National Organic Standards Board | Spring 2011 Meeting

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National Organic Standards Board Meeting

Hotel Albuquerque | Albuquerque, New Mexico

May 22, 2012 – May 25, 2012

Title Page

Agenda 1

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

Proposal – Material Review Organizations review Criteria 7

Discussion Document – Sanitizers and “100% Organic” claim 12

GMO ad hoc Committee | Zea Sonnabend, Chairperson

Letter to Secretary Vilsack 17

Materials Committee | Jennifer Taylor, Chairperson

Research Priorities Framework Discussion Document 19

Discussion Document – Extractants and Solvents 23

Discussion Document – Significant Residues and Classification of Materials 30

Crops Committee | Jay Feldman, Chairperson 

Discussion Document – EPA List 3 Inerts Petitioned Materials Recommendations 34

Livestock Committee | Wendy Fulwider, Chairperson

Proposal – GMO Vaccines 41

Discussion Document – Species Specific Guidance 61

Discussion Document – Dairy Auditor Score Sheet 63

Discussion Document – Dairy Score Card 65

Discussion Document – Guidance for Assessing Animal Welfare: Bison 67

Discussion Document – Guidance for Assessing Animal Welfare: Poultry 83

Discussion Document – Guidance for Assessing Animal Welfare: Sheep 108

Discussion Document – Outcome Score Tally Sheet for Animal Welfare 113
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Policy Development Committee | Colehour Bondera, Chairperson

NOSB Policy and Procedure Manual Recommendations

Section I: Conflict of Interest 115

Proposal - Public Comment Procedures 120

Proposal - Public Communications 125

Handling Committee | John Foster, Chairperson

Petitioned Materials Proposals

Choline 129

Curry leaf 136

Gibberellic Acid 143

Inositol 150

Citrus Hystrix 158

Sunset 2013 Recommendations on § 205.605(a)

Agar Agar 165

Calcium sulfate 167

Carrageenan 168

Glucono delta-lactone 170

Sunset 2012 Recommendations on § 205.605(b)

Cellulose 172
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

 1

National Organic Standards Board Meeting

Albuquerque, New Mexico, May 22-25, 2012

AGENDA

Schedule at a Glance

Tuesday, May 22 Wednesday, May 23 Thursday, May 24 Friday, May 25

AM - Call to Order and 

 Secretary’s Report 

- NOP Update 

- Open Public Comment 

- Materials Subcommittee

- Crops Subcommittee

- Policy Development 

 Subcommittee

- Handling 

 Subcommittee

- Deferred Items

- Final Votes

- Subcommittee Work

 Plans

- Other Business and 

 Closing Remarks

PM - Compliance, Accreditation 

 & Certification 

 Subcommittee 

- GMO ad-hoc Subcommittee

- Livestock Subcommittee - Handling 

 Subcommittee

Meeting Format

• USDA National Organic Program (NOP) National List Manager presents overview of sunset 

substances, petitioned substances and Technical Reports in consistent format. NOSB members

present Subcommittee proposals on petitioned substances and sunset substances.

• Public comments are segmented to correspond with each Subcommittee.

• The agenda has been revised to account for the number of oral public comments that will be 

made for each Subcommittee.

• Each Subcommittee’s proposals are discussed and voted on before moving to the next 

Subcommittee.

• Board votes on Subcommittee proposals can be deferred to Friday for final vote if more 

deliberation is needed.

• Final recommendations are completed during the meeting so that they can be posted on the 

NOP website immediately following the meeting. 

Public Comments

• All persons wishing to comment at NOSB meetings during public comment periods must sign up 

in advance; instructions are available at www.ams.usda.gov/NOSBMeetings

• Persons must give their names and affiliations for the record at the beginning of their public 

comment.

• Each person is provided a 3 minute comment period. 

• Each person may sign up for only one comment period. 
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

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Tuesday, May 22, 2012

8:00 AM Call to Order

Barry Flamm, Chairperson

− Announcements

− Introductions

− NOSB Mission

8:15 AM Secretary’s Report

Wendy Fulwider, Secretary

− Acceptance of December 2011 Meeting Transcripts and Voting Results 

as Official Record

8:30 AM National Organic Program Update

Miles McEvoy, Deputy Administrator

National Organic Program

10:00 AM BREAK

10:15 AM Open Public Comment

− Public comments that are not specific to a particular Subcommittee 

 12:30 PM LUNCH

 

 1:30 PM Compliance, Accreditation and Certification Subcommittee 

Joe Dickson, Chairperson

- Present Subcommittee proposals and summarize written comments

Topics: 

- Discussion paper - Sanitizers and “100% organic” products

- Proposal - Material Review Organizations review criteria

 

 2:00 PM − Public comments related to CAC Subcommittee 

 2:30 PM − Subcommittee modifies proposals as needed 

− Board votes

3:15 PM BREAK
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

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3:30 PM GMO ad-hoc Subcommittee

Zea Sonnabend, Chairperson

− Present Subcommittee proposals and summarize written comments 

− NOP presentation on NOP GMO policy

Topics: 

− Proposal - Letter to Secretary Vilsack

4:10 PM − Public comments related to GMO Subcommittee proposals 

4:45 PM − Subcommittee modifies proposals as needed 

− Board votes

5:30 PM RECESS

Wednesday, May 23, 2012

8:00 AM National Organic Program- Materials Classification Overview

 Dr. Lisa M. Brines, NOP National List Manager

8:30 AM Materials Subcommittee 

Jennifer Taylor, Chairperson

− Present Subcommittee proposals and summarize written comments 

Topics:

− Aquaculture petition update – for use of vitamins (no document)

− Proposal - Research Priorities Framework

− Discussion paper – Extractants and solvents

− Discussion paper – Significant residues and classification of materials

9:30 AM − Public comments related to Materials Subcommittee proposals 

10:15 AM BREAK

10:30 AM − Subcommittee modifies proposals as needed 

− Board votes

11:00 AM Crops Subcommittee 

Jay Feldman, Chairperson 

− Present Subcommittee proposals and summarize written comments 

− Report from Inerts working group
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

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Crops Subcommittee Topics:

Sunset 2013 Recommendations on § 205.601

− EPA list 3 (Inerts)

11:20 AM − Public comments related to Crops Subcommittee proposals

11:50 AM − Subcommittee modifies proposals as needed 

− Board votes

12:30 PM LUNCH

1:30 PM Livestock Subcommittee 

Wendy Fulwider, Chairperson 

− Present Subcommittee proposals and summarize written comments 

Topics:

− Proposal - GMO vaccines

− Discussion paper - Species specific guidance 

− Discussion paper - Dairy auditor score sheet

− Discussion paper - Dairy score card

− Discussion paper - Guidance for Assessing Welfare: Bison

− Discussion paper - Guidance for Assessing Welfare: Poultry

− Discussion paper - Guidance for Assessing Welfare: Sheep 

− Discussion paper - Outcome score tally sheet for Animal Welfare

2:30 PM − Public comments related to Livestock Subcommittee proposals 

3:30 PM BREAK

3:45 PM − Public comments related to Livestock Subcommittee proposals

4:45 PM Livestock Subcommittee continued

− Subcommittee modifies proposals as needed

− Board votes

5:30PM RECESS

Thursday, May 24, 2012

8:00 AM Policy Development Subcommittee

Colehour Bondera, Chairperson

− Present Subcommittee proposals and summarize written comments 
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

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Policy Development Subcommittee Topics:

− Proposal - Conflict of Interest 

− Proposal - Public Comment Procedures

− Proposal – Public Communications

8:45 AM − Public comments related to Policy Subcommittee proposals 

9:15 AM − Subcommittee modifies proposals as needed 

− Board votes

10:00 AM BREAK

10:15 AM Handling Subcommittee

John Foster, Chairperson

− Present Subcommittee proposals and summarize written comments

− Update on ancillary and other ingredients

Topics:

Petitioned Materials Proposals

− Choline

− Curry leaf

− Gibberellic acid

− Inositol

− Citrus hystrix

Sunset 2013 Proposals on § 205.605(a)

− Agar-agar

− Calcium sulfate 

− Carrageenan

− Glucono delta-lactone

Sunset 2013 Proposals on § 205.605(b)

− Cellulose

12:00 PM LUNCH 

1:00 PM Handling Subcommittee, continued 

− Public comments related to Handling Subcommittee proposals 

3:00 PM BREAK

3:15 PM − Subcommittee modifies proposals as needed 

− Board votes 

5:00 PM RECESS
USDA-AMS | National Organic Program

National Organic Standards Board | Spring 2012 Meeting Agenda, Revised 5/15/2012

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Friday, May 25, 2012

8:00 AM Deferred Proposals

Final Votes

10:00 AM BREAK

10:15 AM Deferred Proposals/Final Votes, continued

11:00 AM Subcommittee Workplans

11:30 AM Other Business and Closing Remarks

12:00 PM ADJOURN
National Organic Standards Board

Compliance, Accreditation and Certification Committee

Proposal

Criteria for Material Review by Material Review Organizations

March 29, 2012

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, 2011 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 presented a 

recommendation on the topic at the November, 2011 NOSB meeting in Savannah. This 

recommendation described specific criteria to be used by the NOP in evaluation and 

oversight Materials Review Organizations. During and following the Savannah NOSB 

meeting, a number of stakeholders pointed out that the recommendation failed to 

address the specific criteria and procedures to be used by MROs in evaluating 

materials. The present recommendation addresses those concerns by detailing such 

procedures. 

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 

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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 

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 

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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.

The CACC’s November 2011 recommendation presented a framework for NOP 

oversight and evaluation of MROs. The present recommendation will set out specific 

review criteria to be used by such organizations (both independent MROs and ACAs 

performing materials review activities) in reviewing materials. 

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

 

The NOSB’s fall 2011 Recommendation detailed specific criteria to be used by the NOP 

in evaluation and oversight Materials Review Organizations. A number of commenters, 

including MROs and ACAs, noted that the CACC’s recommendation failed to provide a 

concrete framework for the NOP to use in creating guidance for such organizations in 

the short term. This recommendation addresses that deficiency by adding a number of 

specific criteria and procedures to be used by such organizations in the evaluation of 

specific materials. A number of issues were discussed, including the following: 

Depth of materials review.

At what depth should an input be reviewed (i.e. ingredients within ingredients OR 

ingredients within ingredients within ingredients)

Evaluation of synthetic/non-synthetic and agricultural/non-agricultural status of 

materials. 

How should MROs make these determinations in a way that ensures consistency with 

NOP policy and consistency across MROs?

Duration and expiration of materials review determinations.

How long is a material review decision valid? How often must a substance or input be 

re-reviewed?

Procedures for monitoring ongoing compliance of approved products. 

What are guidelines for surveillance, removal of noncompliant products from the list, 

documentation of formula changes, etc.?

Evaluation of potential use of prohibited methods.

What level of verification is necessary for prohibited methods, especially GMO sourced 

inputs like corn gluten meal or soy meal. 

Substantiation of label claims and other requirements.

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i.e. pH in stabilized fish, purchase records to prove formulas, records for compost 

production, NPK label claims

Recommendation

In its November 2011 recommendation, the NOSB asked that the National Organic 

Program require that MROs become accredited or formally recognized under a newly 

formed Material Review scope, in order to facilitate adequate oversight and 

enforcement of the activities of MROs. The recommendation advocated that Materials 

review activities should ultimately only be allowed by NOP accredited entities.

Since the creation of a new accreditation scope is a complicated and potentially longterm undertaking, the NOSB also recommends a number of short term measures to 

support the consistency of decisions currently being made by MROs. On an immediate 

basis, NOP should provide detailed guidance and criteria on the material review 

process in order to promoted consistency and uniformity among currently operating 

MROs while longer term regulatory changes are undertaken.

We ask that the NOP provide detailed guidance to MROs and ACAs to ensure the 

consistency and integrity of materials review decisions. Such guidance should: 

• Establish that material review organizations may not make synthetic vs. nonsynthetic or agricultural vs. non-agricultural determinations except when made in 

strict compliance with NOP guidance. We urge the NOP to expedite the 

publication of clear guidance for making such determinations, based on earlier 

recommendations of the NOSB. The classification of materials is of foundational 

importance to the integrity of organic products, and such guidance is extremely 

critical, given the thousands of synthetic vs. non-synthetic and agricultural vs. 

non-agricultural determinations made by certifiers each year. 

• Require that MROs obtain and maintain ISO 65 accreditation, which will ensure 

MROs are meeting these strict guidelines regarding consistency and 

transparency. 

• Require that MROs provide a clear and publically available description of its 

review criteria and decision-making procedures. 

• Establish appropriate education, training, and experience levels for personnel 

conducting material review.

• Establish appropriate levels of personnel, resources, infrastructure, and 

documentation to engage in on-site inspections where needed. Establish need, 

frequency, and type of on-site inspections.

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• Create clear expectations about the depth of the review, providing clear direction 

for the evaluation of ingredients, sub ingredients, and processing aids at various 

levels within a formulation. 

• Create clear expectations for the frequency of material review, establishing how 

often and under what conditions approved products must be re-reviewed.

• Contain a mechanism to ensure consistency in decisions across MROs. 

Specifically, it should give direction to MROs about what action, if any, should be 

taken when making a decision it knows conflicts with another MRO’s decision.

• Establish criteria for determining the acceptability of documentation for verifying 

compliance with certain material annotations or required conditions (e.g. pH in 

stabilized fish, purchase records to prove formulas, records for compost 

production, NPK labels claims). 

• Give direction to MROs on verification of products derived from GMO risk crops 

(e.g. corn gluten meal, soy meal). What type of substantiation is sufficient to 

verify that an input has been produced without excluded methods?

• Provide procedures for ongoing monitoring of approved products, including 

market surveillance, testing, removal of noncompliant products from lists, etc. 

• Give direction to MROs about what action should be taken when the NOP issues 

guidance or policy which contradicts an MRO’s listing of an input or material, 

including the expected timeframe for the MRO’s listing to be changed.

• Be developed with the input and participation of current MROs and ACAs, 

through the Accredited Certifiers Association, the Organic Materials Review 

Institute, and others, to draw on the considerable material review expertise of 

those organizations currently making such decisions. The NOP has noted that its 

2012 accreditation audits of ACAs will include materials review processes as a 

focus; we hope that the NOP will use this information to inform the development 

of a policy which incorporates the best practices being currently used. 

• Provide clear definitions of key terms, including the use of the term “certification” 

with regard to materials review activities. 

 

Committee Vote

Motion by: Joe Dickson Second: Barry Flamm

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

11
National Organic Standards Board

Certification, Accreditation & Compliance Committee

Discussion Document Proposal

Use of Sanitizers on Eligibility for 100% Organic Claims

March 29, 2012

Introduction & Background

 

Four labeling categories have been established for products intended for human consumption 

under the National Organic Program (7 CFR Part 205.301). From lowest to highest organic 

composition they are: 

Products comprised of less than 70% organic ingredients 

Products comprised of at least 70% organic ingredients ( “made with”) 

Products comprised of 95% or more organic ingredients 

Products comprised of 100% organic ingredients. 

All four categories may be produced using processing aids which are either removed prior to 

packaging or remain behind in “insignificant amounts,” and which do not have to be identified 

on the ingredient statement. (FDA regulations in 21 CFR Subpart F) However, under the NOP 

the use of such processing aids is restricted in the three highest categories: 

At least 70% - processing aids must be on National List 

95% or more - processing aids must be on National List 

100% - processing aids must be organic 

From the beginning of NOP implementation, the use of food contact sanitizers did not impede 

a producers or handlers ability to make a 100% organic label claim on products coming in 

contact with them. This changed in early 2007, when certifiers were advised during ACA 

trainings that the use of these substances voided 100% organic label claims on processed 

products, but this was later retracted (though not formally) by NOP staff at that time, but in any 

event formal written guidance affirming the loss of 100% organic claim eligibility emerged from 

the NOP and continues in force presently. It is worth noting that several companies were 

forced to change packaging claims as a result to reflect the downgraded organic status. 

In 2010 the NOSB deliberated on the use of inert gases in the packaging of organic products 

and how such use should or should not affect the eligibility for 100% Organic claims. 

The 100% category has been marked by confusion since its inception by certifiers, consumers, 

producers, manufacturers, and by NOP staff at times. This category is not allowed by U.S.

major trading partners the E.U. and Canada and the U.S. is the only jurisdiction to define it

Relevant areas in the Rule

There are no references to processing aids in OFPA. Potentially relevant statutory citations 

pertain to use of synthetic ingredients are found in Sec 2111 - HANDLING 

(a) IN GENERAL – For a handling operation to be certified under this title, each person on 

such handling operation shall not, with respect to any agricultural product covered by this 

title— 

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(1) Add any synthetic ingredient during the processing or any postharvest handling of the 

product:... 

(4) Add any ingredients that are not organically produced in accordance with this title and the 

applicable organic certification program, unless such ingredients are included on the National 

List and represent not more than 5 percent of the weight of the total finished product. 

In NOP 205.2 Terms Defined, the following distinct definitions can be found for “ingredient” and 

“processing aid:” 

“Ingredient. Any substance used in the preparation of an agricultural product that is still present 

in the final commercial product that is consumed. 

“Processing aid. 

(1) A substance that is added to a food during the processing of such food but is removed in 

some manner from the food before it is packaged in its finished form; 

(2) A substance that is added to a food during processing, is converted into constituents 

normally present in the food, and does not significantly increase the amount of the constituents 

naturally found in the food; and 

(3) A substance that is added to a food for its technical or functional effect in the processing 

but is present in the finished food at insignificant levels and does not have any technical or 

functional effect in that food.” 

7 CFR 205.301 (f) (4) states: 

“All products labeled as “100 percent organic” or “organic” ......must not: (4) Be processed 

using processing aids not approved on the National List of Allowed and Prohibited Substances 

in subpart G of this part: Except, That, products labeled as 100% organic,” if processed, must 

be processed using organically produced processing aids; 

The definition of “processing aid” in the Rule is taken verbatim from the FDA definition found in 

21 CFR Subpart F, below: 

21 CFR Subpart F- Exemptions from Food Labeling Requirements comprehensively describes 

those things which do not need not appear on a product ingredient statement. Section 100.101 

(a) (3) (i) and (ii). 

§ 101.100 – Food; exemptions from labeling. 

(a) the following foods are exempt from compliance with the requirements of section 403(i) (2) 

of the act (requiring a declaration on the label of the common or usual name of each ingredient 

when food is fabricated from two or more ingredients).......(3) incidental additives that are 

present in a food at insignificant levels and do not have any technical or functional effect in that 

food. For the purpose of this paragraph (a) (3), incidental additives are:..... 

(ii) Processing aids, which are as follows: 

(a) Substances that are added to a food during the processing of such food but are removed in 

some manner from the food before it is packaged in its finished form. 

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(b) Substances that are added to food during processing, are converted into constituents 

normally present in the food, and do not significantly increase the amount of those 

constituents naturally found in the food. 

 

(c) Substances that are added to a food for their functional effect in the processing 

But are present in the finished food at insignificant levels and do not have any technical 

or functional effect in that food. 

 

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food 

that are not food additives as defined in section 201 (s) of the act; or if they are food 

additives as so defined, they are used in conformity with regulations pursuant to section 

409 of the act. (“Food and Drugs Sub Chapter B-Food for Human Consumption”) 

The definition of “processing aid” found in 7 CFR Part 205 is taken directly from the FDA 

definition of “processing aid,” which, in turn, makes a clear distinction between “processing 

aids” and substances such as some specific atmospheric gases which have no functional 

effect in the food or the processing of that food, but merely modify the environment in which 

the food is packaged. The Organic Rule – 7 CFR Part 205, by including separate definitions for 

“processing aid” and “ingredient” allows that not everything in a package labeled and sold as 

“organic” is an ingredient.

Sanitizers are defined and regulated by FDA (21 CFR Part 178) as “substances used to control 

the growth of microorganisms.” According to the FDA, these substances are classified as Food 

Contact Substances, not processing aids. 

Discussion

CACC members discussed the background and prior activity around this subject, referencing 

especially the 2009-2010 NOSB discussions around inert gas packaging aid use and the 100% 

Organic claim. 

