FDA's Prior Notice Requirement for Imports

In the food packaging industry, certain materials that have "direct food additive" uses also may have properties that make them beneficial for use in the production of food contact articles. However, those materials can create problems for importers when attempting to comply with the U.S. Food and Drug Administration's (FDA's) Prior Notice requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, now commonly known as the "Bioterrorism Act."

This article takes a closer look at FDA's Prior Notice requirement and highlights some of the issues that can arise when products are imported into the U.S. for use as food contact substances, but are also known to have uses in food. Unless the distinction is clearly made prior to import, as discussed below, the imported product may be held unduly at the port of entry. We also look at measures that can be taken to ensure that the line between food contact substances and food is properly drawn so that imported products that do not trigger the Prior Notice requirement may enter the U.S. without being improperly held at the port of entry.

Background

On October 10, 2003, FDA published the interim final rule on Prior Notice of Imported Food Shipments under the Bioterrorism Act. The interim final rule requires an individual to provide prior notice to the FDA or the U.S. Customs and Border Protection (CBP) for all food imported into the U.S. 68 Fed. Reg. 58974 (2003). Prior notice must be received and confirmed electronically by the FDA or CBP no more than five days prior to the shipment's arrival, but no fewer than two hours before arrival by land via road; four hours before arrival by air or by land via rail; and eight hours before arrival by water.

Any individual with knowledge of the required information may submit the prior notice, including, but not limited to, brokers, importers, and U.S. agents. 68 Fed. Reg. 58974, 58977 (2003).

The purpose of the prior notice requirement is to give the FDA and CBP sufficient time to review and evaluate information before a food product arrives in the U.S., to better deploy resources for inspections, and to help intercept any products that either are or may be contaminated.

Prior Notice Requirement and Issues

Prior notice is required when "food" is: (1) imported into the U.S. for use, storage, or distribution; (2) transshipped through the U.S. to another country; and (3) imported for future export. The import of "food" will trigger the Prior Notice requirement if the product in question constitutes "food," as that term is defined in FDA's Prior Notice regulation. The regulation's definition of "food" parallels the definition of "food" in Section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act) with some important exceptions.

Specifically, the Prior Notice regulation carves out explicit exemptions for: (1) food contact substances as defined in Section 409(h)(6) of the Act; and (2) pesticides. Accordingly, if the imported product will be used as an ingredient in food, prior notice is required, while products imported for use in food contact applications are exempt from this regulation.

This distinction is important, but problems can arise for materials that have both "food additive" uses and food contact uses. Depending upon the end-use application, certain products may be considered to be food additives requiring prior notice, or food contact substances that do not require such notice.

For example, zinc oxide can be used as a colorant in plastics or as a nutritive food additive. If the zinc oxide will be used as a nutritive food additive, prior notification of its import would be required. If the zinc oxide will be used as a colorant of food packaging, however, prior notice would not be required because this use would make the zinc oxide a food contact substance and, as discussed above, exempt from the Prior Notice requirement.

Prior notice questions frequently arise when a facility is either a "mixed-type" facility or when the ultimate downstream use of the product is unknown. The import of products from a "mixed-type" facility may include products that will be used in both food and non-food applications, such as the above zinc oxide example. The Prior Notice requirement for products originating from "mixed-type" facilities are applicable only to the import of product that is intended for use in food. Thus, of course, if two separate shipments are imported into the U.S. on two separate carriers, and one shipment will be used in food applications and the other shipment will be used in non-food use applications, only the shipment that will be used in food applications would trigger the Prior Notice requirement.

Changing this scenario slightly, if the two shipments (again, one intended for non-food use and the other intended for use in food) are shipped on the same carrier, still only the shipment containing product that will be used in food applications would trigger the Prior Notice requirement. However, if a single shipment contains product that may be used in both food and non-food applications, prior notification would be required because the shipment contains product that falls under the definition of "food" as defined in FDA's Prior Notice regulation.

Perhaps the more problematic situation arises when an importer does not know whether the product's end-use will be in food or non-food applications. This scenario can be readily addressed by asking the following question: Is it reasonably foreseeable that the imported product will be used as a food or food ingredient? If the answer is "yes," then prior notice is required. If the answer is "no," the product can be imported into the U.S. without prior notification.

Drawing the Line Between Food and Food Contact Substances

There are measures an importer can take to ensure that products imported only for use as food contact substances maintain their exempt status under FDA's Prior Notice regulation, especially when the product, although not imported for such use, is known to be used in food.

First, the invoice should clearly state the product is for food contact use only. For example, "For Use in Food Contact Substances or Packaging Only—Not Intended for Direct Addition to Food" could be marked on the invoice. Second, the shipping container should be labeled to indicate that the shipment will not be used in food. The same language, "For Use in Food Contact Substances or Packaging Only—Not Intended for Direct Addition to Food," is suggested.

Both measures will help alert the FDA and CBP to the fact that the containers being imported into the U.S. do not contain products that will be used in food or food ingredients, but are intended solely for non-food uses.

With the exception of certain "informal entries," e.g., personal baggage and mail, CBP requires any product offered for entry into the U.S. to be identified according to Harmonized Tariff Schedule (HTS) codes. CBP uses the HTS codes, in part, to determine which imports should be reviewed by the appropriate government agency for admissibility into the U.S. These codes also assist CBP with electronically sending to FDA for review entry information about FDA-regulated products. The following flagging codes are used in CBP's Automated Commercial System to indicate that products are, or may be, under FDA jurisdiction:

• FD07 — The imported article is subject to FDA's laws and regulations, but acceptable for CBP release without prior notice or other entry information to FDA.
• FD1 — The imported article may be subject to FDA's jurisdiction, including FDA review of entry information. For products not subject to FDA jurisdiction, an importer may "disclaim" product from FDA notification requirements.
• FD2 — The imported article is subject to FDA's jurisdiction and review of entry information, but the article is not "food" and thus Prior Notice is not required.
• FD3 — The imported article may be subject to the Prior Notice requirement because it has both food and non-food uses.
• FD4 — The imported article is "food" and thus Prior Notice is required.

Last year, FDA published a "Guidance for Industry" document entitled, "Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators" (revised August 26, 2004), to inform the food industry which HTS codes have been "flagged" in CBP entry systems with prior notice indicators, i.e., FD3 or FD4. Accordingly, once the proper HTS code has been identified based on the product of import, one should then determine whether the HTS code has been "flagged" with an FD3 or FD4 indicator. (The HTS code list with the FD3 or FD4 indicators may be found at www.cfsan.fda.gov/~pn/htscodes.html.)

If the imported product has a designated HTS code that is "flagged" with an FD3 indicator, but the product is only intended to be used as a food contact substance, e.g., a pigment that will be used only to impart color in food packaging, even though it can be used, for example, as a food coloring, it may be possible to obtain a Prior Notice disclaimer using an Affirmation of Compliance for shipments of products intended for non-food use.

The precautionary measures discussed above should also be implemented to ensure that the line between imported food contact substances, which are exempt, and imported foods, which are not exempt, is clearly established.