Manufacturer      Y                  Y                Y              N              Y              Y
----------------------------------------------------------------------------------------------------------------
Grower, if known  Y                  Y                N              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Country of        Y                  Y                Y              Y              Y              Y
 production
----------------------------------------------------------------------------------------------------------------
Shipper           Y                  Y                Y              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Country from      Y                  Y                Y              Y              Y              Y
 which article
 is shipped
----------------------------------------------------------------------------------------------------------------
Port of arrival   Anticipated\1\     Anticipated\1\   Anticipated\1  Anticipated\1  N              Actual\1\
                                                       \              \
----------------------------------------------------------------------------------------------------------------
Date of arrival   Anticipated\1\     Anticipated\1\   Anticipated\1  Anticipated\1  N              Actual
                                                       \              \
----------------------------------------------------------------------------------------------------------------
Time of arrival   Anticipated\1\     Anticipated\1\   Anticipated\1  Anticipated\1  N              N
                                                       \              \
----------------------------------------------------------------------------------------------------------------
Date of mailing   N                  N                N              N              Anticipated    N
----------------------------------------------------------------------------------------------------------------
Importer          N                  Y                Y              Y              N              Y
----------------------------------------------------------------------------------------------------------------
Owner             N                  Y                Y              Y              N              Y
----------------------------------------------------------------------------------------------------------------
Ultimate          N                  Y                Y              Y              N              Y
 consignee
----------------------------------------------------------------------------------------------------------------
U.S. recipient    N                  N                N              N              Y              N
----------------------------------------------------------------------------------------------------------------
Mode of           Y                  Y                Y              Y              N              Y
 transport
----------------------------------------------------------------------------------------------------------------
Carrier           Y                  Y                Y              Y              N              Y
----------------------------------------------------------------------------------------------------------------
Bill of lading/   Planned\1\         N                Planned\1\     Planned\1\     N              Actual\1\
 airbill
----------------------------------------------------------------------------------------------------------------
Vessel/Voyage     Planned            Planned          Planned        Planned        N              Actual
----------------------------------------------------------------------------------------------------------------
Flight   Planned\1\         Planned\1\       Planned\1\     Planned\1\     N              Actual\1\
----------------------------------------------------------------------------------------------------------------
Trip     Planned            Planned          Planned        Planned        N              Actual
----------------------------------------------------------------------------------------------------------------
Container
----------------------------------------------------------------------------------------------------------------
Car      Planned            N                Planned        Planned        N              Actual
----------------------------------------------------------------------------------------------------------------
Hold information  N                  N                N              N              N              Y
----------------------------------------------------------------------------------------------------------------
\1\ If the article of food is arriving by express consignment carrier or operator, and the submitter and/or
  transmitter is not 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 this
  information.

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

    In Sec.  1.282 (a)(1) of the IFR, if any of the information
required in Sec.  1.281(a) except the quantity information, the
anticipated arrival information, or the planned shipment information,
changes after FDA has confirmed the prior notice submission for review,
you must resubmit prior notice. For food arriving by international
mail, if any of the information required in Sec.  1.281(b), except the
anticipated date of mailing, changes after FDA has confirmed the prior
notice submission for review, you must resubmit prior notice.
    The IFR also states that the original prior notice should be
cancelled in PNSI or if originally submitted via ABI/ACS, the entry
should be deleted.
    (Comments) Some comments request that FDA revisit the concepts
outlined in Sec. Sec.  1.289 through 1.294 of the proposed rule, which
allowed amendments to be made to product identity, estimated quantity,
and arrival information, without having to cancel the entry and
resubmit the prior notice under a new entry. The comments contend that
such amendments were acceptable and would not taint the adequacy of a
prior notice or compromise food security, if the amendments are made
within the applicable 2-, 4-, or 8-hour timeframes per mode of
transportation at issue. The comments suggest that amendments allow for
a degree of flexibility in the prior notice system and acknowledge a
well-known fact in the industry that this type of information may
change after prior notice has been submitted. Some comments suggest
that allowing the submitter or filer to update or correct information
provided in a prior notice will facilitate the steady flow of prior
notice submissions, without jeopardizing the security and safety of the
food supply.
    (Response) Unlike the proposed rule, the IFR does not allow for
amendments relating to the product identity. After considering the
comments on whether the final rule should allow amendments, and based
on our experience with the IFR, we believe the approach in the IFR is
sound. The reduced timeframes in the IFR, which are continued in the
final rule, provide very little leeway in the time FDA has to receive,
review, and respond to the prior notice submissions. Moreover, the
timeframes are based, in part, on not receiving amendments because
allowing amendments would increase the review time. In addition, ACS
cannot accommodate changes in prior notice submissions that have been
confirmed by FDA for review because CBP also needs finality so it can
complete its own screening of the entry. Therefore, to keep the
timeframes as short as possible, we are not permitting changes to prior
notice without restarting the clock.
    Moreover, we believe that the prior notice information required by
the final rule should be sufficiently fixed to be submitted within the
timeframes. The final rule allows for estimates for some information--
estimated quantity, anticipated arrival information, and planned
shipment information--and changes to any of these data elements does
not require that the prior notice be resubmitted.
    (Comments) Some comments request that FDA create a mechanism to
allow correction of errors in a manner that does not restart the prior
notice clock. One comment requests the final rule provide for
correction of errors within the timeframe of the 2-, 4-, or 8-hour
deadline. The comments suggest that a streamlined process, possibly
through electronic means, of making clerical corrections or correcting
errors in timely filed prior notice should be a permanent feature of
the integrated FDA-CBP process. Some comments contend that without the
opportunity to correct the error post-submission, shippers may find
their shipments frozen in an extended period of delay, which would
frustrate the purpose of the FDA-CBP Integration Plan that is aimed at
reducing such timeframes. Comments also suggest this would create an
unintended legislative loop between the two regulatory frameworks meant
by the Integration Plan to be seamlessly and efficiently integrated.
    Some comments object to the IFR's requirements because after the
CBP entry or entry summary has been certified, there currently is no
mechanism for making corrections, including corrections of simple
clerical errors, without canceling the entry and submitting a new
entry. Comments state that the requirement to cancel and resubmit a
prior notice when submitted information changes or to correct a
clerical error creates additional work in an already overburdened
environment. According to the comments, in the air and truck
environment where cargo is processed on weekends and at off-hour
operations, CBP is unavailable to process these entry cancellations.
The comments state that in such circumstances, cargo could be forced
into refused status due to CBP's inability to act in a timely manner.
    Similarly, other comments state that many imported articles of food
are time sensitive and must be shipped in a temperature controlled
environment. The comments note that clerical errors in the prior notice
may not be corrected, and if an error is discovered after a CBP entry
is certified, the entry must be cancelled. According to the comments,
if CBP is not available to cancel the entry (e.g., the shipment arrives
over the weekend), the delay may cause the shipment to be destroyed.
The comments request that FDA and CBP find a way to address this
problem, either by allowing clerical revisions after the entry has been
certified, permitting entry deletions under certain circumstances, or
ensuring CBP availability on a 24 hours/7 days a week/365 days a year
schedule.
    (Response) Because we reduced the timeframes for submitting prior
notice in the IFR to the least amount of time that we need to meet our
statutory responsibility to receive, review, and respond to prior
notice submissions, the IFR did not provide for amendments or updates.
The timeframes in the final rule also provide the least amount of time
we need to receive, review and respond to prior notice submissions and
therefore, the final rule also does not provide for amendments or
updates. The use of ABI/ACS precludes amendments and updates without
substantial and costly revisions to the system; such technical changes
are not cost-effective or a good use of limited resources given the
development of the Automated Commercial Environment, which will replace
ACS. Changes to ABI/ACS submissions that have been electronically
transmitted to FDA's OASIS and confirmed by FDA for review are not
feasible because CBP also needs finality so it can complete its own
screening of the entry.
    Changes to confirmed prior notice submissions, other than those
relating to estimated quantity, anticipated arrival information, and
planned shipment information, must be processed by resubmission of
prior notice unless the article of food will not be offered for import
or imported into the United States. The responsibility is on submitters
to provide accurate prior notice to FDA, and we encourage affected
parties to take appropriate measures to verify entries for accuracy
before sending. FDA notes that both ABI and PNSI systems allow for
correction of errors that are revealed by the systems' validation
process. In PNSI, a PN confirmation number will not be provided if it
detects errors in the submitted data.
    Moreover, FDA notes that if CBP is unavailable to cancel a prior
notice, submitters can create and submit new

