Thank you for the opportunity to comment on the EU's regulatory system for genetically modified foods. In fact, our biotechnology industry has expressed considerable frustration at the cumbersome and unpredictable procedures in the EU, and at the length of time it takes for the EU to review and approve products for commercialisation. This year, over $200 million in US exports of corn to Spain and Portugal are jeopardised, because—after more than two years and multiple positive safety assessments—the approval process for three new corn varieties is still not complete. We hope that planned revisions to Directive 90/220 and the Novel Foods Regulation will simplify, shorten, and add more certainty and transparency to the EU's review and approval process. Following are some specific concerns:

—  EU time frame for approval is too long: whereas the review process for products derived from biotechnology in the US, Japan, and Canada normally lasts less than a year, in the EU it frequently lasts more than two years. This difference in time frames is not the result of more exhaustive scientific review: in all countries there is a high degree of commonality in the data sets and criteria used to conduct assessments. Rather, it is the politicisation of the EU approval process that has caused lengthy, unnecessary delays.

—  Politicisation of the EU approval system: the overlay of member-state voting on top of the scientific review process causes considerable delays in the approval of notifications—and could possibly cause rejections—which are unrelated to the scientific criteria of safety to humans and the environment. In the US, regulatory agencies conduct scientific reviews and come to independent decisions.

—  Lack of transparency/predictability: The private sector needs to have a predictable and transparent process to make informed decisions about when to notify their genetically modified product. A number of ad hoc changes have been made to the procedure laid out in Directive 90/220, so that business has more difficulty anticipating EU regulatory needs and planning the marketing of their products. Predictability and transparency also has an important international dimension, especially for crops. Companies lose the ability to co-ordinate approvals and plantings in different countries, increasing the risk that a crop will be harvested in a country which historically exports to the EU before that crop is approved for marketing in the EU. For example, Directive 90/220 does not require scientific review by the Commission, yet the Commission recently conducted such a review for four GMO varieties of corn and soybean without giving the companies any prior warning that this would be part of the process. US regulatory agencies also can utilise scientific expert committees during the review process. However, they attempt to predict when such committees will need to be convened and they have defined procedures and timeframes for utilising such committees. In this way, companies are better able to anticipate how long the entire review process will take.

  I am attaching for your information US comments submitted to the WTO on the proposed Commission Regulation concerning labelling of Roundup Ready soybeans and Bt corn (EU notification 97.766) as well as some information on the US regulatory process for commercialisation of products of biotechnology.

  We would be happy to provide additional information that the Committee might request.

Lloyd Harbert

Director

  Re: G/TBT Notification 97.766. Commision Regulation (EC) concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC.

DEAR

  We appreciate the opportunity to review and comment on the above referenced regulation proposed by the Commission of the European Community (Commission). The regulation has been reviewed by scientists in a number of United States (US) federal agencies. The following comments reflect reviews by scientists at the Foreign Agricultural Service of US Department of Agriculture (USDA), the Animal Plant Health and Inspection Service of USDA, the Centre for Food Safety and Applied Nutrition of the US Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).

  We would like to offer several comments for your consideration. These comments are based on the experience in the US with foods and food ingredients derived from sources that have been modified through recombinant DNA techniques and on the scientific expertise and experience of the technical experts in the above listed US federal agencies.

Commission Proposed Regulation and US Policy

  The regulation proposed by the Commission defines when labeling would be required for foods and food ingredients produced from "genetically modified" maize and "genetically modified" soya beans. According to the proposed regulation, the presence in foods and food ingredients of DNA resulting from genetic modification would render that food no longer equivalent to its conventional counterpart and therefore labeling would be required. If the DNA has been destroyed during processing, the food would be considered equivalent as long as there is no protein present as a result of genetic modification. When labeling would be required under the proposed regulation, the words "produced from genetically modified soya" or "produced from genetically modified maize" should appear on the ingredient list or on the labeling of the food. If it is not definitively known if a food or food ingredient is produced from, or contains, genetically modified soya beans or maize, the words "may contain" or "may have been produced from" would be used.

  Current US policy does not require mandatory labeling of all genetically engineered (modified) foods and food ingredients or additives solely because of their means of production (i.e., because they are genetically engineered). Likewise, the US has not required labelling for other methods of plant breeding such as chemical—or radiation—induced mutagenesis, somaclonal variation, or cell culture. For example, varieties of sunflower and safflower have been developed through conventional mutagenesis to yield high levels of oleic acid. The oils from these varieties are labelled as "high oleic sunflower oil" or "high oleic safflower oil", respectively, the method of mutagenesis used to select the new varieties is not required to be included on the label. Similarly, oil derived from genetically engineered canola plants that have high levels of laurate is called "laurate canola", and the oil from genetically modified soybean plants modified to express high oleic acid content is called "high oleic soybean oil." Again, the method of development is not required to be disclosed on the label.

