United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

1

September 30, 2010 

MEMORANDUM FOR THE CHAIRMAN OF THE NATIONAL ORGANIC STANDARDS BOARD 

FROM: Miles McEvoy

Deputy Administrator

National Organic Program (NOP)

SUBJECT: National Organic Standards Board Recommendations (April 2010 & November 2009)

The National Organic Standards Board (NOSB) made recommendations in April 2010 that addressed the 

following: renewal and rejection of materials on the National List used in crop production, livestock production 

and handling; annotation changes for the use of methionine in organic poultry production; a clarification on a 

livestock health practice standard under 205.238; inerts in pesticides allowed for use in organic production; 

regulations for terrestrial plants in containers and enclosures (greenhouses); regulations on the use of inert 

atmospheric gases in products labeled and sold as 100% organic; a two-tiered voting approach for materials 

petitioned to the National List; and the classification of materials. The NOSB also made a recommendation on 

vaccines in November 2009 for which NOP was to provide additional information to the Board.

DISCUSSION: 

1. Sunset 2011 - §205.601: Synthetic substances allowed for use in organic crop production. 

The NOSB reviewed the following material on the National List for use in organic crop production, due to 

sunset in 2011, and recommended continued listing until review of the petition to remove is completed for this 

material. The NOP concurs with the April 2010 NOSB recommendation to renew the following listing for crop 

production substances, and any restrictive annotations, that are due to sunset in 2011:

§205.601

As slug or snail bait. Ferric phosphate (CAS # 10045-86-0). 

2. Sunset 2012 – §205.601: Synthetic substances allowed for use in organic crop production.

The NOSB reviewed the following materials on the National List for use in organic crop production, due to 

sunset in 2012, and recommended to continue listing on the basis that no new information was presented to 

support removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following fortyfour listings for crop production substances, and any restrictive annotations:
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

2

Section Material Sunset Date

§ 205.601 Synthetic 

substances allowed for use 

in organic crop production.

Hydrogen peroxide October 21, 2012

Soap-based algicide/demossers October 21, 2012

Herbicides, soap-based October 21, 2012

Soaps, ammonium October 21, 2012

Ammonium carbonate October 21, 2012

Boric acid October 21, 2012

Elemental sulfur October 21, 2012

Lime sulfur October 21, 2012

Oils, horticultural-narrow range oils as dormant, 

suffocating, and summer oils 

October 21, 2012

Soaps, insecticidal October 21, 2012

Sticky traps/barriers October 21, 2012

Sucrose octanoate esters 

(CAS #s—42922–74–7; 58064–47–4) 

December 11, 2012

Hydrated lime October 21, 2012

Hydrogen peroxide October 21, 2012

Lime sulfur October 21, 2012

Oils, horticultural-narrow range oils as dormant, 

suffocating, and summer oils 

October 21, 2012

Potassium bicarbonate October 21, 2012

Elemental sulfur October 21, 2012

Aquatic plant extracts (other than hydrolyzed) October 21, 2012

Elemental sulfur October 21, 2012

Humic acids October 21, 2012

Soluble boron products October 21, 2012

Sulfates of zinc October 21, 2012

Sulfates of copper October 21, 2012

Sulfates of iron October 21, 2012

Sulfates of manganese October 21, 2012

Sulfates of molybdenum October 21, 2012

Sulfates of selenium October 21, 2012

Sulfates of cobalt October 21, 2012

Carbonates of zinc October 21, 2012

Carbonates of copper October 21, 2012

Carbonates of iron October 21, 2012

Carbonates of manganese October 21, 2012

Carbonates of molybdenum October 21, 2012

Carbonates of selenium October 21, 2012

Carbonates of cobalt October 21, 2012

Oxides of zinc October 21, 2012

Oxides of copper October 21, 2012

Oxides of iron October 21, 2012

Oxides of manganese October 21, 2012

Oxides of molybdenum October 21, 2012

Oxides of selenium October 21, 2012
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

3

Section Material Sunset Date

Oxides of cobalt October 21, 2012

Silicates of zinc October 21, 2012

Silicates of copper October 21, 2012

Silicates of iron October 21, 2012

Silicates of manganese October 21, 2012

Silicates of molybdenum October 21, 2012

Silicates of selenium October 21, 2012

Silicates of cobalt October 21, 2012

Liquid fish products October 21, 2012 

Vitamin B1 October 21, 2012

Vitamin C October 21, 2012

Vitamin E October 21, 2012

The NOP also recognizes that the NOSB will present a recommendation on one material listing for §205.601 at 

the October 2010 Meeting. 

Section Material Sunset Date

§ 205.601 Synthetic 

substances allowed for use in 

organic crop production

EPA List 4-Inerts of Minimal Concern October 21, 2012

The NOP also recognizes that the NOSB has requested additional technical review for nineteen material listings, 

and will defer issuing recommendations for these materials until the spring 2011 NOSB meeting.

