of Food Safety and Labeling Standards
Threats and Opportunities for the U.S.
Food and Drug Administration and the U.S.
Department of Agriculture
Center for Science in the Public Interest
The Center for Science in the Public Interest (CSPI), a non-profit consumer organization
headquartered in the United States, was formed in 1971. CSPI's twin missions are to conduct
innovative research and advocacy programs in the areas of health an nutrition, and to provide
consumers with current, useful information about their own health and well being. CSPI is
supported almost entirely by more than 900,000 subscribers to its Nutrition Action
Center for Science in the Public Interest
1220 L St. N.W., Suite 300
Washington, D.C. 20005
Tel: (202) 332-9110
Fax: (202) 265-4954
This report was prepared by Bruce Silverglade, director of legal affairs, Leila Farzan, senior staff
attorney, and Cassandra Soltis, research assistant.
TABLE OF CONTENTS
PART I - LEGAL FRAMEWORK
A. The Uruguay Round Agreement
B. The Role of Codex under the SPS Agreement
PART II - THREATS TO U.S. HEALTH AND SAFETY REGULATIONS
A. The U.S. May Be Forced to Accept Imports of Unpasteurized Dairy Products
1. Background of the U.S. Regulation of Unpasteurized
Milk and Milk Products
2. Codex Considers Permitting the Sale of Unpasteurized
B. The U.S. May Be Forced to Permit the Importation of Foods Containing
Additives Not Approved as Safe by the FDA
1. The FDA Approval Process for Food Additives
2. The Role of the Codex Alimentarius and the Codex
General Standard on Food Additives
3. The Risks of Harmonizing Food Additive Safety on an
C. The U.S. May Be Forced to Permit Imports of Mineral Water Not Meeting the
FDA's New Bottled Water Standard
2. Codex Considers Weaker Standard
D. The U.S. May Be Forced to Accept the Importation of Meat and Other
Foods Not Inspected as Strictly as Domestic Food Products
E. The U.S. May Be Forced to Accept Imported Food Products Containing
Lead Levels Exceeding FDA Standards
1. Background Regarding Lead Contamination of Food in
the United States
2. Codex to Set Maximum Levels for Lead in Food Items
PART III - OPPORTUNITIES FOR RAISING DOMESTIC HEALTH AND SAFETY
STANDARDS TO INTERNATIONAL LEVELS
A. Dietary Supplements
B. Nutrition Claims for Foods Containing Trans Fatty Acids
PART IV - CONCLUSIONS AND RECOMMENDATIONS FOR THE U.S. GOVERNMENT
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA)
are increasingly participating in international activities intended to harmonize food safety and
labeling regulations on a worldwide basis. The activities of the FDA and USDA may have
significant implications for health and safety regulation in the United States. In numerous cases,
international standards-setting activities may lead to pressure on the U.S. to lower domestic health
and safety regulations to international levels that would provide American consumers less
protection than they now receive. In a few cases, international harmonization activities may
provide opportunities for the FDA and USDA to raise U.S. standards to international levels that
would afford American consumers greater protection than they are currently provided.
Part I of this report explains how and why U.S. regulatory agencies participate in international
standards-setting proceedings involving food safety and labeling by examining the legal
framework for such activities. Part II examines how such activities may place pressure on the
U.S. government to lower health and safety protections in key areas such as dairy pasteurization
and meat inspection. Part III analyzes opportunities for the FDA and USDA to utilize
international standards-setting activities to improve domestic health and safety rules in areas such
as dietary supplement regulation. Part IV of this report concludes that both threats and
opportunities to the welfare of American consumers are created by the participation of FDA and
USDA in efforts to harmonize food safety and labeling regulations and makes recommendations
for ways in which the U.S. government can optimize its participation in such international forums.
PART I - LEGAL FRAMEWORK
A. The Uruguay Round Agreement
The General Agreement on Tariffs and Trade (GATT) is a multilateral agreement that establishes
general rules for international trade and seeks to reduce both tariff and non-tariff trade barriers.
The U.S. government has been a signatory to GATT since its creation in 1947. The first six
rounds of GATT trade negotiations (1947-1975) were devoted exclusively to reducing tariffs.
But as the trade restrictive effect of non-tariff measures became more apparent in the 1970s,
GATT began to shift its focus to non-tariff barriers, such as quotas, import restrictions, and
The Uruguay Round of GATT lasted more than seven years (1986 to 1993) and constituted the
largest trade negotiations in world economic history. In 1994, Congress adopted implementing
legislation for the new GATT and enacted the Uruguay Round Agreements Act.
The Uruguay Round focuses as never before on non-tariff barriers to trade. For example, two of
the Uruguay Round agreements, the Agreement on the Application of Sanitary and Phytosanitary
Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT), have a direct bearing
on the regulation of food safety and labeling. The thrust of both agreements in the area of food
regulation is to encourage nations to support the development of international food safety and
labeling standards and to adopt such standards as domestic requirements, thus easing the flow of
food products across borders. The SPS Agreement urges nations to harmonize food safety
standards, such as food additive regulations, pasteurization requirements, and meat inspection
procedures. The TBT Agreement urges nations to harmonize technical regulations, including
packaging, marking, and labeling requirements, such as nutrition labeling and the minimum
mineral content in mineral water.
