National Organic Standards Board

Livestock Committee

National List Proposal

Vaccines from Excluded Methods

April 3, 2012

Summary of Proposed Action:

See attached document Recommendation of Livestock Committee, on Vaccines derived from 

Excluded Methods, dated March 24, 2012

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.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment Yes X No ☐ N/A 

2. Essential & Availability Criteria Yes X No ☐ N/A

3. Compatibility & Consistency ☐ Yes X No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ 1, 2, 3] Comments: 1. and 2. fail because of the necessity to 

evaluate individual vaccines on a case by case basis. 3 fails because vaccines derived from excluded 

methods are not consistent with organic agriculture

Proposed Annotation (if any): 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. 

Basis for annotation: ☐ To meet criteria above ☐x Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

1. Modify language in 205.238(a) (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 

LC 1 GMO Vaccines
(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. 

Classification Motion: Vaccines are already classified as synthetic on the National List at 

section 205.603, Synthetic substances allowed for use in organic livestock production. The 

Committee did not propose to reclassify the substance.

Motion by: N/A Seconded by: N/A

Yes: # No: # Absent: # Abstain: # Recuse: #

Listing Motion: To accept the recommendations of the committee for listing, as above:

Motion by: Colehour Bondera Seconded by: Jean Richardson

Yes: # 5 No: # 0 Absent: # 3 Abstain: # 0 Recuse: # 0

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.

Refine definition of Emergency pest, disease, and treatment program Motion:

Motion by: Nick Maravell Seconded by: Jean Richardson

Yes: # 8 No: # 0 Absent: # 0 Abstain: # 0 Recuse: # 0

Crops ☐ Agricultural ☐ Allowed1 X

Livestock X Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic X Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.603 with Annotation (if any): 

Biologics—Vaccines, provided, with regard to vaccines produced with excluded methods, the 

requirements of 205.105(e) are satisfied. 

2

Substance to be added as “prohibited” on National List to § 205. with Annotation (if any): 

Describe why a prohibited substance: 

3

Substance was rejected by vote for amending National List to § 205. . Describe why material 

was rejected: 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

LC 2 GMO Vaccines
Wendy Fulwider, Committee Chair April 3, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Class of vaccines 

derived from excluded methods 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, use, 

or disposal?

[§205.600 b.2]

X

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X 

The TR (lines 248-255) finds that any 

effects would be similar to 

conventional, non-GMO vaccines. 

The impact of any environmental 

contamination will be specific to each 

individual vaccine and difficult to 

address for a whole class.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

This is difficult to address since this 

review addresses a broad class of 

materials, but the TR at line 217 finds 

that GMO vaccines are not expected 

to persist in the environment any 

longer than traditional vaccines.

4. Does the substance contain List 1, 2 

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X 

Generally any vaccines causing 

adverse reactions would not be 

allowed on the market unless risks 

were mitigated (TR at lines 263-264)

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]X 

GMO and conventional vaccines are 

evaluated for side effects by 

manufacturers and results are similar 

(TR at lines 287-290). It is difficult to 

answer such question for a class as a 

whole.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X 

As cited above, and it is difficult to 

answer this except on a case by case 

basis rather than as a whole class.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

X 

As cited above, and it is difficult to 

answer this except on a case by case 

basis rather than as a whole class

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

X 

Vaccines, both conventional and 

GMO, are short lived in the 

environment (TR)

LC 3 GMO Vaccines
10.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

X 

The TR (lines 307-323) finds that all 

vaccines are evaluated for potential 

risk to human health risk before being 

licensed; such risk is minimal. It is 

difficult to conclusively answer this 

with reference to an entire class of 

vaccines.

11.Is there an adverse effect on human 

health as defined by applicable 

Federal regulations? [205.600 b.3]

X 

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X 

13.Does the substance contain residues 

of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

LC 4 GMO Vaccines
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: class of 

vaccines derived from excluded methods

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X All vaccines, both conventional and 

GMO, are formulated by a chemical 

process (discussion with 

manufacturers)

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X 

All vaccines, both conventional and 

GMO, are manufactured or extracted 

from naturally occurring sources 

(discussion with manufacturers, and 

TR)

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

X GMO vaccines are derived from 

excluded methods, not created by 

naturally occurring biological 

processes (TR and discussions with 

manufacturers.)

