FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: ___March 18, 2005______

Subject: Livestock Medications recommended by NOSB 

Chair: Jim Riddle__________ 

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ____X____ 

Guidance Statement: ________ 

Other: ____X____ 

Statement of the Recommendation (including Recount of Vote): 

In order to place NOSB-recommended substances on section 205.603 of the National List, the 

NOSB Policy Development and Livestock Committees recommend the following: 

USDA and FDA should pursue further clarification at higher levels of USDA and FDA to 

facilitate co-existence of NOP and FDA regulatory processes for the listing of unapproved 

medications and other substances recommended by the NOSB. 

NOP should pursue rulemaking to create a National List category in section 205.603 of 

“production aids” with reference to specific use. 

USDA should investigate FDA recognition of “organic livestock production” as a “minor 

species/minor use” category. 

NOP should review all recommended materials to more correctly place them in categories 

consistent with FDA regulation. 

Adopted by the NOSB March 1, 2005 Vote: 14 yes, 0 no, 0 abstain. 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

See rationale below.

Response by the NOP:

Updated 2/25/05 
Recommendation for Addressing FDA Regulations 

Affecting NOSB Recommendations 

Concerning Livestock Medications 

Adopted by the NOSB March 1, 2005 

Introduction 

Many livestock medications used by conventional producers have not been formally 

approved by the Food and Drug Administration, since they are relatively benign 

substances that have not been evaluated under the New Animal Drug Evaluation (NADE) 

program, but are considered by the FDA to have a low regulatory priority. Many of these 

substances are non-proprietary general use materials (eg. calcium borogluconate), and no 

manufacturer has sought a NADA (new animal drug approval). FDA in effect permits 

“brand name” products, that have completed formal drug reviews, but no “generic” or 

“over the counter” list for commonly used materials. The use of such drugs, though 

unapproved by FDA, is allowed under FDA’s regulatory discretion. FDA maintains the 

authority to take action against any such unapproved products, should it find evidence of 

adverse reactions. 

A number of such medications have been petitioned for use in organic livestock 

production. The substances have undergone Technical Advisory Panel reviews, and the 

NOSB has voted to recommend that the substances be placed on the National List of 

Allowed and Prohibited Substances. 

The NOSB has been notified by the National Organic Program that livestock medications 

which are not formally approved by FDA, cannot be placed on the National List. The 

NOSB Policy Development and Livestock Committees have developed this briefing 

paper to explore the opportunities for a framework that will allow the approval for use of 

livestock medications compatible with organic production and handling practices. 

Background 

In 2000-2003, the National Organic Standards Board livestock committee conducted 

extensive work to recommend for approval a series of livestock medications compatible 

with organic production and handling standards. During this period, the board 

recommended that several materials be included in §205.603(a) of the Final Rule as 

allowed disinfectants, sanitizers, and medical treatments. 

On June 23, 2003, Sharon Benz, Office of Surveillance and Compliance, Center for 

Veterinary Medicine, U.S. Food and Drug Administration, notified the NOP that all 

products to be included on the National List must comply with FDA regulations. 

Accordingly, on July 31, 2003, the NOP informed the Board that 10 synthetic substances 

recommended to the Secretary for use in organic livestock production would not be 

approved as medications in food animals. Those substances were: 
• Activated Charcoal 

• Bismuth subsalicylate 

• Butorphanol 

• Calcium borogluconate 

• Calcium propionate 

• Kaolin pectate 

• Magnesium hydroxide 

• Magnesium oxide 

• Mineral oil 

• Potasium sorbate 

Subsequently, the Policy Development Committee and the Livestock Committee of the 

National Organic Standards Board have sought feasible methods to accommodate the use 

of alternative medications within the organic livestock sector while meeting FDA 

compliance requirements. FDA representatives were invited to the October 2003 board 

meeting, at which time they expressed willingness to accommodate the NOSB position. 

However, NOP staff informed the board at the October 2004 meeting, that they have 

again been told by FDA compliance division that NOP cannot list unapproved new 

animal drugs as permitted in a Federal Register notice. 

The committees have been presented with the following options: 

1. Create a category of “alternative medicines” on the National List. 

The existing categories on §205.603 “Synthetic substances allowed for use in organic 

livestock production” are: 

(a) As disinfectants, sanitizer, and medical treatments as applicable; 

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

(c) As feed supplements; 

(d) As feed additives; and 

(e) As synthetic inert ingredients as classified by the Environmental Protection 

Agency (EPA), for use with nonsynthetic substances or a synthetic substances 

listed in this section and used as an active pesticide ingredient in accordance 

with any limitations on the use of such substances. 

Under this option, a new category “Alternative medicines” would be created. 

