Sunset 2017 Review Summary 

Meeting 1 - Request for Public Comment

Livestock Substances §205.602, §205.603 

April 30, 2015

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic livestock production that must be reviewed by the NOSB and renewed by 

the USDA before their sunset dates in 2017. This list provides the substance’s current status on the 

National List, use description, references to past technical reports, past NOSB actions, and regulatory 

history, as applicable. If a new technical report has been requested for a substance, this is noted in this 

list. To see if any new technical report is available, please check for updates under the substance name 

in the Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

fall 2015 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the spring 2015 public meeting. These comments should be provided 

through www.regulations.gov by April 7, 2015 as explained in the meeting notice published in the 

Federal Register. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic livestock production. 

Page 229 of 249
For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with livestock production. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

Written public comments will be accepted through April 7, 2015 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the meeting. 

Page 230 of 249
Sunset 2017 Review Summary 

Meeting 1 - Request for Public Comment

Livestock Substances §205.602, §205.603 

April 30, 2015

Reference: 7 CFR 205.603 Synthetic substances 

allowed for use in organic livestock production 

Alcohols: Ethanol, Isopropanol

Aspirin

Atropine

Biologics, Vaccines

Butorphanol

Chlorhexidine

Chlorine Materials: Calcium hypochlorite, 

chlorine dioxide, sodium hypochlorite

Electrolytes

Flunixin

Furosemide

Glucose

Glycerin

Hydrogen peroxide

Iodine

Magnesium hydroxide

Magnesium sulfate

Oxytocin

Parasiticides: Fenbendazole

Parasiticides: Ivermectin

Parasiticides: Moxidectin

Peroxyacetic/Peracetic acid 

Phosphoric acid

Poloxalene

Tolazoline

Xylazine

Copper sulfate

Formic Acid

Iodine

Lidocaine

Lime, hydrated

Mineral oil

Procaine

Sucrose octanoate esters

Methionine

Trace minerals

Vitamins

EPA List 4 - Inerts of Minimal Concern

Excipients

Livestock 205.602 Prohibited nonsynthetic 

substances

Strychnine

Page 231 of 249
Alcohols 

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

 (1)(i) Ethanol-disinfectant and sanitizer only, prohibited as a feed additive

 (1)(ii) Isopropanol-disinfectant only

Technical Report: 1995 TAP; 2014 TR Ethanol; 2014 TR Isopropanol 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 NOSB sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 

Additional information requested by NOSB 

1. Please provide any information regarding the denaturing material typically used in ethanol used in 

organic livestock production.

2. What are the most common uses of ethanol?

Aspirin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(2) Aspirin-approved for health care use to reduce inflammation

Technical Report: 1995 TAP

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 NOSB sunset recommendation; 

10/2010 NOSB recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/15 

Additional information requested by NOSB 

1. Since this material was last reviewed have alternative materials emerged?

2. Is this material essential to organic livestock production?

Atropine

Reference: 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 

Page 232 of 249
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

Technical Report: 2002 TR 

Petition(s): 2002 

Past NOSB Actions: 05/2003 NOSB recommendation; 04/2010 sunset recommendation 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/24/17 

Additional information requested by NOSB 

1.How common is the use of Atropine as a pre-medication before anesthesia? 

2.The 2005 Livestock subcommittee mentions the use of Atropine to treat eye infections. Is this still a 

common practice?

Biologics - Vaccines

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(4) Biologics - Vaccines

Technical Report: 2014 TR (Aquaculture); 2011 TR (Vaccines from Excluded Methods) 

Petition(s): 2012 Petition (Aquaculture) 

Past NOSB Actions: 11/2005 NOSB sunset recommendation; 11/2009 NOSB recommendation on 

Vaccines at §205.105; 04/2010 NOSB sunset recommendation; 10/2014 recommendation on Vaccines 

from Excluded Methods

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

1.Since vaccines were last reviewed have alternative materials emerged?

2.Should all vaccines be allowed for preventive livestock healthcare?

Butorphanol

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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.

Technical Report: 2002 TR

Page 233 of 249
Petition(s): 2002 Petition

Past NOSB Action :s 2002 Livestock Subcommittee recommendation; 09/2002 Meeting minutes and 

vote; 04/2010 sunset recommendation

Recent Regulatory Background: National List Amended 12/12/2007 (72 FR 7049); Sunset renewal notice 

published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 

Background from Subcommittee

The TAP review was thorough with respect to the use of butorphanol as a drug, but information about 

impacts of butorphanol and its metabolites when excreted was missing. Since metabolites of the drug 

can cross the placenta and pass into the mammary gland and into milk, more information about the 

metabolites would be helpful. When petitioned, it was considered as a safe and necessary option.

