[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Rules and Regulations]               
[Page 58975-59077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc03-18]                         
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 02N-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: Interim final rule; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim 
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 interim final rule implements the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), which requires prior notification of imported 
food to begin on December 12, 2003, even in the absence of a final 
regulation. The interim final rule requires that the prior notice be 
submitted to FDA electronically via either the Bureau of Customs and 
Border Protection (CBP) Automated Broker Interface (ABI) of the 
Automated Commercial System (ACS) or the FDA Prior Notice System 
Interface (FDA PN System Interface). The information must be submitted 
and confirmed electronically as facially complete by FDA for review no 
more than 5 days and 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.

DATES: This interim final rule is effective December 12, 2003. Submit 
written or electronic comments by December 24, 2003.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.

FOR FURTHER INFORMATION CONTACT: Deborah Ralston, Office of Regulatory 
Affairs, Office of Regional Operations, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-6230.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Current Process--Admissibility Determinations Under Section 
801(a) of the FD&C Act
    B. Process After December 12, 2003--Prior Notice Determination 
Followed by Admissibility Determination
II. Overview of the Interim Final Rule and Significant Changes Made 
to the Proposed Rule
    A. ``What Definitions Apply to This Subpart?'' (Section 1.276 
Proposed as Sec.  1.277)
    B. ``What is the Scope of This Subpart?'' (Section 1.277 
Proposed as Sec.  1.276)
    C. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278 
Proposed as Sec.  1.285)
    D. ``When Must Prior Notice Be Submitted to FDA?'' (Section 
1.279 Proposed as Sec.  1.286)
    E. ``How Must You Submit Prior Notice?'' (Section 1.280 Proposed 
as Sec.  1.287)
    F. ``What Information Must Be in a Prior Notice?'' (Section 
1.281 Proposed as Sec.  1.288)
    G. ``What Must You Do If Information Changes After You Have 
Received Confirmation of a Prior Notice From FDA?'' (Section 1.282 
Proposed Sec. Sec.  1.289 to 1.294)
    H. ``What Happens to Food That Is Imported or Offered for Import 
Without Adequate Prior Notice?'' (Section 1.283 Proposed as Sec.  
1.278)
    I. ``What Are the Other Consequences of Failing to Submit 
Adequate Prior Notice or Otherwise Failing to Comply With This 
Subpart?'' (Section 1.284 Proposed as Sec.  1.278)
    J. ``What Happens to Food That Is Imported or Offered for Import 
from Unregistered Facilities That Are Required to Register Under 21 
CFR Part 1, Subpart H?'' (Section 1.285)
III. Comments on the Proposed Rule
    A. General Comments and Outreach
    B. Foreign Trade Issues
    C. ``What Definitions Apply to This Subpart?'' (Section 1.276 
Proposed as Sec.  1.277)
    D. ``What Is the Scope of This Subpart?'' (Section 1.277 
Proposed as Sec.  1.276)
    E. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278 
Proposed as Sec.  1.285)
    F. ``When Must Prior Notice Be Submitted to FDA?'' (Section 
1.279 Proposed as Sec.  1.286)
    G. ``How Must You Submit Prior Notice?'' (Section 1.280 Proposed 
as Sec.  1.287)
    H. ``What Information Must Be in a Prior Notice?'' (Section 
1.281 Proposed as Sec.  1.288)
    I. ``What Must You Do If Information Changes After You Have 
Received Confirmation of a Prior Notice From FDA?'' (Section 1.282 
Proposed as Sec. Sec.  1.289 to 1.294)
    J. ``What Happens to Food That Is Imported or Offered for Import 
Without Adequate Prior Notice?'' (Section 1.283) and ``What Are the 
Other Consequences of Failing to Submit Adequate Prior Notice or 
Otherwise Failing to Comply With This Subpart?'' (Sec.  1.284 
Proposed as Sec.  1.278)
    K. ``What Happens to Food That Is Imported or Offered for Import 
From Unregistered Facilities That Are Required to Register Under 
Section 415 of the FD&C Act, 21 U.S.C. 350d and 21 CFR Part 1, 
Subpart H?'' (Section 1.285)
IV. Issuance of an Interim Final Rule and Effective Date; Comments
V. Analysis of Economic Impacts
    A. Final Regulatory Impact Analysis
    1. Need for Regulation
    2. Interim Final Rule Coverage
    3. Regulatory Options Considered
    4. Summary of Options
    5. Benefits
    B. Small Entity Analysis (or Final Regulatory Flexibility 
Analysis)
    1. Number of Establishments Affected
    2. Costs per Entity
    3. Additional Flexibility Considered
    C. Unfunded Mandates
    D. Small Business Regulatory Enforcement Fairness Act (SBREFA) 
Major Rule
VI. Paperwork Reduction Act of 1995
VII. Analysis of Environmental Impact
VIII. Federalism
IX. References

I. Background

    In the Federal Register of February 3, 2003 (68 FR 5428), the 
Department of Health and Human Services (FDA) and the Department of 
Treasury (U.S. Customs Service) issued a joint notice of proposed 
rulemaking requiring submission to FDA of prior notice of human and 
animal food that is imported or offered for import into the United 
States. The events of September 11, 2001, had highlighted the need to 
ensure that FDA had additional tools to help prevent a food-related 
bioterrorism event or other public health emergency. Congress responded 
by passing the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), which 
was signed into law on June 12, 2002. The Bioterrorism Act includes a 
provision in Title III (Protecting Safety and Security of Food and Drug 
Supply), Subtitle A'Protection of Food Supply, section 307, which 
changes 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, 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. Under

[[Page 58975]]

the Homeland Security Act of 2002 (Pub. L. 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, we are issuing this interim final rule jointly with the 
Secretary of Homeland Security.
    Section 307 of the Bioterrorism Act amends the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) by adding section 801(m) (21 U.S.C. 
381(m)) and amending section 301 (21 U.S.C. 331). (In the regulation 
itself, which is codified in Title 21 of the Code of Federal 
Regulations, the Federal Food, Drug, and Cosmetic Act is referred to as 
``the act.'' Thus, when the regulation is quoted in this preamble the 
term ``the act'' will be used to refer to the Federal Food, Drug, and 
Cosmetic Act. However, in this preamble we refer to the Federal Food, 
Drug, and Cosmetic Act as ``the FD&C Act'' in the preamble to 
distinguish it from the Bioterrorism Act.)
    The Bioterrorism Act also requires FDA to issue regulations 
requiring certain food establishments to register with FDA (section 
305), directs FDA to issue regulations regarding maintenance of certain 
records (section 306), and grants FDA the authority to administratively 
detain food (section 303). FDA has published proposed rules 
implementing section 305 of the Bioterrorism Act (68 FR 5378, February 
3, 2003), section 303 of the Bioterrorism Act (68 FR 25242, May 9, 
2003), and section 306 of the Bioterrorism Act (68 FR 25188, May 9, 
2003). The interim final rule implementing the food facility 
registration requirements is published elsewhere in this issue of the 
Federal Register.

A. Current Process--Admissibility Determinations Under Section 801(a) 
of the FD&C Act

    Section 801(a) of the FD&C Act sets out current standards and 
procedures for FDA review of imports under its jurisdiction. Section 
801(a) provides for examination of imports and also authorizes FDA to 
refuse admission of imports that appear, from examination or otherwise, 
to be, inter alia, adulterated or misbranded. When an FDA-regulated 
product is imported, generally customs brokers submit entry information 
to CBP on behalf of the importers of record. CBP then provides entry 
information to FDA to enable admissibility decisions to be made. Under 
CBP authorities, entry of the merchandise can be made up to 15 days 
after arrival.
    CBP regulations provide for different kinds of entries. Commonly, 
merchandise is the subject of an entry for consumption or warehouse 
(i.e., unrestricted, general use) under a basic importation and entry 
bond at the port of arrival. A warehouse entry is a CBP entry procedure 
as described in 19 CFR part 144. It allows imported product (with some 
restrictions) to be entered without payment of duty, provided it is 
kept in a bonded warehouse and not distributed. CBP authorities also 
allow for an Immediate Transportation or IT entry of merchandise for 
transportation under a custodial bond from the port of arrival to 
another port where the consumption or warehouse entry will be made or 
the product will be admitted into a foreign trade zone (FTZ) located 
outside of the port area. In addition, if the merchandise is going to 
an FTZ in the port area, FTZ admission documents are presented to CBP. 
Finally, a transportation and exportation (or T&E) entry may be filed 
if the merchandise is to be transshipped from the port of arrival 
through the United States to another port for export.
    FDA currently receives electronic information about entries from 
CBP through CBP's ABI of the ACS. FDA receives this information through 
its Operational and Administrative System for Import Support (OASIS). 
The entry types currently transmitted through the ABI/ACS interface 
with OASIS include consumption entries and warehouse entries but not IT 
entries, T&E entries, or admissions into FTZs. The customs broker or 
self-filer electronically submits entry information to ABI/ACS, 
including: The identification of the product by the Harmonized Tariff 
Schedule (HTS) code; the entry type; the entry number (including both 
the ACS line number and the FDA line number); the arrival date; the 
port; the port of unlading; the carrier code; the vessel name and 
voyage, flight or trip number; importer and ultimate consignee; the 
quantity; value; country of origin; bill of lading or airway bill 
number; the manufacturer; the importer of record; and the ultimate 
consignee. The HTS codes are flagged to indicate which products will 
require FDA review; all FDA-regulated products are covered, not just 
foods. The additional information that is currently transmitted through 
the ABI/ACS interface to FDA includes: The FDA manufacturer; the FDA 
shipper, the FDA Country of Production (country of origin); the 
complete FDA product code; a description of the food in common business 
terms; the quantity for each FDA line, and, as ``Affirmations of 
Compliance,'' information specific to certain products, such as the 
Food Canning Establishment (FCE) Number.\1\ CBP regulations do not 
mandate electronic transmission of entry information; therefore, some 
entries are filed in paper. If a ``paper'' entry is filed, it is 
customary for CBP to require that copies of entry documentation by 
submitted to FDA. The entry documents contain the same information as 
the electronic filing, typically the information required on CBP's 
Entry/Immediate Delivery (CF3461), and a copy of the foreign invoice. 
The paper entries may be presented at the time of arrival or after.
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    \1\ Affirmations of Compliance are data elements that a customs 
broker or self-filer currently uses when transmitting certain 
information to FDA through ABI/ACS to OASIS. Each provides a 
mechanism to indicate (or affirm) compliance with a specific FDA 
regulatory requirement.
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    After information is transmitted from ABI/ACS, OASIS performs 
additional validations on the data. If no corrections from the customs 
broker or self-filer are needed, it screens the entry information 
against FDA admissibility criteria. If the FDA electronic review 
determines that further evaluation of the information or article of 
food is not necessary, the system transmits a message back through the 
FDA/CBP interface that the article of food ``may proceed without FDA 
examination.'' If further evaluation is necessary, FDA staff will 
review the entry information and may request additional information 
necessary to make an admissibility determination or may examine or 
sample the product. Section 801(b) of the FD&C Act provides for the 
release of FDA regulated products to the importer or owner, under bond, 
before the FDA admissibility decision is made. Accordingly, FDA 
examination may take place at a location to which the product has been 
moved. Because there are no restrictions on movement, the product may 
be at the border, within the confines of a port, at a public storage 
facility in the vicinity of the importer, or at the ultimate 
consignee's warehouse. Finally, if the FDA electronic review indicates 
that the product appears ``by examination or otherwise'' to be subject 
to refusal of admission under section 801(a) of the FD&C Act (e.g., 
appears to be adulterated or misbranded), the FDA reviewer will 
evaluate the entry information based on FDA guidance, take appropriate 
action, and notify the importer as well as the customs broker.
    Under current laws and regulations, FDA may receive the information 
about some food imports some days after the food has arrived in the 
United States,

[[Page 58976]]

has been moved from the port of arrival, and has been delivered to the 
ultimate consignee. While FDA may ultimately receive electronic entry 
notification of IT entries when the consumption entry is later filed, 
FDA does not receive electronic notification with information about 
food entered for transshipment for export or when the food is admitted 
to an FTZ.
    The admissibility standard in section 801(a) of the FD&C Act 
largely focuses on whether the article of food appears to have been 
safely produced, contains no contaminants or illegal additives or 
residues, and is properly labeled. Section 801(a) provides that an 
article of food is subject to refusal of admission if it ``appears, 
from physical examination or otherwise': (1) To have been manufactured, 
processed, or packed under insanitary conditions; (2) to be forbidden 
or restricted in sale in the country in which it was produced or from 
which it was exported; or (3) to be adulterated or misbranded. The food 
adulteration and misbranding provisions (sections 402 and 403 of the 
FD&C Act) set out most of the FD&C Act's safety and labeling standards 
for foods.

