This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Biologics - Vaccines in aquatic animal production

+

February 18, 2014

Summary of Proposed Action:

Biologics – Vaccines, except for those produced by excluded methods, are proposed to be 

added to the National List at 205.611 for use in production of aquatic animals. Section 205.611 

of the National List will contain a list of synthetic substances allowed in aquatic animal 

production.

The petitioner requests vaccines (including vaccines made with excluded methods) for the 

medical treatment of aquatic animals under a new Section 205.611: Synthetic substances 

allowed for use in organic aquatic animal production (x) As ....medical treatments as applicable,

Biologics-Vaccines.

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

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

Section 205.238(a)(6) requires that producers of land based livestock must establish and 

maintain preventive healthcare practices, including administration of vaccines and other 

veterinary biologics. At the present time organic livestock producers are allowed to use vaccines 

as provided in Section 205.603(a)(4) Biologics-vaccines. However, vaccines made with 

excluded methods (GMO) are prohibited as provided in Section 205.105 (e) However there is a

specific reference at 205.105(e) providing an allowance for vaccines made with excluded 

methods if the vaccines are reviewed and recommended for addition to the National List by the 

NOSB. Such review needs to be conducted in accordance with section 205.600(a), using 

criteria specified in the Act at 6517 and 6518. 

Products containing biologics are regulated by the USDA/APHIS Center for Veterinary biologics.

Most vaccines are injected intramuscularly or orally, although the fish can also be immersed or 

sprayed. Vaccines are composed of either weakened live or killed pathogens or antigenic 

components (molecular subunits) of pathogens. The production process begins when the 

virus/bacteria are replicated from “reference” organisms and grown in a protein growth medium 

in the laboratory. Vaccines made from excluded methods differ in that their production may be 

by altering, deleting, adding or otherwise genetically modifying the bacteria or virus. 

The Technical Report (TR) differentiates between inactivated and modified live vaccines. 

Inactivated vaccines contain microorganisms and viruses rendered non-infectious by 

inactivation. When the inactivated microorganism is bacterial the resulting vaccine is called a 

bacterin. Inactivated vaccines produced from the supernatant of a bacterial culture or from an 

inactivated toxin are called toxoids. Formaldehyde is the most widely used agent for inactivating 

viral, bacterial and parasitic pathogens. Addition of necessary adjuvants which are produced 

from a wide range of substances including oil water emulsions, aluminum containing 

compounds and various proteins. Modified live vaccines are produced in a number of ways and 

can be immunosuppressive. (TR 146-168).

Vaccines are useful in preventing or significantly reducing clinical signs and chronic conditions 

and preventing spread of disease. They are best administered in the early stage of life. If 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

injected the fish may need to be sedated somewhat first as this is stressful on the fish and the 

person administering the vaccination.

Farmed fish, for example fish in net pens or tanks, are living in crowded conditions and 

vaccination is an excellent preventive for disease control, reducing disease spread into wild fish 

in the geographic area around.

Internationally vaccines are allowed in aquaculture in the UK , Canada, Japan, Sweden, except 

for GMO vaccines; The European Union allows GMO vaccines in aquaculture as an exception 

to their Rule.

Fish breeding, as with land based livestock, can be used to select highly disease resistant 

breeding lines for farming. Alternative substances and practices can be used to reduce or, in 

some cases, eliminate the need for vaccines. In the past antibiotics were administered after 

disease was noted. Fish can be fed herbal remedies or probiotics and other materials to 

stimulate their natural immune systems. Fish crowding in tanks or net pens can be reduced to 

avoid disease. Fish can be farmed in more complex multispecies environments. Constant 

monitoring of fish behavior and general health and “good husbandry” can reduce the likelihood 

of disease. Fish health in farmed facilities will be largely determined by required standards for 

organic aquaculture.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on the NOSB 

Recommendations of standards voted in 2007, 2008 and 2009.

Evaluation Criteria (see attached checklist for criteria in each category)

Criteria Satisfied? 

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

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

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

Subcommittee Action & Vote:

Classification Motion: Motion to classify Biologics – Vaccines for Aquatic Animals, as 

petitioned as synthetic. 

