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Food
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Prior Notice Final Rule pp 66293- 66297
[Federal Register: November 7, 2008 (Volume 73, Number 217)]
[Rules and Regulations]
[Page 66293-66297]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no08-13]
[[Page 66293]]
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Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 1
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002; Draft Compliance
Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002;'' Availability; Final Rule and Notice
[[Page 66294]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2002-N-0233] (formerly Docket No. 2002N-0278)
RIN 0910-AC41
Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
regulation that requires the submission to FDA of prior notice of food,
including animal feed, that is imported or offered for import into the
United States. The final rule implements the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act), which required prior notification of imported food to begin on
December 12, 2003. The final rule requires that the prior notice be
submitted to FDA electronically via either the U.S. Customs and Border
Protection (CBP or Customs) Automated Broker Interface (ABI) of the
Automated Commercial System (ACS) or the FDA Prior Notice System
Interface (FDA PNSI). The information must be submitted and confirmed
electronically as facially complete by FDA for review no less than 8
hours (for food arriving by water), 4 hours (for food arriving by air
or land/rail), and 2 hours (for food arriving by land/road) before the
food arrives at the port of arrival. Food imported or offered for
import without adequate prior notice is subject to refusal and, if
refused, must be held. Elsewhere in this issue of the Federal Register,
FDA is announcing the availability of a draft compliance policy guide
(CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.''
DATES: This rule is effective May 6, 2009.
FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866-521-2297. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background and Legal Authority
II. Summary of Significant Changes Made to the IFR
A. What Definitions Apply to This Subpart? (Sec. 1.276)
B. What is the Scope of This Subpart? (Sec. 1.277)
C. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
D. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
E. How Must You Submit Prior Notice? (Sec. 1.280)
F. What Information Must Be in a Prior Notice? (Sec. 1.281)
G. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec. 1.282)
H. What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice? (Sec. 1.283)
I. What Are the Other Consequences of Failing to Submit Adequate
Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec.
1.284)
J. What Happens to Food That Is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Subpart H of This
Part? (Sec. 1.285)
III. Comments on the IFR
A. General Comments
B. Comments on the Legal Authority
C. What Definitions Apply to This Subpart? (Sec. 1.276)
1. The Act (Sec. 1.276(a))
2. Calendar Day (Sec. 1.276(b)(1))
3. Country From Which the Article Originates (Sec. 1.276(b)(2))
4. Country From Which the Article is Shipped (Sec. 1.276(b)(3))
5. FDA Country of Production (Sec. 1.276(b)(4))
6. Full Address (Sec. 1.276(b)(6))
7. Grower (Sec. 1.276(b)(7))
8. Registration Number (Sec. 1.276(b)(13))
9. United States (Sec. 1.276(b)(15))
10. You (Sec. 1.276(b)(16))
11. Food (Sec. 1.276(b)(5))
12. International Mail (Sec. 1.276 b)(8))
13. Manufacturer (Sec. 1.276(b)(9))
14. No Longer in Its Natural State (Sec. 1.276(b)(10))
15. Port of Arrival (Sec. 1.276(b)(11))
16. Shipper (Sec. 1.276(b)(14))
17. Comments Requesting Additional Definitions
18. Summary of the Final Rule
D. What is the Scope of this Subpart? (Sec. 1.277)
1. Food for an Individual's Personal Use When Accompanied at
Arrival
2. Homemade Food Sent as Personal Gift
3. Food Imported Then Exported Without Leaving Port of Arrival
Until Export
4. Food Under the Exclusive Jurisdiction of USDA
5. Additional Exclusions Requested--General
6. Additional Exclusions Requested--Special Programs (C-TPAT/FAST)
and Flexible Alternatives
7. Additional Exclusions Requested--Samples
8. Additional Exclusions Requested--Mail
9. Additional Exclusions Requested--Gifts
10. Additional Exclusions Requested--Low-Value
11. Additional Exclusions Requested--Couriers
12. Additional Exclusion Requested--Gift Packs
13. Additional Exclusions Requested--Household Goods and
Unaccompanied Baggage
14. Additional Exclusions Requested--Noncommercial Use