B. Process After December 12, 2003--Prior Notice Determination Followed 
by Admissibility Determination

    Section 801(m) provides that an article of food is subject to 
refusal of admission if adequate prior notice has not been provided to 
FDA. Thus, the refusal standard in section 801(m) focuses in the first 
instance on whether the requisite information has been provided in a 
timely fashion, while the refusal standard in section 801(a) focuses on 
whether the article was safely produced, contains no contaminants or 
illegal additives or residues, and is properly labeled.
    By adding the prior notice requirement to the FD&C Act, Congress, 
in the Bioterrorism Act, changed when information about FDA-regulated 
food imports must be provided to FDA and what happens if the 
information is not provided. The prior notice provisions require that 
notice must be provided on imported food shipments to FDA before 
arrival. If adequate notice is not provided, section 801(m) of the FD&C 
Act provides that the food is subject to refusal, and that refused food 
must be held until adequate notice is given and may not be delivered to 
the importer, owner, or consignee. The stated purpose of requiring 
notice of imported food shipments before arrival in the United States 
is to enable FDA to conduct inspections of imported food at U.S. ports 
(see section 801(m)(1) of the FD&C Act). Thus, FDA intends to use prior 
notice information to make decisions about which inspections to conduct 
at the time of arrival. Currently, we intend to focus on conducting 
these inspections when our information suggests the potential for a 
significant risk to public health.
    As explained in greater detail in the following paragraphs, FDA and 
CBP are coordinating FDA's new prior notice requirements with CBP's and 
FDA's existing entry requirements to the greatest extent possible. 
Thus, the interim final rule allows prior notice to be submitted 
electronically to FDA through either ABI/ACS or the FDA Prior Notice 
(PN) System Interface. The HTS codes will be flagged within ABI/ACS to 
indicate which HTS codes contain foods subject to prior notice 
requirements. In addition, the ABI/ACS interface will provide a new 
transaction for transmission of prior notice information on IT and T&E 
entries, and FTZ admissions, e.g., the types of entries of which FDA 
was not aware or did not know about until many days after arrival in 
the United States. This will allow for FDA electronic screening and FDA 
staff evaluation of the information so that FDA can assess, before the 
food arrives, whether to inspect and to be prepared to conduct that 
inspection upon arrival.
    FDA expects approximately 90 percent of prior notice submissions 
for all importations of foods to be transmitted by a customs broker or 
self-filer through the ABI/ACS interface to FDA. FDA estimates that 
only 10 percent (or less) of the total importations cannot be 
accommodated by the ABI/ACS interface and, therefore, will be submitted 
via the FDA PN System Interface.
    In addition to requiring submission of the information currently 
sent to FDA for admissibility determinations, information identifying 
the grower (if known), the country from which the article is shipped, 
and anticipated arrival information is also required for prior notice. 
If all of the prior notice information is transmitted through the ABI/
ACS interface, no additional transmission of information for 
admissibility determinations under section 801(a) of the FD&C Act will 
be necessary. If prior notice is submitted through the FDA PN System 
Interface, additional transmission through ABI/ACS may be necessary for 
CBP purposes and FDA's admissibility evaluation.
    Regardless of the mode of transmission, the prior notice 
information will undergo both a validation process and screening in 
OASIS for food safety and security criteria. After the validation step 
is complete, the prior notice will be confirmed by FDA for review and a 
reply message sent to the transmitter indicating the prior notice has 
been received and confirmed for FDA review. The form of this reply 
messaging depends upon the mode of initial transmission: ABI/ACS or FDA 
PN System Interface. The clock starts for determining if prior notice 
was timely when this prior notice confirmation message is sent by FDA.
    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 
purposes, the system will transmit a message back through the OASIS to 
ABI/ACS interface for CBP that the article of food ``may be 
conditionally released under section 801(b) of the act.'' However, if 
additional evaluation of the prior notice information is necessary, FDA 
headquarters staff, operating 24 hours a day, 7 days a week, will 
review and assess the information and may initiate an examination or 
other action by FDA or CBP of the article of food at the port of 
arrival or elsewhere, or in the case of rail shipments, within the 
confines of the closest appropriate examination site.
    In addition, the OASIS system review will determine if further 
staff evaluation of the article of food is necessary for admissibility 
determinations under section 801(a) of the FD&C Act (e.g., subject to 
the guidance in an import alert). If so, FDA staff in the appropriate 
district office will take action, which, in addition to the review and 
evaluation of the submitted information or other documentation, could 
include an examination of the article of food for admissibility 
purposes. This admissibility examination may take place at the border 
but may also take place at an examination site, a public warehouse, or 
other appropriate locations. If FDA determines that refusal under 
section 801(a) of the FD&C Act is appropriate, it will follow 
appropriate procedures.

II. Overview of the Interim Final Rule and Significant Changes Made to 
the Proposed Rule

    The highlights of this interim final rule are described briefly in 
the following paragraphs and are discussed in more detail later in the 
preamble.

A. ``What Definitions Apply to This Subpart?'' (Section 1.276 Proposed 
as Sec.  1.277)

    [sbull] The term ``the act'' was not changed.
    [sbull] The term ``calendar day'' was not changed.

[[Page 58977]]

    [sbull] The term ``country from which the article originates'' was 
added and defined as ``FDA Country of Production.''
    [sbull] The term ``country from which the article of food was 
shipped'' was revised to ``country from which the article is shipped.''
    [sbull] The term ``FDA Country of Production'' replaces the term 
``originating country.'' For an article of food that is in its natural 
state, the FDA Country of Production is 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 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 FDA Country of Production 
is the country where the article was made; except that, if an article 
of food is made from wild fish 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.
    [sbull] The term ``food'' has been redefined. The new definition 
excludes ``food contact substances'' as defined in section 409(h)(6) of 
the FD&C Act (21 U.S.C. 348(h)(6)) and ``pesticides'' as defined in 7 
U.S.C. 136(u).
    [sbull] The term ``grower'' has been added to the interim final 
rule. It means a person who engages in growing and harvesting or 
collecting crops (including botanicals), raising animals (including 
fish, which includes seafood), or both.
    [sbull] The term ``international mail'' has been added to the 
interim final rule. The term ``international mail'' means foreign 
national mail services, but not express carriers, express consignment 
operators, or other private delivery services.
    [sbull] The term ``no longer in its natural state'' has been added 
to the interim final rule. The term means 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. However, 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 the prior notice interim final rule. Likewise, 
whole fish headed, eviscerated, or frozen attendant to harvest are 
still in their natural state for purposes of the prior notice interim 
final rule.
    [sbull] The term ``port of entry'' has been defined, as having the 
meaning given in 19 CFR 101.1.
    [sbull] The term ``port of arrival'' has been added to the interim 
final rule. The interim final rule 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.''
    [sbull] The term ``registration number'' has been added to the 
interim final rule. Registration number refers to the registration 
number assigned by FDA under section 415 of the FD&C Act, 21 U.S.C. 
350d, and 21 CFR part 1, subpart H.
    [sbull] The term ``shipper'' has been added to the interim final 
rule. The interim final rule defines ``shipper'' as ``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.''
    [sbull] The term ``United States'' has been added to the interim 
final rule. It defines ``United States'' as the Customs territory of 
the United States, i.e., ``the 50 States, the District of Columbia, and 
the Commonwealth of Puerto Rico.''
    [sbull] The term ``you'' has been revised to reflect the removal of 
limitations on who is authorized to submit prior notice.

B. ``What is the Scope of This Subpart?'' (Section 1.277 Proposed as 
Sec.  1.276)

    This provision has been revised. Section 1.277(a) clarifies that 
the interim final rule applies 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. FTZ. 
Section 1.277(b) 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 the U.S. Department of Agriculture (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.).

C. ``Who Is Authorized to Submit Prior Notice?'' (Section 1.278 
Proposed as Sec.  1.285)

    This provision has been revised. The interim final rule has been 
revised to remove the restriction that the submitter be the U.S. 
importer or purchaser. The interim final rule provides that any person 
with knowledge of the required information may submit prior notice or 
have it transmitted on their behalf.

D. ``When Must Prior Notice Be Submitted to FDA?'' (Section 1.279 
Proposed as Sec.  1.286)

    This provision has been revised. FDA had proposed that all 
information required in the prior notice be submitted to FDA no later 
than 12 noon of the calendar day before the day the article of food 
arrived at the border crossing in the port of entry. Under the interim 
final rule, prior notice must be submitted to FDA and confirmed for FDA 
review no less than 2 hours before arrival by land via road, no less 
than 4 hours before arrival by air and land via rail, and no less than 
8 hours before arrival by water. If the article of food is arriving by 
international mail, the prior notice must be submitted before the food 
has been sent to the United States and the parcel must be accompanied 
by confirmation of FDA receipt of prior notice. With the exception of 
prior notice 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 entry. When an article of food that is carried by 
or otherwise accompanies an individual is subject to prior notice, the 
prior notice must be submitted within the timeframe established for the 
mode of transportation, and the food must be accompanied by a copy of 
the FDA confirmation including the PN Confirmation Number. Because we

[[Page 58978]]

reduced the timeframes for submitting prior notice in the interim final 
rule to the minimum amount of time that we need to meet our statutory 
responsibility to receive, review, and respond to prior notice 
submissions, the interim final rule does not provide for amendments or 
updates to the prior notice. However, as discussed in more detail in 
section D, FDA and CBP will be actively exploring ways to reduce prior 
notice timeframes, while fulfilling the Bioterrorism Act mandates.

E. How Must You Submit Prior Notice? (Section 1.280 Proposed as Sec.  
1.287)

    FDA proposed that prior notice, amendments, and updates be 
submitted electronically to FDA through the FDA PN System. The interim 
final rule provides that prior notice must be submitted electronically, 
in English (except an individual's name, the name of a company, or the 
name of a street), through either CBP's ABI/ACS or the FDA PN System 
Interface. All information must be submitted using the Latin (Roman) 
alphabet. The interim final rule eliminates submission of duplicative 
information to FDA by those who can file import entry information 
through ABI/ACS. FDA and CBP are upgrading and interfacing their 
respective electronic systems so that information required for prior 
notice can be submitted through ABI/ACS. Information required by the 
interim final rule also can be submitted through the FDA PN System 
Interface. The interim final rule also provides that if a customs 
broker's of self-filer's system is not working or if ABI/ACS is not 
working, prior notice must be submitted through the FDA PN System 
Interface. If the FDA PN System Interface or OASIS is not operating, 
prior notice information must be submitted by e-mail, or by fax to the 
FDA, but not in person.