replacement entries and prior notices using either ABI or a combination
of ABI and PNSI even when the original entry has not yet been
cancelled. However, the submitter should cancel the previously
submitted inaccurate ABI entry (via request to CBP) at the first chance
possible to avoid subsequent administrative and operational problems
with entry release. This is a revision to the IFR in that Sec.
1.282(c) of the final rule uses the correct term ``cancel'' versus
``delete'' when describing what CBP should be requested to do in this
case. When an entry is ``deleted'' versus ``cancelled'' in ABI, the
filer is able to re-use the original entry number. However, PNSI will
reject a prior notice submission that attempts to re-use a previous
entry number. Therefore, we revised the final rule to provide for
cancellation of the entry, rather than deletion of an entry.
    (Comments) Some comments request that FDA and CBP develop a process
for reviewing amendments that do not affect the security of the cargo
in less than the full eight hours, so that the shipments' release from
the port is not delayed unduly.
    (Response) The requirements for amendments set forth in the
proposed rule were eliminated from the IFR. This final rule provides
that if required information (except estimated quantity, anticipated
arrival information, including the anticipated date of mailing, and
planned shipment information) changes after FDA has confirmed prior
notice for review, the prior notice should be cancelled and a prior
notice with the correct information must be submitted. The reduced
timeframes in the IFR, which are continued in the final rule, provide
very little leeway in the time FDA has to receive, review, and respond
to the prior notice submissions. Moreover, the timeframes are based, in
part, on not receiving amendments because allowing amendments would
increase the review time. In addition, ACS cannot accommodate changes
in prior notice submissions that have been confirmed by FDA for review
because CBP also needs finality so it can complete its own screening of
the entry. Because we are maintaining the IFR timeframes in the final
rule, it is difficult to accommodate amendments.
    (Comments) Some comments state that changes to prior notice should
be required for material changes only. Materiality would need to be
determined.
    (Response) We agree. The final rule requires that, if certain
required information changes after FDA has confirmed prior notice for
review, the prior notice should be cancelled and a prior notice with
the correct information must be submitted. Changes to other information
(i.e., estimated quantity, anticipated arrival information, and planned
shipment information) do not require the submitter to re-submit a
revised prior notice.
    (Comments) Some comments suggest that entry deletions, rather than
cancellations, should be permitted for legitimate reasons.
    (Response) FDA believes the comment misunderstands Sec.  1.282(c)
of the IFR because that provision states, ``If you submitted the prior
notice via ABI/ACS, you should cancel the prior notice via ACS by
requesting that CBP delete the entry'' (emphasis added). However, the
final rule now recommends that if you cancelled a prior notice
submitted via ABI/ACS, you should cancel the prior notice via ACS by
requesting that CBP cancel, rather than delete, the entry (Sec.
1.282(c)). When an entry is ``deleted'' versus ``cancelled'' in ABI,
the filer is able to re-use the original entry number. However, PNSI
will reject a prior notice submission that attempts to re-use a
previous entry number. Therefore, we revised the final rule to provide
for cancellation of the entry, rather than deletion of an entry.
    (Comments) One comment requested clarification regarding whether
the additional requirement for planned shipment information as
applicable (carrier, vessel name, voyage flight numbers, and bill of
lading number) will necessitate a resubmission when those details
change due to transportation arrangements outside the control of the
supplier.
    (Response) No. The final rule does not require resubmission of
prior notice if the planned shipment information changes after prior
notice has been submitted and confirmed for review by FDA.
    (Comments) One comment notes that part of the process of completing
a prior notice is to obtain a CBP entry number, which many firms use a
customs broker to do. The comment states that this works well in most
cases, but can create problems for products arriving by boat. The
comment further states that of all the modes of transportation, boats
are the most unpredictable and can arrive earlier or later than
expected. Early arrivals pose a problem because of the 8 hour notice
period and the relatively short timeframe in which a company learns of
an impending early arrival. Given the fact that customs brokers may not
work a 24-hour, 7-day per week schedule, prior notice shipments that
arrive on the weekend, holiday, or after normal business hours will be
filed late and could be subject to civil penalties. The comment
recommends that the prior notice system allow custom entry numbers to
be updated after the customs entry has been filed by the customs
brokers and that any penalty considerations be deferred under these
circumstances.
    (Response) The type of updates recommended by this comment is not
necessary because prior notice can be submitted without a customs entry
number. In the situation described, where prior notice must be
submitted before entry can be filed, prior notice may be submitted
using PNSI without a CBP entry identifier (e.g., a CBP entry number).
PNSI will provide a system-generated entry identifier. Once a customs
broker is secured during normal business hours to file the entry, the
prior notice confirmation number(s) can be given to the broker who can
affiliate the prior notice(s) to the customs entry via the ABI
submission.
    (Comments) Some comments request clarification on what happens to
the food if the information relating to product identity, estimated
quantity, or anticipated arrival changes after prior notice is
submitted.
    (Response) The final rule requires that if required information
(except estimated quantity, anticipated arrival information, including
the anticipated date of mailing, and planned shipment information)
changes after FDA has confirmed prior notice for review, the prior
notice must be resubmitted. As we explained in the preamble to the IFR,
``FDA proposed to allow changes to certain information in the prior
notice after a prior notice was submitted. * * *. Some comments stated
that if the timeframe for submitting prior notice was changed, i.e.,
shortened to 4 hours for land and air and 8 hours for water, then
amendments and updates would not be necessary. * * * FDA agrees with
the comments that state that if the deadline for submission of prior
notice were reduced, amendments and updates would not be necessary. FDA
has chosen timeframes that provide it with very little leeway in the
time it has to `receive, review and respond' to the prior notice
submissions. Thus, we concluded that we could no longer permit changes
to prior notice without restarting the clock. In addition, the use of
ABI/ACS precludes amendments and updates: changes to ABI/ACS
submissions that have been electronically transmitted to FDA's OASIS
and confirmed by FDA for review are not feasible because CBP also needs
finality so it can complete its own screening of the entry. Therefore,
the interim final rule does not allow for

changes to a prior notice after the transmitter has been notified that
FDA has confirmed the prior notice for review.'' (68 FR 58974 at 59013
and 59014)
    We retain this view and therefore, changes in product identity
require resubmission of a prior notice with the correct information. We
do not require resubmission of a prior notice if the estimated
quantity, anticipated arrival information, including the anticipated
date of mailing, and planned shipment information changes, because
these data elements are not firm in the first place. Moreover, such
changes would not alter FDA's ability to review the prior notice or to
examine the food.
    (Comments) Some comments request that FDA maintain the flexibility,
as provided by the IFR, to provide anticipated port arrival information
for date and time of arrival and point of crossing. The comments state
that this flexibility is critical for minimizing trade disruption and
note that times of arrival and entry locations often change and
importers need the flexibility to accommodate these unanticipated
changes without refiling entry information.
    (Response) Section 1.281(a)(11), which requires anticipated arrival
information, has been revised in the final rule. The requirement to
provide the identity of the border crossing within the anticipated port
of arrival has been eliminated in the final rule. As with the IFR, in
the final rule, changes in anticipated port of arrival, anticipated
date of arrival, and anticipated time of arrival do not require
cancellation and resubmission of the prior notice.
    (Comments) Some comments suggest that the requirement that all
prior notice data be transmitted via the PNSI portal after the prior
notice time limitations or refusal will increase the load on this
limited system. The comments state that the PNSI system capacity must
be dramatically increased before the August 2004 full enforcement
deadline in order to ensure that legitimate trade is not impacted due
to a failure of the system.
    (Response) FDA does not agree that post-refusal prior notice
submissions have or will impact or overload PNSI. PNSI has operated
effectively since the IFR took effect and has sufficient capacity for
any increase in submissions after the effective date of this final
rule. FDA has carefully monitored both PNSI and OASIS system usage and
performance. No issues related to load on PNSI have been identified
since the IFR took effect. Until such time as ACS or its successor
system can accommodate such transactions, post-refusal prior notice
must be submitted via PNSI (see Sec.  1.280(a)(2)).
    (Final Rule) Section 1.282 of the final rule requires that if
required information (except estimated quantity, anticipated arrival
information, including the anticipated date of mailing, and planned
shipment information) changes after FDA has confirmed prior notice for
review, the prior notice should be cancelled and a prior notice with
the updated information must be submitted.

