[Federal Register: November 7, 2008 (Volume 73, Number 217)]
[Rules and Regulations]
[Page 66293-66410]
[DOCID:fr07no08-13]

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Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1

Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002; Draft Compliance
Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002;'' Availability; Final Rule and Notice

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2002-N-0233] (formerly Docket No. 2002N-0278)
RIN 0910-AC41

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
regulation that requires the submission to FDA of prior notice of food,
including animal feed, that is imported or offered for import into the
United States. The final rule implements the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act), which required prior notification of imported food to begin on
December 12, 2003. The final rule requires that the prior notice be
submitted to FDA electronically via either the U.S. Customs and Border
Protection (CBP or Customs) Automated Broker Interface (ABI) of the
Automated Commercial System (ACS) or the FDA Prior Notice System
Interface (FDA PNSI). The information must be submitted and confirmed
electronically as facially complete by FDA for review no less than 8
hours (for food arriving by water), 4 hours (for food arriving by air
or land/rail), and 2 hours (for food arriving by land/road) before the
food arrives at the port of arrival. Food imported or offered for
import without adequate prior notice is subject to refusal and, if
refused, must be held. Elsewhere in this issue of the Federal Register,
FDA is announcing the availability of a draft compliance policy guide
(CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.''

DATES: This rule is effective May 6, 2009.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Legal Authority
II. Summary of Significant Changes Made to the IFR
    A. What Definitions Apply to This Subpart? (Sec.  1.276)
    B. What is the Scope of This Subpart? (Sec.  1.277)
    C. Who is Authorized to Submit Prior Notice? (Sec.  1.278)
    D. When Must Prior Notice Be Submitted to FDA? (Sec.  1.279)
    E. How Must You Submit Prior Notice? (Sec.  1.280)
    F. What Information Must Be in a Prior Notice? (Sec.  1.281)
    G. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec.  1.282)
    H. What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice? (Sec.  1.283)
    I. What Are the Other Consequences of Failing to Submit Adequate
Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec.
1.284)
    J. What Happens to Food That Is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Subpart H of This
Part? (Sec.  1.285)
III. Comments on the IFR
    A. General Comments
    B. Comments on the Legal Authority
    C. What Definitions Apply to This Subpart? (Sec.  1.276)
    1. The Act (Sec.  1.276(a))
    2. Calendar Day (Sec.  1.276(b)(1))
    3. Country From Which the Article Originates (Sec.  1.276(b)(2))
    4. Country From Which the Article is Shipped (Sec.  1.276(b)(3))
    5. FDA Country of Production (Sec.  1.276(b)(4))
    6. Full Address (Sec.  1.276(b)(6))
    7. Grower (Sec.  1.276(b)(7))
    8. Registration Number (Sec.  1.276(b)(13))
    9. United States (Sec.  1.276(b)(15))
    10. You (Sec.  1.276(b)(16))
    11. Food (Sec.  1.276(b)(5))
    12. International Mail (Sec.  1.276 b)(8))
    13. Manufacturer (Sec.  1.276(b)(9))
    14. No Longer in Its Natural State (Sec.  1.276(b)(10))
    15. Port of Arrival (Sec.  1.276(b)(11))
    16. Shipper (Sec.  1.276(b)(14))
    17. Comments Requesting Additional Definitions
    18. Summary of the Final Rule
    D. What is the Scope of this Subpart? (Sec.  1.277)
    1. Food for an Individual's Personal Use When Accompanied at
Arrival
    2. Homemade Food Sent as Personal Gift
    3. Food Imported Then Exported Without Leaving Port of Arrival
Until Export
    4. Food Under the Exclusive Jurisdiction of USDA
    5. Additional Exclusions Requested--General
    6. Additional Exclusions Requested--Special Programs (C-TPAT/FAST)
and Flexible Alternatives
    7. Additional Exclusions Requested--Samples
    8. Additional Exclusions Requested--Mail
    9. Additional Exclusions Requested--Gifts
    10. Additional Exclusions Requested--Low-Value
    11. Additional Exclusions Requested--Couriers
    12. Additional Exclusion Requested--Gift Packs
    13. Additional Exclusions Requested--Household Goods and
Unaccompanied Baggage
    14. Additional Exclusions Requested--Noncommercial Use
    15. Additional Exclusions Requested--U.S. Goods Returned
    16. Additional Exclusions Requested--In-Transit Shipments
    17. Additional Exclusions Requested--Diplomatic Pouch
    18. Additional Exclusions Requested--Seeds for Planting
    E. Who is Authorized to Submit Prior Notice? (Sec.  1.278)
    F. When Must Prior Notice Be Submitted to FDA? (Sec.  1.279)
    1. IFR Timeframes (2, 4, and 8 hours)
    2. Integration of FDA and CBP Timeframes
    3. Phase-In of FDA and CBP Timeframes
    4. Prior Notice Confirmation Number
    5. 5-Day Maximum Pre-Arrival Limitation
    6. International Mail
    G. How Must You Submit the Prior Notice? (Sec.  1.280)
    1. General Comments
    2. English Language
    3. Technical Issues Concerning Both Systems
    4. ABI/ACS Interface
    5. PNSI
    6. Security of the Systems
    7. Contingency Plans
    H. What Information Must Be in a Prior Notice? (Sec.  1.281)
    1. General Comments
    2. The Submitter
    3. The Transmitter
    4. The CBP Entry Type
    5. The CBP Entry Identifier (e.g., The Customs ACS Entry Number or
In-Bond Number)
    6. The Product Identity
    7. Identity of the Manufacturer
    8. The Grower, If Known
    9. FDA Country of Production

    10. Shipper
    11. The Country From Which the Article is Shipped
    12. Anticipated Arrival Information
    13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient
    14. Mode of Transportation
    15. Carrier
    16. Planned Shipment Information
    I. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec.  1.282)
    J. What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice? (Sec.  1.283)
    1. General Comments
    2. Inadequate Prior Notice (Sec.  1.283(a)(1))
    3. Status and Movement of Refused Food (Sec.  1.283(a)(2))
    4. Segregation of Refused Foods (Sec.  1.283(a)(3))
    5. Costs (Sec.  1.283(a)(4))
    6. Export After Refusal (Sec.  1.283(a)(5))
    7. Post-Refusal Prior Notice Submissions (Sec.  1.283(c))
    8. FDA Review After Refusal (Sec.  1.283(d))
    9. International Mail (Sec.  1.283(e))
    10. Prohibitions on Delivery and Transfer (Sec.  1.283(f))
    11. Relationship to Other Admissibility Decisions (Sec.  1.283(g))
    K. What Are the Other Consequences of Failing to Submit Adequate
Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec.
1.284)
    L. What Happens to Food That is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under Subpart H
of This Part? (Sec.  1.285)
    M. Outreach and Enforcement
    1. General Outreach and Enforcement Issues
    2. Prior Notice Submission Training Program From Flexible
Alternative Question 7
    3. Requests for Additional Outreach
    4. Enforcement Timeframe
    5. Enforcement Penalties
    N. The Joint FDA-CBP Plan for Increasing Integration and Assessing
the Coordination of Prior Notice Timeframes
    1. Increased Integration
    2. General Comments on the Plan
IV. Analysis of Economic Impacts
    A. Final Regulatory Impact Analysis
    B. Small Entity Analysis (or Final Regulatory Flexibility Analysis)
    C. Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA) Major Rule
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. References

I. Background and Legal Authority

    Section 307 of the Bioterrorism Act, which was enacted on June 12,
2002, amended the Federal Food, Drug, and Cosmetic Act (the act)
(section 307 of the Bioterrorism Act added section 801(m) to the act
(21 U.S.C. 381(m)) and amended section 301 of the act (21 U.S.C. 331))
by changing when FDA will receive certain information about imported
foods by requiring the Secretary of Health and Human Services (the
Secretary), after consultation with the Secretary of the Treasury,\1\
to issue an implementing regulation by December 12, 2003, to require
prior notification to FDA of food that is imported or offered for
import into the United States. Beginning on December 12, 2003, food
importers were required to provide FDA with advance notice of human and
animal food shipments imported or offered for import.
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    \1\ Under the Homeland Security Act of 2002 (Public Law 107-
296), the Secretary of the Treasury has delegated all relevant
Customs revenue authorities to the Secretary of Homeland Security
who has, in turn, delegated them to the Commissioner of the Bureau
of Customs and Border Protection (CBP or Customs). Thus, the
Secretary is issuing this final rule jointly with the Secretary of
Homeland Security.
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    FDA and CBP jointly published the proposed prior notice regulation
in the Federal Register of February 3, 2003 (68 FR 5428), for comment
(proposed rule). On October 10, 2003, FDA and CBP issued the prior
notice interim final rule (IFR) (prior notice IFR) (68 FR 58974)
(corrected by a technical amendment on February 2, 2004; 69 FR 4851).
The IFR implemented section 307 of the Bioterrorism Act, and required
that the prior notice be submitted to FDA electronically via either the
CBP ABI/ACS or the FDA PNSI. The information must be submitted and
confirmed electronically as facially complete by FDA for review no less
than 8 hours (for food arriving by water), 4 hours (for food arriving
by air or land via rail), and 2 hours (for food arriving by land via
road) before the food arrives at the port of arrival. Food imported or
offered for import without adequate prior notice is subject to refusal
and, if refused, must be held. The IFR responded to comments from the
public on the proposed rule, and established a 75-day comment period.
In order to ensure that those commenting on the IFR had the benefit of
FDA's outreach and educational efforts and had experience with the
systems, timeframes, and data elements of the prior notice system, FDA
reopened the comment period for 30 days on April 14, 2004 (69 FR
19763), and for an additional 60 days on May 18, 2004 (69 FR 28060),
for a total of 165 days.

II. Summary of Significant Changes Made to the IFR

    The highlights of how this final rule compares to the IFR and the
rationale for certain changes are described briefly in the following
paragraphs and are discussed in more detail later in the preamble.

A. What Definitions Apply to This Subpart? (Sec.  1.276)

    We retain the following terms without change from the IFR:
     ``The act;''
     ``Calendar day;''
     ``Country from which the article originates;''
     ``FDA Country of Production;''
     ``Grower;''
     ``Port of entry;'' and
     ``United States.''
    FDA made the following changes in the final rule:
     We revised the term, ``Country from which the article is
shipped,'' to read, ``* * * or, in the case of food sent by
international mail, the country from which the article is mailed.''
     We revised the term, ``food,'' to add the phrase, ``except
as provided in paragraph (b)(5)(i) of this section,'' in the first
sentence; and reworded Sec.  1.276(b)(5)(i) to read, ``For purposes of
this subpart, food does not include''.
     We added the term, ``full address,'' to the final rule.
Full address means the facility's street name and number; suite/unit
number, as appropriate; city; Province or State as appropriate; mail
code as appropriate; and country.
     We revised the term, ``international mail,'' to make the
sentence easier to read, and to add the phrase, ``unless such service
is operating under contract as an agent or extension of a foreign mail
service,'' at the end of the definition.
     We added the term, ``manufacturer,'' to the final rule.
Manufacturer means the last facility, as that word is defined in Sec.
1.227(b)(2), that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any
similar activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
manufacturing/processing is considered the manufacturer.
     We revised the term, ``no longer in its natural state,''
by deleting ``waxed''

from the list of actions that render an article of food still in its
natural state for purposes of this subpart.
     We revised the term, ``port of arrival'' to read ``* * *
the water, air, or land port at which the article of food is imported
or offered for import into the United States. For an article of food
arriving by water or air, this is the port of unloading. For an article
of food arriving by land, this is the port where the article of food
first crosses the border into the United States. The port of arrival
may be different than the port where consumption or warehouse entry or
foreign trade zone admission documentation is presented to the U.S.
Customs and Border Protection (CBP).''
     We revised the term, ``registration number,'' by changing
the phrase, ``refers to,'' to ``means,'' and by adding the phrase, ``to
a facility,'' after the word, ``assigned,'' to clarify that FDA assigns
registration numbers by facility.
     We revised the term, ``shipper,'' by adding the phrase,
``or express consignment operators or carriers or other private
delivery service,'' after ``international mail'' to clarify that a
shipper is involved with various types of transactions, and not just
international mail shipments.
     We revised the term, ``you,'' to simplify the last phrase
of the definition to ``i.e., the submitter or the transmitter, if
any.''

