Formal Recommendation 

 From: National Organic Standards Board (NOSB)

 To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action:

Guidance Statement:

Other:

Statement of Recommendation:;DŽƚŝŽŶηϭͿ

 

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

 

Committee Vote:

 

Moved: 

Seconded: 

Yes: No: Abstain: Absent: Recuse: 

 

 

 Page 1 revised 04/13 ma
This is a recommendation from the National Organic Standards Board (NOSB) for the National Organic Program. Recommendations are 

documents that the Board has voted to accept and send to the National Organic Program for consideration, but are not NOP policy. 

National Organic Standards Board

Livestock Subcommittee

Findings and Recommendation in Response to September 2010 NOP Memorandum

Livestock Vaccines Made With Excluded Methods

August 19, 2014

I. Introduction:

Vaccines are critical for the prevention of disease and to prevent needless suffering of livestock. For the 

vast majority of diseases for which a vaccine may be used there is a vaccine available which is not made 

with excluded methods. However, most certifiers do not require producers to document that the livestock 

vaccine used is not made with excluded methods. The National Organic Standards Board (NOSB), working 

with the National Organic Program (NOP), has spent considerable time over the last several years reviewing 

how best to address the issue of vaccines made with excluded methods in order to be in compliance with 

the Organic Food Production Act (OFPA) and the Regulations. The NOSB unanimously passed a resolution 

requesting that the NOP help obtain a comprehensive list, similar to the coded list of registered vaccines 

maintained by the Animal Plant Health Inspection Service (APHIS) that could be provided to the NOSB and 

certifiers, to help guide policy and practice. However, attempts to create such a list have not been 

successful. One key finding of our work to date is that the definition of “excluded methods” requires 

revision, and that the use of the term “GMO” (genetically modified organism), while commonly used, 

nationally and internationally, reflects an oversimplification. This document outlines the central issues 

related to vaccine use in organic livestock production, and notes that 7 CFR Section 205 allows for petitions 

for specific vaccines made with excluded methods. We also present the history of NOSB work to clarify 

apparent inconsistencies in practice, review in brief the complexity of the definition of “excluded methods”, 

reiterate some of the Working Group Interim Report, provide a synthesis of public comment received, 

comments on international vaccine use, and recommend that the NOP provides Guidance on this subject. 

II. Background:

In 2009 the NOSB commented on the use of livestock vaccines. They noted that with no antibiotics used in 

organic livestock production, the basic measure of prevention through use of vaccines is critical to the 

health of the animals. They pointed out that all vaccines are produced in federally regulated and licensed 

facilities and in November 2009 the NOSB recommended that all vaccines be allowed, as practiced at that 

time, in order to prevent disease and needless suffering of livestock, with the caveat “that vaccines made 

by non-excluded methods be used before those made by excluded methods” (Board Vote: Yes-11; No-2; 

Abstain - 0; Absent- 2)

In September 2010 the NOP asked the NOSB to formally review GMO vaccines in accordance with the 

criteria in Section 205.600. The NOSB requested a Technical Report which would address the evaluation 

criteria as specified in the Act (7 U.S.C 6517 and 6518).

In November 2011 the Technical Report, “Vaccines made from Genetically Modified Organisms”, was 

received by the NOP. This document provided some critical information to the NOSB

The NOSB conducted a review of Vaccines made with excluded methods using the Checklist and criteria as 

specified at 205.600. The NOSB prepared a Proposal dated April 3, 2012, for public comment and possible 

vote at the Public Meeting in May 2012. This proposal included the following recommendations: 
“This recommendation concerns the class of livestock vaccines derived from excluded methods, 

commonly called GMO vaccines. There are approximately 73 registered animal vaccines, of which 

13 are GMO. Only 2 vaccines, Bovine and Avian Salmonellosis, appear to be presently available only 

as GMO. At present livestock producers use all vaccines and are not required to determine if they 

are using non-GMO (conventional) or GMO derived vaccines. GMO vaccines are not legally allowed 

in organic production. This recommendation proposes a change which will allow GMO vaccines only 

in a declared emergency and, further, that at such time producers could use GMO vaccines without 

losing organic status of livestock. The recommendation also proposes changes to the definition of 

“emergency treatment program”. The entire recommendation applies to the class of vaccines 

derived from excluded methods, but does not foreclose petitions for individual vaccines or a class 

of vaccines to treat specific diseases.”

