NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: November 2008 Substance: Orange Pulp, Dried

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

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

 

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

3. Compatibility & Consistency Yes X No  N/A 

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

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

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 Orange Pulp, Dried to §205.606 of the National List - Agricultural (non-organic) 

substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” 

 

 .

 Motion: Julie Weisman Second: Joe Smillie Yes: 13 No: 1 Abstain: 0 Absent:1

A petition for the addition of Orange Pulp, Dried to the National List of Allowed Substances was received for review by the Handling 

Committee of the NOSB in the spring of 2008. 

Orange Pulp, Dried is produced from the byproduct remaining after the extraction of raw oranges for orange juice production. Most of the pulp 

generated by orange juice processing is recombined into the finished juice, but a relatively small amount remains that is not put back into 

product. This remaining material is washed, sorted, milled, and dried, then packaged for use by the food processing industry as a stabilizer or 

thickener in a variety of processed organic and conventional products. 

Although the material met the requirements of Categories 1, 2, and 3 of the substance evaluation criteria for consideration for listing, the 

Handling Committee originally voted unanimously to not recommend listing of this material due to failure to meet the requirements of Category 

4 of the evaluation criteria, specifically because the petitioner did not provide persuasive information as to the lack of availability of organic 

orange pulp that could be used to produce an organic form of the dry ingredient. The Handling Committee recommendation to not list was 

posted on the NOSB website prior to the November 2008 NOSB meeting. A representative of the petitioning company, Fiberstar, attended the 

November 2008 NOSB meeting and presented information and documentation to the full board explaining the supply inadequacy of organic 

orange pulp to manufacture an organic form of the dry ingredient to fulfill industry needs. Many questions were asked by board members to 

explore the organic orange pulp supply issue. The explanation was compelling. The Handling Committee subsequently reconsidered it’s 

recommendation based on the new information, and voted to recommend listing of the material to 205.606. This material could potentially 

replace non-agricultural 205.605 materials currently listed that perform like functions in processed organic foods. 

It should also be noted that there were no objections made through public comment for the listing of this material. In fact, a number of public 

comments were made by industry members in support of it’s listing, primarily due to it’s potential to replace currently listed non-agricultural

materials. It was also noted however, that this material would still be subject to commercial availability evaluations by potential users and their 

certifiers, and that an organic form of dried orange pulp would hopefully be available in the near future.

1—substance voted to be added as “allowed” on National List on National List to § 205.606 with Annotation (if any): None 

__________________________________________________________________________________________________ _________________

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. ______ Describe why material was rejected: _____ _

Agricultural

 

___________________________________________________ ____________________ 

X Nonagricultural Crops

Synthetic Not synthetic Livestock

Allowed1Prohibited2

Handling X

No restriction Deferred4 Rejected3
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 ________________________________ _______________________________________________________________

E. Approved by NOSB Chair to transmit to NOP

 Rigoberto I. Delgado . 

NOSB Chair Date

 December 12, 2008 .

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: November 2008 Substance: Orange Pulp, dried

Committee: Crops  Livestock  Handling X Petition is for: Inclusion of Orange Pulp, Dried on the National List § 205.606

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

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

 

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

6. Compatibility & Consistency Yes X No  N/A 

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

B. Substance Fails Criteria Category: Comments: 

C. Proposed Annotation (if any): none 

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

D. Recommended Committee Action & Vote (State Actual Motion): Recommend Orange Pulp, Dried for listing on §205.606 

Motion by: Steve DeMuri Seconded: Gerry Davis Yes:- 5 No - 0 Absent: - 1 Abstain: - 0 

 

 

1) Substance voted to be added as “allowed” on National List to § 205.606 with Annotation (if any) - no annotation

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 

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural X Allowed1 X

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic Rejected3

No restriction Commercially UnAvailable as Organic1

 Deferred4

E. Approved by Committee Chair to transmit to NOSB:

______Julie Weisman

 Committee Chair Date

___________________ _________________________
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - Orange Pulp, dried

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 According to the petitioner, the substance is produced from 

orange pulp by washing with water, stabilizing with heat, 

dewatering, mixing, drying, and grinding. No chemicals are 

used in the production process, only water.

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X See number 1 above.

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Material is a component of an agricultural product

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X No, not according to the petitioner.

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 agroecosystem? [§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 According to page 4 of the petition, dried orange pulp is 

GRAS when used in food in accordance with good 

manufacturing practices, and there are no known adverse 

reactions related to dried orange pulp. 

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.
Category 2. Is the Substance Essential for Organic Production? Substance - Orange Pulp, dried

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 According to the manufacturing description on page 1 of the 

petition, the petitioned substance is produced from orange 

pulp by washing with water, stabilizing with heat, dewatering, 

mixing, drying, and grinding. No chemicals are used in the 

production process, only water.

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, 

sources? [6502 (21)]

X See above

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X This is an agricultural product

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

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

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

Substance: Orange Pulp, dried

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 Material is being petitioned for inclusion on §205.606.

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X Material is being petitioned for inclusion on §205.606.

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 According to page 1 of the petition, dried orange pulp is 

currently used as a moisture retention agent and fat substitute 

in baked goods, pastas, salad dressings, confectionery, 

processed cheese spreads, and frozen food entrees. It may 

also be used as flavor enhancing agent in non-carbonated 

beverages and fruit drinks. 

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 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 - Orange Pulp, dried

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

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided

X

as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

 In oral presentation at the Fall 2008 meeting, petitioner cites 

use of this material is potentially as a replacement for 

materials currently on 205.605 (emulsifiers, thickeners). 

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

X

to fulfill an essential function in a 

system of organic handling? 

In oral presentation at Fall 2008 meeting, petitioner 

described difficulties in obtaining sufficient quantities of raw 

material in reasonable proximity to a processing facility. 

Most organic orange juice pulp goes back into orange juice 

production, and is not available for this use.

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

X

to fulfill an essential function in 

a system of organic handling? 

See 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

X

to fulfill an essential function 

in a system of organic handling?

See comment 2 above. In oral presentation, petitioner 

described there is a 20:1 raw pulp to finished dry pulp ratio. 

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 6,000 acres of organic oranges are located in Florida alone. 

Number of suppliers or other regions not discussed. In oral 

presentation, petitioner clarified that unless raw pulp is 

available adjacent to processing it deteriorates too quickly 

to be used to produce dry pulp.

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 information provided regarding these factors.

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X No information provided regarding these factors.

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X Other than cost implications, no other factors discussed.