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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.
ENSURING SAFE FOOD
May 2002
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.
THE U.S. REGULATORY FRAMEWORK
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.
THE REGULATORS' ROLES
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.
A SCIENCE-BASED REGULATORY APPROACH
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.
CODEX ALIMENTARIUS
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.
TWO VIEWS ON FOOD LABELING
May 2002
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.
FOOD LABELING IN CODEX ALIMENTARIUS
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.
COUNTRY OF ORIGIN LABELING
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.
LABELING OF FOOD DERIVED FROM MODERN BIOTECHNOLOGY
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.
MISLEADING FOOD LABELS
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.
******
LABELING AND TRACEABILITY OF BIOENGINEERED FOODS
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.
ENSURING ADEQUATE PROTECTIONS
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."
THE FDA AND SUBSTANTIAL EQUIVALENCE
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.
PRESCRIPTION FOR THE UNITED STATES
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.
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