Mike Wehr has his bags packed. His tickets are bought, his hotel reservations
confirmed, and all other necessary arrangements made. Wehr is about to leave
the country, again. Last year alone he was out of the United States a half dozen
times. He went to Belgium and Australia twice, and to Japan and Brazil once.
In the near future, Wehr expects to go back to each of those countries once
and perhaps to Hungary as well. In all, he is on the road at least 60 days a
year on official U.S. government business.
Wehr's mission is simple: to help make the world's food safe to eat here in
the United States regardless of where it is planted, produced or packaged. He
is one of a small but growing number of Food and Drug Administration employees
who work with international standards-setting institutions, multinational health
and trade organizations, and government and private agencies in other countries
around the world.
And it's a changing world. In the past, FDA focused most of its food safety
efforts within the U.S. borders, where it has legal authority. But changes in
trade, consumer demand for variety, and an increasingly complex regulatory system
have created new challenges for the agency. On one hand, the FDA Modernization
Act, passed in 1997, requires the agency to cooperate with other countries and
international institutions. On the other, FDA often finds that U.S. standards
and rules differ from those of other developed countries. Meanwhile, FDA works
with developing countries to help them understand and meet U.S. standards for
foods and agricultural products they export to the United States.
"It's a very different landscape for this agency than it was five or six years
ago," says Wehr, one of FDA's representatives on food issues to Codex Alimentarius,
an international standards-setting group based in Rome. "There has been a fundamental
change in the importance [of international food safety issues to FDA]. We have
to be part of the international arena. That is a new role for us. It is a role
that continues to evolve every day."
New Ways To Work Together
Even at home, FDA cannot act alone on international food issues since other
governmental agencies play major roles, including the U.S. Departments of Agriculture,
State and Commerce, the Environmental Protection Agency, and the Office of the
U.S. Trade Representative, among others. Further, all federal activities involving
Codex are managed within USDA's Food Safety and Inspection Service (FSIS).
As much as anything else, consumer demand drives these changes, especially
the shifts in where American companies and consumers get their food. "Food has
become a global commodity," says Janice Oliver, deputy director of FDA's Center
for Food Safety and Applied Nutrition (CFSAN). "We Americans have changed our
eating habits. We used to eat whatever was grown locally and in season, and
only one or two varieties of anything. Today, food is international. It is from
Central and South America or Europe or the Asian countries or the islands of
More than ever before, Americans can buy more imported foods at local grocery
stores and supermarkets, adds Linda Horton, director of FDA's international
agreements staff, because of improved ways of packaging and preserving food,
and more rapid means of transporting it. That, she says, means American consumers
"can get anything from anywhere at almost any time."
to USDA's Economic Research Service, Americans are eating more imported foods
than ever before. So much so that imports of processed foods rose 5.8 percent
in 1998, the last full year for which complete records are available. The estimated
value of food imports in 1998 hit $32 billion, a new U.S. record. Moreover,
food imports exceeded exports in 1998 by $2.6 billion, the first U.S. agricultural
trade deficit since 1991.
The numbers for individual commodities are even more striking. Sixty-two percent
of all fish, fish products and shellfish eaten by Americans, for example, came
from abroad in 1997. That's up from 45 percent in 1980.
Similarly, Americans ate almost half again as much fresh fruits from other
countries in 1997 as in 1980, up from 24 to 34 percent. Imported fresh vegetables
accounted for more than 10 percent of vegetable consumption in 1997, compared
with 5.4 percent in 1980. And foreign-grown wheat totaled 10.4 percent of the
American diet in 1997, up from 0.4 percent 20 years ago.
As a result, FDA is more involved in foreign trade issues now than ever, says
Catherine Carnevale, director of CFSAN's office of constituent operations. To
ensure that the food Americans eat is safe to consume, the agency inspects imported
food and refuses entry to unsafe, adulterated or mislabeled products, using
the same standards as for domestic food. Under the evolving international rules,
FDA now certifies that American-made seafood and dairy products sold abroad
meet the importing country's requirements and are the same products as those
sold in this country.
Whatever the specific role, FDA's focus remains on safety. "We are here to
protect American consumers," Carnevale says. "Our goal is to improve the safety
of all foods consumed in the United States." Similar aims drive U.S. Department
of Agriculture policies. "We have legislative mandates to set standards and
encourage trade in food products, but safety comes first," says Catherine Woteki,
USDA's undersecretary for food safety. "All agencies of the U.S. government
are unanimous that a science-based health and safety policy is our paramount
guiding principle. Fair trade will follow."