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

    The IFR in Sec.  1.283 identifies consequences and procedures for
failure to provide adequate prior notice and describes the requirements
and procedures for various situations.
    The comments received will be discussed below in the order each
issue appears in Sec.  1.283 of the IFR, proceeded by comments
generally addressing consequences.
1. General Comments
    (Comments) Some comments suggest that enforcement actions should be
based on levels of culpability (e.g., negligent, grossly negligent, and
fraudulent), number of infractions, and seriousness of infractions.
    (Response) FDA and CBP take various considerations, such as the
seriousness of the violation, into account when deciding whether to
take an enforcement action in response to violations of the prior
notice rule and, if so, what actions to take. For areas in which we
have established enforcement policies for prior notice, these are
contained in, and communicated to the public through a Compliance
Policy Guide (CPG). Elsewhere in this issue of the Federal Register, we
are announcing the availability of the Prior Notice Final Rule Draft
CPG, which describes our proposed enforcement policies for the final
rule.
    (Comments) Some comments request clarification on the penalties for
inadvertent errors, such as clerical errors, in the prior notice
submission.
    (Response) As described in the previous response, FDA and CBP take
into account the nature of the violation in determining how to respond
to prior notice violations. The validation process built into ABI and
PNSI should assist in catching inadvertent errors, such as clerical
errors, because the systems will not accept data with certain errors.
This validation process then allows the submitter to correct errors
before final submission of prior notice data.
    (Comments) Some comments ask if there are any measures that
importers should undertake to avoid delays at the port of entry.
    (Response) FDA advises that most delays based on inaccurate and
untimely submission of prior notice are avoidable and recommends that
importers focus on measures to increase accurate and timely submissions
of prior notice.
    (Comments) Some comments state that the ``Category 3'' refusal and
fine provision is excessive for a shipment showing up at the border in
advance of the 2-hour timeframe elapsing and FDA should consider
lowering the penalty for this type of offense. Other comments request
clarification about what will happen to trucks that arrive too early,
i.e., will they be turned away or will they be allowed to wait in the
compound?
    (Response) Section 1.283(a)(1)(iii) of the final rule provides that
if an article of food arrives early (i.e., before the prior notice time
has elapsed), its arrival will not be considered untimely if FDA
already has reviewed the prior notice, determined its response to the
prior notice, and advised CBP of that response. However, if FDA has not
reviewed the prior notice submission and responded to CBP before the
food arrives, the food is subject to refusal. As noted previously, in
determining whether to refuse the food, assess a CBP civil monetary
penalty, or take other regulatory action, we will take into account the
seriousness of the violation and other considerations. Trucks arriving
before FDA has processed the prior notice will be handled as
appropriate under the individual circumstances.
    (Comments) Some comments state that the implementation plan for the
prior notice rule must include a contingency plan to ensure that border
traffic can still be cleared and does not come to a standstill as new
systems are put in place and problems are resolved. Comments point out
that it is essential for FDA and CBP to have appropriate mechanisms and
procedures in place (such as referral to a secondary inspection, where
appropriate) so that border congestion is not increased by the
application of the rules.
    Some comments request clarification on arrangements between FDA and
CBP, the Canada Border Services Agency, and the bridge authorities to
address issues surrounding refusal of entry due to missing or
incomplete prior notice information. The comments indicate that the
relevant agencies on both sides of the border should have a plan in
place to deal with the inevitable

problems posed by larger volumes of returning trucks to ensure that
busy border crossings do not become a ``no man's'' land. Some comments
indicate that local staff at busy border crossings, such as the Peace
Bridge and Ambassador Bridge, have indicated that trucks will be turned
back for missing/incomplete prior notice if secure storage cannot be
arranged. Comments suggest that CBP could stamp a shipping document
(such as the bill of lading) ``Refused--BTA'' or implement procedures
that CBP had in place for refused trucks prior to the Bioterrorism Act.
    Some comments suggest that carriers should be permitted a variety
of options when and if they are advised that one or more products
within a shipment have been refused due to a failure to have an
adequate prior notice. According to the comments, these options may
include, permission to hold the cargo at the border while the proper
information is submitted to the FDA and before mandatory notice of
intended destination for delivery; returning the cargo to the exporting
facility directly; holding the cargo at a designated carrier's closest
facility; and/or holding the cargo at a designated FDA holding
facility, not necessarily a general order bonded warehouse, near the
port of entry.
    (Response) FDA and CBP have not experienced any major disruptions
in border traffic as a result of the implementation of the IFR in
December 2003. The agencies also have not made any significant
revisions to the IFR in this final rule that cause us to believe there
will be major disruptions in trade once the provisions in this final
rule take effect, particularly since we are providing a 180-day period
between publication of this rule and the effective date of its
provisions. This period of time should allow for full understanding by
affected parties of the requirements of the final rule.
    We also note that the automated validation process in ABI and PNSI
will catch most missing and incomplete submissions before refusal
because the systems will not accept submissions with certain errors or
omissions. If refusal does occur, the carrier will have the option to
segregate refused food from the rest of the shipment (Sec.
1.283(a)(3)), the option to export after refusal with CBP concurrence
(Sec.  1.283(a)(5)), and the option to have refused food held at the
port of entry, unless directed otherwise by CBP or FDA (see Sec.
1.283(a)(1)).
    (Comments) Some comments recommend establishing an electronic means
to resolve the refused admission status.
    (Response) Both the IFR and the final rule provide for a response
to an 801(m) refusal to be provided to FDA by mail, e-mail, fax, or
courier. FDA will respond in kind, as we have not experienced any
problems as a result of this flexibility.
2. Inadequate Prior Notice (Sec.  1.283(a)(1))
    (Comments) Several comments request that FDA notify the submitter,
filer, importer, or ultimate consignee, either in lieu of or in
addition to the carrier, about inadequacies in a prior notice
submission that result in refusal of the food. The comments state that
the carrier is not in a position to resolve the problem when the
article of food is refused. The comments note that the carrier has
temporary possession of the product, has minimal vested interest in the
shipment, particularly if is offloaded, and has little, if any,
resources or incentive to resolve the refusal. However, according to
the comments, the exporter, importer, or ultimate consignee has an
ownership interest in the refused food and a strong economic incentive
to resolve the refusal swiftly, or to export or destroy the refused
food if the prior notice defects cannot be corrected. The comments
state that delaying notification to the submitter, importer, and
ultimate consignee, unduly hinders the resolution of the problem.
    One comment specifies that the filer of the prior notice, who is in
most cases the importer, supplier, owner of the merchandise, or a
representative of one of these entities, should be notified directly,
without any intermediate communication, so that the filer may promptly
take corrective action and mitigate any possible adverse regulatory and
commercial consequences. Some comments request that FDA or CBP notify
the General Order Manager (GOM) when a shipment has been rejected or
denied entry and also provide the rationale for that decision.
    (Response) FDA disagrees. The IFR does not require FDA or CBP to
provide notice about a refusal, and we continue to believe this is
appropriate. As an operational matter, the carrier would have to be
notified of the refusal. The carrier can then notify others, such as
the entity that hired the carrier to transport the article of food,
that there is a problem with the prior notice. It would be resource-
intensive for FDA or CBP to assume responsibility for notifying various
other entities of the refusal. FDA notes that, although we collect the
contact information for the submitter and transmitter, which we could
use to contact parties about certain actions, including refusals,
routinely notifying these and other parties about a refusal would take
limited staff resources away from other functions, such as reviewing
prior notices. FDA will try to notify other parties (e.g., submitter),
in addition to the carrier, if feasible, and we often do contact these
other parties as resources allow. FDA notes that for the future
migration of ABI/ACS to the ITDS/ACE environment, FDA has requested the
ability to provide electronic prior notice ``refusal'' messaging. This
capability does not currently exist. If electronic prior notice refusal
messaging is in place, it would significantly reduce the resources
required to notify ITDS participants of these refusals.
    (Comments) Some comments express concern that trucking companies
that pick up FDA-regulated freight in Canada or Mexico bound for the
United States cannot ascertain that the importer, shipper, or customs
broker has filed the appropriate prior notice. The comments ask what
form of proof FDA (or other border regulatory agencies) will consider
acceptable in order to release the motor carrier from responsibility if
the prior notice was not filed appropriately. The comments state that
it is not clear whether FDA will supply an official document that the
importer, shipper, or customs broker would issue to the motor carrier
to assure the carrier that prior notice has been filed.
    (Response) Under Sec.  1.279(d) of the final rule, FDA notifies the
submitter when the prior notice has been confirmed for review, with a
message containing a prior notice confirmation number. Section 1.279(g)
of the final rule requires that the prior notice confirmation number
must accompany any article of food for which the prior notice was
submitted through PNSI when the article arrives in the United States
and must be provided to CBP or FDA upon arrival. To address the concern
in the comments, carriers may consider, as a matter of business
practice, requesting from their customers proof of confirmation of
prior notice submission prior to transporting the food to the United
States, even when there is no requirement to provide the confirmation
number to CBP or FDA upon arrival.
    (Comments) Some comments request clarification on whether
information for FDA clearance will be allowed to be transmitted via
ABI, PNSI or either, for a shipment of food that will be entered after
the arrival of a vessel or an aircraft. Comments ask what error message
will be sent back to the transmitter for entry that is untimely filed,
e.g., will the transmitter receive a refused admission

