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

Sunset 2019 

Meeting 1 - Request for Public Comment

Livestock Substances §205.603 

April 2017

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 crop 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 2017 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the Spring 2017 public meeting. Comments should be provided 

through Regulations.gov at www.regulations.gov by March 30, 2017 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 

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(3) consistent with organic livestock production. 

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. 

Written public comments will be accepted through March 30, 2017 via www.regulations.gov. Comments 

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

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Sunset 2019 

Meeting 1 - Request for Public Comment

Livestock Substances §205.603 

April 2017 

Note: The materials included in this list are undergoing early sunset review as part of 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

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 Date: 06/27/17 (NOP renewal pending)

Background from Subcommittee:

Specific Uses of the Substance: Used as an antimicrobial during surgery for cleansing wounds, skin, and 

equipment. Also used as a pre- and post- teat dip to aid in controlling bacteria that causes mastitis. 

There are numerous synthetic disinfectants currently on the National List of Approved Synthetics for 

Organic Livestock production including iodine, ethanol, isopropanol, sodium hypochlorite, and hydrogen 

peroxide. Not all are useful both in a surgical environment and as a teat dip, as allowed under the 

chlorhexidine annotation. 

Chlorhexidine reportedly kills mastitis-causing pathogens faster than iodine and is more persistent in its 

disinfection activity. Chlorhexidine is gentler on the skin than iodine, which is especially useful in 

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northern climates where an irritated udder and teats can be especially problematic for the animals in 

cold winter months.

Approved Legal Uses of the Substance: Used in agriculture for disinfection during livestock surgery, on

teats pre and post milking and on milking equipment. Also used in food processing as a hard surface 

disinfectant and in human dentistry as a mouth wash and to disinfect equipment.

Discussion: In April 2015, the NOSB recommended adding one more teat dip: Acidified Sodium Chloriteallowed for use on organic livestock as a pre and post teat dip treatment.

Additional information requested by NOSB

1. Does chlorhexidine provide an essential function that other natural materials or synthetics 

proposed or currently on the national list do not provide?

2. Is chlorhexidine used widely in organic livestock production?

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 published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 (NOP renewal pending) 

Background:

Specific Uses of the Substance: Sodium and calcium hypochlorite are chlorinated inorganic disinfectants 

used to control bacteria, fungi, and slime-forming algae that can cause diseases in people and animals 

(EPA, 1991, 1992). These disinfectants also are used in cleaning irrigation, drinking water, and other 

water and wastewater systems. Chlorine dioxide is an antimicrobial disinfectant and pesticide used to 

control harmful microorganisms including bacteria, viruses, and fungi on inanimate objects and surfaces 

primarily in indoor environments. It is used in cleaning water systems and disinfecting public drinking 

water supplies (ATSDR, 2004a). It also is used as a bleaching agent in paper and textile manufacturing, 

as a food disinfectant (e.g., for fruit, vegetables, meat, and poultry), for disinfecting food processing 

equipment, and treating medical wastes, among other uses (EPA, 2003a). Chlorine materials are 

currently used for disinfection of livestock facilities.

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Approved Legal Uses of the Substance:

Regarding organic production, calcium hypochlorite, sodium hypochlorite, and chlorine dioxide are 

currently approved for disinfecting and sanitizing livestock facilities and equipment and as algicides, 

disinfectants, and sanitizers (including irrigation system cleaning) in organic crop production. Similarly, 

these chlorine materials are approved for disinfecting and sanitizing food contact surfaces in the 

production of processed products labeled as "organic" or "made with organic." Residual chlorine levels 

from these approved uses may not exceed the maximum residual disinfectant limit under the Safe 

Drinking Water Act (currently 4 mg/L).

Discussion: Previous public comments had asked for a comprehensive review of all sanitizers however,

the Subcommittee feels that a review of that scope is beyond the sunset review process.

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?

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 published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 (NOP renewal pending)

Background: 

Glucose has been on the National List since 1995, and has received minimal public comment, both pro 

and con at each sunset review. It is used most frequently in organic dairy operations, to manage ketosis 

or other situations where an infusion of glucose is needed to restore the blood sugar balance in an ill 

animal. On non-organic dairy operations, propylene glycol, glycerin or corticosteroids might also be 

used. Careful management of feed rations before and immediately after birthing is typically used to 

avoid the occurrence of ketosis. There may be some excipient ingredients in glucose used in livestock 

production.

