National Organic Standards Board

Livestock Subcommittee Proposal 

Use of Excluded Method Vaccines in Organic Livestock Production 

July 16, 2019 

Introduction and Background

There are two areas in the organic regulations that address use of vaccines; one on the National List (NL) 

of allowed and prohibited substances, and one in the section that details excluded methods. Through 

public comment and direct interaction with certifiers and organic producers, it became apparent that 

there are inconsistencies between certifiers about which vaccines are allowed. Some certifiers do not

allow the use of excluded method vaccines, relying on the NOP regulation at §206.105 (e) which only 

allows use of this type of vaccine if it has gone through NOSB review and NOP placement on the 

National List. Other certifiers allow any type of vaccine to be used, and may or may not inquire if the 

vaccine has been produced through excluded methods. These certifiers rely on the presence of vaccines 

on the National List at §205.603(a)(4) without any restriction or clarifying annotation.

This issue was reviewed by the NOSB in October 2014: “Findings and Recommendations in Response to 

September 2010 NOP Memorandum on Livestock Vaccines Made With Excluded Methods”. Challenges 

that prevented immediate attention to this issue included: having an updated definition of excluded 

methods that determines if new technologies were to be excluded methods for organic, having a clear 

understanding if there were non-excluded method vaccine equivalents to excluded-method-derived 

vaccines, and how to provide for use of excluded method vaccines if there was an emergency when only 

an excluded method vaccine could address the problem in a timely way. 

In November 2017, the NOSB passed a recommendation that addresses how to determine if specific 

technologies should be considered excluded or not, with descriptions, terminology, and a listing of 

excluded, not excluded, and yet-to-be-determined methods. The NOSB will use this recommendation to 

review new technologies as they develop. The October 2014 NOSB recommendation lists commonly 

used vaccines that are known to have been made through excluded method technology. The NOSB 

strives to correct this inconsistency, to increase the trust of the organic certification system and provide 

consistency and certainty for organic livestock producers. 

The Subcommittee recognizes the importance vaccines play in the prevention of livestock disease. When 

an organic livestock producer loses one or more of their animals, there is the loss of the animal’s 

production capability, as well as a loss of time and resources associated with the breeding and selection 

that resulted in that specific animal. Breeding and selection often take years or even decades. When an 

animal is lost, all of those years of breeding and their unique genetics are also lost. The use of vaccines 

as a preventative can protect this long-term investment in genetic improvement, and vaccines remain

an important tool in the organic livestock producer’s toolbox to protect the investments that producers 

have in individual animals as well as their herds or flocks. The possibility of a livestock health emergency 

is real, and the NOSB is putting forth this proposal to have clarity in the use of vaccines from excluded 

methods, to provide certainty and consistency to both producers and certifiers in the determination of 

which specific vaccines can be used with organic livestock.

NOSB October 2019 proposals and discussion documents Page 191 of 230
Relevant Areas of the Rule and Guidance

From the NOP Rule:

§205.2 Terms defined

 Biologics. All viruses, serums, toxins, and analogous products of natural or synthetic origin, 

such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the 

antigenic or immunizing components of microorganisms intended for use in the diagnosis, 

treatment, or prevention of diseases of animals.

 Commercial availability. The ability to obtain a production input in an appropriate form, 

quality, or quantity to fulfill an essential function in a system of organic production or handling, as 

determined by the certifying agent in the course of reviewing the organic plan.

 Excluded methods. A variety of methods used to genetically modify organisms or influence 

their growth and development by means that are not possible under natural conditions or 

processes and are not considered compatible with organic production. Such methods include cell 

fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including 

gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes 

when achieved by recombinant DNA technology). Such methods do not include the use of 

traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue 

culture.

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and 

handling. To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with 

§205.600(a)

§205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients.

The following criteria will be utilized in the evaluation of substances or ingredients for the organic 

production and handling sections of the National List: 

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List 

of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 U.S.C. 

6517 and 6518). 

