In late December, 2018, the National Organic Program (NOP) issued a final rule to amend the National List of Allowed and Prohibited Substances. The rule changes the use restrictions for 17 substances allowed for organic production and/or handling, adds 16 new allowed substances, and prohibits rotenone in organic crop production and ivermectin as an allowed parasiticide. The rule also amends the national organic standards to allow the use of parasiticides in fiber bearing animals.
The final rule is comprised of 35 National Organic Standards Board (NOSB) recommendations. NOSB made the recommendations from 2000 to 2016.
The rule is effective on January 28, 2019; except for the amendments for ivermectin, flavors, cellulose, and glycerin, which will be implemented on December 27, 2019.
Crop Scope Substances
New substances to u00a7 205.601 u2013 Synthetic substances allowed for use in organic crop production:
u2013 Hypochlorous Acid u2013 Generated from electrolyzed water.
o Added as a chlorine material and allowed as an algicide, disinfectant, and sanitizer, including irrigation cleaning systems in organic crop production.
u2013 Magnesium Oxide (CAS # 1309-48-4) u2013 For use only to control the viscosity of a clay suspension agent for humates.
u2013 Squid Byproducts u2013 From food waste processing only. 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.
Amended use restrictions of substances under u00a7 205.601 u2013 Synthetic substances allowed for use in organic crop production:
u2013 Micronutrients u2013 Not to be used as a defoliant, herbicide, or desiccant. Those made from nitrates or chlorides are not allowed. Micronutrient deficiency must be documented by soil or tissue testing or other documented and verifiable method as approved by the certifying agent.
New prohibited substances added to u00a7 205.602 u2013 Nonsynthetic substances prohibited for use in organic crop production:
u2013 Rotenone (CAS #83-79-4)
Livestock Scope Materials
Removal of substances under u00a7 205.603 (a) u2013 Synthetic substances allowed for use in organic livestock production; as disinfectants, sanitizer, and medical treatments as applicable:
u2013 Ivermectin (CAS #70288-86-7)
o Two synthetic parasiticides remain on the National List: fenbendazole and moxidectin. The final rule removes the requirement for a veterinarian to administer fenbendazole and also reduces the withdrawal times following the use of fenbendazole or moxidectin.
New substances to u00a7 205.603 (a) u2013 Synthetic substances allowed for use in organic livestock production; as disinfectants, sanitizer, and medical treatments as applicable:
u2013 Activated Charcoal (CAS #7440-44-0) u2013 Must be from vegetable sources. May be used as a therapeutic treatment on an as-needed basis with mammalian livestock in cases of suspected ingestion of toxic plants and to control diarrhea caused by moldy silage.
o Synthetic forms of activated charcoal derived from other non-vegetative sources continue to be prohibited in organic livestock production.
u2013 Calcium Borogluconate (CAS #5743-34-0) u2013 For treatment of milk fever only.
o Organic livestock producers should know that calcium borogluconate cannot be used routinely, but only as an emergency treatment for milk fever.
u2013 Calcium Propionate (CAS #4075-81-4) u2013 For treatment of milk fever only.
o Organic livestock producers should know that calcium propionate is not to be used routinely, but only as an emergency treatment for milk fever.
u2013 Hypochlorous Acid u2013 Generated from electrolyzed water.
o Added as a chlorine material allowed for use in disinfecting and sanitizing equipment and facilities in organic livestock production.
u2013 Kaolin Pectin u2013 For use as an adsorbent, antidiarrheal, and gut protectant.
o Organic livestock producers should know that kaolin pectin is not to be used routinely, but only when an adsorbent, antidiarrheal, or gut protectant is needed.
u2013 Mineral Oil u2013 For relief of intestinal compaction. Prohibited for use as a dust suppressant
o Mineral oil is also on the National List as a topical treatment, external parasiticide, or local anesthetic.
u2013 Nutritive Supplements u2013 Injectable supplements of trace minerals per u00a7 205.603(d)(2), vitamins per u00a7 205.603(d)(3), and electrolytes per u00a7 205.603(a)(8), with excipients per u00a7 205.603(f), in accordance with FDA regulations and restricted to use by or on the order of a licensed veterinarian.
o Organic livestock producers will need to keep records that document the need for any use of these materials. Producers may use these substances individually or in combination.
u2013 Propylene glycol (CAS # 57u201355u20136) u2013 Only for treatment of ketosis in ruminants. Organic livestock producers are required to use preventive practices as described in u00a7 205.238 before using propylene glycol to treat ketosis. However, animals in need of medical attention cannot be left untreated in order to retain organic status.
u2013 Sodium chlorite, acidified u2013 Allowed for use on organic livestock as a teat dip treatment only. Preventive health care is essential for organic production. Preventive care through clean milking parlors and clean animals is essential for reducing mastitis in dairy animals and teat dips are used by dairy producers as an essential tool for preventing mastitis.
