**Compliance Policy Guide**

**Guidance for FDA and CBP Staff**

**Prior Notice of Imported Food\
Under the**

**Public Health Security and Bioterrorism Preparedness and Response Act
of 2002**

**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, August 2004, and November 2004**

**Compliance Policy Guide**

**Guidance for FDA and CBP Staff**

**Prior Notice of Imported Food\
Under the\
Public Health Security and Bioterrorism Preparedness\
and Response Act of 2002**

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\
240-632-6861\
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, August 2004, and November 2004**

TABLE OF CONTENTS

1.  [[Introduction]{.underline}](../cpgpn3.html#intro)

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1.  [[Background]{.underline}](../cpgpn3.html#bg)

2.  [[Regulatory Action Guidance]{.underline}](../cpgpn3.html#guidance)

    1.  Types of Violations

    2.  Actions in Response to Violations

    3.  Policy

        **Compliance Policy Guide**

        **Prior Notice of Imported Food Under the\
        Public Health Security and Bioterrorism Preparedness\
        and Response Act of 2002**

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**

**I. INTRODUCTION:**

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) (codified at 21 CFR 1.276 - 1.285)).

FDA\'s guidance documents, including this Compliance Policy Guide (CPG),
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.

**II. BACKGROUND:**

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:

1.  Food for an individual\'s personal use when it is carried by or
    otherwise accompanies the individual when arriving in the United
    States;

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1.  Food that was made by an individual in his/her personal residence
    and sent by that individual as a personal gift (i.e., for
    non-business reasons) to an individual in the United States;

2.  Food that is imported then exported without leaving the port of
    arrival until export;

3.  Meat food products that at the time of importation are subject to
    the exclusive jurisdiction of the U.S. Department of Agriculture
    (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601
    [et]{.underline} [seq]{.underline}.);

4.  Poultry products that at the time of importation are subject to the
    exclusive jurisdiction of USDA under the Poultry Products Inspection
    Act (21 U.S.C. 451 [et]{.underline} [seq]{.underline}.);

5.  Egg products that at the time of importation are subject to the
    exclusive jurisdiction of USDA under the Egg Products Inspection Act
    (21 U.S.C. 1031 [et]{.underline} [seq]{.underline}.).

6.  Prior notice also is not required under FDA requirements for food
    brought into the United States in a diplomatic pouch. The Vienna
    Convention on Diplomatic Relations (1961) provides: \"The diplomatic
    bag shall not be opened or detained.\" Art. 27(3): Any baggage or
    cargo marked \"diplomatic bag\" or \"diplomatic pouch\" is immune
    from search, including by electronic devices, and thus its contents
    are not subject to FDA\'s prior notice requirements.

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
section 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 CPG describes general 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:

1.  FDA and CBP will distribute information flyers at the ports.

2.  FDA and CBP plan to:

    1.  Gather data to track compliance with the prior notice
        requirements and to determine how best to use their resources to
        educate industry and the public in order to achieve full
        compliance.

    2.  Provide industry and the public with summary information about
        the level of compliance with the prior notice requirements,
        including data on the types of errors in submitted prior
        notices.

    3.  Provide the summary information on FDA\'s website at
        [[www.fda.gov]{.underline}](http://www.fda.gov/).

    4.  Utilize the data and summary information to assist the industry
        and the public in improving the submission of prior notice.

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, 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.

**III. REGULATORY ACTION GUIDANCE:**

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).

**A. Types of Violations**

1.  [Inadequate Prior Notice]{.underline}

    1.  [No Prior Notice]{.underline} - The article of food arrives at
        the port of arrival and no prior notice has been submitted and
        confirmed by FDA for review.

    2.  [Inaccurate Prior Notice]{.underline} - Prior notice has been
        submitted and confirmed by FDA for review, but upon review of
        the notice or examination of the article of food, the prior
        notice is determined to be inaccurate.

    3.  [Untimely Prior Notice]{.underline} - Prior notice has been
        submitted and confirmed by FDA for review, but the full time
        that applies under 21 CFR 1.279 for prior notice has not elapsed
        when the article arrives, unless FDA has already reviewed the
        prior notice, determined its response to the prior notice, and
        advised CBP of that response.

