FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: ____3-29-07____________________

Subject: Cloning Recommendation 

Chair: Andrea Caroe 

 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: __XXX___ 

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

The NOSB recommends the attached document be adopted to establish standards regarding the 

issue of cloning.

NOSB Vote: Motion: Kevin Englebert Second: Jeff Moyer 

Board vote: Yes - 12 No - 0 Abstain - 1 Absent - 2 

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

The NOSB is proposing to amend 205.236 Origin of Livestock to be used by the NOP, certifying 

agents, and industry to ensure that cloned animals, their progeny and any derived products there 

from will not be used in the organic industry. This is consistent with OFPA language of not using 

excluded methods.

Response by the NOP:
 Cloning Recommendation 

 National Organic Standards Board 

March 29, 2007 

I. Introduction 

The Center of Veterinary Medicine at the US Food and Drug Administration (FDA) issued a draft 

risk assessment on meat and milk from cloned animals. A Federal Register notice was issued by 

the FDA on January 3, 2007, which requested comments on the draft risk assessment on animal 

cloning. On January 31, 2007 the National Organic Program (NOP) posted a short series of 

questions and answers on its website, clearly stating that cloning technology is prohibited in 

organic production, and that the NOP will be working with the NOSB to determine the organic 

status of the progeny of animals derived using cloning technology, or clones. 

The NOSB concurs with the National Organic Program and believes that the existing federal 

organic rules (NOP) prohibit animal cloning technology and all its products, including all progeny 

and succeeding generations of those progeny in organic production. To strengthen and clarify 

the existing rules, the NOSB recommends that the NOP amend the regulations to ensure animal 

cloning technology, all generations of progeny from cloned animals, and all products derived from 

such organisms be excluded from organic production. Furthermore, the NOSB is very concerned 

with the issues involving the progeny of animals that are derived using cloning technology. 

II. Background 

Cloning, defined by FDA as somatic cell nuclear transfer, is a process by which animals are 

reproduced asexually by introducing a differentiated somatic cell (a non-germ line cell from an 

existing animal) to an oöcyte (a cell which is the immediate precursor of a mature egg) that has 

had its nucleus removed, and then, following some manipulations, is induced to start replicating. 

Cloning can also be accomplished without cell fusion by injecting the DNA from the skin cell 

directly into the egg cell. 

The FDA concluded that animal cloning results in an increased frequency of health risks to 

animals involved in the cloning process, including late gestation complications and an increase of 

mortality. Many cloned animals develop abnormally due to misarranged genetic code, with some 

abnormalities so subtle that they would not be visibly noticeable, but which may have health 

implications for humans if consumed. 

The organic industry has expressed concern to the NOSB that cloned animals, or products of 

cloned animals could enter into the organic production stream and harm the perception of organic 

food products. Likewise, most consumers are uncomfortable with clones and do not want them to 

be part of their food supply. If the FDA does not require clones to be tracked, consumers are 

very likely to turn to organic products, under the assumption that clones are not allowed in 

organic production. 

The NOP rule requires organic farmers to accommodate the health and natural behaviors of 

animals, along with encouraging genetic biodiversity. The rule also states that an organic 

animal's growth and development must not be influenced by means "that are not considered 

compatible with organic production." Clearly, animal cloning technology was not intended to be 

allowed in organic production. 

III. Regulatory Framework 
The Organic Food Production Act (OFPA) does not specifically mention reproductive techniques 

or practices suitable for organic production, but the OFPA does authorize the NOSB to make 

relevant recommendations. 

Under OFPA: 

SEC. 2110. [7 USC 6509] Animal Production Practices and Materials. 

 (d) HEALTH CARE.— 

(2) STANDARDS.--- The National Organic Standards Board shall recommend 

to the Secretary standards in addition to those in paragraph (1) for the care of 

livestock to ensure that such livestock is organically produced. 

At the time of the implementation of the regulation, the NOP Rule was thought to be sufficiently 

clear regarding the exclusion of cloning technologies in organic production. 

From NOP Rule Subpart A - Definitions

§ 205.2 Terms defined. 

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

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

conditions or processes and are not considered compatible with organic production. 

Such methods include cell fusion, microencapsulation and macroencapsulation, and 

recombinant DNA technology (including gene deletion, gene doubling, introducing a 

foreign gene, and changing the positions of genes when achieved by recombinant DNA 

technology). Excluded methods do not include the use of traditional breeding, 

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

 

From NOP Rule Subpart B – Applicability

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

production and handling. 

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

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

of: 

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

accordance with § 205.600(a); 

From NOP Rule Subpart C – Organic Production and Handling Requirements 

§ 205.236 Origin of Livestock. 

 

(b) The following are prohibited: 

 

(1) Livestock or edible livestock products that are removed from an organic 

operation and subsequently managed on a non-organic operation may not be sold, 

labeled, or represented as organically produced. 

(2) Breeder or dairy stock that has not been under continuous organic 

management since the last third of gestation may not be sold, labeled, or 

represented as organic slaughter stock. 

IV. Recommendation 
The Livestock Committee recommends that the NOP implement rule change to clarify 

that cloning technology, including all progeny and succeeding generations of those 

progeny, be excluded from organic production. 

The Livestock Committee recommends the following change to existing regulation: 

§ 205.2 Terms defined. 

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

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

conditions or processes and are not considered compatible with organic production. 

Such methods include cell fusion, microencapsulation and macroencapsulation, cloning, 

and recombinant DNA technology (including gene deletion, gene doubling, introducing a 

foreign gene, and changing the positions of genes when achieved by recombinant DNA 

technology). Such methods do not include the use of traditional breeding, conjugation, 

fermentation, hybridization, in vitro fertilization, artificial insemination, or tissue culture. 

The Livestock Committee recommends the following addition to the regulation: 

§ 205.236 Origin of Livestock 

 

(b) The following are prohibited: 

 

(3) Livestock, progeny and all succeeding generations from cloned livestock, 

reproductive materials, or any other products derived from animals produced 

using animal cloning technology. 

The Livestock Committee and the NOSB will work in collaboration with the NOP on 

further rule making recommendations as additional issues are identified. 

Moved: Hubert Karreman Second: Kevin Englebert 

Committee vote 

 Yes – 6 No – 0 Abstentions – 0 Absent - 1 

Minority opinion 

Conclusion 

To strengthen and clarify the existing rules, the NOSB Livestock Committee recommends that the 

NOP amend the regulations to add animal cloning technology to the definition of “Excluded 

Methods” and that the NOP update other sections of the rule to ensure that animal cloning 

technology is excluded, including all generations of progeny of cloned animals. and that products 

derived from organisms subjected to such technology be excluded.