Workshop Proceedings on Regulatory and Commercialization Issues Related to Genetically Engineered Animals

In March and May 2005, the Pew Initiative on Food and Biotechnology hosted workshops to explore issues related to the regulation and commercialization of the products of animal biotechnology. Participants included animal biotechnology researchers from academia and industry; other representatives from the biotechnology, food, and agriculture industries; consumer, environmental, and animal welfare advocates; ethicists; and federal agency officials. During both the March and May workshops, the assembled group was provided with a strong grounding in the statutory authorities of the various federal agencies that could regulate genetically engineered (GE) animals and in the issues relating to the commercialization and marketing of those animals. In addition, attendees were asked to share their views on an array of issues relating to the regulation and commercialization of GE animals.

Proceedings from the workshop, entitled “Exploring the Regulatory and Commercialization Issues Related to Genetically Engineered Animals” are available below.

Highlights include:

• A detailed discussion on the attributes and components of an ideal regulatory system for governing GE animals and the products derived from those animals.    
• Acknowledgement that there is a need for more clarity regarding the regulatory system governing transgenic animals, including which agencies and statutory authorities, in addition to the Food and Drug Administration (FDA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), will be involved in regulating the animal biotechnology industry.    
• An examination of how the FFDCA new animal drug approval process could be used to regulate transgenic animals, and a debate about the appropriateness of using this authority as the primary regulatory vehicle for transgenic animals.    
• A debate about whether the current FFDCA provisions for approving animal drugs needs to be improved to more clearly cover transgenic animals and to resolve concerns regarding the lack of a clear environmental standard and the lack of transparency in the approval process.    
• Recognition that the general public should be able to comment on regulations or guidelines the FDA, or any other agency, develops regarding the specific process the agency will use to review GE animals, and a debate as to whether the public should be allowed to comment on the approval of specific transgenic animals.    
• An examination of and debate about the benefits and risks of introducing GE animals, and products derived from them, into existing animal production and food marketing systems.