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> **Issued December 2003 Revised June 2004**

![](media/image7.png){width="1.0416666666666666e-2in"
height="1.0416666666666666e-2in"}

**Compliance Policy Guide**

This document also available in
[[French]{.underline}](http://www.cfsan.fda.gov/~pn/fcpgpn.html) and
[[Spanish]{.underline}](http://www.cfsan.fda.gov/~pn/scpgpn.html)

**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\
Bureau of Customs and Border Protection**

**Issued December 2003 Revised June 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\
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\
Bureau of Customs and Border Protection (CBP)**

**Issued December 2003 Revised June 2004**

TABLE OF CONTENTS

I.  [[Introduction]{.underline}](http://www.cfsan.fda.gov/~pn/cpgpn.html#intro)

II. [[Background]{.underline}](http://www.cfsan.fda.gov/~pn/cpgpn.html#bg)

III. [[Policy]{.underline}](http://www.cfsan.fda.gov/~pn/cpgpn.html#policy)

IV. [[Regulatory Action
    Guidance]{.underline}](http://www.cfsan.fda.gov/~pn/cpgpn.html#guidance)

    A.  Types of Violations

    B.  Categories of Violations

    C.  Actions in Response to Violations

    D.  Tables

        **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}.).

7.  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
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]{.underline}](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 tables 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 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.

    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.

        **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:

1.  \(a\) Reflects a history of repeated conduct of a similar nature by
    a person who has been notified of such violations; or

2.  \(b\) 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.
>
> \(e\) 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 Table 4, provide an information sheet on prior notice to the
> importer, owner, consignee, or shipper.

[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 or food imported or offered for
import for non-commercial purposes with a non-commercial shipper.**
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, food carried by or otherwise
accompanying an individual, or food imported or offered for import for
non-commercial purposes with a non-commercial shipper as set out below
under Table 4.

**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 other than food imported or offered for import for
non-commercial purposes with a non-commercial shipper.** 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.
It does not apply to food imported or offered for import for
non-commercial purposes with a non-commercial shipper as set out below
under Table 4.

**Table 4 -- Implementing 21 CFR 1.283(a), (b), and (e) and 1.285(a),
(h) and (k).** **Food imported or offered for import for non-commercial
purposes with a non-commercial shipper, irrespective of the type of
carrier.** Table 4 describes actions FDA and CBP staff typically should
consider taking 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]{.underline}
for non-business purposes and the shipper is [an individual]{.underline}
(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;

-   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]{.underline} 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.)

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                                                      
  or food imported or                                                     
  offered for import                                                      
  for non-commercial                                                      
  purposes with a                                                         
  non-commercial                                                          
  shipper.^\*^**                                                          
  -------------------- -------------- ----------------- ----------------- -----------------
  **If the violation   **and if the   **then for        **then for        **then for
  occurs:**            violation is   violations that   violations that   violations that
                       due to:**      fall within       fall within       fall within
                                      [Category         [Category         [Category
                                      3]{.underline},   2]{.underline},   1]{.underline},
                                      the action FDA    the action FDA    the action FDA
                                      and CBP staff     and CBP staff     and CBP staff
                                      typically should  typically should  typically should
                                      consider taking   consider taking   consider taking
                                      is:**             is:**             is:**

  December 12, 2003\   \(1\) No prior Education/        Education/        Refusal and
  to\                  notice         communication.    communication.    possible CBP
  March 12, 2004                      Analysis of data  Analysis of data  civil monetary
                                      for compliance    for compliance    penalties.
                                      action.           action            

                       \(2\)          Education/        Education/        Refusal and
                       Inaccurate     communication.    communication.    possible CBP
                       prior notice,  Analysis of data  Analysis of data  civil monetary
                       untimely prior for compliance    for compliance    penalties.
                       notice, or an  action.           action.           
                       unregistered                                       
                       facility                                           

  March 13, 2004\      \(1\) No prior Education/        Assessment of CBP Refusal and
  to\                  notice         communication.    civil monetary    possible CBP
  June 3, 2004                        Analysis of data  penalties.        civil monetary
                                      for compliance                      penalties.
                                      action.                             

                       \(2\)          Education/        Education/        Refusal and
                       Inaccurate     communication.    communication.    possible CBP
                       prior notice,  Analysis of data  Analysis of data  civil monetary
                       untimely prior for compliance    for compliance    penalties.
                       notice, or an  action.           action.           
                       unregistered                                       
                       facility                                           

  June 4, 2004\        \(1\) No prior Refusal.          Refusal and/or    Refusal and
  to\                  notice                           assess CBP civil  possible CBP
  August 12, 2004                                       monetary          civil monetary
                                                        penalties.        penalties.