Recommended Committee Action & Vote, 

1. Modify language in 205.238 (6) as follows, change shown in italics.

Administration of vaccines and other veterinary biologics, provided, vaccines produced with 

excluded methods, can only be administered in accordance with §205.105(e).

2. Modify 205.105 (e) as follows: Excluded methods, except for vaccines: Provided,

(1) such vaccines are administered only due to a Federal or State emergency pest or disease 

treatment program, and 

(2) such vaccines are approved in accordance with §205.600(a);

3. Modify language in 205.603(a)(4) as follows: Biologics—Vaccines, provided, with regard to 

vaccines produced with excluded methods, the requirements of 205.105(e) are satisfied.

4. Change the Definition of “Emergency pest or disease treatment program” in section 205.2 with 

the additions shown in italics.

Emergency pest or disease treatment program: A mandatory program authorized by a Federal, 

State or local agency for the purpose of controlling or eradicating a pest or disease, except for a 

program requiring substances described in section 205.105(e) regarding only vaccines produced 

with excluded methods, in which case such program is defined as a mandatory treatment program 

authorized by a declared Federal or State emergency for the purpose of controlling a pest or 

disease.”

Based upon public comment and the need for additional technical information before voting, the NOSB 

decided to table the proposal until a future meeting, but passed a resolution.

1 The resolution requested: 1) 

That NOP identify all vaccines registered with USDA as GMO or non GMO; 2) That Vaccine manufacturers 

voluntarily and truthfully label vaccines about their absence of GMO content; and 3) That the NOP or other 

USDA agency publish a real time tracking system to identify GMO and non GMO vaccines.

In response to the NOSB’s May 2012 resolution, the NOP convened the Vaccines Made With Excluded 

Methods (MWEM) Working Group. The working group included two members of the NOSB, NOP staff, and 

staff from the Center for Veterinary Biologics (CVB), the division in the Animal Plant and Health Inspection 

Service (APHIS) that approves and regulates vaccines for use in livestock and pets.2

1 http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098924

2

 Working Group Participants: 

 
In February 5 2013 the Working Group prepared an Interim Report summarizing its work, and this report 

was sent to the Livestock Subcommittee and subsequently was posted to gather public comment. 

In April 2013 an update was provided at the Public Meeting. 

(Note that there was no public meeting in fall 2013 owing to government shutdown).

In April 2014 the results of a pilot project analysis conducted by one certifier was presented as part of the 

Livestock Subcommittee report indicating that none of the vaccines used by livestock producers certified by 

that certifier were made with excluded methods according to verification received by the certifier from 

manufacturers. The NOSB requested further comment from certifiers.

In summer 2014 the Accredited Certifiers Association (ACA) conducted a simple survey amongst its 

certifiers which indicated that because of the considerable complexity of verification there is a lack of 

consistency nationwide in how certifiers are verifying that vaccines used in organic livestock production are 

not made with excluded methods.

III Relevant Areas of the Rule:

The USDA organic regulations at 7 CFR part 205 contain several references that are relevant to the 

discussion on the use of vaccines in organic livestock production. 

The first reference, under the “Livestock healthcare practice standard”, requires that “the producer must 

establish and maintain preventive healthcare practices, including... administration of vaccines and other 

biologics” (205.238(a)(6)). 

The second reference on the National List of Allowed and Prohibited Substances allows the use of livestock 

vaccines, which are synthetics as follows: 205.603(a)(4) as follows: “Biologics – vaccines” (205.603(a)(4)) 

(without annotation). 

The third reference at 205.672 deals with emergency pest or disease treatment which is defined in 205.2 as 

a “mandatory program authorized by a Federal, State or local agency for the purpose of controlling or 

eradicating a pest or disease.” The OFPA Statute (7 USC 6506(b)(2)) refers to exemptions for organic “farms 

subject to a Federal or State emergency pest or disease treatment program.” This suggests that Congress 

did not intend to include locally declared programs. In the past, vaccines MWEM have been required as 

part of disease eradication programs. It is unclear as to the effects of these eradication programs on organic 

livestock producers. 

The fourth reference is:

Section 205.105 Allowed and prohibited substances, methods, and ingredients in organic 

production and handling.

