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) Nonsynthetics used in organic processing will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).
205.601 Synthetic substances allowed for use in organic crop production.
In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: Provided, That, use of such substances do not contribute to contamination of crops, soil, or water. Substances allowed by this section, except disinfectants and sanitizers in paragraph (a) and those substances in paragraphs (c), (j), (k), and (l) of this section, may only be used when the provisions set forth in 205.206(a) through (d) prove insufficient to prevent or control the target pest.
(a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning systems.
(1) Alcohols.
(i) Ethanol.
(ii) Isopropanol.
(2) Chlorine materials- Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(3) Copper sulfate-for use as an algicide in aquatic rice systems, is limited to one application per field during any 24-month period. Application rates are limited to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
(4) Hydrogen peroxide.
(5) Ozone gas - for use as an irrigation system cleaner only.
(6) Peracetic acid - for use in disinfecting equipment, seed, and asexually propagated planting material.
(7) Soap-based algicide/demossers.
(8) Sodium carbonate peroxyhydrate (CAS 15630-89-4)-Federal law restricts the use of this substance in food crop production to approved food uses identified on the product label.
(b) As herbicides, weed barriers, as applicable.
(1) Herbicides, soap-based-for use in farmstead maintenance (roadways, ditches, right of ways, building perimeters) and ornamental crops.
(2) Mulches.
(i) Newspaper or other recycled paper, without glossy or colored inks.
(ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)).
(c) As compost feedstocks-Newspapers or other recycled paper, without glossy or colored inks.
(d) As animal repellents - Soaps, ammonium-for use as a large animal repellant only, no contact with soil or edible portion of crop.
(e) As insecticides (including acaricides or mite control).
(1) Ammonium carbonate - for use as bait in insect traps only, no direct contact with crop or soil.
(2) Aqueous potassium silicate (CAS 1312-76-1) - the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.
(3) Boric acid - structural pest control, no direct contact with organic food or crops.
(4) Copper sulfate - for use as tadpole shrimp control in aquatic rice production, is limited to one application per field during any 24-month period. Application rates are limited to levels which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
(5) Elemental sulfur.
(6) Lime sulfur - including calcium polysulfide.
(7) Oils, horticultural - narrow range oils as dormant, suffocating, and summer oils.
(8) Soaps, insecticidal.
(9) Sticky traps/barriers.
(10) Sucrose octanoate esters (CAS 42922-74-7; 58064-47-4)-in accordance with approved labeling.
(f) As insect management. Pheromones.
(g) As rodenticides.
(1) Sulfur dioxide-underground rodent control only (smoke bombs).
(2) Vitamin D3.
(h) As slug or snail bait. Ferric phosphate (CAS 10045-86-0).
(i) As plant disease control.
(1) Aqueous potassium silicate (CAS 1312-76-1)-the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.
(2) Coppers, fixed - copper hydroxide, copper oxide, copper oxychloride, includes products exempted from EPA tolerance, Provided, That, copper-based materials must be used in a manner that minimizes accumulation in the soil and shall not be used as herbicides.
(3) Copper sulfate - Substance must be used in a manner that minimizes accumulation of copper in the soil.
(4) Hydrated lime.
(5) Hydrogen peroxide.
(6) Lime sulfur.
(7) Oils, horticultural, narrow range oils as dormant, suffocating, and summer oils.
(8) Peracetic acid - for use to control fire blight bacteria.
(9) Potassium bicarbonate.
(10) Elemental sulfur.
(11) Streptomycin, for fire blight control in apples and pears only.
(12) Tetracycline, for fire blight control only and for use only until October 21, 2012.
(j) As plant or soil amendments.
(1) Aquatic plant extracts (other than hydrolyzed) - Extraction process is limited to the use of potassium hydroxide or sodium hydroxide; solvent amount used is limited to that amount necessary for extraction.
(2) Elemental sulfur.
(3) Humic acids - naturally occurring deposits, water and alkali extracts only.
(4) Lignin sulfonate - chelating agent, dust suppressant, floatation agent.
(5) Magnesium sulfate - allowed with a documented soil deficiency.
