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December 2003; Revised June 2004 and August 2004
Comments and suggestions regarding this Compliance Policy Guide (CPG) should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with docket number 2003D-0554.
For questions regarding this CPG, contact:
Domenic Veneziano, Director
Prior Notice Center
703-621-7809
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Department of Homeland Security
U.S. Customs and Border Protection
Issued December 2003
Revised June 2004 and August 2004
Additional copies are available from:
Division of Compliance Policy HFC-230
Office of Enforcement
Office of Regulatory Affairs
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Send two self-addressed adhesive labels to assist that office
in processing your request or fax your request to
301-827-0482
Copies available on-line at
http://www.fda.gov/ora/compliance_ref/cpg/default.htm
Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs (ORA)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
Department of Homeland Security
U.S. Customs and Border Protection (CBP)
Issued December 2003
Revised June 2004 and August 2004
TABLE OF CONTENTS
This guidance document represents the Food and Drug Administration's (FDA) and Customs and Border Protection's (CBP) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA, CBP, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Sec. 110.310: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The purpose of this document is to provide guidance on FDA's and CBP's strategy for enforcing and otherwise achieving compliance with the requirements of the interim final rule for submitting prior notice for food imported or offered for import into the United States (68 Fed. Reg. 58974 (Oct.10, 2003) (to be codified at 21 CFR 1.276 - 1.285)).
FDA's guidance documents, including this Compliance Policy Guide, do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidance documents means that something is suggested or recommended, but not required.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), section 307, added section 801(m) to the Federal Food, Drug, and Cosmetic Act (the Act) to require that FDA receive prior notice for food imported or offered for import into the United States. Section 801(m) also provides that if an article of food arrives at the port of arrival with inadequate prior notice (e.g., no prior notice, inaccurate prior notice, or untimely prior notice), the food is subject to refusal of admission under section 801(m)(1) of the Act and may not be delivered to the importer, owner, or consignee. If an article of food is refused under section 801(m)(1) of the Act, unless CBP concurrence is obtained for export and the article is immediately exported from the port of arrival under CBP supervision, it must be held within the port of entry for the article unless directed by CBP or FDA.
The Bioterrorism Act, section 305, also amended Chapter IV of the Act by adding section 415 to require domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA, and amended Chapter VIII of the Act by adding section 801(l) to require any food for human and animal consumption from an unregistered foreign facility that is imported or offered for import to be held at the port of entry until the foreign facility has been registered.
On October 10, 2003, FDA and CBP issued interim final regulations establishing the requirements for registration and requiring that FDA receive prior notice of the importation of food beginning on December 12, 2003 (68 FR 58994 and 68 FR 58974). For the purposes of prior notice, "food" has the meaning given in section 201(f) of the Act, and is defined as (1) articles of food or drink for man or other animals, (2) chewing gum, and (3) articles used as components of any such article, except that it does not include food contact substances or pesticides. The requirements for prior notice do not apply to:
Information required to be submitted in a prior notice includes, with certain exceptions, the registration numbers assigned to the foreign manufacturer's and shipper's facilities that are associated with the article of food. FDA's monitoring of compliance by foreign facilities with the requirement to register under section 415 of the Act will be accomplished primarily through the prior notice review process. If an article of food is from a foreign manufacturer that is not registered as required and is imported or offered for import, then the food is subject to refusal under section 801(m)(1) of the Act for failure to provide adequate prior notice. Likewise, the failure to provide the correct registration number of the relevant foreign manufacturer, if registration is required, renders the identity of that facility incomplete for purposes of prior notice. In addition, if an article of food is imported or offered for import from any foreign facility that is not registered as required, then the food is subject to being held under 801(l) of the Act.
In the preamble to the interim final rule, FDA stated that it planned to provide guidance to its staff regarding the agency's enforcement policies. Accordingly, this Compliance Policy Guide establishes policies regarding the enforcement of the prior notice requirements, including the requirement to provide a required registration number.
The requirements for submitting prior notice to FDA were effective beginning December 12, 2003. During the first eight months following this effective date, FDA and CBP focused their resources on education to achieve compliance with the prior notice requirements. The agencies will continue this education and outreach, including the following:
FDA may consider the failure to provide adequate prior notice as a factor in determining whether and where to examine an article of food. However, during this eight-month period and after, if FDA decides not to refuse an article of food under 21 CFR 1.283 or 1.285, this decision has no bearing on whether the article of food is admissible or will be granted admission under other provisions of the Act or other U.S. laws. Thus, for food that is imported or offered for import, FDA will continue its normal review, investigative, and enforcement activities for food safety and security concerns to determine whether the food is subject to refusal under section 801(a) of the Act. In addition, if FDA decides not to refuse an article of food under 21 CFR 1.283 or 1.285, this decision does not affect FDA's ability to initiate other types of actions -- such as seizures, injunctions, prosecutions, or debarments under sections 302, 303, 304, and 306 of the Act -- that may be necessary. Likewise, it does not affect CBP's ability to initiate other types of actions that may be necessary.
