Animal & Veterinary
Working Group Keeps CVM Abreast of New Animal Technologies
by Suzanne Sechen, Ph.D., Office of New Animal Drug Evaluation
FDA Veterinarian Newsletter 2007 Volume XXII, No I
The Center for Veterinary Medicine in the Food and Drug Administration recognizes the regulatory challenges presented by new approaches to increase the food production efficiency and health of animals. Clearly, Center scientists need to stay up-to-date on technological processes and concerns to help guide CVM and FDA to make sound regulatory decisions and to communicate these decisions to the public. To this end, in 2001 CVM established the Animal Biotechnology Working Group (ABWG).
The ABWG provides a science-based forum within CVM to promote greater understanding of not just biotechnology-derived products and genetically engineered animals, but also advanced forms of assisted reproductive technology and new approaches to making and targeting drugs. Membership consists of scientific reviewers, researchers, and managers in CVM’s Office of New Animal Drug Evaluation, Office of Surveillance and Compliance, and Office of Research interested in new technologies. The wide representation across the Center provides members a broad source of information from all regulatory perspectives and also promotes better communication and consistency on decisions within CVM on new issues.
Members of the ABWG develop expertise in the latest advancements in new technologies, and they attend and participate in scientific meetings to communicate the agency’s processes and concerns in regards to these technologies as applied to animals. They provide scientific leadership and technical assistance to CVM and FDA with respect to policy decisions, position papers, guidance documents, and scientific reviews, thereby protecting public, animal, and environmental health.
The ABWG serves a critical role in increasing Center awareness and knowledge about emerging technologies and critical regulatory issues related to these technologies.
Members of the ABWG continue their own education in order to best serve the needs of the Center. For example, members attend lectures and hands-on courses at the National Institutes of Health (NIH) for experience with basic recombinant DNA technology, cloning techniques, proteomics, and nanotechnology.
They also learn specific tools, such as polymerase chain reaction (PCR) and microarray technology. PCR is a technique used to amplify the number of copies of a specific region of DNA in order to produce enough DNA to be adequately tested.
Microarrays identify DNA, RNA, or proteins in cells or tissue samples. Microarrays are extremely useful for characterizing early changes that occur as the result of administering a drug or developing a genetically engineered animal. For example, if an animal is treated with a new drug that may have effects on liver function, scientists can use microarrays to determine the dose levels associated with very early liver changes to help drug developers find less toxic doses. DNA microarrays include thousands of samples of known DNA sequences (for example, genes known to be associated with detoxifying certain classes of drugs in the liver) fixed in specific locations to a support (e.g., glass slide or nylon membrane) in a “grid” design. A sample of RNA from the liver of a treated animal is tagged with fluorescent dye and then hybridized to the array. Only the RNA sequences that correspond to genes that are being expressed to detoxify that drug will bind to those genes (which have been immobilized on the grid), and fluoresce. This process is visualized as bright green or red “dots.” Brighter dots would indicate that more of the RNA was present, and could be used to help understand how the drug exerts its toxic effect.
Members of the ABWG attend scientific conferences to learn about recent research developments in new technologies as well as issues and concerns associated with these developments.
The ABWG also plays a significant role in educating the Center. It has invited experts from FDA, NIH, the U.S. Department of Agriculture (USDA), and various universities to educate CVM scientists on issues such as risks associated with the use of viral sequences as methods for introducing genes of interest into cells or organisms, the potential environmental impact of the release of genetically engineered fish, potential uses of genetically engineered insects, and DNA microarrays. The ABWG also developed several lecture series for Center scientists on the topics of pharmacogenomics, gene transfer, microarray technology, and nanotechnology, with speakers from FDA, universities, and commercial industries.
The ABWG established a “virtual” library of current texts and reference materials associated with new technologies to share among CVM staff. Once a year, the ABWG holds an open meeting to inform the Center of the group’s accomplishments throughout the year as well as new scientific developments in animal technologies.
The ABWG in action
A key role for ABWG members is to serve as a scientific resource for critical and emerging issues for CVM and the agency. They also help to maintain the Center’s expertise on these issues through recommendations on staffing and training opportunities.
Members of the ABWG prepare and present talks and posters at multiple scientific conferences in the United States and abroad to communicate the Center’s and FDA’s processes, findings, and concerns regarding new technologies.
ABWG’s outreach can be seen in the activities leading up to the release of CVM’s Draft Animal Cloning Risk Assessment on December 28, 2006. Many members of the ABWG played key roles in developing that Draft Risk Assessment.
For example, ABWG members and other CVM staff conducted a review of the available data on the health of animal clones and the safety of food from those animals. This review addresses concerns identified by the National Academy of Sciences in a study commissioned by CVM in 2001 to explore the science-based concerns associated with animal biotechnology, including cloning.
ABWG members also participated in a September 2002 Pew Initiative on Food and Biotechnology symposium, cosponsored by the Center entitled, “Animal Cloning and the Production of Food Products – Perspectives from the Food Chain.” The symposium provided a forum for an exchange of perspectives among the various stakeholders in animal cloning: companies that produce and sell clones, animal breeders, processors, retailers, and consumers of foods derived from clones. Members of the ABWG also assisted in the preparations for a Washington Post “Web Chat” on animal cloning in 2002.
The ABWG helps the Center to communicate unfolding regulatory requirements to sponsors developing products and processes using new technologies.
The technologies behind new products being investigated are discussed at monthly ABWG meetings to ensure a current and consistent level of knowledge within the Center.
Related to these communication efforts, members of the ABWG helped draft letters that were issued from CVM to all Land Grant Universities on May 14, 2003. The letter reminded university presidents of the need for researchers on campus to establish Investigational New Animal Drug exemptions with CVM to conduct research involving genetic engineering in animal species commonly used for food. Universities need to document plans regarding the disposition of all investigational animals after their participation in the study is completed. University presidents were also reminded that FDA does not permit investigational animals involved in genetic engineering research to be placed into the human or animal food supply without prior authorization.
Members of the ABWG work cooperatively with other FDA centers and Federal agencies. This cooperation allows the ABWG to draw on the experience of other centers and agencies in dealing with new products and processes, such as gene therapy in humans, and bioengineered plants. The ABWG also provides a unique perspective to other Centers and agencies in dealing with “cross-cutting” technologies that could involve multiple centers and agencies, such as the use of genetically engineered animals to produce drugs for humans. An example of this cooperative effort is the September 2002 Draft Guidance for Industry entitled, “Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for use in Humans and Animals.” Members of CVM’s ABWG worked with scientists throughout FDA and USDA to develop this draft guidance.
Subcommittees within the ABWG study safety questions associated with new technologies, such as potential risks associated with viral vectors, and the risk of allergenicity of foods derived from biotechnology. CVM is represented by ABWG members in agency-wide interest groups focused on specific areas, including genomics, proteomics, and nanotechnology. Participation allows the ABWG to stay abreast of potential new products being developed and to discuss regulatory policies and data issues that may need to be considered. For example, when reviewing new products regulated by FDA, CVM scientists must be familiar with assays and procedures that generate safety and effectiveness data. This allows reviewers to properly evaluate the reliability of these data.
New technologies may provide exciting breakthroughs in drug development and how our food is produced. The ABWG will continue to help the Center and FDA stay informed and educated on these new processes, and it will provide scientific leadership and expertise so that new products will be thoroughly evaluated. These efforts will ensure the continued safety of our health, animals, and environment.