The current guidance from the NOP disallows using the 100% Organic label claim when 

organic goods come into contact with food contact or food contact surface sanitizers, even 

when the sanitizer is no longer present in the finished product prior to sale. This is consistent 

with the loss of 100% Organic eligibility when non-organic (but organic -compliant) processing 

aids are used in otherwise organic products. Of course, any such sanitizers or processing aids 

used must be included on the appropriate section of the National List, included as part of each 

operator’s Organic System Plan, and approved by the operator’s Accredited Certifying Agent 

(ACA).

This guidance leads to some interesting outcomes. For example, organic oranges are 

harvested into bins in the field and may be labeled with a 100% Organic claim. If and when 

those oranges are deposited into a wash tank at the pack shed and that tank has added 

chlorine in it, the oranges lose their 100% organic status. The chlorine is there to keep the 

water from becoming contaminated with pathogens or spoilage organisms. To think of an 

unprocessed orange as anything other than 100% is confusing for some consumers. 

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Beyond that, if and when that orange is sold, for juicing for example, the juice that comes from 

that orange cannot make a 100% Organic claim since the oranges it came from can’t either. 

For the sake of example, assume that no filtering agents are used in the juicing process. If a 

beverage maker wants to use that organic juice in a 100% juice beverage, that operator would 

have to default to allowing only 95% of the orange juice to contribute to the organic percentage 

of the beverage as a whole. This can occur unless the organic certifier of the juice is willing 

and able to issue a letter of some sort to clarify the amount of the juice that may be used in 

excess of 95% toward finished goods percentage calculations. 

Another example of confusion occurs when produce is field packed, such as celery hearts, 

which are typically cut, trimmed and placed on a mobile harvest machine in the field. The belt 

which conveys the produce to those who pack it into cartons is typically sprayed with 

chlorinated water to reduce the likelihood of contamination by pathogens or spoilage 

organisms. Once again, those celery hearts, 100% Organic after being cut from the stem and 

trimmed, are relegated to Organic status (with a presumptive 95% organic percentage) once 

hey touch that belt. 

Other options the Committee discussed were the concept of recommending the removal of the 

100% Organic claim altogether and the concept of recommending the removal of the 

requirement that processing aids used in products making a 100% Organic claim be 

themselves organic. These concepts are more complicated and have intricate ramifications for 

the regulation and industry as a whole, and the Committee is not prepared to focus on those 

options at this time.

It is worth noting, as did the NOSB in 2008, that “sanitizers are defined and regulated by FDA 

(21 CFR Part 178) as “substances used to control the growth of microorganisms.” As such 

these substances are classified as Food Contact Substances, are not processing aids, and do 

not have to be reviewed and approved by NOSB to be placed on the National List to for use in 

organic products.” 

The CACC believes that this issue deserves additional attention and community deliberation. 

The Committee does not feel that adequate information or dialogue has been had on the 

subject to propose a recommendation about guidance on the matter at this time, and we would 

like to promote community discussion. Accordingly, we ask for public comments in response to 

the questions posed below. 

Requested Input from NOSB, NOP and Public Comment

The CACC proposes to put forward the following questions to the NOSB and the organic 

community regarding the use of food contact or food contact surface sanitizers and the 

resultant ability to use labeling claims of “100% Organic”:

1. Does the 100% Organic label claim hold value for you?

2. Do you feel that contact with a non-organic processing aid should prevent an item from 

being 100% organic and why? 

3. Do you feel that contact with a non-organic food contact sanitizer should prevent an 

item from being 100% organic and why?

4. How do you distinguish a processing aid from a food contact sanitizer? 

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5. Does your organic certifier provide guidance on what is a processing aid versus a food 

contact sanitizer? If so, what is that guidance?

6. If your certifier allows you to use a processing aid, how do you show that the processing 

aid “is present in the finished food at insignificant levels and does not have any 

technical or functional effect in that food?” 

7. Should there be a category/list of NOP allowed food contact sanitizers and non-organic 

processing aids that are approved to be used in the 100% organic category? (e.g. 

Chlorine, peracetic acid, diatomaceous earth, etc.) 

8. At what concentration, if any, do you consider a sanitizer/disinfectant to have 

disqualified an item from the 100% organic category? 

9. Should food contact sanitizers be allowed in the 100% organic category if it is proven 

that no residue from the treatment remains in the finished good? 

10.Do you certify items to the 100% organic category? If so, how many? 

11.Do you feel that food contact sanitizers are necessary for food safety concerns? 

12.If food contact sanitizers could be used while still allowing for a 100% organic claim 

would you certify more products with the organic claim? If not, why not? 

13.Do you have customer requests/demand for products in the 100% organic category?

 

The CACC also welcomes comments and input in addition to answers to the questions above.

Committee Vote

Motion: The CACC moves to accept this document and present it for full board discussion at 

the Spring 2012 NOSB meeting

Motion by: John Foster Second: Calvin Walker

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

16
National Organic Standards Board

Ad hoc GMO Committee

Proposal

Letter to the Secretary on GMOs

March 28, 2012

March 28, 2012

The Honorable Tom Vilsack

Secretary of Agriculture

US Department of Agriculture

Washington, DC 20250

Dear Honorable Secretary Vilsack: 

The National Organic Standards Board (NOSB) members appreciate the opportunity to 

carry out our authority under the Organic Foods Production Act (OFPA) to provide 

advice on the development of organic standards and to determine substances for the

National List. 

The NOSB accepts responsibility for making recommendations that pertain to "excluded 

methods" to ensure that GMOs (genetically modified organisms) are prohibited in 

organic production and handling. To do this we have established an Ad Hoc Committee 

on GMOs. The NOSB, speaking for the organic community, believes the USDA’s 

actions on genetically engineered crops have been insufficient to protect the organic 

industry. 

Unsolicited public comments at many NOSB meetings since the rule came out in 2002 

have illustrated the extreme concern about the impact that continued deregulation of 

new genetically engineered crops has had on our community of organic farmers, 

handlers and consumers.

The NOSB ad hoc GMO committee will examine all the areas where GMO 

contamination poses a threat to organics and will provide leadership in clarifying what 

excluded methods actually are, and how compliance to the provisions of the rule can be 

monitored. We see the potential of contamination by genetically engineered crops as a 

critical issue for organic agricultural producers and the consumers of their products.

There are significant costs to organic producers and handlers associated with 

preventing this contamination and market loss arising from it.

Organic farmers must no longer be held solely responsible to prevent contamination 

from practices outside their control. We feel the developers of the GMO technology 

should share the burden that organic farmers now assume in mitigating the gene flow 

between farms and should compensate organic farmers for genetic drift. 

17
We intend to keep you informed of our recommendations on this issue. We would like to 

open the door to continued dialogue with the USDA so that the responsibility to prevent 

GMO contamination of organics is shared by those who develop, use, and regulate this 

technology. USDA actions are critical to the integrity of the organic seal and consumer 

confidence.

Sincerely,

Barry Flamm 

Chair of the National Organic Standards Board

c/o NOP office

Moved: Colehour Bondera Second Mac Stone

Yes 6 No 0 Abstain 0 Absent 0 Recuse 0

18
National Organic Standards Board

Materials Committee

Proposal for

Research Priorities Framework

March 27, 2012

Introduction

A discussion document on a Research Priorities Framework was circulated at the last National 

Organic Standards Board (NOSB) meeting in November 2011. Relatively little public comment 

was received but much of the public comment on the other issues on the agenda brought up 

the ongoing need for research on many topics that come before the NOSB. We are therefore 

proceeding to adopt criteria and a process for making the research priorities of the NOSB 

known to researchers, funders, and the public.

Background

Please refer to the previous (September 27, 2011) Proposed Discussion Document for most of 

the background about why there is a need for this recommendation.

The discussion document was generally viewed favorably by the commenters with the primary 

constructive points being fleshing out how the information is prioritized and disseminated and 

the suggested addition of one criterion about need for alternatives to materials on the National 

List.

Relevant areas in the Rule 

The very definition of Organic Production implies a positive approach to farming and handling 

that would benefit from research into the integration of cultural, biological and mechanical 

practices: 

"§ 205.2 Terms defined.

Organic production. A production system that is managed in accordance with the Act and regulations in 

this part to respond to site-specific conditions by integrating cultural, biological, and mechanical practices 

that foster cycling of resources, promote ecological balance, and conserve biodiversity." 

The National List section requires the NOSB to evaluate a variety of criteria. In doing so, the 

NOSB often finds gaps in the research that would be relevant to making an informed decision 

on whether to add a substance to the National List.

"§ 205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients

The following criteria will be utilized in the evaluation of substances or ingredients for the organic 

production and handling sections of the National List:

......." 

Discussion

Much discussion of this topic occurred in the Discussion document from fall 2011. The goals of 

this recommendation are worth repeating here, with a little streamlining. 

19
The primary goal of this framework is for the NOSB to align on criteria for prioritizing 

research needs and recommend a process for collecting and communicating research 

needs. Additional benefits include:

• Influencing where research dollars are directed and increasing the amount of 

research being done related to organic agriculture. 

• 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

• Reducing disagreement within the organic community by increasing the amount of 

primary research on which decisions could be based, while satisfying many different 

stakeholders that the criteria have been met.

• Making the research community 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. 

It has been recognized through the process of reviewing materials by the NOSB that it is 

important not only to identify the research topic, but to ask the specific questions on a topic 

around which research is needed. 

As a recent example, oxytetracycline, indicates, the topic may be "Alternatives to Antibiotics in 

Organic Fruit Production", but then the supplemental research questions could include (these 

are only examples): 

o Are there common elements, such as cultural or biological methods, that should 

be incorporated into any Organic System Plan for prevention of fireblight?

o What are the region-specific limitations of resistance to fireblight for both 

rootstocks and varieties?

o What strategies and characteristics can make a fireblight resistant apple or pear 

variety acceptable to consumers?

o Are any of the alternative materials and methods named in the TR effective in all 

areas of the country?

o Are there other alternative materials that have not yet been investigated?

Each one of these questions may take a considerable time to research, but each of them are 

important and may fit into different areas of expertise from different researchers. Therefore, the 

committee feels that at least some questions should be associated with each of the top group 

of research priorities chosen. By doing this, aspiring organic researchers from among plant 

breeders, laboratory scientists, livestock nutritionists, pesticide toxicologists and more can 

have some guidance on what is needed and justification to put into research proposals.

Recommendation

This recommendation consists of criteria for identifying research needs, a process for the 

NOSB to use in developing a yearly recommendation on research needs, including making the 

public aware of the research recommendations.

Criteria

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The criteria for prioritization are for those topics that the NOSB believes will have the largest 

long-term impact on growth and integrity of organic agriculture. These criteria are not 

presented in order of importance, but will be evaluated by the Materials Committee in selecting 

the top research needs. 

Criteria for research topics 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, primarily relating to the criteria in OFPA for review of materials.. 

• Relevant to assessing the need for alternative cultural, biological, and mechanical 

methods to materials on the National List.

Process Framework

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. Each NOSB Committee will address the question of research priorities that have been 

uncovered in the course of Committee business. Committees shall identify the specific 

research need(s), background on the problem(s), and a description of how the research 

will contribute to the ability of the NOSB to carry out its function of reviewing materials in 

an organic systems framework. They shall submit their committee list to the Materials 

Committee after each NOSB meeting. 

3. Research topics will be kept by the Materials committee on an all-inclusive ‘running’ list. 

The list would include a description of the research questions that need to be 

addressed, and how the research methods need to be applied in an organic context. It 

can include a preliminary list of what entities are involved in that type of research and an 

evaluation of funding opportunities, collaborations and endorsements. 

4. On an annual basis, the committee will review the list and based on the criteria adopted 

above sort the list into two groups: the top research priorities for NOSB review as a 

recommendation, and the rest of the research suggestions to remain on an on-going 

list. The top priorities will not be ranked, but will have descriptions of the key questions 

that the NOSB wishes to see researched about each topic. 

5. The Materials Committee will present the recommendation of the top research priorities 

to the full NOSB each year at the fall meeting. At this time public comment can be 

sought about the priorities and the research questions, as well as unbiased entities or 

individuals who may be able to conduct pressing organic research activities. The list of 

remaining items that the Materials Committee has chosen not to bring forward to the full 

Board will also be made available to the public, so that individuals with desire to 

research specific subjects can know what some of the broader topics are.

6. After a recommendation is finalized by the NOSB each fall the Chair of the Board will 

make sure it is sent to the primary organic research funders such as NIFA, ARS, NRCS, 

21
OFRF, and private foundations and other funders that may be identified. In addition all 

NOP staff, NOSB members and stakeholders can use the list for inspiring appropriate 

research. 

Committee Vote

Motion to adopt the proposed recommendation on Research Priority Criteria and Process.

Motion by: Zea Sonnabend Second: Calvin Walker

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

22
National Organic Standards Board

Materials Committee

Extractants and Solvents Discussion Paper

March 21, 2012

Background

Extractants or solvents are used to produce materials used in crops, livestock, and 

processing. There are limitations on the use of certain extractants, but they are not 

uniform or consistent. There are numerous places in the rule where solvents are 

prohibited generally and specifically by name of chemical, or “water process only.” The 

lack of consistency leads to problems in deciding on classification and listing issues. 

The Materials Committee seeks to clarify the issues around the use of extractants and 

solvents to ensure more informed and logical decision making across numerous NOSB 

committees and material reviews.

Extractants and Solvents in OFPA and Regulations

The Organic Foods Production Act (OFPA) mentions extracting as a means of 

processing. The only other mention of solvents or extraction is in the definition of 

“synthetic”:

§.2103 [7 U.S.C. 6502] Definitions(21) The term "synthetic" means a substance 

that is formulated or manufactured by a chemical process or by a process that 

chemically changes a substance extracted from naturally occurring plant, animal, 

or mineral sources, except that such term shall not apply to substances created 

by naturally occurring biological processes.

Several definitions in the regulations mention extraction or solvents, including the 

definition of “synthetic” repeated from OFPA:

§ 205.2 Definitions. 

Excipients. Any ingredients that are intentionally added to livestock medications 

but do not exert therapeutic or diagnostic effects at the intended dosage, 

although they may act to improve product delivery (e.g., enhancing absorption or 

controlling release of the drug substance). Examples of such ingredients include 

fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, 

flavors, absorption enhancers, sustained-release matrices, and coloring agents.

Nonagricultural substance. A substance that is not a product of agriculture, such 

as a mineral or a bacterial culture, which is used as an ingredient in an 

agricultural product. For the purposes of this part, a nonagricultural ingredient 

also includes any substance, such as gums, citric acid, or pectin, that is extracted 

from, isolated from, or a fraction of an agricultural product so that the identity of 

the agricultural product is unrecognizable in the extract, isolate, or fraction.

23
Processing. Cooking, baking, curing, heating, drying, mixing, grinding, churning, 

separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, 

preserving, dehydrating, freezing, chilling, or otherwise manufacturing and 

includes the packaging, canning, jarring, or otherwise enclosing food in a 

container.

“Extracting” is mentioned as an allowed processing method in § 205.270(a). § 205.270 

(c) prohibits the use of “volatile synthetic solvents” in organic handling of agricultural 

products: 

(c) The handler of an organic handling operation must not use in or on 

agricultural products intended to be sold, labeled, or represented as “100 percent 

organic,” “organic,” or “made with organic (specified ingredients or food 

group(s)),” or in or on any ingredients labeled as organic:... (2) A volatile 

synthetic solvent or other synthetic processing aid not allowed under §205.605: 

Except, That, nonorganic ingredients in products labeled “made with organic 

(specified ingredients or food group(s))” are not subject to this requirement.

There are a few more specific prohibitions on solvents:

§205.601(j) As plant or soil amendments.

(1) Aquatic plant extracts (other than hydrolyzed)—Extraction process is limited 

to the use of potassium hydroxide or sodium hydroxide; solvent amount used is 

limited to that amount necessary for extraction.

(3) Humic acids—naturally occurring deposits, water and alkali extracts only.

§205.606(k) Gums—water extracted only (Arabic; Guar; Locust bean; and Carob 

bean).

§205.605(a) Nonsynthetics allowed:... Flavors, nonsynthetic sources only and 

must not be produced using synthetic solvents and carrier systems or any 

artificial preservative.

At its November 2011 meeting, the NOSB recommended the approval of a petition for 

Docosahexaenoic acid (DHA) algal oil petition with the following annotation: DHA from 

Algal Oil, not hexane extracted; other ingredients that are agricultural must be organic” 

to the National List at 7 CFR, §205.605(a)

Issues and Discussion

1. What is a volatile synthetic solvent?

A volatile synthetic solvent is, first of all, synthetic. This is important to keep in mind, 

since many natural substances otherwise meet the definition –water, for example.

There are many definitions of volatile in the context of “volatile organic chemical,” which 

is a regulated class of chemicals. Some focus on specific regulatory aspects (such as 

24
EPA’s definition for air pollution purposes, any organic compound that participates in a 

photoreaction.) For our purposes, however, the crucial aspect is volatility. Volatility is 

most precisely defined in terms of vapor pressure, which is not very intuitive to most 

people. Equivalent definitions can be expressed in terms of boiling point, which is more 

intuitive and is a commonly reported property of chemicals. The most commonly used 

definition is a chemical with boiling point between 69 and 287 degrees Celsius, and very 

volatile is defined as having a boiling point below 69 degrees Celsius.1 For our 

purposes, very volatile and volatile should be combined.

A solvent is a chemical capable of dissolving another substance.

Thus, a volatile synthetic solvent is a synthetic chemical with boiling point less than 287 

degrees Celsius that can dissolve another substance.

Some examples of volatile synthetic solvents and their boiling points in degrees Celsius:

Ethanol (may be nonsynthetic) 15.8

Dichloromethane 40

Acetone 56

Chloroform 61

Hexane 69

Benzene 80

Isopropyl alcohol 82

Toluene 111

Super critical carbon dioxide 2

2. When does the use of a synthetic solvent change the classification of the 

material?

Agricultural -> Nonagricultural

A nonagricultural substance is defined as:

A substance that is not a product of agriculture, such as a mineral or a bacterial 

culture, that is used as an ingredient in an agricultural product. For the purposes of 

this part, a nonagricultural ingredient also includes any substance, such as gums, 

citric acid, or pectin, that is extracted from, isolated from, or a fraction of an 

agricultural product so that the identity of the agricultural product is unrecognizable 

in the extract, isolate, or fraction. (§ 205.2)

In November 2009, the Board approved a revised definition of nonagricultural, which 

has so far not been written into regulation: “A product, such as a mineral or atmospheric 

1 Eurofins Product Testing –What means VOC? http://www.eurofins.com/voc.aspx 2 Carbon dioxide usually behaves as a gas in air at standard temperature and pressure (STP), or as a 

solid called dry ice when frozen. If the temperature and pressure are both increased from STP to be at or 

above the critical point for carbon dioxide, it can adopt properties midway between a gas and a liquid. 

More specifically, it behaves as a supercritical fluid above its critical temperature (31.1 °C) and critical 

pressure (72.9 atm/7.39 MPa), expanding to fill its container like a gas but with a density like that of a 

liquid.

25
gas, that does not originate from agriculture. For the purposes of this part agricultural 

refers to the production or handling of crops or livestock.” The NOP stated,3 “The NOP 

does not object to the above definition, but proposes that some ambiguity remains. For 

example, does the removal of the example of ‘bacterial culture’ mean that 

microorganisms, dairy cultures, and their products are considered agricultural? The 

NOSB has indicated they will be determining this on a case by case basis. If so, it would 

be useful to develop criteria for this review of microorganisms and their products. The 

NOP acknowledges that the current definition, which includes pectins and gums as 

nonagricultural conflicts with the present listings at 205.606.”

Thus, the use of a solvent –synthetic or nonsynthetic—may result in production of a 

nonagricultural product from an agricultural substance under the current definition, 

though if the revised definition were written into the regulations, it would not. It is not 

clear whether the definition in the regulations will be changed. The definition is pertinent 

because, as noted below, the prohibition against extraction with a volatile synthetic 

solvent in §205.270(c) applies only to agricultural substances.

