FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: April 29, 2010 

Subject: Sunset Review of National List substances (§205.603) allowed in livestock 

production 

Chair: Daniel G. Giacomini_ ______________ 

 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: __X_ __ 

Guidance Statement: ________ 

Other: ________ 

Summary Statement of the Recommendation (including Recount of Vote): The NOSB voted 

to renew 26 substances in section 205.603 of the National List, with Iodine recommended for use 

in 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable and 205.603(b) As 

topical treatment, external parasiticide or local anesthetic as applicable. The NOSB voted to 

defer action on eight (8) substances in section 205.603 of the National List. 

NOSB Vote: Motion: Jeff Moyer Second: Tina Ellor 

Board vote: Yes - 14 No - 0 Abstain - 0 Absent - 1 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP): Statements from the Livestock Committee explaining the rationale, supported through 

NOSB action, precedes the recommendation presented below. 

Response by the NOP:
NOSB Livestock Committee – Sunset Recommendation – 2012 

I. List: 205.603 Synthetic substances allowed for use in organic livestock 

production 

II. Category Uses 

(a) As disinfectants, sanitizers, and medical treatments as applicable 

(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(c) As feed supplements 

(d) As feed additives 

(e) As synthetic inert ingredients 

(f) As excipients 

III. Committee Summary 

To abide the current rules for the Sunset process, for the Livestock Committee to 

put forth a recommendation that would allow a material on the National List to 

expire, significant evidence must be found by the Committee or presented by the 

public that there is no further need for the substance, because naturals exist that 

can supplant their use. Or, evidence must exist that a substance fails the criteria 

by which it was originally put on the National List. Public comment against a 

material on the National List is not sufficient to recommend removal. Also, 

clarification of or changes to the annotation of a material cannot be dealt with 

during the Sunset process; a new petition would need to be submitted and 

handled through the regular petition process. 

Given the constraints of the current Sunset Review process, the Livestock 

Committee determined which of the materials on 205.603 had enough current 

information to recommend re-listing, and which materials needed further 

technical information (TRs). The committee received no evidence from the public 

that would indicate an individual material should be allowed to sunset, either 

because a natural now exists that would supplant its use, or because there is 

new evidence that it now fails the criteria for listing. The materials presently 

recommended for re-listing include their current annotation. 

DL-Methionine does not appear in this Sunset Review because it was repetitioned on July 31, 2009 with a different annotation and, therefore, will be 

handled through the regular petition process. 
IV. Committee Recommendations: 

The Livestock Committee recommends the renewal of the following 

substances in the use category 205.603. 

(a) As disinfectants, sanitizer, and medical treatments as applicable: 

(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: 

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

(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: 

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

(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. 

(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. 

(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. 

 (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 planapproved 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: 

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

(ii) Use only to reverse the effects of sedation and analgesia caused by Xylazine; 

and 

(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: 

(i) Use by or on the lawful written order of a licensed veterinarian; 
(ii) The existence of an emergency; and 

(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. 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information is 

obtained: 

(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. 

(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. 

(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. 

(16) Magnesium sulfate. 

The Livestock Committee recommends not renewing the following 

substances in this use category: 

 

None 
The Livestock Committee recommends the renewal of the following 

substances in the use category 205.603. 

(b) As topical treatment, external parasiticide or local anesthetic as applicable:

(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 #s–42922–74–7; 58064–47–4)—in 

accordance with approved labeling. 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information obtained: 

(1) Copper sulfate 

The Livestock Committee recommends not renewing the following 

substances in this use category:

None 

The Livestock Committee recommends the renewal of the following 

substances in the use category 205.603. 

(c) As feed supplements:

None 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information is 

obtained: 

None 
The Livestock Committee recommends not renewing the following 

substances in this use category: 

None 

The Livestock Committee recommends the renewal of the following 

substances in the use category 205.603. 

(d) As feed additives: 

(2) Trace minerals, used for enrichment or fortification when FDA approved. 

(3) Vitamins, used for enrichment or fortification when FDA approved. 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information is 

obtained: 

None 

The Livestock Committee recommends not renewing the following 

substances in this use category: 

None 

 

The Livestock Committee recommends the renewal of the following 

substances in the use category 205.603. 

(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. 

None 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information is 

obtained: 

(1) EPA List 4—Inerts of Minimal Concern. 

The Livestock Committee recommends not renewing the following 

substances in this use category: 

None 
The Livestock Committee recommends the renewal of the following 

substance in the use category 205.603. 

(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 Appliction or New Drug Appliction. 

The Livestock Committee recommends deferral of the vote on the following 

materials in this use category until further technical information is 

obtained: 

None 

The Livestock Committee recommends not renewing the following 

substances in this use category: 

None 

Moved: Dan Giacomini Second: Wendy Fulwider 

Committee vote: 6 - yes; 0 - no; 2 - absent; 0 - abstain 

Kevin K. Engelbert, Chair 

NOSB Vote: 

Motion: Jeff Moyer 

Second: Tina Ellor 

Yes: 14 No: 0 Absent: 1 Abstain: 0