94% of total retail value for Mexican produce             $3,251,014,000
------------------------------------------------------------------------
0.6% Reduction in value for 2.5% of Mexican                     $488,000
 produce
------------------------------------------------------------------------
2001 Imported Canadian produce total retail value           $401,826,000
------------------------------------------------------------------------
85% of total retail value for Canadian produce              $341,552,000
------------------------------------------------------------------------
0.6% Reduction in value for 2.5% of Canadian                     $51,000
 produce
------------------------------------------------------------------------
Total lost value for produce                                    $539,000
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Perishable Seafood                                               Dollars
------------------------------------------------------------------------
2001 Imported Mexican seafood total retail value            $112,277,000
------------------------------------------------------------------------
94% of total retail value for Mexican seafood               $105,540,000
------------------------------------------------------------------------
2.1% Reduction in value for 2.5% of Mexican                      $55,000
 seafood
------------------------------------------------------------------------
2001 Imported Canadian seafood total retail value         $1,863,218,000
------------------------------------------------------------------------
85% of total retail value for Canadian seafood            $1,583,638,000
------------------------------------------------------------------------
2.1% Reduction in value for 2.5% of Canadian                    $831,000
 seafood
------------------------------------------------------------------------
Total lost value for seafood                                    $886,000
------------------------------------------------------------------------

    ii. 2-hour minimum prior notice time for food arriving by land by
rail and ``wheels-up'' or 4-hour minimum prior notice time by air. The
2-hour minimum submission time for food imported by land by rail should
reduce the probability of having to resubmit prior notice for virtually
all articles of food imported from Canada and Mexico by that mode of
transport. Data from the PNC for 2007 show that only about 4 percent of
the articles of food imported from Canada and only about 2 percent of
the articles of food imported from Mexico are imported by land by rail.
We do not calculate any lost value due to prior notice resubmission for
products shipped by rail.
    Reducing the prior notice submission time frame to ``wheels-up''
for food imported by air on flights originating in North and Central
America, South America (north of the equator only), the Caribbean, and
Bermuda will eliminate the need for any resubmission of prior notice
information for those shipments. Because prior notice does not need to
be submitted until ``wheels-up'', the probability of not having the
correct prior notice information on the shipment is eliminated.
    A 4-hour minimum prior notice time for flights not originating in
North and Central America, South America (north of the equator only),
the Caribbean, and Bermuda will not constrain these imports because
flights from locations other than those listed will all take longer
than 4 hours. Therefore, the probability of having incorrect shipment
information is all but eliminated as the shipment information can be
verified before the prior notice is sent.
    Table 18 of this document presents a summary of the costs
associated with Option 2B, including the costs of the option at the
OMB-recommended discount rates of 3 and 7 percent.

                Table 18.--Summary of Costs for Option 2B
------------------------------------------------------------------------
                                                     (In Thousands of
                                                         Dollars)
------------------------------------------------------------------------
Learning costs                                   $71,037
------------------------------------------------------------------------
Coordination costs                               $43,574
------------------------------------------------------------------------
Computer acquisition costs                       $10,594
------------------------------------------------------------------------
FDA prior notice system cost and cost of         $19,075
 additional FTEs
------------------------------------------------------------------------
Annual costs to fill out prior notice screens    $202,500
------------------------------------------------------------------------
Additional costs for BRASS users                 $0
------------------------------------------------------------------------
Lost value for produce                           $539
------------------------------------------------------------------------
Lost value for seafood                           $886
------------------------------------------------------------------------
Cost for truck time                              $0
------------------------------------------------------------------------

Costs of manufacturer registration number and    $52,800
 full facility address requirement
------------------------------------------------------------------------
Total first year costs for Option 2              $401,005
------------------------------------------------------------------------
Annual costs after first year                    $218,353
------------------------------------------------------------------------
PV of costs at 7% for 20 years                   $2,483,938
------------------------------------------------------------------------
PV of costs at 3% for 20 years                   $3,425,873
------------------------------------------------------------------------

    b. Benefits of Option 2B. Importers will benefit from the shorter
times for submitting prior notice under Option 2B because it is less
likely that articles of food will need to ``wait'' longer than the
minimum prior notice time frame before entering the United States.
Submitting FDA's Prior Notice information at the same time as CBP's
entry information may reduce costs for submitters.\19\ If FDA's Prior
Notice and CBP submissions can be done simultaneously, submitters may
be able to coordinate the two entry submissions so as to reduce total
submission costs.
---------------------------------------------------------------------------

    \19\ Comments on the IFR stated several reasons for recommending
that prior notice timeframes be the same as CBP's advance electronic
information timeframes for food arriving by air and by land (both by
road and by rail): (1) It would minimize the complexity of the
process by presenting a more streamlined flow of information and
avoid unnecessary duplication, (2) it would result in fewer errors,
(3) it would provide better compliance rates, (4) it would allow for
fewer disruptions at the border, (5) it would significantly reduce
the burden on the trade community without creating additional
security risks, and (6) it would allow operators at close border
points to load and verify truck loads and travel routes prior to
submitting notice.
---------------------------------------------------------------------------

    c. Cost benefit summary table. Table 19 presents the costs of
Options 2B annualized over 20 years.

       Table 19.--Updated Cost Benefit Summary Table for Option 2B
------------------------------------------------------------------------
                                     Annualized Costs   Annualized Costs
                                     Over 20 Years at   Over 20 Years at
                                     7% Discount Rate   3% Discount Rate
                                        (Millions)         (Millions)
------------------------------------------------------------------------
Option 2B--1 hour or 30 minute                   $229               $226
 prior notice for food arriving by
 land by road, 2 hours for rail,
 ``wheels-up'' or 4 hours for air,
 8 hour for vessels; the PNC has
 increased staff
------------------------------------------------------------------------
Benefits--FDA will know what articles of food are being imported or
 offered for import, before they arrive at the port. In the event of a
 potential threat of significant health risk to humans or animals, FDA
 will be able to mobilize and assist in the detention and removal of
 those products.
------------------------------------------------------------------------

Option 3: Minimum prior notice time is 2 hours for articles of food
arriving by land by road, 4 hours for articles of food arriving by land
by rail and by air, and 8 hours for articles of food arriving by water;
information is submitted electronically, most changes in information
require resubmission; the manufacturer registration number is not
required when the submitter is unable to determine it.
    Option 3 represents Option 1 but with a change to the requirement
for providing the identity of the manufacturer.
    As stated in Option 1, smaller importers or individuals that buy
food for import into the United States from brokers, wholesalers, or
foreign retailers because they are too small to buy directly from food
manufacturers may find it difficult to continue importing certain
products when manufacturer name, registration number, and partial
address is required on prior notice. However, the final rule provides
an alternative for submitters in providing the identity of the
manufacturer when they are unable to determine the manufacturer's
registration number. Under the final rule, submitters may provide the
name and full address of the site-specific manufacturing facility along
with the reason why the registration number was not provided.
    Most of the comments concerned with the identity of the
manufacturer were concerned about submitters not being able to provide
registration number; a smaller percentage of the comments also raised
concerns about being able to provide the name and address of the
manufacturer. Unlike the manufacturer's registration number, which many
may view as confidential business information that is to be disclosed
only on a ``need to know'' basis, the name and full address of a
facility is public information that not only is typically in phone
books and on the Internet, but it also often is provided on documents
typically exchanged between buyers and sellers (e.g., receipts,
purchase orders, and bills of lading).
    Even with the flexibility of not requiring the manufacturer
registration number on prior notice when the submitter is unable to
determine it, there will likely be some adjustment costs for small
importers and individuals. These adjustments to business practices
should be less costly and occur less often than those in Option 1
because importers no longer have to provide the manufacturer
registration number but may instead provide only the site-specific
facility name and full address and the reason the registration number
is not provided.
    We adjust the costs of the final rule to now reflect the
requirement that if the manufacturer's registration number is not
available, then the name and full address of the site-specific
manufacturing facility must be provided. For Option 1, using
information from table 9 of this document, we estimated that about 2.91
percent of prior notices submitted for FY 2007 did not contain the
appropriate manufacturer name, address, and/or registration number as
required by the codified of the IFR. With the extra flexibility in
manufacturer identity allowed by Option 3, we expect the percentage of
prior notices still affected by this requirement to be 1.21 percent
(2.91 percent - 1.70 percent). We expect those who submitted prior
notice under the IFR using reason code K--Unable to determine the
registration number of the manufacturer (1.70 percent), should likely
be able to submit the manufacturer site-specific name and full address
as required by the prior notice final rule codified. We expect that
those who submitted prior notice under the IFR using reason codes I, L,
M, and O (0.56 percent, 0.16 percent, 0.16 percent, and 0.33 percent,
respectively),

