NOP Extends Deadline to Comment on National List Proposed Rule

 
The National Organic Program (NOP) extended the commenting deadline for their proposed rule of 35 amendments to the National List of Allowed and Prohibited Substances (National List). NOP will now be accepting comments until May 14, 2018
 
The proposed rule amends the National List by changing the restrictions for 17 substances allowed for organic production or handling; adding 16 new substances; prohibiting rotenone for organic crop production; and removing ivermectin as an allowed parasiticides for organic livestock production. 

 

Proposed Updates to Existing Substances on National List

Substance

National List Section

Current Restriction

Proposed Restriction/Action

Micronutrients

§ 205.601(j)

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.

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, advice from certified crop advisors or professional agronomists, agricultural extension information, or other methods approved by the certifying agent.

Chlorhexidine

§ 205.603(a)

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.

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.

Parasiticides

§ 205.603(a)(17)

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 animals.

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 90 days prior to harvesting of fleece or wool that is to be sold, labeled, or represented as organic.

Fenbendazole (CAS #43210-67-9)

§ 205.603(a)(17)(i)

Only for use by or on the lawful written order of a licensed veterinarian

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.

Moxidectin (CAS #113507-06-5)

§ 205.603(a)(17)(iii)

For control of internal parasites only

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.

Ivermectin (CAS #70288-86-7)

§ 205.603(a)(17)(ii)

 

Removal from National List (Prohibition)

Xylazine

§ 205.603(a)

Federal law restricts this drug for 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:

(i)              Use by or on the lawful written order of a licensed veterinarian;

(ii)            The existence of an emergency;

(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.

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:

(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.

Lidocaine

§ 205.603(b)(4)

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.

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.

Procaine

§ 205.603(b)(7)

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.

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.

DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog calcium (CAS Numbers 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)

§ 205.603(d)(1)

For use only in organic poultry production at the following maximum levels of synthetic methionine per ton of feed: Laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds.

For use only in organic poultry production at the following pounds of synthetic 100 percent methionine per ton of feed in the diet, averaged over the life of the flock: Laying chickens—2 pounds; Broiler chickens—2.5 pounds; Turkeys and all other poultry—3 pounds.

Excipients

§ 205.603(f)

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.

Only for use in the manufacture 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.

Acids (Alginic; Citric—produced by microbial fermentation of carbohydrate substances; and Lactic)

§ 205.605 (a)

 

Remove alginic acid from § 205.605(a) and reinsert alginic acid under §205.605(b)

Flavors

§ 205.605(a)

Nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.

Non-synthetic 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.

Waxes – nonsynthetic (Carnauba wax; and Wood resin)

§ 205.605(a)

 

Remove carnauba wax from § 205.605(a) and insert carnauba wax under § 205.606.

Cellulose

§ 205.605(b)

For use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.

For use in regenerative casings, powdered cellulose as an anti-caking agent (non-chlorine bleached) and filtering aid. Microcrystalline cellulose is prohibited.

Chlorine Materials

§ 205.605(b)

For 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).

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).

Glycerin

§ 205.605(b)

Produced by the hydrolysis of fats and oils.

Produced from agricultural source materials and processed using biological or mechanical/physical methods as described under § 205.270(a).

The proposal also includes updates to colors for nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as organic. USDA is proposing to update the listed colors to include Latin binomials and not CAS numbers. 

Colors Updates - § 205.606(d)

Current § 205.606 listing:
Color – agricultural source/CAS Nos.

Proposed § 205.606 listing:
Color – agricultural source/Binomial nomenclature

Beet juice extract color (pigment CAS #7659-95-2)             

Beet juice extract color, derived from sugarbeet (Beta vulgaris).

Beta-carotene extract color—derived from carrots and algae (pigment CAS #1393-63-1)         

Beta-carotene extract color derived from carrots (Daucus carota), or algae (Dunaliella salina).

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)   

Black currant juice color, derived from Ribes nigrum.

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)        

Black/purple carrot juice color, derived from Apiaceae daucus carota.

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)             

Blueberry juice color, derived from Vaccinium cyanococcus.

Carrot juice color (pigment CAS #1393-63-1)        

Carrot juice color, derived from Daucus carota.

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)             

Cherry juice color, derived from Prunus avium.

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)        

Chokeberry—Aronia juice color, derived from Aronia prunifolia.

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)             

Elderberry juice color, derived from Sambucus nigra.

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)             

Grape juice color, derived from Vitis vinifera.

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)             

Grape skin extract color, derived from Vitis vinifera.

Paprika color—dried, and oil extracted (CAS #68917-78-2)    

Paprika color—dried powder and vegetable oil extract, derived from Capsicum annuum.

Pumpkin juice color (pigment CAS #127-40-2)     

Pumpkin juice color, derived from Cucurbita pepo.

Purple potato juice (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3)             

Purple potato juice color, derived from Solanum andigenum.

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)   

Red cabbage extract color, derived from Brassica oleracea.

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),           

Red radish extract color, derived from Raphanus sativus.

Saffron extract color (pigment CAS #1393-63-1) 

Saffron extract color, derived from Crocus sativus.

Turmeric extract color (CAS #458-37-7)  

Turmeric extract color, derived from Curcuma longa.

 

New Substances to be Added to National List

Substance

National List Section

Restriction/Prohibition

Use

Hypochlorous Acid

§ 205.601(a), 205.603(a), 205.605(b)

Generated from electrolyzed water.

Disinfectant and sanitizer

Magnesium Oxide

§ 205.601(j)

For use only to control the viscosity of a clay suspension agent for humates.

Soil amendment

Squid Byproducts

§ 205.601(j)

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.

Plant and soil amendment

Rotenone

§ 205.602(f)

Prohibited

Prohibited

Activated Charcoal

§ 205.603(a)

Must be from vegetable sources.

Medical treatment for organic livestock

Calcium Borogluconate

§ 205.603(a)

For treatment of milk fever only.

Medical treatment for organic livestock

Calcium Proprionate

§ 205.603(a)

For treatment of milk fever only.

Medical treatment for organic livestock

Kaolin Pectin

§ 205.603(a)

For use as an adsorbent, antidiarrheal, and gut protectant.

Medical treatment for organic livestock

Mineral Oil

§ 205.603(a)

For relief of intestinal impaction, prohibited for use as a dust suppressant.

Medical treatment for organic livestock

Nutritive Supplements – Injectable Vitamins, Minerals, and Electrolytes

§ 205.603(a)

Formulated injectable supplements of trace minerals per 205.603(d)(2), vitamins per 205.603(d)(3), and electrolytes per 205.603(a)(8), and excipients per 205.603(f), in accordance with FDA and restricted for use by or on the order of a licensed veterinarian.

Medical treatment for organic livestock

Propylene Glycol

§ 205.603(a)

Only for treatment of ketosis in ruminants.

Medical treatment for organic livestock

Acidified Sodium Chlorite

§ 205.603(a), 205.603(b)

Allowed for use on organic livestock as a teat dip treatment.

Medical treatment for organic livestock

Zinc Sulfate

§ 205.603(a)

For use in hoof and foot treatments only.

Medical treatment for organic livestock

Potassium Lactate

§ 205.605(b)

For use as an antimicrobial agent and pH regulator only.

Antimicrobial ingredient for use in organic handling

Sodium lactate

§ 205.605(b)

For use as an antimicrobial agent and pH regulator only.

Antimicrobial ingredient for use in organic handling

 
CCOF submitted comments to NOP during the initial commenting period. 
 
For specific information on each material, please review the proposal or contact Robert Pooler of the Standards Division of the NOP at (202) 720-3252.

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