December 10, 1997
Dr. Edward Scarbrough
Manager, U.S. Codex Office
United States Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250-3700
Re: U.S. Position on Codex "Proposed Draft Guidelines for the Development of
Equivalence Agreements Regarding Food Import and Export Inspection Certification
Systems (at Step 4)," Sixth Session, Melbourne, Australia, February 23-27, 1998.
The Center for Science in the Public Interest (CSPI) submits these comments regarding the
United States' position on the Development of Equivalence Agreements Regarding Food Import
and Export Inspection Certification Systems.
We believe that it is premature for the U.S. to advocate international guidelines on equivalence
determinations because the Food and Drug Administration (FDA) has not yet responded to public
comments it has received from its Federal Register notice on domestic Guidance on Equivalency
Criteria for Food. In addition, the U.S. Department of Agriculture (USDA) is planning, but has
not yet held, additional hearings on equivalence determinations. Furthermore, the entire
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) is
scheduled for review, and the Office of the U.S. Trade Representative plans to seek public
comment. The U.S. government should not take positions internationally in policy areas that are
subject to uncompleted domestic administrative proceedings. However, in the event that the U.S.
proceeds with supporting the further development of Codex guidelines in this area, we believe
that a series of modifications needs to be made to the draft U.S. position.
I. The language of the guideline should reflect the intent of the SPS Agreement that each
country retains the right to set its own level of protection.
In 1994, the Congress approved the SPS Agreement. Article 4 of the SPS Agreement is intended
to facilitate the free trade of food products by requiring signatories to the Agreement to recognize
regulatory systems of other countries that are "equivalent to their own." Notwithstanding the
Agreement's aim of harmonizing international requirements for food, the SPS makes clear that
each country has the right to set its own level of protection.
The SPS reaffirms that:
- no Member should be prevented from adopting or enforcing measures necessary to protect
human, animal, or plant life or health, subject to the requirement that they are not applied in a
manner which would constitute a means of arbitrary or unjustifiable discrimination between
Members. . .
Article 2 specifically recognizes the ability of members to "introduce or maintain sanitary or
phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than
would be achieved by measures based on the relevant international standards, guidelines, or
recommendations, if there is a scientific justification. . ." The agreement explains that scientific
justification exists if:
- The Agreement then states that while its purpose is "to further the use of harmonized sanitary
and phytosanitary measures between Members," it aims to do so "without requiring Members
to change their appropriate level of protection of human, animal or plant life or health . . ."
on the basis of an examination and evaluation of available scientific information in
conformity with the relevant provisions of this Agreement, a Member determines
that the relevant international standards, guidelines, or recommendations are not
sufficient to achieve its appropriate level of sanitary or phytosanitary protection.
Article 4 of the Agreement, governing equivalence, must be read in light of these provisions. The
proposed draft guidelines, however, do not take this crucial language into account. The
guidelines do not reflect the fact that an importing country may reject a product as not being
equivalent because "a Member determines that the relevant international standards, guidelines, or
recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary
protection." We strongly recommend that this crucial point be reaffirmed in the proposed
II. The U.S. should support the Codex guidelines only if they ensure that equivalence
determinations will be consistent with U.S. law.
In passing the enabling legislation for the SPS Agreement, Congress precluded the FDA from
modifying its regulations in response to the requirements of the SPS Agreement unless it provides
the public with notice and an opportunity for comment. Furthermore, the FDA may not issue a
final equivalency determination "without taking into account the comments received." To the
extent a modification requires changes in the Federal Food, Drug, and Cosmetic Act (FDCA), the
FDA must seek Congressional authorization.
Congress specified that the FDCA is to prevail in the event of any conflict with the Uruguay
Round Agreements. Congress expressly stated that:
Nothing in this Act shall be construed -- to amend or modify any law of the United States,
including any law relating to -- (I) the protection of human, animal, or plant, life or health . . .
unless specifically provided for in this Act.
In passing this legislation, Congress adopted a Statement of Administrative Action that explicitly
states that the FDCA is not amended or modified by the legislation implementing the Uruguay
Round. The Statement of Administrative Action explains that Section 102(a) of the implementing
legislation "reflects the Congressional view that necessary changes in federal statutes should be
specifically enacted rather than provided for in a blanket preemption of federal statements by
those agreements." The Statement further provides that:
Accordingly, it is the expectation of the Administration that no changes in existing
federal laws, rules, regulations, or orders other than those specifically indicated in
the implementing bill and this Statement will be required to implement the new
international obligations that will be assumed by the United States under the
Uruguay Round agreements. Should it prove otherwise, the Administration would
need to seek new legislation from Congress or, if a change in regulations is required,
follow normal agency procedures for amending regulations.
