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 Dockets Management Branch (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:**

**Office of Regional Operations**

**Joe McCallion @ 301-443-6553**

**or**

**Ted Poplawski @ 301-443-6553**

**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**

**U.S. Department of Homeland Security**

**Bureau of Customs and Border Protection**

**December 2003**

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*

*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 you request to*

*301-827-0842*

*Copies available on-line at*

http://www.fda.gov/ora/compliance_ref/cpg/default.htm

.

**U.S. 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)**

**U.S. Department of Homeland Security**

**Bureau of Customs and Border Protection (CBP)**

**December 2003**

**TABLE OF CONTENTS**

**INTRODUCTION 4**

**BACKGROUND 5**

**POLICY 8**

**REGULATORY ACTION GUIDANCE 9**

**Types of Violations 10**

**Categories of Violations 11**

**Actions in Response to Violations 11**

**Tables 14**

**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

**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) (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.

**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;

\(2\) 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;

\(3\) Food that is imported then exported without leaving the port of
arrival until export;

\(4\) 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}.);

\(5\) 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}.); or

\(6\) 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}.).

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. FDA also stated its intent to provide a transition period,
during which it would emphasize education on the prior notice
requirements to help industry achieve compliance with the regulation.
Accordingly, this Compliance Policy Guide establishes policies regarding
the enforcement of the prior notice requirements, including the
requirement to provide a required registration number.

**Policy:**

The requirements for submitting prior notice to FDA are effective
beginning December 12, 2003. However, as described below, during the
first eight months following this effective date, FDA and CBP plan to
focus their resources on education to achieve compliance with the prior
notice requirements. While educational efforts will be made in response
to specific violations, FDA and CBP also intend to continue their broad,
pro-active educational initiatives during the initial eight-month
period, including the following:

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

2.  FDA and CBP plan to:

    a.  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.

    b.  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.

    c.  Provide the summary information on FDA's website at
        [www.fda.gov](http://www.fda.gov/).

    d.  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, 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.

**REGULATORY ACTION GUIDANCE:**

FDA's Prior Notice Review Center, in conjunction with CBP headquarters,
should use the Number range CHAPTERtables below to make decisions about
whether to refuse a shipment of food pursuant to 21 CFR 1.283 or 1.285
for violations under sections 801(m) and 415 of the Act.

The following definitions and descriptions apply to the tables.

**Types of Violations**

A. [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.

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

C. [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.

**Categories of Violations**

[Category 1 Violations]{.underline} - Available credible evidence or
information, including information in the prior notice, if any,
indicates that the article presents a threat of serious adverse health
consequences or death to humans or animals.

[Category 2 Violations]{.underline} - The violation:

> \(a\) Reflects a history of repeated conduct of a similar nature by a
> person who has been notified of such violations; or
>
> \(b\) Appears to be intentional or flagrant.

[Category 3 Violations]{.underline} - All violations other than those
that fall within Category 1 or 2.

**Actions in Response to Violations**

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

> \(a\) Distribute information flyers at the ports to carriers and
> others associated with the shipment of food.
>
> \(b\) 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.
>
> \(c\) 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.

\(d\) 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.

[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.

[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).

**Table 1 - Implementing 21 CFR 1.283(a) and 1.285(a), (b).**
**Shipments of food, other than food carried by or otherwise
accompanying an individual or food arriving by international mail.**
Table 1 describes actions FDA and CBP staff typically should consider
taking when an article of food is imported or offered for import into
the United States with inadequate prior notice. It does not apply to
food arriving by international mail or food carried by or otherwise
accompanying an individual.

**Table 2 - Implementing 21 CFR 1.283(b) and 1.285(h).** **Food carried
by or otherwise accompanying an individual.** Table 2 describes actions
FDA and CBP staff typically should consider taking 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 PN confirmation.

**Table 3 - Implementing 21 CFR 1.283(e) and 1.285(k).** **Food arriving
by international mail.** Table 3 describes actions FDA and CBP staff
typically should consider taking when an article of food arrives by
international mail with inadequate prior notice or the PN confirmation
number is not affixed as required.

The phrase \"[the action FDA and CBP staff typically should consider
taking]{.underline}\" used in the tables means that FDA and CBP staff,
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.

