FDA'S Bioterrorism Regulations: Food Contact Substances Are Exempt, Aren't They?

Date: Sep 01, 2004

One of the many post-9/11 acts of Congress included the signing into law of a bill known as the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The so-called "Bioterrorism Act" triggered a series of regulations published by the U.S. Food and Drug Administration (FDA) in late 2003. These regulations included: (1) Administrative Detention; (2) Registration of Food Facilities; (3) Prior Notice of Imported Food Shipments; and, (4) Maintenance and Inspection of Records.1 Fortunately, however, those who produce, manufacture, hold, process, or pack "food contact substances," as this term is defined under the Federal Food, Drug and Cosmetic Act2 (FFDCA), are exempt from the registration and prior notice requirements.3 The definition of "food" under the FFDCA encompasses food contact substances; however, for purposes of FDA's bioterrorism regulations on facility registration and prior notice of import, the agency has exempted food contact substances from this definition. The food contact substance exemption has raised some interesting issues, both in theory and at the borders. The purpose of this article is to highlight some of the issues that have arisen over the past year regarding the food contact substance exemption, and to offer some suggestions for ensuring that your product is afforded the exemption status it is entitled to under the law.

By way of brief background, FDA's rule on Registration of Food Facilities requires domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register their individual facilities. Facilities that fall under the bioterrorism registration requirements had to register by December 12, 2003. Registering a facility can be done in a number of different ways, e.g., by facsimile, on FDA's web site, or by mail. FDA's rule on Prior Notice of Imported Food Shipments requires a purchaser or importer of food to provide FDA or U.S. Customs and Border Patrol (CBP) with prior notice before the food is imported into the United States. Prior notice must be sent to either FDA or CBP and confirmed electronically not more than 5 days prior to arrival and, as specified by the mode of transportation, no fewer than, for example, 2 hours prior to arrival by land by road, 4 hours prior to arrival by air or by land by rail, and 8 hours prior to arrival by water.

The common thread that triggers the registration and prior notice regulations rests upon whether the product in question is a "food," as this term is defined under the bioterrorism regulations. Specifically, the definition of "food" mirrors the definition cited in section 201(f) of the FFDCA4 with the following exceptions: (1) food contact substances as defined in section 409(h)(6) of the FFDCA; and (2) pesticides. The definition of food also applies to processing aids that are intended to have a technical effect in the food to which they are added.

As discussed above, only products that meet the definition of "food" are subject to FDA's registration and prior notice regulations. Seems straightforward, right? Not always. Consider the following scenarios:

You have a facility that holds a pigment, such as titanium dioxide. This pigment is often used as a direct additive in food, for example, to whiten candy, as well as to whiten a packaging material. The former application is considered a food and the latter application is considered a food contact substance. Does the facility that holds or manufactures this pigment need to be registered? What if the pigment will be imported into the U.S., does prior notice have to be provided?

The answer to both of the above questions is: It depends.

Here's what you need to consider:

If the pigment is intended to be used in food packaging materials or industrial, non-food applications, for example, in paint, facility registration is not required. Furthermore, the import of such pigment into the U.S. is not subject to FDA's prior import notification requirements. In both cases the pigment does not fall under the definition of "food" as this term is defined under the registration and prior notice regulations and, thus, the obligations under these regulations are not applicable.

On the other hand, what if the above facility manufactures other products that will be used as a food or food ingredient? For example, in one corner of the facility are pigments that will be used in paints, and in the other corner are pigments that will be used in food. Such a facility was contemplated by FDA and is classified as a "mixed-type" facility. As discussed in more detail below, mixed-type facilities must register with FDA. Similarly, products shipped from foreign mixed-type facilities are subject to FDA's prior notice requirements, provided the shipment contains product(s), in whole or in part, that fall under the definition of "food" under FDA's bioterrorism regulations. For example, elaborating on the above scenario, if a shipment contains 10 shipping containers of titanium dioxide that will be used in only food packaging materials, and 1 shipping container holds titanium dioxide that will be used as a direct food ingredient, then FDA's prior notice regulations will be triggered because the shipment contains an article of "food" that is being brought into the United States. (Only details of the containers holding "food" must be provided to FDA or CBP.)

Mixed-type facilities are discussed in the preamble of FDA's facility registration regulation.

Generally, a farm is exempt from registration unless it is a mixed-type facility. A mixed-type facility performs activities of a facility that is both ordinarily required to register and ordinarily exempt. An example of a farm that is a mixed-type facility is a farm that grows oranges and processes them into orange juice for sale to a distributor at the same physical location. However, if the farmer manufactures/processes the oranges into orange juice in a different physical location, the location where the oranges are grown is exempt as a farm and the facility where manufacturing/processing occurs must register.5

Although the above excerpt relates to farm activities, the "mixed-type" facility concept is not limited to farms, i.e., facilities that manufacture, hold, process, or pack food that is exempt under the regulation, i.e., food-contact substances, and food that is not exempt, e.g., a direct food additive, must be registered with FDA. Notably, if an imported substance is for food contact use only, but is from a mixed-type foreign facility, prior notice of import is not required because the shipment only contains product that is exempt from FDA's prior notice regulations.