Nonsynthetic -> Synthetic 

The issue of when the use of a synthetic solvent changes the classification from 

nonsynthetic to synthetic has been addressed in the Recommendation on Classification 

of Materials, adopted by the Board in November 2009: 

It is our intent through this recommendation that a material would be classified as 

synthetic when: 

• The source of the material is not “from mineral, plant, or animal matter” 

(from the definition of nonsynthetic) and is not a “substance created by 

naturally occurring biological processes” (from the definition of synthetic) 

or; 

• The process used to manufacture the material is synthetic (per the definition 

of synthetic and clarifying definitions in our recommendation) or; 

• The material contains, at a significant level, a synthetic substance not on the 

National List of allowed synthetics. (p5) 

Thus, there are two cases in which the use of a synthetic solvent can change the 

classification of a material from nonsynthetic to synthetic:

a. If the addition of the synthetic solvent results in chemical change, then the 

resulting substance is synthetic, and

b. If the material contains a significant level of the synthetic solvent, then it is 

synthetic. 

3 Miles McEvoy, September 30, 2010. Memorandum for the chairman of the National Organic Standards Board, p. 

15.

26
The definition of “chemical change” approved by the NOSB in November 2009 (and 

amended slightly in April 2011 in Update and Proposed Guidance Document, 

Classification of Materials) is:

Chemical Change An occurrence whereby the identity of a substance is modified, 

such that the resulting substance possesses a different distinct identity (see 

related definition of “substance”)

The definition of “substance” included in the November 2009 guidance is:

Substance An element, molecular species, or chemical compound that 

possesses a distinct identity (For example, a distinct identity may be 

demonstrated through the material having a separate Chemical Abstract Service 

(CAS) number (in some cases the same material may have multiple CAS 

numbers), Codex International Numbering System (INS) number, or FDA or other 

agency standard of identity).

The latest April 2011 recommendation to define a significant residue in the classification 

of materials policy was unsuccessful. At the April 2011 meeting, the motion was made 

to accept the proposed guidance that a significant level of a synthetic substance in the 

final material means a level exceeding any applicable regulatory limits, where in effect 

for the material being classified, and a level without any technical and functional effects 

in the final material. The vote was 8 yes and 6 no. Since the vote was not decisive, the 

motion failed and the proposed guidance was sent back to the Materials Committee for 

further refinement.

The other approach that was supported by a minority of the committee and considered, 

as documented in the proposed guidance document was that, “[A]ny known level of a 

synthetic substance in the final material or in the environment, as a result of the 

substance’s manufacture, use and disposal would be a significant level.... Proponents 

believe this standard of review requires a determination as to whether there is harm 

associated with the use of the synthetic substance, and therefore subject to the National 

List review process. Under this approach, all synthetic inputs or residues must be 

examined to determine their associated health and environmental impacts.”

The question as to what level of synthetic residue would result in the change in 

classification of a nonsynthetic material to synthetic therefore awaits clarification by the 

NOSB.

3. Does the use of a volatile synthetic solvent in an ingredient mean that the 

ingredient is not permitted in organic food? This has to do with the 

heritage of an input—does a prohibition against its use carry back to the 

origin of the ingredients?

§205.270(c) of the regulations states, “(c) The handler of an organic handling operation 

must not use in or on agricultural products intended to be sold, labeled, or represented 

27
as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food 

group(s)),” or in or on any ingredients labeled as organic:... (2) A volatile synthetic 

solvent or other synthetic processing aid not allowed under §205.605: Except, that, 

nonorganic ingredients in products labeled “made with organic (specified ingredients or 

food group(s))” are not subject to this requirement.

It is not clear whether the use of a volatile synthetic solvent in an ingredient that is 

subsequently used in another product disqualifies the second product as being labeled 

organic. On one hand, one could argue that it makes the ingredient nonorganic, but the 

ingredient could be used as part of the 5% in an organic product, but not used in a 

100% organic product. But that would make the exception unnecessary.

The alternative interpretation is that by using an ingredient that has been produced 

using a volatile synthetic solvent, one is adding the solvent to the final product as well. 

Since the prohibition is absolute, it may be proper to disallow ingredients made using 

volatile synthetic solvents anywhere in their history. 

Other Issues Concerning Solvents

Regardless of whether the material being extracted is synthetic or nonsynthetic, if the 

material is being considered for use in organic production –for example, as a crop input 

to be listed on §205.601– the impacts of the extractant need to be considered as part of 

the review of the material. These impacts are not limited to the impacts of the residues 

in the material, but also include the impacts of the manufacture, use, and disposal of the 

solvent material. Questions that need to be asked include:

1. Is the site where the solvent is manufactured at a site where there is 

contamination, such as a Superfund site?

2. Is solvent released into the air or water during or following the extraction 

process? 

3. What happens to waste solvent?

Comments Requested

The Committee requests public comments on the following questions:

1. How should “volatile synthetic solvent” be defined, especially in relationship to 

the rule 205.270(c)2? Should we make a distinction between different types of 

solvents? If possible, reference to a standard scientific or regulatory definition is 

preferred. Should the toxicity of a volatile synthetic solvent affect how it is treated 

in classification and materials evaluation? Does supercritical carbon dioxide meet 

the definition?

2. Is there a distinction between volatile solvents used for extraction vs. volatile 

solvents used for other purposes? Solvents are also used for purposes other 

than extraction, such as purification of a substance via crystallization. Solvents 

are also common inert ingredients in formulated pesticide products.

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3. Should the process of extraction change the classification of an agricultural 

product to a nonagricultural material? Does it matter whether the extractant is 

synthetic or nonsynthetic? When this happens to an agricultural material that is 

currently organically grown, does this changed material then need to be 

petitioned?

4. Since §205.270 Organic Handling Requirements explicitly prohibits volatile 

organic solvents, [“(c) The handler of an organic handling operation must not use 

in or on agricultural products intended to be sold, labeled, or represented as “100 

percent organic,” “organic,” or “made with organic (specified ingredients or food 

group(s)),” or in or on any ingredients labeled as organic: (2) A volatile synthetic 

solvent or other synthetic processing aid not allowed under §205.605: Except, 

That, nonorganic ingredients in products labeled “made with organic (specified 

ingredients or food group(s))” are not subject to this requirement”], should 

consumers expect that non-agricultural ingredients identified as “organic” be 

produced or extracted with the same restriction? Please explain the rationale for 

a different standard for agricultural and non-agricultural if that is the position.

5. Similarly, should synthetic substances allowed for use in organic crop production 

under §205.601 be allowed or prohibited from using volatile synthetic solvents in 

their production or extraction? Should nonsynthetic substances used in organic 

crop production be allowed or prohibited from using volatile synthetic solvents in 

their production or extraction, regardless of chemical change or significant 

residues?

6. Is guidance needed concerning whether or under what circumstances the use of 

an extractant/solvent causes chemical change in the extraction process? 

7. What is a significant residue of a synthetic solvent? Should the prohibition on the 

use of volatile synthetic solvents include the use in any ingredient in the history of 

the product?

8. For substances already on the National List, should it be assumed that any 

extractant is allowed, or should the NOSB attempt to specify allowed extractants 

moving forward or for previously listed substances?

Committee Vote:

The Materials Committee moves to accept this document and present it for full Board 

discussion at the spring 2012 NOSB meeting:

Moved: Jay Feldman Second: C. Reuben Walker

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

29
 

National Organic Standards Board

Materials Committee

Discussion Document

Significant Residues Definition in Classification of Materials Policy

March 27, 2012

This discussion paper addresses a key issue left unresolved in the Materials 

Classification Policy adopted by the Board. The Addendum to November 6, 2009 

Recommendation on Classification of Materials states that, “It is our intent through this 

recommendation that a material would be classified as synthetic when: . . . The material 

contains, at a significant level, a synthetic substance not on the National List of allowed 

synthetics.” However, the Board did not clarify this guidance by defining “significant” in 

this context.

The dictionary defines “significant” as “important” or “of consequence.” However, the 

question that remains is what level of a synthetic impurity found in a material under 

review is determined to be “of consequence” under the Organic Foods Production Act 

(OFPA). This discussion paper asks how the NOSB should apply the framework of 

OFPA to the definition of “significant.” Three different approaches are presented, and 

input is sought on the broad approach as well as details. 

Materials Classification Policy

At the November 2009 National Organic Standards Board (NOSB) meeting, the NOSB 

passed a recommendation on Classification of Materials. The recommendation included 

several “Next Steps” that the NOSB felt are required in order to implement the 

recommendation. In passing the recommendation, the NOSB indicated that further work 

is required of the Board to develop a Guidance Document that the various stakeholders 

(e.g., Accredited Certifying Agents, committees of the NOSB, National Organic Program 

personnel) could use when classifying materials. 

At the April 2010 NOSB meeting, the Joint Materials and Handling Committee 

presented a draft Guidance Document for public input. It was clear from that public input 

that the guidance document needed more work. A key topic left unresolved was the 

question, “What is a significant amount/level of a synthetic input to the process 

remaining in the final material?” Prior to the April 2011 meeting, the Materials 

Committee evaluated two different approaches in the context of work on a classification 

of materials worksheet. They are discussed, along with a third approach, in “Issues and 

Discussion” section below.

OFPA and the Rule

The underlying statutory standard in the Organic Foods Production Act with regard to 

synthetic agents and their allowance is found in Sec. 2118 [7 U.S.C. 6517] National List, 

(c) Guidelines for Prohibitions on Exemptions.– (1) Exemption from Prohibited 

30
Substances in Organic Production and Handling Operations.– The National List may 

provide for the use of substances in an organic farming or handling operation that are 

otherwise prohibited under this title only if– (A) the Secretary determines, in consultation 

with the Secretary of Health and Human Services and the Administrator of the 

Environmental Protection Agency, that the use of such substances– (i) would not be 

harmful to human health or the environment...” The list criteria provide the mechanism 

for evaluating harm for all substances by weighing information from the other agencies 

along with the unique organic considerations.

This statutory intent is captured in the “Evaluation Criteria for Substances Added to the 

National List” with the questions, “Is there any harmful effect on human health? [§6517 

(c)(1)(A)(i); 6517(c)(2)(A)(i); §6518(m)(4)]” and, “Is the substance harmful to the 

environment and biodiversity? [§6517c(1)(A)(i);6517(c)(2)(A)i]” The scope of the 

possible harm that OFPA requires the NOSB to examine is identified in the question, “Is 

there environmental contamination during manufacture, use, misuse, or disposal? 

[§6518(m)(3)]”

Issues and Discussion

In the context of OFPA and materials classification, a level of a synthetic impurity is 

“significant” when it is “of consequence” to materials classification and review. A major 

issue in defining “significant” is the degree to which harm must be identified before 

deciding the residue is significant. We also understand that decisions about significant 

residues are made not only by the Board, but also by materials review organizations 

(MROs) and certifiers, and that a definition of “significant synthetic residue” must allow 

MROs and certifiers to act on the information available to them. Two of the three 

approaches outlined below were discussed in the April 2011 Materials Committee 

Recommendation.

The first approach is the one proposed by the Materials Committee in the April 2011 

recommendation, which failed to pass the Board by the required 2/3 margin. This 

approach says that an insignificant level of a synthetic substance in the final material 

means a level below any applicable regulatory limits for the type of substance and 

without any technical and functional effects in the final material. Proponents of this 

approach believe this approach is more consistent with past NOSB practices, is 

consistent with the recommendation of the Materials Working Group and reflects the 

bulk of the public comment received on this topic. Additionally, the majority of the 

Materials Committee was concerned with using an approach of “any known level” 

knowing that technology allows the detection of ever-decreasing amounts of material. 

So a material that today has no known level of synthetic input in it may very well 

tomorrow have a detectable level. The majority of the committee felt that using the “any 

known level” approach would be disruptive to the industry as it differs from past practice 

and would lead to an on-going reevaluation of materials on a perpetual basis as 

detection levels change. As this approach was discussed, it was acknowledged that a 

given material may not have any applicable regulatory limits or may have several. In the 

case where no regulatory limit is available, technical and functional effects of any 

remaining synthetic would need to be evaluated. In the case where multiple regulatory 

31
limits exist, the reviewer would evaluate which best applies for the classification. For 

example, for a synthetic solvent used to extract a natural sourced material there may be

an OSHA inhalation limit and EPA residue limit. Since the synthetic is present in a 

material to be used in crops, the EPA limit is most appropriate.

The second approach was supported by a minority of the Materials Committee in April 

2011. It would characterize any known or detectable level of a synthetic substance in 

the final material or in the environment, as a result of the substance’s manufacture, use, 

and disposal as a significant level triggering NOSB review. Proponents of this approach 

point to the statutory standard in OFPA §6517(c)(1) with regard to synthetic agents and 

their allowance. Proponents believe this standard of review requires a determination as 

to whether there is harm associated with the use of the synthetic substance, analogous 

to the standard of review used in the process of allowing synthetic substances on the 

National List. The minority felt that citing regulatory standards set under different 

statutory criteria does not meet the OFPA intent or standards, but, like all other 

regulatory standards, we must be prepared to adjust regulatory action to advances in 

good laboratory practices as they improve. Finally, proponents believe that the quantity 

of synthetic residue is not the sole determinant of “harm” in the end product. The 

minimal residue that causes harm may not be known, and harm may be more 

dependent on other factors, like timing of exposure, than dose. Furthermore, OFPA 

requires consideration of the material’s residual harm from manufacture to disposal, 

including its use in organic agriculture or processing.

A third approach acknowledges that MROs and certifiers have to make frequent 

evaluations of a variety of residues that occur in both food processing and crop inputs 

that do not always come to the attention of the NOSB because they are not petitioned or 

may change frequently. Therefore, the NOSB would need to offer guidelines to screen 

these potential synthetic residues rather than review each one. What would emerge 

would be a screen for all synthetic residues by evaluating them against a list of known 

harmful chemicals created by governmental and international organizations to 

determine whether they are significant. This process might be applied in field situations 

by Material Review Organization (MROs) and certifiers when a full NOSB review is not 

practical. Slightly different screens for crop inputs and food ingredients may be used

because there are different sources of information on them and they are handled 

differently in the regulation. The first two steps in the screening process would be, 

"What chemical is it?" "Is it measurable?" Then, it would be compared to lists of known

harmful materials. If the chemical is found on one of the lists of known harmful 

materials, then the residues would be considered significant and this would trigger a full 

NOSB review. In this scenario the guidelines would appear in the NOP Program 

Handbook or in guidelines for MROs and the individual impurity chemicals would not 

have to appear on the National List.

Comments Requested

The Committee requests comments on the following questions:

1. Under what circumstances, should the presence of a synthetic impurity trigger an 

examination of the impacts of the synthetic in relation to OFPA criteria?

32
2. Do any of the three approaches described make sense? If so, why?

3. Is it reasonable to tie the definition of “significance” in materials classification to 

the need for review under OFPA? If not, is there another way to ensure that the 

presence of a synthetic impurity in levels of consequence under OFPA trigger a 

review? And how would “significance” be defined in the context of materials 

classification if not in relation to the need for review under OFPA?

4. The need for defining a significant residue arises from the Classification of 

Materials Policy adopted earlier that says that the use of a synthetic extractant or 

reactant does not affect the classification of a material, thereby allowing the use 

of synthetic extractants, reactants, or processing aids that may end up as 

impurities in the material. Should that policy be changed instead?

5. When residues of a certain synthetic impurity are identified as significant, how 

should the review proceed (a) if the material containing the impurity is under 

review by a MRO prior to use, (b) if the significant residues are discovered by a 

MRO/ACA when the material is in use, (c) if the material is under review by the 

NOSB?

Committee Vote:

The Materials Committee moves to accept this document and present it for full Board 

discussion at the spring 2012 NOSB meeting:

Moved: Jay Feldman _ Second: __Jennifer Taylor__ 

Yes: __5__ No: __0__ Abstain: __0__ Absent: __1__ 

33
National Organic Standards Board

Crops Committee

2012 Sunset Recommendation

List 3 Inert Ingredients in Passive Pheromone Dispensers

March 20, 2012

List: 205.601 Synthetic substances allowed for use 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. 

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

dispensers.

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 require disclosure 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

34
... (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;

Summary

OFPA, Regulations, and Previous NOSB Action

OFPA, in establishing the National List (§2118, 7 U.S.C. 6517), creates a list of 

exemptions for prohibited substances in organic production and handling and in so 

doing lists the categories of substances that must be reviewed by the NOSB if they are 

to be listed: “(B) the substance (i) is used in production and contains an active synthetic 

ingredient in the following categories: ........; (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; or...” Tracking the 

U.S. Environmental Protection Agency (EPA) categorization of active and inert 

ingredients in pesticide formulations, OFPA subjects all allowed substances to the 

underlying statutory standards of health and safety, essentiality, and compatibility in this 

section of the law. Section 2118(c)(1)(B)(i) creates a category of active ingredients

that may be allowed, which is parallel to Section 2118(c)(1)(B)(ii) creating the category 

of inerts that may be allowed --those found by EPA to not be “inerts of toxicological 

concern.” In summary, the categories of active and inert ingredients in Section 2118 

establish an NOSB duty to review these substances.

The fact that OFPA uses the language the “substance...contains synthetic inert 

ingredients...” is somewhat confusing. The confusion is amplified by the fact that inert 

ingredients are themselves “substances.”1 The language in OFPA is clarified in the 

Conference Report, which states: “The Conference substitute adopts the House 

provision with an amendment that adds production aids to the category of synthetic 

active ingredients and the category of synthetic inert ingredients not of toxicological 

concern to the Administrator of EPA as possible exemptions on the National List.” 

[Emphasis added.]

The language of the Conference Report thus makes it clear that “synthetic inert 

ingredients not of toxicological concern to the Administrator of EPA” is a category of 

substances that may be considered for listing on the National List.

1 §205.2

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)).

Classification of Materials November 2009: “Substance”: “An element, molecular species, or chemical 

compound that possesses a distinct identity (For example, a distinct identity may be demonstrated 

through the material having a separate Chemical Abstract Service (CAS) number (in some cases the 

same material may have multiple CAS numbers), Codex International Numbering System (INS) number, 

or FDA or other agency standard of identity).” 

35
However, even if we take the interpretation that it is “substances containing synthetic 

inert ingredients not of toxicological concern to the Administrator of EPA” that may be 

listed on the National List, §6517(c)(1)(B) only allows such substances to be listed on 

the National List if the requirements of §6517(b), §6517(c)(1)(A), and §6517(d) are met. 

This requires that the “substance” undergo review according to the criteria of OFPA. If 

the inert is regarded as a component of the substance and not a substance itself, it still 

must be reviewed as part of the review of the substance.

The NOSB responsibility has its roots in both the Senate Report and the Preamble to 

OFPA and the subsequent action by the NOSB. 

The Senate Report makes it clear that inert ingredient review was to be subject to the 

National List process:

Until such time as FIFRA is altered to require the full disclosure of inert 

ingredients, organic farmers should be allowed to continue using compounded 

substances if the active ingredient is natural and if use of the substance is 

recommended by the National Organic Standards Board and approved by the 

Secretary for inclusion on the National List. However, in order for the National 

Organic Standards Board to evaluate whether certain compounds should be 

listed, the Board will need some information about the inert ingredients in 

question. The Committee directs the Board to seek the advice of the 

Administrator of the EPA, who has information on inert ingredients submitted as 

part of registration, as to whether such inert material would be appropriate for 

organic production. EPA's response will not limit its regulatory responsibility for 

such material.

In the Preamble to the Final Rule, December 21, 2000, USDA said,

In this final rule, only EPA List 4 Inerts are allowed as ingredients in formulated 

pesticide products used in organic crop and livestock production. The allowance 

for EPA List 4 Inerts only applies to pesticide formulations. Synthetic ingredients 

in any formulated products used as organic production inputs, including 

pesticides, fertilizers, animal drugs, and feeds, must be included on the National 

List. As sanctioned by OFPA, synthetic substances can be used in organic 

production and handling as long as they appear on the National List. The organic 

industry should clearly understand that NOSB evaluation of the wide variety of 

inert ingredients and other nonactive substances will require considerable 

coordination between the NOP, the NOSB, and industry.

