FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB)

TO THE NATIONAL ORGANIC PROGRAM (NOP)

Date: 11-5-09

Subject: Vaccines

Chair: Jeff Moyer

Recommendation

The NOSB hereby recommends to the NOP the following:

Rulemaking Action: X

Guidance Statement: ________

Other: ________

Summary Statement of the Recommendation (including Recount of Vote):

This recommendation is to clarify which types of vaccines can be used to prevent disease and 

needless suffering of livestock. 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 

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.

NOSB Vote: Motion: Hubert Karreman Second: Tina Ellor

Board vote: Yes - 11 No- 2 Abstain- 0 Absent - 2 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP):

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

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

authorization was implemented through regulation at § 205.238(a)(6) of the National Organic 

Program standards. Those standards were published in the Federal Register on December 21, 

2000 (65 FR 80548). Section 205.238(a)(6) provides that producers must establish and maintain 

preventive livestock health care practices including the administration of vaccines and other 

veterinary biologics. Further, vaccines were approved by the NOSB as a group at 205.603(a)(4) 

and ultimately put on the list without annotation (whereas some other materials listed do specify 

or limit the methods of production). It is clear that 6509(d)(1)(C), 205.238(a)(6) and 

205.603(a)(4) don’t mention anything about vaccines produced by excluded methods needing to 

be individually petitioned.

Response by the NOP:
National Organic Standards Board (NOSB)

Livestock Committee

RECOMMENDATION TO CHANGE 205.105 (e)

Current 205.105 (e):

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

accordance with 205.600(a).

I. Introduction: 

Vaccines are critical for the prevention of disease. Since antibiotics cannot be used 

therapeutically in organic livestock production without permanent removal from the 

organic system, prevention of disease is all the more important. Livestock producers 

should not be hindered in any way from using vaccines to help prevent morbidity and 

mortality for the animals under their care. Nor should the organic community in general 

be held back when it comes to such basic measures as prevention of disease through the 

utilization of vaccines, regardless of the method of production that occurs in federally 

regulated and licensed manufacturing facilities. To ensure that livestock producers are not 

hindered from preventing disease in their herds, the Livestock Committee is proposing to 

change the wording of 205.105(e) such that it is harmonized with the rest of the language 

of OFPA and the regulation in regards to vaccines. 

II. Background: 

It has come to our attention that one or more ACAs may be denying livestock producers 

the authority to use vaccines that the ACA previously allowed producers to use on the 

grounds that the vaccines are produced using excluded methods. Section 205.105(e) has 

been cited as the controlling regulation, creating in effect a bottle neck prior to the 

regulatory sections that also specifically speak to vaccine use. It will be shown that at no 

other location in OFPA or in the Regulation are vaccines disallowed in any way. 

First, however, it should be emphasized that more and more vaccines are being produced 

using “excluded” methods. For instance, in a scholarly review paper on the current status 

of veterinary vaccines (Els N. T. Meeusen, et al., CLINICAL MICROBIOLOGY REVIEWS, July 2007, p. 

489–510) it is clear that the majority of methods of vaccine production would be termed 

“excluded methods” by certified organic definitions. These production methods include: 

marker vaccines that have a gene deleted to allow differentiation from field strains for 

diagnostic purposes (example: foot and mouth disease vaccines), sub-unit vaccines from 

isolated genes that allow for completely safe, non-replicating vaccines (example: 

postweaning multisystemic wasting syndrome for swine), chimera viruses that combine 

two different viral DNAs (examples: recently developed poultry avian influenza vaccine 

and a west Nile virus vaccine for horses), live viral vector vaccines (example: new rabies 
vaccine), and DNA vaccines (recently registered in 2005 in Canada to protect Atlantic 

salmon from infectious hematopoietic necrosis). 

The obvious trend is to vaccines being produced using genetic engineering, thus making 

the sourcing of vaccines not derived from genetic engineering more and more difficult. 