But neither FDA nor USDA can inspect every food package brought into the United
States. " We don't have the resources to examine all imported products or to
inspect most overseas production facilities," FDA's Horton says, adding, "We
have very porous borders. We need to work with those who export food to the
United States [to make sure it's safe leaving those countries]. Cooperating
with them is one way of protecting American consumers and promoting public health
A Codex Consensus
That brings the issue back to Codex, the object of Mike Wehr's many foreign
travels. The Codex Alimentarius Commission, as it is formally known, was created
in 1962. It is jointly run by two United Nations groups, the World Health Organization
(WHO) and the Food and Agricultural Organization (FAO). As its name--Latin for
"food code"--suggests, Codex sets international standards of identity for agricultural
products and food commodities, and determines safety standards for food additives
and contaminants and for veterinary drugs. By the end of 1999, Codex's 165 member-countries
had agreed on maximum safe limits for 1,300 food additives, 197 pesticides and
25 contaminants. Codex had also set 204 food standards, completed 54 veterinary
drug evaluations, and adopted 43 codes of practice.
Codex exists, Wehr says, because countries have long argued over agricultural
trade. Most have traditionally sought to protect their farmers, growers and
ranchers by a system of tariffs that imposed duties on and raised the cost of
imported food. Since the signing of the General Agreement on Tariffs and Trade
(GATT) in 1948, however, the world's tariffs have generally declined and even
have been eliminated for many industrial and agricultural products. The creation
of regional trading blocks such as the European Union (EU) and the North American
Free Trade Association (NAFTA) has further lowered food duties within these
But, as tariffs have come down, other technical or safety issues have sometimes
replaced them as barriers to free trade in agricultural and food products. The
EU, for example, banned exports of beef products from Great Britain to the rest
of Europe in 1996 for fear of spreading bovine spongiform encephalopathy (BSE),
or "mad cow" disease. More recent concerns have included the potentially carcinogenic
chemical dioxin that was found in egg products from Belgium, the use of growth-promoting
hormones in animals raised for their meat in the United States, and EU rules
requiring the labeling of food grown using the new techniques of genetic engineering.
Because of increasingly complicated trade negotiations arising from the creation
of the World Trade Organization in 1993, Codex's role in international food
safety issues "has been consciously elevated," FDA's Wehr says. From a little-known
group focused on what were often seen as narrow commodity issues, he adds, overnight
Codex "became the standard ... [and] its standards will be difficult to get
While Codex's standards are voluntary, Wehr says, "It is to our country's advantage
to work with Codex and to follow its standards." Individual countries do not
have to adopt them, and countries can also implement stricter standards than
Codex if they can scientifically justify a higher level of protection. But countries
that do not follow Codex or that lack justification for stricter food standards
could lose any trade dispute over food brought before the World Trade Organization,
The Biotech Dilemma
Most issues that come before Codex are highly arcane and of little interest
to the general public. Some, however, may directly affect not only the safety
of the food that reaches the American dinner table, but also the practices of
U.S. processors and growers. Food produced using modern biotechnology is a good
example. American companies have pioneered methods using genetic engineering
to alter a plant's genes to improve yields or provide greater resistance to
insects, fungus or disease. But, since many people in Europe fear the unknown
consequences of genetic engineering, the European Union has enacted rules to
require labeling that identifies imported foods produced by biotechnology. Some
U.S. officials fear that such rules could be used to keep American food out
of European markets.
"We do not regulate food manufacturing processes unless the process matters,"
says Eric Flamm, an FDA senior policy advisor. "Biotechnology alone does not
make a food safe or unsafe." Genetic engineering would have to introduce into
plants a potentially dangerous allergen, change the nutritional content of a
food, or require different handling, storage, cooking or preservation to warrant
On this issue, USDA policy parallels FDA's. "Biotechnology-produced foods are
regulated as foods," food safety official Woteki says. "If the process introduces
a significant change in the food, that change must be stated on the label."
That position may be correct under U.S. law, says James Maryanski, CFSAN's biotechnology
coordinator, but it leaves the United States increasingly isolated in a world
apparently poised to adopt stricter regulation of biotech foods. While the number
of countries that have given serious consideration to the question of labeling
is still small, only a few other countries support the U.S. position.
Resolving the biotechnology debate within Codex will continue to be a complex,
cumbersome, and long, drawn-out process. The issue has been before Codex since
the mid-1990s. A drafting group met in India in October to prepare a document
that would give countries several approaches to labeling from which to choose.
