USDA Amends National List of Allowed and Prohibited Substances

May 2, 2019 | Categories: Organic, Industry Updates

On February 15, 2019, the U.S. Department of Agriculture (USDA) published a proposed rule in the Federal Register to amend the National Organic Program’s (NOP) National List of Allowed and Prohibited Substances for crops and handling based on April 2018 recommendations from the National Organic Standards Board. If you have any questions about the changes or implementation dates, please contact QAI.

For crop producers, the proposed rule (§205.601 and 205.602) would allow:

  • Elemental sulfur to be used as a slug or snail bait to reduce crop losses
  • Polyoxin D zinc salt to control fungal diseases when other organic fungicides have been found to be less effective

For handling operations, the proposed rule (§205.605 and 205.606) would allow:

  • Magnesium chloride to be reclassified from a synthetic to a nonsynthetic substance, requiring handlers to ensure that the product complies with the nonsynthetic classification by obtaining details about the source of the magnesium chloride and its full manufacturing process

On December 27, 2018, the NOP published a final rule that amends the National List of Allowed and Prohibited Substances. The rule was implemented on January 28, 2019, except for the amendments for the substances ivermectin, flavors, cellulose, glycerin and carnauba wax, which will be implemented December 27, 2019.

The following additions and amendments were made to the National List:

All Scopes

  1. Hypochlorous acid (aka electrolyzed water): This substance is allowed as chlorine material for crops, livestock and handling.

Livestock Operations (§205.603 and 205.604)

  1. Parasiticides: This substance is prohibited in slaughter stock, but allowed in emergency treatment for dairy and breeder stock. 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. Parasiticides are 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. The milk withhold periods for fenbendazole and moxidectin are reduced to two days for cattle and 36 days for other species.

    Milk or milk products from a treated animal cannot be labeled as organic for two days following treatment of cattle and 36 days following treatment of goats, sheep and other dairy species.

  2. Ivermectin: This substance is to be prohibited in livestock production. This change must be fully implemented by December 27, 2019.
  3. Methionine (for poultry production): This substance is restricted to the following 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.
  4. Lidocaine and procaine (in livestock production): Withholding periods are reduced to eight days for slaughter stock and six days for dairy stock.
  5. New allowed materials:
    • Activated charcoal: Must be from vegetative sources only
    • Calcium borogluconate: For treatment of milk fever only
    • Calcium propionate: For treatment of milk fever only
    • Kaolin pectin: For use as an adsorbent, antidiarrheal and gut protectant
    • Mineral oil: §205.603 is modified to read: Mineral oil, for relief of intestinal compaction, prohibited for use as a dust suppressant.
    • Injectable nutrients: §205.603 is modified to read: Nutritive supplements: injectable supplements of trace minerals per 205.603(d)(2), vitamins per 205.603(d)(3), and electrolytes per 205.603(a)(8), with excipients per 205.603(f), in accordance with FDA regulations and restricted to use by or on the order of a licensed veterinarian.
    • Propylene glycol: For treatment of ketosis in ruminants only
    • Acidified sodium chlorite: This substance may be used as a teat dip when used as a disinfectant, sanitizer or medical treatment. This rule also adds sodium chlorite, acidified to § 205.603(b) as a teat dip when used as a topical treatment or external parasiticide.
    • Zinc sulfate: Is allowed in livestock production for use in hoof and foot treatments only
  6. Chlorhexidine: This substance may be used for medical procedures conducted under the supervision of a licensed veterinarian. Also, it is allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.
  7. Xylazine: Now allowed for non-emergency uses.
  8. Excipients: The rule adds a provision that the excipient must be approved by the USDA Animal and Plant Health Inspection Service (APHIS) for use in veterinary biologics.

Handling Operations (§205.605 and 205.606)

  1. Flavors: In processing and handling, flavoring is to be restricted so that organic flavors are required when commercially available. The listing of flavors in paragraph 205.605(a) reads: “Flavors—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. This rule change does not apply to non-organic flavors in ‘made with organic…’ products.” This change must be fully implemented by December 27, 2019. Please note that the change to glycerin described below also applies to glycerin used in natural flavors.
  2. Carnauba wax: In processing and handling, this substance is to be re-classified as agricultural, thereby requiring the use of organic forms when commercially available. The basis for this reclassification is new information on how carnauba wax is extracted from the leaves and buds of palm trees. This information shows that carnauba wax extracted from this process meets the definition of an agricultural product in § 205.2 of the USDA organic regulations. This change must be fully implemented by December 27, 2019.
  3. Glycerin: In processing and handling, this substance is to be re-classified as agricultural, thereby requiring the use of organic forms when commercially available. This final rule removes glycerin from § 205.605(b) and amends § 205.606 —produced from agricultural source materials and processed using biological or mechanical/physical methods as described under § 205.270(a). For organic handling and processing, this action changes the classification of 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. This rule change applies to products making both an “organic” or “made with organic…” claim in that glycerin must be manufactured according to the new annotation above but the commercial availability requirements for glycerin do not apply to products making a “made with organic…” claim. This change must be fully implemented by December 27, 2019.
  4. Potassium lactate and sodium lactate: These substances are allowed in processing and handling for use as an antimicrobial agent and pH regulator only.
  5. Chlorine (clarifies restriction in accordance with NOP guidance NOP 5026): The rule now reads that chlorine used for 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).
  6. Alginic acid (reclassified as synthetic): This rule change is based on updated information on the sourcing of alginic acid and the definition of synthetic in § 205.2 of the USDA organic regulations.
  7. Cellulose (clarifies that microcrystalline forms are prohibited): This change must be fully implemented by December 27, 2019.
  8. Colors (replaces CAS numbers with binomial nomenclature): This final rule amends the USDA organic regulations to replace the Chemical Abstract Services (CAS) numbers included in the annotation of each color listed under National List at § 205.606 with the binomial nomenclature of the agricultural source of the color.

Crop Producers (§205.601 and 205.602)

  1. New allowed materials:
    • Magnesium oxide: This substance is now allowed for use in controlling the viscosity of a clay suspension agent for humates.
    • Squid byproducts: These byproducts may now be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used must not exceed the minimum needed to lower the pH to 3.5. Only squid byproducts from food waste processing are permitted for use as a soil amendment in organic crop production.
  2. Rotenone: This substance will be prohibited in crop production and has been added to section 205.602. This change must be fully implemented by December 27, 2019.
  3. Micronutrients: The annotation is amended to read as follows: “Micronutrients 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.” This change removes the restriction on documenting micronutrient deficiency that was imposed by allowing soil testing as the only method for demonstrating a soil micronutrient deficiency. This rule change allows alternative verifiable methods, such as tissue testing when approved by the certifying agent, to be used to document micronutrient deficiency.

QAI will be enforcing the changes as outlined by the final rule by issuing reminders and requesting plans for compliance for several materials that have the December 2019 implementation date. Similarly, we will be issuing non-compliances if materials with the January 28, 2019 implementation date are used. Please contact QAI with any questions.