National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Required Synthetic Amino Acids for Pet Foods

August 20, 2012

Summary of Proposed Action:

Thirteen synthetic amino acids were petitioned for use in organic pet foods. The Subcommittee 

evaluated the petition, TR, had discussion with State Feed Control Officials and concluded that 

only Taurine for cats was deemed necessary as a synthetic addative and thus allowed. It was 

determined that the manufacturers could meet the required levels of Arginine, DL-Methionine, 

Cysteine, L-Lysine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, 

Tyrosine, Valine to meet the criteria for “complete and balanced” as required by American 

Association of Feed Control Officials (AAFCO) with typical ingredients.

This petition checklist is only for Taurine for cats.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? 

(see “B” below)

1. Impact on Humans and Environment ☒ Yes ☐ No ☐

N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐

N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐

N/A

4. Commercial Supply is Fragile or Potentially Unavailable ☒ Yes ☐ No ☐

N/A

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments:

Proposed Annotation (if any): 205.603(e)(4) Taurine (CAS 107-35-7) for cats

Basis for annotation: ☒ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: The other 12 petitioned Amino Acids failed to meet the necessity criteria

Recommended Committee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Motion to classify amino acids (Arginine, Methionine, Cystine, 

Lysine, Taurine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, 

Tyrosine, and Valine) as synthetic. 

Motion by: Mac Stone Seconded by: Colehour Bondera

Yes: # 7 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0
Listing Motion: Motion to list amino acids (Arginine, Methionine, Cystine, Lysine, Taurine, 

Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, Tyrosine, and Valine) 

on section 205.603 on the National List for use in organic pet food.

Motion by: Mac Stone Seconded by: Colehour Bondera

Yes: # No: # 7 Absent: # 1 Abstain: # 0 Recuse: #0

Listing Motion: Motion to list Taurine (CAS 107-35-7) on 206.603(e)(4) for cats

Motion by: Wendy Fulwider Seconded by: Calvin Walker

Yes: # 7 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0

Crops ☐ Agricultural ☐ Allowed1 ☒

Livestock ☒ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☒ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.603 with Annotation (if 

any): Taurine (CAS 107-35-7) on 206.603( e)(4) for cats

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. . Describe why 

material was rejected: 12 petitioned items rejected for lack necessity to formulate complete 

and balanced feeds for cats and dogs 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

Wendy Fulwider, Committee Chair 8/16/12

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment?

Substance: Taurine

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

x
use, or disposal?

[§205.600 b.2]

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x

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

6. Are there adverse biological and 

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

x

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

x

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment? [§6518 m.2]

x

10.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

x

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.
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production?

Substance: Taurine

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

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

3. Is the substance created 

by naturally occurring 

biological processes? 

[6502 (21)]

x

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 

Taurine

Arginine, DLMethionine, 

Cysteine, LLysine, 

Tryptophan, 

Threonine, 

Histidine, 

Isoleucine, 

Leucine, 

Phenylalanine, 

Tyrosine, 

Valine

From the TAP and petition 

and discussions with Feed 

Control Officials, only 

Taurine was determined

absolutely necessary for 

cats, for diet formulators to 

meet AAFCO guidelines

7. Is there a wholly natural 

substitute product?

[§6517 c (1)(A)(ii)]

X

8. Is the substance used in 

handling, not synthetic, 

but not organically 

x
produced?

[§6517 c (1)(B)(iii)]

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.

NOSB Evaluation Criteria for Substances Added To the National List

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

Taurine

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

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

x

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 

x
emulsions, treated seed, 

vitamins and minerals?

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.
NOSB Evaluation Criteria for Substances Added To the National List

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: Name: Taurine

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic 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 

X
as hurricanes, floods, and 

droughts that may temporarily 

halt production or destroy 

crops or supplies; 

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

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.
National Organics Standard Board

Livestock Subcommittee

Proposal: Pet Food Amino Acids

August 10, 2012

Introduction

The growth of the organic food sector extends into the pet food market. Consumers are looking 

for organic alternatives for their pets because they understand the strict policies behind the 

organic logo and it corresponds with their values in terms of no GMOs, transparent sourcing of 

ingredients, and lessened environmental impact of production. Certifiers currently certify pet food 

products by following the livestock standards for production purposes, and the processed foods 

labeling regulations in the marketplace. To date, the National Organic Program (NOP) allows 

synthetic AA, like vitamins and minerals, to be allowed for organic livestock feed, if required by 

