Suggestions on how to apply international safety testing guidelines for genetically modified organisms

Type of content
Reports
Publisher's DOI/URI
Thesis discipline
Degree name
Publisher
Centre for Integrated Research in Biosafety (INBI)
University of Canterbury. Biological Sciences
Journal Title
Journal ISSN
Volume Title
Language
Date
2012
Authors
Heinemann, J.A.
Abstract

Summary of recommendations Recommendation 1: The regulatory review process should begin with the participation of all stakeholders, from industry (not just the applicant’s industry), civil society and government and seek a consensus endorsement in the scope and nature of the risk assessment. The stakeholder engagement should not begin with an evaluation of the outcome of a risk assessment. Recommendation 2: A scientific risk assessment should be based on scientific information that is available for review and verifiable (through independent testing) by qualified scientists who have reliable career independence from the commercial incentives pervading both public and private research. Recommendation 3: The regulatory review process should follow that outlined in the Flowchart to the Roadmap for risk assessment for the CPB, with particular emphasis on articulating and addressing uncertainty in the assessment and on an integrated approach that builds confidence in the assessment as it progresses. Recommendation Four: The regulator should reduce uncertainty in the industry about the standards required in the risk assessment process. The most straightforward approach is to establish the minimum expectation that the developer will conduct the risk assessment by addressing each step of the procedures in relevant international guidance documents. In establishing this standard, the regulator should expect a response to every paragraph of the CAC guidelines (and any other chosen risk assessment procedures) rather than picking and choosing post hoc which CAC recommendations to pursue. Recommendation Five: The regulator should review and address all data relevant to the outcome of the risk assessment, regardless of whether the data was obtained for the purpose of the risk assessment. Recommendation Six: Recommendations 1-5 should be completed before approving field trials or releases into the environment, or approval for use of the product as food.

Description
Requested by the Petitioner to the Supreme Court of India
Citation
Heinemann, J.A. (2012) Suggestions on how to apply international safety testing guidelines for genetically modified organisms. 33pp..
Keywords
Ngā upoko tukutuku/Māori subject headings
ANZSRC fields of research
Field of Research::06 - Biological Sciences::0604 - Genetics::060499 - Genetics not elsewhere classified
Fields of Research::30 - Agricultural, veterinary and food sciences::3004 - Crop and pasture production::300405 - Crop and pasture biomass and bioproducts
Field of Research::09 - Engineering::0908 - Food Sciences::090802 - Food Engineering
Field of Research::05 - Environmental Sciences::0599 - Other Environmental Sciences::059999 - Environmental Sciences not elsewhere classified
Rights
Collections