status or some other error message? In addition, comments ask what the
mechanism is for communicating with the carrier on the disposition of
the prior notice. The comment states that carriers cannot view the FDA
``may proceed'' messages in CBP's AMS, and the ABI participant (usually
the customs broker) is responsible for communicating freight holds to
the various parties involved, including importers, container freight
stations (CFS), and truckers.
    (Response) FDA clarifies that if an article of food subject to
prior notice requirements arrives in the United States and prior notice
has not been received for review by FDA in the timeframes prescribed in
the final rule, the food is subject to refusal under section 801(m) of
the act, unless FDA already reviewed the prior notice, determined its
response, and advised CBP of that response. See also the discussion
above regarding communication of refusal status.
    (Comments) One comment requests clarification as to how
transmitters may confirm the validity and existence of registration
numbers provided by the shippers, importers, and carriers. The comment
states that the transmitter might bring in goods based on erroneous,
but good faith information.
    (Response) FDA will identify anomalies in the initial submission of
registration numbers based on review of the information prior to
confirmation of receipt of the prior notice, and will respond
accordingly. If our subsequent review, after the prior notice is
confirmed for review, reveals problems with a submitted registration
number that causes the prior notice submission to be deemed inaccurate,
the food is subject to refusal under section 801(m) of the act.
Subsequent corrections to the submitted information can be provided by
resubmitting corrected information in a post-refusal prior notice (see
Sec.  1.283(c)).
    If our subsequent review reveals problems with the submitted
registration number such that an article of food is from a foreign
facility that is not registered under section 415 of the act and 21
CFR, part 1, subpart H, and is imported or offered for import into the
United States, the food is subject to hold under section 801(l) of the
act. To resolve a hold, the facility must register and obtain a
registration number, and that number must be provided to FDA. This is
covered under Sec.  1.285(i) of the final rule.
    As discussed in response to comments 157 and 158 in the preamble to
the Registration of Food Facilities Interim Final Rule (68 FR 58894 at
58931, October 10, 2003), section 305 of the Bioterrorism Act states
that FDA's list of registered facilities and registration documents FDA
receives under the rule are not subject to disclosure under FOIA.
Furthermore, section 305 of the Bioterrorism Act provides that any
information derived from the list of facilities or registration
documents that would disclose the identity or location of a specific
registered person is not subject to disclosure under FOIA. This does
not preclude the registered facility from disclosing its registration
number, such as to the submitter or others with whom it has a business
relationship.
    (Comments) Some comments request that FDA clarify the penalties for
inadequate prior notice. One comment asks about the consequences when
foods are accidentally shipped without meeting the prior notice
requirements, i.e. can they be transshipped?
    (Response) Prior notice is required for food imported or offered
for import into the United States, including shipments intended for
transshipment. If adequate prior notice is not provided, the food is
subject to refusal. Refused food must be held, in accordance with the
provisions of Sec.  1.283(a), unless CBP concurrence is obtained for
export and the food is immediately exported from the port of arrival
under CBP supervision. An article of food that has been refused is
considered general order merchandise and can only be moved under
appropriate custodial bond unless immediately exported under CBP
supervision. If the food is held at a secure facility outside of the
port, FDA must be notified of the location of the secure facility
before the food is moved there. Post-refusal prior notice can be
submitted as provided by Sec.  1.283(c).
    We also note that CBP may seize goods imported contrary to law,
assess civil monetary penalties, including those under 19 U.S.C.
1595a(b) against every person who directs, assists, financially or
otherwise, or is in any way concerned in the importation of any
merchandise contrary to law, and refer violations for criminal
investigation and prosecution. Section 1.284 of the final rule lists
other consequences for failure to submit adequate prior notice. For
example, under 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.
    (Comments) Some comments ask whether an entry of food would be
subject to detention if the product code does not precisely reflect the
nature of the product.
    (Response) The final rule requires the submission of accurate
information that is submitted in the prior notice, including the
product code, which is required in Sec.  1.281 (a)(5)(i), (b)(4)(i),
and (c)(5)(i) of the final rule. If the product code does not
accurately identify the food, the food is subject to refusal. Section
1.283(a)(1)(ii) of the final rule states that 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.
3. Status and Movement of Refused Food (Sec.  1.283(a)(2))
    (Comments) Some comments request that FDA clarify the process for
food that is refused and later deemed to be admissible.
    (Response) Section 1.283 of the final rule identifies the
consequences and procedures for food that is refused because of
inadequate prior notice. If the refused food is not immediately
exported with CBP concurrence, it is considered general order
merchandise and must be held until adequate prior notice is submitted
and FDA has notified CBP and the transmitter that the food is no longer
refused because of inadequate prior notice. If in response to a request
for FDA review, FDA determines that the article is not subject to the
prior notice requirements 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. 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. Moreover, a determination
that an article of food is no longer refused under section 801(m)(1)
does not mean that it will be granted admission under other provisions
of the act or other U.S. laws (Sec.  1.283(g)). Further information
regarding the process may be found in the preamble to the IFR (68 FR
58974 at 59016 through 59022).
    (Comments) Some comments state that the holding period for prior
notice should be no longer than the original required prior notice
timeframe. The comments contend that exceeding this