4. Is there a natural source of the 

substance? [§205.600 b.1]

X

5. Is there an organic substitute? 

[§205.600 b.1]

X

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

X

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X X At present conventional vaccines are 

available for all but 2 diseases, avian 

and bovine salmonellosis (TR line 416 

Table 1.)

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative substances? 

[§6518 m.6]

X X At present conventional vaccines are 

available for all but 2 diseases, avian 

and bovine salmonellosis (TR line 416 

Table 1.) In addition there are 

homeopathic substances available 

(TR)

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X X Depending upon each vaccination on 

a case by case basis. Management 

practices might have an influence on 

whether the substance is necessary.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

LC 5 GMO Vaccines
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? Substance: class 

of vaccines derived from excluded methods 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X

2. Is the substance consistent with 

organic farming and handling? [§6517 

c (1)(A)(iii); 6517 c (2)(A)(ii)]

X Based on extensive comments 

received during the formulation of the 

NOP regulations in 2000 and in 

response to USDA’s questions posed 

to the public, excluded methods, also 

known as GMOs, were not 

considered consistent with an organic 

production and handling system. 

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X X This would have to be determined on 

a case by case basis.

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X

5. Is the primary use as a preservative? 

[§205.600 b.4]

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive values lost in processing 

(except when required by law, e.g., 

vitamin D in milk)? [205.600 b.4]

X

7. Is the substance used in production, 

and does it contain an active 

synthetic ingredient in the following 

categories:

a. copper and sulfur 

compounds;

X

b. toxins derived from 

bacteria;

X X Generally No (discussion with 

manufacturer), but this would need to 

be determined on a case by case 

basis

c. pheromones, soaps, 

horticultural oils, fish 

emulsions, treated seed, 

vitamins and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and 

X

LC 6 GMO Vaccines
seals, insect traps, sticky 

barriers, row covers, and 

equipment cleaners?

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

LC 7 GMO Vaccines
NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or 

potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 

205.600 (c)] Substance: vaccines derived from excluded methods

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling? 

X

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in a 

system of organic handling? 

X 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function in 

a system of organic handling? 

X 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential function 

in a system of organic handling?

X

5. Does the industry information provided 

on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and 

number of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts 

that may temporarily halt 

production or destroy crops or 

supplies; 

X

LC 8 GMO Vaccines
d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

LC 9 GMO Vaccines
Livestock Committee Proposal

Expanded narrative on Vaccines derived from Excluded Methods

March 24, 2012

SUMMARY

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 or GMO 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 vaccines as a 

class but does not foreclose petitions for individual vaccines or a class of vaccines to treat specific

diseases.

I Introduction

At the present time organic livestock producers are allowed to use all vaccines as provided in 

205.105 (e) and 205.603 (a)(4). Genetically Modified Organism (GMO) vaccines, also referred to 

as vaccines derived from “excluded methods” in regulation, are not currently allowed in organic 

production. The National Organic Progam (NOP) received advice from the USDA General 

Counsel that GMO vaccines could only be allowed if specifically added to the National List. 

Currently, GMO vaccines are not on the National List.

II Background

Vaccines are used by a majority of organic livestock producers throughout the various geographic 

regions of the U.S. The use of vaccines is considered critical to disease prevention. A significant 

number of organic livestock producers do not routinely use vaccines, especially for smaller poultry 

flocks and for closed herds. 

“All vaccines” includes, de facto, both GMO and non-GMO derived vaccines.

The use of genetic engineering is prohibited in organic production and handling under the NOP 

regulations. However, on most organic farms the producer does not ask if the vaccine to be 

administered is GMO or Non-GMO. 

Producers are presently not required to ask to document use of GMO vaccines.

Since implementation of the NOP regulations in 2002, certifiers were routinely allowing all 

vaccines. Thus, in November 2009 the NOSB recommended that if non-GMO vaccines were not 

commercially available, then a GMO vaccine would be allowed, as practiced at that time. 

Nonetheless, consumers continue to assume that all organic products reaching market are NonGMO in production and handling.

III Relevant Areas of the Rule

Section 6509 (d)(1)(C) of the Organic Food Production Act (OFPA) of 1990, authorizes the use of 

vaccinations as an allowed healthcare practice in the production of organic livestock.

