB Livestock 

Committee minority opinion concurs with the aforementioned statements.

During the commenting period of March and April of 2011, 337 citizens submitted 

written or provided oral comments on poultry and pigs. The results showed that 73.5% 

(83 out of 113 commenters) recommended more space for poultry. Similarly, 99.6% 

(223 out of 224 commenters) recommended more space for pigs. Despite the 

overwhelming request for more space, the poultry numbers have barely changed, while 

no numerical change was provided to increase the space requirements for pigs. 

 

The Minority Opinion supports increasing the space requirement of pigs to be at least 

equal to the Canadian space requirements. The current use of the phrase permitting 

swine, “to lie down and apart from one another simultaneously” can be difficult to 

measure. The wording does not capture the essence of pig space requirements, 

outdoor access, nor does it provide a clear measure for evaluating organic pig 

operations. The issue of space requirements and outdoor access for pigs could soon 

explode like the poultry issue as it pertains to space requirements, outdoor access, and 

natural behavior. If one thought that poultry was tumultuous; pigs could be the same. 

Therefore, the Minority Opinion is that both pigs and poultry need to be included in 

rulemaking. 

Space requirements with meaningful standards that address natural behavior, outdoor 

access, and the environment as necessary components of the indivisible whole. The 

Minority Opinion recommends that poultry and pigs be provided the minimum space as 

outlined in tables 1 and 2, respectively. A timeline of 36 months is recommended for 

producers to comply after submittal for rulemaking is recommended. In addition, a 

minimum range of 40-50% vegetation covers is recommended, with 75% poultry and 

pigs being able to be outside at one time. We suggest the addition at section 205.239 

(e) (i) of the regulation. This provision will conform to environmental protection 

requirements in other sections of the regulation. 

57
Page 10 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

 Recommendations 

1. Prohibit routine beak conditioning or beak tipping. Except, beak conditioning may be 

authorized by the certifier for safety or if they are intended to improve the health, welfare 

or hygiene of the livestock on a case-by-case basis. 

 

2. Add to section 205.2 (Term defined) the term “natural behavior.” We suggest the 

definition by or similar to Bracke and Hopster, (2006). They defined natural behavior as 

behavior that animal’s exhibit under natural conditions. The ability of livestock to 

express natural behavior is consistent with section 205.239 (Livestock living 

conditions) of the regulation. 

3. Poultry and pigs’ space requirements need to be submitted for rulemaking, NOT just 

poultry. If pigs are left in guidance, then measureable requirements must be included. 

4. All types of forced molting must be prohibited. 

5. Minimum space requirements for avian are shown in Table 1. These requirements 

should be viewed as minimums and producers should focus on the requirements in #7 

as the best guidance for ensuring adequate living conditions for birds. A maximum 36-

month transition period after submittal for rulemaking is recommended. 

Table 1. Avian Minimum Space Requirements Chart 

Avian Species Indoor Space* Outdoor Runs and Pens 

Chickens

Laying hens and breeders 2.0 square feet/bird 5.0 square feet/bird 

Pullets 1.0 square feet/2.0 lbs live 

weight

1.0 square feet/2.0 lbs live 

weight

Broilers 1.0 square feet/1.0 lb live 

weight

1.0 square feet/2.0 lbs live 

weight

Other poultry

Turkeys** 1.0 square feet/5.3 lbs live 

weight

1.0 square feet/3.5 lbs live 

weight

Geese** 1.0 square feet/5.3 lbs live 

weight

1.0 square feet/3.5 lbs live 

weight

Ducks-meat+++ 1.0 square feet/5.0 lbs live 

weight

1.0 square feet/2.0 lbs live 

weight

Ducks-laying hen+++ 1.0 square feet/2.0 lbs live 

weight

1.0 square feet/1.0 lb live 

weight

Ducks-breeder+++ 1.0 square feet/3.3 lbs live 

weight

1.0 square feet/1.0 lb live 

weight

Mobile Units 

Same as avian species requirements above 

* Indoor space is for the “temporary” confinement as outlined in the regulation **Canadian standards 

58
Page 11 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

+++NOSB Fall 2011 Livestock Committee Majority Recommendation 

6. The Minority Opinion recommends the minimum space requirement for porcine are 

shown in Table 2. These requirements should be viewed as minimums and producers 

should focus on the requirements in #7 as the best guidance for ensuring adequate 

living conditions for pigs. A maximum 36-month transition period after submittal for 

rulemaking is recommended. 

Table 2. Porcine Minimum Space Requirements Chart 

Classification Indoor Space* Outdoor Runs and Pens 

Sows and piglets+

(up to 40 days’ old)

80.7 square feet for each sow 

& litter

26.9 square feet for each sow 

and litter++

Sows in group 

pens+

32.3 square feet/head 32.3 square feet/head

Boars in individual 

pens+

96.9 square feet/head 96.9 square feet/head

Growing pigs+

a. Up to 66# 

b. 66# - 110#

c. 110# - 187#

d. >187#

a. 6.5 square feet/head

b. 8.6 square feet/head

c. 11.8 square feet/head

d. 14.0 square feet/head

a. 4.3 square feet/head

b. 6.5 square feet/head

c. 8.6 square feet/head

d. 10.8 square feet/head

* Indoor space is for the “temporary” housing as outlined in the regulation 

+ Canadian standards 

++European standards 

7. The Minority Opinion recommends adding the following at § 205.239 Livestock 

living conditions of the regulation. 

(e) The producer of an organic livestock operation must manage manure in a manner 

that does not contribute to contamination of crops, soil, or water by plant nutrients, 

heavy metals, or pathogenic organisms and optimizes recycling of nutrients and must 

manage pastures and other outdoor access areas in a manner that does not put soil or 

water quality at risk. 

(1) Access to the outdoors (Avian and Porcine).The operator of an organic 

poultry and pigs operation shall establish and maintain living conditions that 

accommodate health and natural behavior including: 

(i) Poultry and pigs space requirements as shown in Table 1 and Table 2, 

respectively 

(ii) Enclosed spaces that have roofs overhead do not meet the definition of 

outdoor access and cannot be included in the space calculation of outdoor 

access. 

(iii) Pullets must be provided outdoor access by 12 weeks of age when 

weather permits. 

(iv) Broilers must be provided outdoor access by 4 weeks of age, provided 

that they are sufficiently feathered and weather permits. 

(v) Once layers are accustomed to going outdoors, a brief confinement period 

of no more than 5 weeks to allow for nest box training is permitted. 

59
Page 12 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

(vi) Outdoor access must include providing birds with the opportunity to 

scratch and dust bathe in soil, turn around, flap their wings, spread their 

wings, and forage, without touching another bird. 

(vii) Access to outdoor areas with direct sunlight must be provided during 

daylight hours when temperatures exceed 50oF.

(viii) Poultry of all species and pigs outdoor access area must have a minimum 

of 40-50% vegetative cover throughout the vegetative growing season and 

the Organic System Plan must provide a detailed description of the 

management proactive designed to implement this provision.

(ix) The outdoor access area must include providing for at least 75% of the 

poultry and pigs to be outside at one time; birds must have enough space 

to include allowing birds to stretch their wings, run, forage, and find refuge 

areas away from other birds or predators. 

(x) Shade and outdoor areas may be provided by brush, trees or other 

structures. 

(xi) For poultry, all exit doors must be 14” high and be spaced evenly 

throughout buildings, with a total door opening of six linear feet per 1,000 

hens. 

(xii) Poultry may provide cover (a horizontal barrier) and blinds (a vertical 

barrier) in both and outdoor areas that enables birds to hide and isolate 

themselves from other chickens as long as these structures do not 

constitute confinement. 

(xiii) Poultry and pig outdoor areas must be designed to prevent or minimize 

soil erosion and runoff. 

(xiv) Outdoor environments must be managed to prevent soil degradation and 

overgrazing. 

(xv) For pigs, the outdoor living conditions must have adequate shade, 

shelter, rotational pastures or paddocks with the appropriate use of 

portable structures. Buildings and housing structures for pigs must be 

designed to allow outdoor access beyond door openings. 

(xvi) Farrow crates, flat decks, cages, and trimming or clipping teeth are 

prohibited. Castration should be performed before the piglets reach 2 

weeks of age and by trained personnel. 

(xvii) Pigs should be weaned at 7 to 8 weeks of age. All pigs aged 6 weeks and 

older must have access to the outdoors. 

(xviii) Nose rings and tail docking are prohibited. 

 

 

The Minority Opinion is being expressed as a means for enhancing the existing animal 

welfare document proposed by the majority. It is our opinion that if the lines are blurred 

between conventional and organic practices and standards, then organic consumers 

and producers will lose faith in the organic label. 

60
Page 13 of 13

Animal Welfare and Stocking Rates Regulatory Recommendation 

October 14, 2011 

Nature hits back when her rule about the correct relation between the plant and the 

animal is disregarded. She is trying to tell us that we shall have to retrace our steps and 

restore the natural partnership. 

Sir Albert Howard, 1947 

(Father of the organic movement) 

61
National Organic Standards Board 

Livestock Committee 

Proposed Guidance Recommendation 

Animal Welfare and Stocking Rates 

October 14, 2011 

Introduction 

Animal welfare is a fundamental principle of organic production, and consumers expect 

that organic certification ensures humanely treated animals allowed to fulfill natural 

behaviors. The Livestock Committee of the NOSB considers that a focus on animal 

welfare warrants appropriate and effective regulation and guidance. It is important to 

consider the social and ethical implications as well as scientific research with regard to 

animal welfare. This proposal is intended to refine—not replace—the November 2009 

NOSB Animal Welfare Recommendation. The combination of the 2009 and this 

guidance recommendation aim to more clearly identify the parameters that define 

animal welfare on certified organic operations. As requested by the National Organic 

Program, it is our intention to create a comprehensive animal welfare program that 

benefits both livestock and farmers. Except for the specific sections whose proposed 

changes or addition is detailed in this recommendation, the November 2009 

recommendation is still current. This recommendation details the specific measures 

which the committee feels the program should include in guidance issued to the 

certifiers and the organic community. We have also made a separate recommendation 

regarding the measures that should be implemented via changes to the regulation. 

Background 

At the May 2009 NOSB meeting, the Livestock Committee presented a Discussion 

Document on Animal Health and Living Conditions. This document proposed that 

numerical scoring be used to assess body condition, lameness, coat/feather conditions 

and cleanliness. Please note that, as described in the discussion section, these 

assessment measures will be outlined in species-specific Guidance Documents that will 

be presented at the fall 2011 NOSB meeting. 

At the November 2009 NOSB meeting, the NOSB approved an Animal Welfare 

recommendation that proposed changes to §205.238 Livestock health care practice 

standard and §205.239 Livestock living conditions (including the separation into 

mammalian and avian sections) to give more detail to requirements to ensure animal 

welfare. This 2009 recommendation also noted the need for the establishment of indoor 

and outdoor space provision minimums. 

At the fall 2010 NOSB meeting, the Livestock Committee presented Discussion 

Documents on Stocking Density and Handling, Transport and Slaughter, receiving 

public comment on both documents. This recommendation aims to refine the 2009 

recommendation and consolidate it with the Livestock Committee’s current 

62
Page 2 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

recommendations on stocking density and humane handling, transport and slaughter. 

In completing the current proposal, the Livestock Committee considered public 

comment and existing animal welfare standards, reviewed studies presented on animal 

welfare, and considered existing legislation from other countries. 

Relevant Areas in the Rule 

The areas of the Rule currently addressing animal welfare include 205.2. Terms 

defined, §205.237 Livestock feed, §205.238 Livestock health care practice 

standard, §205.239 Livestock living conditions, and §205.240 Pasture practice 

standard. This recommendation includes and builds upon changes recommended 

by the NOSB in November of 2009. 

Recommended for guidance. 

Livestock living conditions 

Indoor stocking density. The stocking density table lists livestock by species and weight. 

All livestock must be provided with bedding as needed to maintain comfort and 

cleanliness per outcome based standards whether they are housed with or without a 

roof. The indoor bedded space allowance provided in this recommendation is to be 

considered a minimum for housed animals during temporary confinement. (205.239(b). 

All animals must be able to lie down in a clean, dry place at the same time without lying 

on top of one another at all times. The less space provided per animal, the more laborintensive it may be to keep them clean and in good health. Bedding keeps animals 

warm, clean, and dry and also protects animals from developing lesions due to abrasion 

on rough surfaces. Animals must be managed in a manner that lameness does not 

become a common or routine occurrence. If routine hoof trimming due to lameness or 

overgrown hooves is required, diet or management adjustments will be necessary. 

Bison. Bison are not domesticated animals and therefore indoor bedded space would 

be an added stressor. Bison should not be confined indoors except for medical 

treatment. 

Dairy calf housing. When considering shelter design, it should be taken into account 

that calves are social animals and should ideally be housed in small groups. Calves 

may be housed in individual pens or hutches providing that they have enough room to 

turn around, lie down, stretch out while lying down, get up, rest, and groom themselves; 

individual calf pens shall be designed and located so that each calf can see, smell, and 

hear other calves present on the farm. 

Calves are tied on some farms while being wintered in the dairy barn or tethered to a 

hutch. Tethering is less desirable than group housing but may be necessary in some 

systems to prevent cross-sucking. Tethering is acceptable if calves are safe and meet 

the requirements that will be laid out in the outcome based standards and movement is 

not restricted. 

63
Page 3 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

Dairy cow housing. Standard tie-stall and free-stall operations that have individual stalls 

are not included in the stocking density table. Individual stall barns must be managed to 

keep cows comfortable and to meet the outcome based standards that are in 

development. These standards will include cleanliness, body condition, injuries and 

lesions, lameness, etc., as relevant to dairy. This means large stalls are necessary for 

Holsteins and Brown Swiss, while smaller stalls are indicated for smaller breeds such as 

Jerseys. Copious amounts of bedding such as chopped straw increase comfort and 

may contribute to cleaner animals, and prevent injuries and lesions. 

Broken tails. 

The great majority of farms do not have livestock with broken tails. Accidents do 

happen and occasionally tail injuries occur. Dairy cattle may be more prone to this 

injury. An incidence greater than 3% may indicate a problem with housing or handling. 

This as well as any other issue will be addressed in the Organic System Plan. 

Swine. Swine farms will establish and maintain living conditions that accommodate the 

health and natural behavior of all pigs. The space requirement for pigs must allow every 

pig to lie down, stand up, turn around freely, run, root, explore, and express other 

normal patterns of natural behavior. The outdoor living conditions should provide shade, 

shelter, rotational pastures or paddocks and portable structures as needed. 

Buildings and housing structures for pigs must be designed to allow outdoor access for 

all when seasonally appropriate. The outdoor environment must be managed to 

minimize soil erosion and overgrazing. Vegetation cover provides grazing, prevention of 

soil erosion, and promotes soil health. This approach allows for re-growth of vegetation 

after moving pigs. 

All pigs must have access to fresh water and a high-quality feed according to their 

needs. Farrow crates, flat decks, cages, tail docking, and routine trimming or clipping of 

teeth are prohibited. Castration should be performed before the piglets reach 2 weeks 

of age and by trained personnel. Indoor space for pigs must be designed to allow 

outdoor access on the ground. Pigs should be weaned at 7 to 8 weeks of age. The farm 

plan must show how the time pigs are outdoors will be maximized. All pigs aged 6 

weeks and older must have access to the outdoors. Temporary confinement is only 

permitted as outlined in OFPA Rule. 

Poultry houses. In considering shelter for avian species, dry litter must be provided and 

maintained. Special considerations for the areas beneath the waterers may be needed 

to maintain dry litter. Complete clean out of a poultry house is necessary when there 

have been adverse health issues with the previous flock; otherwise a clean layer of 

bedding should be provided between flocks to provide a sanitary environment for the 

new flock coming in. 

Poultry houses and outdoor areas must be managed in a manner that allows birds to 

perform natural behaviors which minimize stress and aggressive acts. Producers should 

be encouraged to provide environmental enrichments in the house that will relieve 

64
Page 4 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

boredom and discourage aggressive acts such as pecking behaviors. It is the intent of 

the livestock committee that outdoor areas provide birds with access to the soil. If birds 

do not utilize outdoor areas it may be necessary to make these areas more attractive 

with environmental enrichments or larger doorways for the birds. This should be 

incorporated into the organic farm plan. 

Outdoor stocking density. Outdoor access is important for all livestock to enhance 

muscle tone and relieve boredom. Outdoor runs for cattle are to be considered a 

minimum during the non-grazing season when weather allows animals to leave the 

indoor bedded area. Cattle pastured during the non-grazing season may not require an 

indoor bedded area. Since piglets and chicks must be protected from freezing weather, 

outdoor runs are not necessary. Calves, lambs, kids, and other young animals require 

protection from extreme weather conditions and threat from predators. 

Minimum space requirements charts. The following chart is meant to address periods of 

temporary confinement or during the non-grazing season for mammalian species. Tieand free-stall barns are exempt from the space requirements in this chart and must 

provide one stall for every animal with access to the building. The values in this chart 

are MINIMUM amounts only and provision of larger areas of enriched environment 

appropriate to the species is strongly encouraged. Outcome-based requirements (to be 

developed) will be an integral part of the animal welfare standard. 

Mammalian Minimum Space Requirements Charts 

Livestock Indoor Floor Space Outdoor Runs and 

Pens 

Bison weight (pounds) Square feet / animal Square feet /animal

Up to 220 NA 70.0 

220-440 NA 120.0

440-770 NA 190.0

Over 770 NA 400 .0

Beef cattle weight

(pounds)

Square feet / animal Square feet /animal

Up to 220 15.0 10.0 

220-440 25.0 20.0 

440-770 40.0 30.0 

65
Page 5 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

770-1100 50.0 40.0 

over 1100 10.0 per 220 pounds 8.0 per 220 pounds 

66
Page 6 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

Dairy cattle weight 

(pounds)

Square feet / animal Square feet /animal

Up to 220 15.0 10.0 

220-440 25.0 20.0 

440-770 40.0 30.0 

770-1100 50.0 40.0 

over 1100 10.0 per 220 pounds 8.0 per 220 pounds 

Mammalian Minimum Space Requirements Charts (continued) 

Livestock Indoor Floor Space Outdoor space 

Swine Square feet / animal Square feet / animal

Sow and piglets 48.0 40.0 

Sows 30.0 30.0 

Boars 64.0 85.0 

Growing pigs Square feet / animal Square feet /animal

Up to 24 2.0 Sufficient space for 

animals to all lie down 

and apart

from one another 

simultaneously

24—47 3.0

47—109 

 

6.0 

109—157 9.0 

157—225 13.0 

225 and up 

 

16.0

67
Page 7 of 7 

Animal Welfare and Stocking Rates Guidance Recommendation 

October 14, 2011 

Livestock Indoor Floor Space Outdoor Space

Sheep and goats 

(pounds)

Square feet / animal Square feet / animal

Sheep and Goats 16.0 30.0 

Nursing lamb or kid 4.0 8.0 

Rabbits Square feet / animal Square feet /animal

Adult rabbits 3.0 20.0 

Pregnant does 5.0 20.0 

Doe and litter 8.0 20.0 

Young rabbits 5-12 weeks 1.0 N/A 

Committee Vote

Motion: Wendy Fulwider Second: Mac Stone 

Yes: 4 No: 2 Absent: 1 Abstain: 0 Recuse: 0 

68
National Organic Standards Board

Livestock Committee

Proposed Recommendation

Animal Handling, Transport, and Slaughter

September 21, 2011

Introduction

Humane treatment of animals is a basic principle of organic production. The Livestock 

Committee of the NOSB feels that appropriate and effective expanded regulations, based on 

social, ethical, and scientific evidence, are necessary to ensure that animal welfare 

considerations are upheld. The Livestock Committee recommends the addition of 

§ 205.241 Animal handling, transport and slaughter: general conditions of animal 

welfare in handling and slaughter to move towards a comprehensive animal welfare 

program in certified organic livestock operations. 

Background

The Livestock Committee has presented handling, transport, and slaughter documents at the 

October 2010 and April 2011 meetings. The Committee has taken public comments into 

consideration while crafting this recommendation. The recommended regulatory language 

reflects current industry standards in practice due to separate animal welfare certification 

programs, which are verified by third party audits. The only additional proposed regulatory 

language included in this recommendation is intended to guard against slaughter plant abuse 

of newborn calves, an issue that has recently been in the public spotlight. Transporters and 

slaughter plants which accept organic livestock are already meeting the listed organic 

requirements. 

Relevant Areas in the Rule

USDA organic regulations do not currently specifically cover animal handling, transport, and 

slaughter. Therefore, the Livestock Committee is recommending the addition of a new section 

titled § 205.241: Animal handling, transport, and slaughter. 

Discussion

The intent of this document is to assure consumers that certified organic livestock are treated 

with respect and according to need. This document clearly states expectations for producers, 

haulers, and slaughter plant personnel. The accompanying guidance document will provide 

additional clarity. 

To avoid mistreatment on the farm, during transport to, or at the slaughter plant, specific 

prohibited practices are described within the willful acts of abuse. Livestock slips, and falls are 

also defined. 

Fitness for transport. To avoid the need to cull unfit animals at slaughter, it is essential that 

only fit animals be loaded for transport to slaughter. Unfit cull animals are one of the biggest 

problems encountered at slaughter plants. Livestock that are likely to be condemned or 

69
Page 2 of 5

Animal Handling, Transport, and Slaughter

September 21, 2011

become downers should not be shipped. Although this shouldn’t be considered a 

comprehensive list, animals are unfit for transport if they are any of the following: disabled, 

fatigued, sick, injured, lame, weak, have unhealed wounds, are within the final 10% of their 

gestation, are less than 48 hours old, or completely blind. Additionally, animals that are 

aggressive, wild, or have had little contact with humans will require good handlers, chutes, and 

corrals to reduce the stress of transport and confinement. The NOSB intends to create clear 

and concise guidance documents to assist farmers, certifiers, and others decision-makers 

regarding fitness for transport. 

Young calves. Language protecting young calves will be new to the animal industry. In many 

areas of the country, there is no market for raising dairy bull calves for beef. These calves 

have little value and are therefore sent to slaughter at the earliest-possible age. Bull calves 

should be fed and managed as heifer calves on farm and must be strong enough for transport 

before being shipped. 

Transport conditions. To ensure continued health and comfort during transport to slaughter, all 

shipping containers must have seasonally-appropriate ventilation, bedding (as needed), and 

non-slip flooring. Roughages used as bedding must be certified organic. Bedding is needed 

when temperatures are below freezing and animals may be in danger of being frozen to the 

floor or side of the trailer. If transport time exceeds 12 hours, arrangements must be made to 

provide food, water and rest. Additionally, emergency plans for animal care and alternative 

transport must be in place to cover unforeseen circumstances, such as accidents or truck 

breakdown. 

Animal handling. Slaughter plant staff must be available after hours if needed to receive 

livestock. Animals are to be treated in a calm, quiet, and humane manner, which reduces 

stress and incidences of bruising and injury. Additionally, lighting must be enough to read a 

newspaper, in order to adequately identify and/or manage ill or injured livestock. 

 

Slaughter. The recommended language below is intended to ensure that animals are handled 

properly and with respect throughout the slaughter process. Electric prods and euthanasia 

equipment must be stored in a clean, dry location. Prods are to be used solely by trained staff 

for human safety or medical purposes only, typically to save down animals. If an animal does 

not attempt to rise after being shocked once, it is to be moved immediately and carefully to a 

safe resting place or euthanized; it is not to be shocked a second time. If the animal makes 

one or two unsuccessful attempts to rise after being shocked, a second or third shock may be 

applied to the animal after a rest period. Plants generally allow at least twenty minutes to two 

hours rest. For each attempt, human assistance must be provided to help the animal to its 

feet. Additionally, sand or lime should be applied to the flooring as necessary to provide 

increased traction. If the animal is not on its feet after a third shock, it is to be moved 

immediately and humanely to a safe resting place or euthanized. 

Ritual slaughter. Ritual slaughter is done according to religious requirements. The animal is 

slaughtered, without being stunned, with a razor sharp knife. When the cut is done correctly, 

the animal appears not to feel it. From an animal welfare standpoint, the major concern during 

ritual slaughter is the method of restraint. Slaughter plants will use devices that hold the animal 

70
Page 3 of 5

Animal Handling, Transport, and Slaughter

September 21, 2011

in a comfortable, upright position. For both humane and safety reasons; plants that conduct 

ritual slaughter will use modern upright restraining equipment. 

Slaughter plant audits. Audits of slaughter plants provide confirmation that animals are being 

treated appropriately throughout the process. Animal welfare audits are currently being done 

in most slaughter facilities as part of various animal welfare certifications’ requirements. To 

comply with these new organic regulations, all slaughter facilities will need to be audited 

yearly. Organic certifying agents can review documentation from these third-party animal 

welfare audits and can do any additional auditing as necessary. In-between annual third-party 

audits, it is necessary for plants to do self-audits on a weekly basis. Self-audits ensure that 

animal welfare standards are being upheld, identify problems that may arise within the facility 

or with individual staff members, and identify specific farms that may be shipping problematic 

animals to the slaughter plant. These problems may be due to animals’ genetics or handling; 

slaughter facilities are encouraged to contact the producers of problematic animals so that 

these problems can be addressed in the future. 

Recommendation 

The language shown in the following pages is recommended for rulemaking. The livestock 

committee respectfully requests that the National Organic Program places only what is 

necessary into rule. The livestock committee wants to assure consumers that the organic 

industry practices a high level of animal welfare. The livestock committee does not wish to 

increase the paperwork burden, certification costs, or discourage small slaughter plants from 

organic certification. 

§ 205.2 Terms defined. 

Willful acts of abuse. Includes but not limited to dragging non-ambulatory, conscious 

animals; intentionally applying prods to sensitive animal parts, e.g., anus, ears, eyes, or 

reproductive parts; malicious driving of livestock on top of one another with or without direct 

contact with motorized equipment; loading of non-ambulatory animals for transport is 

excluded; beating or hitting live animals; live animals frozen to trailer floors or sides; lifting 

an animal by the wool or throwing the animal; and slamming gates on animals. 

Livestock slip. A knee or hock touching the floor. 

Livestock fall. The body touching the floor. 

§ 205.241 Animal handling, transport and slaughter: general conditions of animal 

welfare in handling and slaughter. 

(a) Handling and Transport to slaughter: Certified organic livestock will be clearly identified as 

organic and transported in pens within the livestock trailer clearly labeled for organic use and 

be contained in those pens for the duration of the trip. 

71
Page 4 of 5

Animal Handling, Transport, and Slaughter

September 21, 2011

(1) It is the responsibility of the organic producer to ensure that calves have a dry 

navel cord and are able to stand and walk without human assistance if they are 

being transported to a slaughter or auction facility. 

(2) The livestock trailer/shipping container and slaughter plant must provide seasonappropriate ventilation to protect against cold and heat stresses. 

(3) Bedding must be provided on trailer floors and in holding pens as needed to keep 

livestock clean, dry, and comfortable during transportation and prior to slaughter. 

Poultry crates are exempt from the bedding requirement. When roughages are 

used for bedding they must be organically produced and handled by a certified 

organic operation. 

(4) Arrangements for water and organic feed must be made if transport time exceeds 

twelve hours. 

(5) Slaughter plant management shall coordinate with transporters to ensure that 

waiting time once the livestock trailer/shipping container arrives at the slaughter 

facility is no more than one hour. If this is not possible animals will be covered, 

sheltered, or provided comfort as needed for the species. 

(6) Emergency plans that adequately address animal welfare must be in place to 

cover any encountered problems during transport. 

(7) Slaughter plants and livestock trailers/shipping containers must have non-slip 

flooring. 

(8) Gates in the unloading area must swing freely, latch securely, and be free of sharp 

or otherwise injurious parts. Gates are never to be slammed on animals. 

(9) Adequate lighting must be in place to allow animals to be easily observed. 

(10) Livestock slips and falls must be scored in all parts of the facility including holding 

areas, chutes, stun box and the stunning area. No more than 1% of livestock that 

walk off the trailer may fall during the unloading process. No more than 1% of 

cattle, sheep, or hogs may slip during unloading. 

(11) Willful acts of abuse, as defined in § 205.2, are prohibited. 

(12) Humane treatment procedures for handling immobile and fatigued animals upon 

arrival at the slaughter plant are in place. Handlers may use sleds and place 

livestock in the bucket, but may not push them up against a wall, gate, or any other 

object. 

 

(13) Electric prods are available if needed for human safety or for medical use, i.e., in 

an effort to save down animals. Prod use must stop after three shocks interspersed 

with rest periods or if the animal does not attempt to rise. Prods may never be 

72
Page 5 of 5

Animal Handling, Transport, and Slaughter

September 21, 2011

applied to sensitive parts of the animal: eyes, nose, ears, rectum, or reproductive 

organs. Prods may not be used on animals less than twelve months of age. 

(14) Euthanasia must only be performed by trained personnel. 

(15) Euthanasia equipment must be properly stored at slaughter plants and 

maintenance records must be available. 

(b) Slaughter Plants must meet all FSIS requirements including Humane Slaughter Act. 

(1) No more than 3% of cattle vocalize as they move through the restrainer, stunning 

box and stunning area. No more than 5% of hogs squeal in the restrainer due to 

human provocation. No more than 5% of livestock vocalize when a head holder 

is used during stunning or slaughter. 

(2) Conscious, sensible mammals must never be restrained by suspending them by 

their limbs. 

(3) No more than 1% of animals slip at the stun box or in the stunning area. No more 

than 1% of animals’ fall entering the stun box or in the stun box area. 

(4) One hundred percent of animals are insensible prior to being hung on the bleed rail. 

(5) 95% of cattle and sheep are effectively stunned with one shot via captive bolt or 

gunshot. 99% of electrodes are placed correctly when livestock are stunned with 

electricity. 

(6) No more than 1% of hogs vocalize due to hot wanding. Electrodes must not be 

energized before they are in firm contact with the animal. 

(7) When carbon dioxide (CO2) or other controlled atmosphere stunning systems, 

including gondolas or other conveyances for holding a group of animals, are 

used, animals must be able to lie down or stand without being on top of one 

another. When head to tail conveyor systems are used, this score may be 

omitted. 

Committee Vote 

Move to accept the Livestock Committee recommendation on animal handling, transit, and 

slaughter proposal with discussed changes. 

Motion by: Wendy Fulwider Second: Joe Dickson 

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

73
National Organic Standards Board

Livestock Committee 

Proposed Guidance Recommendation

Animal Handling, Transport, and Slaughter 

October 14, 2011

Introduction

Humane and respectful treatment of animals is a basic principle of organic production. 

The Livestock Committee of the NOSB submits this recommendation to the National 

Organic program and requests they issue formal guidance to assist producers, harvest 

facility personnel, and certifiers in developing systems that provide care and respect for 

the animals during this aspect of the organic food production system. 

Background

Harvesting animals for meat is conducted in a countless number of types of systems as 

designed by individual companies or operators. These facilities must adhere to 

numerous food safety, worker safety, and animal welfare state or federal regulations. 

Many also extend religious ritual standards to the process, for clientele that demand 

further requirements for the process. This guidance will allow the organic food 

production system suppliers to verify for their customers that the harvest process is 

conducted in a manner consistent with the Organic Food Production Act. 

Relevant Areas in the Rule

USDA organic regulations do not currently explicitly cover animal handling, transport, 

and slaughter. Therefore, the Livestock Committee is recommending the addition of a 

new section titled § 205.241: Humane handling, transport, and slaughter. The 

protection of organic integrity of the products from commingling and contamination in 

the harvesting process are currently in place for operations that are certified to meet all 

processing facility regulations and be labeled as organic under §205.272 

:Commingling and contact with prohibited substance prevention practice 

standard. 

Committee Recommendation for Guidance

On Farm Handling and Facilities 

Handling of livestock is necessary for proper health administration, care of newborns, 

aiding those with special needs, weaning, and preparation for transport. Handling of 

animals for transport is a stressful time for livestock. Often it is the only time they have 

ever been handled in such a deliberate fashion. Livestock are very aware of their 

surroundings and sense when operations are secure and peaceful in nature. 

74
Page 2 of 4 

Animal Handling, Transit, and Slaughter Guidance Recommendation 

October 14, 2011 

a. Operations should have appropriate scale physical restraint mechanisms in 

place so that animals feel secure in the space confined. 

b. Even when a facility is temporarily modified to corral, sort, and load livestock, 

the equipment should always be adequate to keep animals from triggering 

their fight or flight response mechanisms. 

c. Structures, fencing, gates, and catching mechanisms must be sound and 

adequately designed to perform the required tasks and keep the animals 

calm. 

d. Facilities should be constructed and maintained to prevent injury due to sharp 

edges, obstruction to movement, and weak latching mechanisms. 

e. Holding facilities should be designed to allow ease of entry, ability to sort 

larger animals from smaller ones, and adjacent lots for weak or injured ones. 

f. Lighting, non-slip footing, and sufficient personnel are also necessary to keep 

animals calm and safe at this time. 

g. Young stock should not be transported until navels are dry or at least 48 

hours of age. 

h. Reduced crowding for weak or lame animals, improved lighting for those with 

poor vision may be necessary. 

i. Excessive use of force, electric prods, lifting or restraining techniques that 

could further harm the animal are not permitted. 

j. Animals should be euthanized by trained personnel in a manner that 

minimizes suffering. 

 

Transportation of Animals 

a. Loading of animals should be performed in a quiet, deliberate, and respectful 

manner. 

b. Ramp inclines should be gradual to discourage balking, likewise stepping up 

and down should be appropriate for the size of stock being loaded. 

c. Footing should be secure to reduce or eliminate slipping. 

d. Shipping containers should provide adequate footing, be structurally sound, 

and provide seasonally appropriate environmental conditions. 

75
Page 3 of 4 

Animal Handling, Transit, and Slaughter Guidance Recommendation 

October 14, 2011 

e. Animals should have enough room to move within the container and be able 

to regain a standing position in the event of falling. 

f. Bedding may be necessary for extended duration, which if considered 

roughage, must be certified organic. 

g. Trips in duration longer than 12 hours may require animals have access to 

feed and/or water as environmental conditions dictate for animal health 

considerations. 

h. Poultry crates should be packed at a rate that allows sufficient space for all to 

lie down and maintain appropriate temperature regulation. Crates should be 

stacked in a manner to allow sufficient ventilation for respiration and 

temperature regulation. Protection from the elements may also be necessary. 

i. Poultry should not be frightened into an area which causes piling while being 

handled for crating or loading. Broilers should not be held by their neck or 

wings alone. 

Slaughter Facilities 

a. Receiving pens at the plant must be sized appropriately for the class of 

animal being handled and designed to reduce balking. 

b. Stepping up or down should not be difficult for the animal. Ramps should also 

be gentle enough to encourage movement. 

c. Gaps between the shipping container and flooring of the facility must be 

minimal to prevent injury and provide safe and secure footing. 

d. Lighting, gates, pens, and latches should be adequate for the animals being 

handled and provide staff the ability to move and sort the animals in an 

orderly manner. 

e. Slaughter facilities are required to meet numerous local, state, and/or federal 

food safety regulations. Organic inspectors should have access to and the 

ability to review all relevant Federal or State inspection reports. These 

reports will show if the facility is already under the purview of an animal 

welfare inspection system. 

 

f. Inspectors and reviewers can be aided in assessing welfare in plants that are 

not animal welfare certified by using the species specific criteria outlined in 

the guidance documents also being developed by the NOSB Livestock 

committee. These “core” criteria will not attempt to replicate a complete 

76
Page 4 of 4 

Animal Handling, Transit, and Slaughter Guidance Recommendation 

October 14, 2011 

welfare audit, but will ensure that the most crucial aspects of animal welfare in 

handling for slaughter are defined in a way that can be objectively observed 

and assessed. 

g. Slaughter facilities exempt from State or Federal inspection are least likely to 

be animal welfare certified. Slaughter in these plants usually involves a small 

number of animals slaughtered at a time, and the process is slower and less 

mechanized than in larger plants. These conditions make it feasible for 

organic inspectors to observe slaughter handling and assess whether these 

core welfare criteria are met. 

h. Animals that arrive in a compromised physical condition must be handled in a 

respectful manner without the use of excessive human intervention. 

i. The use of electric prods is prohibited, except where animal and human 

safety is in jeopardy and is a means of last resort. 

 

j. Euthanasia must only be performed by trained personnel. 

k. Plants offer humane ritual slaughter, which is an indicator of respect for 

animal welfare. 

l. Slaughter plants may be certified by one or more animal welfare programs. 

Inspectors may make note of these as they may show intent of the operator to 

perform their duties in a respectful manner. These do not supersede the 

organic regulations like state or federal regulations do. 

Committee Vote 

Motion: Wendy Fulwider Second: Mac Stone 

Yes: 4 No: 0 Absent: 3 Abstain: 0 Recuse: 0

77
National Organic Standards Board 

Livestock Committee 

Proposed Recommendation 

Species-Specific Animal Welfare Scorecards 

October 14, 2011 

Introduction 

Animal welfare is a basic principle of organic production. As the number of farmers in 

the United States decline, consumer concerns for farm animal care have increased. 

There are numerous animal welfare organizations and methods to verify animal welfare. 

The Livestock Committee believes that outcome based scores are the best measure of 

farm animal welfare. 

Background 

The United States Congress anticipated the need to elaborate livestock standards in 

1990 when the Organic Foods Production Act was passed. The Humane Society of the 

United States played a central role in advocating for the passage of OFPA. It was 

understood at that time that animal welfare standards would eventually be developed. 

Several animal health and welfare practices were described in the Preamble 

accompanying the NOP Final Rule that organic livestock farmers must adhere to. 

Discussion 

The Livestock Committee feels that outcome based standards are the best measure for 

assessing the health and well-being of livestock. The four major concerns for dairy 

cattle are: 

 Body condition 

 Locomotion 

 Cleanliness 

 Injury and lesions 

These measures are currently in use and have been well documented as welfare 

indicators in the livestock industry. Body condition is affected by stage of lactation and 

diet. Cows generally score less than 2 only if they are ill. Locomotion score may be 2 or 

greater if there is an injury. When cattle have a clean, dry place to lie down the majority 

of the herd will be clean. Grazing cattle generally have safe and spacious environments 

which minimize injuries and lesions. The Livestock Committee will discuss what is 

considered normal and acceptable for each of these measures in the future. Other 

welfare measures on the tally sheet include: 

 Cattle affected with mange or lice 

 Cattle with broken tails 

 Ammonia concentration in buildings 

78
Page 2 of 2 

Species-Specific Animal Welfare Scorecards Recommendation 

October 14, 2011

 Other items that may need attention 

Cattle may be affected with mange and lice during the winter months. This is an 

uncomfortable condition and requires immediate treatment. Broken tails are uncommon 

and are generally the result of an accident. High numbers indicate a problem with 

animal handling or the farm environment. Ammonia smell in buildings may indicate a 

lack of ventilation. 

The photographs and descriptions on the dairy score card clearly show the difference 

between scores and have a corresponding spot on the tally sheet. The shaded boxes 

on the tally sheet represent areas of concern. Inspectors should view all of the cows 

and young stock but tally only the animals that would score in a shaded box. This 

identifies any issues that may need to be addressed and minimizes the amount of 

additional inspection time. 

Committee Recommendations 

I. Dairy Auditor Tally Sheet 

II. Dairy Scorecard 

Committee Vote

Motion: Wendy Fulwider Second: Mac Stone 

Yes: 6 No: 0 Absent:1 Abstain: 0 Recuse: 0 

79
Dairy Auditor Score Sheet

Date

Producer

Number of milk cows:

Dry cows:

Bred heifers:

6-12 months

0-6 months

Tally the number of cows that score in the appropriate shaded box. 

Overview of livestock health and conditions:

Extremely thin 1 Frame obvious 2 Body condition 3

Good fat cover

Well covered 4 Obese 5

Very clean 1 Hygiene 2

Manure stains

Wet or dry manure 3

On legs udder 

Extremely dirty 4

Normal 1 Locomotion 2

Slightly affected

3

Cannot keep up with 

herd 

Limping 4 Can’t bear weight 5

Hock condition 1

May have hair loss

Swelling 2

Number of cows missing patches 

of hair due to mange or lice

Number of cows with broken 

tails 

Ammonia odor present

Housing type: Milking herd __________________________Dry cows __________________________

 Heifers ______________________________ Calves ____________________________

Three items done well at this farm: 

Three items that may need attention at this farm:

80
Locomotion Scoring 

Score 1 Normal Stands and 

walks normally. Her back is 

level. She makes long 

confident strides. 

Score 5 Severely Lame - 

Pronounced arching of the 

back. Reluctant to move, 

with almost complete 

weight transfer off the 

affected limb. 

Score 4 Lame - Arched back 

standing and walking. 

Favoring one or more limbs 

but can bear some weight 

on affected limb(s). 

Score 3 Cannot keep up with 

the grazing herd. Stands and 

walks with an arched back. 

Makes short strides and 

favors one or more legs. 

Score 2 Slightly affected - 

Stands with flat back and 

arches when she walks. 

Gait is slightly off. 

1 2 3 4 5 

Body Condition Scoring 

Score 1 Extremely thin Score 4 Frame not as visible Score 5 Obese 

as covering 

Score 3 Frame and covering 

well balanced 

Score 2 Frame obvious 

1 2 3 4 5 

81
Hock Lesions 

Score 1 No damage or may have patches of hair loss on the hock Score 2 Swellings at the hock may be extensive, bleeding, or draining 

1 1 2 2 

Cow Cleanliness 

Score 1 No manure stains or 

dried manure attached to 

cow. 