time period does not increase the safety to the public and may cause a
bottleneck for all freight movements if thousands of shipments are held
at their port of arrival. Comments suggest that, before the holding
period is fully implemented, FDA should determine the percentage of
shipments that are still not in conformity with the prior notice rule
and determine the potential for harming the movement of all freight
into and out of the United States when prior notice is fully
implemented.
    (Response) Section 1.283(a)(2) of the final rule states that
refused food will be considered general order merchandise. In the first
instance, it is not within our control how long it will take the
parties associated with the article of food being held to satisfy the
prior notice requirements. Moreover, CBP regulations address the length
of time an imported product will be held in General Order (G.O.) Status
(19 CFR part 127). Section 1.283(a)(1) of the final rule states that
refused food that is not immediately exported must be held at the port
of entry unless directed by CBP or FDA. Accordingly, the final rule
does not require refused food to be held at the port of arrival unless
so directed by CBP or FDA. In Sec.  1.283(c)(3), we state that FDA will
try to review and respond to post-refusal prior notice submissions
within the prior notice timeframes.
    (Comments) Some comments request that FDA establish procedures for
handling refused merchandise. The comments contend that secure storage
facilities and cargo movement procedures have not been established for
refused merchandise. According to the comments, there is no mechanism
to handle refused refrigerated or frozen shipments. The comments state
that perishable food that is held or is not properly stored may no
longer be commercially viable when it is released or sold at auction.
Comments also state that highly perishable shipments that are held past
their commercially viable time period and small shipments that have
little commercial value will quickly fill any warehouse, including any
G.O. warehouse, with no one to claim them. Other comments request that
FDA and CBP develop a joint operational plan for handling refused
merchandise with input from the importing and shipping industries.
Another comment states that directions on executing CBP 6043 Permit to
Transfer or CBP 7512 ``Restricted in-bond'' is needed to avoid major
congestion.
    (Response) Section 1.283(a)(2)(i) of the final rule provides that
food refused under section 801(m)(1) of the act has ``General Order''
status. Under CBP laws and regulations, general order merchandise must
generally be held in a general order warehouse (19 CFR 127.1). CBP
regulations also empower the port director, if merchandise requires
specialized storage facilities that are unavailable in a bonded
facility, to direct the storage of the merchandise by the carrier or by
any other appropriate means (see 19 CFR 4.37(f), 122.50(f), or
123.10(f)). Additionally, fruit and other perishables may be held by
the port director in a bonded cold-storage warehouse for a reasonable
period, if it is probable that entry will be made at an early date (19
CFR 127.28(c)).
    FDA and CBP believe that general order storage qualifies as secure
facilities for purposes of the Bioterrorism Act, as it is subject to
the requirements set forth at 19 CFR part 19. In particular, 19 CFR
19.9 contains controls that will ensure that refused food will be
adequately controlled while in storage and will not be released from
general order storage without CBP authorization.
    FDA also emphasizes that refusal under section 801(m) of the act
occurs when no prior notice or inadequate or untimely prior notice is
submitted, as required under the Bioterrorism Act for articles of food
imported or offered for import into the United States. Costs and other
consequences described by the comments due to refusal for inadequate
prior notice should be avoided when adequate prior notice is submitted
to FDA. The final rule also outlines procedures for satisfying the
prior notice requirements after food has been refused and procedures
for requesting an FDA review of the refusal.
    (Comments) One comment requests that FDA establish a clear
definition of ``perishable'' shipments. The comment states that
destroying or selling frozen, refrigerated, and fresh merchandise held
at a secure facility after 3 days, for inadequate prior notice, is
unreasonable and an excessive financial burden on international trade.
    (Response) FDA does not agree that it is necessary or pertinent to
establish a definition of ``perishable'' for purposes of implementing
the prior notice requirements of the Bioterrorism Act, which requires
FDA to receive prior notice of food imported or offered for import into
the United States. Financial burdens associated with merchandise
directed to a secure facility because of inadequate, untimely or no
prior notice generally can be avoided by ensuring FDA receives adequate
prior notice in accordance with this final rule.
    (Comments) Some comments request that FDA consider the ``port of
entry'' to be the port where legal entry is accomplished. The comments
state that these ports have facilities for proper food storage, as well
as the CBP and FDA processes and personnel to deal with any
irregularities. The comments point out that international shipments are
not legally ``entered'' with CBP at the port of arrival, but instead
are moved under bond to a subsequent port where CBP entry is made.
Further, shipments are not released at the port of entry until
clearance is obtained from CBP, and carriers are under a strict
obligation to retain control of shipments from the port of arrival to
the legal entry port. The comments note that under the IFR, shipments
of food will not be permitted to be moved from the port of first
arrival to the port of legal entry if prior notice is not provided or
is inadequate. According to the comments, express carriers may be
required to unload and reload entire planes in order to find one or two
shipments. The comments state that this is especially problematic
because proper facilities for the storage of food may not be available
at the ports of arrival. Comments further note that express consignment
operators have invested millions of dollars to construct and operate
dedicated sorting facilities that use state of the art automation and
scanning equipment. These facilities are far better suited to
identifying and detaining food shipments of concern to FDA than the
ramps or conventional air freight handling facilities commonly found at
the ports of arrival. Other comments state that there are no cold
storage facilities currently available in San Diego/Otay Mesa. The
comments contend that the Mexican authorities will not permit such
shipments to be returned to Mexico.
    (Response) The IFR and the final rule at Sec.  1.283(a)(1) require
that food refused due to inadequate prior notice food must be held
within the port of arrival only if directed by CBP or FDA, and that
otherwise refused food must be held within the port of entry.
    As we discussed in the preamble to the IFR, we defined ``port of
arrival'' and ``port of entry'' to provide flexibility to ensure that
``food that has been refused may move to the port of destination where,
for example the consumption or warehouse entry will be filed, unless
directed by CBP or FDA. Generally, we do not intend to hold shipments
at the border unless our assessment of the situation leads us to
believe it is warranted; e.g., the food may present a serious risk to
public health or that the prior notice violation is egregious.'' (See
68 FR 58974 at 58988.)