could still have problems submitting the identity of the manufacturer
as required by the final rule.
    We must further adjust the 1.21 percent of prior notices expected
to still be affected by the manufacturer identity requirement of prior
notice to address the fact that the final rule is more restrictive than
the IFR in regards to providing the identity of the manufacturer on
prior notice for food sent by an individual as a personal gift.
    In cases of food sent by an individual as a personal gift, the IFR
allows the name and address on the product label to substitute for the
manufacturer's name, address, and registration number on prior notice.
The final rule requires that if the manufacturer's registration number
is not available, the full name and address of the site-specific
facility that manufactured the gift must be included on prior
notice.\20\ Therefore, we add 0.38 percent (for reason code G--
Individual gift label name/address in lieu of registration number from
the November 2004 revision of the IFR CPG) to the 1.21 percent we
expect may have problems with the manufacturer identity requirement of
the final rule. Thus, we expect a total of 1.59 percent of all prior
notices annually to be affected by the revised manufacturer identity
requirement of the final rule as opposed to the 2.91 percent affected
by the manufacturer identity requirement of the IFR.
---------------------------------------------------------------------------

    \20\ FDA plans to continue its enforcement policy that it should
typically consider not taking any regulatory action for prior notice
violations relating to individual gifts; however, the final rule
does require at least the name and full address of the site-specific
facility where the gift was manufactured.
---------------------------------------------------------------------------

    We can again use the data from table 10 of this document, adjusted
now by 1.59 percent instead of 2.91 percent, to determine the potential
imported food value affected by the final rule requirement that either
the registration number or the name and address of the site-specific
facility be included in prior notice. We repeat the data from table 10
here in table 20 of this document. As with Option 1, we present the
best and worst case scenarios to represent the possible range of
imported foods value that may be affected by the final rule requirement
and then adjust that value to reflect changes in business practices and
businesses ceasing importing food into the United States. Taking the
midpoint of the lost value due to cessation of importation ($21
million) plus the costs to the 1,725 firms to change business
practices, we estimate that the cost of the manufacturer identity
requirement in the final rule to be about $28.8 million.

   Table 20.--Imports of Goods by End Use Category and Commodity (2006
                        Seasonally Adjusted Data)
------------------------------------------------------------------------
                                        Best Case          Worst Case
                                         Scenario           Scenario
                                        (Millions)         (Millions)
------------------------------------------------------------------------
Foods, feeds, and beverages (FFB)             $64,782            $64,782
 total\1\
------------------------------------------------------------------------
Categories of imported food
 products subtracted
  Meat products                                $5,611             $5,611
  Fish and shellfish                           $9,867  .................
  Vegetables                                   $4,943  .................
  Cane and beet sugar                          $1,121  .................
  Cocoa beans                                    $520  .................
  Tea, spices, etc.                              $715  .................
  Food oils, oilseeds                          $1,999  .................
  Feedstuff and food grains                    $1,577  .................
  Fruits, frozen juices                        $5,503  .................
  Nuts                                           $856  .................
  Green coffee                                 $2,035  .................
  Dairy products and eggs                      $1,070  .................
------------------------------------------------------------------------
Remaining value of imports that               $28,965            $59,171
 may be affected by identity of
 the manufacturer requirement
------------------------------------------------------------------------
Imported value reduced further to                $461               $941
 represent that only 1.59% of
 prior notice submissions could
 not provide manufacturing
 facility site-specific
 information on prior notice for
 CY 2007
------------------------------------------------------------------------
3 percent of imported food value
 lost through cessation of
 importation into U.S.                     $13.8 to $28.2 million
------------------------------------------------------------------------
Costs that reflect change in
 business practices for 1,725
 submitters (80 hours x $56.74 per
 hour)                                          $7.8 million
------------------------------------------------------------------------
Total Value Affected                            $28.8 million
------------------------------------------------------------------------
\1\ Source of original data: U.S. Census Bureau, U.S. Bureau of Economic
  Analysis, US DOC News, November 9, 2007, pages 12 and 15, available
  online at http://www.bea.gov/newsreleases/international/trade/2007/pdf/
  trad0907.pdf. (FDA has verified the Web site address, but FDA is not
  responsible for any subsequent changes to the Web site after this
  document publishes in the Federal Register.)

    a. Changes in to the final rule that are not quantified. The final
rule is more restrictive than the IFR in regards to providing the
identity of the manufacturer on prior notice for the importation of
transshipments. For transshipments, the IFR allows the name and full
address of the manufacturer to substitute for the manufacturer's name
and partial address, and registration number on prior notice. The final
rule requires that if the manufacturer's registration number is not
available, the site-specific full name and address of the facility that
manufactured the article of food must be included on prior notice. We
do not expect this requirement of the final rule to affect
transshipments significantly as the final rule does allow the importer
to provide the site-specific name and full address of the manufacturing
facility instead of the registration number.
    Also, for the final rule, FDA removed a few of the prior notice
data elements that are required in the IFR. Specifically, submitters no
longer need to include the fax number of the submitter and transmitter,
the anticipated border crossing, the country

of the carrier, or the 6-digit HTS code on their prior notices. Other
changes include making the shipper's registration number optional but
always requiring its full addresses; and the option of submitting the
tracking number for articles of food arriving by express consignment
instead of anticipated arrival information when the prior notice is
submitted through PNSI. However, these and other changes in filing
requirements, on net, are not large enough to affect the time needed to
file prior notice or the costs charged by brokers to file prior notice;
therefore, we do not update the estimated time needed or the estimated
costs charged to file prior notice.
    Table 21 of this document presents a summary of the revised
estimated costs associated with Option 3, the final rule, including the
marginal costs to importers who may be affected by the identity of the
manufacturer requirement. Also included in table 21 of this document
are the discounted present value of the costs at the OMB-recommended
discount rates of 3 and 7 percent.

        Table 21.--Summary of Costs for Option 3--The Final Rule
------------------------------------------------------------------------
                                                     (In Thousands of
                                                         Dollars)
------------------------------------------------------------------------
Learning costs                                   $71,037
------------------------------------------------------------------------
Coordination costs                               $43,574
------------------------------------------------------------------------
Computer acquisition costs                       $10,594
------------------------------------------------------------------------
FDA prior notice system cost                     $13,000
------------------------------------------------------------------------
Annual costs to fill out prior notice screens    $202,500
------------------------------------------------------------------------
Additional costs for BRASS users                 $61,003
------------------------------------------------------------------------
Lost value for produce                           $4,261
------------------------------------------------------------------------
Lost value for seafood                           $11,533
------------------------------------------------------------------------
Cost for truck time                              $0
------------------------------------------------------------------------
Costs of change in manufacturer identity         $28,800
 requirement
------------------------------------------------------------------------
Total first year costs for Option 3              $446,302
------------------------------------------------------------------------
Annual costs after first year1                   $293,118
------------------------------------------------------------------------
Present value (PV) of costs at 7% for 20 years   $3,248,454
------------------------------------------------------------------------
PV of costs at 3% for 20 years                   $4,509,571
------------------------------------------------------------------------
\1\ Annual costs include the startup costs of prior notice to the
  estimated 10 percent of new businesses that enter the market each
  year.

    b. Benefits of Option 3 (final rule). Option 3 allows for the
submission of alternative manufacturer information that could be used
to verify the registration status of the manufacturer. This is more
flexible to importers than the requirements of Option 1, the IFR. Once
the facility has been identified in the database and a valid
registration has been verified, the manufacturer information required
on prior notice for Option 3 provides the same level of security and
assurance as the registration number required by Option 1.
    c. Cost benefit summary table. Table 22 presents the costs of
Option 3 annualized over 20 years.