Let's say, however, you have a foreign facility that manufactures titanium dioxide and the owner or operator of the facility has no idea whether the end-user will use this pigment in food, as a food contact substance, or for industrial uses, or all of the above. FDA considers the product as one that will be used for food if the owner, operator, or agent in charge of the facility has reason to believe that the substance will be directed to a food use. In other words, is it reasonably foreseeable that the product in question will be used in food or as a food ingredient? If the answer is yes, then the bioterrorism regulations on facility registration and prior notice of import will be triggered.

The above being said, there have been instances where a product falls outside the scope of the bioterrorism regulations but the product is improperly held at port. Such cases typically occur when the product is intended for use in food contact or industrial applications, and the product is commonly known as a food ingredient, like the pigment examples above. From a practical standpoint, an FDA or CBP official may look at the identity of the shipment and, if it is a product that has dual uses, place it in the category of "food" without considering it may be exempt from the bioterrorism regulations as a "food contact substance." Measures, however, can and should be taken by manufacturers, processors, packers, or holders of products that have dual uses. Some suggested measures are set forth below.

First, shipping invoices should clearly state that the product is intended for use as a food contact substance and/or in industrial applications only. For example, "For Use in Industrial Applications Only" "Not Intended for Direct Addition to Food." This should highlight to CBP and FDA that the shipment should not be classified as food and, thus, is exempt from FDA's registration and prior notice regulations.

Second, it is helpful for each shipping container used to hold the food contact substance and/or industrial-use product to be labeled to indicate that the shipment is not a food if this is not too great a burden. Again, language such as "For Use in Industrial Applications Only" "Not Intended for Direct Addition to Food" will highlight the fact that the shipment is exempt from prior notice and registration.

Third, the proper Harmonized Tariff Schedule (HTS) code should be used to identify a food contact substance or industrial use product; such coding will assist and highlight to FDA and CBP that the prior notice and registration regulations are not applicable. For example, the HTS code for corks and stoppers for use in wine bottles is 4503.10, whereas the HTS code for sparkling wine is 2204.10.00; the former HTS code would trigger the food contact substance exemption, while the latter HTS code would trigger the obligations under the regulations. While there is no guarantee that the HTS coding system will be a panacea, proper labeling on the shipping containers and/or shipping invoices, along with proper HTS coding, may significantly decrease the chance of products being improperly held or delayed at port.

Notably, FDA has compiled a list of HTS codes that apply to products for which FDA believes prior notice of import is or may be required. FDA has "flagged" these select HTS codes, which can be found on FDA's Web site, as either "FD3" or "FD4."

An "FD3" code indicates that FDA believes the article may be subject to prior notice; such a code is used for articles that have both food and non-food uses. For example HTS code 0301100000 for "Fish, Live, Ornamental" has an FD3 code. An "FD4" code indicates that FDA believes the article is a food that is subject to prior notice. For example, HTS code 0301100000 is for “Fish, Other, Live,” and has an FD4 code. FDA provided this list to CBP so that CBP can flag the HTS codes in its entry systems to help identify products for which prior notice to FDA is required. For products that have an FD3 designation, particularly when the product is only imported into the U.S. for use as a food contact substance or industrial application, the measures recommended above should be taken to further highlight to FDA and CBP that the shipment is not subject to FDA's prior notice regulations.


1 For a detailed analysis of the legislative history of these four regulations, see this month's Packaginglaw.com article entitled, Brief History of Bioterrorism Legislation: Keller & Heckman, SPI Defeat Law of Unintended Consequences. For a summary of each regulation, see the Packaginglaw.com article entitled, "FDA's Efforts to Implement Bioterrorism Act's Provisions: Rules on Registration, Import Notification, Recordkeeping, and Adminstrative Detention."

2 Section 409(h)(6) of the FD&C Act defines "food contact materials" as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food."

3 The "food contact substance" status under the remaining two regulations is as follows: (1) Administrative Detention: gives FDA the authority to order the detention of any article of food if there is "credible evidence" or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals; this regulation applies to food and food contact substances. As discussed elsewhere in this month's Focus, Keller and Heckman LLP, representing SPI, did not ask that food contact substances be exempt from administrative detention because this authority depends on the existence of credible evidence that the article is a threat to public safety, whether the article is a food, as this term is defined under the bioterrorism regulations, or a food packaging material; (2) Maintenance and Inspection of Records: the publication of this final rule has not occurred; however, based on FDA's action to exempt food contact substances under the prior notice and facility registration regulations, we hope that the exemption afforded to food contact substances will carry over to the recordkeeping regulation, as well. The publication of this final rule has been delayed several times, but FDA has announced that it will be published this year.

4 That definition states that food "means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."

5 See 68 Fed. Reg. 58894, 58906 (October 10, 2003).