Bernard A. Schwetz, D.M.V, Ph.D.
Acting Principal Deputy Commissioner
U.S. Food and Drug Administration
200 C Street, S.W.
Washington, D.C. 20201
Dear Dr. Schwetz:
During its annual meeting in September 2001, the National Association of State Departments of Agriculture (NASDA) adopted a new policy regarding approval of dairy products imported into the United States from a food safety perspective.
FDA's Milk Safety Branch identifies three channels through which dairy imports into the United States can be deemed to meet the requirements of applicable U.S. laws: full membership by a the exporting country in the U.S. National Conference on Interstate Milk Shipments, a determination by FDA that the foreign country's inspection system is equivalent to the U.S. system, or the provision of a safety program for the foreign country or exporting plants and their suppliers by an NCIMS member—that is, by the milk inspection service of an individual state.
To the knowledge of our member states, FDA has never made an equivalency determination regarding a foreign country's inspection system, and no foreign country has ever applied to join the NCIMS. We are not even sure that it would be feasible for a foreign country to do so. That leaves a substantial part of the burden of assuring the safety of those dairy products of foreign origin that are now entering U.S. commerce on those states that choose to exercise their authority in this area, or whose state laws do not permit them to ignore the situation. We recognize that FDA does perform some safety checks at the point of entry, but these are hardly the equivalent of the full program of controls from farm to consumer that apply to milk products produced in the United States.
The enclosed policy statement (listed below) reflects the view of our association that the regulation of imports is properly a federal function, and that no dairy products should enter U.S. commerce without positive steps taken by federal authorities to assure their safety.
We would welcome your comments or observations concerning our position on this matter.
Sincerely,
<signed>
Billy Ray Smith
President, NASDA
Commissioner, Kentucky Department of Agriculture
cc: Richard A. Barnes, Director, Division of Federal-State Relations
Ann M. Veneman, USDA Secretary
**Policy Details*
NASDA Policy 4.6 State Food Inspection Programs
Dairy Product Safety — As the distribution of dairy products moves from a regional to a national market, it is important that milk regulatory agencies utilize uniform interpretations of the FDA's Pasteurized Milk Ordinance (PMO) and USDA's Milk for Manufacturing Purposes and its Productions and Processing Recommended Requirements.
Passage of the GATT and NAFTA agreements are advancing the National Conference on Interstate Milk Shipments (NCIMS) into the area of international trade. State and federal milk regulators and the NCIMS Program must ensure that regulations are uniform and equivalent, providing a safe and wholesome product, while allowing international commerce to progress. Milk regulatory agencies and the NCIMS Program should have the following goals:
• To produce a safe raw milk supply and provide safe finished products for the consumer.
• To more efficiently use resources to continue to protect the public health, enhance food safety and accommodate a changing regulatory and industry environment without reducing milk safety.
• Development of a system to allow the free flow of dairy products both domestically and internationally utilizing equivalent safety standards.
• To enhance the oversight program through state field audits, program evaluations and when necessary, check ratings. To increase uniformity and ensure product safety.
• To address how a Hazard Analysis Critical Control Point (HACCP) system should be implemented, evaluated, and monitored utilizing current National Advisory Committee on Microbiological Criteria for Foods (NACMCF) HACCP principles consistent with current Food and Drug Administration HACCP recommendations.
As a precondition for the importation of all dairy products (Grade A and Non-Grade A) into this country, the FDA should be required, through legislation or other means, to make a timely determination as to whether a dairy product proposed to be imported meets the sanitary standards of this country. The determination could be made either by FDA's direct inspection of individual plants and farms, or upon its finding that foreign country's dairy inspection system is equivalent to that of the United States.
USDA should work in concert with NASDA and re-evaluate the cooling temperature requirements for can milk for manufacturing purposes. Research is needed in order to determine uniform maximum-allowable temperature standards that will ensure the safety and quality of milk products made from milk for manufacturing purposes.