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1.  [Unregistered Facility]{.underline} - The article of food is
    imported or offered for import from a foreign facility that is not
    registered as required.

2.  [No PN Confirmation]{.underline}

    1.  When a copy of the Prior Notice (PN) Confirmation is required
        for food carried by or otherwise accompanying an individual, but
        cannot be provided by the individual.

    2.  When the PN Confirmation Number is not affixed to an article of
        food that arrives by international mail.

    3.  When the PN Confirmation Number for an article of food for which
        prior notice was submitted through PNSI is not provided to CBP
        or FDA upon arrival.

        **B. Actions in Response to Violations**

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1.  [Education/Communication]{.underline} - To the extent possible:

    1.  Distribute information flyers at the ports to carriers and
        others associated with the shipment of food.

    2.  Provide, to the extent practicable, notice of the violation and
        of the prior notice and registration requirements to the
        person(s) who transmits and/or files the prior notice.

    3.  When an article of food that is carried by or otherwise
        accompanying an individual is not for personal use and has
        inadequate prior notice or the individual cannot provide FDA or
        CBP with a copy of the prior notice (PN) confirmation, provide
        the individual with an information sheet on prior notice.

    4.  When an article of food arrives by international mail with
        inadequate prior notice or the PN confirmation number is not
        affixed, provide an information sheet on prior notice and
        forward the package to the addressee.

    5.  When an article of food is imported or offered for import for
        non-commercial purposes with a non-commercial shipper as set out
        below under Section C.4, provide an information sheet on prior
        notice to the importer, owner, consignee, or shipper.

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1.  [Assessment of CBP Civil Monetary Penalties]{.underline} - CBP, in
    consultation with FDA, may assess civil monetary penalties for
    violation of 19 U.S.C. 1595a(b) against any party who aids or abets
    the importation of any merchandise contrary to law.

2.  [Refusal]{.underline} - FDA, in consultation with CBP, may refuse
    admission of an article of food under section 801(m)(1) of the Act
    or place it under hold under section 801(l) of the Act for
    violations under sections 801(m) and 415 of the Act. If an article
    of food is refused or placed under hold under these provisions,
    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 (21 CFR 1.283(a) and 1.285(a),(b)). For food
    that is carried by or otherwise accompanying an individual, and is
    refused, and if, before leaving the port, the individual does not
    arrange to have the food held at the port or exported, the article
    of food shall be destroyed (21 CFR 1.283(b) and 1.285(h)). For food
    that arrives by international mail and is refused, if there is a
    return address, the parcel will be returned to sender stamped \"No
    Prior Notice - FDA Refused.\" If there is no return address, or if
    FDA determines that the article of food in the parcel appears to
    present a hazard, FDA may dispose of or destroy the parcel (21 CFR
    1.283(e) and 1.285(k)).

3.  The phrase [\"the action FDA and CBP staff typically should consider
    taking\"]{.underline} used in this CPG means that FDA and CBP staff,
    exercising enforcement discretion pursuant to their agency\'s
    policies and procedures, may take these actions or may take
    different or additional actions if they believe particular
    circumstances warrant them.

    **C. Policy**

    This policy provides guidance to FDA and CBP staff when they
    encounter the prior notice situations described within this section.

    The policy contains several references to Tables 1 and 2, which are
    set out below.

> Table 1 - Requirements for the Identity of the Manufacturer (see 21
> CFR 1.281)

+----------------------------------+-----------------------------------+
| **In the following               | **Provide the following           |
| circumstances**                  | information**                     |
+----------------------------------+-----------------------------------+
| 1\. Any article of food, when    | Name, Registration Number, City,  |
| the facility that manufactured   | and Country of the facility that  |
| the food [is                     | manufactured the food.            |
| required]{.underline} to be      |                                   |
| registered.                      |                                   |
+----------------------------------+-----------------------------------+
| 2\. Any article of food, when    | Name, Street Address, City, and   |
| the facility that manufactured   | Country of the facility that      |
| the food [is not                 | manufactured the food, as well as |
| required]{.underline} to be      | a reason code identifying this    |
| registered.                      | situation and the reason the      |
|                                  | facility is not required to be    |
|                                  | registered.                       |
+----------------------------------+-----------------------------------+
| 3\. An article of food that is   | Name, Street Address (or          |
| for transshipment, storage and   | Registration Number in lieu of    |
| export, or further manipulation  | Street Address), City, and        |
| and export.                      | Country of the facility that      |
|                                  | manufactured the food.            |
+----------------------------------+-----------------------------------+
| 4\. An article of food that is   | Name, Registration Number (or     |
| sent by an individual as a       | Street Address if the facility is |
| personal gift (i.e., for         | not required to be registered),   |
| nonbusiness reasons) to an       | City, and Country of the facility |
| individual in the United States. | that manufactured the food        |
| Note: Under this circumstance,   |                                   |
| you should also refer to Section | or                                |
| C.3. of this CPG.                |                                   |
|                                  | Name and Address of the firm that |
|                                  | appears on the label under 21 CFR |
|                                  | 101.5.                            |
+----------------------------------+-----------------------------------+