The Uruguay Round Agreement enhances the legal effect of GATT by providing that the
Agreement is binding on all World Trade Organization (WTO) members. This provision reflects a
shift from past rounds where parties to GATT could selectively choose which agreements to
The Uruguay Round Agreement also establishes a procedure by which a nation may bring a
complaint before the WTO and challenge a WTO member's regulation. In such cases, the WTO
establishes a Dispute Settlement Body (DSB) to hear challenges and issue rulings determining
whether the regulation of a particular nation constitutes an improper restriction on trade. The
DSB, which generally consists of three trade ministers selected by the WTO, meets in proceedings
closed to the public. If the DSB finds that a regulation violates the SPS or TBT Agreements, and
hence constitutes an illegal trade barrier, a nation must abide by the decision or face
WTO-ordered trade sanctions, such as higher tariffs or other punitive measures.
B. The Role of Codex under the SPS Agreement
Codex is a subsidiary body of the Food and Agriculture Organization (FAO) of the United
Nations and the World Health Organization (WHO). Codex develops international food safety
and quality standards, such as standards concerning the safety of food additives. Standards set by
Codex traditionally served as a minimum floor for less developed countries. The U.S. has
participated in Codex since its formation in 1962 and has shared its technical expertise in efforts
to aid less developed countries.
The SPS Agreement designated the Codex Alimentarius Commission as one of the sources for
recognized international standards for use in resolving trade disputes between nations.
Regulatory requirements of a nation that are based on Codex standards are presumed to be
consistent with the SPS Agreement. Regulatory requirements that exceed Codex standards may
be challenged as trade barriers.
As a result, Codex standards now carry legal significance within the United States because other
countries may challenge any U.S. regulatory standard as a trade barrier if the standard exceeds
those set by Codex. Thus, due to the Uruguay Round Agreement, the Codex Alimentarius
Commission has obtained unprecedented influence over U.S. food safety and quality standards.
Threats to U.S. regulations are already being made in the context of Codex proceedings. For
example, a number of Codex standards -- each of which is significantly weaker than current U.S.
regulatory requirements -- are slated for consideration by the full Codex Commission which meets
in June 1997 in Geneva, Switzerland. If they are finalized by the full Codex Commission, the
standards would carry a presumption of validity in trade disputes brought under the SPS
Agreement. While the SPS Agreement permits nations to have different standards if they are
scientifically justified, an interim WTO decision has interpreted this provision narrowly.
The TBT Agreement also requires governments to use relevant international standards as a basis
for their technical regulations. Thus, technical regulations that are in accordance with
international standards are presumed to be in compliance with the TBT Agreement. A technical
regulation that is not in accordance with international standards may be found to violate the TBT
Agreement if another measure is reasonably available to the government that fulfills the
government's legitimate objectives and is significantly less trade-restrictive.
As a result of objections by consumer and environmental protection organizations made towards
the end of negotiations on the Uruguay Round Agreement, a number of provisos were added to
the SPS Agreement before it was finalized. For example, the SPS Agreement purportedly
reaffirms the right of countries to take unilateral measures to protect human, animal, and plant life
and health. In this regard, health-related regulations that exceed Codex standards may be
permitted if there is a scientific justification, or as a consequence of the level of protection a
Member determines to be appropriate. Similarly, in the TBT Agreement, if international
standards are an ineffective or inappropriate means to fulfill the government's legitimate
objectives, a nation need not use them.
However, the SPS Agreement also states that in determining the appropriate level of sanitary or
phytosanitary protection, other factors should be taken into account including the overall
objective of minimizing trade effects, the special needs of developing countries, and any risks to
which consumers voluntarily expose themselves.
The White House Office of the Special Trade Representative has taken the position that the fact
that a sanitary or phytosanitary measure differs from a relevant international standard...does not,
in itself, create any adverse presumption concerning that measure. The U.S. also contended that
the SPS Agreement would not authorize a dispute settlement panel to substitute its scientific
judgment for that of the government imposing the sanitary or phytosanitary measure and states
that the SPS Agreement preserves the ability of governments to make such judgments. The
Special Trade Representative has made similar assurances regarding the TBT Agreement.
Unfortunately, the position of the U.S. is simply not binding in international forums. The U.S. is
just one of many nations who participate in the international arena and thus the U.S. government
is in no position to provide assurances to American consumers on how any provision of the SPS
or TBT Agreements will likely be applied in particular cases.
Thus, most consumer groups in the United States, and around the world believe that the SPS
provisions will lead to downward harmonization of national standards. The SPS Agreement itself
does not specify what level of scientific evidence is adequate to demonstrate consistency with the
agreement, which country carries the burden of proof, or whether a WTO dispute resolution panel
can substitute its scientific judgement for that of a member country.
It is a general tenant of statutory construction, however, that ambiguous provisions of a law are
to be construed in accord with the law's overall purpose. The overriding purpose of the SPS and
TBT Agreements are to facilitate trade by harmonizing regulatory requirements on an
international basis. Given the overarching purpose of the agreements, the U.S. government can
provide no real assurances to American consumers that FDA and USDA regulations will not be
Moreover, a recent report issued by the WTO confirms such fears. In May 1997, the WTO issued
an interim report in response to a complaint by the U.S. regarding the European Communities'
(EC) ban on imports of beef treated with growth hormones. The report stated that the
complaining party bears the burden of proof of presenting a prima facie case of inconsistency with
the SPS Agreement. Thus, the complaining party must present factual and legal arguments that, if
unrebutted, would demonstrate a violation of the SPS Agreement, i.e., that there is an
international standard with respect to the measure in dispute and that the measure in dispute is not
based on this standard.