F. What Information Must Be in a Prior Notice? (Section 1.281 Proposed 
as Sec.  1.288)

    The interim final rule requires the following information to be 
submitted in the prior notice:
    [sbull] Submitter (name of individual, individual's telephone, fax, 
e-mail, name/address of submitting firm);
    [sbull] Transmitter, if different than submitter (name of 
individual, individual's telephone, fax, e-mail, name/address of 
transmitting firm);
    [sbull] Entry type;
    [sbull] CBP entry identifier, such as the CBP entry number or in-
bond number;
    [sbull] The identity of the article of food as follows: The 
complete FDA product code; the common or usual name or market name; the 
estimated quantity described from largest container to the smallest 
package size; and the lot or code numbers or other identifier of the 
food if required by the FD&C Act or FDA regulations;
    [sbull] Manufacturer, for food no longer in its natural state 
(name, address, registration number, except that the requirement to 
provide registration number does not apply to an article of food that 
is imported for transshipment or other export;
    [sbull] Grower, if known, for an article of food that is in its 
natural state (name and growing location);
    [sbull] Consolidator may voluntarily be provided by the submitter, 
at the submitter's option, if the grower is not known (name and 
address);
    [sbull] FDA Country of Production;
    [sbull] Shipper (name, address, registration number; except that 
the requirement to provide registration number does not apply to an 
article of food that is imported for transshipment or other export;
    [sbull] The country from which the article is shipped;
    [sbull] Anticipated arrival information (port of arrival and 
crossing location within that port, date, and time) or, if the food is 
imported by international mail, the anticipated date of mailing;
    [sbull] 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 T&E entry, or, if the 
food is imported by international mail, the U.S. recipient (name and 
address);
    [sbull] Mode of transportation;
    [sbull] Carrier (SCAC/Standard Carrier Abbreviated Code or IATA/
International Air Transportation Association code or, if codes are not 
applicable, the name and country of the carrier) (except for food 
imported by international mail);
    [sbull] Planned shipment information as applicable (except for food 
imported by international mail), including 6-digit HTS code; and
    [sbull] If the article of food is under hold for failure to submit 
prior notice or submit an adequate prior notice, the location where it 
is being held, the date the article has arrived or will arrive at the 
location, and the name of a contact individual at the location.
    FDA eliminated from the interim final rule telephone and fax 
numbers and e-mail addresses for most firms, entry line numbers, trade 
or brand name, and consumption entry information (port of entry/
anticipated date of entry for Customs purposes). FDA revised 
information requirements regarding the quantity, lot/code identifier, 
manufacturer, grower, and carrier in the interim final rule. FDA added 
mode of transportation and planned shipment information to the interim 
final rule. In the interim final rule, registration numbers are 
required only for manufacturer and shipper, if the shipper is a 
facility that is required to be registered under section 415 of the 
FD&C Act (21 U.S.C. 350d) and 21 CFR part 1, subpart H, for that 
article of food. For clarity, the interim final rule segregates the 
information required for food arriving by international mail (Sec.  
1.281(b)) and also segregates the information required for food refused 
under section 801(m) of the FD&C Act (Sec.  1.281(c)).
    Table 1A, which appears later in this preamble, describes the 
information required in prior notice.

G. ``What Must You Do If Information Changes After You Have Received 
Confirmation of a Prior Notice From FDA?'' (Section 1.282 Proposed as 
Sec. Sec.  1.289 to 1.294)

    This provision has been revised in the interim final rule. The 
proposed rule allowed one product identity amendment for certain 
product identity information that was not known at the time of 
submission and for arrival updates. Product identity amendments could 
be submitted up to 2 hours before arrival at the border. Arrival 
updates were required if the port of entry changed or if the time of 
arrival was expected to be more than 3 hours later or 1 hour earlier 
than the anticipated time of arrival.
    The interim final rule does not provide for product identity 
amendments or arrival updates. Because we reduced the timeframes for 
submitting prior notice in the interim final rule to the least amount 
of time that we need to meet our statutory responsibility to receive, 
review, and respond to prior notice submissions, the interim final rule 
does not provide for amendments or updates. The interim final rule 
requires that if required information (except estimated quantity, 
anticipated arrival information including the anticipated date of 
mailing, and planned shipment information) changes after FDA has 
confirmed prior notice for review, the prior notice should be cancelled 
and a prior notice with the correct information must be submitted.

H. ``What Happens to Food That Is Imported or Offered for Import 
Without Adequate Prior Notice?'' (Section 1.283 Proposed as Sec.  
1.278)

    FDA revised the proposed rule to provide for more specificity, to 
clarify

[[Page 58979]]

the status of refused food, and to provide a mechanism for FDA review 
after refusal. In the interim final rule, FDA identifies the 
consequences and procedures for the following situations:
1. Inadequate Prior Notice (No, Inaccurate, or Untimely Prior Notice)
    Unless immediately exported with CBP concurrence, an article of 
food that is refused for inadequate prior notice shall be held in 
accordance with Sec.  1.283.
2. Status and Movement of Refused Food
    [sbull] A refused food is considered general order merchandise 
under section 490(a) of the Tariff Act of 1930, as amended (19 U.S.C. 
1490(a)).
    [sbull] The refused food must be moved under an appropriate 
custodial bond. FDA must be notified of the location where the food has 
been or will be moved within 24 hours of refusal. If the food is held, 
it must be taken directly to the designated location within 48 hours, 
shall not be entered, and shall not be delivered to any importer, 
owner, or ultimate consignee.
3. Segregation of Refused Foods
    If a refused food is part of a shipment that contains other 
articles, the refused food may be segregated from the rest of the 
shipment within the port of arrival or at the hold location if 
different.
4. Costs
    Neither FDA nor CBP are liable for transportation, storage, or 
other expenses resulting from refusal.
5. Export After Refusal
    A refused food may be exported with CBP concurrence and supervision 
(unless CBP or FDA has administratively detained or seized the article 
under other authority).
6. No Post-Refusal Submission or Request for Review
    If no prior notice submission or request for FDA review is 
submitted in a timely fashion after a food is refused, the food will be 
dealt with as set forth in CBP regulations relating to general order 
merchandise. It may only be sold for export or destroyed as agreed to 
by CBP and FDA.
7. Food Carried by or Otherwise Accompanying an Individual
    For food that is not for personal use, if the article of food is 
refused because prior notice is inadequate or the individual cannot 
provide FDA or CBP with a copy of the PN confirmation, the article may 
be held at the port or exported. If the individual cannot make 
arrangements for holding or export, the food may be destroyed.
8. Post-Refusal Prior Notice Submissions
    If an article of food is refused for no or inaccurate prior notice, 
the prior notice must be submitted or corrected and resubmitted to FDA 
and confirmed by FDA for review.
9. FDA Review After Refusal
    After refusal, only the submitter, importer, owner, or ultimate 
consignee may submit a written request asking FDA to review whether the 
article is subject to the requirements of this subpart under Sec.  
1.276(b)(5) and Sec.  1.277, or whether the prior notice submission is 
accurate. The interim final rule also sets out procedures and 
timeframes for the review process.
10. International Mail
    In the case of food arriving by international mail, if prior notice 
is inadequate or if the PN Confirmation Number is not affixed, the 
article will be held by CBP for 72 hours for FDA inspection and 
disposition. If refused and there is a return address, the parcel may 
be returned to sender. If there is no return address or the food in the 
shipment appears to present a hazard, FDA may dispose of or destroy the 
parcel at its expense. If FDA does not respond within 72 hours of the 
CBP hold, CBP may return the parcel back to the sender or, if there is 
no return address, destroy the parcel, at FDA expense.
11. Prohibitions on Delivery and Transfer
    A refused article of food may not be delivered outside of the port 
where the article is held and may not be delivered to the importer, 
owner, or ultimate consignee or transferred by any person from the port 
or secure facility until FDA has examined the prior notice, determined 
the adequacy of the prior notice, and notified CBP and the transmitter 
that the article is no longer refused. After this notification by FDA 
to CBP and transmitter, entry may be made in accordance with law and 
regulation.
12. Relationship to Other Admissibility Provisions
    A determination that an article of food is no longer subject to 
refusal under section 801(m)(1) of the FD&C Act is different than, and 
may come before, determinations of admissibility under other provisions 
of the FD&C Act or other U.S. laws. A determination that an article of 
food is no longer subject to refusal under section 801(m)(1) of the 
FD&C Act does not mean that it will be granted admission under other 
provisions of the FD&C Act or other U.S. laws.

I. What Are the Other Consequences of Failing to Submit Adequate Prior 
Notice or Otherwise Failing to Comply With This Subpart? (Section 1.284 
Proposed as Sec.  1.278)

    The interim final rule provides that failure of a person who 
imports or offers to import an article of food to submit prior notice 
is a prohibited act under section 301(ee) of the FD&C Act (21 U.S.C. 
331(ee)) and sets out the civil, criminal, and debarment actions that 
the United States may bring against persons who are responsible for the 
commission of a prohibited act.

J. What Happens to Food That Is Imported or Offered for Import From 
Unregistered Facilities That Are Required to Register Under 21 CFR Part 
1, Subpart H? (Section 1.285)

    The interim final rule also sets out the consequences concerning 
what happens at the border to food from facilities that are not 
registered as required under section 415 of the FD&C Act and 21 CFR 
part 1, subpart H. These are similar to provisions in the interim final 
rule for dealing with food that is refused for inadequate prior notice.
    Table 1A of this document shows the information required by 
sections 1.281(a), (b), and (c). For clarity, the table also identifies 
under what circumstances certain information is not required, e.g., 
registration numbers when the article of food is imported or offered 
for import for transshipment, storage and export, or further 
manipulation and export.

BILLING CODE 4160-01-P

[[Page 58980]]

[GRAPHIC] [TIFF OMITTED] TR10OC03.074

BILLING CODE 4160-01-C

III. Comments on the Proposed Rule

    FDA received approximately 470 timely responses containing one or 
more comments in response to the proposed rule. To make it easier to 
identify comments and responses to the comments, the word ``Comments'' 
will appear before the description of the comment, and the word 
``Response'' will appear before our response. A summary follows which 
includes a description of the appropriate section in the interim final 
rule.