Section Material Sunset Date

§ 205.601 Synthetic 

substances allowed for use 

in organic crop production.

Calcium hypochlorite October 21, 2012

Chlorine dioxide October 21, 2012

Sodium hypochlorite October 21, 2012

Ethanol October 21, 2012

Isopropanol October 21, 2012

Copper hydroxide October 21, 2012

Copper oxide October 21, 2012

Copper oxychloride October 21, 2012

Copper sulfate October 21, 2012

Newspapers or other recycled paper, without glossy or 

colored inks (2 listings)

October 21, 2012

Plastic mulch and covers October 21, 2012

Pheromones October 21, 2012

Sulfur dioxide October 21, 2012

Vitamin D3 October 21, 2012

Streptomycin October 21, 2012

Lignin sulfonate (2 listings) October 21, 2012

Magnesium sulfate October 21, 2012

Ethylene gas October 21, 2012

Sodium silicate October 21, 2012
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

4

3. Sunset 2012 – §205.602: Nonsynthetic substances allowed for use in organic crop production. 

The NOSB reviewed the following materials on the National List for use in organic crop production, due to 

sunset in 2012, and recommended to continue listing on the basis that no new information was presented to 

support removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following seven 

listings for crop production substances, and any restrictive annotations:

Section Material Sunset Date

§ 205.602 Nonsynthetic 

substances allowed for use 

in organic crop production.

Ash from manure burning October 21, 2012

Arsenic October 21, 2012

Lead salts October 21, 2012

Potassium chloride October 21, 2012

Sodium fluoaluminate (mined) October 21, 2012

Strychnine October 21, 2012

Tobacco dust (nicotine sulfate) October 21, 2012

The NOP recognizes that the NOSB has requested additional technical review for the listing for Sodium nitrate, 

due to sunset in October 2012, and will defer issuing a recommendation for this material until the spring 2011 

NOSB meeting. 

4. Sunset 2012 – §205.603: Synthetic substances allowed for use in organic livestock production.

The NOSB reviewed the following materials on the National List for use in organic livestock production, due to 

sunset in 2012, and recommended to continue listing on the basis that no new information was presented to 

support removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following twentyfive listings for livestock production substances, and any restrictive annotations:

Section Material Sunset Date

§ 205.603 Synthetic 

substances allowed for use 

in organic livestock 

production

Atropine (CAS #–51–55–8) December 13, 2012

Vaccines October 21, 2012

Butorphanol (CAS #–42408–82–2) December 13, 2012

Chlorhexidine October 21, 2012

Electrolytes—without antibiotics October 21, 2012

Flunixin (CAS #–38677–85–9) December 13, 2012

Hydrogen peroxide October 21, 2012

Iodine October 21, 2012

Magnesium hydroxide 

(CAS #–1309–42–8)

December 13, 2012

Oxytocin—use in postparturition therapeutic applications October 21, 2012

Ivermectin October 21, 2012

Peroxyacetic/peracetic acid (CAS #–79–21–0) December 13, 2012

Phosphoric acid October 21, 2012

Poloxalene (CAS #–9003–11–6) December 13, 2012

Tolazoline (CAS #–59–98–3) December 13, 2012

Xylazine (CAS #–7361–61–7) December 13, 2012

Iodine October 21, 2012

Lidocaine October 21, 2012
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

5

Section Material Sunset Date

Lime, hydrated October 21, 2012

Mineral oil October 21, 2012

Procaine October 21, 2012

Sucrose octanoate esters 

(CAS #s–42922–74–7, 58064–47–4)

December 11, 2012

Trace minerals October 21, 2012

Vitamins October 21, 2012

Excipients December 13, 2012

The NOP recognizes that the NOSB will present recommendations on twelve material listings for §205.603 at 

the October 2010 Meeting. 

Section Material Sunset Date

§ 205.603 Synthetic 

substances allowed for use 

in organic livestock 

production

Ethanol October 21, 2012

Isopropanol October 21, 2012

Aspirin October 21, 2012

Calcium hypochlorite October 21, 2012

Chlorine dioxide October 21, 2012

Sodium hypochlorite October 21, 2012

Furosemide December 13, 2012

Glucose October 21, 2012

Glycerine October 21, 2012

Magnesium sulfate October 21, 2012

Copper sulfate October 21, 2012

EPA List 4-Inerts of Minimal Concern October 21, 2012

5. Sunset 2012 – §205.604: Nonsynthetic substances prohibited for use in organic livestock.

The NOSB reviewed the following materials on the National List for use in organic livestock production, due to 

sunset in October 2012, and recommended to continue listing on the basis that no new information was 

presented to support removal. The NOP concurs with the April 2010 NOSB recommendation to renew the 

listing for strychnine for livestock production substances, and any restrictive annotations.