LC 10 GMO Vaccines
This authorization was implemented in Section 205.238(a)(6) “Livestock health care practice 

standard” which requires that “producers must establish and maintain preventive livestock 

healthcare practices including: ...(6) the administration of vaccines and other veterinary biologics”.

In 2002 the NOP implemented Section 205.603(a)(4) “Synthetic substances allowed for use in 

livestock production.” This section lists without annotation, “Biologics-Vaccines.” 

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

production and handling,” states, in part, as follows:

“To be sold or labeled as “100% organic”, “organic”, or “made with organic”... 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).”

The phrase “excluded methods” is defined in section 205.2 as:

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 relevant Section 205.600(a)“Evaluation criteria for allowed and prohibited substances, 

methods and ingredients” states: “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)”.

A Technical Report (TR), dated November 29, 2011, entitled “ Vaccines Made from Genetically 

Modified Organisms - Livestock” utilizing the criteria as specified in the Act (7 USC 6517 and 

6518) has been submitted to the NOSB.

Thus the NOSB is now in a position to clarify whether the use of GMO vaccines as a class of 

substances is allowed or prohibited under the requirements stipulated in 205.105(e), and 205.600 

(a).

IV Discussion

1. Should the present practice allowing use of all livestock vaccines, whether GMO or Non-GMO, 

continue?

The current regulation has a provision for a Federal or Sate emergency pest or disease 

treatment program (section 205.672). Plants and animals treated with a prohibited substance 

are taken off the market--plants and meat animals may not be sold as organic. Milk animals 

must wait one year before the milk can be labeled organic. For mammalian brood stock, 

newborns must be from livestock under continuous organic management from the last third of 

gestation to be labeled organic. The organic operation does not loose it certification, but the 

loss of certified organic plants and animals for sale could lead to immediate economic ruin.

Previous NOSB Action in 2009

LC 11 GMO Vaccines
The text of the Livestock Committee recommendation adopted by the NOSB on November 5 

2009 is in italics:

 

§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” the 

product must be produced and handled without the use of:

(e) Excluded methods, except for vaccines, Provided, that, vaccines made from nonexcluded methods are used if commercially available.

The livestock committee summary rationale in 2009 was: 

Previously, vaccines made by excluded methods were to be individually petitioned to the 

Board for allowance or prohibition for use. In reality since implementation of the Rule, 

certifiers have routinely allowed all vaccines, since they are used to prevent disease and 

needless suffering of animals. This recommendation will more closely align what has 

been occurring in the field since 2002. However, it will actually make it encumbent[sic] 

upon the producers and certifiers that vaccines made by non-excluded methods are 

located and used before those made by excluded methods can be used.

NOP 2010 Response to the NOSB 2009 Action

The NOP responded to this NOSB recommendation on September 30, 2010, in part, as follows:

The preamble to the National Organic Program final rule (FR Vol. 65, No. 246, page 

80554) 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. 

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 ―BiologicsVaccines‖. 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).

2.If GMO vaccines are allowed ONLY if non-GMO vaccines are unavailable, or commercially 

unavailable, how can vaccines be identified by GMO content or origin.?

LC 12 GMO Vaccines
APHIS List

The Animal and Plant Health Inspection Service (APHIS) maintains a periodically updated list of 

all registered vaccines with coded alpha-numeric annotations that could allow a certifier or a 

producer to identify which individual vaccines are produced with GMO methods. Most 

producers are not aware of this list and the coding on the list requires some skill to use properly. 

In addition, most vaccines are given as combinations of vaccines which makes cross checking 

with the APHIS list a complex process.

Direct Inquiry

Some large livestock producers, such as Albert Straus of Straus Family Creamery in California, 

currently take on the responsibility of asking the manufacturer for a letter of non-GMO origin for 

vaccines. This approach may be less feasible for small producers: will manufacturers want to 

answer hundreds of inquiries? Also, could a certifier verify the information, and how "current" or 

up-to-date does the manufacture's letter have to be? Vaccines change on a constant basis to 

reflect new strains of disease and other factors. These are issues that might be addressed in 

guidance by the NOP.

Combinations of Vaccines

Because multiple vaccines are often combined into one dosage, a single GMO vaccine could 

rule out the administration of 6 other non-GMO vaccines, if the non-GMO vaccines were not 

available in singular or non-GMO formulations. The TR did not identify vaccines that would be 

unavailable in non-GMO form due to the combination of vaccines.