Melissa Bailey, PhD, Director, Standards Division, National Organic Program, AMS-USDA* 

Scott Updike, PhD, Agricultural Marketing Specialist, National Organic Program, AMS-USDA 

Patricia Foley, DVM, PhD –Center for Veterinary Biologics (CVB), APHIS 

Nick Maravell, Organic Producer Representative & NOSB Livestock Subcommittee Member 

Jean Richardson, PhD, Consumer/Public Interest Representative & NOSB Livestock Subcommittee Member 

(* indicates working group facilitator) 

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

ingredients or food groups)”, the product must be produced or handled without the use of:...

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

with 205.600 (a).”

Section 205.600 (a) “Evaluation criteria for allowed and prohibited substances, methods and ingredients” 

specifies:

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

production and handling sections of the National List: 

205.600(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)”.

Thus, under this section (205.105(e)), the use of excluded methods is prohibited in organic production. 

To date the NOSB has not recommended any vaccines made with excluded methods be added to the 

National List. 

Excluded methods are defined under the USDA organic regulations (205.2):

“A variety of methods used to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions and 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 positions of genes when 

achieved by recombinant DNA technology). Such methods do not include traditional breeding, 

conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. “

The methods that are excluded and, thus, prohibited, are those 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. 

IV Discussion:

The preamble to the final rule (65 FR 80554) in 2000 discussed the NOP’s response to comments about use 

of vaccines MWEM in organic livestock production. Some commenters wanted all vaccines MWEM to be 

completely prohibited from organic livestock production while others wanted all vaccines to be temporarily 

allowed until more information could be assembled in the future to determine if any of the vaccines 

MWEM were necessary for production. At the time, NOP chose to structure the provision so that vaccines 

MWEM could only be used by organic production if they are affirmatively included on the National List after 

review by the NOSB. But, with no information or guidance about how to identify vaccines MWEM, many 

organic livestock producers, with approval from their certifiers, have chosen vaccines based upon disease 

prevention and not based on whether they are made with excluded methods. 

To rectify this divergence between regulatory language and industry practice, the NOSB, in 2009, 

recommended a change to section 205.105(e) to allow the use of vaccines made with excluded methods if 

vaccines made without excluded methods were not commercially available. That recommendation stated 
that such a change would not require individual review of vaccines made with excluded methods. The NOP 

has not implemented this change into the USDA organic regulations. Therefore, the current exception at 

section 205.105(e) to allow vaccines made with excluded methods only applies to those that are reviewed 

according to 205.600.

In September 2010, the NOP requested that the NOSB review vaccines made with excluded methods (i.e. 

GMO vaccines or genetically engineered vaccines) in accordance with section 205.600. 

The Livestock Subcommittee requested a Technical Review of GMO Vaccines which used the criteria found 

at 7 U.S.C. 6517 and 6518. The Livestock subcommittee drafted a proposal and submitted it to the full 

Board. The NOSB discussed the proposal pertaining to the use of vaccines MWEM at its May 2012 public 

meeting. The NOSB received considerable public comment on this issue leading up to and at this public 

meeting. Comment was split with members of the general public advocating for a prohibition on vaccines 

MWEM and certifiers and producers asking for more detailed information about current vaccine use and 

clarification about which vaccines were MWEM. Due to the need for additional technical information 

before voting, the NOSB decided to table the proposal until a future meeting, but passed a resolution that 

included a request for more information from USDA. 

In response to the NOSB’s May 2012 resolution, the NOP convened the Vaccines Made with Excluded 

Methods Working Group. 

The Working Group first collected information regarding the use of vaccines, government programs that 

may require the use of vaccines, technical information about how vaccines are made and how vaccines are 

regulated. In response to requests from the NOP, CVB and Veterinary Services (VS) from APHIS elaborated 

on regulations that could require livestock producers to use vaccines. The working group’s understanding is 

that the Secretary of Agriculture has the authority to declare emergencies at various levels depending upon 

the severity of the outbreak. Emergency declarations allow both state and the federal government to 

require livestock producers to use specific vaccines, including vaccines MWEM. The only regional 

emergency in the past decade was an Exotic Newcastle outbreak in unvaccinated backyard poultry and 

game fowl. No vaccination program was used in this emergency because USDA determined that most 

commercial poultry operations in the area, whether conventional or organic, had already vaccinated their 

birds for this disease.