In February, 1999, the NOSB recommended: 

Inert ingredients on EPA Lists 1 and 2 shall be prohibited for use in organic 

production and handling effective on the date of implementation of the final rule 

of NOP. Synthetic inerts on EPA List 3 shall be prohibited if not specifically 

approved by the NOSB. This approval process will be completed and published 

36
by January 1, 2002. Any inert currently in use in organic production that is not 

approved by the NOSB will be banned within 18 months after the review is 

completed and published. To that goal, inerts on EPA List 3 used in products that 

have active ingredients approved for organic production shall be reviewed by the 

NOSB on a case-by-case basis for possible inclusion on the National List. 

Thus, the board voted that the consideration of individual List 3 materials was to be 

completed by January 1, 2002 –more than 10 years ago.

In October 2002, the Board passed the motion to list pheromones, which resulted in the 

current listing for List 3 inerts. 

Pheromones—includes only EPA-exempt pheromone products, EPA registered 

pheromone products with no additional synthetic toxicants unless listed in this 

section and any inert ingredients used in such pheromone formulations that are 

not on EPA List 1, that is inerts of toxicological concern or EPA List 2, that is 

potentially toxic inerts, provided the pheromone products are limited to passive 

dispensers, pheromone products containing only pheromone active ingredients 

listed in this section and List 4 inerts may be applied without restriction.

At the same meeting, the Board also passed a motion temporarily allowing the 

continued listing of certain List 3 inerts:

The NOSB recommends that any list 3 inert material forwarded for a technical 

review be allowed for use until that material is approved or prohibited by the 

Secretary of Agriculture.

When the List 3 inerts came up for sunset in November 2007, the summary of the 

recommendation said, 

Future petitions to add, remove or renew an inert ingredient to the National List 

will need to reference a specific inert ingredient. A petition may be submitted to 

the NOSB using the National List petition procedures. Individually petitioned 

substances must be recommended by the NOSB and added to the National List 

through notice and comment rulemaking before use in organic agriculture.

That recommendation was reaffirmed in February 2008. And, in presenting the 

discussion paper on List 4 inerts in November 2008, Gerald Davis said, “[Discussion 

paper point number] Five concerns the list 3 inerts currently used in passive pheromone 

dispensers. The current policy is that they need to be petitioned individually and are 

subject to regular sunset reevaluations, that that has already been in place as an NOP 

policy for a couple years now, since we were first notified about the EPA change.”

Consultations with USDA and EPA

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

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

37
prohibiting List 1 and 2 inerts, and List 3 inerts that are not specifically approved by the 

NOSB, 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 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 

tolerance reassessment 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 reclassification, NOP regulations concerning allowed inert ingredients are 

out-of-date when compared with current EPA regulations, since EPA eliminated its list 

categories when it completed its tolerance reassessment. 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”.3

 The current exemption that permits former List 3 inerts in passive 

pheromone dispensers only is scheduled to sunset November 3, 2013. 

An NOSB-NOP-EPA working group was established in June 2010. Current members 

include: Jay Feldman (NOSB), Zea Sonnabend (NOSB), Chris Pfeifer (EPA 

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

Division), Emily Brown Rosen (NOP), and Lisa Brines (NOP). The group has collected 

information regarding current classification of the former List 3 and 4 inerts and 

presented a discussion document at the November 2011 NOSB meeting.4 

This NOSB policy recommendation phases out former EPA List 3 inerts in passive 

pheromone dispensers from a general approval provision to full review under the 

National List standards. Currently, based on information from EPA, OMRI, and WSDA, 

we believe that there are three formerly List 3 inerts in use under this provision, three of 

which were the subject of petitions filed to the NOSB. It is understood that the former 

List 3 inerts requiring review are limited to the following substances: (i) Butylated 

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 28, 2010 recommendation available at 

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

4 Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094901&acct=nosb

38
hydroxytoluene (CAS # 128-37-0); (ii) 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 

1843-05-6); (iii) 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-chlorobenzotriazole (CAS 

#3896-11-5)]. It is also understood that there may be a fourth inert in this category that 

has been identified by the Washington State Department of Agriculture.

The proposed annotation creates a timeframe for evaluation of these formerly List 3 

inerts in passive pheromone dispensers: a review and board action is set for Dec. 31, 

2015. This gives the board two years to review the petitions and act, and it provides the 

NOP a year to go to rulemaking. If for some reason the timeframes are delayed, the 

backup sunset provision allows the former List 3 uses to continue until Board action and 

rulemaking are complete. If the NOP adopts a policy by December 31, 2015 that covers 

former List 3 as well as other inerts, then that policy will prevail.

Committee Recommendation

The italicized text is new proposed language. Deleted text is indicated with a strikethrough line.

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

(m) As synthetic inert other ingredients not as classified by the Environmental Protection 

Agency (EPA) as active ingredients, 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.

2) Inert ingredients exempt from the requirement of a tolerance under 40 CFR 180.1122 

that were formerly on EPA List 3 in passive polymeric dispenser products may be used 

until December 31, 2015, after which point they are subject to individual review under 

205.601, unless already covered by a policy adopted by the NOP for all other inert 

ingredients.

Committee Vote

Moved: Jay Feldman Second: Nick Maravell

Yes__8___ No__0__ Abstain__0__ Absent__0__ Recuse__0__

Committee Backup Vote to Relist: 

List: 205.601 Synthetic substances allowed for use 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.

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

dispensers.

39
Committee Vote: 

Moved: Zea Sonnabend Second: Jay Feldman

Yes__8__ No__0__ Abstain__0__ Absent__0__ Recuse___0___

§ 205.2 Terms defined.

Passive polymeric dispenser products. Solid matrix dispensers delivering 

pheromones through volatilization only 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.] 

To be removed as a definition when 205.601(m)2(a) and (b) expire.] 

Moved: Jay Feldman Second: Zea Sonnabend

Yes__8___ No__0___ Abstain__0__ Absent__0___ Recuse ___0__

40
National Organic Standards Board

Livestock Committee

National List Proposal

Vaccines from Excluded Methods

April 3, 2012

Summary of Proposed Action:

See attached document Recommendation of Livestock Committee, on Vaccines derived from 

Excluded Methods, dated March 24, 2012

This recommendation concerns the class of livestock vaccines derived from excluded methods, 

commonly called GMO vaccines. There are approximately 73 registered animal vaccines, of which 13 

are GMO. Only 2 vaccines, Bovine and Avian Salmonellosis, appear to be presently available only as 

GMO. At present livestock producers use all vaccines and are not required to determine if they are 

using non-GMO (conventional) or GMO derived vaccines. GMO vaccines are not legally allowed in 

organic production. This recommendation proposes a change which will allow GMO vaccines only in a 

declared emergency and, further, that at such time producers could use GMO vaccines without losing 

organic status of livestock. The recommendation also proposes changes to the definition of “emergency 

treatment program”. The entire recommendation applies to the class of vaccines derived from excluded 

methods, but does not foreclose petitions for individual vaccines or a class of vaccines to treat specific 

diseases.

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 ☐ Yes ☐ No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ 1, 2, 3] Comments: 1. and 2. fail because of the necessity to 

evaluate individual vaccines on a case by case basis. 3 fails because vaccines derived from excluded 

methods are not consistent with organic agriculture

Proposed Annotation (if any): Modify language in 205.603(a)(4) as follows: Biologics—Vaccines, 

provided, with regard to vaccines produced with excluded methods, the requirements of 205.105(e) 

are satisfied. 

Basis for annotation: ☐ To meet criteria above ☐x Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

1. Modify language in 205.238(a) (6) as follows, change shown in italics.

Administration of vaccines and other veterinary biologics, provided, vaccines produced with excluded 

methods, can only be administered in accordance with §205.105(e).

2. Modify 205.105 (e) as follows: Excluded methods, except for vaccines: Provided, 

(1) such vaccines are administered only due to a Federal or State emergency pest or disease 

treatment program, and 

41
(2) such vaccines are approved in accordance with §205.600(a);

3. Modify language in 205.603(a)(4) as follows: Biologics—Vaccines, provided, with regard to 

vaccines produced with excluded methods, the requirements of 205.105(e) are satisfied. 

Classification Motion: Vaccines are already classified as synthetic on the National List at 

section 205.603, Synthetic substances allowed for use in organic livestock production. The 

Committee did not propose to reclassify the substance.

Motion by: N/A Seconded by: N/A

Yes: # No: # Absent: # Abstain: # Recuse: #

Listing Motion: To accept the recommendations of the committee for listing, as above:

Motion by: Colehour Bondera Seconded by: Jean Richardson

Yes: # 5 No: # 0 Absent: # 3 Abstain: # 0 Recuse: # 0

4. Change the Definition of “Emergency pest or disease treatment program” in section 205.2 with the

additions shown in italics.

Emergency pest or disease treatment program: A mandatory program authorized by a Federal, State 

or local agency for the purpose of controlling or eradicating a pest or disease, except for a program 

requiring substances described in section 205.105(e) regarding only vaccines produced with 

excluded methods, in which case such program is defined as a mandatory treatment program 

authorized by a declared Federal or State emergency for the purpose of controlling a pest or disease.

Refine definition of Emergency pest, disease, and treatment program Motion:

Motion by: Nick Maravell Seconded by: Jean Richardson

Yes: # 8 No: # 0 Absent: # 0 Abstain: # 0 Recuse: # 0

Crops ☐ Agricultural ☐ Allowed1 X

Livestock X Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic X Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.603 with Annotation (if any): 

Biologics—Vaccines, provided, with regard to vaccines produced with excluded methods, the 

requirements of 205.105(e) are satisfied. 

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: 

Approved by Committee Chair to Transmit to NOSB

42
Wendy Fulwider, Committee Chair April 3, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

derived from excluded methods 

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 

The TR (lines 248-255) finds that any 

effects would be similar to 

conventional, non-GMO vaccines. 

The impact of any environmental 

contamination will be specific to each 

individual vaccine and difficult to 

address for a whole class.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

This is difficult to address since this 

review addresses a broad class of 

materials, but the TR at line 217 finds 

that GMO vaccines are not expected 

to persist in the environment any 

longer than traditional vaccines.

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 

Generally any vaccines causing 

adverse reactions would not be 

allowed on the market unless risks 

were mitigated (TR at lines 263-264)

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]X 

GMO and conventional vaccines are 

evaluated for side effects by 

manufacturers and results are similar 

(TR at lines 287-290). It is difficult to 

answer such question for a class as a 

whole.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X 

As cited above, and it is difficult to 

answer this except on a case by case 

basis rather than as a whole class.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

X 

As cited above, and it is difficult to 

answer this except on a case by case 

basis rather than as a whole class

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

X 

Vaccines, both conventional and 

GMO, are short lived in the 

environment (TR)

43
10.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

X 

The TR (lines 307-323) finds that all 

vaccines are evaluated for potential 

risk to human health risk before being 

licensed; such risk is minimal. It is 

difficult to conclusively answer this 

with reference to an entire class of 

vaccines.

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.

44
NOSB Evaluation Criteria for Substances Added To the National List

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

vaccines derived from excluded methods

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 All vaccines, both conventional and 

GMO, are formulated by a chemical 

process (discussion with 

manufacturers)

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 

All vaccines, both conventional and 

GMO, are manufactured or extracted 

from naturally occurring sources 

(discussion with manufacturers, and 

TR)

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

X GMO vaccines are derived from 

excluded methods, not created by 

naturally occurring biological 

processes (TR and discussions with 

manufacturers.)

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 X At present conventional vaccines are 

available for all but 2 diseases, avian 

and bovine salmonellosis (TR line 416 

Table 1.)

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative substances? 

[§6518 m.6]

X X At present conventional vaccines are 

available for all but 2 diseases, avian 

and bovine salmonellosis (TR line 416 

Table 1.) In addition there are 

homeopathic substances available 

(TR)

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X X Depending upon each vaccination on 

a case by case basis. Management 

practices might have an influence on 

whether the substance is necessary.

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.

45
NOSB Evaluation Criteria for Substances Added To the National List

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

of vaccines derived from excluded methods 

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 Based on extensive comments 

received during the formulation of the 

NOP regulations in 2000 and in 

response to USDA’s questions posed 

to the public, excluded methods, also 

known as GMOs, were not 

considered consistent with an organic 

production and handling system. 

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X X This would have to be determined on 

a case by case basis.

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 X Generally No (discussion with 

manufacturer), but this would need to 

be determined on a case by case 

basis

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 

X

46
seals, insect traps, sticky 

barriers, row covers, and 

equipment cleaners?

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.

47
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: vaccines derived from excluded methods

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? 

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

48
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

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.

49
Livestock Committee Proposal

Expanded narrative on Vaccines derived from Excluded Methods

March 24, 2012

SUMMARY

This recommendation concerns the class of livestock vaccines derived from excluded methods, 

commonly called GMO vaccines. There are approximately 73 registered animal vaccines, of 

which 13 are GMO. Only 2 vaccines, Bovine and Avian Salmonellosis, appear to be presently 

available only as GMO. At present livestock producers use all vaccines and are not required to 

determine if they are using non-GMO or GMO vaccines. GMO vaccines are not legally allowed in 

organic production. This recommendation proposes a change which will allow GMO vaccines only 

in a declared emergency and, further, that at such time producers could use GMO vaccines 

without losing organic status of livestock. The recommendation also proposes changes to the 

definition of “emergency treatment program”. The entire recommendation applies to vaccines as a 

class but does not foreclose petitions for individual vaccines or a class of vaccines to treat specific

diseases.

I Introduction

At the present time organic livestock producers are allowed to use all vaccines as provided in 

205.105 (e) and 205.603 (a)(4). Genetically Modified Organism (GMO) vaccines, also referred to 

as vaccines derived from “excluded methods” in regulation, are not currently allowed in organic 

production. The National Organic Progam (NOP) received advice from the USDA General 

Counsel that GMO vaccines could only be allowed if specifically added to the National List. 

Currently, GMO vaccines are not on the National List.

II Background

Vaccines are used by a majority of organic livestock producers throughout the various geographic 

regions of the U.S. The use of vaccines is considered critical to disease prevention. A significant 

number of organic livestock producers do not routinely use vaccines, especially for smaller poultry 

flocks and for closed herds. 

“All vaccines” includes, de facto, both GMO and non-GMO derived vaccines.

The use of genetic engineering is prohibited in organic production and handling under the NOP 

regulations. However, on most organic farms the producer does not ask if the vaccine to be 

administered is GMO or Non-GMO. 

Producers are presently not required to ask to document use of GMO vaccines.

Since implementation of the NOP regulations in 2002, certifiers were routinely allowing all 

vaccines. Thus, in November 2009 the NOSB recommended that if non-GMO vaccines were not 

commercially available, then a GMO vaccine would be allowed, as practiced at that time. 

Nonetheless, consumers continue to assume that all organic products reaching market are NonGMO in production and handling.

III Relevant Areas of the Rule

Section 6509 (d)(1)(C) of the Organic Food Production Act (OFPA) of 1990, authorizes the use of 

vaccinations as an allowed healthcare practice in the production of organic livestock.

50
This authorization was implemented in Section 205.238(a)(6) “Livestock health care practice 

standard” which requires that “producers must establish and maintain preventive livestock 

healthcare practices including: ...(6) the administration of vaccines and other veterinary biologics”.

In 2002 the NOP implemented Section 205.603(a)(4) “Synthetic substances allowed for use in 

livestock production.” This section lists without annotation, “Biologics-Vaccines.” 

Section 205.105 – “Allowed and prohibited substances, methods and ingredients in organic 

production and handling,” states, in part, as follows:

“To be sold or labeled as “100% organic”, “organic”, or “made with organic”... the product must be 

produced and handled without the use of :....(e) Excluded methods, except for vaccines: Provided, 

that the vaccines are approved in accordance with 205.600(a).”

The phrase “excluded methods” is defined in section 205.2 as:

A variety of methods used to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions and processes and are not 

considered compatible with organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA technology (including gene 

deletion, gene doubling, introducing a foreign gene, and changing positions of genes when 

achieved by recombinant DNA technology). Such methods do not include traditional breeding, 

conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. 

The relevant Section 205.600(a)“Evaluation criteria for allowed and prohibited substances, 

methods and ingredients” 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: 

205.600(a) Synthetic and nonsynthetic substances considered for inclusion on, or deletion from, 

the National List of allowed and prohibited substances will be evaluated using the criteria 

specified in the Act (7 U.S.C. 6517 and 6518)”.

A Technical Report (TR), dated November 29, 2011, entitled “ Vaccines Made from Genetically 

Modified Organisms - Livestock” utilizing the criteria as specified in the Act (7 USC 6517 and 

6518) has been submitted to the NOSB.

Thus the NOSB is now in a position to clarify whether the use of GMO vaccines as a class of 

substances is allowed or prohibited under the requirements stipulated in 205.105(e), and 205.600 

(a).

IV Discussion

1. Should the present practice allowing use of all livestock vaccines, whether GMO or Non-GMO, 

continue?

The current regulation has a provision for a Federal or Sate emergency pest or disease 

treatment program (section 205.672). Plants and animals treated with a prohibited substance 

are taken off the market--plants and meat animals may not be sold as organic. Milk animals 

must wait one year before the milk can be labeled organic. For mammalian brood stock, 

newborns must be from livestock under continuous organic management from the last third of 

gestation to be labeled organic. The organic operation does not loose it certification, but the 

loss of certified organic plants and animals for sale could lead to immediate economic ruin.

Previous NOSB Action in 2009

51
The text of the Livestock Committee recommendation adopted by the NOSB on November 5 

2009 is in italics:

 

§205.105 Allowed and prohibited substances, methods, and ingredients in organic 

production and handling. 

To be sold or labeled as “100 percent organic”, “organic”, or “made with organic” the 

product must be produced and handled without the use of:

(e) Excluded methods, except for vaccines, Provided, that, vaccines made from nonexcluded methods are used if commercially available.

The livestock committee summary rationale in 2009 was: 

Previously, vaccines made by excluded methods were to be individually petitioned to the 

Board for allowance or prohibition for use. In reality since implementation of the Rule, 

certifiers have routinely allowed all vaccines, since they are used to prevent disease and 

needless suffering of animals. This recommendation will more closely align what has 

been occurring in the field since 2002. However, it will actually make it encumbent[sic] 

upon the producers and certifiers that vaccines made by non-excluded methods are 

located and used before those made by excluded methods can be used.

NOP 2010 Response to the NOSB 2009 Action

The NOP responded to this NOSB recommendation on September 30, 2010, in part, as follows:

The preamble to the National Organic Program final rule (FR Vol. 65, No. 246, page 

80554) states: 

The Act allows use of animal vaccines in organic livestock production. Given the 

general prohibition on the use of excluded methods, however, we believe that 

animal vaccines produced using excluded methods should not be allowed 

without an explicit consideration of such materials by the NOSB and without an 

affirmative determination from the NOSB that they meet the criteria for inclusion 

on the National List. It is for that reason that we have not granted this request of 

commenters but, rather, provided an opportunity for review of this narrow range 

of materials produced using excluded methods through the National List process. 

The NOP’s understanding is that excluded methods are prohibited under Section 

205.105(e) except for vaccines. Further, this exception applies to vaccines that are 

produced through excluded methods only if those GMO vaccines are approved 

according to 205.600(a). Vaccines are listed under 205.603(a)(4) under ―BiologicsVaccines‖. The NOSB has not reviewed vaccines in accordance with 205.600(a). The 

listing under 205.603(a)(4) of Biologics-Vaccines does not include the allowance of GMO 

vaccines. The NOP requested a legal review from USDA’s Office of General Counsel 

(OGC) to determine whether vaccines produced through excluded methods are currently 

allowed under 205.603(a)(4). The OGC opinion supports the position that GMO vaccines 

are allowed only if they are approved according to 205.600(a). 

The NOP recommends that the NOSB review GMO vaccines under the provisions of 

205.600(a).

2.If GMO vaccines are allowed ONLY if non-GMO vaccines are unavailable, or commercially 

unavailable, how can vaccines be identified by GMO content or origin.?

52
APHIS List

The Animal and Plant Health Inspection Service (APHIS) maintains a periodically updated list of 

all registered vaccines with coded alpha-numeric annotations that could allow a certifier or a 

producer to identify which individual vaccines are produced with GMO methods. Most 

producers are not aware of this list and the coding on the list requires some skill to use properly. 

In addition, most vaccines are given as combinations of vaccines which makes cross checking 

with the APHIS list a complex process.