The burden then shifts to the responding party to demonstrate that the measures in dispute meet
the requirements imposed by the SPS Agreement, i.e., that the measures are based on a risk
assessment in accordance with Article 5 of the Agreement. In order for the measure to be
considered as based on a risk assessment, the responding party must provide evidence that it
actually took a risk assessment into account when it enacted or maintained its sanitary measure.
The report concluded that the EC did not satisfy this burden and that the EC measures were
therefore inconsistent with the SPS Agreement. The report recommended that the DSB request
the EC to bring its measures into conformity with its obligations under the SPS Agreement.
Given this analysis provided in the WTO's interim report, it is likely that other regulations that are
not in conformity with international standards will be similarly challenged. For this reason, public
interest organizations continue to express concern that the SPS and TBT Agreements will exert
pressure on the U.S. government to accede to a lowering of domestic health and safety
regulations that exceeded the level of protection provided by international standards. It has now
been three years since the enactment of the Uruguay Round Agreements Act, and it is time to
examine whether such pressure is being exerted on the FDA and USDA and whether those
agencies are taking advantage of opportunities presented by international regulatory proceedings
to improve domestic health and safety standards.
PART II - THREATS TO U.S. HEALTH AND SAFETY
Current activities of the Codex Alimentarius raise serious threats to many domestic health, safety,
and consumer protection regulations. This report examines the impact of the SPS and TBT
Agreements in five areas:
- Pasteurization of dairy products
- Mineral content of bottled water
The Codex commission is scheduled in June to approve, or recommend for final approval,
standards in all of those areas. In each case, the Codex standard falls below existing FDA and
USDA regulatory requirements. The threat to American consumers is thus real and imminent.
A. The U.S. May Be Forced to Accept Imports of Unpasteurized Dairy Products
1. Background of the U.S. Regulation of Unpasteurized Milk and Milk Products
In 1987, the Food and Drug Administration (FDA) issued a final regulation requiring all milk and
milk products in interstate commerce to be pasteurized. 21 C.F.R. Sec. 1240 (1996). FDA
banned the interstate shipment of unpasteurized milk and milk products because of the
overwhelming evidence that such foods were the cause of serious disease outbreaks.
Unpasteurized (raw) milk is a vehicle for outbreaks of campylobacteriosis, salmonellosis, and a
myriad of other human pathogens that may cause serious or fatal illness. Since 1952, 49 of 53
milkborne disease outbreaks reported in the Centers for Disease Control's Morbidity and
Mortality Weekly Report were associated with raw milk. Many of those outbreaks resulted in
serious illness and death.
2. Codex Considers Permitting the Sale of Unpasteurized Dairy Products
In 1996, over the objections of the FDA personnel representing the U.S., the Codex Committee
on Milk and Milk Products (CCMMP) approved seven dairy standards, none of which requires
pasteurization. The CCMMP, in accordance with Codex practice, then asked the Codex
Committee on Food Hygiene (CCFH), which is chaired by the U.S., to endorse the standards.
Because of the controversial nature of these standards, the CCFH was also asked to consider a
U.S. proposal, which read: Pasteurization, or an equivalent measure approved by the official
agency having jurisdiction, shall be used in order to achieve the appropriate level of public health
France and other European members of the two Codex committees strongly opposed the U.S.
proposal. Certain cheeses made from raw milk have been traditionally sold in France and other
European countries. However, the U.S. had strong support from several other nations that
recognized the level of protection that pasteurization provides. After intense discussions, CCFH
decided to proceed and forward the dairy standards to the full Codex Commission for final
approval. The CCFH did not approve the amendments favored by the U.S., but also did not
specifically endorse the standards for final approval by the full Codex Commission.
The U.S. delegation expressed reservations regarding CCFH's decision. In its reservation, the
U.S. stated that the public health protection benefits that pasteurization provides had been
scientifically established, internationally recognized, and were irrefutable. The Delegation of
France also expressed reservations, stating that the common hygiene provisions provided
adequate health protection without pasteurization.
In June 1997, the full Codex Commission will meet in Geneva, Switzerland and decide whether to
approve the milk product standards without the endorsement of the CCFH. Unless the U.S.
mounts a successful international lobbying campaign, the full Codex Commission may very well
give final approval to the dairy standards. If final approval is given, any European dairy company
could demand that the FDA allow the import of unpasteurized cheese into the U.S. If the FDA
refuses to allow such imports to enter the U.S., a trade complaint could be filed with the WTO.
The burden would then be on the FDA to demonstrate why U.S. requirements for pasteurization
are justified. Since FDA could not carry this burden even in the context of a Codex Committee
which it chairs, it is possible that the agency would not be able to convince a WTO dispute panel
consisting of three trade ministers of the merits of the U.S. regulation.
B. The U.S. May Be Forced to Permit the Importation of Foods Containing Additives Not
Approved as Safe by the FDA
1. The FDA Approval Process for Food Additives
Since 1958, the Food, Drug and Cosmetic Act has required that all new preservatives, thickening
agents, sweeteners, stabilizers, and other substances added to food be either approved by the FDA
as safe prior to marketing or be considered generally recognized as safe (GRAS). This system has
been relied on to assure the safety of additives in the U.S. for almost four decades.