Thus, although the SPS Agreement places pressure on the FDA to harmonize U.S. standards with
those adopted by Codex and to declare other nations' regulatory schemes "equivalent," the FDA
may not take any action that would violate the terms of the FDCA. Nor may the FDA take any
action to modify regulations without providing notice and comment.
Therefore, the FDA must keep in mind that its Congressional mandate has not changed: its
primary mission is to protect the health of consumers. The drafting of this comment, however,
suggests that the FDA, in attempting to juggle the dual obligations of protecting health and
promoting trade, may be compromising the former.
III. The draft U.S. position must be modified to meet the intent of Congress in passing the
SPS Agreement and to ensure consistency with the Federal Food, Drug, and Cosmetic Act.
We support FDA's attempt to ensure that portions of the draft Codex guidelines are consistent
with the agency's statutory authority. For example, we support the proposed requirement that the
public be provided an opportunity to comment on the basis of equivalency determinations.
In other areas, however, the draft guidelines fall far short of meeting both the letter and the spirit
of the law. For example, in the section of the proposal setting forth priorities that countries may
wish to consider when determining whether to establish an equivalency agreement, the FDA lists
whether an equivalency agreement would facilitate trade as the first priority. Public health risks
come second. The FDA should take immediate steps to reorder these provisions so that public
health, not merely trade concerns, rank as the number one priority for establishing equivalency
Furthermore, the guidelines must recognize that food safety laws are only one aspect of an
exporting country's regulations that need to be considered before making an equivalency
determination. Production of safe food can be dependent on a combination of many factors
including water, air and soil quality, climate, transportation infrastructure, and overall sanitation
conditions, such as water treatment. In addition, food borne pathogens may be different in
different regions. Such considerations may dramatically increase the possibility of importing
adulterated and misbranded foods and spreading food borne illness from one region to another.
The U.S. should also ensure that the guidelines specify that only official government agencies
responsible for public health protection can enter into equivalency agreements. Although the
guidelines refer to "competent authorities," the guidelines do not specify that such authorities may
only be the appropriate officials from a government agency with jurisdiction over the safety and
purity of the product at issue.
To ensure that equivalency is being maintained once an agreement is signed, the guidelines should
specify that monitoring should occur every two years, unless problems are detected that warrant
more frequent scrutiny. Under the proposed language, audits could occur as infrequently as
every 10 years, which is clearly insufficient to protect the public health. Furthermore, equivalency
agreements should remain in effect for only five years, unless they are renewed by mutual
To ensure that renewals do not occur on a pro forma basis, the Codex guidelines must specify that
signatories to equivalency agreements must notify the public annually of all products that have
been imported pursuant to an equivalency determination. The guidelines should also specify that
the public be provided with a summary of the results of the monitoring of such agreements. The
costs and benefits of establishing, monitoring, and renewing equivalency determinations should
also be made available to the public for comment.
We support the FDA's decision to permit importing countries to audit potential exporters to
assess the level of protection. However, it is crucial that the guidelines specify that government
authorities have access to records and facilities that is comparable to what the U.S. can inspect
The Codex guidelines should also ensure that equivalence determinations are subject to peer
review by independent scientific experts when significant health, safety, or policy issues arise.
Although the proposed guidelines call for public comment on the basis for equivalence
determinations, the failure to specify a requirement for peer review by independent experts could
greatly undermine the credibility of specific equivalence determinations.
Equivalency agreements should also be subject to trial periods before being made final. Based on
the experience that the U.S. has gained in implementing the U.S.-Canada Free Trade Agreement
(USCFTA), it is clear that it is easy for important considerations to be overlooked when making
an equivalence determination. For example, the General Accounting Office strongly criticized a
USDA determination that the Canadian meat inspection system was equivalent to the U.S. system.
U.S. meat inspectors complained that Canadians were taking advantage of the agreement and
shipping contaminated meat, while at the same time doubling the rejection rate of U.S. meat. In
addition, a dispute arose between Canada and Puerto Rico over the Canadian export of ultra-high
temperature milk, resulting in a 1991 ban of such products and a formal trade challenge under
The draft U.S. position merely states that equivalency agreements "may consider" a trial period.
Given the checkered history of some past equivalency agreements, we believe that no agreement
should be finalized until after a reasonable trial period has been completed successfully. We,
therefore, urge that the word "may" in section 40 be changed to "shall."
For the foregoing reasons, CSPI respectfully requests that the U.S. delay the advancement of the
proposed guidelines. In the event the U.S. decides to proceed, we urge that the guidelines be
modified to ensure that countries retain the right to set their own level of protection. In addition,
we urge that the guidelines be modified in the specific manner suggested herein.
Director of Legal Affairs
Ilene Ringel Heller
Senior Staff Attorney
cc: Fred R. Shank, Director
Center for Food Safety and Applied Nutrition
Food and Drug Administration