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Ensuring safe food and Two views on food labeling

(May 15, 2002 CropChoice news) We are republishing the following two articles with the permission of the U.S. State Department.

Economic Perspectives: An Electronic Journal of the U.S. Department of State, Vol. 7, No. 2
Sally L. McCammon, Science Advisor, Animal and Plant Health Inspection Service, U.S. Department of Agriculture

The U.S. government, with more than 16 years' experience in evaluating biotechnology products, has instituted the most thorough and scientifically based regulatory system anywhere in the world, says Sally McCammon, chief scientist with the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. McCammon outlines the roles played by key U.S. regulatory agencies and their approach to food safety, and to ensuring that the most current scientific information is available to those regulatory bodies before any genetically engineered product is released in the U.S. market. Few food issues have raised as much interest, particularly internationally, as has the safety of genetically engineered foods. And few foods have been as thoroughly examined, dissected, tested, and regulated. The fact is that genetically modified foods developed in the United States have gone through the most intense regulatory and scientific review that exists anywhere in the world and would not be found in the U.S. marketplace unless regulators were completely convinced about their safety. This article reviews the U.S. regulatory process and the key agencies responsible for the safety of the U.S. food supply and consequently U.S. food exports.


In 1986 the White House issued the Coordinated Framework for the Regulation of Products of Biotechnology proactively establishing a strong commitment by the U.S. government to the safe development of biotechnology products from the laboratory, through field-testing and development, and into the marketplace. Over the last 16 years, the United States has gained considerable experience in evaluating the products of biotechnology for safety. The framework's underlying assumption is that the risks from the products of biotechnology are the same in kind as those of similar products -- risks to agriculture, the environment, and human health. Thus, existing U.S. laws and regulations for addressing these risks have been deemed adequate to address any risks posed by products developed using biotechnology, and no new "gene law" has been considered necessary.

To assure safety, the U.S. regulatory structure is based on risk rather than process, and its success is due to the fact that regulatory agencies with established credibility and expertise evaluate these products. Many aspects are evaluated when determining safety. Regulations establish procedures and criteria by which different types of products are evaluated, including those produced using biotechnology, products such as vaccines, plant varieties for food, pesticides, animal products, and pharmaceuticals. Certain products of modern biotechnology can easily be assessed under existing regulations, while other products require new regulations. The U.S. regulatory agencies that examine plants and plant products intended for use as food are the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) of the Department of Health and Human Services, and the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture (USDA-APHIS). A new genetically engineered plant could be reviewed by one or all three of these agencies, depending on the plant and trait engineered into it. For instance, a Bacillus thuringiensis Bt gene in a food crop would be reviewed by USDA-APHIS, EPA, and FDA; a plant with modified oil content for food would be reviewed by FDA and USDA-APHIS; and modified flower color in a horticultural crop would be reviewed by USDA-APHIS alone. It can take five years of field-testing, under USDA-APHIS oversight, for the developer of a new plant variety to evaluate the new line and to collect the data needed to pass through the regulatory system. Another two years may be needed for USDA-APHIS, EPA, and/or FDA to complete their reviews. Multiple agencies reviewing the same product from different perspectives provide a comprehensive system for assuring safety. The United States has built upon its experience using a science-based approach to evaluating other products to evaluate the products of modern biotechnology. Science-based means that the review of the product is done using scientific criteria relevant to that product. The approach is constantly evolving due to new types of products and the availability of new scientific information. Science is the basis by which regulatory officials can assure and build upon credibility, remain current, and assure a rational basis for decision-making. Science and the legal processes are inextricably linked for regulations that evaluate biological products.


Under the authority of the Plant Protection Act, USDA-APHIS regulates the development and field-testing of genetically engineered plants, microorganisms, and certain other organisms. USDA-APHIS regulations provide procedures for obtaining permission to release (field test), import into the country, or move interstate within the United States. After several years a developer may petition USDA-APHIS for non-regulated status. The USDA-APHIS review process evaluates agricultural and environmental safety issues. Particular attention is paid to evaluating any changes in agronomic characteristics of the new plant line. Although usually not related to the change intended, such unintended changes could impact food safety as well as agricultural and environmental safety. Fortunately, over 98 percent of these "off-types" are discarded by developers early in the development process. Only the healthiest and well-characterized lines survive the selection in the subsequent development process and are sent to regulators for evaluation. To date 53 petitions have been granted and almost 8,000 permits and notifications issued for field-testing at almost 30,000 sites. Although no petitions have been denied, 21 have been withdrawn due to insufficient information or other inadequacies in the application.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA sets tolerance limits for substances used as pesticides on and in food and feed, or establishes an exemption from the requirement of a tolerance if such a tolerance is not necessary to protect the public health (determined after evaluation by the agency). EPA's responsibility is to ensure the safety of pesticides, both chemical and biological, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by regulating the distribution, sale, use, and testing of plants and microbes producing pesticidal substances. Both EPA and USDA-APHIS review many transgenic plants for agricultural and environmental effects.

