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The United States Food & Drug Administration and NAFTA

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA, effective on January 1, 1994, is an agreement between Canada, US and Mexico designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. As such, no changes in US Food and Drug Administration standards were needed nor proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use, pesticide combined with other chemical residue, or contaminant standards for fresh or processed foods; instead, NAFTA provisions safeguard the ability of the US Food & Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continually be applied to both imported foods and domestically produced foods, and the U.S. will continue to prohibit any food shipments found not to meet pesticide residue or other food safety requirements.

AFTA has no effect on US Food and Drug Administration laws and regulations in the area of safety, effectiveness and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA neither changes nor affects US Food Drug Administration laws and regulations regarding US Food and Drug safety or appropriate labeling of dietary supplements imported in to the U.S.

US FDA and TWG

Within the auspices of NAFTA, three countries have developed a technical working group on pesticides called TWG, serving as a focal point for all issues related to pesticides. TWG's aim is to ensure that countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. The US Food and Drug Administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a US Food and Drug Administration safety measure will have the duty of showing that theUS Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is "appropriate" is a social and political judgment reserved for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment "as appropriate to the circumstances," and is not to be maintained without scientific basis. The US Food and Drug Administration standards are already based on risk assessments on a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.





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