3. Should GMO vaccines be allowed ONLY in “extraordinary” circumstances?

Relieving economic hardship in the event of emergency treatment programs

The option of allowing GMOs in emergency treatment programs would change current policy. 

Under current policy, GMO vaccines are not permitted at all, as the NOP outlined. If they were 

required as part of an emergency treatment program, then organic producers would be 

penalized by having the affected products taken out of organic status, creating economic 

hardship beyond the control of the organic livestock producer, but in the furtherance of a larger 

public policy goal for all livestock producers. Creating an exception to allow GMO vaccines in 

organic production in cases of an emergency treatment program, and allow livestock to retain 

their organic status would relieve the economic hardship or the prospect of destroying entire 

organic herds or flocks if non-GMO vaccines were not located in time. 

Use of GMO vaccines if non-GMO vaccines are not commercially available 

In the alternative, the proposal put forward by the NOSB in 2009 would allow GMO vaccines if 

non-GMO vaccines were simply not commercially available. Under this scenario also, there 

would be no penalty to the organic product. The use of GMO vaccines would be permitted in 

the absence of either 1) a declared emergency treatment program, or 2) an indication that a 

specific vaccine was needed. 

Commercial Availability

Commercially available also presents some issues because many “off-the-shelf” and prescribed 

commercially available vaccines are not effective or not as effective as desired because 

diseases evolve new strains. It is also difficult to tell whether two vaccines, one GMO and one 

non-GMO, are functionally equivalent for a specific livestock operation. 

Autogenous, or customized, vaccines are prepared from microorganisms which have been 

freshly isolated from the lesion of the animal which is to be treated with it. These vaccines are 

LC 13 GMO Vaccines
not “commercially available’ in the sense that they are already developed and ready for 

administration for any given livestock population. 

Autogenous vaccines do not appear on the APHIS list. They are subject to different USDA 

licensing requirements. Autogenous vaccine regulations do not require confirmation of 1) 

efficacy, 2) potency correlated to efficacy; or 3) host-animal safety data submitted to the USDA 

prior to product licensure and use. 

Variances

A variance cannot be granted for a prohibited substance, ingredient, or method (excluded 

methods). The current regulations contemplate a possible exemption for GMO vaccines from 

being an excluded method--hence no variance would be needed. However, GMO vaccines 

would have to be added to the National List, which they currently are not.

4. Should GMO vaccines be prohibited in livestock production and handling?

The Livestock Committee has concluded that at this point in time there is not enough evidence of 

essential need to allow GMO vaccines as a class of substances for all diseases in livestock 

production, except in cases of a declared emergency. A declared emergency may emanate from 

acts of bio-terrorism or from outbreaks of diseases of major significance or foreign animal 

diseases. Nothing in the Committee recommendation is intended to preclude the possibility of 

successful future petitions to the NOSB for specific GMO vaccines or for GMO vaccines as a 

class for specific animal diseases. 

The NOSB should recommend policy based on what is consistent with an organic system of 

production rather than administrative and enforcement exigencies. 

A key factor regarding GMO vaccines is: are we making the decision based on the proper 

considerations. The NOSB is a policy body, not an administrative or enforcement body. The 

NOP is responsible for administering and enforcing policy related to GMO vaccine use.

It is the NOSB responsibility to consider, among other things, whether the use of GMO vaccines 

would be consistent with an organic system of production or considered essential to organic 

production. In general, GMOs are considered “excluded methods” and not consistent with 

organic production. In addition information in the TR and information received from other 

sources in the field did not indicate that GMO vaccines were essential to organic production at 

this time.

Any recommendation providing an exception to the general policy should not be unduly 

influenced by administrative and marketplace factors such as 1) currently many certifiers and 

producers do not know which vaccines are derived from excluded methods 2) current public 

policy chooses not to identify by label which vaccines contain GMOs or are derived from 

excluded methods, 3) the larger marketplace may not take GMO status into account in deciding 

how to produce and market vaccines, and 4) speculatively, some future unknown diseases of 

non-emergency proportions or new strains of diseases may be addressed by manufacturers 

with GMO only vaccines. 