Additional information requested by NOSB 

1. Is this material essential in organic production and why?

2. Are there nonsynthetic materials or methods that can be used to treat the illnesses associated 

with glucose use?

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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 published 06/06/12 (77 FR 33290) 

Sunset Date: 06/27/17 (NOP renewal pending)

Background: 

Oxytocin is a hormone, naturally produced in the pituitary glands of humans, cattle and other mammals. 

In nonorganic production, it can be used regularly to help dairy cows relax and “let down their milk”. 

There are some concerns with over use of oxytocin in nonorganic production systems, as well as the 

abuse of this hormone in the human population. In the NOP regulations, it is only allowed post 

birthing, in a therapeutic way to ease various dam issues that are associated with the birthing of the 

calf, including displaced abomasum and retained placenta. It has been on the National List of approved 

synthetics since 1995, with minimal public comment on this material, pro or con. Some organic milk 

marketers require their organic milk suppliers to not use this material. There was very little public 

comment on this material over the years, and it appears to be used rarely in organic production. 

However, it could be considered essential for animal health and welfare in emergency situations.

Additional information requested by NOSB 

1. Is oxytocin an essential material for organic production and why?

2. Are there nonsynthetic alternatives, or other methods that can be used to accomplish the same 

results as oxytocin?

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

sunset recommendation

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

Sunset Date: 6/27/2017 (NOP renewal pending) 

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Background: 

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

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

During the 2015 comment period for the 2017 sunset, several comments were received indicating that 

xylazine/tolazoline are important tools for farmers and veterinarians and that they should stay on the 

list. 

Additional information requested by NOSB

1. Is tolazoline still considered useful and/or necessary by the organic community for the purpose 

allowed?

2. Are there any alternative practices or substances available that might be preferable?

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 published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 (NOP renewal pending)

Background: 

Copper Sulfate in livestock management is used specifically as a walk-through footbath to help control 

and prevent hoof- related diseases in dairy cattle and sheep. Some of the specific problems affect skin 

adjacent to the claw horn of dairy cattle and sheep, i.e., digital dermatitis (DD) (hairy heel warts), foot 

rot lesions (interdigital area and invading the subcutaneous tissue), and heel erosions. Depending on 

the severity of the infection the impact on managed cattle and or sheep ranges from minor discomfort 

to severe debilitating lameness, reproductive problems and in the dairy industry a reduction of milk 

production ranging from 20 to 50 percent (Brown, et al., 2000, Losinger, 2006). A five to ten percent 

copper sulfate solution is commonly used as the antimicrobial agent in the footbath and is considered 

effective for 150 to 300 animal passes.

According to the Technical Review commissioned by the Livestock Subcommittee, there are no natural 

(nonsynthetic) products available that can be used as a management strategy to treat hoof- related 

diseases and lameness in dairy cattle and sheep operations. However, there are various management 

tools available that could help reduce the cost of treatment and prevent hoof-related diseases. These 

include the use of additional dietary supplements (i.e., feeding of iodine, feeding of zinc methionine), 

free stall (cubicle) design, limiting contact with gravel or rocky surfaces, and hoof trimming practices 

(Maas 2009).

Zinc sulfate may be considered a viable alternative, and the NOSB voted at the Spring 2015 meeting to 

add this substance to the National List for foot and hoof treatment (rulemaking in process by NOP). 

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Additional information requested by NOSB

1. The livestock subcommittee requests public comment on the use of Copper Sulfate and its 

 essentiality in organic processing. 

2. Are there any alternative practices or substances available that might be preferable?

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 published 06/06/12 (77 FR 33290) 

Sunset Date: 6/27/2017 (NOP renewal pending)

Background: 

Lidocaine is a local anesthetic which has a rapid onset of action and is short term in duration. It numbs 

only the area to be worked on. For example, Lidocaine is used to humanely de-bud horns on calves, and 

for minor surgery on mature animals.

During the 2015 sunset review of lidocaine and procaine the Livestock Subcommittee was unable to find 

any record of the rationale for the much extended withdrawal period of 90 days for these materials 

when used on slaughter stock. Historical NOSB and NOP documents from 1995 to the present were 

reviewed. The December 2007 commentary (72 FR 70479) implies that perhaps the 90 days is a doubling 

of the FDA or FARAD (Food Animal Drug Residue Avoidance) withholding period, but no such 45 day 

withholding was found in FDA or FARAD or other sources. 