B. What is the Scope of This Subpart? (Sec.  1.277)

    We revised this provision and added ``Articles of food subject to
Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961),
i.e., shipped as baggage or cargo constituting the diplomatic bag'' to
the list of food that does not require prior notice.

C. Who is Authorized to Submit Prior Notice? (Sec.  1.278)

    We retain this provision without change.

D. When Must Prior Notice Be Submitted to FDA? (Sec.  1.279)

    FDA revised this provision. Section 1.279(b) of the IFR states
that, except for international mail, prior notice may not be submitted
more than 5 calendar days before the anticipated date of arrival at the
anticipated port of arrival. We revised this section to permit prior
notice submissions to be submitted no more than 15 calendar days before
the anticipated date of arrival for submissions made through the PNSI
and no more than 30 calendar days before the anticipated date of
arrival for submission made through the ABI/ACS.

E. How Must You Submit Prior Notice? (Sec.  1.280)

    FDA revised this provision. Under 21 CFR 1.280(a)(2) (Sec.
1.280(a)(2)) of the IFR, prior notice must be submitted via PNSI for
articles of food that have been refused under section 801(m)(1) of the
act. Under the final rule, prior notice for articles that have been
refused under section 801(m) of the act must be submitted through PNSI
until such time as ACS or its successor system can accommodate such
transactions.
    FDA also simplified the IFR provisions pertaining to system outages
at Sec.  1.280(b) through (e) by providing the outage notification at
one Web address (http://www.fda.gov) and stating that FDA will accept
prior notice submissions in the format it deems appropriate during the
system(s) outage.

F. What Information Must Be in a Prior Notice? (Sec.  1.281)

    FDA revised the following information requirements:
     Submitter: The IFR states that ``if a registration number
is provided, city and country may be provided instead of the full
address.'' For clarity, in the final rule, FDA has revised this phrase
to state that ``if the business address of the individual submitting
the prior notice is a registered facility, then the facility's
registration number, city, and country may be provided instead of the
facility's full address.'' FDA also deleted the requirement for
providing the submitter's fax number.
     Transmitter: The IFR states that ``if a registration
number is provided, city and country may be provided instead of the
full address.'' For clarity, in the final rule, FDA has revised this
phrase to state that ``if the business address of the individual
submitting the prior notice is a registered facility, then the
facility's registration number, city, and country may be provided
instead of the facility's full address.'' FDA also deleted the
requirement for providing the transmitter's fax number.
     Manufacturer, for food no longer in its natural state:
    Under the IFR, the name, address, and registration number of the
manufacturer must be submitted; if a registration number is provided,
city and country may be provided instead of the full address. The final
rule requires the name of the manufacturer and either: (1) The
registration number, city and country of the manufacturer or (2) both
the full address of the manufacturer and the reason the registration
number is not provided. Publishing elsewhere in this issue of the
Federal Register, the Prior Notice Final Rule Draft CPG lists the
reasons to use when the registration number is not provided.
    In the IFR, a registration number is not required for a facility
associated with an article of food if the article is imported or
offered for import for transshipment, storage, and export, or further
manipulation and export. We have removed this from the final rule and
are requiring the registration number of the manufacturer (or the full
address of the manufacturer and a reason) in all circumstances.
    In the final rule, we have removed the option provided in the IFR
that allows the label information in Sec.  101.5 (21 CFR 101.5) to be
submitted instead of the name, address, and registration number of the
manufacturer for food sent by an individual as a personal gift (i.e.,
for nonbusiness reasons) to an individual in the United States. FDA
notes, however, that under the enforcement policy proposed in the Prior
Notice Final Rule Draft CPG, FDA and CBP should typically consider not
taking any regulatory action when no prior notice is submitted for food
imported or offered for import for noncommercial purposes with a
noncommercial shipper, irrespective of the type of carrier.
     Shipper: The IFR required the name and address of the
shipper and, if the shipper is required to register, the registration
number assigned to the shipper's facility; if a registration number is
provided, city and country may be provided instead of the full address.
The final rule requires the name and full address of the shipper, if
the shipper is different from the manufacturer in order to eliminate
duplicative requirements. If the address of the shipper is a registered
facility, the submitter may submit the registration number of the
shipper's registered facility.
    In the IFR, the shipper's registration number was not required for
a facility associated with an article of food if the article is
imported or offered for import for transshipment, storage, and export,
or further manipulation and export. We have removed this from the final
rule because the shipper's registration number is now optional.
     Anticipated arrival information: Under the final rule, we
removed the requirement for the identity of the anticipated border
crossing within the port of arrival because FDA and CBP have determined
that it is no longer necessary for purposes of communication. For post-
refusal submissions, actual date the article arrived is now a required
data element so that FDA knows how long it has been since the refused
food shipment arrived

in the United States and how to connect the refused prior notice to the
post-refusal prior notice submission for shipments where a previously
refused prior notice was filed.
    The final rule also includes a new provision for food arriving by
express consignment operator or carrier since certain information may
not be available to persons who ship food using an express consignment
operator or courier. If the article of food is arriving by express
consignment operator or carrier, and neither the submitter nor
transmitter is the express consignment operator or carrier, and the
prior notice is submitted via PNSI, the express consignment operator or
carrier tracking number may be submitted in lieu of the anticipated
arrival information.
     The name and address of the importer, owner, and ultimate
consignee: The IFR required the name and address of the importer,
owner, and ultimate consignee, unless the shipment is imported or
offered for import for transshipment through the United States under a
Transportation and Exportation (T&E) entry. In the final rule, FDA is
inserting the word ``full'' in front of ``address'' to make clear that
the complete address is required. Consequently, FDA is revising the
subsequent text to state that if the business address of the importer,
owner, or ultimate consignee is a registered facility, then the
facility's registration number also may be provided in addition to the
facility's full address.
     Planned shipment information: FDA revised this provision
by clarifying that the required planned shipment information is
applicable by mode of transportation and when it exists. Moreover, FDA
added a new provision in the final rule for the Airway Bill number/Bill
of Lading number and flight number since this information is generally
not available to individual submitters. The final rule provides that
for food arriving by express consignment operator or carrier when
neither the submitter nor transmitter is the express consignment
operator or carrier, the tracking number can be submitted in lieu of
the Bill of Lading or Airway Bill number and the flight number for
prior notices submitted via PNSI.
    FDA also revised the IFR by deleting the requirement to provide the
Harmonized Tariff Schedule (HTS) code since FDA and CBP have determined
that the HTS code is no longer critical for communication with CBP.
    In the final rule, we deleted the requirement for the license plate
number (and State or Province that issued the license) for food
arriving by privately owned vehicle from the planned shipment
information and added this data element to the section identifying the
carrier of the article of food (Sec.  1.281(a)(16) and (c)(16)).
    Table 2, which appears later in this preamble, summarizes the
information required in a prior notice.

G. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec.  1.282)

    The IFR required that for prior notices submitted via ABI/ACS, the
submitter should cancel the prior notice via ACS by requesting that CBP
``delete'' the entry. FDA has revised the final rule to state that the
submitter should request that CBP ``cancel'' the entry. Moreover, we
changed references to ``PN System Interface'' to ``PNSI.''

H. What Happens to Food That Is Imported or Offered for Import Without
Adequate Prior Notice? (Sec.  1.283)

    The IFR stated that refused food must be moved under appropriate
custodial bond. FDA has revised this paragraph in the final rule to
state that the refused food must be moved under appropriate custodial
bond unless immediately exported under CBP supervision. The final rule
clarifies that the refused food may be held at the port or at a secure
facility outside the port. FDA also changed the timeframe for notifying
FDA of the hold location from within 24 hours of refusal to before the
food is moved to the hold location. For clarity and consistency
throughout the final rule, we are changing the phrase, ``designated
location,'' to ``designated secure facility.''
    Under the section describing FDA review after refusal, FDA revised
the final rule by including the carrier as one of the entities who can
submit a request for FDA review. FDA also revised the final rule to
delete acceptance of requests for review by mail and express courier.
We are limiting delivery to fax and e-mail.

I. What Are the Other Consequences of Failing to Submit Adequate Prior
Notice or Otherwise Failing to Comply With This Subpart? (Sec.  1.284)

    We corrected the word ``federal'' in the IFR to read ``Federal.''
We also corrected the citation to ``section 303 of the act'' in the IFR
to read ``sections 301 and 303 of the act.''

J. What Happens to Food That Is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under Subpart H
of This Part? (Sec.  1.285)

    The final rule removes the provision in Sec.  1.285(a) that if food
is from a foreign manufacturer that is not registered as required and
is imported or offered for import, it is subject to refusal of
admission for failure to provide adequate prior notice. It also deletes
the text in that provision that states that failure to provide the
manufacturer's registration number renders the identity of the facility
incomplete for purposes of prior notice. The final rule retains, with
revisions, the provision that states that if food is from a foreign
facility that is not registered and is imported or offered for import,
it is subject to being placed under hold under section 801(l) of the
act.

III. Comments on the IFR

    FDA received 320 timely submissions in response to the IFR. To make
it easier to identify comments and FDA's responses to the comments, the
word ``Comment'' will appear in parentheses before the description of
the comment, and the word ``Response'' will appear in parentheses
before FDA's response. A summary follows which includes a description
of the appropriate section in the final rule.

A. General Comments

    (Comments) Most comments generally support the intent of the
Bioterrorism Act and FDA's efforts to implement its provisions with the
IFR. Some comments commend FDA for revising certain proposed
requirements to address the needs of international trade by shortening
timeframes, reducing the amount of information required to be
submitted, and adding a reasonable amount of flexibility for the
submission of prior notice based on the mode of transportation in the
IFR. However, several comments assert that the agency has
misinterpreted the Bioterrorism Act and some comments suggest that the
final rule should be more consistent with the existing trade practices
established in accordance with CBP.
    (Response) FDA drafted the IFR in response to the comments to the
proposed rule, the needs of international trade, and the continued
threat of international terrorism and other significant risks to public
health posed by imported food. We also drafted the final rule
accordingly.
    (Comments) Several comments support the graduated enforcement
policy the agency used to implement the