The preamble to the National Organic Program final rule (65 FR 80547, December 21, 2000) states: 

The Act allows use of animal vaccines in organic livestock production. Given the general 

prohibition on the use of excluded methods, however, we believe that animal vaccines 

produced using excluded methods should not be allowed without an explicit consideration of 

such materials by the NOSB and without an affirmative determination from the NOSB that they 

meet the criteria for inclusion on the National List. It is for that reason that we have not granted 

this request of commenters but, rather, provided an opportunity for review of this narrow range 

of materials produced using excluded methods through the National List process.

NOSB October 2019 proposals and discussion documents Page 192 of 230
Excerpt from NOP Memo to NOSB dated September 30, 2010: 

The NOP’s understanding is that excluded methods are prohibited under Section §205.105(e) 

except for vaccines. Further, this exception applies to vaccines that are produced through 

excluded methods only if those GMO vaccines are approved according to 205.600(a). Vaccines 

are listed under §205.603(a)(4) under “Biologics-Vaccines”. The NOSB has not reviewed vaccines 

in accordance with §205.600(a). The listing under §205.603(a)(4) of Biologics-Vaccines does not 

include the allowance of GMO vaccines. The NOP requested a legal review from USDA’s Office of 

General Counsel (OGC) to determine whether vaccines produced through excluded methods are 

currently allowed under 205.603(a)(4). The OGC opinion supports the position that GMO 

vaccines are allowed only if they are approved according to 205.600(a). 

The NOP recommends that the NOSB review GMO vaccines under the provisions of §205.600(a). 

The NOP suggests that the Board request a technical review for biologics-vaccines, including the 

status of genetically modified vaccines and an assessment of the economic impact of using 

commercial availability criteria for non-genetically modified vaccines. After the Board completes 

the evaluation according to the OFPA criteria, it may submit a recommendation to the NOP to 

add GMO vaccines to the National List of Allowed and Prohibited Substances.

 

Discussion and Goals of this Proposal

The Livestock Subcommittee strongly supports the use of vaccines as an essential component of 

maintaining animal health and promoting animal welfare. Vaccines are an essential tool for livestock 

producers to prevent serious health events in both individual animals as well as their entire herds or 

flocks. Interstate and international movement of livestock may require specific vaccinations for animals 

to be transported and sold. Currently, § 205.105(e) requires excluded method vaccines be reviewed and 

placed on the National List before use. This approach is impractical for a variety of reasons: 

• There are new individual vaccines continually being developed; the NOSB will have difficulty 

reviewing these in a timely manner.

• Putting each of the excluded method vaccines on the NL is a lengthy process (2+ years) and 

puts organic livestock at risk in emergency situations when that vaccine may be needed 

immediately.

• Some excluded method vaccines may be patented and there may be confidential information 

that will not allow NOSB standard review of the material.

• Both the European Union and Canadian organic standards do not differentiate between the 

use of excluded method vaccines or standard vaccines, putting US organic livestock producers 

at a disadvantage when addressing animal disease.

• Some certifiers observe this restriction, and do not currently allow any excluded method 

vaccines, while others ignore this restriction and allow excluded method vaccines, or do not 

determine if a vaccine is made from an excluded method. This inconsistency causes problems 

for some producers and may lead to “certifier-shopping”. Any time we can correct an 

inconsistency, we increase the trust of the organic certification system for both producers and 

consumers.

The NOSB, supported by the majority of public comment, is committed to not endorsing the blanket use 

of excluded method technologies. We seek to find a pragmatic way to stand against pervasive use of 

excluded methods in organic agriculture and foods, while being practical in accepting the fact that 

sometimes the only vaccines that are available are those made with excluded method technology. 

NOSB October 2019 proposals and discussion documents Page 193 of 230
In our discussion, we reviewed three options: 

1. Allow all vaccines without any review or consideration if they were produced through excluded 

methods.

2. Allow vaccines from excluded methods, but only if they were individually reviewed and 

approved by the NOSB and placed on the National List by the NOP.

3. Allow vaccines from excluded methods, but only if a vaccine is not “commercially available” that 

had not been produced from excluded methods to effectively treat that health issue.

For option 1, the NOSB considered the issues below if there would be an allowance of excluded method 

vaccines “as a class” with no restriction.

• This is what is currently done in Europe and Canada. 

• Less documentation needed by operators and certifiers. 

• Allows for use of needed vaccines in an emergency with no restrictions. 