Further, NOSB recommendations should not be limited by current USDA and FDA discretionary 

policy that does not require labeling of GMO content because GMOs are considered 

"functionally equivalent" to non-GMOs. It is clear GMOs are not functionally equivalent in the 

eyes of the consumer in the organic marketplace and in the legal interpretation of NOP 

LC 14 GMO Vaccines
regulations. 

Difficulties in enforcement

The Livestock Committee recognizes several administrative factors making it difficult to manage 

and enforce a non-GMO vaccine policy, including: 1) a lack of access to an easily identified and 

up-to-date list of which vaccines are of GMO origin, and 2) a lack of access to an easily 

identified and up-to-date list of the availability of non-GMO vaccines for all livestock diseases. 

Given that there are approximately 73 APHIS registered animal vaccines (livestock, feral 

animals and pets) and only 13 (or 18 % ) are thought to be livestock GMO vaccines, the 

construction of a usable list of GMO and non-GMO livestock vaccines is quite possible. The 

basic data should be in the APHIS list. 

In addition, the TR describes the current state of GMO vaccine use in organic production as 

follows:

Because organic certifying agents generally do not consider GMO status, no data are 

available on how many GMO vaccines are being used in organic production at this time.

Determination of Excluded Method

Because the NOP regulations do not use the words genetically modified organism(GMO) or 

“genetically engineered”(GE), we are concerned with “excluded methods.” A method is usually a 

process rather than a material or product. As such, how do we evaluate excluded methods when 

looking at vaccines? Are we looking at the entire method of producing a vaccine? Does the 

method include all of the materials and steps necessary to produce the vaccine? If any of those 

methods, steps, or materials resulted from excluded methods (such as a GMO produced 

substrate that does not remain in the final product or is not the "active" ingredient), then do we 

conclude the vaccine is a GMO--a result of a process that used excluded methods?

From a purely policy perspective, it would seem that any use of excluded methods could be 

interpreted to mean that a vaccine is of GMO origin. This interpretation would mean that if a 

vaccine were only grown in a substrate from a GMO product (e.g. corn), it would be classified as a 

GMO vaccine even though no GMO substance remained in the finished vaccine. It is highly 

unlikely that the APHIS list would ever be detailed and precise enough to make these distinctions, 

since APHIS is not tasked with administering or enforcing organic certification. This conclusion 

could also lead to an unknown GMO status for a large number of vaccines. The committee 

recommends that NOP guidance specify that the information from the APHIS list of registered 

vaccines be used to determine GMO or non-GMO status.

Definition of emergency treatment program.

Background

Organic Foods Production Act of 1990 (OFPA)

OFPA 7 U.S.C. 6506 (b)(2) only confers on the Secretary the power to

“provide for reasonable exemptions from specific requirements of this title ... on certified organic 

farms if such farms are subject to a Federal or Sate emergency pest or disease treatment 

program.” (Complete quotation is included below) No mention is made of “local” or “eradication” 

programs.

Maryland Department of Agriculture

LC 15 GMO Vaccines
Committee research indicates that Maryland and most states have very broad powers to 

enforce eradication programs without ever declaring a state of emergency. If the intent of a 

recommendation for GMO vaccines in organic production were to limit their use to major 

outbreaks and to diseases of major significance or foreign animal diseases, such as hoof and 

mouth disease, then it would be appropriate to require a declared state of emergency. 

Requiring a declared state of emergency would definitely limit the use of GMO vaccines to 

major events.

In Maryland and other states, the Secretary of Agriculture would have to go the Governor to 

declare a state of emergency because only the Governor has such authority. In some states 

the chief agricultural officer may be able to make a declaration of emergency. A local agency 

would be unlikely to have the authority to declare an emergency, and in Maryland no local 

agencies have that authority. 

The Secretary of Agriculture in Maryland could not recall a case of a vaccine ever being 

required within the Maryland. However, they have the authority to investigate outbreaks and to 

require treatment as necessary without declaring an emergency. It is also possible that they 

could require animals entering the State to have been vaccinated for a specific disease known 

to be a problem from the livestock’s point of origin, although they were not sure that situation 

had ever occurred.

National Organic Program

The NOP currently administers the emergency treatment program provision in the regulations, 

responding to declared emergencies by an appropriate State official, and all products which are 

touched by or which received a prohibited substance are no longer eligible to be sold as 

organic, although the organic operation did not lose its certification.