Additional information requested by NOSB 

1. Do metabolites have an impact on unborn animals if the mother is treated during pregnancy?

2. What are the effects of metabolites that are excreted?

3. Is butorphanol considered the preferred choice at this time, or are there other options?

Chlorhexidine

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. 

(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

Technical Report: 1999 TAP; 01/2010 TR; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1999 NOSB meeting minutes and vote; 11/2005 NOSB sunset recommendation; 

11/2009 Annotation change/clarification; 04/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 

Additional information requested by NOSB 

Chlorhexidine is a disinfectant that is used as a topical antiseptic during surgery, for “cold sterilization” 

of surgical instruments, and as a teat dip. Because chlorhexidine can have residual effects, it is only 

allowed for use as a teat dip when other teat dips have lost their effectiveness. 

1. Have you used chlorhexidine as a teat dip? If so, why did you need to use it?

Chlorine materials

Page 234 of 249
Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. 

(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.

Technical Report: 2006 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 05/2006 NOSB sunset recommendation; 10/2010 

NOSB recommendation 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 

Additional information requested by NOSB 

1. Are there less toxic disinfecting and sanitizing materials that could be substituted for chlorine 

materials?

2. Are all three chlorine materials needed for use in livestock production? 

Electrolytes

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(8) Electrolytes—without antibiotics

Technical Report: 1995 TAP; 2015 TR in development 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation, 04/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

NONE

Flunixin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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

Technical Report: 2007 TAP Report

Petition(s): N/A

Past NOSB Actions: 10/2002 NOSB recommendation; 10/2010 NOSB sunset recommendation

Recent Regulatory Background: National List Amended 12/12/2007 (72 FR 7049); Sunset renewal notice 

Page 235 of 249
published 06/06/12 (77 FR 33290)

Sunset Date: 06/27/17

Additional information requested by NOSB 

1. In the event the NOSB votes to remove Flunixin from the National List, would aspirin serve and a

replacement? If not, why not?

Furosemide

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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

Technical Report: 2003 TR

Petition(s): 2002 Petition 

Past NOSB Actions: 05/2003 NOSB recommendation for addition to the National List; 10/2010 sunset 

recommendation

Recent Regulatory Background: National List Amended 12/12/2007 (72 FR 7049); Sunset renewal notice 

published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

NONE

Glucose

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(11) Glucose

Technical Report: 1995 TAP 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

1. What is the ongoing use of glucose? 

2. Is this glucose currently necessary or essential in organic livestock production? Please explain.

3. Are there commercially available alternative(s) since glucose last sunset review in 2012? 

Page 236 of 249
4. Are there any annotation(s) needed for glucose? If so, explain and reference evidence.

Glycerine

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(12) Glycerine - Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils

Technical Report: 1995 TAP (Livestock); 2010 TAP (Livestock)

Petition(s): N/A

Past NOSB Actions: 1997 NOSB recommendation; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

NONE

Hydrogen peroxide

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(13) Hydrogen peroxide

Technical Report: 1995 TAP (Crops); 2015 TR (Crops)

Petition(s): N/A

Past NOSB Actions: 11/2005 sunset recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

1. What is the ongoing use of hydrogen peroxide?

2. Is this hydrogen peroxide currently necessary or essential in organic livestock production? 

Please explain.

3. Are there commercially available alternative(s) for hydrogen peroxide last sunset review in 

2012? 

4. Are there any annotation(s) needed for hydrogen peroxide? If so, explain and reference 

evidence.

Iodine

Page 237 of 249
Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

 (14) Iodine

Reference: 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable

 (3) Iodine

Technical Report: 1995 TAP; 2014 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

1. Can iodophor forms of iodine be produced using less toxic surfactants than nonphenol 

polyethylene glycol ether (NPE) and similar NPE’s? If so what might be substituted?

2. If the use of NPE surfactants was prohibited in teat dips for use in organic livestock production 

how would this impact your farm?

3. Are there equally effective alternatives to iodophor based teat dips for commercial use in 

organic livestock production?

Magnesium hydroxide

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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.

