Building Regulatory Capacities for Biotechnology (Genetic Engineering)

Organized by the the APEC High Level Policy Dialogue on Agricultural Biotechnology (HLPDAB), the virtual workshop Building Regulatory Capacities for Biotechnology (Genetic Engineering) sought to enhance the awareness of APEC and non-APEC developing member economies of the various policy and regulatory approaches available toward genetic engineering that would facilitate the adoption, use, and commercialization of biotech products. Products of genetic engineering have contributed to food security, environmental sustainability, and climate change mitigation since their adoption in 1996. Safe and effective use of this technology requires transparent, predictable, and science-based regulatory approaches that are consistent with international standards. Through this workshop, the capacities of select APEC and non-APEC developing member economies were developed through a greater appreciation of the different regulatory approaches economies take that promote science-based and transparent regulatory processes, are harmonized with international fora, and have resulted in commercial success.

Drs. Andrew Roberts and Bhavneet Bajaj delivered presentations on the second day of the virtual workshop, which focused on regulatory model systems for targeted needs. Dr. Roberts’ presentation on Elements of a “Gold Standard” Regulatory System introduced the aspirations vs. practical realities of regulatory systems and how to achieve good regulatory systems in the context of existing regulations and administrative processes. Delving further into regulatory risk assessment, he discussed the balance between case-by-case considerations vs. consistent and predictable assessments, as well as how to establish and define protection goals to develop practical assessment endpoints.

Dr. Bajaj’s presentation on Resources to Facilitate Regulatory Reviews showcased useful tools for conducting regulatory reviews, including the BioSafety Clearing-House, OECD BioTrack Product Database, OECD Consensus Documents, Codex Alimentarius, FAO GM Foods Platform, BioTrade Status Database, ISAAA GM Approval Database, along with AFSI’s Crop Composition Database (CCDB) and Global Environmental Zones Explorer (GEnZ)