A. General Comments and Outreach

    (Comments) Some comments suggest revision of section 307 of the 
Bioterrorism Act. Other comments recommend that FDA repropose the rule 
or not implement the rule.
    (Response) Changes to the statute are beyond the scope of this 
rulemaking. Postponing implementation of or not implementing the rule 
is not viable under section 307(c) of the Bioterrorism Act, which not 
only directs the FDA to ``promulgate proposed and final regulations for 
the requirement of

[[Page 58981]]

providing notice in accordance with section 801(m)'' by December 12, 
2003, but also provides that an 8 hour prior notice requirement takes 
effect on this date even if FDA has not promulgated regulations that 
are in effect by this deadline. However, we are publishing this rule as 
an interim final rule and are, accordingly, soliciting comment on its 
provisions.
    (Comments) Most comments generally support the protections of the 
food supply provided under the Bioterrorism Act. Although comments 
recommend that the final rule be amended to reflect more accurately 
industry practices, other comments suggest the regulation should be 
strengthened to ensure that FDA has all of the information required to 
identify foods that may pose a health or security threat. Some comments 
argue that FDA already has access to information currently submitted to 
CBP to allow for identification and quick interdiction of foods that 
may pose a health or security threat. Other comments question how the 
final rule would enhance FDA's ability to improve food safety and 
whether the benefits outweigh the costs.
    (Response) Through section 307 of the Bioterrorism Act, Congress 
amended the FD&C Act to require the submission to FDA of a notice 
providing information regarding food before its importation into the 
United States. Congress also required FDA to issue implementing 
regulations to be effective not later than December 12, 2003. Thus, a 
postponement of the rule is not an option. Although FDA is aware that 
the prior notice regulation will affect industry, Congress determined 
the need for prior notice by passing the Bioterrorism Act. Prior notice 
of imported food will give FDA better information about the food 
earlier, enabling FDA to review and respond to the information before 
the arrival of the food at the border. Prior notice also will give FDA 
information with which it will be able to better focus its inspection 
resources. Section V of this preamble, Analysis of Economic Impacts, 
discusses the benefits of this interim final rule in detail. To address 
many of the concerns raised by the comments, FDA has made significant 
modifications in the interim final rule. However, we are publishing 
this rule as an interim final rule and are, accordingly, soliciting 
comment on its provisions.
    (Comments) Some comments ask that FDA provide clear guidance and 
training to industry and agency field personnel about the procedures 
for implementing the regulation.
    (Response) FDA conducted extensive outreach on the proposed prior 
notice rule, including having relevant FDA staff attend 6 international 
meetings and over 100 domestic meetings to ensure that affected parties 
were aware of the Bioterrorism Act prior notice requirements. On 
January 29, 2003, FDA held a public meeting (via satellite downlink) to 
discuss both the registration and prior notice proposed rules (see 68 
FR 1568, January 13, 2003) or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
 Nearly 1,000 participants in North and South 
America and the Caribbean viewed that live broadcast. The meeting was 
later re-broadcast to Europe, Asia, Africa, and the Pacific. FDA has 
also posted transcripts of the broadcast in English, French, and 
Spanish on the agency's Web site.
    FDA plans similar outreach efforts directed to both domestic and 
international stakeholders after publication of the interim final rule 
implementing the registration and prior notice provisions of the 
Bioterrorism Act. Outreach will include many methods of communication:
    [sbull] Dissemination of materials to guide affected domestic and 
international food facilities through the new processes established to 
implement the registration and prior notice requirements;
    [sbull] Domestic outreach meetings to State regulators and 
industry;
    [sbull] A satellite downlink video broadcast and a series of 
videoconferences to various regions of the world;
    [sbull] Materials and events for the media;
    [sbull] International outreach to food trading partners;
    [sbull] Presentations by FDA officials and exhibits at professional 
and trade conferences and meetings to inform industry and state and 
local government representatives of the new requirements; and
    [sbull] Cooperative arrangements with CBP and other Federal 
agencies to ensure that information on the interim final regulations 
and their requirements is disseminated to affected companies and 
individuals.
    More specifics regarding each of these will be included in FDA's 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov. In addition, FDA also plans training in 
new or revised procedures for its field personnel, as well as CBP field 
personnel. FDA will also provide guidance on enforcement to its staff 
containing the agency's policies on injunctions, prosecution, and 
debarment related to failure to provide timely and accurate prior 
notice, as well as the agency's policies regarding refusals under 
section 801(m)(1) of the FD&C Act and holds under section 801(l). As 
described in greater detail later, FDA intends to include a transition 
period in this guidance, during which it will emphasize education to 
achieve compliance. Guidance documents are available to the public, and 
FDA will shortly publish a notice of availability in the Federal 
Register.
    FDA will notify the World Trade Organization (WTO) of this interim 
final rule. Shortly after publication of this interim final rule, FDA 
will begin disseminating at U.S. ports flyers and posters summarizing 
the new requirements and informing representatives of affected entities 
how to provide prior notice to FDA. Online assistance and a help desk 
will be available when the interim final rule becomes effective.

B. Foreign Trade Issues

    (Comments) Some comments questioned the consistency of the proposed 
regulation with U.S. obligations under various WTO agreements, NAFTA, 
and other international agreements.
    (Response) FDA is aware of the international trade obligations of 
the United States and has considered these obligations throughout the 
rulemaking process for this regulation and the interim final regulation 
is consistent with these international obligations.
    (Comments) Some comments asserted that the proposed regulation is 
burdensome, confusing, costly, disproportionate, discriminatory, and 
will have a negative impact on foreign trade.
    (Response) In drafting the proposed rule, FDA considered how best 
to structure the proposed rule consistent with the statutory mandates 
of the Bioterrorism Act and, at the same time, to reduce the costs 
associated with compliance. As discussed in more detail in the 
following paragraphs, FDA has carefully considered comments received 
regarding the burden imposed by the proposed rule, including its 
effects on international trade. Furthermore, based on the comments 
received on the proposed requirements, FDA has made a number of 
significant changes that minimize the impact of prior notice 
requirements on the food industry. These changes include removing 
restrictions on who can submit prior notice; allowing submission to be 
made either through ABI/ACS (the existing mechanism for filing entry 
information with CBP) or the FDA PN System Interface (the FDA PN Web 
system described in the proposed rule); reducing the timeframes for 
submission of prior notice and tying them to mode

[[Page 58982]]

of transport; and streamlining the information requirements.

C. ``What Definitions Apply to This Subpart?'' (Section 1.276 Proposed 
as Sec.  1.277)

1. The Act (Sec.  1.276(a))
    The proposed rule defined ``the act'' as the Federal Food, Drug, 
and Cosmetic Act. The proposed rule also applies the definitions of 
terms in section 201 of the act (21 U.S.C. 321) to such terms as used 
in the proposed rule.
    (Comments) FDA did not receive comments on the definition of ``the 
act.''
    (Response) We did not change the definition in the interim final 
rule. We have clarified that the definitions in the FD&C Act do not 
apply if a term is defined differently in the interim final rule.
    (Interim final rule) Section 1.276(a) of the interim final rule 
defines ``the act'' as the Federal Food, Drug, and Cosmetic Act. 
Section 1.276(b) provides the definitions in the FD&C Act apply unless 
a term is defined differently in the interim final rule.
2. Calendar Day (Sec.  1.276(b)(1))
    The proposed rule defined ``calendar day'' as ``every day shown on 
the calendar.''
    (Comments) FDA did not receive comments on the definition of 
``calendar day.''
    (Response) We did not change the definition in the interim final 
rule.
    (Interim final rule) ``Calendar day'' is defined in Sec.  
1.276(b)(1) of the interim final rule as ``every day shown on the 
calendar.''
3. Country From Which the Article Originates (Sec.  1.276(b)(2))
    Section 801(m)(1) of the FD&C Act requires that ``the country from 
which the article originates'' be identified in a prior notice. The 
proposed rule used the term ``originating country'' and defined it as 
``the country from which the article of food originates.''
    (Comments) Comments were received on the proposed definition of 
``originating country.'' These comments are addressed under ``FDA 
Country of Production,'' which is the term that FDA has chosen in the 
interim final rule to replace ``originating country.''
    (Response) The term ``the country from which the article 
originates'' has been added to the interim final rule to refer back to 
the statutory language.
    (Interim final rule) ``Country from which the article originates'' 
is defined as ``FDA Country of Production.''
4. Country From Which the Article Is Shipped (Sec.  1.276(b)(3))
    The proposed rule defined ``country from which the article of food 
was shipped'' as ``the country in which the article of food was loaded 
onto the conveyance that brings it to the United States.'' A conveyance 
is the means of transportation, e.g., ship, truck, car, van, plane, 
railcar, etc., not the shipping container that can be moved from a ship 
to a truck to a train. FDA requested comment on whether the phrase 
``country from which the article of food was shipped'' should include 
the countries of intermediate destination.
    (Comments) Several comments support identifying countries of 
intermediate destination, noting that it would be desirable to have 
this information to support product tracing. One states that even if a 
food product were merely shipped through another country without 
further manufacturing/processing, the potential for tampering would 
still exist. This comment is concerned that, without information on 
every intermediate country, FDA would lack the ability to trace food 
for potential contamination back through the distribution chain. 
Another comment supports providing the countries of intermediate 
destination. It states that, except in the case of sealed containers, 
the manufacturer cannot control manipulation that occurs in countries 
of intermediate destination.
    Several comments state that the information required in a prior 
notice should not include countries of intermediate destination. Other 
comments note that: An imported article may pass through a number of 
ports or stops in a variety of countries and never be unloaded; a U.S. 
importer in most cases has no control of which ports or stops a carrier 
may make; and exporters cannot guarantee which ports the ship will 
enter or pass through on its way to a U.S. port. Another comment states 
the information would not be necessary for sealed containers because 
alteration or absence of a seal alerts the owner to tampering, but it 
may be necessary for bulk or unpackaged products. Most of the comments 
that object conclude that submission of additional countries of 
intermediate destination would be unreasonable and burdensome and would 
not improve the safety and security of the food supply.
    (Response) Section 801(m)(l) of the FD&C Act uses the singular 
``country'' when it directs submission of the identity of the country 
from which the article is shipped, not the plural ``countries.'' Thus, 
FDA has concluded that the text of the statute dictates that the 
definition be singular. The interim final rule thus retains the 
proposed definition of the term ``country from which the article was 
shipped.''
    (Comments) One comment states that the proposed definition of 
``country from which the article of food was shipped'' is clear and 
suggests that it be maintained. Several commenters suggest that 
``country from which the article of food was shipped'' should be 
defined as the country from which the goods were ``exported'' to the 
United States as that phrase is used in the CBP regulations defining 
``country of export.''
    Other comments suggest that FDA's definition failed to take into 
account the following considerations: That ocean and air carriers 
routinely use ``feeder'' vessels/aircraft to move cargo from the 
country of origin to a ``gateway'' for transfer to a larger vessel or 
aircraft that will transport the cargo to its final destination; and 
that ocean vessels frequently discharge containers destined for the 
United States in Canada where they are transferred to a motor carrier 
for transport to the United States. The comments conclude that the 
proposal, if implemented, would confuse importers and require them to 
attempt to obtain the cargo routing from master carriers. They suggest 
that FDA require instead the reporting of the last country in which a 
product was stored if that is different from the country in which it 
was produced (the country of production).
    (Response) Section 801(m)(1) of the FD&C Act requires that prior 
notice submissions identify ``the country from which the article is 
shipped.'' ``Country of export'' is not a term formally defined in 
CBP's regulations.
    We acknowledge that food may pass through more than one country 
before it reaches the United States. However, we do not believe that 
this practice changes the definition dictated by the statutory 
language. Several examples may be helpful. In one scenario, a shipper 
in country A arranges for a food manufactured in country B to be 
transported to the United States via country C. The food arrives in 
country C on an ocean vessel and is transferred to a truck that brings 
it to the U.S. port of arrival. In this first scenario, the country 
from which the article is shipped is country C.
    In a second scenario, a shipper in country A arranges for a food 
manufactured in country B to be transported to the United States by a 
ship that is loaded in country B but stops in country C and then 
continues to the United States where the food is discharged. In this 
second scenario, the country from which the article is

[[Page 58983]]

shipped is country B. In a third scenario, if the food was transferred 
to a different vessel in country C, the country from which the article 
is shipped is country C.
    (Interim final rule) Section 1.276(b)(3) of the interim final rule 
defines ``country from which the article is shipped'' as ``the country 
in which the article of food is loaded onto the conveyance that brings 
it to the United States.'' We changed the term from ``country from 
which the article was shipped'' to ``country from which the article is 
shipped'' to accurately reflect the language of the statute.
5. FDA Country of Production and Originating Country (Sec.  
1.276(b)(4))
    The proposed rule defined ``originating country'' as ``the country 
from which the article of food originates,'' which means the country 
where the article of food was grown and harvested, or if processed, 
where the article of food was produced.
    (Comments) Many comments regarding the definition of ``originating 
country'' suggest that FDA use the ``country of origin'' definition 
used by CBP, or the standard rules of origin used by CBP, USDA, and 
associations such as the WTO.
    (Response) Section 801(m)(1) of the FD&C Act requires prior notice 
submissions to FDA identify ``the country from which the article 
originates.''
    We have not changed the definition of ``originating country'' to 
align it with ``country of origin'' as that term is defined by CBP. CBP 
defines ``country of origin'' at 19 CFR 134.1(b) as follows:

the country of manufacture, production, or growth of any article of 
foreign origin entering the United States. Further work or material 
added to an article in another country must effect a substantial 
transformation in order to render such other country the ``country 
of origin'' within the meaning of this part; however, for a good of 
a NAFTA country, the NAFTA Marking Rules will determine country of 
origin.