When the FDA proposes to approve a new additive, or proposes to affirm that a substance is
GRAS, it publishes a notice of proposed rulemaking in the Federal Register and provides the
public with an opportunity to comment. This process of notice and comment is vital to ensuring
the safety of additives because public health experts, physicians, scientists, consumer groups and
others are given an opportunity to bring to the FDA's attention information of which the agency
may not be aware. For example, in the early 1980s the FDA published a Federal Register notice
proposing to affirm as GRAS a family of preservatives known as sulfiting agents. During the
public comment period, the agency was alerted to medical journal reports indicating that sulfites
could be dangerous to asthmatics. The FDA eventually limited the use of sulfites based on this
information. This system of notice and comment is thus an integral part of the FDA's process for
determining the safety of additives.
2. The Role of the Codex Alimentarius and the Codex General Standard on Food
The Codex Committee on Food Additives and Contaminants is in the process of drafting a
General Standard on Food Additives (GSFA) that will list all additives in use around the world
that Codex considers safe. The draft GSFA presently lists more than 170 additives as safe that
have not been approved or considered GRAS by the FDA.
The Codex Committee on Food Additives and Contaminants met in the Netherlands in March
1997 and decided to submit a large portion of the draft GSFA additives to the full Codex
Commission for final approval in June. The Committee has proposed that all of those additives be
permitted for use in accordance with Good Manufacturing Practices (GMP). In other words, no
specific limits on their use in specific foods would be required. The FDA, however, does not
permit some of those additives to be used simply in accordance with GMPs. For example, one
ingredient on this list, sorbitol, is approved for limited use by the FDA. Furthermore, the agency
requires foods that contain sorbitol to have a statement on the label to inform consumers that
excess consumption of the product may have a laxative effect. The Codex committee has not
proposed such a warning on the use of this additive.
The committee also proposed to allow the use of other additives that the FDA has not approved
for any purposes. In some cases, the FDA has received a petition from a food company asking
the agency to approve the use of an additive on the GSFA, but the additive in question is still
under investigation by the agency, presumably because issues relating to safe use of the additive
have not been resolved.
Before supporting approval of the GSFA, the FDA should systematically examine the safety of all
additives not approved for use in the U.S., as well as additives that the Codex committee has
approved for use in accordance with GMPs, but for which the FDA allows to be used only under
specified conditions. Furthermore, the American public should be given an opportunity to
comment on whether such additives should be approved for use in the United States before the
FDA supports the adoption of the GSFA.
3. The Risks of Harmonizing Food Additive Safety on an International Scale
The U.S. may be forced to accept imported foods that contain additives considered by Codex to
be safe even though those substances have neither been approved by the FDA nor are considered
by the agency to be GRAS. In some cases the U.S. may even be forced to accept the importation
of foods containing additives listed in the Codex GSFA that have been banned by the FDA.
If the FDA attempts to stop the importation of products that contain additives listed as safe in the
Codex GSFA, then the exporting country could file a complaint with the WTO. The FDA, in
consultation with representatives of the Office of the U.S. Special Trade Representative, would
then be forced to defend its position on scientific grounds. Under American law, the process is
exactly the opposite -- the party that wishes to add a substance to food must demonstrate to the
FDA why the substance should be considered safe.
The FDA would have an especially difficult time convincing a WTO dispute panel that a U.S.
prohibition of an additive listed in the Codex GSFA was proper because the FDA, to date, has
participated fully in all Codex committee meetings and has not objected to the listing of any of the
additives in the draft GSFA. Moreover, the FDA has actually recommended that the Codex
Committee of Food Additives delete from the draft General Standard a list of substances
prohibited in various countries, thus eliminating any reference in the Codex standard to U.S. laws
If the WTO panel found that the FDA's restriction on an additive approved by Codex was not
justified, the U.S. would be found in breach of the SPS provision of the GATT code. The U.S.
would then have to review the safety of the additive and change its standard to that of Codex or
face retaliatory trade measures. Under pressure from the White House Office of the Special
Trade Representative and Congress, it is certainly possible that the FDA would choose to change,
and possibly lower, its standards to international levels rather than permit U.S. companies to face
retaliatory trade measures.
C. The U.S. May Be Forced to Permit Imports of Mineral Water Not Meeting the FDA's
New Bottled Water Standard
Over the past several years, the bottled water industry has grown tremendously. But until 1996,
bottled-water labeling was often misleading and inconsistent. Definitions of terms like spring
water varied from state to state. Some bottled waters were labeled mineral water, even though
they had a lower mineral content than many tap waters. About 25 percent of all bottled water
came from the same municipal supplies that deliver water to people's kitchen and bathroom sinks,
but bottlers were not required to convey that fact to consumers.
After years of protest by consumer organizations, a Congressional hearing, a petition from the
International Bottled Water Association, and the submission of more than 400 public comments,
the FDA announced new regulations for bottled water on November 13, 1995.
The regulations, which became effective May 13, 1996, established a standard of identity for
bottled water and brought mineral water under existing quality standards for bottled water. The
regulations also required that mineral water contain a minimum amount of minerals and that the
label inform consumers if the mineral content is high or low. Unfortunately, recent international
developments may threaten to overturn those new regulations.
2. Codex Considers Weaker Standard
In June 1997, the full Codex Commission will consider adopting a new international standard for
mineral water. This draft standard was recommended by the Codex Committee on Natural
Mineral Waters over the objections of the U.S.
The Codex draft standards are weaker than the FDA regulations in several areas. For example,
the standard allows mineral water to contain as much as 0.01 milligrams/liter of lead. 21 C.F.R.
165.110(b)(4)(iii)(A). During Committee discussions, the U.S. expressed the view that this level
was too high. The U.S. delegation of FDA employees noted that in the case of children, this level
would correspond to a significant proportion of their provisional tolerable weekly intake and
proposed to reduce it by half in order to minimize the risk.