Score 4 Cows with wet or 

dried manure on legs, udder, 

and ventral abdomen. 

Score 3 Dried or wet manure 

on legs or udder. 

Score 2 Manure stains but 

no dried manure attached to 

cow. 

1 2 3 4 

82
National Organic Standards Board 

Livestock Committee 

Proposed Recommendation 

Species-Specific Guidance 

October 14, 2011 

Introduction 

Animal welfare is a basic principle of organic production. As the number of farmers in 

the United States decline, consumer concerns for farm animal care have increased. 

There are numerous animal welfare organizations and methods to verify animal welfare. 

The Livestock Committee wishes to provide guidance that will assist producers and 

certifiers to improve and assess welfare on farm and assure consumers that animals 

are well cared for and that the organic community is leading with a focus on continuous 

improvement. 

Background 

The United States Congress anticipated the need to elaborate livestock standards in 

1990 when the Organic Foods Production Act was passed. The Humane Society of the 

United States played a central role in advocating for the passage of OFPA. It was 

understood at that time that animal welfare standards would eventually be developed. 

Several animal health and welfare practices were described in the Preamble 

accompanying the NOP Final Rule. An organic livestock farmer must conform to the 

following list according to the Description of Regulations:

 select species and types of livestock with regard to suitability for site-specific 

conditions and resistance to prevalent diseases and parasites 

 provide a feed ration including vitamins, minerals, protein, and/or amino acids, 

energy sources, and, for ruminants, fiber. 

 establish appropriate housing, pasture conditions and sanitation practices to 

minimize the occurrence and spread of diseases and parasites. 

 maintain animals under conditions which provide for exercise, freedom of 

movement, and reduction of stress appropriate to the species. 

 conduct all physical alterations to promote the animals’ welfare and in a manner 

that minimizes stress and pain. 

 establish and maintain livestock living conditions which accommodate the health 

and natural behavior of the livestock. 

 provide access to the outdoors, shade, shelter, exercise areas, fresh air, and 

direct sunlight suitable to the species, its stage of production, the climate, and the 

environment.

 provide shelter designed to allow for the natural maintenance, comfort level, and 

opportunity to exercise appropriate to the species 

83
Page 2 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

The NOSB was further tasked in the Preamble with creating species specific guidelines. 

These were to include specifics on temporary confinement, space requirements, and 

management guidance. The current Livestock Committee has worked with Temple 

Grandin, the Livestock Issues Working Group, and other individuals with specific areas 

of expertise toward completing this task. The Livestock Committee feels that outcome 

based standards best measure the health and well-being of livestock and will continue 

to work on those documents. The guidance documents are intended to help the 

program, certifiers and producers to understand and meet the regulations. These 

documents were written to enhance the regulations, clarify the expectation for animal 

welfare on organic farms and minimize the need for increased regulations. 

Committee Recommendation 

The Livestock Committee intends to develop species specific guidance for all species. 

To date, the Livestock Committee has worked with members of the organic community, 

certifiers, animal welfare specialists, and previous NOSB members to develop the 

following three species specific guidance pieces: 

I. Guidance for Assessing Animal Welfare on Organic Bison 

II. Guidance for Assessing Animal Welfare on Organic Poultry Operations 

III. Guidance for Assessing Animal Welfare on Organic Sheep Operations 

Committee Vote 

Motion: Wendy Fulwider Second: Mac Stone 

Yes: 4 No: 2 Absent: 1 Abstain: 0 Recuse: 0 

84
Page 3 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Guidance for Assessing Animal Welfare on Organic Bison

Introduction

The North American Bison has undergone little modification through domestication or 

selective breeding. Consequently, it is still possible to compare the characteristics of 

today’s bison to what was historically roaming the North American continent to identify 

the similarities to what is called typical for this animal. 

Because bison remain largely undomesticated, the optimal nutritional requirements, and 

body conditioning will vary significantly on a seasonal basis. In addition, humane 

handling procedures are crucial to minimizing stress on the animals. We attempt to 

address those factors in this guidance document. 

Bison Nutrition 

General Guidance 

Because bison are grazing ruminants with a four chambered stomach for feed digestion, 

it is easy to assume that the feed requirements for bison are similar to cattle. However, 

there are some significant differences in the species that require an understanding of 

the nutritional needs of bison. 

A bison’s rumen is very structured, ensuring that forage based feeds are retained for 

long periods of time. Bison retain feed in their digestive system longer than cattle. 

Longer feed retention 

means that bison have 

more time to digest the 

fiber in feeds such as 

sedges and grasses. 

However, when 

consuming alfalfa or 

alfalfa brome hay, there 

is virtually no difference 

in digestibility between 

bison and cattle because the fiber level in alfalfa based forages is typically lower than in 

grasses and sedges. Forages with lower fiber levels do not need to stay in the digestive 

tract as long to be fully digested as compared to forages with higher fiber levels. 

Bison seem to naturally self-limit intake with less dry matter consumed per unit body 

weight than bovines. Bison also consume feed in several small meals throughout the 

day vs. fewer large meals observed in bovines. This habit maintains a more uniform 

ruminal environment and may contribute to more complete nutrient extraction by bison 

vs. bovines. 

Protein needs to be treated entirely different in bison diets than bovines. Bison recycle 

nitrogen efficiently, an evolutionary response to very low protein diets from mature 

Comparison of total tract retention time and dry matter 

digestibility of forages between bison and cattle 

85
Page 4 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

grasses during several months of the year. This recycling may cause high blood urea 

nitrogen levels from modestly high protein levels in the diet. In some areas, many feeds 

contain protein levels higher than many bison producers consider optimum making it 

difficult to formulate diets. Eleven or 12% protein is considered the maximum from 

anecdotal experience. 

Animals given too high protein and feed have produced rapid growth and resulted in 

horn, hoof and kidney problems that lead to other problems. The over-feeding of highnutrient feed may lead to lethargic animals that have trouble moving about, and could 

lead to calving problems. A cow needs nine percent protein just to maintain her 

condition over winter and try to develop her calf. Less than that amount of protein or 

severe winter could result in pulling her down physically, and thus would take more time 

to bring her back into condition prior to breeding. The result is a late calf or no calf the 

following year. 

Forage samples alone would indicate that the forage or feed is sufficient for the bison’s 

need, but examining the water could show that a critical element like copper is tied up 

by iron and manganese and thus causes a deficiency. Molybdenum, sulfate, nitrate, 

calcium and sodium can also cause mineral deficiencies due to interference. 

Many producers experiencing cold winter climates realize that they need to supplement 

with more of an energy supplement to insure that their animals have the energy to eat 

and be active. 

Seasonal Considerations 

Bison have a strong anabolic/catabolic cycle based on day length (anabolic means build 

up – catabolic means to tear down). All wildlife species in the northern hemispheres 

require this cycle for survival. It relies on the animal’s ability to have a strong anabolic 

cycle in spring, summer, and early fall and survive nutritional deficiencies in the winter 

with the nutrients they stored during the anabolic cycle. 

Summer grazing usually meets most bison nutrient requirements so long as carrying 

capacity is not exceeded and minerals are supplemented. If pasture quality and quantity 

is low, supplementation with hay or grains may be necessary.

It is not uncommon for bison older than 18 months of age to lose 10 to 15% of prewinter body weight from December to April. Dry matter intake during the winter period 

tends to range from 1.4 to 1.8% of body weight depending on forage quality, fiber levels, 

metabolism and total tract retention time. In the spring to autumn, dry matter intake can 

be expected to range from 2.0 to 3.0% of body weight. 

Nutrition and Bison Reproduction 

Heifers/Cows 

Bison typically mature at two years of age for both male and females. Some yearling 

females will breed at one year of age and give birth to a calf as they turn two years of 

age, but this is an exception. The nutrient intake during the pregnancy of first and 

second calf heifers is significantly higher than a mature cow, especially during the third 

86
Page 5 of 46 

Species-Specific Guidance Recommendation 

October 14, 2011 

trimester. These young females must have sufficient nutrient intake to finish growing 

their own body in addition to finish growing a calf. 

This nutrient demand will continue after the calf is born and taper off some as the calf 

forages on grass. Her ability to seek sufficient nutrition to grow and come into cycle 

during the normal breeding period is dependent on the quality of food available to her. 

The result is that calves are then born 45 days following the spring equinox. Normal 

practice is to breed females at age two with bulls that are two years or older. If a heifer 

does not attain sufficient size, it may be difficult for her to stand up under the weight of 

large mature bulls. A key concern for first and second calf heifers is to grow them to 

sufficient size prior to being bred to insure pregnancy each year of their lives. 

A critical issue affecting pregnancy is the ability of a female to flush on highly nutrient 

forage or feed. Spring time usually brings forth lush vegetation that is high in nutrients. 

Having this available to females that have recovered from previous pregnancies will 

help insure a high calving percentage the following year. 

Drought and high temperatures prior to and during the normal rut (breeding) period can 

have a negative effect on pregnancy rate. Often times, a fall green up will cause a flush 

in the cows that did not breed or take during the normal rut period, and the result is a 

late calf the next year. 

 

Bulls 

A bison male at 18 months of age will begin a lifetime cycle of winter weight loss 

followed by spring/summer weight gain. Mature bulls will also lose weight during the 

breeding season, followed by a final period in the fall to allow for weight gain. 

Much like mature females, bison bulls can lose 10 to 15% of their pre-winter body 

weight from December to April due to a slower metabolism. During this winter period, 

dry matter intake will range from 1.4 to 1.8% of body weight. If grass hay diets are 

supplemented with grain, winter weight loss will be minimized, but compensatory gains 

in the spring and summer will not be as great. 

During the breeding season, bulls can potentially lose 10 to 15% of body weight again. 

Therefore, it may be necessary to provide extra energy through supplementation to 

prevent too much loss of body condition. Excessive loss of body weight during breeding 

makes it more difficult for the bulls to regain a proper weight status prior to the start of 

the wintering period. It is important to ensure the bulls are of adequate body condition 

prior to the winter and breeding seasons. Much like the cows, thin or poorly conditioned 

bulls entering the winter will still lose weight and be more expensive to feed. 

87
Page 6 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Body Condition and Scoring 

As mentioned above, the idea body condition for bison is based upon the attributes that 

the animal carries in nature. Survivability and low management requirements are 

important characteristics. 

Even though bison in commercial organic operations are selected for the meat 

marketplace, it is important that the commercial characteristics (size, yield, etc.) are not 

accomplished at the expense of sacrificing the unique genetic characteristics that allow 

bison to survive in a wide variety of conditions, and to calve easily. In other words, bison 

producers must avoid an attitude of ―screw the hump, and build the rump.‖ 

Bison characteristics are usually developed and identifiable by the time they mature at 

two years of age. The characteristics become more pronounced with age such as the 

horn growth and overall size. Calves start exhibiting typical bison characteristics late in 

their first year of life. The more angular and triangle shaped heads, greater horn bases 

and growth are found on the males, while the females have smaller horns both in 

diameter and length. 

Female bison heads are longer and narrower than the male. Female horns are typically 

more curved and possess less circumference and more curvature, with the horn tips 

curved up and inward and often times pointing at each other. 

Typical bison characteristics of the Plains bison, (Bison, bison, bison), include long hair 

under the chin forming a large rounded beard, long hair on the front legs forming 

leggings, and a raised pelage of usually longer and lighter colored hair located over the 

front shoulder. The pelage extends along the back to just behind the front shoulders. 

The raised hump is a distinguishing characteristic as well. Calves should exhibit the 

development of the hump as they approach one year of age. 

Wood bison, normally associated with the Canadian provinces, (Bison, bison 

athabascae) tend to have less developed beard, leggings, and an incomplete pelage. 

The structure of the Wood bison is taller, more moose-like in form. The incomplete 

development of the beard, leggings and raised pelage, and the body higher off the 

ground is an advantage for Wood bison, who have to endure the deep snow and ice 

conditions found in Canada. 

The head and neck projection of the Plains bison favored grazing of the plains in more 

mild climates. The Plains bison’s highest point is typically found by extending a line 

straight up the center of the leg to a point on the back. The highest point on a Wood 

bison is also the hump, but it is typically projected as much as one foot forward from a 

line extending up the middle of the front leg to a point on the back. 

88
Page 7 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Bulls that have to compete within a herd for breeding rights need to have size, muscling 

and strength less they be overpowered by a bull having more strength. Bison strength 

is a result of a wide and deep body conformation. The lack of muscle development may 

be attributed in part to nutrition and exercise. 

Female bison need to have sufficient ―spring of rib‖ (width and depth to provide for room 

for an unborn calf to grow, develop and be born). Pelvic structure is important. 

Females possessing a narrow pelvis or a serious drop in the top line in the last foot 

before the tail could very easily develop calving problems due to restriction of the 

birthing canal. A high tail head can also produce a problem, due to narrowing of the 

birthing canal to compensate for the projected high tail head. 

Bison are seldom caught in a squeeze to allow a ―hands on‖ body condition scoring 

system so most of the criteria used to assess the animal are visual clues. 

A body condition score (BCS) of 1 indicates that the animal is very thin. A BCS of 5 

indicates that it is very fat. Alberta Agriculture has developed a comprehensive guide for 

body conditioning scoring for bison. The table below is excerpted from that guide. The 

entire guide is available at: 

http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/agdex9622/$FILE/bcsbison.pdf. The guide can also be obtained through the National Bison Association at 

www.bisoncentral.com. 

89
Page 8 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Source: Alberta Agriculture, "What's the Score; Bison"

http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/agdex9622/$FILE/bcs-bison.pdf

90
Page 9 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Optimal body condition for bison varies with the seasonal weight fluctuations of the 

animals. 

For example, the weight of 

mature females will vary up to 

15% throughout the year. The 

animals’ typically achieve top 

weight in the late fall as they 

graze to store fat to provide 

energy for both mother and 

unborn calf to overwinter. The 

females will lose up to 100 lbs. 

from December to April, when 

calving season typically 

begins. 

The chart at right illustrates a typical weight change for mature female bison. 

Most people aim to have their bison fat in the fall so that they do not require as much 

feed over the winter. Most experienced producers aim to have their bison lean in the 

spring because excess fat may lead to calving problems. 

By the beginning of breeding season, the cows should be back to a moderate to good 

body condition to ensure optimal conceptions rates. 

The best indication of overall 

bison health and condition 

throughout the season is the 

hair. Healthy animals have a 

good hair coat that is full of life 

that may give a producer an 

indication of proper nutrition. 

Bison Health 

Bison are not cattle. Differences include the age to breeding (2.5 years), nutritional 

requirements over winter, nutrition for slaughter animals, social structure, and longevity. 

Bison have a relatively good resistance to many pathogens that affect cattle. 

The two primary factors affecting the health of bison are environmental/nutritional 

considerations, and chronic stress. Paying attention to these two areas is critical 

Source: USDA NRCS Grazing Lands Technology Institute

91
Page 10 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

because typical livestock therapeutic drugs are not as effective in bison as in cattle. In 

fact, one saying in the bison business is: ―A sick bison is a dead bison.‖ 

Because bison still carry the prey/predator instinct, they will mask a sickness until 

seriously ill (why let the predators know your sick?). At that point, antibiotics and other 

therapeutic remedies will have only limited efficacy. In addition, the added stress 

induced to administer the treatment is so great that it often pushes the animal over the 

edge. This stress can be effectively eliminated by using one of the modern air-powered 

dart guns. 

Poor environmental and feed conditions will weaken the animal’s natural immune 

system, and increase susceptibility for disease. A successful organic systems plan for 

bison must focus heavily on the ecosystem and developing systems that will provide 

optimal nourishment for the bison while sustaining the natural environment. 

Chronic stress will have the same effect as more environmental and nutritional 

conditions. Bison can readily handle the acute stress that comes from a short-term 

perceived threat. That is the ―fight or flight‖ response to a stimulus. They can fight or 

run from grizzlies or humans and when all threats are passed, go back to grazing and 

the adrenalin and steroid levels return to normal. However, they react poorly to 

extended or continuous (chronic) stress. That stress can be minimized through humane 

handling procedures (discussed later).

Pathogens 

Bison have a strong resistance to many pathogens prevalent in other livestock. Much of 

this resistance is the result of the ―bottleneck‖ that the species passed through roughly 

110 years ago. 

In the 1850’s, the bison population was estimated to be somewhere between 30 and 60 

million animals. The domesticated livestock species introduced to the West allowed the 

pathogens these species carried to adapt to these new and different species. BVD, 

IBR, PI3, BRSV, TB, Johne’s, mycoplasma, leptosirosis, clostridia, Staph, Strep, 

internal and external parasites and probably pasteurella found a plethora of new ways 

to reproduce and spread their DNA (genes) to the demise of these native ungulates. 

In the late 1800’s, bison were driven to the brink of extinction because of market 

hunting, war tactics against the Native Americans, and because of the introduced 

pathogens. Fewer than 1,000 bison survived this onslaught. The surviving animals were 

those bison that had a genetic resistance to these new pathogens. Testing of wild 

ungulate species has been undertaken for the past several decades across the western 

states. All wild populations show exposure to these introduced pathogens without large 

detrimental effects - yet these same pathogens remain of utmost importance to the 

livestock industry. 

Today, the primary diseases affecting bison are bovine TB, brucellosis, Bovine Virus 

Diarrhea (BVD) and Malignant Catarrhal Fever (MCF). 

92
Page 11 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Bovine Tuberculosis (TB)

Bovine Tuberculosis (TB) is a slow, progressive bacterial disease that is difficult to 

diagnose in the early stages. As the disease progresses, animals may exhibit 

emaciation, lethargy, weakness, anorexia, low-grade fever, and pneumonia with a 

chronic, moist cough. It usually is transmitted through contact with respiratory 

secretions from an infected animal. TB is a zoonotic disease meaning it can be 

transferred to other species, including man. 

Free-ranging and privately owned bison in the U.S. have been free of TB for several 

decades. TB testing in bison has proven to be effective in diagnosing infected animals. 

If you are buying animals to start or augment your herd, have the bison over 12 months 

old tested. Many states are TB free and testing is not required, but as a precautionary 

measure require TB testing before purchasing. 

Brucellosis 

Brucellosis is a disease that has strong regulatory and economic guidelines for all 

states. A majority of states have been brucellosis free in livestock for many years. 

The notable exceptions are the states that border Yellowstone National Park. State and 

federal regulatory agencies consider the Greater Yellowstone Area (GYA) an area of 

interaction with these wildlife species the last nidus of infection in the U.S. Brucellosis 

was introduced into bison and elk in the early 20th century. Once the organism was in 

these wildlife populations it became problematic to control. To this day 20 to 40 percent 

of the bison and elk in the GYA have been proven to harbor titers from exposure or 

infection. 

Abortion is the most obvious indication of the disease in a herd. Brucellosis is a disease 

not spread from cow to cow, but from a birthing or abortive event where the abortive 

event including the aborted, stillborn, newborn calf and afterbirth are exposed to other 

animals. There are several tests to determine if bison are infected or exposed. These 

tests are, for the most part, accurate. There are cross-reactions with other organisms 

that can create suspects in your bison. Regulators are working on being able to identify 

these other organisms and incorporate them in the battery of tests for brucellosis 

―suspect‖ bison. 

Calfhood vaccination for brucellosis (Bang’s vaccinations) is not mandatory in many 

states. The vaccine (RB51) is safe for use in bison. It is not as protective against 

abortion or infection as in cattle, but does offer limited protection. Brucellosis is also a 

zoonotic disease and can be transmitted to other species including man. 

Bovine Virus Diarrhea (BVD) 

Anywhere in the world there are cattle, there is Bovine Virus Diarrhea (BVD). This 

worldwide distribution makes this disease important to cattle producers. BVD is a 

complicated disease to discuss as it can result in a wide variety of disease problems 

from very mild to very severe. BVD can be one of the most devastating diseases cattle 

encounter and one of the hardest to get rid of when it attacks a herd. The viruses that 

93
Page 12 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

cause BVD have been grouped into two genotypes, Type I and Type II. The disease 

syndrome caused by the two genotypes is basically the same. However, disease 

caused by Type II infection is often more severe in cattle. The various disease 

syndromes noted in cattle infected with BVD virus are mainly attributed to the age of the 

animal when it became infected and to certain characteristics of the virus involved. 

As mentioned earlier, bison appear to be resistant to clinical manifestations from 

exposure. BVD has been incriminated in losses of bison placed in feedlots in 

conjunction with cattle. Vaccinations for BVD Type I and Type II are effective in 

preventing the disease in bison. I have never seen the disease in free-ranging or any 

captive herd. 

Malignant Catarrhal Fever (MCF) 

Malignant Catarrhal Fever (MCF) is a generally fatal disease of cattle, bison, true 

buffalo species, and deer. It is caused by viruses belonging to the Herpesvirus family. 

MCF occurs worldwide and is a serious problem, particularly for bison in the United 

States and Canada.

MCF in bison is caused by a virus called ovine herpesvirus-2 (OvHV-2). Most infections 

are characterized by depression, separation from the rest of the herd, loss of appetite, 

and in many bloody diarrhea. Unlike MCF in cattle, discharge from the eyes and nasal 

passages of affected bison is minimal. Animals develop a fever and may pass bloody 

urine. The clinical course is generally 1-7 days. Most animals die within three days of 

developing clinical signs. There is no effective treatment for MCF in bison. Bison older 

than six months, particularly if stressed by bad weather, transportation and handling are 

the most susceptible to infection. Large outbreaks occur in feedlots, where stress due 

to crowding is likely. 

Studies of field outbreaks strongly suggest that sheep infected with OvHV-2 are the 

principal source of MCF outbreaks in bison. A strong association between outbreaks in 

bison and recent exposure to sheep has been documented repeatedly since 1929. In 

some outbreaks, however, no sheep were in the vicinity immediately prior to the first 

case being identified. There is no evidence that transmission occurs horizontally from 

one bison to another. Currently there is a study supported in part by the National Bison 

Association to establish whether bison-to-bison transmission is a factor in natural 

outbreaks. 

Internal parasites 

It is necessary for special attention to be given to managing internal parasites on 

organic bison operations. Each parasite’s life cycle is different and many cycles can be 

interrupted by changes in management. Sometimes small changes in the way the 

producer pastures or feed bison may slow or stop the future spread of the parasite 

based on the available facilities. 

94
Page 13 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

If breed selection, pasture management, supplements and allowed treatments are not 

successful in keeping sheep parasite loads from impacting well-being, individual 

animals need to be given conventional treatments. 

External Parasites 

Ticks and lice have been identified on bison and could potentially be detrimental. Bison 

have a thicker hair coat and identification of lice in bison is rare. Ticks have been found 

on bison around the tail head. In many areas where elk and deer are infested with ticks, 

bison sharing the same habitat are tick free. 

Physical Alterations 

Consistent with the low-management approach to bison, bulls are not castrated. Nor is 

there any need to dehorn bison. 

Bison Handling 

The primary objective of any handling program is to reduce stress on the animals while 

assuring the safety of handlers. A bison organic systems plan must discuss how the 

producer will handle or move bison; how they manage them on range; how they confine 

and feed them; as well as how they are worked in the corral. 

It is important to recognize that bison are an extremely social animal with strong 

matriarchal divisions. Establishing a herd with the correct social balance, and the ability 

for animals to express their natural behavior, is the first step in reducing stress. 

Bison have a very intact social structure that has definite spacing requirements between 

individuals and family groups. This spacing requirement may be different for different 

sexes and ages of animals throughout various times of the year. Herds that generate 

their own replacements from offspring will develop family groups between related 

individuals. 

The pasture environment includes the size and shape of the pastures, forage quantities 

and qualities available, watering sources, spatial requirements for individuals and/or 

family groups as well as a myriad of other considerations. Social stress will become a 

factor if pasture size is too small to give adequate spatial requirements for individuals or 

family groups for large herds. This causes discontent and disharmony within the herd, 

causing animals to breach fences and become difficult to handle. 

Bulls will separate from the herds after breeding and only young bulls are allowed to 

stay with the cows and calves. Post-breeding, the bulls have been nutritionally and 

physically stressed and should be checked for wounds or other forms of trauma. 

95
Page 14 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Corrals 

Corrals and working facilities should be designed to minimize the stress on animals, and 

to facilitate the ability of handlers to gently apply and release pressure. The amount of 

space allowed for each individual animal depends upon the amount of time that the 

animal will be maintained in the corral. When animals are introduced into a new herd, is 

advisable to house those animals in the corral for several days so that the animal s can 

adjust to their new environment. The producer should allow a minimum of 250 sq. /ft. 

(preferably 400 sq. ft.) per adult animal in this type of confined situation. 

Never place just one bison in a corral or pasture for extended periods. Because they 

are extremely social, they will experience chronic stress when isolated from the herd. 

When handling bison, the producer should strive for a gentle ―dance‖ of applying 

pressure, the animal moving away from the pressure and then releasing the pressure. 

The fact that we move into an animal’s flight zone giving it pressure and when it moves 

away from us, we release the pressure by either not moving with them in the same 

direction (by stopping) or we move in a different direction. This sets up a positive cause 

and effect relationship – that is we get into their flight zone putting pressure on them, 

and they, by moving away from us get released from the pressure. 

The National Bison Association—in cooperation with Dr. Temple Grandin of Colorado 

State University—developed has developed a bison welfare audit form to measure 

several areas of working bison in the corral. That audit form is included as an 

attachment at the end of the Guidance Document. 

Inside housing is rarely used for bison. These animals are adapted for extreme weather 

conditions in the outdoors. Bringing the animals inside actually increases stress. 

Calving 

Human interaction with calving bison should be held to a minimum. Because bison have 

not been bred to produce calves larger than nature intended, cows rarely need 

assistance in calving. 

One of the most important things a bison cow needs at calving time is peace. There is 

no fixed rule regarding amount of space a calving bison cow needs. However, the 

producer can judge that space by monitoring the cow’s behavior: If she changes her 

behavior with the producer’s presence (such as standing up, running off or her labor 

arrests) she needs more space. If the other bison pester her and she cannot get away, 

then she needs more room. 

Nature also needs the cow to be leaner to give birth effectively. A fat bison cow will 

have trouble giving birth, and the calf from such a cow will likely be too big and too hard 

to birth. 

96
Page 15 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Reference Material 

Alberta Agriculture (2007) “What’s the Score: Bison” Body Condition Scoring Guide. 

Anderson, Vern PhD (____) “perspectives on Nutritional Management of Bison Bulls 

Fed for Meat, Carrington Research Extension Center, North Dakota State University. 

Feist, Murray (2000)”Basic Nutrition of Bison,” Saskatchewan Agriculture, Agriculture 

Knowledge Centre, Saskatoon, Saskatchewan, CA 

National Bison Association (2010) The Bison Producers’ Handbook, A Complete Guide 

to Production and Marketing, Westminster, CO. 

USDA NRCS (2006) “Bison Body Condition.” Grazing Lands Technology Institute, Fort 

Worth, TX 

97
Page 16 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Guidance for Assessing Animal Welfare on Organic Poultry Operations 

Introduction

The following is provided to aid in assessment of whether or not the requirements of § 

205.238-241 are being met sufficiently to demonstrate adequate animal welfare 

conditions on organic poultry operations. In addition, this document provides further 

guidance to producers for improving poultry welfare. The internationally recognized 

―five freedoms‖ (freedom from hunger, thirst and malnutrition; freedom from fear and 

distress; freedom from physical and thermal discomfort; freedom from pain, injury and 

disease; and freedom to express normal patterns of behavior) promulgated by the Farm 

Animal Welfare Council are a useful framework for considering animal welfare. 

Nutritional requirements 

Poultry must be fed a wholesome diet that meets their nutritional needs and promotes 

optimal health. Feed should be formulated to meet or exceed the National Research 

Council’s Nutrient Requirements of Poultry, and adjusted with bird age and stage of 

production. Feed and water should be palatable and free from contaminants. Unless 

using a commercially prepared complete feed, laying hens must have access to a 

course calcium source, such as ground limestone. Water should be fresh, potable, and 

clean. Feed and water delivery systems should be checked daily and kept clean and in 

good working order. Birds must be provided with feed on a daily basis and water should 

be available continuously, with the rare exception of withholding for medical treatment 

under the advice of a veterinarian. 

There should be enough feed and water space to prevent competition between birds. In 

double sided liner feed track, there should be at least 2 inches of feed space per bird, 

and 4 inches per bird for single sided feed track. Circular feeders should provide at 

least 1.5 inches of feeding space per bird. 

Adjust the height of drinkers for easy access at each bird age and so that droppings do 

not fall into the water supply. There should be at least 1 bell-type drinker for every 100 

hens and 1 nipple drinker per 12 hens. In small flocks, there should be a minimum of 

two drinkers. 

Physical Alterations 

Management methods should be implemented to reduce feather pecking and 

cannibalism (see ―preventing injurious pecking‖ below). If these management strategies 

fail, therapeutic beak trimming using the infrared laser method should be considered for 

subsequent flocks. This amputation must be performed on chicks no later than 10 days 

of age, and is commonly carried out at the hatchery. 

While not pain-free, infrared laser beak trimming is superior to the conventional hot 

blade trimming in that open wounds are eliminated and the method is more precise, 

98
Page 17 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

minimizing error and inconsistency. It also leaves a greater proportion of the beak 

intact.i 

With the exception of toe trimming of turkey poults at the hatchery using infrared laser, 

other alterations including de-snooding, caponization, dubbing and toe clipping of birds 

are not permitted. 

Force Molting 

Forced molting by feed withdrawal is not permitted under the National Organic Program, 

as it causes hunger and distress. If force molting is practiced, a molt ration should be 

supplied that is palatable and acceptable to the birds. A molt diet is acceptable to the 

birds if, on average, the total amount of feed consumed per day does not differ during 

the molting and non-molting period. Flocks should be carefully monitored during a molt, 

and individual hens that are not faring well should be separated into a designated sick 

pen and provided with a non-molt diet. Water should never be withheld for molting 

purposes. 

Poultry health 

Poultry should be monitored for signs of stress and disease. Birds should have a 

healthy body condition, have good feather cover for their stage of life, and no more than 

2% should have poor hygiene, lesions or other injuries. Sick or injured birds must be 

treated without delay or, if suffering and unlikely to recover, euthanized humanely. 

Producers must not withhold medical treatment from a sick animal in an effort to 

preserve its organic status. 

Animal health plan 

All poultry farms should draft and follow an animal health plan that covers the specific 

circumstances unique to each farm. The plan should include, at a minimum, the 

disease prevention strategy (such as vaccination schedules and biosecurity protocols), 

contingency plans for emergency situations (including failure of the power or water 

supply), predator exclusion steps, veterinary contacts and emergency euthanasia 

procedures. 

Sick pens 

A designated area for the treatment of injured or moribund birds should be prepared to 

aid recovery, by preventing competition between birds and allowing a greater level of 

individual care. Sick pens should be arranged for the comfort and safety of the birds 

during convalescence. Feed and water must be provided, with the rare exception of 

withholding for medical treatment under the advice of a veterinarian. 

Lameness 

Broiler chickens, turkeys and ducks are prone to leg problems, including angular 

deformities, tibial dyschondroplasia (TD), and in severe cases, ruptured tendons. 

These may manifest as lameness or more severe mobility impairment. 

99
Page 18 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Gait scoring is a tool that can be used to assess the degree of lameness in a broiler 

chicken flock.ii,iii,iv Randomly score 100 birds individually by viewing their walking ability 

using the following scale: 

Score 0. No detectable gait impairment 

Score 1. Slight gait defect. Wobbling or uneven gait. 

Score 2. Gait abnormality. Bird has impairment, but will move away from handler when 

approached. 

Score 3. Gait abnormality that impairs function. Bird has a limp, jerky or unsteady gait 

and moves away from the observer when approached, but squats again within 15 

seconds. Bird prefers to squat when not coerced by handler. 

Score 4. Severe gait defect. Bird remains sitting when approached or nudged, but can 

stand or walk when placed in a standing position by a handler. 

Score 5. The bird is completely lame and cannot walk. The bird may shuffle along on 

its hocks. 

Gait score tends to worsen as birds age.v Birds that are suffering or are too crippled to 

reach feed and water should be humanely euthanized. Birds at gait score 3 and above 

are probably experiencing pain,vi,vii so ideally no birds should reach this level. However, 

a reasonable place to set the target for lameness is that 95% of the birds should be gait 

score 2 or less at seven weeks of age or older. 

Broiler chickens, turkeys and ducks are also prone to contact dermatitis. When heavy 

birds spend excessive time lying down in wet or soiled litter, they are prone to skin 

lesions on the feet, legs and breast.viii, ix,x Focal ulcerative dermatitis is small skin 

lesions (commonly called ―breast buttons‖) that develop on the keel bone of turkeys.xi A 

reasonable place to set target levels is that no more than 5% of birds should show hock 

burn, breast blisters or foot pad dermatitis. 

Additional producer guidance on preventing leg problems 

While dietary deficiencies are one factor that can lead to skeletal deformities,xii genetic 

selection for rapid early growth rate is the major contributing factor. Rapid growth is 

also implicated in metabolic disorders, including ascites and Sudden Death 

Syndrome.xiii

 Some commercial broiler crosses are more susceptible to leg problems 

than others,xiv but slow growing broiler strains are generally less prone to these 

weaknesses. They are also less prone to heart and circulatory problems.xv

 The use of 

slow growing breeds is therefore recommended. Broiler growth should be limited to no 

more than 45g per day and should be achieved without feed restriction. 

Other factors that can improve gait score include: increasing the daily period of 

darkness, lowering the stocking density, and adding whole wheat to an otherwise 

balanced diet. Increasing the daily period of darkness allows chickens more time to rest 

and less time to feed. Feeding whole wheat is thought to be effective though slowing 

the rate of digestion. Both of these interventions work through reducing growth rate.xvi

 

The reason that higher stocking densities can lead to lameness is more complex, 

100
Page 19 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

involving both lack of room available for exercise and movement, as well as factors 

such as additional ammonia and litter moisture.xvii,xviii,xix

Additional producer guidance on preventing dermatitis 

Dermatitis lesions are painful and create a gateway for bacterial infection. Avoid them 

by preventing wet, sticky, or compact litter. Use bedding with good moisture holding 

capacity, such as wood shavings, and keep litter dry (but not dusty), with good 

ventilation. Drinkers should be monitored to ensure they are not spilling over and 

causing wet areas in the litter. Water nipples with drip cups can reduce water spillage.xx

 

Moisture and temperature of the litter increase with stocking density, so if these 

variables become problematic, it may be necessary to raise fewer birds in the allotted 

space.xxi

 Manually turning the litter can help. Floor heating systems have also been 

found to improve litter quality.xxii

Conversely, well-managed litter is a soft substrate, while outdoor environments can 

cause abrasion and foot-pad dermatitis if not carefully managed.xxiii Birds should be 

kept on cushioned, dry, clean surfaces outdoors. Rotate or move birds onto fresh 

pasture often enough to prevent the build-up of droppings and damage to the protective 

vegetative cover. 

Feed composition affects the consistency and composition of bird droppings, and is 

therefore a factor influencing irritant qualities of litter. Protein, fat and salt content can 

all affect the levels of contact dermatitis, as can the source and type of raw ingredients. 

Within the limits of meeting nutritional requirements, adjustments to the diet may help 

improve litter quality.xxiv

For ducks, bell-type drinkers and open water troughs have been correlated with low 

levels of foot pad dermatitis. Conversely, foot pad dermatitis tends to worsen in houses 

with nipple drinkers. There is also evidence that increasing relative humidity and 

ammonia levels are associated with foot pad dermatitis of ducks.xxv

The health status of the flock will also affect the prevalence of contact dermatitis. 

Intestinal parasites, infectious disease, and poor feed quality can cause diarrhea, which 

will negatively impact litter friability (looseness and dryness). Prevent coccidiosis and 

other enteric diseases and feed good quality feed. Also strive to reduce leg problems, 

as lame birds will sit for longer periods of time in contact with litter.xxvi

101
Page 20 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Disease 

Disease incidence is a welfare indicator. Respiratory disease may indicate poor air 

quality. Incidence of internal parasites can indicate management issues such as lack of 

sanitation and failure to rotate outdoor areas often enough. 

Poultry houses must be cleaned out completely between flocks if there have been 

adverse health issues with the previous flock; in other cases, the addition of a clean 

layer of litter will help maintain a sanitary environment. 

If there is a documented occurrence of a disease outbreak in the region or relevant 

migratory pathway, or state or federal advisory order to confine birds, then poultry must 

be kept indoors to reduce the likelihood of pathogen transmission. 

Any dead birds must be removed daily and disposed of in accordance with state and 

local laws. 

Varying degrees of foot pad dermatitis on the feet of turkeys

Foot pad dermatitis and hock burns on a broiler chicken

102
Page 21 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Additional producer guidance on management of disease risk 

Disease risk should be managed by using multiple approaches, including attention to 

outdoor range area, good litter management indoors, adherence to an effective 

biosecurity plan and ensuring clean, hygienic facilities. 

Overcrowded and unsanitary outdoor environments are a disease hazard. Providing a 

rest period in-between flocks reduces the buildup of infectious organisms and allows the 

regeneration of vegetation and soil. Where stocking density is high, the environmental 

pathogen load may be correspondingly heavy, and bird-to-bird contact will be more 

frequent. Providing as much space as possible is therefore important, and the stocking 

density guidelines set out in the organic rule are minimum space allowances—where 

conditions permit, the aim should be to lower stocking densities and provide as much 

space as possible, while balancing freedom of movement with safety of the flock, 

including protection from predators. 

Disease risk can be reduced in barn housing by removing droppings (e.g., via a belt in 

aviary systems, for example) or by preventing birds from accessing heavily soiled areas 

(e.g., by placing drinkers on a raised, slatted platform above a manure pit). Contact 

with droppings—exacerbated by high stocking density and wet, cool conditions—is a 

risk factor for enteric disease.xxvii Litter that ―stops working‖, leaking drinkers, and an 

inadequate ventilation system (to remove water vapor) may all increase disease 

risk.xxviii,xxix Maintain litter in friable condition.xxx,xxxi Introduce only healthy young birds 

from genetic lines resistant to intestinal parasites.xxxii

The build-up of parasites around the barn can be avoided with the use of mobile 

housing,xxxiii pasture rotation, reduced stocking density, and by using land with good 

drainage.xxxiv,xxxv Other methods that are helpful include regularly mowing or grazing to 

keep vegetation short on pasture, and removing heavily contaminated soil around the 

barn before introducing a new flock.xxxvi

 Gravel around the outside of permanent 

housing structures, by the exits where birds tend to congregate, can prevent muddy 

conditions in wet weather and provide additional drainage. 

Biosecurity is a strategic plan to prevent the introduction of harmful pathogens. A good 

biosecurity plan will minimize disease risks and protect flocks. To prevent the spread of 

disease, limit movement between flocks and outside visitors. Always start with the 

youngest birds on the farm when doing daily chores and inspections to avoid carrying 

pathogens from older flocks to younger flocks. Microorganisms, such as coccidiosis for 

example, can be spread on vehicles and equipment, so designate specific tools and 

equipment for each poultry house or farm area. Transport crates should be cleaned 

between uses. Visitors should not enter a poultry farm if they have recently visited other 

flocks, unless they wear protective, disposable outerwear at both locations and ideally 

change clothes and shoes and shower between farms. 

103
Page 22 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Mortality rates (deaths, culls) 

Mortality rate is a key indicator of poultry welfare. Low mortality is also important for the 

economic viability of a poultry or egg production enterprise. A reasonable place to set 

the target for mortality is 3-5%. Birds must be protected from predators.

Additional producer guidance on lowering mortality rates 

A low mortality rate is the hallmark of a well-managed poultry farm. Mortality spikes can 

be caused by a number of different problems, including disease outbreaks, cannibalism, 

and excessive losses due to predation. It is vital that producers take steps to prevent 

each of these outcomes, as they are all serious welfare and economic problems. 

When poultry are given outdoor access, they become targets for many types of 

predators including coyotes, opossums, hawks, owls, and domestic dogs, to name a 

few. Predation is a welfare issue, as birds may suffer when attacked, are not 

necessarily killed quickly, and flocks can become fearful and reluctant to use outdoor 

areas if they are threatened by repeated attacks. To protect free-range flocks from 

nocturnal predators, birds must be secured in a fully enclosed coop, barn, mobile 

chicken house or other safe facility at night, without fail. Depending on the predator 

pressure at individual farm sites, further steps may be necessary; perimeter fences can 

be dug deep in the ground to prevent predators from digging underneath, and an 

overhang at the top of the fence will help prevent animals from climbing over. Electric 

fencing can further discourage ground predators, and overhead netting may be 

necessary to protect hens from aerial predators. Do not permit repeated heavy losses. 

Preventing Injurious Pecking 

Injurious pecking, including feather pecking and cannibalism should be managed so that 

severe outbreaks do not occur. 

Additional producer guidance on management of injurious pecking 

Feather pecking and cannibalism are common behavioral abnormalities of poultry, 

usually most problematic in large flocks of laying hens, but also sometimes seen in 

other poultry such as turkeys, ducks and pheasants. Severe feather pecking can lead 

to denuded plumage and eventually to cannibalism.xxxvii,xxxviii

 Outbreaks of cannibalism 

are unpredictable, and once they begin, are very difficult to stop. Prevention is the best 

approach.