> Table 2 - Enforcement Discretion Policy for the Identity of the
> Manufacturer

+-----------------------------------+-----------------------------------+
| **If, after a good faith effort,  | **Then the person submitting      |
| the person submitting prior       | prior notice should provide . .   |
| notice does not know . . .**      | .**                               |
+-----------------------------------+-----------------------------------+
| 1\. The Registration Number of    | Name, Street Address, City, and   |
| the facility that manufactured    | Country of the facility that      |
| the food (and the facility [is    | manufactured the food, and a      |
| required]{.underline} to be       | reason code identifying this      |
| registered).                      | situation.\*                      |
+-----------------------------------+-----------------------------------+
| 2\. Either the Registration       | Name, Street Address, City, and   |
| Number or the name and full       | Country of the headquarters of    |
| address of the facility that      | the facility that manufactured    |
| manufactured the food.            | the food, and a reason code       |
|                                   | identifying this situation.\*     |
+-----------------------------------+-----------------------------------+
| 3\. The information in items 1    | Name, Street Address, City, and   |
| and 2 of this table.              | Country of the invoicing firm,    |
|                                   | and a reason code identifying     |
|                                   | this situation.\*                 |
+-----------------------------------+-----------------------------------+
| \* Notes for Table 2:             |                                   |
|                                   |                                   |
| -   If the facility that          |                                   |
|     manufactured the food is a    |                                   |
|     foreign facility that is      |                                   |
|     required to be registered and |                                   |
|     either its registration       |                                   |
|     number is not provided or the |                                   |
|     name and address of a         |                                   |
|     different facility (i.e., the |                                   |
|     manufacturing facility's      |                                   |
|     headquarters or the invoicing |                                   |
|     firm) is provided, then it    |                                   |
|     will be more difficult and/or |                                   |
|     may take more time for FDA    |                                   |
|     and CBP to verify the         |                                   |
|     identity of the manufacturing |                                   |
|     facility and its registration |                                   |
|     status and to determine       |                                   |
|     whether the article of food   |                                   |
|     is subject to being held      |                                   |
|     under section 801(l) of the   |                                   |
|     Act. As a result, if an       |                                   |
|     article of food is imported   |                                   |
|     or offered for import with    |                                   |
|     the alternative information   |                                   |
|     provided in Table 2 in lieu   |                                   |
|     of the identity of the        |                                   |
|     facility that manufactured    |                                   |
|     the food, and if FDA has      |                                   |
|     concerns that the food may    |                                   |
|     pose a serious health threat, |                                   |
|     then the food may be delayed  |                                   |
|     at the port of arrival until  |                                   |
|     the verification is           |                                   |
|     completed.                    |                                   |
|                                   |                                   |
| -   As with other types of prior  |                                   |
|     notice violations, FDA may    |                                   |
|     consider the failure to       |                                   |
|     provide required information  |                                   |
|     about the facility that       |                                   |
|     manufactured the food as a    |                                   |
|     factor in determining whether |                                   |
|     and where to examine the      |                                   |
|     article of food.              |                                   |
|                                   |                                   |
| -   We intend to reject prior     |                                   |
|     notice submissions unless the |                                   |
|     prior notice includes a valid |                                   |
|     registration number           |                                   |
|     [or]{.underline} an           |                                   |
|     appropriate reason code       |                                   |
|     selected from among those     |                                   |
|     provided in [the Prior Notice |                                   |
|     System Interface              |                                   |
|     (PNSI)]{.underline} and [the  |                                   |
|     Automated Broker Interface of |                                   |
|     the Automated Commercial      |                                   |
|     System (ABI/ACS) (see         |                                   |
|     Appendix 1)]{.underline}.     |                                   |
|     Rejected submissions are not  |                                   |
|     confirmed for FDA review.     |                                   |
+-----------------------------------+-----------------------------------+