It was noted that there is a discrepancy between section 205.672 “Emergency pest or disease 

treatment” and 205.2 “Definitions—Emergency pest or disease treatment program.” This is a 

potential legal ambiguity. Which provision would be controlling, since they say different things? 

It is advisable to change the Definition, section 205.2, “Emergency pest or disease treatment 

program:” (see language in recommendation section at end of document).

1) to comply with the statutory authority in 7 U.S.C. 6506 (b)(2); 

2) to clarify any potential legal ambiguity in the reading of 7 CFR 205.672 “Emergency pest or 

disease treatment” with 7 CFR 205.2 “Definitions-- Emergency pest or disease treatment 

program;” 

3) to reflect what appears to be the current NOP practice and ;

4) to accurately reflect the intent of the NOSB Livestock Committee recommendation on the use 

of vaccines derived from excluded methods.

Some central questions not completely addressed by the TR

1)WHAT SPECIFIC DISEASE PROBLEM(S) CAN ONLY BE ADDRESSED WITH A GMO 

VACCINE?

The TR does not point to a single or narrow group of problem diseases in organic livestock that 

LC 16 GMO Vaccines
are creating hardship and urgently need to be addressed with GMO vaccines. Rather than 

addressing specific vaccines for specific diseases, we are addressing vaccines as a class of 

substances used in an organic livestock healthcare program. The TR seems to identify two 

diseases for which a GMO only vaccine is available: 1) Avian Salmonellosis and 2) Bovine 

Salmonellosis. For salmonella, improved management practices are often the first line of 

defense, with vaccination as an option if the disease cannot be controlled by management 

practices alone. Due to the changeable nature of Salmonella, finding an effective vaccination for 

a specific herd or flock may be challenging and may require customizing the vaccine.

2)WILL CREATING A GMO EXCEPTION LEAD TO LEGAL AMBIGUITY, PERCEPTIONS OF 

UNFAIRNESS, OR SUCH FREQUENT USE THAT IT LEADS TO POTENTIAL ABUSE?

The exception(s) created are to be narrowly construed and not used as a precedent for allowing 

excluded methods (GMOs) elsewhere in organic production or handling, unless specifically 

authorized, vigorously reviewed by the NOSB and NOP, and subject to public comment.

The intention with regard to organic use of GMO vaccines is that they should be legal, fair, and 

rare. The Committee feels its recommendation meets these tests.

Legality

The use of GMO vaccines, to the extent allowed in organic in emergency treatment programs, 

has to be clearly and understandably legal--a producer/consumer/certifier/public agency must 

be able to read and understand the policy easily and not have it subject to questions that could 

lead to legal challenges. 

Fairness

The GMO exception policy must be fair to accommodate both the organic producer's ideals and 

livelihood and the organic consumer's expectations. 

Rareness

GMO vaccine use in organics should be so rare (i.e. emergency use only). The rarity of GMO 

use should be an accepted outcome with regard to legality--everyone agrees to the ground rules 

(Federal vs. State authority, for emergency use, etc) and GMO vaccine use does not lead to 

abuses. 

Additionally, the rarity should be recognized as fair and the rationale for the GMO vaccine use

should meet the concerns of both producers and consumers, i.e. all livestock producers, both 

organic and conventional, must take concerted action in the face of a publicly declared 

emergency to safeguard livestock production for all concerned.

 

3)HAS THERE EVER BEEN AN EMERGENCY TREATMENT PROGRAM DECLARED BY THE 

FEDRAL OR STATE LEVEL IN RECENT MEMORY, AND HAS IT LEAD TO TREATMENT 

WITH GMO VACCINES?

This is a factual question not addressed by the TR because it was never posed. 

4) DOES THE CURRENT REQUIREMENT TO USE NON-GMO VACCINES IN ORGANIC 

LIVESTOCK PRODUCTION LEAD TO UNACCEPTABLE ANIMAL DISEASE AND 

SUFFERING?

This is not a question that was explicitly posed or addressed in the TR with regard to organic 

production. The following information that has some bearing on a response to this question was 

presented to the committee from the TR and other sources. 

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Number of GMO vaccines

GMO vaccines became available in the early 1980s. Of the approximately 73 vaccines licensed 

for use in wild and domesticated animals, 28 are GMO and 13 (about 18%) are given to 

livestock animals. 