Beak trimming is commonly used as a prophylactic measure to prevent feather pecking 

and cannibalism. Beak trimming is usually effective in significantly reducing 

cannibalism and subsequent mortality,xxxix,xl although occasional outbreaks do occur in 

beak trimmed flocks. Beak trimming as a solution is not ideal though, as it is a painful 

procedure. Further, the beak tip is highly innervated and contains abundant sensory 

receptors;xli,xlii cutting off the beak tip thus impairs sensory function. Welfare can be 

improved by controlling cannibalism using alternative means. 

104
Page 23 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Dietary deficiencies have been linked to increased incidence of pecking damage,xliii

especially protein deficiencies,xliv,xlv so the first step in preventing injurious pecking is to 

ensure that the feed is nutritionally complete. However, outbreaks of feather pecking 

still often occur in flocks that are fed to their nutritional requirements. There are a 

variety of other factors involved. 

Successful control of feather pecking and cannibalism requires an integrated approach 

that includes consideration of three main factors: early-life experiences, the environment 

and genetics.xlvi

Feather pecking and cannibalism are not aggressive acts—rather, science 

demonstrates that these are foraging pecks that have been re-directed toward 

feathers.xlvii,xlviii,xlix In natural conditions, domestic fowl spend over 50% of their active 

time in foraging related activity.l,li Studies have shown that hens will choose to forage 

for feed on the ground in loose substrate rather than eat identical food freely available 

from a feeder.lii,liii

 Thus, the natural urge to forage remains strong, even when full feed 

is provided. The acquisition process itself—including seeking, investigating, and 

manipulating feed items—is nearly as important as the act of consuming the feed 

itself.liv 

Pecking preferences are formed early in life, and these are learned through 

experience.lv Therefore, providing appropriate pecking and foraging substrate from day 

onelvi,lvii is a critical factor shaping adult pecking preferences. Scientific research has 

demonstrated that early access to loose litter—such as wood shavings, sand and 

straw—is an important first step in reducing feather pecking, cannibalism and 

subsequent mortality.lviii,lix,lx, lxi,lxii,lxiii Conversely, studies also show that the absence of 

loose-litterlxiv and poor litter quality are risk factors for plumage deterioration due to 

feather pecking.lxv

 Scattering grain or feed into loose litter for young chicks can also be 

beneficial.lxvi 

Lack of perches during early rearing is another important risk factor for feather pecking 

on organic farms.lxvii Early access to perches can decrease cloacal cannibalism by 

giving potential victims a safe place to avoid hens who would peck them from the 

floor.lxviii,lxix,lxx Young birds must learn how to successfully navigate perches by gaining 

experience with them from a young age, which shapes their cognitive spatial abilities.lxxi 

Pullets should have access to perches elevated above 35 centimeters at no later than 

four weeks of age.lxxii,lxxiii

 Higher perches are generally better, lxxiv although they must be 

constructed and arranged in a way that allows easy access, or else hens can miss a 

landing, fall and become injured (see section on providing perches for laying hens in 

indoor housing below). 

Feather pecking often begins to appear in affected flocks shortly after moving pullets 

from the rearing to the laying house. When transferring pullets, there are many 

potential stressors including changes in light intensity, diet, house layout and access to 

the outdoors. Stress can be partially alleviated by matching the rearing and laying 

105
Page 24 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

environments as closely as possible.lxxv Do not change the feed or lighting program at 

the same time pullets are moved into the laying house. 

Since cannibalism is thought to have a hormonal basis, the risk of cannibalism may be 

reduced by using lighting programs that delay the age at which hens first begin to lay 

eggs to after 20 weeks of age.lxxvi

 Flocks that begin laying eggs before 20 weeks of age 

have approximately four times the risk for vent pecking as compared with flocks that 

begin laying at a later age.lxxvii 

When feather pecking outbreaks occur in adult hens, lowering the light level is a 

commonly used intervention. While somewhat effective, the problem with dimming the 

light is that, like beak trimming, the underlying cause of the problem is not addressed. 

To truly attend to the welfare issue, the natural early motivation of a hen to forage and 

peck should be channeled appropriately into desirable adult pecking behavior, as 

discussed above. 

Feed form is also important for attracting and sustaining foraging related pecks and 

regulating appetite. Studies show that a mash diet is better than pelleted feed for 

reducing feather pecking and cannibalism.lxxviii,lxxix

 The small particle form takes longer 

to consume, sustaining foraging related pecking behavior for a longer period of time as 

birds pick out individual feed particles.lxxx

 A diet high in insoluble fiber has also been 

shown to help to reduce and control cannibalism,lxxxi and millrun, oat hulls, rice hulls, 

and lucerne meal are effective sources.lxxxii Additional foraging enrichments such as 

maize, barley-pea silage, carrots,lxxxiii strawlxxxiv,lxxxv seeds in suet, and cabbage 

leaveslxxxvi have been shown to attract interest and reduce the tendency to perform 

injurious pecking. 

Most importantly, it has been repeatedly demonstrated in scientific studies that flocks 

making good use of an outdoor range area (where more foraging and exploring 

opportunities are provided for them) are significantly less likely to feather peck and 

cannibalize flock mates.lxxxvii,lxxxviii,lxxxix,xc,xci,xcii,xciii

 One study found that when at least half 

the flock was observed outdoors during good weather, there was a five-fold decrease in 

the risk of feather pecking. On these farms, it is likely that hens are directing their 

pecking behavior at appropriate foraging substrate, rather than at each other.xciv 

Therefore it is essential to provide attractive outdoor areas and encourage hens to go 

outside (see section on outdoor access below). 

If possible, time the introduction of pullets into the laying house so that they will have 

good weather when the doors are first opened to permit outdoor access. If inclement 

weather prevents them from using the range area when they are young, it may be 

difficult to encourage them out when they grow older.xcv

Other risk factors that have been associated with injurious pecking include: 

 Restricting access to portions of the indoor litter area;xcvi

 Restricting access to the outside range area;xcvii

 Changing the diet three or more times during the laying period;xcviii,xcix

106
Page 25 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 Using lights inside the nest boxes;c

 Use of bell drinkers;ci,cii

 Inadequate number of drinking places;ciii

 Reduced indoor temperature (below 68o F);civ

 Not keeping cockerels with the hen flock;cv and 

 Dietary deficiencies.cvi

Feather pecking, cannibalism, and the associated mortality have genetic components, 

which means that these traits can be selected against in breeding programs.cvii,cviii,cix,cx

 

Different hen strains vary in their propensity to exhibit injurious pecking behavior.cxi It is 

therefore critical to source hens that exhibit low levels of feather pecking behavior. 

Because breeding efforts to control cannibalism are ongoing, it is difficult to pinpoint 

lasting recommendations on specific genetic lines. If a severe outbreak occurs, 

consider using a different supplier, switch to a different hen strain, or use a different 

breed or hybrid altogether. 

For more information on managing feather pecking without beak trimming see: 

―A guide to the practical management of feather pecking & cannibalism in free range 

laying hens‖ at: 

www.defra.gov.uk/publications/files/pb10596-feather-pecking-050309.pdf

Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, 

Poultry Science Symposium Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-

58). 

Indoor Living Conditions 

Housing must protect birds from the elements, maintain a comfortable temperature, 

provide ventilation and allow birds to exercise and conduct natural behavior. Cages are 

not permitted. Bedding indoors provides comfort, insulation, and pecking and 

scratching opportunity. However, it must be maintained in clean, dry condition. Slattedfloor systems are useful under watering areas to prevent wet litter. 

The indoor climate must be modulated for light, temperature, and air quality to provide a 

comfortable environment for the birds. Lighting should provide for an 8 hour rest period 

daily. Indoor temperatures must not be so warm that birds pant or so cold that they 

huddle together. Ventilation must be adequate to prevent the buildup of ammonia. 

Ammonia levels should generally be less than 10 ppm. Ammonia level testing must be 

documented and ammonia levels must be at or below 25ppm. General levels can be 

tested using ammonia test strips and if excessive ammonia is noted a second test using 

passive dosimeter or gas detection tubes should be conducted. Dust should also be 

kept to a minimum. 

107
Page 26 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Layers should be provided with nest boxes—at least one box per 5 birds is 

recommended. If community nest boxes are provided, there should be at least 9 square 

feet of nesting space for every 100 hens. 

Laying hens must also be provided with perches—at least 6 inches of elevated perch 

space per hen is suggested. There must be enough perch and/or flat roost space for all 

hens to simultaneously rest off of the floor at night. Turkeys can be provided with 

elevated platforms and ramps in addition to or instead of perches.cxii

Poultry must be provided with dustbathing areas. Preferred substrates include sand, 

wood shavings and peat. On outdoor range areas, chickens usually create their own 

preferred dustbathing locations in loose, dry dirt. Dustbathing balances oil levels in the 

feathers,cxiii,cxiv,cxv and helps keep the plumage in good condition. 

Ducks should have access to water for bathing and head dunking in addition to water 

for drinking. Water related activity is part of the natural behavior of waterfowl. At a 

minimum, ducks should be able to dip their heads and splash their feathers with water. 

This behavior will help keep their nostrils, eyes and feathers clean.cxvi,cxvii

 Troughs are 

often used to provide an open water source and these can be situated on grids or slats 

over a drainage channel to prevent adjacent litter from becoming wet. Nipple drinkers 

do not permit ducks to wet their eyes or feathers, and can lead to poor eye and plumage 

cleanliness.cxviii Open water sources should be cleaned daily. 

Additional producer guidance on providing perches for laying hens in indoor housing 

Perches are an important enrichment in indoor housing for laying hens. The foot of a 

hen is anatomically adapted to close around a perch,cxix,cxx and this is the natural resting 

position for chickens. Perch use maintains bone volume and bone strength,cxxi,cxxii,cxxiii

and can serve as a refuge for subordinate hens to avoid aggressive interactions with 

more dominant hens.cxxiv

 Research demonstrates that hens are highly motivated to 

perch at night.cxxv,cxxvi,cxxvii When given a choice, hens often prefer to roost on higher 

perches as opposed to those that are closer to the floor.cxxviii,cxxix

 

Bumblefoot is a bulbous swelling of the footpad caused by a localized infection.cxxx 

Some hen breeds are more susceptible than others, and the condition is associated 

with poor hygiene and poor perch design.cxxxi,cxxxii

 The use of plastic perches or the 

commonly used soft wooden perches measuring 25 mm (0.98 in) in width are thought to 

contribute to poor foot health, as manure and moisture are able to accumulate on the 

structure’s top where the birds’ feet rest.cxxxiii

 Incidence of bumblefoot can be reduced 

by providing hens with hardwood perches that are approximately 1.5 inches in diameter 

with a flattened topcxxxiv,cxxxv and by limiting walking exposure to mud and manure.cxxxvi

Hens selected for egg production are prone to osteoporosis and subsequent bone 

fractures.cxxxvii,cxxxviii,cxxxix These often go undetected unless hens are palpated by an 

experienced veterinarian. The way perches are arranged inside the poultry house can 

have an effect on the incidence of bone fractures. Research suggests that the upper 

limit on a hen’s ability to jump from one perch to another is about three feet,cxl and 

108
Page 27 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

angles greater than approximately 45o can be difficult to navigate.cxli At a minimum, 

hens need approximately 6 inches of perch space to take-off, and 6-9 inches to land.cxlii 

Perches should be large enough for hens to maintain stable footing, about 1.5 inches in 

diameter.cxliii,cxliv These general requirements may differ depending on the size and 

previous experience of the hen, so adjustments may be necessary for individual flocks. 

Injuries are more likely to occur if perch design and layout require hens to jump beyond 

their natural capabilities.cxlv

Providing perches at a young age can also help reduce the risk of floor eggs,cxlvi as 

pullets must be skilled at flying up and down in order to access elevated nest boxes.cxlvii

Outdoor Access and Living Conditions 

Outdoor access must be provided to all poultry, with the following exceptions: 

 Pullets younger than 12 weeks of age. 

 Broiler chickens younger than 4 weeks of age. 

 Outdoor temperatures below 50oF. 

 Other inclement weather such as heavy snow, sleet, rain, wind or extreme heat that 

would endanger the health or welfare of the animals. 

Pullets must be provided outdoor access by 12 

weeks of age, when weather permits. As a 

guide, doors for outdoor access should be at 

least 14 inches high, spaced uniformly and 

provide direct access to the outdoors. Total 

door opening should be at least 6 feet/1000 

birds.cxlviii Once layers are accustomed to going 

outdoors, a brief confinement period of no 

more than 5 weeks to allow for nest box 

training is permitted. Broiler chickens must be 

provided outdoor access by 4 weeks of age, 

provided that they are fully feathered and 

weather permits. 

Enclosed spaces that have a solid roof overhead (sometimes called ―porches‖ or ―winter 

gardens‖) do not meet the definition of outdoor access and cannot be included in the 

space calculation of outdoor access. 

Additional producer guidance on outdoor access 

Outdoor areas for poultry should be fully vegetated, where possible. Grasses, legumes, 

and other forage provide interest and enrichment to poultry, who consume not only 

greens, but also insects, grubs, and seeds. However, high traffic areas tend to become 

denuded of vegetation, so steps must be taken to keep outdoor areas in good condition. 

Rotate the use of range areas by taking flocks off of pasture to prevent the buildup of 

infectious organisms and allow the re-growth of vegetation. Fields can also be rotated 

109
Page 28 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

between species with different parasite spectrums, such as cattle and poultry. 

Harvested crop fields also make good poultry runs. 

Layout is important for attracting hens to use outdoor space. There should be plenty of 

exits from the hen house, and they should be easily accessible and large enough for 

several hens to pass through simultaneously. Since hens are prey animals, they are 

naturally wary of overhead predators, and will sometimes avoid open range if some sort 

of cover is not provided. Cover, either artificial or natural structures, should therefore be 

provided.cxlix Natural cover can take many forms, including tall plantings of vegetation, 

bushes, and trees,cl however, large swaths of thick undergrowth can actually attract 

ground predators if fences don’t exclude them. Maize plantings and low pollard willows 

(Salix), for example, have worked on organic farms to attract hens outdoors.cli

 In ―treerange‖ production, the outdoor area is planted with short trees, such as orchard 

varieties. Flocks with canopy cover from trees are more likely to have better plumage 

condition at the end of lay than those without canopy cover.clii 

Artificial structures that provide shelter, shade, 

and security can also be constructed.cliii,cliv Cover 

made from a wide variety of wood, plastic or 

recycled materials, in designs both low to the 

ground and high enough to include perches, 

have been innovated by producers with success. 

Camouflage nets are another option.clv

 If 

artificial cover is portable, it can be moved to 

different range areas to encourage more even 

distribution of the flock, preventing buildup of 

contamination over highly frequented areas. 

For more information see: Fanatico, A. 2006. Alternative poultry production systems 

and outdoor access. Available through the National Sustainable Agriculture Information 

Service at: www.attra.ncat.org 

Space Allowances 

Poultry housing must be sufficiently spacious to allow all birds to move freely, stretch 

their wings and engage in natural behavior. Perching areas and nest boxes may not be 

used in the calculation of floor space. Slatted/grated floors may be considered floor 

space. Mobile poultry units require the same amount of indoor space per bird but allow 

the house to be moved so birds always have access to fresh vegetation. 

110
Page 29 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Livestock Species Indoor Space Outdoor Runs and 

Pens 

Chickens

Laying hens and 

breeders

1.5 sq ft / bird 2.0 sq ft / bird

 

Pullets 5 lbs / sq ft 5 lbs / sq ft

Broilers 5 lbs / sq ft 5 lbs / sq ft

Other poultry

Turkeys and 

Geese—breeding, 

laying, or meat birds 

(pounds)

7.5 lbs / sq ft 2lbs / sq ft

 

Ducks-meat 5 lbs / sq ft 2 lbs / sq ft

Ducks-laying hen 2 lbs / sq ft 1 lbs / sq ft

Ducks—breeder 3.3 lbs / sq ft 1 lbs / sq ft

Humane Handling of Poultry 

Poultry should be handled quietly and firmly, with care taken to avoid unnecessary 

distress and dislocated or broken bones during catching and loading for transport. 

Poultry catching should be scheduled to minimize the time to slaughter as well as 

climatic stress during catching, transport and holding. Birds should not be picked up by 

the neck or wings. 

Transport is a stressful experience,clvi,clvii as birds are subjected to noise, vibration, 

motion, overcrowding, feed and water deprivation, social disruption, and potential 

temperature extremes.clviii,clix,clx Aim to reduce these stressors and comfort the birds 

wherever possible. Transportation units should provide space enough that all birds can 

lie down at the same time and none are on top of each other. Birds must be protected 

from heat and cold. Delivery of poultry for slaughter should be scheduled such that they 

are not deprived of water for longer than 12 hours. 

Birds must be fit for transport before being loaded for slaughter. Due to the stress 

involved, animals must be healthy enough to withstand the rigors of the journey. Birds 

exhibiting obvious signs of poor health, weakness or injury are not fit for transport. 

These birds should be euthanized using the most humane method available. 

Inspectors should discuss procedures for poultry catching and loading with the producer 

and must observe poultry being caught and loaded for slaughter at the annual 

inspection and note percentage of birds with broken/dislocated legs/wings. 

Additional producer guidance on humane handling of poultry 

Low-stress handling is as important for poultry as it is for livestock. Although commonly 

carried this way, research shows that birds react with a significant stress response 

when picked up and held upside-down by the legs, as this is a physiologically abnormal 

111
Page 30 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

posture for chickens.clxi Handling, crating and loading for transportation, have been 

identified by researchers as major sources of stress and trauma.clxii Bruising and injuries 

are well-documented, and these are not only welfare problems, but can also result in 

carcass downgrading and economic loss to producers.clxiii, clxiv,clxv,clxvi,clxvii Ideally, all 

poultry should be handled individually, upright, and carried gently using two hands.

Catching and carrying turkeys can also cause bruises and injuries. Turkeys can be 

driven or herded into transport crates instead, which reduces stress levels.clxviii

Euthanasia and Depopulation 

Individual birds who are ill or injured, are suffering, and are unlikely to recover, should 

be euthanized without delay. All euthanized and depopulated birds must be confirmed 

dead before disposal. No live birds should be found on dead piles. 

Permitted methods include: 

 Hand held electrical or percussive stunning using an instrument designed for the 

specific size/age of the species, followed by neck cutting; 

 Cervical dislocation by stretching the neck to sever the spinal cord and cause 

extensive damage to the major blood vessels. 

 Barbiturate overdose administered by a licensed veterinarian (with special 

considerations noted below) 

 Decapitation 

 Carbon dioxide or a mixture of nitrogen and argon gases, delivered in an appropriate 

container at acceptable concentrations. 

Acceptable gas mixtures include: 

 a minimum of 2 minutes exposure to any mixture of argon, nitrogen or other inert 

gases with atmospheric air and carbon dioxide, provided that the carbon dioxide 

concentration does not exceed 30 percent by volume and the residual oxygen 

concentration does not exceed 2 percent by volume; or 

 a minimum of 2 minutes exposure to argon, nitrogen, other inert gases or any mixture 

of these gases in atmospheric air with a maximum of 2 percent residual oxygen by 

volume. 

Methods that are not permitted include, but are not limited to: 

 Suffocation 

 Blow to the head by blunt instrument 

 Equipment that crushes the neck including killing pliers or burdizzo clamps 

 Carbon monoxide 

 Neck wringing (holding the head while swinging the body in a circular motion) 

 Maceration in a wood chipper 

112
Page 31 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Additional producer guidance on euthanasia and depopulation 

The term euthanasia is derived from Greek words meaning ―good death‖ and is applied 

to the killing of an animal with minimal pain and distress.clxix Animals that are suffering 

must be euthanized in a timely manner, and should not be left for extensive periods, 

over a weekend, for example. 

Barbiturate injection or inhalant anesthetics administered by a veterinarian are the ideal 

methods for a limited numbers of hens, as they most closely meet the goals of killing 

with minimal pain and distress. However, these methods have not been widely used on 

farm settings due to cost and convince issues associated with culling large numbers of 

birds. Producers should also be aware that drug residues associated with the use of 

barbiturate injections will prevent the use of carcasses for human consumption, and 

dead birds must be disposed of carefully, because residues could also be unwittingly 

consumed by other animals eating the carcass or could become an environmental 

pollutant. Dead poultry should be disposed of in a way that does not attract wildlife. 

Research demonstrates that inhalation of an inert gas (including argon and nitrogen) is 

probably painless, as they are colorless, odorless gases and birds do not demonstrate 

aversive reactions with initial exposure. In carefully controlled behavior experiments, 

turkeys and chickens are willing to enter a chamber filled with inert gas in order to 

access food.clxx,clxxi

 Argon and nitrogen can be used to kill chickens on the farm. 

Containerized gas killing systems have been developed for culling large numbers of 

birds,clxxii and these can be built on either a large or small scale, depending on the 

needs of individual producers. Such a system is the most humane method for killing 

large numbers of chickens on the farm that researchers have identified to date. 

The use of CO2 is problematic as there are both physiological and behavioral lines of 

scientific evidence suggesting that CO2 may be unpleasant and possibly very 

distressing to inhale, as it is an acidic gas, pungent at high concentrations.clxxiii,clxxiv

 

Exhaust fumes from an idling car engine are an unacceptable source of carbon 

monoxide, due to problems with production of other gases, inadequate gas 

concentration, and gas temperature. 

While purpose-build macerators are sometimes used to kill unwanted chicks at 

hatcheries, using a wood chipper to dispose of a spent laying-hen flock is never 

acceptable. 

It is extremely important to confirm that all animals are dead before disposal. When 

depopulation is performed on large flocks, depending on the methods used, it can be 

difficult to ensure that birds are actually dead and not simply lying still or unconscious. 

There is a very high potential for birds that are not dead, but are severely injured, to 

suffer greatly. Each bird must be methodically checked, and dead piles must be 

examined carefully for any sign of movement. A backup method of euthanasia must be 

in place to kill any birds that recover. Careful attention to this step in the euthanasia 

process is essential to ensuring a humane end for farmed poultry. 

113
Page 32 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Slaughter of Poultry 

All slaughter facilities must be audited yearly. Organic certifiers can use documentation 

from other third-party animal welfare audits that have been performed and should do 

additional auditing as necessary. 

Slaughter establishments must also perform self-audits on a weekly basis. Self-audits 

ensure that animal welfare standards are being upheld, identify problems that may arise 

within the facility or with individual staff members, and identify specific farms that may 

be shipping problematic animals to the slaughter plant. These problems may be due to 

animals’ genetics or handling; slaughter facilities are encouraged to contact the 

producers of problematic animals so that these problems can be addressed in the 

future. 

In electrical water-bath stunning systems, birds must be shackled by both legs. Birds 

with broken or dislocated wings should be humanely killed before being shackled. 

Stunning 

Poultry must be rendered unconscious by stunning, or killed before being bled by 

simultaneous severance of both carotid arteries or by decapitation. Bleeding without 

stunning requires a high level of operator competency to avoid causing pain and 

missing cutting of both carotid arteries. A very sharp blade or knife of sufficient length is 

needed so that the point of the knife remains outside the incision during the cut; the 

point of the knife should not be used to make the incision. The incision should not close 

over the knife during the throat cut. Decapitation may be achieved by manual or 

automatic means. 

Decapitation must be performed using a sharp instrument which achieves the complete 

severance of the head from the body by cutting all the major vessels of the neck and the 

spinal cord with a sharp instrument. All mechanical and automatic instruments used in 

this method shall be sharp and inspected frequently for sharpness. The poultry 

slaughter establishment shall ensure that all instruments and equipment are maintained 

so that they function effectively. All birds (100%) should be dead before they enter the 

scald tank. 

For inspector assessment, 99% of the birds must be rendered insensible by the 

stunning method chosen. Arched neck and wings tucked in are visible signs of effective 

stunning. 

Additional producer/processor guidance on stunning for slaughter 

Electric stunning: The disadvantage of electric stunning for poultry is that birds must be 

shackled and hung upside-down before they enter the stunner. Care must be taken to 

avoid pre-stun electrical shocks. Amperage must be high enough that birds lose 

consciousness and are not merely paralyzed. The electric current shall be administered 

so as to produce effective surgical anesthesia or death with a minimum of excitement 

and discomfort. The current necessary to produce an effective stun changes depending 

114
Page 33 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

the species and electrical frequency. These are outlined in the World Organization for 

Animal Health, Terrestrial Animal Health Guide, Chapter 7.5, Slaughter of animals 

(available at: www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.7.5.htm), and the 

minimum currents are as follows: 

 Broiler chickens and spent laying hens, 100 milliamperes per bird 

 Turkeys, 150 milliamperes per bird 

 Ducks and geese, 130 milliamperes per bird 

For high frequency settings of 200-400 Hz, the minimum current needed to stun 

chickens is 150 milliamperes. For frequency settings of 400-1500 Hz, the minimum 

current is 200 milliamperes. For turkeys, frequency settings of 200-1500 Hz require a 

400 milliampere currency setting. 

These are minimal settings, and higher current levels better ensure that more birds will 

be effectively rendered unconscious.clxxv

 

Gas stunning: Acceptable gas mixtures include argon, nitrogen, and low initial levels of 

CO2 in one of the following combinations, as described by the World Organization for 

Animal Health: 

 a minimum of 2 minutes exposure to 40 percent carbon dioxide, 30 percent oxygen 

and 30 percent nitrogen, followed by a minimum of one minute exposure to 80 percent 

carbon dioxide in air; or 

 a minimum of 2 minutes exposure to any mixture of argon, nitrogen or other inert 

gases with atmospheric air and carbon dioxide, provided that the carbon dioxide 

concentration does not exceed 30 percent by volume and the residual oxygen 

concentration does not exceed 2 percent by volume; or 

 a minimum of 2 minutes exposure to argon, nitrogen, other inert gases or any mixture 

of these gases in atmospheric air with a maximum of 2 percent residual oxygen by 

volume. 

To avoid unnecessary stress and trauma due to handling, chickens should remain in 

their transport crates while being conveyed through the gas tunnels. Gas 

concentrations must be monitored for precision at all times. An alarm system is 

necessary to indicate malfunctions. 

Bleeding 

Once stunned, birds should be bled without delay to ensure that consciousness is not 

regained. Bleeding shall be accomplished by severing both carotid arteries or by 

decapitation. Sufficient bleeding time (at lest 30 seconds, 60 seconds for gas stunning, 

and approximately 2 to 3 minutes for electric stunning resulting in cardiac arrest) shall 

be allowed to prevent the unacceptable condition known as ―red skins‖ or ―cadavers‖

which may occur with insufficient bleeding. For inspector assessment, 99% must be 

115
Page 34 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

effectively cut by hand or by the bleed machine. Remaining birds must be cut by a 

backup person. 

The inspector will monitor condition of carcasses exiting the scald tank. Birds exiting 

the scald tank should not show signs that they entered it alive. ―Red skins‖ with uncut 

throats indicate that they entered the scalding water alive, and those with cut throats 

could possibly have entered before becoming unconscious. 

For poultry, the percentage of chickens with broken or dislocated wings should not 

exceed 2%, with zero being the goal. No broken legs should be noted. 

 

i

 Dennis RL, Fahey AG, and Cheng HW. 2009. Infrared beak treatment method compared with conventional hotblade trimming in laying hens. Poultry Science 88:38-43.

ii Garner JP, Falcone C, Wakenell P, Martin M and Mench JA. 2002. Reliability and validity of a modified gait 

scoring system and its use in assessing tibial dyschondroplasia in broilers. British Poultry Science 43:355-63.

iii Kestin SC, Knowles TG, Tinch AE, and Gregory. 1992. Prevalence of leg weakness in broiler chickens and its 

relationship with genotype. The Veterinary Record 131:190-4.

iv Mench J. 2004. Lameness. In: Weeks C and Butterworth A (ed.s), Measuring and Auditing Broiler Welfare 

(Walingford, U.K.: CABI Publishing, pp.3-17). 

v

 Knowles TG, Kestin SC, Haslam SM, Brown SN, Green LE, Butterworth A, Pope SJ, Pfeiffer D, and Nicol CJ. 

2008. Leg Disorders in Broiler Chickens: Prevalence, Risk 

Factors and Prevention. PLoS ONE 3(2):e1545. doi:10.1371/journal.pone.0001545. 

vi Danbury TC, Weeks CA, Chambers JP, Waterman-Pearson AR, and Kestin SC. 2000. Self selection of the 

analgesic drug carprofen by lame broiler chickens. The Veterinary Record 146:307-11.

vii McGeown D, Danbury TC, Waterman-Pearson AE, and Kestin SC. 1999. Effect of carprofen on lameness in 

broiler chickens. Veterinary Record 144: 668-71.

viii Bessei W. 2006. Welfare of broilers: a review. World’s Poultry Science Journal 62:455-66.

ix Berg C. 2004. Pododermatitis and hock burn in broiler chickens. In: Weeks C and Butterworth A (ed.s), 

Measuring and Auditing Broiler Welfare (Walingford, U.K.: CABI Publishing, pp.37-49). 

x

 Jones TA and Dawkins MS. 2010. Environment and management factors affecting Pekin duck production and 

welfare on commercial farms in the UK. British Poultry Science 51(1):12-21.

xi Kamyab A. 1997. Studies on the etiology of enlarged sternal bursa and focal ulcerative dermatitis on market tom 

turkeys. Ph.D. Dissertation, University of Minnesota, pp. 1, 33-43, 50. 

xii Cook ME. 2000. Skeletal deformities and their causes: introduction. Poultry Science 79:982-4.

xiii Bessei W. 2006. Welfare of broilers: a review. World’s Poultry Science Journal 62:455-66.

xiv Kestin SC, Su G, and Sorensen P. 1999. Different commercial broiler crosses have different susceptibilities to leg 

weakness. Poultry Science 78:1085-90.

xv Van Middelkoop K, van Harn J, Wiers WJ, and van Horne P. 2002. Slower growing broilers pose lower welfare 

risks. World Poultry 18(8):20-1.

xvi Knowles TG, Kestin SC, Haslam SM, Brown SN, Green LE, Butterworth A, Pope SJ, Pfeiffer D, and Nicol CJ. 

2008. Leg Disorders in Broiler Chickens: Prevalence, Risk 

Factors and Prevention. PLoS ONE 3(2):e1545. doi:10.1371/journal.pone.0001545. 

xvii Knowles TG, Kestin SC, Haslam SM, Brown SN, Green LE, Butterworth A, Pope SJ, Pfeiffer D, and Nicol CJ. 

2008. Leg Disorders in Broiler Chickens: Prevalence, Risk 

Factors and Prevention. PLoS ONE 3(2):e1545. doi:10.1371/journal.pone.0001545. 

xviii Dawkins MS, Donnelly CA and Jones TA. 2004. Chicken welfare is influenced more by housing conditions than 

by stocking density. Nature 427:342-4.

xix Bessei W. 2006. Welfare of broilers: a review. World’s Poultry Science Journal 62:455-66.

xx Berg C. 2004. Pododermatitis and hock burn in broiler chickens. In: Weeks C and Butterworth A (ed.s), 

Measuring and Auditing Broiler Welfare (Walingford, U.K.: CABI Publishing, pp.37-49). 

xxi Bessei W. 2006. Welfare of broilers: a review. World’s Poultry Science Journal 62:455-66.

116
Page 35 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

xxii Berg C. 2004. Pododermatitis and hock burn in broiler chickens. In: Weeks C and Butterworth A (ed.s), 

Measuring and Auditing Broiler Welfare (Walingford, U.K.: CABI Publishing, pp.37-49). 

xxiii Pagazaurtundua A and Warriss PD. 2006. Levels of foot pad dermatitis in broiler chickens reared in 5 different 

systems. British Poultry Science 47(5):529-32.

xxiv Berg C. 2004. Pododermatitis and hock burn in broiler chickens. In: Weeks C and Butterworth A (ed.s), 

Measuring and Auditing Broiler Welfare (Walingford, U.K.: CABI Publishing, pp.37-49). 

xxv Jones TA and Dawkins MS. 2010. Environment and management factors affecting Pekin duck production and 

welfare on commercial farms in the UK. British Poultry Science 51(1):12-21.

xxvi Berg C. 2004. Pododermatitis and hock burn in broiler chickens. In: Weeks C and Butterworth A (ed.s), 

Measuring and Auditing Broiler Welfare (Walingford, U.K.: CABI Publishing, pp.37-49). 

xxvii European Food Safety Authority, Animal Health and Animal Welfare. 2005. Scientific report on the welfare 

aspects of various systems for keeping laying hens. EFSA-Q-2003-92, p. 27. Annex to The EFSA Journal 197, 1-23. 

www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_scirep_final1.pdf. 

xxviii Scientific Panel on Animal Health and Welfare. 2005. Opinion of the Scientific Panel on Animal Health and 

Welfare on a request from the Commission related to the welfare aspects of various systems of keeping laying hens. 

The EFSA Journal 197:1-23. www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_opinion1.pdf. 

xxix Hane M, Huber-Eicher B, and Frohlich E. 2000. Survey of laying hen husbandry in Switzerland. World’s Poultry 

Science Journal 56:21-31.

xxx Fanatico A. 2006. Parasite Management for Natural and Organic Poultry: Coccidiosis. National Sustainable 

Agriculture Information Service. http://attra.ncat.org/attra-pub/PDF/coccidiosis.pdf. 

xxxi Hy-Line®. 2007-2008. W-36 commercial management guide. www.hy-line.com/userdocs/library/W36_Eng_indd.pdf. 

xxxii McDougald LR. 2003. Internal parasites. In: Saif YM, Barnes HJ, Gilsson JR, Fadly AM, McDougald LR, and 

Swayne DE (eds.), Diseases of Poultry, 11th Edition (Ames, IA: Iowa State Press, p. 943). 

xxxiii Bassler A, Ciszuk P, Sjelin K: Management of laying hens in mobile houses – a review of experiences. 1999. 

In: Hermansen JE, Lund V, and Thuen E (eds.), Proceedings NJF-seminar No 303, Ecological Animal Husbandry in 

the Nordic Countries (Horsens, Denmark: Danish Research Center for Organic Farming, pp. 45-50). 

www.foejo.dk/publikation/rapport/dar_2.pdf. 

xxxiv Fanatico A. 2006. Alternative poultry production systems and outdoor access. National Sustainable Agriculture 

Information Service. http://attra.ncat.org/attra-pub/PDF/poultryoverview.pdf. 

xxxv Thear K. 2002. Free-Range Poultry Production (Suffolk, U.K.: Whittet Books Ltd., pp. 70-2). 

xxxvi Fanatico A. 2006. Alternative poultry production systems and outdoor access. National Sustainable Agriculture 

Information Service. www.attra.ncat.org/attra-pub/PDF/poultryoverview.pdf. 

xxxvii Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

xxxviii Rodenburg TB, Komen H, Ellen ED, Uitdehaag KA, van Arendonk JAM. 2008. Selection method and earlylife history affect behavioural development, feather pecking and cannibalism in laying hens: A review. Applied 

Animal Behaviour Science 110:217-28.

xxxix Hartini S, Choct M, Hinch G, Kocher A, and Nolan JV. 2002. Effects of light intensity during 

rearing and beak trimming and dietary fiber sources on mortality, egg production, and performance of ISA brown 

laying hens. Journal of Applied Poultry Research 11:104-10.

xl Lambton SL, Knowles TG, Yorke C, and Nicol CJ. 2010. The risk factors affecting the development of gentle and 

severe feather pecking in loose housed laying hens. Applied Animal Behaviour Science 123(1):32-42.

xli Cheng H. 2006. Morphopathological changes and pain in beak trimmed laying hens. World’s Poultry Science 

Journal 62(1):41-52.

xlii Lunam CA. 2005. The anatomy and innervation of the chicken beak: effects of trimming and re-trimming. In: 

Glatz PC (ed.), Poultry Welfare Issues: Beak Trimming (Nottingham, U.K.: Nottingham University Press, pp.51-

68). 

xliii Hughes BO and Duncan IJH. 1972. The influence of strain and environmental factors upon feather pecking and 

cannibalism in fowls. British Poultry Science 13:525-47.

xliv Ambrosen T and Petersen VE. 1997. The influence of protein level in the diet on cannibalism and quality of 

plumage of layers. Poultry Science 76:559-63.

117
Page 36 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

xlv Van Krimpen MM, Kwakkel RP, Reuvekamp BFJ, Van der Peet-Schwering CMC, Den Hartog LA, and 

Verstegen MWA. 2005. Impact of feeding management on feather pecking in laying hens. World’s Poultry Science 

Journal 61:663-86.

xlvi Rodenburg TB, Komen H, Ellen ED, Uitdehaag KA, van Arendonk JAM. 2008. Selection method and early-life 

history affect behavioural development, feather pecking and cannibalism in laying hens: A review. Applied Animal 

Behaviour Science 110:217-28.

xlvii Dixon LM, Mason GJ, and Duncan IJH. 2007. What’s in a peck? A comparison of the motor patterns involved in 

feather pecking, dustbathing and foraging. In: Galindo F and Alvarez L (eds.), Proceedings of the 41st International 

Congress of the ISAE (Merida, Mexico: International Society for Applied Ethology, p.47). 

xlviii Huber-Eicher B and Wechsler B. 1997. Feather pecking in domestic chicks: its relation to dustbathing and 

foraging. Animal Behaviour 54:757-68.

xlix Blokhuis HJ. 1986. Feather-pecking in poultry: its relation with ground-pecking. Applied Animal Behaviour 

Science:16:63-7.

l

 Savory CJ, Wood-Gush DGM, and Duncan IJH. 1978. Feeding behaviour in a population of domestic fowls in the 

wild. Applied Animal Ethology 4:13-27.

li Dawkins MS. 1989. Time budgets in Red Junglefowl as a baseline for the assessment of welfare in domestic fowl. 

Applied Animal Behaviour Science 24:77-80.

lii Dawkins MS. 1989. Time budgets in Red Junglefowl as a baseline for the assessment of welfare in domestic fowl. 

Applied Animal Behaviour Science 24:77-80.

liii Duncan IJH and Hughes BO. 1972. Free and operant feeding in domestic fowls. Animal Behaviour 20:775-7.

liv Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

lv Rogers L. 1995. The Development of Brain and Behaviour in the Chicken (Wallingford, U.K.: CAB International, 

pp. 95-110). 

lvi Rogers L. 1995. The Development of Brain and Behaviour in the Chicken (Wallingford, U.K.: CAB International, 

pp. 95-110). 

lvii Huber-Eicher B and Sebö F. 2001. Reducing feather pecking when raising laying hen chicks in aviary systems. 

Applied Animal Behaviour Science 73:59-68.

lviii Johnsen PF, Vestergaard KS, Nørgaard-Nielsen G.1998. Influence of early rearing conditions of the development 

of feather pecking and cannibalism in domestic fowl. Applied Animal Behaviour Science 60:25-41.

lix Huber-Eicher B and Sebö F. 2001. Reducing feather pecking when raising laying hen chicks in aviary systems. 

Applied Animal Behaviour Science 73:59-68.

lx Aerni V, Brinkhof MWG, Wechsler B, Oester H, and Fröhlich E. 2005. Productivity and mortality of laying hens 

in aviaries: a systematic review. World’s Poultry Science Journal 61(1):130-42.

lxi Johnsen PF, Vestergaard KS, and Nørgaard-Nielsen G. 1998. Influence of early rearing conditions on the 

development of feather pecking and cannibalism in domestic fowl. Applied Animal Behaviour Science 60:25-41.

lxii Nicol CJ, Lindberg AC, Phillips AJ, Pope SJ, Wilkins LJ, and Green LE. 2001. Influence of prior exposure to 

wood shavings on feather pecking, dustbathing and foraging in adult laying hens. Applied Animal Behaviour 

Science 73:141-55.

lxiii Huber-Eicher B and Sebö F. 2001. Reducing feather pecking when raising laying hen chicks in aviary systems. 

Applied Animal Behaviour Science 73:59-68.

lxiv Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking 

in laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-

8.

lxv Knierim U, Staack M, Gruber B, Keppler C, Zaludik K, and Niebuhr K. 2008. Risk factors for feather pecking in 

organic laying hens –starting points for prevention in the housing environment. 16th IFOAM Organic World 

Congress, Modena, Italy, June 16-20.

lxvi Knierim U, Staack M, Gruber B, Keppler C, Zaludik K, and Niebuhr K. 2008. Risk factors for feather pecking in 

organic laying hens –starting points for prevention in the housing environment. 16th IFOAM Organic World 

Congress, Modena, Italy, June 16-20.

lxvii Knierim U, Staack M, Gruber B, Keppler C, Zaludik K, and Niebuhr K. 2008. Risk factors for feather pecking in 

organic laying hens –starting points for prevention in the housing environment. 16th IFOAM Organic World 

Congress, Modena, Italy, June 16-20.