IFR, noting that this policy facilitated the transition into compliance
with the prior notice requirements. Comments ask that FDA provide a
similar transition period after publication of the final rule during
which time submitters may become familiar with new requirements,
understand the new procedures and adjust business processes and
practices.
    (Response) After publication of the IFR, FDA published guidance
that included a transition period during which we emphasized education
to achieve compliance (the December 2003 Prior Notice Interim Final
Rule CPG) (68 FR 69708, December 15, 2003). FDA agrees that
implementing a graduated enforcement policy using enforcement
discretion has assisted submitters to become accustomed to the new
requirements. The new requirements of the final rule will not take
effect until 180 days after publication. Since the final rule retains
most of the requirements found in the IFR, and with the 180-day delay
in effective date, we are not implementing a graduated enforcement
policy for implementing the final rule.
    FDA and CBP have issued elsewhere in this issue of the Federal
Register a new CPG (hereinafter the Prior Notice Final Rule Draft CPG)
that explains our proposed policies for enforcing violations of this
final rule. The draft CPG describes the circumstances under which FDA
and CBP should typically consider not taking any regulatory action, the
types of violations FDA and CBP intend to focus on, and other
enforcement policies.
    (Comments) Several comments thank FDA for providing an opportunity
to provide comments on the provisions of the IFR after a period of
active FDA/CBP enforcement.
    (Response) FDA agrees that providing several comment periods
following publication of the IFR has permitted affected stakeholders an
additional opportunity to offer specific and informed comments on the
new requirements.
    (Comments) One comment requests that FDA clarify that prior notices
submitted to FDA will not be subject to public disclosure under the
Freedom of Information Act (5 U.S.C. 552, et seq.) (FOIA) because
information contained in a prior notice is confidential business
information. Alternatively, the comment requests that FDA develop
policies to protect confidential business information contained in
prior notices from public disclosure.
    (Response) FDA does not believe this is necessary. FDA already has
relatively detailed regulations, in 21 CFR part 20, governing the
disclosure of information under FOIA, including the disclosure of
confidential business information. Likewise, the agency's general
policies, procedures, and practices relating to the protection of
confidential information received from third parties apply to
information received under prior notice. We do not believe rules,
policies, or procedures specific to prior notice are needed.
    (Comments) One comment states that during the period of enforcement
discretion, various ports of arrival took different approaches to
enforcement and suggests that FDA ensure that all ports and all
officials act in a similar fashion to achieve a consistent enforcement
posture. The comment also suggests that FDA and CBP conduct ``cross-
training'' of their officials staffing FDA or CBP help desks.
    (Response) All prior notice field operations and procedures are
directed by the FDA Prior Notice Center (PNC). The PNC works to ensure
a consistent implementation and enforcement program. Since the initial
implementation of the prior notice rule, FDA staff has received
additional training and guidance on prior notice requirements.
    (Comments) Several comments acknowledge the efforts of CBP and FDA
to work together to achieve the common goal of securing the imported
food supply. In particular, comments congratulate FDA for coordinating
with CBP to allow transmission of FDA-required information through the
ABI to CBP's ACS. In addition, comments support the integration and
cooperation of both agencies in utilizing CBP's targeting system to
efficiently and rapidly spot anomalies in freight crossing our borders;
reducing the FDA proposed timeframes for submission of prior notice in
the advance electronic information requirements; and the commissioning
of CBP staff to conduct examinations and investigations. One comment
requests that CBP and FDA ensure that there are adequate resources at
ports of arrival to mitigate anticipated delays at border crossings
when the rule is enforced. Several comments anticipated that trade
would collapse on December 12, 2003, when the new regulations took
effect.
    (Response) FDA and CBP are continuously coordinating efforts to
receive, review, and respond to prior notice submissions. We further
note that trade continued without significant interruption on December
12, 2003, or anytime after that implementation date. Rather, the
implementation of the prior notice requirements was relatively smooth.
    (Comments) Several comments acknowledge the importance and value of
FDA's educational outreach efforts to the trade industry through
scheduled outreach and education sessions, port-specific flyers,
foreign government training and Web site communications, especially
those that summarize certain compliance data. The comments also applaud
the unprecedented efforts the FDA has made in this regard.
    (Response) FDA and CBP will continue outreach and education efforts
as resources permit. See section III.M entitled ``Outreach and
Enforcement'' later in this document for further discussion on this
subject.
    (Comments) Several comments commend FDA for its efforts in
developing the prior notice regulation in an efficient and effective
manner, reaching out to affected stakeholders for input and comment,
and acknowledge the tremendous effort put forth by the agency in the
development of the regulation. Other comments state that the rule
lacked real world international business input and will have both
business and government unable to function because of the amount of
paperwork generated, which will not stop a terrorist attack. In
particular, one comment notes that tracing a grower of a particular
shipment is impossible in many instances.
    (Response) FDA and CBP systems have been able to manage the
millions of prior notice submissions received, reviewed, and responded
to since December 12, 2003. The agencies strove to implement the
requirements in the Bioterrorism Act in a manner that required only
that information deemed necessary and appropriate to ensure FDA could
meet its statutory obligation to receive, review and respond to prior
notices and target those shipments needing inspection upon arrival in
the United States. Based on FDA's and CBP's experience since December
2003, the agencies have revised some of the requirements in the IFR and
eliminated some of the information we no longer deem necessary (e.g.,
HTS codes). FDA notes that the grower of a food in its natural state is
required only when known.
    (Comments) One comment suggests that the prior notice IFR is
``functionally redundant'' because prior notice has long been a part of
FDA protocol long before the Bioterrorism Act.
    (Response) While FDA agrees that most of the information required
by the IFR has been submitted to FDA via CBP processes for decades, the
information has not been required prior to arrival of the food, making
prior notice a new, unique, and valuable process.

    (Comments) One comment suggests that the IFR was unduly costly,
ill-considered and generally more harmful than useful. An additional
comment believes that the prior notice requirements would restrict
trade more than necessary and hopes that the United States will
implement the Bioterrorism Act in the least trade-restrictive manner.
Another comment states that despite efforts to comply with the new
requirements, massive problems seem to constantly occur. Another
comment complains about accessibility to the Web site, cost and time of
the submission procedures, language barriers, and complexity of the
information requested.
    (Response) FDA disagrees. The prior notice process, which allows
submission of the required information via either ABI/ACS or PNSI, has
been relatively smooth. Although there were some technical problems
encountered during the early implementation phase, FDA believes that
the graduated enforcement process coupled with the vigorous education
and outreach efforts by both the government and the industry have
supported a relatively smooth transition to the new procedures and have
improved compliance with the new requirements. FDA also has considered
its international trade obligations under various World Trade
Organization agreements, North America Free Trade Agreement, and other
international agreements throughout the rulemaking development
processes for both the IFR and this final rule. Both rules are
consistent with our international obligations.
    (Comments) Some comments believe there is a disincentive towards
product diversification when exporting articles of food to the United
States because the prior notice requirements put them at a competitive
disadvantage compared to shipments that originate in the United States.
    (Response) The requirement for prior notice was established by
Congress with the passage of the Bioterrorism Act to improve the
ability of the United States to prevent, prepare for, and respond to
bioterrorism and other public health emergencies. Section 307 of the
Bioterrorism Act requires prior notice of all food imported or offered
for import into the United States. FDA is aware of the international
trade obligations of the United States and has considered these
obligations throughout the rulemaking process for this final rule and
the IFR preceding it. Both are consistent with these international
obligations. FDA and CBP have actively explored ways to reduce the
burden on industry to the extent feasible while fulfilling the
Bioterrorism Act mandates. Accordingly, we have made a number of
changes in the final rule that minimize the impact of prior notice
requirements on the food being imported or offered for import into the
United States. We also note that the registration requirement applies
to domestic facilities, as well as foreign facilities, and that the
registration provisions in the Bioterrorism Act contain certain
exclusions that apply only to foreign facilities. (See e.g., 21 CFR
1.226(a), which exempts from the requirement to register a foreign
facility, if food from such facility undergoes further manufacturing/
processing (including packaging) by another facility outside the United
States; no similar exclusion applies to facilities within the Unites
States.)
    (Comments) Other comments suggest that the IFR failed to include a
provision that would ensure that high risk imports arrive at ports
staffed by FDA inspection personnel and notes that this could be
accomplished by designating particular ports of entry for accepting
high risk products or requiring importers of such products to provide
longer notice to ensure adequate inspection coverage.
    (Response) FDA disagrees. Section 307 of the Bioterrorism Act
specifically prohibits FDA from limiting the port of entry by stating,
``Nothing in this section may be construed as a limitation on the port
of entry for an article of food.'' We also disagree that certain
shipments require longer timeframes for submission of prior notice to
ensure adequate inspection coverage. Under a Memorandum of
Understanding (MOU) between FDA and CBP, published on January 7, 2004
(69 FR 924), FDA has commissioned thousands of CBP officers in ports
and other locations to conduct, on FDA's behalf, investigations and
examinations of imported foods. This helps ensure that there is
adequate inspection coverage, including at ports where FDA does not
currently have personnel.

B. Comments on the Legal Authority

    (Comments) One comment requests that FDA delegate authority to the
U.S. Department of Agriculture (USDA), as it has with CBP, to enable
USDA to implement prior notice requirements on products where the USDA
shares jurisdiction.
    (Response) FDA disagrees. FDA has not delegated its authority under
section 801(m) of the act to CBP, although FDA has commissioned CBP
officers in ports and other locations to conduct, on FDA's behalf,
investigations and examinations of imported foods. FDA recognizes that
there are some products over which both FDA and USDA have jurisdiction.
For example, both FDA and USDA's Animal and Plant Health Inspection
Service (APHIS) regulate the importation of fruits and vegetables into
the United States, although the goal of APHIS' regulation is to
safeguard U.S. agriculture and natural resources from the risks
associated with the plant pests. Nonetheless, FDA does not believe that
there is a need to have USDA implement the prior notice requirements
for products for which we share jurisdiction, nor do we believe that
doing so would lead to an efficient enforcement of the prior notice
requirements. The Bioterrorism Act mandates that advance notice be
given to FDA for any article of food that is being imported or offered
for import into the United States and that the Secretary receive,
review, and appropriately respond to such notifications. To accomplish
this, FDA established the PNC that operates 24 hours a day, 7 days a
week, to receive, review, and respond to these notices as they are
submitted. The purpose of prior notice is to enable FDA to conduct
inspections of imported foods at U.S. ports upon arrival and target
foods that may pose a significant risk to public health, based on the
information submitted.
    Prior Notice is submitted electronically to FDA through either
Customs' ABI/ACS or FDA's PNSI. Regardless of the mode of transmission,
the prior notice information will undergo both a validation process and
a screening in FDA's Operational and Administrative System for Import
Support (OASIS) for food safety and security criteria. If the FDA
system does not indicate that further evaluation of or action on the
notice or article of food is necessary for prior notice, the system
will transmit a message through OASIS to the ABI/ACS interface for CBP
that the article of food may be conditionally released. However, if
additional evaluation of the prior notice information is necessary,
personnel at the FDA's PNC will access the information provided and
determine if that information suggests the potential for a significant
risk to public health.
    FDA personnel are able to make this determination by using their
experience of imported foods, utilizing the expertise within the Center
for Food Safety and Nutrition (CFSAN), the Center for Veterinary
Medicine (CVM), the inspectional information obtained by the Office of
Regulatory Affairs (ORA), and utilizing the expertise of CBP staff who
are co-located with the PNC. If FDA determines that a potential health
risk is present, FDA or CBP will

examine the food or take other appropriate action.
    Evaluations of imported articles of food are made on an article-of-
food by article-of-food basis. CBP and FDA are continuously working
together to incorporate further intelligence gained from this process.
The recent addition of USDA personnel to assist in the sharing of
information affecting the safety and security of imported foods will
help further this effort.
    FDA does note that food items that are under the exclusive
jurisdiction of the USDA are not subject to the requirements of prior
notice. (See the discussion on Sec.  1.277 (scope), discussed infra.)
    (Comments) Another comment suggests that to be consistent with the
Bioterrorism Act, FDA should permit an alternative to prior notice for
administrative flexibility. The comments suggest that this could be
accomplished by including in the final rule a provision which states,
``Other measures as appropriate that provide an equivalent level of
assurance of compliance with the requirements of this part.''
    (Response) FDA disagrees. Section 801(m) of the act requires the
submission of prior notice for all food imported or offered for import
into the United States, except as outlined in Sec.  1.277(b). FDA is to
use that information to determine whether it should inspect the food
upon arrival in the United States. Compliance with prior notice,
therefore, means providing the required information within the
specified timeframes. No other ``measures'' would ``provide an
equivalent level of assurance of compliance'' with the prior notice
requirements.

