IFBiC TASK FORCE ACTIVITIES (DEVELOPMENT OF CONSENSUS DOCUMENTS)

Safety and Nutritional Assessment of Foods and
Feeds Nutritionally Improved through Biotechnology

In the first phase of the Task Force’s work, a framework was developed and the Executive Summary was published in the March 2004 issue of the Journal of Food Science.  The full manuscript was published in April 2004 in Comprehensive Reviews in Food science and Food Safety. Click here for more information about the development of the framework.

Phase 2: Case Studies
Now, in the second phase of its work, this Task Force collaborated with international experts to develop a manuscript that examines five real world examples of nutritionally improved crops as case studies for applying the general principles and recommendations on nutrition and safety assessment of improved nutrition crops published in 2004. These examples include: lysine maize (Dr. Richard Phipps); double embryo maize (Dr. Martina McGloughlin); Golden Rice 2 (Dr. Bruce Chassy); a transgenic sweet potato with ASP-1 protein, and a sweet potato conventionally bred for enhanced β-carotene content (Dr. Gijs Kleter). A draft document, simultaneously undergoing external review, was the background and focus of a September 12 workshop for the delegates to the 12th meeting of the OECD Task Force on Novel Foods and Feeds in Athens, Greece. 

During the plenary session of the workshop, presentations by the authors highlighted key points and recommendations specific to each case study. This information served as background for workshop participants to discuss in break-out groups various scientific issues related to the recommendations being brought forward in this case study document regarding nutritionally improved foods. The ideas generated during the break-out session were related to the group in final discussion session.

There was broad participant agreement that the comparative assessment process is valid in the safety assessment of improved nutrition crops such as those included as case studies in the manuscript.  It was concluded that both the nutrition and safety assessment processes should be done on a case-by-case basis.  Further, including an evaluation of the intended human nutrition impact or health benefit with the risk/safety assessment framework is desirable, provided it can be done with the same scientific rigor as the risk analysis.  It was also clear that many challenges lie ahead for refining the framework (e.g., under what circumstances might ‘omic’ analyses be appropriate, if or how to conduct post-market monitoring).  Overall, those in attendance felt that the manuscript successfully applies the 2004 recommendations to the case studies. 

The Task Force will integrate the comments from the workshop into the final manuscript to be submitted for publication by January 2007.

To view the workshop presentations, please click here. 

To learn more about the development of the 2004 framework and publications, click here.
 
For more information about this or other IFBiC activities, please contact Dr. Marci Levine, mlevine@ilsi.org.

Best Practices for the Conduct of Animal Studies to Evaluate Genetically Modified Crops

Animal feed performance studies are being requested by regulatory agencies in various world areas for the approval of biotech crops as well as by the livestock industry to assure that farm animals perform comparably with grain derived from biotech crops as with grain derived from conventionally-bred crops.  The purpose of this project is to develop comprehensive, internationally harmonized guidelines for conducting nutritional studies designed to evaluate animal performance of biotech feeds that are substantially equivalent to their conventional counterparts.  The project was conducted in collaboration with the Federation of Animal Sciences Societies (FASS).  The final document was published in December 2003.  In 2004, it was referenced in the European Food Safety Authority’s (EFSA) Draft Guidance Document for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed.
This document is available free of charge as a PDF file on the ILSI Webpage. Click here to download. 

The task force is currently working on Phase 2 of the project, which focuses on nutritionally improved feeds.  The resulting document will have two parts, one that will focus on the trait and its biology, and another that will have animal study protocols.  Draft document will go through extensive international peer review.  A publication is anticipated in early 2007.

ILSI Crop Composition Database  (www.cropcomposition.org)

In April 2006, ILSI released Version 3.0 of its crop composition database, which provides up-to-date information on the natural variability in composition of conventional crops and provides a reference for comparing the composition of new crop varieties, including those developed through biotechnology.

Crop, food, and feed composition studies are considered an essential part of the safety assessment of new crop varieties, including those developed through biotechnology.  Information obtained from such studies is used to assess similarities and differences in important nutrients and anti-nutrients. This database was generated from crop composition data obtained from studies conducted by members of the agricultural biotechnology industry over a number of years at multiple worldwide locations.  Information collected in the database includes data on numerous biochemical parameters, such as proximates, amino acids, lipids, carbohydrates, key vitamins, and anti-nutrients. 

