Katrina Heinze

Chairperson, NOSB Materials Committee

NOSB Public Meeting

November 2011

National List of Allowed & 

Prohibited Substances

Materials Update
Topics

• National List of Allowed and Prohibited Substances

• Material Review Process

• National List Criteria

• Sunset Review Criteria

• Material Review Notes

• Update on Petitioned and Sunset Review Items
National List of Allowed and 

Prohibited Substances
National List of Allowed and Prohibited Substances

Crop Livestock Handling

(Ingredients listed on product ingredient listing)

§ 205.601

Synthetic

substances 

allowed for use in 

organic crop 

production

§ 205.603

Synthetic

substances allowed

for use in organic 

livestock production

§ 205.605

Non-agricultural (nonorganic) 

substances allowed as ingredients in or 

on processed products labeled as 

“organic” or “made with organic (specific 

ingredients or food group(s))”

(a) Nonsynthetics allowed

(b) Synthetics allowed

§ 205.602

Nonsynthetic

substances 

prohibited for use 

in organic crop 

production

§ 205.604

Nonsynthetic

substances 

prohibited for use in 

organic livestock 

production

§ 205.606

Nonorganically produced agricultural

products allowed as ingredients in or on 

processed products labeled as “organic”

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“[Listed] nonorganically produced 

agricultural products may be used as 

ingredients in or on processed products 

labeled as “organic”, only in accordance 

with any restrictions specified in this 

section, and only when the product is not 

commercially available in organic form.”
Material Review Process

• Material Petitions – Use to:

o Add a new listing to the National List

o Change the annotation for an existing listing on the 

National List

o Remove a material currently on the National List

• Guidelines are available:

Federal Register Notice, 72 FR 2167, January 18, 2007
Material Review Process

• The minimum timeframe for National List Material

Review is 145 days.

– Absolute minimum timeframe

– Does not include time for Rulemaking

• Timeframe is dependent on:

– Completeness of petition on initial submission

– Manpower within the specific reviewing committee and board 

overall

– Timeframe relative to NOSB public meetings

– Completion and review of Technical Reviews
Material Review Process

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NOP Review

• Petition received by 

NOP & reviewed for 

completeness.

• Issues determined to 

NOT be complete: 

NOP contacts 

petitioner to 

complete petition.

• Upon determination 

of completeness by 

the NOP, petition 

forwarded to NOSB 

Materials 

Chairperson.

• Minimum of 14 days

NOSB Committee 

Review

• MC Chair forwards 

petition to the chair 

of the designated 

NOSB committee 

(i.e.. Crops, 

Livestock, or 

Handling). 

• Petition is reevaluated for 

completeness

• Need for external 

technical review (TR) 

determined

• Specific 

issues/questions 

which the committee 

wishes addressed in 

the TR are submitted 

to the NOP. 

• Minimum of 30 days

NOSB Committee 

Recommendation

• TR reviews sent to 

NOSB.

• TAP/TR reviews 

posted on the NOP 

website for review 

and public comment.

• Committee 

recommendations 

posted for public 

comment.

• Within 45-day period 

prior to the meeting, 

public comment is 

accepted by the NOP 

and posted on the 

website.

• 60 days before 

meeting

NOSB Meeting

• Committee 

recommendations 

are submitted

• Further comments 

are accepted from 

the public and all 

public comments are 

taken into 

consideration

• Action is taken by the 

full NOSB board 

regarding committee 

recommendations

All communication between petitioners and the NOSB should go through the NOP
Material Review Process

National List Criteria

• Organic Foods Production Act 1990 – as amended (7 

U.S.C. 6518(m))

• NOP Regulations (§205.600)
National List Criteria -- GENERAL

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

other materials used in organic farming systems;

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

products of any contaminants, and their persistence and areas of 

concentration in the environment;

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

misuse, or disposal of such substance;

4. The effect of the substance on human health;

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

agroecosystem, including the physiological effects of the substance on soil 

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

livestock;

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

materials; and

7. Its compatibility with a system of sustainable agriculture.

--Federal Register [Docket Nos. AMS-TM-06-0223; TM-06-12]
National List Criteria: PROCESSING AID OR ADJUVANT

1. The synthetic substance cannot be produced from a natural source and there is 

no organic substitute;

2. The substance’s manufacture, use and disposal do not have adverse effects on 

the environment and are done in a manner compatible with organic handling;

3. The nutritional quality of the food is maintained when the substance is used, and 

the substance itself, or its breakdown products do not have an adverse effect on 

human health as defined by applicable Federal regulations;