15. Additional Exclusions Requested--U.S. Goods Returned
16. Additional Exclusions Requested--In-Transit Shipments
17. Additional Exclusions Requested--Diplomatic Pouch
18. Additional Exclusions Requested--Seeds for Planting
E. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
F. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
1. IFR Timeframes (2, 4, and 8 hours)
2. Integration of FDA and CBP Timeframes
3. Phase-In of FDA and CBP Timeframes
4. Prior Notice Confirmation Number
5. 5-Day Maximum Pre-Arrival Limitation
6. International Mail
G. How Must You Submit the Prior Notice? (Sec. 1.280)
1. General Comments
2. English Language
3. Technical Issues Concerning Both Systems
4. ABI/ACS Interface
5. PNSI
6. Security of the Systems
7. Contingency Plans
H. What Information Must Be in a Prior Notice? (Sec. 1.281)
1. General Comments
2. The Submitter
3. The Transmitter
4. The CBP Entry Type
5. The CBP Entry Identifier (e.g., The Customs ACS Entry Number or
In-Bond Number)
6. The Product Identity
7. Identity of the Manufacturer
8. The Grower, If Known
9. FDA Country of Production
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10. Shipper
11. The Country From Which the Article is Shipped
12. Anticipated Arrival Information
13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient
14. Mode of Transportation
15. Carrier
16. Planned Shipment Information
I. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec. 1.282)
J. What Happens to Food That Is Imported or Offered for Import
Without Adequate Prior Notice? (Sec. 1.283)
1. General Comments
2. Inadequate Prior Notice (Sec. 1.283(a)(1))
3. Status and Movement of Refused Food (Sec. 1.283(a)(2))
4. Segregation of Refused Foods (Sec. 1.283(a)(3))
5. Costs (Sec. 1.283(a)(4))
6. Export After Refusal (Sec. 1.283(a)(5))
7. Post-Refusal Prior Notice Submissions (Sec. 1.283(c))
8. FDA Review After Refusal (Sec. 1.283(d))
9. International Mail (Sec. 1.283(e))
10. Prohibitions on Delivery and Transfer (Sec. 1.283(f))
11. Relationship to Other Admissibility Decisions (Sec. 1.283(g))
K. What Are the Other Consequences of Failing to Submit Adequate
Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec.
1.284)
L. What Happens to Food That is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under Subpart H
of This Part? (Sec. 1.285)
M. Outreach and Enforcement
1. General Outreach and Enforcement Issues
2. Prior Notice Submission Training Program From Flexible
Alternative Question 7
3. Requests for Additional Outreach
4. Enforcement Timeframe
5. Enforcement Penalties
N. The Joint FDA-CBP Plan for Increasing Integration and Assessing
the Coordination of Prior Notice Timeframes
1. Increased Integration
2. General Comments on the Plan
IV. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
B. Small Entity Analysis (or Final Regulatory Flexibility Analysis)
C. Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA) Major Rule
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. References
I. Background and Legal Authority
Section 307 of the Bioterrorism Act, which was enacted on June 12,
2002, amended the Federal Food, Drug, and Cosmetic Act (the act)
(section 307 of the Bioterrorism Act added section 801(m) to the act
(21 U.S.C. 381(m)) and amended section 301 of the act (21 U.S.C. 331))
by changing when FDA will receive certain information about imported
foods by requiring the Secretary of Health and Human Services (the
Secretary), after consultation with the Secretary of the Treasury,\1\
to issue an implementing regulation by December 12, 2003, to require
prior notification to FDA of food that is imported or offered for
import into the United States. Beginning on December 12, 2003, food
importers were required to provide FDA with advance notice of human and
animal food shipments imported or offered for import.
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\1\ Under the Homeland Security Act of 2002 (Public Law 107-
296), the Secretary of the Treasury has delegated all relevant
Customs revenue authorities to the Secretary of Homeland Security
who has, in turn, delegated them to the Commissioner of the Bureau
of Customs and Border Protection (CBP or Customs). Thus, the
Secretary is issuing this final rule jointly with the Secretary of
Homeland Security.
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FDA and CBP jointly published the proposed prior notice regulation
in the Federal Register of February 3, 2003 (68 FR 5428), for comment
(proposed rule). On October 10, 2003, FDA and CBP issued the prior
notice interim final rule (IFR) (prior notice IFR) (68 FR 58974)
(corrected by a technical amendment on February 2, 2004; 69 FR 4851).