Pros: 

The creation of a new category for alternative medicines would make the National List 

more user friendly for producers, consumers, and certifying agents. Approved alternative 

medicines would be clearly listed in their own section. 

Cons: 

Creation of an “Alternative medicines” category on the National List does not resolve the 

issues concerning the use of medications not formally approved by FDA. 

 
2. Create a “negative over-the-counter” list. 

Human drugs are regulated differently than animal drugs, and there is a provision for 

review of Over the Counter (OTC) human drugs through the FDA’s Center for Drug 

Evaluation (CDER) or the CFSAN Office of Color and Cosmetics. Originally, it was 

intended that some livestock drugs would also be covered by the OTC program, but this 

aspect was never developed. FDA does have a “drug listing” program for unapproved 

animal drugs, this database contained 3160 products as of October 20031

, and there are 

likely many animal drugs additionally on the market that are not registered in this 

database. 

There was initial discussion about allowing all over-the-counter medications for use in 

organic livestock production. However, a number of antibiotics are now allowed as overthe-counter medications for livestock. This led to a discussion about creating a “negative 

list” of prohibited over-the counter medications. 

Pros: 

This proposal would allow numerous medications to be used by organic livestock 

producers. 

Cons: 

FDA does not have an OTC program for livestock medications, so there is no context to 

create a negative list of prohibited medications. In addition, evaluation criteria, 

procedures, and bureaucracy would need to be created to manage such a list. 

3. Create a National List category of “production aids” with reference to specific 

use. 

OFPA 6517(c)(1)(B)(i) allows for the consideration of “production aids.” A category of 

“production aids” could be created, whereby substances listed in the category do not have 

medical use claims. 

Pros: 

The creation of a “production aid” category for alternative livestock materials is 

consistent with OFPA and could satisfy FDA’s concerns about unapproved animal drugs 

appearing on a USDA list as medical treatments. 

Cons: 

While creation of a “production aid” category may be part of the solution, it would 

require a new rule change, in addition to the rule change necessary for adding the 

recommended substances to the list. It would not likely resolve all of FDA’s concerns, 

since “unapproved” medications would appear on the USDA’s National List. 

 

4. Include “organic” as a “minor species/minor use” category by FDA. 

 

1

 Dr. V. Vengris, FDA. Transcript, Oct. 22, 2003 NOSB meeting. p.39. 

http://www.ams.usda.gov/nosb/transcripts/NOSBMeetingOctober2203WashingtonDC.pdf 
The Minor Use and Minor Species (MUMS) Animal Health Act, enacted 

 in August 2004, is a mechanism to provide FDA-authorized drugs for those less 

common species and indications. Specifically, it seeks to provide labeled drugs for needy 

minor species, as well as major species with needed therapeutics for uncommon 

indications (minor uses). 

 FDA's Center for Veterinary Medicine is announcing the establishment of a new Office 

of Minor Use and Minor Species (MUMS) Animal Drug Development and is requesting 

comment on the implementation of the newly enacted MUMS Animal Health Act. 

The law has two relevant sets of provisions. First, the MUMS Act allows conditional 

approval of drugs for minor species and uses. Full safety data must l be developed before 

FDA can conditionally approve a drug, but manufacturers have five years post-approval 

to develop data on drug efficacy. Second, the MUMS Act allows “indexing” – an 

expedited non-approval process – for drugs used in early non-food life stages of foodproducing minor species or in minor species not consumed by humans. 

 

Several elements of the law became immediately effective on that date including the 

provisions for designation of MUMS drugs and for conditional approval of MUMS 

drugs. Implementing regulations for drug designation will be the first to be developed by 

the new Office, with proposed regulations due by August 2, 2005, as mandated by the 

MUMS Act. The indexing provisions of the law will only become effective upon 

publication of final implementing regulations. 

Organic usage is not currently defined as a minor usage under the MUMS legislation. Inclusion of organic 

livestock medications in this Act would ease the approval process for such medications. 

Pros: 

This option may provide a long-term opportunity to facilitate the FDA approval, or in 

some cases indexing, of medications used by organic livestock producers. 

Cons: 

The conditional approval process still requires considerable data development, and the 

indexing process is not applicable to major species, which includes most organic 

livestock. 

While offering some promise in the long run, no work is being done to define organic 

livestock production as a minor use category. The NOSB exists to “advise the Secretary.” 

The NOSB has no authority to directly advise FDA on creation of an organic usage 

category under MUMS legislation. NOSB could recommend to the Secretary, however, 

that this action be taken. 

