FDA Revises its "Q&A" on the Registration of Food Facilities

(On October 10, 2003, the FDA issued an interim final rule that requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA by December 12, 2003.)

According to the FDA, the first edition of its Q&A was issued as Level 2 guidance pursuant to 21 CFR 10.115 and was made available on the FDA's Web site on December 4, 2003. However, FDA states that this revision (Edition 2) is being issued as Level 1 guidance and includes answers to new questions regarding the implementation of its October 10, 2003 interim final rule on the registration of food facilities.

(21 CFR 10.115 characterizes Level 1 guidance documents as those that (a) set forth initial interpretations of statutory or regulatory requirements; (b) set forth changes in interpretation or policy that are more than minor in nature; (c) include complex scientific issues; or (d) cover highly controversial issues. Level 2 guidance documents are characterized as those that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.)

Highlights of FDA's Revised Q&A

The following are highlights of the new questions included in the FDA's revision of its Q&A, which takes effect immediately (partial list):

Post offices and similar facilities owned or operated by express couriers. The FDA states that for purposes of its registration interim final rule, post offices and express courier facilities are not required to be registered with FDA as food facilities.

According to FDA, the activities of both postal services and express courier services are focused on the transport of goods; their facilities generally serve only as a point of transfer of packages and other freight, including packages containing food. Thus, it is appropriate to view both types of facilities as part of the transportation process.

The FDA states that the definition of "facility" in its interim final rule (21 CFR 1.226(b)(2)) does not include transportation vehicles "if they hold food only in the usual course of business as carriers."

According to the FDA, although the registration interim final rule does not define "transportation vehicles," the proposed rule on the establishment and maintenance of records (published in the May 9, 2003 Federal Register) defines "transporter" as "a person who has possession, custody, or control of an article of food -- for the sole purpose of transporting the food." FDA believes that it is appropriate to apply this same rationale to exclude from registration facilities that house food only because they are part of the process of transporting it from one location to another. FDA states that this analysis is also consistent with the definition of "facility" in 21 CFR 1.227(b)(2).

Thus, for the purpose of the registration interim final rule, FDA states that post offices and express courier facilities operating in a manner comparable to post offices that are part of the transportation network and have possession, custody, or control of food for the sole purpose of transporting it are not required to be registered with FDA.

Truck terminals and freight forwarders with food on their premises. The FDA states that truck terminals and other stationary facilities that serve merely to assist transportation vehicles in the process of transporting food are not required to be registered with FDA.

According to the FDA, the above analysis for post offices and similar facilities is also applicable here. Thus, for the purpose of the registration interim final rule, truck terminals and freight forwarders that are part of the transportation network and have possession, custody, or control of food for the sole purpose offacilitating its transport are not required to be registered with FDA.

The FDA notes that this response is not completely consistent with certain prior guidance, but that it has further considered this issue, as well as related ones, resulting in a revision of its earlier guidance.

Definition of "owner," "operator," and "agent in charge." The FDA states that the owner, operator, or agent in charge is a person (21 USC 321(e)) who has an ownership interest in, or management authority of, a facility or a portion of a facility (e.g., a lessee of a part of a public warehouse).

Definition of "parent company." FDA states that the term "parent company" is used in 21 CFR 1.232(b) and is intended to have the meaning it has in the corporate context. If a facility is part of a company that is owned by another corporation, then the corporation would be the parent company.

Who must register in a lessor-lessee relationship, such as a food-producing business that rents space from a landlord. According to the FDA, either the lessor or the lessee may register the facility as follows.

The Bioterrorism Act and the FDA's interim final rule on the registration of food facilities place the duty to register a facility on the owner, operator, or agent-in-charge of the facility. Each of these persons has an independent obligation to comply with the registration requirement, and any one of them may satisfy the obligation for the other two. On the other hand, if a facility is not registered, FDA could proceed with an enforcement action against one or all of the three. A facility is defined as "any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States."

Thus, for a public warehouse, FDA states that either the owner of the entire warehouse may register the warehouse and satisfy the obligation for all lessees, or an individual lessee, functioning as the operator or agent-in-charge of the portion of the warehouse he/she leases, may register that portion of the facility.

(See ITT's Online Archives or 12/11/03 news, 03121130, for BP summary of the FDA's initial Q&A, dated December 2003.)

(See ITT's Online Archives or 11/10/03 news, 03111010, for Part XIV (with links to Parts I-XIII) of BP's series of summaries on this interim final rule, as well as on the FDA's interim final rule requiring prior notice of imported food.)

FDA's revised Q&A (dated January 12, 2004) available at http://www.cfsan.fda.gov/dms/ffregui2.html.

BP Note

BP is checking with U.S. government sources to see whether its decision, to exempt from registering with the FDA truck terminals, freight forwarders, and postal and express courier services that are part of the transportation network and have possession, custody, or control of food for the sole purpose of facilitating its transport, will also affect Customs brokers.