The working group also learned that disease eradication programs authorized by the federal government 

may include mandated use of vaccines. The two recent eradication programs, Brucellosis in cattle and 

Pseudorabies in swine both required vaccines. These two eradication programs used vaccines that allow 

blood tests to differentiate between those animals that have an immune response due to the vaccine and 

those animals that have an immune response due to the disease. In order to differentiate between 

vaccinated animals and animals which had the disease, producers must use a modified live vaccine that 

results in a strong immune response, has mutations that alter at least one epitope and is not virulent. The 

Brucellosis vaccine was developed using cell culture passages, a presumably allowed technology in organic 

production. The Pseudorabies vaccines, several vaccines were approved for this eradication program, were

developed using excluded methods. Based on discussions with APHIS, the working group believes that 

vaccines made with excluded methods may be USDA’s preferred vaccine choice in future eradication 

programs. 

APHIS’ CVB regulates vaccines and vaccine manufacturers under the Virus-Serum-Toxin Act. CVB’s primary 

role is to review and license vaccines based upon purity, safety, potency, and efficacy. CVB requires certain 

label terms depending upon specific configurations of the vaccine seed (form of the agent used to create 
the vaccine). CVB also tracks vaccines that are made through the use of biotechnology. However, CVB’s 

evaluation of whether a vaccine is produced through “biotechnology” does not align well with how 

“excluded methods” is defined under the USDA organic regulations. Because of this lack of alignment, it is 

difficult to know the extent to which vaccines on CVB’s list of biotechnology derived vaccines overlaps with 

what could be considered produced through an “excluded method”. CVB does review the use of 

biotechnology in manufacturing of the vaccines, e.g. if a vaccine is produced using cells made with excluded 

methods. However, if only the cell line used to culture the vaccine seed has a genetic insertion, deletion or 

other mutation, the vaccine itself is not considered to be a recombinant. 

Finally, the working group could not identify a comprehensive path of “partial” alignment such that if a 

vaccine were identified as biotechnology derived by CVB then it is was definitely considered made with 

“excluded methods” as defined by the NOP.

It must also be noted that European organic standards allow the use of all vaccines if they are needed to 

prevent a disease in the area. Canadian organic standards forbid genetically engineered vaccines outright. 

In addition, Canadian organic livestock producers may only use a nongenetically engineered vaccine that 

was grown in a cell culture system that included genetic modifications if no other vaccine is available. 

After considering background research, information from other USDA agencies and public comments, the 

Working Group came to the conclusion that developing criteria for certifiers and Material Evaluation 

Programs (MEPs) to use to identify vaccines MWEM would be the only approach to allow the organic 

industry to determine which, if any, vaccines made with excluded methods are being used and if there are 

reasonable alternatives to these vaccines. 

The working group considered creating a list of all vaccines produced with (or without) use of excluded 

methods. This would be the easiest resource for organic livestock producers and certifiers to use. However, 

creation of a negative and/or positive list is difficult for a variety reasons, including the lack of precise 

criteria to decide whether something should be considered produced through excluded methods. 

Furthermore, for such lists to be useful, the lists would need to specify the branded vaccine products that 

livestock producers purchase and use, not just generic names of the disease or pathogen that is being used 

to create the vaccine. Another reason the working group chose not to create a list is that the CVB does not 

differentiate vaccines based upon excluded methods. USDA is concerned that creating such a list would 

imply a deficiency of vaccines MWEM, which would not be scientifically accurate within USDA’s 

responsibility to regulate the purity, safety, potency, and efficacy of vaccines. The working group was also 

concerned 1) with liabilities due to the possibility of inaccurately placing a specific vaccine on a list, and 2) 

the possibility of not being able to obtain necessary vaccine manufacturing information, which is often 

submitted as confidential business information to APHIS CVB.

The working group identified criteria that would allow certifiers and MEPs to identify vaccines MWEM. The 

three criteria to be used in conjunction are: 

• _Label Guidelines 

• _Product Codes 

• _Methods of Production Analysis 

Label Guidelines: CVB 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. 

Vaccines must be labeled with the term “Subunit” when the vaccine is an extracted or purified protein that 

was expressed in a recombinant system. These vaccines do not contain any genetic information (DNA). 