5. Review all recommended materials to more correctly place them in categories 

consistent with FDA regulation. 
Some materials that NOSB has recommended for use in health care products do not fall 

into FDA’s definition of a new animal drug. For example, NOSB recommended the 

listing of two preservatives used in herbal products (Herbal products themselves are 

considered unapproved animal drugs, but as natural substances do not have to appear on 

the National List). Potassium sorbate was approved for use as preservative in aloe vera. 

Calcium propionate was approved as preservative in dried herbal remedies. The NOSB 

has recommended that the broad category of “excipients” be added to the National List 

for use in animal medications. Depending on the language in the Federal Register notice 

concerning “excipients,” the individual listing of potassium sorbate for aloe vera and 

calcium propionate for dry herbal remedies may be unnecessary. 

Some of the problematic substances may fall into broad categories already on the 

National List. For example, §205.603(a)(6) allows the use of electrolytes. The use of 

calcium borogluconate is considered an electrolyte,when the substance is used in an IV 

solution. 

A number of the recommended substances such as activated charcoal, kaolin pectate, 

calcium propionate for use as a calcium supplement to treat milk fever, and mineral oil 

cannot be reclassified as another permitted category, unless some are available in natural 

form. 

Pros: 

This option would address a few of the problematic substances without additional rule 

change, and without formally listing substances not approved by FDA. 

Cons: 

This option does not allow use of all substances recommended by the NOSB, and does 

not address the structural problem of allowing organic livestock producers to officially 

use the same substances currently used by conventional producers. 

6. Pursue further clarification at higher levels of USDA and FDA to facilitate coexistence of NOP and FDA regulatory processes for these substances. 

On October 22, 2003, Drs. Steve Vaughn and Vitolis Vengris of the FDA’s Center for 

Veterinary Medicine made a presentation to the NOSB on how the FDA determines 

regulatory discretion or low regulatory priority for unapproved animal drugs. Drs. 

Vaughn and Vengris explained to the board why FDA would have no problem with the 

use of certain drugs. 

Dr. Vaughn clarified that NOP has the authority to set organic standards, and that NOSB 

should be aware that both approved and unapproved drugs exist in the marketplace, 

including those unapproved drugs permitted to be marketed under FDA regulatory 

discretion.2

 He noted that since NOSB is deciding whether animal drugs “meet the 

qualifications of an organic product” he saw no conflict with FDA authority over 

 

2

 Transcript, Oct.22, 2003 NOSB meeting. p.61. Note: Dr. Vaughn is incorrectly identified as Mr. 

Mathews. http://www.ams.usda.gov/nosb/transcripts/NOSBMeetingOctober2203WashingtonDC.pdf 
marketability.3

 Linda Tollefson, Deputy Director of FDA's Center for Veterinary 

Medicine, has expressed support for statements made by Drs. Vaughn and Vengris, but 

has also indicated that FDA is exploring other options to allow the use of certain 

substances in organic production – such as considering these substances to be GRAS.4

 NOSB could recommend that USDA explore the situation with FDA further, perhaps by 

revisiting the issue with Dr. Vaughn, Director of the New Animal Drug Evaluation 

program, to facilitate the approval process for livestock medications to be used in organic 

agriculture. 

Some of the FDA objections to NOSB action have been specifically related to the 

terminology contained in the NOSB recommendations. For example, FDA specifically 

objected to annotations specifying “double FDA withhold time.” According to the 

agency, only FDA has the authority to establish withhold periods. FDA and USDA could 

establish a framework for defining acceptable terminology to be used in future NOSB 

recommendations. 

Pros: 

This option allows for the current list of substance recommended by the NOSB to be 

added to the National List. It also addresses the structural issues so that future substances 

can be added to the National List with the full approval and cooperation of USDA and 

FDA. 

Cons: 

While the NOSB can lay the groundwork and urge cooperation between USDA and FDA, 

communication and effective action must occur at between officials within the two 

agencies. 

Recommendation – 

In order to place NOSB-recommended substances on section 205.603 of the National 

List, the NOSB Policy Development and Livestock Committees recommend the 

following: 

1) USDA and FDA should pursue further clarification at higher levels of USDA and 

FDA to facilitate co-existence of NOP and FDA regulatory processes for the 

listing of unapproved medications and other substances recommended by the 

NOSB. 

2) NOP should pursue rulemaking to create a National List category in section 

205.603 of “production aids” with reference to specific use. 

3) USDA should investigate FDA recognition of “organic livestock production” as a 

“minor species/minor use” category. 

4) NOP should review all recommended materials to more correctly place them in 

categories consistent with FDA regulation. 

 

3

 Ibid. p.68 

4

 emails to Becky Goldburg, 12-22-05 and 1-17-05 
Board vote – 

14 yes, 0 no, 0 abstain. 

Minority opinion – 

None.