In FARAD the recommended withdrawal interval for lidocaine in cattle is listed as 1 day for meat and 24 

hours for milk after epidural use of lidocaine, and 4 days for meat and 72 hours for milk after 

subcutaneous use of lidocaine.

The NOSB in its initial request for public comment in April 2015, for Sunset 2107 Review had asked:

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?

In 2015 public comment did not provide any alternatives and did not provide any scientific rationale for 

the lengthy withholding period. Recommendations were received suggesting that a short withholding 

period would be scientifically acceptable. Lidocaine was unanimously approved for continued listing at 

the October 2015 NOSB meeting. A discussion document on changing the withholding period was 

presented at the October 2015 meeting, and a proposal to amend section 205.603 was unanimously 

approved by the NOSB at the April 2016 meeting as follows:

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 To amend Section 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 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals 

In 2015 and 2016 public comment indicated broad public support from farmers, dairy organizations, 

industry groups and consumer groups to reduce the withholding period in order to ensure humane 

treatment of animals. The public finds that a 90-day withholding period is far in excess of the 

withholding period used in conventional livestock production. Public comment supports a 

recommendation for slaughter stock withholding period of 8 days, which is double the FARAD 

recommendation for subcutaneous use in conventional livestock. Public comment agreed with the 

rationale of using double the FARAD time for conventional production. The public supports a 

withholding period of 6 days, which is double the FARAD recommendation of 72 hours (3 days) for 

conventional milk production and 8 days for slaughter stock.

There was broad stakeholder support for continuing to list lidocaine and for the annotation for shorter 

withholding period.

Additional information requested by NOSB 

No additional information requested.

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; 10/2015 sunset recommendation, 2016 annotation change recommendation

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

Sunset Date: 6/27/2017 (NOP renewal pending)

Background: 

Procaine is a local anesthetic which has a rapid onset of action and is of short term duration. It numbs 

only the area to be worked on and can be used to humanely de-bud horns on calves, and for minor 

surgery on mature animals. 

During the 2015 Sunset Review of Lidocaine and Procaine the Livestock subcommittee was unable to 

find any record of the rationale for the much extended withdrawal period of 90 days for these materials 

when used on slaughter stock. Historical NOSB and NOP documents from 1995 to the present were 

reviewed. The December 2007 commentary (72 FR 70479) cited above implies that perhaps the 90 days 

is a doubling of the FDA or FARAD withholding period, but no such 45 day withholding was found in FDA 

or FARAD or other sources

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FARAD provides information on procaine only as it relates to procaine with an antibiotic as part of 

delivery and thus it would not be used in organic production. Procaine on its own is apparently not 

readily available in the US and public comment from veterinarians only suggests a similarity with 

lidocaine. Procaine was recommended for continued listing because no public comment was provided 

to recommend its removal on any criteria. However procaine appears to be rarely used in organic 

livestock production.

The NOSB in its initial request for public comment in 2015 for Sunset 2017 Review, asked:

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?

In 2015 and 2016 Public comment did not provide any alternatives and did not provide any scientific 

rationale for the lengthy withholding period. Recommendations were received suggesting that a short 

withholding period would be scientifically acceptable. Procaine was unanimously approved for 

continued listing at the October 2015 NOSB meeting. A Discussion Document on changing the 

Withholding period was presented at the October 2015 meeting, and a Proposal to amend Section 

205.603 was unanimously approved by the NOSB at the April 2016 meeting in DC. As follows:

 To amend Section 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 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals. 

In 2015 and 2016 public comment indicated broad public support from farmers, dairy organizations, 

industry groups and consumer groups to reduce the withholding period in order to ensure humane 

treatment of animals. The public finds that a 90-day withholding period is far in excess of the 

withholding period used in conventional livestock production. Public comment supported a 

recommendation for slaughter stock withholding period of 8 days, which is double the FARAD 

recommendation for subcutaneous use in conventional livestock. Public comment agreed with the 

rationale of using double the FARAD time for conventional production. The public supports a 

withholding period of 6 days, which is double the FARAD recommendation of 72 hours (3 days) for 

conventional milk production and 8 days for slaughter stock.

There was broad stakeholder support for continuing to list procaine with the annotation for shorter 

withholding period. Public comment indicates procaine is not readily available in the United States and 

does not appear to be widely used. Procaine may not be essential and may not need to continue to be 

listed. 

Additional information requested by NOSB 

1. Is procaine used in organic livestock production?

2. Is procaine available in the US in its pure form or only in combination with antibiotics?

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