C. What Definitions Apply to This Subpart? (Sec.  1.276)

    Section 1.276 of the IFR provides definitions for the following
terms: The act, calendar day, country from which the article
originates, country from which the article is shipped, FDA Country of
Production, food, grower, international mail, no longer in its natural
state, port of arrival, port of entry, registration number, shipper,
United States, and you. FDA received no comments on the definitions for
the act, calendar day, country from which the article originates, FDA
Country of Production, grower, and United States, and thus, the final
rule retains the definitions for these terms that were in the IFR.
Although no comments were received on the definitions for ``country
from which the article is shipped,'' ``registration number,'' and
``you,'' we made minor revisions to these definitions. We also added a
definition for the term, ``full address,'' although we did not get any
comments on this term.
1. The Act (Sec.  1.276(a))
    The final rule defines ``the act'' to mean ``the Federal Food,
Drug, and Cosmetic Act.''
2. Calendar Day (Sec.  1.276(b)(1))
    The final rule defines ``calendar day'' to mean ``every day shown
on the calendar.''
3. Country From Which the Article Originates (Sec.  1.276(b)(2))
    The final rule defines ``country from which the article
originates'' to mean ``FDA Country of Production.''
4. Country From Which the Article is Shipped (Sec.  1.276(b)(3))
    The final rule defines ``country from which the article is
shipped'' to mean ``the country in which the article of food is loaded
onto the conveyance that brings it to the United States or, in the case
of food sent by international mail, the country from which the article
is mailed.'' For clarity, we revised the last phrase of this definition
to change, ``the country in which the article will be mailed'' to ``the
country from which the article is mailed.''
5. FDA Country of Production (Sec.  1.276(b)(4))
    The final rule defines ``FDA Country of Production'' to mean, for
an article of food that is in its natural state, the country where the
article of food was grown, including harvested or collected and readied
for shipment to the United States. If an article of food is wild fish,
including seafood that was caught or harvested outside the waters of
the United States by a vessel that is not registered in the United
States, the FDA Country of Production is the country in which the
vessel is registered. If an article of food that is in its natural
state was grown, including harvested or collected and readied for
shipment, in a Territory, the FDA Country of Production is the United
States. For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a vessel, the
FDA Country of Production is the country in which the vessel is
registered. If an article of food that is no longer in its natural
state was made in a Territory, the FDA Country of Production is the
United States.
6. Full Address (Sec.  1.276(b)(6))
    The IFR did not have a definition for the term, ``full address.''
However, we added this term to the final rule for clarity since this
term is used throughout the rule. The final rule defines ``full
address'' to mean ``the facility's street name and number; suite/unit
number, as appropriate; city; Province or State as appropriate; mail
code as appropriate; and country.''
7. Grower (Sec.  1.276(b)(7))
    The final rule defines ``grower'' to mean ``a person who engages in
growing and harvesting or collecting crops (including botanicals),
raising animals (including fish, which includes seafood), or both.''
8. Registration Number (Sec.  1.276(b)(13))
    The final rule defines ``registration number'' to mean ``the
registration number assigned to a facility by FDA under section 415 of
the act (21 U.S.C. 350d) and subpart H of this part.'' FDA made a minor
change in this definition in the final rule by adding the phrase ``to a
facility'' after the word ``assigned'' to clarify that FDA assigns
registration numbers by facility.
9. United States (Sec.  1.276(b)(15))
    The final rule defines ``United States'' to mean ``the Customs
territory of the United States (i.e., the 50 States, the District of
Columbia, and the Commonwealth of Puerto Rico), but not the
Territories.''
10. You (Sec.  1.276(b)(16))
    The final rule defines ``you'' to mean ``the person submitting the
prior notice, i.e., the submitter or the transmitter, if any.'' We made
a minor change to this definition by simplifying the last phrase of the
definition to ``i.e., the submitter or the transmitter, if any.''
    FDA received comments on the definitions for the following terms in
the IFR: food, international mail, no longer in its natural state, port
of arrival, and shipper. FDA also received comments that recommend that
FDA include additional definitions for the following terms in the IFR:
Carrier, manufacturer, trip number, and ultimate consignee. FDA
responds to these comments in the following paragraphs.
11. Food (Sec.  1.276(b)(5))
    The IFR defines ``food'' as having the meaning given in section
201(f) of the act, except that it does not include food contact
substances as defined in section 409(h)(6) of the act (21 U.S.C.
348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u). Examples of
food include fruits, vegetables, fish, including seafood,

dairy products, eggs, raw agricultural commodities for use as food or
as components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods,
candy, and canned foods.
    (Comments) One comment asks FDA to define food contact substances,
which are exempt from the requirements of prior notice, to include
secondary direct food additives. The comment reasons that secondary
direct food additives, many of which are food processing aids, meet the
criteria for food contact substances as defined in section 409(h)(6) of
the act (21 U.S.C. 348(h)(6)). The comment further reasons that
secondary direct food additives meet the criteria that FDA used in the
registration IFR to exclude food contact materials from the
requirements of the registration IFR as they are not ``food for
consumption'' in that ``they are not intentionally eaten for their
taste, aroma, or nutritive value'' (68 FR 58894 at 58911).
    (Response) Some secondary direct food additives meet the definition
of food contact substances as given in section 409(h)(6) of the act
and, therefore, would not be subject to the prior notice requirements
(Sec.  1.276(b)(5)(i)(A)). The comment, however, asks about secondary
direct food additives that are not food contact substances, for example
food processing aids. The IFR concluded that food processing aids that
are not food contact substances are subject to prior notice ``Whether a
food processing aid or `indirect additive' is subject to prior notice
depends upon whether such a substance is `food' under this rule. As
noted, for purposes of the interim final rule, `food' excludes `food
contact substances' as defined at section 409(h)(6) of the FD&C Act.
Among other things, unlike food processing aids and `indirect
additives,' `food contact substances' are not `intended to have any
technical effect in food,' [section 409(h)(6) of the act]. In addition,
`food' excludes pesticides as defined at 7 U.S.C. 136(u). Thus, if the
substance is not a pesticide and is intended to have a technical effect
in the food being processed, the substance is not exempt from the
definition of `food' under Sec.  1.276(b)(5) in the interim final rule.
This is a reasonable result in that such processing aids are
intentionally and directly added to `traditional' foods.'' (68 FR 58974
at 58986). We continue to hold this view. Thus, if a secondary direct
food additive is not a food contact substance but is a food processing
aid, then it would be subject to prior notice.
    (Comments) Two comments ask the FDA to clarify the term,
``reasonably expected to be directed to a food use.'' One comment
states that seed produced by seed companies is intended to be used for
planting crops, but the production process inevitably results in
remnant or culled seed that is suitable for use as animal feed (and to
a far lesser degree, as food for human consumption), which generally is
sold by the seed company as such. The comment states that a similar
issue arises with some crops, such as onions, for which bulbs sold to
farmers may also be used as feed or, in limited cases, as food if they
are determined to be remnant or culled. The comment believes that FDA
should provide specific limitations on the definitions of ``reasonably
believes'' and ``reasonably expected'' that take into consideration
that the seed produced by seed companies is intended to be used for
planting crops, even though it is understood that there inevitably will
be some remnant seed and culls. Without such limitations, the comment
believes the rule is unreasonably broad, imposes a burden on seed
companies primarily marketing seeds for planting purposes that is out
of proportion to the protective goals of the act, and is subject to
widely varying interpretations. Another comment notes that the seed
industry's research and development activities generate very small
amounts of seed that may be found ``unsuitable'' for planting and end
up in the food supply, and similarly asks for clarification of the
``reasonably believes'' and ``reasonably expected'' language.
    (Response) In the preamble to the IFR, we state that ``FDA will
consider a product as one that will be used for food if any of the
persons involved in importing or offering the product for import (e.g.,
submitter, transmitter, manufacturer, grower, shipper, importer, owner,
or ultimate consignee) reasonably believes that the substance is
reasonably expected to be directed to a food use'' (68 FR 58974 at
58987). The purpose of this statement was to explain when an article of
food would be subject to prior notice if it is capable of multiple
uses. The comments, and our experience with the IFR, have shown that
there is some confusion as to how to determine when a substance that is
capable of a food use and a nonfood use is a ``food'' for purposes of
prior notice. To clarify, we will consider such a substance to be
``food'' for the purpose of prior notice if it is reasonably likely to
be directed to a food use. This should make it clearer that, as
explained in the preamble to the IFR, the determination is not based on
the intended use of the article (68 FR 58974 at 58987).
    In one of the comments, the seed will ``inevitably'' contain
remnant seed and culls that will be diverted to human or animal feed.
In this case, since at the time of import, the seed is reasonably
likely to be directed to a food use, prior notice is required. FDA
believes this is consistent with the purpose of the Bioterrorism Act.
With respect to the other comment about seeds found ``unsuitable'' for
planting, there is insufficient detail in the comment to determine
whether these seeds would be considered food.
    Nonetheless, we note that the Prior Notice Final Rule Draft CPG,
announced elsewhere in this issue of the Federal Register, proposes an
enforcement policy regarding seeds for planting. Under the draft
policy, FDA and CBP would typically consider not taking any regulatory
action regarding seeds that will be used for cultivation. The policy
would apply when no more than a small portion of that seed is diverted
from cultivation to animal feed or other food use. It would not apply,
however, where the seed is used for the production of edible sprouts,
such as alfalfa seeds for the production of alfalfa sprouts.
    (Comments) One comment states that the Bioterrorism Act regulations
do not present a means to provide FDA with certification that any of
the indicated persons (i.e., submitter, transmitter, manufacturer,
grower, shipper, importer, owner, or ultimate consignee) do not
reasonably believe that an item is reasonably expected to be directed
to a food use prior to arrival at a U.S. port. The comment further
states that there is no method to avoid classifying their products as
anything other than those flagged as FD4 \2\ articles requiring prior

notice, thereby providing no means to avoid refusal of the goods upon
arrival because the prior notice was not filed.
---------------------------------------------------------------------------

    \2\ HTS codes are ``flagged'' in ACS as follows to indicate that
products are or may be under FDA jurisdiction:
    FD0--Indicates that FDA has determined the article, even though
subject to FDA's laws and regulations, is acceptable for CBP release
without further presentation of prior notice or other entry
information to FDA.
    FD1--Indicates that the article may be subject to FDA
jurisdiction, including FDA review under 801(a) of the act. For
products not subject to FDA jurisdiction, a filer can ``Disclaim''
product from FDA notification requirements.
    FD2--Indicates that the article is under FDA jurisdiction and
review of entry information by FDA under section 801(a) of the act
will take place. However, the article is not ``food'' for which
prior notice information is required.
    FD3--Indicates that the article may be subject to prior notice
under section 801(m) of the act and 21 CFR Part 1, subpart I. ,
e.g., the article has both food and nonfood uses.
    FD4--Indicates that the article is ``food'' for which prior
notice is required under section 801(m) of the act and 21 CFR Part
1, subpart I.
---------------------------------------------------------------------------