FDA. Based on a report from the Office of the Inspector General, this interpretation of the Rule 

has been overturned and the NOP is crafting Rulemaking language that will require any 

“accessory nutrient”, other than vitamins and minerals, to be petitioned to the NOSB. The Pet 

Food Institute has petitioned the NOSB to place the 13 essential synthetic amino acids for dogs 

and cats on the National List. Pet food standards are not currently part of the Rule; however, the 

NOP is working towards a Proposed Rule based on the 2008 NOSB recommendation to regulate 

organic pet food. (See Appendix 1). Sourcing organic ingredients to achieve “organic” or “made 

with” status is challenging in terms of seasonal and geographic constraints on availability of 

feedstuffs. Dogs, cats, and animals that live in tanks or cages, have dietary demands that must 

be met with a sole source feed formulation specific to their species and stage of life.

Background

Meeting the nutritional needs of pets with a single source of feed requires manufacturers to 

follow strict dietary guidelines regulated by a series of regulators and scientific communities. The 

Food and Drug Administration (FDA) regulates pet food under the Federal Food, Drug, and 

Cosmetic Act that requires all animal feeds, like human foods, to be safe to eat, produced under 

sanitary conditions, contain no harmful substances, and be truthfully labeled. The FDA Center 

for Veterinary Medicine (CVM), that manages the non-human aspect of the regulation for the 

agency, accepts the determination of an ad hoc expert nutrition committee under the Committee 

on Animal Nutrition for the National Research Council in the National Academy of Sciences to 

establish nutrient requirements for dogs, cats, and all other species of animals. For dogs and 

cats, the required essential nutrients are listed and described in the 2006 edition of Nutrient 

Requirements of Dogs and Cats. The 2006 edition is the standard State Feed Control Officials 

use when evaluating diet formulations and to verify labels as sufficient for use in their state. 

These State Feed Officials have formed the Association of American Feed Control Officials 

(AAFCO) to act as a forum and clearinghouse for developing an overall regulatory structure that 

is consistent across the country for continuity of interstate commerce. FDA officials sit on the 

standing committees of this organization to ensure compliance with the regulations. The State 

Feed Control Officials implement the regulatory process through their legislative system. 

Through this system, for a pet food to make the label claim “complete and balanced,” it must 

meet the standards in the NRC 2006 edition of Nutrient Requirements for Dogs and Cats.

The current AAFCO standard classifies 13 amino acids (AA) as essential for dogs and cats. (See 

Appendix 2). This means they cannot be synthesized by the body and must be supplied by the 

feed. All of these AA are naturally occurring in nature. Prior to domestication, these animals 

sought out food sources to supply these AA in the correct balance to meet their needs. With 

domestication came the need to supply the animals a complete and balanced diet with the 

correct food sources. It can be difficult to achieve the required balance of AA given access to 

ingredients and the processing requirements for preserving and packaging them for market. 
These AA are also manufactured by chemical synthesis, fermentation, and enzymatic synthesis 

to supplement diets that may be deficient in one or more of them. The AA produced from each of 

these processes would be considered synthetic under the working definition of the NOSB. The 

fermentation process could use excluded methods. The 13 essential AA petitioned for use in 

organic pet foods are listed in Appendix 3.

Some pet foods on the market are certified organic without the use of synthetic AA and meet the 

complete and balanced claim, albeit a very small segment of the market. Some are certified 

using the previous NOP ruling that synthetic nutrients are allowed, along with vitamins and 

minerals, without regard to source and “other ingredients” under the livestock feed standards. 

Certifiers, to date, are using the livestock feed standards 205.237 for processing and handling; 

and label standards 205.301 to certify these products. The synthetic AA have been considered 

accessory nutrients to vitamins and minerals as permitted by the 1995 NOP ruling allowing such. 