1.  [Shipments of food, other than food covered by another section of
    this CPG]{.underline}

> In general, 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.
>
> a\. *Manufacturer*. Table 1 lists the prior notice requirements for
> providing information about the identity of the manufacturer for an
> article of food that is no longer in its natural state. If there is a
> prior notice violation because this information is not provided, FDA
> and CBP should typically consider not taking any regulatory action
> under the circumstances described in the first column of Table 2 if
> the information in the second column of that table is provided.

b.  *Express Courier*

If prior notice is inadequate because it does not include the required
anticipated arrival information and/or planned shipment information, FDA
and CBP should typically consider not taking any regulatory action if:

1.  The article of food is imported or offered for import via an express
    courier;

2.  The person submitting prior notice is not the express courier;

3.  The prior notice is submitted via the Prior Notice System Interface
    (PNSI); and

4\) The prior notice includes the shipment's tracking number in lieu of
the required anticipated arrival information and/or planned shipment
information.

c.  *Time Frame*

> FDA and CBP should typically consider not taking any regulatory action
> if there is a prior notice violation because the prior notice was
> submitted more than 5 calendar days before the anticipated date of
> arrival, provided that: (1) the prior notice was submitted less than
> 10 calendar days before the anticipated date of arrival; and (2) the
> prior notice was submitted through the Prior Notice System Interface
> (PNSI). In addition, under the same conditions, FDA should typically
> provide the Prior Notice Confirmation Number when prior notice has
> been confirmed for review even if prior notice was submitted more than
> 5 calendar days before the anticipated date of arrival. Because of the
> way the Automated Broker Interface of the Automated Commercial System
> (ABI/ACS) is programmed, when prior notice is submitted through
> ABI/ACS, the Prior Notice Confirmation Number cannot be provided more
> than 5 calendar days before the anticipated date of arrival.
>
> Please note that if any of the prior notice information, except the
> anticipated arrival information, the estimated quantity, or the
> planned shipment information, changes after FDA has confirmed the
> prior notice submission for review, the prior notice must be
> resubmitted (21 CFR 1.282(a)). The resubmission must be confirmed by
> FDA for review no less than 2, 4, or 8 hours before arriving at the
> port of arrival, with the minimum time depending on the mode of
> transportation (21 CFR 1.279(a)). If prior notice is resubmitted, the
> previous prior notice should be cancelled (21 CFR 1.282(b)).

2.  [Food carried by or otherwise accompanying an individual that is not
    for personal use]{.underline}

    In general, 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.

> *Manufacturer*. Table 1 lists the prior notice requirements for
> providing information about the identity of the manufacturer for an
> article of food that is no longer in its natural state. If there is a
> prior notice violation due to the fact that this information is not
> provided, FDA and CBP should typically consider not taking any
> regulatory action under the circumstances described in the first
> column of Table 2 if the information in the second column of that
> table is provided.

3.  [Food imported or offered for import for non-commercial purposes
    with a non-commercial shipper, irrespective of the type of
    carrier]{.underline}

    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:

-   food in household goods, including military, civilian, governmental
    agency, and diplomatic transfers;

-   food purchased by a traveler and mailed or shipped to the
    traveler\'s U.S. address by the traveler, not the commercial
    establishment; and

-   gifts purchased at a commercial establishment and shipped by the
    purchaser, not the commercial establishment.

    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 policy described
    above 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.)

4.  [Food arriving by international mail that is **not** food imported
    or offered for import for non-commercial purposes with a
    non-commercial shipper]{.underline}

    In general, 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.

> *Manufacturer*. Table 1 lists the prior notice requirements for
> providing information about the identity of the manufacturer for an
> article of food that is no longer in its natural state. If there is a
> prior notice violation because this information is not provided, FDA
> and CBP should typically consider not taking any regulatory action
> under the circumstances described in the first column of Table 2 if
> the information in the second column of that table is provided.

