United States Department of Agriculture 1400 Independence Avenue SW. Policy Memo 11-11

Agricultural Marketing Service Room 2646-South Building

National Organic Program Washington, DC 20250

PM 11-11 NOP Statements on Cloning and Organic Livestock Production Rev02 10 31 11 Authorized Distribution: Public 

Page 1 of 1

Policy Memorandum

To: Stakeholders and Interested Parties

From: Miles McEvoy, Deputy Administrator

Subject: Retained Memos: NOP Statements on Cloning and Organic Livestock Production

Date: Original Issue Date – January 31, 2011

Attached are the January 31, 2007 “NOP Announcement on Cloning and Organic Livestock 

Production”, and the January 15, 2008 “NOP Cloning and Organic Livestock Production 

Talking Points” and “NOP Cloning and Organic Livestock Production Q and A’s” memos issued 

by the National Organic Program (NOP). These memos are being retained by the NOP as a new 

policy memo and remain in effect. This document has been assigned the control number “PM 11-

11”.

Enclosures: “NOP Announcement on Cloning and Organic Livestock Production” January 31, 

2007 memo, “NOP Cloning and Organic Livestock Production Talking Points” January 15, 2008 

memo, and “NOP Cloning and Organic Livestock Production Q and A’s” January 15, 2008 

memo
National Organic Program 

Cloning and Organic Livestock Production 

Recently, FDA announced its approval of a draft risk assessment of cloning as a 

production technique in agriculture. Since that announcement, many questions 

have been raised about cloning and animals produced using cloning technology 

(called clones) respecting organic production and their allowance under the 

National Organic Program (NOP) regulations. The following questions and 

answers explain the position of the NOP regarding cloning and animals produced 

using cloning technology for organic livestock production. 

Q. Is cloning as a livestock production practice allowed under the NOP 

regulations? 

A. No. Cloning as a production method is incompatible with the Organic Foods 

Production Act (OFPA) and is prohibited under the NOP regulations. 

Q. May animals produced using cloning technology, or clones, be considered 

organic under the NOP regulations? 

A. No. Animals produced using cloning technology are incompatible with OFPA 

and cannot be considered organic under the NOP regulations. 

Q. What about the progeny of animals produced using cloning technology, or 

clones – can they be organic under the NOP regulations in organic livestock 

production? 

A. AMS intends to work with the National Organic Standards Board (NOSB) to 

develop a rulemaking proposal to determine the organic status of the progeny of 

animals derived using cloning technology, or clones. 

January 31, 2007 
National Organic Program 

Cloning and Organic Livestock Production 

as of 1/15/2008 8:05 AM 

• Since the Dec. 2006 announcement of FDA’s approval to conduct a risk assessment, 

questions have been raised about cloning and clones related to organic production and 

their allowance under the National Organic Program (NOP) regulations. 

• Public statements against cloning in organic production have been issued by the 

Organic Trade Association, Organic Valley, Organic Consumers Association, and the 

Center for Food Safety. 

• On Jan. 31, 2007, USDA’s NOP issued a statement on its web site that cloning as a 

production method is incompatible with the Organic Foods Production Act (OFPA) 

and is prohibited under the NOP regulations. Q&A’s on cloning in connection with 

organic programs were published along with the statement on the NOP website. 

• Although not specifically identified, the basis for excluding cloning technology from 

organic production stems from the definition of an excluded method in the NOP 

regulations: 

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

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

[Emphasis added.] 

• The prohibition on the progeny of clones is less clear. The NOP asked its advisory 

committee, the National Organic Standards Board, to discuss the issue at their March 

2007 meeting. After discussion and public comment, on March 29, 2007, the Board 

voted to accept the following Livestock Committee recommendation: 

“To strengthen and clarify existing rules, the National Organic Standards Board 

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.” [Emphasis added.] 

• Work has been initiated on a National Organic Program origin of livestock public 

rulemaking that will encompass the National Organic Standards Board’s 

recommendation regarding cloning and the progeny of clones. 
National Organic Program 

Cloning and Organic Livestock Production 

On Jan. 15, 2008, FDA released final versions of three documents on animal cloning: A 

Risk Assessment, a Risk Management Plan, and Guidance for Industry. These documents are the 

final versions of drafts released for public comment in December 2006. These documents 

represent FDA’s conclusions regarding the health of animals involved in the cloning process, and 

the safety of food from four species of livestock that have been cloned, as well as food from the 

offspring of clones from any species traditionally consumed as food. 

FDA’s Final Risk Assessment and Risk Management Plan on Animal Clones and their 

Progeny concludes that according to all available science, food from clones of cattle, swine, and 

goats, and the offspring of clones from any species traditionally consumed as food, are as safe to 

eat as food from conventionally bred animals. FDA concludes that it has insufficient 

information to reach a conclusion on the safety of food from clones of other animal species, such 

as sheep. 

Last year, when FDA announced its approval of the draft risk assessment of cloning as a 

production technique in agriculture, many questions were raised about cloning and animals 

produced using cloning technology (called clones) respecting organic production and their 

allowance under the National Organic Program (NOP) regulations. The following questions and 

answers explain the position of the NOP regarding cloning and animals produced using cloning 

technology for organic livestock production. 

Q: When consumers hear that USDA will *not* certify products from cloned animals 

or their offspring as ORGANIC, doesn't that indeed send the signal that the 

products are not healthy? 

A. No, it simply reflects the fact that organics is a marketing program. As such, by 

consensus of the market participants, many production methods and materials are 

excluded from use. 

Q: Is cloning as a livestock production practice allowed under the USDA National 

Organic Program regulations? 

A. No. Cloning as a production method is incompatible with the Organic Foods Production 

Act and is prohibited under the NOP regulations. 

Q: Can animals produced using cloning technology, or clones, be considered organic 

under the National Organic Program regulations? 

A. No. Animals produced using cloning technologies are incompatible with Organic Foods 

Production Act and cannot be considered organic under the National Organic Program 

regulations. 

Q: What about the progeny of animals produced using cloning technology or clones – 

can they be organic under the NOP regulations in organic livestock production? 

A. Based on a recommendation of the National Organic Standards Board, USDA’s 

Agricultural Marketing Service is preparing the necessary public rulemaking to address 

the organic status of the progeny of animal clones.