The IFR implemented section 307 of the Bioterrorism Act, and required
that the prior notice be submitted to FDA electronically via either the
CBP ABI/ACS or the FDA PNSI. The information must be submitted and
confirmed electronically as facially complete by FDA for review no less
than 8 hours (for food arriving by water), 4 hours (for food arriving
by air or land via rail), and 2 hours (for food arriving by land via
road) before the food arrives at the port of arrival. Food imported or
offered for import without adequate prior notice is subject to refusal
and, if refused, must be held. The IFR responded to comments from the
public on the proposed rule, and established a 75-day comment period.
In order to ensure that those commenting on the IFR had the benefit of
FDA's outreach and educational efforts and had experience with the
systems, timeframes, and data elements of the prior notice system, FDA
reopened the comment period for 30 days on April 14, 2004 (69 FR
19763), and for an additional 60 days on May 18, 2004 (69 FR 28060),
for a total of 165 days.
II. Summary of Significant Changes Made to the IFR
The highlights of how this final rule compares to the IFR and the
rationale for certain changes are described briefly in the following
paragraphs and are discussed in more detail later in the preamble.
A. What Definitions Apply to This Subpart? (Sec. 1.276)
We retain the following terms without change from the IFR:
<bullet> ``The act;''
<bullet> ``Calendar day;''
<bullet> ``Country from which the article originates;''
<bullet> ``FDA Country of Production;''
<bullet> ``Grower;''
<bullet> ``Port of entry;'' and
<bullet> ``United States.''
FDA made the following changes in the final rule:
<bullet> We revised the term, ``Country from which the article is
shipped,'' to read, ``* * * or, in the case of food sent by
international mail, the country from which the article is mailed.''
<bullet> We revised the term, ``food,'' to add the phrase, ``except
as provided in paragraph (b)(5)(i) of this section,'' in the first
sentence; and reworded Sec. 1.276(b)(5)(i) to read, ``For purposes of
this subpart, food does not include''.
<bullet> We added the term, ``full address,'' to the final rule.
Full address means the facility's street name and number; suite/unit
number, as appropriate; city; Province or State as appropriate; mail
code as appropriate; and country.
<bullet> We revised the term, ``international mail,'' to make the
sentence easier to read, and to add the phrase, ``unless such service
is operating under contract as an agent or extension of a foreign mail
service,'' at the end of the definition.
<bullet> We added the term, ``manufacturer,'' to the final rule.
Manufacturer means the last facility, as that word is defined in Sec.
1.227(b)(2), that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any
similar activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
manufacturing/processing is considered the manufacturer.
<bullet> We revised the term, ``no longer in its natural state,''
by deleting ``waxed''
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from the list of actions that render an article of food still in its
natural state for purposes of this subpart.
<bullet> We revised the term, ``port of arrival'' to read ``* * *
the water, air, or land port at which the article of food is imported
or offered for import into the United States. For an article of food
arriving by water or air, this is the port of unloading. For an article
of food arriving by land, this is the port where the article of food
first crosses the border into the United States. The port of arrival
may be different than the port where consumption or warehouse entry or
foreign trade zone admission documentation is presented to the U.S.
Customs and Border Protection (CBP).''
<bullet> We revised the term, ``registration number,'' by changing
the phrase, ``refers to,'' to ``means,'' and by adding the phrase, ``to
a facility,'' after the word, ``assigned,'' to clarify that FDA assigns
registration numbers by facility.
<bullet> We revised the term, ``shipper,'' by adding the phrase,
``or express consignment operators or carriers or other private
delivery service,'' after ``international mail'' to clarify that a
shipper is involved with various types of transactions, and not just
international mail shipments.
<bullet> We revised the term, ``you,'' to simplify the last phrase
of the definition to ``i.e., the submitter or the transmitter, if
any.''
B. What is the Scope of This Subpart? (Sec. 1.277)
We revised this provision and added ``Articles of food subject to
Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961),
i.e., shipped as baggage or cargo constituting the diplomatic bag'' to
the list of food that does not require prior notice.
C. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
We retain this provision without change.
D. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
FDA revised this provision. Section 1.279(b) of the IFR states
that, except for international mail, prior notice may not be submitted
more than 5 calendar days before the anticipated date of arrival at the
anticipated port of arrival. We revised this section to permit prior
notice submissions to be submitted no more than 15 calendar days before
the anticipated date of arrival for submissions made through the PNSI
and no more than 30 calendar days before the anticipated date of
arrival for submission made through the ABI/ACS.
