NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: 

May 2009

Substance: Red Corn Color

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

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

 

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

3. Compatibility & Consistency Yes X No  N/A 

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

B. Substance fails 

criteria? 

Criteria category: 2 

and 4.

Comments: see 

summary narrative 

below.

C. Proposed Annotation: NONE

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): To add Red Corn Color to the National List in section 205.606

Motion: Steve DeMuri Second: Katrina Heinze Yes: 0 No: 14 Abstain: 0 Absent: 1

 

Provide a summary narrative here or attach a more complete narrative, and attach the original committee recommendation

that includes the evaluation criteria checklist:

Categories 2 and 4, essence and availability criteria, were not met. The fragility or unavailability of a commercial supply of red corn as 

organic is not adequately addressed or explained in the petition, and there was no substantive written or oral comment provided as 

explanation after the committee recommendation was posted on the NOP website. A review of common, public accessible websites

and phone calls to several organic ingredient suppliers revealed that a significant quantity of organic red corn exists in the marketplace 

currently, and there was no explanation provided as to why this organic agricultural material could not be converted into organic color. 

Additionally, although there are other conventional red color compounds listed in 205.606, there was no explanation as to why the 

currently listed red colors could not be used as an alternative to conventional red color made from red corn. 

1—substance voted to be added as “allowed” on National List on National List to § 205.______ with Annotation (if any): ____ __ 

__________________________________________________________________________________________________ _ 

2—substance to be added to “prohibited” paragraph of National List to § 205.______ Describe why a prohibited substance:

_____________________________________________________ ___________________________________

__ ____

 _

 

___ 

3—substance was rejected by vote for amending National List to § 205. 606. Describe why material was rejected: 

See summary narrative in Section D above and attached Committee Recommendation documentation. 

 

4-substance was recommended to be deferred § 205. ______ Describe why deferred; if any follow-up is needed. If follow-up needed, 

who conducts follow-up ________________________________ ____________________________________ 

Agricultural X Nonagricultural Crops

Synthetic Not synthetic X Livestock

Allowed1Prohibited2

Handling X

No restriction Deferred4 Rejected X 3

E. Approved by NOSB Chair to transmit to NOP

Jeff Moyer 

Chair Date

May 6, 2009 .

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB Reason: ____________________________________________________________________ 

_____________________________________ _________________________ 

 Date 
NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: May 2009 Substance: Red Corn Color

Committee: Crops  Livestock  Handling X Petition is for inclusion of Red Corn Color on the National List § 

205.606.

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

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

(see B below) 

5. Essential & Availability Criteria Yes  No X N/A 

6. Compatibility & Consistency Yes X No  N/A 

7. Not or Inconsistently Available as Organic Yes  No X N/A  

B. Substance Fails Criteria Category: 2 and 4 Comments: The fragility or unavailability of a commercial supply of red corn as 

organic is not adequately addressed or explained. 

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________

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

D. Recommended Committee Action & Vote (State Motion): Move to add Red Corn Color to the National List section 205.606. 

________________________________________________________________________________________________________

Motion by: Steve DeMuri Seconded: Katrina Heinze Yes: 0 No: 4 Absent: 1 Abstain: 1 

 

 

 

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. 606. Categories 2 and 4, essence and availability criteria, 

were not met.

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural X Allowed1

 

Livestock Non-Synthetic X Prohibited2 

Handling X Synthetic Rejected X 3

No restriction Commercially UnAvailable as Organic1

 Deferred4

E. Approved by Committee Chair to transmit to NOSB:

 

 Committee Chair Date: 

Steve DeMuri 

March 14, 2009
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance – Red Corn Color

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 The manufacturing process is identified as CBI in the 

petition, but a review with NOP staff indicates that this 

criteria is satisfied. No adverse affects from use or 

disposal.

2. Is there environmental 

contamination during 

manufacture, use, misuse, or 

disposal? [§6518 m.3]

X Same as above.