The Codex draft standard also does not require that mineral water contain a minimum amount of
minerals. In the U.S., mineral water must naturally contain at least 250 parts per million (ppm)
total dissolved solids (TDS) because this is the level at which minerals begin to impart a particular
taste to the water. The FDA stated that a minimum requirement is necessary to ensure that when
consumers purchase a product labeled as mineral water, the product contains minerals at a level
that justifies calling the product by that name.
The Codex Committee also failed to require a label notification when the mineral level was
relatively low or high. In the U.S., if the TDS content of mineral water is below 500 ppm, the
statement low mineral content must appear on the principal display panel (PDP). If the TDS of
mineral water is greater than 1,500 ppm, the statement high mineral content must appear on the
PDP. The FDA concluded that this information is important to consumers because the mineral
content of mineral water may vary greatly, and because the high and low ends of the range of
mineral contents may have a significant bearing on the characteristics of the water.
In addition, the Codex draft uses the term natural to distinguish mineral waters that naturally
contain minerals from mineral waters which result from the addition of minerals.
In the U.S., the FDA requires that all minerals be naturally occurring -- no minerals may be added.
Notwithstanding those inadequacies, the full Codex Commission may give final approval to the
Codex Committee's bottled water standard. If final approval is given, any European mineral
water company can demand that the FDA allow the import of its product into the U.S., even if the
product contains trivial levels of added minerals and twice the lead content of U.S.-produced
water. If the FDA refused to allow such imports to enter the U.S., a trade complaint could be
filed with the WTO. The burden would then be on the FDA to demonstrate why its rule is
justified. Since FDA could not carry this burden even in the context of a Codex committee
discussion, it is possible that the agency would not be able to convince a WTO dispute panel of
the merits of the U.S. regulation. Accordingly, consumer protection rules may be sacrificed to
international trade obligations.
D. The U.S. May Be Forced to Accept the Importation of Meat and Other Foods Not
Inspected as Strictly as Domestic Food Products
The United States has required government inspection of meat for almost a century. Recently,
President Clinton announced a new food safety initiative to improve further the safety of our meat
and other food products.
At about the same time, the Codex Committee on Import and Export Food Inspection and
Certification Systems was drafting guidelines for the Design, Operation, Assessment and
Accreditation of Food Import and Export Inspection and Certification Systems. The proposed
guidelines attempt to set out criteria by which nations can determine whether inspection systems
for meat and other food products used by an exporting country are equivalent to those of the
country that is receiving imported foodstuffs. In making this determination, the proposed
guidelines state that [e]valuations of inspection and certification systems carried out by the
authorities of the importing country should take into account other relevant inspections already
validly carried out by self-evaluation or by competent third-party evaluations in the exporting
country. The proposed guidelines therefore contemplate that an inspection system of a nation
that relies on self evaluation and/or non-governmental third-party evaluations (i.e., inspections
paid for by a food producer) may be equivalent to U.S. inspection requirements that are based on
mandatory inspections by government personnel.
U.S. law, however, has long been based on the premise that food safety inspection systems that
rely on self-evaluations, or evaluations by a third party, create conflicts of interest and are not
equivalent to food safety inspections conducted by government personnel. In light of this
problem, the U.S. opposed finalization of the guidelines and urged the Codex committee to allow
further deliberation before proceeding to the final stage of the Codex approval process. The U.S.,
however, was unsuccessful and the guidelines are now scheduled for adoption by the full Codex
Commission in June.
Final adoption of the Codex guidelines would be particularly inappropriate as the USDA and the
FDA have recently begun to implement new stricter domestic inspection systems for meat, poultry
and seafood. Moreover, federal agencies have not yet had an opportunity to review public
comments on the criteria that should be used to judge whether an inspection system of a foreign
country is equivalent to our own. Should the Codex guidelines be approved in their present form,
the U.S. could find itself in the untenable position of being forced to accept imports of meat and
other products that have been inspected under regimes weaker than those now employed in the
Such results would be detrimental to the health of Americans, and ironic given that the President
has recently called the public's attention to improvements in U.S. meat inspection requirements
and has stated that the Administration is further committed to improving domestic food safety
programs. In light of such statements by the President, few Americans would expect that federal
agencies are engaged in international deliberations that could lead to our country being forced to
accept imported food products inspected under much weaker systems than our own. That result,
however, may occur unless the U.S. is successful in urging the full Codex Commission to reject
E. The U.S. May Be Forced to Accept Imported Food Products Containing Lead Levels
Exceeding FDA Standards
1. Background Regarding Lead Contamination of Food in the United States
Since the 1930s, FDA has taken steps to reduce the public's exposure to lead because excessive
exposure can cause severe health problems. Lead toxicity can damage the nervous system, red
blood cells, and the renal system. Lead exposure to children and infants, who are particularly
susceptible to lead toxicity, has been associated with decreased intelligence, slower
neurobehavioral development, and damage to the central nervous system.
Lead enters the bloodstream mainly through the food we eat. The primary source of lead in food
used to be from the use of lead-soldered cans in the packaging and holding of food. However, in
1991, U.S. can manufacturers voluntarily stopped using lead-soldered cans because of the harm
associated with lead exposure. In 1995, the FDA promulgated a regulation prohibiting the use of
lead-soldered cans by U.S. manufacturers and prohibiting the importation of food items contained
in lead-soldered cans.