    In rulings, CBP has further defined ``country of origin'' and 
substantial transformation to identify the country of growth of the 
main ingredient in a processed food rather than the country of 
production of ``the article [of food]'' (emphasis added) in the form it 
is being imported into the United States. For example, a CBP ruling 
identified the country of origin as the United States where beans were 
rehydrated and canned in the Dominican Republic, but grown and dried in 
the United States (Ref. 1). For purposes of the prior notice provisions 
of the FD&C Act, the ``article of food'' is canned beans, not dried 
beans. From a food safety standpoint, FDA is most interested in knowing 
where the article of food was processed and canned. We believe that it 
best serves the language and the purposes of section 801(m)(l) of the 
FD&C Act to define the term to focus on the country of production of 
the specific article of food that is being shipped to the United 
States. To avoid confusion between FDA's prior notice requirements and 
CBP requirements, the interim final rule uses the term ``FDA Country of 
Production'' instead of the term ``originating country'' or ``country 
from which the article originates.'' ``FDA Country of Production'' is 
already familiar to customs brokers and self-filers using ABI/ACS 
interface with OASIS.
    (Comments) One comment suggests that ``EU'' (European Union) be 
acceptable for use as an originating country.
    (Response) FDA disagrees. Section 801(m) of the FD&C Act requires 
identification of ``the country from which the article originates'' 
(emphasis added). Accordingly, for purposes of this provision, each 
sovereign country must be identified when declared as part of the prior 
notice submission.
    (Comments) Several comments suggest that the definition of 
``country of origin'' for fish be the country in which the vessel is 
flagged or in which the fish was last processed. Another comment asks 
FDA to use the definition of ``country of origin'' being used by USDA's 
Agricultural Marketing Service for fish and seafood.
    (Response) We generally agree. The proposed rule relied in part on 
USDA's proposed definition as set out in USDA guidance published in the 
Federal Register on October 11, 2002, and is based on the Farm Security 
and Rural Investment Act of 2002 (commonly known as the 2002 Farm 
Bill), as amended. As set out in Sec.  1.276(b)(4) of the interim final 
rule, if an article of food is wild fish that is still in its natural 
state and 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 the article of food is made from wild fish aboard a vessel, the FDA 
Country of Production is the country in which the vessel is registered.
    (Comments) Several comments express concern that the proposed 
definition, ``[o]riginating country means the country from which the 
article of food originates,'' does not take into consideration the 
producer, processor, vessel or common carrier feeder and consolidation 
practices in which components of the shipment may be composites or 
commingled from more than one country. One comment asks that FDA 
describe when the country of canning would be the originating country, 
and when it would not. One comment suggests that decaffeinating or 
blending coffee be considered processing and that decaffeinated or 
blended coffee be considered as processed food for the purposes of 
prior notice.
    (Response) Some of these comments appeared to confuse the proposed 
definition of ``country from which the article of food was shipped'' 
with the proposed definition of ``originating country,'' another reason 
why we decided to use the term ``FDA Country of Production.'' As 
explained above in the discussion of ``the country from which the 
article is shipped,'' the two countries will sometimes be different. 
When determining which country is the FDA Country of Production, the 
focus should be on the production of the specific article of food. For 
example, if the article of food is raw, whole, unpeeled carrots, the 
FDA Country of Production is the country where the carrots were grown 
and harvested. If the article of food is raw peeled and chopped carrots 
or canned carrots, the FDA Country of Production is the country where 
the carrots were peeled and chopped or canned. As a general matter, for 
canned foods, the FDA Country of Production should be the country where 
food was canned. Similarly, we consider decaffeinated coffee to be no 
longer in its natural state and the FDA Country of Production would be 
the country in which the coffee was decaffeinated.
    (Interim final rule) Section 1.276(b)(4) of the interim final rule 
defines the ``FDA Country of Production'' for an article of food that 
is in its natural state, as 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. For an 
article of food that is no longer in its natural state, the FDA country 
of production is defined as 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

[[Page 58984]]

a Territory, the FDA Country of Production is the United States.
6. Food (Sec.  1.276(b)(5))
    The proposed rule defined ``food'' as having the meaning given in 
section 201(f) of the FD&C Act. The proposed rule provided examples of 
food including:

fruits, vegetables, fish, dairy products, eggs, raw agricultural 
commodities for use as food or components of food, animal feed, 
including pet food, food and feed ingredients and additives, 
including substances that migrate into food from food packaging and 
other articles that contact food, dietary supplements and dietary 
ingredients; infant formula, beverages, including alcoholic 
beverages and bottled water, live food animals (such as hogs and 
elk), bakery goods, snack foods, candy, and canned foods.

    a. Food packaging and other food contact substances.
    (Comments) We received several comments on the subject of food 
contact substances, including packaging. The comments ask that FDA 
clarify the definition of ``food'' because the proposed rule included 
as examples of food not only those items traditionally understood as 
food, but also items that come into contact with and may migrate into 
food during processing or packaging. In particular, the comments ask 
that food packaging and components of food packaging, other food 
contact articles (such as food processing equipment and components of 
such equipment, glassware, dishware, cutlery, kitchen appliances), and 
so-called indirect additives (including those applied to food contact 
surfaces) be excluded from the final rule's definition of ``food.''
    In support, the comments contend the legislative history of the 
prior notice provisions establish that Congress did not intend to apply 
prior notice requirements to these substances even though they can be 
food within the meaning of section 201(f) of the FD&C Act. In addition, 
some point to language in section 415 of the FD&C Act (21 U.S.C. 350d) 
relating to registration and language in section 414(b) of the FD&C Act 
relating to recordkeeping (21 U.S.C. 350c). Finally, some comments 
argued that an overly broad definition of ``food'' would dilute the 
government's resources, thereby hampering the government's opportunity 
to achieve the protective goals of the Bioterrorism Act.
    (Response) We expressly included food packaging and other food 
contact materials in the proposed definition, with the result that 
prior notice would have been required for food packaging and other food 
contact materials and their components (see 68 FR 5428 at 5430). The 
breadth of the proposed definition of ``food'' was based on both the 
statutory definition in section 201(f)(3) of the FD&C Act, which 
defines articles used as components of food as ``food,'' as well as the 
case law interpreting the definition, including Natick Paperboard v. 
Weinberger, 525 F.2d 1103 (1st Cir. 1975) (paperboard containing PCBs 
intended for food use is adulterated food; U.S. v. Articles of food * * 
* 688 Cases * * * of Pottery (Cathy Rose), 370 F. Supp. 371 (E.D. Mi. 
1974) (ceramic pottery that leaches lead is adulterated food).
    The comments on food contact substances raise the question of what 
Congress intended ``food'' to mean for purposes of prior notice. In 
construing the prior notice provision of the Bioterrorism Act, FDA is 
confronted with two questions. First, has Congress directly spoken to 
the precise question presented? (``Chevron step one'') Chevron, U.S.A., 
Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984). To find no ambiguity, 
Congress must have clearly manifested its intention with respect to the 
particular issue (Young v. Community Nutrition Institute, 476 U.S. 974, 
980 (1986)). If Congress has spoken directly and plainly, the agency 
must implement Congress's unambiguously expressed intent (Chevron, 467 
U.S. at 842-843). If, however, the Bioterrorism Act is silent or 
ambiguous as to the meaning of ``food,'' FDA may define ``food'' in a 
reasonable fashion (``Chevron step two''); Chevron, 467 U.S. at 842-
843; FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132 
(2000)).
    The agency has determined that, in enacting section 801(m) of the 
FD&C Act, Congress did not speak directly and precisely to the meaning 
of ``food.'' As noted, the FD&C Act has a definition of ``food'' at 
section 201(f). It may be a reasonable assumption that, when the term 
``food'' is used in the FD&C Act, section 201(f) applies. However, 
although there may be ``a natural presumption that identical words used 
in different parts of the same act are intended to have the same 
meaning [citation omitted], * * * the presumption is not rigid * * *.'' 
(Atlantic Cleaners & Dyers, Inc. v. U.S., 286 U.S. 427, 433 (1932); 
(accord: U.S. v. Cleveland Indians Baseball Co., 532 U.S. 200, 213 
(2000)). Thus, the same word may be given different meanings, even in 
the same statute, if Congress intended different interpretations or if 
such different interpretations are reasonable (at step 2) (Atlantic 
Cleaners & Dryers, Inc., supra).
    Even before the Bioterrorism Act amendments, the term ``food'' was 
not defined identically throughout the FD&C Act. For example, in 
construing the parenthetical ``(other than food)'' in section 
201(g)(1)(C) of the FD&C Act, the Seventh Circuit Court noted that 
Congress meant to exclude only ``articles used by people in the 
ordinary way that most people use food--primarily for taste, aroma, or 
nutritive value'' and not all substances defined as food by section 
201(f) (Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir. 
1983)). Similarly, section 409(h)(6) of the FD&C Act defines a ``food 
contact substance'' as ``any substance intended for use as a component 
of materials used in manufacturing, packing, packaging, transporting, 
or holding food if such use is not intended to have any technical 
effect in such food'' (emphasis added). This definition makes sense 
only if ``food'' in this context excludes materials that contact food 
because components of food contact materials are plainly intended to 
have a technical effect in such materials.\2\
---------------------------------------------------------------------------

    \2\ FDA's long-standing interpretation of the FD&C Act's 
definition of color additive, section 201(t), is an additional 
example of where ``food'' is used more narrowly than as defined in 
section 201(f). A color additive is defined in section 201(t) of the 
FD&C Act as a substance that ``when applied to a food * * * is 
capable * * * of imparting color thereto * * *.'' The agency's food 
additive regulations distinguish between color additives and 
``colorants,'' the latter being used to impart color to a food-
contact material (21 CFR 178.3297(a); see also 21 CFR 70.3(f)). 
Thus, ``food'' as it appears in the statutory definition of color 
additive, necessarily excludes food contact materials.
---------------------------------------------------------------------------

    Thus, in this larger statutory context, FDA has evaluated section 
801(m) of the FD&C Act to determine whether the meaning of the word 
``food'' is ambiguous. In conducting this Chevron step one analysis, 
all of the traditional tools of statutory interpretation are available 
to determine whether the language Congress used is ambiguous 
(Pharmaceutical Research & Manufacturers of America v. Thompson, 251 F. 
3d 219, 224 (D.C. Cir. 2001)). Beginning with the language of the 
statute, in section 801(m) of the FD&C Act, ``food'' is used to 
describe which subset of FDA-regulated articles are subject to prior 
notice:

    In the case of an article of food that is being imported or 
offered for import into the United States, the Secretary, after 
consultation with the Secretary of the Treasury, shall by regulation 
require, for the purpose of enabling such article to be inspected at 
ports of entry into the United States, the submission to the 
Secretary of a notice * * * (emphasis added).