In 2010, the NOP determined this interpretation incorrect and all accessory nutrients must be 

petitioned individually, as they are not vitamins or minerals. In 2005 a Pet Food Task Force 

(PFTF) was formed by the NOSB and NOP to advise the NOSB on future recommendation to 

implement pet food standards. This led to the NOSB making recommendations to the NOP in fall 

2008 on numerous Rule changes to regulate pet foods in the Rule. These recommendations 

included the use of mammalian and poultry products and by-products as allowed since pets are 

not part of the food chain. This point is the fundamental reason pet foods must be distinguished 

from livestock feeds. It also clarified labeling requirements, and the need for additions to the 

National List. Currently the NOP is set to announce proposed rulemaking on this topic late in 

2012 or early 2013. When the rulemaking process is completed, only approved synthetic AA will 

be allowed in organic pet foods. 

Discussion 

The Pet Food Institute has petitioned the NOSB to place Arginine, Methionine, Cystine, Lysine, 

Taurine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, Tyrosine, and 

Valine, as synthetic AA, on the National list. These AA, must be supplied by the feed, in some 

form, at minimum levels, for the feed to meet the AAFCO standards of complete and balanced. 

However, the petition goes on to say, Threonine, Histidine, Isoleucine, Leucine, Phenylalinine, 

and Valine are available in agricultural products used as feedstuffs and will not need to be 

utilized in synthetic form. Therefore, the committee focused its work on Arginine, Methionine, 

Cystine, Lysine, Taurine, and Tryptophan, the AA listed on the 2008 NOSB pet food 

recommendation as potentially necessary in synthetic form. Carnitine was also on the 2008 

recommendation, however, it is not part of this petition.

Dog foods must be at least 22% protein, however, some go much higher to mimic natural diets. 

The higher protein (meat based) diets may require less AA supplementation, yet be more 

expensive to produce. Many commercial dog food formulations have synthetic Taurine, DLMethionine, L-Lysine and Carnitine listed on the ingredient panel. In addition, there are many 

dog foods on the market with no added synthetic AA.

Virtually all cat foods have synthetic Taurine because of the relatively high requirement for cats, 

and degradation during processing no matter the protein percentage. Many cat foods also list 

synthetic Methionine and Lysine on their labels. The Technical Report states several pet food 

brands are on the market as complete and balanced without the use of synthetic AA. 

There is no mention of “other ingredients” such as anti-oxidants, carriers, etc. associated with 

these AA. The committee would like to know more about other ingredients associated with these 
products. Those derived from fermentation would have to document no excluded methods are 

used in the process. It is reported that Taurine is particularly sensitive to heating and is severely 

degraded in the manufacturing process. 

The use of synthetic AA in pet foods is based on the ability of the manufacturer to formulate a 

diet that supplies the correct balance of AA to meet AAFCO standards of “complete and 

balanced”. In the case of organic pet foods, manufacturers have limited access to organic 

ingredients, thus the petitioner’s stated need to utilize synthetic nutrients to balance the 

formulations. It is unclear from the information at hand that the allowance of synthetic AA will 

foster the expanded use of organic by-products and other organic inputs because manufacturers 

will be have these limiting AA at their disposal. It is also unclear that if these synthetic AA are 

available to manufacturers, if it will allow the use of lower quality ingredients, supplemented with 

these AA, to be more competitive in the market place.

Relative Areas of the Rule

Based on the NOSB recommendation in 2008:

§205.603 Synthetic substances allowed for use in organic livestock and pet food 

production. 

In accordance with restrictions specified in this section, the following synthetic substances may 

be used in organic livestock production, and for organic pet food production, as applicable. 

(b) As livestock feed supplements—Milk replacers—without antibiotics, as emergency use only, 

no nonmilk products or products from BST treated animals. 

(d) As feed supplements for pet food (reserved) 

(d e) As feed additives. 

(1) DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog 

calcium—for use only in organic poultry production until October 21, 2008. 

(2) Trace minerals, used for enrichment or fortification when FDA approved. 

(3) Vitamins, used for enrichment or fortification when FDA approved. 

(4) Other nutrients for use in pet foods: (reserved)

Individual AA would be listed under 205.603( e)(4)

Recommendation

Given the numerous pet food formulations on the market without synthetic AA, the committee 

feels that manufacturers have access to ingredients for organic pet foods to supply the balance 

of AA to meet the AAFCO standards for complete and balanced diet, except for Taurine for cats.