Amended use restrictions to substances under u00a7 205.603 (a) u2013 Synthetic substances allowed for use in organic livestock production; as disinfectants, sanitizer, and medical treatments as applicable:
u2013 Chlorhexidine (CAS #55u201356u2013 1) u2013 For medical procedures conducted under the supervision of a licensed veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.
u2013 Parasiticides u2013 Prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. 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. Allowed for fiber bearing animals when used a minimum of 36 days prior to harvesting of fleece or wool that is to be sold, labeled, or represented as organic.
u2013 Fenbendazole (CAS #43210u2013 67u20139) u2013 Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days following treatment of goats, sheep and other dairy species.
o Amended to remove the requirement for a veterinarian to administer substance and withdrawal period reduced.
u2013 Moxidectin (CAS #113507u201306u20135) u2013 Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days following treatment of goats, sheep and other dairy species.
o Amended to reduce withdrawal period.
u2013 Xylazine (CAS # 7361u201361u2013 7) u2013 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, paragraph (a)(30) also includes the following requirements: (i) Use by or on the lawful written order of a licensed veterinarian; (ii) 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.
o The final rule allows for non-emergency use of xylazine.
New substances to u00a7 205.603 (b) u2013 Synthetic substances allowed for use in organic livestock production; as topical treatment, external parasiticide or local anesthetic as applicable:
u2013 Sodium chlorite, acidified u2013 Allowed for use on organic livestock as a teat dip treatment only.
o Preventive care through clean milking parlors and clean animals is essential for reducing mastitis in dairy animals and teat dips are used by dairy producers as an essential tool for preventing mastitis.
u2013 Zinc sulfate u2013 For use in hoof and foot treatments only.
o The rule allows zinc sulfate to be used in a footbath for control of foot rot in livestock: primarily dairy cattle, sheep, and goats.
Amended use restrictions to substances under u00a7 205.603 (b) u2013 Synthetic substances allowed for use in organic livestock production; as topical treatment, external parasiticide or local anesthetic as applicable.
u2013 Lidocaine u2013 as a local anesthetic. Use requires a withdrawal period of 8 days after administering to livestock intended for slaughter and 6 days after administering to dairy animals.
o NOP notes that a reduction in the withholding time was needed to improve animal welfare because a lengthy withholding time for lidocaine could result in animals not being timely treated, or not treated at all.
u2013 Procaine u2013 as a local anesthetic. Use requires a withdrawal period of 8 days after administering to livestock intended for slaughter and 6 days after administering to dairy animals.
o NOP notes that a reduction in the withholding time was needed to improve animal welfare because a lengthy withholding time for procaine could result in animals not being timely treated, or not treated at all.
Amended use restrictions to substances under u00a7 205.603 (d) u2013 Synthetic substances allowed for use in organic livestock production; as feed additives:
u2013 DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS # 59u201351u20138, 583u201391u20135, 4857u201344u20137, and 922u201350u2013 9) u2013 For use only in organic poultry production at the following pounds of synthetic 100 percent methionine per ton of feed in the diet, maximum rates as averaged per ton of feed over the life of the flock: Laying chickens, 2 pounds; broiler chickens, 2.5 pounds; turkeys and all other poultry, 3 pounds.
Amended use restrictions to substances under u00a7 205.603 (f) u2013 Synthetic substances allowed for use in organic livestock production:
u2013 Excipients u2013 Only for use in the manufacturing of drugs and biologics used to treat organic livestock when the excipient is: (1) Identified by the FDA as Generally Recognized As Safe; (2) Approved by the FDA as a food additive; (3) Included in the FDA review and approval of a New Animal Drug Application or New Drug Application; or (4) Approved by APHIS for use in veterinary biologics.
Amendments to Livestock Health Care Practice Standard
u00a7 205.238 (b) u2013 When preventive practices and veterinary biologics are inadequate to prevent sickness, a producer may administer synthetic medications provided that such medications are allowed under u00a7 205.603. Parasiticides allowed under u00a7 205.603 may be used on:
u2013 (2) Dairy animals, as allowed under u00a7 205.603,
u2013 (3) fiber bearing animals, as allowed under u00a7 205.603.