(6) Micronutrients-not to be used as a defoliant, herbicide, or desiccant. Those made from nitrates or chlorides are not allowed. Soil deficiency must be documented by testing.
(i) Soluble boron products.
(ii) Sulfates, carbonates, oxides, or silicates of zinc, copper, iron, manganese, molybdenum, selenium, and cobalt.
(7) Liquid fish products - can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the minimum needed to lower the pH to 3.5.
(8) Vitamins, B1, C, and E.
(9) Sulfurous acid (CAS 7782-99-2) for on-farm generation of substance utilizing 99% purity elemental sulfur per paragraph (j)(2) of this section.
(k) As plant growth regulators. Ethylene gas - for regulation of pineapple flowering.
(l) As floating agents in postharvest handling.
(1) Lignin sulfonate.
(2) Sodium silicate - for tree fruit and fiber processing.
(m) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances.
(1) EPA List 4 - Inerts of Minimal Concern.
(2) EPA List 3 - Inerts of unknown toxicity-for use only in passive pheromone dispensers.
(n) Seed preparations. Hydrogen chloride (CAS 7647-01-0)-for delinting cotton seed for planting. (o) - (z)
205.602 Nonsynthetic substances prohibited for use in organic crop production.
The following nonsynthetic substances may not be used in organic crop production:
(a) Ash from manure burning.
(b) Arsenic.
(c) Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to treat a physiological disorder associated with calcium uptake.
(d) Lead salts.
(e) Potassium chloride-unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil.
(f) Sodium fluoaluminate (mined).
(g) Sodium nitrate-unless use is restricted to no more than 20% of the crop's total nitrogen requirement; use in spirulina production is unrestricted until October 21, 2005.
(h) Strychnine.
(i) Tobacco dust (nicotine sulfate). (j) - (z)
205.603 Synthetic substances allowed for use in organic livestock production.
In accordance with restrictions specified in this section the following synthetic substances may be used in organic livestock production:
(a) As disinfectants, sanitizer, and medical treatments as applicable.
(1) Alcohols.
(i) Ethanol-disinfectant and sanitizer only, prohibited as a feed additive.
(ii) Isopropanol-disinfectant only.
(2) Aspirin-approved for health care use to reduce inflammation.
(3) Atropine (CAS 51-55-8)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(ii) A meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a milk discard period of at least 12 days after administering to dairy animals.
(4) Biologics-Vaccines.
(5) Butorphanol (CAS 42408-82-2)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR Part 205, the NOP requires:
(ii) A meat withdrawal period of at least 42 days after administering to livestock intended for slaughter; and a milk discard period of at least 8 days after administering to dairy animals.
(6) Chlorhexidine-Allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.
(7) Chlorine materials-disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(8) Electrolytes-without antibiotics.
(9) Flunixin (CAS 38677-85-9)-in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required by the FDA.
(10) Furosemide (CAS 54-31-9)-in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required that required by the FDA.
(11) Glucose.
(12) Glycerine-Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils.
(13) Hydrogen peroxide.
(14) Iodine.
(15) Magnesium hydroxide (CAS 1309-42-8)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires use by or on the lawful written order of a licensed veterinarian.
(16) Magnesium sulfate.
(17) Oxytocin - use in postparturition therapeutic applications.
(18) Paraciticides. Ivermectin-prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period for breeding stock.
(19) Peroxyacetic/peracetic acid (CAS 79-21-0)-for sanitizing facility and processing equipment.
(20) Phosphoric acid-allowed as an equipment cleaner, Provided , That, no direct contact with organically managed livestock or land occurs.
(21) Poloxalene (CAS 9003-11-6)-for use under 7 CFR part 205, the NOP requires that poloxalene only be used for the emergency treatment of bloat.
(22) Tolazoline (CAS 59-98-3)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(iii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.
(23) Xylazine (CAS 7361-61-7)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(iii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.
(b) As topical treatment, external parasiticide or local anesthetic as applicable.
(1) Copper sulfate.
(2) Iodine.
(3) Lidocaine - as a local anesthetic. Use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.
(4) Lime, hydrated - as an external pest control, not permitted to cauterize physical alterations or deodorize animal wastes.