Choice of vaccines

In summary, organic producers have choices of non-GMO vaccines in many cases, and only 

two cases of individual vaccines only available in GMO form were identified in the TR. 

Combination vaccines were identified as a problem, but often the individual non-GMO 

components were available, and no specific case was identified when they were not available. 

Advantages of GMO vaccines

From the information presented in the TR and other sources, it would appear that GMO 

vaccines are sometimes, but not always, faster to develop, more quickly targeted to the specific 

disease, safer and cheaper than their counterparts, and may have advantages for efficacy, 

lower production costs, better storage and transportation, and ability to track which animals 

have been vaccinated. In general it was not possible to make broad conclusive generalizations 

regarding the advantages of GMO vaccines. Non-GMO vaccines generally can more quickly 

meet Federal registration criteria.

Types and Use of Vaccines

Non-GMO live bacterial vaccines are still used extensively and GMO live bacterial vaccines are 

still very rare. GM viral vaccines are more prevalent than GM bacterial vaccines, although there

are many conventional viral vaccines. 

Concerns about GMO vaccines

With bacterial GMO vaccines (which are predominantly administered via the mouth), there are 

concerns that the engineered bacteria may recombine with natural bacteria in the 

gastrointestinal tract. Furthermore, it is unclear how long the altered virus/bacteria will remain in 

the vaccinated animal.

Vaccines manufactured from artificial DNA created by combining several sequences of DNA are 

not used livestock. DNA from these types of vaccines may integrate into a host’s chromosomes 

and initiate a cancer-initiating event, although results have been negative in experiments thus 

far. In addition, the modified DNA could theoretically integrate into the sperm or egg cells and be 

passed on to future generations. 

Market for non-GMO vaccines for organic production

While the TR is not explicit about whether organic livestock production is too small to warrant 

attention from manufacturers to produce non-GMO vaccines, it presents evidence that organic 

represents a very small percentage of total livestock production. The clear implication is that 

the organic market does not command enough demand for independent non-GMO vaccine 

development. Organic poultry production is seen as the largest potential livestock market. 

Autogenous vaccine development was not specifically addressed.

Findings

LC 18 GMO Vaccines
1. Section 205.238 (a) (6) requires that producers must establish and maintain preventive 

healthcare practices, including administration of vaccines and other veterinary biologics, thus to 

deny use of a vaccine because it is ONLY available as GMO could be construed, incorrectly, by 

certifying agency as a non-compliance with the Rule. 

2. Withholding treatment to an animal to maintain organic status is prohibited. Administering a 

GMO vaccine would prevent the animal or animal products and some mammalian offspring from 

being sold as organic.

3. A review of commonly administered livestock vaccines suggests that routine vaccinations are 

relatively common, and that they tend to be given as combinations of vaccines in single delivery 

format.

4 A review the USDA’s APHIS list of Livestock Vaccines, regulated by the Center for Veterinary 

Biologics, suggest that there are non-GMO vaccines available for virtually all common potential 

livestock sicknesses. However there is presently no list which easily allows identification of GMO 

status.

5. Presently there is no requirement that a producer make inquiries of the veterinarian or 

pharmaceutical company as to the GMO or recombinant nature of vaccines to be administered.

6. Canada does not allow GMO vaccines (CGSB, 2009)

7. Europe allows GMO vaccines: Council Reg EC No 834/2007, Article 4 , Overall Principles: 

Organic production shall be based on the following principles: (iii) exclude the use of GMO’s and 

products produced from or by GMO’s with the exception of veterinary medicinal products.

8. The WHO, OIE and FAO clarified the difference between GM foods and use of GMO vaccines. 

With engineered foods the intention is to introduce a new trait into a food; this trait will be present 

in the food eaten by the consumer. On the other hand, the intention of genetically modified 

vaccines is to introduce into food animals “a protective immune response by means of an 

immunogen that is often no longer itself present at the time the animal is slaughtered.”

V Recommendations 

 

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.

LC 19 GMO Vaccines
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.

VI Committee Vote on Main Motion: Motion : Nick Maravell 

Second : Jean Richardson 

Yes 5 No 0 Abstain 0 Recuse 0 Absent 3

Committee Vote on Motion to Amend emergency treatment program: Motion: Colehour Bondera

Second: Calvin Walker

Yes 8 No 0 Abstain 0 Recuse 0 Absent 0

LC 20 GMO Vaccines