118
Page 37 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

lxviii Gunnarsson S, Keeling LJ, Svedberg J. 1999. Effect of rearing factors on the prevalence of floor eggs, cloacal 

cannibalism and feather pecking in commercial flocks of loose housed laying hens. British Poultry Science 40:12-8.

lxix Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

lxx Huber-Eicher and Audigé. 1999. Analysis of risk factors for the occurrence of feather pecking in laying hen 

growers. British Poultry Science 40:599-604.

lxxi Gunnarsson S, Yngvesson J, Keeling LJ, and Forkman B. 2000. Rearing without early access to perches impairs 

the spatial skills of laying hens. Applied Animal Behaviour Science 67:217-28.

lxxii Gunnarsson S, Keeling LJ, Svedberg J. 1999. Effect of rearing factors on the prevalence of floor eggs, cloacal 

cannibalism and feather pecking in commercial flocks of loose housed laying hens. British Poultry Science 40:12-8.

lxxiii Huber-Eicher and Audigé. 1999. Analysis of risk factors for the occurrence of feather pecking in laying hen 

growers. British Poultry Science 40:599-604.

lxxiv Wechsler B and Huber-Eicher B. 1998. The effect of foraging material and perch height on 

feather pecking and feather damage in laying hens. Applied Animal Behaviour Science 58:131-41.

lxxv Bright A. 2009. Time course of plumage damage in commercial layers. Veterinary Record 164:334-5.

lxxvi Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

lxxvii Pötzsch CJ, Lewis K, Nicol CJ, and Green LE. 2001. A cross-sectional study of the prevalence of vent pecking 

in laying hens in alternative systems and its associations with feather pecking, management and disease. Applied 

Animal Behaviour Science 74:259-72.

lxxviii Aerni V, El-Lethey H And Wechsler B. 2000. Effect of foraging material and food form on feather pecking in 

laying hens. British Poultry Science 41:16-21.

lxxix Lambton SL, Knowles TG, Yorke C, and Nicol CJ. 2010. The risk factors affecting the development of gentle 

and severe feather pecking in loose housed laying hens. Applied Animal Behaviour Science 123(1):32-42. 

lxxx Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

lxxxi Hartini S, Choct M, Hinch G, Kocher A, and Nolan JV. 2002. Effects of light intensity during rearing and beak 

trimming and dietary fiber sources on mortality, egg production, and performance of ISA brown laying hens. Journal 

of Applied Poultry Research 11:104-10.

lxxxii Choct M and Hartini S. 2005. Interaction between nutrition and cannibalism in laying hens. In: Glatz PC (ed.), 

Poultry Welfare Issues: Beak Trimming (Nottingham, U.K.: Nottingham University Press, pp.111-5). 

lxxxiii Steenfeldt S, Kjaer JB, and Engberg RM. 2007. Effect of feeding silages or carrots as supplements to laying 

hens on production performance, nutrient digestibility, gut structure, gut microflora and feather pecking behaviour. 

British Poultry Science 48(4):454-68.

lxxxiv Nørgaard-Nielsen G, Vestergaard K, and Simonsen HB. 1993. Effects of rearing experience and stimulus 

enrichment on feather damage in laying hens. Applied Animal Behaviour Science 38:345-52.

lxxxv Martrenchar A, Huonnic D, and Cotte JP. 2003. Influence of environmental enrichment on injurious pecking 

and perching behaviour in young turkeys. British Poultry Science 42:161-70.

lxxxvi Dixon LM, Duncan IJH, and Mason GJ. 2010. The effects of four types of enrichment on feather-pecking 

behaviour in laying hens housed in barren environments. Animal Welfare 19:429-35.

lxxxvii Nicol CJ, Pötzsch C, Lewis K, and Green LE. 2003. Matched concurrent case-control study of risk factors for 

feather pecking in hens on free-range commercial farms in the UK. British Poultry Science 44:515-23.

lxxxviii Bestman MWP. 2001. The role of management and housing in the prevention of feather pecking in laying 

hens. In: Hovi M and Bouilhol M (eds.), Human-Animal Relationship: Stockmanship and Housing in Organic 

Livestock Systems. Proceedings of the Third NAHWOA Workshop (Clermont-Ferrand, France: Network for 

Animal Health and Welfare in Organic Agriculture, University of Reading, pp.77-86). 

www.veeru.rdg.ac.uk/organic/ProceedingsFINAL.pdf. 

lxxxix Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking 

in laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-

8.

xc Lambton SL, Knowles TG, Yorke C, and Nicol CJ. 2010. The risk factors affecting the development of gentle and 

severe feather pecking in loose housed laying hens. Applied Animal Behaviour Science 123(1):32-42.

xci Nicol CJ, Pötzsch C, Lewis K and Green LE. 2003. Matched concurrent case-control study of risk factors for 

feather pecking in hens on free-range commercial farms in the UK. British Poultry Science 44(4):515-23. 

119
Page 38 of 46 

Species-Specific Guidance Recommendation 

October 14, 2011 

 

xcii Bestman MWP and Wagenaar JP. 2003. Farm level factors associated with feather pecking in organic laying 

hens. Livestock Production Science 80:133-40.

xciii Mahboub HDH, Müller J, and von Borell E. 2004. Outdoor use, tonic immobility, heterophil/lymphocyte ratio 

and feather condition in free-range laying hens of different genotype. British Poultry Science 45(6):738-44.

xciv Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking 

in laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-

8.

xcv Elwinger K., Tufvesson M., Lagerkvist G, and Tauson R. 2008. Feeding layers of different genotypes in organic 

feed environments. British Poultry Science 49(6):654-65.

xcvi Nicol CJ, Pötzsch C, Lewis K, and Green LE. 2003. Matched concurrent case-control study of risk factors for 

feather pecking in hens on free-range commercial farms in the UK. British Poultry Science 44:515-23.

xcvii Nicol CJ, Pötzsch C, Lewis K, and Green LE. 2003. Matched concurrent case-control study of risk factors for 

feather pecking in hens on free-range commercial farms in the UK. British Poultry Science 44:515-23.

xcviii Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking 

in laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-

8.

xcix Pötzsch CJ, Lewis K, Nicol CJ, and Green LE. 2001. A cross-sectional study of the prevalence of vent pecking 

in laying hens in alternative systems and its associations with feather pecking, management and disease. Applied 

Animal Behaviour Science 74:259-72.

c

 Pötzsch CJ, Lewis K, Nicol CJ, and Green LE. 2001. A cross-sectional study of the prevalence of vent pecking in 

laying hens in alternative systems and its associations with feather pecking, management and disease. Applied 

Animal Behaviour Science 74:259-72.

ci Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking in 

laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-8.

cii Pötzsch CJ, Lewis K, Nicol CJ, and Green LE. 2001. A cross-sectional study of the prevalence of vent pecking in 

laying hens in alternative systems and its associations with feather pecking, management and disease. Applied 

Animal Behaviour Science 74:259-72.

ciii Knierim U, Staack M, Gruber B, Keppler C, Zaludik K, and Niebuhr K. 2008. Risk factors for feather pecking in 

organic laying hens –starting points for prevention in the housing environment. 16th IFOAM Organic World 

Congress, Modena, Italy, June 16-20.

civ Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather pecking 

in laying hens in alternative systems and its associations with management and disease. Veterinary Record 147:233-

8.

cv Bestman MWP and Wagenaar JP. 2003. Farm level factors associated with feather pecking in organic laying hens. 

Livestock Production Science 80:133-40. 

cvi Newberry RC. 2003. Cannibalism. In: Perry GC (ed.), Welfare of the Laying Hen, Poultry Science Symposium 

Series, 27 (Wallingford, U.K.: CABI Publishing, pp. 239-58). 

cvii Brunberg E, Jensen P, Isaksson A, and Keeling L. 2011. Feather pecking behavior in laying hens: Hypothalamic 

gene expression in birds performing and receiving pecks. Poultry Science 90:1145-52.

cviii Ellen ED, Visscher J, van Arendonk JAM, and Bijma P. 2008. Survival of laying hens: genetic parameters for 

direct and associative effects in three purebred layer lines. Poultry Science 87:233-9.

cix Rodenburg TB, Uitdehaag KA, Ellen ED, and Komen J. 2009. The effects of selection on low mortality and 

brooding by a mother hen on open-field response, feather pecking and cannibalism in laying hens. Animal Welfare 

18: 427-32.

cx Hocking PM, Channing CE, Robertson GW, Edmond A, and Jones RB. 2004. Between breed genetic variation for 

welfare-related behavioural traits in domestic fowl. Applied Animal Behaviour Science 89:85-105.

cxi Rodenburg TB, Komen H, Ellen ED, Uitdehaag KA, van Arendonk JAM. 2008. Selection method and early-life 

history affect behavioural development, feather pecking and cannibalism in laying hens: A review. Applied Animal 

Behaviour Science 110:217-28.

cxii Berk J and Cottin E. 2007. Effect of stocking densities and elevated platforms on behaviour, walking ability and 

leg posture of tom turkeys. In: Galindo F and Alvarez L (ed.s), Proceeding of the 41st International Congress of the 

ISAE, Merida, Mexico, July 30th-August 3rd. 

cxiii Van Liere DW and Bokma S. 1987. Short-term feather maintenance as a function of dust-bathing in laying hens. 

Applied Animal Behaviour Science 18(2):197-204.

120
Page 39 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

cxiv Olsson IAS and Keeling LJ. 2005. Why in earth? Dustbathing behaviour in jungle and domestic fowl reviewed 

from a Tinbergian and animal welfare perspective. Applied Animal Behaviour Science 93(3-4):259-82.

cxv Shields SJ. 2004. Dustbathing by broiler chickens: characteristics, substrate preference, and implications for 

welfare. Ph.D. Dissertation, University of California, Davis, pp.10-2.

cxvi Jones T, Waitt CD, and Stamp Dawkins M. 2009. Water off a duck’s back: Showers and troughs match ponds for 

improving duck welfare. Applied Animal Behaviour Science 116(1):52-7.

cxvii O’Driscoll KKM and Broom DM. 2011. Does access to open water affect the health of Pekin ducks (Anas 

platyrhynchos)? Poultry Science 90:299-307.

cxviii Jones TA and Dawkins MS. 2010. Environment and management factors affecting Pekin duck production and 

welfare on commercial farms in the UK. British Poultry Science 51(1):12-21.

cxix Baxter M. 1994. The welfare problems of laying hens in battery cages. The Veterinary Record 134(24):614-9.

cxx Blokhuis HJ. 1984. Rest in poultry. Applied Animal Behaviour Science 12(3):289-303, citing: Ellenberger W and 

Baum H. 1943. Handbuch der vergleichenden Anatomie der Haustiere (Berlin, Germany: Springer Verlag, p. 1155). 

cxxi Wilson S, Hughes BO, Appleby MC, and Smith SF. 1993. Effects of perches on trabecular bone volume in 

laying hens. Research in Veterinary Science 54(2):207-11.

cxxii Hughes BO, Wilson S, Appleby MC, and Smith SF. 1993. Comparison of bone volume and strength as measures 

of skeletal integrity in caged laying hens with access to perches. Research in Veterinary Science 54(2):202-6.

cxxiii Duncan ET, Appleby MC, and Hughes BO. 1992. Effect of perches in laying cages on welfare and production 

of hens. British Poultry Science 33(1):25-35.

cxxiv Appleby MC and Hughes BO. 1991. Welfare of laying hens in cages and alternative systems: environmental, 

physical and behavioural aspects. World’s Poultry Science Journal 47(2):109-28.

cxxv Baxter M. 1994. The welfare problems of laying hens in battery cages. The Veterinary Record 134(24):614-9.

cxxvi Olsson IAS and Keeling LJ. 2000. Night-time roosting in laying hens and the effect of thwarting access to 

perches. Applied Animal Behaviour Science 68(3):243-56.

cxxvii Olsson IAS and Keeling LJ. 2002. The push-door for measuring motivation in hens: laying hens are motivated 

to perch at night. Animal Welfare 11(1):11-9.

cxxviii Newberry RC, Estevez I, and Keeling L. 2001. Group size and perching behaviour in young domestic fowl. 

Applied Animal Behaviour Science 73:117-29.

cxxix Schrader L and Müller B. 2009. Night-time roosting in the domestic fowl: The height matters. Applied Animal 

Behaviour Science 121:179-83.

cxxx European Food Safety Authority, Animal Health and Animal Welfare. 2005. Scientific report on the welfare 

aspects of various systems for keeping laying hens. EFSA-Q-2003-92, p. 34. Annex to The EFSA Journal 197, 1-23. 

www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_scirep_final1.pdf. 

cxxxi Scientific Panel on Animal Health and Welfare. 2005. Opinion of the Scientific Panel on Animal Health and 

Welfare on a request from the Commission related to the welfare aspects of various systems of keeping laying hens. 

The EFSA Journal 197:1-23. www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_opinion1.pdf. 

cxxxii Tauson R and Abrahamsson P. 1996. Foot and keel bone disorders in laying hens: effects of artificial perch 

material and hybrid. Acta Agriculturae Scandinavica Section A, Animal Science 46:239-46.

cxxxiii European Food Safety Authority, Animal Health and Animal Welfare. 2005. Scientific report on the welfare 

aspects of various systems for keeping laying hens. EFSA-Q-2003-92, p. 35. Annex to The EFSA Journal 197, 1-23. 

www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_scirep_final1.pdf. 

cxxxiv Tauson R and Abrahamsson P. 1996. Foot and keel bone disorders in laying hens: effects of artificial perch 

material and hybrid. Acta Agriculturae Scandinavica Section A, Animal Science 46:239-46.

cxxxv European Food Safety Authority, Animal Health and Animal Welfare. 2005. Scientific report on the welfare 

aspects of various systems for keeping laying hens. EFSA-Q-2003-92, p. 35. Annex to The EFSA Journal 197, 1-23. 

www.efsa.europa.eu/EFSA/Scientific_Opinion/lh_scirep_final1.pdf. 

cxxxvi LayWel. 2006. Welfare implications of changes in production systems for laying hens. 

www.laywel.eu/web/pdf/deliverable%2071%20welfare%20assessment.pdf. 

cxxxvii Gregory NG and Wilkins LJ. 1991. Broken bones in hens. The Veterinary Record 129(25-26):559. 

cxxxviii Nicol CJ, Brown SN, Glen E, et al. 2006. Effects of stocking density, flock size and management on the 

welfare of laying hens in single-tier aviaries. British Poultry Science 47(2):135-46.

cxxxix Wilkins LJ, Brown SN, Zimmerman PH, Leeb C, and Nicol CJ. 2004. Investigation of palpation as a method 

for determining the prevalence of keel and furculum damage in laying hens. The Veterinary Record 155(18):547-9.

121
Page 40 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

cxl Scott GB and Parker CAL. 1994. The ability of laying hens to negotiate between horizontal perches. Applied 

Animal Behaviour Science 42:121-7.

cxli Scott GB, Lambe,NR, and Hitchcock D. 1997. Ability of laying hens to negotiate horizontal perches at different 

heights, separated by different angles. British Poultry Science 38:48-54. 

cxlii Moinard C, Rutherford KMD, Haskell MJ, McCorquodale C, Jones RB, and Green PR. 2005. Effects of 

obstructed take-off and landing perches on the flight accuracy of laying hens. Applied Animal Behaviour Science 

93:81-95.

cxliii Struelens E, Tuyttens FAM, Ampe B., O ̈Dberg F, Sonck B, and Duchateau L. 2009. Perch width preferences of 

laying hens. British Poultry Science 50(4):418-23.

cxliv Pickel T, Scholz B, and Schrader L. 2010. Perch material and diameter affects particular perching behaviours in 

laying hens. Applied Animal Behaviour Science 127:37-42.

cxlv Scott GB and Parker CAL. 1994. The ability of laying hens to negotiate between horizontal perches. Applied 

Animal Behaviour Science 42:121-7.

cxlvi Gunnarsson S, Keeling LJ, Svedberg J. 1999. Effect of rearing factors on the prevalence of floor eggs, cloacal 

cannibalism and feather pecking in commercial flocks of loose housed laying hens. British Poultry Science 40:12-8.

cxlvii Colson S, Arnould C, and Michel V. 2008. Influence of rearing conditions of pullets on space use and 

performance of hens placed in aviaries at the beginning of the laying period. Applied Animal Behaviour Science 

111:286-300.

cxlviii Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying 

hens, chapter 1, article 4.3.b.1. Official Journal of the European Communities. 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:203:0053:0057:EN:PDF 

cxlix Hegelund L, Sørensen JT, Kjær JB, and Kristensen IS. 2005. Use of the range area in organic egg production 

systems: effect of climatic factors, flock size, age and artificial cover. British Poultry Science 46(1):1-8.

cl Bestman MWP. 2001. The role of management and housing in the prevention of feather pecking in laying hens. In: 

Hovi M and Bouilhol M (eds.), Human-Animal Relationship: Stockmanship and Housing in Organic Livestock 

Systems. Proceedings of the Third NAHWOA Workshop (Clermont-Ferrand, France: Network for Animal Health 

and Welfare in Organic Agriculture, University of Reading, pp.77-86). 

www.veeru.rdg.ac.uk/organic/ProceedingsFINAL.pdf. 

cli Bestman MWP and Wagenaar JP. 2003. Farm level factors associated with feather pecking in organic laying hens. 

Livestock Production Science 80:133-40. 

clii Bright A, Brass D, Clachan J, Drake KA and Joret AD. 2011. Canopy cover is correlated with reduced injurious 

feather pecking in commercial flocks of free-range laying hens. Animal Welfare 20:329-38. 

cliii Zeltner E and Hirt H. 2008. Factors involved in the improvement of the use of hen runs. Applied Animal 

Behaviour Science 114:395-408.

cliv Thear K. 2002. Free-Range Poultry (Suffolk, U.K.: Whittet Books Ltd., pp. 72-3). 

clv Bestman MWP and Wagenaar JP. 2003. Farm level factors associated with feather pecking in organic laying 

hens. Livestock Production Science 80:133-40.

clvi Mitchell M. 1992. Indicators of physiological stress in broiler chickens during road transportation. Animal 

Welfare 1:91-103.

clvii Freeman BM, Kettlewell PJ, Manning ACC, and Berry PS. 1984. The stress of transportation for broilers. The 

Veterinary Record 114:286-7.

clviii Mench J. 1992. The welfare of poultry in modern production systems. Poultry Science Reviews 4:107-28.

clix Weeks C. 2007. Poultry handling and transport. In: Grandin T (ed.), Livestock Handling and Transport, 3rd 

Edition (Wallingford, U.K.: CAB International, pp. 295-311). 

clx Duncan IJH. 1989. The assessment of welfare during the handling and transport of broilers. In: Faure JM and 

Mills AD (eds.), Proceedings of the Third European Symposium on Poultry Welfare (Tours, France: French Branch 

of the World Poultry Science Association, pp. 79-91). 

clxi Kannan G, Heath JL, Wabeck CJ, and Mench JA. 1997. Shackling of broilers: effects on stress responses and 

breast meat quality. British Poultry Science 38(4):323-32.

clxii Kettlewell PJ and Mitchell MA. 1994. Catching, handling and loading of poultry for road transportation. 

World’s Poultry Science Journal 50:54-6.

clxiii Kettlewell PJ and Turner MJB. 1985. A review of broiler chicken catching and transport systems. Journal of 

Agricultural Engineering Research 31:93-114.

122
Page 41 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

 

clxiv McGuire AR. 2003. Improving carcass quality. Poultry 10(1):25-6.

clxv Farsaie A, Carr LE, and Wabeck CJ. 1983. Mechanical harvest of broilers. Transactions of the American 

Society of Agricultural Engineers 26:1650-3.

clxvi Nijdam E, Zailan ARM, van Eck JHH, Decuypere E, and Stegeman JA. 2006. Pathological features in dead on 

arrival broilers with special reference to heart disorders. Poultry Science 85:1303-8.

clxvii Gregory NG and Austin SD. 1992. Causes of trauma in broilers arriving dead at poultry processing plants. 

Veterinary Record 131:501-3.

clxviii Prescott NB, Berry PS, Haslam S, and Tinker DB. 2000. Catching and crating turkeys: effects on carcass 

damage, heart rate, and other welfare parameters. Journal of Applied Poultry Research 9:424-32.

clxix American Veterinary Medical Association. 2007. AVMA Guidelines on Euthanasia. 

www.avma.org/issues/animal_welfare/euthanasia.pdf 

clxx Webster AB and Fletcher DL. 2004. Assessment of the aversion of hens to different gas atmospheres using an 

approach-avoidance test. Applied Animal Behaviour Science 88(3-4):275-87.

clxxi Raj ABM. 1996. Aversive reactions of turkeys to argon, carbon dioxide and a mixture of carbon dioxide and 

argon. The Veterinary Record 138(24):592-3.

clxxii Raj M, O'callaghan M, Thompson K, et al. 2008. Large scale killing of poultry species on 

farm during outbreaks of diseases: evaluation and development of a humane containerised gas killing system. 

World’s Poultry Science Journal 64:227-44.

clxxiii Raj ABM. 2004. Stunning and slaughter of poultry. In: Mead GC (ed.), Poultry Meat Processing and Quality 

(Cambridge, U.K.: Woodhead Publishing Ltd.). 

clxxiv Raj M. 1998. Welfare during stunning and slaughter of poultry. Poultry Science 77(12):1815-9.

clxxv Hindle VA, Lambooij E, Reimert HGM, Workel LD, and Gerritzen MA. 2010. Animal welfare concerns during 

the use of the water bath for stunning broilers, hens, and ducks. Poultry Science 89:401-12.

123
Page 42 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Guidance for Assessing Animal Welfare on Organic Sheep Operations 

Introduction

The following is provided to aid in assessment of whether or not the requirements of § 

205.238-241 are being met sufficiently to demonstrate adequate animal welfare 

conditions on organic sheep operations. 

Nutritional Requirements 

Body condition scoring of sheep

Because wool covering makes visual examination of sheep body condition more difficult 

than with other species of livestock, body condition scoring may be helpful in 

determining whether the nutritional requirements of the ewe flock are being met and 

also in assessing the health status of sheep.

Estimated external fat cover is used as a base for estimating body condition. The 

fingertips are used to palpate fat cover over and around the vertebrae in the loin region. 

The best area to palpate is just behind the last rib. The spinal column has a vertical 

process at the midpoint of the back and a transverse process horizontal to the back and 

just below the loin. The prominence of these two points, or their lack of prominence due 

to fat cover, is helpful when estimating body condition. The recommended scoring 

system uses body condition scores ranging from 0 to 5. A condition score of 0 indicates 

extreme emaciation; a score of 5 represents excessive obesity. A condition score of 

2.5-3 is considered as a medium fat-condition score for a healthy ewe at breeding and 

starting into the late gestation stage of pregnancy. If, within a ―uniform‖ group or flock, 

several or more ewes differ from the majority in body condition score it may mean they 

are parasitized, diseased, aged (lacking teeth) or have other non-nutritional problems. 

As a rule, no more than 5% of the ewe flock should be below target body condition 

scores for the stage of production.

Scoring: 

1. Feel for fullness of muscle and fat cover. (illustration)

2. Feel for the spine in the center of the sheep’s back behind the last rib and 

anterior to the hipbone. (illustration)

3. Feel for the tips of the transverse processes. (illustration)

Target body condition scores based on stage of production 

Dry Ewe 1.5-2.0 

Breeding 2.5-3.0 

Early Gestation 2.0-2.5 

Late Gestation* 2.5-3.0 

Early Lactation* 3.0-3.5 

Late Lactation, Weaning 2.0-2.5 

*Add .5 to the target score for ewes expecting or nursing twins. 

124
Page 43 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Body Condition Score 0: Sheep is extremely thin, unthrifty and weak. Skeletal features, 

such as backbone, shoulder blades and ribs, very prominent. Wasted muscle tissue 

evident. Eye socket is prominent and sunken. May be humped back and isolates self 

from flock. 

Body Condition Score 1: Sheep is extremely thin, unthrifty but agile. Skeletal features 

are prominent with no fat cover. No apparent muscle tissue degeneration. Has 

strength to remain with the flock. 

Body Condition Score 2: Sheep is thin but strong and thrifty with no apparent muscle 

structure wasting. No evident fat cover over the backbone, rum and ribs, but skeletal 

features do not protrude. 

Body Condition Score 3: Sheep are thrifty with evidence of limited fat deposits in fore 

rib, over top of shoulder, backbone, and tail head. Hipbone remains visible. 

Body Condition Score 4: Moderate fat deposits give the sheep a smooth external 

appearance over the shoulder, back, rump, and fore rib. Hipbone is not visible. Firm fat 

deposition becomes evident in brisket and around the tail head. 

Body Condition Score 5: Sheep are extremely fat with the excess detectable over the 

shoulder, backbone, rump, and fore rib. Excess fat deposits in brisket, flank, and tail 

head regions lack firmness. Sheep appear uncomfortable and reluctant to move about. 

Quality fleeces are generally found. 

Other areas of importance in providing adequate nutrition to sheep: 

 Sheep need to be provided with enough roughage in the diet to ensure proper 

rumen function. After weaning, 70% of daily dry matter fed should be long fiber 

roughage/forage.

 There should be sufficient access to forage when fed that all sheep have 

sufficient access to meet their nutritional requirements within 24 hours.

 If supplementary concentrates are fed, all animals in a group should be able to 

eat at the same time.

 Ewe lambs should not be bred unless they have reached 70% of their mature 

body weight. If ewe lambs are bred to lamb before they are 18 months of age, 

they may need to be fed separately from the ewe flock to ensure adequate 

nutrition during gestation.

 Lambs should not be weaned before 5 weeks of age. Early weaned lambs need 

a high-protein ration and should not be put on forage only.

 If culling does not remove older sheep with damaged or missing teeth from the 

flock, attention should be given to providing sufficient feed of a type these sheep 

can eat and digest. 

125
Page 44 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Sheep Health 

When managed in a pasture-based or range system as required by organic production, 

with attention to suitability of species, and selective breeding for desirable traits, sheep 

can require few health inputs, require little lambing intervention, operator- or veterinaryprovided health treatment and yet display optimal health. 

Internal Parasites 

It is necessary for special attention to be given to managing internal parasites on 

organic sheep operations. If breed selection, pasture management, supplements and 

allowed treatments are not successful in keeping sheep parasite loads from impacting 

well-being, individual animals need to be given conventional treatments. Lambs are 

more susceptible to parasites than ewes. 

Lameness 

Sheep hooves should be examined periodically or at least once yearly, and trimmed if 

necessary. 95% of the sheep should walk with no obvious limp. Animals with chronic or 

infrequent trimming management will be seen grazing on their knees and often will have 

grass stains on their knees. To simplify assessment, sheep can be classified as either 

lame or not lame. On a 5 point lameness scoring system, sheep that score as 3, 4, or 5 

would be classified as lame. 

Score 1. Completely normal walking 

Score 2. No obvious limp, but may have slight gait abnormalities. 

Score 3. All sheep that walk with an obvious limp. Sheep with a score 3 are able to keep 

up with their flock mates when the group is walking. 

Score 4. All sheep that walk with an obvious limp and refuse to bear their full weight on 

one or more legs. Score 4 animals are not able to keep up with their flock mates when 

the group is walking. 

Score 5. All sheep that have great difficulty walking. Score 5 sheep are barely able to 

walk. 

Physical Alterations 

Tail docking should only be done if needed for prevention of fly strike. When necessary, 

tail docking should be performed by suitably trained and competent individuals on lambs 

that are between 24 hours and 14 days old. Tails should not be docked shorter than the 

distal end of the caudal tail fold. 

If castration is necessary to avoid breeding by ram lambs, banding should be done by 

suitably trained and competent individuals on lambs that are between 24 hours and no 

more than 30 days old. 

126
Page 45 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Sheep Living Conditions 

Flocks may be managed with only natural shelter, depending upon climate, breed and 

lambing season. If sheep are housed or fed in lots, conditions should be such to 

maintain a cleanliness score or 1 or 2 for 95% of the flock. 

Cleanliness Scoring 

Fleece maintenance is necessary to prevent manure from accumulating on the back 

end, rear legs and tail if present. The presence of manure in the fleece is an indicator of 

poor management that can lead to low conception rates and harbor external parasites. 

Messy rear ends may be due to washy forage growth or may be from untreated internal 

parasite loads. Excessive wool growth is problematic for newborn lambs to find the 

nipple and receive the valuable colostrum. 

Score 1. The entire sheep is clean except its feet and lower half of the legs. Animals on 

lush green pastures may have some soiling of the rear legs.. 

Score 2. Both the upper and lower legs are soiled and the body/breast and sides are 

clean. 

Score 3. Both the legs and belly are soiled. 

Score 4. The legs, belly and sides of the body are soiled. 

95% of the sheep should have a cleanliness score of 1 or 2. 

Space Allowances 

If sheep are confined in buildings or lots during the non-grazing season, the following 

minimum space allowances should be met. Because the standards require outdoor 

access for organic livestock unless weather conditions would be injurious to animal 

health, and because sheep tend towards respiratory difficulties when confined unless 

ventilation and moisture control is optimum, it is important than confinement of sheep to 

buildings be of a temporary nature—for treatment of illness, or shelter due to inclement 

weather, winter lambing or post-shearing—and that outdoor access be provided as 

soon as possible. 

Livestock Indoor Floor Space Outdoor Space 

Sheep and goats 

(pounds)

Square feet / animal Square feet / animal

Sheep and Goats 16.0 30.0 

Nursing lamb or kid 4.0 8.0 

For ewes with lambs add 5 square feet for lambing percentages over 170%. Ewes 

lambing in confinement should be provided with a dry, bedded area for lambing and 

should be checked at least 3 times daily during lambing time for lambing difficulties or 

unclaimed lambs. Lambing jugs (pens) as small as 16 square feet in area may be used 

for up to three days for a ewe and her lamb(s) to separate them from the rest of the 

flock for a period of bonding and observation. 

127
Page 46 of 46

Species-Specific Guidance Recommendation 

October 14, 2011 

Pasturing Sheep 

Important factors in managing sheep on pasture: 

 Pastures need to be rotated and rested to minimize parasite infestation. 

 Sheep need to be protected from predation. 

 If electronet fencing is used, it should be kept properly energized. 

 Sheep on pasture should be checked at least twice/day during lambing, once/day 

otherwise. 

Humane Handling of Sheep 

Sheep should be handled quietly and firmly, with care taken to avoid unnecessary pain 

or distress. Sheep should not be caught by the fleece, or lifted or dragged by fleece, 

limbs, ears or tail. Electric prods should not be used on sheep. 

Mortality Rates in Sheep Production 

In assessing the level of animal welfare that is met on an organic sheep operation, 

mortality rates and causes should be examined and considered. Mortality in sheep 

production is generally looked at in terms of lamb mortality before and after weaning 

and ewe mortality. 

Lamb mortality rates are impacted by the prolificacy of the ewe breed (multiple 

births=higher mortality rate) and lambing conditions. The primary causes of neonatal 

lamb death are starvation and hypothermia. A lamb survival rate of 95% at weaning is 

considered to be a goal by many sheep producers. 

Similarly, a death loss of 5% or less in weaned lambs or ewes is considered to be 

indicative of good management. Weaned lambs in organic systems are impacted most 

greatly by parasites or predation. The mortality rate of ewes is affected by culling rate; if 

older ewes are kept on the farm, the mortality rate could be higher. 

128
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: November 2011 Substance: Annatto extract color (pigment CAS # 1393–63–

1)—water and oil soluble_

Committee: Crops  Livestock  Handling X Petition is for removal of Annatto extract color (pigment CAS # 1393–

63–1)—water and oil soluble on the National List § 205.606

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes X No  N/A 

3. Compatibility & Consistency Yes X No  N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No X N/A  

B. Substance Fails Criteria Category: _4___ Comments: At this time, the Handling Committee believes that sufficient evidence 

exists that both forms, liquid and powdered, of organic annatto extract color are available. We understand that there may be 

applications where the forms available do not perform. We ask that handlers or certifiers who are aware of these applications 

provide written public comment for the fall 2011 NOSB meeting so they can be considered. 

C. Proposed Annotation (if any): _Current annotation is “Oil and Water Extracted.” Proposed annotation is “Liquid and powdered 

forms.” See committee comments at end of document for details________

 Basis for annotation: To meet criteria above: __X_ Other regulatory criteria: _______ Citation:__The Handling Committee is 

recommending an annotation change to include both forms of annatto extract color so that the NOSB has the flexibility to list one or 

the other should public comment be received that the forms of organic extract color that are available do not perform in all 

applications__

D. Recommended Committee Action & Vote (State Actual Motion): Recommend changing the annotation of Annatto Extract 

Color from “Water and Oil Soluble” to “Liquid and Powdered Forms.”

Motion by: Heinze Seconded: Dickson Yes: 6 No: 0 Absent: 1 Abstain: 0

Recommend removing Annatto color, with all annotations, from the National List §205.606

 

Motion by: Heinze Seconded: Dickson Yes: 6 No: 0 Absent: 1 Abstain: 0

 

1) Substance voted to be REMOVED as “allowed” on National List to § 205. 606 with Annotation (if any) Liquid and Powdered 

Forms________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) ______________________

Describe why a prohibited substance:_________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. ___. Describe why material was rejected: _________

4) Substance was recommended to be deferred because___________ If follow-up needed, who will follow up __________

Crops Agricultural X

Allowed1 / 

REMOVED X

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic Rejected3

No restriction Commercially UnAvailable as Organic1

 

Deferred4

E. Approved by Committee Chair to transmit to NOSB:

 _Steve Demuri__ __September 29, 2011____

 Committee Chair Date

129
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance – Annatto extract color (pigment CAS # 

1393–63–1)—water and oil soluble

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 

[§205.600 b.2]

X

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

X

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

130
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance – Annatto extract color (pigment CAS 

# 1393–63–1)—water and oil soluble

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X Material is manufactured by extraction from the annatto seed 

with either oil or water combined with physical agitation. 

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X

4. Is there a natural source of the 

substance? [§205.600 b.1]

X This is the natural source

5. Is there an organic substitute? 

[§205.600 b.1]

X Organic forms of this material are available in the marketplace

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X Not used for production 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X This is the natural source

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X This petition is for evaluation of commercial availability. See 

category 4.

9. Is there any alternative 

substances? [§6518 m.6]

X

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

131
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? Substance – Annatto extract color 

(pigment CAS # 1393–63–1)—water and oil soluble

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

X

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X

5. Is the primary use as a 

preservative? [§205.600 b.4]

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X Primary use is as a color. However use is not to recreate or 

improve color lost in processing but to provide consumers 

with a color with which they are familiar. For example, 

cheddar cheese is orange due to use of annatto. 

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds; X

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

132
Decision Sheets 

December 2006 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance - Annatto extract color (pigment CAS # 1393–63–1)—water and oil soluble 

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

X Annatto extract color (pigment CAS # 1393–63–1)—water 

and oil soluble was added to the National List (Federal 

Register Vol. 72, #123, June 27, 2007). The NOSB 

recommended relisting at the October 2010 NOSB meeting: 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=ST

ELPRDC5088016&acct=nosb

2. Does the current and historical 

industry information, research, or

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling?

X When annatto was originally listed public comment was 

received saying that organic annatto seeds were not 

available. Today organic seeds are available. However, 

annatto is used in both a liquid and powdered form. During 

the Sunset 2012 review of this material public comment was 

received, and supported by an informal market review by 

the NOSB Handling Committee, that the liquid form was 

available. Mixed public comment was received about the 

availability of the powdered form. At the time, removing 

one form but not the other could not be done during the 

sunset review process. 

This petition is for the removal of all forms from §205.606. 

The petitioner states that they have provided an organic 

liquid form for some time and have just recently, spring 

2010, introduced a powdered form. The Handling 

Committee has conducted a second informal market survey 

and found that some, but not most, products (e.g., some 

brands of organic mac & cheese) that would be expected to 

be using the powdered form have switched to using organic 

annatto. 

At this time, the HC believes that sufficient evidence exists 

that both forms, liquid and powdered, of organic annatto 

extract color are available. We understand that there may be 

applications where the forms available do not perform. We 

ask that handlers or certifiers who are aware of these 

applications provide written public comment for the fall 

2011 NOSB meeting so they can be considered. 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quality to fulfill an essential function 

in a system of organic handling?

X Quality of the organic annatto extract color has not been a 

question. The committee has no information indicating that 

organic forms of the material are not commercially 

available.

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quantity to fulfill an essential 

function in a system of organic 

handling?

X The petitioner states that there is sufficient supply of organic 

annatto seeds and both liquid and powdered organic annatto 

extract color to meet demand. The committee has no 

information to contradict this statement.

133
Decision Sheets 

December 2006 

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

X

b. Number of suppliers and amount 

produced;

X The petition is from the supplier of organic annatto extract 

color. 

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

134
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: __Fall 2011 Substance: _ Arachidonic acid single-cell oil (ARA)

_______________________________________

Committee: Crops • Livestock • Handling X Petition is for:__Inclusion on the National List 7CFR § 205.605(a)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No • N/A •

2. Essential & Availability Criteria Yes X No • N/A •

3. Compatibility & Consistency Yes X No • N/A •

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes • No • N/A X 

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________ 

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________ 

D. Recommended Committee Action & Vote (State Actual Motion): ____Approve as 

Motion is list the material as a non-synthetic, designating the material for §205.605(a) 

Motion by: _Tracy MIedema______________ Seconded:_Steve DeMuri_______________ Yes: 6_____ No: _0____ 

Absent: __1_____ Abstain: ___0__ 

 Motion is to list the petitioned material Arachidonic acid single-cell oil (ARA) on the National List 7 CFR, §205.605(a) 

as Arachidonic acid single-cell oil (ARA) 

Motion by: _Tracy Miedema______________ Seconded:___Steve DeMuri_____________ Yes: ___6__ No: __0___ 

Absent: __1_____ Abstain: __0___ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ______________________

________________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________ 

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 X

Livestock Non-Synthetic X Prohibited2 

Handling X Synthetic Rejected3

No restriction 

Commercially UnAvailable as Organic1

 

Deferred4 

135
Decision Sheets 

December 2006 

E. Approved by Committee Chair to transmit to NOSB: 

Steve DeMuri__________________________________ October 7, 2011 

 Committee Chair Date

136
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance Arachidonic acid single-cell oil 

(ARA)

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal?1

[§205.600 b.2] 

 x The TR concluded that the petitioned substance, ARA Singlecell Oil, is produced primarily by a “non-genetically-modified 

soil fungus Mortierella alpina,” and that the fungus is safe for 

consumption by humans and other life. See TR at lines 204-

205 (fungus “not believed to cause disease in humans and 

biota.”) 

The TR described the production, extraction and purification 

method of the natural oil. See TR lines 212-256. The TR 

noted that the post-extraction and purification processes 

“remove any extraction and purification solvents from the oil,” 

see TR at lines 270-73, and concluded that the removed 

solvents are typically “recycled and reused.” See TR at 271-2 

Any other impurities such as “trace metals, and oxidation 

products” are “removed physically through filtration or 

addition of adsorbents” See TR at lines 249-50 

Lastly, the TR stated at 273: “No residual hexane from the 

extraction process has been detected in samples of ARA 

Single-cell Oil using methods with detection limits of 0.3 ppm 

.” The TR also cited a single Swiss study that tested more 

than 40 non-organic vegetable oils that used a similar 

extraction technology for hexane residues and concluded that 

less than 13% had any detectable residue and the level was 

“below acceptable tolerances.” See TR at line 237 

See also Question 2 below 

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

(m)(3)] 

 x The TR concluded that the petitioned substance is produced 

under completely controlled conditions--“aerobic fermentation 

of the fungus in shake flasks containing a growth medium.” 

See generally TR line212; see also generally TR lines 204-256 

(describing inputs, manufacturing process and waste 

byproducts) Because the fungus is grown in a controlled 

environment, there appear to be no environmental issues 

arising from the process. see also lines 407-409 (noting FDA 

GRAS notice reported no heavy metals or pesticides detected 

in petitioned substance) 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

 x See Question 2 above, citing TR lines 204-256; see also TR at 

lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”) 

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is not used in production and contains no 

listed inerts. 

 

1The criteria set forth in 7 CFR §205.600(b) are applicable solely to “synthetic substances used as a processing aid 

or adjuvant.” The petitioned substance is not a processing aid or adjuvant. See TR at line 90-94 The TR 

determined the petitioned substance be a non-synthetic. See TR at line 286 (“ARA Single-cell Oil does not appear 

to be a synthetic substance.”) Accordingly, the criteria listed in §205.600(b) are inapplicable to the petitioned 

substance. See e.g. 7 CFR §205.600(c)(“Non-synthetics...will be evaluated using the criteria [in the OFPA].”) 

However, the TR included review of most of these questions so the results are cited out of an abundance of caution.

137
Decision Sheets 

December 2006 

5. Is there potential for detrimental 

chemical interaction with other 

materials used? 

[§6518 m.1] 

 x The substance is used as an ingredient in an organic processed 

food. No detrimental interactions were noted in the TR. See 

TR lines 123-145 (discussing combinations with substances in 

formulations); see also TR at lines 204-205 (fungus “not 

believed to cause disease in humans and biota.”) 

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”) 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”) 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”) 

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”) 

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4] 

 x The Safety of the Fungus: The TR concluded that the 

scientific literature regarding the fungus from which the oil is 

extracted discloses that there is no reason to believe that any 

harm to humans or other life will occur. See TR at lines 204-

205 

Health Benefits from Consumption: With regard to the 

health of those that consume the petitioned substance, the TR 

concluded: “Research suggests that a balance of ARA and 

DHA are necessary to the normal growth and development of 

infants.” See TR at lines 126-27 The TR also noted that many 

studies have reported “statistically significant improvements 

to retinal maturation, visual acuity, and cognitive function” 

while one study cited “reported no benefit.” See TR at lines 

418-32 The TR appears to conclude the vast body of evidence 

of health benefits far outweighed the single study that found 

no measurable benefit. 