EPA issues experimental use permits for field-testing of "pesticidal" plants and registrations for commercialization of these plants. The Bt toxin, which occurs naturally in soil bacterium, is considered a biological pesticide. or plants containing Bt toxin, the manufacturer must prepare a resistance management plan as a condition for registration with the EPA. The plan describes how the manufacturer registering the plant product will assure that resistance does not build up in affected insect populations and reduce the effectiveness of Bt applied topically or used through the plant's genetics. EPA also evaluates the new use of herbicides on herbicide-tolerant transgenic plants, while USDA-APHIS evaluates the herbicide-tolerant plant. FDA assesses the food (including animal feed) safety and nutritional aspects of new plant varieties as part of a consultation procedure published in the 1992 Statement of Policy: Foods Derived From New Plant Varieties. FDA expects developers of new plant varieties to consult with the agency on safety and regulatory questions under the authority of the FFDCA. FDA policy is based on existing food law and requires that genetically engineered foods meet the same rigorous safety standards as are required of all other foods. The FDA biotechnology policy treats substances intentionally added to food through genetic engineering as food additives if they are significantly different in structure, function, or amount from substances currently found in food. Many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already in the diet and thus do not require pre-market approval. Although the FDA system currently is voluntary, every new plant line that is commercialized in the United States has been evaluated by the FDA through this consultation process. In public meetings held in 2000 no concerns with the substance of the FDA review were voiced for those products already reviewed by FDA. In 2001 FDA proposed to make this review mandatory, and it is currently studying the almost 100,000 comments received before finalizing this rule. The FDA's assessment includes evaluating the composition of major nutrients and levels of toxicants that many plants produce naturally, and determining potential for allergenicity, particularly assessing whether the inserted genes are from allergenic sources. Also evaluated is whether a new method of food preparation must be used as a result of the genetic change, or whether the food is changed so that it is unrecognizable. The food safety issues addressed assess whether the food is safe and wholesome. If there is any material change to the food, then labeling is required.

Labeling of food in the United States must be truthful and not misleading. To provide guidance to developers of food involving genetic engineering, the FDA also provided draft guidance in 2001 on Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering. Transparency is built into the U.S. system at every step, beginning with the initial passage of laws by Congress, and public input is important to assuring that concerns are addressed. Regulations developed to implement these laws consider all public comments before the regulations are finalized. Public comment is also invited for decision documents such as environmental assessments and future evaluations.

Comprehensive field-tests, petition databases, and U.S. regulations and regulatory decisions are accessible at http://www.aphis.usda.gov.


Science informs the decision-making process of U.S. regulators at many levels. Regulators evaluating specific products use the available published scientific literature, particularly from peer-reviewed journals. Applicants cite this literature in their applications for regulatory approval. The U.S. National Academy of Sciences (NAS) or other parts of the scientific enterprise may be asked to identify the scientific issues and recommend approaches to evaluating particular types of products. Meetings of scientists can be called to address specific issues, as have past meetings on Bt, viral recombination, and relevant biological factors for evaluating crop plants. Information can even be requested on specific products. The EPA meets with its scientific advisory panels. The FDA refers questions to its Food Advisory Committee. Recently, the NAS reviewed the scientific underpinnings of the regulatory decisions made by USDA. The USDA also has a Risk Assessment Grants Program that specifically funds research on emerging issues with genetically engineered organisms. Regulators use all of this information to assure that the most current approaches and information are available to inform regulatory decisions.


Internationally, the appropriate scientifically based standards, guidelines, and recommendations for evaluating the food safety of transgenic products as they move into the international marketplace are being developed by the representatives of national governments in the ad hoc Intergovernmental Codex Task Force on Foods Derived From Biotechnology under the Codex Alimentarius. The first international Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants as well as the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, both currently in draft status, are slated for adoption in 2003 by the Codex Alimentarius Commission. These standards are a milestone in agreement on the approaches to assuring food safety of the products of modern biotechnology.

