FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _August 17, 2005________

Subject: ___Chitosan_______ 

Chair: ____Jim Riddle______________________________________ 

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ___X_____ 

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

The NOSB recommends that chitosan be added to 205.601 for use in organic crop production with the 

following annotation, “as an adjuvant only.” 

Board vote – August 16, 2005 

13 yes, 0 no, 1 absent 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Rationale provided in text of recommendation below. 

Response by the NOP:

Updated 2/25/05 
EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance Chitosan (poly-D-Glucosamine) 

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 

Hydrochloric acid, sodium hydroxide, mild organic acid, 

e.g., acetic, are used in the manufacture of this product. 

TAP pg. 2, lines 81-95, pg 3 All the material can be 

neutralized. Misuse or disposal with neutralizing first could 

be detrimental. TAP pg 4, lines 126-146 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

Raw material for Chitosan is crustacean shell waste 

byproduct. TAP Pg2, lines 81-81 EPA exemption from 

tolerance; abundant in environment, TAP pgs 4-5, lines 

151-155. 

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 

This form of chitosan could cause negatively charged 

particles to stick to plant surfaces but this is not likely. This 

material (non ionized form) is found in the environment as 

chitosan and chitin. Soluble chitosan is not highly reactive. 

TAP pg 5, lines 161-184. 

6. Are there adverse biological 

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

X 

This material (non ionized form) is found in the 

environment as chitosan and chitin. Soluble chitosan is not 

highly reactive. TAP pg 5, lines 161-184. 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5] 

X 

May have adversely impact soil; shown to be antimicrobial, 

antifungal, and antiviral. Enhances plant growth. As an 

adjuvant, the quantity of material used is insufficient to 

result in above effects. TAP pg5, lines 189-205 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2] 

X 

Chitosan is non-toxic to mice rates and rabbits. TAP pg 5, 

lines 154-155. Breakdown products are non-toxic. TAP pg 

6, lines 214-217 

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

X 

Not persistent, highly biodegradable due to chitinases and 

chitosanases that occur naturally in environment. TAP pg 

8, lines 222-226 

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4] 

X 

Not known to be toxic to humans; used as a dietary 

supplement. TAP pg 6, lines 231-234 

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 Chitosan (poly-D-Glucosamine) 

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is there a natural source of the 

substance? [§205.600 b.1] X

2. Is there an organic substitute? 

[§205.600 b.1] 

X

3. Is the substance essential for 

handling of organically 

produced agricultural products? 

[§205.600 b.6] 

X

4. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)] 

X X 

Other available wholly natural adjuvants leave residues on 

produce thus the adjuvant is unacceptable (the combination 

of lactose, bentonite, and casein). [personal knowledge – 

Gerald Davis] The two that are formulated with pine-based 

functional agents may be synthetic and contain List 3 

compounds. TAP pg 6, lines 243-254; personal knowledge 

– Brian Baker – OMRI] 

5. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)] 

X

6. Is there any alternative 

substances? [§6518 m.6] X

There are three adjuvants marketed as organic but it is 

unknown if they are synthetic. None are on the National 

List. TAP pg 6-7, lines 259-264 

7. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6] 

X

No, the adjuvant is necessary to accomplish the function. 

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 Chitosan (poly-D-Glucosamine)

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 X

Is made from renewable resources. TAP pg 2, lines 81-83. 

As an adjuvant, it is consistent with organic farming. It is 

used at a very low rate as a sticking agent; used after other 

methods of disease control. TAP pg 1, lines 26-28. As an 

adjuvant, it is expected to reduce the number and quantity 

of applications of copper sulfate. TAP pg 7, lines 269-273 

At higher levels of use the material is a plant growth 

enhancer and a plant defense booster. TAP pg 1, lines 37-

44. It is a flocculant, a hydrating agent, a pharmaceutical 

agent in biomedicine, an antimicrobial in food wrap, and a 

soil amendment (Oregon, with no amount restrictions). TAP 

pg 2, lines 51-55 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7] 

X X

Consistent with other materials on National List – derived 

from naturally occurring materials and reduces waste 

products from other industries. TAP pg 4, lines 145-146 

It is a plant growth enhancer and a plant defense booster. 