**Table 1: Implementing 21 CFR 1.283(a) and 1.285(a), (b). Shipments of
food, other than food carried by or otherwise accompanying an individual
or food arriving by international mail.^\*^**

+------------+-------------+-------------+-------------+-------------+
| **If the   | **and if    | **then for  | **then for  | **then for  |
| violation  | the         | violations  | violations  | violations  |
| occurs:**  | violation   | that fall   | that fall   | that fall   |
|            | is due      | within      | within      | within      |
|            | to:**       | [Category   | [Category   | [Category   |
|            |             | 3]{.        | 2]{.        | 1]{.        |
|            |             | underline}, | underline}, | underline}, |
|            |             | the action  | the action  | the action  |
|            |             | FDA and CBP | FDA and CBP | FDA and CBP |
|            |             | staff       | staff       | staff       |
|            |             | typically   | typically   | typically   |
|            |             | should      | should      | should      |
|            |             | consider    | consider    | consider    |
|            |             | taking      | taking      | taking      |
|            |             | is:**       | is:**       | is:**       |
+============+=============+=============+=============+=============+
| December   | \(1\) No    | Education/  | Education/  | Refusal and |
| 12, 2003   | prior       | com         | com         | possible    |
| to         | notice      | munication. | munication. | CBP civil   |
|            |             | Analysis of | Analysis of | monetary    |
| March 12,  |             | data for    | data for    | penalties.  |
| 2004       |             | compliance  | compliance  |             |
|            |             | action.     | action.     |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\)       | Education/  | Education/  | Refusal and |
|            | Inaccurate  | com         | com         | possible    |
|            | prior       | munication. | munication. | CBP civil   |
|            | notice,     | Analysis of | Analysis of | monetary    |
|            | untimely    | data for    | data for    | penalties.  |
|            | prior       | compliance  | compliance  |             |
|            | notice, or  | action.     | action.     |             |
|            | an          |             |             |             |
|            | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
| March 13,  | \(1\) No    | Education/  | Assessment  | Refusal and |
| 2004       | prior       | com         | of CBP      | possible    |
|            | notice      | munication. | civil       | CBP civil   |
| to         |             | Analysis of | monetary    | monetary    |
|            |             | data for    | penalties.  | penalties.  |
| May 12,    |             | compliance  |             |             |
| 2004       |             | action.     |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\)       | Education/  | Education/  | Refusal and |
|            | Inaccurate  | com         | com         | possible    |
|            | prior       | munication. | munication. | CBP civil   |
|            | notice,     | Analysis of | Analysis of | monetary    |
|            | untimely    | data for    | data for    | penalties.  |
|            | prior       | compliance  | compliance  |             |
|            | notice, or  | action.     | action.     |             |
|            | an          |             |             |             |
|            | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
| May 13,    | \(1\) No    | Refusal.    | Refusal     | Refusal and |
| 2004       | prior       |             | and/or      | possible    |
|            | notice      |             | assess CBP  | CBP civil   |
| to         |             |             | civil       | monetary    |
|            |             |             | monetary    | penalties.  |
| August 12, |             |             | penalties.  |             |
| 2004       |             |             |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\)       | Education/  | Assess CBP  | Refusal and |
|            | Inaccurate  | com         | civil       | possible    |
|            | prior       | munication. | monetary    | CBP civil   |
|            | notice,     | Analysis of | penalties.  | monetary    |
|            | untimely    | data for    |             | penalties.  |
|            | prior       | compliance  |             |             |
|            | notice, or  | action.     |             |             |
|            | an          |             |             |             |
|            | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
| After      | \(1\) No    | Refusal     | Refusal     | Refusal and |
|            | prior       | and/or      | and/or      | possible    |
| August 12, | notice      | assess CBP  | assess CBP  | CBP civil   |
| 2004       |             | Civil       | civil       | monetary    |
|            |             | Monetary    | monetary    | penalties.  |
|            |             | Penalties.  | penalties.  |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\)       | Refusal     | Refusal     | Refusal and |
|            | Inaccurate  | and/or      | and/or      | possible    |
|            | prior       | Assess CBP  | Assess CBP  | CBP civil   |
|            | notice,     | civil       | civil       | monetary    |
|            | untimely    | monetary    | monetary    | penalties.  |
|            | prior       | penalties.  | penalties.  |             |
|            | notice, or  |             |             |             |
|            | an          |             |             |             |
|            | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+

**^\*^** Definitions and descriptions of the types of violations,
categories of violations, and actions in response to violations are
given above.