FDA's Prior Notice Review Center, in conjunction with CBP headquarters, should use the information below to make decisions about whether to refuse a shipment of food pursuant to 21 CFR 1.283 or 1.285 or take other actions for violations under sections 801(m) and 415 of the Act.
The following definitions and descriptions apply to this compliance policy guide (CPG).
Shipments of food, other than food covered by another section of this CPG
After August 12, 2004, for any prior notice violation, the action FDA and CBP staff typically should consider taking is refusal and/or assessment of CBP Civil Monetary Penalties. This does not apply if the article of food is covered by another section listed below.
However, until November 1, 2004, the paragraph above does not apply to prior notice violations that are due to the fact that:
In those situations, FDA and CBP should typically consider not taking any regulatory action. If, however, the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties.
Food carried by or otherwise accompanying an individual implementing 21 CFR 1.283(b) and 1.285(h)
After August 12, 2004, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent prior notice violations and refusal for all other prior notice violations. This applies to food carried by or otherwise accompanying an individual. Prior notice is not required when an article of food is carried by or otherwise accompanying an individual and is for personal use.
However, until November 1, 2004, the paragraph above does not apply to prior notice violations that are due to the fact that:
In those situations, FDA and CBP should typically consider not taking any regulatory action. If, however, the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties.
Food arriving by international mail other than food imported or offered for import for non-commercial purposes with a non-commercial shipper implementing 21 CFR 12.83(e) and 1.285(k)
After August 12, 2004, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent prior notice violations and refusal for all other prior notice violations. This applies to food arriving by international mail other than food imported or offered for import for non-commercial purposes with a non-commercial shipper.
However, until November 1, 2004, the paragraph above does not apply to prior notice violations that are due to the fact that:
In those situations, FDA and CBP should typically consider not taking any regulatory action. If, however, the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties.
Food imported or offered for import for non-commercial purposes with a non-commercial shipper, irrespective of the type of carrier implementing 21 CFR 1.281(a)(6) and (b)(5)
FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for non-commercial purposes with a non-commercial shipper. Generally, staff should consider a non-commercial purpose to be when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.)
Examples of foods imported or offered for import that may be covered by this non-commercial category are:
Note that the shipper and the carrier are different entities, and the carrier is likely to be a commercial entity even when the shipper is an individual. Thus, the food for non-commercial purposes may arrive by international mail or any other mode of transportation, but must be shipped by one individual to another individual (self, family member, or friend) to be considered for non-commercial purposes. For example, when an individual ships his or her own household goods, even when the goods are delivered to a mover or carrier for international movement, the individual is the shipper, e.g., the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States (see § 1.276(b)(12) of the prior notice interim final rule). In another example, when an individual purchases food at Store A and sends that food to an individual by mail, the individual is the shipper and the carrier is the mail service. If the individual uses an express courier, the result is the same: the individual is the shipper and the express courier is the carrier. However, if Store A ships the food, Store A is the shipper. Since Store A is not an individual, this last example is not covered by the criteria because the food was not imported or offered for import with a non-commercial shipper. (While a "person" sometimes can be an individual, partnership, corporation, or association, see 21 U.S.C. 321(e), by "individual" we mean a sole human being, not a partnership, corporation, or association.)
Food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale
If prior notice is inadequate because it does not include the registration number assigned to the manufacturing facility that is associated with the article of food, FDA and CBP should typically consider not taking any regulatory action if the article of food is imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale.
For the purpose of this compliance policy guide, samples of food are considered to be imported or offered for import for quality assurance, research or analysis purposes when they are imported in small quantities (i.e., quantities consistent with the quality assurance, research, or analysis purposes) and the entire sample is used up by the analysis or is destroyed after analysis or a reasonable retention period after analysis. The analysis may include sensory analysis or evaluations such as those organoleptic analyses for testing the quality of tea or for testing for histamines. Evidence that an article of food is imported for quality assurance, research, or analysis purposes only might include, among other evidence, that the food and shipment documents are marked accordingly. The policy in this section does not apply to samples intended for test marketing, such as tasting at trade shows or product promotional tasting events.
Information about when samples are "food" for the purposes of prior notice is provided in the 2nd Edition of Guidance for Industry, Prior Notice of Imported Food, Questions and Answers, May 2004. This guidance states that, in general, prior notice is required for samples of food, including animal feed, for research and development and test marketing (Q&A, Section C., Question 1.3). However, if the samples are items that are in such early stages of research and development that they cannot yet be considered food for the purposes of prior notice, then they would not be subject to prior notice requirements (Q&A, Section C., Question 1.3). In addition, if the sample is in a form that is not an article of food, such as a slurry of lettuce for pesticide analysis or a sterile sample container filled with juice for heavy metal analysis, then prior notice would not apply (Q&A, Section C., Question 17.2).
Issued: [December 2003]
Revised: [June 2004]
Revised: [August 2004]
The above document supercedes the previous version issued in June 2004.