Version 3.0 of the database is an extension of previous versions.  It contains approximately 118,000 data points that may be searched and accessed based upon user-selected queries.  The analyses of the samples were conducted using validated analytical methods, many of them being AOAC Official Methods of Analysis.  The database complements existing food and nutrient databases, such as the USDA Nutrient Database and FAO’s INFOODS database, and should be of interest to research and regulatory scientists in many areas such as plant biology, food science, and animal nutrition. 

The development and application of the database has been described in a June 2004 article in the Journal of Food Composition and Analysis.  The database was referenced by the European Food Standards Authority (EFSA) in its Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed (the EFSA Journal [2004] 99, 1-93).

ILSI welcomes and highly encourages submission of other publicly available composition data that meet the acceptability criteria outlined on the website.

The database is available for public use (free of charge) via the Internet at www.cropcomposition.org.

Expert Scientific Paper on Safety Evaluation of Proteins Introduced into Food and Feed Crops

Safety evaluations of food and feed derived from crops produced via modern biotechnology focus on a variety of considerations, including the nature of the trait, the expected and potential unexpected effects owing to the introduction and/or presence of the new trait, and the anticipated conditions of use of the product.  Most traits result from the expression of one or more newly introduced proteins.  Therefore, the safety of food and feed derived from genetically modified crops includes the examination of the properties of these introduced proteins. A robust safety evaluation process has evolved in the regulatory and international scientific communities to address the potential safety concerns of these proteins. 

The objective of this project is to conduct a scientific review of the approach to safety assessment of proteins in order to develop scientific consensus on this topic.  The resulting document, drafted by Task Force members, describes:

• The characteristics of proteins and how that drives safety assessment
• A tiered, weight of evidence approach to the safety assessment of proteins
• A detailed description (including applicability, best practices for use and limitations) of the assessments currently done to demonstrate protein safety, including expression level and pattern, history of safe use, bioinformatics, mode of action, protein stability, and toxicological testing.
• Four examples of protein safety assessments are described in the manuscript:  PMI, PAT, Y coat protein, and CP4 EPSPS. 

The document brings together a considerable body of information about the science underlying protein safety assessment that has not previously been brought together in one place, and includes information from experts responsible for assessment of products currently on the market.  This document is designed to describe the scientific underpinnings of protein safety assessment to a scientific audience, and is intended to serve as a key reference for scientific and regulatory considerations.

After peer review by scientific and regulatory experts worldwide, it is anticipated that the document will be submitted for publication in Food and Chemical Toxicology by the end of 2006.

Application of Food and Feed Safety Assessment Principles to Evaluate Biotechnolgy-Derived Crops Produced Using New Technologies: Modifications that Affect Endogenous Plant Gene Expression

Modern biotechnology is increasingly being used to achieve phenotypes that have been long sought through traditional breeding, such as increased tolerance to environmental stresses (e.g., drought, frost, salt), disease resistance, improved nutrition, increased yield, and altered growth or development.  These new phenotypes are often affected through modification of endogenous plant gene expression.  These modifications can be produced through gene suppression technologies or through alterations in regulatory or signaling pathways.  Though these processes occur naturally in plants and have been selected for during plant domestication and conventional breeding, there remains a possibility that use of these technologies may increase the probability of secondary effects on plant physiology due to pleiotropy or epistasis.  These newer technologies sometimes act differently than many of the genes currently used in commercialized biotech crops in which the gene product is able to directly confer the desired trait (e.g., expression of a Bt protein for insect protection). 

For the currently commercialized biotech crops, a comparative safety assessment process was implemented in the 1990s in which scientific studies identified the similarities and differences between the newly developed crop and a conventional counterpart that has a history of safe use.  The analysis assessed: (1) the agronomic/morphological characteristics of the plant, (2) macro- and micronutrient composition and content of important antinutrients and toxicants, (3) molecular characteristics and expression and safety of any proteins new to the crop, and (4) the toxicological and nutritional characteristics of the novel product compared to its conventional counterpart in appropriate animal models.  The identified differences were subjected to further scientific assessment, as needed, to clarify whether any safety issues or concerns existed and then to evaluate or address any such issues or concerns. 

The objective of this project is to clarify whether the comparative safety assessment process, as currently implemented, is sufficiently robust to assess the food and feed safety of products produced utilizing new technologies that affect endogenous plant regulatory pathways and gene expression, given the potential for increased production of secondary effects produced by such technologies.  A task force and an expert working group were convened in 2006 to prepare a monograph that describes how the principles of food and feed safety assessment should be applied to products developed using these technologies that affect endogenous plant gene expression or plant signaling pathways.  It is anticipated that the project will be completed and a manuscript published in early 2008.