6. Sunset 2012 – §205.605(a): Nonsynthetic substances allowed as ingredients in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

The NOSB reviewed the following materials on the National List for use in organic handling, due to sunset in 

2012, and recommended to continue listing on the basis that no new information was presented to support 

removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following seventeen 

listings for handling substances, and any restrictive annotations:

Section Material Sunset Date

§ 205.605(a) Nonsynthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

Calcium hypochlorite October 21, 2012

Alginic acid October 21, 2012

Citric acid October 21, 2012

Lactic acid October 21, 2012
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

6

Section Material Sunset Date

as ―organic‖ or ―made with 

organic

Bentonite October 21, 2012

Calcium carbonate October 21, 2012

Calcium chloride October 21, 2012

Dairy cultures October 21, 2012

Diatomaceous earth October 21, 2012

Kaolin October 21, 2012

Nitrogen – oil free grades October 21, 2012

Oxygen – oil free grades October 21, 2012

Perlite October 21, 2012

Potassium chloride October 21, 2012

Sodium bicarbonate October 21, 2012

Sodium carbonate October 21, 2012

Carnauba wax—nonsynthetic October 21, 2012

The NOP recognizes that the NOSB will present recommendations on seven material listings for §205.605(a) at 

the October 2010 Meeting. 

Section Material Sunset Date

§ 205.605(a) Nonsynthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

as ―organic‖ or ―made with 

organic

Flavors October 21, 2012

Magnesium sulfate October 21, 2012

Autolysate October 21, 2012

Bakers yeast October 21, 2012

Brewers yeast October 21, 2012

Nutritional yeast October 21, 2012

Smoked yeast October 21, 2012

The NOP also recognizes that the NOSB has requested additional technical review for two material listings, and 

will defer issuing recommendations for these materials until the spring 2011 NOSB meeting.

Section Material Sunset Date

§ 205.605(a) Nonsynthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

as ―organic‖ or ―made with 

organic for use in organic 

crop production.

Enzymes October 21, 2012

Potassium iodide October 21, 2012

7. Sunset 2012 – §205.605(b): Synthetic substances allowed as ingredients in or on processed products 

labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

The NOSB reviewed the following materials on the National List for use in organic handling, due to sunset in 

2012, and recommended to continue listing on the basis that no new information was presented to support 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

7

removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following twenty-five 

listings for handling substances, and any restrictive annotations:

Section Material Sunset Date

§ 205.605(b) Synthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

as ―organic‖ or ―made with 

organic

Alginates October 21, 2012

Ammonium bicarbonate October 21, 2012

Ammonium carbonate October 21, 2012

Ascorbic Acid October 21, 2012

Calcium citrate October 21, 2012

Calcium hydroxide October 21, 2012

Calcium phosphates monobasic October 21, 2012

Calcium phosphates dibasic October 21, 2012

Calcium phosphates tribasic October 21, 2012

Carbon dioxide October 21, 2012

Ethylene October 21, 2012

Monoglycerides* To be reconsidered at Fall 2010 meeting 

due to public comments after close of ANPR

October 21, 2012

Diglycerides* To be reconsidered at Fall 2010 meeting due 

to public comments after close of ANPR

October 21, 2012

Glycerin October 21, 2012

Hydrogen peroxide October 21, 2012

Magnesium carbonate October 21, 2012

Magnesium chloride October 21, 2012

Magnesium stearate October 21, 2012

Ozone October 21, 2012

Potassium acid tartrate October 21, 2012

Potassium carbonate October 21, 2012

Potassium citrate October 21, 2012

Potassium hydroxide October 21, 2012

Potassium phosphate October 21, 2012

Xanthan gum October 21, 2012

The NOP recognizes that the NOSB will present recommendations on eleven material listings for §205.605(a) at 

the October 2010 Meeting. 

Section Material Sunset Date

§ 205.605(b) Synthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

as ―organic‖ or ―made with 

organic

Calcium hypochlorite October 21, 2012

Chlorine dioxide October 21, 2012

Sodium hypochlorite October 21, 2012

Ferrous sulfate October 21, 2012

Pectin (low-methoxy) October 21, 2012

Phosphoric acid October 21, 2012

Silicon dioxide October 21, 2012

Sodium citrate October 21, 2012

Sodium hydroxide October 21, 2012

Sodium phosphates October 21, 2012

Sulfur dioxide October 21, 2012
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

8

The NOP also recognizes that the NOSB has requested additional technical review for four material listings, and 

will defer issuing recommendations for these materials until the spring 2011 NOSB meeting.

Section Material Sunset Date

§ 205.605(a) Nonsynthetic 

substances allowed as 

ingredients in or on 

processed products labeled 

as ―organic‖ or ―made with 

organic for use in organic 

crop production.

Nutrient vitamins October 21, 2012

Nutrient minerals October 21, 2012

Potassium iodide October 21, 2012

Tocopherols October 21, 2012

8. Sunset 2012 – §205.606: Nonorganically produced agricultural products allowed as ingredients in or 

on processed products labeled as “organic.”