                       \(2\)          Education/        Assess CBP civil  Refusal and
                       Inaccurate     communication.    monetary          possible CBP
                       prior notice,  Analysis of data  penalties.        civil monetary
                       untimely prior for compliance                      penalties.
                       notice, or an  action.                             
                       unregistered                                       
                       facility                                           

  After\               \(1\) No prior Refusal and/or    Refusal and/or    Refusal and
  August 12, 2004      notice         assess CBP Civil  assess CBP civil  possible CBP
                                      Monetary          monetary          civil monetary
                                      Penalties.        penalties.        penalties.

                       \(2\)          Refusal and/or    Refusal and/or    Refusal and
                       Inaccurate     Assess CBP civil  Assess CBP civil  possible CBP
                       prior notice,  monetary          monetary          civil monetary
                       untimely prior penalties.        penalties.        penalties.
                       notice, or an                                      
                       unregistered                                       
                       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 violation   **and if the   **then for        **then for        **then for
  occurs:**            violation is   violations that   violations that   violations that
                       due to:**      fall within       fall within       fall within
                                      [Category         [Category         [Category
                                      3]{.underline},   2]{.underline},   1]{.underline},
                                      the action FDA    the action FDA    the action FDA
                                      and CBP staff     and CBP staff     and CBP staff
                                      typically should  typically should  typically should
                                      consider taking   consider taking   consider taking
                                      is:**             is:**             is:**

  December 12, 2003\   \(1\)          Education/        Education/        Refusal.
  to\                  Inadequate     communication.    communication.    
  August 12, 2004      prior notice                                       
                       or an                                              
                       unregistered                                       
                       facility                                           

                       \(2\) No PN    Education/        Education/        Refusal.
                       confirmation   communication.    communication.    

  After\               \(1\)          Education/        Refusal.          Refusal.
  August 12, 2004      Inadequate     communication                       
                       prior notice   (minor or                           
                       or an          inadvertent                         
                       unregistered   problems) or                        
                       facility       refusal.                            

                       \(2\) No PN    Education/        Refusal.          Refusal.
                       confirmation   communication                       
                                      (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                                                      
  other than food                                                         
  imported or offered                                                     
  for import for                                                          
  non-commercial                                                          
  purposes with a                                                         
  non-commercial                                                          
  shipper.^\*^**                                                          
  -------------------- -------------- ----------------- ----------------- -----------------
  **If the violation   **and if the   **then for        **then for        **then for
  is on or after:**    violation is   violations that   violations that   violations that
                       due to:**      fall within       fall within       fall within
                                      [Category         [Category         [Category
                                      3]{.underline},   2]{.underline},   1]{.underline},
                                      the action FDA    the action FDA    the action FDA
                                      and CBP staff     and CBP staff     and CBP staff
                                      typically should  typically should  typically should
                                      consider taking   consider taking   consider taking
                                      is:**             is:**             is:**

  December 12, 2003\   \(1\)          Education/        Education/        Refusal.
  to\                  Inadequate     communication.    communication.    
  August 12, 2004      prior notice                                       
                       or an                                              
                       unregistered                                       
                       facility                                           

                       \(2\) No PN    Education/        Education/        Refusal.
                       confirmation   communication.    communication.    

  After\               \(1\)          Education/        Refusal.          Refusal.
  August 12, 2004      Inadequate     communication                       
                       prior notice   (minor or                           
                       or an          inadvertent                         
                       unregistered   problems) or                        
                       facility       refusal.                            

                       \(2\) No PN    Education/        Refusal.          Refusal.
                       confirmation   communication                       
                                      (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 4:                                                         
  Implementing 21                                                    
  CFR                                                                
  1.283(a)(b)(e)                                                     
  and 1.285(a)(h)                                                    
  (k).  Food                                                         
  imported or                                                        
  offered for                                                        
  import for                                                         
  non-commercial                                                     
  purposes with a                                                    
  non-commercial                                                     
  shipper,                                                           
  irrespective of                                                    
  the type of                                                        
  carrier.**                                                         
  ---------------- ----------- ----------------- ------------------- -----------------
  **If the         **and if    **then for        **then for          **then for
  violation is on  the         violations that   violations that     violations that
  or after:**      violation   fall within       fall within         fall within
                   is due      [Category         [Category           [Category
                   to:**       3]{.underline},   2]{.underline}, the 1]{.underline},
                               the action FDA    action FDA and CBP  the action FDA
                               and CBP staff     staff typically     and CBP staff
                               typically should  should consider     typically should
                               consider taking   taking is:**        consider taking
                               is:**                                 is:**

  After June 24,   No PN       No action         Education/          Refusal.
  2004                                           communication.      
  ------------------------------------------------------------------------------------

Issued: \[December 2003\]

Revised: \[June 2004\]