March 29, 2000
The Honorable Charlene Barshefsky
Office of the U.S. Trade Representative
600 17th St. N.W.
Washington, D.C. 20508
Dear Ms. Barshefsky:
We are writing on behalf of our almost 1,000,000 members in North America
concerning ongoing negotiations between the United States and Canada to develop a seafood
equivalency agreement. We urge that the U.S. refrain from pressuring Canada to deem the
U.S. Food and Drug Administration's (FDA) current regulatory requirements as equivalent to
those administered by the Canadian Food Inspection Agency (CFIA). Your office and the
FDA should instead use the current negotiations as an opportunity to make improvements in
the U.S. regulatory program by adopting certain key aspects of the Canadian system.
Under equivalency agreements, countries demonstrate that regulatory requirements
designed to protect consumers from unsafe and unwholesome products, while different,
achieve the same level of public health protection. In this case, a seafood equivalency
agreement between the U.S. and Canada could help reduce the number of shipments that are
delayed at the border to determine if they are in compliance with appropriate regulatory
While the primary objective of equivalency agreements is to facilitate trade, such
agreements can lead to improvements in consumer protection if they are based on the
principle of "upward harmonization," i.e. that each country modifies its domestic regulatory
program to reflect the best aspects of the other country's regulatory program. Unfortunately,
commercial pressures to facilitate trade may instead pressure one country to accept the other
country's weaker regulatory requirements as equivalent. That result would lead to
"downward harmonization" and ill serve consumers.
This matter is of the utmost importance given the frequency of food borne illness in
the U.S. According to FDA estimates, fish and shellfish are responsible for over 110,000
illnesses per year, many of them fatal. In economic terms, those illnesses and deaths cost this
country more than $245 million per year.
We have reviewed several key aspects of the Canadian inspection system that we
believe provide a higher level of protection than that provided to consumers in the United
States. The U.S. should incorporate those measures into its own regulatory program for
seafood instead of urging Canada to deem the weaker U.S. system as equivalent to its own.
Specifically, we urge the you to consider the following:
- Canada requires all members of the industry to register with the CFIA which has the
authority to suspend or revoke a registration for non-compliance with regulatory
requirements. The FDA has no similar authority. This leads to a number of
weaknesses in the FDA enforcement system. For example, if the FDA wanted to
trace back an outbreak by contacting all seafood processing facilities in a particular
region of the U.S., it would be relegated to flipping through a public telephone
directory to try to find the names and telephone numbers of each establishment.
- The CFIA pre-approves Hazard Analysis and Critical Control Point (HAACP) plans.
This ensures that the HAACP plan meets the requirements of the law. Both the CFIA
and the FDA require processing establishments to have HAACP plans but the FDA
does not require processors to have them pre-approved. The FDA thus has no way of
knowing whether a processing plant's HAACP plan is in accordance with the
agency's requirements until it inspects the plant.
- Canada maintains a large inspection force and conducts much more frequent
inspections than the FDA.
- Canadian regulatory requirements also contain significant provisions designed to
maintain quality and ensure honest labeling. The FDA's seafood program does not
incorporate such measures. This means that Canadian consumers are more likely than
U.S. consumers to receive a higher quality, more accurately labeled product.
Those elements, taken together, indicate that U.S. regulatory requirements cannot be
deemed "equivalent" to Canada's requirements because it is highly unlikely that the U.S.
system could provide consumers with the same level of protection as that afforded by the
Canadian system. In negotiating a legitimate equivalency agreement, the U.S. should
therefore "harmonize upward" and bring its regulatory requirements up to the level of
Canada's requirements. While such requirements do not have to be identical, they should,
on balance, provide consumers with the same level of protection from unsafe and
unwholesome products already enjoyed by Canadian consumers.
We are concerned, however, that in the interest of facilitating U.S. exports, just the
opposite is happening -- the U.S. may be pressuring Canada to deem the FDA's regulatory
system as equivalent even though it is weaker than the Canadian regulatory system in several
material respects. That negotiating stance would deprive American consumers of the
benefits of upgrading seafood safety and related requirements to the level adhered to in
Canada; meanwhile, Canadian consumers would be forced to accept U.S. exports that comply
with regulatory requirements that are deemed to provide an "equivalent" level of protection
but, in fact, comply with requirements that provide less protection than those administered in
Canada. Ultimately, Canadian companies might pressure the CFIA to lower its standards to
those of the U.S.
To the extent that other aspects of the U.S. regulatory program provide consumers
with a greater level of protection than the program administered by the CFIA, the
government of Canada should make similar efforts to upgrade its standards to the U.S. level.
In this manner, consumers on both sides of the border will be well served by the ongoing
As the Administration is well aware, public support for free trade agreements is
declining. To stem this decline, the Administration must ensure that free trade agreements
like NAFTA are implemented in a manner that increases, not decreases, consumer protection.
President Clinton himself recognized this in an address to the World Trade Organization
(WTO) where he said:
In order to build a trading system for the 21st Century that honors our values and expands opportunity, we must do more to ensure that spirited economic competition among nations never becomes a race to the bottom in environmental protections, consumer protections or labor standards. We should be leveling up, not leveling down [emphasis added].(1)
We further request that meetings of the NAFTA Sanitary and Phytosanitary
Committee and the NAFTA Fish and Fishery Product Inspection Technical Working Group
be opened to officially recognized consumer organizations with expertise in this area. Since
September 1999, we have made three formal requests to attend meetings of these groups but
have received no responses whatsoever to our requests. The President also told the WTO at
its recent meeting in Seattle, Washington that trade proceedings should be more open to the
public. He stated:
We can do it a little bit now and little bit later. We can drag our feet, or we can run through an open door. But my preference is to open the meetings, open the records, and let people file their opinions.(2)
In order to give credence to the President's words, the U.S. should implement this
policy in its own back yard and work aggressively to open up meetings of these NAFTA
groups to qualified NGOs that represent consumer interests. In this regard, we note that
CSPI has long worked on the matter of seafood safety, maintains offices in both the U.S. and
Canada, and has been granted observer status at meetings of the Codex Alimentarius
sponsored by the United Nations Food and Agriculture Organization and the World Health
We would be pleased to meet with you concerning this matter. Please let us know if
our office can be of assistance. Because these issues involve matters of concern to the FDA,
a similar letter has been sent to the FDA commissioner Dr. Jane Henney.
Director of Legal Affairs
Dr. Catherine Woteki
Undersecretary of Agriculture for Food Safety
1. President William Jefferson Clinton, Statement to the World Trade Organization,
(May 18, 1998).
2. President William Jefferson Clinton, Statement to the World Trade Organization,
(December 1, 1999.)