4. The substance's primary use is not as a preservative or to recreate or improve 

flavors, colors, textures, or nutritive value lost during processing, except where 

the replacement of nutrients is required by law;

5. The substance is listed as generally recognized as safe (GRAS) by Food and 

Drug Administration (FDA) when used in accordance with FDA's good 

manufacturing practices (GMP) and contains no residues of heavy metals or 

other contaminants in excess of tolerances set by FDA; and

6. The substance is essential for the handling of organically produced agricultural 

product

--§205.600 (b)
National List Criteria: § 205.606 –

AGRICULTURAL AND POTENTIALLY COMMERCIALLY

UNAVAILABLE

The NOSB will consider:

A. Why the substance should be permitted in the production or handling or an 

organic product;

B. The current industry information regarding availability of and history of 

unavailability of an organic form in the appropriate form, quality, or quantity 

of the substance. Industry information includes, but is not limited to the 

following:

1. Regions of production, including factors such as climate and number of regions;

2. Number of suppliers and amount produced; 

3. Current and historical supplies related to weather events such as hurricanes, 

floods, and droughts that may temporarily halt production or destroy crops or 

supplies;

4. Trade related issues such as evidence of hoarding, war, trade barriers or civil 

unrest that may temporarily restrict supplies; and

5. Other issues which may present a challenge to a consistent supply.
Material Review Process

Sunset Review Criteria
Sunset Review Criteria

Sunset Provision -- No exemption or prohibition contained in the 

National List shall be valid unless the National Organic Standards 

Board has reviewed such exemption or prohibition as provided in this 

section within 5 yrs of such exemption or prohibition being adopted 

or reviewed and the Secretary has renewed such exemption or 

prohibition.

-OFPA §2118(e)

Exemptions (NL listings) were accepted because the evidence 

available showed that the:

– Material was found not harmful to human health or the environment,

– Material was necessary because of the unavailability of wholly 

nonsynthetic alternatives, and

– Use of the material was consistent and compatible with organic practices
Sunset Review Criteria

Sunset is the opportunity to revisit the continued need for the exemption.

– Sunset review is to determine if conditions relevant to acceptance of exemption 

(listing) have changed

– If a review finds that the initial conditions still exist, the listing is renewed for an 

additional period of time

The sunset review process is NOT:

– to add new substances to the NL

– the time to reinterpret unchanged information and conditions

 These issues are dealt with in the Petition Process

Resources:

– November 2010 Sunset Process to include annotations recommendation -- 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088004&acct=nosb

– June 2005 ANPR on Sunset

– March 2005 NOSB Sunset Process

– October 2004 Sunset Recommendation from Materials
Sunset Review – Changing Annotations

(added November 2010 to NOSB Policy)

Process Highlights – “The committee and subsequently the Board will 

first take up the annotation amendment and then vote on the 

material’s renewal.”

• The committee may request a third party technical review in anticipation of 

scientific evidence and claims likely to be made during public comment to the 

ANPR.

• The appropriate NOSB committee begins review of the material with the intent 

of providing a recommendation to the entire Board for the material’s removal, 

renewal, or renewal with the addition of an annotation. The review is conducted 

based on “Force of Evidence” as presented by Board members, public 

comments, and scientific data from other sources. 

• The reviewing NOSB committee provides its recommendation to the full Board 

and the public no less than 60 days prior to the Board Meeting which would 

include the following:

(i). Simple motion to remove, add, or amend an annotation, resulting in the

restriction or clarification of the use of a material (if applicable).

(ii). Simple motion to renew the existing listing.

Two 

Vote 

Process {
Sunset Review – Changing Annotations

(added November 2010 to NOSB Policy)

Considerations on Process

• Use of materials on the NL is allowed in context of the entirety of Final Rule 

and the process of being certified. For example,

– OSP’s require that cultural, mechanical, physical and other management practices be used prior 

to use of NL allowed synthetic (§205.206)

– Certifiers verify compliance of non-organic ingredients with §205.105 (produced without use of 

excluded methods, ionizing radiation and sewage sludge

• Our recommendation says that annotation changes during sunset are the 

result of the Force of Evidence

– Must be supported by technical reviews and /or public comment

– Sunset review is not the time to reinterpret unchanged information and conditions. 

We must have evidence that the information was not originally considered by 

NOSB. 

– Materials coming off the NL during the sunset process are a tool being removed 

from producers/handlers 

• Are the alternatives viable or experimental? Is there scientific data supporting the efficacy 

of the alternative? 