E. How Must You Submit Prior Notice? (Sec. 1.280)
FDA revised this provision. Under 21 CFR 1.280(a)(2) (Sec.
1.280(a)(2)) of the IFR, prior notice must be submitted via PNSI for
articles of food that have been refused under section 801(m)(1) of the
act. Under the final rule, prior notice for articles that have been
refused under section 801(m) of the act must be submitted through PNSI
until such time as ACS or its successor system can accommodate such
transactions.
FDA also simplified the IFR provisions pertaining to system outages
at Sec. 1.280(b) through (e) by providing the outage notification at
one Web address (http://www.fda.gov) and stating that FDA will accept
prior notice submissions in the format it deems appropriate during the
system(s) outage.
F. What Information Must Be in a Prior Notice? (Sec. 1.281)
FDA revised the following information requirements:
<bullet> Submitter: The IFR states that ``if a registration number
is provided, city and country may be provided instead of the full
address.'' For clarity, in the final rule, FDA has revised this phrase
to state that ``if the business address of the individual submitting
the prior notice is a registered facility, then the facility's
registration number, city, and country may be provided instead of the
facility's full address.'' FDA also deleted the requirement for
providing the submitter's fax number.
<bullet> Transmitter: The IFR states that ``if a registration
number is provided, city and country may be provided instead of the
full address.'' For clarity, in the final rule, FDA has revised this
phrase to state that ``if the business address of the individual
submitting the prior notice is a registered facility, then the
facility's registration number, city, and country may be provided
instead of the facility's full address.'' FDA also deleted the
requirement for providing the transmitter's fax number.
<bullet> Manufacturer, for food no longer in its natural state:
Under the IFR, the name, address, and registration number of the
manufacturer must be submitted; if a registration number is provided,
city and country may be provided instead of the full address. The final
rule requires the name of the manufacturer and either: (1) The
registration number, city and country of the manufacturer or (2) both
the full address of the manufacturer and the reason the registration
number is not provided. Publishing elsewhere in this issue of the
Federal Register, the Prior Notice Final Rule Draft CPG lists the
reasons to use when the registration number is not provided.
In the IFR, a registration number is not required for a facility
associated with an article of food if the article is imported or
offered for import for transshipment, storage, and export, or further
manipulation and export. We have removed this from the final rule and
are requiring the registration number of the manufacturer (or the full
address of the manufacturer and a reason) in all circumstances.
In the final rule, we have removed the option provided in the IFR
that allows the label information in Sec. 101.5 (21 CFR 101.5) to be
submitted instead of the name, address, and registration number of the
manufacturer for food sent by an individual as a personal gift (i.e.,
for nonbusiness reasons) to an individual in the United States. FDA
notes, however, that under the enforcement policy proposed in the Prior
Notice Final Rule Draft CPG, FDA and CBP should typically consider not
taking any regulatory action when no prior notice is submitted for food
imported or offered for import for noncommercial purposes with a
noncommercial shipper, irrespective of the type of carrier.
<bullet> Shipper: The IFR required the name and address of the
shipper and, if the shipper is required to register, the registration
number assigned to the shipper's facility; if a registration number is
provided, city and country may be provided instead of the full address.
The final rule requires the name and full address of the shipper, if
the shipper is different from the manufacturer in order to eliminate
duplicative requirements. If the address of the shipper is a registered
facility, the submitter may submit the registration number of the
shipper's registered facility.
In the IFR, the shipper's registration number was not required for
a facility associated with an article of food if the article is
imported or offered for import for transshipment, storage, and export,
or further manipulation and export. We have removed this from the final
rule because the shipper's registration number is now optional.
<bullet> Anticipated arrival information: Under the final rule, we
removed the requirement for the identity of the anticipated border
crossing within the port of arrival because FDA and CBP have determined
that it is no longer necessary for purposes of communication. For post-
refusal submissions, actual date the article arrived is now a required
data element so that FDA knows how long it has been since the refused
food shipment arrived
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in the United States and how to connect the refused prior notice to the
post-refusal prior notice submission for shipments where a previously
refused prior notice was filed.