    (Comments) One comment requests that FDA notify public food storage
warehouses when a shipment is being held, is not accepted for entry, or
when such shipments are released. The comment points out that the
warehouses receive shipments via multiple transport methods, store them
for multiple customers, and should be officially informed of the status
of the shipments, rather than relying on information from the owners of
the articles of food.
    (Response) Under Sec.  1.283(a)(2), refused food shall not be
entered and shall not be delivered to the importer, owner, or
consignee. As discussed previously, FDA does not believe it should
modify the rule to require notice of the refusal to any specific entity
or entities. The entity moving the food to a warehouse can notify the
warehouse of the food's status, and the warehouse can likewise ask or
require that it be provided this information before accepting the food
for storage.
    (Comments) Some comments state that the requirement in Sec.
1.283(a)(2)(ii) for carriers to notify FDA regarding delivery of
refused shipments within 24 hours of arrival and then to make delivery
immediately imposes an unreasonable burden on carriers.
    (Response) We have changed the requirement to notify FDA of the
location where the food has been or will be moved from within 24 hours
of refusal to before the food is moved to that location. FDA needs this
information before the food is moved to verify that the facility where
the food is to be held is a secure facility. Moreover, because refused
food shall not be delivered to the importer, owner, or ultimate
consignee, before the food is moved, FDA needs to verify that the
secure facility is not owned by any of these parties.
    For clarity and consistency, we also are changing the phrase
``designated location'' to ``secure facility'' in Sec.  1.283(a)(2)(ii)
and throughout the final rule. In addition, Sec.  1.283(a)(2)(ii) of
the IFR states that refused food must be moved under appropriate
custodial bond. We have revised this paragraph in the final rule to
state that the refused food must be moved under appropriate custodial
bond, unless immediately exported under CBP supervision. The final rule
also clarifies that the refused food may be held at the port of entry
or at a secure facility.
    (Comments) Some comments request clarification on whether ``refused
goods'' will have to be exported or destroyed.
    (Response) Articles of food that have been refused under section
801(m) of the act because of inadequate prior notice must be held until
prior notice requirements have been satisfied, unless the food is
immediately exported with CBP concurrence from the port of arrival. The
decision to export the refused food is not the responsibility of FDA or
CBP. If no prior notice submission or request for FDA review is
submitted in a timely fashion after a food is refused, the food will be
dealt with as set forth in CBP regulations relating to general order
merchandise. It may only be sold for export or destroyed as agreed to
by CBP and FDA.
    (Comments) One comment requests clarification on the process for
designating a ``secure facility'' after a shipment of food is refused
admission status. The comment points out that the CF3461 entry document
currently designates a CBP exam site in box 29 and requests
clarification on whether refused goods will be sent automatically to
the designated CBP exam site or if arrangements can be made to
designate another facility.
    (Response) FDA clarifies that a refusal under section 801(a) of the
act, relating to admissibility, differs from a refusal under section
801(m) of the act, relating to prior notice. A food refused under
section 801(m) of the act must be held within the port of entry for the
article of food unless directed to another location by CBP or FDA. If
CBP or FDA directs the food to be delivered to a secure facility, this
will not necessarily be the CBP exam site designated in box 29 of the
CF3461 entry document.
    (Comments) Some comments ask if FDA will publish a list of approved
``secure facilities'' by port so that transmitters can designate these
facilities.
    (Response) Early in our prior notice experience, FDA had indicated
that we would publish a list of secure facilities. However, our
experience has shown us that it is not practicable to maintain such a
list since the secure status of facilities changes very rapidly. While
we will not maintain such a list, FDA will verify whether a facility is
secure on a case-by-case basis.
    (Comments) Some comments request that FDA and CBP jointly issue a
guidance document explaining in greater detail how they intend to hold
and store articles of food, particularly perishable food, refused
admission into the United States. One comment requests that FDA clarify
the process for food that is held and later deemed to be admissible.
    (Response) FDA agrees and, as resources permit, will publish a
guidance document that will set out procedures for food refused for
failure to meet prior notice requirements.
    (Comments) Some comments state that there are an insufficient
number of general order warehouses to store the food articles that have
been refused for noncompliance with these regulations.
    (Response) FDA disagrees. Under CBP laws and regulations, general
order merchandise must generally be held in a general order warehouse
(19 CFR 127.1). However, in ports where there is no bonded warehouse
authorized to accept general order merchandise, CBP regulations also
empower the port director to direct the storage of the merchandise by
the carrier or by any other appropriate means (see 19 CFR 4.37(f),
122.50(f), or 123.10(f)). In addition, our experience has not shown
that there are an insufficient number of general order warehouses to
store food that has been refused under prior notice.
    (Comments) Some comments state that FDA must delay full enforcement
of the prior notice regulations until it has done all that is necessary
to equip the U.S. ports to handle refused perishable goods.
    (Response) FDA believes that the ports are equipped to handle
refused perishable goods. Since the IFR took effect, we have not been
aware of problems relating to perishable goods not being properly
maintained while being held at the ports.
    (Comments) Some comments ask whether public storage warehouses will
be stuck with unsaleable food items or whether they will be compelled
to re-export at their own expense if the owner abandons a shipment that
is refused entry because of inadequate prior notice. Comments indicate
that a warehouse loses its lien abilities if a refused shipment is not
allowed in interstate/intrastate trade and is re-exported. Thus,
according to the comments, if the owner of the food does not pay
storage and handling for the product, the warehouse has no collateral
to compel payment. Comments also state that even if it does remain at
the warehouse and the owner declines payment, the product has been
refused entry so it cannot be sold to allow the warehouse to recoup its
charges.
    (Response) Under the final rule, food refused under section 801(m)
of the act is considered to be general order merchandise and generally
must be held at a general order warehouse. If the refused food is not
immediately exported and if no prior notice is submitted or resubmitted
and no request for FDA review of the refusal is submitted, then the
food will 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 (Sec.
1.283(a)(6)).
    We made a minor change to the final rule by changing the last
phrase of Sec.  1.283(a)(6) from ``* * * except that the article may
only be sold for export or destroyed as agreed to by CBP and FDA'' to
``* * * except that, unless otherwise agreed to by CBP and FDA, the
article may only be sold for export or destroyed.'' This change was
needed because concurrence from FDA is not needed whenever a refused
article of food is sold for export or destroyed, and no prior notice is
submitted or resubmitted and no request for FDA review is submitted. We
are adding the phrase ``unless otherwise agreed to by CBP and FDA'' to
allow for the improbable (but not impossible) scenario when a refused
prior notice shipment would need to be transferred to another agency
for examination or investigation; in these cases, we would want
concurrence from both FDA and CBP.
    (Comments) Some comments request that FDA revise the requirement to
store refused merchandise at local port facilities. One comment
indicates that this provision of the IFR does not make sense and does
not provide any measure of security or safety to the food supply. The
comment points out that, before the IFR, shipments were allowed to be
held at the importer's premises and suggested that this practice should
be allowed to continue. According to the comment, ports and land
borders do not have sufficient storage capacity to handle the possibly
overwhelming demand for space that will be needed when the prior notice
regulations are implemented.
    (Response) FDA disagrees. Section 801(m)(2)(B) of the act
specifically requires that food refused under section 801(m) be held
and not delivered to the importer, owner, or consignee. The IFR and the
final rule require that refused food must be held within the port of
entry for the article unless directed to another location by CBP or
FDA. Therefore, an importer's premises, as suggested by the comment,
would not be appropriate since the Bioterrorism Act specifically
requires that the refused food not be delivered to the importer, owner,
or consignee. Nor would such a location be adequate because it also may
not be secure.
    (Comments) Some comments object because shipments of food for which
prior notice has not been provided will not be permitted to be moved to
the port of entry. According to the comments, the operator will be
required to off-load these shipments and detain them at the port of
arrival until the prior notice is provided.
    (Response) FDA disagrees. The IFR and the final rule require that
refused food must be held within the port of entry for the article
unless directed to another location by CBP or FDA. Thus, refused food
may be permitted to move to the port of entry; such food is not
required to be held at the port of arrival.
    (Comments) Some comments express concern about the time it takes
for FDA to release food offered for import into the United States, and
request that FDA examine its inspection procedures and reduce the time
to clear and release the food. The comments indicate that some
shipments of food have been held at the port of entry for periods
ranging from 2 weeks to 2 months, which has a serious economic impact
on importers of perishable foods. The comments point out that there are
already additional costs associated with the IFR, such as fees charged
by custom brokers to file the prior notice. The comments further state
that the delays are adding more costs that importers must bear,
including the cost to store the food during this period, additional
freight charges, and costs incurred due to spoilage of perishable
products.
    (Response) We know of no instance where a food has been held at any
port facility or secure location for an extended period of time as
described in the comment (2 weeks to 2 months) due to FDA's review of a
prior notice submission or due to FDA's refusal of food for failure to
provide adequate prior notice. Perhaps the comment actually is
referring to delays caused by FDA's admissibility review under section
801(a) of the act. Nevertheless, FDA will make every effort to minimize
the time necessary to perform prior notice assessments to minimize
delays in releasing shipments.
4. Segregation of Refused Foods (Sec.  1.283(a)(3))
    (Comments) Some comments state that in an ``LTL'' (less-than-
truckload) environment, where an average trailer contains about 40
shipments, there is a potentially serious impact on several parties
when prior notice is not filed in a timely fashion for one of the
articles of food. The comments point out that the motor carrier's
potential loss of productivity from having equipment tied up when an
article of food has been denied entry or is being held has a serious
negative impact on the profitability of cross-border trucking
operators. According to the comments, this kind of down time has a
serious negative impact on truck drivers' compensation, when they are
paid based on miles driven, and greatly reduces the number of allowable
hours a driver is allowed to operate under Federal Motor Carrier Safety
regulations. The comments also indicate that holding a trailer at a
port of entry affects not only the motor carrier's operations, but also
all of the shippers, importers, and consignees whose goods are on
board. Some comments request that FDA require importers to provide
motor carriers with proof that prior notice was transmitted to FDA. The
comments state that currently FDA and CBP only suggest that motor
carriers require proof of prior notice filing from customers, but this
type of arrangement is not required by law or regulation. According to
the comments, because FDA system's acknowledgement of receipt of a
prior notice does not mean that the information received is correct or
complete, carriers are still left vulnerable to carrying goods that
could be turned back at the border. The comments indicate that this
type of action by FDA would tie up a carrier's equipment, negatively
affect driver wages, and have a serious effect on carrier productivity.
    (Response) Financial burdens associated with refused food because
of inadequate or no prior notice generally can be avoided by ensuring
FDA receives adequate prior notice in accordance with this final rule.
For example, while the final rule requires only that the prior notice
confirmation number accompany any food for which the prior notice was
submitted through PNSI when the article arrives in the United States,
it does not preclude the carrier from requiring proof of confirmation
of prior notice submission prior to transporting the food to the United
States when prior notice is submitted through ABI/ACS. Moreover,
according to Sec.  1.283(a)(3) of the final rule, segregation may take
place to separate food that has not been placed under hold from food
refused for inadequate prior notice.
    (Comments) Some comments request clarification on who is
responsible for the physical segregation of the refused food from the
rest of the shipment: The carrier, FDA or CBP, customs broker, or
importer. Comments also ask whether FDA or CBP officials will always
supervise the segregation.
    (Response) The IFR at Sec.  1.283(a)(3) states that segregation may
take place to separate food that has not been placed under hold from
food refused for inadequate prior notice. The final rule clarifies this
paragraph by adding that other merchandise not subject to prior notice
requirements may be segregated from refused food.