The Livestock Sub-committee recommends Taurine (CAS 107-35-7) for cats, produced using 

chemical synthesis methodology, be added to 205.603( e)(4) when the pet food standards are 

implemented as part of the Rule. 

Recommended Committee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Motion to classify amino acids (Arginine, Methionine, Cystine, 

Lysine, Taurine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, 

Tyrosine, and Valine) as synthetic. 

Motion by: Mac Stone Seconded by: Colehour Bondera

Yes: # 7 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0

Listing Motion: Motion to list amino acids (Arginine, Methionine, Cystine, Lysine, Taurine,

Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, Tyrosine, and Valine) 

on section 205.603 on the National List for use in organic pet food.

Motion by: Mac Stone Seconded by: Colehour Bondera

Yes: # No: # 7 Absent: # 1 Abstain: # 0 Recuse: #0
Listing Motion: Motion to list Taurine (CAS 107-35-7) on 206.603(e)(4) for cats

Motion by: Wendy Fulwider Seconded by: Calvin Walker 

Yes: # 7 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0

Appendix 1

Recommendations for Regulatory Change to 7 CFR Part 205 to include Organic

Pet Food

Suggested additions to 7 CFR Part 205 are included in underline format. Deletions are

marked in strikethrough format.

Subpart A Definitions:

205.2 Terms defined

Agricultural product. Any agricultural commodity or product, whether raw or

processed, including any commodity or product derived from livestock, that is marketed

in the United States for human, pet, specialty pet or livestock consumption.

2

Livestock. Any cattle, sheep, goat, swine, poultry, or equine animals used for food or in

the production of food, fiber, feed, or other agricultural-based consumer products; wild or

domesticated game; or other nonplant life, except such term shall not include pets or

specialty pets. aquatic animals or bees for the production of food, fiber, feed, or other

agricultural-based consumer products.”

3

Meat (feed ingredient) is clean flesh derived from slaughtered mammals and limited to

that part of the striate muscle which is skeletal or that which is found in the tongue, in

the diaphragm, in the heart, or in the esophagus; with or without the accompanying

overlying fat and the portions of the skin, sinew, nerve, and blood vessels which

normally accompany the flesh.

4

Pet - dog or cat

Pet food - any commercial feed prepared and distributed for consumption

by dogs or cats.

For the purposes of this regulation unless specifically noted the term “pet food” will

include both pet and specialty pet food. Rabbits, horses and camelids are specifically

excluded from this definition as they are classified as “livestock."

Poultry (feed ingredient) – is the clean combination of flesh and skin with or without

accompanying

bone, derived from the parts or whole carcasses of poultry or a combination thereof,

exclusive of feathers, heads, feet and entrails.

5 May not be listed as “poultry meat”, may

only be identified as “poultry”; or if species specific, can denote a species, as “chicken

meat”, “duck meat”, “turkey meat”, etc.
Slaughter by-products are all parts of the animal or poultry produced at slaughter,

such as, but not limited to organs, blood, plasma, etc. but does not include meat from

animals, poultry, or fish, or harvest products like eggs, milk, milk products, or wool.

6

Specialty pet- any domesticated animal normally maintained in a cage or tank, such as,

but not limited to, gerbils, hamsters, canaries, psittacine birds, mynahs, finches, tropical

fish, goldfish, snakes, reptiles and turtles. For the purposes of this regulation unless

specifically noted the term “pet” will include both pet and specialty pet.

Specialty Pet food: any commercial feed prepared and distributed for consumption by

specialty pets:

which includes any domesticated animal normally maintained in a cage or tank, such as,

but not limited

to, gerbils, hamsters, canaries, psittacine birds, mynahs, finches, tropical fish, goldfish,

snakes and turtles. For the purposes of this regulation unless specifically noted the term

“pet food” will include both pet and specialty pet food.

2 This addition was necessary due to many other references in the rule to “agricultural product.” 3 We have proposed removing the reference to aquatic animals to be consistent with the

recommendation of the Aquaculture

Task Force. 4 AAFCO 2005 Official Publication, Feed ingredient definition 9.2 5 AAFCO 2005 Official Publication, Feed ingredient definition 9.57 6 AAFCO, 2005, sections 9 and 54 of Feed ingredient definitions
Subpart B Applicability:

§ 205.100 What has to be certified.

