National Organic Standards Board

Livestock Subcommittee

Proposal - Annotation Change for Lidocaine and Procaine Use in Livestock Production

 January 19, 2016 

I INTRODUCTION:

Lidocaine and Procaine are local anesthetics. They are used to reduce or prevent pain during de-budding 

horns in livestock, or general minor surgery on mature livestock. They numb only the area to be worked 

on. Humane treatment of animals is critically important and the public expects high standards of animal 

welfare for organic livestock. A lengthy withholding period after treatment may result in animals not 

being treated in a timely manner, or not being treated at all. Based on new information received during 

Sunset Review in 2015 and public comment, the NOSB proposes a recommendation to reduce the 

withholding period for both lidocaine and procaine from the present 90 days to 8 days for slaughter 

stock and 6 days for milk. 

II BACKGROUND:

When added to the National List in 1995, there was no scientific rationale for the 90 day withholding, 

and the NOSB analysis in their document entitled “Local Anesthetics” provided very little information. 

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

recommendation 

In December 2007, after much public comment and consultation, the NOP agreed that the NOSB could 

require double FDA withdrawal times, or double FARAD times (when appropriate), on a number of 

livestock materials . 

“..... As a proposed compromise to satisfy the intent of the NOSB, many commenters suggested 

that USDA should consider amending the annotations of Atropine, Butorphanol, Flunixin, 

Furosemide, Tolazoline, and Xylazine by establishing extended withdrawal periods, calculated 

using withdrawal times from the Food Animal Residue Avoidance Databank(FARAD).The FARAD 

is a National Food Safety Project administered through the USDA Cooperative State Research, 

Education, and Extension Service. It is a system designed to provide livestock producers, 

extension specialists, and veterinarians with practical information on how to avoid drug, 

pesticide and environmental contaminant residue problems. FARAD is a repository of 

comprehensive residue avoidance information. It is also sanctioned to provide ‘‘withholding 

period’’ (also known as withdrawal period) estimates to the U.S. Pharmacopeia-Drug 

Information (USP–DI) Veterinary Medicine Advisory Committee. Commenters suggested that 

USDA account for an extra margin of at least double the withdrawal times of FARAD to safely 

capture the intent of the NOSB.USDA agrees with the position ..... “

“...Based on public comment, USDA consulted further with the FDA, concerning the ability to 

extend the withdrawal period on these approved drugs. Based on our consultations, USDA 

agreed to clarify the rationale for extending the FDA established withdrawal period. Secondly, 

USDA agreed to clarify the language used to authorize the use of the substances by indicating 

the extended withdrawal periods (at least two-times that required by the FDA) were only 

relevant for use of the substances under the NOP regulations. Therefore, to clarify our rationale 

for extending the withdrawal periods established by the FDA, we acknowledge that this 

determination was not based on scientific research or risk assessments. The decision to extend 

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the FDA withdrawal periods (or any other withdrawal period) for the use of Flunixin and 

Furosemide (and other substances) was based on consumer preference and the 

recommendations of the NOSB. FDA exercises full responsibility for determining and enforcing 

the withdrawal intervals for animal drugs. No food safety arguments are used or implied to 

support the use of extended withdrawal periods authorized under the NOP regulations. Rather, 

we determined that extended withdrawal periods are more compatible with consumer 

expectations of organically raised animals“ (72 FR 70479) .

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

Sunset Date: 6/27/2017 

Sunset Review took place in 2015, and lidocaine and procaine were approved for continued listing at 

the October 2015 NOSB Meeting in Stowe, Vermont. (On a motion to Remove, Vote 0:14)

III RELEVANT AREAS OF THE RULE:

Section 205.238 Livestock healthcare practice standard.

(a) The producer must establish and maintain preventive livestock healthcare practices, including ...

(5) performance of physical alterations as needed to promote the animal’s welfare and in a 

manner that minimizes pain and stress;

...

(c) The producer of an organic livestock operation must not: ...

(7) Withhold medical treatment from a sick animal in an effort to preserve its organic status. All 

appropriate medications must be used to restore an animal to health when methods acceptable 

to organic production fail. Livestock treated with a prohibited substance must be clearly 

identified and shall not be sold, labeled or represented as organically produced. 

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 after 

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

animals.

...

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.

IV DISCUSSION:

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

find any record of the rationale for the very 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.

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.

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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.

During Review of these materials the NOSB in its initial request for public comment asked:

* Since this material was last reviewed have alternative materials emerged?

* What is the scientific rationale for what appears to be an excessively long withdrawal period?

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

Public comment did not provide any alternatives to these materials, did not provide any scientific 

rationale for the lengthy withholding period, and recommendations were received suggesting that a 

very short withholding period would be scientifically acceptable. Public comment agreed with the 

rationale of using double the FARAD time for conventional production.

In contrast to butorphanol, which is a systemic anesthetic, lidocaine and procaine numb only the area to 

be worked on. Science indicates that the half-life of lidocaine and procaine in all animals studied is very 

short, typically less than one hour. 

Based on new information and public comment during Sunset Review, the NOSB developed a Discussion 

Document to allow public comment on a possible annotation change. Public comment was received in 

Fall 2015 and discussion took place at the October 2015 NOSB meeting. 

Public comment indicates that there appears to be 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. The public supports a 

recommendation for withholding for milk of 6 days, which is double the FARAD recommendation of 72 

hours (3 days) for conventional milk production.

V RECOMENDATION: 

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 

(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.

Sub Committee Vote : - Two Motions

1. That the deleted language be removed and underlined language added at:

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

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(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 

Motion: Jean Richardson

Second: Francis Thicke

Vote: 6 Yes 0 No 0 Abstain 0 Absent 0 Recuse

2. That the deleted language be removed and underlined language added at: 

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. 

Motion: Jean Richardson

Second: Francis Thicke

Yes: 6 No: 0 Abstain: 0 Absent: 0 Recuse: 0

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