    The segregation may be done by any person as long as the refused
food is held as required and not delivered to the importer, owner, or
consignee. Neither FDA nor CBP is responsible for segregation. However,
the IFR and final rule state that FDA or CBP may supervise the
segregation. If FDA or CBP determine that supervision is necessary,
segregation must not take place without supervision.
    (Comments) Some comments indicate that carriers should have the
option of unloading refused articles of food so they can deliver the
rest of their load without being detained any longer than necessary.
The comments point out that carriers do not have title or financial
interest in the goods they transport and they cannot provide
information to provide or correct an inadequate prior notice.
    (Response) Carriers already have the option to segregate food so
that they can deliver the rest of their load. As discussed previously,
the IFR and the final rule at Sec.  1.283(a)(3) state that segregation
may take place to separate food that has not been placed under hold
from food refused for inadequate prior notice.
5. Costs (Sec.  1.283(a)(4))
    (Comments) Some comments ask who is responsible for costs
associated with FDA verification of a shipment that is initially
refused and then it is later determined that the shipment's
documentation fulfills all requirements and complies with regulations;
i.e., the shipment was improperly refused.
    (Response) Section 1.283(a)(4) of the final rule provides that
neither FDA nor CBP will be responsible for transportation, storage, or
other expenses resulting from refusal.
6. Export After Refusal (Sec.  1.283(a)(5))
    (Comments) Some comments request clarification on procedures for
exporting fresh vegetables after refusal. The comments indicate that
some ports of arrival do not have cold storage facilities.
    (Response) The procedures for exporting fresh vegetables after a
refusal under section 801(m) of the act are no different than other
exports, with the following qualifications: Food refused under section
801(m) must be immediately exported from the port of arrival with CBP
concurrence and under CBP supervision.
7. Post-Refusal Prior Notice Submissions (Sec.  1.283(c))
    In Sec.  1.283(c)(2) of the final rule, FDA revised the text to
read ``the prior notice should be canceled'' instead of ``you should
cancel'' to indicate that the cancellation of the prior notice can be
done by CBP, upon request by the filer, if originally submitted in ABI/
ACS or by the transmitter if originally submitted in PNSI.
    (Comments) Some comments object because the current ABI system
cannot accept prior notice after the articles of food arrive in the
United States. Instead, filers must use the PNSI system. The comments
suggest there is no valid reason for this limitation and request
modifications to allow filers to use the ABI system for submitting
prior notice, even after cargo has arrived in the United States. Other
comments request removal of edits for date sensitive prior notice in
ABI and PNSI. Some comments point out that if prior notice is
transmitted after the articles of food arrive, the filer must enter an
incorrect anticipated date of arrival, which is on or after the actual
date of arrival. According to the comments, this skews FDA information,
prevents FDA from determining whether prior notice was filed timely,
and gets the filer in the habit of submitting false information. The
comments also ask that if prior notice is submitted in this manner, how
FDA can determine if the date was filed timely or not? The comments
also state that because ABI will not accept prior notice on articles of
food that have already arrived, this leads to the more time consuming
filing of prior notice in PNSI and also leads to a corruption of the
correct data.
    (Response) Prior notice submitted after the food has arrived in the
United States is a post-refusal submission. Under Sec.  1.280(a)(2) of
the IFR, post-refusal submission of prior notice must be completed via
PNSI. The final rule retains this provision, but re-worded the text to
state that post-refusal submissions must be submitted in PNSI until
such time as ACS or its successor system can accommodate such a
transaction. Post-refusal information requirements are found at Sec.
1.281(c). Among other data elements, a post-refusal submission requires
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.
1.281(c)(18)). The final rule now also requires the date the article of
food arrived at the port of arrival.
    Post-refusal submissions cannot be submitted via ABI/ACS because
CBP's system cannot be modified at this time to accept information
about the location where the article of refused food will be or is
being held and the actual date of arrival of the article of refused
food. Amending ABI/ACS would entail substantial and costly revisions to
the system; such technical changes are not cost-effective or a good use
of limited resources given the development of the Automated Commercial
Environment, which will replace ACS.
    PNSI programming changes should address the concern raised in the
comment about ``submitting false information.'' These same concerns
should not arise under the final rule since the final rule requires the
actual date of arrival for post-refusal submissions.
    FDA made a minor change in the text of Sec.  1.283(a)(6) by
replacing the phrase, ``in a timely fashion,'' with the phrase, ``in
accordance with paragraph (d) of this section,'' to clarify that the
timeliness of a request for FDA review is found at paragraph (d). We
made a similar change in Sec.  1.285(g).
8. FDA Review After Refusal (Sec.  1.283(d))
    (Comments) One comment requests that the final regulations make it
clear that the request for the review and/or the participation in the
review can be conducted by any of the parties named in Sec.  1.283(d)
of the IFR or by a designated representative, such as a customs broker,
freight forwarder, or attorney.
    (Response) Section 1.283(d)(2) of the final rule provides that the
carrier, submitter, importer, owner, or ultimate consignee may submit a
written request asking FDA to review whether the article of food is
subject to the requirements of this subpart under Sec.  1.277. FDA has
added carrier in the final rule since the carrier is often the entity
notified of the refusal. Although not explicitly stated in the rule, a
designated representative of any of the parties listed (carrier,
submitter, importer, owner, and ultimate consignee) may act on behalf
of that party.
    Furthermore, FDA revised Sec.  1.283(d)(1) to state that the
request for FDA review may include whether the information submitted in
a prior notice is complete, in addition to accurate. (In the IFR, we
also cited Sec.  1.276(b)(5), but we deleted it in the final rule
because it is redundant.) FDA revised Sec.  1.283(d)(5) to be
consistent with the changes made to Sec.  1.283(d)(1). In Sec.
1.283(d)(3), FDA revised the final rule to delete acceptance of
requests for review by mail and express courier. We are limiting
delivery to fax and e-mail to ensure that requests are expeditiously
received and directed to the appropriate staff.

