INTRODUCTION

In July of 1998, regulatory officials of the Canadian Food Inspection Agency (CFIA), Health Canada, and the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) met to compare, and harmonize where possible, aspects of molecular genetic characterization that are part of their review processes for transgenic plants. Agreement on common requirements and acceptable analytical approaches for molecular genetic characterization will facilitate the submission of supporting data by developers seeking regulatory approval to incorporate such plants into agricultural production or commerce in both countries. This Appendix is one of the outcomes of this meeting. The Appendix summarizes and identifies similarities and differences in the critical elements of the molecular genetic characterization of transgenic plants considered during the review process by these participating agencies. Molecular genetic characterization is only part of the information considered during assessments of such plants conducted prior to commercialization.

The scope of this document is limited to consideration of the transformation process and vectors used during transformation; the genetic material that was potentially delivered to the recipient plant; the identification, inheritance, and expression of the genetic material in the transgenic plant, and the production of new proteins encoded by the introduced genetic material. This document does not address specific types of techniques nor quality assurance practices (e.g., good laboratory practices) that are used to generate molecular genetic characterization data.

The agencies found very substantial areas of agreement in the types of molecular genetic characterization data they require to be submitted and considered. In addition to the specific data sets reviewed, the participants of both countries reaffirmed that reviews are still conducted on a case-by-case basis which allows for reviewing additional or fewer data sets, depending upon the individual case and the regulatory authority of the individual agencies. The use of the word “may” in this document is intended to reflect some of this flexibility in determining when data sets will be considered as an appropriate part of the entire application package. Therefore, consultations between regulatory agencies and individual applicants are considered to be an important part of the overall application process in making such determinations.

The critical elements of the molecular genetic characterization of transgenic plants described below apply to the review process of the participating agencies in both Canada and the United States, except where noted. The contents of this document will be reviewed and amended as necessary by these agencies. The glossary which follows has been included to provide definition to certain terms within the context of this document.