Economic Perspectives: An Electronic Journal of the U.S. Department of State, Vol. 7, No. 2

Few food issues have elicited as much controversy as has labeling. While all agree that consumers around the world should have accurate information about the nutritional content of their food, the exact nature of what food labels should include is at the heart of international negotiations within the Codex Alimentarius Commission -- a joint body of the Food and Agriculture Organization and World Health Organization charged with reaching common agreement on key food safety issues.

Two opposing views follow to provide a full picture of the shape of the discussion in the United States. Ellen Matten, international policy analyst in the U.S. office of Codex, argues that labels that show the country of origin of individual ingredients of food would be burdensome -- particularly for developing country exporters -- and provide no additional safety benefits to consumers. She also suggests that labels on genetically engineered foods, where there is no evidence that the composition, nutritional value, or intended use of the food has been altered, have the potential to be perceived by many consumers as a warning that the product is unsafe. Kristin Dawkins and Neil Sorensen of the Institute for Agriculture and Trade Policy say that the lack of information on the long-term health effects of genetically engineered foods argues for mandatory labeling.


Ellen Matten, International Policy Analyst, U.S. Codex Office International trade in food increased dramatically in the 20th century. At the same time, countries independently adopted different sets of food laws and standards, giving rise to trade barriers that have been of increasing concern to food traders.

The Codex Alimentarius Commission (Codex) was created in 1962 by two United Nations organizations -- the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) -- as a result of these concerns. Organizers felt that if all countries harmonized their food laws and adopted internationally agreed standards, such issues would be dealt with naturally. Through harmonization, they envisaged fewer barriers to trade and a freer movement of food products among countries, which would benefit farmers and their families and help reduce hunger and poverty. Codex has become the major international mechanism for encouraging fair international trade in food while promoting the health and economic interests of consumers. Codex has special relevance to the ever-expanding global food market. The advantages of having universally uniform food standards to protect consumers are evident.

The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT) both encourage the international harmonization of food standards. A product of the Uruguay Round of multinational trade negotiations, the SPS agreement cites Codex standards, guidelines, and recommendations as the preferred international measures for facilitating international trade in food. Codex standards have become the benchmarks against which national food measures and regulations are evaluated within the legal parameters of the Uruguay Round Agreements. The Codex Alimentarius Commission established the Codex Committee on Food Labeling in 1965. The commission recognized that food labeling is the primary means of communication between the producer and seller of food on one hand, and the purchaser and consumer on the other. The committee tackles tough issues where multiple labeling regimes may cause barriers to trade. Issues currently before the committee include country of origin labeling, labeling of foods derived from modern biotechnology, and misleading food labels.


Many countries have a "country of origin" labeling requirement for food products sold in their country. In the existing Codex General Standard for the Labeling of Prepackaged Foods, there is a requirement for country of origin labeling where its omission would mislead or deceive the consumer. Most countries, including the United States, already have in place regulatory requirements for country of origin labeling of food.

Discussions are currently taking place in the Codex Committee on Food Labeling (CCFL) about whether to expand current requirements and mandate that country of origin labeling include labeling ingredients of composite foods. Some countries feel this would be burdensome, impractical, and provide no additional benefit to the consumer. And there is no evidence to warrant these changes because of food safety concerns.

Expanding country of origin labeling requirements beyond the origin of the food to the food's ingredients is particularly troublesome to some countries, including the United States.

Ingredients may be sourced from suppliers in different countries during different times of the year or from multiple countries and then commingled. Variations in ingredient availability as well as quality affect usage and manufacturing decisions by food companies. Ingredient manufacturers, brokers, and food processors and manufacturers would be required to segregate ingredients from different countries in order to ensure proper compliance with ingredient origin labeling requirements and to maintain a myriad of labels to correspond to every possible mix or combination of sources of ingredients. This would be particularly burdensome for less developed countries.

Because of this, work on international harmonization of rules of origin has been under way for several years in the World Trade Organization (WTO), with technical assistance from the World Customs Organization, as part of the WTO Agreement on Rules of Origin concluded in 1994.

Existing international trade rules under the WTO Agreement on Technical Barriers to Trade prohibit technical regulations -- including labeling requirements -- from creating unnecessary obstacles to international trade. Regulations may not be more restrictive than necessary to fulfill certain identified legitimate objectives. Expanded mandatory country of origin labeling requirements would most likely create an unnecessary obstacle to trade with no legitimate or internationally recognized justification.