The final rule also includes a new provision for food arriving by
express consignment operator or carrier since certain information may
not be available to persons who ship food using an express consignment
operator or courier. If the article of food is arriving by express
consignment operator or carrier, and neither the submitter nor
transmitter is the express consignment operator or carrier, and the
prior notice is submitted via PNSI, the express consignment operator or
carrier tracking number may be submitted in lieu of the anticipated
arrival information.
<bullet> The name and address of the importer, owner, and ultimate
consignee: The IFR required the name and address of the importer,
owner, and ultimate consignee, unless the shipment is imported or
offered for import for transshipment through the United States under a
Transportation and Exportation (T&E) entry. In the final rule, FDA is
inserting the word ``full'' in front of ``address'' to make clear that
the complete address is required. Consequently, FDA is revising the
subsequent text to state that if the business address of the importer,
owner, or ultimate consignee is a registered facility, then the
facility's registration number also may be provided in addition to the
facility's full address.
<bullet> Planned shipment information: FDA revised this provision
by clarifying that the required planned shipment information is
applicable by mode of transportation and when it exists. Moreover, FDA
added a new provision in the final rule for the Airway Bill number/Bill
of Lading number and flight number since this information is generally
not available to individual submitters. The final rule provides that
for food arriving by express consignment operator or carrier when
neither the submitter nor transmitter is the express consignment
operator or carrier, the tracking number can be submitted in lieu of
the Bill of Lading or Airway Bill number and the flight number for
prior notices submitted via PNSI.
FDA also revised the IFR by deleting the requirement to provide the
Harmonized Tariff Schedule (HTS) code since FDA and CBP have determined
that the HTS code is no longer critical for communication with CBP.
In the final rule, we deleted the requirement for the license plate
number (and State or Province that issued the license) for food
arriving by privately owned vehicle from the planned shipment
information and added this data element to the section identifying the
carrier of the article of food (Sec. 1.281(a)(16) and (c)(16)).
Table 2, which appears later in this preamble, summarizes the
information required in a prior notice.
G. What Must You Do If Information Changes After You Have Received
Confirmation of a Prior Notice From FDA? (Sec. 1.282)
The IFR required that for prior notices submitted via ABI/ACS, the
submitter should cancel the prior notice via ACS by requesting that CBP
``delete'' the entry. FDA has revised the final rule to state that the
submitter should request that CBP ``cancel'' the entry. Moreover, we
changed references to ``PN System Interface'' to ``PNSI.''
H. What Happens to Food That Is Imported or Offered for Import Without
Adequate Prior Notice? (Sec. 1.283)
The IFR stated that refused food must be moved under appropriate
custodial bond. FDA has revised this paragraph in the final rule to
state that the refused food must be moved under appropriate custodial
bond unless immediately exported under CBP supervision. The final rule
clarifies that the refused food may be held at the port or at a secure
facility outside the port. FDA also changed the timeframe for notifying
FDA of the hold location from within 24 hours of refusal to before the
food is moved to the hold location. For clarity and consistency
throughout the final rule, we are changing the phrase, ``designated
location,'' to ``designated secure facility.''
Under the section describing FDA review after refusal, FDA revised
the final rule by including the carrier as one of the entities who can
submit a request for FDA review. FDA also revised the final rule to
delete acceptance of requests for review by mail and express courier.
We are limiting delivery to fax and e-mail.
I. What Are the Other Consequences of Failing to Submit Adequate Prior
Notice or Otherwise Failing to Comply With This Subpart? (Sec. 1.284)
We corrected the word ``federal'' in the IFR to read ``Federal.''
We also corrected the citation to ``section 303 of the act'' in the IFR
to read ``sections 301 and 303 of the act.''
J. What Happens to Food That Is Imported or Offered for Import From
Unregistered Facilities That Are Required to Register Under Subpart H
of This Part? (Sec. 1.285)
The final rule removes the provision in Sec. 1.285(a) that if food
is from a foreign manufacturer that is not registered as required and
is imported or offered for import, it is subject to refusal of
admission for failure to provide adequate prior notice. It also deletes
the text in that provision that states that failure to provide the
manufacturer's registration number renders the identity of the facility
incomplete for purposes of prior notice. The final rule retains, with
revisions, the provision that states that if food is from a foreign
facility that is not registered and is imported or offered for import,
it is subject to being placed under hold under section 801(l) of the
act.
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Prior Notice Final Rule
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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