TAP pg 1, lines 37-44. It is a flocculant, a hydrating agent, 

a pharmaceutical agent in biomedicine, an antimicrobial in 

food wrap, and a soil amendment (Oregon, with no amount 

restrictions). TAP pg 2, lines 51-55 

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

An adhesive adjuvant for use in organic crop production – a 

sticking agent. TAP pg 1, lines 31-34 

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. 
NOSB RECOMMENDED DECISION 

Form NOPLIST2. Full Board Transmittal to NOP 

For NOSB Meeting: __August 2005__ Substance Chitosan (poly-D-Glucosamine)

A. Evaluation Criteria (Documentation attached; committee recommendation attached) 

 Criteria Satisfied? 

1. Impact on humans and environment Yes X No  (see B below) 

2. Availability criteria Yes X No  (see B below) 

3. Compatibility & consistency Yes X No  (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: __as an adjuvant only____________________ 

___________________________________________________________ 

Basis for annotation: its use is being limited to levels that produce the 

necessary function but do not enhance plant growth 

To meet criteria above: _X___ Criteria: _____3__________ 

Other regulatory criteria: ____ Citation:_______________ 

D. Final Board Action & Vote: Motion by: _Nancy Ostiguy___________ Second:____Goldie Cauglan___________ 

 

 Vote: 

 

 Yes: __13__ 

 

 No: ___0__ 

 Abstain: ___0__ 

 Absent: __1__ 

 1—substance voted to be added as “allowed” on National List 

Annotation: _______ as an adjuvant only _________________________________________ 

 ___________________________________________________________________ 

 2—substance to be added to “prohibited” paragraph of National List 

Describe why a prohibited substance:_______________________________________________ 

_____________________________________________________________________________ 

 3—substance was rejected by vote for amending National List 

Describe why material was rejected:________________________________________________ 

_____________________________________________________________________________ 

 4-substance was recommended to be deferred 

Describe why deferred; if any follow-up is needed. If follow-up needed, who conducts followup._____________________________________________________________________ 

_____________________________________________________________________________ 

Agricultural Nonagricultural Crops X 

Synthetic X Not synthetic Livestock 

Allowed1 X Prohibited2 Handling 

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP: 

______________________________________ _________________________ 

 Dave Carter, NOSB Chair Date 

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

 Return to NOSB  Reason: ____________________________________________________________________ 

_____________________________________ _________________________ 

 Richard H. Mathews, Program Manager Date 
NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: ___August 2005___ Substance Chitosan (poly-D-Glucosamine)

Committee: Crops X Livestock  Handling 

A. Evaluation Criteria (Documentation attached; committee recommendation attached) 

 Criteria Satisfied? 

1. Impact on humans and environment Yes X No  (see B below) 

2. Availability criteria Yes X No  (see B below) 

3. Compatibility & consistency Yes X No  (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: _c____ 

______________________________________________________________ 

Basis for annotation: material is a production aid (EPA regs); restricted to 

petitioned use 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

D. Recommended Committee Action & Vote: Motion by: _____Rose_____________________ 

 Seconded:_____Gerry______________________ 

Poly-D-Glucosamine (Chitosan) [CAS NO. 9012-76-4] is synthetic and allowed as an insecticidal soap [205.505.(e)6] 

 

 Vote: 

 

 Yes: __3___ 

 

 No: __0___ 

 Abstain: __0___ 

 

 Absent: 1 

 1—substance voted to be added as “allowed” on National List 

Annotation: ___ as an adjuvant only ________________________________________________ 

 ___________________________________________________________________ 

 2—substance to be added to “prohibited” paragraph of National List 

Describe why a prohibited substance:_______________________________________________ 

_____________________________________________________________________________ 

 3—substance was rejected by vote for amending National List 

Describe why material was rejected:________________________________________________ 

_____________________________________________________________________________ 

 4-substance was recommended to be deferred 

Describe why deferred; if follow-up is needed. If follow-up needed, who will follow 

up_____________________________________________________________________ 

_____________________________________________________________________________ 

Agricultural Nonagricultural Crops X 

Synthetic X Not synthetic Livestock 

Allowed1 X Prohibited2 Handling 

No restriction Deferred4 Rejected3

E. Approved by Committee Chair to transmit to NOSB: 

______________________________________ _________________________ 

 Committee Chair Date