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X This is an agricultural product

4. Does the substance contain 

List 1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X This is an agricultural product

5. Is there potential for 

detrimental chemical interaction 

with other materials used?

[§6518 m.1]

X This is an agricultural product

6. Are there adverse biological 

and chemical interactions in 

agro-ecosystem? [§6518 m.5]

X This is an agricultural product

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X This is an agricultural product

8. Is there a toxic or other 

adverse action of the material or 

its breakdown products? 

[§6518 m.2]

X This is an agricultural product

9. Is there undesirable 

persistence or concentration of 

the material or breakdown 

products in environment?[§6518 

m.2]

X This is an agricultural product

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X This is an agricultural product

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X This is an agricultural product

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X This is an agricultural product

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X This is an agricultural product

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.
Category 2. Is the Substance Essential for Organic Production? Substance – Red Corn Color

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated 

or manufactured by a chemical 

process? [6502 (21)]

X The petition states that red corn colorant is a vegetable 

juice extract of red corn kernels from Gramineae Zea 

Mays. The manufacturing process is identified as CBI in 

the petition, but a review with NOP staff indicates that this 

criteria is satisfied. No synthetic solvents are used in the 

extraction process. No adverse affects from use or 

disposal.

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 A simple extraction process is employed. No chemical 

change.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X

4. Is there a natural source of 

the substance? [§205.600 b.1]

X This is an agricultural product.

5. Is there an organic 

substitute? [§205.600 b.1]

X This is an agricultural product.

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 This is an agricultural product.

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 There are some red color extracts (red cabbage, cherry 

juice, beet, red radish) currently listed in 205.606, but this 

petition does not explain why these currently listed nonorganic red colors cannot be used as an alternative to the 

petitioned substance. 

10. Is there another practice 

that would make the substance 

unnecessary? [§6518 m.6]

X Potentially, the use of already listed non-organic red colors 

could be substituted for this petitioned substance.

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

Corn Color

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 This is an agricultural product

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X This is an agricultural product, and could be grown 

sustainably.

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 The substance is used to color food products, but not 

necessarily to recreate or improve colors lost in 

processing.

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.
Category 4. Is the agricultural substance inconsistently or not commercially available as organic? 

Substance – Red Corn Color

Question Ye

s

No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, 

unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic 

handling?

X The petitioner describes the use of the red corn color as 

a natural color additive in beverages, yogurts, 

confectionary, soups, sauces, desserts, etc., but it does 

not satisfactorily address the reasons why a non-organic 

form must be used. 

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 Although red corn color does not appear to be available 

in an organic form, the raw source of the color, red corn, 

is available currently in an organic form. It is quite 

common in organic red tortilla chips and similar 

products. There is no compelling explanation as to the 

reasons for not being able to use organic red corn as 

opposed to conventional red corn to produce the color. 

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 There is some explanation regarding the breeding 

program currently underway to develop organic red corn 

for organic color manufacture, but there is no compelling 

evidence as to why currently available organic red corn 

is not suitable for this purpose. 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate quantity to fulfill an 

essential function in a system of 

organic handling?

X The petitioner describes development of a hybrid that is 

suitable for the red color they desire, but there is also no 

compelling explanation as to the reasons why the hybrid 

can’t be grown organically, especially considering the 

relatively wide ranging growing area of red corn 

throughout the US and the world, and the availability of 

organic land. A narrative is given as to difficulty in 

obtaining organic growers, but it is not backed up by 

evidence. 

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 There is some brief description of local (to the petitioner) 

red corn growing areas, but it does not appear to be 

comprehensive. 

b. Number of suppliers and amount 

produced;

X No data provided.

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 No data provided.

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X No explanation of any of these trade related factors was 

given, but they may not be relevant to red corn 

production.
e. Are there other issues which may 

present a challenge to a consistent 

supply?

X None that were explained.