• New excluded method technologies might provide additional animal health effects beyond just 

control of a specific disease, having a carte blanche approach might have unintended 

consequences beyond our intention of preventing animal illness.

• Might open the door to more use of excluded methods in organic.

For option 2, the NOSB considered these issues if there was no change to the current two references in 

the USDA organic regulations, both within the regulatory text and on the National List.

• Use of vaccines from excluded methods, at times the only vaccine to prevent the health issue, 

would not be available to some producers since their certifiers will continue to follow the 

current regulation as written.

• Certifiers who currently allow the use of excluded method vaccines, would continue to ignore 

the language of the regulation that requires these vaccines be in the National List before use, 

leading to a lack of consistency in implementation of the regulation, as well as confusion in the 

certification community resulting in some areas of the regulation to be ignored without 

consequences.

• The NOSB would need to solicit petitions for review of excluded method vaccines that are 

currently in use, to place them on the National List. Optimistically, the placement of these 

vaccines on the NL would take 2 to 4 years. 

• In the case of a livestock disease outbreak, that can only be treated by excluded method 

vaccines, organic livestock producers would be at a disadvantage due to the lag time between 

the petitioning of a new excluded method vaccine and its eventual possible placement on the 

National List.

For option 3- change to the regulatory language could require that vaccines from excluded methods only 

be used when there are no commercially available vaccines produced without excluded methods. 

Allowance for the use of nonorganic seeds and some nonorganic agricultural products in processed 

organic foods, is currently allowed when there is no “commercially available” organic alternative. The 

term “commercially available” is defined in the USDA organic regulations as:

Commercially available. The ability to obtain a production input in an appropriate form, quality, or 

quantity to fulfill an essential function in a system of organic production or handling, as determined by 

the certifying agent in the course of reviewing the organic plan. 

NOSB October 2019 proposals and discussion documents Page 194 of 230
• A clear definition of how “commercial availability” will be applied when searching for vaccines 

made without excluded method technology and what documentation is sufficient to prove this 

search.

• Operators and certifiers are accustomed to “commercial availability” since it applies to use of 

organic seed and agricultural products found on §205.606.

• Would allow for quick use of an excluded vaccine in an emergency, when no other option is 

available.

• Encourages market availability of vaccines not made with excluded methods by providing

organic buyers for these vaccines and showing a need for their continued manufacture.

• Might be difficult to clearly identify which vaccines are from excluded methods and which are 

not. Currently there is a list of widely used vaccines, but there may be others in use regionally 

or sporadically that are not listed.

Public Comment

At the April 2019 NOSB meeting, a discussion document was circulated with the following options and 

questions provided to the public for comment. 

1. Follow the requirements of § 205.105 (e) and start reviewing known excluded method vaccines 

for individual placement on the National List. 

2. Approve all vaccines produced through excluded methods as a “class” of vaccines and place this 

class of vaccines on § 205.603(a)(4).

3. Change § 205.105 (e) to read as follows:

(e) Excluded methods, except for vaccines: Provided, That, there are no commercially available 

vaccines that are not produced through excluded methods to prevent that specific animal 

disease or health problem.

In addition, please provide information on the following:

4. What type of documentation would be used to prove non-commercial availability of vaccines 

produced without excluded methods?

5. When reviewing vaccines under commercial availability, are there special issues that should be 

considered?

The significant majority of the public responses supported option 3, changing the regulatory language to 

allow use of vaccines from excluded methods when no other vaccines were commercially available. 

There were some commenters that supported allowing all vaccines as a class, with no consideration 

applied if the vaccine was produced from excluded methods or not. There were no comments 

supporting the current regulatory language, which has led to inconsistency among certifiers in 

implementation of the regulation.

Determining commercial availability of a vaccine not produced through excluded method technology

The definition of commercial availability can be applied to vaccines in this manner. 