       Table 22.--Updated Cost Benefit Summary Table for Option 3
------------------------------------------------------------------------
                                     Annualized Costs   Annualized Costs
                                     Over 20 Years at   Over 20 Years at
                                     7% Discount Rate   3% Discount Rate
                                        (Millions)         (Millions)
------------------------------------------------------------------------
Option 3--2-hour prior notice for                $655               $652
 vehicle, 4-hour for rail and air,
 8-hour for vessels; change in the
 identity of the manufacturer
 requirement (Final rule)
------------------------------------------------------------------------
Benefits--FDA will know what articles of food are being imported or
 offered for import, before they arrive at the port. In the event of a
 threat of significant public health risk to humans or animals, FDA will
 be able to mobilize and assist in the detention and removal of those
 products. The benefits of the final rule are enhanced by the change in
 the identity of the manufacturer requirement.
------------------------------------------------------------------------

Summary Table of All Options Analyzed

                              Table 23.--Costs and Benefits of All Options Analyzed
----------------------------------------------------------------------------------------------------------------
                                           Option 1          Option 2A          Option 2B           Option 3
                                     ---------------------------------------------------------------------------
                Costs                  In Thousands of    In Thousands of    In Thousands of    In Thousands of
                                           Dollars            Dollars            Dollars            Dollars
----------------------------------------------------------------------------------------------------------------
Learning costs                                  $71,037            $71,037            $71,037            $71,037
----------------------------------------------------------------------------------------------------------------
Coordination costs                              $43,574            $43,574            $43,574            $43,574
----------------------------------------------------------------------------------------------------------------
Computer acquisition costs                      $10,594            $10,594            $10,594            $10,594
----------------------------------------------------------------------------------------------------------------
FDA prior notice system cost                    $13,000            $13,000            $19,075            $13,000
----------------------------------------------------------------------------------------------------------------
Annual costs to fill out prior                 $202,500           $202,500           $202,500           $202,500
 notice screens
----------------------------------------------------------------------------------------------------------------
Additional costs for BRASS users                $61,003                 $0                 $0            $61,003
----------------------------------------------------------------------------------------------------------------

Lost value for produce                           $4,261               $857               $539             $4,261
----------------------------------------------------------------------------------------------------------------
Lost value for seafood                          $11,533             $1,549               $886            $11,533
----------------------------------------------------------------------------------------------------------------
Cost for truck time                                  $0                 $0                 $0                 $0
----------------------------------------------------------------------------------------------------------------
Costs of change in manufacturer                 $52,800            $52,800            $52,800            $28,800
 identity requirement
----------------------------------------------------------------------------------------------------------------
Total first year costs                         $470,302           $395,911           $401,005           $446,302
----------------------------------------------------------------------------------------------------------------
Annual costs                                   $293,118           $218,727           $218,353           $293,118
----------------------------------------------------------------------------------------------------------------
PV of costs at 7% for 20 years               $3,270,884         $2,482,785         $2,483,938         $3,248,454
----------------------------------------------------------------------------------------------------------------
PV of costs at 3% for 20 years               $4,532,872         $3,426,122         $3,425,873         $4,509,571
----------------------------------------------------------------------------------------------------------------
Benefits for all options (benefits not quantified)
FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In
 the event of a threat of significant public health risk to humans or animals, FDA will be able to mobilize and
 assist in the detention and removal of those products.
----------------------------------------------------------------------------------------------------------------

Sensitivity Analysis
    The prior notice rule is unique in that the rule is published with
an accompanying Compliance Policy Guide (CPG). The CPG provides
guidance regarding enforcement of the prior notice requirements,
including describing the circumstances where FDA and CBP should
typically consider not taking any regulatory action even though certain
requirements are not met. In some of these circumstances, the
compliance policy applies when alternative information is submitted. If
we estimate the costs of the IFR taking into account information from
the IFR CPG and compare those costs to the final rule taking into
account information from the final rule draft CPG, the main cost
difference, as when comparing Option 1 and Option 3, is the cost of the
change regarding providing the manufacturer identity.
    For Option 1 (the IFR) we estimated that this cost was about $52.8
million and for Option 3 (the final rule) we estimated this cost was
about $28.8 million. If information based on the CPG is included in the
estimate of the cost of the IFR and final rule, then the rule costs
regarding providing the identity of the manufacturer are $0 and $5.9
million respectively. The costs regarding providing the identity of the
manufacturer is $0 under the IFR taking into account information from
the IFR CPG based on the assumption that the submitter would use one of
the reason codes in table 9 (A through O) when the submitter is not
able to satisfy some or all of the requirements regarding providing the
identity of the manufacturer of the product. The same cost under the
final rule taking into account information from the final rule draft
CPG is about $5.9 million\21\ based on the assumption that if the
submitter would otherwise use reason code L or M in table 9, because it
was unable to determine the identity of the site-specific manufacturer,
it would now change supply chains, find some other means to continue
importing the food, or cease importing the food because it finds it
unprofitable to attempt to continue to do so under the circumstances
(0.32 percent or 31,513 of the 9.8 million entry lines for which prior
notice was submitted in 2007).
---------------------------------------------------------------------------

    \21\ We calculated this cost using the same method we used in
Option 1 (table 10) and Option 3 (table 20) except we use 0.32
percent for the reduction of imported value and to reduce the number
of submitters from 108,500 to reflect changing business practices.
---------------------------------------------------------------------------

    As discussed in more detail elsewhere in this document, the benefit
of not including reason codes L and M in the final rule draft CPG is
that knowing the identity of the facility involved in the food's
production, as opposed to the identity of the facility's headquarters
or the invoicing firm, is critical to ensuring that FDA can effectively
determine whether food should be held because it is from an
unregistered manufacturing facility.

B. Small Entity Analysis (or Final Regulatory Flexibility Analysis)

    FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA finds that
this final rule may have a significant economic impact on a substantial
number of small entities. While this final rule provides more
flexibility to small entities than the IFR because the final rule
allows the full address of the site-specific manufacturer to be given
instead of the partial address and registration number on prior notice,
this information may still be difficult for some businesses to obtain.
Comments on the IFR Related to Small Businesses
    (Comment) One comment states that smaller U.S. importers cannot
afford the additional costs charged by a broker to submit the FDA
information via the ABI system. As a result, they are having their
foreign suppliers submit prior notice. Some small companies estimate
that, including Web site disruptions, 80 packages would take 40 to 80
hours for prior notice. The comment believes that this is totally
unmanageable.
    (Response) We account for increase in broker costs due to prior
notice in our analysis; the comment estimate of the time it takes to
complete prior notice is accurately reflected in the IFR and final rule
analysis. FDA expects importers to modify their business practices to
find the most cost effective way to deal with prior notice
requirements. In this case, the small importer can avoid higher broker
fees by having the foreign supplier submit the prior notice. Another
alternative would be for the small importer to submit prior notice

