Genetically Engineered Animals: Frequently Asked Questions

What is genetic engineering?  

Genetic engineering is the direct manipulation of an organism’s genes.  Genetic engineering is different from traditional breeding, where the organism’s genes are manipulated indirectly.  Thanks to this technology, scientists can precisely transfer beneficial genes from one animal species to another.    

What animals are being genetically engineered?

In research studies, animals that have been safely genetically engineered (GE) include cattle, pigs, chickens, goats, sheep, dogs, cats, fish, rats, and mice.

Why are animals being genetically engineered?

As scientists have sequenced the genomes of domestic animals, more is known about genes and the traits that they control.  By finding genes that control beneficial traits, we are able to precisely introduce those genes into another animal’s genome, so the GE animal will possess that trait.  

One example is the Enviro-Pig™.  Through genetic engineering, this animal emits 30 to 60 percent less phosphorus than traditional pigs fed the same conventional diet.  This lessens livestock’s impact in the environment.

Is a GE animal an animal clone?  

No.  A GE animal has a deliberate modification made to its genome.  In genetic engineering, scientists can precisely transfer a beneficial gene (for disease resistance, for example) from one animal species to another. 

Cloning technology is a type of breeding technology to produce an exact genetic copy of an animal – usually a high quality animal with desirable breeding traits. 

Benefits of Genetic Engineering

What are the benefits of genetic engineering?

Genetic engineering of animals offers solutions for improving public health and enhancing quality of life.  The benefits include advancing human health, enhancing food production, reducing environmental impact, optimizing animal health and welfare and production of cutting edge industrial applications.  

What is the most important application of genetic engineering -- human health or food applications?

Genetic engineering provides significant opportunity to improve human health and the foods we eat.  It follows that the regulatory process used by the federal government should equally apply to all possible applications, particularly agricultural animals, which by their nature, are food animals.      

What are the primary issues holding up realization of these benefits?

The primary issue holding up the realization of these benefits has been the lack of a U.S. federal regulatory process.  However, in January 2009, the United States Food and Drug Administration (FDA) clarified the regulatory process for GE animals.  Then on February 6, 2009, the FDA approved the first product from a GE animal in the United States.  Now new approvals from the FDA of applications that are in the pipeline are needed.  The lengthy delay in reaching this point has contributed to a lack of investor confidence as well as a decline in the availability of government research funding.  The good news is that because of the published federal regulatory process the industry is now on a positive pathway to provide consumer benefits from new approved products.    

General Questions:

How many GE animals exist currently?

The numbers of GE animals in research facilities in the U.S. are unknown to BIO, but researchers/producers are required by law to keep records regarding their disposition.

Are GE animals in the food supply?

No.  To date, FDA has not permitted GE animals to be placed into the human food supply. 

Are GE animals tracked or labeled?

Yes. As a requirement of the regulatory review process, all GE animals are identified and tracked throughout the research and development (R&D) process.  Since no GE animals or products of GE animals have been approved for commercialization, this is only being done at the R&D stage at this time.  

If GE animals or the products of GE animals have been approved and deemed as safe as conventional animals by the government’s arduous review and approval process, then it should not be necessary to differentiate them.  Some companies, however, may choose to voluntarily implement labeling programs for specific products for marketing and branding purposes.  

BIO supports the labeling policies of FDA and USDA, which state that the labeling of foods is not required unless there has been a significant change in the nutritional components (or an anti-nutritional component) or other chemical characteristic compared to its conventional counterpart.  BIO supports voluntary labeling of products.

Will industry propose a supply chain management program for GE animals similar to that developed to track animal clones?

No.  Since approved GE animals will be as safe as any animal and no different, there will be no safety or health reason for a supply chain management program.

Industry is exploring other aspects for such a program, such as meeting marketing claims and identity preservation to track a branded product.

How does genetic engineering affect animal welfare?