Kim Folk - Comment

Comment on 21 CFR Part 1 – Docket No. FDA-2007-N-0465 Proposed Rule: Label Requirement for Food that Has Been Refused Admission into the United States The FDA proposed rule requiring owners or consignees to label imported food that is refused entry into the United States is, in theory, a good rule. In consideration of the recent melamine scare with respect to foods imported from China, it seems that most people would favor a rule that helps protect citizens against the introduction of violative foods into the United States and that reduces the number of foodborne illness due to unsafe or mislabeled imported foods. Further, the proposed rule is a positive rule because it will reduce port shopping, and it will deter owners or consignees from attempting to introduce violative foods into the country by increasing the costs of trying to do so. However, while the spirit of the rule is positive, several items in the proposed rule must be addressed. First, the proposed rule, § 1.98(b) would require the label to be permanently affixed to shipping containers. The proposed rule also states that “the use of adhesive labels, ink stamps, paint and stencils, or any other tool or device would satisfy the rule’s requirements as long as the label is permanent . . . .” The question is, how would adhesive labels be permanent? Couldn’t owners or consignees merely affix the label and detach it later? Further, the proposed rule offers several mechanisms for demonstrating that the label was properly affixed to the shipping containers. These mechanisms include: (1) arranging to affix the labels in the FDA’s presence or under its supervision; (2) submitting photographs or other visual evidence to us to show the label was affixed to the containers; or (3) any other means to show the labels were affixed to the FDA’s satisfaction. If owners or consignees choose the second mechanism to demonstrate that the label was affixed, couldn’t they merely rip off the label after the photographs were taken? While the FDA states that this method could be used in situations where the owner or consignee has a good record of compliance with the Federal Food, Drug and Cosmetic Act, doesn’t mechanism two provide incentives to cheat the system? Second, in relation to the first mechanism mentioned in the preceding paragraph, the proposed rule states that the agency would seek reimbursement for its expenses when it supervises an importer’s affixing of labels on shipping containers and documents. The proposed rule states that the costs that may be reimbursed include: inspector’s time, the per diem allowance under government travel regulations, and travel expenses. If owners and consigners have a choice, why would they choose this mechanism when there are alternatives that are less expensive? Thus, both mechanisms one and two above are unattractive options to demonstrate that labels have been properly affixed to containers and, or documents. Third, the proposed rule requires the label on the shipping container to be clear and conspicuous, but does not define what clear or conspicuous entails. The final rule should definitely incorporate an explanation of what clear and conspicuous demands. For example, if the FDA is worried about people complying with the “letter, but not the spirit, of the law” and ultimately placing the labels at the bottom of the shipping container, or on the top to be hidden through a stacking mechanism, why not define clear and conspicuous as requiring a label on all sides of the box? While this option may cost more than only requiring a label on one side of the box, it would heighten the probability that the label will be unable to be hidden. A small increase in the number of label guns that the FDA proposes each port to have, potentially to five label guns instead of three, should be able to take care of this problem with a relatively small increase in cost. Further, to really ensure that owners and consignees do not attempt to fly goods that have been refused entry under the radar, another option, although admittedly more costly, would be to define clear and conspicuous as putting refused goods into red boxes. Red boxes would signal that goods have been refused, and there would not be a concern that labels were covered up or removed. However, it could be argued that owners or consignees could just put the refused goods into non-red boxes. The FDA should address which option is more likely to ensure that refused goods are kept out of the country. Fourth, the proposed rule states that labels must also be affixed to the documents accompanying the refused food, despite the lack of a shipping container. However, the proposed rule states that a permanent label is only required on the “top page” of each accompanying document. What if the top page of the document is lost, or somehow detached from the rest of the document? Adding a label to various pages in a document will provide additional protection against the re-importation of refused food. Finally, the proposed rule asks for comments on how to frame the regulatory requirement to ensure that the owner or consignee has a reasonable amount of time to affix the required labels and for the FDA to verify that the labels are affixed properly in light of the 90-day deadline in 801(a) of the FDCA for the exportation of refused food. In light of the 90-day deadline, the FDA should make general estimates as to how long it will usually need to verify labels are affixed properly and how long it takes for businesses to arrange for the exportation of refused items. The agency should subtract those estimates from the 90-day deadline and whatever time remains should be the amount of time in which a business has to affix the labels. In conclusion, while the FDA’s proposed rule will, in theory, provide benefits to the United States population at large, there are a few minor revisions I would make before promulgating the final rule to ensure that the letter of the rule is effective, and that the spirit of the rule remains intact.