Technical Report: 2007 TR

Petition(s): 2002 Petition 

Past NOSB Actions: 2002 NOSB recommendation; 11/2005 NOSB sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

NONE

Magnesium sulfate

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(16) Magnesium sulfate

Technical Report: 1995 TAP; 2011 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/2010 sunset recommendation

Page 238 of 249
Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

NONE

Oxytocin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

 (17) Oxytocin -use in post parturition therapeutic applications

Technical Report: 1995 TAP; 2005 TR, 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation, 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Additional information requested by NOSB 

1. What is the ongoing use of oxytocin? 

2. Is this oxytocin currently necessary or essential in organic livestock production? Please explain.

3. Are there commercially available alternative(s) since oxytocin last sunset review in 2012? 

4. Are there any annotation(s) needed for oxytocin? If so, explain and reference evidence.

Parasiticides, Fenbendazole

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(18) Parasiticides—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

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian

(ii) Ivermectin (CAS #70288-86-7) 

(iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only

Technical Report: 1999 TAP (Fenbendazole, Ivermectin); 2015 TR in development, 

Petition(s): Fenbendazole

Past NOSB Actions: 2008 NOSB recommendation

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472) 

Sunset Date: 5/16/2017

Page 239 of 249
Background from Subcommittee

In the October 1999 NOSB meeting, Ivermectin was voted to be put on the National List (8-3-0). Two 

other parasiticides failed to pass at that meeting: Fenbendazole (5-6-0) and Levamisole (0-11-0). In April 

2004, Moxidectin was recommended to be added to the List (11-1-1-1) with NOSB members expressing 

reservation about putting it on the List, but thinking it was preferable to Ivermectin, which was already 

on the List. In May 2008 Fenbendazole was recommended for addition to the list, with discussion among 

NOSB members that Fenbendazole was safer and more environmentally benign, particularly so because 

it did not harm dung beetles as Ivermectin does. The Livestock Committee indicated that they would like 

to eventually see all of the parasiticides come off the List except the best one.

Additional information requested by NOSB 

Are the three parasiticides (Ivermectin, Moxidectin and Fenbendazole) different enough in their modes 

of action that they should all remain on the National List? If not, which one(s) would you recommend be 

removed from the List, and why?

Parasiticides, Ivermectin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(18) Parasiticides—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.

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian.

(ii) Ivermectin (CAS #70288-86-7). 

(iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only.

Technical Report: 1999 TAP (Fenbendazole, Ivermectin); 

Petition(s): N/A

Past NOSB Actions: 10/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17

Background from Subcommittee

In the October 1999 NOSB meeting, Ivermectin was voted to be put on the National List (8-3-0). Two 

other parasiticides failed to pass at that meeting: Fenbendazole (5-6-0) and Levamisole (0-11-0). In April 

2004, Moxidectin was recommended to be added to the List (11-1-1-1) with NOSB members expressing 

reservation about putting it on the List, but thinking it was preferable to Ivermectin, which was already 

on the List. In May 2008 Fenbendazole was recommended for addition to the list, with discussion among 

NOSB members that Fenbendazole was safer and more environmentally benign, particularly so because 

it did not harm dung beetles as Ivermectin does. The Livestock Committee indicated that they would like

to eventually see all of the parasiticides come off the List except the best one.

Page 240 of 249
Additional information requested by NOSB 

Are the three parasiticides (Ivermectin, Moxidectin and Fenbendazole) different enough in their modes 

of action that they should all remain on the National List? If not, which one(s) would you recommend be 

removed from the List, and why?

Parasiticides, Moxidectin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(18) Parasiticides—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

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian.

(ii) Ivermectin (CAS #70288-86-7). 

(iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only.

Technical Report: 2003 TAP (Moxidectin); 2015 TR in development, 

Petition(s): Moxidectin

Past NOSB Actions: 2004 NOSB recommendation 

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472)

Sunset Date: 5/16/2017

Background from Subcommittee

In the October 1999 NOSB meeting, Ivermectin was voted to be put on the National List (8-3-0). Two 

other parasiticides failed to pass at that meeting: Fenbendazole (5-6-0) and Levamisole (0-11-0). In April 

2004, Moxidectin was recommended to be added to the List (11-1-1-1) with NOSB members expressing 

reservation about putting it on the List, but thinking it was preferable to Ivermectin, which was already 

on the List. In May 2008 Fenbendazole was recommended for addition to the list, with discussion among 

NOSB members that Fenbendazole was safer and more environmentally benign, particularly so because 

it did not harm dung beetles as Ivermectin does. The Livestock Committee indicated that they would like 

to eventually see all of the parasiticides come off the List except the best one.