    (Response) FDA disagrees. FDA is continuously reviewing the FD3 and
FD4 flags associated with HTS codes. The HTS codes are flagged to
indicate which products will (FD4) or may (FD3) require prior notice
and which product will or may require FDA review under section 801(a)
of the act for admissibility; all FDA-regulated products are covered,
not just foods. If you believe that an item has been incorrectly
flagged, you should contact the FDA and provide a statement that
explains your rationale. The designation will be reviewed and action
taken to correct the flag if deemed appropriate. With respect to the
comment about providing certification about the belief of the
``indicated persons,'' submitters may disclaim articles of food marked
FD3 if the article is not reasonably likely to be directed to a food
use by using an affirmation of compliance in ABI/ACS.
    (Comments) Many comments address the FD flags associated with the
HTS codes. Two comments state that they are currently importing a
product that was flagged FD4, which requires that prior notice be
submitted for that article. However, the item is not an article of food
and the commenter would like the HTS code changed from a FD4 flag to a
FD3 flag. An additional comment had concerns about multiple use
products, where one use would require prior notice and another use
would not. Another comment states that there is no clear methodology
provided to disclaim an item beyond the initial FD3 designation. The
comment recommends that the agency outline the elements of a due
diligence protocol that would become part of the disclaimer process.
One comment suggested that the data elements in the prior notice
submission be amended to permit an affirmation that a substance is not
directed for a food use. This would avoid the article of food from
being refused if the prior notice was submitted for a category that
required prior notice. Another comment wants FDA to develop a method
that would allow the submitter or the transmitter to disclaim the need
for prior notice at the time of the prior notice transmission.
    (Response) If there is a concern regarding the FD flags associated
with the HTS codes, you should contact FDA and provide a detailed
description of why you believe the HTS code is flagged incorrectly. FDA
and CBP are continuously reviewing and updating the FD flags associated
with the HTS codes. If you have questions regarding whether prior
notice is required for a particular article of food, contact the PNC
for assistance. Furthermore, we have established procedures in place to
disclaim articles of food the submitter believes does not require prior
notice. This can be accommodated by ABI/ACS as an affirmation of
compliance.
    (Comments) One comment states that the list of HTS codes flagged
for prior notice (both FD3 and FD4) (as provided by Customs Admin
message 03-2605 dated October 31, 2003) contains 762 tariff numbers.
The comment asks if this is a definitive list at this point, especially
since FDA and CBP estimated the number to be around 2,000.
    (Response) This is not a definitive list. FDA and CBP are
continuously reviewing and updating the FD flags associated with the
HTS codes. Guidance regarding the HTS flags is posted at http://
www.cfsan.fda.gov/~dms/htsguid3.html. The lack of an FD3 or FD4
designation does not mean that prior notice is not required. If the
article of food fits the definition of food provided in Sec.  1.276 of
the final rule, then prior notice is required for that article of food.
    (Final rule) Section 1.276(b)(5) of the final rule defines ``food''
as having the meaning given in section 201(f) of the act, except that
it does not include food contact substances as defined in section
409(h)(6) of the act (21 U.S.C. 348(h)(6)) or pesticides as defined in
7 U.S.C. 136(u). Examples of food include fruits, vegetables, fish,
including seafood, dairy products, eggs, raw agricultural commodities
for use as food or as components of food, animal feed (including pet
food), food and feed ingredients, food and feed additives, dietary
supplements and dietary ingredients, infant formula, beverages
(including alcoholic beverages and bottled water), live food animals,
bakery goods, snack foods, candy, and canned foods.
    We revised this definition for clarity in the final rule by adding
the phrase, ``except as provided in paragraph (b)(5)(i) of this
section,'' in the first sentence; and reworded paragraph (b)(5)(i) to
read, ``For purposes of this subpart, food does not include:''.
12. International Mail (Sec.  1.276(b)(8))
    The IFR defines ``international mail'' to mean foreign national
mail services. International mail does not include express carriers,
express consignment operators, or other private delivery services.''
    (Comments) One comment asks FDA to define international mail to
include express carriers. Another comment asks FDA to clarify whether
sending an item by express delivery will be considered ``international
mail'' or ``express carrier.''
    (Response) FDA declines to make the requested change. The IFR
defines ``international mail'' to mean ``foreign national mail
services'' and expressly excluded express carriers, express consignment
operators, or other private delivery services from the definition. We
retain this definition in the final rule but revised the wording to
make the definition easier to read, and to add the phrase, ``unless
such service is operating under contract as an agent or extension of a
foreign mail service,'' at the end of the definition. This phrase was
needed to clarify that a contractor working for a foreign mail service
also is included in the definition of ``international mail.''
International mail is a function of the foreign postal organizations of
sovereign countries who are members of the International Postal Union.
International mail shipments generally do not utilize any of the
electronic data transmission systems commonly used by express
consignment carriers and private delivery services.
    (Final rule) Section 1.276(b)(8) of the final rule defines
``international mail'' to mean foreign national mail services.
International mail does not include express consignment operators or
carriers or other private delivery services unless such service is
operating under contract as an agent or extension of a foreign mail
service.
13. Manufacturer (Sec.  1.276(b)(9))
    (Comments) Two comments request that we define the word
``manufacturer.'' One of these suggests that we define ``manufacturer''
to mean the last entity to conduct a processing operation; e.g.,
including bottling but excluding labeling.
    (Response/Final rule) As discussed in section III.H.7.a of this
document, FDA agrees and has added a definition for manufacturer.
Section 1.276(b)(9) of the final rule defines manufacturer as the last
facility, as that word is defined in Sec.  1.227(b)(2) (in the
registration rule), that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any
similar activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional

manufacturing/processing is considered the manufacturer.
14. No Longer in Its Natural State (Sec.  1.276(b)(10))
    The IFR defines ``no longer in its natural state'' to mean that
``an article of food has been made from one or more ingredients or
synthesized, prepared, treated, modified, or manipulated. Examples of
activities that render food no longer in its natural state are cutting,
peeling, trimming, washing, waxing, eviscerating, rendering, cooking,
baking, freezing, cooling, pasteurizing, homogenizing, mixing,
formulating, bottling, milling, grinding, extracting juice, distilling,
labeling, or packaging. Crops that have been cleaned (e.g., dusted,
washed), trimmed, or cooled attendant to harvest or collection or
treated against pests, waxed, or polished are still in their natural
state for purposes of this subpart. Whole fish headed, eviscerated, or
frozen attendant to harvest are still in their natural state for
purposes of this subpart.''
    (Comments) One comment asks FDA to clarify the term, ``no longer in
its natural state'' by expressly stating that seed for sowing or
planting that are shucked, sorted and sized remain ``in their natural
state'' for purposes of prior notice. Another comment believes that
activities such as trimming, washing, waxing, and packaging of produce
are part of normal harvesting activities and seeks to clarify that
produce that has been trimmed, washed, waxed, and/or packaged is still
``in its natural state.''
    (Response) The IFR defines ``no longer in its natural state'' as
meaning ``an article of food has been made from one or more ingredients
or synthesized, prepared, treated, modified, or manipulated. Examples
of activities that render food no longer in its natural state are
cutting, peeling, trimming, washing, waxing, eviscerating, rendering,
cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing,
formulating, bottling, milling, grinding, extracting juice, distilling,
labeling, or packaging. Crops that have been cleaned (e.g., dusted,
washed), trimmed, or cooled attendant to harvest or collection or
treated against pests, waxed, or polished are still in their natural
state for purposes of this subpart. Whole fish headed, eviscerated, or
frozen attendant to harvest are still in their natural state for
purposes of this subpart.'' In the final rule, we are deleting the word
``waxed'' in the list of activities that render the food still in their
natural state because this was included in error.
    After publishing the prior notice IFR, FDA issued guidance in the
form of questions and answers to help clarify the prior notice
requirements. In the second edition of ``Questions and Answers
Regarding the Interim Final Rule on Prior Notice of Imported Food
(Edition 2)'' (the prior notice question and answer guidance document)
available at http://www.cfsan.fda.gov/~pn/pnqagui2.html, issued May
2004, under section B, Definitions, question 4.1 of the guidance, we
discuss seeds. If the seed will be used only for sowing or planting,
and not directed to food use, then no prior notice is required and,
therefore, there is no need to determine whether the seeds are in their
natural state for the purposes of prior notice.
    Regarding the other comments, the definition for ``no longer in its
natural state'' in the final rule already states that trimmed or washed
produce is still in its natural state, if those activities are
attendant to harvest or collection. This same definition states that
waxing and packaging are activities that render food no longer in its
natural state.
    (Final Rule) Section 1.276(b)(10) of the final rule defines ``no
longer in its natural state'' to mean that ``an article of food has
been made from one or more ingredients or synthesized, prepared,
treated, modified, or manipulated. Examples of activities that render
food no longer in its natural state are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging. Crops that have been cleaned (e.g., dusted, washed),
trimmed, or cooled attendant to harvest or collection or treated
against pests, or polished or packaged are still in their natural state
for purposes of this subpart. Whole fish headed, eviscerated, or frozen
attendant to harvest are still in their natural state for purposes of
this subpart.''
15. Port of Arrival (Sec.  1.276(b)(11))
    The IFR defines ``port of arrival'' to mean ``the water, air, or
land port at which the article of food is imported or offered for
import into the United States, i.e., the port where the article of food
first arrives in the United States. This port may be different than the
port where consumption or warehouse entry or foreign trade zone
admission documentation is presented to the U.S. Customs and Border
Protection (CBP).''
    (Comments) Two comments ask FDA to clarify what is meant by the
term, ``port of arrival.'' One comment notes that notwithstanding the
definition in the IFR, FDA representatives have stated that ``port of
arrival'' means the first port where the articles of food are ``off-
loaded'' and that if the articles remain on the vehicle or vessel, then
the port of arrival definition has not been met for these and only
these articles. Another comment reports being told by FDA
representatives that when a ship arrives from Europe, only goods ``off
loaded'' in that port must be given prior notice within the timeframes
required. If the ship has food destined to be ``off loaded'' in other
ports, prior notice must be filed for each port in accordance with the
timeframes required by the regulations. The comments ask FDA to clarify
this definition.
    (Response) FDA agrees to clarify the term, ``port of arrival,'' as
it is a required data element in a prior notice and important for
gauging the timeframes for prior notice submission. The interim final
rule defined ``port of arrival'' as ``the water, air, or land port at
which the article of food is imported or offered for import into the
United States, i.e., the port where the article of food first arrives
in the United States.'' In essence, the comments ask us to identify the
point at which an article of food ``first arrives'' in the United
States when the food is arriving by water.
    The preambles to the proposed rule and IFR explained that for FDA
to be able to protect U.S. consumers from terrorism or other food-
related emergencies, it was important for FDA to receive prior notice
before the food covered by that notice is shipped around the country
and potentially lost to government oversight (68 FR 5428 at 5431 and 68
FR 58974 at 58991). The preambles concluded that prior notice must be
given before the food first physically appears in the United States so
that FDA can inspect the food upon arrival.
    As noted in the comments, some shipments contain both food and
nonfood cargo. If the carrier stops at multiple ports, the articles of
food may remain on board at intermediate ports where nonfood articles
are unloaded. The articles of food are then unloaded at one or more
subsequent ports. When food is shipped via water and FDA has
bioterrorism or other public health emergency concerns about the food,
it would inspect the food at the point of unloading. This is because
before the food is unloaded it would remain on the carrier either at a
secured port under CBP authority or in open water, preventing
intentional or unintentional diversion until unloading. The same is
true for food shipped by air. When an article of food remains on board
at one airport to be unloaded at a subsequent airport, FDA would not
need to examine the food until the point where that food is unloaded.
In contrast, when food is shipped via land, any articles of food

remaining on board would travel through the United Stated while outside
of secured ports and, therefore, could be potentially lost to
government oversight due to off-loading in noncontrolled areas.
    Therefore, we believe that when an article of food is shipped via
water or air, the article ``first arrives'' at the port where it is
unloaded. When an article of food is shipped via land, the article
``first arrives'' at the port where it crosses the border. We are
revising the definition of ``port of arrival'' in the final rule to
clarify this distinction. We have added a statement that for an article
of food arriving by water or air, the port of arrival is the port of
unloading. For an article of food arriving by land, the definition now
states that the port of arrival is the port where the article of food
first crosses the border into the United States.
    (Comments) One comment asks FDA to clarify the word ``port.'' The
comment asks whether the IFR applies to U.S. Navy ships returning to
``port'' or to a U.S. Naval Base from outside U.S. territorial waters.
The comment notes that U.S. Navy fleet ships always have been
considered U.S. territory. The comment also notes that the CPG states
that food entering and then leaving the ``port area'' is not subject to
prior notice and asks FDA to clarify the term, ``port area.''
    (Response) FDA clarifies that the term, ``port,'' is not defined
but that ``port of arrival'' and ``port of entry'' are defined. The
term, ``port,'' as used in the rule relates to ports identified by CBP.
In 19 CFR 101.1 Definitions, ``Port and port of entry refer to any
place designated by Executive Order of the President, by order of the
Secretary of the Treasury, or by Act of Congress, at which a Customs
officer is authorized to accept entries of merchandise to collect
duties, and to enforce the various provisions of the Customs and
navigation laws. The terms `port' and `port of entry' incorporate the
geographical area under the jurisdiction of a port director.'' If CBP
changes this definition in the future, we will evaluate whether Sec.
1.276(b)(12) should be revised to incorporate those changes. Proposed
policies in the Prior Notice Final Rule Draft CPG, would apply to most
articles of food on U.S. Navy ships returning to ``port'' or a U.S.
Naval Base from outside U.S. territorial waters. One policy states that
FDA and CBP should typically consider not taking any regulatory action
when an article of food is imported or offered for import for an
official government purpose without prior notice, provided that a
Federal Government agency is the importer of record. Another states
that FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for
noncommercial purposes with a noncommercial shipper without prior
notice. One of the examples of foods imported or offered for import
that may be covered by this policy is food in household goods,
including military transfers.
    (Final rule) Section 1.276 (b)(11) of the final rule defines ``port
of arrival'' as ``the water, air, or land port at which the article of
food is imported or offered for import into the United States. For an
article of food arriving by water or air, this is the port of
unloading. For an article of food arriving by land, this is the port
where the article of food first crosses the border into the United
States. The port of arrival may be different than the port where
consumption or warehouse entry or foreign trade zone admission
documentation is presented to the U.S. Customs and Border Protection
(CBP).''
16. Shipper (Sec.  1.276(b)(14))
    The IFR defines ``shipper'' to mean ``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.''
    (Comments) Two comments request that we clarify the IFR's
definition of ``shipper.'' One comment asks whether the shipper is the
person who physically loads the shipment for its final journey to the
United States, the company that has the business contract to export the
food to the U.S. importer, or someone in the middle who removes the
shipment from temporary storage for the initial phase of its entire
journey to the United States. Another comment asks for clarification as
to who is the shipper when the producer's shipping platform is involved
in the shipment--the transporter who takes responsibility for the whole
shipment or the producer's own facility (assuming that neither would be
classified as ``manufacturer'')?
    (Response) In the IFR, we defined ``shipper'' based upon the
description of shipper as it is discussed in CBP's proposed rule
``Required Advance Electronic Presentation of Cargo Information'' (July
23, 2003, 68 FR 43574 at 43577). We have decided to continue to use
this definition in the final rule. In the examples cited in the
comments above, the shipper is considered to be the entity that
arranges or directs the shipment to be sent to the United States,
irrespective of who physically transports it. In the first example it
would be the company having the business contract to export the food;
in the second, assuming that the producer is sending the food to a firm
in the United States, they (the producer) would be the shipper. It
should also be noted that a firm may be both a shipper and a
manufacturer with respect to the same product if the product is shipped
from the point of manufacture to the United States. Moreover, we have
added the phrase, ``or express consignment operators or carriers or
other private delivery service,'' after the term, ``international
mail,'' in the definition of ``shipper'' to clarify that a shipper is
involved with various types of transactions, and not just international
mail shipments.
    (Final rule) Section 1.276(b)(14) of the final rule defines shipper
to mean ``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 or express consignment operators
or carriers or other private delivery service to the United States.''
17. Comments Requesting Additional Definitions
    (Comments) Several comments request that we define additional terms
in the final rule, including: ``trip number,'' ``carrier,'' and
``ultimate consignee.''
    (Response) FDA disagrees. FDA believes these terms are sufficiently
clear based on our experience since the initial implementation of the
prior notice IFR. FDA intends to interpret the ``ultimate consignee''
consistent with CBP's use of that term in regards to the entry of
merchandise, which is contained in paragraph 6.3 of Customs Directive
No. 3550-079A, June 27, 2001. As stated in that CBP Directive, ``if the
merchandise has not been sold or consigned to a U.S. party at the time
of entry or release, then the Ultimate Consignee at the time of entry
or release is defined as the proprietor of the U.S. premises to which
the merchandise is to be delivered.''
18. Summary of the Final Rule
    Section 1.276 of the final rule defines the following terms: The
act, calendar day, country from which the article originates, country
from which the article is shipped, FDA Country of Production, food,
full address, grower, international mail, manufacturer, no longer in
its natural state, port of arrival, port of entry, registration number,
shipper, United States, and you.