  The US does not believe that information based solely on the method of production would convey any meaningful information to consumers. As is the case for foods produced by other technologies, the US does require labeling of foods produced through modern biotechnology to denote significant changes in a food with respect to composition (e.g., nutritional content) storage, preparation or usage, and the presence of a new allergen. The US encourages industry to disseminate information concerning genetically engineered foods, but does not believe that labelling is the most practical way to provide access to such information, particularly for comingled commodities and processed foods containing material from different sources. The costs of applying such labelling would ultimately be borne by the consumer regardless of the level of their concern without providing any greater assurances of safety.

Labeling Requirements

  The proposed regulation states the necessity of establishing clear labeling rules that can be controlled on a "reliable, readily, repeatable practicable basis" and that common scientifically validated testing methods should be developed. In the proposed regulation, the Commission has stated that the labeling requirements should not be overly burdensome. The approach proposed in the regulation would be reconsidered as new scientific information is developed. Although we agree with these overall goals, we believe a number of issues addressed in the proposed regulation have a questionable scientific basis and are ambiguous and impractical.

  The proposed regulation considers the presence of DNA resulting from genetic modification to be sufficient for identifying a food as no longer equivalent to an existing food, using the approach taken in the European Parliament and Council Regulation on Novel Foods and Novel Food Ingredients under which a food would not be equivalent if its composition, nutritional value or intended use would be different from existing food. (see Paragraph 9 of proposed regulation). In doing so, a questionable link is made in the proposed regulations between labeling for scientifically based health reasons such as composition, nutritional value or nutritional effects and labeling that requires scientific methodologies be used purely for monitoring purposes. The presence of DNA "from genetic modification" does not by itself result in food no longer being equivalent to its conventional counterpart as described in paragraph 9 of the proposed regulation. The logical extension to this approach would be that any changes in DNA due to genetic manipulation (e.g., chemical mutagenesis, somaclonal variation) would result in food no longer being equivalent. The proposed regulation appears in reality to be using the presence of DNA from genetic modification for monitoring purposes to determine whether a food or food ingredient is in some way made from a genetically modified component.

  There are a number of practical questions that are raised by the proposal as well. The proposal does not address if and when tests would be required to determine if DNA (or protein) from genetic modification is present. It does not stipulate a standard test that would be used or the limits of detection for these tests. For example, under the proposal, a food would not have to be labeled if DNA has been destroyed by processing but the proposed regulation does not stipulate a limit of detection for determining whether DNA would be considered to be present in that food.

  There are a growing number of extremely sensitive tests for both protein and DNA. However, these tests are used primarily for research purposes and are not time efficient and are costly. In addition, in order to test for the presence of DNA or protein from genetic modification, it will be necessary to know what specific piece of DNA, or which protein, is being monitored. The variety and number of traits that are introduced into crops via modern biotechnology is increasing. As these agriculture biotechnology products enter the market, the complexity and difficulty of such testing will be greatly magnified. The end result is that most products would be labeled as "may contain" or "may be produced from" genetically modified soya or maize. As stated earlier in these comments, we question the relevance of information based purely on process as giving the consumer any meaningful information.

  The proposal also does not describe how the regulation will be enforced and how uniformity in this enforcement will be maintained among the member states. This lack of precise explanation could result in different levels of enforcement and specificity in any required monitoring. Such a lack of clarity will place an undue burden on producers when attempting to comply with the regulation.

  We urge the Commission to take the above points into account when finalising the proposed regulation. Without addressing these issues, we believe it will be extremely difficult for the Commission to implement a regulation that is scientifically based, predictable and transparent.

  US authorities regulate bioengineered products based on a determination of their safety to humans and the environment. In the United States, four federal agencies are responsible for ensuring the safety of bioengineered plants, animals, seafood, microorganisms, and the products obtained from them:

—  USDA/Animal Plant Health Inspection Service (APHIS)

—  Environmental Protection Agency (EPA)

—  Food and Drug Administration (FDA)

—  USDA/Food Safety Inspection Service (FSIS)

  Depending on the properties and intended use of a bioengineered plant, animal, seafood, microorganism, or product, one or more of these agencies is responsible for regulation or approval:

—  APHIS issues a "determination of non-regulated status" for the commercialization of bioengineered plants and pathogenic plant microorganisms that meet its safety criteria, with a particular focus on their environmental release (planting). In addition, APHIS issues permits and acknowledges notifications for field testing, importation, and inter-state movement of genetically engineered organisms. USDA has authority to prevent the introduction and dissemination of plant pests under the Federal Plant Pest Act and the Plant Quarrantine Act.