Additional information requested by NOSB 

Are the three parasiticides (Ivermectin, Moxidectin and Fenbendazole) different enough in their modes 

of action that they should all remain on the National List? If not, which one(s) would you recommend be 

removed from the List, and why?

Peroxyacetic/peracetic acid

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. 

(19) Peroxyacetic/peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing equipment.

Technical Report: 2000 TAP

Page 241 of 249
Petition(s): 2008 Petition

Past NOSB Actions: 11/2000 NOSB recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017

Additional information requested by NOSB 

1. Since this material was last reviewed have alternative materials emerged?

2. Is this material essential to organic livestock production?

Phosphoric acid

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(20) Phosphoric acid - allowed as an equipment cleaner, Provided, That, no direct contact with 

organically managed livestock or land occurs

Technical Report: 2003 TAP (Handling)

Petition(s): N/A

Past NOSB Actions: 10/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

1. Since this material was last reviewed have alternative materials emerged?

2. Is this material essential for organic livestock production?

Poloxalene

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(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

Technical Report: 2001 TAP

Petition(s): 2000 Petition 

Past NOSB Actions: 03/2001 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Background from Subcommittee

Poloxalene is a synthetic substance that can be used in an emergency to reverse the process of bloating 

in ruminant animals. Bloat can be an acute condition which can occur in ruminant animals when they 

Page 242 of 249
eat lush forage legumes. When foaming of the rumen contents becomes persistent foam, gases are 

produced in the rumen faster than they can be expelled. Rapid expansion of the rumen from the gases 

can lead to asphyxiation of the animal. There are preventative strategies for bloat, and there are 

alternative treatments for bloat, but poloxalene is a fast acting treatment for acute bloat and is 

approved only for emergency treatment of bloat.

Additional information requested by NOSB 

NONE

Tolazoline

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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.

Technical Report: 2002 TAP

Petition(s): 2002 Petition 

Past NOSB Actions: 09/002 NOSB recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Background from Subcommittee

Tolazoline is used in conjunction with Xylazine. Xylazine is used as a sedative, analgesic (pain killer) and 

muscle relaxant in veterinary medicine. Tolazoline is used to reverse the effects of Xylazine.

Additional information requested by NOSB 

1. Are there alternative materials that should be petitioned for use? 

2. What alternative practices are available?

Xylazine

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(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: 

Page 243 of 249
(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.

Technical Report: 2002 TAP

Petition(s): 2002 Petition

Past NOSB Actions: 09/002 NOSB recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017

Background from Subcommittee

Tolazoline is used in conjunction with Xylazine. Xylazine is used as a sedative, analgesic (pain killer) and 

muscle relaxant in veterinary medicine. Tolazoline is used to reverse the effects of Xylazine.

Additional information requested by NOSB 

3. Are there alternative materials that should be petitioned for use? 

4. What alternative practices are available?

 

Copper sulfate

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(1) Copper sulfate.

Technical Report: 1995 TAP; 2015 TR

Petition(s); N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

Zinc Sulfate has recently been petitioned for use as a footbath treatment. In the event that the NOSB 

votes to add Zinc Sulfate to the National List, how likely are you to use this material instead of Copper 

Sulfate? 

Formic acid

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(2) Formic acid (CAS # 64-18-6) - for use as a pesticide solely within honeybee hives

Technical Report: 2011 TR 

Petition(s): 2010 Petition 

Past NOSB Actions: 2010 NOSB recommendation

Page 244 of 249
Recent Regulatory Background: Added to National List, effective August 3, 2012 [77 FR 45903]

Sunset Date: 8/3/2017

Additional information requested by NOSB 

1. Do the alternatives documented in the TR control varroa and tracheal mites?

2. Are the alternatives discussed in the TR available for organic beekeepers?

Lidocaine 

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(4) 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

Technical Report: None

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

1. Since this material was last reviewed have alternative materials emerged?

2. What is the scientific rational for what appears to be an excessively long withdrawal period?

3. Is there research to indicate that a shorter withdrawal period would be appropriate?

Lime, hydrated

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(5) Lime, hydrated—as an external pest control, not permitted to cauterize physical alterations or 

deodorize animal wastes

Technical Report: 1995 TAP; 2015 TR in development 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

NONE

Page 245 of 249
Mineral oil

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(6) Mineral oil - for topical use and as a lubricant

Technical Report: 2002 TAP; 2015 TR in development 

Petition(s): 2002 Petition 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 2003 NOSB recommendation, 11/2005 sunset 

recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

NONE

Procaine 

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable. 