Handling and Processing Scope Substances
Amended use restrictions to substances under u00a7 205.605 (a) u2013 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as u201cOrganicu201d or u201cMade with Organic (Specified Ingredients or Food Group(s))u201d; nonsynthetics allowed:
u2013 Flavors u2013 Nonsynthetic flavors may be used when organic flavors are not commercially available. All flavors must be derived from organic or nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.
New substances added to u00a7 205.605 (b) u2013 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as u201cOrganicu201d or u201cMade with Organic (Specified Ingredients or Food Group(s))u201d; synthetics allowed:
u2013 Hypochlorous acid u2013 Generated from electrolyzed water.
u2013 Potassium lactate u2013 For use as an antimicrobial agent and pH regulator only.
u2013 Sodium lactate u2013 For use as an antimicrobial agent and pH regulator only.
Amended use restrictions to substances under u00a7 205.605 (b) u2013 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as u201cOrganicu201d or u201cMade with Organic (Specified Ingredients or Food Group(s))u201d; synthetics allowed:
u2013 Cellulose (CAS # 9004u201334u20136) u2013 For use in regenerative casings, powdered cellulose as an anti-caking agent (non-chlorine bleached) and filtering aid. Microcrystalline cellulose is prohibited.
u2013 Chlorine Materials u2013 Disinfecting and sanitizing food contact surfaces, equipment, and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide; and Sodium hypochlorite).
Reclassified substances to u00a7 205.605 (b) u2013 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as u201cOrganicu201d or u201cMade with Organic (Specified Ingredients or Food Group(s))u201d; Synthetics allowed:
u2013 Alginic Acid (CAS # 9005u201332u20137)
o The rule change is based upon updated information on the sourcing of alginic acid and the definition of u201csyntheticu201d in u00a7 205.2 of the USDA organic regulations.
Reclassified substances to u00a7 205.606 u2013 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as organic:
u2013 Carnauba Wax
o The rule reclassifies carnauba wax from a nonagricultural substance on u00a7 205.605(a) to an agricultural product on u00a7 205.606 that may be used in organic handling when organic carnauba wax is not commercially available.
u2013 Glycerin (CAS # 56u2013 81u20135) u2013 produced from agricultural source materials and processed using biological or mechanical/physical methods as described under u00a7 205.270(a).
o The rule reclassifies glycerin under the USDA organic regulations from an allowed synthetic substance to an agricultural product that must be an organic product unless such organic products are not commercially available
Updates to Colors Derived from Agricultural Products
The final rule replaces Chemical Abstract Services (CAS) numbers with binomial nomenclature for the agricultural sources that the color extract is derived from:
u2013 u00a7 205.606 (d) u2013 Colors derived from agricultural products must not be produced using synthetic solvents and carrier systems or any artificial preservative
- Beet juice extract color u2013 Derived from Beta vulgaris L., except must not be produced from sugarbeets.
- Beta-carotene extract color u2013 Derived from carrots (Daucus carota L.) or algae (Dunaliella salina).
- Black currant juice color u2013 Derived from Ribes nigrum L.
- Black/purple carrot juice color u2013 Derived from Daucus carota L.
- Blueberry juice color u2013 Derived from blueberries (Vaccinium spp.).
- Carrot juice color u2013 Derived from Daucus carota L.
- Cherry juice color u2013 Derived from Prunus avium (L.) L. or Prunus cerasus L.
- Chokeberry, aronia juice color u2013 Derived from Aronia arbutifolia (L.) Pers. or Aronia melanocarpa (Michx.) Elliott.
- Elderberry juice color u2013 Derived from Sambucus nigra L.
- Grape juice color u2013 Derived from Vitis vinifera L.
- Grape skin extract color u2013 Derived from Vitis vinifera L.
- Paprika color u2013 Derived from dried powder or vegetable oil extract of Capsicum annuum L.
- Pumpkin juice color u2013 Derived from Cucurbita pepo L. or Cucurbita maxima Duchesne.
- Purple sweet potato juice color u2013 Derived from Ipomoea batatas L. or Solanum tuberosum L.
- Red cabbage extract color u2013 Derived from Brassica oleracea L.
- Red radish extract color u2013 Derived from Raphanus sativus L.
- Saffron extract coloru2014 u2013 Derived from Crocus sativus L.
- Turmeric extract color u2013 Derived from Curcuma longa L.
For questions regarding the impact of the final rule on your operation, please contact your CCOF Certification Service Specialist.