Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Washington, DC 20852

Re:     Proposed Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States; Docket No. 00N-1633

Dear Sir or Madam:

The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration’s (FDA’s) request for comments on the proposed amendment to the food import regulations. 66 Fed. Reg. 6502 (Jan. 22, 2001). In relevant part, the Agency intends to require the mark “UNITED STATES REFUSED ENTRY” to be placed on food products that have been denied entry into the United States for safety reasons. Proposed 21 C.F.R. § 1.98.

FMI1 strongly supports FDA’s efforts to improve the safety of imported foods. In this regard, enclosed please find testimony that FMI presented on imported food safety before the Senate Subcommittee on Investigations in 1998.2   As you will see from the enclosed, FMI has been actively involved in food safety programs, including the Partnership for Food Safety Education’s Fight BAC! campaign. During our testimony, we urged Congress and the Administration to take concrete steps to improve the safety of imported food, and we specifically urged the government to end unscrupulous practices, such as “port shopping,” that diminish the safety of our food supply. See FMI Testimony at 3. Accordingly, we fully support FDA’s proposed regulation to require clear and conspicuous marks to be placed on foods that have been refused entry for safety reasons.

     A.     Legal Background

Section 801 of the Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to inspect food, drugs, devices and cosmetics that are being imported or offered for import into the United States. 21 U.S.C. § 381(a). Articles that are adulterated, misbranded, or manufactured, processed or packed under insanitary conditions will not be admitted for sale into the U.S. 21 U.S.C. § 381(a)(1), (2).

FDA’s examination of imports often begins with a review of records to determine whether additional scrutiny of the product itself is warranted. 66 Fed. Reg. at 6503. Based on the records, FDA may permit the goods to proceed or else further examine them visually or through laboratory analysis. Articles that comply with the FD&C Act will be allowed to proceed; rejected articles must be destroyed unless they are re-exported or reconditioned and, thus, brought into compliance with the Act. 21 U.S.C. § 801(b).

Demand on FDA’s resources for reviewing imported products has increased significantly in recent years. According to the Agency, more than 3 million line items were offered for import in 1998. 66 Fed. Reg. at 6503. FDA states that its ability to inspect a sufficient proportion of the imports “has been severely hampered by this increase.” Id. Currently, the Agency examines less than 2 percent of imported foods for compliance with the FD&C Act. Id.

According to a recent Government Accounting Office (GAO) report, some unscrupulous importers try to take advantage of FDA’s limited resources by evading the current import controls and introducing contaminated, adulterated or unsafe food into the United States, even when FDA refused to admit the food and the food was ordered to be re-exported or destroyed.3   In particular, FDA is concerned about unscrupulous importers’ attempts to reimport goods refused at one port through a different U.S. port in a practice referred to as “port shopping.”

     B.     Proposed Rule

In response to the foregoing concerns, FDA has proposed to amend the food import regulations by adding a new Section 1.98, “Marking Requirements for and Prohibitions on the Reimportation of Food Products That Have Been Refused Admission into the United States.” Proposed 21 CFR § 1.98; 66 Fed. Reg. at 6511. Proposed Section 1.98 would require importers or consignees of a shipment of imported food that FDA has refused to admit for safety reasons to mark the refused food as “UNITED STATES REFUSED ENTRY.”   The mark must be affixed clearly, conspicuously, and permanently to the packing container holding the refused food and on invoices, bills of lading, and any other documents accompanying the food when it is exported from the United States. Proposed 21 CFR § 1.98.

FMI supports the rule proposed by FDA. As the purchasing agents for the consumer, our members want to ensure that the food products entering our stores are as safe as possible. As the GAO report indicates, FDA does not have the ability to inspect more than a tiny fraction of the imported foods. To maximize the Agency’s inspection resources, it makes sense to highlight foods that have been refused entry for safety reasons at one port so that it will be harder for unscrupulous importers to move the food through a second U.S. port.

The mark FDA has proposed is reasonable. That is, it declares only that the United States has refused to admit the food, but does not characterize the reason in a way that might interfere with the ability of a shipper to import the food to a country with different standards.4   Therefore, the mark should be placed clearly and conspicuously on the product, rather than in “invisible ink” as reportedly suggested in the preamble. 66 Fed. Reg. at 6504.

Moreover, the U.S. Department of Agriculture (USDA) currently requires meat and meat food products that have been refused admission into the United States to bear a similar mark. 9 CFR § 327.26(c). Specifically, Section 327.3 prohibits the import of any meat or meat food product if the product is adulterated, misbranded, or does not comply with all of the regulatory requirements that would apply to the product if it were domestically produced. 9 CFR § 327.3(a). Meat products that are denied entry into the United States must be marked as “UNITED STATES REFUSED ENTRY.” 9 CFR § 327.326(c). Accordingly, the regulation that FDA has proposed will provide more consistency to the treatment of imported foods.5

Finally, we would like to call your attention to a suggestion made in our 1998 congressional testimony to address the underlying problem; namely, the chronic shortage of resources available to FDA to inspect imported foods. As discussed more fully in the enclosed document, the critical need for additional inspection personnel can be met by redeploying the USDA inspectors and inspection resources that have been freed up as a result of USDA’s successful implementation of the Hazard Analysis Critical Control Point (HACCP) program in processing plants to ports of entry to inspect imported produce and seafood. We believe that redeployment can be accomplished by the development of a cross-utilization program between USDA and FDA that would allow USDA to share its resources with FDA for the purpose of inspecting imported seafood and produce. The complete proposal is described in our testimony. See FMI Testimony at 4-6.


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We appreciate the opportunity to comment on FDA’s proposal to improve the safety of imported foods and we appreciate your consideration of our remarks. If you have any questions regarding the foregoing, or if we may be of assistance in any other way, please do not hesitate to call on us.

Sincerely,

Tim Hammonds
President and CEO

Enclosure
     


1   FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI’s domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $300 billion, which accounts for more than three-quarters of all grocery sales in the United States. FMI’s retail membership is composed of large multi-store chains, small regional firms, and independent supermarkets. Our international membership includes 200 members from 60 countries.

2   Improving the Safety of Food Imports: Hearing Before the Senate Permanent Subcommittee on Investigations, 105th Cong., 2d Sess. (Sept. 25, 1998) (statement of Tim Hammonds, President and CEO, FMI) (hereinafter FMI Testimony).

3   GAO, “Food Safety: Federal Efforts To Ensure the Safety of Imported Foods Are Inconsistent and Unreliable” (April 1998).

4   For example, the presence of any food additive in the food that is not cleared in FDA’s food additive regulations will render the food “unsafe” as a matter of law, even though the food might not be unsafe as a matter of science. See 21 U.S.C. § 348(a). Thus, the food might be acceptable in a country in which the food additive in question was cleared. Simply marking the product as having been refused entry into the United States does not brand the food as generally adulterated (which term encompasses food that may be deleterious to health or that was manufactured under insanitary conditions) even though these bases for adulteration are sufficient reasons for marking the refused food under the proposed rule.

5   We note that the treatment will not be completely consistent as USDA requires the refused entry mark to be place don all meat products that are denied admission will FDA will only require the mark to be placed on those products that are prohibited for safety reasons.