Other rules have been issued to eliminate or significantly reduce the amount of lead in food. In
1996, the FDA prohibited the use of tin-coated lead foil capsules on wine bottles because lead
becomes a component of wine when poured from the bottle or stored for an extended period of
time. In 1994, the agency required decorative ceramicware, which may leach hazardous amounts
of lead into food, to have a stick-on label stating that it is not for food use.
In 1973, the EPA issued regulations that gradually reduced the content of lead in leaded gasoline,
and in 1996 it issued regulations that prohibit the use of gasoline which is produced with any lead
additive or which contains more than 0.05 grams of lead per gallon. Lead particle emissions from
motor vehicles polluted not only the air, but also the ground from which we obtain many of our
foods; consequently, many crops contained lead.
Due to the FDA's regulations on lead-soldered cans, tin-coated lead foil capsules, and decorative
ceramic ware, the EPA's regulations on leaded gasoline, and related public health efforts, the
amount of lead in our food supply has been reduced significantly.
2. Codex to Set Maximum Levels for Lead in Food Items
The Codex Committee on Food Additives and Contaminants (CCFAC) has proposed acceptable
levels for lead in various food items. There are no equivalent U.S. regulations that set maximum
levels of lead. Rather, the FDA monitors the amount of lead in food by periodically conducting
lead tests and taking appropriate enforcement actions when the amount of avoidable lead exceeds
typical background levels.
Unfortunately, other countries have not taken the necessary steps to ensure that lead is removed
from their food supply. While most countries, except some less-developed nations, have banned
the use of lead-soldered cans, several nations still use outdated manufacturing equipment that
allows lead to leach into food. Moreover, not all countries have banned leaded gasoline.
The proposed Codex standards for maximum lead levels in food may benefit countries that have
not eliminated such avoidable sources of lead in their food supplies. However, the proposed
Codex standards would allow significantly higher levels of lead in food than American consumers
are now exposed to.
For example, according to the FDA's Total Diet Study, 85% of food samples tested had less than
20 ppb of lead. However, most of CCFAC's proposed draft maximum levels for lead are higher.
For instance, the maximum level of lead allowed in fruit juice is 100 ppb, in leafy vegetables
(except spinach) is 300 ppb, and in crustaceans is 1000 ppb.
Additional comparisons between FDA policy and the draft Codex maximum lead level standards
illustrate the disparity between the FDA and Codex. In 1993, the FDA announced emergency
action levels for lead in food packaged in lead-soldered cans to protect young children and infants
from high lead exposure until the pending rulemaking to prohibit the use of lead-soldered cans
was completed. The FDA's emergency action level was 80 ppb for fruit beverages packed in
lead-soldered cans. However, the permanent standard proposed by Codex for all fruit juices is
Lead levels in milk and infant formula in the United States rarely exceed 5 ppb. In contrast, the
proposed Codex standard would permit milk and milk products to contain up to 20 ppb of lead.
The FDA has urged the Codex committee to reduce its proposed maximum lead levels. Such
efforts have had only limited success. One barrier to persuading the CCFAC to reduce maximum
lead levels further is the inability of less developed Codex member nations to test for levels of lead
in food below 100 ppb. For this reason, the FDA has failed to advocate lower maximum lead
levels in some cases.
Allowing higher levels of lead in food will only increase the chances that American consumers will
develop health problems as a consequence of lead exposure. Research shows that in utero
exposure to low levels of lead in maternal blood can affect fetal neurobehavioral development,
gestational age, and birth weight. Furthermore, even low blood lead levels in adults have been
associated with a significant elevation in blood pressure, which may in turn increase the incidence
of hypertension-related diseases.
If the Codex standard is finalized, the U.S. could refuse to accept any food that contains lead
levels higher than those now tolerated by the FDA. However, the exporting country could take
its dispute to the WTO. The burden then would shift to the FDA to demonstrate that its
regulations are based on a valid risk assessment and scientifically justified. This would be difficult
for the FDA to demonstrate, especially since it has not formally objected to the draft Codex
standard, and instead has worked to accommodate other member nations and reach a consensus
among committee members. If the FDA could not carry this burden, the regulations would be
found to be in violation of the SPS Agreement.
PART III - OPPORTUNITIES FOR RAISING DOMESTIC
HEALTH AND SAFETY STANDARDS TO INTERNATIONAL
The U.S. is not the leader in every area of food safety and consumer protection. In some cases,
other nations have instituted requirements that provide consumers with a greater degree of
protection. In such instances, harmonizing standards upwards would provide opportunities for
the FDA and USDA to improve the public health. Unfortunately, those agencies have not taken
advantage of such opportunities. This situation is illustrated by the actions of the FDA in the
Codex Committee on Nutrition and Foods for Special Dietary Use.
A. Dietary Supplements
The Codex Committee on Nutrition and Foods for Special Dietary Use (CCNFSDU) at a meeting
in Bonn-Bad Godesberg, Germany in October 1996, undertook the issue of how to protect
consumers from hazards associated with unconventional herbal medicines marketed as health
foods or dietary supplements.
The FDA has been grappling with this same problem since 1994, when Congress passed the
Dietary Supplement Health and Education Act (DSHEA). That Act limited the FDA's authority
to require supplement manufacturers to demonstrate that herbal products or other dietary
supplements were safe prior to marketing. The FDA opposed the legislation as it made its way
through Congress and after its enactment, then FDA Commissioner Dr. David Kessler made
numerous public statements about the law's inadequacies and the difficulties the FDA faced when
trying to restrict the sale of hazardous supplements. In the two years following the passage of the
DSHEA, more than a dozen deaths involving dietary supplements containing herbs were reported
to the FDA.