The TR also cited the World Health Organization (“WHO”) 

recommendation that “ARA should be supplied in the diets of 

infants aged 0–6 months” and noted the Institute of Medicine 

has established intake levels for infants aged 0–6 months and 

small children. See TR at lines, 593-596 

Safety Analysis 

“ARA Single-cell Oil is generally recognized as safe for 

human consumption, even in vulnerable infant populations.” 

See TR at lines, 496-97 The TR cited the “most recent safety 

assessment of ARA Single-cell Oil” in the scientific literature,

TR at lines 448-52, and summarized its findings: “All results 

of the genotoxicity assays were negative” and “No adverse 

effects attributed to consumption of the ARA Single-cell Oil 

were observed even at the highest dose” which in the study 

was “29-times higher than the anticipated intake” for term 

infants. See also TR at lines 459-62 (noting that Australia and 

New Zealand “reviewed the toxicological database for ARA 

Single-cell Oil and determined that ARA Single-cell oil did 

138
Decision Sheets 

December 2006 

not induce any histopathological, biochemical, or 

hematological changes that would be indicative of toxicity” at 

doses far higher than allowed for infant formula.) 

With regard to the safety of the consumption of the petitioned 

substance by infants (the extracted ARA) the TR at lines 430-

32, stated: “Despite mixed results on many of the purported 

benefits of ARA supplementation in infant formula, adverse 

effects in infants fed formulas enriched with ARA/DHA have 

not been observed in randomized trials for up to one year.” 

The TR noted that a now ten year old from 2001 study 

reported incidents of “flatulence, diarrhea, apnea, and jaundice 

in infants that were fed formulas with long-chain PUFA.” TR 

at lines 438-9 However, the TR did not did attribute these 

common infant ailments to any particular infant formula 

ingredient. To the extent these common infant ailments have 

been reported to FDA as “adverse events” arising from infant 

formula consumption, FDA’s review has apparently concluded 

the events are de minimis in light of the nearly universal 

consumption of infant formula, and thus below the threshold 

of regulatory action. 

Excessive Consumption 

The TR cited one study that examined “the effect of increasing 

dietary ARA seven-fold” and concluded, “no effects on 

platelet aggregation, bleeding times, balance of vasoactive 

metabolites, serum lipid levels, or immune response were 

observed” TR at lines 438-9 In addition, after review of a 

meta-analysis of 25 case-control studies evaluating a variety 

of effects, the TR concluded: “No effects in humans at high 

ARA doses were identified.” See TR at lines 438-9 

Absence of Contaminants 

The TR accepted the data provided by Petitioner that was also 

provided to the FDA and concluded: “No residues of heavy 

metals or other contaminants have been reported in ARA 

Single-cell Oils at levels higher than FDA tolerances.” See TR 

at lines 378-9 The TR also accepted as unrebutted by other 

literature the finding that no solvent used in processing the 

ARA oil was detectable in the final product, and that the sole 

study in the scientific literature that tested more than 40 

conventional (non-organic) vegetable oils for residues from 

processing solvents found no residue at an actionable level. 

See TR at lines 386-90 

Global Regulatory Treatment on Safety 

Because organic authorities do not assess food safety 

generally, the TR surveyed a few jurisdictions to assess the 

regulatory treatment by agencies charged with safety 

evaluations. Of course, the TR noted that the substance is 

recognized as GRAS in the U.S. See e.g. TR at lines 90-92 

(petitioned substance is GRAS); TR, at lines 616-17 (noting 

one GRAS petition that cited 5 safety studies) 

139
Decision Sheets 

December 2006 

The petitioned substance has been evaluated from a safety 

perspective by several countries and multi-lateral institutions. 

See e.g. TR at lines, 459 (citing Australia and New Zealand). 

In particular, the TR noted that in Canada approved the 

petitioned substance “after assessing the toxicology, 

chemistry, microbiology, and nutrition of ARASCO®as a 

food ingredient.” See TR at lines 185-89 Other regulatory 

approvals for the petitioned substance for use in infant formula 

include, Australia, New Zealand, China, France, and the 

Netherlands—of note also, the European Union similarly 

allows “ARA Single-cell Oil from M. alpina" in infant 

formula. See TR at lines 190-93 Lastly, the TR noted that the 

petitioned substance would fall under Codex’s general rule for 

food grade oils that allows their use provided they are free of 

prohibited additives like coloring agents etc. See TR at lines 

197-98 

In the United States, ARA Single-cell Oil is proposed for 

addition to infant formula and other organic food products. 

See TR at lines 141-143 ARA has not currently been 

petitioned for GRAS designation as an addition to food items 

other than infant formula. See TR at lines, 573-4 

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3] 

 x The TR concluded that there is no adverse human health 

impact under federal regulations. “ARA Single-cell Oil is 

considered by FDA as GRAS in infant formula when used in 

combination with docosahexaenoic acid (DHA).” See TR at 

lines 90-92 Also, “ARA Single-cell Oil is generally 

recognized as safe for human consumption, even in vulnerable 

infant populations.” See e.g. TR at lines, 496-97ARA is 

presently allowed for use solely in infant formula and 

growing-up milks. See TR at lines, 650-51. 

The TR plainly stated that the state of the science is that, 

“adverse effects in infants fed formulas enriched with 

ARA/DHA have not been observed in randomized trials for up 

to one year.” See TR at lines, 431-32 

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5] 

x The TR concluded: “ARA Single-cell Oil is characterized as 

GRAS under three different names submitted by four different 

applicants” See TR at lines 332-36 (citing Martek Biosciences 

(GRN No. 41), Mead Johnson Nutritionals (GRN No. 80), 

Abbott Laboratories (GRN No. 94), and Cargill, Inc. (GRN 

No. 326)) when used in term and preterm infant formula 

along with GRAS concentrations of DHA. 

In addition to GRAS status, when ARA oil appears as an 

ingredient in infant formulas, the manufacturers submit 

premarket notification to FDA under section 412 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA). Section 412 

of FFDCA describes the more stringent statutory requirements 

that apply to infant formula as compared to the regulation of 

other foods (FDA, 2006) 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5] 

 x The TR described the production, extraction and purification 

method of the natural oil. See TR lines 212-256. The TR 

noted that the post-extraction and purification processes 

“remove any extraction and purification solvents from the oil,” 

see TR at lines 270-73, and concluded that the removed 

140
Decision Sheets 

December 2006 

solvents are typically “recycled and reused.” See TR at 271-2 

Any other impurities such as “trace metals, and oxidation 

products” are “removed physically through filtration or 

addition of adsorbents” See TR at lines 249-50 

Lastly, the TR cited Petitioner’s evidence at line 273: “No 

residual hexane from the extraction process has been detected 

in samples of ARA Single-cell Oil using methods with 

detection limits of 0.3 ppm.” The TR also cited a single Swiss 

study that tested more than 40 non-organic vegetable oils that 

used a similar extraction technology for hexane residues and 

concluded that less than 13% had any detectable residue and 

the level was “below acceptable tolerances.” See TR at line 

237

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

141
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance Arachidonic acid single-cell oil 

(ARA)

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)] 

x The TR concluded the fungus from which the petitioned 

substance is isolated is “produced naturally via fermentation” 

line 260-63, but the extraction process typically involves a 

“nonpolar solvent.” See TR at 263 (“ARA Single-cell Oil is 

produced naturally via fermentation of M. alpina and some 

other single-celled organisms. However, to extract the ARA 

Single-cell Oil from the fungus, a nonpolar solvent (usually 

hexane) is used.”) See TR at 260-63 

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)] 

 x The TR concluded that the petitioned substance is a nonsynthetic. See TR at line 286 (“ARA Single-cell Oil does not 

appear to be a synthetic substance.”); see also TR at lines 274-

78 (Applying National Organic Standards Board (NOSB) 

Joint Materials and Handling Committee draft policy: 

“extraction with a synthetic not on the National List would not 

result in a material being classified as synthetic unless either 

the extraction resulted in chemical change or the synthetic 

remained in the final material at a significant level”(NOSB, 

2010).”)

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)] 

x The TR concluded that the petitioned substance is the product 

of a biological process. See TR lines 260-63

4. Is there a natural source of the 

substance? [§205.600 b.1] 

x ARA is present in foods, but for use in infant formula, or as a 

supplemental micronutrient in adult food products, the ARA 

must be extracted by a chemical process. See TR lines 221-

240 (noting extraction methodologies). “Chicken and eggs are 

the primary sources of ARA in the U.S. diet.” TR at lines, 

660-61. 

5. Is there an organic substitute? 

[§205.600 b.1] 

 There are no known certified organic sources of the extracted 

ARA oil. See TR lines 466-80 (citing no certified source of 

ARA oil) 

The TR noted that fish oil is not an acceptable substitute 

because (a) “fish oil is not an organic agricultural product per 

se” and (b) “[f]ish oil does not contain high levels of preformed ARA” thus it must be “supplemented with another 

source of ARA (e.g., egg phospholipid or ARA Single-cell 

Oil) to achieve a fatty acid profile for optimal nutrition” and 

(c) “fish oil contains high levels of EPA, which can result in 

adverse effects on growth of pre-term infants even at low 

concentrations.” See TR at lines, 475-80 

The TR noted that using organic eggs as an ARA source is 

generally not commercially feasible because achieving an egg 

with sufficient phospholipids requires “feeding chickens the 

biomass of ARA-producing fungus.” See TR at lines, 468-72 

The TR also noted this approach is generally considered 

“wasteful of resources because ARA contents in egg 

phospholipids are relatively low and most of the egg is often 

discarded after phospholipid extraction.” (internal citations 

omitted) See TR at lines, 303-07. Based on the TR, the 

necessary chicken feed would not be organic because ARA 

142
Decision Sheets 

December 2006 

producing fungus would have to be added to complete its 

nutrient profile and it is not an organic material at this time. 

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6] 

x 

 

The petitioned substance is unique because it is the only plantbased source of ARA currently available and is the most 

widely used ARA source in conventional and organic infant 

formulas. See e.g. TR at lines, 468-69 (“There are three main 

sources of ARA ...for supplementing infant formula: ARA 

Single-cell Oil, fish oil, and egg phospholipids.”) Unlike 

animal sources, such as eggs or animal flesh, ARA from 

fungal oil is vegetarian, carries no risk of containing harmful 

environmental contaminants that an animal may ingest, see TR 

at line 212 (noting fungus is grown in flasks) and there is no 

literature suggesting this production methodology adversely 

impacts biodiversity. See TR at lines 394-95 (“No information 

was found on the effect of ARA Single-cell Oil on the 

environment or biodiversity”) 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)] 

 x The TR concluded that there are “Three main sources of ARA 

...for supplementing infant formula: ARA Single-cell Oil, fish 

oil, and egg phospholipids.” See TR at lines, 468-69 The 

petitioned substance is the only plant-based source of ARA. 

Id. non-synthetic, non-agricultural substance under 

205.605(a). See TR 286 (“ARA Single-cell Oil does not 

appear to be a synthetic substance.”) There is no plant-based 

agricultural substitute for the petitioned substance. TR at 

lines, 657-665 (discussing common sources); TR at lines, 666 

(noting “ eggs, poultry, beef, some fish” are principle ARA 

sources.) 

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)] 

x The TR concluded the substance is a non-synthetic, nonagricultural substance. See TR 286 (“ARA Single-cell Oil 

does not appear to be a synthetic substance.”) 

9. Is there any alternative to using 

the petitioned substance in terms 

of practices or other available 

materials? [§6518(m)(6)] 

 x According to the TR, there are no other plant-based sources of 

ARA, thus there is no vegetarian alternative to the petitioned 

substance. TR at lines, 657-665 (discussing common 

sources); TR at lines, 666 (noting “ eggs, poultry, beef, some 

fish” are principle ARA sources in adult diet.) For infants, the 

adult sources are not alternatives. See also Question 7 

10. Is there an “alternative[s] to 

using the substance in terms of 

practices” that would make the 

substance unnecessary? [§6518 

(m)(6)] 

 x The petitioned substance is a food additive and there are no 

“practices” that substitute for its presence. 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

143
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? Substance Arachidonic acid singlecell oil (ARA)

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is the substance compatible 

with organic handling? [§205.600 

b.2] 

x The petitioned substance is not the product of an excluded 

method and is a non-synthetic according to the TR. 

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)] 

 x 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7] 

 x 

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3] 

x The petitioned use of ARA Single-cell Oil is as a nutritional 

food ingredient added to infant formulas. ARA Single-cell Oil 

is added to infant formula to increase free ARA levels in 

formula to those comparable to ARA levels in human breast 

milk. TR at lines, 37-40 

5. Is the primary use as a 

preservative? [§205.600 b.4] 

 x TR at lines, 37-40

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4] 

 x TR at lines, 37-40

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories: 

a. copper and sulfur compounds; 

 x The petitioned substance is not used in production. 

b. toxins derived from bacteria; x The petitioned substance is not used in production. 

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals? 

 x The petitioned substance is not used in production. 

d. livestock parasiticides and 

medicines? 

 x The petitioned substance is not used in production. 

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners? 

 x The petitioned substance is not used in production. 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

144
Decision Sheets 

December 2006 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance Arachidonic acid single-cell oil (ARA)

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown) 

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling? 

 x The substance is not petitioned for inclusion on 7 CFR 

§205.606 

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

 x 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

 x 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential 

function in a system of organic 

handling? 

 x 

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following: 

a. Regions of production (including 

factors such as climate and number of 

regions); 

 x 

b. Number of suppliers and amount 

produced; 

 x 

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

 x 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or 

 x 

145
Decision Sheets 

December 2006 

e. Are there other issues which may 

present a challenge to a consistent 

supply? 

 x 

146
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: ____Fall 2011__________ Substance: Color, Beta-carotene extract, derived from carrots

Committee: Crops  Livestock  Handling X Petitioned for annotation change from Beta-carotene extract color, 

derived from carrots (CAS# 1393-63-1) to beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7) on the 

National List § 205.606

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes X No  N/A 

3. Compatibility & Consistency Yes X No  N/A 

4. Not or Inconsistently Available as Organic Yes X No  N/A  

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): annotation change from Beta-carotene extract color, derived from carrots (CAS# 1393-63-1) to 

beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7)

 Basis for annotation: To meet criteria above: ________ Other regulatory criteria: The petition is to change the annotation for 

the current §205.606 listing of beta-carotene extract color to add beta-carotene derived from algae (see evaluation category #4 for 

details) and to change the CAS# to the correct one for beta-carotene. The current CAS# is for annatto extract Citation:__

D. Recommended Committee Action & Vote (State Motion): __Recommend changing the annotation for colors derived from 

agricultural products (3) Beta-carotene extract color, derived from carrots (CAS# 1393-63-1) to colors derived from agricultural 

products (3) beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7) 

________________________________________________________________________________________________________

Motion by: Heinze Seconded:_Demuri___ Yes: _4__ No: _0___ Absent: _3______ Abstain: _____ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205.606 with Annotation (if any) beta-carotene extract color, 

derived from carrots or algae (CAS#7235-40-7______________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural X Allowed1 X

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic Rejected3

No restriction Commercially UnAvailable as Organic1

 

Deferred4

147
Decision Sheets 

December 2006 

E. Approved by Committee Chair to transmit to NOSB:

___Steve Demuri_________ ___September 20, 2011____________

 Committee Chair Date

148
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - Color, Beta-carotene extract, 

derived from carrots

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 

[§205.600 b.2]

X Technical Review lines 531-545: “Production of betacarotene from (algae) will surpass synthetic as well as other 

natural sources due to microalgae sustainability of production 

and their renewable nature.”

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X Technical Review lines 531-545: “Production of betacarotene from (algae) will surpass synthetic as well as other 

natural sources due to microalgae sustainability of production 

and their renewable nature.”

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Naturally present in variety of agricultural products

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X See #11 below

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X Technical Review lines 136-140: Recognized as GRAS by 

FDA. Certification of the color not needed to protect human 

health

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X Technical Review lines 136-140, 385-416: Recognized as 

GRAS by FDA. 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X Technical Review lines 485-492

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

149
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance - Color, Beta-carotene extract, derived 

from carrots

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X Petition: Beta-carotene is produced from natural strains of the 

algae D. salina and is extracted from the algae using carbon 

dioxide, ethanol, or vegetable oil. 

Technical Report lines 243-248: Other extraction solvents 

that can be used to extract beta-carotene from algae are carbon 

dioxide, acetone, methanol, propan-2-ol, hexane, ethanol, and 

vegetable oil. Note that a previous NOSB recommendation 

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STE

LPRDC5088018&acct=nosb) recommended an annotation be 

added to the broad listing of colors, derived from agricultural 

products on §205.606. The added annotation change was 

“Must not be produced using synthetic solvents and carrier 

systems or any artificial preservative.”

Full description of manufacturing, derived from algae, is listed 

in Technical Review lines 325-346. The TR also describes 

synthetic sources of beta-carotene. These are not the subject 

of this petition.

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X Beta-carotene is extracted from the algae

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X Beta-carotene produced by strains of algae (petition and TR)

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Petitioned material is from a natural source

5. Is there an organic substitute? 

[§205.600 b.1]

X Beta-carotene derived from carrots was originally 

recommended for listing by the NOSB (see transcripts from 

Spring 2007 meeting) because of evidence that specific 

varieties of carrots/growing conditions were required to 

produce the color and none were available in organic form. 

This petition goes on (see question #1 above) to say that the 

color derived from carrots is not available in organic form 

because of the solvents that would be used for extraction. 

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X

 

Petitioner states that color is used to make products meet 

consumer expectations. 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X Petitioned material is from a natural source

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X Material is being petitioned for listing on §205.606. See 

category 4.

9. Is there any alternative 

substances? [§6518 m.6]

 X Beta-carotene extract derived from carrots is currently listed 

on §205.606. The petition is to add an annotation to also list 

beta-carotene extracted from algae. The petitioner states that 

beta-carotene extracted from carrots is not commercially 

available because use of synthetic solvents is required. The 

Technical Review supports that statement (lines 257-262, 353-

355).

150
Decision Sheets 

December 2006 

Technical Review states that annatto color may be used as an 

alternate in some applications. 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

151
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? Substance - Color, Beta-carotene 

extract, derived from carrots

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

X Use of colors in organic handling is fairly common. There are 

other colors on §205.606

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X Not used in farming. Use of colors in organic handling is 

fairly common

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is not used in agriculture.

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X Nutritional quality of food not affected by use of color.

5. Is the primary use as a 

preservative? [§205.600 b.4]

X Use is as a color in handling products

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X This material is not used to replace color lost during 

processing, but to enhance color of finished product to meet 

consumer expectations.

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds;

X Petitioned material is not for use in production

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

152
Decision Sheets 

December 2006 

Category 4. Is the agricultural substance inconsistently or not commercially available as organic? 

Substance - Color, Beta-carotene extract, derived from carrots

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

X The petitioner states that beta-carotene extracted from 

carrots is not commercially available because use of 

synthetic solvents is required. The Technical Review 

supports that statement (lines 257-262, 353-355).

2. Does the current and historical 

industry information, research, or

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling?

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quality to fulfill an essential function 

in a system of organic handling?

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quantity to fulfill an essential 

function in a system of organic 

handling?

X

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X See response to question #1. 

153
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: Fall 2011 Substance: DHA from Algal Oil 

Committee: Crops • Livestock • Handling X Petition is for: inclusion on the National List 7 

CFR, §205.605

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No • N/A •

2. Essential & Availability Criteria Yes X No • N/A •

3. Compatibility & Consistency Yes X No • N/A •

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes • No • N/A X 

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________ 

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________ 

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________ 

D. Recommended Committee Action & Vote (State Actual Motion): _ 

Motion is list the material as a non-synthetic, designating the material for §205.605(a) 

Motion by: _Tracy MIedema______________ Seconded:_Katrina Heinze_______________ Yes: 7_____ No: _0____ 

Absent: _______ Abstain: _____ 

Motion is to list the petitioned material, “DHA Algal Oil” on the National List 7 CFR, §205.605(a) as “DHA from Algal 

Oil” 

________________________________________________________________________________________________________

Motion by: _Tracy MIedema______________ Seconded:_Katrina Heinze_______________ Yes: 7_____ No: _0____ 

Absent: _______ Abstain: _____ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ______________________

________________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________ 

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 x 

Livestock Non-Synthetic x Prohibited2 

Handling x Synthetic Rejected3

No restriction 

Commercially UnAvailable as Organic1

 

Deferred4 

154
Decision Sheets 

December 2006 

E. Approved by Committee Chair to transmit to NOSB: 

Steve Demuri October 7, 2011 

 Committee Chair Date

155
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - _ DHA from Algal Oil 

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 1

[§205.600 b.2] 

 x The TR evaluated the petitioned substance and concluded that 

there are no adverse effects under this criterion. See TR lines

409-407 and 430-455; see also Question 2 below (statutory 

form of criterion) 

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3] 

 x The TR concluded that there are no adverse environmental 

impacts, noting that the sole solvent used is “recycled.” See 

generally TR lines 430-455 (describing inputs, manufacturing 

process and waste byproducts); (disposal method for biomass 

substrate for algal growth “eliminates” any possibility of 

adverse environmental impact); (noting that algae are grown 

and not wild-harvested so possibility of “excessive harvesting” 

is inapplicable); (no information that algal oil production has 

“adverse impact on biodiversity”); see also lines 407-409 

(noting FDA GRAS notice reported no heavy metals or 

pesticides detected in petitioned substance) 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

 x See Question 2 above, citing TR lines 407-409 and 430-455 

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is not used in production and contains no 

listed inerts. 

5. Is there potential for detrimental 

chemical interaction with other 

materials used?2

[§6518 m.1] 

 x No detrimental interactions were noted in the TR. See TR 

lines 123-151 (discussing combinations with substances) 

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. 

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

 x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. 

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

 x The substance is widely added to food products, including 

infant formulas, for its healthful benefits. See TR at lines 496-

524 The TR contains a chart at lines 775-776 that lists more 

 

1

The criteria set forth in 7 CFR §205.600(b) are applicable solely to “synthetic substances used as a processing aid 

or adjuvant.” The petitioned substance is not a processing aid or adjuvant. See TR at lines 49-50 The TR 

determined the petitioned substance be a “nonsynthetic.” See TR at line 298 (“the substance should be considered 

non-synthetic.”) Accordingly, the criteria listed in §205.600(b) are inapplicable to the petitioned substance. See e.g. 

7 CFR §205.600(c)(“Nonsynthetics...will be evaluated using the criteria [in the OFPA].”) However, the TR 

included review of most of these questions so the results are cited out of an abundance of caution.

2 The criterion appearing at 7 U.S.C. §6518(m)(1), applies only to “interactions with other materials used in organic 

farming systems.” Because this substance is petitioned as a handling material, this criterion appears inapplicable.

156
Decision Sheets 

December 2006 

§6518 m.4] than 10 countries, including the U.S., E.U., Canada, Japan, 

France, Belgium, U.K. etc. that have set reference intake 

levels of DHA for optimal health. The chart includes intake 

levels from leading organizations, such as the World Health 

Organization, World Association of Perinatal Medicine, Early 

Nutrition Academy and the Child Health Foundation. 

With regard to harmful effects, the TR reported that the 

scientific literature revealed no harmful effects for adults 

except those associated with “Consumption of high levels of 

DHA (in the form of fish oil)...” See TR at lines 463-494 

With regard to infant formula, no studies were cited that found 

adverse events reported to FDA have been treated as de 

minimis and below the threshold of regulatory significance by 

FDA. See TR at lines 463-494; See also #11 below 

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3] 

 x The petitioned substance is recognized as GRAS, and thus is 

considered safe under federal law, and is defined as a food 

additive that is properly used in foods, beverages and infant 

formula. It has no adverse impact on human health when used 

under normal conditions. The TR notes that specific GRAS 

notices were submitted by Petitioner that described DHA use 

levels for certain products, including infant formula and that 

“The notices were reviewed by FDA and at the time of 

submission, FDA had no questions about the proposed 

supplementation levels of DHA or the rationale behind adding 

DHA to the specific food products.” See TR at lines 804-06 

The TR cites reports of adverse events for adults based on 

excessive consumption via fish oil sources. See TR at lines

457-524. The safety of the substance is also evident in that 

adverse events reported to FDA regarding infant formula that 

contains DHA have been treated as de minimis and below the 

threshold of regulatory significance by the FDA See also #12 

below. 

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5] 

x See e.g. TR Line 670 (“DHA Algal Oil is a substance which is 

considered GRAS (FDA, 2001)”); TR lines 75-85 (citing FDA 

GRAS Notices No. GRN 000041 and No. GRN 000137) The 

GRAS notices establish that FDA has no objection to the use 

of DHA Algal Oil under the conditions of use. (FDA, 2001). 

In addition to GRAS status, when DHA Algal Oil appears as 

an ingredient in infant formulas, the manufacturers submit 

premarket notification to FDA under section 412 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA). Section 412 

of FFDCA describes the more stringent statutory requirements 

that apply to infant formula as compared to the regulation of 

other foods (FDA, 2006). 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5] 

 x The TR concluded the available literature demonstrates no 

heavy metal or other harmful residues have been detected in 

the petitioned product. See TR lines 403-424 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 

157
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance - DHA from Algal Oil

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)] 

x The TR concluded the algal oil is the product of a “naturally 

occurring biological process,” line 278, but the DHA 

extraction process is a “chemical process.” See TR at 279

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)] 

 x See TR line 298 (“the substance should be considered nonsynthetic.”); see also TR lines 288-292 (Applying National 

Organic Standards Board (NOSB) Joint Materials and 

Handling Committee draft policy: “extraction with a synthetic 

not on the National List would not result in a material being 

classified as synthetic unless either the extraction resulted in 

chemical change or the synthetic remained in the final material 

at a significant level.”) 

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)] 

x The TR concluded that the petitioned substance is the product 

a biological process. See TR lines 278-279 

4. Is there a natural source of the 

substance? [§205.600 b.1] 

 x DHA is found in fish flesh, eggs and marine algae. See TR 

lines 327-341 (noting fish, shellfish and egg sources). 

However, DHA must be extracted from the natural materials 

using extraction technologies. See TR lines 330-338 (noting 

extraction methodologies). For example, while fish oil 

appears on 7 CFR §205.606, it is not known if the processing 

necessary to obtain or isolate the DHA from fish oil renders 

the final food additive a synthetic or non-agricultural, nonsynthetic under 7 CFR §205.605. See e.g. TR at line 685 

(“DHA and EPA are components of fish oil but are not 

specifically regulated” by the GRAS specifications for fish 

oil)(italics in TR) 

5. Is there an organic substitute? 

[§205.600 b.1] 

 x There are no known certified organic sources of algal oil, nor 

certified organic sources of algal oil DHA. There are no 

certified organic sources of fish oil or DHA obtained from fish 

oil. 

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6] 

 

 x 

DHA Algal Oil is the most widely used source of DHA in 

infant formula. Unlike fish oil sources of DHA, DHA from 

algal oil is vegetarian, carries no risk of containing harmful 

environmental contaminants like mercury and does not deplete 

wild fish or algae stocks. See TR at lines 399-419 

In addition, DHA is currently widely used in organic foods. 

Consumers, seeing products labeled as both Organic and 

containing DHA have chosen to purchase these products. 

DHA is essential for consumers to continue to have access to 

these organic products. 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)] 

 x The petitioned substance is plant based non-synthetic, nonagricultural substance. There is no plant-based agricultural 

substitute for the petitioned substance.. 

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)] 

x The TR concluded the substance is a non-synthetic, nonagricultural substance. See TR line 298 (“the substance should 

be considered non-synthetic.”). 

9. Are there “alternatives to using 

the substance in terms of practices 

or other available materials”? 

 x According to the TR, there are no other plant-based sources of 

DHA. See TR lines 327-341 (noting fish, shellfish and egg 

sources). Fish sources of DHA require the animals be 

158
Decision Sheets 

December 2006 

[§6518(m)(6)] “cooked, then strained and pressed to extract the oil and other 

liquids.” TR at line 331 The TR noted that several factors 

can cause fish oil additives to “increase fishy off-flavors in 

milk,” see TR at lines 905-907, and that the various types of 

fish oil each behave differently in formulation and several 

types of antioxidants to “prevent oxidation and development 

of off-flavors” have been studied. TR at lines 910-917 Lastly, 

unlike animal-based DHA sources that require the animal be 

slaughtered, the TR notes the absence of any findings in the 

scientific literature that the algal source lessens biodiversity. 

See TR at line 455 

The breadth of uses for the petitioned substance also suggests 

that another material is unlikely to always be an acceptable 

substitute—“DHA Algal Oil is as an ingredient as a source of 

DHA in foods, beverages, infant formulas, and as a dietary 

supplement. Some of the foods and products the petitioner 

lists as intended or current foods to supplement with DHA 

Algal Oil include: cookies and crackers, breads and rolls, meat 

products, condiments, beverages (including flavored milk and 

milk products, soy milk, other dairy products, and juices), 

pasta, dietary supplements, and infant formula.” See TR at 

lines 49-54.

10. Is there an “alternative[s] to 

using the substance in terms of 

practices” that would make the 

substance unnecessary? [§6518 

(m)(6)] 

 x The petitioned substance is a food additive and there are no 

“practices” that substitute for its presence. 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 

159
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? Substance - DHA from Algal 

Oil

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is the substance compatible 

with organic handling? [§205.600 

b.2] 

x As noted earlier, the criteria set forth in 7 CFR §205.600(b) 

are applicable solely to “synthetic substances used as a 

processing aid or adjuvant.” The petitioned substance is not a 

processing aid or adjuvant. See TR at lines 49-50 The TR 

determined the petitioned substance be a “nonsynthetic.” 

For a lengthy description of the manufacturing process of this 

substance, please See TR lines 225-272 

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)] 

 x 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7] 

 x 

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3] 

x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”) 

5. Is the primary use as a 

preservative? [§205.600 b.4] 

 x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”) 

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4] 

 x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”) 

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories: 

a. copper and sulfur compounds; 

 x The substance is not used in production. 

b. toxins derived from bacteria; x The substance is not used in production. 

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals? 

 x The substance is not used in production. 

d. livestock parasiticides and 

medicines? 

 x The substance is not used in production. 

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners? 

 x The substance is not used in production. 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 

160
Decision Sheets 

December 2006 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance DHA from Algal Oil

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown) 

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling? 

 x The substance is not petitioned for inclusion on 7 CFR 

§205.606 

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

 x 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

 x 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential 

function in a system of organic 

handling? 

 x 

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following: 

a. Regions of production (including 

factors such as climate and number of 

regions); 

 x 

b. Number of suppliers and amount 

produced; 

 x 

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

 x 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

 x 

161
Decision Sheets 

December 2006 

temporarily restrict supplies; or 

e. Are there other issues which may 

present a challenge to a consistent 

supply? 

 x 

162
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: ____November 2011___ Substance: Potassium Hydroxide

Committee: Crops  Livestock  Handling X Petitioned for annotation change from ―Potassium hydroxide—

prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the Individually Quick Frozen 

(IQF) production process‖ to ―Potassium hydroxide—prohibited for use in lye peeling of fruits and vegetables except when used for 

peeling peaches‖ on the National List § 205.605(b)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes X No  N/A 

3. Compatibility & Consistency Yes X No  N/A 

4. Not or Inconsistently Available as Organic Yes X No  N/A  

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): annotation change from ―Potassium hydroxide—prohibited for use in lye peeling of fruits and 

vegetables except when used for peeling peaches during the Individually Quick Frozen (IQF) production process‖ to ―Potassium 

hydroxide—prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the canning or 

Individually Quick Frozen (IQF) production process‖

 Basis for annotation: To meet criteria above: ________ Other regulatory criteria: The petition is to change the annotation for 

the current §205.605 (b) listing of potassium hydroxide to add the allowed use of lye peeling of peaches for canning, in addition to 

peaches for freezing. Citation:__

D. Recommended Committee Action & Vote (State Motion): __Recommend changing the annotation for potassium hydroxide 

from ―Potassium hydroxide—prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during 

the Individually Quick Frozen (IQF) production process‖ – to ―Potassium hydroxide—prohibited for use in lye peeling of fruits and 

vegetables except when used for peeling peaches during the canning or Individually Quick Frozen (IQF) production process‖ on the 

National List § 205.605(b)

________________________________________________________________________________________________________

Motion by: DICKSON Seconded: MIEDEMA Yes: 6 No: 0 Absent: 1 Abstain: 0 

 

 

1) Substance voted to be added as ―allowed‖ on National List to § 205. X with Annotation (if any) prohibited for use in lye 

peeling of fruits and vegetables except when used for peeling peaches

2) Substance to be added as ―prohibited‖ on National List to § 205. with Annotation (if any) _________________________

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic X Rejected3

No restriction Commercially UnAvailable as Organic1

 

Deferred4

163
Decision Sheets 

December 2006 

E. Approved by Committee Chair to transmit to NOSB:

______________________________________ _________________________

 Committee Chair Date

164
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance – Potassium Hydroxide

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 

[§205.600 b.2]

X TAP lines 163-186: “Peach processing plants using lye 

peeling are generally restricted by state and local waste water 

treatment requirements, which has resulted in a limited 

number of plants and sites in operation (O„Bara, 2001). Data 

supplied by the petitioner indicates that alkalinity of waste is 

not a factor, due to the natural acidity of the fruit, which must 

be additionally buffered during on-site treatment (Finn, 

2001).”

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X See #1 above. 

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X See #1 above. 

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is no longer in the agro-ecosystem.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X TAP lines 193-194: “The petitioner has submitted 

experimental data showing no increase in potassium content of 

the fruit due to 193 the use of potassium hydroxide.”

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X See #10 above. 

12. Is the substance GRAS when 

used according to FDA‟s good 

manufacturing practices? [§205.600 

b.5]

X TAP lines 216-237: “Potassium Hydroxide is Generally 

Recognized As Safe under 21 CFR 184.1631. Federally 

approved food uses are 218 summarized in Table 1.” 

Referenced table includes used in peeling of fruits and 

vegetables, allowed under 21 CFR 173.315(a)(1) 

13. Does the substance contain X TAP lines 229-236

165
Decision Sheets 

December 2006 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

166
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance - Potassium Hydroxide

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X

The petition and the TAP describe the production method in 

detail. TAP lines 48-51:

Food grade potassium hydroxide is obtained 

commercially from the electrolysis of potassium 

chloride solution in the presence of a porous 

diaphragm [21 CFR 184.1631(a)]. The reaction can be 

characterized as follows: 

KCl + H2O → HCl + KOH

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X According to the TAP, the source potassium chloride is 

natural, but the process renders the resultant potassium 

hydroxide synthetic (lines 138-139). Potassium chloride 

occurs naturally as sylvite, and it can be extracted from 

sylvinite or from salt water. Potassium hydroxide is also a byproduct of the synthesis of nitric acid from potassium nitrate 

and hydrochloric acid.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X See #2.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Potassium hydroxide can be obtained naturally by the leaching 

of wood ash, but this method is not commercially practiced

(TAP lines 136-140). 

5. Is there an organic substitute? 

[§205.600 b.1]

X

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X

 

Petitioner states that this substance is the only viable method 

of commercial peach peeling, and as such, is used to make 

products meet consumer expectations. 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X TAP lines 141-143: 

Solutions of some natural acids such as citric and 

tartaric have been used to peel peaches. This works 

by disintegrating the peel and requires large volumes 

of water. It also prevents browning. However, this is 

not apparently used due to the corrosive effect of the 

solutions on metal equipment (Woodruff, 1986).

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X Substance is synthetic. 

9. Is there any alternative 

substances? [§6518 m.6]

 X

See #7. The only natural alternative is not commercially 

viable. 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

167
Decision Sheets 

December 2006 

Category 3. Is the substance compatible with organic production practices? Substance - Potassium Hydroxide

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

X 

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X This substance is used as an ingredient in an organic processed 

food. It is not used in agriculture.

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X Nutritional quality of food is not degraded, and is in some 

cases improved over other processing methods. 

5. Is the primary use as a 

preservative? [§205.600 b.4]

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds;

Petitioned material is not for use in production

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

168
Decision Sheets 

December 2006 

Category 4. Is the agricultural substance inconsistently or not commercially available as organic? 

Substance - Color, Beta-carotene extract, derived from carrots

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

X This is not an agricultural substance. 

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling?

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling?

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quantity to fulfill an essential 

function in a system of organic 

handling?

X

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

169
Decision Sheets 

December 2006 

Additional Background 

List: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as ―organic‖ or ―made with organic (specified ingredients or 

food group(s)).‖ (b) Synthetics allowed--Potassium hydroxide—prohibited for use in lye 

peeling of fruits and vegetables except when used for peeling peaches. 

Committee Summary 

Potassium hydroxide is a synthetic, inorganic compound produced by the electrolysis of 

potassium chloride. Also known as potash, it is a strong base and alkaline in solution. 

Much of its utility in food processing is based on its function as a caustic strong base. 

Potassium hydroxide is widely used in food processing as a pH adjuster, cleaning 

agent, stabilizer, thickener and poultry scald agent. It is also used in the lye peeling of 

fruits and vegetables. The FDA lists potassium hydroxide as GRAS for humans (21 

CFR 184.1631), which are allowed under 21CFR 173.315(a)(1) - Chemicals used in 

washing or to assist in the peeling of fruits and vegetables. In fruit and vegetable 

peeling, potassium hydroxide serves to weaken the glycolytic bonds of pectin, which is 

responsible for skin adhesion. Weakening these bonds allows the peeling of fruit and 

vegetable skins by water spray or other mechanical methods. 

In 1995, the NOSB approved the addition of potassium hydroxide to 205.605(b), with an 

annotation prohibiting its use in the lye peeling of fruits and vegetables. This restriction 

was based on concerns about the environmental effects of the waste products of the lye 

peeling process, and the fact that mechanical and non-chemical alternatives were 

available for most fruits and vegetables. 

In 2001, a petitioner sought to expand the use of potassium hydroxide by amending the 

annotation to read ―prohibited for use in lye peeling of fruits and vegetables except 

when used for peeling peaches during the Individually Quick Frozen (IQF) production 

process.‖ The 2001 TAP review for that expansion noted that ―The stone fruit (peaches, 

nectarines, and apricots) do not appear to currently have alternative methods available 

on a commercial scale to achieve peeling without the use of caustic substances.‖ The 

2001 TAP review also noted that the environmental effects which had originally resulted 

in the restrictive annotation could be mitigated with the use of good wastewater 

management practices. Peach processing plants are generally restricted by state and 

local wastewater treatment requirements, and the natural acidity of the fruit and 

additional pH adjusments buffer the alkalinity of the wastewater. Because no 

commercially viable alternatives are available, and processing practice mitigates the 

potential environmental effects, the NOSB approved the expanded annotation. 

A new petition from the same petitioner was filed in 2011, seeking to expand the 

annotation again to allow the use of potassium hydroxide for the peeling of fresh 

peaches to be canned. The petition confirms the lack of commercially viable alternatives 

for this use, and the mitigation of potential environmental impact. The processing of 

peaches for canning and freezing is identical up until the freezing or canning step. 

Based on the petition, the 2001 TAP review, and the rationale of the 2001 NOSB, the 

Handling Committee supports the expansion of this annotation to allow potassium 

hydroxide to be used in the peeling of both IQF and canned peaches. Accordingly, since 

170
Decision Sheets 

December 2006 

canning and freezing are the primary commercially processing methods used for 

peaches, we favor removing the language regarding IQF methods so that the exception 

to the prohibition on lye peeling applies to all peach peeling. 

Committee Recommendation(s) 

The handling committee recommends the expansion of the annotation of the following 

substance in this use category as published in the final rule: 

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as ―organic‖ or ―made with organic (specified ingredients or 

food group(s)).‖ (b) Synthetics allowed--Sulfur dioxide—Potassium hydroxide—

prohibited for use in lye peeling of fruits and vegetables except when used for peeling 

peaches. 

171
Decision Sheets 

Dec 2011 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: __Fall 2011-Savannah, GA_______ Substance: __Silicon Dioxide_______

Committee: Crops  Livestock  Handling X Petition is for: Removal of Silicon Dioxide from the National List § 205.605(b)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No  N/A 

2. Essential & Availability Criteria Yes  No X N/A 

3. Compatibility & Consistency Yes  No X N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A X 

B. Substance Fails Criteria Category: _2, 3__ Comments: Silicon Dioxide (synthetic) no longer meets criteria 2, 3 because a natural, certified 

organic alternative is available for organic processors for certain applications._______ 

C. Proposed Annotation (if any): _ 

205.605(b) Synthetics allowed—Silicon Dioxide—providing sufficient evidence showing natural alternatives are not commercially 

available for a specific produce/process is presented.__

 Basis for annotation: To meet criteria above: __2___ Other regulatory criteria: _______ Citation:_205.600(b)(1)____________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

_________________________________________________________________________________________________

Classification of the material: Synthetic _____ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _____

Recommended Committee Action & Vote ____Change annotation—see Committee Recommendation______

____________________________________________________________________________________________________

 

Motion by: __John Foster Seconded:_Steve DeMuri_ Yes: _5 No: _1_ Absent: __1__ Abstain: _0_

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) (b) Synthetics allowed—Silicon 

Dioxide—providing sufficient evidence showing natural alternatives are not commercially available for a specific product/process is 

presented.

