FDA Center for Food Safety and Applied Nutrition
USDA Food Safety and Inspection Service
December 27, 1999

Dr. Shunsaku Minami
Director for International Food Safety Programme
Ministry of Health and Welfare
1-2-2, Kisumigaseki, Chiyoda-ku
100-8045, Tokyo
Japan

Dear Dr. Minami:

The following comments are offered in response to CL 1999/27 - FBT, Request for Submission of Discussion and Information Papers on the Elaboration of Standards, Guidelines or Other Principles for Foods Derived from Biotechnology.

The CL requested a response to the following areas regarding the first Session of the Task Force.

• Identification of areas of the work of the Task Force;
• Work priorities;
• Key concepts and definitions;
• Core principles for risk assessment; risk management and risk communication;
• Collection, dissemination and exchange of information;
• National and regional experience.

The following response is complete with respect to most items. However, because of the short period of time to respond to this CL, the United States is planning to provide a supplemental response by mid January, 2000 that will respond more fully to the following areas: 1) key concepts and definitions, specifically as related to standards for safety for foods and food ingredients and the application of "substantial equivalence" to food safety assessment; 2) core principles for risk assessment/risk management/risk communication; and 3) national/regional experience.

1. IDENTIFICATION OF POSSIBLE AREAS OF WORK (i.e., needs for Codex Texts)

The United States believes that the Codex Alimentarius Commission is the appropriate international forum for establishing food standards and guidance. Therefore, the United States recommends the following Terms of Reference for the work of the Task Force:

Terms of Reference:

The United States believes that the Task Force should take account of the limited time available to complete the work requested by the Commission and focus its effort on topics pertaining to food safety and nutritional assessment of foods derived from biotechnology. Priorities for the work in these areas should be established to ensure that the work of the Task Force can be completed within the available time.

The United States believes that the work of the Task Force should focus on the safety and nutritional assessment of food and food ingredients derived from microorganisms, plants, and animals developed using biotechnology. Issues related to the use of animal feed should be considered to the extent that the issues pertain to the safety and nutrient composition of food and food ingredients obtained from animals that are fed feed derived from biotechnology.

The United States recommends that the Task Force develop guidance documents based on sound scientific principles and information for food safety and nutritional assessment of foods derived from biotechnology taking into account and closely adhering to the Four Statements of Principle of Codex. Further, this work should take into account and build upon existing scientific principles available in international guidance documents, including the 1996 Report of a Joint FAO/WHO Consultation (FAO Food and Nutrition Paper 61). The work should also take into consideration and draw from, as appropriate, current work on biotechnology by other international bodies, especially the OECD.

The United States believes that the Codex Committee on Food Labelling (CCFL) is the appropriate body to consider issues related to food labeling. Labeling of foods obtained through biotechnology is under development by the CCFL, and the United States believes that consideration of labeling of foods derived from biotechnology by the Task Force should be strictly limited the identification of issues related to health and safety that should be referred to the CCFL.

The United States recognizes that environmental safety is an important element to be taken into account in decisions related to research and commercial distribution. However, the United States believes that the Task Force should limit its initial discussions to food safety and nutritional assessment of foods derived from biotechnology.

The United States also recognizes that there are many issues in addition to food safety and nutritional assessment related to foods derived from biotechnology, sometimes referred to as "other legitimate factors." Currently, the Codex Committee on General Principles is considering the role of these factors in Codex. The United States believes that the Task Force should focus its work on food safety and nutritional assessment to ensure that this important work can be completed in the limited time available.

The United States views the work of the Task Force as developing general guidance which may be further developed, as appropriate by the various Codex technical committees. We also view the guidance developed by the Task Force to be of value to the FAO/WHO Joint Expert Groups as they carry out their work.

Identification of Work:

The United States recommends that the Task Force develop the following guidance texts:

1. Guidance for food safety and nutritional assessment of food and food ingredients obtained from plants developed using modern biotechnology;

2. Guidance on specific food safety/scientific topics related to food safety assessment:

   1. Evaluation of possible allergenicity of proteins;
   2. Evaluation of the use of antibiotic resistance marker genes;
   3. Analytical evaluation of food composition (possibly OECD Consensus Documents);
   4. Evaluation of molecular and genetic information;
   5. Considerations related to feeding studies in animals.

3. Guidance for food safety and nutritional assessment of food and food ingredients obtained from microorganisms developed using modern biotechnology;

4. Guidance for food safety and nutritional assessment of food and food ingredients obtained from animals developed using modern biotechnology.

2. WORKING PRIORITIES (In descending order of priority)

1. Foods and food ingredients obtained from plants, because these products are currently the focus of many questions;

2. Guidance documents that support food safety and nutritional assessment of plants;

3. Foods and food ingredients obtained from microorganisms.
   Microorganisms obtained through modern biotechnology are widely used in food production;

4. Foods and food ingredients obtained from animals.
   Currently, there are no commercial products and few examples in research of genetic modifications achieved using modern biotechnology. However, research in transgenic fish is progressing, and some products may reach the market in the foreseeable future. Therefore, the Task Force should elaborate guidance for food safety and nutritional assessment of foods obtained from animals.

The United States believes that, at least in the initial phase of its work, the Task Force should focus its effort on the priorities in A and B as these are the most important areas of need, then on C, and on D only if time permits.

3. KEY CONCEPTS AND DEFINITIONS

1. Definition of foods and food ingredients obtained through modern biotechnology.

   The United States believes that key concepts and definitions used by the Task Force for food safety and nutritional assessment should science-based. The United States notes that current definitions under consideration by the CCFL for "genetic modification" and "GMO" are based on popular usage, not on scientific principles.

2. Standards for safety for foods and food ingredients and the application of "substantial equivalence" to food safety assessment.

This Section will be further developed and provided through a supplemental response to this CL.

4. CORE PRINCIPLES FOR RISK ASSESSMENT/RISK MANAGEMENT

1. General approach to safety and nutritional assessment for foods and food ingredients.

2. Principles of FAO/WHO.

This Section will be further developed and provided through a supplemental response to this CL.

5. COLLECTION, DISSEMINATION AND EXCHANGE OF INFORMATION

The United States believes that collection, dissemination and exchange of information is not within the remit of Codex and believes that this issue should be referred to the Codex Secretariat. If appropriate, the Task Force may wish to identify relevant international fora or organizations that can facilitate information exchange.

6. NATIONAL EXPERIENCE

The United States believes that consideration of experience gained by countries in conducting food safety and nutritional assessments will aid the work of the Task Force.

This Section will be further developed and provided through a supplemental response to this CL.

Thank you for the opportunity to provide comments on this CL. As noted above, we expect to provide further information relating to the items standards for safety for foods and food ingredients and the application of "substantial equivalence" to food safety assessment, core principles for risk assessment/risk management and risk communication and national and regional experiences.

Sincerely,

F. Edward Scarbrough, Ph.D.
U.S. Manager for Codex
Office of the Administrator
USDA Food Safety and Inspection Service