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Harmonizing Practical Application of Guidance on GE Foods

Overview

While the majority of governments design safety assessments of genetically engineered (GE) foods around the Codex Alimentarius’ principles and guidelines, there remain significant differences in the practical application of requirements at national and regional levels. This adds complexity, time, and cost to the regulatory process, further exacerbates asynchronous authorizations, and stands in the way of achieving regional or sub-regional regulatory cooperation.

What We Are Doing

The Agriculture & Food Systems Institute’s efforts focus on technical training of regulators and public sector scientists who are called upon to undertake safety assessments on behalf of institutional or national biosafety committees. This includes training around concepts and principles of GE food safety assessment, as well as providing experiential learning opportunities in, for example, state of the art testing facilities.

Current Work

Understanding the Use and Safety of Microbial Biotechnology for Novel Foods

Microbial biotechnology, which includes the use of both conventional and genetically engineered microbes, is used to produce a range of foods, beverages, and their ingredients including:

  • Enzymes used to make wine, cheese, beer, and processed products ranging from baked goods to sauces.
  • Vitamins used to make infant formula similar to human milk and wellness-enhancing products.
  • Food additives for seasoning, flavoring, coloring, or thickening, including those used for plant-based meat products, and many other applications.

Supported by a grant from the New Technologies and Production Methods Division at the U.S. Department of Agriculture (USDA) Foreign Agricultural Service (FAS) Trade Policy and Geographic Affairs (TPGA) area, the Agri-culture & Food Systems Institute is developing a series of seminars and workshops focused on bringing increased attention to the development, use, and safety assessment process for microbial biotechnology. The goal is to help countries implement informed polices that meet the need for governments, producers, and consumers to assess and access products produced using microbial biotechnologies.

The Agriculture & Food Systems Institute launched our program with the Microbial Biotechnology for Novel Foods Webinar Series, which addressed the past, present, and future of microbial biotechnology for novel foods. Taking place between July 9-17, 2020, each of four webinars allowed for an open discussion on the topics of safety, regulation, and trade of products of microbial biotechnology, enriched by companion papers prepared by each of the expert presenters.

New activities in 2021 will include a series of international and regional workshops combining online and in-person programming.

“I work for the Biotechnology Office at the National Service for Agrifood Health and Quality. We are starting a committee to evaluate food safety of GMM so all this information is really useful. Also, I participate in a working group that evaluates enzymes produced in microorganisms, and this webinar has helped me to get more perspective in the matter.”
Yamile Barca, SENASA
“I will be using some of the work cited as a reference in my own work. I will also give an account of what has been discussed, plus highlights of presentations to colleagues who were unable to attend.”
Dr. Gijs A. Kleter, Wageningen University
“I am working in a regulatory laboratory for food safety, hence the information from the webinars will be of use with respect to knowledge updating.”
Lijo John, Export Inspection Agency Kochi, India

Discover

Publications

Information Tools for Environmental Risk Assessment of Low Level Presence
December 31, 2011

In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.

Low Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment
March 31, 2014

The Agriculture & Food Systems Institute organized a workshop held in Buenos Aires, Argentina on December 18-19, 2013 on low level presence (LLP) in seed. This document contains the conference proceedings to address the potential adverse environmental impacts that might arise from an LLP in seed situation using a consistent and scientifically defensible approach to environmental risk assessment.

The Use of Whole Food Animal Studies in the Safety Assessment of Genetically Modified Crops: Limitations and Recommendations
Critical Reviews in Toxicology | January 1, 2013

This manuscript by Bartholomaeus et al., published in Critical Reviews in Toxicology, focuses on the relevance and utility of whole food animal studies in safety assessments of GM crops (Task Force #10).

Natural Variation in Grain Composition of Wheat and Related Cereals
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Shewry et al. 2013;61(35):8295-8303) (Task Force #12).

How Composition Methods Are Developed and Validated
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Rogers. 2013;61(35):8312-8316) (Task Force #12).

Bringing a Transgenic Crop to Market: Where Compositional Analysis Fits
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Privalle et al. 2013;61(35):8260-8266) (Task Force #12).

Application of Laws, Policies, and Guidance From the United States and Canada to the Regulation of Food and Feed Derived From Genetically Modified Crops: Interpretation of Composition Data
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Price and Underhill. 2013;61(35):8349-8355) (Task Force #12).

Biological Importance and Statistical Significance
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Lovell. 2013;61(35):8340–8348) (Task Force #12).

Availability and Utility of Crop Composition Data
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (KItta. 2013;61(35):8304–8311) (Task Force #12).

Food Safety: Importance of Composition for Assessing Genetically Modified Cassava (Manihot esculenta Crantz)
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Jansen van Rijssen et al. 2013;61(35):8333-8339) (Task Force #12).

Compositional Analysis of Genetically Modified (GM) Crops: Key Issues and Future Needs
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Hoekenga et al. 2013;61(35):8248–8253) (Task Force #12).

Evaluation of Endogenous Allergens for the Safety Evaluation of Genetically Engineered Food Crops: Review of Potential Risks, Test Methods, Examples and Relevance
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Goodman et al. 2013;61(35):8317–8332).

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