5.  [Gift Pack purchased or otherwise acquired by an individual and
    imported or offered for import for non-business
    purposes]{.underline}

> FDA and CBP staff should typically consider not taking regulatory
> action if there is a prior notice violation because a single prior
> notice is submitted for a gift pack and the identity of the facility
> that packed the gift pack is submitted in lieu of the identity of the
> manufacturer, provided that the gift pack is purchased or otherwise
> acquired by an individual and imported or offered for import for
> non-business purposes. The person submitting the prior notice should
> provide the appropriate reason code, selected from among those
> provided in the Prior Notice System Interface (PNSI) and the Automated
> Broker Interface of the Automated Commercial System (ABI/ACS) (see
> Appendix 1).
>
> Food is considered to be for non-business purposes when it is not for
> sale, resale, barter, business use, or commercial use. The policy
> described in this section applies irrespective of where the individual
> who purchased or otherwise acquired the gift pack lives and
> irrespective of the type of carrier. While the policy also applies
> irrespective of whether it involves a commercial or non-commercial
> shipper, please note that the guidance contained in section C.3 of
> this CPG applies to gift packs, and other foods, that are imported or
> offered for import for non-commercial purposes with a non-commercial
> shipper. More information about non-commercial purposes, the
> difference between shippers and carriers, and the difference between
> commercial and non-commercial shippers is contained in section C.3 of
> this CPG.
>
> For the purpose of this CPG, gift packs are considered to be food that
> is described with FDA Product Code 37Y\--01 (human food) or FDA
> Product Code 72E\--99 (animal food). Examples of gift packs that may
> be covered are:

-   A gift basket containing fresh fruit and/or vegetables.

-   A gift box containing crackers and cheeses and canned condensed
    soups.

-   A gift basket of crackers, cheeses and fresh fruit.

-   A wicker basket with champagne, port, scotch whisky, smoked salmon,
    cheese, tea, coffee, chutney, pistachio nuts, biscuits, marmalade,
    honey, butter biscuits, crackers, cake, mustard, olive oil, and
    olives.

-   Tote bag with infant clothing, bib, booties, and coffee and candy
    for the parents; or a toy dispenser with hard candy and powdered
    candy.

-   A gift bag with multiple pet food items such as rawhide chews and
    dog biscuits, with or without non-food items.

6.  [Food imported or offered for import for quality assurance, research
    or analysis purposes only, not for human or animal consumption or
    resale]{.underline}

    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, then FDA and CBP should
    follow the enforcement policies described in section C.1. of this
    CPG. Please note that with respect to item 1 of Table 2, there is a
    specific reason code for samples of food that are imported or
    offered for import for quality assurance, research or analysis
    purposes (see Appendix 1). This reason code should be used when it
    is applicable.

    For the purpose of this CPG, 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).

    Appendix 1: Reason Codes for Registration Number of Manufacturer Not
    Provided

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A.  Facility is out of business

B.  Facility is private residence (21 CFR 1.227(b)(2))

C.  Facility is a restaurant (21 CFR 1.226(d); 1.227(b)(10))

D.  Facility is retail food establishment (21 CFR 1.226(c); 1.227(b)
    (11))

E.  Facility is non‑processing fishing vessel (21 CFR 1.226(f))

F.  Facility is non‑bottled drinking water collection and distribution
    establishment (21 CFR 1.227(b)(2))

G.  Individual gift ‑ label name/address in lieu of registration number
    (21 CFR 1.281(a)(6), (b)(5), and (c)(6))

H.  Grower ‑ satisfies farm exemption (21 CFR 1.226(b); 1.227(b)(3))

I.  Samples -- quality assurance, research or analysis purposes only

J.  U.S. manufacturing facility that is not required to register

K.  Unable to determine the registration number of the manufacturer.

L.  Unable to determine identity of manufacturer - providing identity of
    manufacturer's headquarters

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M.  Unable to determine identity of manufacturer or headquarters -
    providing invoicing firm's identity

O. Gift pack for non-business purposes -- providing single prior notice
and identity of packer

Issued: \[December 2003\]

Revised: \[June 2004\]

Revised: \[August 2004\]

Revised: \[November 2004\]