Motion by: Jean Richardson 

Seconded by: C. Reuben Walker

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Listing Motion: Motion to list Biologics: Vaccines for Aquatic Animals at §205.611 with the 

following annotation: except those produced with excluded methods 

Motion by: Jean Richardson 

Seconded by: Joe Dickson

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

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

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair to transmit to NOSB February 18, 2014
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Biologics-Vaccines (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of 

environmental contamination during 

use or misuse? [§6518(m)(3)]

X In the case of killed and modified live 

vaccines there is potential for incomplete 

inactivation for a particular vaccine lot 

leaving live pathogen and the reversion to 

virulence of the modified vaccine 

inadvertently precipitating a new epizootic 

through vaccination. But the vaccines 

themselves contain mostly organic material 

that rapidly degrades in the 

environment.(TR 656-659)

All vaccines under USDA license are 

manufactured under strictly controlled 

facilities and stringently regulated under 

EPA, thus environmentally detrimental 

waste is unlikely (TR 660-666)

Modified live vaccines are desirable and 

highly effective in closed systems. 

However the virus is still capable of 

infection. These vaccines have not usually 

been considered acceptable due to the 

environmental risk that non-virulent viruses 

could revert to virulent forms or that 

attenuated viruses that are not virulent in 

vaccinated species could prove virulent to 

other species in open systems (TR 296-

299)

Host density plays a critical role in spread 

of fish disease in the environment among 

wild and farmed fish. Low host density 

reduces rate of encounter between 

susceptible hosts and pathogens. (TR 748-

754) and thus much will depend on the 

scope and detail provided in the yet to be 

promulgated Standards for Aquaculture.

2. Is there a probability of 

environmental contamination during, 

manufacture or disposal? 

[§6518(m)(3)]

X See 1 above.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Because live vaccines have a short life 

span outside the host, environmental 

damage is not expected from accidental 

release or shedding from animals (Petition 

p. 10) and see 1 above.

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X The substance falls into the category of a 

medicine (TR 504)
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

5. Is there potential for detrimental 

chemical interaction with other 

materials used in organic farming 

systems?

[§6518(m)(1)]

X Many chemicals are used in producing fish 

vaccines. Formaldehyde and 

ethyleneimine for example are not on the 

National List, yet they are presently used in 

production of approved vaccines. 

Adjuvants are added to vaccines to 

promote antigenicity and are not

considered excipients 

Polyvalent vaccines should always be used 

under veterinary supervision as adverse 

events could occur between vaccines from 

different sources.(TR 337-353)

6. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518(m)(2)]

X See 1 and 5 above

Some reports have described autoimmune 

disease development in farmed salmon 

after vaccination with oil adjuvated 

vaccines. There is possibility of increased 

infection with unvaccinated pathogens as a 

result of vaccine induced autoimmunity.

Vaccines can largely reduce risks for large 

scale animal suffering caused by disease 

in fish farming.(TR 620-636)

7. Is there persistence or concentration 

of the material or breakdown 

products in the environment? 

[§6518(m)(2)]

X See 1 above

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); 

§6517 (c)(2)(A)(i); §6518(m)(4)]

X The aim of vaccines is to prevent mass 

destruction of large numbers of infected or 

potentially contagious animals, prevent 

transmission of diseases to humans, 

promote good health of animals farmed 

and wild, and protect the environment. (TR 

300-302)

Self injection appears to be the most 

important human health risk from use of 

fish vaccines. (TR 760-761). All vaccines 

are rigorously tested in the USA.

See also 1 above

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)]

X Vaccination is aimed to imitate natural 

processes in fish and have been found to 

be effective. (TR 684-712) Much depends 

on management of host density farmed in 

tanks or net pens (TR748)

There is one DNA vaccine to control an 

infectious virus (hematopoietic necrosis) 

but little is known about impacts of this in 

net pens or tanks (TR 713-727)

Ongoing research will be needed to 

evaluate impacts after regulations are 

promulgated. (TR 728-738)

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X See 1 and 9 above
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 2. Is the Substance Essential for Organic Production? Biologics-Vaccines (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X X Vaccines are created by naturally 

occurring biological processes including 

cell culture and fermentation. (TR548-

585). However, some vaccines are 

produced with formaldehyde inactivation, 

or chemical bonding with adjuvants 

3. 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 See 1 above

Most of the vaccines approved for use by 

the USDA for fish are produced by 

conventional methods starting from 

natural pathogens gown in culture. (TR 

73-86)

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X

8. Are there any alternative substances? 

[§6518(m)(6)]

X Host density increases the spread of 

aquatic pathogens in to and within farmed 

fish populations, and from farmed fish to 

wild fish. (TR 778-780)

There are some alternative substances, 

but probably not as effective as vaccines.