(a) Except for operations exempt or excluded in § 205.101, each production or handling

operation or specified portion of a production or handling operation that produces or

handles crops, livestock, livestock products, pet food or other agricultural products

that are intended to be sold, labeled, or represented as "100 percent organic,"

"organic," or "made with organic (specified ingredients or food group(s))" must be

certified according to the provisions of subpart E of this part and must meet all other

applicable requirements of this part.

§205.105 Allowed and prohibited substance, method, and ingredients in organic

production and handling.

To be sold or labeled as "100 percent organic," "organic," or "made with organic

(specified ingredients or food group(s))," the product must be produced and handled

without the use of:

(a) Synthetic substances and ingredients, except as provided in §

205.601 or § 205.603; (b) Nonsynthetic substances prohibited in §

205.602 or § 205.604;

(c) Nonagricultural substances used in or on processed products, except as otherwise

provided in §

205.605;

(d) Nonorganic agricultural substances used in or on processed products, except as

otherwise provided in

§ 205.606;

(e) Synthetic substances and ingredients used in or on pet food, except as provided in

§205.603, or

§205.605 7

(e f) Excluded methods, except for vaccines, Provided, That, the vaccines are

approved in accordance with § 205.600(a);

(f g) Ionizing radiation, as described in Food and Drug Administration regulation, 21 CFR

179.26 and 21

CFR 579; 8

(g h) Sewage sludge.

Subpart C Organic Production and Handling Requirements:

§ 205.237 Livestock feed and pet food.
(a) The producer of an organic livestock operation must provide livestock with a total

feed ration composed of agricultural products, including pasture and forage, that are

organically produced and, if

7 This means that synthetic substances approved for use either in human food processing or

for livestock use may be used in pet food formulations as feed additives or supplements, must 

also be FDA approved for this use, see new 205.237(c). NOSB recommended in Nov. 2000

and again in Sept. 2002 that synthetics allowed at 205.605 for food should be allowed in 

livestock production, subject to FDA or AAFCO regulations. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5058542

8 21 CFR 179.26 applies specifically to production, processing and handling of food. 21 CFR 

579 is the appropriate reference for irradiation applied to livestock feed and pet food.
applicable, organically handled: Except, that, nonsynthetic substances and synthetic

substances allowed under § 205.603 may be used as feed additives and supplements.

(b) The producer of an organic livestock operation must not:

(1) Use animal drugs, including hormones, to promote growth;

(2) Provide feed supplements or additives in amounts above those needed for

adequate nutrition and health maintenance for the species at its specific stage of

life;

(3) Feed plastic pellets for roughage;

(4) Feed formulas containing urea or manure;

(5) Feed mammalian or poultry slaughter by-products, meat, or poultry to

mammals or poultry9; or (6) Use feed, feed additives, and feed supplements in

violation of the Federal Food, Drug, and Cosmetic Act.

(7) Feed organic pet food to livestock.

(c) Pet food must be composed of agricultural products that are organically produced

and, if applicable, organically handled: Except that, nonagricultural nonsynthetic

substances, and synthetic substances allowed under §205.603, and 205.605 may be

used as feed additives and supplements provided they are allowed by the FDA in animal

feed, Nonorganic agricultural ingredients allowed under § 205.606 may be used in

products labeled organic provided they are commercially unavailable in organic form and

allowed by the FDA in animal feed.

Subpart D Labels, Labeling and Market information:

§ 205.300 Use of the term, “organic.”

(a) The term, “organic,” may only be used on labels and in labeling of raw or processed

agricultural products, including ingredients that have been produced and handled in

accordance with the regulations in this part. The term, “organic,” may not be used in a

product name to modify a nonorganic ingredient in

the product.

(b) Products for export, produced and certified to foreign national organic standards or

foreign contract buyer requirements, may be labeled in accordance with the organic

labeling requirements of the receiving country or contract buyer: Provided, That, the

shipping containers and shipping documents meet the labeling requirements specified in

§ 205.307(c).

(c) Products produced in a foreign country and exported for sale in the United States

must be certified pursuant to subpart E of this part and labeled pursuant to this

subpart D.