D. What is the Scope of this Subpart? (Sec.  1.277)

    Section 1.277(a) of the IFR states that the prior notice
requirements apply to all food for humans and other animals that is
imported or offered for import into the United States. This covers food
for use, storage, or distribution in the United States, and includes
food for gifts, trade and quality assurance/quality control samples,
food for transshipment through the United States to another country,
food for future export, and food for use in a U.S. Foreign Trade Zone
(FTZ).
    Section 1.277(b) of the IFR sets out the exclusions from prior
notice. It excludes food for an individual's personal use when it is
carried by or otherwise accompanies the individual when arriving in the
United States (i.e., for consumption by themselves, family and friends,
not for sale or other distribution); food that was made by an
individual in his/her personal residence and sent by that individual as
a personal gift (i.e., for nonbusiness reasons) to an individual in the
United States; food that is imported then exported without leaving the
port of arrival until export; and meat food products, poultry products,
and egg products that, at the time of importation, are subject to the
exclusive jurisdiction of USDA under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.).
    FDA received many comments about Sec.  1.277(b), which are
addressed in order of the exclusions covered in the IFR: Food for an
individual's personal use when carried by or otherwise accompanying an
individual; homemade food; food that is imported for immediate
exportation; and foods under exclusive USDA/Food Safety and Inspection
Service jurisdiction. The comments concerning requests for additional
exclusions from the scope of the prior notice requirements are
addressed by issue, beginning with general comments/requests.
1. Food for an Individual's Personal Use When Accompanied at Arrival
    Section 1.277(b)(1) of the IFR excludes food for an individual's
personal use when it is carried by or otherwise accompanies the
individual when arriving in the United States. The IFR explains that in
this situation there was no ``shipper'' as that term is used in section
801(m) of the act.
    (Comments) One comment requests that FDA expand the exemption for
food carried in to the United States for personal use to include all
food products carried in personal baggage; or to allow declaration of
entry to be made through existing general CBP entry declaration
procedures.
    (Response) FDA disagrees. Prior notice is not required for food
that is carried by or otherwise accompanies an individual entering the
United States (e.g., food that is in his or her carry-on or checked
baggage) when the food is for that individual's personal use (Sec.
1.277(b)(1)). This means that the food is for consumption by the
individual or by the individual's family and friends and is not for
sale or other distribution. If the food carried by or otherwise
accompanying an individual is for commercial purposes, then prior
notice requirements apply.
    As we explained in the IFR preamble, we do not believe that
Congress intended for us to characterize travelers bringing food back
from their travels in their personal baggage for their own use as
``shippers'' for purposes of section 801(m) of the act. When there is a
commercial purpose involved, there is a ``shipper,'' i.e., the person
or entity on whose behalf the traveler is bringing in the food. Thus,
by its terms, section 801(m) of the act requires that food carried by
or otherwise accompanying an individual arriving in the United States
that is not for personal use be subject to prior notice. Moreover, we
explained that we would potentially create a loophole that would defeat
the purpose of the prior notice rule if we were to exempt all food
products carried in personal baggage.
    (Final rule) Section 1.277(b)(1) of the final rule continues to
state that the rule does not apply to food for an individual's personal
use when it is carried by or otherwise accompanies the individual when
arriving in the United States.
2. Homemade Food Sent as Personal Gift
    Section 1.277(b)(2) of the IFR excludes food that was made by an
individual in his/her personal residence and sent by that individual as
a personal gift (i.e., for nonbusiness reasons) to an individual in the
United States.
    (Comments) No comments were received about this issue.
    (Final rule) Section 1.277(b)(2) is retained without change.
3. Food Imported Then Exported Without Leaving Port of Arrival Until
Export
    Section 1.277(b)(3) of the IFR excludes food that is imported then
exported without leaving the port of arrival until export.
    (Comments) One comment states that if food moves for immediate
export \3\ (IE) out of the same port, it is not subject to prior
notice. However, if the food moves on a T&E entry, prior notice is
required. The comment provides a scenario where a shipment arrives at
Los Angeles Harbor and then moves to Los Angeles Airport for export.
Los Angeles Harbor and Los Angeles Airport are separate ports and each
has its own port code assigned by CBP. The comment states that CBP
considers this an IE entry. Similarly, the comment questioned if FDA
considers this an IE entry as well, or if it is considered a T&E entry
that requires prior notice.
---------------------------------------------------------------------------

    \3\ Food that is brought to a U.S. port but is then directly
exported from that port of arrival is entered under a CBP IE entry
and subject to the limitations of an IE bond. In essence, this food
may not leave the port of arrival until export.
---------------------------------------------------------------------------

    (Response) If the food arrives in and is exported from the same
port, then it is not subject to prior notice. FDA considers a port to
be the same as defined by CBP in 19 CFR 101.1; i.e., the term ``port''
incorporates the geographical area under the jurisdiction of a port
director. The geographical boundaries of the port of Los Angeles-Long
Beach are described in 19 CFR 101.3(b)(1). While Los Angeles Harbor and
Los Angeles Airport are separate for CBP management purposes, they are
considered to be within the same port. Accordingly, IE entries may be
filed for movements between Los Angeles Harbor and Los Angeles Airport
followed by exportation of the goods. Similarly, because such movements
would not leave the port of arrival until export, prior notice would
not be required.
    (Comments) One comment suggests that articles of food imported and
admitted into a FTZ in or adjacent to the port of arrival as ``zone
restricted status'' merchandise, and then exported from the port of
arrival under an IE entry, are sufficiently similar to an IE entry that
the same restrictions as for an IE entry would apply if the food were
refused admission under 801(m) of the act. The comment, therefore,
recommends that these articles should be exempt from the prior notice
requirements.
    (Response) The fact that food is for admission into an FTZ does
not, by itself, mean that the food is not subject to the requirements
of the prior notice regulation (Sec.  1.277(a)). In the first instance
described in the comments, where the article of food is imported and
admitted into an FTZ located in the port of arrival and then exported
from the port of arrival, prior notice is not required (Sec.
1.277(b)(3)). In the second instance, where the article of food is
imported and admitted into an FTZ

located adjacent to the port of arrival and then exported, prior notice
would be required since the food has left the port of arrival before
export and may not be subject to the limitations of an IE bond. An FTZ
adjacent to the port of arrival is considered to be outside the port of
arrival, and therefore not sufficiently similar to those IE entries
that have never left the port of arrival.
    (Comments) Several comments ask that FDA exempt the airline
industry's food service from the requirements of prior notice. The
comments assert that there is no danger to the American public from
this operation. One comment suggests that leftover unopened cans of
soda, unopened small bottles of liquor (to be held in bonded storage)
or other ``dry-stores'' items on flights inbound to the United States
and intended for use on later flights should be exempt from prior
notice. In addition, the comment states that it is not possible to
determine at ``wheels up'' what will remain upon landing in the United
States. One comment states that it is impossible to provide detailed
information about leftover soda and liquor on incoming international
aircraft. One comment proposes the addition of the following exception
to Sec.  1.277(b): ``Food that is imported by a shipper operating an
aircraft in international air transportation, then exported by the same
shipper, [as] long as such food remains on board the aircraft at all
times from import to export.''
    (Response) If the aircraft food is consumed on the international
flight or discarded and is not entered into the United States for use,
storage, or distribution or remains on board and is exported from the
same port into which it arrived, it is outside the scope of the
regulation and prior notice is not required. By contrast, prior notice
is required for in-flight food that is moved out of the port of arrival
to caterers for use on other international or domestic flights (Sec.
1.277).
    (Comments) One comment questions whether wines manufactured in a
foreign country and present on a passenger ship that may cruise or dock
in the United States Territorial Sea require prior notice.
    (Response) If the wine remains on the ship, it does not require
prior notice (Sec.  1.277(b)(3)). However, if the wine is offloaded
from the ship and leaves the port of arrival in the United States,
prior notice would be required.
    (Comments) One comment asks that if wines are loaded onto a
passenger ship at a U.S. port, but such an article of food has been
previously imported into the U.S. to be exported or transshipped, does
the prior notice for such an article of food require the manufacturer's
registration number.
    (Response) Prior notice is required for food imported or offered
for import into the United States before arrival and not when the food
is loaded onto a passenger ship in the United States.
    (Final rule) Section 1.277(b)(3) is retained without change in the
final rule and excludes food that is imported then exported without
leaving the port of arrival until export.
4. Food Under the Exclusive Jurisdiction of USDA
    The IFR in Sec.  1.277(b)(4), (b)(5), and (b)(6) excludes: Meat
food products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.); 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 seq); and 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 seq). The IFR explains that these are excluded as directed in
the Bioterrorism Act.
    (Comments) Comments state that live animals including cattle, pig,
chickens, etc. require prior notice, whereas prior notice is not
required for products exclusively regulated by the Federal Meat
Inspection Act. The comments recommend that animals regulated
exclusively by USDA/Veterinary Services such as live cattle, pigs, and
chickens be exempt from prior notice because USDA examines them upon
importation. One comment further suggests that live animals requiring
prior notice should be those animals regulated by FDA, such as turtles,
game animals, etc. Another comment asks whether prior notice is
required for livestock sent to the United States for recreational
purposes, but after a number of years are expected to be slaughtered
and enter the food chain as pet food. One comment asks that FDA exempt
breeder livestock not imported for immediate slaughter and remove
``FD3'' flags from HTS codes that cover breeder livestock to avoid
confusion at the ports of arrival regarding applicability of prior
notice requirements.
    (Response) FDA disagrees. Live animals, such as poultry and cattle,
are food for purposes of prior notice (Sec.  1.276(b)(5)(ii)) if the
article of food is reasonably likely to be directed to a food use (see
discussion supra on the definition of food in section III.C.11). Note
that live food animals are not excluded from prior notice under section
801(m)(3)(B) of the act and Sec.  1.277(b)(4) or (b)(5) because live
food animals do not fall within the exclusive jurisdiction of USDA
under the Federal Meat Inspection Act or Poultry Products Inspection
Act. If the live animals are imported for a nonfood use (i.e., as a
pet, for show purposes, racing) and are not reasonably likely to be
directed to a food use, then prior notice is not required. USDA/
Veterinary Services inspects imported live animals for animal health,
not human health, purposes. An FD3 flag associated with breeder
livestock means that the livestock may be subject to prior notice
requirements. If the live animal is not reasonably likely to be
directed to a food use, then the HTS code may be disclaimed because
prior notice is not required.
    (Comments) Some comments had a concern regarding USDA-regulated
products. One comment noted that USDA-regulated products were excluded
from the FDA prior notice rule, but that an HTS codes document released
on November 20, 2003, highlights a number of products that are
regulated by USDA. Another comment questions why cattle imported for
slaughter are coded FD4 and all other cattle are coded FD3 when the
importation of cattle is under the responsibility and jurisdiction of
USDA.
    (Response) Only items that are under the exclusive jurisdiction of
the USDA are excluded from the requirements of prior notice. Articles
of food that are jointly regulated by FDA and USDA are subject to the
requirements of prior notice. Live animals raised for food, even though
not in their final, edible form, are considered to be food under the
act. United States v. Tomahara Enterprises Ltd., Food Drug Cosm. L.
Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live calves intended as veal are
food) and United States v. Tuente Livestock, 888 F. Supp. 1416 (S.D.
Ohio 1995) (live hogs are food).
    (Final rule) Section 1.277(b)(4), (b)(5), and (b)(6) of the final
rule are retained without change and exclude meat food products that at
the time of importation are subject to the exclusive jurisdiction of
the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
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 seq.); and 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 seq.).

