Food
Safety Reform: What the FDA Can Learn From Other Major Importing Countries
by Bradford L. Ward and Lisa W. Wang
Given the abundant news reports, congressional hearings, and trade data on imported food safety concerns, American consumers are justifiably concerned that the imported food products they consume, particularly seafood imports, are tainted with banned and harmful substances, and that the federal agency charged with ensuring the safety of 80 percent of our nation's food supply, the U.S. Food and Drug Administration ("FDA"), is not taking the necessary steps to safeguard the health and safety of its people. In contrast to the FDA, other major food importing countries including the European Union ("EU"), Japan, and Canada have instituted stringent food safety controls for animal products that been effective in protecting food supplies while facilitating trade in safe products. The FDA's lax enforcement efforts coupled with the stringency of foreign import safety regimes has had significant trade effects in that it has encouraged the diversion of unsafe and contaminated food imports to the United States.
Fundamentally, the FDA does not require foreign countries or individual exporters to guarantee equivalence with U.S. food safety standards as a prerequisite for entry into the United States. In the absence of equivalence guarantees, the FDA relies solely on point-of-entry inspection. However, because the frequency of FDA testing is not mandated by statute, FDA inspection rates have hovered at approximately 1 percent since 2002. A July 2007 House Energy and Commerce Committee investigation on import safety summarized the FDA's imported food safety regime as:
FDA is responsible for assuring the safety of 80 percent of the food supply, but lacking a user fee system, is able to inspect only about 1 percent of all food imports, and does not ensure that foreign food processors and suppliers meet U.S. food safety standards.
In stark contrast to the FDA's food safety regime, which primarily relies on ad hoc border inspections to verify that the safety of imported products, the EU, Japan, Canada, and even the U.S. Department of Agriculture ("USDA") all have implemented forms of effective food safety controls throughout the life-cycle of imported products to ensure their wholesomeness and integrity.
European Union
The EU requires equivalence certification as a condition of entry into the
EU meat and seafood market. That means that such products may not enter the
EU market unless an exporting country first has established that its food
safety program and procedures are at least equivalent to the EU's standards.
In addition, individual foreign producers within an approved exporting country
must demonstrate equivalence and obtain approval to export to the EU. Equivalence
is verified by mandatory on-site inspections of foreign production facilities
as part of the initial approval process and on a routine basis afterwards.
Stringent follow-up inspections are conducted at the EU's border, as imported
animal products may enter only through official border inspection posts under
the supervision of an official veterinarian. If systemic problems arise with
an individual exporter or exporting country, the EU has imposed absolute importation
bans (i.e., no exports may enter the EU until the ban has been lifted).
The EU's imported food safety regime provides a high level of assurance to its consumers while still facilitating the free trade of goods because the burden of ensuring food safety is shared between the EU and the exporting country. On the other end of the spectrum, the entire burden for ensuring imported food safety is on the FDA, which must discover, through a minimal testing regime at U.S. ports of entry, whether imported food products are unsafe for human consumption.
Japan
While the FDA purports to enforce a risk-based system, Japan has instituted a strict risk-based system that is reinforced by high inspection rates, certification requirements and significant penalties for noncompliance. Annually, Japan's food safety agency assesses the risks posed by food imports, and issues implementation and inspection guidelines for the upcoming year. Thus, while the general inspection rate of imported foods is 10.2 percent, high-risk food imports are subject to higher inspection rates. Like the EU, continuing and systemic food safety problems caused by an individual exporter or exporting country may result in compulsory 100 percent testing and/or an import ban.
Canada
Canada imposes minimum standard inspection rates for imported food products and has strict licensing requirements for importers. Exporting countries with bilateral equivalence agreements with Canada are subject to reduced inspection requirements. In return, the exporting country agrees to inspect and certify products bound for Canada. Repeated failure of inspections may lead to the imposition of an import alert and 100 percent testing of shipments from the particular exporter or exporting country.
U.S. Department of Agriculture
Within the United States, different categories of food imports are subject to different food safety enforcement standards. For USDA-regulated food imports (meat, poultry, and egg products), equivalence is a prerequisite for import into the United States. Currently, only 34 countries are eligible to export USDA-regulated products to the United States. The USDA verifies equivalence through foreign on-site inspections and 100 percent reinspection at U.S. ports of entry. A country's equivalence certification may be revoked if these on-site audits reveal inadequate health and safety controls.
Consequences of the FDA's Lax Enforcement Efforts
The United States has essentially become a magnet for unsafe and contaminated food imports. When faced with the stringent and rigorously enforced food safety standards described above in the EU, Canada and Japan, and a 1 percent chance of being inspected by the FDA, it is easy to understand why exporters choose to ship unsafe food products to the U.S. market. The FDA's lax oversight of imported food products is putting U.S. consumers at risk and threatens the integrity of our nation's food supply.
The incentive created by the FDA for foreign producers to export unsafe products is not a matter of conjecture, but instead can be demonstrated with trade data. When other major importing markets take action against unsafe seafood products, the affected products are diverted to the United States. There is a direct cause and effect between market closures or restrictions on imports in major importing countries and the diversion of contaminated and likely contaminated products to the United States. For example, when the EU banned all Pakistani seafood producers in April 2007 for severe deficiencies in the country's food safety controls, Pakistani shrimp exports to the United States jumped from zero to 75,000 kilograms in June 2007.
Proposals for Food Safety Reform
Opponents of meaningful reform to the FDA's imported food safety system have inaccurately implied that the FDA's regulatory system is stringent in comparison to other major seafood importing countries and that any reform would be "protectionist." In actuality, these countries' imported food safety regimes far exceed the FDA's current enforcement efforts. Thus, any improvement in the FDA's regulatory authority would, at most, simply bring the U.S. in line with international best practices. Further, as explained in Article XX of the GATT, nothing in our multilateral trade obligations prevents the United States from adopting or enforcing any measure "necessary to protect human, animal, or plant life or health . . . ." Accordingly, the improvement of FDA's regulatory program related to the safety of imported food would not be inconsistent with our international trade obligations.
Statutory reform of the FDA system must be effectuated in order to restore the integrity of our nation's food supply. Consistent with the practice of other major seafood importing markets, reform of the FDA's must include the following four fundamental principles of imported food safety enforcement.
First, the FDA must require equivalence as a prerequisite for entry into the U.S. market. Exporting countries and foreign producers must be subject to certification of equivalence with U.S. food safety standards, foreign on-site inspection, and revocation of exporting privileges for repeated food safety violations.
Second, the FDA must implement mandatory minimum inspection and testing rates imposed at U.S. borders, with testing increased as problems are detected.
Third, there must be effective enforcement of U.S. food safety standards, meaning that the FDA must consistently and rigorously impose significant penalties for noncompliance with U.S. food safety standards.
Finally, there must be increased multilateral cooperation with other major importing countries in order to ascertain best practices, identifying risks, and facilitate information sharing.
Bradford L. Ward is a Partner and Lisa W. Wang is an Associate at Dewey & LeBoeuf LLP