—  EPA approves bioengineered pesticides, bioengineered plants with pesticidal characteristics, and reviews "integeneric microorganisms" (formed by combining genetic material from microorganisms in different taxonomic genera) prior to activities related to commercialization. EPA focuses on food safety (tolerance levels) and the environment (target and non-target organisms). EPA regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Generally, before a pesticide may be sold, distributed or used in the United States, it must be registered under FIFRA. Under FFDCA, EPA is responsible for setting tolerances or exemptions from the requirement of a tolerance for pesticide residues in foods. EPA regulates intergeneric microorganisms under Section 5 of the Toxic Substances Control Act (TSCA). Before a new microorganism can be manufactured processed or imported for a commercial purpose, a notice must be submitted to EPA.

—  FDA regulates foods (except meat and poultry products), including fruits, vegetables, grains, fish, and shellfish, milk, and substances added to food such as vegetable oils, flavors, sweeteners, spices, and enzymes., Food additives, color additives, and new animal drugs require pre-market approval by FDA. FDA consultation is recommended for bioengineered foods. Additionally, FDA can take regulatory action against foods that are adulterated or improperly labeled. A food is considered adulterated, and unlawful, if it bears or contains an added poisonous or deleterious substance that may render the food injurious to health or a naturally occurring substance at a level that is ordinarily injurious.

—  FSIS approves the slaughter of research animals for meat for human consumption.

  The timeframe for approval of a bioengineered product depends on which agencies are regulating or being consulted. This normally ranges between 2 and 12 months, with an average product approval time of 6-8 months. APHIS expedites a determination of non-regulated status for organisms which are largely similar to organisms already granted such status. EPA decisions are normally made within 12 months from receipt of the application, but take 60 to 90 days in the case of applications for R&D and commercial use of intergeneric micro-organisms. However, product approval can be delayed if the application is incomplete or if more data is required to conclude the safety assessment.

BACKGROUND

  Since 1990, more than 25 agricultural biotechnology products have successfully progressed through the US regulatory system to commercialization into the marketplace. Some of these products are very familiar. For example, in 1990, FDA approved the commercial use of chymosin (rennet) produced from bacteria for use in making cheese and other dairy products. In 1994, the "flavr savr" tomato was first commercialized. In 1996, EPA approved the use of a genetically engineered Bacillus thuringiensis, a commonly used microbial pesticide. Other products approved in the United States represent technological advances in producing crops with new insect and disease resistances, other improved agronomic characteristics, and improved processing characteristics. In the last three years, the United States approved for commercial use insect resistant corn, cotton and potato; herbicide tolerant canola, cotton, soybeans and corn; delayed ripening tomatoes; and canola with a different oil composition.

  In the 1970s, the United States regulatory framework for agricultural biotechnology products initially focused on contained testing in laboratories and greenhouses with the publication of the "National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules" (NIH guidelines). As products moved from basic research and development to field testing and eventual commercial release, the United States government published the "Co-ordinated Framework for Regulation of Biotechnology" in 1986 to explain how the federal agencies would regulate research as well as commercialization.

  The Co-ordinated Framework takes a "vertical" or sectoral approach to the regulation of biotechnology products, including agricultural biotechnology products. Under this approach, biotechnology products are regulated, using existing statutes, as are other similar products. For example, biotechnology products that are food would be regulated by the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FFDCA), biotechnology products that are pesticides would be regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and FFDCA, and plant pests would be regulated by the United States Department of Agriculture (USDA) under the Plant Pest Act and the Plant Quarantine Act. In the Co-ordinated Framework, USDA, EPA, and FDA are identified as the primary regulatory agencies responsible for products of agricultural biotechnology. Under this framework, some products may be regulated by all three agencies and some may be regulated by one or two agencies.

  The basis of the Co-ordinated Framework was the belief that use of existing health and safety laws provided more immediate regulatory protection and certainty than was possible with new legislation specific to biotechnology. Moreover, there did not appear to be an alternative, unitary statutory approach because the broad spectrum of products obtained through genetic engineering cuts across many different types of products regulated by different agencies. The US Government believes that the new techniques of genetic engineering are an extension of biotechnology in general and, thus, new products developed through these techniques are extensions of existing product classes.

FOR MORE INFORMATION

  Detailed descriptions of procedures and contact information related to biotechnology can be obtained from the following US government websites:

APHIS:  http://www.aphis.usda.gov/oa/new/ab.html

EPA:  http://www.epa.gov/opptintr/biotech/index.html (for TSCA)

  http://www.epa.gov/pesticides/activity.htm#bio (for biopesticides)

FDA:  http://vm.cfsan.fda.gov/~lrd/biopolcy.html