• The vaccine is available in the specific route of delivery required by the operator (Injection, 

needle-free or transdermal, intranasal, ocular, oral, spray, topical.) (FORM)

NOSB October 2019 proposals and discussion documents Page 195 of 230
• Information is present that details similar or not similar efficacies of the excluded and nonexcluded method vaccines for that specific illness or health problem (QUALITY)

• Sufficient volume of the vaccine is present for the operator to purchase in their region, within 

the timeframe necessary for perishable vaccines, to vaccinate their livestock. (QUANTITY)

Resources to determine if a vaccine had or had not been produced through excluded methods

Commenters expressed concern that it could be difficult for both operators and certifiers to determine if 

there are commercially available vaccines not made from excluded methods. There are some 

references to aid in this determination. The August 2014 NOSB document, entitled “Findings and 

Recommendation in Response to September 2010 NOP Memorandum on Livestock Vaccines Made With 

Excluded Methods”, provides a variety of references and labeling options to aid producers and certifiers 

in determining if the vaccine may have been produced using excluded method. A summary is excerpted 

here, with more detail found in the original document.

Label Guidelines: CVB (Center for Veterinary Biologics) regulations require that certain vaccine seed 

configurations have specific terms on the labels of branded vaccine products. These terms are required 

for a subset of biotechnology derived vaccines. While these terms are not added to the labels because an 

excluded method was used, CVB states that all such vaccines were created using methods that the NOP 

would exclude. The terms on labels that identify vaccines were made with excluded method are 

“Subunit,” “Vector,” and “Chimera.” Because these vaccines are labeled with the identified terms, CVB 

can disclose a trade names list for all of these vaccines.

Product Code: The CVB requires that every biologic, including vaccines, produced must have a product 

code. The CVB guide on true names and product codes notes that the 5th digit of the product code may 

contain “D” or “R.” The letter “D” in the fifth digit signifies that the vaccine is a nucleic acid vaccine. Such 

vaccines, also called DNA vaccines, are made with excluded methods and depend upon foreign genes 

being expressed in some of the cells of the vaccinated animals. The letter “R” in the fifth digit signifies 

the vaccine has a recombinant component or is a subunit protein derived from a recombinant organism. 

The recombinant designation only applies to components in the vaccine and not to methods used to 

make the vaccine such as genetically engineered cells that are used for cell culturing the vaccine seed. 

In addition, the terms nucleic acid vaccine, naked DNA vaccine, RNA vaccine and genetic vaccine may be 

used to label vaccines produced through methods that are considered excluded by the NOSB.

An important reference is the USDA publication “Veterinary Biological Products- Licensees and 

Permittees”, with the most current version from July 1, 2019 present at this link 

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/CurrentProdCodeBook.pdf

Operators and certifiers can refer to this publication, and when using the coding system discussed above 

by the CVB, it would be the first step to determine if a vaccine, had or had not been produced through 

excluded method technologies. As a final confirmation, certifiers could provide an affidavit for 

manufacturers to complete detailing whether or not their vaccines were produced through excluded 

methods, using the list of excluded method technologies maintained by the NOSB. The APHIS 

publication also lists vaccines that had not been produced through excluded technologies that target the 

same disease, and would facilitate the search for commercially available vaccines that had not been 

produced through excluded methods. 

NOSB October 2019 proposals and discussion documents Page 196 of 230
Another source of information is present in the NOSB requested Technical Review of “Vaccines Made 

from Genetically Modified Organisms” from 2011. While this information is somewhat dated, it can be 

used as a starting point for updating using more recent information.

Table 1. Selected Conventional and GMO Vaccines Used for Food Animalsa

Disease Conventional vaccine/strain GMO vaccine/strain

Bacterial

Brucellosis (ruminants) Brucella abortus, strain 19, strain 

RB51

None identified

Brucellosis (swine) Brucella suis, strain 2 None identified

Anthrax (bovine, ovine, equine) Bacillus anthracis, strain Sterne None identified

Johne’s disease Mycobacterium paratuberculosis

strain 316F

None identified

Contagious bovine

pleuropneumonia

Mycoplasma mycoides subsp.

mycoides SC, strain T1/44

None identified

Avian salmonellosis Salmonella enteric servo.

