NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP 

 

For NOSB Meeting: MAY 2008 ________ Substance: METHIONINE

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 & 3 

Comments: Rations that supply adequate naturally 

occurring methionine appear to exist, especially if 

poultry have true access to the outdoors (pasture); 

management practices are preferred to off farm inputs 

in organic agriculture. Synthetic methionine is used 

primarily to increase growth rates and production, not 

only to maintain health. 

 C. Proposed Annotation: . 

 Basis for annotation: expiration date of October 1, 2010 

To meet criteria above: X 

Criteria: _______________ 

 

Other regulatory criteria: ____ 

Citation:_______________ 

D. Final Board Action & Vote (State Actual Motion):

Motion: HJK Second: KE JS amendment to 2011 1st, 2nd – SD- withdrawn Yes: 14 No: 0 Abstain: Absent: 1 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: To grow the market availability of natural alternatives to synthetic Methionine. Based 

on public presentations in Washington, DC (Nov. 2007) and La Crosse, WI (Upper Midwest Organic Farming Conference Feb. 2008),

alternatives exist but need a few years to create sufficient supplies of naturally occurring methionine. 

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. 603 Describe why material was rejected: Original petition to 

remove the expiration date entirely was rejected by the Board unanimously. With this official vote, the material will still be on the list 

with a new expiration deadline of October 1, 2010. It is the intent of the Livestock Committee to stimulate further commercial 

development and management changes to provide methionine to poultry in a non-synthetic manner. This should be done in the most 

expeditious manner possible. 

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 Crops 

Synthetic √ Not synthetic Livestock √

Allowed1

√ Prohibited2

Handling 

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP 

Rigoberto Delgado June 20-2008 . .

Chair Date

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

 Return to NOSB Reason: ____________________________________________________________________ 

 

_____________________________________ 

 Date 

 _________________________ 
NOSB Evaluation Criteria for Substances added to the National List

Category 1. Adverse impacts on humans or the environment? Substance - Methionine________________

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 

Potential for release of highly toxic substances during 

manufacturing, including hydrogen cyanide, methane, ammonia, 

and acrolein, in the form of air pollution. 

TAP p. 5 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

Rapidly degraded in water and neutralized by bacteria in the soil 

TAP p. 11 

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 X 

Most toxic of all amino acids. Petition p. 15 

Excessive feeding may cause deficiencies in other amino acids 

and induce toxicity, but rates of inclusion are well understood. 

TAP p. 5,21 

6. Are there adverse biological and 

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

X See 3 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5] 

X 

See 3 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2] 

X See 3 

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

X See 3 

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4] 

X 

Appears to present no human health problems. Well utilized 

by poultry. Used in medicine. 

TAP p. 11 

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 - Methionine_______________

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 

May be isolated from naturally occurring sources, produced 

from genetically engineered organisms, or entirely synthesized 

by a wide number of processes. 

TAP p. 3 

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 

One method uses propylene, hydrogen sulfide, methane, and 

ammonia. Another uses acrolein and methyl mercaptan in the 

presence of a catalyst. 

TAP p. 3 

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)] 

X 

TAP p. 3 

4. Is there a natural source of the 

substance? [§205.600 b.1] 

X 

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 

Fish meal, kelp, crab meal, insects, earthworms, seed meals, 

dairy products and by-products, rice hull extract, pearl millet, 

sorghum, crab shell meal, lobster shell meal, white corn gluten, 

potato protein, barley, oats, wheat, flax meal, annelids, leeches, 

fresh green forage, field peas, quinoa 

TAP & Petition various pages 

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 See 7 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6] 

X 

Slower growing breeds, more diverse feed rations, use of 

alternative feeds, true outdoor access and other management 

strategies. 

TAP & Petition 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 - Methionine________

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 

Use of synthetic substances not compatible with organic farming 

and handling, and does not follow the principles of organic 

agriculture 

TAP p. 14 

3. Is the substance compatible with 

a system of sustainable 

agriculture? [§6518 m.7] 

X 

Natural sources are allowed and are more compatible. 

TAP 

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 

Sulfur. 

TAP p. 3 

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 - Methionine________________________________

Question Yes 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 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 

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 
Livestock Committee 

Minority Opinion 

Methionine Recommendation, May 2008 

The following minority opinion suggests that there is no need to continue the allowance of synthetic Methionine for an 

additional two years for organic poultry production on the National List §205.603. 

 While the petition to remove the expiration date from the annotation does list immunological stress and 

reduced feathering as potential consequences of the absence of synthetic methionine supplementation, the actual data 

reported in the same petition does not show any of these as observed consequences. 

 The only potential consequence listed in the petition that is supported in the data submitted is a reduction in 

performance as measured in growth or egg production. 

 The petition further notes that amino acid requirements are directly tied to performance. An allowance within 

the industry for a reduced performance as being acceptable decreases the total methionine requirement and the need for 

synthetic methionine supplementation in the diet. 

 While the minority opinion agrees that methionine is an essential amino acid and required in the diet of poultry 

and all animals, the petitioner has not provided data that supports the necessity of supplementation of synthetic 

methionine, to provide total methionine at a level above the level provided by available organic livestock feeds, for any 

function except improvement of production parameters. 

 Therefore the listing of methionine only for poultry seems to be an allowance for organic poultry to more 

closely meet the performance expectations of conventional poultry production. This allowance has already been 

granted for six years via two subsequent listings of DL-methionine on §205.603 of three years each. 

 The lack of any real data that nothing but a decrease in performance will likely occur because of the removal of 

DL-methionine from the NL does not support the exemption for continued use of this substance for two more years. 

 If this exemption is allowed for an additional two years for poultry, then, since it appears to be essentially a 

substance to improve performance, there seems to be no support to limit this advantage to only the poultry sector of the 

organic livestock industry. Other omnivore and carnivore species would benefit from supplementation of synthetic 

methionine and even some herbivore livestock species have shown production benefits from synthetic methionine 

supplementation. 

 This minority opinion recommends either a) to vote to not relist synthetic DL-methionine and it’s analogs on 

the NL §205.603, or b) to amend the recommendation to remove the portion of the annotation limiting this performance 

benefit to the poultry sector of the organic livestock industry.