• Sunset is NOT the only time NOSB can initiate annotation changes
Material Review Process

Notes
Motions from Committees

Affirmative Motion

• Motion is to list Google Rocks on 

the NL section §205.602 Nonsynthetic substances prohibited for 

use in crop production

• Motion fails in the crops committee 

with 1 yes, 5 no votes

• CC brings motion to full board with a 

motion to list

• NOSB then can vote to list or 

motion can fail

Non-affirmative Motion

• Motions is not to list Google Rocks 

on the NL

• Motion passes in the CC with 5 yes, 

1 no vote

• CC brings motion to full board with 

motion to not list

• NOSB Vote

– Motion passes then Google 

Rocks not listed

– Motion fails then Google Rocks 

are in limbo and get sent back 

to CC to come back at next 

NOSB meeting

Our practice is for recommendations on materials to be 

made in the affirmative from committee
Technical Reviews – NOP request for consideration

• Capacity and resources for TR’s is not unlimited

• Volume of petitions under review is high -- There are 27 

petitions under consideration by the NOSB, not including 

those on the Fall agenda. 

• Plan TR requests and workplans

– What TR’s are already available?

– What new information do we believe is available?

– Does every material need a new TR every time?
NOSB Reviewer Role – Overview for Public

• Our practice is for committee chair to assign a petitioned or 

sunset material to a committee member to lead the review

– Often chosen due to their area of expertise

• Role of this lead person is to:

– Find relevant information on material

– Develop initial perspective for recommendation

– Provide all perspectives to rest of committee

– Lead committee debate

– Write committee recommendation with input from rest of committee

– Present committee recommendation at NOSB meeting

– Write final NOSB recommendation

NOSB Reviewer represents the committee

May or may not represent their own personal perspective
Materials – Status Update
Update – Petitioned Material Status

Crops Committee

This meeting

• Ammonium nonanoate

• Indole-3-butyric acid

• Propane

• Sunset 2013 (5 listings)

Petitions to Remove

• Ferric Phosphate

Petitions to Add a Substance

• Oxidized lignite

• Propylene glycol monolaurate

Technical Reports Requested

• Propylene glycol monolaurate

Petitions for Inert Ingredients

• 1,1-Difluoroethane

• Manganese sulfate monohydrate 

Petitions and technical reports are available to the public on the NOP website
Update – Petitioned Material Status

Livestock Committee

This Meeting

• None

Petition to Amend Annotation

• Methionine

Petitions to Add a Substance

• Nonanoic acid (pelargonic

acid)

Technical Reports requested

• Vaccines from GMOs

• Methionine

• Nonanoic acid

Petitions and technical reports are available to the public on the NOP website
Update – Petitioned Material Status

Handling Committee

This Meeting

• Annatto extract color

• ARA single-cell oil

• Beta-carotene color

• DHA algal oil

• Potassium hydroxide

• Silicion dioxide

• Sulfur dioxide

• Sunset 2013 (3 listings)

Petitions to Remove

• Tartaric acid (synthetic)

Waiting for Petitioner Response

• Caramunch malt

Petitions and technical reports are available to the public on the NOP website
Update – Petitioned Material Status

Handling Committee

Petitions to Add a Substance to

§205.605 (Non-Agricultural)

• Ascorbyl palmitate 

• Beta-carotene (nutrient)

• Choline (two petitions)

• Dextrin

• Gibberellic acid

• Inositol

• L-Methionine

• Lycopene

• Nucleotides

• Sodium gluconate

• Sulfuric acid

• Taurine

Petitions to Add a Substance to

§205.606 (Agricultural)

• Barley betafiber

• Bergamot bitter orange 

powder

• Curry leaf

• Kaffir lime leaves and fruit

• Lutein

• Sugar beet fiber

Petitions and technical reports are available to the public on the NOP website

Explanation that the NOSB will 

be prioritizing nutrient petitions 

for Spring 2012 due to 

anticipated annotation change 

for nutrient vitamins and 

minerals
Update – Sunset Review Status

Committee

Sunset 2013

(Fall 2011

NOSB meeting)

Sunset 2013 

(Spring 2012 

meeting)

Sunset 

2014

Sunset 

2015

Sunset 

2016*

Crops 6 1 None 4 2

Livestock None None None None TBD

Handling 3 5 None 4 10

* Sunset 2016 will also include any materials added to the National List 

through rulemaking by December 31, 2011
THANK YOU 

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