themselves through PNSI. We would expect small firms would comply in
whichever manner is most cost effective. It is also possible some of
the costs of prior notice could be passed on to consumers in the form
of higher retail prices for some foods; in this case the small importer
would not feel the complete impact of the higher broker submission
costs.
    (Comment) The cost to complete a prior notice to send food by mail,
for companies that ship low volumes of inexpensive food products, is
higher than the value of the product being shipped and therefore
shipping to the United States may be discontinued.
    (Response) FDA stated in the analysis of the IFR that the costs of
completing prior notice submissions may be partially passed along to
the consumer in the form of higher retail prices for some foods (68 FR
58974 at 59024). FDA's IFR analysis also acknowledged the possibility
that companies in the business of sending small shipments of food to
private individuals in the United States may stop shipping to U.S.
addresses (68 FR 58974 at 59067).
    (Comment) A number of postal services take issue with the requiring
of filing prior notice for personal food items. The comments state that
the labor-intensive process of mailing personal food items will cause a
decrease in the items being shipped, thus decreasing the business of
the mail system.
    (Response) When the cost of shipping increases, the number of items
shipped is indeed likely to decrease. Although some of reduction in
postal revenues would represent a dead-weight loss, it is primarily a
transfer, not a social cost and therefore is not included in the cost
estimates for this analysis.
    (Comment) Several comments express concern about their continued
ability to import fine wine because although they can obtain the name
and address of the site-specific manufacturer of the wine, obtaining
the manufacturers' (i.e., the wineries') registration numbers for these
products often is difficult to those not in the winery's direct
distribution chain. The comments state that smaller importers,
wholesalers, retailers, restaurants, clubs, or hotels will be
negatively affected by not having the registration number for the
manufacturer of the fine wine. The comments further state that the
prior notice rule will negatively impact small producers by reducing
the number of potential representatives and sales venues as secondary
fine wine market importers disappear.
    (Response) FDA does not believe that the fine wine industry will be
negatively affected by the prior notice final rule. The final rule at
Sec.  1.281(a)(6) requires the identity of the manufacturer as follows:
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
(hereafter ``the identity of the manufacturer''). Even if a wine
importer, retailer, or wholesaler cannot obtain the registration number
(e.g., the winery refuses to disclose its registration number because
the importer, retailer, or wholesaler is outside the winery's
distribution chain), the prior notice can include the name and full
address of the winery, which comments stated is obtainable. We do not
include additional costs to fine wine manufacturers or importers in
this final rule analysis; however, we do refine the estimate of the
difference between the IFR requirements and this final rule
modification.
    (Comment) Smaller importers that buy from brokers and wholesalers
because they are too small to buy directly from larger food
manufacturers will be put out of business. These smaller importers
allege that they will not be able to provide the manufacturers'
registration numbers on their prior notices as required by the final
rule. The comments argue that the registration number requirement
interferes with small businesses' rights to free trade because now only
larger businesses that deal with the manufacturers directly, rather
than buying through brokers and wholesalers, will be able to obtain the
manufacturer's information that is required for prior notice.
    (Response) The final rule provides an alternative for submitters to
provide the identity of the manufacturer when the manufacturer's
registration number is not obtainable. Under the final rule, submitters
may provide the name and full address of the site-specific
manufacturing facility along with a reason as to why the registration
number was not used in the prior notice.
    (Comment) While most comments state that the name and address of
the manufacturer could be submitted in prior notice, one comment states
that re-sellers will not normally supply the name of their supplier or
the name of the manufacturer of a particular product to their
customers. The comment asserts that supplying the name of the
manufacturer would allow that customer to circumvent the re-seller and
attempt to make direct contact with the supplier or manufacturer, thus
taking business away from the re-seller. Another comment states,
however, that smaller importers buy from brokers and wholesalers
specifically because they are too small to buy directly from larger
manufacturers and other corporations, as large entities typically would
not find it cost-effective to deal with smaller importers.
    (Response) Depending on the business atmosphere, FDA believes that
it is likely that many resellers will be willing to supply the name and
the address of the manufacturers of the products they sell. Unlike the
manufacturer's registration number, which many may view as confidential
business information that is to be disclosed only on a ``need to know''
basis, the name and full address of a facility is public information
that not only is typically in phone books and on the Internet, but it
also often is provided on documents typically exchanged between buyers
and sellers (e.g., receipts, purchase orders, and bills of lading). The
issues discussed in these comments are addressed further in Options 1
and 3.
Costs per Small Entity
    FDA does not have detailed information on the approximately 108,500
persons (e.g. exporters, U.S. importers or U.S. purchasers or their
agents) that will be primarily responsible for submitting the prior
notice information; table 3 gives a description of some of these
entities. Many of these submitters may have fewer than 100
employees\22\, thus making them small businesses as defined by the
Small Business Administration. Because many of the prior notice
submitters are likely to be small businesses, all options considered in
the Final Regulatory Impact Analysis in section IV.A of this document
are regulatory relief options.
---------------------------------------------------------------------------

    \22\ For NAICS industry sector 42-Wholesale Trade, a business is
defined as small by SBA if it has fewer than 100 employees.
---------------------------------------------------------------------------

    FDA does not have enough information about the 108,500 prior notice
submitters to perform a detailed analysis of the costs per small
business by industry sector. We do, however, update some of the costs
per submitter that were presented in the IFR Regulatory Flexibility
Analysis (68 FR 59066). Table 24 of this document shows the average
costs per submitter to learn the rule, coordinate information, and
submit prior notice. Table 24 also shows the average costs to the
submitter to absorb the costs of not being able to use BRASS, to absorb
costs of lost value of perishable products, and the cost regarding
providing the identity of the manufacturer.

                         Table 24.--Costs per Submitter for PN Final Rule Chosen Option
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per importer (n
                              Activity                                     Total Costs           = 108,500)
----------------------------------------------------------------------------------------------------------------
Learning costs                                                                 $71,037,000                  $655
----------------------------------------------------------------------------------------------------------------
Coordination costs                                                             $43,574,000                  $402
----------------------------------------------------------------------------------------------------------------
Annual costs to fill out prior notice screens                                 $202,500,000                $1,866
----------------------------------------------------------------------------------------------------------------
Costs for BRASS users                                                          $61,003,000                  $562
----------------------------------------------------------------------------------------------------------------
Lost value for perishables                                                     $15,794,000                  $146
----------------------------------------------------------------------------------------------------------------
Costs of change in manufacturer identity requirement                           $28,800,000                  $265
----------------------------------------------------------------------------------------------------------------
Total estimated average costs per submitter                                                               $3,896
----------------------------------------------------------------------------------------------------------------

C. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)
Major Rule

    SBREFA (Public Law 104-121) defines a major rule for the purpose of
Congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million
or more; a major increase in costs or prices; significant adverse
effects on competition, employment, productivity, or innovation; or
significant adverse effects on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic or
export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, OMB has determined that this final rule is
not a major rule for the purpose of Congressional review.

V. Paperwork Reduction Act of 1995

    The collection of information provisions of this final rule are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec.  1.280, 1.281, 1.282, 1.283,
and 1.285 have been approved under OMB Control No. 0910-0520.
    From the IFR to the final rule, FDA removed a few of the required
prior notice data elements. Specifically, submitters no longer need to
include the fax number of the submitter and transmitter, the
anticipated border crossing, the country of the carrier, or the 6-digit
HTS code in their prior notices. Other changes include the addition of
the registration number of the transshipper for articles of food for
transshipment, storage and export, or manipulation and export;
flexibility in submitting the registration number and the city and
country of the manufacturer and shipper instead of full addresses of
these entities; and the option of submitting the tracking number for
articles of food arriving by express consignment instead of anticipated
arrival information when the prior notice is submitted through PNSI.
However, these and other changes in filing requirements, on net, are
not large enough to affect the time needed to file prior notice or the
costs charged by brokers to file prior notice. Therefore we do not re-
estimate a Paperwork Reduction Act burden for this final rule.

VI. Analysis of Environmental Impact

    The agency has carefully considered the potential environmental
effects of this action. FDA has concluded under 21 CFR 25.30(h) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. Taube, Anthony C., Memorandum to file, November 13, 2006.
    2. U.S. Customs and Border Protection, http://www.cbp.gov/
linkhandler/cgov/trade/cargo_security/ctpat/fast/fast_ref_
guide.ctt/fast_ref_guide.pdf.
    3. The NAICS Association, September 29, 2008, available online
at http://www.naics.com.
    4. U.S. International Trade in Goods and Services September
2007, U.S. Census Bureau, U.S. Bureau of Economic Analysis, US DOC
News, November 9, 2007, pages 12 and 15, available online at http://
www.bea.gov/newsreleases/international/trade/2007/pdf/trad0907.pdf.
    5. The Small Business Administration, Office of Advocacy,
Frequently Asked Questions Updated September 2008, available online
at http://www.sba.gov/advo/stats/sbfaq.pdf.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.