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops Agricultural Allowed1 

x

Livestock Non-Synthetic Prohibited2 

Handling x Synthetic x Rejected3

No restriction Commercially UnAvailable as Organic1

 

Deferred4

E. Approved by Committee Chair to transmit to NOSB:

_Steve Demuri_________________________ ___October 4, 2011_______________

 Committee Chair Date

172
Decision Sheets 

Dec 2011 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

 

Category 1. Adverse impacts on humans or the environment? Substance __ Silicon Dioxide ______

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Are there adverse effects on environment from 

manufacture, use, or disposal? [§205.600 b.2] 

x 7/29/10 Petition pg. 3

1996 TAP questions. 1, 3

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? [§6518 

m.3] 

X 1996 TAP (Montecalvo, Jefferey) reviews 

questions. 2, 3

3. Is the substance harmful to the environment and 

biodiversity? [§6517c(1)(A)(i);6517(c)(2)(A)i] 

X CP Kelco 2005 Petition to keep SiO2 on 

list, pg 1

1996 TAP questions 1, 2,3, 5 (Montecalvo, 

Jefferey, Zimmer)

4. Does the substance contain List 1, 2, or 3 

inerts? [§6517 c (1 ) (B)(ii); 205.601(m)2] 

X The petition and TAP do not note any

5. Is there potential for detrimental chemical 

interaction with other materials used? [§6518 

m.1] 

X 1996 TAP (Jefferey, Montecalvo)

7/29/10 Petition to remove, pg. 3

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5]

X 1996 TAP (TR (Jefferey, Montecalvo) 

questions 2, 5

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5] 

X This is a handling material

8. Is there a toxic or other adverse action of the

material or its breakdown products? 

[§6518 m.2] 

X 1996 TAP

7/29/10 Petition to remove, pg. 3

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment? [§6518 m.2] 

X 1996 TAP questions: 2, 3, 5, 7

7/29/10 Petition to remove, pg. 3

CP Kelco 2005 Petition to keep SiO2 on 

list, pg 1

10. Is there any harmful effect on human health? 

[§6517 c (1)(A) (i) ; 6517 c(2)(A)I; §6518 

m.4] 

X Only with improper use/handling.

MSDS

1996 TAP, question 4

7/29/10 Petition to remove, pg 3

11. Is there an adverse effect on human health as 

defined by applicable Federal regulations? 

[205.600 b.3] 

X NOSB materials database information

7/29/10 Petition to remove, pg 3

12. Is the substance GRAS when used according to

FDA’s good manufacturing practices? 

[§205.600 b.5] 

X NOSB materials database information

13. Does the substance contain residues of heavy 

metals or other contaminants in excess of FDA 

tolerances? [§205.600 b.5] 

X Petition and TAP do not mention any.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

173
Decision Sheets 

Dec 2011 

Category 2. Is the Substance Essential for Organic Production? Substance __ Silicon Dioxide _ 

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Is the substance formulated or manufactured by 

a chemical process? [6502 (21)] 

x 7/29/10 petition to remove, pg 2

1996 TAP 

1/20/10 pg 1 Ribus Letter to Miles 

McEvoy

2. Is the substance formulated or manufactured by 

a process that chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral, sources? [6502 (21)] 

X 7/29/10 petition to remove, pg 2

1996 TAP 

NOSB Materials Database

3. Is the substance created by naturally occurring 

biological processes? [6502 (21)] 

X 7/29/10 petition to remove, pg 2

1996 TAP 

NOSB Materials Database

4. Is there a natural source of the substance? 

[§205.600 b.1] 

X Yes, but not in functional amounts

1996 TAP 

5. Is there an organic substitute? [§205.600 b.1] X 7/29/10 Ribus petition to remove, pg 11

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

X The function it performs is essential; not 

the substance

7/29/10 petition to remove, pg 11

7. Is there a wholly natural substitute product? 

[§6517 c (1)(A)(ii)]

X 7/29/10 petition to remove, pg 11

8. Is the substance used in handling, not synthetic, 

but not organically produced? [§6517 c 

(1)(B)(iii)]

X 1996 TAP 

NOSB materials database

7/29/10 petition to remove, pg 1-11

9. Is there any alternative substances? [§6518 m.6] X 1996 TAP 

7/29/10 petition to remove, pg 1-11

1/20/10 pg 1 Ribus Letter to Miles 

McEvoy

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X Using an alternate compound only.

7/29/10 petition to remove, pg 1-11

1996 TAP 

1/20/10 pg 1 Ribus Letter to Miles 

McEvoy

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

 

174
Decision Sheets 

Dec 2011 

Category 3. Is the substance compatible with organic production practices? Substance ___ Silicon Dioxide 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible with

organic handling? [§205.600 b.2] 

X Synthetic substance and only needed if no 

alt. substances are avail.

1996 TAP review (Montecalvo)

2. Is the substance consistent with organic 

farming and handling, and biodiversity? 

[§6517 c (1)(A)(iii); 6517 c (2)(A)(ii)] 

X Synthetic substance and only needed if no 

alt. substances are avail.

1996 TAP review (Montecalvo)

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518 m.7] 

x This is a handling input. No negative 

impact on environment following use.

7/29/10 Petition pg. 3

1996 TAP questions. 1, 3

4. Is the nutritional quality of the food maintained 

with the substance? [§205.600 b.3] 

X TAP and petition do not note any.

5. Is the primary use as a preservative? [§205.600 

b.4] 

X 7/29/10 petition to remove, pg 1

NOSB materials database

1996 TAP review

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values lost 

in processing (except when required by law, 

e.g., vitamin D in milk)? [205.600 b.4] 

X 7/29/10 petition to remove, pg 1

NOSB materials database

1996 TAP review

7. Is the substance used in production, and does it 

contain an active synthetic ingredient in the 

following categories: 

X 

a. Copper and sulfur compounds; X

b. Toxins derived from bacteria; X

c. Pheromones, soaps, horticultural oils, fish 

emulsions, treated seed, vitamins and 

minerals? 

X

d. Livestock parasiticides and medicines? X

e. Production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row 

covers, and equipment cleaners? 

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

175
Decision Sheets 

Dec 2011 

Category 4. Is the commercial supply of an agricultural substance as organic, 

fragile or potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 

(c) 205.2, 205.105 (d), 205.600 (c)] 

Substance:_ Silicon Dioxide _

Question Yes No N/A Comments on Information Provided 

(sufficient, plausible, reasonable, 

thorough, complete, unknown)

1. Is the comparative description provided as to 

why the non-organic form of the material 

/substance is necessary for use in organic 

handling?

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling?

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling?

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

5. Does the industry information provided on 

material / substance non-availability as 

organic, include ( but not limited to) the 

following:

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

a. Regions of production (including factors 

such as climate and number of regions);

X The petition is for removal of SiO2 from 

205.605 The petition is for removal of SiO2 

from 205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

b. Number of suppliers and amount produced; X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

c. Current and historical supplies related to 

weather events such as hurricanes, floods, 

and droughts that may temporarily halt 

production or destroy crops or supplies; 

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil unrest 

that may temporarily restrict supplies; or

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

e. Are there other issues which may present a 

challenge to a consistent supply?

X The petition is for removal of SiO2 from 

205.605

7/29/10 Petition to remove proposes use of 

organic alternative to SiO2

176
National Organic Standards Board 

Handling Committee 

Proposed Recommendation 

Silicon Dioxide 

October 14, 2011 

List: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified ingredients 

or food group(s)).” 

 (b) Synthetics allowed--Silicon dioxide. 

Committee Summary 

Silicon dioxide is a naturally occurring substance that is generated following oxidation 

reactions involving silicon in the Earth’s crust. Silicon dioxide is a major component in sand, 

quartz, diatomaceous materials, and is found as biogenic silica in organisms. Silicon dioxide’s 

(chemical formula is SiO2) exists both as a amorphous and crystalline structures and is 

frequently found in a three-dimensional polytetrahydral structure where the two oxygen atoms 

of one SiO2 molecule are associated with a silicon atom of another SiO2 molecule. This 

molecular association generates structures exhibiting unique properties such as immiscibility in 

both water and oil and an extremely large surface area. These characteristics have been 

capitalized upon for their functionally in a diverse set of applications and industries including 

(but not limited to): glass production, ceramics, optical cable fiber production, food processing, 

food packaging, pharmaceutical production/packaging, soil amendments, and as inert 

compounds/carrier systems within pesticides. While silicon dioxide is found in natural sources, 

most industrial applications use silicon dioxide generated from synthetic sources/processes. 

The food industry frequently uses a silicon dioxide as its properties allow for enhanced 

process-ability and functionality in food products and manufacturing practices. Some common 

applications of silicon dioxide in the food industry are: as an anti-caking agent (most common 

application), an anti-foam agent, a stabilizer in beer production, an adsorbent in foods 

prepared as tablets for special dietary use, as carriers (such as a component of microcapsules 

for flavoring oils), and for various other uses allowed under jurisdiction of the FDA. Silicon 

dioxide is also allowed internationally for various uses in food products (in both conventional 

and organic foods) by the European Union, Codex, Canada, Japan, and by IFOAM for organic 

processing. 

In 2010 the NOSB voted to relist silicon dioxide despite knowing that an application to remove 

silicon dioxide was at the NOP. During the relisting process, the Handling Committee 

produced the following concerns based upon debate and information presented during the 

sunset review process: 

1. The Handling Committee has discussed and collectively agrees that there is the need 

to encourage the growth of agricultural--and preferably organic--alternatives to 

nonagricultural substances presently allowed on the National List for use in organic 

handling operations, and considers this to be just such an opportunity. 

177
Page 2 of 4

October 10, 2011

Petition to Remove Silicon Dioxide-Handling

2. Public comment indicates that while organic alternatives exist that may replace silicon 

dioxide as currently listed, the Handling Committee is concerned that applicable

alternatives do not exist for sufficient uses and applications of silicon dioxide in organic 

handling. 

Given the above concerns, the NOSB voted to relist silicon dioxide and publically note that 

additional information, data, and clarification of processors’ needs regarding silicon dioxide 

would be needed for future deliberation during the upcoming discussion on silicon dioxide’s 

removal from § 205.605(b). 

As such, § 205.605(b) today allows silicon dioxide to be utilized in organic foods labeled in the 

“organic” and “made with organic” categories. The petition currently under consideration is to 

remove its listing on § 205. 605(b), stating there now exists a viable, non-synthetic, certified 

organic substitute to silicon dioxide available from a rice-hull based material. This alternative 

substance exhibits similar functional properties as silicon dioxide since it is produced from rice 

hulls which naturally contain a high concentration of silica. In addition, the current petition 

claims that the rice-hull product’s applicability should not be in question as: 

“The proposed rice concentrate has been produced and sold in commercial quantities 

(domestically and internationally) to organic and natural food / feed producers for many 

of the exact same uses as SiO2.” 

While an extensive review has been completed by the Handling Committee concerning the 

environmental, health, and applicability concerns of synthetic dioxide from the TAP reviews, 

previous petitions, prior NOSB discussions; the primary consideration/debate for whether or 

not synthetic silicon dioxide should remain on § 205.605(b) is rooted in consideration of § 

205.600(b)(1) which states: 

The following criteria will be utilized in the evaluation of substances or ingredients for 

the organic production and handling sections of the National List: 

(b) In addition to the criteria set forth in the Act, any synthetic substance used as a 

processing aid or adjuvant will be evaluated against the following criteria: 

(1) The substance cannot be produced from a natural source and there are no organic 

substitutes 

Given this section of the regulation, and the charge of the NOSB to make decisions consistent 

with the overall intent of the regulation, the NOSB has considered the current petition to 

remove silicon dioxide by analyzing the previous information as to why synthetic silicon dioxide 

was originally listed on § 205.605(b). Resultant of this analysis, it has been concluded that 

silicon dioxide was previously listed due its unique properties and its overall safety and limited 

environmental concerns. However, since the initial listing, the following new information 

regarding a new agricultural substitute has been presented: 

178
Page 3 of 4

October 10, 2011

Petition to Remove Silicon Dioxide-Handling

Table 1. Use Rates of Organic Rice Concentrate vs. SiO2

 2007-2008* 2009-Present* 

 Spice Blends 1:1 or 1.2:1 1:1 

 Dry Beverages Did not work 1:1 

 Dried Fruit Did not work 1:1 

Tablets 1.1 or 1.2:1 1:1 

 Sauce Mixes 1.1 or 1.2:1 1:1 

 Flavor Carrier (oil & water) 1.2:1 0.8:1 or 1:1 

*Ratios are expresses as rice concentrate: SiO2

The above table from the petition attempts to demonstrate that the rice-hull based alternative 

described in the 2010 petition to remove silicon dioxide has been available since 2007 and has 

undergone reformulation in 2009 such that it now can be substituted for silicon dioxide nearly 

1:1 ratios. Given this new information, the NOSB must determine whether sufficient evidence 

has been presented by the petitioner as to whether this natural organic alternative is sufficient 

in all applications to remove silicon dioxide from § 205.605(b). 

While the new data does address concerns noted by the Handling Committee during the 

Sunset review process; the Handling Committee feels that it is still limited, not published from a 

third party source, and does not conclusively demonstrate its applicability in all products and 

processes. However, while the data presented in this petition is not sufficient to completely 

remove silicon dioxide, the Handling Committee feels that the availability of a natural 

alternative must be acknowledged. 

Therefore, with respect to the change in NOSB Policy and Procedures Manual, the Handling 

Committee did not vote to remove silicon dioxide in its entirety but recommends a change to 

the annotation to silicon dioxide as noted below to be consistent with the intent of § 

205.600(b)(1). 

Committee Recommendations 

1. Motion to remove the following substance: 

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” 

(b) Synthetics allowed—Silicon dioxide

179
Page 4 of 4

October 10, 2011

Petition to Remove Silicon Dioxide-Handling

Committee Vote 

Motion: John Foster Second: Steve DeMuri 

Yes: 0 No: 5 Abstain: 0 Absent: 2 

2. Motion to amend the annotation of the following substance: 

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” 

(b) Synthetics allowed—Silicon dioxide—providing sufficient evidence showing natural 

alternatives are not commercially available for a specific product/process is presented.

Committee Vote 

Motion: John Foster Second: Steve DeMuri 

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

180
Decision Sheets 

December 2011 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: Fall 2011 Savannah, GA Substance: Sulfur dioxide

Committee: Crops  Livestock x Handling  Petition is for: 

Amendment of Sulfur dioxide annotation from the National List § 205.605(b)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes  No x N/A 

2. Essential & Availability Criteria Yes x No  N/A 

3. Compatibility & Consistency Yes x No  N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A x 

Substance Fails Criteria Category: Comments: Annotation provides adequate mitigating conditions. 

Proposed Annotation (if any): § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as 

“organic” or “made with organic (specified ingredients or food group(s)).” (b) Synthetics allowed--Sulfur dioxide—for use only in wine, 

provided that total sulfite concentration does not exceed 100 ppm.

 Basis for annotation: To meet criteria above: __1___ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

_________________________________________________________________________________________________

Classification of the material: Synthetic ________ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _____

Recommended Committee Action & Vote § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” (b) Synthetics allowed--Sulfur dioxide—for use 

only in wine, provided that total sulfite concentration does not exceed 100 ppm.

 

Motion by: ___John Foster_ Seconded:___Steve DeMuri_ Yes: __5 No: _0_ Absent: __2__ Abstain: _0_

 

1) Substance voted to be added as “allowed” on National List to § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or 

on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” (b) Synthetics allowed--Sulfur 

dioxide—for use only in wine, provided that total sulfite concentration does not exceed 100 ppm.

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

____________________________________________________________________________________________________

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

4) Substance was recommended to be deferred because _________________________________________________________

If follow-up needed, who will follow up _____________________________________________________________________

Crops Agricultural Allowed1 

x

Livestock Non-Synthetic Prohibited2 

Handling x Synthetic x Rejected

3

No restriction Commercially UnAvailable as Organic1

 

Deferred4

E. Approved by Committee Chair to transmit to NOSB:

Steve DeMuri 10-14-10

Committee Chair Date

181
Decision Sheets 

December 2011 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

 

Category 1. Adverse impacts on humans or the environment? Substance: sulfur dioxide

 

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Are there adverse effects on environment 

from manufacture, use, or disposal? 

[§205.600 b.2] 

X Yes, but not at levels used TAP 9-26-11 

Draft ln 422-424.

TAP 9-26-11 Draft ln 84-89

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3] 

X Yes, but not at levels used TAP 9-26-11 

Draft ln 422-424.

TAP 1-14-11 ln 68-73, 270-275, 277-

281; TAP 9-26-11 Draft ln 84-89, ln 

406-414.

3. Is the substance harmful to the environment

and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X N/A-for handling purposes

4. Does the substance contain List 1, 2, or 3 

inerts? [§6517 c (1 ) (B)(ii); 205.601(m)2] 

X N/A-for handling purposes

5. Is there potential for detrimental chemical 

interaction with other materials used? 

[§6518 m.1] 

X

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5]

X N/A-for handling purposes

7. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518 m.5] 

X N/A-for handling purposes

8. Is there a toxic or other adverse action of the 

material or its breakdown products? 

[§6518 m.2] 

X Yes, but not at levels used TAP 9-26-11 

Draft ln 422-424.

TAP 9-26-11 Draft ln 84-89

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment? [§6518 m.2] 

X Yes, but not at levels used TAP 9-26-11 

Draft ln 422-424.

TAP 9-26-11 Draft ln 84-89. TAP 1-14-

11 422-434; 

10. Is there any harmful effect on human health? 

[§6517 c (1)(A) (i) ; 6517 c(2)(A)I; §6518 

m.4] 

X TAP 1-14-11 ln; TAP 9-26-11 Draft ln 

434-459, 461-462;

11. Is there an adverse effect on human health as 

defined by applicable Federal regulations? 

[205.600 b.3] 

X TAP 1-14-11 ln 440-445, 447-477; 21 

CFR 182.3762; TAP 9-26-11 Draft ln 

430-432. 1995 TAP Bob Durst.

12. Is the substance GRAS when used according 

to FDA’s good manufacturing practices? 

[§205.600 b.5] 

X TAP 9-26-11 Draft ln 338-347; 21 CFR 

182.3762

13. Does the substance contain residues of heavy 

metals or other contaminants in excess of 

FDA tolerances? [§205.600 b.5] 

X TAP 9-26-11 Draft ln 395-396;

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

182
Decision Sheets 

December 2011 

Category 2. Is the Substance Essential for Organic Production? Substance sulfur dioxide

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; 

other)

1. Is the substance formulated or manufactured 

by a chemical process? [6502 (21)] 

X TAP 1-14-11 ln 258-265. 

2. Is the substance formulated or manufactured 

by a process that chemically changes a 

substance extracted from naturally occurring 

plant, animal, or mineral, sources? [6502 

(21)] 

X Possible: TAP 9-26-11 Draft ln 402-

403; 1995 TAP R.C. Theuer. 

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)] 

X TAP 1-14-11 ln 258; TAP 9-26-11 Draft 

ln 

4. Is there a natural source of the substance? 

[§205.600 b.1] 

X TAP 1-14-11 ln 258-260. TAP 9-26-11 

Draft 322-331; 1995 TAP R.C. Theuer.

5. Is there an organic substitute? [§205.600 b.1] X

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

X TAP 9-26-11 Draft 327-328. 1995 TAP 

Bob Durst. TAP 9-26-11 Draft ln 172-

176.

7. Is there a wholly natural substitute product? 

[§6517 c (1)(A)(ii)]

X TAP 9-26-11 Draft ln 467-478. 1995 

TAP R.C. Theuer.

8. Is the substance used in handling, not 

synthetic, but not organically produced? 

[§6517 c (1)(B)(iii)]

X N/A- Synthetic

9. Is there any alternative substances? [§6518 

m.6]

X TAP 9-26-11 Draft ln 467-478. 1995 

TAP Bob Durst

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X TAP 9-26-11 Draft ln 467-478

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b)are N/A—not applicable. 

 

183
Decision Sheets 

December 2011 

Category 3. Is the substance compatible with organic production practices? Substance; sulfur dioxide

 

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Is the substance compatible with

organic handling? [§205.600 b.2] 

X

2. Is the substance consistent with organic 

farming and handling, and biodiversity? 

[§6517 c (1)(A)(iii); 6517 c (2)(A)(ii)] 

X N/A-for handling purposes

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518 m.7] 

X N/A-for handling purposes

4. Is the nutritional quality of the food 

maintained with the substance? [§205.600 

b.3] 

X TAP 9-26-11 Draft ln 387-389.

5. Is the primary use as a preservative? 

[§205.600 b.4] 

X TAP 9-26-11 Draft ln 377. 1995 TAP 

R.C. Theuer

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law, e.g., vitamin D in milk)? [205.600 b.4] 

X TAP 9-26-11 Draft ln 377

7. Is the substance used in production, and does 

it contain an active synthetic ingredient in 

the following categories: 

X N/A-for handling purposes

a. Copper and sulfur compounds; X N/A-for handling purposes

b. Toxins derived from bacteria; X N/A-for handling purposes

c. Pheromones, soaps, horticultural oils, fish 

emulsions, treated seed, vitamins and 

minerals? 

X N/A-for handling purposes

d. Livestock parasiticides and medicines? X N/A-for handling purposes

e. Production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners? 

X N/A-for handling purposes

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

184
Decision Sheets 

December 2011 

Category 4. Is the commercial supply of an agricultural substance as 

organic, fragile or potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 

(d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

 

Substance: sulfur dioxide

Question Yes No N/A Comments on Information Provided 

(sufficient, plausible, reasonable, 

thorough, complete, unknown)

1. Is the comparative description provided as to 

why the non-organic form of the material 

/substance is necessary for use in organic 

handling?

X Petition is to amend annotation of an all ready 

allowed synthetic.

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential function 

in a system of organic handling?

X N/A.

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling?

X N/A.

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X N/A.

5. Does the industry information provided on 

material / substance non-availability as organic, 

include ( but not limited to) the following:

X

a. Regions of production (including factors such 

as climate and number of regions);

X

b. Number of suppliers and amount produced; X

c. Current and historical supplies related to 

weather events such as hurricanes, floods, 

and droughts that may temporarily halt 

production or destroy crops or supplies; 

X

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil unrest 

that may temporarily restrict supplies; or

X

e. Are there other issues which may present a 

challenge to a consistent supply?

X

185
National Organic Standards Board 

Handling Committee 

Sunset 2013 Proposed Recommendation 

Animal Enzymes on §205.605(a) 

August 16, 2011 

List: 205.605 Nonagricultural (nonorganic) substances allowed as 

ingredients in or on processed products labeled as “organic” or “made 

with organic (specified ingredients or food group(s)).” 

(a) Nonsynthetics allowed 

Committee Summary: 

Federal register notice of the sunset of these materials elicited no public 

comments against re-listing. 

Review of the original recommendation, historical documents, and public 

comments does not reveal unacceptable risks to the environment, human, or 

animal health as a result of the use or manufacture of this material. There is no 

new information contradicting the original recommendation which was the basis 

for the previous NOSB decision to list this material. 

Committee Vote:

The handling committee recommends the renewal of the following substance in 

this use category as published in the final rule: 

Animal enzymes—(Rennet—animals derived; Catalase—bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin). 

Moved: Steve DeMuri Second: Katrina Heinze 

Yes: 5 No: 0 Abstain: 0 Absent: 2 

186
National Organic Standards Board 

Handling Committee 

Sunset 2013 Proposed Recommendation 

Tartaric acid on §205.605(a) and §205.605(b) 

October 4, 2011 

List: National Organic Program Subpart G: The National List of Allowed and 

Prohibited Substances. §205.605 Nonagricultural (nonorganic) substances 

allowed as ingredients in or on processed products labeled as “organic” or 

“made with organic (specified ingredients or food group(s)).”

(a) Nonsynthetics allowed AND 

(b) Synthetics allowed

Committee Summary: 

Tartaric acid is currently included on the National List §205.605 Nonagricultural 

(nonorganic) substances allowed as ingredients in or on processed products labeled as 

“organic” or “made with organic (specified ingredients or food group(s)).” This material 

is listed both as a Nonsynthetic allowed with an annotation of “made from grape wine” 

(§205.605 (a)) and a Synthetic allowed with an annotation of “made from malic acid” 

(§205.605 (b)).

Tartaric acid was added in both locations through a Federal Register notice on 

October 31, 2003 (61988 Federal Register, Volume 68, No. 211, #61988) resulting 

from a October 31, 1995 NOSB recommendation. Transcripts from that meeting are 

included below: 

“Tartaric Acid (Made from grape wine)

Determined to be non-synthetic; Vote – Unanimous (1 absent). 

The NOSB’s decision is to allow this material for use in organic food 

processing; 

Vote – Unanimous (1 absent). 

“Tartaric Acid (Made from malic acid) 

Determined to be synthetic; Vote – Unanimous (1 absent). 

The NOSB’s decision is to allow this material for use in organic food 

processing; 

Vote: 10 aye / 4 opposed. 

Both listings of tartaric acid were recommended by the NOSB for relisting as part of 

the sunset process at the May 2008 meeting. The non-synthetic listing, “made from 

grape wine,” was recommended for relisting by a vote of 13 yes, 1 abstention and 1 

absent. The synthetic listing, “made from malic acid,” was recommended for 

relisting by a vote of 10 yes, 3 no, 1 abstention and 1 absent. At the meeting public 

comment was received saying that the two sources of tartaric acid result in materials 

187
Page 2 of 2 

Tartaric acid on §205.605(a) and §205.605(b) 

October 4, 2011 

with different properties that are used in different applications but that the 

predominant form of tartaric acid on the market is made from grape(s) or grape wine. 

No public comment was received at that meeting indicating that tartaric acid made 

from malic acid and listed on §205.605(b) was no longer necessary. The board 

recommendation from the May 2008 meeting said, “A petition to remove tartaric acid 

made from malic acid from 205.605 b) would allow for the fuller reconsideration of 

the listing of material as well at a future date.”

The listings of tartaric acid on both sections of §205.605 are due for a sunset review 

by 2013 (Federal Register Vol. 76, No. 105: AMS–NOP–11–0003). In response to 

this Federal Register notice, six public comments have been received with all 

supporting the relisting of tartaric acid. Specifically to the §205.605a non-synthetic 

listing, four public comments supported the relisting and one supported relisting or 

moving to §205.606 if there was sufficient evidence to demonstrate that it could be 

produced organically in appropriate form, quality and quantity. For the §205.605b 

synthetic listing, four public comments supported the relisting. One public comment 

supported relisting tartaric acid but did not indicate whether that support was for one 

or both listings. 

In early September 2011 the NOSB received a petition for removal of tartaric acid 

from §205.605b. The petition indicates that there are no functional differences 

between the tartaric acid sourced from grape wine or from malic acid and that there 

is sufficient tartaric acid sourced from grape wine. Additionally, the petition goes on 

to say that tartaric acid is not sourced from malic acid but rather maleic anhydride. A 

Technical Review has been requested from the National Organic Program. It is 

expected to be completed by the end of October to allow for public comment. 

Should it not be received, the Handling Committee intends to defer a vote on this 

material until the spring 2012 meeting. 

At this time however, we believe that there is insufficient evidence to support the 

need for both listings of tartaric acid. In two sunset reviews, we have received little 

public comment providing technical reasons why a synthetic source and form is 

needed when the non-synthetic source/form is the predominant version available. 

Committee Vote 

The Handling Committee recommends renewal of Tartaric Acid, made from grape wine 

on the National List section §205.605(a) 

Moved: Katrina Heinze Second: Steve Demuri 

Yes: 6 No: 0 Absent: 1 Abstain: 0 Recuse: 0

The Handling Committee recommends renewal of Tartaric Acid, made from malic acid 

on the National List section §205.605(b) 

Moved: Katrina Heinze Second: Steve Demuri 

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

188
National Organic Standards Board 

Handling Committee 

Proposed Recommendation 

Chlorine Materials 

October 5, 2011 

List: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in 

or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).” 

 (b) Synthetics allowed--Chlorine materials.

Committee Summary 

Chlorine is a member of the salt-forming halogen series, combines readily with many 

other elements, and is extracted from chlorides through oxidation often by electrolysis. 

With metals, it forms salts called chlorides. As the chloride ion, Cl−, it is also the most 

abundant dissolved ion in ocean water. In nature, chlorine is found primarily as the 

chloride ion, a component of the salt that is deposited in the earth or dissolved in the 

oceans — about 1.9% of the mass of seawater is chloride ions and is not infrequently 

found in higher natural concentrations as well. In industry, elemental chlorine is usually 

produced by the electrolysis of sodium chloride dissolved in water. 

Chlorine compounds are the most common equipment and food contact sanitizers used 

in the food processing and handling and are recognized by the FDA as being 

appropriate for their intended use. The health and environmental hazards associated 

with its manufacture and use are well researched and are mitigated through worker 

protection protocols, Good Manufacturing Practices, and oversight by local, state and 

federal agencies. The food processing community, pre-NOP certification programs, and 

past NOSB decisions have determined that—coupled with these mitigating features—

the proven efficacy and reliability of these chlorine materials in support of food safety 

concerns outweighs the risks. 

The annotations limiting the use of chlorine in §205.601(a) (2), §205.603(a)(7), and 

§205.605(b), do not align with a November 1995 NOSB recommendation on chlorine 

materials. This recommendation stated that chlorine materials should be allowed for use 

in organic crop production, organic food processing, and organic livestock production 

with the following annotation: 

 “Allowed for disinfecting and sanitizing food contact surfaces. Residual 

chlorine levels for wash water in direct crop or food contact and in flush 

water from cleaning irrigation systems that is applied to crops or fields 

cannot exceed the maximum residual disinfectant limit under the Safe 

Drinking Water Act (currently 4mg/L expressed as Cl2).” 

189
Page 2 of 3

Annotation Recommendation Chlorine Materials

October 5, 2011

This annotation was crafted to acknowledge that levels of chlorine permitted in 

municipal drinking water were considered acceptable for organic food production and 

handling. The language used in the proposed NOP rule published in March 2000 did not 

include the terms “in direct crop or food contact” and “in flush water ... that is applied to 

crops or fields.” The language used under §205.605 (handling uses) only mentions use 

in disinfecting food contact surfaces, leading some handlers to question whether 

chlorine could be used in direct food contact. The NOP responded in the preamble of 

the final rule (65 FR 80548, 80616, December 21, 2000) which stated that the use of the 

term “residual chlorine” referred to the chlorine that was present in water when it exited 

the facility as effluent. 

The NOSB revisited the issue through a May 2003 recommendation. At that time, the 

NOSB noted that “residual chlorine” is a scientific term used when measuring chlorine. 

Residual chlorine (also called free or available chlorine) is the chlorine that remains 

available in solution after the disinfection step is complete, when the initial added 

chlorine material has been reduced by reaction, bound to the organic matter, or 

evaporated. The residual chlorine is what is still available to oxidize other substances. 

Residual chlorine is the fraction of available chlorine in solution derived from the 

disinfectant source. When calcium hypochlorite or sodium hypochlorite is used, the 

proper measure for residual chlorine is the sum of the concentrations of hypochlorous 

acid (HOCl) and hypochlorite ion (OCl-). For chlorine dioxide (ClO2), all unreacted 

chlorine is considered to be free chlorine. Another frequently used term is total chlorine, 

which is a measurement of the free plus inactive forms. 

In 2003, the NOSB stated: “The Organic Foods Production Act is not designed to 

function as a waste water regulation. Instead, it is a regulation designed to protect 

organic integrity. As such, processing operations must demonstrate compliance with the 

chlorine annotation by monitoring the chlorine content of the water which is in direct 

contact with organic products, not the wash water which is discharged from the facility.” 

In December 2010, the NOP issued draft guidance clarifying the use restrictions of 

chlorine materials in organic production and handling (the background of which is 

provided again within this recommendation). On review and consideration of this draft 

guidance, informed by public comment and review of a new TR provided by the NOP 

(supplied for Crops Committee sunset review), and with respect to the change in NOSB 

Policy and Procedures Manual, the Handling Committee wishes to recommend a 

change to the annotation to chlorine materials as noted below. 

Additionally, the Handling Committee would like to note that other chlorine compounds, 

such as hypochlorous acid, may be appropriate materials to add to the annotation upon 

appropriate review, recommendation and Board vote. 

Committee Recommendation 

The Handling Committee recommends the annotation of the following substance as 

follows: 

190
Page 3 of 3

Annotation Recommendation Chlorine Materials

October 5, 2011

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or 

food group(s)).” 

(b) Synthetics allowed--Chlorine materials 

Chlorine materials (calcium hypochlorite, chlorine dioxide, and sodium hypochlorite) for 

disinfecting and sanitizing food contact surfaces, equipment and facilities may be used 

up to maximum labeled rates. 

 

Chlorine materials in water used in direct crop or food contact is permitted at levels 

approved by the FDA or EPA for such purpose, provided the use is followed by a rinse 

with potable water at or below the maximum residual disinfectant limit for the chlorine 

material under the Safe Drinking Water Act or followed by other effective intervention or 

testing steps that would reduce and verify the residual chlorine levels to be 4mg/L or 

less on the product. 

Chlorine in water used as an ingredient in organic food handling must not exceed the 

maximum residual disinfectant limit for the chlorine material under the Safe Drinking 

Water Act. 

Committee Vote 

Motion: John Foster Second: Tracy Miedema

Yes: 6 No: 0 Abstain: 0 Absent: 1

191
National Organic Standards Board 

Materials Committee 

Proposed Discussion Document 

Aquaculture Materials Review Update 

September 27, 2011 

Background 

Based on work of the Aquaculture Task Force over the period of several years, the 

NOSB has adopted some recommendations regarding aquaculture: 

Aquaculture Standards

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5056878) 

3/29/07 

Aquatic Plants

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5070396&ac

ct=nosb) 5/22/08 

Net Pens and Related Issues

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5074509&ac

ct=nosb) 11/19/08 

Fish Feed – Fish Oil and Fish Meal & Related Issues

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5074508&ac

ct=nosb) 11/19/08 

Bivalves

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5081491&ac

ct=nosb) 11/5/09 

None of these have been implemented as regulations. If they were to become 

regulations, they would establish new sections of the National List: 

§ 205.609 Synthetic substances allowed for use in organic aquatic plant 

production. 

§ 205.610 Nonsynthetic substances prohibited for use in organic aquatic plant 

production. 

§ 205.611 – Synthetic substances allowed for use in organic aquatic animal 

production. 

§ 205.612 Nonsynthetic substances prohibited for use in organic aquatic animal 

production. 

In order to determine what changes might need to be made to the materials evaluation 

process, the Aquaculture Task Force submitted two ―trial balloon‖ petitions, for carbon 

dioxide and vitamins. The Materials Committee has drawn some conclusions from the 

process of considering those petitions and formulated some questions for discussion. 

192
Page 2 of 3 

Aquaculture Materials Review Update 

September 27, 2011 

What we learned from the trial balloons 

 We need different criteria for open systems as opposed to closed systems. We 

don’t know what those criteria will be, but we can’t even start to think about them 

without knowing whether the substance will be contained in a land-based pond or 

tank, or will be used in net pens in open water. 

 Petitions need to include: 

o The use pattern of the material—quantity, how it is added to the system, 

etc. 

o Aquaculture-specific information—for example, on environmental fate, 

interactions with other substances and organisms. 

o References to applicable laws and regulations that are aquaculturespecific. 

 Petitions should not only cite petitions and TRs for crops and livestock, but also 

cite references that are relevant to the use of the material in an aquatic system. 

Some issues will carry over, but others will not. 

 We need to deal with specific materials, not categories, at least until we get our 

material evaluation process worked out. 

Further Committee Thoughts on Development of an Aquaculture Review Process 

 The review of aquaculture materials needs to align with NOP’s drafting of 

proposed aquaculture standards. Petitioners may submit petitions to the NOP for 

review of aquaculture materials by the NOSB. However, the NOSB will defer 

requests for technical review until the program publishes proposed aquaculture 

standards, or until the NOP otherwise notifies the NOSB to take up these 

petitions to coordinate with rulemaking. 

 The Materials committee will continue to develop the process of evaluating 

aquaculture materials through the review of the two ―trial balloons‖ submitted by 

the Aquaculture Working Group. 

 The Materials Committee proposes that a separate Aquaculture Committee, 

overlapping in membership with Crops and Livestock, be established to evaluate 

materials. 

Questions about the Development Process for Board Discussion and Public 

Comment 

1. Are there international bodies or organizations with a good material review process? 

If so, who? How could we interact with these entities to address material evaluation 

issues that we have? 

2. How do we ensure that our organic aquaculture material review process is viewed 

from an aquaculture lens rather than a crop or livestock lens, while not compromising 

organic farming and environmental principles? In other words, how do we maintain the 

level of review of materials consistent with crops and livestock uses, while viewing 

materials in their unique application to aquaculture systems? 

193
Page 3 of 3 

Aquaculture Materials Review Update 

September 27, 2011 

3. How can the review of aquaculture materials proceed cautiously while not 

compromising consumer expectation of the organic label? What do consumers expect 

from organically produced aquaculture products, and how does that translate into 

specific requirements concerning materials, e.g., environmental impacts, hormones, 

organic feed, etc.? 

Questions Concerning the Material Evaluation Process: 

1. What criteria are specific to open systems? Closed systems? 

2. Which evaluation questions in current crops/livestock evaluations are relevant to 

aquaculture materials? 

3. Which evaluation questions do not apply, or need to be modified? 

4. What new questions need to be asked about aquaculture materials? 

5. What information needs to be considered in assessing the essentiality of a 

material in the context of cultural practices as they apply to water instead of soil 

ecosystems? 

6. Do different questions need to be asked about carnivorous and herbivorous fish? 

Carnivorous fish pose additional problems, as has been pointed out by 

commenters. Because of the bioaccumulation of toxic chemicals, it is difficult to 

find clean natural foods for carnivorous fish. 

Committee Vote 

Moved: Katina Heinze Second: Tina Ellor 

Yes: 7 No: 0 Abstain: 0 Absent: 0 

194
National Organic Standards Board 

Materials Committee 

Proposed Discussion Document 

Research Priorities Framework 

September 27, 2011

Introduction 

At the April 2011 National Organic Standards Board (NOSB) meeting, public 

comment was received, and supported by discussion among NOSB members, 

asking the NOSB to create a process to collect, prioritize and advocate for research 

related to use of materials in organic production or handling. The Materials 

Committee accepted the request as a workplan item. This document shares the 

committee‟s current thinking on a process to collect, prioritize, and maintain research 

needs related to organic production methods and materials on the National List of 

Allowed and Prohibited Substances, or being petitioned for listing on, the National 

List. The committee has posed questions at the end of the document on which we 

seek the input of the full NOSB, the USDA National Organic Program (NOP) and the 

public so that we can continue our work.

Background 

The discussion of whether a material should be listed on the National List is 

sometimes a balance of the benefits that use of the material brings balanced against 

concerns with the use of the material—that is, we are concerned about both whether 

the use of the material is consistent with a system of organic and sustainable 

agriculture and whether effective and efficient alternatives exist. Over the past 

several years the NOSB has been faced with extending use of several materials 

(e.g., methionine and tetracycline) concerning which we heard public comment that 

the public wished that better alternatives had been identified. The NOSB has heard 

evidence that alternatives exist, but has found the evidence insufficient in some way, 

such as the lack of „hard‟ science to support their viability or an inadequate 

consideration of the variation in production conditions.

The discussion and public comment at the April 2011 NOSB meeting related to the 

use of tetracycline and streptomycin for use in fire blight control on apple and pear 

trees highlighted the need for research into alternatives for some materials on the 

National List. Several public comments talked about the lack of funding for these 

topics or the need for adequate justification that research was necessary. As a 

result of those discussions, the NOP issued letters to the USDA National Institute for 

Food and Agriculture (NIFA) and the USDA Agricultural Research Service (ARS) to 

request their assistance in prioritizing research on alternatives to tetracycline and 

streptomycin for fire blight control in apples. 

Subsequent to NOSB debate on tetracycline, the NOSB heard public comment 

asking the NOSB to be more proactive in advocating for research related to 

195
Page 2 of 4 

Research Priorities Framework 

September 27, 2011 

materials use in organic production. It was clear at the meeting that a more 

formalized approach to advocating for research was needed. Hence, the Materials 

Committee accepted the workplan item to develop a framework for doing so. 

In developing this framework, the committee asked what problems such a framework 

was intended to address. As we reviewed the past several years of board 

discussion on materials we saw that: 

• The NOSB continues to receive petitions to extend the listing date of 

materials for which the NOSB has recommended an “expiration” date (e.g., 

methionine). A lack of research on alternatives means that these extensions 

continue to be requested and recommended by the board without NOSB 

consensus. 

• We want to see more resources invested into priority areas of need related to 

materials and organic production practices. 

• Some materials being reviewed by the Board come with widely differing 

perspectives related to benefits and risks, and the NOSB has no opportunity 

to be proactive about getting research into alternatives. 

• There is no public forum for publishing a list of research needs and priorities. 

As a consequence, there is little incentive to research those areas because 

there is no public acknowledgment that funding is needed. 