Direct Inquiry

Some large livestock producers, such as Albert Straus of Straus Family Creamery in California, 

currently take on the responsibility of asking the manufacturer for a letter of non-GMO origin for 

vaccines. This approach may be less feasible for small producers: will manufacturers want to 

answer hundreds of inquiries? Also, could a certifier verify the information, and how "current" or 

up-to-date does the manufacture's letter have to be? Vaccines change on a constant basis to 

reflect new strains of disease and other factors. These are issues that might be addressed in 

guidance by the NOP.

Combinations of Vaccines

Because multiple vaccines are often combined into one dosage, a single GMO vaccine could 

rule out the administration of 6 other non-GMO vaccines, if the non-GMO vaccines were not 

available in singular or non-GMO formulations. The TR did not identify vaccines that would be 

unavailable in non-GMO form due to the combination of vaccines.

3. Should GMO vaccines be allowed ONLY in “extraordinary” circumstances?

Relieving economic hardship in the event of emergency treatment programs

The option of allowing GMOs in emergency treatment programs would change current policy. 

Under current policy, GMO vaccines are not permitted at all, as the NOP outlined. If they were 

required as part of an emergency treatment program, then organic producers would be 

penalized by having the affected products taken out of organic status, creating economic 

hardship beyond the control of the organic livestock producer, but in the furtherance of a larger 

public policy goal for all livestock producers. Creating an exception to allow GMO vaccines in 

organic production in cases of an emergency treatment program, and allow livestock to retain 

their organic status would relieve the economic hardship or the prospect of destroying entire 

organic herds or flocks if non-GMO vaccines were not located in time. 

Use of GMO vaccines if non-GMO vaccines are not commercially available 

In the alternative, the proposal put forward by the NOSB in 2009 would allow GMO vaccines if 

non-GMO vaccines were simply not commercially available. Under this scenario also, there 

would be no penalty to the organic product. The use of GMO vaccines would be permitted in 

the absence of either 1) a declared emergency treatment program, or 2) an indication that a 

specific vaccine was needed. 

Commercial Availability

Commercially available also presents some issues because many “off-the-shelf” and prescribed 

commercially available vaccines are not effective or not as effective as desired because 

diseases evolve new strains. It is also difficult to tell whether two vaccines, one GMO and one 

non-GMO, are functionally equivalent for a specific livestock operation. 

Autogenous, or customized, vaccines are prepared from microorganisms which have been 

freshly isolated from the lesion of the animal which is to be treated with it. These vaccines are 

53
not “commercially available’ in the sense that they are already developed and ready for 

administration for any given livestock population. 

Autogenous vaccines do not appear on the APHIS list. They are subject to different USDA 

licensing requirements. Autogenous vaccine regulations do not require confirmation of 1) 

efficacy, 2) potency correlated to efficacy; or 3) host-animal safety data submitted to the USDA 

prior to product licensure and use. 

Variances

A variance cannot be granted for a prohibited substance, ingredient, or method (excluded 

methods). The current regulations contemplate a possible exemption for GMO vaccines from 

being an excluded method--hence no variance would be needed. However, GMO vaccines 

would have to be added to the National List, which they currently are not.

4. Should GMO vaccines be prohibited in livestock production and handling?

The Livestock Committee has concluded that at this point in time there is not enough evidence of 

essential need to allow GMO vaccines as a class of substances for all diseases in livestock 

production, except in cases of a declared emergency. A declared emergency may emanate from 

acts of bio-terrorism or from outbreaks of diseases of major significance or foreign animal 

diseases. Nothing in the Committee recommendation is intended to preclude the possibility of 

successful future petitions to the NOSB for specific GMO vaccines or for GMO vaccines as a 

class for specific animal diseases. 

The NOSB should recommend policy based on what is consistent with an organic system of 

production rather than administrative and enforcement exigencies. 

A key factor regarding GMO vaccines is: are we making the decision based on the proper 

considerations. The NOSB is a policy body, not an administrative or enforcement body. The 

NOP is responsible for administering and enforcing policy related to GMO vaccine use.

It is the NOSB responsibility to consider, among other things, whether the use of GMO vaccines 

would be consistent with an organic system of production or considered essential to organic 

production. In general, GMOs are considered “excluded methods” and not consistent with 

organic production. In addition information in the TR and information received from other 

sources in the field did not indicate that GMO vaccines were essential to organic production at 

this time.

Any recommendation providing an exception to the general policy should not be unduly 

influenced by administrative and marketplace factors such as 1) currently many certifiers and 

producers do not know which vaccines are derived from excluded methods 2) current public 

policy chooses not to identify by label which vaccines contain GMOs or are derived from 

excluded methods, 3) the larger marketplace may not take GMO status into account in deciding 

how to produce and market vaccines, and 4) speculatively, some future unknown diseases of 

non-emergency proportions or new strains of diseases may be addressed by manufacturers 

with GMO only vaccines. 

Further, NOSB recommendations should not be limited by current USDA and FDA discretionary 

policy that does not require labeling of GMO content because GMOs are considered 

"functionally equivalent" to non-GMOs. It is clear GMOs are not functionally equivalent in the 

eyes of the consumer in the organic marketplace and in the legal interpretation of NOP 

54
regulations. 

Difficulties in enforcement

The Livestock Committee recognizes several administrative factors making it difficult to manage 

and enforce a non-GMO vaccine policy, including: 1) a lack of access to an easily identified and 

up-to-date list of which vaccines are of GMO origin, and 2) a lack of access to an easily 

identified and up-to-date list of the availability of non-GMO vaccines for all livestock diseases. 

Given that there are approximately 73 APHIS registered animal vaccines (livestock, feral 

animals and pets) and only 13 (or 18 % ) are thought to be livestock GMO vaccines, the 

construction of a usable list of GMO and non-GMO livestock vaccines is quite possible. The 

basic data should be in the APHIS list. 

In addition, the TR describes the current state of GMO vaccine use in organic production as 

follows:

Because organic certifying agents generally do not consider GMO status, no data are 

available on how many GMO vaccines are being used in organic production at this time.

Determination of Excluded Method

Because the NOP regulations do not use the words genetically modified organism(GMO) or 

“genetically engineered”(GE), we are concerned with “excluded methods.” A method is usually a 

process rather than a material or product. As such, how do we evaluate excluded methods when 

looking at vaccines? Are we looking at the entire method of producing a vaccine? Does the 

method include all of the materials and steps necessary to produce the vaccine? If any of those 

methods, steps, or materials resulted from excluded methods (such as a GMO produced 

substrate that does not remain in the final product or is not the "active" ingredient), then do we 

conclude the vaccine is a GMO--a result of a process that used excluded methods?

From a purely policy perspective, it would seem that any use of excluded methods could be 

interpreted to mean that a vaccine is of GMO origin. This interpretation would mean that if a 

vaccine were only grown in a substrate from a GMO product (e.g. corn), it would be classified as a 

GMO vaccine even though no GMO substance remained in the finished vaccine. It is highly 

unlikely that the APHIS list would ever be detailed and precise enough to make these distinctions, 

since APHIS is not tasked with administering or enforcing organic certification. This conclusion 

could also lead to an unknown GMO status for a large number of vaccines. The committee 

recommends that NOP guidance specify that the information from the APHIS list of registered 

vaccines be used to determine GMO or non-GMO status.

Definition of emergency treatment program.

Background

Organic Foods Production Act of 1990 (OFPA)

OFPA 7 U.S.C. 6506 (b)(2) only confers on the Secretary the power to

“provide for reasonable exemptions from specific requirements of this title ... on certified organic 

farms if such farms are subject to a Federal or Sate emergency pest or disease treatment 

program.” (Complete quotation is included below) No mention is made of “local” or “eradication” 

programs.

Maryland Department of Agriculture

55
Committee research indicates that Maryland and most states have very broad powers to 

enforce eradication programs without ever declaring a state of emergency. If the intent of a 

recommendation for GMO vaccines in organic production were to limit their use to major 

outbreaks and to diseases of major significance or foreign animal diseases, such as hoof and 

mouth disease, then it would be appropriate to require a declared state of emergency. 

Requiring a declared state of emergency would definitely limit the use of GMO vaccines to 

major events.

In Maryland and other states, the Secretary of Agriculture would have to go the Governor to 

declare a state of emergency because only the Governor has such authority. In some states 

the chief agricultural officer may be able to make a declaration of emergency. A local agency 

would be unlikely to have the authority to declare an emergency, and in Maryland no local 

agencies have that authority. 

The Secretary of Agriculture in Maryland could not recall a case of a vaccine ever being 

required within the Maryland. However, they have the authority to investigate outbreaks and to 

require treatment as necessary without declaring an emergency. It is also possible that they 

could require animals entering the State to have been vaccinated for a specific disease known 

to be a problem from the livestock’s point of origin, although they were not sure that situation 

had ever occurred.

National Organic Program

The NOP currently administers the emergency treatment program provision in the regulations, 

responding to declared emergencies by an appropriate State official, and all products which are 

touched by or which received a prohibited substance are no longer eligible to be sold as 

organic, although the organic operation did not lose its certification.

It was noted that there is a discrepancy between section 205.672 “Emergency pest or disease 

treatment” and 205.2 “Definitions—Emergency pest or disease treatment program.” This is a 

potential legal ambiguity. Which provision would be controlling, since they say different things? 

It is advisable to change the Definition, section 205.2, “Emergency pest or disease treatment 

program:” (see language in recommendation section at end of document).

1) to comply with the statutory authority in 7 U.S.C. 6506 (b)(2); 

2) to clarify any potential legal ambiguity in the reading of 7 CFR 205.672 “Emergency pest or 

disease treatment” with 7 CFR 205.2 “Definitions-- Emergency pest or disease treatment 

program;” 

3) to reflect what appears to be the current NOP practice and ;

4) to accurately reflect the intent of the NOSB Livestock Committee recommendation on the use 

of vaccines derived from excluded methods.

Some central questions not completely addressed by the TR

1)WHAT SPECIFIC DISEASE PROBLEM(S) CAN ONLY BE ADDRESSED WITH A GMO 

VACCINE?

The TR does not point to a single or narrow group of problem diseases in organic livestock that 

56
are creating hardship and urgently need to be addressed with GMO vaccines. Rather than 

addressing specific vaccines for specific diseases, we are addressing vaccines as a class of 

substances used in an organic livestock healthcare program. The TR seems to identify two 

diseases for which a GMO only vaccine is available: 1) Avian Salmonellosis and 2) Bovine 

Salmonellosis. For salmonella, improved management practices are often the first line of 

defense, with vaccination as an option if the disease cannot be controlled by management 

practices alone. Due to the changeable nature of Salmonella, finding an effective vaccination for 

a specific herd or flock may be challenging and may require customizing the vaccine.

2)WILL CREATING A GMO EXCEPTION LEAD TO LEGAL AMBIGUITY, PERCEPTIONS OF 

UNFAIRNESS, OR SUCH FREQUENT USE THAT IT LEADS TO POTENTIAL ABUSE?

The exception(s) created are to be narrowly construed and not used as a precedent for allowing 

excluded methods (GMOs) elsewhere in organic production or handling, unless specifically 

authorized, vigorously reviewed by the NOSB and NOP, and subject to public comment.

The intention with regard to organic use of GMO vaccines is that they should be legal, fair, and 

rare. The Committee feels its recommendation meets these tests.

Legality

The use of GMO vaccines, to the extent allowed in organic in emergency treatment programs, 

has to be clearly and understandably legal--a producer/consumer/certifier/public agency must 

be able to read and understand the policy easily and not have it subject to questions that could 

lead to legal challenges. 

Fairness

The GMO exception policy must be fair to accommodate both the organic producer's ideals and 

livelihood and the organic consumer's expectations. 

Rareness

GMO vaccine use in organics should be so rare (i.e. emergency use only). The rarity of GMO 

use should be an accepted outcome with regard to legality--everyone agrees to the ground rules 

(Federal vs. State authority, for emergency use, etc) and GMO vaccine use does not lead to 

abuses. 

Additionally, the rarity should be recognized as fair and the rationale for the GMO vaccine use

should meet the concerns of both producers and consumers, i.e. all livestock producers, both 

organic and conventional, must take concerted action in the face of a publicly declared 

emergency to safeguard livestock production for all concerned.

 

3)HAS THERE EVER BEEN AN EMERGENCY TREATMENT PROGRAM DECLARED BY THE 

FEDRAL OR STATE LEVEL IN RECENT MEMORY, AND HAS IT LEAD TO TREATMENT 

WITH GMO VACCINES?

This is a factual question not addressed by the TR because it was never posed. 

4) DOES THE CURRENT REQUIREMENT TO USE NON-GMO VACCINES IN ORGANIC 

LIVESTOCK PRODUCTION LEAD TO UNACCEPTABLE ANIMAL DISEASE AND 

SUFFERING?

This is not a question that was explicitly posed or addressed in the TR with regard to organic 

production. The following information that has some bearing on a response to this question was 

presented to the committee from the TR and other sources. 

57
Number of GMO vaccines

GMO vaccines became available in the early 1980s. Of the approximately 73 vaccines licensed 

for use in wild and domesticated animals, 28 are GMO and 13 (about 18%) are given to 

livestock animals. 

Choice of vaccines

In summary, organic producers have choices of non-GMO vaccines in many cases, and only 

two cases of individual vaccines only available in GMO form were identified in the TR. 

Combination vaccines were identified as a problem, but often the individual non-GMO 

components were available, and no specific case was identified when they were not available. 

Advantages of GMO vaccines

From the information presented in the TR and other sources, it would appear that GMO 

vaccines are sometimes, but not always, faster to develop, more quickly targeted to the specific 

disease, safer and cheaper than their counterparts, and may have advantages for efficacy, 

lower production costs, better storage and transportation, and ability to track which animals 

have been vaccinated. In general it was not possible to make broad conclusive generalizations 

regarding the advantages of GMO vaccines. Non-GMO vaccines generally can more quickly 

meet Federal registration criteria.

Types and Use of Vaccines

Non-GMO live bacterial vaccines are still used extensively and GMO live bacterial vaccines are 

still very rare. GM viral vaccines are more prevalent than GM bacterial vaccines, although there

are many conventional viral vaccines. 

Concerns about GMO vaccines

With bacterial GMO vaccines (which are predominantly administered via the mouth), there are 

concerns that the engineered bacteria may recombine with natural bacteria in the 

gastrointestinal tract. Furthermore, it is unclear how long the altered virus/bacteria will remain in 

the vaccinated animal.

Vaccines manufactured from artificial DNA created by combining several sequences of DNA are 

not used livestock. DNA from these types of vaccines may integrate into a host’s chromosomes 

and initiate a cancer-initiating event, although results have been negative in experiments thus 

far. In addition, the modified DNA could theoretically integrate into the sperm or egg cells and be 

passed on to future generations. 

Market for non-GMO vaccines for organic production

While the TR is not explicit about whether organic livestock production is too small to warrant 

attention from manufacturers to produce non-GMO vaccines, it presents evidence that organic 

represents a very small percentage of total livestock production. The clear implication is that 

the organic market does not command enough demand for independent non-GMO vaccine 

development. Organic poultry production is seen as the largest potential livestock market. 

Autogenous vaccine development was not specifically addressed.

Findings

58
1. Section 205.238 (a) (6) requires that producers must establish and maintain preventive 

healthcare practices, including administration of vaccines and other veterinary biologics, thus to 

deny use of a vaccine because it is ONLY available as GMO could be construed, incorrectly, by 

certifying agency as a non-compliance with the Rule. 

2. Withholding treatment to an animal to maintain organic status is prohibited. Administering a 

GMO vaccine would prevent the animal or animal products and some mammalian offspring from 

being sold as organic.

3. A review of commonly administered livestock vaccines suggests that routine vaccinations are 

relatively common, and that they tend to be given as combinations of vaccines in single delivery 

format.

4 A review the USDA’s APHIS list of Livestock Vaccines, regulated by the Center for Veterinary 

Biologics, suggest that there are non-GMO vaccines available for virtually all common potential 

livestock sicknesses. However there is presently no list which easily allows identification of GMO 

status.

5. Presently there is no requirement that a producer make inquiries of the veterinarian or 

pharmaceutical company as to the GMO or recombinant nature of vaccines to be administered.

6. Canada does not allow GMO vaccines (CGSB, 2009)

7. Europe allows GMO vaccines: Council Reg EC No 834/2007, Article 4 , Overall Principles: 

Organic production shall be based on the following principles: (iii) exclude the use of GMO’s and 

products produced from or by GMO’s with the exception of veterinary medicinal products.

8. The WHO, OIE and FAO clarified the difference between GM foods and use of GMO vaccines. 

With engineered foods the intention is to introduce a new trait into a food; this trait will be present 

in the food eaten by the consumer. On the other hand, the intention of genetically modified 

vaccines is to introduce into food animals “a protective immune response by means of an 

immunogen that is often no longer itself present at the time the animal is slaughtered.”

V Recommendations 

 

1. Modify language in 205.238 (6) as follows, change shown in italics.

Administration of vaccines and other veterinary biologics, provided, vaccines produced with 

excluded methods, can only be administered in accordance with §205.105(e).

2. Modify 205.105 (e) as follows: Excluded methods, except for vaccines: Provided, 

(1) such vaccines are administered only due to a Federal or State emergency pest or disease 

treatment program, and 

(2) such vaccines are approved in accordance with §205.600(a);

3. Modify language in 205.603(a)(4) as follows: Biologics—Vaccines, provided, with regard to 

vaccines produced with excluded methods, the requirements of 205.105(e) are satisfied. 

4. Change the Definition of “Emergency pest or disease treatment program” in section 205.2 

with the additions shown in italics.

59
Emergency pest or disease treatment program. A mandatory program authorized by a Federal, 

State or local agency for the purpose of controlling or eradicating a pest or disease, except for a 

program requiring substances described in section 205.105(e) regarding only vaccines 

produced with excluded methods, in which case such program is defined as a mandatory 

treatment program authorized by a declared Federal or State emergency for the purpose of 

controlling a pest or disease.

VI Committee Vote on Main Motion: Motion : Nick Maravell 

Second : Jean Richardson 

Yes 5 No 0 Abstain 0 Recuse 0 Absent 3

Committee Vote on Motion to Amend emergency treatment program: Motion: Colehour Bondera

Second: Calvin Walker

Yes 8 No 0 Abstain 0 Recuse 0 Absent 0

60
National Organic Standards Board

Livestock Committee

Proposed Discussion Document

March 28, 2012

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

61
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.

Proposed Materials

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 four species specific guidance pieces. 

Guidance for Assessing Animal Welfare on Organic Bison

Guidance for Assessing Animal Welfare on Organic Poultry Operations

Guidance for Assessing Animal Welfare on Organic Sheep Operations

Committee Vote

Motion: Wendy Fulwider Second: Colehour Bondera

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

62
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: 

63
Three items that may need attention at this farm:

64
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 

65
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 

66
National Organic Standards Board

Livestock Committee

Proposed Discussion Document

Guidance for Assessing Animal Welfare on Organic Bison Operations

March 28, 2012

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 bison operations.

Contents

Introduction ....................................................................................................................... 2

Bison Nutrition................................................................................................................... 2

General Guidance.......................................................................................................... 2

Seasonal Considerations............................................................................................... 3

Nutrition and Bison Reproduction .................................................................................. 3

Heifers/Cows.............................................................................................................. 3

Bulls ........................................................................................................................... 4

Body Condition and Scoring.............................................................................................. 4

Bison Health...................................................................................................................... 8

Pathogens ..................................................................................................................... 9

Bovine Tuberculosis (TB)......................................................................................... 10

Brucellosis................................................................................................................ 10

Bovine Virus Diarrhea (BVD) ................................................................................... 10

Malignant Catarrhal Fever (MCF)............................................................................. 11

Internal parasites ......................................................................................................... 11

External Parasites........................................................................................................ 12

Physical Alterations ..................................................................................................... 12

Bison Handling ................................................................................................................ 12

Corrals ......................................................................................................................... 12

Calving......................................................................................................................... 13

Reference Material:......................................................................................................... 13

Attachment -- Bison Welfare Audit .................................................................................. 15

67
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 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 

Comparison of total tract retention time and dry matter 

digestibility of forages between bison and cattle

68
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 pre-winter 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 

trimester. These young females must have sufficient nutrient intake to finish growing 

their own body in addition to finish growing a calf. 