0
2. Subpart I, consisting of Sec. Sec.  1.276 through 1.285, is revised
to read as follows:

Subpart I--PRIOR NOTICE OF IMPORTED FOOD

General Provisions

Sec.
1.276 What definitions apply to this subpart?
1.277 What is the scope of this subpart?

Requirements to Submit Prior Notice of Imported Food

Sec.
1.278 Who is authorized to submit prior notice?
1.279 When must prior notice be submitted to FDA?
1.280 How must you submit prior notice?
1.281 What information must be in a prior notice?
1.282 What must you do if information changes after you have
received confirmation of a prior notice from FDA?

Consequences

Sec.
1.283 What happens to food that is imported or offered for import
without adequate prior notice?
1.284 What are the other consequences of failing to submit adequate
prior notice or otherwise failing to comply with this subpart?
1.285 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?

General Provisions

Sec.  1.276  What definitions apply to this subpart?

    (a) The act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms in section 201 of the act (21 U.S.C.
321) apply when the terms are used in this subpart, unless defined in
this section.
    (1) Calendar day means every day shown on the calendar.
    (2) Country from which the article originates means FDA Country of
Production.
    (3) Country from which the article is shipped means the country in
which the article of food is loaded onto the conveyance that brings it
to the United States or, in the case of food sent by international
mail, the country from which the article is mailed.
    (4) FDA Country of Production means: (i) For an article of food
that is in its natural state, the country where the article of food was
grown, including harvested or collected and readied for shipment to the
United States. If an article of food is wild fish, including seafood
that was caught or harvested outside the waters of the United States by
a vessel that is not registered in the United States, the FDA Country
of Production is the country in which the vessel is registered. If an
article of food that is in its natural state was grown, including
harvested or collected and readied for shipment, in a Territory, the
FDA Country of Production is the United States.
    (ii) For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a vessel, the
FDA Country of Production is the country in which the vessel is
registered. If an article of food that is no longer in its natural
state was made in a Territory, the FDA Country of Production is the
United States.
    (5) Food has the meaning given in section 201(f) of the act, except
as provided in paragraph (b)(5)(i) of this section.
    (i) For purposes of this subpart, food does not include:
    (A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)); or
    (B) Pesticides as defined in 7 U.S.C. 136(u).
    (ii) 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.
    (6) 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.
    (7) Grower means 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 means foreign national mail services.
International mail does not include express consignment operators or
carriers or other private delivery services unless such service is
operating under contract as an agent or extension of a foreign mail
service.
    (9) 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.
    (10) No longer in its natural state 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. Crops that have been cleaned (e.g., dusted, washed),
trimmed, or cooled attendant to harvest or collection or treated
against pests, or polished are still in their natural state for
purposes of this subpart. Whole fish headed, eviscerated, or frozen
attendant to harvest are still in their natural state for purposes of
this subpart.
    (11) Port of arrival means 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).
    (12) Port of entry, in section 801(m) and (l) of the act (21 U.S.C.
381(m) and (l)), means the port of entry as defined in 19 CFR 101.1.
    (13) Registration number means the registration number assigned to
a facility by FDA under section 415 of the act (21 U.S.C. 350d) and
subpart H of this part.
    (14) Shipper means the owner or exporter of the article of food who
consigns and ships the article from a foreign country or the person who
sends an article of food by international mail or express consignment
operators or carriers or other private delivery service to the United
States.
    (15) United States means the Customs territory of the United States
(i.e., the 50 States, the District of Columbia, and the Commonwealth of
Puerto Rico), but not the Territories.
    (16) You means the person submitting the prior notice, i.e., the
submitter or the transmitter, if any.

Sec.  1.277  What is the scope of this subpart?

    (a) This subpart applies to all food for humans and other animals
that is imported or offered for import into the

United States for use, storage, or distribution in the United States,
including food for gifts and trade and quality assurance/quality
control samples, food for transshipment through the United States to
another country, food for future export, and food for use in a U.S.
Foreign Trade Zone.
    (b) Notwithstanding paragraph (a) of this section, this subpart
does not apply to:
    (1) Food for an individual's personal use when it is carried by or
otherwise accompanies the individual when arriving in the United
States;
    (2) Food that was made by an individual in his/her personal
residence and sent by that individual as a personal gift (i.e., for
nonbusiness reasons) to an individual in the United States;
    (3) Food that is imported then exported without leaving the port of
arrival until export;
    (4) Meat food products that at the time of importation are subject
to the exclusive jurisdiction of the U.S. Department of Agriculture
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
    (5) Poultry products that at the time of importation are subject to
the exclusive jurisdiction of USDA under the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.);
    (6) Egg products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Egg Products Inspection Act
(21 U.S.C. 1031 et seq.); and
    (7) Articles of food subject to Article 27(3) of The Vienna
Convention on Diplomatic Relations (1961), i.e., shipped as baggage or
cargo constituting the diplomatic bag.

Requirements To Submit Prior Notice of Imported Food

Sec.  1.278  Who is authorized to submit prior notice?

    A prior notice for an article of food may be submitted by any
person with knowledge of the required information. This person is the
submitter. The submitter also may use another person to transmit the
required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be
the same person.

Sec.  1.279  When must prior notice be submitted to FDA?

    (a) Except as provided in paragraph (c) of this section, you must
submit the prior notice to FDA and the prior notice submission must be
confirmed by FDA for review as follows:
    (1) If the article of food is arriving by land by road, no less
than 2 hours before arriving at the port of arrival;
    (2) If the article of food is arriving by land by rail, no less
than 4 hours before arriving at the port of arrival;
    (3) If the article of food is arriving by air, no less than 4 hours
before arriving at the port of arrival; or
    (4) If the article of food is arriving by water, no less than 8
hours before arriving at the port of arrival.
    (b) Except in the case of an article of food imported or offered
for import by international mail:
    (1) If prior notice is submitted via Automated Broker Interface/
Automated Commercial System (ABI/ACS), you may not submit prior notice
more than 30-calendar days before the anticipated date of arrival.
    (2) If prior notice is submitted via the FDA Prior Notice System
Interface (FDA PNSI), you may not submit prior notice more than 15-
calendar days before the anticipated date of arrival.
    (c) Notwithstanding paragraphs (a) and (b) of this section, if the
article of food is arriving by international mail, you must submit the
prior notice before the article of food is sent to the United States.
    (d) FDA will notify you that your prior notice has been confirmed
for review with a reply message that contains a Prior Notice (PN)
Confirmation Number. Your prior notice will be considered submitted and
the prior notice time will start when FDA has confirmed your prior
notice for review.
    (e) The PN Confirmation Number must accompany any article of food
arriving by international mail. The PN Confirmation Number must appear
on the Customs Declaration (e.g., CN22 or CN23 or U.S. equivalent) that
accompanies the package.
    (f) A copy of the confirmation, including the PN Confirmation
Number, must accompany any article of food that is subject to this
subpart when it is carried by or otherwise accompanies an individual
when arriving in the United States. The copy of the confirmation must
be provided to U.S. Customs and Border Protection (CBP) or FDA upon
arrival.
    (g) The PN Confirmation Number must accompany any article of food
for which the prior notice was submitted through the FDA PNSI when the
article arrives in the United States and must be provided to CBP or FDA
upon arrival.

Sec.  1.280  How must you submit prior notice?

    (a) You must submit the prior notice electronically to FDA. You
must submit all prior notice information in the English language,
except that an individual's name, the name of a company, and the name
of a street may be submitted in a foreign language. All information,
including the items listed in the previous sentence, must be submitted
using the Latin (Roman) alphabet. Unless paragraph (c) of this section
applies, you must submit prior notice through:
    (1) The U.S. Customs and Border Protection (CBP) Automated Broker
Interface of the Automated Commercial System (ABI/ACS); or
    (2) The FDA PNSI at http://www.access.fda.gov. You must submit
prior notice through the FDA Prior Notice System Interface (FDA PNSI)
for articles of food imported or offered for import by international
mail, and other transaction types that cannot be made through ABI/ACS.
Prior notice for articles that have been refused under section
801(m)(1) of the act and under this subpart must be submitted through
the FDA PNSI until such time as FDA and CBP issue a determination that
ACS or its successor system can accommodate such transactions.
    (b) If a customhouse broker's or self-filer's system is not working
or if the ABI/ACS interface is not working, prior notice must be
submitted through the FDA PNSI.
    (c) If FDA determines that FDA PNSI or the Operational and
Administration System for Import Support (OASIS) is not working, FDA
will post prominent notification and instructions at http://
www.fda.gov. FDA will accept prior notice submissions in the format it
deems appropriate during the system(s) outage.

