DRAFT FORM 

FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB)

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: __March 18, 2005_______

Subject: _Renewal of DL-Methionine on National List until October 1, 2008___ 

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 the use of synthetic methionine in organic poultry production be 

extended to October 1, 2008 to provide time for thorough research to be completed. This 

recommendation follows inclusion allowances provided in 205.603 Synthetic substances 

allowed for use in organic livestock production as (d) feed additives. 

NOSB vote: 11 yes, 0 no, 2 abstain, 1 recuse 

The NOSB recommends that the petitioners’ request for a research variance for the 

feeding of non-organic feed alternatives to poultry that would be labeled and sold as 

“organic” be rejected. 

NOSB vote: 13 yes, 0 no, 0 abstain, 1 recuse 

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

Rationale for the positions taken by the Board explained in the DL-Methionine final 

recommendation form and decision sheets. 

Response by the NOP:

Updated 2/25/05
NOSB Livestock Committee - Synthetic Methionine Recommendation 

Draft 1-30-05

Background: 

A petition has been submitted to the NOP requesting that the use of synthetic methionine 

in poultry diets be extended past the current sunset date of October 1, 2005. The basic 

arguments presented by the petitioners include: 

Research on organic alternatives to synthetic methionine is incomplete. Projects 

in progress show promise but more time is needed to assure science is sound. No 

clear solution is available at the present time. 

Even if science had identified viable organic alternatives to synthetic methionine, 

they would not yet be available in sufficient quantity. 

Sufficient dietary levels of methionine are a necessity for organic poultry 

production from an economic, animal health/welfare, and environmental 

standpoint. 

 

Methionine is not a growth promoter. It is a necessary dietary requirement 

essential to maintain the health of poultry. 

Feed ingredients that provide methionine include soybeans, field peas, white corn 

gluten, potato protein, seed meals (sunflower, flax, and hemp), quinoa, alfalfa 

meal, fresh pasture, and casein. Insects and earthworms are also rich in 

methionine. 

Research into natural methionine production through extraction and fermentation 

continues. A natural source of methionine feed additive would be allowed 

according to current National Organic Program standards. 

Production systems and cultural practices, including selection of breeds and 

pastured poultry production, may obviate the need for synthetic methionine. 

Research projects are underway to examine alternative feed sources, alternative 

production systems, and alternative breeds. 

The Livestock Committee concurs with the petitioners that it is desirable to eliminate the 

use of synthetic methionine from the organic poultry industry. We support continued 

intense and good faith research efforts to eliminate synthetic methionine from organic 

poultry diets. 

Recommendation: 
After careful consideration and discussion of the merits of the petition, the NOSB 

Livestock Committee recommends the use of synthetic methionine in organic poultry 

production be extended to October 1, 2008 to provide time for thorough research on 

organic alternatives to be completed. This recommendation follows inclusion allowances 

provided in 205.603 Synthetic substances allowed for use in organic livestock production 

(d) as feed additives. 

A temporary variance petition for the allowance of the use of non-organic feed 

ingredients in organic poultry production for research purposes was also submitted by the 

petitioners. The requested variance would allow the feeding of non-organic feed 

ingredients for research purposes. The variance would require approval by NOP, be 

limited to trials of 1,000 birds or less, require immediate and full disclosure of research 

findings, and expire October 1, 2008. If the variance is granted, the birds would be able to 

be labeled and sold as “organic.” The Livestock Committee recommends that this request 

be rejected. This Committee cannot support a request to feed non-organic feed to birds 

that would be labeled and sold as “organic.” 

Committee vote: 

6 yes, 0 no, 2 absent 
Decision Sheets 

April 1, 2004 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

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

See Footnote # 1 below. 

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3] 

 X 

 Some air pollution is caused by the 

manufacturing process. 

(EPA, TAP) 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

 

 X 

 Substance is “rapidly degraded in 

water; metabolized by bacteria in 

sediments.” 

(TAP) 

4. Does the substance contain List 1, 2, or 

3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2] 

 

 X 

 Methionine is a List 4 Inert. 

(EPA) 

5. Is there potential for detrimental 

chemical interaction with other materials 

used? 

[§6518 m.1] 

 

 X 

 Use of the substance is “well 

understood, unlikely to be misused, 

misformulated, or cause detrimental 

interactions or results.” 

(TAP) 

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5] 

 

 X 

 See Question # 3 and # 5 above. 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5] 

 

 X 

 See Question # 3 and # 5 above. 

8. Is there a toxic or other adverse action of 

the material or its breakdown products? 

[§6518 m.2] 

 

 X 

 See Question # 3 and # 5 above. 

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment?[§6518 m.2] 

 

 X 

 See Question # 3 and # 5 above. 

10. Is there any harmful effect on human 

health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; §6518 

m.4] 

 

 X 

 No human health implications. 

Common dietary supplement. Used in 

medicine. Not detectable in poultry 

meat or eggs. 

(TAP) 

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3] 

 

 X 

See Footnote # 1 below. 

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5] 

 

 X 

See Footnote # 1 below. 

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 b.5] 

 

 X 

See Footnote # 1 below. 

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. 
Decision Sheets 

April 1, 2004 

Category 2. Is the Substance Essential for Organic Production? Substance Synthetic 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 

 Chemically synthesized from the 

combination of nitrogen, carbon and 

sulfur compounds. 

(TAP) 

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 X 

 Methionine may be isolated from 

naturally occurring sources, produced 

from genetically engineered organisms, 

or entirely synthesized by a wide 

number of processes. D- and Lmethionine (DL-methionine) are 

usually produced entirely by chemical 

methods. 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 

 See Question # 1 above. (Produced 

naturally by plants and bacteria, for 

example in the rumen of cows, sheep, 

etc.) 