69
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.

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 

70
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. 

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. 

71
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. 

72
Source: Alberta Agriculture, "What's the Score; Bison" 

http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/agdex9622/$FILE/bcs-bison.pdf

73
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

74
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). 

75
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 

76
encounter and one of the hardest to get rid of when it attacks a herd. The viruses that 

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. 

77
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. 

Corrals

78
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. 

Reference Material:

Alberta Agriculture (2007) “What’s the Score: Bison” Body Condition Scoring Guide. 

79
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

80
Attachment -- Bison Welfare Audit

The National Bison Association—in cooperation with Dr. Temple Grandin of Colorado 

State University—developed the following bison welfare audit to measure several areas 

of working bison in the corral.

 

Bison Welfare Audit 

ranch 

_________________________

auditor 

_____________________ date _____________

class of 

animals_____________________ time of day _____________________ total time__________

(score 50 consecutive head - score each animal individually - repeat audit as necessary)

a) ELECTRIC PROD usage ---- Circle number if prod is USED --- Slash otherwise

(The goal is to not carry a Hot-Shot in hand - even a touch without the shock counts as usage.)

1 2 3 4 5 6 7 8 9 1

0

1

1

1

2

1

3

1

4

1

5

1

6

1

7

1

8

1

9

2

0

2

1

2

2 23 24

2

5

2

6

2

7

2

8

2

9

3

0

3

1

3

2

3

3

3

4

3

5

3

6

3

7

3

8

3

9

4

0

4

1

4

2

4

3

4

4

4

5

4

6

4

7 48 49

5

0

note where usage took placeb) COLLISION with HEAD GATE ---- Circle number IF HARD HIT occurred --- Slash otherwise 

(use your best judgment here - If the bison hits hard enough to cause a bad headache, count it)

(moving further from the chute, or enclosing the sides and/or front of the chute are common solutions)

1 2 3 4 5 6 7 8 9 1

0

1

1

1

2

1

3

1

4

1

5

1

6

1

7

1

8

1

9

2

0

2

1

2

2 23 24

2

5

2

6

2

7

2

8

2

9

3

0

3

1

3

2

3

3

3

4

3

5

3

6

3

7

3

8

3

9

4

0

4

1

4

2

4

3

4

4

4

5

4

6

4

7 48 49

5

0

c) CHUTE EXIT SPEED ---- Circle number if the bison FELL exiting the chute --- Slash otherwise 

(a rubber mat for footing, or a visual barrier in front of the chute will help this problem)

(a knee hitting the ground, or worse, constitutes a fall) 

1 2 3 4 5 6 7 8 9 1

0

1

1

1

2

1

3

1

4

1

5

1

6

1

7

1

8

1

9

2

0

2

1

2

2 23 24

2

5

2

6

2

7

2

8

2

9

3

0

3

1

3

2

3

3

3

4

3

5

3

6

3

7

3

8

3

9

4

0

4

1

4

2

4

3

4

4

4

5

4

6

4

7 48 49

5

0

d) INJURY ---- Circle number, if at any time, recent injuries are apparent --- slash otherwise 

(broken legs, broken horns, broken ribs, puncture wounds, etc.)

1 2 3 4 5 6 7 8 9 1

0

1

1

1

2

1

3

1

4

1

5

1

6

1

7

1

8

1

9

2

0

2

1

2

2 23 24

2

5

2

6

2

7

2

8

2

9

3

0

3

1

3

2

3

3

3

4

3

5

3

6

3

7

3

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3

9

4

0

4

1

4

2

4

3

4

4

4

5

4

6

4

7 48 49

5

0

b) CROWDING ---- Circle number if any bison climbs on another --- slash otherwise 

(position in the stack does not matter, count all involved; also include bison that turn over backwards) 

1 2 3 4 5 6 7 8 9 1

0

1

1

1

2

1

3

1

4

1

5

1

6

1

7

1

8

1

9

2

0

2

1

2

2 23 24

2

5

2

6

2

7

2

8

2

9

3

0

3

1

3

2

3

3

3

4

3

5

3

6

3

7

3

8

3

9

4

0

4

1

4

2

4

3

4

4

4

5

4

6

4

7 48 49

5

0

81
note where crowding occurred -

Questions: (to assist in improvement - check appropriate box) ye

s

n

o

? 

1) Bison were gathered from the pasture into a holding area at a slow pace ----------------------

- 

2) Bison were moved into the corral system at a reasonably slow pace ----------------------------

- 

3) The bison were generally relaxed while in the corral system before processing --------------

4) Bison flowed through the corral system to the tub smoothly with minimal effort -------------- 

5) Personnel moved slowly without making excessive noise (yelling, slamming gates, etc.) --

-- 

6) Bison were moved easily through the corral with one or two people -----------------------------

- 

7) Post processing, bison receive ample space, water, and feed ------------------------------------

-- 

8) Weaning pens have adequate space, water and bunks, and dust is minimal -----------------

9) Panting was observed in some animals in the corral -------------------------------------------------

-- 

10) Dust was a problem during processing ------------------------------------------------------------------

-- 

11) Excessive poking, beating on, or multiple electric prod use on animals occurred -----------

--- 

12) Old bulls were a problem when gathering and/or processing -------------------------------------

--- 

13) Too many serious bison injuries occur during processing ------------------------------------------

-- 

14) The corral system needs significant modifications ---------------------------------------------------

--- 

Additional comments: 

Committee vote:

Motion: Wendy Fulwider Second: Colehour Bondera

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

82
National Organic Standards Board

Livestock Committee

Proposed Discussion Document

March 28, 2012

Guidance for Assessing Animal Welfare on Organic Poultry Operations

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, minimizing

error and inconsistency. It also leaves a greater proportion of the beak intact.1

 

83
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.

Gait scoring is a tool that can be used to assess the degree of lameness in a broiler chicken 

flock.

2,3,4

 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.

84
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.5

 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,

6,7

 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.8, 9,10 Focal ulcerative dermatitis is small skin lesions (commonly called 

“breast buttons”) that develop on the keel bone of turkeys.11 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,12 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.13 Some 

commercial broiler crosses are more susceptible to leg problems than others,

14 but slow 

growing broiler strains are generally less prone to these weaknesses. They are also less 

prone to heart and circulatory problems.

15 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.16 The reason that higher 

stocking densities can lead to lameness is more complex, involving both lack of room 

available for exercise and movement, as well as factors such as additional ammonia and litter 

moisture.17,18,19

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.

20 Moisture and temperature of the 

85
litter increase with stocking density, so if these variables become problematic, it may be 

necessary to raise fewer birds in the allotted space.

21 Manually turning the litter can help. 

Floor heating systems have also been found to improve litter quality.22

Conversely, well-managed litter is a soft substrate, while outdoor environments can cause 

abrasion and foot-pad dermatitis if not carefully managed.23 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.24

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.

25

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.26

Varying degrees of foot pad dermatitis on the feet of 

turkeys

86
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. 

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 

Foot pad dermatitis and hock burns on a broiler chicken

87
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.

27 Litter that “stops working”, leaking drinkers, and an inadequate ventilation system 

(to remove water vapor) may all increase disease risk.28,29 Maintain litter in friable

condition.30,31 Introduce only healthy young birds from genetic lines resistant to intestinal 

parasites.

32

The build up of parasites around the barn can be avoided with the use of mobile housing,33

pasture rotation, reduced stocking density, and by using land with good drainage.34,35 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.

36 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. 

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 

88
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.37,38 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,

39,40 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;

41,42 cutting off the beak tip 

thus impairs sensory function. Welfare can be improved by controlling cannibalism using 

alternative means. 

Dietary deficiencies have been linked to increased incidence of pecking damage,43 especially 

protein deficiencies,44,45 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.46

Feather pecking and cannibalism are not aggressive acts—rather, science demonstrates that 

these are foraging pecks that have been re-directed toward feathers.

47,48,49 In natural 

conditions, domestic fowl spend over 50% of their active time in foraging related activity.

50,51 

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.52,53 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.

54 

Pecking preferences are formed early in life, and these are learned through experience.55

Therefore, providing appropriate pecking and foraging substrate from day one56,57 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.

58,59,60, 61,62,63 Conversely, 

studies also show that the absence of loose-litter64 and poor litter quality are risk factors for 

89
plumage deterioration due to feather pecking.65 Scattering grain or feed into loose litter for 

young chicks can also be beneficial.66 

Lack of perches during early rearing is another important risk factor for feather pecking on 

organic farms.67 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.68,69,70 Young

birds must learn how to successfully navigate perches by gaining experience with them from 

a young age, which shapes their cognitive spatial abilities.

71 Pullets should have access to 

perches elevated above 35 centimeters at no later than four weeks of age.72,73 Higher 

perches are generally better, 74 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 environments as closely as 

possible.75 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.76 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.77 

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.78,79 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.80 A diet high in insoluble fiber has also been shown to help to 

reduce and control cannibalism,

81 and millrun, oat hulls, rice hulls, and lucerne meal are 

effective sources.82 Additional foraging enrichments such as maize, barley-pea silage, 

carrots,83 straw84,85 seeds in suet, and cabbage leaves86 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.

87,88,89,90,91,92,93 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 

90
foraging substrate, rather than at each other.

94 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.95

Other risk factors that have been associated with injurious pecking include:

• Restricting access to portions of the indoor litter area;

96

• Restricting access to the outside range area;

97

• Changing the diet three or more times during the laying period;98,99

• Using lights inside the nest boxes;100

• Use of bell drinkers;

101,102

• Inadequate number of drinking places;

103

• Reduced indoor temperature (below 68o F);

104

• Not keeping cockerels with the hen flock;

105 and

• Dietary deficiencies.

106

Feather pecking, cannibalism, and the associated mortality have genetic components, which 

means that these traits can be selected against in breeding programs.107,108,109,110 Different 

hen strains vary in their propensity to exhibit injurious pecking behavior.111 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. Slatted-floor 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 

91
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.

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.112

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,113,114,115 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.116,117 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.

118 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,

119,120 and this is the natural resting position for 

chickens. Perch use maintains bone volume and bone strength,

121,122,123 and can serve as a 

refuge for subordinate hens to avoid aggressive interactions with more dominant hens.

124 

Research demonstrates that hens are highly motivated to perch at night.

125,126,127 When 

given a choice, hens often prefer to roost on higher perches as opposed to those that are 

closer to the floor.

128,129 

Bumblefoot is a bulbous swelling of the footpad caused by a localized infection.130 Some hen 

breeds are more susceptible than others, and the condition is associated with poor hygiene 

and poor perch design.

131,132 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.133 Incidence of bumblefoot can be reduced by providing hens with hardwood perches 

that are approximately 1.5 inches in diameter with a flattened top134,135 and by limiting 

walking exposure to mud and manure.136

Hens selected for egg production are prone to osteoporosis and subsequent bone 

fractures.

137,138,139 These often go undetected unless hens are palpated by an experienced 

92
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,140 and angles greater than approximately 

45o can be difficult to navigate.

141 At a minimum, hens need approximately 6 inches of perch 

space to take-off, and 6-9 inches to land.

142 Perches should be large enough for hens to 

maintain stable footing, about 1.5 inches in diameter.

143,144 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.145

Providing perches at a young age can also help reduce the risk of floor eggs,146 as pullets 

must be skilled at flying up and down in order to access elevated nest boxes.147

Outdoor access and living conditions

Outdoor access must be provided to all poultry, with the following exceptions:

• Pullets younger than 16 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 16 

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.

148 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 between species with 

different parasite spectrums, such as cattle and poultry. Harvested crop fields also make 

good poultry runs.

93
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.149

Natural cover can take many forms, including tall plantings of vegetation, bushes, and 

trees,150 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.151 In “tree-range” 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.152 

Artificial structures that provide shelter, shade, and 

security can also be constructed.153,154 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.155 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. 

Livestock Species Indoor Space Outdoor Runs and 

Pens 

Chickens

Laying hens and 

breeders

2.0 sq ft / bird 2.0-5.0 sq ft / bird 

Pullets 2.0 to 3.0 lbs / sq ft 2.0-3.0 lbs / sq ft

Broilers 1.0 to 5.0 lbs / sq ft 2.0 to 5.0 lbs / sq ft

Other poultry

Turkeys and 7.5 lbs / sq ft 2 lbs / sq ft

94
Geese—breeding, 

laying, or meat birds 

(pounds)

 

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,

156,157 as birds are subjected to noise, vibration, motion, 

overcrowding, feed and water deprivation, social disruption, and potential temperature 

extremes.158,159,160 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 posture for 

chickens.161 Handling, crating and loading for transportation, have been identified by 

researchers as major sources of stress and trauma.162 Bruising and injuries are welldocumented, and these are not only welfare problems, but can also result in carcass 

downgrading and economic loss to producers.

163, 164,165,166,167 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.

168

95
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

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.169 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 

96
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.

170,171 

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,172 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.173,174 

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.

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. 

97
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 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.

175 

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:

98
• 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 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.

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103
98 Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather 

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100 Pötzsch CJ, Lewis K, Nicol CJ, and Green LE. 2001. A cross-sectional study of the prevalence of vent 

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101 Green LE, Lewis K, Kimpton A, and Nicol CJ. 2000. Cross-sectional study of the prevalence of feather 

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Committee vote:

Motion: Wendy Fulwider Second: Colehour Bondera

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

 

107
National Organic Standards Board

Livestock Committee

Proposed Discussion Document

March 28, 2012

Guidance for Assessing Animal Welfare on Organic Sheep Operations

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

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Late Lactation, Weaning 2.0-2.5

*Add .5 to the target score for ewes expecting or nursing twins.

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 (illustration)

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 (illustration)

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 (illustration)

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 (illustration)

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

(illustration)

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 (illustration)

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.

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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 veterinary-provided 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.

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.

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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 postshearing—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.

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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.

 Committee vote:

Motion: Wendy Second: Colehour

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

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National Organic Standards Board

Livestock Committee

Proposed Discussion Document

March 28, 2012

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:

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• Cattle affected with mange or lice

• Cattle with broken tails 

• Ammonia concentration in buildings

• 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. 

Proposed Materials

I. Dairy auditor tally sheet

II. Dairy Scorecard

Committee Vote

Motion: Wendy Fulwider Second: Colehour Bondera

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

114
National Organic Standards Board

Policy Development Committee

Proposal

Conflict of Interest

 March 29, 2012 

I. Introduction

The National Organic Standards Board (NOSB) is seeking to enhance the NOSB’s 

conflict of interest (COI) policy by providing two definitions and outlining general 

procedures for declaring, evaluating, and acting upon a COI. The recommendations are 

responsive to a number of requests by stakeholders to improve the NOSB COI policy. 

The proposed additions should provide greater transparency of and expectations 

around NOSB members’ work on behalf of the organic community.

NOSB’s Policy Development Committee (PDC) initially presented a version of this 

recommendation at the November, 2011 NOSB meeting. Based on feedback from the 

National Organic Program, the NOSB and the public, the PDC chose to retract the 

recommendation and make substantial revisions. 

II. 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 

represent various interests involved in the organic community, enabling them to advise 

the Secretary of Agriculture on the implementation of the Organic Foods Production Act 

(OFPA). The statutory composition of NOSB is composed of 15 members. OFPA 

describes the composition of the NOSB as follows:

• 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.

NOSB members – like most federal advisory board members - are chosen specifically 

because of their professional expertise within a given area. Especially since NOSB 

members represent sectors of the industry directly impacted by the board’s decisions, it 

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is necessary to maintain a clear and detailed NOSB COI policy. 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 & Procedures 

Manual (2011, pg. 9). At this time, the PDC of the NOSB seeks to update the Board’s 

policy and procedures on COI. 

The proposed COI policy will enhance and build upon the existing NOSB’s COI policy. 

The recommendations include definitions of key terms and guidance on the procedural 

steps to be followed in declaring and acting upon a COI. 

III. Relevant Areas of the Rule

The OFPA establishes the NOSB at §2119 (7 U.S.C. 6518) (a). It reads, “The Secretary 

shall establish a NOSB (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 2011 

NOSB Revised Policy and Procedures Manual (PPM) dated April 29, 2011 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. 

IV. Discussion

The benefits of the proposed recommendations include providing clear definitions of key 

terms and providing procedural steps for managing a COI in the course of the NOSB’s 

business. The updated COI policy will provide greater transparency and confidence in 

Board decisions by the organic community. 

An alternative approach would be to keep the current COI policy. However, an

enhanced COI policy should help the Board’s in its continued responsiveness to the 

organic community’s feedback and address a number of opportunities for enhanced 

clarity, particularly with regard to the specific procedures to be followed in declaring, 

evaluating, and acting upon a COI. 

Previously, the June, 1999 NOSB Procedures Taskforce Report to the Board on COI 

was approved. 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 circumstances, the Board may determine whether 

it is appropriate for the member to vote. 

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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, 2011, page 9.]

The current document seeks to enhance the existing COI policy. It attempts to do so by, 

(1) proposing clear definitions for “conflict of interest,” and “immediate family member,” 

and (2) suggesting procedural steps for dealing with a declared COI. 

V. Recommendations

Recommendation #1

The first three paragraphs shown below are on page 9 of the 2011 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 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 include private discussion with members of the 

Board advocating the value of the material, public discussion and/or written 

advocacy.

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Recommendation #2

The definitions below are to be inserted before paragraph #4 on page 9 of the 2011 

PPM. 

The term “conflict of interest” is defined as a situation in which there is an actual 

or potential direct financial interest of a Board member which could impair the 

individual's objectivity or which has the potential to create an unfair competitive 

advantage for said Board member, board member’s immediate family member, 

or Board member’s organization or affiliated business.

An “immediate family member” includes a Board member’s relative by blood or 

marriage who may be a spouse or partner, children or step children, parents or 

step-parents, brother or sister.

 

A “direct financial gain” is defined as a 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. 

Recommendation #3

We recommend the added section below. 

Procedural Steps for a COI Determination and Resolution

1. Each Board member is responsible for declaring his/her COI when an issue is 

first being discussed, to include one’s participation on a committee, task force, or 

full NOSB meeting. 

2. In opening the discussion of each issue and prior to each vote, the chair will ask 

all Board or committee members to raise any COI or potential COI in that 

particular matter. 

3. Upon such declaration, the member may voluntarily refrain from participating, or 

may request that the Board or committee decide whether the conflict warrants 

said Board member abstaining from participating in the discussion in said matter 

and from voting on said matter.

4. The chair will ask the Board or committee for any objections to the Board 

member participating in said discussion or voting on said matter. If no member(s) 

object, then said Board member may participate in said discussion and vote on 

said matter. If any member(s) do object, then said matter will be subject to a full 

Board or committee vote. The motion requires a simple majority to pass. 

5. The Board’s or committee’s final decision on all COI must be clearly recorded in 

the minutes.

 

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VI. 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. 

VII. Committee Vote:

Moved: Barry Flamm Second: Jean Richardson

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recusals: 0

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National Organic Standards Board

Policy Development Committee

Proposal

NOSB Meeting Public Comment Procedures

March 29, 2012

I. Introduction 

Public input and transparency are central to the effective functioning of the 

NOSB. The proposed amendments to the Policy and Procedures Manual are 

intended to improve the ability of the NOSB to receive public comment.

II. Background

The six NOSB committees meet using teleconference calls on a regular, typically 

twice a month basis, sharing information received from the public, actively 

seeking further information and data as they review an ever increasing range of 

complex substantive issues and develop recommendations. Twice a year the full 

NOSB physically meets together at a location within the U.S. These public 

meetings take place at different geographic locations in order to ensure that 

those who cannot travel long distances for reason of cost or time are more likely 

to have their voices heard, and assumes that more regional members of the 

public will attend in person, and also that regional differences in agriculture will 

thus be better understood by the Board as it develops recommendations to 

forward to the NOP.

For anyone involved in public policy it is well understood that input through public 

comment at open public meetings provides both challenges and opportunities. 

