NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: 

May 2009

Substance: Propionic Acid – CAS Reg Number 79-09-4

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  No X N/A 

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

B. Substance fails 

criteria? 

Criteria category: 2 

and 3

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 Propionic Acid CAS # 79-09-4 to the National List in section 205.605(b)

 .

Motion: Steve DeMuri Second :Julie Weisman Yes: 0 No: 13 Abstain: 0 Absent: 1 Recuse: 1

 

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

that includes the evaluation criteria checklist:

Substance’s primary petitioned use is as a preservative for feed and grain, failing one of the criteria for listing (See Category 3 No. 5 in 

attached Handling Committee criteria checklist)) Substance was also rejected because it failed criteria 2 - not considered to be 

essential, & other factors of Category 3. Organic alternatives and non-synthetics sources are available; synthetics are not allowed, and 

preservatives are not allowed in organic food products.

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 § 205.605(b). Describe why material was rejected:

Substance’s primary petitioned use is as a preservative for feed and grain, failing one of the criteria for listing (See Category 3 No. 5 in 

attached Handling Committee criteria checklist)) Substance was also rejected because it failed criteria 2 - not considered to be 

essential, & other factors of Category 3. Organic alternatives and non-synthetics sources are available; synthetics are not allowed, and 

preservatives are not allowed in organic food products.

_____ _ ___________________________________________________ 

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 Nonagricultural X Crops

Synthetic X Not synthetic 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: Propionic Acid - CAS 79- 09- 4

Committee: Crops  Livestock  Handling X Petition is for: addition of Propionic Acid as a mold inhibitor for grains and 

feed to the National List § 205.605(b)

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  No X N/A 

6. Compatibility & Consistency Yes  No X N/A 

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

B. Substance Fails Criteria Category: 2 & 3. Comments: Organic alternatives and non-synthetics sources are available; synthetics 

are not allowed, and preservatives not allowed. 

___________________________________________________________________________________

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________

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

D. Recommended Committee Action & Vote (State Actual Motion): To add Propionic Acid to the National List 

________________________________________________________________________________________________________

205.605(b).

Motion by: Steve DeMuri Seconded: Katrina Heinze ____ Yes: ____ No: _4__ Absent: _1___ Recusal: _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. 605(b) Describe why material was rejected:___________ 

Substance’s primary petitioned use is as a preservative for feed and grain, failing one of the criteria for listing (See Category 3 No. 5) 

Substance was also rejected because it failed criteria 2 -not considered to be essential, & other factors of Category 3. 

_______________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic X Rejected3

No restriction Commercially UnAvailable as Organic1

 Deferred4
E. Approved by Committee Chair to transmit to NOSB:

Steve DeMuri ___March 17, 2009

Committee Chair Date

__________
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

 Category 1. Adverse impacts on humans or the environment? Substance - Propionic 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 Page 4 of the TR claims there are no adverse effects on 

the environment, and that it is only slightly toxic to birds, 

fish, aquatic invertebrates, and mammals. The U. S. EPA 

has waived environmental fate data requirements for the 

currently registered uses of propionic acid. Therefore, any 

concerns over the improper storage, use, and disposal of 

propionic acid should be minimal. 

2. Is there environmental 

contamination during 

manufacture, use, misuse, or 

disposal? [§6518 m.3]

X See 1 above

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X See 1 above.

4. Does the substance contain 

List 1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X No, the substance itself is on EPA’s List 4B as an inert 

ingredient.

5. Is there potential for 

detrimental chemical interaction 

with other materials used?[§6518 

m.1]

X There is no information available to indicate that using 

propionic acid has detrimental chemical interaction with 

other materials used. 

6. Are there adverse biological 

and chemical interactions in 

agro-ecosystem? [§6518 m.5]

X There is no information available to indicate that propionic acid 

has adverse biological or chemical interactions in the agroecosystem. The U.S. EPA has reviewed the available eco-toxicity 

data on propionic acid and found that it is only slightly toxic to 

birds, fish, aquatic invertebrates, and mammals. (pg 4 of TR). 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X There is no information available to indicate that using 

propionic acid has detrimental physiological effects on soil, 

organisms, crops, or livestock. 

