Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 66294-66410 [E8-26282]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 217 (Friday, November 7, 2008)]
[Rules and Regulations]
[Pages 66294-66410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26282]



[[Page 66293]]

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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

Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / 
Rules and Regulations

[[Page 66294]]


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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, 866-521-2297.

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

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    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''

[[Page 66296]]

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 (https://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

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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

[[Page 66298]]

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.

[[Page 66299]]

    (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

[[Page 66300]]

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,

[[Page 66301]]

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

[[Page 66302]]

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 https://
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) On