There is a delicate balance between letting everyone speak for as long as they 

want to, while allowing time for everyone present to be heard, and then time for 

their comments to be digested by those who listen and pose questions. In 

addition the public needs to feel confident that their views have been heard and 

taken into consideration before decisions are voted on. Well run and effective 

Public Meetings require clear rules and leadership. Over the last five years there 

has been an increasing interest by the public to attend the semi-annual meetings 

to provide public comment, and increasing mutual desire by the public and the 

Board to clarify and improve procedures for taking public comment. Thus, in 

October - November 2011 the NOSB sought public input to clarify policy and 

procedures for receiving public comment specifically with reference to public 

meetings.

III. Relevant Areas of the Rule

The Organic Foods Production Act (OFPA) establishes the National Organic 

Standards Board at Section 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. 2et seq.) [hereafter referred to as the 

“Board”] to assist in the development of standards for substances to be used in 

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organic production and to advise the Secretary on any other aspects of the 

implementation of this title.”

The Policy Procedures Manual (PPM), Section VI “Policy for Public Comment at 

NOSB Meetings” lays out the process and the time designations of public 

comment and further provides for “Other suggestions that would be appreciated 

by NOSB members”.

IV. Discussion

It is clear that many members of the public are frustrated by the procedures for 

public comment at the national meetings and they seek clarification and a desire 

for greater confidence that the Board members have heard what they have to 

say, and have seriously considered their input. Comments also requested 

flexibility with public involvement.

Following are some of the issues raised:

Length of time to speak 

With an increased interest in public comment at meetings, there are typically 

many more speakers for time allotted. While 10 minutes is too long to permit, it is 

clear that for many even 5 minutes is a short time to speak given the complexity 

of issues and range of topics covered in one meeting. Requiring a 3 minute time 

limit forces speakers to be concise and prioritize topics covered in verbal 

presentation. In addition speakers need to be reminded that they can also submit 

an expanded written version of their comments during the meeting. 

One comment stated” the length of time is not as important as that the 

designation of a time be regarded as a commitment.”

While it may seem that speakers have travelled long distances, incurring 

expense and taking time to speak for only 3 minutes, it is obvious that attending 

the meeting allows face to face exchange of data, information and policy 

concerns throughout the week.

Several organizations requested that length of time be set at 5 minutes and 

decreased to 3 minutes if too many presenters for time period allotted, with 

flexibility being provided by the Chair.

Time allotted on agenda for public comment

There is widespread concern that there is not enough time on the week’s agenda 

for public comment. While this is probably a normal perception by the public for 

any national board, it is nonetheless an important issue to address. In past years 

public comment extended into evening hours and the Board may wish to 

seriously consider returning to this option.

One comment suggested extending time allotted for public comment by one 

hour.

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Another stated “we may reach a point when comments need to be prioritized, 

either on a first come first served, or randomized basis in order to ensure equity 

and diverse public input”.

Another comment suggested maintaining a waiting list for public comment.

Board Questions to Public speakers

There is a perception that Board members are not listening to the speakers 

because they do not ask many questions. And it is a perception that not all 

Board members are knowledgeable on the subject at hand because they do not 

ask questions. Thus it would seem counterproductive to consider “limiting Board 

questions” as a way to allow more public input, and none of the comments 

received suggested limiting Board questions.

Two organizations wanted it to be clear that Board question time was not 

considered part of the 3 minutes of public comment, while being sure that Board 

members ask questions to clarify issues under consideration.

Board members should be encouraged by the Chair to ask questions that are 

relevant and required to assist the Board in reaching decisions on substantive 

issues, and to be active listeners. Further, there needs to be far greater public 

understanding of the inordinate number of hours every week that individual board 

members in fact spend on reviewing TR, public input, committee meetings, email exchanges and phone calls.

Public Comment impact on board decisions. 

There is a perception that the Board does not take the time to adequately review 

and apply public input prior to making their decision. In order to address this very 

real concern the Board should always have time to recess following a public 

comment period prior to making a public decision on an agenda item.

Use of Proxy speakers

There is a mix of public perception on use of proxy speakers. One organization 

suggested continued use of proxy presentations, but stated that the information 

could also be achieved through written testimony. Three other comments 

suggested refined limitations to monitor implementation. 

There is a public perception that those who turn up and speak at the meeting will 

have a more direct impact on the immediate decisions of the board. However 

there is the counter argument that the proxy is not in fact the originator of the 

input and cannot really answer any board question, and such information could 

simply be provided in writing prior to the meeting. Eliminating proxy speakers will 

allow more time for those who are present in person.

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Use of electronic participation in lieu of physical presence

This is not an easy issue to address. On the one hand, attending the meeting is 

expensive and time consuming, limiting those who may attend, and there are a 

number of electronic means for communicating, such as via skype, or conference 

speaker phone, constant tweet inputs or other social networking tools, or by 

having a room full of people at a distant location with a TV type satellite 

connection. Any one of these or a combination could allow for increased input 

during the hours allotted to public comment. 

Indeed one might envisage a national meeting where committee members are 

scattered at various regional geographical locations nationwide using TV 

“classroom” connections, a teaching tool which University and other teachers 

have been using for years to teach at diverse locations simultaneously. All input 

would thus be essentially electronic. This would be an improvement over the 

faceless nature of the phone conference calls, but would be complex to set in 

place and would increase participation which would in turn require more time 

allotment.

Conversely interested members of the public can submit public comment in 

writing, and public meetings rotate geographically around the US, allowing for 

greater regional participation over time. Further there are already many people 

who physically attend and not enough time to allow everyone to comment on 

everything that they would like to comment on. 

Based on comments reviewed and experience, the use of electronic 

communication is not recommended presently.

V. Recommendations 

Amend SECTION VI of the PPM, entitled NOSB Policy for Public Comment at 

NOSB Meetings, as follows:

NOSB Policy for Public Comment at NOSB Meetings: 

 

1. All persons wishing to comment at NOSB meetings during public comment 

periods must sign up in advance per the instructions in the Federal Register 

Notice for the Meeting. 

2. All presenters are encouraged to submit public comment in writing according 

to the Federal 

Register Notice. Advance submissions allow NOSB members the opportunity to 

read comments in advance electronically, and decrease the need for paper 

copies to be distributed during the meeting. 

3. Persons will be called upon to speak in the order they sign up. Persons called 

upon who are absent from the room could potentially miss their opportunity for 

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4. Time allotment for public comment per person will be 3 minutes with the option 

of extending to a maximum of 5 minutes at discretion of Chair during meeting

5. Persons must give their names and affiliations for the record at the beginning 

of their public comment. 

6. Proxy speakers are not permitted.

7. Public comment requests may be scheduled by the Board by major topics 

under consideration.

8. Individuals providing public comment will refrain from any personal attacks and 

from remarks that otherwise impugn the character of any individual. 

Other suggestions that would be appreciated by NOSB members: 

• 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. 

• Members of the public are asked to define clearly and succinctly the 

issues they wish to present before the Board. This will give NOSB 

members a comprehensible understanding of the speaker’s concerns. 

VI Committee Vote: 

Moved: Jean Richardson Second: Calvin Walker 

Yes 6 No 0 Abstain 0 Absent 2 Recuse 

124
National Organic Standards Board

Policy Development Committee

Proposal

Public Communications

March 29, 2012

I. Introduction

A primary role of the National Organic Standards Board (NOSB) is to advise and 

counsel the Secretary, to represent the segments of the population from which they 

were selected, and to treat the business of the Board as fiduciaries for all members of 

the organic community and public at large (NOSB Policy and Procedures Manual, pp4-

8). 

The Federal Advisory Committee Act (FACA) Meeting Obligations to the Public (41 CFR 

102-3.140) suggest that, “Any member of the public is permitted to file a written 

statement with the advisory committee during meetings.”

In addition, the NOSB infrequently receives public communications outside of the 

designated public comment period. These communications include verbal and written 

information. 

II. Background

The Organic Foods Production Act (OFPA), enacted under Title 21 of the 1990 Farm 

Bill, serves to establish uniform national standards for the production and handling of 

foods labeled as “organic.” The Act authorized a new USDA National Organic Program 

(NOP) to set national standards for the production, handling, and processing of 

organically grown agricultural products. In addition, the Program oversees mandatory 

certification of organic production. The Act also established the National Organic 

Standards Board (NOSB), which advises the Secretary of Agriculture in setting the 

standards upon which the NOP is based. 

http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml

Sec.2119 [7 U.S.C. 6518] states that the NOSB consist of four individuals who own or 

operate an organic farming operation; two individuals who own or operate an organic 

handling operation, one individual who own or operates a retail establishment with 

significant trade in organic products; three individuals with expertise in areas of 

environmental protection and resource conservation; three individuals who represent 

public interests or consumer interest groups; one individual with expertise in the fields of 

toxicology, ecology or biochemistry, and one individual who is a certifying agent. 

125
The statutory mission in OFPA states:

“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.” (OFPA, Sec 2119 (a))

As stated in the NOSB Policy and Procedures Manual (PPM, p5), the NOSB Mission 

Statement is: 

“To provide effective and constructive advice, clarification and guidance to the 

Secretary of Agriculture concerning the National Organic Program (NOP), and 

the consensus of the organic community. 

 

In carrying out the mission, key activities of the Board include:

 

• “Assist in the development and maintenance of organic standards and 

regulations; 

• Review petitioned materials for inclusion on or deletion from the National List 

of Approved and Prohibited Substances (National List); Recommend changes 

to the National List; 

• Communicate with the organic community, including conducting public 

meetings, soliciting and taking public comments, provide timely information 

and education on the NOP, making reasonable use of a variety of 

communication channels.

• Communicate, support and coordinate with the NOP staff.

The PPM (p8) states that NOSB members shall act impartially and not give 

preferential treatment to any organization or individual.

The PPM indicates (p6) that,

“To fulfill their responsibilities, Board members agree to adhere to three duties:

Duty of Care, Duty of Loyalty, and Duty of Obedience (p6). 

The PPM continues, 

“The Duty of Care calls upon a member to participate in the decisions of the 

Board and to be informed as to the data relevant to such decisions. In essence, 

the Duty of Care requires that a member:

 

Be reasonably informed—It is the duty of all Board members to seek and study 

the information needed to make a reasoned decision and/or recommendation on 

all business brought before the Board. The NOP will provide some of that 

information, but other information must be developed from independent sources.”

The National Organic Standards Board members study and evaluate all public 

communications, written and verbal communications, as a function of the NOSB 

role and duties, in order to benefit the organic community. In so doing, National 

126
Organic Standards Board members are able to provide effective and constructive 

advice, clarification and guidance to the Secretary of Agriculture and the NOP. 

NOP said in the National Organic Program Newsletter, December 11, 2011:

The members of the National Organic Standards Board (NOSB) and the National 

Organic Program (NOP) often receive letters and requests from people 

interested in our upcoming regulatory activities and meetings. In this note, we 

summarize the best way to direct your letters and requests.

As a Federal Advisory Committee, the NOSB has a well-defined scope of activity. 

If you have opinions and requests to share with the Board, please use the public 

comment period that is open before each NOSB meeting to submit your 

thoughts. Or, submit a formal National List petition for consideration using the 

guidelines provided in the link below.

The NOP is the best place to send your letters outside the NOSB public 

comment and petition process. In addition to formal public comment periods on 

specific regulatory actions, we are always open to comments on a variety of 

topics related to organic agriculture. While we cannot guarantee that every letter 

will receive a direct response, your letters do get an audience and help us 

identify and prioritize needs. We look forward to hearing from you!

This explanation by NOP describes the current official means of communication 

outlined in the PPM, which does not prohibit other forms of communication 

between the public and NOSB members. The NOP statement, however, 

suggests a need to clarify the ability of the public to communicate with NOSB 

members outside of Board meetings and the public comment period to inform 

the ongoing deliberations of committee work.

III. Summary

The National Organic Standards Board through it Policy and Procedures Manual 

establishes procedures for its activities. The Manual, “is designed to assist the Board in 

its responsibilities” (PPM, p4), and establish procedures for carrying out its 

responsibilities in accordance with its advisory mission.

Because of the opportunities that the Board has to hear from the organic community in 

the course of fulfilling its mission, it has both an opportunity and responsibility to bring to 

the Secretary of Agriculture information that it believes may impact on the 

implementation of OFPA. This communication may, by necessity, extend to organic 

standards and practices as well as related issues that may affect those standards and 

practices. Therefore, based on the communications and input it receives from the public 

the National Organic Standards Board may provide effective and constructive advice, 

clarification, and written information, as it deems necessary, directly to the Secretary of 

Agriculture after each of its Board meetings. 

127
Additionally, and as a part of its responsibility to communicate with the organic 

community pertaining to the implementation of OFPA, the Board must receive and 

review information from the NOP and other sources during its deliberations. As a 

stakeholder Board, the input from the organic community is valuable in the deliberations 

of the Board and the community decision making process. The procedures of the Board 

should facilitate public communication with Board members in the course of those 

deliberations.

IV. Recommendations

PPM, Section VI, Miscellaneous Policies, page 26 is amended by adding a new 

subcategory (in italics):

NOSB Policy on Its Advisory Role and Communication with the Secretary of 

Agriculture

Based on the communications and input it receives from the public the National Organic 

Standards Board may provide effective and constructive advice, clarification, and written 

information, as it deems necessary, directly to the Secretary of Agriculture after each of 

its Board meetings. This information is intended to facilitate public communication with 

the Secretary on critical issues that may emerge that it believes are important to the 

implementation and integrity of the organic standards and practices under the Organic 

Foods Production Act.

PPM, Section VI, Miscellaneous Policies (page 27), is amended by adding a new 

subcategory (in italics).

NOSB Policy for Public Communication Between NOSB Meetings.

The NOSB accepts public communications to NOSB members outside of Board 

meetings and public comment periods to inform the ongoing deliberations of committee 

work. The Board requests that communications on specific subject matters be sent to 

the entire Board membership of the relevant committee or, on matters relating to the full 

Board, be sent to all Board members.

PPM Section II (page 13) Role of the Executive Director is amended to include the 

following language (in italics):

Receive and maintain an archival record of all communications submitted by the public 

to the National Organic Standards Board and make communications available to the 

Board members. 

Maintain a public listing posted on the NOP website of contact information for NOSB 

members, including an email address or other points of contact.

V. Committee Vote

 Moved: Jean Richardson Second: Jennifer Taylor

Yes 6 No 0 Abstain 0 Absent 2 Recuse 0 

128
National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Choline

March 20, 2012

Summary of Proposed Action:

Choline is a synthetically made nutrient that also occurs naturally in food. It is considered by most 

regulatory bodies to be essential in non-milk-based infant formula and is required by the FDA for this 

purpose. It is permitted but not required to be added to milk-based infant formulas. All the organic 

infant formula brands that could be found through an internet search contain added choline, both 

milk-based and non-milk-based. 

Choline has been petitioned for addition to adult food items as well as infant formula. There is no 

compelling reason to think that this is essential to handling organic food, although it is not harmful 

either. Therefore there are 2 proposed actions on choline. First, to add it to the National List for use in 

infant formula labeled organic or made with organic ( ). Second, to add it to the National List for use 

only in agricultural products other than infant formula labeled "made with organic (specified 

ingredients or food group(s))" and prohibited in agricultural products labeled "organic".

Allowing it in adult foods that are in the Made with organic category would allow such foods to 

highlight the fact they are fortified, while at the same time limiting the number of non-essential 

synthetics in organic processing.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: Essential Comments: 

The substance is deemed essential in infant formula by regulating authorities but the NOSB 

committee does not feel it is essential to supplement it for adults.

Proposed Annotation (if any): 

Basis for annotation: ☒ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Move that Choline as petitioned is synthetic.

Motion by: Zea Sonnabend Seconded by: Harold Austin 

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

129
Listing Motion: 1. Move to add Choline to the National List 205.605(b) for use in infant formula 

labeled organic or made with organic (specified ingredients or food group(s))

Motion by: Zea Sonnabend Seconded by: Harold Austin 

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

Listing Motion: 2. Move to add Choline to the National List 205.605(b) for use only in agricultural 

products other than infant formula labeled "made with organic (specified ingredients or food 

group(s))" and prohibited in agricultural products labeled "organic".

Motion by: Zea Sonnabend Seconded by: Tracy Favre 

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

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

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: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair March 20, 2012

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]

X

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X

3. Is the substance harmful to the 

environment and biodiversity?

X

130
[§6517c(1)(A)(i);6517(c)(2)(A)i] 

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.

131
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

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 food sources are abundant, such as 

eggs, liver, wheat germ, lecithin, 

human milk.

5. Is there an organic substitute? 

[§205.600 b.1]

X X food sources can be organic but are 

not strictly substitutes in infant 

formula.

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

X all the products in the petition can be 

made without this substance, 

although it is required by the FDA in 

non-milk-based infant formula.

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X For uses in adult food, the food is a 

substitute. In infant formula there is no 

natural substitute.

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

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 breastfeeding. However in some 

circumstances breastfeeding is not 

feasible.

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
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]

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 nutritional quality is improved.

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 It is required by law for non-milkbased infant formula only.

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 Although this is considered a vitamin 

on product labels, it is not considered 

a vitamin by other entities.

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.

133
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? 

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 Other than for infant formula, there 

seems no compelling justification as 

to why choline should not be obtained 

from organic food sources.

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 same as above.

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 

X

134
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

X

e. Are there other issues which may 

present a challenge to a 

consistent supply?

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.

135
National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Murraya koenigii (curry leaves)

March 31, 2012

Summary of Proposed Action:

A petition has been received to add Murraya koenigii (curry leaves) to be added to §205.606- 

Nonorganically produced agricultural products allowed as ingredients in or on processed products 

labeled as “organic.” Murraya koenigii (more commonly known as curry leaves or sweet neem leaves) 

is an extremely fragrant leaf commonly used for Indian cuisine. 

Discussion

Since curry leaves are natural, not reported to be toxic or dangerous and are in fact a common 

condiment or ingredient in human diets, the Handling Committee chose not to request a TR. 

Searches of the NOP database and two major organic certifiers’ online databases (QAI) and 

directories (CCOF) have yielded only three suppliers of organic curry leaves. The NOP’s database 

lists two distinct suppliers of curry leaves, both located in Sri Lanka while the CCOF directory lists one 

domestic source. QAI’s product listing database did not return any results. Since curry leaves are 

an important ingredient in numerous Indian recipes, and it is reported that no common ingredient 

substitution exists, this agricultural item appears to meet the requirements defined for “commercially 

available” in §205.2 in the NOP regulation (appropriate form, quality, quantity). As a result, curry 

leaves are a candidate for listing on §205.606. 

The petitioner indicated that a pest species quarantined in the United States, the Asian citrus 

psyllid, is commonly found on curry leaves in common countries of origin; as a result, imported 

organic curry leaves are not reliably available. A simple internet search for the pest yields numerous 

reliable stories on the quarantines in place. Additionally, the single domestic supplier has limited 

quantities available, well under the quantity claimed to be needed by the petitioner.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

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

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

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

4. Commercial Supply is Fragile or Potentially Unavailable x Yes ☐ No ☐ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Motion to determine substance as non-synthetic.

Motion by: John Foster Seconded by: Harold Austin

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

136
Listing Motion: Motion to add Murraya koenigii (curry leaves) to §205.606- Nonorganically 

produced agricultural products allowed as ingredients in or on processed products labeled as 

“organic.”

Motion by: John Foster Seconded by: Joe Dickson

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

Crops ☐ Agricultural ☐ Allowed1 x

Livestock ☐ Non-synthetic x Prohibited2 ☐

Handling x Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

x Deferred4 ☐

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: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair 3/31/12

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Murraya koenigii (Curry Leaves)

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 and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x

4. Does the substance contain List 1, 2 x

137
or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

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.

138
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Substance Essential for Organic Production? 

Substance: Murraya koenigii (Curry Leaves)

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

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

5. Is there an organic substitute? 

[§205.600 b.1]

x But limited and uncertain supply

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

x For those foods needing the profile 

the ingredient imparts

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. 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.

139
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Substance compatible with organic production practices? 

Substance: Murraya koenigii (Curry Leaves)

Question

Y

e

s 

No N/A

1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x Petition

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

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.

140
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: Murraya koenigii (Curry Leaves)

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? 

x Petition

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 

x

141
temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

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.