(d) Livestock feeds produced in accordance with the requirements of this part

must be labeled in accordance with the requirements of § 205.306.

(e) Pet foods produced in accordance with the requirements in this part must be labeled

in accordance with the requirements of subpart D, except for section 205.306. Pet food

must be composed in accordance with the requirements of 205.301(g) and must be

labeled in accordance with state and federal regulations.

10
§ 205.301 Product Composition

9 With this addition and the new definition of slaughter by-products, the rules clarify that

neither slaughter by-products or mammalian or poultry products (meat) are permitted to be fed

to organic livestock. Milk and eggs, are not prohibited as feed ingredients. Wool is a source of

lanolin, used in production of some forms of Vitamin D. 10 This change means that almost all of subpart D, except for the section specific to livestock 

feed labeling will apply to pet food. Pet food will be composed according to the new section 

205.301(g), rather than the current 205.301 (a-f).
(f) All products labeled as "100 percent organic" or "organic" and all ingredients identified

as "organic" in the ingredient statement of any product must not:

(1) Be produced using excluded methods, pursuant to § 

201.105(e); (2) Be produced using sewage sludge,

pursuant to § 201.105(f);

(3) Be processed using ionizing radiation, pursuant to § 201.105(g);

(4) Be processed using processing aids not approved on the National List of

Allowed and Prohibited Substances in subpart G of this part: Except, That, products

labeled as "100 percent organic," if processed, must be processed using organically

produced processing aids.

(5) Contain sulfites, nitrates, or nitrites added during the production or handling

process, Except, That, wine containing added sulfites may be labeled "made with

organic grapes";

(6) Be produced using nonorganic ingredients when organic ingredients are available;

or

(7) Include organic and nonorganic forms of the same ingredient.

(g) Pet Food

1. Products sold, labeled, or represented as "100 percent organic.” A raw or

processed agricultural product sold, labeled, or represented as "100 percent

organic" must contain (by weight or fluid volume, excluding water and salt) 100

percent organically produced ingredients. If labeled as organically produced,

such product must be labeled pursuant to § 205.303. No products may be

produced using prohibited practices or substances specified in §205.301(f).

2. Products sold, labeled, or represented as "organic.” A raw or processed

agricultural product sold, labeled, or represented as "organic" must contain

(by weight or fluid volume, excluding water and salt) not less than 95 percent

organically produced raw or processed agricultural ingredients products.

11

Any remaining agricultural ingredients or processing aids must be organically

produced, unless not commercially available in organic form and included on

205.606. Nonagricultural substances must be used in accordance with

205.237(c). No products may be produced using prohibited practices or

substances specified in §205.301(f), except that nonsynthetic processing aids

may be used. If labeled as organically produced, such product must be labeled

pursuant to § 205.303.

3. Products sold, labeled, or represented as "made with organic (specified

ingredients or food group(s))." Multi-ingredient agricultural product sold, labeled,

or represented as "made with organic (specified ingredients or food group(s))"

must contain (by weight or fluid volume, excluding water and salt) at least 70

percent organically produced ingredients which are produced and handled

pursuant to requirements in subpart C of this part. Nonorganic nonagricultural

ingredients must be in accordance with 205.237(c). No products may be produced

using prohibited practices specified in paragraphs (1), (2), (3), (5), and (7) of §

205.301(f). If labeled as containing organically produced ingredients or food

groups, such product must be labeled pursuant to § 205.304.

12
11 Product labeled “organic” may contain multiple organic agricultural ingredients. 12 We have included the requirement from 205.301(f) that organic and non-organic forms of

the same ingredient are not permitted in a “Made with Organic” claim. This is an effort to

prevent a misleading label claim; such as a product that claims

it is “made with organic chicken” that might have 5% organic chicken and 25% non-organic 

chicken, as well as 65% other

organic ingredients. A “made with organic” product could have organic chicken, as well as

non-organic chicken meal however, as these are two distinct ingredients according to AAFCO

definition. Although there is some uncertainty in the industry if organic and non-organic forms 

of the same ingredient are prohibited in a “Made with Organic” claim for human food, NOP has

stated it concurs that this is the correct interpretation. NOSB has recommended this 

clarification; see “Final Recommendation for Rule Change Concerning Made with Organic 

Ingredients”, March 18, 2005. This pet food requirement should be made in concert with

change to the requirements for human food.
4. Products with less than 70 percent organically produced ingredients. The organic

ingredients in multi-ingredient agricultural product containing less than 70 percent

organically produced ingredients (by weight or fluid volume, excluding water and

salt) must be produced and handled pursuant to requirements in subpart C of this

part. The nonorganic ingredients may be produced and handled without regard to

the requirements of this part. Multi-ingredient agricultural products containing less

than 70 percent organically produced ingredients may represent the organic

nature of the product only as provided in § 205.305.

