FY 2011 was a groundbreaking year for the CVM’s Animal Biotechnology Interdisciplinary Group. CVM initiated the Group in 2010 as a 2-year pilot project to address the new and challenging set of regulatory issues posed by animal biotechnology including genetically engineered animals. The Center converted the Animal Biotechnology Interdisciplinary Group into a permanent program in March 2011.
Because of the crosscutting nature of the issues presented by animal biotechnology and lifecycle approach to regulation, the Animal Biotechnology Interdisciplinary Group resides in the Office of the Center Director. At the end of FY 2011, the Group had nine dedicated members and numerous associates matrixed-in from all the other organizational units in CVM. (Staff members are “matrixed-in” when they are working outside their office structure in partnership with members of the Animal Biotechnology Interdisciplinary Group and other FDA centers to form a team best suited to review a particular product.)
The Animal Biotechnology Interdisciplinary Group program has two overarching features: (1) it follows genetically engineered animals over the lifecycle of the product within one administrative structure, and (2) it leverages expertise from across the Center in a matrix-managed environment to ensure the entire project life cycle is covered, from early research to post-market surveillance. The Group’s approach is intended to maximize the existing resources across CVM and FDA by engaging professionals with the appropriate expertise, regardless of administrative unit as each application requires.
The Animal Biotechnology Interdisciplinary Group has continued its progress in developing full life-cycle approach to the regulation of genetically engineered animals. To this end, the Group “matrixed in” experts from CVM’s Office of New Animal Drug Evaluation, Office of Surveillance and Compliance, and Office of Research, as well as reviewers from human product centers, to its risk-based review processes. In addition, The Group’s members have “matrixed out,” having actively engaged in a number of CVM and FDA initiatives. Because products derived from genetically engineered animals are often regulated by different parts of FDA, the Animal Biotechnology Interdisciplinary Group is actively engaging with other centers, including the Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Food Safety and Applied Nutrition, and the Office of the Commissioner, to coordinate regulatory efforts in order to leverage agency resources and avoid duplicative regulation.
The Animal Biotechnology Interdisciplinary Group has spent much of FY 2011 working on adapting and developing regulatory documents to address the specific needs of products of animal biotechnology. As noted in CVM’s FY 2010 Annual Report, CVM conducted a Veterinary Medicine Advisory Committee Meeting in September 2010 on AquAdvantage Salmon, the first genetically engineered animal intended for food use. The Group continued working on the AquAdvantage Salmon application during FY 2011.
In FY 2011, the Animal Biotechnology Interdisciplinary Group continued to develop and refine its review process. The critical aspect of this review process is that the Group actively engages the sponsors as they design and initiate studies in support of each step of the hierarchical review process. Data and information are reviewed throughout the entire product development process, which enables the Animal Biotechnology Interdisciplinary Group to analyze and review information soon after it is generated.
As part of this review paradigm, the Animal Biotechnology Interdisciplinary Group continues to work in concert with the Office of Research and sponsors to validate regulatory analytical methods that can be used to identify the genetically engineered animal or its edible products. In collaboration with sponsors, the scientists at the Office of Research have developed customized rapid, cost-effective, molecular methods to enable discrimination between genetically engineered and non-genetically engineered animals and edible products specific to the applications we have received. These methods have been validated on test samples, and rapid response kits have been prepared specific to each method. Using this review process, the Group has completed evaluations of a number of submissions for several active Investigational New Animal Drug files (INADs).
Working in collaboration with CVM’s Office of Surveillance and Compliance, FDA’s Office of Regulatory Affairs and, in one case, the Center for Devices and Radiological Health, the Animal Biotechnology Interdisciplinary Group conducted three biomonitoring inspections in FY 2011. Members of the Animal Biotechnology Interdisciplinary Group team visited research and farm facilities that participate in the development or housing of genetically engineered animals. Reviewers conducted a quality audit of raw data and provided recommendations on process improvement that could positively impact future submissions.
The Animal Biotechnology Interdisciplinary Group members were invited to speak, attend, or lead discussions at almost 30 scientific conferences, interagency meetings, or international meetings on various scientific and regulatory topics during FY 2011. The Group’s members have also been very active in international outreach activities such as providing technical assistance to the Office of the U.S. Trade Representative for the World Trade Organization Case on U.S./European Union beef hormones, technical assistance to Office of the U.S. Trade Representative on cloning-related issues, chairmanship on the Organisation for Economic Co-Operation and Development Task Force for the Safety of Novel Foods and Feeds, and co-chairmanship of the Organisation for Economic Co-Operation and Development Task Force and authorship for the consensus document on Atlantic salmon. The Group’s members also served as invited speakers and session chairs at the First International Workshop on Food and Environmental Safety Assessment of Genetically Modified Animals, held in Buenos Aires, Argentina.