142
National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Giberellic Acid

March 20, 2012

Summary of Proposed Action:

This is a non-synthetic material that is allowed already for crop production and is being petitioned for 

post-harvest use to delay ripening of bananas, citrus, and pineapple. The need for it in bananas is 

also partially to delay or prevent development of the disease Black Sigatoka during transport to 

market.

Two issues are of concern to the Handling Committee that we are seeking public comment on. The 

first is whether there are cultural practices that would serve the same function in bananas to reduce 

the disease pressure after harvest. The second is the effect of post-harvest treatment on the 

nutritional content of the fruit. For this reason, it is being recommended for bananas, where the 

nutritional profile remains the same, and not recommended for other uses.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☒ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: Essential and Compatible Comments: 

The Handling committee recognizes the lack of alternatives in bananas and acknowledges that the 

research that its use does not harm nutrition of bananas. But for citrus there is evidence that it harms 

the nutritive value and its essentiality was not shown convincingly. Very little support was provided for 

the use in pineapple.

Proposed Annotation (if any): for post-harvest use on bananas only.

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: There was not sufficient evidence in either the petition or the TR that the material is 

necessary for citrus and pineapple. Furthermore, there is some evidence that the use in citrus can 

decrease nutritional content.

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Move to determine that Giberellic Acid is non-synthetic

Motion by: Zea Sonnabend Seconded by: Harold Austin

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

Listing Motion: Move that Giberellic Acid be added to the National List section 205.605(a) for 

post-harvest use on bananas only.

143
Motion by: Zea Sonnabend Seconded by: Tracy Favre

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

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

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: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair March 20, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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 and biodiversity?

[§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 active ingredient only under 

consideration. Formulations are

unknown.

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and X

144
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.

chemical interactions in agroecosystem? [§6518 m.5]

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X does not come in contact with soil, 

crop or livestock.

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 it is unclear whether the FDA 

regulates this as post-harvest 

material. The TR states it is not

GRAS but it is an approved food 

additive used in malting barley. (TR, 

2011, page 4)

13.Does the substance contain residues 

of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X

145
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

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 the fungus Gibberella fujikuroi is the 

source.

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 X it does seem essential for bananas to 

prevent large amounts of loss in 

shipping. Sufficient evidence was not 

shown for essentiality for citrus or 

pineapple. (petition, 2011)

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. Is there any alternative substances? 

[§6518 m.6]

maybe waxes are alternative 

substances for citrus. No alternatives 

in bananas.

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

Perhaps there are cultural practices 

for bananas that would reduce the 

disease incidence and thus make the 

substance less necessary. The 

Handling committee seeks input on 

this issue.

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.

146
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]

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 while the TR states that bananas will 

ripen to their full nutritional profile, in 

other fruits (including citrus) there is 

some evidence that GA treatment can 

decrease flavonoids and polyphenols. 

(TR, Evaluation Question #7, 2011)

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.

147
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? 

X Non-agricultural

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 

X

148
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

X

e. Are there other issues which may 

present a challenge to a 

consistent supply?

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.

149
National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Inositol

April 1, 2012

Summary of Proposed Action:

Inositol is an important biologic compound that serves numerous biologic functions/roles including but 

not limited to the following: a structural component of cell membranes, messenger molecules in 

reactions/processes, assist in overall muscle function and cell growth. Inositol may be formed 

endogenously using glucose as a substrate or it may be obtained by the human body through dietary 

sources. In addition to the aforementioned roles, inositol has been found to influence fat 

accumulation within the liver/intestines, control triacyglycerol and esterified cholesterol levels, and 

impact insulin resistance. Due to its association with these biologic processes/conditions, inositol is 

often marketed as a dietary supplement for those with these afflictions. The category of dietary 

supplements in the United States are not required to be regulated by the FDA in order to assure the 

validity and safety of using a substance to treat conditions, and as long as no health claims are made 

on the supplement they may be sold to American consumers without restrictions.

Inositol is found naturally in many foods which include fruits, beans, grains, seeds, and nuts. Another 

notable source of inositol is human breast milk which has been found to contain high concentrations 

of inositol (1500- 4000 mM/L) as stated in the March 2012 Tap review. The FDA list inositol as 

Generally Recognized as Safe (GRAS) for human consumption by the under 21 CFR 184.1370 and 

also mandates that all infant formulas sold in the United States must contain a minimum 4mg/ 100 

kilocalories of inositol in order to assure infants fed solely on formula sources acquire adequate 

nutrition to grow as successfully as breast-fed infants. 

Commercial production of inositol is often obtained from hydrolysis and acidification that begins from 

the corn/rice steeping process by using the phytic acid extracted from the corn/rice, and then using 

this phytic acid in one of several different chemical processes that ultimately results in isolating 

inositol. Additional methods also include utilization of microbial byproducts and processes (yeast); 

however these reactions are also dependent on synthetic reactions, or reactions that would not 

normally occur in nature to produce the final product of isolated inositol. Therefore, while inositol is a 

natural compound, the methods by which we can obtain commercial quantities of inositol are 

synthetic. 

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

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

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

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

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

150
Basis for annotation: X To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Move that inositol as petitioned is synthetic.

Motion by: John Foster Seconded by: Joe Dickson 

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

Listing Motion: 1. Move to add inositol to the National List 205.605(b) for use in infant formula 

labeled organic or made with organic (specified ingredients or food group(s))

Motion by: John Foster Seconded by: Joe Dickson 

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

Listing Motion: 2. Move to add inositol to the National List 205.605(b) for use only in agricultural 

products other than infant formula labeled "made with organic (specified ingredients or food 

group(s))" and prohibited in agricultural products labeled "organic".

Motion by: John Foster Seconded by: Joe Dickson 

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

Crops ☐ Agricultural ☐ Allowed1 X

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic X Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.605 with Annotation (if any): 

As noted above.

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? 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair April 2, 2012

NOSB Evaluation Criteria for Substances Added To the National List

151
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]

x TR 3/9/12

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TR 3/9/12

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TR 3/9/12 

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

152
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.

153
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

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 May be obtained through yeast 

hydrolysis

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

x Yes, but can also be made 

synthetically

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 Yes, but only for infant formula as req 

in 21 CFR 107.100

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 Mass production is via synthetic 

pathways. Could be produced using 

organic yeast to provide organic 

inositol

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.

154
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]

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 Nutritive, but not replacing nutrients

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.

155
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? 

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 

X

156
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

X

e. Are there other issues which may 

present a challenge to a 

consistent supply?

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.

157
National Organic Standards Board

Handling Committee

Petition Proposal

Citrus hystrix leaves and fruit

March 31, 2012

Introduction

A petition has been received to add the leaves and fruit of Citrus hystrix to §205.606- Nonorganically 

produced agricultural products allowed as ingredients in or on processed products labeled as 

“organic.” The species is also known by several common names including kieffer lime, kaffir lime, and 

makrut lime.

Background

Citrus hystrix leaves and fruit are traditional ingredients in Lao and Thai cuisine/curries. The 

ingredient is known for its “bumpy” skin and for imparting a unique intense flavor and aroma in foods 

(particularly curries) due to its high concentration of essential oils. Citrus hystrix is not a common crop 

in the United States; and is limited in its potential to be cultivated in that there a plant quarantine 

exists from the USDA due to citrus greening disease (Asian citrus psyllid) and the threat of spreading 

this debilitating plant disease throughout the country. Citrus greening disease is not limited to Citrus 

hystrix and it may be spread to other varieties of citrus. Due to this threat of disease, and the 

relatively unknown status of the ingredient in cuisines most common in the United States, this plant 

and its products are currently not well known or propagated.

Relevant areas in the Rule

§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Discussion

Searches of the NOP database and two major organic certifiers’ online databases (QAI) and 

directories (CCOF) have yielded exceedingly few suppliers for Citrus hystrix fruit or its products. The 

NOP database was the only source that identified a supplier (two distinct organic certificates but one 

farm name) that has these items listed in the NOP database. Given the limited supply availability, and 

the threat of spreading the area afflicted by citrus greening disease, there appears to be little 

likelihood of procuring organic Citrus hystrix leaves and fruit in the immediate future in any significant 

quantity. With this knowledge, and the considerations of commercial availability as defined in under 

§205.2 (appropriate form, quality, quantity) it seems that Citrus hystrix is not commercially available 

for organic producers in the quantity that is required and should be listed on §205.606.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

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

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

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

4. Commercial Supply is Fragile or Potentially Unavailable x Yes ☐ No ☐ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

158
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Motion to determine substance as non-synthetic.

Motion by: John Foster Seconded by: Harold Austin

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

Listing Motion: Motion to add Citrus hystrix leaves and fruit

to §205.606- Nonorganically produced agricultural products allowed as ingredients in or on 

processed products labeled as “organic.”

Motion by: John Foster Seconded by: Joe Dickson

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

Crops ☐ Agricultural ☐ Allowed1 x

Livestock ☐ Non-synthetic x Prohibited2 ☐

Handling x Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

x Deferred4 ☐

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: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair 3/31/12

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Citrus hystrix leaves and fruit

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 and biodiversity?

x

159
[§6517c(1)(A)(i);6517(c)(2)(A)i] 

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.

160
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Substance Essential for Organic Production? 

Substance: Citrus hystrix leaves and fruit

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

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

5. Is there an organic substitute? 

[§205.600 b.1]

x But limited and uncertain supply

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

x For those foods needing the profile 

the ingredient imparts

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. 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.

161
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Substance compatible with organic production practices? 

Substance: Citrus hystrix leaves and fruit

Question

Y

e

s 

No N/A

1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x Petition

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

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.

162
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: Citrus hystrix leaves and fruit

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? 

x Petition

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 

x

163
barriers, or civil unrest that may 

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

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.

164
 

 National Organic Standards Board

Handling Committee

Sunset 2013 Proposal

Agar- Agar on 205.605(a)

February 21, 2012

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) Non-synthetics allowed

Committee Summary:

Federal register notice of the sunset of this material elicited several public comments in 

favor of its re-listing. There were no comments against re-listing of it.

Review of the original TAP, the original recommendation to list, historical documents 

and public comments does not reveal any unacceptable risks to the environment, 

human, or animal health as a result of the use or manufacture of this material, at this 

time.

Upon review of the Technical Evaluation Report submitted on October 3, 2011, there 

does appear to be a question as to whether two forms of agar-agar being used exists. 

While there are extraction processes that are natural, without chemical modifications or 

non-synthetic, there are others that can be considered synthetic. An example of the 

synthetic method would be when the Graciliara species of algae are subjected to an 

alkaline pretreatment (heated in sodium hydroxide solution) to modify the 

polysaccharides in the algae. This process brings about a chemical change in the 

polysaccharides (L-galactose-6-sulfate groups are converted to 3,6-anhydro-Lgalactose), increasing the gel strength of the agar-agar. Data would indicate that without 

this treatment the gel extracted would be too weak for most food applications.

While the Technical Review does list several methods of extraction, it does state that 

only 1 -2 % of the Agar- Agar supply is from the natural form of extraction. Furthermore, 

the product from the natural extraction method does not appear to be readily available 

in the U.S. market, or at least on a very limited basis. 

The Technical Evaluation Report submitted on October3, 2011, under Evaluation 

Question #9: (which pertains to possible harmful effects on the environment or 

biodiversity) states that the current world demand for agar-agar is increasing and has 

the potential for over harvesting of these natural resources, which would affect 

165
biodiversity of nearby beaches and the algae beds themselves. There were no studies 

found to indicate whether or not the harvesting of agarophytes, in particular, is harmful 

to the biodiversity on nearby beaches or in the algae beds at this time. There are

alkaline waste waters that result from the manufacture of agar-agar, but there were no 

documents found that show this to be a problem to the environment, at this time. Based 

off of the information provided in the Technical Evaluation Report we are making the 

following recommendations, but we do think that continued review of this material and 

these areas of possible concerns should be duly noted in this recommendation.

Recommendation:

At this time we would recommend the relisting of Agar- Agar as it is currently listed 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)).”

(a) Nonsynthetics allowed

We would also recommend an additional listing of Agar- Agar under: 

(b) Synthetics allowed

This recommendation would be based from information presented in the October 3, 

2011 Technical Evaluation Report. The NOSB Classification Guidance of 11/05/2009 

was also considered for making this recommendation.

We would propose to list both with the following Annotations: 

(a) Non-synthetic allowed 

(b) Synthetics allowed 

We would also recommend that this listing be revisited once the NOP has finalized the 

Draft Guidance for Materials Classifications (agricultural, nonagricultural substances). 

This would help to ensure that the materials have been properly classified and thus 

remove any further confusion from their status and help during future reviews.

Agar continues to be an important material used by the organic community.

Committee Vote

5 – yes 0 – no 1- absent 0-recused 0- abstain 

166
National Organic Standards Board

Handling Committee

2013 Sunset Proposal

Calcium Sulfate on § 205.605(a)

March 20, 2012

Current National List Citation

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 

Calcium sulfate—mined.

Committee Summary

Calcium sulfate can be chemically synthesized, or mined as gypsum. As a food additive, it is 

used as a coagulant in tofu production (the original petitioned use), and also as a nutrient, 

dough conditioner, sequestrant, jelling aid, firming agent, leavening agent, and pH buffer, 

among other uses. The use of gypsum as a tofu coagulant can be traced back at least 2000 

years, according to the 2001 Technical Advisory Panel (TAP) review, which considered all food 

additive uses of this substance. The panel also found that the use of calcium sulfate was 

necessary for the production of certain types of tofu. 

Processing of mined gypsum deposits into food grade calcium sulfate is minimal; mined 

deposits are crushed, screened, milled, graded and packaged in food grade facilities. The 

current annotation restricts the use of calcium sulfate to that from mined sources only. 

Review of the original recommendation, the 2001 TAP review, historical documents, the 2007 

sunset recommendation, 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 decisions to list and again re-list this material. 

Committee Recommendation(s)

The handling committee recommends the renewal of the following substance in this use 

category as published in the final rule:

Calcium sulfate – mined.

Committee Vote

Motion: Tracy Favre Second: Harold Austin

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

167
National Organic Standards Board

Handling Committee

Sunset 2013 Proposal

Carrageenan on 205.605(a)

February 21, 2012

List: 205.605 Nonagricultural (non-organic) substances allowed as ingredients in 

or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).”

(a) Non-synthetics allowed

Committee Summary:

Federal register notice of the sunset of this material elicited several public comments in 

favor of its re-listing. There were no comments against the re-listing of it.

Review of the Technical Evaluation Report of October 3, 2011 showed that while new 

uses are being explored for Carrageenan in the food industry as protective coatings, the 

food uses of it have not changed substantially since the original TAP review was 

conducted in 1995.

The FDA says that carrageenan may be safely used as a food additive for human 

consumption as long as its use is in accordance with 21 CFR 172.620. This regulation 

specifies that carrageenan should be prepared by aqueous extraction from any of the 

following eight species of Rodophyceae seaweeds: Chondrus crispus, Chondrus 

ocellatus, Eucheuma cottonii, Gigartina acicularis, Gigartina pistillata, Gigartina radula, 

and Gigartina stellata.

There are three primary extraction methods used to produce Carrageenan from its 

seaweed source: alcohol preparation (which is the most traditional method), gel press, 

and semi-refined or PES extraction. While Carrageenan is a naturally occurring 

polysaccharide extracted from seaweed and considered non-synthetic, the extraction 

process used, may in most instances, alter it. The Technical Evaluation Report of 

October 3, 2011 makes point of the fact that when industrial extraction methods using

alcohol or alkali are used that modifications of the chemical structure of the 

polysaccharides occur. The predominant carrageenan present (i.e., kappa, iota, or 

lamda) and the resulting properties of the final product, are determined by the amount of 

time and the type of alkali used for the alkali treatment (all three extraction processes 

use a form of alkali as part of the aqueous extraction process). Examples: kappa 

carrangeenans are modified in a way that allows adjacent chains to form helical 

structures, resulting in firm, brittle gels. Iota carrageenans are modified to form weak, 

elastic gels and lamda carrageenans do not gel but rather form high viscosity liquids. 

This would appear to show that alkali treatments are used to promote structural 

168
changes to carrageenan to acquire the specifically desired gel strength or textures.

Thus, Carrageenan produced using these types of methods should be considered to be 

synthetic rather than non-synthetic, according to the information provided in the TR. 

This would be true for all three types of commercial extraction, currently being used by 

the industry to produce Carrageenan.

The Technical Evaluation Report of October 3, 2011 states that there were no other 

means of extraction currently being used.

Carrageenan continues to be an important material used by the organic community. 

Recommendations: 

At this time we would recommend the relisting of Carrageenan 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 groups(s)). We are going to make the following recommendations to allow the 

current listing to sunset 605(a) and then move to relist it under 605(b). We are hoping 

that there will not be any disruption in the current use of Carrageenan, since this should 

hopefully occur at the same time.

We recommend allowing this current listing to sunset 605(a)

(a) Nonsynthetics allowed

We recommend then relisting under 605(b)

(b) Synthetics allowed

These recommendations are based from information presented in the October 3, 2011 

Technical Evaluation Report. The NOSB Classification “draft” Guidance of 11/05/2009 

was also considered for the making of this recommendation.

We would also recommend that this listing be revisited once the NOP has finalized the 

Draft Guidance submitted by the NOSB on November 5, 2009. Re-evaluation of the 

materials classification (agricultural, nonagricultural substances) should be considered 

to ensure that the listed materials have been properly classified and thus remove any 

further confusion from their status and help during future reviews.

Committee Vote:

5 – yes 0 – no 1 – absent 0-resused 0- abstain

169
National Organic Standards Board

Handling Committee

2013 Sunset Proposal

Glucono Delta-Lactone on § 205.605(a)

March 20, 2012

Current National List Citation

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 

Glucono delta-lactone—production by the oxidation of D-glucose with bromine water 

is prohibited.

Committee Summary

Glucono delta-lactone (GDL) is used as a coagulant in tofu production, and also as an 

acidulant, leavening agent and sequestrant in food. It is produced by the oxidization of gluconic 

acid by a number of methods. The petition focused on the use of the substance as a tofu 

coagulant, and delineated a number of key advantages which make the use of this substance 

necessary relative to other coagulants. Because of the slow speed at which hydrolyzes back to 

gluconic acid, it results in tofu products with preferable texture and consistency. It also imparts 

a far less sour taste than other available coagulants. 

The substance was reviewed by a Technical Advisory Panel (TAP) in 2002 at the request of 

the NOSB. The TAP found that the substance can be either synthetic or non-synthetic 

depending on the production method, and the current annotation prohibits its production using 

bromine water, which would render it synthetic. The other methods of GDL production – 

oxidation of gluconic acid with microorganisms, or oxidation with enzymes derived from those 

microorganisms – result in a non-synthetic form of GDL. 

Review of the original recommendation, the 2002 TAP review, historical documents, the 2007 

sunset recommendation, 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 decisions to list and again re-list this material. 

Committee Recommendation

The handling committee recommends the renewal of the following substance in this use 

category as published in the final rule:

Glucono delta-lactone—production by the oxidation of D-glucose with bromine water is 

prohibited.

170
Committee Vote

Motion: John Foster Second: Tracy Favre

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

171
National Organic Standards Board

Handling Committee

2013 Sunset Proposal

Cellulose on § 205.605(b)

March 20, 2012

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 

Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine 

bleached) and filtering aid.

Committee Summary

Cellulose, in its natural form, is the main component of plant cell wells and one of the most 

abundant organic substances on earth. However, most commercially available cellulose is 

produced from wood pulp or other plant sources through a delignification process that results 

in sufficient chemical change to render the substance synthetic. While there are many uses for 

cellulose in food production, the 2002 Technical Advisory Panel (TAP) report focused on the 

petitioned uses for and forms of the substance – as a filtering aid, as a component of 

processed meat casings, and as an anti-caking agent. The current annotation restricts the 

substances use to these specific areas. While the production of non-synthetic (and even 

organic) cellulose is technically possible, no commercial sources of non-synthetic cellulose are 

currently known. 

Review of the original recommendation, the 2001 TAP review, historical documents, the 2007 

sunset recommendation, 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 decisions to list and again re-list this material. 

Committee Recommendation(s)

The handling committee recommends the renewal of the following substance in this use 

category as published in the final rule:

Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine 

bleached) and filtering aid.

Committee Vote

Motion: Harold Austin Second: Zea Sonnabend

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

172