Perhaps the most complex and controversial labeling issue in the international arena is the labeling of foods derived through modern biotechnology. Within the Codex Committee on Food Labeling there appears to be consensus that labeling is needed for foods derived from modern technology when there are significant changes in composition, nutritional value, or intended use and it is important to provide such information to consumers. The CCFL has achieved a consensus on the labeling of allergens in foods derived from modern biotechnology and believes that such provisions provide considerable assistance to and protection for consumers. However, there is no consensus among Codex countries about a mandatory process-based labeling of foods derived from modern biotechnology.

Some countries believe that a mandatory process-based label on genetically engineered food may be perceived by many consumers as a warning label that the product is unsafe, and therefore could be misleading and inappropriate as a mandatory international guideline. Foods derived from biotechnology are not inherently less safe than other foods.

These same countries are concerned that the text of draft guidelines the committee is developing fails to address the practical implications that must be considered by countries before mandatory process-based labeling is implemented. More specifically, the text fails to address many technical matters that are as yet unresolved and are potentially problematic in the implementation of such labeling. The United States believes that the CCFL should more carefully and more thoroughly explore and consider the numerous and potentially problematic implications of any process-based labeling before recommending such an approach for an international standard.


Consumers around the world increasingly have access to new food products and information about food. While this is generally positive, it has raised concerns that consumers could be mislead by food labels. This topic is very important to Codex because of the potential for misleading food labels to adversely affect both consumer health and food trade. Truthful but misleading communications may lead consumers to make incorrect inferences. Both the presence and absence of information are relevant to whether labeling is misleading.

The influence of culture is particularly important in understanding why consumers in different countries interpret identical communications differently. Culture can be defined as the values, preferences, and acceptable rules of behavior of a group - such as people within a country or region -- that are handed down from one generation to the next. Cultural differences influence the type of inferences, if any, that consumers make when they process a label statement, symbol, or image. Therefore, a communication may result in misleading inferences in one culture but not in another. For example, consumers in one culture might perceive terms such as "premium" and "best" to imply superior quality, while consumers in another culture might disregard such terms because they view such statements as typical promotional exaggerations.

Misleading communications often involve statements, symbols, or images that are literally true but lead consumers to make false inferences. The interpretation of misleading claims may be affected by factors such as culture, knowledge and education, and label characteristics. A label that is misleading to one group or culture may not be misleading to another. Labels can be misleading because a material fact has been omitted, confusing language or symbols are used, consumers make incorrect inferences to an attribute that is the subject of a claim, consumers make incorrect inferences to unmentioned attributes, or an endorser is improperly used. Misleading representations on the food label can be prevented, for example, by requiring additional information, by establishing standards, or by prohibiting representations that are judged inherently misleading. In the future, Codex and the CCFL will continue to elaborate recommendations, guidelines, and standards in the area of food labeling in response to their mandate to improve communications between food producers and sellers, and purchasers and consumers.

Perhaps then some barriers to trade will be removed and a freer movement of foods among countries will take place, which will be of benefit to farmers and their families and help reduce hunger and poverty.


By Kristin Dawkins, Vice President, and Neil Sorensen, Program Associate, Institute for Agriculture and Trade Policy

The United States has long been the world's preeminent leader in the development of food safety laws and regulations. In 1902 the U.S. Congress appropriated money to study the effects of chemical preservatives and colors on digestion and health. Public support for federal food and drug laws has been growing ever since.

In 1906 President Theodore Roosevelt signed the Wiley Act, making it illegal to distribute any mislabeled or adulterated foods or drugs. In 1943, in U.S. v. Dotterweich, the U.S. Supreme Court ruled that the responsible officials of a corporation and the corporation itself may be prosecuted for violations of food and drug laws. The 1954 Federal Food, Drug, and Cosmetic Act established the Delaney Clause, which banned pesticide residues or food additives that had been found to be carcinogenic in animals. President John F. Kennedy in 1962 called on Congress to develop a Consumer Bill of Rights that included the right to safety, the right to choose, the right to be heard, and the right to be informed. In 1966 the United States passed the Fair Packaging and Labeling Act, requiring that all consumer products in interstate commerce be honestly and informatively labeled. With respect to conventional foods, the Food and Drug Administration has effectively implemented this law.

The significance of U.S. leadership in food safety issues should not be underestimated, nor should the role of the United States as the world's leader and innovator in sound policies toward biosafety and consumer protection be diminished. Now more than ever, the United States should follow the path it inaugurated long ago and institute the most comprehensive and stringent regulations possible to protect the health and safety of every American, and ultimately of everyone in the world.