Sec.  1.281  What information must be in a prior notice?

    (a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in
paragraphs (a)(1) through (a)(17) of this section:
    (1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name
and address of the submitting firm, if applicable. 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;
    (2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-

mail address. If the business address of the individual transmitting
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;
    (3) The entry type;
    (4) The U.S. Customs and Border Protection (CBP) entry identifier
(e.g., CBP entry number or in-bond number), if available;
    (5) The identity of the article of food being imported or offered
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The estimated quantity of food that will be shipped,
described from largest container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of
this chapter; and infant formula, by Sec.  106.90 of this chapter;
    (6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the
reason the registration number is not provided;
    (7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
    (8) The FDA Country of Production;
    (9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number
of the shipper's registered facility;
    (10) The country from which the article is shipped;
    (11) Anticipated arrival information about the article of food
being imported or offered for import, as follows:
    (i) The anticipated port of arrival;
    (ii) The anticipated date on which the article of food will arrive
at the anticipated port of arrival;
    (iii) The anticipated time of that arrival; and
    (iv) Notwithstanding paragraphs (a)(11)(i) through (a)(11)(iii) of
this section, 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 prior notice is submitted
via the FDA PNSI, the express consignment operator or carrier tracking
number may be submitted in lieu of the information required in
paragraphs (a)(11)(i) through (a)(11)(iii) of this section. Until such
time as FDA and CBP issue a determination that ACS or its successor
system can accommodate such transactions, the tracking number may not
be submitted in lieu of information required in paragraphs (a)(11)(i)
through (a)(11)(iii) of this section, if the prior notice is submitted
via ABI/ACS.
    (12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
    (13) The name and full address of the owner if different from the
importer or ultimate consignee. If the business address of the owner is
a registered facility, you also may submit the registration number of
the owner's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
    (14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a registered facility,
you also may submit the registration number of the ultimate consignee's
registered facility. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
    (15) The mode of transportation;
    (16) The Standard Carrier Abbreviation Code (SCAC) or International
Air Transportation Association (IATA) code of the carrier which is, or
will be, carrying the article of food from the country from which the
article is shipped to the United States to the port of arrival, or if
this code is not applicable, then the name of the carrier. If the
carrier is a privately owned vehicle, the license plate number of the
vehicle and the State or Province that issued the license plate number;
    (17) Planned shipment information, as applicable to the mode of
transportation and when it exists:
    (i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable. This information is not required for an article of food
when carried by or otherwise accompanying an individual when entering
the United States. 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 the FDA PNSI, the express consignment
operator or carrier tracking number may be submitted in lieu of the
Airway Bill number(s) or Bill of Lading number(s), as applicable. Until
such time as FDA and CBP issue a determination that ACS or its
successor system can accommodate such transactions, the tracking number
may not be submitted in lieu of the Airway Bill number(s) or Bill of
Lading number(s), if the prior notice is submitted via ABI/ACS;
    (ii) For food arriving by ocean vessel, the vessel name and voyage
number;
    (iii) For food arriving by air carrier, the flight number. 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 the FDA
PNSI, the express consignment operator or carrier tracking number may
be submitted in lieu of the flight number. Until such time as FDA and
CBP issue a determination that ACS or its successor system can
accommodate such transactions, the tracking number may not be submitted
in lieu of the flight number, if the prior notice is submitted via ABI/
ACS;
    (iv) For food arriving by truck, bus, or rail, the trip number;
    (v) For food arriving as containerized cargo by water, air, or
land, the container number(s). This information is not required for an
article of food when carried by or otherwise accompanying an individual
when entering the United States; and
    (vi) For food arriving by rail, the car number. This information is
not required for an article of food when carried by or otherwise
accompanying an individual.
    (b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article
that is required in paragraphs (b)(1) through (b)(11) of this section:
    (1) The name of the individual submitting the prior notice and his/
her

business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. 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;
    (2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting 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;
    (3) The entry type (which will be a mail entry);
    (4) The identity of the article of food being imported or offered
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The estimated quantity of food that will be shipped,
described from largest container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of
this chapter; and infant formula, Sec.  106.90 of this chapter;
    (5) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the
reason the registration number is not provided;
    (6) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
    (7) The FDA Country of Production;
    (8) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number
of the shipper's registered facility;
    (9) The country from which the article is shipped (i.e., mailed);
    (10) The anticipated date of mailing; and
    (11) The name and address of the U.S. recipient.
    (c) Refused articles. If the article of food has been refused under
section 801(m)(1) of the act and under this subpart, you must submit
the information for the article that is required in paragraphs (c)(1)
through (c)(18) of this section. However, if the refusal is based on
Sec.  1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to
resubmit any information previously submitted unless it has changed or
the article has been exported and the original prior notice was
submitted through ABI/ACS. If the refusal is based on Sec.
1.283(a)(1)(ii), you should cancel the previous submission per Sec.
1.282(b) and (c).
    (1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name
and address of the submitting firm, if applicable. 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;
    (2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting 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;
    (3) The entry type;
    (4) The CBP entry identifier (e.g., CBP entry number or in-bond
number), if available;
    (5) The identity of the article of food being imported or offered
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The quantity of food that was shipped, described from largest
container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of
this chapter; and infant formula, by Sec.  106.90 of this chapter;
    (6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the
reason the registration number is not provided;
    (7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know any of the growers, you
may provide the name and address of the firm that has consolidated the
articles of food from different growers or different growing locations;
    (8) The FDA Country of Production;
    (9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number
of the shipper's registered facility;
    (10) The country from which the article is shipped;
    (11) Arrival information about the article of food being imported
or offered for import, as follows:
    (i) The port of arrival; and
    (ii) The date on which the article of food arrived at the port of
arrival.
    (iii) Notwithstanding paragraph (c)(11) of this section, if the
article of food arrived 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 the FDA
PNSI, the express consignment operator or carrier tracking number may
be submitted in lieu of the information required in paragraph (c)(11)
of this section. Until such time as FDA and CBP issue a determination
that ACS or its successor system can accommodate such transactions, the
tracking number may not be submitted in lieu of information required in
paragraph (c)(11) of this section, if the prior notice is submitted via
ABI/ACS;
    (12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
    (13) The name and full address of the owner, if different from the
importer or

ultimate consignee. If the business address of the owner is a
registered facility, you also may submit the registration number of the
importer's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
    (14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a registered facility,
you also may submit the registration number of the ultimate consignee's
registered facility. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
    (15) The mode of transportation;
    (16) The SCAC or IATA code of the carrier which carried the article
of food from the country from which the article is shipped to the
United States to the port of arrival, or if this code is not
applicable, then the name of the carrier. If the carrier is a privately
owned vehicle, the license plate number of the vehicle and the State or
Province that issued the license plate number;
    (17) Shipment information, as applicable to the mode of
transportation and when it exists:
    (i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable; however, this information is not required for an article of
food when carried by or otherwise accompanying an individual when
entering the United States. If the article of food arrived 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 the FDA PNSI, the express consignment
operator or carrier tracking number may be submitted in lieu of the
Airway Bill number(s) or Bill of Lading number(s), as applicable. Until
such time as FDA and CBP issue a determination that ACS or its
successor system can accommodate such transactions, the tracking number
may not be submitted in lieu of the Airway Bill number(s) or Bill of
Lading number(s), if the prior notice is submitted via ABI/ACS;
    (ii) For food that arrived by ocean vessel, the vessel name and
voyage number;
    (iii) For food that arrived by air carrier, the flight number. If
the article of food arrived 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 the FDA
PNSI, the express consignment operator or carrier tracking number may
be submitted in lieu of the flight number. Until such time as FDA and
CBP issue a determination that ACS or its successor system can
accommodate such transactions, the tracking number may not be submitted
in lieu of the flight number, if the prior notice is submitted via ABI/
ACS;
    (iv) For food that arrived by truck, bus, or rail, the trip number;
    (v) For food that arrived as containerized cargo by water, air, or
land, the container number(s); however, this information is not
required for an article of food when carried by or otherwise
accompanying an individual when entering the United States; and
    (vi) For food that arrived by rail, the car number; however, this
information is not required for an article of food when carried by or
otherwise accompanying an individual;
    (18) The location and address where the article of refused food
will be or is being held, the date the article has arrived or will
arrive at that location, and identification of a contact at that
location.

