Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: November 2, 2017

Subject: Livestock 2019 Sunset Substances 

NOSB Chair: Tom Chapman

The NOSB recommends to the NOP the following: 

Rulemaking Action: X

The NOSB recommends the following sunset substances be renewed:

Chlorhexidine

Chlorine materials (calcium hypochlorite, chlorine dioxide, sodium hypochlorite)

Glucose

Tolazoline

Copper sulfate

Lidocaine

The NOSB recommends the following sunset substances be removed from the National List: 

Oxytocin

Procaine

NOSB Vote: See below for votes and rationale supporting each recommendation.
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Sunset 2019 

Meeting 2 - Review

Livestock Substances §205.603 

November 2017

As part of the National List Sunset review process, the NOSB has evaluated the need for the continued 

allowance for or prohibition of the following substances for use in organic livestock production.

Note: The materials included in this list underwent early sunset review as part of the November 18, 

2016 NOSB recommendation on efficient workload re-organization. 

Reference: 7 CFR 205.603 Synthetic substances allowed for use in organic livestock production

Chlorhexidine

Chlorine Materials: Calcium hypochlorite, chlorine dioxide, sodium hypochlorite

Glucose

Oxytocin

Tolazoline

Copper sulfate

Lidocaine

Procaine
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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: 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; 10/2015 

sunset recommendation

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

renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of this material. Based on the Subcommittee 

review and public comment, the NOSB finds this material compliant with OFPA criteria, and does not 

recommend removal from the National List.

NOSB vote:

Motion to remove chlorhexidine from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Harriet Behar

Seconded by: Ashley Swaffar

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

Outcome: Motion failed

Chlorine Materials

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; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of chlorine materials. The NOSB also 

recognizes the public’s request for a comprehensive review of sanitizers, however, a review of that 

scope is beyond that of the sunset review process. Based on the Subcommittee review and public 

comment, the NOSB finds this material compliant with OFPA criteria, and does not recommend removal 

from the National List.

NOSB vote:

Motion to remove chlorine materials from §205.603(a) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Ashley Swaffar

Seconded by: Sue Baird

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

Outcome: Motion failed 

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; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of this material. Based on the Subcommittee 

review and public comment, the NOSB finds this material compliant with OFPA criteria, and does not 

recommend removal from the National List.

NOSB vote:

Motion to remove glucose from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Harriet Behar

Seconded by: Sue Baird

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

Outcome: Motion failed
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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; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

Subcommittee Review

NOSB review:

The NOSB has determined this material is not a necessary tool in organic dairy production. There are 

numerous alternative methods and materials for addressing the health issues where oxytocin would be 

used. Its removal addresses consumer expectation that organic dairy animals are not treated with 

synthetic hormones.

There was public support for the delisting of this material. Based on the Subcommittee review and 

public comment, the NOSB finds this material to be non-compliant with the OFPA criteria of essentiality, 

and recommends removal from the National List.

NOSB vote:

Motion to remove oxytocin from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) Section 2118 (7 U.S.C. 6517) National List (b) (1) (A) (ii) and (iii), Section 2119 (7 

U. S. C. 6518 (m) (6) and (7) and/or 7 CFR 205.600(b) (1): essentiality 

Motion by: Harriet Behar

Seconded by: Ashley Swaffar

Yes: 15 No: 0 Abstain: 0 Absent: 0 Recuse: 0

 Outcome: Motion passed

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 
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Past NOSB Actions: 09/2002 NOSB recommendation; 10/2010 sunset recommendation; 10/2015 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of this material. Based on the Subcommittee 

review and public comment, the NOSB finds this material compliant with OFPA criteria, and does not 

recommend removal from the National List.

The Livestock Subcommittee noted, however, that were xylazine to be removed from the National List 

in the future, tolazoline, which is used in conjunction with xylazine, would probably no longer be needed 

for organic production. Thus if xylazine is removed, the NOSB should consider removing tolazoline as 

well.

NOSB vote:

Motion to remove tolazoline from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none 

Motion by: Daniel Seitz

Seconded by: Jesse Buie

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

 Outcome: Motion failed

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; 10/2010

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of this material. Based on the Subcommittee

review and public comment, the NOSB finds this material compliant with OFPA criteria, and does not 

recommend removal from the National List.
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

NOSB vote:

Motion to remove copper sulfate from §205.603(b) as topical treatment, external parasiticide or local 

anesthetic based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) if applicable: none 

Motion by: Jessie Buie

Seconded by: Harriet Behar

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

Outcome: Motion failed 

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; 10/2015 sunset recommendation, 2016 annotation change recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

 

Subcommittee Review

NOSB review:

There was strong public support for the continued listing of this material. Based on the Subcommittee 

review and public comment, the NOSB finds this material compliant with OFPA criteria, and does not 

recommend removal from the National List.

NOSB vote:

Motion to remove lidocaine from §205.603(b) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Motion by: Daniel Seitz

Seconded by: Francis Thicke

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

Outcome: Motion failed

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 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

sunset recommendation; 10/2015 sunset recommendation, 2016 annotation change recommendation

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420)

Sunset Date: 03/15/2022

 Subcommittee Review

 NOSB review:

Six written comments on procaine were submitted prior to the spring 2017 NOSB meeting, which made 

the following points: (i) procaine is rarely used, (ii) procaine is not as effective as lidocaine, which is 

used for the same purpose, (iii) procaine is only available in combination with the antibiotic penicillin, 

which is not allowed for use in organic livestock production, and (iv) since lidocaine is more effective 

than procaine, keeping procaine on the National List may create confusion. Several of these six 

comments suggested continued listing despite the points noted above. 

Seven written comments on procaine were submitted prior to the fall 2017 NOSB meeting, several of 

which reiterated the concern that procaine is only available in combination with an antibiotic, and one 

of which stated that a number of products containing procaine have been voluntary withdrawn from 

list of FDA Approved Animal Drug Products and are not considered to be FDA approved. Only one 

comment recommended continued listing. 

A majority of the Subcommittee members recommended that procaine be removed from the list due 

to the various concerns that had been raised, most notably that procaine is only available in 

combination with an antibiotic, and because it is widely considered to be less effective than lidocaine, 

which is used for the same purpose. 

There was public support for delisting of this material based on the fact that this material is not 

available in a form without antibiotics. Based on the Subcommittee review and public comment, the 

NOSB finds this material to be non-compliant with OFPA criteria, and recommends removal from the 

National List.

NOSB vote:

Motion to remove procaine from §205.603(b) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: essentiality.

Motion by: Daniel Seitz

Seconded by: Sue Baird

Yes: 14 No: 1 Abstain: 0 Absent: 2 Recuse: 0

Outcome: Motion passed