With advances in agricultural biotechnology, it would behoove the United States to enhance existing food regulations and launch across-the-board pre-market safety testing, labeling, and traceability requirements for all food products and animal feed. We are at the threshold of a new era in which scientists have broken the boundaries of life forms and can extract, add, and manipulate genetic information in infinitely conceivable ways. With these abilities comes an even greater responsibility to ensure that adequate protections for the food supply are maintained and to limit the possibility of any negative consequences that may result from the introduction of foreign genetic material. If we choose not to track the inputs and constitution of food and feed, we will not be able to correct potentially dangerous outcomes or determine sources of contamination, let alone comply with the Fair Packaging and Labeling Act.

The Codex Alimentarius Commission is the body responsible for compiling the standards, codes of practice, guidelines, and recommendations that constitute the "food code" -- or Codex Alimentarius -- for the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations. The commission recommends that the "presence in any food or food ingredients obtained through biotechnology of an allergen" from soybeans, milk and milk products, and many other foods known to be allergenic be labeled as such. The commission also recommends that genetically modified foods be subject to risk management considerations in accordance with the draft Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology before consideration for commercial distribution.

The standards for safety assessment are characterized by a comparison between bioengineered whole foods or their components relative to the traditionally cultivated varieties. The standards attempt to take into account both intended and unintended effects to identify new or altered hazards and changes in key nutrients. Risk management practices should, the draft standards say, at a minimum include the verification of conclusions about the absence or the possible occurrence, impact, and significance of potential consumer health effects, and should monitor changes in nutrient intake levels to determine their human health impact.

Further, the Codex Draft Guidelines for the Conduct of Food Safety Assessment of Foods Derived From Recombinant DNA Plants states that "animal studies cannot readily be applied to testing the risks associated with whole foods, which are complex mixtures of compounds, often characterized by a wide variation in composition and nutritional value."

The guidelines continue to say that "detecting any potential adverse effects and relating these conclusively to an individual characteristic of the food can therefore be extremely difficult."


In stark contrast to the draft Codex guidelines, the U.S. Food and Drug Administration (FDA) performs safety testing only on animals, particularly mice. The resulting information is used to justify the doctrine of substantial equivalence, which, according to a 1992 Federal Register notice, means that the FDA regulates bioengineered foods by applying rules identical to those governing plants developed by traditional plant breeding. A joint FAO/WHO report by the Expert Consultation on Foods Derived from Biotechnology in June 2000 defined substantial equivalence much differently. The report's authors concluded that the notion of substantial equivalence is only a starting point, and that "further safety assessment will be focused on establishing the safety of the differences in the new product such that the safety of the food can be established."

In 2001 the European Union (EU) abandoned the doctrine of substantial equivalence, opting for more stringent scientific risk assessment. Actions to be carried out by the new European Food Authority now cover environmental risk and human and animal health and safety, and its opinions will be shared with the public for comment. The EU then has a democratic procedure by which a majority of member states within the European Food Safety Authority Regulatory Committee vote to authorize or refuse a product.

The FDA's Voluntary Labeling Guidelines indicate that more than 50,000 comments about its policy regarding the safety and labeling of bioengineered foods have been received, and the vast majority of the comments are in favor of mandatory disclosure of genetically modified foods. The guidelines dismissed concern about the possible long-term consequences of bioengineered foods on health and the environment, concluding that "the comments were mainly expressions of concern about the unknown." That being said, the FDA's strategy for safety assessment and risk management has not attempted to substantiate the material facts of bioengineered foods and food safety. Furthermore, the FDA claims that "appropriately validated testing methods are not currently available for many foods," when, in fact, rapid quantitative tests are now common and inexpensive.

Many major U.S. trading partners have instituted labeling regimes for genetically modified foods and feed. Most notably, the European Union and China will require labeling and stringent traceability requirements, threatening the livelihoods of U.S. farmers and businesses who have already suffered as a result of the lack of regulatory oversight of biotechnology.


In sum, the United States should adopt a comprehensive pre-market safety testing, labeling, and traceability regime for bioengineered foods and feed to protect the health and safety of its citizenry and the environment and to ensure continued trade with our major economic partners. The United States has the responsibility to continue its leadership role in the development of sound policies for food safety around the world. In the case of genetically modified foods, the United States is quickly falling behind.

The doctrine of substantial equivalence should be abandoned, and the safety assessment and risk management strategies contained in the draft principles and guidelines of the Codex Alimentarius Commission should be formally adopted by the U.S. government and expanded upon.

Note: The opinions expressed in the article by Kristin Dawkins and Neil Sorensen do not necessarily reflect the views or policies of the U.S. Department of State.