The NOSB reviewed the following materials on the National List for use in organic production and handling, 

due to sunset in 2012, and recommended to continue listing on the basis that no new information was presented 

to support removal. The NOP concurs with the April 2010 NOSB recommendation to renew the following 

nineteen listings for organic production and handling substances, and any restrictive annotations:

Section Material Sunset Date

§ 205.606 Nonorganically 

produced agricultural 

products allowed as 

ingredients in or on 

processed products labeled 

as ―organic.‖

Casings, from processed intestines June 27, 2012

Celery powder June 27, 2012

Chia (Salvia hispanica L.) June 27, 2012

Dillweed oil (CAS # 8006-75-5) June 27, 2012

Fish oil (fatty acid CAS #’s 10417-94-4 and 25167-62-8) June 27, 2012

Galangal, frozen June 27, 2012

Gelatin (CAS # 9000-70-8) June 27, 2012

Arabic gum October 21, 2012

Guar gum October 21, 2012

Locust bean gum October 21, 2012

Carob bean gum October 21, 2012

Kelp October 21, 2012

Konjac flour (CAS # 37220-17-0) June 27, 2012

Lemongrass, frozen June 27, 2012

Orange shellac – unbleached (CAS # 9000-59-3) June 27, 2012

Peppers (chipotle chile) June 27, 2012

Sweet potato starch, for bean thread production only June 27, 2012

Turkish bay leaves June 27, 2012

Wakame seaweed (Undaria pinnatifida). June 27, 2012

The NOP recognizes that the NOSB will present recommendations on twenty-five material listings for §205.606 

at the October 2010 Meeting. 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

9

Section Material Sunset Date

§ 205.606 Nonorganically 

produced agricultural 

products allowed as 

ingredients in or on 

processed products labeled 

as ―organic.‖

Annatto extract color (pigment CAS # 1393-63-1) – water 

and oil soluble

June 27, 2012

Beet juice extract color (pigment CAS # 7659-95-2) June 27, 2012

Beta-carotene extract color from carrots (CAS # 1393-63-1) June 27, 2012

Black currant juice color (pigment CAS #’s: 528-58-5, 

528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Black/purple carrot juice color (pigment CAS #’s: 528-58-

5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Blueberry juice color (pigment CAS #’s: 528-58-5, 528-53-

0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Carrot juice color (pigment CAS # 1393-63-1) June 27, 2012

Cherry juice color (pigment CAS #’s: 528-58-5, 528-53-0, 

643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Chokeberry – Aronia juice color (pigment CAS #’s: 528-

58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3)

June 27, 2012

Elderberry juice color (pigment CAS #’s: 528-58-5, 528-

53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Grape juice color (pigment CAS #’s: 528-58-5, 528-53-0, 

643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Grape skin extract color (pigment CAS #’s: 528-58-5, 528-

53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Paprika color - dried powder and vegetable oil extract (CAS 

# 68917-78-2)

June 27, 2012

Pumpkin juice color (pigment CAS # 127-40-2) June 27, 2012

Purple potato juice color (pigment CAS #’s: 528-58-5, 528-

53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3), 

June 27, 2012

Red cabbage extract color (pigment CAS #’s: 528-58-5, 

528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Red radish extract color (pigment CAS #’s 528-58-5, 528-

53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)

June 27, 2012

Saffron extract color (pigment CAS # 1393-63-1) June 27, 2012

Turmeric extract color (CAS # 458-37-7) June 27, 2012

Fructo-oligosaccharides (CAS#308066-66-2) June 27, 2012

Hops (humulus lupulus) June 27, 2012

Inulin, oligofructose enriched 

(CAS # 9005-80-5)

June 27, 2012

Pectin (high-methoxy) October 21, 2012

Cornstarch (native) October 21, 2012

Whey protein June 27, 2012

9. Methionine

The NOSB issued a two-part recommendation on the use of synthetic methionine in organic poultry production 

in April 2010. The first part of the recommendation extended the allowance for methionine in organic poultry 

production until October 1, 2012, at the following maximum allowable limits of methionine per ton of feed: 4 

pounds for layers, 5 pounds for broilers, and 6 pounds for turkeys and all other poultry. 

The NOP responded to this recommendation by issuing an interim rule on August 24, 2010 that extends the use 

of methionine at the levels specified above. The interim rule will become effective Oct. 1, 2010, and is 

currently available for comments until October 25, 2010. The NOP will issue a final rule for this amendment to 

the National List no later than March 2011. 

The second part of the recommendation is for a step down in the maximum allowable limits of methionine per 

ton of feed after October 1, 2012 to the following: 2 pounds for layers and broilers and 3 pounds for turkeys and 

all other poultry. The NOSB recommendation indicates that this step down will be feasible in conjunction with 

stocking rates for poultry specified in the NOSB’s November 2009 animal welfare recommendation. 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

10

The NOP is concerned that there is limited scientific or economic justification for the step down in the 

maximum allowable limits of methionine. It will be challenging for the NOP to complete the rulemaking 

process on the step down rates without additional justification. The NOP may not be able to complete a 

proposed and final rule before October 1, 2012 without additional justification. If the NOP is unsuccessful in 

completing rule making prior to October 1, 2012, then methionine will not be allowed in organic poultry 

production after October 1, 2012.