Sec.  1.282  What must you do if information changes after you have
received confirmation of a prior notice from FDA?

    (a)(1) If any of the information required in Sec.  1.281(a), except
the information required in:
    (i) Section 1.281(a)(5)(iii) (quantity),
    (ii) Section 1.281(a)(11) (anticipated arrival information), or
    (iii) Section 1.281(a)(17) (planned shipment information), changes
after you receive notice that FDA has confirmed your prior notice
submission for review, you must resubmit prior notice in accordance
with this subpart unless the article of food will not be offered for
import or imported into the United States.
    (2) If any of the information required in Sec.  1.281(b), except
the information required in Sec.  1.281(b)(10) (the anticipated date of
mailing), changes after you receive notice that FDA has confirmed your
prior notice submission for review, you must resubmit prior notice in
accordance with this subpart, unless the article of food will not be
offered for import or imported into the United States.
    (b) If you submitted the prior notice via the FDA PNSI, you should
cancel the prior notice via the FDA PNSI.
    (c) If you submitted the prior notice via ABI/ACS, you should
cancel the prior notice via ACS by requesting that CBP cancel the
entry.

Consequences

Sec.  1.283  What happens to food that is imported or offered for
import without adequate prior notice?

    (a) For each article of food that is imported or offered for import
into the United States, except for food arriving by international mail
or food carried by or otherwise accompanying an individual, the
consequences are:
    (1) Inadequate prior notice--(i) No prior notice. If an article of
food arrives at the port of arrival and no prior notice has been
submitted and confirmed by FDA for review, the food is subject to
refusal of admission under section 801(m)(1) of the act (21 U.S.C.
381(m)(1)). If an article of food is refused for lack of prior notice,
unless U.S. Customs and Border Protection (CBP) concurrence is obtained
for export and the article is immediately exported from the port of
arrival under CBP supervision, it must be held within the port of entry
for the article unless directed by CBP or FDA.
    (ii) Inaccurate prior notice. If prior notice has been submitted
and confirmed by FDA for review, but upon review of the notice or
examination of the article of food, the notice is determined to be
inaccurate, the food is subject to refusal of admission under section
801(m)(1) of the act. If the article of food is refused due to
inaccurate prior notice, unless CBP concurrence is obtained for export
and the article is immediately exported from the port of arrival under
CBP supervision, it must be held within the port of entry for the
article unless directed by CBP or FDA.
    (iii) Untimely prior notice. If prior notice has been submitted and
confirmed by FDA for review, but the full time that applies under Sec.
1.279 for prior notice has not elapsed when the article of food
arrives, the food is subject to refusal of admission under section
801(m)(1) of the act, unless FDA has already reviewed the prior notice,
determined its response to the prior notice, and advised CBP of that
response. If the article of food is refused due to untimely prior
notice, unless CBP concurrence is obtained for export and the article
is immediately exported from the port of arrival under CBP supervision,
it must be held within the port of entry for the article unless
directed by CBP or FDA.
    (2) Status and movement of refused food. (i) An article of food
that has been refused under section 801(m)(1) of the act and paragraph
(a) of this section shall be considered general order merchandise as
described in section 490 of the Tariff Act of 1930, as amended (19
U.S.C. 1490).

    (ii) Refused food must be moved under appropriate custodial bond
unless immediately exported under CBP supervision. If the food is to be
held at the port, FDA must be notified of the location where the food
is held at that port before the food is moved there. If the food is to
be held at a secure facility outside the port, FDA must be notified of
the location of the secure facility before the food is moved there. The
refused food shall not be entered and shall not be delivered to any
importer, owner, or ultimate consignee. If the food is to be held at a
secure facility outside a port, the food must be taken directly to that
secure facility.
    (3) Segregation of refused foods. If an article of food that is
refused is part of a shipment that contains articles of food that have
not been placed under hold or other merchandise not subject to this
subpart, the refused article of food may be segregated from the rest of
the shipment. This segregation must take place where the article is
held. FDA or CBP may supervise segregation. If FDA or CBP determines
that supervision is necessary, segregation must not take place without
supervision.
    (4) Costs. Neither FDA nor CBP are liable for transportation,
storage, or other expenses resulting from refusal.
    (5) Export after refusal. An article of food that has been refused
under paragraph (a) of this section may be exported with CBP
concurrence and under CBP supervision unless it is seized or
administratively detained by FDA or CBP under other authority. If an
article of food that has been refused admission under paragraph (a) of
this section is exported, the prior notice should be cancelled within
5-business days of exportation.
    (6) No post-refusal submission or request for review. If an article
of food is refused under section 801(m)(1) of the act and no prior
notice is submitted or resubmitted, no request for FDA review is
submitted in accordance with paragraph (d) of this section, or export
has not occurred in accordance with paragraph (a)(5) of this section,
the article of food shall be dealt with as set forth in CBP regulations
relating to general order merchandise (19 CFR part 127), except that,
unless otherwise agreed to by CBP and FDA, the article may only be sold
for export or destroyed.
    (b) Food carried by or otherwise accompanying an individual. If
food carried by or otherwise accompanying an individual arriving in the
United States is not for personal use and does not have adequate prior
notice or the individual cannot provide FDA or CBP with a copy of the
prior notice (PN) confirmation, the food is subject to refusal of
admission under section 801(m)(1) of the act. If before leaving the
port, the individual does not arrange to have the food held at the port
or exported, FDA or CBP may destroy the article of food.
    (c) Post-Refusal prior notice submissions. (1) If an article of
food is refused under paragraph (a)(1)(i) of this section (no prior
notice) and the food is not exported, prior notice must be submitted in
accordance with Sec. Sec.  1.280 and 1.281(c).
    (2) If an article of food is refused under paragraph (a)(1)(ii) of
this section (inaccurate prior notice) and the food is not exported,
the prior notice should be canceled in accordance with Sec.  1.282 and
you must resubmit prior notice in accordance with Sec. Sec.  1.280 and
1.281(c).
    (3) Once the prior notice has been submitted or resubmitted and
confirmed by FDA for review, FDA will endeavor to review and respond to
the prior notice submission within the timeframes set out in Sec.
1.279.
    (d) FDA review after refusal. (1) If an article of food has been
refused admission under section 801(m)(1) of the act, a request may be
submitted asking FDA to review whether the article is subject to the
requirements of this subpart under Sec.  1.277, or whether the
information submitted in a prior notice is complete and accurate. A
request for review may not be used to submit prior notice or to
resubmit an inaccurate prior notice.
    (2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee. A request must identify which
one the requester is.
    (3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at
http://www.fda.gov_see Prior Notice. A request must include all
factual and legal information necessary for FDA to conduct its review.
Only one request for review may be submitted for each refused article.
    (4) The request must be submitted within 5-calendar days of the
refusal. FDA will review and respond within 5-calendar days of
receiving the request.
    (5) If FDA determines that the article is not subject to the
requirements of this subpart under Sec.  1.277 or that the prior notice
submission is complete and accurate, it will notify the requester, the
transmitter, and CBP that the food is no longer subject to refusal
under section 801(m)(1) of the act.
    (e) International mail. If an article of food arrives by
international mail with inadequate prior notice or the PN confirmation
number is not affixed as required, the parcel will be held by CBP for
72 hours for FDA inspection and disposition. If FDA refuses the article
under section 801(m)(1) of the act and there is a return address, the
parcel may be returned to sender marked ``No Prior Notice--FDA
Refused.'' If the article is refused and there is no return address or
FDA determines that the article of food in the parcel 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 to the sender or, if there is no return address,
destroy the parcel, at FDA expense.
    (f) Prohibitions on delivery and transfer. (1) Notwithstanding
section 801(b) of the act, an article of food refused under section
801(m)(1) of the act may not be delivered to the importer, owner, or
ultimate consignee until prior notice is submitted to FDA in accordance
with this subpart, FDA has examined the prior notice, FDA has
determined that the prior notice is adequate, and FDA has notified CBP
and the transmitter that the article of food is no longer refused
admission under section 801(m)(1) of the act.
    (2) During the time an article of food that has been refused under
section 801(m)(1) of the act is held, the article may not be
transferred by any person from the port or other designated secure
facility until prior notice is submitted to FDA in accordance with this
subpart, FDA has examined the prior notice, FDA has determined that the
prior notice is adequate, and FDA has notified CBP and the transmitter
that the article of food no longer is refused admission under section
801(m)(1) of the act. After this notification by FDA to CBP and
transmitter, entry may be made in accordance with law and regulation.
    (g) Relationship to other admissibility decisions. A determination
that an article of food is no longer refused under section 801(m)(1) of
the act is different than, and may come before, determinations of
admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer refused under
section 801(m)(1) of the act does not mean that it will be granted
admission under other provisions of the act or other U.S. laws.