In the past farmed fish were treated with 

antibiotics when sick. Today the goal is 

prevention. Use of probiotics and feed 

additives, herbal extracts etc. can be fed 

to stimulate natural immune systems (TR 

781-806)

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X See 8 above

Vaccines should only be administered to 

healthy fish. Healthy Fish populations for 

farming can be selected from certain 

breeding lines. Management and good 

husbandry can reduce possibility of 

infection both in open and closed 

systems. Disease surveillance must be a 

rigorous aspect of fish farming to avoid 

disease as far as possible.(TR 25-259)
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 3. Is the substance compatible with organic production practices? Biologics-Vaccines 

(aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

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

X Biologics-vaccines are allowed in land

based livestock production 

7 U.S.C.Section 6509(d)(1)(C))

7 CFR 205. 238(a)(6)

Section 205.603(a)(4)

Section 205.103(e) excludes vaccines 

made with excluded methods except as 

provided in 205.600(a), using criteria at

7 U.S.C Section 6517 and 6518

NOTE that this proposal does NOT 

propose to add to the National List any 

vaccine made with excluded methods 

(GMO)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above.

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i);

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X The substances fall into the category of a 

medicine (TR 504)

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

Minority Opinion – Biologics - Vaccines in aquatic animal production

February 21, 2014

Annotation motion for aquaculture vaccines: Add annotation, “Until May 1, 2019 [or sunset 

date].”

Justification: Since this petition is being considered in the absence of regulations defining 

acceptable practices in organic aquaculture, essentiality in particular cannot be judged at this 

time, so the NOSB needs to reconsider the approval in five (5) years. Current consideration of 

the material has raised issues relating to health or environmental impacts, especially relating to 

those in water receiving discharges or open water systems; and alterative natural materials and 

management methods. The review in five (5) years provides an opportunity for the Board to 

reevaluate and vote for the continued or modified use of the material under the same standard 

of review that is used to approve the material initially. 

In addition, the minority makes the following comments:

The answers (yes/no) checked often do not conform to the evidence presented in the 

comments/documentation column.

With regard to checklist Category 1, Adverse Impacts on Humans and the Environment, the 

minority believes the following need to be considered:

• The following statements in response to the question, “Is there a probability of 

environmental contamination during use or misuse?” suggest that the answer should be 

yes instead of no:

o In the case of killed and modified live vaccines there is potential for incomplete 

inactivation for a particular vaccine lot leaving live pathogen and the reversion to 

virulence of the modified vaccine inadvertently precipitating a new epizootic 

through vaccination. (TR 656-659)

o Modified live vaccines are desirable and highly effective in closed systems. 

However the virus is still capable of infection. These vaccines have not usually 

been considered acceptable due to the environmental risk that non-virulent 

viruses could revert to virulent forms or that attenuated viruses that are not 

virulent in vaccinated species could prove virulent to other species in open 

systems. (TR 296-299)

• The following responses to, “Is there potential for detrimental chemical interaction with 

other materials used in organic farming systems?” suggest that the answer should be 

yes instead of no:

o Many chemicals are used in producing fish vaccines. Formaldehyde and 

ethyleneimine for example are not on the National List, yet they are presently 

used in production of approved vaccines. Adjuvants are added to vaccines to 

promote antigenicity and are not considered excipients. (TR 338-348)

o Polyvalent vaccines should always be used under veterinary supervision as 

adverse events could occur between vaccines from different sources. (TR 349-

354)

• The following response to, “Is there a toxic or other adverse action of the material or its 

breakdown products?” suggests that the answer should be yes instead of no:

o Some reports have described autoimmune disease development in farmed 

salmon after vaccination with oil adjuvated vaccines. There is possibility of 

increased infection with unvaccinated pathogens as a result of vaccine induced 

autoimmunity. (TR 630-634)

• The following responses to, “Are there adverse biological and chemical interactions in 

the agro-ecosystem?” indicate that not enough is known to justify the no answer:
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

o There is one DNA vaccine to control an infectious virus (hematopoietic necrosis) 

but little is known about impacts of this in net pens or tanks. (TR 714-728; 642-

656)

o Ongoing research will be needed to evaluate impacts after regulations are 

promulgated. (TR 728-738)