Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

 

Date: October 28, 2010 

Subject: Reaffirm Prior Sunset 2012 Recommendations on National List 

§205.603 & §205.604 Substances. 

Chair: Daniel Giacomini 

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action X 

Guidance Statement 

Other 

 

Statement of the Recommendation (Including Recount of Vote): 

 

At the Spring 2010 Meeting, 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. The public comment period for these substances 

did not close until after the Spring 2010 meeting, so at the Fall 2010 Meeting, 

the NOSB reaffirmed the Spring vote based on the additional comments 

received. One comment was received that stated Oxytocin should be removed 

from 205.603, but offered no supportive evidence to support the position. A 

similar comment was received for Furosemide, but again, no supporting 

evidence was presented. All other additional comments favored relisting all 

substances on 250.603 & 205.604. Therefore, the NOSB reaffirms the Sunset 

2012 Recommendations on §205.603 & §205.604 Substances. 

 

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 

regarding the Spring 2010 vote; those statements remain valid for the Fall 2010 

NOSB vote. 

 

NOSB Vote: 

Moved: Jeff Moyer Second: Kevin Engelbert

Yes: 14 No: 0 Abstain: 0 Absent: 0 Recusal: 0 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

Page 2 of 9

National Organic Standards Board 

Livestock Committee 

Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010 

Committee Summary 

At the Spring 2010 NOSB Meeting, the Livestock Committee recommended, and the NOSB 

passed, a recommendation involving twenty five (25) Sunset materials on §205.603 (included 

below). The public comment period for the Spring recommendations did not close until after 

the meeting was completed; therefore, the Livestock Committee agreed to determine of any of 

those comments warranted a change in our recommendation. We received two (2) comments 

on §205.603 materials: one commentator stated that Oxytocin and Ivermectin should be 

removed from the National List, and another stated that all materials should remain on the 

National List. No evidence was presented to justify removing those two (2) materials, and 

therefore, in accordance with the current Sunset process rules, the Livestock Committee 

recommends the vote stands. 

With regard to §205.604 (also included below), no additional comments were received, and the 

Livestock Committee recommends the vote stands. 

Committee Recommendations

The Livestock Committee recommends that the votes at the Spring 2010 Meeting on 

Sunset Recommendations – 2012 stand as recorded. 

Committee Vote: 

Motion: Dan Giacomini Second: Jeff Moyer 

Yes: 7 No: 0 Abstain: 0 Absent: 1 

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 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

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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 re-petitioned 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 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

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(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 twotimes 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 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: 

(i) Use by or on the lawful written order of a licensed veterinarian; 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

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(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 twotimes 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 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

Page 6 of 9

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 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

Page 7 of 9

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: 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

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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 

Committee Vote: 

Motion: Dan Giacomini Second: Wendy Fulwider 

Yes: 6 No: 0 Abstain: 0 Absent: 2 

NOSB Final Vote: 

Motion: Jeff Moyer Second: Tina Ellor 

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

NOSB Livestock Committee – Sunset Recommendation – 2012 

I. List: 205.604 Nonsynthetic substances prohibited for use in organic livestock 

production 

II. Category Use 

(a) Strychnine 

III. Committee Summary: Some commentors specifically mentioned that strychnine should 

remain as a prohibited substance on the National List. The Livestock Committee agrees with 

the commentors that strychnine should remain as a prohibited substance on the National List 

because its use negatively impacts humans and the environment, is not considered essential 

for organic production and is not compatible with organic production practices. While the 
Reaffirmation of Spring 2010 Meeting Votes on 

Sunset 2012 Recommendation 

July 13, 2010

Page 9 of 9

committee did receive some comments that some forms of strychnine may be beneficial as 

animal health care products, the committee did not agree that this reason justified removal of 

strychnine from §205.604. Interested parties should proceed with the petition process for 

amending annotations to allow specific uses of strychnine. 

IV. Committee Recommendation(s): 

The Livestock Committee recommends the renewal of the following substances in this use 

category: 

 

(a) Strychnine 

 

Committee Vote: 

Motion: Dan Giacomini Second: Wendy Fulwider 

Yes: 5 No: 0 Abstain: 0 Absent: 3