Subpart G Administrative:

§205.600 Evaluation criteria for allowed and prohibited substances, methods, and

ingredients.

The following criteria will be utilized in the evaluation of substances or ingredients for the

organic production and handling sections of the National List:

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion

from the National

List of allowed and prohibited substances will be evaluated using the criteria specified

in the Act (7

U.S.C. 6517 and 6518).

(b) In addition to the criteria set forth in the Act, any synthetic substance used as a

processing aid or adjuvant will be evaluated against the following criteria:......

(c) In addition to criteria set forth in the Act, any synthetic nutrient used in pet food

should be considered in accordance with need established as requirements under

FDA or in AAFCO Nutrient Profiles. 13

§205.603 Synthetic substances allowed for use in organic livestock and pet food

production.

In accordance with restrictions specified in this section, the following synthetic substances may

be used in organic livestock production, and for organic pet food production, as applicable.

(b) As livestock feed supplements—Milk replacers—without antibiotics, as

emergency use only, no nonmilk products or products from BST treated animals.

(d) As feed supplements for pet food (reserved)

(d e) As feed additives.

(1) DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog

calcium—

for use only in organic poultry production until October 21, 2008.

(2) Trace minerals, used for enrichment or fortification when

FDA approved. (3) Vitamins, used for enrichment or fortification

when FDA approved.

(4) Other nutrients for use in pet foods: (reserved)
§ 205.604 Nonsynthetic substances prohibited for use in organic livestock and pet food

production.

The following nonsynthetic substances may not be used in organic

livestock production: (a) Strychnine

(b)-(z) [Reserved]

13 Determinations of necessity of a nutrient in a specific pet food diet can be justified by 

the requirements as established under FDA regulations or by the Dog and Cat Food 

Nutrient Profiles, as referenced in the most current AAFCO Official Publication. See 

www.aafco.org for ordering information. The other OFPA criteria at 6518(m) would also

apply (lack of organic alternatives, toxicity, environmental contamination, etc.)
§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on

processed products, including pet food, labeled as “organic” or “made with organic

(specified ingredients or food group(s)).”

§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on

processed

products, including pet

food,

labeled as “organic.”

Only the following nonorganically produced agricultural products may be used as

ingredients in or on processed products labeled as “organic,” only in accordance with

any restrictions specified in this section, and only when the product is not

commercially available in organic form.

a) Allowed for all processed products

(1)Casings, from

processed intestines..... 

(23) Whey protein

concentrate.