(5) Mineral oil - for topical use and as a lubricant.
(6) Procaine - as a local anesthetic, use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.
(7) Sucrose octanoate esters (CAS 42922-74-7; 58064-47-4)-in accordance with approved labeling.
(c) As feed supplements-None.
(d) As feed additives.
(1) DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS 59-51-8; 63-68-3; 348-67-4)-for use only in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: laying chickens-4 pounds; broiler chickens-5 pounds; turkeys and all other poultry-6 pounds.
(2) Trace minerals, used for enrichment or fortification when FDA approved.
(3) Vitamins, used for enrichment or fortification when FDA approved.
(e) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances.
(1) EPA List 4-Inerts of Minimal Concern. (2)
(f) Excipients, only for use in the manufacture of drugs used to treat organic livestock when the excipient is: Identified by the FDA as Generally Recognized As Safe; Approved by the FDA as a food additive; or Included in the FDA review and approval of a New Animal Drug Application or New Drug Application. (g)-(z)
205.604 Nonsynthetic substances prohibited for use in organic livestock production.
The following nonsynthetic substances may not be used in organic livestock production:
205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food group(s))."
The following nonagricultural substances may be used as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food group(s))" only in accordance with any restrictions specified in this section.
(a) Nonsynthetics allowed:
Acids (Alginic; Citric-produced by microbial fermentation of carbohydrate substances; and Lactic).
Agar-agar.
Animal enzymes-(Rennet-animals derived; Catalase-bovine liver; Animal lipase; Pancreatin; Pepsin; and Trypsin).
Bentonite.
Calcium carbonate.
Calcium chloride.
Calcium sulfate-mined.
Carrageenan.
Dairy cultures.
Diatomaceous earth-food filtering aid only.
Enzymes-must be derived from edible, nontoxic plants, nonpathogenic fungi, or nonpathogenic bacteria.
Flavors, nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.
Gellan gum (CAS 71010-52-1)-high-acyl form only.
Glucono delta-lactone-production by the oxidation of D-glucose with bromine water is prohibited.
Kaolin.
L-Malic acid (CAS 97-67-6).
Magnesium sulfate, nonsynthetic sources only.
Microorganisms-any food grade bacteria, fungi, and other microorganism.
Nitrogen-oil-free grades.
Oxygen-oil-free grades.
Perlite-for use only as a filter aid in food processing.
Potassium chloride.
Potassium iodide.
Sodium bicarbonate.
Sodium carbonate.
Tartaric acid-made from grape wine.
Waxes-nonsynthetic (Carnauba wax; and Wood resin).
Yeast-nonsynthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional; and Smoked-nonsynthetic smoke flavoring process must be documented).
(b) Synthetics allowed:
Activated charcoal (CAS 7440-44-0; 64365-11-3)-only from vegetative sources; for use only as a filtering aid.
Alginates.
Ammonium bicarbonate-for use only as a leavening agent.
Ammonium carbonate-for use only as a leavening agent.
Ascorbic acid.
Calcium citrate.
Calcium hydroxide.
Calcium phosphates (monobasic, dibasic, and tribasic).
Carbon dioxide.
Cellulose-for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.
Chlorine materials-disinfecting and sanitizing food contact surfaces, Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide; and Sodium hypochlorite).
Cyclohexylamine (CAS 108-91-8)-for use only as a boiler water additive for packaging sterilization.
Diethylaminoethanol (CAS 100-37-8)-for use only as a boiler water additive for packaging sterilization.
Ethylene-allowed for postharvest ripening of tropical fruit and degreening of citrus.
Ferrous sulfate-for iron enrichment or fortification of foods when required by regulation or recommended (independent organization).
Glycerides (mono and di)-for use only in drum drying of food.
Glycerin-produced by hydrolysis of fats and oils.
Hydrogen peroxide.
Lecithin-bleached.
Magnesium carbonate-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".
Magnesium chloride-derived from sea water.
Magnesium stearate-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".
Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines For Foods.
Octadecylamine (CAS 124-30-1)-for use only as a boiler water additive for packaging sterilization.
Ozone.
Pectin (low-methoxy).