The NOP is requesting that the NOSB provide additional justification on the methionine step down rates of 2 

pounds of methionine per ton of feed for layers and broilers and 3 pounds of methionine per ton of feed for 

turkeys and all other poultry. The NOP is requesting that the board provide scientific and economic justification 

as well as the likelihood that natural alternatives to synthetic methionine will be available by October 1, 2012. 

The NOP would also suggest the Board revisit the National Research Council (NRC) requirements for poultry 

feed to determine whether the step down levels are appropriate. 

Furthermore, the NOP believes that it is unlikely for a rule change on stocking rates to be completed prior to

October 2012. The Board may want to consider whether the time horizon for a stocking rate rule has any 

implications for the second part of their recommendation on the use of synthetic methionine.

10. Clarification on Livestock Health Care Practice Standard (205.238(c)(1))

In November 2009 the NOSB approved an animal welfare recommendation. In April 2010 the NOSB 

reconsidered a portion of the November 2009 recommendation and voted to delete the last sentence of 

§205.238(c)(1) from their November recommendation. The intent of this deletion is to permit milk from a cow 

treated with an allowed synthetic substance under §205.603 to be fed to young organic livestock during the 

withholding period. The NOSB’s animal welfare recommendation affirms the intent of the regulations that milk 

produced after the treatment but during the withholding period may be fed to young organically managed 

livestock. The NOP concurs with the NOSB’s clarification and will consider this sentence removed from the 

NOSB’s November 2009 animal welfare recommendation. 

11. Inerts in Pesticides

In April 2010, the NOSB issued a formal recommendation to the National Organic Program (NOP) regarding 

the use of inerts in pesticides allowed for use in organic production. The NOSB proposed six steps to 

accomplish the changes in regulation needed to amend the current listing for inert ingredients on the National 

List. These steps include NOSB review of synthetic inert materials currently on the obsolete EPA List 4, inerts 

of minimal concern; and EPA List 3, inerts of unknown toxicity.

The NOSB requested that the NOP create and enter into a Memorandum of Understanding (MOU) with the EPA 

to assist in the evaluation of the materials previously known as EPA List 4 and EPA List 3. The MOU will 

involve collaboration between EPA, NOSB, and NOP to determine how best to evaluate these materials for 

listing, maintain the list, and continue to evaluate new inert materials for inclusion on the List.

In response to the Board’s recommendation, the NOP has written a draft MOU for EPA to consider how the 

NOP and EPA can work together in conjunction with the NOSB to resolve issues surrounding inert ingredients 

used in pesticides allowed in organic production. The NOP understands that the evaluation of inert pesticide 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

11

ingredients for organic agriculture production will be challenging work for the NOSB. The NOP is concerned 

about the feasibility of the NOSB’s proposal to have the NOSB individually review all synthetic inert 

ingredients currently used in NOP compliant pesticide formulations. Neither the NOSB nor the NOP has access 

to necessary information or expertise to successfully and efficiently complete the task. The NOP is requesting 

support from EPA in identifying and evaluating suitable inert pesticide ingredients to be considered for use in 

organic agriculture production.

As the collaboration between NOSB, EPA, and NOP continues, the NOP would also like the NOSB to consider 

how inert ingredients are regulated under other organic standards. At this time, the National Organic Standards 

have one of the most prescriptive requirements for inert ingredients among organic standards worldwide. 

Outside of the United States most organic standards generally specify allowed active ingredients but leave it to 

the respective governmental environmental agencies to evaluate the safety of inert ingredients. 

The NOP recognizes that amending the current listing for inert ingredients will take time. In the interim, the 

approval of new inert ingredients must continue to follow the process outlined in the NOP policy statement 

issued on September 6, 2007. Petitions for new inert ingredients may be submitted to the NOSB using the 

National List petition procedures. Petitioned substances must be recommended by the NOSB and added to the 

National List through notice and comment rulemaking before use in organic agriculture.

12. Production Standards for Terrestrial Plants in Containers and Enclosures (Greenhouses)

The NOP thanks the NOSB for their completion of work on greenhouse standards through their April 2010 

recommendation. The NOP will develop a proposed rule based on the NOSB final recommendations.

13. The Use of Inert Atmospheric Gases in Products Labeled and Sold as 100% Organic

The April 2010 NOSB recommendation on the use of inert atmospheric gases in packaging states that such 

gases should not be considered ingredients or processing aids, but rather as ―packaging aids‖ that do not need 

consideration in determination of a 100% organic label claim.