b) Allowed for pet food only

Appendix 2

AAFCO Dog Food Nutrient 

Profiles

Growth Adult

Unit

s

D

Reproduct Maintena

Basis Minimu Minimu Maxim

Arginine % 0.62 0.51

Histidine % 0.22 0.18

Isoleucine % 0.45 0.37

Leucine % 0.72 0.59

Lysine % 0.77 0.63

Methionine- ti% 0.53 0.43

Phenlyalanine- t i% 0.89 0.73

Threonine % 0.58 0.48

Tryptophan % 0.20 0.16

Valine % 0.48 0.39
Required Amino Acid Organic Petition 

Prepared by Crystal Springs 

Page 8 of 117

AAFCO Dog Food Nutrient 

Profiles

Units Growth & Adu

1000 Reproduct Maintenan

M Minimum Minimum Maxim

Arginine g 1.77 1.46

Histidine g 0.63 0.51

Isoleucine g 1.29 1.06

Leucine g 2.06 1.69

Lysine g 2.20 1.80

Methionine- ti g 1.51 1.23

Phenlyalanine- t i g 2.54 2.09

Threonine g 1.66 1.37

Tryptophan g 0.57 0.46

Valine g 1.37 1.11

AAFCO Cat Food Nutrient 

Profiles

Growth & Adu

Units Reproduct Maintenan

Basis Minimum Minimum Maxim

Arginine % 1.25 1.04

Histidine % 0.31 0.31

Isoleucine % 0.52 0.52

Leucine % 1.25 1.25

Lysine % 1.20 0.83

Methionine- ti% 1.10 1.10

Methionine % 0.62 0.62 1.5

Phenlyalanine- 0

t i

% 0.88 0.88

Phenylalanine % 0.42 0.42

Threonine % 0.73 0.73

Tryptophan % 0.25 0.16

Valine % 0.62 0.62

Taurine (Dry % 0.10 0.10

Taurine (Wet

F d)

% 0.20 0.20

AAFCO Cat Food Nutrient 

Profiles

Units Growth & Adu

1000 Reproduct Maintenan

M Minimum Minimum Maxim

Arginine g 3.10 2.60

Histidine g 0.78 0.78

Isoleucine g 1.30 1.30

Leucine g 3.10 3.10 1

Lysine g 3.00 2.08
Required Amino Acid Organic Petition 

Prepared by Crystal Springs 

Page 9 of 117

Methionine- ti g 2.75 2.75

Methionine g 1.55 1.55 3.7

5 Phenlyalanine- g 2.20 2.20

Phenylalanine g 1.05 1.05

Threonine g 1.83 1.83

Tryptophan g 0.63 0.40

Valine g 1.55 1.55

Taurine (Dry F d) g 0.25 0.25

Taurine (Wet

F d) g 0.50 0.50

2

3 Appendix 3
Livestock:PetFoodAminoAcids

Common 

Name Chemical Name CAS Number Trade Names Other Codes

Arginine (S)-2-Amino-5-

guanidinopentanoic acid

74-79-3 Arginine (L-) EINECS: 

230-571-

3

Methionine 2-amino-4-

(methylthio)butanoic 

acid

63-68-3 (L-); 

59-51-8 (DL-)

Mepron®; Alimet® EINECS: 

200-432-

1

Cysteine 2-amino-3-

sulfanylpropanoic acid

52-90-4; 3374-

22-9 (DL-)

L-Cysteine; LCysteine 

Hydrochloride 

Monohydrate

EINECS: 

222-160-

2

Lysine 2,6-diaminohexanoic 

acid

56-87-1 (L-); 

70-54-2 (DL-)

VitaLys®; LLysine Premium®EINECS: 

200-740-

6

Taurine 2-aminoethane sulfonic 

acid

107-35-7 Taurine: AI3-

18307; O-Due; 

Taurina; Taukard

EINECS: 

203-483-

8

Tryptophan (2S)-2-amino-3-(1Hindol-3-yl)propanoic acid73-22-3 (L-); 

54-12-6 (DL-)

TryptoPure®; LTryptophanEINECS: 

200-194-

9

Threonine 2-Amino-3-

hydroxybutanoic acid

72-19-5 (L-); 

80-68-2 (DL-)

L-Threonine; DLThreonine; EINECS: 

201-300-

6

Histidine 2-Amino-3-(1H-imidazol4-yl)propanoic acid71-00-1 (L-); 

4998-57-6 (DL-

)

L-Histidine EINECS: 

225-660-

9

Isoleucine 2-Amino-3-

methylpentanoic acid

73-32-5 (L-); 

328-39-2 (DL-)

L-Isoleucine EINECS: 

207-139-

8

Leucine 2-Amino-4-

methylpentanoic acid

61-90-5 (L-); 

328-39-2 (DL-)

L-Leucine EINECS: 

206-328-

2

Valine 2-Amino-3-

phenylpropanoic acid

72-18-4 (L-); 

516-06-3 (DL-)

L-Valine EINECS: 

208-220-

0

Phenylalanine 2-Amino-3-

phenylpropanoic acid

63-91-2 (L-); 

150-30-1 (DL-)

L- Phenylalanine EINECS: 

205-756-

7

Tyrosine L-2-Amino-3-(4-

hydroxyphenyl)propanoi

c acid

60-18-4 (L-); 

556-03-6 (DL-)

L-Tyrosine EINECS: 

209-113-

1