These vaccines only contain the protein antigen that induces an immune response. To create “Subunit” 

vaccines, the gene for the antigenic protein is inserted into an expression vector or expression system. The 

gene from the pathogenic organism may be expressed in prokaryotic or eukaryotic cell culture systems. The 

expressed protein is then extracted or purified and used in the vaccine. Currently there are no active 

licenses for subunit vaccines. 

Certain modified live vaccines must be labeled with the term “Vector” or “Chimera” to denote that the 

vaccine contains DNA from two pathogens. These vaccines are created by identifying a viral structure that 

induces a strong immune response. This viral structure is termed the expression vector. In many cases, the 

expression vector is a virus that in its unaltered form can cause a disease in the target species. The vector 

will then have at least one gene from another disease causing agent inserted into the viral genome. 

Vaccines labeled with “Vector” may be efficacious against two diseases, the disease caused by the 

unaltered vector and the disease caused by the source of the gene that was inserted into the vector or only 

be efficacious against the disease caused by the source of the gene that was inserted into the vector. 

Vaccines labeled with “Chimera” are similar to “Vector” labeled vaccines, except that certain genes 

required for replication competency are supplied by the added genes and not contained in the expression 

vector. 

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 public comments, some certifiers stated that they were aware of the R code in the fifth digit of the 

product code as designating that a component in the vaccine was recombinant or recombinant-derived. 

However, these certifiers were not able to translate the product code information to actual vaccines on the 

market. CVB is unable to provide a list of the trade names of the vaccines with a “D” or “R” in the product 

code because confidential business considerations will not permit discussion of production methods, unless 

the biologics firm specifically agrees to disclose the information. The working group was unable to develop 

a method to identify the trade names of vaccines and other biologic products that have a D or R in the 

product code other than the trade names that are already identified as MWEM, e.g. are labeled as 

containing a “Vector” or “Chimera.” Vaccines that have a “D” or “R” in the product code may or may not be 

made with excluded methods since the production methods may not be identified for evaluation. The 

working group requested input from the NOSB and the organic community to identify methods of linking 

product codes to trade names in a manner that clearly identifies whether or not an excluded method was 

used. The pilot project by one certifier in 2013 and by the ACA in 2014 provided some analysis of the use of 

vaccines in practice.

Method of Production Analysis: Some firms have waived confidentiality by describing how the vaccines 

were made in public comment to the NOSB. However, some vaccines were and in the future may be made 

with methods that are not clearly excluded or allowed in organic production. The working group requested 
input from the NOSB and the organic community to provide comments on this issue. 

Modified live vaccines generally have been found to produce greater immune responses in vaccinated 

animals and have become more common in new vaccines than killed vaccines. Live vaccines require that 

the genome of the disease causing organism be modified to create a living, but not virulent, pathogen 

which can be packaged in the vaccine. The excluded methods definition (205.2) includes methods which 

genetically modify organisms or influence their growth and development by means not possible under 

natural conditions or processes which are not considered compatible with organic production. The 

definition identifies some of the methods that are excluded including recombinant DNA technology (gene 

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

recombinant DNA technology). The definition states that some methods to genetically modify organisms 

are allowed, including traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization or 

tissue culture. 

Many of the older non-biotechnology derived modified live vaccines were made by using bacterial culture, 

cell culture or tissue culture with multiple passages to induce genetic modifications, including gene 

deletions, to the disease causing pathogen. The various cultures were then screened to identify a modified 

version that induced an immune response but that was no longer virulent. This is a process of random 

genetic modification followed by screening for the desired phenotype. The Brucellosis vaccine that is part 

of the Brucellosis eradication program was produced by growing the parent strain in various concentrations 

of an antibiotic cocktail over several passages to induce random mutations in the genome of the bacteria. 

These random mutations resulted in a non-virulent bacterial strain that did not produce the O-chain 

component of the lipopolysaccharide that was one of the epitopes for immune response. This change in at 

least one epitope was required for eradication programs so that vaccinated animals could be differentiated 

from animals infected by the actual pathogen. 