The Bioterrorism Act is silent as to the meaning of ``food.'' Congress 
did not specify whether it intended the definition in section 201(f) of 
the FD&C Act to apply, one of the other

[[Page 58985]]

possibilities noted above, or another meaning. Where, as here, the 
statutory language on its face does not clearly establish Congress's 
intent, it is appropriate to consider not only the particular statutory 
language at issue, but also the language and design of the statute as a 
whole (Martini v. Federal Nat'l Mortgage Association, 178 F. 3d 1336, 
1345 (D.C. Cir. 1999), citing K Mart Corp. v. Cartier, Inc., 486 U.S. 
281 (1988)). Indeed, the analysis should not be confined to the 
specific provision in isolation, because the meaning or ambiguity of a 
term may be evident only when considered in a larger context (FDA v. 
Brown & Williamson Tobacco Corp., supra at 132 (2000)).
    Consistent with this instruction, FDA has considered other parts of 
the Bioterrorism Act in assessing whether the meaning of ``food'' in 
section 801(m) of the FD&C Act ambiguous. In particular, FDA has 
considered the language of section 415 of the FD&C Act. The 
Bioterrorism Act's registration provision is one piece of several 
enacted by Congress to enhance the safety of the U.S. food supply. 
Registration is designed to work in concert with prior notice. This is 
reflected in the Bioterrorism Act's amendment of section 801 of the 
FD&C Act to provide that food from an unregistered foreign facility be 
held at the port when imported or offered for import (section 801(l) of 
the FD&C Act). The information provided by registration will allow FDA 
to cross-check prior notice submissions against registration data to 
confirm the identity of manufacturers and others who are required to 
register. Furthermore, the information provided by prior notice 
submissions can serve as a cross-check as to whether firms are 
registered as required and have been providing the necessary updates.
    As explained in the preamble to the interim final registration rule 
published elsewhere in this issue of the Federal Register, FDA has 
concluded that the meaning of the term ``food'' in section 415 of the 
FD&C Act is ambiguous. First, the use, in section 415(a)(1) of the FD&C 
Act, of the phrase ``for consumption'' after the word ``food'' creates 
an ambiguity because it could be read to suggest that ``food'' within 
the context of the section 415 registration requirement only refers to 
food that is ordinarily thought of as ``consumed.'' By modifying the 
term ``food,'' Congress apparently intended to limit the term ``food'' 
to something less than the broad definition in section 201(f) of the 
FD&C Act. In addition, in section 415(b)(1) of the FD&C Act, when 
defining ``facility'' for purposes of section 415, Congress expressly 
exempted ``farms; restaurants; other retail food establishments; 
nonprofit food establishments in which food is prepared for or served 
directly to the consumer * * *.'' These exemptions do not make clear 
whether Congress intended them to cover only food that is ordinarily 
eaten at some point by consumers primarily for taste, aroma, or 
nutritive value or whether, for example, a retail food establishment 
could include retailers of food contact materials, such as retail 
cookware stores.
    The legislative history of section 415 of the FD&C Act also 
supports the conclusion that Congress did not speak directly to the 
meaning of ``food'' in that Bioterrorism Act provision. Such history is 
appropriately consulted at Chevron step one (Atherton v. FDIC, 519 U.S. 
213, 228-29 (1997)). In particular, the Conf. Rept. to H.R. 3448, which 
became the Bioterrorism Act, explains what Congress intended by 
``retail food establishments,'' which is used to create an exemption 
from registration.

    The Managers intend that, for the purposes of this section, the 
term 'retail food establishments' includes establishments that 
store, prepare, package, serve, or otherwise provide articles of 
food directly to the retail consumer for human consumption, such as 
grocery stores, convenience stores, cafeterias, lunch rooms, food 
stands, saloons, taverns, bars, lounges, catering or vending 
facilities, or other similar establishments that provide food 
directly to a retail consumer.

(H. Conf. Rept. No. 481, 107th Cong., 2d Sess., 133 (2002)). Similarly, 
the Conf. Rept. notes that the term ``non-profit food establishments'' 
includes not-for-profit establishments in which food is prepared for, 
or served directly to the consumer, such as food banks, soup kitchens, 
homebound food delivery services, or other similar charitable 
organizations that provide food or meals for human consumption'' (Id. 
at 133-34). Notably, the examples provided by Congress for both types 
of exempt food establishments are not those that generally sell or 
distribute food contact materials. Accordingly, the legislative history 
of section 415 of the FD&C Act creates additional ambiguity as to the 
meaning of ``food.''
    This ambiguity in the word ``food'' is further underscored by the 
legislative history of section 801(m) of the FD&C Act. For example, the 
Conf. Rept. states that the prior notice provision is to be construed 
not to apply to ``packaging materials if, at the time of importation, 
such materials will not be used for or in contact with food * * *'' 
(see H. Conf. Rept. No. 481, 107th Cong., 2d Sess., 136 (2002)). This 
statement implies that Congress was not relying on the definition of 
food in section 201(f) of the FD&C Act. For example, the statement 
could be read to mean that the term ``food'' does not include packaging 
or other materials that contact food.
    Having concluded that the meaning of ``food'' in section 801(m) of 
the FD&C Act is ambiguous, FDA has considered how to define the term to 
achieve a ``permissible construction'' of the prior notice provision 
(Chevron, USA, Inc. v. NRDC, Inc., supra at 843). In conducting this 
Chevron step two analysis, the agency has considered the same 
information evaluated at step one of the analysis (Bell Atlantic 
Telephone Co. v. FCC, 131 F. 3d 1044, 1049 (D.C. Cir. 1997); Chevron 
U.S.A., Inc. v. FERC, 193 F. Supp. 2d 54, 68 (D.D.C. 2002)). FDA has 
determined that it is permissible, for purposes of the prior notice 
provision, to exclude food contact materials from the definition of 
``food.''
    Restricting ``food'' to substances other than food contact 
materials is consistent with the legislative history of the prior 
notice provision relating to food packaging and other food contact 
substances. In addition, it is consistent with the ``food for 
consumption'' language in section 415(a)(1) (FD&C Act) of the 
registration provision. That is, foods that are ``consumed'' are 
generally those eaten for their taste, aroma, or nutritive value. In 
addition, excluding food contact materials from ``food'' in this 
regulation is consistent with the exemptions in section 415(b)(1) of 
the FD&C Act, as well as the legislative history of section 415.
    As discussed in the following paragraphs in responses to other 
comments, FDA has also interpreted ``food'' for purposes of section 
801(m) of the FD&C Act to exclude pesticides as that term is defined 
under 7 U.S.C. 136(u). Accordingly, FDA has determined that a 
reasonable interpretation of ``food'' for purposes of section 801(m) of 
the FD&C Act is as follows and has revised Sec.  1.276(b)(5) of this 
interim final rule to provide:

    Food has the meaning given in section 201(f) of the act, except 
for purposes of this subpart, 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.


[[Page 58986]]


    Importantly, FDA still considers food packaging and other food 
contact substances to be ``food'' within the meaning of section 201(f) 
of the FD&C Act when they, or their components, migrate into other 
food. Therefore, these items are still ``food'' for purposes of the 
other provisions of section 801 of the FD&C Act (with the exception of 
section 801(l), which shares the same definition of food as section 
801(m)). Accordingly, although not subject to the section 801(m) of the 
FD&C Act requirement of prior notice, food packaging materials and 
other food contact substances will remain, as they have been, subject 
to determinations of admissibility under section 801(a) of the FD&C 
Act.
    b. Food processing aids. (Comments) One comment argues that food 
processing aids and ``indirect food additives'' should not be 
considered food for purposes of section 801(m) of the FD&C Act. 
According to the commenter, these substances resemble food contact 
substances, which Congress, as evidenced by the prior notice 
legislative history of food contact substances, did not expect FDA to 
subject to prior notice.
    (Response) 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 
4091(h)(6) of the FD&C 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.
    c. Antimicrobial pesticides. (Comments) One comment expresses 
concern about including antimicrobial pesticides within the scope of 
this regulation. The comment states that pesticides are imported 
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), not the FD&C Act, and are subject to Environmental Protection 
Agency (EPA) approval before they are admitted to the United States. 
The comment asks that FDA clarify that this regulation is not 
applicable to antimicrobial pesticides with FDA and/or EPA approved 
food contact uses. The comment states that including antimicrobial 
pesticides within the scope of this regulation would impose unnecessary 
burdens on antimicrobial pesticide registrants, without enhancing the 
protection of the food supply.
    (Response) As discussed previously, the meaning of ``food'' in 
section 801(m) of the FD&C Act is ambiguous. Therefore, FDA may define 
``food'' in a reasonable manner. FDA believes that excluding pesticides 
from the definition of food is reasonable. Pesticides, including those 
used in or on food for human or animal use, are comprehensively 
regulated by the Federal Government. Under FIFRA, 7 U.S.C. 136 et seq., 
all pesticides (both food and nonfood use) are registered with EPA. As 
part of the registration process, establishments in which pesticides 
are produced must register with EPA (40 CFR 167.3 and 167.20). As part 
of the importation process, prior notice of pesticide shipments must be 
provided to EPA (19 CFR 12.112).
    Importantly, the Federal regulatory scheme for pesticides was 
substantially revised in 1996 by the Food Quality Protection Act (FQPA) 
(Pub. L. 104-170), and EPA's authority over pesticides was consolidated 
and expanded. As a result of FQPA, pesticides and their residues are 
subject to substantial and comprehensive regulation by EPA. Where 
another Federal agency has the types of specific and comprehensive 
authority described previously to regulate the safety of a substance, 
FDA believes that it is appropriate to interpret ``food'' in section 
801(m) of the FD&C Act as not including that substance. Accordingly, 
FDA has revised the definition of ``food'' in Sec.  1.276(b)(5) to 
exclude pesticides as defined by FIFRA.
    d. Chemicals (Comments) One comment seeks clarification as to 
whether chemicals are considered ``food.'' The comment expects that 
chemicals intended for human consumption will likely be included in the 
requirements for prior notice.
    (Response) We are not sure exactly what substances or products the 
comment refers to; ``chemicals'' is a very broad term. Unless excluded 
because they are food contact substances or pesticides, chemicals that 
are ``used for food or drink'' or are ``used for components of any such 
articles'' are ``food'' under section 201(f) of the FD&C Act and the 
definition in the interim final rule (Sec.  1.276(b)(5)). If the 
substance is used in some applications that make the substance ``food'' 
and some that do not, the principles applicable to further processing 
and multi-use substances, set out in the following paragraphs, apply.
    e. Live animals. (Comments) Two comments address inclusion of live 
animals. One comment urges FDA to exempt live food animals from this 
regulation, as it will have far-reaching impacts on all Canadian 
farmers who export live food animals to the United States. The other 
comment asks for clarification as to how prior notice applies to live 
food animals imported for further processing, such as finishing.
    (Response) As discussed previously, the meaning of ``food'' in 
section 801(m) of the FD&C Act is ambiguous. Therefore, FDA may define 
``food'' in a reasonable manner. FDA believes that it is reasonable to 
interpret ``food'' in section 801(m) of the FD&C Act to include live 
animals. Such inclusion is consistent with the explicit reference to 
animals in the statutory standard, ``serious adverse health 
consequences or death to humans or animals'' in section 
801(m)(2)(B)(ii) of the FD&C Act--the provision that relates to FDA 
review of prior notices submitted for food refused for lack of adequate 
prior notice. In addition, it is consistent with the legislative 
history of section 801(m) of the FD&C Act that refers only to the 
exclusion of food contact substances. Moreover, the products of live 
food animals are an integral part of the food consumed in the United 
States, and thus, it is logical to protect the raw materials (i.e., the 
live animals) by including them under the Bioterrorism Act's 
safeguards. Finally, the inclusion of live animals in the definition of 
``food'' is consistent with the reasonable interpretation of the 
registration provision, section 415 of the FD&C Act. Accordingly, the 
interim final rule's definition of ``food'' includes live food animals. 
Defining ``food'' to include live animals is also consistent with the 
case law interpreting the term ``food'' in the broader context of the 
FD&C Act. See United States v. Tuente Livestock, 888 F. Supp. 1416 
(S.D. Ohio, 1995).
    f. Articles for further processing or capable of multiple uses. 
(Comments) Some comments ask that FDA clarify that the definition of 
``food'' does not include substances that are not edible, but may be 
further processed to be rendered edible, for example, crude vegetable 
oils, crude petroleum, and minerals such as phosphates which may be 
refined and processed into food ingredients such as glycerin and 
phosphoric acid. The comments state that where bulk commodities have 
potential food and nonfood uses, there should be an exemption from 
import notification where these commodities have not been sufficiently 
refined to be