The primary goal of this framework is to gain NOSB alignment on criteria for 

prioritizing research needs and a process for collecting and communicating research 

needs. Additional benefits could include: 

• Influencing where research dollars are directed 

• Allowing the NOSB to be more proactive with regards to problematic or 

controversial National List substances by creating a mechanism to advocate 

for primary research ahead of material review dates 

• Highlighting research results that will satisfy many different stakeholders and 

align the various stakeholders on research conclusions 

• Reducing disagreement within the organic community by increasing the 

amount of primary research on which decisions could be based 

• Increasing the amount of research being done related to organic agriculture. 

Today, the research community may not always be aware of the research 

needs of organic producers and handlers. Awareness could allow for USDA 

funding of primary research in these top priority areas and provide support for 

researchers submitting grants requests these research areas. 

• Encouraging publication of field-level work. We know that organic farmers 

are continually „researching‟ new production methods at the farm level but 

often these ideas are discussed at farm conferences and not further 

disseminated. Our hope is that a list of „top needs‟ could encourage certifiers, 

regulators and other stakeholders to support farmers in their research and 

publication of their research. 

196
Page 3 of 4 

Research Priorities Framework 

September 27, 2011 

Process Framework 

In the Materials committee discussions the following process framework was 

developed:

1. The Materials Committee will collect research topics from public comment, 

NOP and NOSB committees on an on-going basis. Specifically, the Materials 

committee should review research topic needs after every NOSB meeting to 

ensure that public comment and NOSB discussion on new research needs 

are added to a „running‟ list. 

2. Research topics will be kept by the committee on an all-inclusive „running‟ list. 

The list would include a description of the research and how the research 

needs to apply in an organic context. 

3. On an annual basis, the committee will review the list and based on the 

criteria discussed below recommend the top research priorities for NOSB 

review, discussion, change and approval. We envision that the top priorities 

will be about five topics but discussed that a „hard‟ number was not needed or 

even desirable. Additionally, we do not envision ranking the top priorities. 

Our goal would be to have a short list of the „select few‟ research topics for 

which the NOSB believes research would have the largest long-term impact 

on growth and integrity of organic agriculture. 

4. On an annual basis, the NOSB will review the list and make any needed 

additions, amendments and deletions from the top priorities list. The list will 

be published as an NOSB recommendation that the items on it be a focus for 

research needs. It is not our intention that the NOP would have to take action 

on the list beyond making it available for public awareness. 

The criteria for prioritization are focused on selecting the few „big ideas‟ that the 

NOSB believes will have the largest long-term impact on growth and integrity of 

organic agriculture. The criteria would be research topics that are: 

• Persistent and chronic (i.e., perennial topics of debate and need) 

• Challenging

• Controversial (i.e., topics on which there are widely differing perspectives or 

for which there have been close NOSB votes) 

• Nebulous (i.e., the research need is hard to identify but the organic agriculture 

need is clear). For example, improved methods of weed control. 

• Lacking in primary research. That is, topics for which there is no active 

research being conducted. 

Although we hope that the research will eventually address the problems on the list, 

we also realize that solutions will not be found immediately. If properly used, the 

„select few‟ research topics should not change drastically from year to year but 

should reflect long-standing, difficult to address needs within the industry. Over a 

longer timeframe, topics will drop off and be replaced with others. The committee 

notes that while the „running‟ list of research needs may be long, the goal of 

197
Page 4 of 4 

Research Priorities Framework 

September 27, 2011 

prioritization will be to select only a few „big ideas‟ that will have the largest impact 

for the industry. Therefore, many worthwhile research needs will not be prioritized. 

As the committee discussed this framework there was some discussion on how 

these research needs worked with material Technical Reviews. It was clear to the 

committee that duplicating or replicating Technical Reviews was not the intention. 

Rather, the Technical Reviews can highlight areas where primary research is 

lacking--for example, research into eliminating barriers to commercial availability 

(e.g., alternatives to de-oil soy lecithin) or research into viable, available alternatives 

for current materials or methods. No topic on the list should be a review of existing 

research. For that, Technical Reviews are the best course. 

Requested Input from NOSB, NOP and Public Comment 

1. What additions or changes would you make to the process for collecting and 

maintaining the list of research needs? 

2. Are there other criteria that you would want the board to consider when 

prioritizing research topics? What research needs would our proposed 

criteria have „missed‟ without the addition of additional criteria? 

3. The committee proposes that the top priorities be reviewed on an annual 

basis. What benefits or drawbacks exist for extending or shortening this 

review time? Specifically with respect to research, funding and topic 

awareness time frames? 

4. Is the collection, prioritization and publication of research needs an topic in 

which the NOSB should engage? 

Committee Vote: 

The Materials Committee moves to accept this document and present it for full board 

discussion at the fall 2011 NOSB meeting: 

Moved: Katrina Heinze Second: Tina Ellor 

Yes: 6 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

198
National Organic Standards Board 

Compliance, Accreditation and Certification Committee 

Proposed Recommendation 

Evaluation of Materials Review Organizations 

October 1, 2011 

Introduction 

The assessment of specific substances for compliance with the National Organic 

Standards – known as “Materials Review” – is a foundational element in the organic 

supply chain. Certifiers and other materials review organizations regularly review 

materials as a service to their clients, and these decisions directly impact the organic 

integrity of growing, livestock and handling operations and ultimately the integrity of the 

USDA Organic label. The uniformity, consistency and integrity of materials review 

decisions is of paramount importance to the integrity of the entire organic supply chain, 

and the National Organic Program must play a primary role in supervising and 

monitoring these activities. 

Following the NOP’s request for NOSB advice on this issue, the CACC prepared a 

discussion document for the April, 2010 NOSB meeting in Seattle. This document 

summarized the issue and the NOP request, and posed a number of specific questions 

about specific facets of this complex subject. The board received written and oral public 

comment from numerous stakeholders, including certifiers, materials review 

organizations, input manufacturers and others. The CACC has evaluated these 

comments and has carefully considered them in making the current recommendation. 

Background 

On January 18, 2011, the NOP Deputy Administrator requested the participation of the 

NOSB in developing a clearer NOP policy on the oversight of materials review 

organizations: 

The NOP is interested in developing a more uniform and consistent procedure for 

evaluating the competency and quality of material evaluation programs, as 

approved by accredited certification agencies or by other third party 

organizations. 

The NOP is requesting that the National Organic Standards Board (NOSB) 

develop a recommendation that delineates the criteria that should be used by 

certifying agents and third party organizations to evaluate materials used in 

organic production and handling. The recommendation should include the criteria 

and process that should be used to determine the approval of input substances 

used in crop production (e.g. fertilizers, pest control materials, soil amendments, 

crop production aids), livestock production (e.g. feed supplements, feed 

199
Page 2 of 5

Evaluation of Materials Review Organizations

October 1, 2011

additives, medications and livestock production aids), post-harvest handling and 

food processing (e.g. processing aids, sanitizers, facility pest control materials). 

A number of organizations currently provide materials review services to producers and 

certifiers. At least one of those organizations is an independent organization that is not 

an Accredited Certifying Agent or under any NOP oversight. At least one other materials 

review organization is a formal subdivision of an ACA, and many ACAs provide some 

material review services to clients on a formal or informal basis. The CACC agrees with 

the NOP that there is a clear need for more uniform and consistent policies governing 

material review services, and we believe that all organic stakeholders would benefit 

from a clearly defined NOP guidance around the qualification and activities of these 

organizations. 

Challenges 

1. All certifying agents review input materials for compliance with the NOP 

regulations. Most certifying agents do not publish their list of approved inputs. 

This leads to a lack of transparency of what materials have been approved for 

use in organic production and handling. 

2. There are numerous organizations reviewing materials for compliance with the 

NOP regulations. On numerous occasions a material that is allowed by one 

certifying agent is prohibited by another. This lack of consistency in what 

materials are approved creates an uneven regulatory landscape, is unfair to 

organic producers and handlers, and leads to certifier shopping to find the 

certifying agent that allows more materials. 

3. There have been situations where the NOP has disallowed the continued use of 

materials and material review organizations continue to list/register these 

materials as approved for use in organic production/handling. 

4. A universal list of approved substances is not currently available to organic 

producers and handlers. It is difficult for many organic producers and handlers to 

understand what materials are allowed and which materials are prohibited. This 

regulatory uncertainty causes reluctance by many potential organic producers 

and handlers to enter the organic trade. 

5. OMRI and WSDA maintain a publically available list of approved materials. The 

process for removing substances from these approved lists is not consistent. 

There is not a consistent process for material input manufacturers to appeal 

decisions made by OMRI, WSDA or certifying agents. 

6. The NOP does not have direct regulatory authority over material manufacturers. 

If material manufacturers violate the organic standards or fraudulently represent 

their product as approved for organic use the NOP does not have authority to 

issue civil penalties or propose adverse actions. Currently organic producers 

and handlers bear the risk of using substances that may not comply with the 

NOP regulations. 

200
Page 3 of 5

Evaluation of Materials Review Organizations

October 1, 2011

Relevant Areas in the Rule 

While both OFPA and the Rule deal extensively with the review of materials as 

performed by NOSB, NOP and ACAs, neither provides any language that relates 

directly the work or oversight of materials review organizations. 

Discussion 

Based on the challenges presented above, the committee’s March discussion document 

solicited feedback from impacted stakeholders on a number of specific questions. 

Those specific questions are attached to this document as Appendix A. 

The committee spent several meetings carefully weighing and discussing each of the 

stakeholder responses to the various discussion questions. This analysis yielded the 

following recommendation. 

 

Recommendation 

The NOSB recommends that the National Organic Program actively regulate materials 

evaluation programs, in order to facilitate consistent and uniform materials review 

decisions. 

Materials Review Organization (MRO) Qualification 

In order to facilitate adequate oversight and enforcement of the activities of 

MROs, the National Organic Program should require that MROs become 

Accredited Certifying Agents (ACAs). MROs that only perform material review 

services should be certified under a new accreditation scope which restricts 

certification activities to materials review. ACAs who perform other certification 

types would simply add the materials review scope to their existing accreditation. 

Furthermore, the NOSB feels that materials review activities (providing a public 

“list” of approved NOP compliant inputs) should ultimately only be allowed by 

NOP accredited entities. 

The NOSB acknowledges that the creation of a new accreditation scope is a 

complicated and potentially long-term undertaking. In the shorter term, we 

encourage the NOP to provide detailed guidance on the material review process 

in order to promoted consistency and uniformity among currently operating 

MROs while longer term regulatory changes are undertaken. At minimum, such 

guidance should cover personnel training and qualification, audit standards, input 

disclosure, and other factors necessary for evaluating materials with regard to 

NOP compliance. 

MRO operation and review criteria 

MROs should use OFPA, the USDA National Organic Standards, NOP guidance 

and the National List as the base standards for their operations and activities. 

MROs should not make synthetic vs. non-synthetic determinations except as 

201
Page 4 of 5

Evaluation of Materials Review Organizations

October 1, 2011

guided by NOP materials classification guidelines. MROs should be compliant 

with ISO 65 standards, which require the development of detailed review 

protocols and policies. 

MROs must make their review process -- including organizational hierarchies, 

procedures and governance structures related to materials decisions --

transparent to all stakeholders. While the creation of such review criteria and 

procedures by the NOP should necessarily be done in partnership with certifiers, 

MROs and other stakeholders, we do not believe that a the creation of a formal 

Task Force is necessary to accomplish this goal. The NOSB functions as an 

advisory body which represents diverse factions of the organic community, and 

has carefully considered rich stakeholder feedback in creating this 

recommendation. 

Structure and Consistency of a Materials List 

We believe that the most effective way to ensure consistency among MROs is to 

ensure that all such organizations are operating by a consistent set of review 

protocols and procedures. NOP oversight and accreditation will promote 

consistency both by requiring a uniform set of procedures and by allowing NOP 

to monitor materials review decisions made by accredited MROs. 

While a generic materials list is an extremely valuable guidance tool to the 

organic producers and input manufacturers who rely on MRO services, we do not 

believe it is the interest of the organic community to require producers to only use 

inputs on any materials list. Many local products and custom mixes are provided 

on a regional basis, and such materials are reviewed by ACAs as part of the 

certification process. Membership on a list should never be a requirement for use 

of an input on an organic operation. 

The NOP should work closely with certifiers and existing MROs to determine a 

set of subcategories and list structure which reflects the review criteria to be used 

for each category. Such structure should at minimum reflect the National List 

Categories reflected in 205.601-201.606, and potentially include sub-types of 

National List categories. For example, OMRI’s generic materials list currently 

divides the “Crops” category into the classes Crop Fertilizers and Soil 

Amendments (CF), Crop Pest, Weed and Disease Control (CP), and Crop 

Management Tools and Production Aids (CT). We also note that the effective use 

of such a list is contingent on guidance as to the point at which an agricultural 

product ceases to be a crop and becomes the subject of processing/handling. 

The current National List contains several post-harvest handling substances in 

both 206.601 and 605.605, and the precise contour of the line between crops 

and handling should be resolved prior to the design of such a list. 

We believe that the NOP should maintain a single, national Generic Materials 

List along with a Brand Name Materials List. The generic materials list would 

serve as guidance to ACAs and the industry on specific substances’ consistency 

with the rule, and as a record of NOP decisions on such materials (including 

synthetic vs. non-synthetic and agricultural vs. non-agricultural determinations). A 

202
Page 5 of 5

Evaluation of Materials Review Organizations

October 1, 2011

brand name list would serve as an aggregation of ACA/MRO decisions which 

had been reported the NOP. Such a list would drive inter-ACA/MRO consistency 

and provide a valuable service to the organic community. Both lists should be 

available to the public via the NOP website, and updated in real time. Such lists 

will only be possible once consistent and transparent review criteria and 

oversight mechanisms are established. Regular communication of materials 

review decisions by MROs to the NOP would also facilitate NOP monitoring of 

MRO decisions. 

Finance and Oversight 

We believe that the MRO program should at least be financed in part by those 

input producers seeking review. Under a model which follows the existing ACA 

structure, entities seeking certification (or review) would pay certification costs 

directly to the ACA/MRO. Accreditation would managed financed through the 

existing NOP accreditation structures. 

Similarly, programmatic oversight and appeals would also be handled by the 

same set of structures which currently govern the oversight of ACAs. MROs 

would be different from other ACAs only in terms of the scope of their certification 

activities. As with existing ACAs, the NOP should provide clear and uniform 

guidance, training, oversight, audits and enforcement over MROs. NOP should 

review their existing appeals process to ensure that input manufacturers have the 

same ability to appeal and MRO decision as producers currently have to appeal 

ACA decisions. 

Enforcement and Fraud 

The NOP MRO process should clearly hold the MRO accountable for mistakes 

and prescribe penalties, just as is currently the case for ACA certification 

decisions. NOP should pursue legal action against fraudulent manufacturers. 

We believe that NOP oversight of MROs as ACAs is the most effective way to 

ensure consistency and integrity in the organic input material supply chain, and 

provides the most powerful set of tools to prevent fraud, monitor compliance, and 

enforce the National Organic Standards. 

Committee Vote 

Motion by: Joe Dickson Second: John Foster 

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

203
National Organic Standards Board 

Certification, Accreditation and Compliance Committee 

Proposed Recommendation 

Inspector Qualifications 

September 14, 2011 

Background 

On June 23, 2011, the Deputy Administrator of the National Organic Program (NOP) 

issued a memorandum to the chair of the National Organic Standards Board (NOSB) 

requesting a proposal outlining the criteria that inspectors should be required to meet 

prior to conducting inspections of organic production and handling operations. The 

Certification, Accreditation and Compliance Committee (CACC) has reviewed this 

request and, in consultation with representatives from the organic community, 

developed this proposal. We believe that it would be appropriate, and in the best 

interest of the organic community, for the NOP to issue guidance to Accredited 

Certification Agencies (ACAs) on this subject and respectfully submit our 

recommendations below. 

Relevant Regulatory Text 

The NOP regulations require that certifiers use employees and contractors with 

sufficient expertise in organic production. The following passages represent all of the 

rule language directly addressing or related to inspector qualifications: 

 205.501 General requirements for accreditation. 

(a) A private or governmental entity accredited as a certifying agent under this subpart 

must:

(1) Have sufficient expertise in organic production or handling techniques to fully 

comply with and implement the terms and conditions of the organic certification 

program established under the Act and the regulations in this part; 

(2) Demonstrate the ability to fully comply with the requirements for accreditation 

set forth in this subpart; ... 

(4) Use a sufficient number of adequately trained personnel, including inspectors 

and certification review personnel, to comply with and implement the organic 

certification program established under the Act and the regulations in subpart E 

of this part; 

(5) Ensure that its responsibly connected persons, employees, and contractors 

with inspection, analysis, and decision-making responsibilities have sufficient 

expertise in organic production or handling techniques to successfully perform 

the duties assigned. 

204
Page 2 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

(6) Conduct an annual performance evaluation of all persons who...perform onsite inspections... 

§ 205.504 Evidence of expertise and ability. 

A private or governmental entity seeking accreditation as a certifying agent must submit 

the following documents and information to demonstrate its expertise in organic 

production or handling techniques...: 

(a) Personnel. 

(1) A copy of the applicant‟s policies and procedures for training, evaluating, and 

supervising personnel; 

(2) The name and position description of all personnel to be used in the 

certification operation, including ... certification inspectors, ...; 

(3) A description of the qualifications, including experience, training, and 

education in agriculture, organic production, and organic handling, for: 

(i) Each inspector to be used by the applicant and... 

(4) A description of any training that the applicant has provided or intends to 

provide to personnel to ensure that they comply with and implement the 

requirements of the Act and the regulations in this part. 

Discussion 

Organic inspectors perform a critical function in the ongoing fulfillment the Organic 

Foods Production Act and the NOP regulations. What professional and technical skills, 

knowledge and training are necessary to conduct effective inspections? There are 

currently no specific qualification criteria or standards for what constitutes the “sufficient 

expertise” called for by the section 205.501(a)(1) of the regulations. This discussion 

seeks to clarify issues related to defining standard inspector qualifications for all ACAs, 

and offers a proposal for baseline levels of: 

a) pre-requisite experience, training and knowledge, 

b) continuing education and training, and 

c) performance oversight and assessment . 

Because there are a number of different scenarios under which ACAs employ 

inspectors-including full time employees, part time employees, regular contractors, 

one-off contractors, etc- we must consider a system that allows for a wide variety of 

ACA- inspector relationships while ensuring that the inspectors are doing their part to 

uphold the high levels of integrity expected by the organic community. 

205
Page 3 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

In the absence of specific regulatory requirements for the qualifications of organic 

inspectors, ACAs have instituted a wide range of requirements and criteria in their hiring 

process, training, and performance monitoring. While the CACC is aware of the 

requirements of a few ACAs in particular, the actual extent and range of these specific 

requirements among the 100 worldwide NOP approved ACAs is not fully known. 

The International Organic Inspectors Association (IOIA), formed in 1991, offers an 

organic inspector training program which is broadly recognized among ACAs. The IOIA 

training is currently the only training of which we are aware that is targeted at organic 

inspectors. Most ACAs include IOIA training certificate among their baseline inspector 

qualification criteria. Some ACAs require additional training beyond the IOIA certificate. 

These commonly include apprentice inspections and/or annual inspector trainings. 

Some ACAs, especially those located outside the United States, do not require IOIA 

training. 

The CACC believes that targeted training, such as that provided by IOIA, should be 

strongly encouraged. We suggest that the NOP consider entering in to a Memorandum 

of Understanding or other recognition agreement or subcontract with IOIA so that IOIA 

can be formally recognized and authorized by the NOP. This could allow IOIA to create 

a formal inspector approval for inspectors who have successfully passed their training 

course and participate in continuing education. While IOIA currently offers an 

“accredited inspector” status, it is the understanding of the CACC that this designation is 

not particularly meaningful to ACAs during their hiring process, and that relatively few 

qualified inspectors seek “accreditation”. We believe that having a pool of inspectors 

which are formally approved by IOIA under the auspices of the NOP would be extremely 

beneficial to the entire organic community. 

It is essential that during the accreditation process, ACAs are verified as hiring only 

competent, trained inspectors. Anecdotal evidence suggests that while the qualifications 

of certification personnel are evaluated during current NOP audits, those of contract or 

part-time inspectors are not often reviewed. The CACC is particularly concerned about 

situations where an ACA may rely on only one inspector, or a small handful of 

inspectors, to perform all of the inspections for an ACA. In particular, it is essential that 

the ACA has sufficient criteria for assigning different types of operations to that 

inspector. 

At minimum, all ACA‟s should be required to attend annual NOP trainings and those 

trainings must include clear direction as to inspector qualification and continuing 

education. We find arguments that such trainings are cost prohibitive unconvincing. 

The NOP has been offering these trainings in many locations in the US and abroad for 

many years and has been clear of their intention to continue to do so. Those ACAs who 

need to adjust fees or adjust budgets accordingly need to do so. This is essential in 

206
Page 4 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

assuring their clients—and thereby the general public—that they are operating on a 

level playing field in the national and international arena. This is critical to prevent 

responsible ACAs from falling victim to certifier shopping based on costs which have 

been subsidized by systematic use of under qualified inspectors who charge less for 

their services. The training of ACAs is essential to ensuring that they have the 

opportunity to make judgments about the qualifications of the inspectors they use. 

We recognize that there is not absolutely uniform need for training, experience or 

education for inspector qualifications across all types of inspections. Distinctions are 

needed according to the types of operations that are being inspected. These can be 

defined in different layers and to different degrees. The first and broadest categorization 

is by scope: Crops, Handling, or Livestock. Wild crop harvesting, the fourth scope under 

the NOP, should be considered a subtype of crop production, as it is of minor 

prevalence, and an experienced organic crops auditor can effectively perform these 

inspections after a focused briefing on specific issues and standards related to wild crop 

harvesting practices. 

Within those three major lenses of the scope of production there are then a range of 

specialties and levels of complexity. Because of the significant diversity of crops and 

operation types, we cannot reasonably set the same requirements for inspectors of all 

the possible different crops, processes, products, animals and livestock rearing 

methods. While a good inspector should be capable of inspecting any operation under 

the general scope to which they are qualified, some types of production are particularly 

complicated and may require additional training. Dairy is one sub-category of livestock 

that arguably calls for a separate qualifications category. Dairy operations often involve 

unique practices and standards from other livestock production that require special 

training and experience for the inspector. 

An additional challenge posed in appropriately assigning inspectors to operations is 

balancing the need for familiarity with the production system and ensuring a lack of 

conflict of interest. Operations being inspected rightfully expect that the inspector 

understand the fundamentals of the product being produced or handled. For example, 

an otherwise qualified inspector who is also growing strawberries or has grown 

strawberries might likely be a qualified inspector to inspect another strawberry farm. 

However, the strawberry farm being inspected may object to an inspector who currently 

or previously worked for a business that is in direct market competition. We recognize 

that this may be less of an issue for ACAs where inspectors are full time employees. 

While familiarity of the inspector with the type of operation being inspected is necessary, 

what is more critical is the type of general auditing skills that are not easily taught. To a 

large extent, a typical organic inspector is a “general practitioner”. Many of the general 

auditing skills are applicable across the entire range of organic inspections. Expertise in 

207
Page 5 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

one of the three general areas makes it easier for an inspector to increase their scope 

to include additional types of inspections. We believe that a successful crop inspector 

can be more quickly trained to also do handling inspections than someone who has no 

inspection experience. Therefore, we believe that the specific-scope qualification 

criteria should be more flexible for an experienced inspector who is extending the scope 

of their existing qualifications. 

We believe that ongoing continuing education is essential for organic inspectors. Like 

many other professions, we believe that organic inspectors should stay up to date on 

the emerging issues in the field through attending conferences, advanced trainings, or 

other educational events where either specific or general knowledge can be acquired. 

While most, if not all, ACAs do not currently require this of their inspectors, we assert 

that they can, and indeed should. 

We recognize that we must be careful to implement requirements that are fair to all 

ACAs, regardless of size, but also seek to provide a meaningful baseline for hiring 

inspectors to assure to the greatest degree possible consistency the organic production 

marketplace an the consumer marketplace. At this time, we suggest that standardized 

inspector qualifications requirements should remain somewhat broadly defined. The 

organic inspector profession is not large or deep enough presently to accommodate 

many narrowly define scopes of qualifications. There is a need for definitions and 

requirements for baseline qualifications that will meet the needs of having capable 

knowledgeable inspectors but that are practical and achievable by inspectors and the 

ACAs. 

Beyond the required NOP annual performance evaluation for all inspectors, it is 

unknown to what extent ACAs monitor inspector performance, provide constructive 

feedback, and require corrective action when correctable performance issues are 

detected. Some ACAs provide an evaluation of every inspection report. Some ACAs 

may require periodic witness audits of their inspectors, however this is currently 

unusual, perhaps due to limited administrative and over-sight resources within the 

ACAs. We believe that more rigorous oversight of the inspectors by ACAs would 

provide value to the organic community. Organic inspectors, especially those that work 

on contract for a number of ACAs, would likely welcome more feedback about their 

performance. 

It is essential that ACAs are capable of ensuring that only qualified inspectors perform 

their inspections and assert that annual NOP training is essential for ACAs just as 

annual inspection training is for inspectors. While some ACAs use complex database 

systems to match inspector qualifications with the operation type, this can also be 

accomplished using simpler methods not requiring computerized systems. However it is 

done, we believe that each ACA must be able to justify why the specific inspector has 

208
Page 6 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

been assigned to a particular operation and why they are qualified to perform the 

inspection. 

Proposed Guidance 

Baseline Qualification Criteria for Organic Inspectors 

A. As fundamental initial “organic inspector” criteria: 

1. Baseline pre-requisite knowledge and expertise for initial „organic inspector‟ 

status. 

a. Minimum two years of combined work experience, education, and training 

in organic production, applicable to the scope of inspections to be initially 

performed: crops, handling, or livestock. 

b. Must include at least two of the three different criteria: experience with the 

scope of operations to be inspected, education relevant to the scope of 

operations to be inspected, or specific training within the scope of 

operations to be inspected. 

c. Training equivalent to the Independent Organic Inspectors Association 

(IOIA) basic training, i.e. four days of concentrated training culminating in 

a qualifying exam. 

d. Apprenticeship consisting of a minimum of three shadow inspections, 

accompanied by an experienced organic inspector and followed by 

witness inspections where the apprentice is observed and deemed 

competent by the experienced inspector or certifying agent. 

e. Must have a good evaluations and recommendations by an experienced 

organic inspector or certifying agent assessing the inspector 

understanding of inspection protocols and applicable organic standards. 

f. Once an individual has established themselves as a competent organic 

inspector in any one of the three general areas, addition of a new scope 

does not require an additional two years of focused experience and 

training in that area. General organic inspecting skills are applicable to all 

areas and can therefore greatly assist the inspector in expanding their 

scope, while seeking whatever specific additional knowledge is required to 

sufficiently understand the new area. 

B. As continuing organic inspector criteria: 

1. Continuing Education 

a. Annual training by Accredited Certifiers Association (ACA) to update on 

specific procedures of the ACA as well as National Organic Program 

(NOP) standards updates and guidelines. 

b. Minimum 8 hours annual continuing education related to the type of 

inspection work performed. Each hour of curriculum time (e.g. class time, 

209
Page 7 of 7 

Proposed Inspector Qualifications 

September 14, 2011 

coursework, field study, testing), equals one hour of continuing education 

hours. Trainings conducted by ACAs and closed to the general inspection 

community do not apply toward continuing education hours given their 

tendency to focus on certifier procedures, rather than broad knowledge 

such as agronomic and food industry practices, and general auditing skills. 

c. In-depth training on the topic of recordkeeping and/or accounting must be 

included as part of continuing education, and IOIA is encouraged to 

develop a training to fulfill this need. 

d. Continuing education credits include webinars, seminars, workshops, and 

colleges and university extension programs related to the type of 

inspection work performed or new scope of inspection interest. 

C. ACA accreditation criteria to ensure adequate monitoring and oversight of inspector 

qualifications: 

1. Annual attendance of NOP trainings. 

2. Documented inspector qualification monitoring program that readily provides 

verification that all inspectors employed or contracted in the service of the 

ACAs are qualified according to these criteria. 

3. Provide programmatic and consistent annual training to inspectors regarding 

processes, policies and procedures specific to the ACA. Training materials 

used must be available for review during accreditation audits and included in 

annual ACA updates to the NOP. 

4. Provide all inspectors with performance assessment and oversight 

accordingly: 

a. Witness audits by ACA to be conducted at a minimum every 300 

inspections or 3 years, whichever is less. Results must be 

documented. Witness audits may be conducted by certification 

management, senior inspectors or senior reviewers. 

b. Evaluation of every inspection provided to the inspector. 

c. Annual performance evaluation provided to the inspector. 

d. All serious or persistent performance issues that arise during any of 

the above assessments must be documented by the ACA, and must 

include documented corrective action and improvement measures as 

deemed necessary by the ACA. 

Committee Vote 

Motion: John Foster Second: Barry Flamm 

Yes: 6 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

210
National Organic Standards Board 

Certification, Accreditation and Compliance Committee 

Proposed Recommendation 

Unannounced Inspections 

September 14, 2011 

Background 

On June 23, 2011, the Deputy Administrator of the National Organic Program (NOP) 

issued a memorandum to the chair of the National Organic Standards Board (NOSB) 

requesting a proposal on best practices for unannounced inspection. The Certification, 

Accreditation and Compliance Committee (CACC) has reviewed this request and, in 

consultation with representatives from the organic community, developed this proposal. 

Currently, unannounced inspections are allowed, but not required, under the NOP 

regulations. Some Accredited Certification Agencies (ACA’s) conduct many 

unannounced inspections, often to fulfill international requirements, while others may 

conduct none. We believe that it would be appropriate for the NOP to issue guidance to 

ACA’s on this subject and respectfully submit our recommendations below. 

Relevant Regulatory Text 

7 CFR § 205.403 On-site inspections. 

(a) On-site inspections. 

(1) A certifying agent must conduct an initial on-site inspection of each production 

unit, facility, and site that produces or handles organic products and that is 

included in an operation for which certification is requested. An on-site 

inspection shall be conducted annually thereafter for each certified operation 

that produces or handles organic products for the purpose of determining 

whether to approve the request for certification or whether the certification of 

the operation should continue. 

(2) 

(i) A certifying agent may conduct additional on-site inspections of 

applicants for certification and certified operations to determine 

compliance with the Act and the regulations in this part. 

(ii) The Administrator or State organic program's governing State official 

may require that additional inspections be performed by the certifying 

agent for the purpose of determining compliance with the Act and the 

regulations in this part. 

(iii) Additional inspections may be announced or unannounced at the 

discretion of the certifying agent or as required by the Administrator or 

State organic program's governing State official.

211
Page 2 of 7 

Unannounced Inspections 

September 14, 2011 

(b) Scheduling. 

(1) The initial on-site inspection must be conducted within a reasonable time 

following a determination that the applicant appears to comply or may be able 

to comply with the requirements of subpart C of this part: Except, That, the 

initial inspection may be delayed for up to 6 months to comply with the 

requirement that the inspection be conducted when the land, facilities, and 

activities that demonstrate compliance or capacity to comply can be observed. 

(2) All on-site inspections must be conducted when an authorized representative 

of the operation who is knowledgeable about the operation is present and at a 

time when land, facilities, and activities that demonstrate the operation's 

compliance with or capability to comply with the applicable provisions of 

subpart C of this part can be observed, except that this requirement does not 

apply to unannounced on-site inspections. 

(c) Verification of information. The on-site inspection of an operation must verify: 

(1) The operation's compliance or capability to comply with the Act and the 

regulations in this part; 

(2) That the information, including the organic production or handling system 

plan, provided in accordance with §§205.401, 205.406, and 205.200, 

accurately reflects the practices used or to be used by the applicant for 

certification or by the certified operation; 

(3) That prohibited substances have not been and are not being applied to the 

operation through means which, at the discretion of the certifying agent, may 

include the collection and testing of soil; water; waste; seeds; plant tissue; and 

plant, animal, and processed products samples. 

(d) Exit interview. The inspector must conduct an exit interview with an authorized 

representative of the operation who is knowledgeable about the inspected operation to 

confirm the accuracy and completeness of inspection observations and information 

gathered during the on-site inspection. The inspector must also address the need for 

any additional information as well as any issues of concern. 

(e) Documents to the inspected operation. 

(1) At the time of the inspection, the inspector shall provide the operation's 

authorized representative with a receipt for any samples taken by the 

inspector. There shall be no charge to the inspector for the samples taken. 

(2) A copy of the on-site inspection report and any test results will be sent to the 

inspected operation by the certifying agent. 

Discussion 

The CACC believes that unannounced inspections are one of the most powerful and 

useful tools in the NOP regulations to ensure compliance across certified operations 

and give consumers additional reasons to trust the organic label. We believe that all 

ACA’s should be conducting unannounced inspections of a significant portion of their 

clients every year. 

212
Page 3 of 7 

Unannounced Inspections 

September 14, 2011 

Unannounced inspections serve the dual purpose of giving the ACA the opportunity to 

observe the activities of a specific operation without the advance notice provided in the 

annual monitoring inspections, but also acts as a deterrent factor to other operations 

who may consider acting in noncompliance with the NOP. ACA’s who already conduct 

significant unannounced inspections report that word of unannounced inspections tends 

to spread among groups of organic operations. A consistent approach to unannounced 

inspections is essential in order to ensure organic integrity, reinforce the public trust in 

the organic label and create an even playing field for certifiers and certified operations 

alike. 

We strongly recommend that the NOP provide guidance that includes a specific 

percentage of operations which must have unannounced inspections every year. We 

are proposing a five percent requirement across the board for all ACA’s. This will 

ensure fair and equitable application of unannounced inspections by certifiers of all 

sizes and will not unfairly or impact small or large ACA’s. Because ACA’s have the 

option of charging certified operations for unannounced inspections (either on a per 

inspection basis or as part of their overall fee structure), we do not believe that requiring 

ACA’s to conduct unannounced inspections will have a negative financial impact on 

ACA’s. The proposal for five percent of operations per year is in line with IFOAM and 

COR. As these international organic standards already require unannounced 

inspections, a number of NOP ACA’s have experience in conducting these types of 

inspections and are already performing at least the 5% proposed. 

ACA’s may be disinclined to conduct unannounced inspections in remote geographic 

areas or areas where they do not have regular inspection services or inspectors. While 

we understand the financial and operational considerations, we believe that an ACA 

should and must be able to conduct an unannounced inspection in any area they offer 

certification services or they are failing to maintain adequate resources to effectively 

and equally apply this oversight. At this time, we are not proposing that the ACA be 

required to conduct annual unannounced inspections in each country, of each product 

type, or each certification scope. Such requirements could result in a single operation 

having an unannounced inspection every year, while the majority of a certifier’s 

operations would not receive an unannounced inspection in any year, which predictably 

leads to absurd outcomes. Instead, we recommend that ACA’s have a systematic plan 

for equitably distributing unannounced inspections across their clients to ensure a 

reasonable representation of certified operators. 

We believe that ACA’s can appropriately use unannounced inspections either for 

targeted, risk based investigation purposes or simply randomly. We do not believe that 

ACA’s should be limited to performing either one type of unannounced inspection or the 

other, and will be able to determine the appropriate balance of the two types. We 

213
Page 4 of 7 

Unannounced Inspections 

September 14, 2011 

recommend that ACA’s develop risk assessment systems to document the operations 

who they have determined to be most at risk for noncompliance, and therefore a higher 

priority for an unannounced inspection. While we have provided some elements of a risk 

assessment guide, we believe that this is not comprehensive, and that ACA’s will be 

able to use other criteria for determining whether an operation is a good candidate for 

an unannounced inspection. ACA’s are encouraged to share their risk assessment 

criteria among themselves to facilitate this process. 

Some ACA’s may use unannounced inspections in conjunction with sampling visits. 

Collecting samples during the course in order to fulfill the (currently draft) requirements 

for pesticide residue testing can be an efficient use of ACA and inspector resources. 

While we do not discourage this practice, we want to be clear that a sample collection 

alone is not sufficient to fulfill an unannounced inspection requirement. The inspector 

must also observe some aspects of an operation’s activities or fields, facilities or 

products. An unannounced inspection must include the creation of an inspection report 

by the inspector and review by the ACA, even though the inspection may be limited in 

scope. Especially if the operator’s representative was not present at the inspection, it is 

important that the ACA document the visit and the observations of the inspector and 

supply a copy of this report to the inspected operation. 

While operations are required by the NOP to make all documents relevant to 

certification available during normal business hours, in practice, many operations 

(particularly small farmers) may not be able to make all records available during an 

unannounced inspection. When an operation is able to make all records available, and 

the operator’s representative is able to spend the necessary time with the inspector, 

there is no reason why an unannounced inspection cannot fulfill the annual on-site 

monitoring requirements of NOP 205.403. If the ACA conducts unannounced 

inspections at their own expenses, as some do, it may even be preferred by the 

operation to have the unannounced inspection be a full annual inspection. While we 

think it is reasonable for inspectors to show up unannounced and require some time 

from the operation, we expect that ACA’s respect the business realities of the certified 

operations. Inspectors should not make unreasonable demands on their time, such as 

expecting an operation to stop all activity and spend an entire day with the inspector. 

Especially in cases where the unannounced inspection is being conducted randomly, as 

opposed to based on risk factors, or in the case of small businesses and sole 

proprietorships, unannounced inspections can be done relatively quickly and without too 

much interruption in daily activities. We discourage ACA’s, inspectors or certified 

operations from expecting all or most unannounced inspections from fulfilling the annual 

inspection requirements. 

214
Page 5 of 7 

Unannounced Inspections 

September 14, 2011 

The issues of trespassing and property access can be controversial. ACA’s must 

provide specific, written guidance to their inspectors and their clients describing their 

policies on having inspectors access certified operations when a representative of the 

operation is not present. While laws may vary from state to state (and country to 

country), we strongly recommend that ACA’s instruct inspectors never to enter on to 

private land or roadways without permission. Even if an operation has signed a 

certification contract stating that they allow access at any time, we are concerned that 

inspectors could be in violation of trespassing laws if they do so. At many operations, 

there are observations that can be made by an inspector from public property, such as 

roadways and parking lots. 

At some operations, such as closed facilities or biosecure chicken houses, it may be 

absolutely essential that a representative be present to allow access to the facilities in 

order for an unannounced inspection to provide any kind of meaningful observation by 

the inspector. In these cases, we believe that it may be useful to provide some advance 

notice to the operation so that they can ensure a representative is present. ACA’s 

currently have a number of different approaches to pre-inspection notification. Some 

ACA’s may provide as long as 48 hours advance notice before an “unannounced” 

inspection. We believe that the latter is excessive notice and could allow a fraudulent 

operation sufficient time and warning to clean or obscure elements of their facilities, 

storage areas, ledgers, and so on. We suggest that a limit of no more than four hours 

pre-inspection notice provides reasonable time for an operation to make a 

representative available, while limiting the amount of pre-inspection preparation that can 

occur. We recognize that this is a somewhat arbitrary time limit, and we suggest 

feedback from ACA’s on this requirement. In any event, The ACA must include notice to 

applicants of their policies regarding notice and expectations for compliance. 

Proposed Guidance 

1. ACA’s are required to conduct periodic unannounced inspections at minimum of 

five percent (5%) of their total certified operations per year. For calculation 

purposes, the number of operations will be counted as the number reported by 

the ACA to the NOP during the annual update each January. For ACA’s with 

less than 20 certified operations, they are required to conduct one (1) 

unannounced inspection each year. 

2. The ACA should strive to conduct unannounced inspections broadly across all 

certified operations, including a broad spectrum of production types, products 

and locations. ACA’s should not limit unannounced inspections to nearby 

operations or certain production types. ACA’s should have a long term plan for 

conducting unannounced inspections across their client base, including 

geographic location and certification scope. ACA’s shall not accept applications 

215
Page 6 of 7 

Unannounced Inspections 

September 14, 2011 

for certification from locations where they are unable or unwilling to conduct 

unannounced inspections. 

3. ACA’s may choose operations for periodic unannounced inspections may be 

random, risk based, or the result of a complaint or investigation. The ACA is not 

required to disclose to the operation the reason for the unannounced inspection. 

a. Risk factors for conducting an unannounced inspection of an operation 

may include, but are not limited to: 

i. Previous noncompliance issues 

ii. Complaints 

iii. Organic and non-organic production, especially of visually 

indistinguishable varieties 

iv. Likelihood of drift or contamination potential 

v. Product market value or prevalence 

4. Unannounced inspections may fulfill the requirements for annual on-site 

monitoring inspections required by section 205.403 only if the inspector is able to 

conduct a full inspection of the operation as required by this section. 

Unannounced inspections may be limited in scope, depth and breadth, and may 

cover only certain aspects of the operation such as parcels, facilities, products, 

etc. ACA’s may direct the inspector to a portion of the operation to review during 

an unannounced inspection. 

5. An inspection report must be written by the inspector, sent to the client and 

reviewed by the ACA and a decision communicated to the clietnas per NOP 

205.403 and the ACA’s internal protocols. 

6. Inspectors may conduct sampling during an unannounced inspection. Such an 

inspection may count towards both the number of samples and towards the 

number of unannounced inspections an ACA is required to take annually. 

However, if a visit of the operation is to count as both an instance of sample 

collection and an unannounced inspection, the inspector must review some 

aspects of the operation besides simply collecting a sample. 