5. Additional Exclusions Requested--General
    (Comments) One comment states that cough drops containing OTC
(over-the-counter) Monograph active ingredients are regulated as an
over-the-counter drug by the FDA, and therefore, are not subject to
prior notice. However, CBP categorizes all cough drops, including ones
regulated as drugs by the FDA, as candy subject to regulation by FDA as
food. Therefore, due to this classification by CBP, cough drops would
require prior notice. In addition, another comment asks if
pharmaceuticals, such as over-the-counter drugs, are exempt from prior
notice requirements.
    (Response) CBP classification does not identify foods requiring
prior notice. However, CBP and FDA have worked together to provide
indicators; i.e., flags associated with HTS codes to indicate which
articles being imported may require prior notice submission. The FD3
flag indicates that the products categorized by that HTS code may
require prior notice submission; those products categorized in those
HTS codes flagged as FD3 that do not require prior notice submission
may be disclaimed by the filer upon entry. On the other hand, the FD4
flag indicates that the products categorized by that HTS code require
prior notice submission. FDA has published guidance regarding these
flags and has published a list of the HTS codes with FD3 and FD4 flags.
The guidance is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html
and the list of codes is posted at http://www.cfsan.fda.gov/~pn/
htscodes.html.
    The comment asks about such articles containing OTC monograph
active ingredients. HTS Code<PHONE_NUMBER> (cough and cold preparations)
would apply to, among other articles, cough suppressants that contain
OTC monograph active ingredients. This HTS Code is not flagged for
either FD3 or FD4, meaning that prior notice would not be required.
Candies, which are food, would fall under different HTS Codes and would
be subject to prior notice.
    (Comments) One comment recommends that FDA's food category codes
for raw materials could be made more complete to cover the range of
materials known to be used in products marketed as foods. The comment
states that there are numerous CBP ``Customs Codes'' that do not
contain the appropriate FD3 or FD4 codes and that this causes confusion
among the industry with some groups interpreting the lack of an FDA
code as meaning that that food ingredient was exempt from prior notice,
even if the ingredient is known to be used in food. Other comments
assume that ingredients lacking an FD3 or FD4 code that are best known
as being active ingredients in drugs, but are also used in dietary
supplements, are exempt from prior notice. The comment recommends that
these codes should be made as complete as possible and that FDA should
indicate that ingredients without a FD3 or FD4 code may still require
prior notice.
    (Response) FDA and CBP continuously evaluate the HTS codes in order
to attach the appropriate FD3 and FD4 designations. However, the lack
of an FD3 or FD4 designation does not mean that prior notice is not
required. If the article fits the definition of food provided in Sec.
1.276 of the final rule, then prior notice is required for that article
of food. If you believe that an item has been incorrectly flagged, or
is not currently flagged, but should be, you should contact the FDA and
provide a statement with your suggestion and basis for the flag
designation.
    (Comments) One comment believes that there is a conflict between
the registration (21 CFR part 1, subpart H) and prior notice IFRs,
where the former is based upon the intended use of food (i.e.,
consumption), and the latter applies to ``all'' food. The comment
states that this has caused difficulties with the import process by:
(1) Requiring foreign facilities to register in order to meet the prior
notice requirements and (2) requiring drug and device establishments to
register as food facilities in order to facilitate importation of
intra-company articles. The comment believes this places an undue
burden on drug and device establishments and hampers the importation
process for articles not intended for use in food, as well as for food
articles not intended for consumption. The comment suggests that
section Sec.  1.277 be changed to read: ``This subpart applies to all
food intended for consumption by humans and other animals * * *.'' In
addition, the comment suggests that the HTS codes be modified to allow
articles designated with a FD3 or FD4 code to be disclaimed, with
rationale, depending on their intended use.
    (Response) FDA disagrees. FDA disagrees with changing Sec.  1.277
to read that prior notice is only required for food that is intended
for consumption. In the preamble to the IFR, FDA noted that the
determination of whether a substance is ``food'' is not a question of
intended use (See 68 FR 58974 at 58987). Moreover, we do not believe
that there is a conflict between the registration and prior notice
requirements. Under the registration rule, in general, a facility
engaged in the manufacturing/processing, packaging, or holding of food
for consumption in the United States must be registered. Regardless of
whether the facility that manufactured the food manufactured it for
consumption in the United States, section 801(l) of the act prohibits
food that is from an unregistered foreign facility from being delivered
for distribution in the United States until the facility is registered.
Thus, if the owners, operators, or agents in charge of facilities want
to ensure these types of food are not subject to being held under
section 801(l) of the act, they can register in accordance with section
415 of the act (21 U.S.C. 350d) (and if the food is for consumption in
the United States, they must register unless the facility qualifies for
an exemption). An importer can likewise ensure that food is not subject
to being held under section 801(l) of the act by not importing or
offering for import food that is from an unregistered foreign facility.
    Throughout this preamble to the final rule, we often use the phrase
``food is subject to being held'' in describing our enforcement of the
registration requirement through prior notice. Under section 801(l) of
the act, ``[i]f an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to the
Secretary under section 415, such article shall be held at the port of
entry for the article, and may not be delivered to the importer, owner,
or consignee of the article, until the foreign facility is so
registered'' (emphasis added). In this situation, the article of food
is being prevented from moving forward past the port of arrival because
the food is from a foreign facility that has not registered. This
situation is distinct from a situation where, after FDA reviews the
prior notice information, the food is held upon arrival for examination
because it may pose a significant risk to public health, usually
referred to as a ``BT Hold.'' In addition, we do not believe that prior
notice places an undue burden on the drug and medical device industry.
Items designated with a FD4 code are all believed to be used
exclusively in food, and therefore, require prior notice. Articles
designated by a FD3 code can have food and nonfood uses. These items do
not require prior notice if the use of the article does not fit the
definition of food provided in Sec.  1.276 of

the final rule and may be disclaimed by the filer as such upon entry.
    (Comments) One comment states that there is no facility
registration requirement for transshippers; however, goods processed
under CBP's Form CF7512 (T&Es and ITs) require a prior notice to be
filed. The comment notes that this cannot be accomplished without the
corresponding facility registration number. In addition, T&Es and ITs
do not have a designated submitter. The comment requests that T&E and
IT transactions be exempt from prior notice.
    (Response) FDA disagrees that T&E or IT transactions should be
exempt from the requirements of prior notice. These articles of food
leave the port of arrival prior to exportation from the United States
or for subsequent movement through the United States prior to entry.
    Under Sec.  1.281(a)(9) of the IFR, a shipper's (transshipper's)
registration number was not required for a facility associated with an
article of food if the article is imported for transshipment. Under the
final rule, if the shipper's identity is provided, the shipper's
registration number is optional. Therefore, the absence of a shipper's
registration number should not prevent submission of a prior notice
under either the IFR or final rule. Moreover, FDA disagrees with the
comment's implication that a prior notice requires a designated
submitter. Under Sec.  1.278 of the IFR and final rule, a prior notice
may be submitted by any person with knowledge of the required
information.
    (Comments) Several comments request that FDA generally exempt
Canada and Mexico from submitting prior notice for food shipments. One
comment requests that FDA exempt Canada, in keeping with the nature of
cooperation and shared security risks between the United States and
Canada, in particular the 30 point border plan. The comment reasons
that Canadian origin food is easily traceable through existing Canadian
registration requirements, while already meeting or exceeding United
States standards in some instances. The comment further notes that the
legislation acknowledges the largest threat is from offshore, yet the
regulations most severely hit continental trade between the United
States, Canada, and Mexico. One comment suggests that the exemption
could be limited to shipments of food which are under similar security
controls, especially small quantity shipments of fish imported via
package delivery. Another comment asks that FDA exempt goods being
imported into the United States from companies which are inspected by
the Canadian Food and Inspection Agency.
    (Response) FDA disagrees. While we welcome any additional
information that supports our ability to quickly review prior notice
submissions and determine which food to inspect at U.S. ports of
arrival, the Bioterrorism Act does not provide for blanket exclusions
based on the country from which the food is shipped or the country in
which the food originates. FDA currently is reviewing flexible
alternative programs (e.g., CBP's Customs-Trade Partnership Against
Terrorism (C-TPAT), which was adopted into law (still as a voluntary
system) by Subtitle B of Title II of the SAFE Port Act of 2006 (Public
Law 109-347), and Free and Secure Trade (FAST) (a voluntary program
authorized under 19 U.S.C. 1411) ) to determine their potential for
streamlining the prior notice review process, but notes that these
programs do not meet or affect the requirement to submit prior notice.
Moreover, FDA notes that many shipments from Canada and Mexico into the
United States in fact are transshipments from other countries, which
prior notice submissions identify with the FDA Country of Production
data element.
    (Comments) One comment suggests that FDA create a relational
database to give unique identification numbers to an importer's
specific items. The comment states that this would speed submission,
reduce time to enter the data, and increase compliance with the
regulation. The comment reasons that most food importers will bring in
the same product, in the same package, from the same country, over and
over. Another comment suggests that a single weekly summary of all
shipments by a company to individual consumers or a summary of orders
received should be adequate for this type of commerce.
    (Response) FDA disagrees. Not all importers consistently import the
same types of food. The Bioterrorism Act requires submission of prior
notice before an article of food is imported or offered for import into
the United States. A weekly summary as suggested by the comment would
not meet this requirement, as such a summary would not provide prior
(advance) notice before the article of food is imported or offered for
import. FDA notes, however, that a number of the software programs that
customs brokers use to file prior notice and entry submissions with
ABI/ACS do allow for repetitive information to be saved on the filer's
computer and used for future shipments, as appropriate. Similarly,
FDA's PNSI has been designed to accommodate repetitive information,
such that the basic prior notice information that will repeat on each
prior notice can be created and saved for use on subsequent prior
notices. A separate prior notice confirmation number is generated for
each article of food or recipient.
    (Comments) One comment requests that FDA exempt highly perishable
food products. The comment states that highly perishable food products,
such as ice cream, must be delivered in a timely manner. A delay in the
delivery schedule due to holdups at the border could potentially ruin
these products, and customers inconvenienced by the time delay may
choose to stop importing them. A number of comments request that FDA
exempt fresh produce. Several comments note that produce is already
carefully monitored by CBP and placed on automatic quarantine for
mandatory inspection at the first port of arrival by USDA/CBP. Other
comments state that produce is already subject to 100 percent USDA
inspection and approval prior to release. Another comment requests that
produce be exempt from the requirement of prior notice because it
already meets the requirements of the Bioterrorism Act. The comment
reasons that the purpose of the prior notification to FDA is to provide
FDA with the information necessary to make a decision (prior to
arrival) for a possible physical inspection. The comment states that
the CBP Agriculture Specialist performs the physical inspection (or
reviews original documentation that confirms ``pre-inspection'').
Therefore, the comment reasons, importations of fresh produce are
already meeting the requirements of the Bioterrorism Act. The comments
further state that because prior notice is already given for produce,
the new procedure created by this new legislation will only increase
costs and cause extreme hardship for small business. An additional
comment states that their shipments are subject to four levels of
inspection: County, State, Federal, Customs and ``Bio Terrorist'' and
reasons that the redundancy is wasteful.
    (Response) FDA disagrees. Highly perishable foods, like all other
foods that are covered by the final rule, are subject to prior notice
requirements. The timeframes are sufficiently short, allowing for
submission of prior notice as soon as 2, 4, or 8 hours before arrival
in the United States depending on mode of transportation. While the
Bioterrorism Act provides for an exclusion for certain types of food,
such as meat and meat food products subject to USDA's exclusive
jurisdiction, it does not exclude perishable foods generally