Gallinarium, strain R9

Salmonella typhimurium vaccine,

live culture

Table 1. Selected Conventional and GMO Vaccines Used for Food Animalsa

Disease Conventional vaccine/strain GMO vaccine/strain

Bovine salmonellosis None identified Salmonella dublin vaccine

Poultry cholera Pasturella multocida (various

strains)

None identified

Cattle pasteurellosis Manheimia (Pasteurella)

haemolytica (various strains)

None identified

Swine atropic rhinitis Bordetella bronchiseptica (various

strains)

None identified

Bovine clostridiosis Clostridium perfringens None identified

Escherichia Coli in poultry Escherichia coli vaccine, avirulent

live culture

Escherichia coli vaccine, live 

culture 

Viral

Avian encephalomyelitis Live and modified live virus Avian encephalomyelitis-fowl 

pox-laryngotracheitis vaccine

Porcine circovirus (swine) Type 2, killed virus Porcine circovirus vaccine (Type

1 -Type 2 chimera, killed virus; 

and Type 2 killed, baculovirus 

vector)

Marek’s disease (poultry) Live strains of Marek’s disease

virus, serotypes 1, 2, or 3 

Marek's Disease-Newcastle

Disease live virus vaccine, 

Serotypes 1 & 2 & 3, live 

Marek's disease vector; and 

Marek’s disease live herpesvirus 

chimera

Newcastle disease (poultry) Bursal-disease-newcastle

disease-bronchitis vaccine, 

killed or live virus; live virus 

VG/GA strain; killed virus; and 

B1 type, B1 strain live virus 

Newcastle disease-fowl pox

vaccine, live fowl pox vector; 

and Marek's disease-Newcastle 

disease vaccine, serotype 3, live 

Marek's disease vector 

NOSB October 2019 proposals and discussion documents Page 197 of 230
Bursal disease (poultry) Live or killed avian bursitidis 

infectivae virus type 1 

Bursal disease-Marek's disease 

vaccine, Serotype 3, live Marek's 

disease vector

Fowl pox Live fowl pox vaccine Fowl pox-laryngotracheitis 

vaccine, live fowl pox vector

Fowl laryngotracheitis Modified live virus vaccine Fowl pox-laryngotracheitis 

vaccine, live fowl pox vector

aSources: Frey (2007); USDA (2011)

Lastly, certifiers and the NOP could communicate with each other and develop a listing of excluded 

method vaccines, that do not have any commercially available equivalents and that were not produced 

through prohibited technologies, as well as excluded method vaccines that do have a commercially 

available equivalent that were not produced through excluded method technologies. Manufacturers of 

vaccines not produced through excluded method technologies, could choose to be OMRI listed as well. 

Public interest groups may also choose to do some of the research to aid certifiers and operators in 

understanding which vaccines are or are not produced through excluded methods.

The NOSB understands that this will add another layer of review for some operators, however, with the 

2+ years of lag time between NOSB approval of this regulatory change, and a NOP final rule, the 

identification and tracking system for the various types of vaccines could be put in place.

The NOSB continues to work on determining which types of technologies should be excluded from 

allowance in organic production, with a complete list of the reviewed technologies provided in the most 

recent recommendation. The NOSB, through this work, can provide the organic community with the 

excluded method determinations needed when new technologies are put into commercial use.

The current rule reads:

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and 

handling.

To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients 

or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with 

§205.600(a)

Subcommittee proposal

The NOSB Livestock Subcommittee recommends the following change to the National Organic Program 

Final Rule §205.105 (e) (Changes to the current rule noted in bold). 

Motion to change the USDA organic regulations at §205.105 (e). (Additions to the current rule 

noted in bold). 

(e) Excluded methods, except for vaccines: Provided, That, vaccines produced through excluded 

methods may be used when an equivalent vaccine not produced through excluded methods is 

not commercially available.

NOSB October 2019 proposals and discussion documents Page 198 of 230
Subcommittee Vote

Motion to change the USDA organic regulations at § 205.105 (e). Addition to the current rule noted 

in bold. 

(e) Excluded methods, except for vaccines: Provided, That, vaccines produced through excluded 

methods may be used when an equivalent vaccine not produced through excluded methods is 

not commercially available.

 

Motion by: Harriet Behar 

Seconded by: Ashley Swaffar

Yes: 5 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Sue Baird, Subcommittee Chair, to transmit to NOSB July 17, 2019

NOSB October 2019 proposals and discussion documents Page 199 of 230