In light of similar problems in other countries, the Codex committee decided to develop a
guidance document on the sale of potentially harmful herbs and botanical preparations sold as
foods. The United States, however, represented by FDA employees, opposed the development of
guidelines or standards for herbal products. The U.S. delegation told the Committee that herbal
medicines in the U.S. are regulated as dietary supplements pursuant to the DSHEA, and need not
be reviewed for safety or approved by the FDA prior to marketing. The U.S. delegation,
however, did not fully inform the committee about the difficulties that the FDA has had trying to
restrict the sale in the U.S. of harmful herbs such as ephedra, chaparral, comfrey, and other
The proposal by Canada to prepare a list of hazardous herbal supplements created an opportunity
for the FDA to protect the American public by supporting the development of an international list
of harmful herbal substances and then urging that U.S. laws and regulations be harmonized with
international standards. Inexplicably, the FDA failed to take advantage of this opportunity. It is
noteworthy that the U.S. delegation to the Codex committee meeting did contain numerous
observers from U.S. trade associations and pressure groups representing the viewpoint of the
dietary supplement industry, but did not contain a single observer from any U.S. consumer
B. Nutrition Claims for Foods Containing Trans Fatty Acids
In 1992, the FDA finalized regulations governing the use of nutrition claims like no cholesterol
and low fat. The FDA regulations required that foods which claim to have no saturated fat
must also contain fewer than 0.5 grams of trans fatty acids, which also raise blood cholesterol
levels. The FDA did not require, however, that foods making low saturated fat claims also
contain low amounts of trans fatty acids, or that foods claiming to be reduced in saturated fat
also have limited levels of trans fatty acids.
Health experts and consumer organizations complained to the FDA and urged the agency to
revise its rules. In support of their position, they cited intervention trials and epidemiological
studies that provided convincing evidence that both trans fat and saturated fat raise cholesterol
levels and the risk of heart disease. Several food industry trade associations and individual food
companies, however, filed comments with the FDA opposing any changes to the agency's
Subsequently, at the October 1996 meeting of the Codex Committee on Nutrition and Foods for
Special Dietary Uses, the same issue was being discussed in the context of developing an
international standard for nutrition claims. The government of Malaysia urged the committee to
support proposals to include trans fat as a component of saturated fat for the purpose of making
nutrition claims. This proposal was in line with what U.S. consumer groups and many health
experts had urged the FDA to do, was consistent with the FDA's own policy on saturated fat
free claims, and if approved by Codex, could have provided an impetus for the FDA to
harmonize U.S. regulations with international standards.
The FDA, however, opposed the recommendation by Malaysia, even though the agency's own
regulations for saturated fat free claims already acknowledged implicitly that both saturated fats
and trans fats raise cholesterol levels and the risk of heart disease. The FDA stated:
The United States believes that the establishment of any criteria related to trans fatty acids in
nutrition claims or any action to require that trans fatty acids be declared on the label or as a
component of saturated fat would be premature.
Again, the presence of numerous food industry observers within the U.S. delegation and the
absence of consumer group representatives may explain the behavior of FDA personnel in this
PART IV - CONCLUSIONS AND RECOMMENDATIONS FOR
THE U.S. GOVERNMENT
Threats to basic U.S. regulatory standards requiring pasteurization of dairy products, limiting lead
contamination of food, mandating government inspection of meat, setting standards for bottled
water, and protecting consumers from unsafe food additives are being made in the context of
proceedings of the Codex Alimentarius. The FDA has stated in the Federal Register that
improving public health is the agency's paramount consideration when participating in Codex and
other international proceedings. Similarly, the USDA has stated that [f]ood production practices
all over the world have been upgraded as a result of Codex standards. This report, however,
demonstrates that U.S. participation in such proceedings may cause public health concerns to be
weighed against international trade obligations. Indeed, USDA has recently stated that [t]he
makeup of U.S. Codex should reflect a balance between trade and regulatory perspectives.
In 1995, the U.S. Codex office, headquartered within the Food Safety and Inspection Service of
USDA, issued the U.S. Codex Strategic Plan. The plan made five recommendations:
1. The scientific basis for Codex decisions should be
2. The management of the Codex Alimentarius should be
3. Codex should use U.S. approaches to risk management.
4. Balanced non-governmental participation in Codex proceedings should be
5. The staffing and budget for the U.S. Codex office should be
This five-point strategic plan has failed to prevent the problems described in this report. Recently,
a new strategic plan was announced. While the new plan calls for greater participation of
non-governmental organizations (NGOs) in Codex proceedings, and better training of government
participants in the Codex process, the plan does not adequately address the concerns raised in this
report. The FDA and USDA should therefore review the following recommendations and modify
the government's strategic plan to incorporate the following principles:
Most Codex proceedings operate by consensus. FDA and USDA employees have traditionally
worked with representatives of other member nations on a collegial basis to facilitate the
development of final Codex standards. In many situations, the U.S. supported Codex committee
decisions calling for the finalization of standards weaker than those set by FDA or USDA. This
procedure may have made sense when the U.S. was simply providing technical expertise to Codex
in order to benefit less developed countries that had no health or safety standards at all.
However, this approach to Codex proceedings no longer serves the interests of the United States.
U.S. delegations to Codex proceedings should be instructed to officially object to the
development of any Codex standard that falls below U.S. regulatory requirements.
