Product Launch Stewardship: Food and Agriculture Section
Through its advocacy efforts, BIO’s Food and Agriculture Section supports a regulatory framework that facilitates and enables the development and commercialization of new biotechnology-derived plant products1. Therefore, BIO’s Food and Agriculture Section is committed to supporting appropriate regulatory and complementary stewardship efforts, in coordination with the relevant stakeholders in the value chain, to advocate globally for synchronous authorizations and elimination of non-science-based zero-tolerance regulatory approaches and to facilitate the introduction of new biotechnology-derived plant products in such a manner as to facilitate the flow of goods in commerce and minimize trade disruptions.
New product introduction can effectively be achieved by a company, in part through its use of trade and processing impact assessments (“Assessments”) prior to commercialization that anticipate and consider the potential impacts within the value chain. The engagement with various stakeholders in the value chain is important to the success of these Assessments (e.g., identifying conditions related to handling, distributing, processing and testing the products). Because of the differences in crops, products, product uses and applications, each new biotechnology-derived plant product should undergo case-by-case Assessments by the company introducing that product.
This policy, through its annexes2, sets forth general policy statements and recommended processes for such Assessments as guidance for companies engaged in the launch of a new biotechnology-derived plant product and as a basis for BIO’s Food and Agriculture Section’s advocacy.
BIO’s Food and Agriculture Section believes that member companies should develop and implement company product launch stewardship policies consistent with the general policy statements and the guidance set forth in the annexes to this policy.
General Policy Statement
To encourage the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food and Agriculture Section supports actions that facilitate the flow of goods in commerce, minimize trade disruptions, and facilitate the availability of crops and products with the appropriate function and composition for intended uses. BIO’s Food and Agriculture Section believes that henceforth and pursuant to the specific policy statements set forth in the annexes to this policy, individual companies should determine whether biotechnology-derived plant products, which a company intends to commercialize, are intended for commodity use or special use, and then conduct Assessments appropriate to the biotechnology-derived plant product, develop management plans appropriate to the product and the Assessments, and undertake early, regular and mutual consultations with relevant stakeholders during the assessment and management plan development process. Companies should communicate promptly, broadly and in a transparent manner with stakeholders regarding company-specific product launch stewardship policies and their implementation.
1 Biotechnology-derived plant products means those derived by the application of 1) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles or 2) fusion cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection. This definition of modern biotechnology has been adopted by the Cartagena Biosafety Protocol under the Convention on Biological Diversity and by the Codex Alimentarius Commission.
2 Under BIO’s bylaws and applicable antitrust law, individual member companies are not bound by this Association policy or its annexes.
In light of the constantly changing regulatory and trade environment, the Food and Agriculture Section Governing Board will undertake regular reviews of this policy and its annexes and adopt additional annexes, as appropriate.
Policy Approved: May 21, 2007
Updated: Dec. 10, 2009
Updated: June 18, 2012
Updated: November 27, 2012