While “conventional” vaccine products are still available, it is obvious that the future for 

scientific breakthroughs in producing vaccines is through genetic manipulation, as cited 

from the scientific review article above. It should be noted that if an exotic (nonendemic) disease were to establish itself in a national herd which has had no exposure to 

it previously (i.e. hog cholera or foot and mouth disease), huge losses along with pain and 

suffering would occur. Any vaccine that could be rapidly produced to be used against 

such a scenario would undoubtedly use excluded methods. As some ACAs interpret the 

regulations currently, organic livestock producers would have to wait for the materials 

petition process to run its normal 18 month course before using such a vaccine. For the 

special case of vaccines, we simply cannot jeopardize the well-being of potentially 

millions of animals or the public by prohibiting selected vaccines because they may have 

been produced utilizing excluded methods. 

III. Relevant areas in the Rule: 

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

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

This authorization was implemented through regulation at § 205.238(a)(6) of the National 

Organic Program standards. Those standards were published in the Federal Register on 

December 21, 2000 (65 FR 80548). Section 205.238(a)(6) provides that producers must 

establish and maintain preventive livestock health care practices including the 

administration of vaccines and other veterinary biologics. Further, vaccines were 

approved by the NOSB as a group at 205.603(a)(4) and ultimately put on the list without 

annotation (whereas some other materials listed do specify or limit the methods of 

production). It is clear that 6509(d)(1)(C), 205.238(a)(6) and 205.603(a)(4) don’t mention 

anything about vaccines produced by excluded methods needing to be individually 

petitioned. 

IV. Discussion: 

We acknowledge that § 205.105(a)(6) provides that organic products must be produced 

and handled without the use of “Excluded methods, except for vaccines; Provided, That 

the vaccines are approved in accordance with § 205.600(a)”. However, when the final 

rule was published, vaccines were listed, without annotation, as allowed synthetics at § 

205.603(a)(4). The preamble to the final rule addresses that § 205.105(a)(6) was 

structured so that vaccines produced using excluded methods could only be used if they 

are affirmatively included on the National List. This provision was created as an 

exception to the prohibition on the use of excluded methods and is only applicable to the 

production of vaccines. This exception was created to allow for the use of vaccines that 

may only be available in a form produced using excluded methods. The NOP concluded 

in 2000 that the potential impact of prohibiting vaccines produced using excluded 
methods on animal production systems was unknown. It is highly likely that vaccines 

produced without the use of excluded methods are less available today than they were in 

2000 and that this trend is constantly increasing. It should be recognized that unlike 

chemotherapeutic pharmaceuticals which have very specific unchanging formulae, 

biologics and vaccines are constantly being revised due to changing field conditions. 

Coupling ever changing vaccines due to dynamic field conditions and technologic 

advances in production, it is easy to see that there will be an exponential increase in the 

amount of vaccines produced by excluded methods. To conclude, the specific language of 

205.105(e) is out of date and, moreover, it simply cannot be taken as a stand alone 

statement. Taken in its true context with the other regulations to which it is linked, it is 

imperative to change the wording of 205.105(e).

Even by reading section 205.105(e) as it is currently written, the logical progression of 

reading the regulation thus shows:

§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 the vaccines re

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).

§205.603 Synthetic substances allowed for use in organic livestock

production.

In accordance with restrictions specified in this section the following

synthetic substances may be used in organic livestock production:

(a) As disinfectants, sanitizers, and medical treatments as applicable.

(4) Biologics – Vaccines.

In conclusion, for the special situation of vaccines - and vaccines only - the Livestock 

Committee would like to permanently clarify the situation on vaccines by truncating 

205.105(e) to no longer make reference to excluded methods.

Should this recommendation pass at the full board level and submitted to the NOP for 

rulemaking, included in the affirmative vote is the request that the NOP continue to allow 

all vaccines that have been previously allowed by ACAs, indeed require that any 
vaccines previously allowed stay allowed, including those derived from excluded 

methods, until rulemaking is completed.

V. Recommendation: 

Following from the above logical progression, the Livestock Committee recommends:

§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.

VI. Committee Vote: 

Motion: Hubert Karreman Seconded: Tina Ellor

Yes: 6 No: 0 Abstain: 0 Absent: 1