or foods jointly regulated by USDA and FDA.
    As we explained in the IFR preamble, merely obtaining existing
information about the food from other agencies would not guarantee that
FDA has the information required by section 801(m) of the act's prior
notice requirements because there is wide variation in the purposes and
information required by other government programs (68 FR 58974 at
58992). Moreover, our ability to respond to bioterrorism incidents or
other food-related emergencies in a timely manner may be more difficult
if the information is not easily accessible.
    (Comments) One comment recommends that the rule be amended to
include an exemption from prior notice for organizations that are
importing FD4 materials for nonfood uses.
    (Response) FDA disagrees. Items designated with an FD4 code are all
believed to be used exclusively in food, and therefore, food
encompassed by an HTS code that is flagged FD4 is subject to prior
notice requirements. Moreover, as discussed previously, FDA provided
extensively its rationale for not limiting the prior notice
requirements to food for consumption in the United States. (See 68 FR
58974 at 58990 and 58991.) As FDA noted in the IFR, Congress did not
explicitly limit the prior notice requirement to articles of food that
are intended for consumption in the United States even though it could
have done so as shown in section 415 of the act (requirement to
register food facilities). If anyone believes that an HTS code has been
flagged FD4 in error, they can inform FDA and, if we agree, we will
change the flag accordingly.
    (Comments) Two comments request that FDA exempt small businesses.
    (Response) FDA disagrees. Prior notice is required for all FDA-
regulated food that is imported or offered for import. The Bioterrorism
Act does not provide for exclusions based upon the size or nature of
the firms or facilities associated with that importation.
    (Comments) One comment asks FDA to permit an exemption from prior
notice, by importer number, to be recognized in ACS at the time of
entry transmission, to importers who demonstrate that their products
will not reasonably be expected to be directed to a food use.
    (Response) FDA disagrees. Prior notice requirements are associated
with food, not the person manufacturing, growing, shipping, importing,
or owning the food. A product is food for purposes of prior notice if
the article of food is reasonably likely to be directed to a food use.
Prior notice is required for each article of food imported or offered
for import, and food imported or offered for import by or for select
importers will not be excluded from prior notice requirements. If an
importer does not import articles of food, then no ``exemption'' would
be needed since prior notice would not apply to such imports. The FD
flags associated with HTS codes are designed to help identify which
products will require prior notice. If an import is marked FD3 but it
is not food subject to prior notice, the importer can disclaim this
import and prior notice would not need to be submitted.
6. Additional Exclusions Requested--Special Programs (C-TPAT/FAST) and
Flexible Alternatives
    In the explanation of the reduced timeframes and the relationship
of special programs to those timeframes, FDA stated in the IFR that the
``interim final rule provides for greatly reduced timeframes for foods
based on mode of transportation. These timeframes are what FDA has
determined are the minimum timeframes necessary to allow it to satisfy
the statutory mandate that the timeframes give the agency the time it
needs to `receive, review, and respond' to prior notices. However, FDA
is also interested in exploring flexible alternatives for submission of
prior notice for foods or firms covered by programs of other agencies,
such as C-TPAT, or imported by other agencies.'' (68 FR 58974 at
58995).
    FDA and CBP reopened the comment period for the IFR in the Federal
Register of April 14, 2004 (69 FR 19763). On page 19764 of that
publication, FDA and CBP wrote ``In the prior notice [interim final
rule], we expressed interest in exploring flexible alternatives for
submission of prior notice for foods or firms covered by programs of
other agencies, such as CBP's Customs-Trade Partnership Against
Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or
food imported by other government agencies (68 FR 58974 at 58995). C-
TPAT is a government/business initiative to increase cargo security
while improving the flow of trade. Under this program, businesses must
conduct comprehensive self-assessments of their supply chain using the
security guidelines developed jointly with CBP, and they must
familiarize companies in their supply chain with the guidelines and the
program. These businesses must provide CBP with specific and relevant
information about their supply chains and security practices and
procedures. As C-TPAT members, companies may become eligible for
expedited processing and reduced inspections, but are not exempt from
advance electronic information requirements. (See CBP's advance
electronic information rule). FAST, an acronym for Free and Secure
Trade between the United States and Canada, and the United States and
Mexico, is an expedited-clearance system designed to improve border
security without slowing the flow of legitimate trade across the
northern and southern U.S. borders. FAST processing is available to
importers, carriers and foreign manufacturers (southern border) who
participate in C-TPAT and who use a FAST-registered driver. The
initiative builds on the same concepts that drove the rapid, post-9/11
construction and implementation of C-TPAT. FDA and CBP plan to assess
the feasibility of including the FAST timeframes in FDA's prior notice
final rule, as well as other flexible alternatives raised by comments.
    To assist in this assessment, FDA and CBP requested comments on
several questions, including three regarding special programs (69 FR
19763 at 19764):
    C-TPAT/FAST Questions:
    (1) Should food products subject to FDA's prior notice requirements
be eligible for the full expedited processing and information
transmission benefits allowed with C-TPAT and FAST? If so, how should
this be accomplished?
    (2) If the timeframe for submitting prior notice for food arriving
by land via road is reduced to 1 hour consistent with the timeframe in
the advance electronic information rule, would a shorter timeframe be
needed for members of FAST?
    (3) Should the security and verification processes in C-TPAT be
modified in any way to handle food and animal feed shipments regulated
by FDA? If so, how?
    The comments received addressing these issues are discussed in the
following paragraphs in order of the questions posed in the Federal
Register notice, beginning with comments addressing general issues
regarding C-TPAT and FAST.
    a. General comments. (Comments) Numerous comments address special
trade programs, such as C-TPAT and FAST. These comments recommend that
FDA and CBP modify these CBP programs to reflect the criteria required
by FDA and to develop integrated data elements for low risk FAST/C-TPAT
shipments, which would meet both agencies' requirements. The comments
believe it is necessary to have harmonization between FDA and CBP for
``low-risk'' shippers.

    Many comments contend that the IFR does not take into account the
Canada-United States Smart Border Plan (SBP). A key element of the SBP
is the FAST bilateral arrangements. Under the C-TPAT and the Canadian
Partnerships in Protection (PIP) programs, companies approved by both
countries have invested in specific counter-terrorism and supply-chain
integrity measures, and are therefore, accorded more expedited
treatment at the Canada-U.S. border in recognition of the lower risk
they present.
    The comments recommend that FDA recognize foods imported under
these programs as low risk and to afford them benefits, such as reduced
information requirements for each shipment; reduced timeframes for
providing prior notice; reduced clearance time at the border; and
reduced number of verifications of information. The comments further
urge FDA and CBP to permit importers who are participants in C-TPAT and
FAST to comply with their prior notice obligations in a manner that
does not undermine the benefits of participation in these programs. The
comments contend that C-TPAT and FAST improve U.S. security on a number
of levels, including reducing the risk of bioterrorism, and help to
focus limited border resources on higher risk cargo. The comments
suggest that FDA and CBP therefore should be careful not to remove
incentives for participation in these programs by making importation of
food items more cumbersome than other types of entries. Otherwise, the
comments contend prior notice will dilute a key advantage offered to
FAST/C-TPAT participants, thereby weakening the incentive to join the
program. The companies participating in these programs have made a
substantial commitment to improving security by putting in place
appropriate security systems, and submitting to periodic review of
those systems by CBP.
    The comments believe that these programs strengthen FDA's ability
to meet the objectives of the prior notice rule. They contend that this
is achieved in two ways: (1) Through the rigorous security screening
that participants must comply with in order to obtain a low-risk
status; and (2) by removing low-risk shipments from the queue, FAST/C-
TPAT work to shrink the number of shipments that must be screened,
thereby ``freeing up'' FDA officials to focus limited resources on
higher risk shipments.
    One comment states that a firm having to manage its systems to
track C-TPAT products and non-C-TPAT products will incur increased
complexity, increased cost, and will be subject to making errors. This
comment suggests that firms who routinely send products across the
border could provide prior notice on a quarterly basis. The facility
would track the number of shipments each quarter and update FDA with
any changes to the anticipated amounts. These shipments would be
permitted to cross the border without waiting, but still could be
subjected to FDA or CBP inspection.
    Another comment questions the cost, benefits, etc. of these
programs for small companies. In addition, a few comments address the
creation of similar programs and/or the expansion of the current
programs. One comment requests that FDA permit the use of Line Release
(i.e., an automated system designed to release and track repetitive
shipments) for food shipments arriving by rail. The comment states that
their member railroads participate in C-TPAT and it would be
discriminatory to permit the use of an expedited clearance system for
motor carriers, but not rail transportation.
    One comment urges FDA to begin working with all interested parties
to identify criteria for qualification and participation in a program
like C-TPAT, FAST, and others as it applies to prior notice. The
comment suggests that participation might hinge on the submission and
verification of documentation evidencing the implementation of, and
continued adherence to, validated supply chain risk management
techniques. The comment believes that there would be mutual benefits of
such a program. FDA could reallocate its resources to closer review and
examination of shipments from those importers that do not participate
in the program and, thus, have not demonstrated the same level of
commitment to food safety and shipment security as participating
importers do. Program participants would benefit from the agency's
recognition of their commitment to safety and security, which
presumably would be reflected in more efficient and timely processing
of their entries at the border. In that regard, the comment suggests
that the agency consider extending to participating low risk importers
the option of submitting a single prior notice for all entries in a
mixed load container or truck. FDA product codes for all line entries
would continue to be available to FDA through FDA's existing OASIS
system.
    Another comment hopes that the multiple U.S. agencies (FDA,
Department of Homeland Security, and USDA) could collectively address
this issue and develop a protocol for food products that are currently
ineligible for any FAST benefits.
    A few comments request that C-TPAT should be open to all foreign
operators willing to participate and that companies participating in C-
TPAT should be exempt from the procedures under the Bioterrorism Act.
These comments encourage partnerships between the U.S. and E.U. similar
to C-TPAT, which would facilitate trade in food and feed between the
E.U. and U.S. and avoid delays at the U.S. border, especially with
respect to perishable products. In addition, one comment suggests that
food transporters should be allowed eligibility in C-TPAT and FAST to
ensure that all transporters operate on a level playing field.
    One comment notes that C-TPAT is not currently offered to Canadian
manufacturers unless they are an Importer of Record for U.S. Customs'
purposes.
    Finally, one comment expresses concern that any motor carrier who
is not Pre-Arrival Processing System (PAPS)-certified may be required
to present the prior notice confirmation number upon arrival at the
border, even if prior notice was submitted through ACS. The comment
states that truck drivers are generally unable to obtain the prior
notice confirmation number prior to arrival given the short distance
between Canada and the United States and the fact that prior notice is
not generally submitted until after the trucker has left with the load.
The comment states that requiring PAPS authorization as a way to avoid
delays is to mandate that truck companies become C-TPAT certified or
otherwise comply with the designation requirements. The comment notes
that this is not possible, sometimes for cost reasons alone. The