The NOP is considering this proposal in context of additional guidance under development regarding 

clarification of the 100% organic labeling category. The NOP regulations do not provide for another category of 

food additives, aside from ingredients and processing aids. The NOP regulation provides an allowance for most 

packaging materials, provided they do not contain synthetic fungicides, preservatives or fumigants. 

Gases used in packaging are regulated by FDA as direct food substance, at 21 CFR, Part 184—Direct Food 

Substances Affirmed As Generally Recognized As Safe (GRAS). Nitrogen gas is regulated by FDA at 21 CFR 

184.1540, which states; 

―The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food 

ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a propellant, aerating agent, and gas as defined in §170.3(o)(25) of this 

chapter.‖
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

12

Carbon dioxide is similarly characterized by FDA as an ingredient at the GRAS listing of 21 CFR 184.1240, 

with permitted uses as leavening agent, processing aid, and as a propellant and gas. 

Argon gas is not listed by FDA as GRAS; however, FDA did issue a notice in 2000 stating that they did not 

have questions about a manufacturer’s claim that the substance is GRAS for the use as a replacement for air in 

containers of wines, and fruit and vegetable juices. Argon is not listed in the FDA Inventory of Effective Food 

Contact Substance Notifications. 

The NOSB describes a new category of substances as ―packaging aids‖ and believes that these should not be 

considered ingredients or processing aids. However, no definition of ―packaging aid‖ or ―inert atmospheric 

gases‖ is provided in their recommendation. 

NOP does not see a basis for exempting a category of ingredients as ―packaging aids‖ from regulations 

governing composition or labeling of products, since they are not considered packaging. Packaging aids as a 

class of materials may include substances that are designed to react with foods and should not be exempted from 

review by the NOSB. 

Inert atmospheric gases include nitrogen (N2 - approximately 80% by volume of dry air) and argon 

(approximately 1% by volume of dry air). Nitrogen and carbon dioxide (which is atmospheric though not an 

inert gas) are currently listed as allowed ingredients on 205.605(b). However, argon is not listed. It is not 

permitted in organic food products.

NOP will take the recommendation under advisement for future guidance on clarification of the 100% label 

category. 

14. Two-tiered Voting Approach for Materials Petitioned to the National List 

The NOP recognizes the amendments to the NOSB Policy Manual. The changes to the manual will be 

incorporated into the official NOSB Policy Manual.

15. Classification of Materials

The NOP appreciates the extensive work completed by NOSB on this important subject. The classification of 

materials is a key function of the NOSB and the foundation for decisions made by certifying agents, materials 

review programs, and the NOP. The distinction between synthetic and nonsynthetic materials is a fundamental 

premise of the OFPA in determining what is permitted or not in organic production. The classification of some 

substances as agricultural is also important as this determines whether they must be sourced from organic 

sources for use in handling or livestock feed. Substances classified as agricultural may be used in ―made with 

organic (specified ingredient(s))‖ products without appearing on the National List. 

The November 2009 and April 2010 NOSB recommendations on materials classification proposed a number of 

new definitions to help clarify the Board’s decision making process. The NOP agrees that some additional 

definitions are useful, but would like further clarification from the Board of how these definitions will be used in 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

13

the classification process. Such clarification is necessary for NOP to determine whether guidance or a 

regulatory change is more appropriate to address this issue.

The NOP urges the NOSB to continue to formulate procedures (such as the draft worksheet decision trees) for 

classification of materials. However, the NOP recommends that the NOSB work on classification of materials 

according to their use. For instance, crop materials and inputs for livestock health care should be evaluated to 

determine whether they are synthetic or nonsynthetic, as this is the fundamental question in regards to the 

National List. Materials used in food handling and livestock feed should be reviewed first to determine whether 

they are agricultural or non-agricultural as this is the fundamental question in how they are considered under the 

NOP regulations. The NOP does not believe it is necessary or appropriate to have one single classification 

system for classes of substances that have different criteria for end use. The National List includes substances 

that are allowed in one category but are not allowed in other categories (e.g. phosphoric acid is a prohibited 

synthetic in crop production but allowed as a processing aid). 

The NOP is responding to the NOSB proposal (shown in italics) on classification of materials by section as 

detailed below: 

1. Guiding Principles

 The classification of a material is determined by both the source of the inputs and the process used to 

make the material. 

 The same material can be agricultural, non-synthetic or synthetic depending on source and process. 

The NOP supports the first statement, but finds the second point redundant. As a material is reviewed by the 

NOSB, it should be classified accurately based on the review of information available at the time. If multiple 

forms of the same substance are possible, the NOSB should annotate the listing to indicate which forms are 

allowed. 

 If a material is processed such that it is classified as synthetic then the material is classified as synthetic 

regardless of source. A material of this type would most correctly be referred to as an “agriculturally 

sourced material which has been processed in such a way as to classify the material synthetic.” 