8. Is there a toxic or other 

adverse action of the material or 

its breakdown products? [§6518 

m.2]

X One adverse reaction of propionic acid is that it is 

corrosive due to it’s acidic nature, which could cause 

corrosion of handling equipment, such as storage tanks 

and silos, where it might be used. 

9. Is there undesirable 

persistence or concentration of 

the material or breakdown 

products in environment?[§6518 

m.2]

X None indicated in the Technical Report.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X US EPA R.E.D. Facts and page 5 of the Technical Review 

indicate contact with concentrated solutions of the substance 

may cause damage to the eyes, skin, and mucous membranes. 

It has been placed in Toxicity Category I for acute eye and 

dermal irritation effects. (I is the highest category, IV the lowest 

in degree of toxicity) It is placed in Category III for acute oral, 

dermal, and inhalation effects. However, under normal useage 

and concentrations, it is not considered toxic. It is a normal 

metabolite of the human body, and is rapidly absorbed from the 

mammalian GI tract and utilized by most organs and tissues. 

(page 4 & 5 of the TR) 

11. Is there an adverse effect on 

human health as defined by 

X See # 10 above.
applicable Federal regulations? 

[205.600 b.3]

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X Propionic acid was assigned GRAS status in May 1984. 

Page 3 of the Technical Review. 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X None indicated in the Technical Review.

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 - Propionic Acid

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 Propionic acid is produced synthetically by reacting 

ethylene (petroleum based) with a mixture of carbon 

monoxide and hydrogen to yield propionaldehyde. Either 

rhodium or cobalt is used as a catalyst in this reaction. 

The propionaldehyde is treated with air or pure oxygen in 

a carefully controlled reaction to reduce the 

propionaldehyde to propionic acid. The propionic acid is 

distilled to produce a purified product. (pg 3 of TR)

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 Petroleum based ethylene (a synthetic ), is reacted with 

syn gas with a rhodium or cobalt catalyst. The distilled 

propionaldehyde is then treated with air or pure oxygen to 

partially oxidize it to propionic acid. The resulting product 

is then distilled. (Page 2 of the petition) 

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X The petitioned form of the substance is not, but natural 

forms ARE available.

4. Is there a natural source of 

the substance? [§205.600 b.1]

X Propionic acid can be naturally produced by bacterial 

fermentation (pg 3 of TR) In fact, there is a large amount 

of naturally produced propionic acid available on the 

market. 

5. Is there an organic 

substitute? [§205.600 b.1]

X Organic vinegar is available; or propionic acid derived 

from bacteria could conceivably be organic. There are 

other certified organic food mold inhibitors available on the 

market currently.

6. Is the substance essential for 

handling of organically 

produced agricultural products? 

[§205.600 b.6]

X

 

Good Manufacturing Practices and proper handling 

procedures could eliminate the need for this substance, 

and the availability of certified organic alternatives make 

this substance non-essential.

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X One wholly natural product that possibly could be 

substituted for propionic acid is vinegar. 

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X The petitioned substance is synthetic.

9. Is there any alternative 

substances? [§6518 m.6]

 X See #5 above.

10. Is there another practice 

that would make the substance 

unnecessary? [§6518 m.6]

X Yes, proper crop post harvest handling procedures and

Good Manufacturing Practices, or the use of organic 

alternatives when necessary to inhibit mold growth in 

organic food. . 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- Propionic 

Acid

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? 

[§205.600 b.2]

X It is a synthetic.

2. Is the substance consistent 

with organic farming and 

handling? [§6517 c (1)(A)(iii); 

6517 c (2)(A)(ii)]

X No, because it is a synthetic, and it’s primary petitioned 

use is as a preservative. 

3. Is the substance compatible

with a system of sustainable 

agriculture? [§6518 m.7]

X Synthetically produced from a petroleum base.

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X There is no evidence or information available which 

indicates the substance adversely affects food nutritional 

quality.

5. Is the primary use as a 

preservative? [§205.600 b.4]

X Petitioned as a preservation method to inhibit mold growth 

as stated in item B number3 of the petition.

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.
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 - Propionic Acid

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

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 

temporarily restrict supplies; or

X
e. Are there other issues which may 

present a challenge to a consistent 

supply?

X