The working groups assumed other genetic modification methods that would be allowed are exposure to 

chemical or physical mutagens. Physical mutagens include ionizing radiation, UV radiation and radioactive 

decay. These mutagens create genetic modifications in a random manner through a variety of ways. Some 

chemical mutagens break the double stranded DNA, allowing a recombination event to occur which can 

cause gene deletion and changing the position of genes. Other mutagens cause DNA bases to switch to 

other bases, errors in DNA repair or errors in replication. These mutagens all genetically modify organisms 

in a random manner that is not targeted. Generally, the vaccines working group considered chemical and 

physical mutagens to be traditional breeding techniques. Biological mutagens are excluded if they are 

considered to be a recombinant technology. Recombination is the process by which double stranded DNA is 

broken, rearranged and then rejoined. Recombination naturally occurs between chromosomes during the 

process of meiosis to form gametes for sexual propagation, in plants, animals and other organisms. 

Recombination naturally occurs during high frequency recombinant (Hfr) conjugation in which part of the 

chromosome from one bacterium is transferred to another bacterium, resulting in homologous 

recombination which genetically modifies the target bacteria. These are just two examples of genetic 

modifications through recombination events which are allowed by the current definition of excluded 

methods. 

Some biological mutagens are clearly excluded by the current definition. Restriction enzymes are naturally 

occurring proteins in many bacteria that will cleave DNA at specific sequences. These enzymes are defense 

against phage (viruses that target bacteria) which insert their genetic material, usually but not always DNA. 

Restriction enzymes have been used to cleave a gene of interest and then through a targeted 

recombination event create a specific gene deletion, clone the gene in a vector or cause a changing of 

positions of genes in a controlled, nonrandom manner. 
Other biological mutagens are neither explicitly allowed or excluded and may be allowed when used one 

way but not when used in a different way. Specifically, the working group discussed the methods used to 

create a vaccine which the manufacturer has stated, in public comments to the NOSB, was not made with 

excluded methods. This particular gene-deleted product was created using transposons and phage 

transduction. Transposons and phage transduction both result in genetic modifications mediated through 

recombination events. However, the working group was divided as to whether or not these methods were 

excluded. Are these methods considered traditional breeding techniques? 

Transposons, also called transposable elements are naturally occurring, double stranded DNA sequences 

with a defined structure. Each end of the transposon includes inverted repeats. In prokaryotes, the internal 

structure includes at least one gene for transposase and may contain many more depending upon the type 

of transposon. Genes for antibiotic resistance, one example of the types of genes within the transposon 

occur both naturally and sometimes as a marker in lab modified transposons. When the transposase gene is 

expressed, the protein binds to the inverted repeats of the transposon, cleaves the genomic DNA and 

excises the transposon. Transposase can then cleave the genomic DNA at another spot and recombine the 

transposon into a new position in the genome.

In order to evaluate the use of transposons in vaccine production, the working group considered if 

transposons would fit into the allowance for traditional breeding techniques. The working group was not 

clear at which point traditional breeding techniques are divided from modern or non-traditional breeding 

techniques. Is there a time point at which all techniques before that time are considered traditional and all 

new techniques developed after that time are not considered traditional? The definition of excluded 

methods allows all traditional breeding techniques, so the distinction is important for organic producers.

The other method used by the vaccine manufacturer under discussion was transduction, which is the 

process through which the genomes of bacteria can be modified with the use of bacterial virus, called a 

phage. Some types of phage attach to the bacterial cell wall and insert the viral genome into the cell. The 

viral genome may then be inserted into the bacterial genome through a recombination event which is part 

of the lysogenic cycle. After receiving a trigger, the viral genome will be excised and the lytic cycle will be 

triggered. The excision of the viral genome is not perfect and in some cases, parts of the bacterial genome 

will be excised and packaged into the new phage. The phage can then be used to infect additional bacteria. 

The bacterial genetic material in the phage will be inserted into the newly infected cell. A homologous 

recombination event may occur so that some of the genes from the originally infected cell’s genome will 

replace the genes in the newly infect cells. This method can stably introduce genetic mutations into the 

new bacteria.

The working group did not come to a decision about the status of vaccines developed using these methods. 

Certifiers and MEPs who examine vaccines for compatibility with the organic regulations will need guidance 

on future determinations of other vaccines as well. 

Public Comment on the Interim Report of the Working Group, and the subsequent efforts of Certifiers to 

clarify how to verify use of vaccines not Made With Excluded Methods, clearly reflects the frustration of 

certifiers and producers seeking to be fully compliant with the regulations, while needing to ensure the 

health of organic livestock.