(TAP) 

4. Is there a natural source of the 

substance? [§205.600 b.1] 

 

 X 

See Footnote # 1 below. 

5. Is there an organic substitute? [§205.600 

b.1] 

 

 X 

See Footnote # 1 below. 

6. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600 b.6] 

 

 X 

See Footnote # 1 below. 

7. Is there a wholly natural substitute 

product? 

[§6517 c (1)(A)(ii)] 

 X 

 There are feed ingredients that contain 

higher levels of natural methionine 

relative to other feed ingredients. See 

TAP and Livestock Committee 

Recommendation for a listing of several 

of these. 

(TAP, Livestock Committee 

Recommendation) 

8. Is the substance used in handling, not 

synthetic, but not organically produced? 

[§6517 c (1)(B)(iii)] 

 

 X 

 Substance is not used in handling and is 

synthetic. 

9. Is there any alternative substances? 

[§6518 m.6] 

 X Research is ongoing examining the 

feasibility of alternative feed 

ingredients. See Question 7 above. 

10. Is there another practice that would 

make the substance unnecessary? [§6518 

m.6] 

 X 

 Research may provide information 

relative to other practices that would 

make synthetic methionine 

unnecessary. Slower growing breeds, 

alternative feed ingredients, other 

management and housing strategies 

may eliminate the need for synthetic 

methionine supplementaion. 

(TAP, Livestock Committee 

Recommendation) 
Decision Sheets 

April 1, 2004 

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. 
Decision Sheets 

April 1, 2004 

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

Substance Synthetic 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 See Footnote # 1 below. 

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

(1)(A)(iii); 6517 c (2)(A)(ii)] 

X X Proper nutrition is the cornerstone of 

organic livestock production. In terms of 

animal welfare, animal health, and 

minimizing environmental impact, synthetic 

methionine is consistent with organic 

farming principles. The substance causes 

no chemical modification of poultry 

products and organic quality of products 

remains intact. 

(TAP, Livestock Committee 

Recommendation) 

3. Is the substance compatible with a 

system of sustainable agriculture? [§6518 

m.7] 

X X Natural sources of methionine are allowed 

according to current National Organic 

Program standards, and are more compatible 

with a system of sustainable agriculture than 

synthetic forms. Feed ingredients that 

provide methionine include soybeans, field 

peas, white corn gluten, potato protein, seed 

meals (sunflower, flax, and hemp), fish 

meal, crab meal, yeast, quinoa, alfalfa meal, 

fresh pasture, and casein. Insects and 

earthworms are also rich in methionine. 

Compatible production systems and cultural 

practices, including selection of breeds, 

alternative feeds, and pastured poultry 

production, may obviate the need for 

synthetic methionine in the future. 

4. Is the nutritional quality of the food 

maintained with the substance? [§205.600 

b.3] 

 X See Footote # 1 below. 

5. Is the primary use as a preservative? 

[§205.600 b.4] 

 X See Footote # 1 below. 

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 See Footote # 1 below. 

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 Synthetic methionine and natural 

methionine both contain sulfur. 

(TAP) 

b. toxins derived from bacteria; X 

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins and 

minerals? 

 X 
Decision Sheets 

April 1, 2004 

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. 
Decision Sheets 

April 1, 2004 

NOSB RECOMMENDED DECISION 

Form NOPLIST2. Full Board Transmittal to NOP 

For NOSB Meeting: February 28 – March 3, 2005 

_____________________ 

Substance: Synthetic Methionine 

___________________________ 

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

 Criteria Satisfied? 

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

2. Availability criteria Yes No  (see B below) 

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

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: Allowed until October 2008 to allow research on 

natural sources of methionine to be 

completed.______________________________________ 

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

D. Final Board Action & Vote: Motion by: ____________________ Second:____________________________ 

 

Agricultural

Nonagricultural 

Crops 

Synthetic X 

Not synthetic 

Livestock X 

Allowed1

 X 

Prohibited2 

Handling 

No restriction 

Deferred4 

Rejected3 

 Vote: 

 

 Yes: _____ 

 

 No: _____ 

 Abstain: _____ 

 

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

April 1, 2004 

Annotation: Allowed until October 2008 to allow research on natural sources of methionine to be completed. 

___________________________________________________________________ 

 ___________________________________________________________________ 

 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._____________________________________________________________________ 

_____________________________________________________________________________ 

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 
Decision Sheets 

April 1, 2004 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: February 28 – March 3, 2005 

_____________________ 

Substance: Synthetic Methionine 

___________________________ 

Committee: Crops  Livestock  Handling 

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

 Criteria Satisfied? 

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

5. Availability criteria Yes No  (see B below) 

6. Compatibility & consistency Yes No  (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: Allowed until October 2008 to allow research on 

natural sources of methionine to be 

completed._________________________________________ 

______________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

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

 Seconded:____________________________ 

 

Agricultural

Nonagricultural 

Crops 

Synthetic X 

Not synthetic 

Livestock X 

Allowed1

 X 

Prohibited2 

Handling 

No restriction 

Deferred4 

Rejected3 

 Vote: 

 

 Yes: _____ 
Decision Sheets 

April 1, 2004 

 

 No: _____ 

 Abstain: _____ 

 

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

Annotation: Allowed until October 2008 to allow research on natural sources of methionine to be completed. 

___________________________________________________________________ 

 ___________________________________________________________________ 

 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_____________________________________________________________________ 

_____________________________________________________________________________ 

E. Approved by Committee Chair to transmit to NOSB: 

______________________________________ _________________________ 

 Committee Chair Date