- U.S. government employees participating in Codex proceedings should be instructed not
to agree to Codex standards that are weaker than U.S. regulations.
The new U.S. strategic plan calls for USDA and FDA employees who participate in Codex
proceedings to determine whether acceptance of a Codex standard would affect the health and
safety of American consumers. This action, however, is only a first step towards making the
Codex process work in the interest of consumers. The plan must mandate that FDA and USDA
employees not only ascertain when Codex standards fall below U.S. requirements, but also object
to the approval of such standards by Codex.
If the U.S. cannot successfully block the development of final Codex standards that are weaker
than FDA and USDA regulatory requirements, then it should make a concerted effort to record its
position in the minutes and reports of Codex proceedings to establish a record that clearly
demonstrates why the U.S. believes the Codex standard does not accord sufficient protection to
consumers. The most effective way of establishing such a record is for the U.S. delegation to call
for a vote on standards that fall below U.S. regulatory requirements and to file dissenting views in
situations where the U.S. does not prevail. The building of such a record will help discourage
potential trade complaints and serve as a basis for a defense before the WTO should any
complaints be brought.
- Build a record to defend against potential trade complaints based on Codex standards
that are weaker than U.S. regulatory requirements.
The U.S. should take a more proactive role in determining what items are placed on the agendas
of Codex committees. For example, the Codex Committee on Food Labeling has recently
considered setting a Codex standard for nutrition labeling of foods. The United States and Israel
are the only nations in the world that currently have requirements for mandatory nutrition labeling
of foods. Thus, it is unlikely that any standard for nutrition labeling produced by Codex would
include a mandatory nutrition labeling requirement.
- Instruct U.S. delegations to Codex committee meetings to object to the addition of new
agenda items that could lead to a weakening of U.S. regulatory requirements.
If a Codex standard is developed, and does not call for mandatory nutrition labeling, other nations
will be able to use the Codex standard as a basis for a complaint to the WTO alleging that the
U.S. requirement for mandatory labeling constitutes a barrier to trade. It is thus in the best
interest of the U.S. to oppose the consideration of a Codex standard for nutrition labeling.
The new U.S. strategic plan calls on USDA and FDA to help Codex improve its priority setting
process, but does not address the more important problem of how the placement of certain issues
on the Codex agenda may undermine U.S. health and safety standards.
The U.S. Codex office is currently located within the Food Safety Inspection Service of the U.S.
Department of Agriculture. Most of the work of the Codex Alimentarius, however, involves
regulatory matters that fall under the FDA's jurisdiction. Thus, the functions of the U.S. Codex
office should be transferred to the FDA.
- Move the U.S. Codex office from USDA to FDA
This step would also help ensure that public health protection remains at the top of the agenda of
the U.S. Codex office. Unlike the FDA, the USDA's mission includes promoting the sale of U.S.
agricultural products abroad. This dual mission -- protecting the health of American consumers
and also promoting the development of U.S. agricultural exports -- often creates conflicts of
interest where trade objectives compete with public health goals.
The SPS and TBT Agreements accord legal status to all Codex standards and guidelines, even
though Codex guidelines, in most cases, were not intended to be binding standards. Thus, the
U.S. should urge Codex to create a process for developing non-binding standards that have no
effect under the SPS and TBT Agreements. Such voluntary standards would serve the original
mission of Codex by providing guidance to less developed countries without binding the U.S. to
international standards that are weaker than FDA and USDA regulatory requirements.
- Urge the Codex Committee on General Principles to develop procedures for the
development of non-binding Codex standards.
Presently, U.S. delegations to Codex meetings have numerous representatives from the food
industry, while few, if any consumer representatives. The overwhelming presence of food
industry representatives has caused embarrassment for the U.S. For example, a Codex official
recently warned a working group of the Codex Committee on Food Additives and Contaminants
to cease permitting representatives of Nabisco from participating in official meetings with
government delegates from Codex member nations. The chairman of the U.S. working group had
to make a public apology to Codex for the indiscretion. This incident is indicative of the influence
of the food industry in international proceedings that the FDA has said are supposed to benefit the
public health. This situation must be changed if Codex standards are to carry any legitimacy in
the hearts and minds of the general public. The FDA and USDA should therefore limit the
participation of industry and redouble the agencies' efforts to increase public participation in
- Require that U.S. delegations to Codex proceedings be balanced.
The new U.S. strategic plan calls for greater participation of NGOs in Codex proceedings and
discusses a number of steps that the USDA and FDA can take to help involve more NGOs in
Codex matters. While these actions are a step in the right direction, USDA and FDA must also
take action to limit industry participation in Codex proceedings. Because the food industry has
much greater financial resources, representatives of industry will almost always outnumber
representatives of NGOs. To achieve a true balance between interests, USDA and FDA must not
only involve NGOs to a greater extent, but also limit participation of industry.
Ultimately, the U.S. government needs to reconsider the legal effect given to Codex standards,
guidelines, and recommendations under the SPS and TBT Agreements. Because the needs of less
developed countries are different than those of developed countries, USDA and FDA should
recognize that in many cases, it may neither be possible nor desirable to establish a uniform
international standard in a particular area of food safety and/or labeling. For this reason, it is
necessary for the U.S. government to review the SPS and TBT Agreements de novo to determine
how the interests of the American public can be better served by the process of international
harmonization. The U.S. should advocate specific modifications consistent with the concerns
raised in this report as the WTO undertakes a periodic review of the Agreements over the next
- The United States should urge the WTO to modify the SPS and TBT Agreements.