7. An unannounced inspection may occur even if no representative of the operation 

is present. 

a. Wherever possible, an unannounced inspection should include no prior 

notification of the operation to be inspected before the inspector arrives on 

site. In special cases or where extenuating circumstances make it 

impossible to conduct any type of observation of the operation without 

prior notification (such as biosecurity issues), the ACA may notify the 

operation up to four (4) hours prior to the inspector arriving on site to 

ensure that appropriate representatives are present. 

b. If a representative of the operation is not present, observations of the 

operation including, but not limited to, the following may be observed: 

i. Condition of soil fertility 

ii. Health of the plants 

iii. Condition of soil and water 

216
Page 7 of 7 

Unannounced Inspections 

September 14, 2011 

iv. Erosion issues 

v. Evidence of, or lack of, herbicide, fungicide or pesticide use 

vi. Condition of facilities, including pest control and contamination risks 

vii. Condition of pastures and indicators of grazing 

8. ACA’s are responsible for providing adequate training to their inspectors to 

ensure that inspectors do not trespass or break any other laws during 

unannounced inspections. Inspectors should not enter private property without 

explicit permission of the operation. Inspectors must have adequate 

identification, such as a business card and/or explanatory letter from the ACA, to 

demonstrate that they are acting on behalf of the ACA. ACA’s must have a 

written policy on unannounced inspections and inspector access to certified 

facilities that is provided to all clients and to inspectors. 

9. If an operation refuses to allow an inspector access to any part of an operation, 

including the non-organic portions of the operation, during normal business 

hours, the operation shall be considered non-compliant with NOP section 

205.403 and the ACA should promptly issue a Notice of Noncompliance to the 

operation. 

10.ACA’s must clearly disclose to their clients their protocols for unannounced 

inspections. ACA’s may charge their clients fees for unannounced inspections 

as long as these fees are clearly disclosed to all clients preemptively. 

Committee Vote 

Motion by: John Foster Second: Barry Flamm 

Yes: 6 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

217
National Organic Standards Board 

Policy Development Committee 

Proposed Recommendation 

Administrative Team 

July 12, 2011 

Introduction and Background 

The Policy and Procedures Manual (PPM) of the NOSB represents the board policies 

on committee responsibilities, board procedures, and other matters of board operational 

policy. It was noted at the Spring 2011 NOSB meeting that there is no description in the 

PPM of the Administrative Team, an informal group consisting of the Chair, Vice Chair, 

Secretary and Executive Director which has traditionally convened on a regular basis to 

coordinate the operations and logistics of the board’s work. This recommendation 

updates the PPM to add a description of this group. 

Relevant Areas in the Rule 

The Organic Foods Production Act of 1990, 7 USC 6518 (a), directed the Secretary of 

Agriculture to establish the National Organic Standards Board and described its 

composition, authority and duties.

Discussion 

As noted, the Administrative Team has met on a regular basis (generally weekly) as a 

forum for the Officers of the board and the Executive Director to plan, coordinate and 

administer the board’s operations. This team does not deal directly with the substance 

of the board's work but rather with the administrative and operational details of the 

NOSB's meetings and overall work. While this is not an official committee of the NOSB, 

the PDC recommends that a brief description of the Administrative Team be included in 

the PPM since this team is often referenced in board and committee meetings. 

Recommendation 

The PDC recommends that Section IV of the NOSB Policy and Procedures Manual be 

amended by insertion of the following description, in the section entitled “Officer 

Responsibilities,” immediately following the “Secretary” description: 

Administration Team 

The term “Administrative Team” describes a group consisting of the Chair, Vice 

Chair, Secretary and Executive Director. This group may meet on a weekly basis or 

as needed by teleconference or correspond by email in order to coordinate the 

overall logistics and operations of the board, the officer responsibilities noted above, 

and the overall support provided to the Board by the Executive Director. 

218
Page 2 of 2 

Administrative Team 

July 12, 2011 

Committee Vote 

Motion: to accept the proposed amendment to the Policy and Procedures Manual 

described above. 

Motion by: Joe Dickson Second: Calvin Walker 

Yes: 6 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

219
National Organic Standards Board 

Policy Development Committee 

Proposed Recommendation 

Committee Transparency 

October 03, 2011

Introduction: 

A number of stakeholders in the organic community have recently requested 

more visibility and transparency of National Organic Program (NOP), National 

Organic Standards Board (NOSB) meetings and actions. We recognize that the 

public availability of these records is critical to the meaningful engagement of the 

full organic community in public decision-making. The purpose of transparency is 

to create accessibility to organic program records and materials- including 

minutes of committee meetings associated with the NOP and NOSB activities. 

Enhanced public awareness of how NOSB decisions are made would enhance 

collaboration between the organic community and the Board. 

Transparency should be a relevant concept throughout the NOP and NOSB. 

According to OGC opinion the NOSB committee meetings are subject to 

Freedom of Information Act (FOIA)and the Federal Advisory Committee Act 

(FACA). 

Background: 

The 1967 Freedom of Information Act (FOIA) establishes the public’s right to 

obtain information from federal government agencies and allows for openness 

and disclosure of information to the public. The FOIA requires that the activities 

of government be accountable and transparent. 

 

A foundational role for transparency has been recognized by the NOSB and 

NOP. 

The Executive Director is obligated to, “Record and maintain records of 

Board and committee meetings, this includes maintaining all board

archives and records in a manner that provides for easy access to all 

public information in cooperation with the Board Secretary” . 

 In regard to formal collaboration procedures between the NOSB and NOP, 

 the PPM indicates that, 

The NOSB is a FACA advisory committee, and as such, must conduct 

business in the open, under the requirements of P.L. 94-409, also known 

as “Government in the Sunshine Act” (5 U.S.C. 552b)”, (PPM, pg23). 

220
Page 2 of 3 

Committee Transparency 

October 3, 2011 

Therefore, the NOSB and NOP are encouraged to act in a manner that will 

support visibility, openness, and transparency in all business operations with 

easy access to all public information. 

As per a July 25, 2011 communication with USDA/OGC Attorney Advisor, Karen 

Carrington: 

The Section 10(b) of the Federal Advisory Committee Act (FACA), as, 

(Public Law 92-463, 5 U.S.C. App.) provides that, 

"Subject to section 552 of title 5, United States Code, the records, 

reports, transcripts, minutes, appendixes, working papers, drafts, 

studies, agenda, or other documents which were made available to 

or prepared for or by each advisory committee shall be available for 

public inspection and copying at a single location in the offices of 

the advisory committee or the agency to which the advisory 

committee reports until the advisory committee ceases to exist. 

The purpose of section 10(b) is to provide for the contemporaneous 

availability of advisory committee records that, when taken in 

conjunction with the ability to attend committee meetings, provide a 

meaningful opportunity to fully comprehend the work undertaken by 

the committee. “ 

Attorney Carrington further indicated that before materials are given public 

access, the agency would conduct a review of them under the Freedom of 

Information Act to ensure that personal information is not revealed. 

Nevertheless, deliberative information that goes to the essence of duties as a 

board member will most likely be disclosed publicly under the FOIA process. 

Recommendations 

Section III (pg 12) Role of the Executive Director is amended to include the 

following language: 

Arrange, facilitate, and record the NOSB Committee conference calls 

necessary to achieve the most efficient workings of the Board. Minutes 

are distributed to committees for confirmation of accuracy and approval. 

Committee minutes must fully capture the discussion, reflect the diversity 

of opinions expressed during meetings, and provide context for those 

opinions by identifying their source (name or position) i.e. farmer/grower, 

environmentalist/resource conservationist, consumer/public interest 

advocate, handler/processor, retailer, scientist, USDA accredited certifying 

agent, NOP, etc - in order that transparency exist and content remain 

221
Page 3 of 3 

Committee Transparency 

October 3, 2011 

useful for committee members, board members and our stakeholder 

public. 

Section III (pg 13) Role of the Executive Director is amended to include the 

following language: 

Maintain executive committee meeting minutes and committee meeting 

minutes, committee records, reports, transcripts, appendices, working 

papers, drafts, studies, agendas and other documents which were made 

available to or prepared for or by the NOSB or its committees, and make 

such documents available for public inspection and copying at the Agency, 

electronically via the World Wide Web; and/or, upon written request in 

printed form. 

Committee Vote: 

 Moved: Jennifer Taylor Second: Calvin Walker 

 Yes: 6 No: 0 Abstain: 0 Absent: 0 

222
National Organic Standards Board 

Policy Development Committee 

Proposed Recommendation 

 Conflict of Interest 

August 28, 2011 

Introduction 

The National Organic Standards Board (NOSB) seeks to update the Board‟s conflict of 

interest (COI) policy. The major issue for the NOSB„s Policy Development Committee 

(PDC) is to strengthen the NOSB‟s policy on COI. The goals for updating the existing 

NOSB‟s COI policy are (1) to update the COI policy and (2) outline general procedures 

for dealing with a real, apparent, and potential COI by NOSB members, if it arises. The 

proposed recommendations are part of a continued quest by NOSB members in being 

responsive to requests by stakeholders. The proposed policy additions should provide 

for greater transparency of NOSB members‟ work for the greater good of the organic 

community. 

Background 

The NOSB recognizes that members have been specifically appointed to the NOSB to 

provide advice and counsel to the Secretary of Agriculture concerning policies related to 

the development of organic standards and the creation of amendments to the National 

Organic Program‟s National List. NOSB members have been appointed because they 

have professional expertise that enables them to advise the Secretary of Agriculture. 

The statutory composition of NOSB is composed of 15 members. The federal statutory 

composition of the NOSB provides for: 

 four (4) members who own or operate an organic farming operation; 

 three (3) members with expertise in areas of environmental protection and 

resource conservation; 

 three (3) members who represent the public interest or consumer interest groups; 

 two (2) members who own or operate an organic handling operation; 

 one (1) member who owns or operates a retail establishment with significant 

trade in organic products; 

 one (1) member with expertise in the fields of toxicology, ecology, or 

biochemistry; and

 one (1) member who is a certifying agent. 

Within this statutory framework, the professional expertise may, at times, present an 

inherent COI. To prevent overt advocacy for direct financial gain and the appearance of 

self-interest or the appearance of wrongful activity, the NOSB has adopted a COI policy 

(NOSB, Policy & Procedure Manuel, 2010, pg. 9). At this time, the PDC of the NOSB 

seeks to update the Board‟s policy and procedures on COI. The updates are 

223
Page 2 of 7 

Conflict of Interest 

August 28, 2011 

stakeholder driven. Some of the stakeholder advocates, who have expressed a need to 

update the NOSB‟s COI policy, include (1) the National Organic Coalition, (2) Center for 

Food Safety, (3) Cornucopia, (4) Food and Water Watch, and (5) former NOSB Chair 

Jim Riddle. 

The proposed COI policy will enhance and build upon the existing NOSB‟s COI policy. 

The recommendations include providing a definition for (1) COI (real), (2) apparent COI, 

(3) potential COI, (4) immediate family member, and (5) financial interest. A listing of 

procedural steps is outlined. 

Relevant Areas of the Rule 

The Organic Foods Production Act (OFPA) establishes the National Organic Standards 

Board at §2119 (7 U.S.C. 6518) (a). It reads, “The Secretary shall establish a National 

Organic Standards Board (in accordance with the Federal Advisory Committee Act (5 

U.S.C. App. 2 et seq.) (hereafter referred to in this section as the "Board") to assist in 

the development of standards for substances to be used in organic production and to 

advise the Secretary on any other aspects of the implementation of this title.” The 2010 

NOSB Revised Policy and Procedures Manual (PPM) dated October 28, 2010, on page 

9 sets forth the current NOSB‟s COI policy. The professional conduct of NOSB 

members are alluded to in the PPM on page 8. Therefore, action and activities of the 

NOSB members on matters pertaining to organic should be in the best interest of the 

organic community as a whole. 

Discussion 

The benefits of the proposed recommendations are (1) to define terms such as COI 

(real), apparent COI, potential COI, immediate family members, and financial interest, 

and (2) suggest procedures for managing COI in the conduct of business by the Board. 

The fruition of an updated COI policy should help provide greater transparency and 

confidence in Board decisions by the organic community. The lack of an updated COI 

policy can give a negative connotation of the Board responsiveness to many constituent 

groups‟ request. 

An alternative approach would be to keep the current COI policy. However, a revised 

Board COI will enhance the Board‟s continued responsiveness to the organic 

community‟s request, in addition to maintaining high professional and ethical standards. 

Previously, the June, 1999 NOSB Procedures Taskforce Report to the Board on COI 

was approved. Ultimately, the Board‟s COI policy was updated to read: 

“Members of the Board shall refrain from taking any official Board action from which that 

Board member is or would derive direct financial gain. Board members shall disclose 

their interest to the Board and the public, when they or their affiliated business stand to 

gain from a vote, which they cast in the course of Board business. Under certain 

224
Page 3 of 7 

Conflict of Interest 

August 28, 2011 

circumstances, the Board may determine whether it is appropriate for the member to 

vote. 

That members of the Board shall refrain from promoting for consideration any material, 

process or practice for which the member is or would derive direct financial gain arising 

out of such Board action. The act of promoting such material, process or practice shall 

include private discussion with members of the Board advocating the value of the 

material, public discussion and/or written advocacy. 

A "direct financial gain" is defined as monetary consideration, contractual benefit or the 

expectation of future monetary gain to a Board member, including but not limited to, 

financial gain from a party who manufactures, distributes or holds exclusive title to a 

formula for a material or product, process or practice.” [NOSB‟s PPM, 2010, page 9.] 

The current document seeks to enhance the existing COI policy. It attempts to do so by, 

(1) proposing definitions for COI (real), apparent COI, potential COI, immediate family 

member, and financial interest, (2) suggesting procedures for dealing with a given COI, 

and (3) developing a Declaration of Interest Form. 

Recommendations 

Recommendation #1 

The first three paragraphs shown below are on page 9 of the 2010 PPM and will remain 

the same. 

The NOSB recognizes that members have been specifically appointed to the NOSB to 

provide advice and counsel to the Secretary concerning policies related to the 

development of organic standards and the creation and amendment of the National List. 

NOSB members have been appointed because they have professional expertise which 

enables them to advise the Secretary. This professional expertise may, at times, 

present an inherent conflict of interest (COI). To prevent overt advocacy for direct 

financial gain and the appearance of self-interest or the appearance of wrongful activity, 

the NOSB has adopted an updated COI policy. 

Members of the Board shall refrain from taking any official Board action from which that 

Board member is or would derive direct financial gain. Board members shall disclose 

their interest to the Board and the public, when they or their affiliated business stand to 

gain from a vote, which they cast in the course of Board business. Under certain 

circumstances, the Board may determine whether it is appropriate for the member to 

vote. 

That members of the Board shall refrain from promoting for consideration any material, 

process or practice for which the member is or would derive direct financial gain arising 

out of such Board action. The act of promoting such material, process or practice shall 

225
Page 4 of 7 

Conflict of Interest 

August 28, 2011 

include private discussion with members of the Board advocating the value of the 

material, public discussion and/or written advocacy. 

Recommendation #2 

The definitions below are to be inserted before paragraph #4 on page 9 of the 2010 

PPM. 

A “conflict of interest (real)” is defined as a financial or non-financial interest that could 

cause or influence a Board member decision directly or indirectly as it relates to matters 

that are before the Board as a whole or as part of a committee, task force, advisory 

group, public hearing, etc. 

An “apparent conflict of interest” is defined as a financial or other interest that would not 

necessarily influence a Board member, but could result in one‟s objectivity and 

independence being questioned by others. 

A “potential conflict of interest” is defined as a financial or other interest that a 

reasonable person could be uncertain as to whether or not it should be reported. 

An “immediate family member” includes a Board member‟s spouse, children, parents, 

brother, sister, or spouse of a brother or sister. 

A “financial interest” is defined as any kind of financial interest. No specific dollar 

amount of the financial interest needs to be disclosed. Some of the examples of 

financial interest include (1) employment, (2) shares, (3) contract, (4) stocks, (5) 

consultancy, (6) paid work, etc. 

A “direct financial gain” is define as monetary consideration, contractual benefit or the 

expectation of future monetary gain to a Board member, including but not limited to, 

financial gain from a party who manufacture distributes or holds exclusive title to a 

formula for a material or product, process or practice. 

Conflicts can be real, perceived, and numerous. Below are two examples 

 

Example #1 

What is the situation? Board member Z‟s spouse works in sales of Company A. She 

stands to gain a cash bonus if Company A is successful in getting the approval of a 

certain product by the Board. 

Why could this be perceived as a conflict of interest? Board member Z has an 

immediate family member who stands to gain financially by Company A lobbying the 

Board for the approval of a certain product. 

226
Page 5 of 7 

Conflict of Interest 

August 28, 2011 

What should be done? Board member Z should abstain from voting due to an 

immediate family member who stands to gain financially from a Board action. 

Example #2 

What is the situation? Board member X frequently plays golf with representatives of 

Company A over the last year. Company A is lobbying the Board for the approval of a 

certain material.

Why could this be perceived to be a conflict of interest? The frequent golfing connection 

with Company A could create a perceived conflict of interest. 

What should be done? Board member X should decide if he/she can be objective and if 

he/she has a COI. If no COI, is determined, said Board member can participate in the 

discussion and vote. If not sure, said Board and/or committee should determine if Board 

member X can participate in the discussion and vote on said matter. The final decision 

must be clearly recorded in the minutes. 

Recommendation #3 

Add the section below: 

Procedural Steps for Conflict of Interest Determination and Resolution 

Step 1. Annually, each Board member must complete a Declaration of Interest Form 

(DIF). The DIF should show all interests (businesses, investments, and agricultural 

endeavors) of their own, those of immediate family members, and those of the 

companies and/or organizations they have represented over the last 12 months. All 

conflicts regarding substances and practices being considered by the NOSB should be 

declared on the DIF. Each member is responsible for the timely revision of their annual 

DIF, if warranted. 

Step 2. The DIF will be compiled annually and given to the Board Chair or Secretary so 

it can be easily referenced during the Board‟s and/or a particular committee discussion 

and voting sessions. 

Step #3. Each Board member is mainly responsible for declaring his/her conflict of 

interest (COI) prior to any specific discussion during any committee meeting, public 

hearing, etc. 

Step #4: Prior to each vote, the chair will ask all Board members, if anyone has a COI in 

that particular matter. 

227
Page 6 of 7 

Conflict of Interest 

August 28, 2011 

Step #5. Upon such declaration, the member can either voluntarily refrain from voting, 

or can request that the Board decide if the conflict warrants said member abstaining 

from voting. 

Step #6. The ability to participate in a particular discussion and vote must be by a 

majority vote. 

 Step #7: The Board‟s or committee‟s final decision must be clearly recorded in the 

minutes.

Summary 

NOSB members with diverse backgrounds are recruited to provide balance to the 

NOSB. While individual NOSB members represent the segments of the population from 

which they were selected, they also represent the greater good of the population as a 

whole. The revised COI policy and procedures are an attempt to address several 

stakeholders‟ request for updating the Board„s COI policy and provide for a greater level 

of transparency in the deliberation, discussion, and voting on matters pertaining to the 

Board authority for the benefit of the organic community. 

DECLARATION OF INTEREST FORM 

Directions: The declaration of interest form must be completed each year. If additional 

space is needed, please continue on a separate sheet of paper. 

Name: ___________________ Period(MM/DD/YYYY): _ _

A. Interest (I and or an immediate family member)

 1. ______________________________________________ works for an 

organization that uses, sells, reviews, or otherwise involves a number of substances or 

topics related to organic production or processing. I do not think that my involvement 

with any of these substances or issues would constitute a conflict of interest and/or

preclude my ability to vote on recommendations that may be on the National Organic 

Standards Board (NOSB) or committee work plans.

2. ________________________________________________ works for an 

organization with a vested interest in a specific substances or topic related to organic 

production or processing. If this substance or issue were to be voted on by NOSB, I will 

declare a conflict of interest and ask the NOSB for an opinion, or recuse myself due to a 

conflict of interest. 

B. Affiliations/organizations (last 12 months)

 1. Provide a listing of affiliations/organizations 

228
Page 7 of 7 

Conflict of Interest 

August 28, 2011 

I hereby declare that the disclosed information is correct. I will inform the Board Chair or 

designee of any change in these circumstances in a timely manner.

Signature ............................................................. Date ............................................

Committee Vote: 

Moved: C. Reuben Walker Second: Colehour J. Bondera 

Yes: 7 No: 0 Abstain: 0 Absent: 0 

229
National Organic Standards Board 

Policy Development Committee 

Proposed Recommendation 

NOSB Member and Leadership Transition 

July 26, 2011 

Introduction 

Critical to the effective functioning of the committees of the NOSB is the smooth 

transition between and during terms of the Board. The proposed addition to the 

Policy and Procedures Manual is intended to clarify the transition process to enable 

continuity and effective participation. 

Background 

While the NOSB Board Chair, elected by the members at the Fall meeting, has 

typically appointed committee Chairs and members to take their positions at the start 

of the new year-long term, the manual is not clear on the timing of the transition, 

except to say, “The outgoing committee chair should work as mentor for the new 

committee chair and vice-chair for a period of at least two months after transition.” 

(p20) This transition could most effectively be achieved by appointments taking 

effect after an orientation and mentorship period, with the incoming Chairs, ViceChairs, and members being seated at the beginning of the new term. 

The manual does not specifically set a timeframe for the effective date of committee 

appointments with the new committee composition, but implies that terms of 

committee membership are to be concurrent with the yearly Board term. The manual 

only refers to officers in indicating that they “will assume their positions at the 

conclusion of the Fall Board meeting pursuant to the election.” (p14) 

The manual is silent on the issue of transitioning board members between 

committees during a Board term, leaving the issue of committee assignments to the 

discretion of the Board Chair. (p11) 

Relevant Areas of the Rule 

The Organic Foods Production Act (OFPA) establishes the National Organic 

Standards Board at §2119 (7 U.S.C. 6518) “(a) The Secretary shall establish a 

National Organic Standards Board (in accordance with the Federal Advisory 

Committee Act (5 U.S.C. app. 2 et seq.) (hereafter referred to in this section as the 

"Board") to assist in the development of standards for substances to be used in 

organic production and to advise the Secretary on any other aspects of the 

implementation of this title.” The Policy and Procedures Manual sets forth 

procedures (p20) for the transition of Committee Chairs, “In order to avoid disruption 

in the quality and volume of work produced by the NOSB...” At the same time, the 

230
Page 2 of 5 

NOSB Member and Leadership Transition 

July 26, 2011 

2

section of the manual entitled Board Member Standards reads, “Each [NOSB] 

member must be willing to serve on committees as assigned by the Chair...” (p11) 

Discussion 

Committee transitions after the Fall Board meeting. 

To effect a smooth and seamless transition between Board member terms, it is 

believed by the Policy and Development Committee that committee Chair, ViceChair, and member terms on their respective committees should run concurrent with 

Board terms, providing for orientation and mentorship periods, as outgoing Chairs, 

Vice-Chairs and members help train those incoming. In terms of Chairs, it is 

particularly helpful for continuity that the followup to the Fall board meeting be 

conducted with the committee leadership during that term. To the extent that 

additional work must be completed relative to Fall Board meeting decisions, 

clarifications issued, follow through on public comments presented at the meeting, 

and new assignments for moving forward, new committee leadership and 

membership during the period after the election of new officers could be disruptive. 

In addition, with the Board composition changing after the Fall appointment of new 

NOSB members by the Secretary and until an assessment can be made of new 

member expertise and background, the reconfiguration of committee assignments is 

premature and can be disruptive to the ongoing committee process. Therefore, the 

Committee believes that changes to committee composition should generally not be 

made between the Fall Board meeting and the seating of the new Board in January. 

In an effort to ensure full and active participation of new committee members and 

newly appointed NOSB members, the transition period after the Fall Board meeting 

should be used as an orientation and mentorship period. In that regard, new NOSB 

members should be notified that it is expected that they take their committee 

assignments in observer status directly after their appointment to the Board to the 

extent feasible. This will require the Chair to speak with newly appointed and 

existing Board members within two weeks of the appointment of new NOSB 

members and announce committee assignments within a two-week period after that. 

New Board members should be encouraged to attend the Fall Board meeting after 

their appointment. It is the committee’s belief that the travel costs associated with 

their participation should be reimbursed by NOP if necessary to facilitate their 

participation. 

Committee transitions after the Spring Board meeting. 

If after the Spring Board meeting a Board member would like to change committees, 

either adding to or stepping down from his/her assignments, a request should be 

made to the Board Chair. If the request does not alter the preferred number of 

committee members in the range of five to seven, the expectation is that the request 

will be approved, unless the Board Chair states in writing that such change will 

231
Page 3 of 5 

NOSB Member and Leadership Transition 

July 26, 2011 

3

interfere with the functioning of the committee. 

Establishing a mentorship system. 

The committee believes that the Board should formally institute a mentorship system 

to ensure effective participation by new Board members in committee and Board 

deliberations. To accomplish this, the committee believes that new Board members 

should be asked by the Board Chair to identify a mentor from existing Board 

members as soon after their appointment as possible, but no later than two weeks, 

or if the Board member prefers the Board Chair shall assign a buddy in the same 

time frame. 

A section in the Policy and Procedures Manual must be amended to provide 

clarification and guidance regarding the transition of committee Chairs, Vice-Chairs, 

as well as existing and newly appointed members. 

Filling Officer Vacancies 

Language is needed to clarify the process for replacing the Chair of the Board, 

should there be a resignation. The current process of filling vacancies in the 

positions of Vice-Chair and Secretary clearly states that, “Should the Vice-Chair or 

Secretary resign or fail to serve the full term, the Executive Committee shall appoint 

an interim officer.” (p14) However, under the responsibilities of the Vice-Chair, there 

is only a reference to an “absence” of the Chair with the language, “The Vice Chair 

shall act in the absence of the Chair.” (p13) To clarify the process for replacing the 

Chair in the case of a resignation, the committee proposes to use the same process 

that is used in the case of the resignation of the Vice-Chair and Secretary by having 

the Executive Committee appoint an interim Chair “until the next regularly scheduled 

meeting of the Board, during which an election will be held to fill the remainder of the 

term.” (p14) 

Recommendations 

I. Amend Section V to read (changes are in italics): 

Section V 

This section starts by defining the responsibilities of the different Committee Chairs 

and respective Vice-Chairs, and includes guidance on procedures for transition of 

Committee Chairs, Vice-Chairs, and existing and newly appointed members. In 

addition, this section covers the general and specific collaboration procedures 

between NOSB and NOP. [p20] 

The Section “PROCEDURES FOR THE TRANSITION OF COMMITTEE CHAIRS”

is amended as follows: 

PROCEDURES FOR THE TRANSITION OF COMMITTEE CHAIRS, VICECHAIRS, AND MEMBERS

232
Page 4 of 5 

NOSB Member and Leadership Transition 

July 26, 2011 

4

Committee Chairs, Vice-Chairs and members shall be appointed to serve annually 

by the Chair of the Board. The annual committee term shall be concurrent with the 

one-year term established by the Secretary (beginning on January 24 and ending on 

the following January 23). Newly appointed Chairs, Vice-Chairs and committee 

members will assume their positions at the beginning of the new term, after a period 

of orientation and mentorship provided by the outgoing Chair, Vice-Chair, and 

members. 

In order to avoid disruption in the quality and volume of work produced by the 

NOSB, the appointment of Committee Chairs, Vice-Chairs, and members will follow 

these procedures: 

After Election of NOSB Officers at Fall NOSB Meeting 

1. Appointment of Committee Chairs 

The Board Chair should appoint Committee Chairs from members with at 

least one year of NOSB experience, ideally. It is recommended that a new 

Committee Chair should have experience as Committee Vice-Chair. 

2. Appointment of Committee Vice-Chairs 

A Committee Vice-Chair shall be appointed by the Committee Chair and 

should be someone who has expressed to the Chair of the Committee 

interest in eventually serving as Committee Chair. 

3. Time Frame for Appointments 

 Committee Chairs shall be appointed as Incoming Chairs in not more than 

30 days after the newly elected NOSB Chair takes office (or continues in 

office), and incoming Vice-Chairs shall be appointed by Committee Chairs in 

no more than two weeks after that. 

4. Exchange of Committee Files 

 Upon appointment, new and outgoing Committee Chairs should have a 

formal meeting to exchange all files related to the committee’s work and to 

complete the first committee work plan under the new committee leadership. 

5. Review of Committee Files

 New Committee Chairs should review all work plan items and active files 

involving committee work. 

6. Mentorship Period 

 The Incoming Chair and Vice-Chair of each committee shall participate in an 

orientation and mentorship period with the outgoing Chair and Vice-Chair of 

their committee until being seated in their positions at the beginning of the 

new term on January 24. 

After the Appointment of the New NOSB Members, Prior to January 24 

7. New Committee Member Appointments 

 New incoming committee members shall be appointed by the Board Chair, 

in consultation with the outgoing and incoming committee Chairs, no more 

than two weeks after the appointment of the new NOSB members by the 

233
Page 5 of 5 

NOSB Member and Leadership Transition 

July 26, 2011 

5

Secretary, with the Chair seeking and taking into account the expressed 

member interest, expertise, background, as well as new board composition. 

8. Communication with Newly Appointed Members 

 Once appointed, incoming committee members shall be included in all 

emails pertaining to the committee assignments. 

9. Attendance at Committee Meetings and Fall NOSB Meeting 

 New incoming members of the committee should participate in observer 

status in committee meetings upon their appointment, and should be 

encouraged to attend the Fall Board meeting. 

10. New Member Mentorship. 

 The Board Chair, to facilitate an effective transition for new members of the 

Board and ensure effective participation in committee and board 

deliberations, shall ask incoming Board members to identify a mentor from 

existing Board members as soon after their appointment as possible, but no 

later than two weeks, or, if the Board member prefers or the Board member 

takes no action, the Board Chair shall assign a mentor in same time frame. 

Between Board Appointments and Fall Board Meeting 

11. Changing Committee Appointments 

 If a Board member would like to change committees, either adding to or 

stepping down from his/her assignments, a request shall be made to the 

Board Chair. If the request does not alter the preferred number of committee 

members in the range of five to seven, the expectation is that the request 

will be approved, unless the Board Chair states in writing that such change 

will interfere with the functioning of the committee. The Chair’s 

determination should be made in consultation with Committee Chairs and 

the Executive Committee. 

12. Filling Vacancy of Committee Chair and/or Vice-Chair 

 In the case of a vacancy in the positions of Committee Chair, the Committee 

Vice-Chair shall assume the Committee Chair position and the new 

Committee Chair shall appoint a new Vice-Chair in accordance with the 

consultation procedures cited above. 

II. Amend Section III (ELECTION OF OFFICERS. A. NOMINATION, p14) to read as 

follows: 

“Should the Chair, Vice Chair, or Secretary resign or fail to serve the full term, the 

Executive Committee shall appoint an interim officer.” 

 

Committee Vote: 

Moved: Jay Feldman Second: Barry Flamm 

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

234
 National Organic Standards Board 

Policy Development Committee 

Proposed Discussion Document 

Public Comment Procedures 

October 4, 2011 

Introduction 

With the goal of involvement from all parts of the organic community, the National 

Organic Standards Board (NOSB) has historically sought to ensure that public input is 

central to its decision making process. The Policy Development Committee (PDC) 

seeks to collect public input on its miscellaneous policy on this subject, in an effort to 

assess the effectiveness of its public hearing process and its perceived utility in 

assisting the Board to make decisions that build public support for and trust in the 

standard. In order to do this, the PDC seeks public input regarding the establishment of 

a policy that clearly defines an effective public comment process in NOSB deliberations. 

Background 

Activities of the NOSB include, “conducting public meetings, soliciting and taking public 

comments” (NOSB Policy Procedure Manual [PPM] p5), in order to carry out the NOSB 

mission. 

As discussed in the PPM (p27 - Miscellaneous Policies), several items stand out as vital 

for public comment at NOSB meetings. Specifically, it is stated that people who wish to 

comment at NOSB meetings during public comment periods can do so by following the 

rules in place, as well as using suggestions to better ensure that they are well-received. 

Further, current policy states, “Each person will be given 5 minutes to speak, unless 

otherwise indicatd by the Chair,” (p27) and continues, “No person will be allowed to 

speak during the public comment period for more than 10 minutes, unless otherwise 

indicated by the Chair.” (p27) 

Finally, it is put forth that written proxies can be submitted to allow another person to 

speak on behalf of a member of the public, and that, “Individuals providing public 

comment will refrain from any personal attacks and from remarks that otherwise impugn 

the character of any individual.” (p27) 

The policy gives the NOSB Chair discretionary authority in determining time allotments 

for public commenters within the established parameters. The PDC is seeking public 

input on issues that may require additional clarity, including, but not limited to, the 

following: 

• How the NOSB informs the public of time allotments for public commenters 

during NOSB meetings; 

235
Page 2 of 5 

Public Comment Procedures 

October 4, 2011 

• How the NOSB publicly acknowledges public comment; 

• How the NOSB responds to popular or pressing issues raised in numerous 

public statements, but not included in the meeting agenda; 

• Whether the time designated refers to presentation time, or to question and 

discussion time by NOSB members, or a combination of both; and, 

• Whether comments from those who cannot be present can only take either the 

form of submitted written comment, or of proxy-delivered live comment, or 

whether, in addition, other options with modern media tools might allow live- or 

pseudo-live input from public members who are not present. (Along these lines, 

although Skype may not be an appropriate method, should the public input 

process make available by electronic or real-time technology a means for 

fostering broader public access to the public comment process?) 

This document presents a set of questions and seeks public input. In addition, there 

may be additional questions and issues raised by the public that merit responses and 

the PDC encourages those being brought to this process. 

Relevant Areas of the Rule 

The Organic Foods Production Act (OFPA) establishes the National Organic Standards 

Board at §2119 (7 U.S.C. 6518), “(a) The Secretary shall establish a National Organic 

Standards Board (in accordance with the Federal Advisory Committee Act (5 U.S.C. 

app. 2 et seq.) [hereafter referred to in this section as the "Board"] to assist in the 

development of standards for substances to be used in organic production and to 

advise the Secretary on any other aspects of the implementation of this title.” The PPM 

[http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3013893] (Section 

VI, Miscellaneous Policies) includes (p27), “Policy for Public Comment at NOSB 

Meetings.” This lays out the process and the time designations of public comments, 

including that, “Each person will be given 5 minutes to speak,” and, “No person will be 

allowed to speak during the public comment period for more than 10 minutes.” Both of 

these statements are followed by the caveat, “unless otherwise indicated by the Chair.” 

Furthermore, process and time designation points are made in a subsequent section 

entitled, “Other suggestions that would be appreciated by NOSB members,” which 

provides additional direction to the public comment process 

Discussion 

In both policy and practice, the NOSB has traditionally put great value in comments 

delivered in person. The NOSB moves meetings around the country to allow easier 

access by a broad group of people and organizations, that otherwise would not have 

access, during each meeting. The Board sets aside a large proportion of the meeting 

time for public comment. And, the Board has adopted policy that guarantees those who 

have pre-registered and attend meetings at least a minimum amount of time in which to 

deliver their message. 

A modification to the basic structure that the Policy provides for public comment is being 

236
Page 3 of 5 

Public Comment Procedures 

October 4, 2011 

considered. The Committee seeks input and discussion from all interested parties that 

will assist in clarifying and addressing public needs, and ensuring the effectiveness and 

efficiency of the process. Public comment is sought to address questions included 

within the discussion points that follow. 

Time limits and adequate representation 

In the Federal Register notice announcing an NOSB meeting, the public is informed 

about the public comment period and the time restrictions. As increased numbers of 

people seek to participate in this process, time limitations become a factor in scheduling 

time allotments for individual participants. 

There may be several ways to handle a large number of requests for public comments. 

1. A special announcement could be posted in the Federal Register subsequent to 

the initial announcement indicating that a time reduction is being put in place for 

public comments. This was done for the Spring 2011 NOSB meeting, reducing 

the time allotment from 5 to 3 minutes. 

2. A need to condense public statements could be announced at the beginning of 

the NOSB meeting, indicating that there are many who wish to make comments 

and requesting that comments be kept as brief as possible. In addition, NOSB 

members could be asked to keep their questions limited. This voluntary time 

reduction approach may achieve the time savings needed. 

3. An assessment of those signed up and those actually present at the meeting 

could be made at the beginning of the meeting (or at the beginning of each day 

of the meeting), and a determination made as to whether time reductions are 

necessary. 

4. The Board could decide to extend public comment into the evening hours to 

accommodate more people. 

Given that the public comment period cannot be unlimited, should the requests to make 

public comment be prioritized? Should the total number of public comment slots be 

limited by category/topic or by some other means? Should more time be allocated for 

public comments (including going into the evening/night as necessary)? Should the 

published announcement indicating time periods for public comment be eliminated and 

full authority be given to the NOSB Chair or designated Board committee to determine 

how the issue can best be decided? 

Another component regarding public comment at NOSB meetings pertains to whether 

the allocated time refers to „presentation‟ time, „question and discussion‟ time from 

NOSB members, or a combination. Should the policy be clarified to state a fixed 

presentation time, as well as a maximum question and discussion time? Should NOSB 

member questions be limited? Who should allow the variation or combine the time into 

some clear total? Or, is this best done by the Board Chair during the meeting, subject to 

the circumstances at hand? Also, should the time allocated be flexible or related to the 

number of requests? Or should it remain as it is now in the PPM? Is some other 

designation of time(s) more appropriate? 

237
Page 4 of 5 

Public Comment Procedures 

October 4, 2011 

Hearing from those who cannot attend 

Comments from those who cannot be present be present during public comment could 

be submitted in written from, through a live proxy, or by electronic means with modern 

media tools that allow for live- or pseudo-live input. (Along these lines, while Skype may 

not be the appropriate method, it may be necessary to identify and maintain an 

electronic or real-time means of fostering public comment access.) Should public 

comment through live/”remote” means be allowed and/or encouraged? Furthermore, 

given the limits of time, should the recent revisions to the PPM to clarify proxy 

procedures (p27) continue, or should the proxy practice be abolished1

? 

Responding to public comment and serving the advisory role 

It can further be posited that the NOSB should respond to overarching issues, which are 

repeatedly raised by the public at the meeting, even if those issues were not on the 

agenda. Some stakeholder groups have suggested that at the end of each Board 

meeting a communication from the NOSB be sent to the Secretary of Agriculture to 

convey issues that have come up during public comment and to fulfill the Board‟s 

statutory responsibility in its advisory capacity. According to some stakeholders, both 

those within and outside the NOSB, it is a responsibility of the Board that public 

comment is publicly acknowledged in this and possibly other ways. How should this be 

handled: prior to, during, or after public comment has occurred? Furthermore, what type 

of response or action should the public expect from the NOSB when issues not on the 

agenda are raised repeatedly in public comment? Should communications to the 

Secretary on issues raised in public comment be formalized? Does this communication 

and advisory function serve as an important public-private partnership that is responsive 

to the concerns raised by the broader organic community? 

Conclusion 

In order to best meet the goals of the NOSB and incorporate public comment into its 

decision making, the PDC is seeking public input on the Board‟s decision making 

process and efforts that may better ensure that the public feels welcome and is heard 

through its participation. Time for clarification and discussion has been viewed as 

helpful to both NOSB members and the public. How can this be balanced with the 

number of interested public commenters vis-à-vis the time available on the schedule? 

The PDC is seeking the public‟s perspective on the questions below. (Please indicate 

the question number in responses provided on this topic.) 

 

1

 The PPM (p27) on this point reads, “The NOSB will attempt to accommodate all persons requesting 

public comment time, however, persons requesting time after the closing date in the Meeting Notice, or 

during last minute sign-up at the meeting, will be placed on a waiting list and will be considered at the 

discretion of the NOSB Chair depending on availability of time. Similarly, persons who have signed up to 

address the NOSB for their 5-minute slot and have also served as a proxy for another person will be 

placed on a waiting list if they wish to speak for a third time on the same topic, and will be considered at 

the discretion of the NOSB Chair depending on availability of time. This should allow more members of 

the public time to present.”

238
Page 5 of 5 

Public Comment Procedures 

October 4, 2011 

1) Given that the public comment period cannot be unlimited, how should the 

requests to make public comment be prioritized? 

2) Should the policy be clarified to state a fixed presentation time for public 

comment? 

3) Should policy also define a maximum question and discussion time once public 

comment is received? 

4) Who should allow the variation or combine the time(s) into a defined total in #3 

above? 

5) Is time setting best done by the Board Chair, at the time of the meeting, 

depending upon the circumstances at hand? 

6) Should the time allocated be flexible or related to the number of requests? 

7) Should the public comment time allowed remain as it is now in the PPM? 

8) Is some other designation of time(s) more appropriate? 

9) Should public comment through live/”remote” means be allowed and/or 

encouraged? 

10) Given the limits of time, should the recent revisions to the PPM to clarify proxy 

procedures (p27) continue? Or, should the proxy practice be abolished? 

11) How can this function (NOSB serving as an advisory role) best serve as a publicprivate partnership that is responsive to the concerns raised by the broader 

organic community? 

The public is encouraged to provide any additional questions and thoughts regarding 

the most effective and efficient approach for the NOSB to manage the public comment 

process associated with its Board meetings. 

Committee Vote 

Moved: Colehour Bondera Second: Barry Flamm 

Yes__6___ No__0___ Abstain__0__ Absent__0___ 

239