Materials that are manufactured in full compliance with the final rule are outside the scope of this 

principle; their status with regards to use in organic is not affected by this recommendation

The NOP agrees that an agricultural material can be processed in a manner that renders it synthetic.

2. NOSB Practices

 Voting on the classification of a petitioned material before voting on whether a petitioned material 

should be listed on the National List. 

 Increase, where appropriate, the NOSB’s use of annotations to properly list source or process where 

either are a determining factor for how a material is classified and placed on the National List. 

 Refocus on fully understanding the technical aspects of a petitioned material and all the variations of 

source and process available in the marketplace to manufacture the material. 

The NOP supports these practices and would like to clarify the response given to the Board in April regarding 

voting process. The NOP supports the NOSB taking two votes on each material: the first to classify the 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

14

substance, and the second to decide whether to list the substance. As noted above, the process for classification 

should be tailored to the category of use. Crop and livestock materials need only to be considered as synthetic or 

nonsynthetic, whereas materials used in handling or in livestock feed require a determination of agricultural 

status. 

3. NOSB Proposed Definitions 

 a. Chemical Change An occurrence whereby the identity of a substance is modified, such that the 

resulting substance possesses a different distinct identity (see related definition of “substance”) 

Processing, as defined in §205.2, of agricultural products using materials allowed on the applicable 

section of the National List (i.e., §205.601 for crops, §205.603 for livestock and §205.605 / §205.606 for 

handling), does not result in chemical change as it applies to classification of materials.

The NOP does not support the above definition. The additional underlined sentence, as adopted in the May 

NOSB recommendation, adds a meaning to the term ―chemical change‖ that is contrary to common 

understanding of a widely used term. It is a tenet of good regulatory drafting that definitions adopted should not 

contradict commonly understood definitions or include a substantive rule within a definition. The proposal to 

exempt certain processing methods and synthetic materials from causing the effect of chemical change is a 

substantial regulatory provision, which conflicts with the common understanding of chemical change, and could 

cause unintended consequences. Substances derived from agriculture used in food processing can be classed as 

agricultural despite common chemical changes achieved through baking, cooking, roasting etc. This criterion 

can be added to the evaluation worksheet for determination of agricultural status, and should not be in the larger 

definition of chemical change.

The NOP prefers the definition and discussion regarding chemical change provided in the NOP April 2006 

―Recommended Framework to Further Clarify the Definition of Synthetic‖.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5070270&acct=nosb

 b. Extract - To separate, withdraw, or obtain one or more essential constituents of an organism,

substance or mixture by use of solvents, mechanical or physical methods. 

The NOSB discussion of this point states: 

“For our recommendation, extraction with a synthetic not on the National List would not result in a 

material being classified as synthetic unless either the extraction resulted in chemical change or the 

synthetic remained in the final material at a significant level. Also, extraction is broadly defined to also 

include mechanical and physical separation in addition to solvent extraction. This is consistent with current 

classification practices.”

The NOP believes this is an important definition, but feels that it needs further clarification. The NOSB only 

mentions solvent extraction, but does not clarify if other synthetic materials may be used in the extraction 

process. More elaboration is needed to describe what constitutes change when a substance is extracted from a 

natural source (as referenced in the April 2006 framework). 

 c. Formulate: To combine different materials according to a recipe or formula to prepare the product 

being evaluated. 
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

15

 d. Manufacture: To make a crop, livestock or handling input from raw materials. 

The NOP does not object to the definitions for ―formulate‖ and ―manufacture‖ but questions the need for them.

It is not clear how these definitions will be used.

 e. Nonagricultural Substance: A product, such as a mineral or atmospheric gas, that does not originate 

from agriculture. For the purposes of this part agricultural refers to the production or handling of crops 

or livestock. 

The NOP does not object to the above definition, but proposes that some ambiguity remains. For example, does 

the removal of the example of ―bacterial culture‖ mean that microorganisms, dairy cultures, and their products 

are considered agricultural? The NOSB has indicated they will be determining this on a case by case basis. If 

so, it would be useful to develop criteria for this review of microorganisms and their products. The NOP 

acknowledges that the current definition, which includes pectins and gums as nonagricultural conflicts with the 

present listings at 205.606. 

 f. Naturally Occurring Biological Process: Chemical changes that occur in living cells or due to the 

action of products of living organisms, such as enzymes. 

NOP supports the above definition.

 g. Substance: An element, molecular species, or chemical compound that possesses a distinct identity 

(For example, a distinct identity may be demonstrated through the material having a separate Chemical 

Abstract Service (CAS) number (in some cases the same material may have multiple CAS numbers), 

Codex International Numbering System (INS) number, or FDA or other agency standard of identity).

The NOP believes that the definition of ―substance‖ is important for clarifying the meaning of chemical change. 

However, this needs careful consideration as to the impact this definition may have since the word ―substance‖ 

is used extensively throughout the current rule. It is part of the definitions of agricultural inputs, fertilizer, and 

ingredient. One must petition a ―substance‖ to the National List following procedures referenced at 205.607. 