Sec.  1.284  What are the other consequences of failing to submit
adequate prior notice or otherwise failing to comply with this subpart?

    (a) The importing or offering for import into the United States of
an article of food in violation of the requirements of section 801(m)
of the act, including the requirements of this subpart, is a prohibited
act under

section 301(ee) of the act (21 U.S.C. 331(ee)).
    (b) Section 301 of the act prohibits the doing of certain acts or
causing such acts to be done.
    (1) Under section 302 of the act (21 U.S.C. 332), the United States
can bring a civil action in Federal court to enjoin persons who commit
a prohibited act.
    (2) Under sections 301 and 303 of the act (21 U.S.C. 331 and 333),
the United States can bring a criminal action in Federal court to
prosecute persons who are responsible for the commission of a
prohibited act.
    (c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek
debarment of any person who has been convicted of a felony relating to
importation of food into the United States or any person who has
engaged in a pattern of importing or offering for import adulterated
food that presents a threat of serious adverse health consequences or
death to humans or animals.

Sec.  1.285  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?

    (a) Consequences. If an article of food from a foreign facility
that is not registered as required under section 415 of the act (21
U.S.C. 350d) and subpart H of this part is imported or offered for
import into the United States, the food is subject to being held under
section 801(l) of the act (21 U.S.C. 381(l)).
    (b) Hold. Unless CBP concurrence is obtained for export and the
article is immediately exported from the port of arrival, if an article
of food has been placed under hold under section 801(l) of the act, it
must be held within the port of entry for the article unless directed
by CBP or FDA.
    (c) Status and movement of held food. (1) An article of food that
has been placed under hold under section 801(l) of the act shall be
considered general order merchandise as described in section 490 of the
Tariff Act of 1930, as amended (19 U.S.C. 1490).
    (2) Food under hold under section 801(l) of the act must be moved
under appropriate custodial bond unless immediately exported under CBP
supervision. If the food is to be held at the port, FDA must be
notified of the location where the food is held at the port before the
food is moved there. If the food is to be held at a secure facility
outside the port, FDA must be notified of the location of the secure
facility before the food is moved there. The food subject to hold shall
not be entered and shall not be delivered to any importer, owner, or
ultimate consignee. If the food is to be held at a secure facility
outside a port, the food must be taken directly to that secure
facility.
    (d) Segregation of held foods. If an article of food that has been
placed under hold under section 801(l) of the act is part of a shipment
that contains articles that have not been placed under hold, the food
under hold may be segregated from the rest of the shipment. This
segregation must take place where the article is held. FDA or CBP may
supervise segregation. If FDA or CBP determine that supervision is
necessary, segregation must not take place without supervision.
    (e) Costs. Neither FDA nor CBP will be liable for transportation,
storage, or other expenses resulting from any hold.
    (f) Export after hold. An article of food that has been placed
under hold under section 801(l) of the act may be exported with CBP
concurrence and under CBP supervision unless it is seized or
administratively detained by FDA or CBP under other authority.
    (g) No registration or request for review. If an article of food is
placed under hold under section 801(l) of the act and no registration
number or request for FDA review is submitted in accordance with
paragraph (j) of this section or export has not occurred in accordance
with paragraph (f) of this section, the food shall be dealt with as set
forth in CBP regulations relating to general order merchandise, except
that, unless otherwise agreed to by CBP and FDA, the article may only
be sold for export or destroyed.
    (h) Food carried by or otherwise accompanying an individual. If an
article of food carried by or otherwise accompanying an individual
arriving in the United States is not for personal use and is placed
under hold under section 801(l) of the act because it is from a foreign
facility that is not registered as required under section 415 of the
act and subpart H of this part, the individual may arrange to have the
food held at the port or exported. If such arrangements cannot be made,
the article of food may be destroyed.
    (i) Post-hold submissions. (1) To resolve a hold, if an article of
food is held under paragraph (b) of this section because it is from a
foreign facility that is not registered, the facility must be
registered and a registration number must be obtained.
    (2) The FDA Prior Notice Center must be notified of the applicable
registration number in writing. The notification must provide the name
and contact information for the person submitting the information. The
notification may be delivered to FDA by fax or e-mail. The contact
information for these delivery methods is listed at http://
www.fda.gov_see Prior Notice. The notification should include the
applicable CBP entry identifier.
    (3) If FDA determines that the article is no longer subject to
hold, it will notify the person who provided the registration
information and CBP that the food is no longer subject to hold under
section 801(l) of the act.
    (j) FDA review after hold. (1) If an article of food has been
placed under hold under section 801(l) of the act, a request may be
submitted asking FDA to review whether the facility associated with the
article is subject to the requirements of section 415 of the act. A
request for review may not be submitted to obtain a registration
number.
    (2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee of the article. A request must
identify which one the requestor is.
    (3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at
http://www.fda.gov_see Prior Notice. A request must include all
factual and legal information necessary for FDA to conduct its review.
Only one request for review may be submitted for each article under
hold.
    (4) The request must be submitted within 5-calendar days of the
hold. FDA will review and respond within 5-calendar days of receiving
the request.
    (5) If FDA determines that the article is not from a facility
subject to the requirements of section 415 of the act, it will notify
the requestor and CBP that the food is no longer subject to hold under
section 801(l) of the act.
    (k) International mail. If an article of food that arrives by
international mail is from a foreign facility that is not registered as
required under section 415 of the act and subpart H of this part, the
parcel will be held by CBP for 72 hours for FDA inspection and
disposition. If the article is placed under hold under section 801(l)
of the act and there is a return address, the parcel may be returned to
sender marked ``No Registration--No Admission Permitted.'' If the
article is under hold and there is no return address or FDA determines
that the article of food in the parcel 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 to
the sender marked ``No Registration--No Admission Permitted'' or, if
there is no return address, destroy the parcel, at FDA expense.
    (l) Prohibitions on delivery and transfer. Notwithstanding section
801(b)

of the act, while an article of food is under hold under section 801(l)
of the act, it may not be delivered to the importer, owner, or ultimate
consignee. If an article of food is no longer subject to hold under
section 801(l) of the act, entry may be made in accordance with law and
regulation.
    (m) Relationship to other admissibility provisions. A determination
that an article of food is no longer subject to hold under section
801(l) of the act is different than, and may come before,
determinations of admissibility under other provisions of the act or
other U.S. laws. A determination that an article of food is no longer
under hold under section 801(l) of the act does not mean that it will
be granted admission under other provisions of the act or other U.S.
laws.

    Dated: October 29, 2008.
Michael Chertoff,
Secretary of Homeland Security.

    Dated: July 1, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
[FR Doc. E8-26282 Filed 10-31-08; 11:15 am]

BILLING CODE 4160-01-S