BIO Guidance for Genetically Engineered Animal Stewardship

This Guidance on Genetically Engineered Animal Stewardship (“Guidance” or “BIO Guidance”) is being developed by BIO’s Animal Policy Committee (APC) to address the stewardship of genetically engineered (GE) animals. This Guidance is ultimately targeted toward providing stewardship throughout the full animal and (or) animal product life cycle. This Guidance will assist companies and the industry in developing and adopting stewardship principles for conducting research, and developing and commercializing safe and efficacious agricultural and biomedical products from GE animals for societal benefit. The first guideline developed for this Guidance is related to research and development, and is a strong step forward to help support this innovative technology in an emerging marketplace for animals and animal products.

Mission of BIO’s APC Stewardship Initiative

The mission of BIO’s APC Stewardship Initiative is to institute and promote guidelines for the development and use of GE animals, which promote good animal welfare, enhance industry credibility, and comply with current regulatory requirements.

Background and Introduction

The focus of this Guidance is to support the responsible development and use of GE agricultural animals for agricultural, biomedical, and industrial applications. The genetic engineering of livestock, including poultry and fish, has the potential to improve public health, food nutrition and safety, enhance animal welfare and minimize the impact of animal agriculture on the environment. For the purpose of this Guidance the focus is on vertebrate members of the animal kingdom that are agricultural animals.

This Guidance places a high priority on the industry’s stewardship of animal well being. The industry involved with production of GE animals, until recently, has been centered primarily in North America, with the United States having the most developed regulatory system of government oversight. So references to government oversight in this Guidance will focus on the United States.

For over two decades, product developers in the biotechnology industry have been conducting research and development while following strict governmental standards for good animal welfare in the development of GE animals and their products. In addition to animal well being, animal product safety and efficacy are critical elements to the stewardship of animal biotechnology.

To reach these stewardship goals, BIO supports an appropriate regulatory framework, which includes a rigorous mandatory regulatory process that is coordinated among relevant governmental agencies for GE animals and their products. For example, in the United States, coordination is expected among the agencies involved in approving GE animals and products derived from them, primarily, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), as well as among individual components within the relevant agencies. The U. S. industry seeks timely approvals of the animals and their products - an approval affirming the government’s finding of safety and effectiveness. A final guidance document explaining FDA’s regulation of GE animals was published in 2009, and the USDA has requested information from the public regarding its role in regulating these animals and their products. While FDA recently clarified the regulatory process for GE animals containing heritable recombinant DNA constructs, the FDA signaled their intention to provide additional guidance for GE animals with non-heritable constructs. Therefore, this BIO Guidance covers GE animals containing either heritable or non-heritable recombinant DNA constructs.

Purpose

This Guidance will provide information for the development and implementation of stewardship programs for product developers that plan to engage in research, development and commercialization of GE animals. The Guidance is being developed as a series of educational modules that can be adapted to the specific activities pertinent to the user’s own operations. The modules that are planned for inclusion in the Guidance include Research and Development, Commercialization, Post-Market Monitoring, and Discontinuation -Product Recall. Each module will provide guidelines under the following six themes: 1) Animal Identification, Labeling, and Inventory Control; 2) Animal Well Being; 3) Product Safety; 4) Animal Health; 5) Environment; and 6) Worker Safety. The guidelines for the first module, Research and Development, are provided below.

The guidelines in the first module are intended to be flexible and will differ in their application according to the animal species, the animal products, and the size, nature and complexity of the industry or other organizations that are product developers. The guidelines in the first module are focused primarily on North America.

International guidelines for GE animals either have not been initiated or are in various stages of development. It is intended that in the future, the BIO guidelines will assist developers throughout the world in developing and adopting stewardship principles for conducting research, and developing and commercializing agricultural and biomedical products from GE animals. Further development of stewardship programs for GE animals will be facilitated by aligning the regulatory processes for GE animals throughout the world.

Scope

This Guidance addresses stewardship of GE animals through the life cycle of animals and animal products, addressing engineered-derived traits that could be present in the environment, food, feed, or products for human health, industrial, or consumer applications. It is being designed to provide guidelines for each stage of the animal and animal product lifecycles, from initial research and development through commercialization, post-market monitoring and discontinuation and (or) product recall activities.