**Table 2: Implementing 21 CFR 1.283(b) and 1.285(h). Food carried by or
otherwise accompanying an individual.^\*^**

+------------+-------------+-------------+-------------+-------------+
| **If the   | **and if    | **then for  | **then for  | **then for  |
| violation  | the         | violations  | violations  | violations  |
| occurs:**  | violation   | that fall   | that fall   | that fall   |
|            | is due      | within      | within      | within      |
|            | to:**       | [Category   | [Category   | [Category   |
|            |             | 3]{.        | 2]{.        | 1]{.        |
|            |             | underline}, | underline}, | underline}, |
|            |             | the action  | the action  | the action  |
|            |             | FDA and CBP | FDA and CBP | FDA and CBP |
|            |             | staff       | staff       | staff       |
|            |             | typically   | typically   | typically   |
|            |             | should      | should      | should      |
|            |             | consider    | consider    | consider    |
|            |             | taking      | taking      | taking      |
|            |             | is:**       | is:**       | is:**       |
+============+=============+=============+=============+=============+
| December   | \(1\)       | Education/  | Education/  | Refusal.    |
| 12, 2003   | Inadequate  | com         | com         |             |
| to         | prior       | munication. | munication. |             |
|            | notice or   |             |             |             |
| August 12, | an          |             |             |             |
| 2004       | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\) No PN | Education/  | Education/  | Refusal.    |
|            | c           | com         | com         |             |
|            | onfirmation | munication. | munication. |             |
+------------+-------------+-------------+-------------+-------------+
| After      | \(1\)       | Education/  | Refusal.    | Refusal.    |
|            | Inadequate  | co          |             |             |
| August 12, | prior       | mmunication |             |             |
| 2004       | notice or   | (minor or   |             |             |
|            | an          | inadvertent |             |             |
|            | u           | problems)   |             |             |
|            | nregistered | or refusal. |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\) No PN | Education/  | Refusal.    | Refusal.    |
|            | c           | co          |             |             |
|            | onfirmation | mmunication |             |             |
|            |             | (minor or   |             |             |
|            |             | inadvertent |             |             |
|            |             | problems)   |             |             |
|            |             | or refusal. |             |             |
+------------+-------------+-------------+-------------+-------------+

**^\*^** Definitions and descriptions of the types of violations,
categories of violations, and actions in response to violations are
given above.

**Table 3: Implementing 21 CFR 1.283(e) and 1.285(k). Food arriving by
international mail.^\*^**

+------------+-------------+-------------+-------------+-------------+
| **If the   | **and if    | **then for  | **then for  | **then for  |
| violation  | the         | violations  | violations  | violations  |
| is on or   | violation   | that fall   | that fall   | that fall   |
| after:**   | is due      | within      | within      | within      |
|            | to:**       | [Category   | [Category   | [Category   |
|            |             | 3]{.        | 2]{.        | 1]{.        |
|            |             | underline}, | underline}, | underline}, |
|            |             | the action  | the action  | the action  |
|            |             | FDA and CBP | FDA and CBP | FDA and CBP |
|            |             | staff       | staff       | staff       |
|            |             | typically   | typically   | typically   |
|            |             | should      | should      | should      |
|            |             | consider    | consider    | consider    |
|            |             | taking      | taking      | taking      |
|            |             | is:**       | is:**       | is:**       |
+============+=============+=============+=============+=============+
| December   | \(1\)       | Education/  | Education/  | Refusal.    |
| 12, 2003   | Inadequate  | com         | com         |             |
| to         | prior       | munication. | munication. |             |
|            | notice or   |             |             |             |
| August 12, | an          |             |             |             |
| 2004       | u           |             |             |             |
|            | nregistered |             |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\) No PN | Education/  | Education/  | Refusal.    |
|            | c           | com         | com         |             |
|            | onfirmation | munication. | munication. |             |
+------------+-------------+-------------+-------------+-------------+
| After      | \(1\)       | Education/  | Refusal.    | Refusal.    |
|            | Inadequate  | co          |             |             |
| August 12, | prior       | mmunication |             |             |
| 2004       | notice or   | (minor or   |             |             |
|            | an          | inadvertent |             |             |
|            | u           | problems)   |             |             |
|            | nregistered | or refusal. |             |             |
|            | facility    |             |             |             |
+------------+-------------+-------------+-------------+-------------+
|            | \(2\) No PN | Education/  | Refusal.    | Refusal.    |
|            | c           | co          |             |             |
|            | onfirmation | mmunication |             |             |
|            |             | (minor or   |             |             |
|            |             | inadvertent |             |             |
|            |             | problems)   |             |             |
|            |             | or refusal. |             |             |
+------------+-------------+-------------+-------------+-------------+

**^\*^** Definitions and descriptions of the types of violations,
categories of violations, and actions in response to violations are
given above.