Data Requirements for Unconfined Release of Agricultural Biotechnology Products
Regulatory officials of Canada, the United States and Mexico have met and are agreeing to common requirements and acceptable analytical approaches to facilitate the submission of these data by developers seeking regulatory approval. Early documents were agreed by Canada and US, while the most recent document (Molecular Characterization) is agreed to by all parties.
Lessons Learned 2007
In 2007, APHIS released a report from an investigation focused on the unintentional release of trace amounts of regulated genetically engineered rice detected in two commercial varieties. In addition, APHIS prepared a “lessons learned” document from this and other investigations, and from its scientific expertise and experience in reducing the likelihood of pollen flow, and this second document was incorporated into the 2008 Farm Bill.
Guidelines for Research Involving Planned Introductions into the Environment of Genetically Modified Organisms
In 1991, the Agricultural Biotechnology Research Advisory Committee (ABRAC) developed guidelines that recommend practices and procedures for the safe conduct of research involving the planned introduction into the environment of certain genetically modified organisms.
White Paper on Tier-Based Testing for the Effects of Proteinaceous Insecticidal Plant-Incorporated Protectants on Non-Target Invertebrates for Regulatory Risk Assessments
This paper summarizes scientific and regulatory information on non-target invertebrate testing and evaluation of new products expressing insecticidal proteins in an ecological risk assessment. This paper is not intended as official policy or guidance.