The next full committee meeting is not scheduled until April 2001. "The deadlock
is very frustrating," says USDA's Woteki. "We may have to change our negotiating
Toward that end, last spring FDA announced plans to strengthen premarket reviews
of biotechnology-produced foods. FDA is developing a proposed new rule that
will require manufacturers to notify the agency at least 120 days before they
put on the market foods and animal feeds derived from genetically engineered
plants. Under the new rule, once it has reviewed a company's submission, FDA
will issue a letter regarding the regulatory status of the product involved.
The agency will also help guide manufacturers who want to, or are required to,
label their biotechnology products for foreign markets.
Learning to be Cautious
Meanwhile, biotechnology is not the only international food issue to involve
FDA or to create a split between the United States and the European Union. The
"precautionary principle" has similarly sparked debate among policy makers here
and abroad. The precautionary principle, as defined in February 2000 by the
EU Commission, would ban, require additional labeling, or otherwise restrict
the use of any food if the science to determine its safety or level of risk
is judged to be uncertain.
"Scientific uncertainties cannot serve as an excuse for decision-makers to
do nothing," says Bernard Chevassus-au-Louis, president of the French Agency
for Food Safety. "Science is not always predictive," Chevassus adds. "It is
too often too late. It often underestimates the evidence for risk. The use of
the precautionary principle is not a denial of science, but a call for more
FDA and USDA officials disagree. The precautionary principle "would require
another level of risk management based on 'what ifs,'" says FDA's Carnevale.
"There may not be any evidence that [a food] poses any hazard, despite the scientific
uncertainty. Precaution is a part of our food safety process. It is embedded
throughout our decision-making, not an add-on for politicians."
The United States is not opposed to European countries adopting the precautionary
principle, Carnevale adds, so long as it is not directed solely against foods
they import from the United States. Many Americans are concerned that the French
could use it, she says, to restrict imported meat from cattle in the United
States that were fed growth hormones, when, for example, French health agencies
have so far been unwilling to apply the same principle to Listeria monocytogenes
in French cheeses. The use of raw milk--which is a known source of the bacterium
Listeria--to manufacture fresh and soft cheese is of particular concern
to FDA. Listeriosis in pregnant women can result in miscarriage, fetal death,
and severe illness or death of a newborn infant. Others at risk for severe illness
or death are the elderly and those with weakened immune systems.
FDA and USDA are also concerned because the European Union has asked Codex
and the Organization for Economic Cooperation and Development (OECD) to endorse
the precautionary principle. OECD is an organization of the United States and
other developed countries. "The European Union is doing the right thing in discussing
the precautionary principle," Woteki says, "but it is premature to recommend
that it be adopted for all countries. Countries with strong laws and regulations
with a strong element of caution in them have no need for a precautionary principle."
Unfortunately, not all countries have strong food safety rules or the resources
to adopt and enforce them. Yet, for many developing countries, exporting food
and agricultural products is key to their economies. Unless they can meet standards
set by FDA, FSIS and EPA, however, they may have trouble exporting food to the
United States. To help resolve that problem, FDA has designed programs to help
developing countries understand and meet U.S. requirements. "We may not be able
to get developing countries to our level [of safety]," Carnevale says, "but
we can get them to a higher level."
All food imports, however, must meet FDA safety standards before they can come
into the United States.
FDA sponsored multi-agency seminars in Mexico City and Santiago, Chile, in
September 1999 and in New Zealand for Pacific Rim and island countries in August
2000. The effort is part of the Food Safety Initiative, a multi-agency program
launched by the White House aimed at reducing the incidence of foodborne diseases.
The seminars involve experts from FDA, USDA, EPA, the Centers for Disease Control
and Prevention, and the State Department. Their job, CFSAN's deputy director
Oliver explains, is to help government officials, food exporters, and academics
in other countries understand U.S. requirements. "We tell them what we expect
so they can meet our standards and keep the food we import safe," she says.
Additionally, FDA sponsored a "train-the-trainers" session, also held in Santiago,
Chile, last year. That weeklong session targeted mid-level government officials,
representatives of growers' associations, and others in a position to train
farmers in good agricultural and food handling practices. "We hope to take elements
of our safety program and adapt it to their local conditions," says Camille
Brewer, CFSAN's international coordinator for the Food Safety Initiative. Additional
sessions are planned for Brazil and Trinidad and Tobago.
"We are operating more and more in a complex global environment," Wehr says
of FDA's continuing involvement in international food issues. "It's not clear
yet how these issues will play out. But the decisions that Codex and other international
institutions make will drive U.S. and FDA policies. These are big issues for
FDA and for agriculture, industry and consumers."