[[Page 58987]]

directly used as food ingredients without further processing or 
refining.
    Another comment notes that gelatin is used for food, 
pharmaceutical, and technical applications and seeks assistance with 
establishing a labeling protocol to distinguish between edible gelatin, 
pharmaceutical gelatin, and technical gelatin. Some comments state FDA 
should require prior notice only for food intended for consumption and 
ask FDA to specify the articles that would be considered ``food.'' The 
comments also state that some imports have both food and nonfood uses 
and that prior notice should only be required for imports that will be 
used as a food. In addition, one comment strongly urges FDA to remove 
indirect food contact colors (i.e., material used to color food contact 
material) from the requirements of prior notice. The comment indicates 
that food contact colors are often prepared in bulk and then shipped to 
companies that can use these pigments in both food and nonfood 
applications. The process of manufacturing color pigments could be many 
steps removed from the process of actually using these products in food 
packaging. Therefore, the decision to use the product in food may not 
be made until after the pigment has entered commerce.
    (Response) For purposes of the interim final rule, ``food'' has the 
definition in section 201(f) of the FD&C Act except that ``food contact 
substances'' as defined at section 409(h)(6) of the FD&C Act and 
``pesticides'' as defined at 7 U.S.C. 136(u) are excluded from 
``food.'' Under section 201(f) of the FD&C Act, ``food'' means 
``articles used for food or drink'' (section 201(f)(1)) and articles 
``used for components of any such article'' (section 201(f)(3)). The 
determination of whether a substance is ``food'' is not a question of 
intended use (Nutrilab v. Schweiker, 713 F.2d. 335, 337 (7th Cir. 
1983); U.S. v. 52 Drums Maple Syrup, 110 F.2d 914, 915 (2d Cir. 1940); 
U.S. v. Technical Egg Products, 171 F.Supp. 326, 328 (N.D. Ga. 1959)). 
Courts interpreting the ``food'' definition in the FD&C Act have held 
that articles at both ends of the food continuum are ``food'' for 
purposes of the FD&C Act (U.S. v. O.F. Bayer & Co., 188 F.2d 555 (2d. 
Cir. 1951); U.S. v. Tuente Livestock, 888 F. Supp. 1416 (S.D. Ohio, 
1995) (live animals for food use are ``food'' under the FD&C Act); U.S. 
v. Technical Egg Products, supra, 171 F.Supp. at 328 (rotten eggs are 
``food'')). Thus, FDA believes that an item may be food even if the 
food is not yet in the form in which it will be used for food. 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.
    If the substance can be used in some applications that make the 
substance ``food'' and some that do not, the same principles apply. 
With respect to gelatin and other substances that may exist in multiple 
grades, including food grade, FDA will consider an article 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.
    Finally, as set forth previously, the interim final rule excludes 
food contact substances from the definition of ``food.'' Thus, when 
substances to color food contact substances or their components are 
imported, they are not subject to prior notice. However, colors used in 
such substances are still subject to regulation as food under section 
201(f) of the FD&C Act for purposes of other provisions of the FD&C 
Act.
    (Interim final rule) In the interim final rule (Sec.  1.276(b)(5)), 
``food'' has the meaning given in section 201(f) of the FD&C Act, 
except for purposes of this rule, 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.
7. Grower (Sec.  1.276(b)(6))
    Although the statute and proposed rule used the term grower, the 
proposed rule did not define the term. However, FDA solicited comments 
on whether the term ``grower'' includes a harvester or collector of 
wild products, e.g., some fish and botanicals.
    (Comments) A comment states that although harvesters or collectors 
of wild botanicals do not grow botanicals and should be differentiated 
from growers for certain purposes, these can be included in the term 
``grower'' consistent with the congressional intent in Sec.  307 of the 
Bioterrorism Act to identify the direct source of the agricultural raw 
commodity.
    (Response and interim final rule) FDA agrees. Accordingly, we have 
defined ``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. International Mail (Sec.  1.276(b)(6))
    Although the proposed rule applied to food imported or offered for 
import by mail, see, e.g., 68 FR 5436, the proposed rule did not define 
``international mail.''
    (Comments) There were no comments received concerning any 
definition of ``international mail.''
    (Response and interim final rule) The interim final rule imposes 
slightly different requirements relating to prior notice for food 
arriving by international mail. Thus, FDA determined that a definition 
of ``international mail'' would be helpful. The interim final rule 
defines ``international mail'' to mean ``foreign national mail 
services.'' It also expressly excludes express carriers, express 
consignment operators, or other private delivery services from this 
definition.
9. No Longer In Its Natural State (Sec.  1.276(b)(8))
    Section 801(m)(1) of the FD&C Act requires that the identity of the 
manufacturer be submitted as part of a prior notice. However, the 
proposed rule did not define ``manufacturer'' or address what 
constituted the product of a manufacturer versus the product of a 
grower.
    (Comments) Comments raised questions concerning when a manufacturer 
must be identified for an article of food.
    (Response) These comments are discussed under the heading ``What 
Information Must be in a Prior Notice.'' However, as a result of the 
comments, we determined that a definition of when food would be ``no 
longer in its natural state'' would be helpful to clarify when the 
identity of a manufacturer versus the identity of a grower must be 
provided in a prior notice.
    (Interim final rule) The interim final rule (Sec.  1.276(b)(8)), 
defines the term ``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,

[[Page 58988]]

pasteurizing, homogenizing, mixing, formulating, bottling, milling, 
grinding, extracting juice, distilling, labeling, or packaging. 
However, 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 the 
prior notice interim final rule. Likewise, whole fish headed, 
eviscerated, or frozen attendant to harvest are still in their natural 
state for purposes of the prior notice interim final rule.
10. Port of Arrival (Sec.  1.276(b)(9)) and Port of Entry (Sec.  
1.276(b)(10))
    The proposed rule defined ``port of entry'' 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 food first arrives 
in the United States.''
    (Comments) Many comments suggest harmonizing with, or adopting, the 
CBP definition for ``port of entry.'' In the opinion of two comments, 
the CBP definition is consistent with congressional intent and the FDA 
departure from the CBP definition is unsupported. Many of these 
comments state the two definitions would cause confusion in the import 
community and could delay proper prior notice. Other comments suggest 
changing the FDA definition of ``port of entry'' to the ``port of 
arrival.'' Another comment suggests defining ``port of entry'' as the 
entering point of a country where the merchandise is checked by 
official authorities. Two comments state that defining ``port of 
entry'' as the port of arrival would change business practices by 
essentially stopping the use of CBP ``in-transit'' (i.e., IT) entries 
under bond to inland ports.
    (Response) Section 801(m)(2)(A) of the FD&C Act states that FDA's 
implementing regulations must require that the notice ``be provided by 
a specified period of time in advance of importation of the article 
involved * * *.'' The stated purpose of section 801(m)(1) is ``enabling 
[articles of food] to be inspected at ports of entry into the United 
States * * *.'' Moreover, the overall purpose of the Bioterrorism Act 
is ``[t]o improve the ability of the United States to prevent, prepare 
for, and respond to bioterrorism and other public health emergencies.'' 
(Pub. L. 107-188.) The ability to examine or, if necessary, hold a 
suspect article of food when it first arrives at a port of entry in the 
United States, rather than later at the port where CBP will process the 
entry, will most effectively serve this overall purpose. Thus, to 
ensure that there is clarity that prior notice must be provided in 
advance of arrival, we are defining the term ``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 addition, we are adopting the CBP definition of ``port of 
entry'' to allow flexibility when designating where refused merchandise 
will be held. The CBP ``Port of entry'' definition states:
    The terms ``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. (The 
Customs ports in the Virgin Islands, although under the jurisdiction of 
the Secretary of the Treasury, have their own Customs laws (48 U.S.C. 
1406(i)). These ports, therefore, are outside the Customs territory of 
the United States and the ports thereof are not ``port of entry'' 
within the meaning of these regulations) (19 CFR 101.1).
    This flexibility will ensure that food that has been refused may 
move to the port of destination where, for example the consumption or 
warehouse entry will be filed, unless directed by CBP or FDA. 
Generally, we do not intend to hold shipments at the border unless our 
assessment of the situation leads us to believe it is warranted, e.g., 
the food may present a serious risk to public health or that the prior 
notice violation is egregious. We intend to implement prior notice, 
both in terms of determining what warrants a refusal in the first 
place, and in terms of determining which shipments may move to the port 
of destination, in a risk-based way.
    (Comments) Other comments state rail transportation would be 
especially affected because inbound trains often are not required to 
stop at the U.S. border but proceed to inland terminals.
    (Response) As explained later, rail shipments that have been 
refused admission per section 801(m)(1) of the FD&C Act are considered 
to have the status of general order merchandise. In many cases, it will 
be operationally difficult to stop an entire train because an article 
of food on it has been refused admission because of inadequate prior 
notice. Under CBP regulation, general order merchandise may be stored 
by the carrier or as the CBP port director may direct (see 19 CFR 
123.10(f)). Moreover, in situations involving shipments by rail, FDA 
and CBP have the discretion to allow the movement of the cargo from the 
border crossing to the nearest point where it can be safely and 
securely held. We intend, whenever possible, to examine articles of 
food arriving by rail at the appropriate examination site closest to 
the border. However, if the shipment might pose an immediate danger to 
public health and safety, an article of food arriving by train may be 
held at the border pending resolution of the situation.
    (Interim final rule) The interim final rule, Sec.  1.276(b)(9) 
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, i.e., the port where the article of food first arrives in the 
United States,'' (Sec.  1.276(b)(9)). This port may be different from 
the port where consumption or warehouse entry or FTZ admission 
documentation is presented to CBP. The interim final rule (Sec.  
1.285(b)(10)) also defines port of entry as follows:
11. Registration Number (Sec.  1.276(b)(11))
    Although the term appears in several places in the proposed rule, 
the term ``registration number'' was not defined.
    (Comments) No comments addressed the definition or meaning of 
``registration number.''
    (Response) To clarify that the term refers to registration of food 
facilities, the interim final rule defines ``registration number'' as 
the registration number assigned by FDA under section 415 of the FD&C 
Act and 21 CFR part 1, subpart H, Sec.  1.276(b)(11). Specific comments 
addressing when a registration number is required and other aspects of 
providing registration numbers as information submitted in prior notice 
are addressed later in this preamble--see ``What Information Must be in 
a Prior Notice?'.
12. Shipper (Sec.  1.276(b)(12))
    Section 801(m)(1) of the FD&C Act requires that the ``shipper of 
the article'' be provided in a prior notice submission. The proposed 
rule included the shipper as required information in a prior notice, 
but did not define the term ``shipper.''
    (Comments) FDA received no comments concerning the meaning of this 
term.
    (Response) In the proposed rule, we described the ``shipper'' as 
``the person who arranges for a shipment to get to its first 
destination in the United States * * *. The shipper is usually a 
foreign firm that is located or maintains an address in the country 
from which the