Peracetic acid/Peroxyacetic acid (CAS 79-21-0)-for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces.
Phosphoric acid-cleaning of food-contact surfaces and equipment only.
Potassium acid tartrate.
Potassium carbonate.
Potassium citrate.
Potassium hydroxide-prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the Individually Quick Frozen (IQF) production process.
Potassium iodide-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".
Potassium phosphate-for use only in agricultural products labeled "made with organic (specific ingredients or food group(s))," prohibited in agricultural products labeled "organic".
Silicon dioxide.
Sodium acid pyrophosphate (CAS 7758-16-9)-for use only as a leavening agent.
Sodium citrate.
Sodium hydroxide-prohibited for use in lye peeling of fruits and vegetables.
Sodium phosphates-for use only in dairy foods.
Sulfur dioxide-for use only in wine labeled "made with organic grapes," Provided, That, total sulfite concentration does not exceed 100 ppm.
Tartaric acid-made from malic acid.
Tetrasodium pyrophosphate (CAS 7722-88-5)-for use only in meat analog products.
Tocopherols-derived from vegetable oil when rosemary extracts are not a suitable alternative.
205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products 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) Casings, from processed intestines.
(b) Celery powder.
(c) Chia ( Salvia hispanica L. ).
(d) Colors derived from agricultural products.
(1) Annatto extract color (pigment CAS 1393-63-1)-water and oil soluble.
(2) Beet juice extract color (pigment CAS 7659-95-2).
(3) Beta-carotene extract color, derived from carrots (CAS 1393-63-1).
(4) Black currant juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(5) Black/Purple carrot juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(6) Blueberry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(7) Carrot juice color (pigment CAS 1393-63-1).
(8) Cherry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(9) Chokeberry-Aronia juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(10) Elderberry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(11) Grape juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(12) Grape skin extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(13) Paprika color (CAS 68917-78-2)-dried, and oil extracted.
(14) Pumpkin juice color (pigment CAS 127-40-2).
(15) Purple potato juice (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(16) Red cabbage extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(17) Red radish extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(18) Saffron extract color (pigment CAS 1393-63-1).
(19) Turmeric extract color (CAS 458-37-7).
(e) Dillweed oil (CAS 8006-75-5).
(f) Fish oil (Fatty acid CAS: 10417-94-4, and 25167-62-8)-stabilized with organic ingredients or only with ingredients on the National List, 205.605 and 205.606.
(g) Fortified cooking wines.
(1) Marsala.
(2) Sherry.
(h) Fructooligosaccharides (CAS 308066-66-2).
(i) Galangal, frozen.
(j) Gelatin (CAS 9000-70-8).
(k) Gums-water extracted only (Arabic; Guar; Locust bean; and Carob bean).
(l) Hops ( Humulus luplus ).
(m) Inulin-oligofructose enriched (CAS 9005-80-5).
(n) Kelp-for use only as a thickener and dietary supplement.
(o) Konjac flour (CAS 37220-17-0).
(p) Lecithin-unbleached.
(q) Lemongrass-frozen.
(r) Orange shellac-unbleached (CAS 9000-59-3).
(s) Pectin (high-methoxy).
(t) Peppers (Chipotle chile).
(u) Starches.
(1) Cornstarch (native).
(2) Rice starch, unmodified (CAS 977000-08-0)-for use in organic handling until June 21, 2009.
(3) Sweet potato starch-for bean thread production only.
(v) Tragacanth gum (CAS 9000-65-1).
(w) Turkish bay leaves.
(x) Wakame seaweed (Undaria pinnatifida).
205.607 Amending the National List.
(a) Any person may petition the National Organic Standard Board for the purpose of having a substance evaluated by the Board for recommendation to the Secretary for inclusion on or deletion from the National List in accordance with the Act.
(b) A person petitioning for amendment of the National List should request a copy of the petition procedures from the USDA at the address in 205.607(c).
(c) A petition to amend the National List must be submitted to: Program Manager, USDA/AMS/TMP/NOP, 1400 Independence Ave., SW., Room 4008-So., Ag S 0268, Washington, DC 20250.