Some ―substances‖ now on the National List are more accurately described as combinations or classes of 

substances, such as mulches, soaps, vaccines, natural flavors, microbial cultures, etc. 

The NOP appreciates the work the NOSB has done to provide clarification on this challenging area. The NOP 

looks forward to collaboration in development of worksheets used for decision making for classification of

crops, livestock, and processing materials. It may be worth considering the revision of committee 

recommendation forms for materials into specific versions according to their petitioned end use. The revised 

versions could retain the current OFPA and rule criteria questions that are currently in the checklist format and

incorporate a new section that spells out the relevant end-use specific classification questions supported by the 

decision-making criteria essential to those classifications.

16. Vaccines

On November 5, 2009, the NOSB made a recommendation to clarify that vaccines produced through excluded 

methods (genetically modified organisms or GMOs) are allowed under 205.603 and do not need to be 

individually petitioned for allowance on the National List. Further, the NOSB recommended that vaccines 

produced from non-excluded methods be located and used before those produced by excluded methods.
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

16

The preamble to the National Organic Program final rule (FR Vol. 65, No. 246, page 80554) states:

The Act allows use of animal vaccines in organic livestock production. Given the general prohibition 

on the use of excluded methods, however, we believe that animal vaccines produced using excluded 

methods should not be allowed without an explicit consideration of such materials by the NOSB and 

without an affirmative determination from the NOSB that they meet the criteria for inclusion on the 

National List. It is for that reason that we have not granted this request of commenters but, rather, 

provided an opportunity for review of this narrow range of materials produced using excluded methods 

through the National List process. 

The NOP’s understanding is that excluded methods are prohibited under Section 205.105(e) except for

vaccines. Further, this exception applies to vaccines that are produced through excluded methods only if those 

GMO vaccines are approved according to 205.600(a). Vaccines are listed under 205.603(a)(4) under 

―Biologics-Vaccines‖. The NOSB has not reviewed vaccines in accordance with 205.600(a). The listing under 

205.603(a)(4) of Biologics-Vaccines does not include the allowance of GMO vaccines. The NOP requested a 

legal review from USDA’s Office of General Counsel (OGC) to determine whether vaccines produced through 

excluded methods are currently allowed under 205.603(a)(4). The OGC opinion supports the position that 

GMO vaccines are allowed only if they are approved according to 205.600(a). 

The NOP recommends that the NOSB review GMO vaccines under the provisions of 205.600(a). The NOP

suggests that the Board request a technical review for biologics-vaccines, including the status of genetically 

modified vaccines and an assessment of the economic impact of using commercial availability criteria for nongenetically modified vaccines. After the Board completes the evaluation according to the OFPA criteria, it may 

submit a recommendation to the NOP to add GMO vaccines to the National List of Allowed and Prohibited 

Substances.
United States Agricultural 1400 Independence Avenue, S.W.

Department of Marketing Room 2646-S, Ag Stop 0268

Agriculture Service Washington, D.C. 20250-0268

17

Attachment to Memorandum: References pertinent to Classification of Materials 

The Organic Food Production Act of 1990, (7U.S.C. 6501 et. seq.)

7 USC 6502 Definitions

Agricultural Products- the term ―agricultural product‖ means any agricultural commodity or product, whether 

raw or processed, including any commodity of product derived from livestock that is marketing in the United 

States for human or livestock consumption. 

Organically Produced - the term ―organically produced‖ means an agricultural product that is produced and 

handled in accordance with this title.

Synthetic – The term ―synthetic‖ means a substance that is formulated or manufactured by a chemical process or 

by a process that chemically changes a substance extracted from a naturally occurring plant, animal, or mineral 

sources, except that such term shall not apply to substances created by naturally occurring biological processes. 

Processing – The term ―processing‖ means cooking, baking, heating, drying, mixing, grinding, churning, 

separating, extraction, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, or otherwise 

manufacturing, and included the packaging, canning, jarring, or otherwise enclosing food in a container. 

NOP regulation, 7CFR Part 205

§205.2 Terms defined

Nonagricultural substance. A substance that is not a product of agriculture, such as a mineral or bacterial culture 

that is used as an ingredient in an agricultural product. For the purposes of this part, a nonagricultural ingredient 

also includes any substance, such as gums, citric acid, or pectin that is extracted from, isolated from or a fraction 

of an agricultural product so that the identity of the agricultural product is unrecognizable in the extract, isolate, 

or fraction. 

Nonsynthetic (natural). A substance that is derived from mineral, plant, or animal matter and does not undergo a 

synthetic process as defined in section 6502 (21) of the Act (7 U.S.C. 6502(21)). For the purposes of this part, 

nonsynthetic is used as a synonym for natural as the term used in the Act‖ 

Processing. Cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extraction, 

slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling, or 

otherwise manufacturing and in includes the packaging, canning, jarring or otherwise enclosing food in a 

container.