[[Page 58989]]

article was shipped.'' (68 FR 5437). However, in drafting the interim 
final rule, we have realized that this description was not written in a 
way that was useful in identifying the shipper in the case of food 
imported by international mail. Accordingly, we have revised the 
description of the ``shipper'' and included it in the definitions to 
make it easier to find.
    The definition is based on the description of ``shipper'' used by 
CBP in their proposed rule, ``Required Advance Electronic Presentation 
of Cargo Information,'' published in the Federal Register on July 23, 
2003 (68 FR 43574 at 43577), which is similar to, but clearer than, the 
description we used in the preamble to the proposed prior notice rule.
    (Interim final rule) The interim final rule (Sec.  1.276(b)(12)), 
defines ``shipper'' as ``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.''
13. United States (Sec.  1.267(b)(13))
    Although the term appears in several places in section 801(m) of 
the FD&C Act itself, the proposed rule did not contain a definition of 
``United States.''
    (Comments) A comment seeks clarification whether the prior notice 
regulation applies to food imported into Guam, the U.S. Virgin Islands, 
the Northern Mariana Islands, and other U.S. Territories.
    (Response) This comment raises the question of what the term 
``United States'' means for purposes of section 801(m) of the FD&C Act. 
In construing the prior notice provision of the Bioterrorism Act, FDA 
is confronted with two questions. First, has Congress directly spoken 
to the precise question presented? (``Chevron step one'') (Chevron, 
U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984)). To find no 
ambiguity, Congress must have clearly manifested its intention with 
respect to the particular issue (Young v. Community Nutrition 
Institute, 476 U.S. 974, 980 (1986)). If Congress has spoken directly 
and plainly, the agency must implement Congress's unambiguously 
expressed intent (Chevron, 467 U.S. at 842-843). If, however, the 
Bioterrorism Act is silent or ambiguous as to the meaning of ``United 
States,'' FDA may define ``United States'' in a reasonable fashion 
(``Chevron step two''); (Chevron, 467 U.S. at 842-843; FDA v. Brown & 
Williamson Tobacco Corp., 529 U.S. 120, 132 (2000)). The agency has 
determined that, in enacting section 801(m) of the FD&C Act, Congress 
did not speak directly and precisely to the meaning of ``United 
States.''
    The FD&C Act does apply to Guam, the U.S. Virgin Islands, the 
Northern Mariana Islands, and other U.S. Territories. Section 201(a)(1) 
of the FD&C Act (21 U.S.C. 321 (a)(1)) defines the term ``State'' to 
mean any State or Territory of the United States, the District of 
Columbia, and the Commonwealth of Puerto Rico. The term ``Territory'' 
is defined to mean any Territory or possession of the United States, 
including the District of Columbia, and excluding the Commonwealth of 
Puerto Rico and the Canal Zone, section 201(a)(2) of the FD&C Act (21 
U.S.C. 321(a)(2)). However, the terms ``State'' and ``Territory'' are 
not used in section 801(m) of the FD&C Act.\3\ Instead, section 801(m) 
of the FD&C Act deals with ``articles imported or offered for import 
into the United States,'' (section 801(m)(1)).
---------------------------------------------------------------------------

    \3\ The terms ``State'' and ``Territory'' are key to the FD&C 
Act's definition of ``interstate commerce,'' which is, in turn, key 
to many of the FD&C Act's general inspection and enforcement 
provisions, see, e.g., sections 301, 304, and 704 (21 U.S.C. 331, 
334, and 374). However, while articles that ``are imported or 
offered for import into the United States,'' section 801(m)(1) of 
the FD&C Act, are in ``interstate commerce,'' see, e.g., U.S. v. 
2,998 Cases * * * First Phoenix Group, Ltd, 64 F.3d 984 (5th Cir. 
1995), the term ``interstate commerce'' does not appear in section 
801(m).
---------------------------------------------------------------------------

    The term ``United States'' is not defined in the FD&C Act's general 
definitions in section 201. Nor is it defined in section 801(m) of the 
FD&C Act. It is defined for purposes of section 702(a) of the FD&C Act 
(21 U.S.C. 372(a)), which provides:

    In the case of a food packed in the Commonwealth of Puerto Rico 
or a Territory [FDA] shall attempt to make inspection of such food 
at the first point of entry within the United States * * *. For the 
purposes of this subsection, the term 'United States' means the 
States and the District of Columbia.

This definition in section 702(b) seems to imply that, in other places 
in the FD&C Act, the term ``United States'' would include all 
Territories. However, in section 801(m) of the FD&C Act, the term 
``United States'' appears as part of the phrase ``for purposes of 
enabling inspection of such [food] articles at the ports of entry into 
the United States'' (emphasis added). As defined by CBP, ``port of 
entry'' means ports within the part of the United States that has been 
denominated as the ``Customs territory of the United States.'' (19 CFR 
101.1 and 101.3). Notably, though, the Territories are not considered 
part of the Customs territory of the United States. CBP defines 
``Customs territory of the United States'' to ``include[] only the 
States, the District of Columbia, and Puerto Rico.'' (19 CFR 101.1).
    Because of this reference to ``the ports of entry into the United 
States,'' FDA has concluded that the term ``United States'' is best 
interpreted in section 801(m) of the FD&C Act to be the Customs 
territory of the United States and include only the 50 States, the 
District of Columbia, and Puerto Rico, but not the U.S. Territories and 
possessions. Defining the ``United States'' to be the Customs territory 
of the United States will maximize FDA's ability to coordinate prior 
notice with the CBP entry process, as CBP entry is made for articles 
from the Territories when they arrive in the Customs territory of the 
United States. Thus, section 801(m) of the FD&C Act does not apply to 
articles of food imported or offered for import into Guam, the U.S. 
Virgin Islands, the Northern Mariana Islands, and other U.S. 
Territories; section 801(m) does apply, however, when articles of food 
are imported or offered for import from the Territories into the United 
States as defined by Sec.  1.276(b)(11) of the interim final rule.
    (Interim final rule) The interim final rule (Sec.  1.276(b)(13)), 
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 any other part of the United 
States.
14. You (Sec.  1.276(b)(14))
    The proposed rule defined ``you,'' based on who was authorized to 
submit prior notice, as ``the purchaser or importer of an article of 
food who resides or maintains a place of business in the United States, 
or an agent who resides or maintains a place of business in the United 
States acting on the behalf of the U.S. purchaser or importer or the 
arriving carrier * * *'' or, if known, the in-bond carrier.
    (Comments) No comments were received concerning the definition of 
``you.'' However, comments were received about who may submit prior 
notice.
    (Response) Discussion of those comments and our responses are found 
in the section ``Who is Authorized to Submit Prior Notice?'' FDA 
decided, based on revisions to who may submit prior notice, to revise 
the definition of ``you.'' The interim final rule clarifies that 
``you'' means the persons (i.e., individuals and firms) submitting or 
transmitting the prior notice. The submitter is responsible for the 
prior notice. The persons who send the prior notice are transmitters. 
If the submitter sends the prior notice, he or she is both

[[Page 58990]]

the submitter and transmitter. FDA notes that all messages sent via the 
FDA PN System Interface will be sent to the transmitter. If prior 
notice is submitted via ABI/ACS, all messaging goes to the customs 
broker or self-filer via ABI/ACS.
    (Interim final rule) The interim final rule (Sec.  1.276(b)(14)), 
defines ``you'' as the person submitting the prior notice (the 
``submitter'') or the person transmitting prior notice information on 
behalf of the submitter (the ``transmitter'').
13. Summary of the Interim Final Rule
    The interim final rule defines the following terms:

    [sbull] The act;
    [sbull] Calendar day;
    [sbull] Country from which the article originates;
    [sbull] Country from which the article is shipped;
    [sbull] FDA Country of Production;
    [sbull] Food;
    [sbull] Grower;
    [sbull] International mail;
    [sbull] No Longer in Its Natural State;
    [sbull] Port of arrival;
    [sbull] Port of entry;
    [sbull] Registration Number;
    [sbull] Shipper;
    [sbull] United States; and
    [sbull] You.

D. ``What Is the Scope of This Subpart?'' (Section 1.277 Proposed as 
Sec.  1.276)

    FDA proposed that the prior notice requirements apply to food for 
humans and other animals that is imported or offered for import into 
the United States. The proposed rule specified that this included food 
that is imported or offered for import into U.S. FTZs, for consumption, 
storage, immediate export from the port of entry, transshipment through 
the United States to another country, or import for export. The 
proposed rule said that prior notice did not apply to food carried by 
an individual in that individual's personal baggage for that 
individual's personal use, meat food products, poultry products, and 
egg products that are subject to the exclusive jurisdiction of USDA.
    (Comments) Some comments state that the prior notice requirements 
should not apply to food that is brought across the U.S. border but not 
for consumption in the United States. In particular, the comments focus 
on food exported from the port of arrival, food imported for 
transshipment and export from another port, and food imported for 
further processing and export. The comments argue that Congress did not 
envision that the prior notice requirements would cause importers to 
give notice of food not for consumption within the United States and 
that notice of such food would not give FDA any useful or actionable 
information. One comment states that the Bioterrorism Act repeatedly 
refers to ``offered for import into the United States'' and concludes, 
based on this phrase, that prior notice should apply only to food for 
consumption by the citizens of the United States. One comment points to 
statutory language that stipulates ``for human and animal 
consumption.'' Based on this language, the comment argues that FDA 
would exceed its statutory authority by requiring prior notice for 
shipments not intended for consumption within the United States. 
Another comment states that prior notice should not apply to food of 
U.S. origin, especially if it was simply transshipped through another 
country then ``re-imported'' into the United States.
    (Response) These comments on scope raise the question of what 
Congress intended the phrase ``imported or offered for import into the 
United States'' to mean for purposes of section 801(m) of the FD&C Act. 
In construing the prior notice provision of the Bioterrorism Act, FDA 
is confronted with two questions. First, has Congress directly spoken 
to the precise question presented? (``Chevron step one''). (Chevron, 
U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984)). To find no 
ambiguity, Congress must have clearly manifested its intention with 
respect to the particular issue (Young v. Community Nutrition 
Institute, 476 U.S. 974, 980 (1986)). If Congress has spoken directly 
and plainly, the agency must implement Congress's unambiguously 
expressed intent (Chevron, 467 U.S. at 842-843