Here are some samples of public comment:
“Any expectation of verifying vaccines made with excluded methods will need a clear and practical 

framework of how to determine compliance. Even with a stricter rule regarding GM vaccine use, there will 

likely need to be some exceptions because some critical vaccines are only available from GM sources.”

“We find that the technology itself is quite difficult for the layperson to understand, and phrases such as 

“excluded methods” and “traditional breeding” are surprisingly challenging to define. “

“One of the most difficult aspects of understanding the use of genetic engineering in vaccines is the lack of 

disclosure to the public or public understanding about these techniques. Without government regulation 

and increased disclosure, it will be very difficult for organic agriculture to make strides in the goal of 

refraining from the use of vaccines developed using excluded methods.”

“Developing a clearer definition of “excluded methods,” although outside of the scope of the Vaccines 

Working Group’s Interim Report, was discussed as an option in that report.”

“It seems clear that the definition needs to be revised. Certifiers experience difficulty interpreting 

“excluded methods” at present, especially because the language of the NOP’s definition does not always 

align with the language used by vaccine manufacturers. However, revision of terminology must be done 

extremely carefully. We ask that, in any revision of the definition, or tightening of restrictions on vaccines, 

be done with consideration of the following questions:

1) GE is an evolving technology. How are producers, veterinarians, certifiers, and the NOP to keep up with 

the knowledge needed to interpret these evolving techniques?

2) When considering implementation of a stricter rule with regard to GM vaccine use, how far back into the 

development or manufacture of a substance should the excluded methods prohibition apply? How far back 

is practical and verifiable? As indicated in the recent discussion document, many challenges exist in this 

area.”

“We are informed that Canadian Organic Standards prohibit all GE vaccines. How are Canadian certifiers 

able to verify this, especially given the international nature of the pharmaceutical supply chain? In terms of 

implementing a system of transparency in this area, is there anything we can learn from Canadian 

certifiers?”

“In the case that a reliable system of disclosure is developed and implemented, it will be essential for the 

National List to include certain vaccines that, while essential, are not available except through genetic 

engineering. One of our foremost concerns is a Salmonella vaccine for poultry. We also need to take into 

account emergency situations and eradication programs that may require the use of vaccines developed by 

excluded methods. Overall, food safety needs to be our largest concern.”

“In our experience, it is too much to expect certifiers and material review organizations to be able to 

analyze the effects of each method to determine if the genetic modifications are random or targeted. In 

order to make this determination on a consistent basis, the organizations would have to have geneticists or 

equally qualified staff. This is simply too difficult to achieve on a regular basis, given the amounts of 

vaccines and combinations of brand names that certifiers have to review every year. Thus, it is logical to 

suggest that a given technique should be declared excluded or allowed.”

“Vaccines are also used in other countries as well. Those vaccines are regulated and labeled differently 

internationally and we cannot expect that international certifiers should be held to different standards. 

Please consider the international implications of any final recommendation that the livestock 

subcommittee proposes.
A veterinarian commented: “The working group is to be commended for their extensive work on this

subject. The relevant issues have been identified and described. The group has solicited input from

certifiers and the greater organic community. This is not a simple topic with clearly defined boundaries

and limits. I encourage the NOSB and NOP to approach this area with a system of regulation that is not

rigid but will be open to further review and rule modification as time progresses and technology continues

to evolve.”

In summary: Organic livestock producers, certifiers and material evaluation programs can, theoretically, 

identify certain vaccines as being produced with excluded methods by the presence of the words 

“chimera,” “vector,” or “subunit” on the label of the vaccine. However, in practice, this is an extremely 

difficult process, and thus there is lack of consistency in verification that livestock vaccines used in organic 

livestock production are not Made with Excluded Methods. Given this complexity and the need for revision 

of the definition of excluded methods, as detailed in this report, NOP Guidance is needed on how to make a 

determination of whether a vaccine has been produced with Excluded Methods. Actions could eventually 

include a rule change. It is certainly clear that the definition of excluded methods seems to be a less than 

ideal fit with vaccine production methods. 

Motion: The Livestock Subcommittee requests that the NOP review this document and provide Guidance 

to the NOSB, certifiers and MRO’s on the use of Vaccines MWEM in organic Livestock production.

Motion by: Jean Richardson

Seconded by: Colehour Bondera

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recusals: 0

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB, August 26, 2014