(7) 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

Technical Report: N/A

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017

Additional information requested by NOSB 

1. Since this material was last reviewed have alternative materials emerged?

2. What is the scientific rational for what appears to be an excessively long withdrawal period?

3. Is there research to indicate that a shorter withdrawal period would be appropriate?

Sucrose octanoate esters

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(8) Sucrose octanoate esters (CAS #s-42922-74-7; 58064-47-4)—in accordance with approved labeling

Technical Report: 2005 TR

Petition(s): 2004 Petition; 05/2004 petition amendment; 09/2004 petition amendment

Past NOSB Actions: 08/2005 NOSB recommendation; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Background from Subcommittee

Page 246 of 249
Sucrose octanoate esters (SOEs) are surfactants that lower the surface tension of a liquid, allowing 

easier spreading and evaporation. SOE is an EPA-registered biopesticide. As a biopesticide, SOEs are 

currently used as an insecticide to control certain soft-bodied insects, including mites (varroa) on adult 

honey bees. Sucrose octanoate esters act as biopesticides by dissolving the waxy protective coating 

(cuticle) of target pests (e.g. mites), causing them to dry out and die.

Additional information requested by NOSB 

NONE

DL-Methionine

Reference: 205.603(d) As feed additives 

(1) DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS #'s 

59-51-8, 583-91-5, 4857-44-7, and 922-50-9) - 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.

Technical Report: 2001 TAP; 2011 TR

Petition(s): 2005 Methionine; 2007 Methionine; 2009 Methionine; M2011 Methionine

Past NOSB Actions: 10/2001 NOSB recommendation; 04/2010 NOSB recommendation on Methionine 

annotation through October 2012; 04/2010 NOSB recommendation on Methionine step-down

annotation after October 2012 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 10/02/17

Additional information requested by NOSB 

What would be the impact on your poultry operation should the current annotation remain in effect for 

an additional 5 years?

Trace minerals 

Reference: 205.603(d) As feed additives 

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

Technical Report: none

Petition(s): N/A

Past NOSB Actions: 1995 NOSB recommendation; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Background from Subcommittee

From the Livestock Committee’s October 1995 recommendations: “Producers often may not be able to 

control the quantity of vitamins and minerals naturally occurring in feedstuffs. Non-synthetic vitamins 

and minerals should be used if available, but synthetics are allowed...Synthetic vitamins and minerals 

Page 247 of 249
should be used in keeping with the recommendations of the National Research Council and the 

Association of Animal Feed Control Officials,... specific to each species.”

Additional information requested by NOSB 

NONE

 

Vitamins 

Reference: 205.603(d) As feed additives 

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

Technical Report: 2015 TR in development

Petition(s): N/A 

Past NOSB Actions: 1995 NOSB recommendation; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

1. What is the ongoing use of vitamins? 

2. Is this listing for vitamins currently necessary or essential in organic livestock production? Please 

explain.

3. Are there commercially available alternative(s) for vitamins since the last sunset review in 2012? 

4. Are there any annotation(s) needed for vitamins? If so, explain and reference evidence.

EPA List 4—Inerts of Minimal Concern

Reference: 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.

(1) EPA List 4 -Inerts of Minimal Concern

Technical Report: 2015 TR Nonylphenol Ethoxylates (NPEs) (one group only of List 4 inerts) 

Petition(s): N/A

Past NOSB Actions: 02/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017

Additional information requested by NOSB 

NONE

Right COt

Page 248 of 249
Excipients

Reference: 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 Application or 

New Drug Application

Technical Report: 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/2002 NOSB minutes and vote; 10/2010 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017

Additional information requested by NOSB 

In reviewing the recent Technical Report, does the present annotation for Excipients continue to provide 

adequate guidance to MRO's and certifiers doing material review? 

Strychnine

Reference: §205.604 Nonsynthetic substances prohibited for use in organic livestock production. 

The following nonsynthetic substances may not be used in organic livestock production: 

(a) Strychnine

Technical Report: None

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote (crops only), 11/2005 sunset recommendation;

10/2010 sunset recommendation 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 

Additional information requested by NOSB 

NONE

Page 249 of 249