9. International Mail (Sec.  1.283(e))
    (Comments) Some comments request clarification on the disposition
of mail for which prior notice is required, but is not provided.
Comments also ask about the U.S. Postal Service's responsibilities for
mail lacking prior notice.
    (Response) In the case of food arriving by international mail, if
prior notice is inadequate or if the prior notice confirmation number
is not affixed, the article will be held by CBP for 72 hours for FDA
inspection and disposition. If the article is refused and there is a
return address, the parcel may be returned to the sender. If there is
no return address or the food in the shipment appears to present a
hazard, FDA may dispose of or destroy the parcel at its expense. If FDA
does not respond within 72 hours of the CBP hold, CBP may return the
parcel back to the sender or, if there is no return address, destroy
the parcel, at FDA expense. Under the prior notice final rule, only FDA
and CBP have responsibilities for the destruction or return of refused
foods that arrive via international mail.
    FDA revised Sec.  1.283(e) and Sec.  1.285(k) in the final rule to
change the word ``stamped `No Prior Notice--FDA Refused''' to ``marked
`No Prior Notice--FDA Refused''' to more accurately describe the
marking that is placed on international mail packages arriving with
inadequate prior notice or without the prior notice confirmation number
affixed as required. In certain cases, the package cannot be stamped
and a label/sticker is placed on the package.
    We also note that the Prior Notice Final Rule Draft CPG proposes an
enforcement policy for foreign-to-foreign mail. Under the proposed
policy, if there is no prior notice FDA and CBP should typically
consider not taking any regulatory action in the case of international
mail where the recipient is not in the United States since the sender
does not have control over the transportation route that the foreign-
to-foreign mail will transit.
10. Prohibitions on Delivery and Transfer (Sec.  1.283(f))
    (Comments) Some comments ask whether CBP will put a manifest
``hold'' on food cargo until the prior notice confirmation is received.
The comments state that, at the present time, cargo can be moved inland
on an IT or T&E entry without FDA review. The comments ask if FDA will
remind the transmitters that products should remain intact until a
``may proceed'' message is received. The comments further ask if ocean
carriers will be advised of the FDA status of the articles of food when
the shipment involves ``doors moves'' beyond 50 miles from the port of
entry.
    (Response) Food arriving as an IT or T&E entry is subject to FDA
review of prior notice before it arrives in the United States. Food
that arrives with no prior notice is subject to refusal and must be
held within the port of entry for the article unless directed to
another location by CBP or FDA. Food that is refused under section
801(m) of the act is considered G.O. merchandise and cannot be entered
or delivered to the importer, owner, or consignee.
    For clarity, FDA revised Sec.  1.283(f)(2) of the final rule to
state that an article of food refused under section 801(m)(1) of the
act may not be transferred by any person from the port or other
designated secure facility.
11. Relationship to Other Admissibility Decisions (Sec.  1.283(g))
    (Comments) Some comments request that FDA integrate the section
801(m) and the section 801(a) clearance processes and develop
mechanisms to expedite the release of imported food for sale and use in
domestic commerce. One comment states that currently numerous shipments
that are offered for import are cleared for section 801(m), but are
held pending section 801(a) review. The comments indicate that little
is gained if shipments with adequate prior notice under section 801(m)
are permitted to move promptly across the borders of the United States,
only to encounter delays arising from the release process under section
801(a). The comments further note that in many cases, the shipments
held for section 801(a) review are eventually released without another
further examination or sampling. The comments suggest that a concurrent
section 801(a) and section 801(m) review would eliminate rework,
decrease unnecessary holds on shipments, and decrease the burden on
both the importing community and FDA.
    Another comment also suggests that FDA integrate the prior notice
information collection system with the existing OASIS (section 801(a)
of the act) information management system as fully as possible. The
comment states that these systems currently function separately,
essentially creating two sequential FDA reviews. The comment believes
that by merging these systems and resources, food security would be
enhanced and productivity for FDA and the industry will be improved. In
addition, the comment states that such a merger would be a natural
extension of the ongoing integration efforts with CBP.
    (Response) FDA does not agree that doing the OASIS review under
section 801(a) of the act concurrently with the prior notice review
under section 801(m) of act would reduce the burden on the industry or
FDA. Under section 801(m), prior notice for imported food shipments
must be provided to FDA before the arrival, and an article of food is
subject to refusal of admission if adequate prior notice has not been
provided. Section 801(m) also provides that refused food must be held
until adequate notice is given and may not be delivered to the
importer, owner, or consignee. Thus, the refusal standard under section
801(m) is based on whether the requisite information has been provided
in a timely fashion.
    The refusal standard in section 801(a) of the act is based on,
among other things, whether the article appears to be adulterated or
misbranded. Admissibility decisions under section 801(a) may be made
after entry has been made. Thus, if prior notice is adequate, requests
for further information, examination, or sampling of the food that is
necessary to determine admissibility under section 801(a) may occur.
The article of food need not be held at the port for FDA to accomplish
its section 801(a) review.
    Because the section 801(m) review must occur prior to arrival,
concurrent section 801(a) and section 801(m) reviews also would have to
occur prior to arrival. FDA also notes that section 801(a) reviews
typically take longer to complete than section 801(m) reviews. FDA
believes such a concurrent process would be inefficient and impractical
and would likely increase congestion at the ports of arrival. Thus, FDA
generally intends to continue with its current practice of reviewing
prior notice prior to arrival to decide whether to inspect the food at
the time of arrival, based on information that suggests that the food
is a potential significant risk to public health, and to allow
shipments to proceed beyond the point of arrival to conduct section
801(a) reviews.
    (Comments) One comment asks FDA to clarify expectations at the port
regarding ``may proceed'' decisions. The comment notes that the IFR
indicates that ``the system will transmit a message back through OASIS
to ABI/ACS interface for CBP that the article of food may be
conditionally released.'' The comments continue to state that the IFR
indicates that staff operating ``24 hours a day, seven days a week''
will review at the port of arrival or closest examination site. The
comment notes that this implies decisions were to be

made at the port of entry. However, companies have reported that since
December 12, 2003, conditional release messages have not consistently
been received at entry. The comment asks that FDA clarify when this
message should be received and the implications for companies that
enter the United States within the ``release.''
    (Response) The IFR states, ``If the FDA system does not indicate
that further evaluation of or action on the notice or article of food
is necessary for prior notice purposes, the system will transmit a
message back through the OASIS to ABI/ACS interface for CBP that the
article of food `may be conditionally released under section 801(b) of
the act.' However, if additional evaluation of the prior notice
information is necessary, FDA headquarters staff, operating 24 hours a
day, 7 days a week, will review and assess the information and may
initiate an examination or other action by FDA or CBP of the article of
food at the port of arrival or elsewhere, or in the case of rail
shipments, within the confines of the closest appropriate examination
site.'' (68 FR 58974 at 58976) The IFR clearly states that the
conditional release message is sent from FDA to CBP, not to any other
person. This is to ensure that CBP staff will know when the food
arrives if prior notice has been satisfied and that no further
examination by FDA is necessary. This conditional release does not
provide information about FDA's section 801(a) admissibility decision.
Further, the IFR clearly states that FDA headquarters staff operates 24
hours a day, 7 days a week and will review the prior notice and make
the decision regarding further action on the prior notice submission.
FDA and CBP do not intend to change these procedures for implementation
of the final rule.
    (Comments) One comment encourages FDA to consider low risk status
to expedite its section 801(a) deliberations.
    (Response) FDA does use a risk based approach when making prior
notice and admissibility decisions. FDA screening under section 801(a)
is separate from the subject of the final rule, FDA's screening under
section 801(m) of the act. Therefore, this comment is outside the scope
of the final rule.
    (Final rule) Section 1.283 of the final rule describes the
consequences for an article of food that is imported or offered for
import with inadequate prior notice. The final rule sets out procedures
for resolving the inadequacy as well as for the movement and status of
the refused food.

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

    Section 1.284 of the IFR provides that failure of a person who
imports or offers for import an article of food to submit prior notice
is a prohibited act under section 301(ee) of the act (21 U.S.C.
331(ee)) and sets out the civil, criminal, and debarment actions that
the United States may bring against persons who are responsible for the
commission of a prohibited act.
    (Comments) One comment states that many of the mistakes made during
the initial implementation of the prior notice IFR can be attributed to
difficulties with both government and industry computer systems. The
comment indicates that such mistakes should not be part of an
importer's record.
    (Response) FDA acknowledges that some mistakes in prior notice
submissions may have occurred because changes were needed in PNSI and
CBP's ABI/ACS or because industry needed to develop appropriate
software to facilitate the submission of prior notice. During the
initial implementation of the IFR that extended for more than 8 months
after the IFR took effect, FDA and CBP exercised enforcement discretion
to accommodate that situation. During this period, the two agencies
focused their resources on education to achieve compliance with the
prior notice requirements, escalating imposition of civil monetary
penalties, and ultimately refusal of shipments. This final rule will
take effect 180 days after today's publication date to allow affected
parties time to understand the requirements that differ from those in
the IFR, and make appropriate changes, including changes that may be
needed to filers' software. In enforcing prior notice, we will continue
to take into account the circumstances, such as whether a violation is
due to mistakes that can be attributed to difficulties in government
and industry computer systems during initial implementation.
    (Comments) Some comments request clarification on the penalties
that apply for food that arrives without proper prior notice. Some
specifically request clarification of civil monetary penalties and an
explanation of the mechanism and criteria for application of these
penalties. One comment notes that, in the absence of clearly defined
procedures for assessing penalties, the current policy of liquidated
damages would apply, which has always been unacceptable with the
community and sureties.
    (Response) CBP, in consultation with FDA, may assess civil monetary
penalties under 19 U.S.C. 1595a(b) against any person who directs,
assists, financially or otherwise, or is in any way concerned in the
importation of any merchandise contrary to law. During the early
implementation phase, FDA recommended to CBP that civil monetary
penalties (CMPs) be assessed only to those parties who failed to submit
prior notice. The parties were notified via e-mail regarding their
failure to submit prior notice before FDA recommended CMPs. As of May
2008, CBP has pursued CMPs on a total of 29 PNC related cases. Any CMPs
that CBP brings are subject to the administrative proceedings described
in 19 U.S.C. 1618 and 19 CFR part 171. Furthermore, liquidated damages
would not apply in the case of prior notice violations because no bond
obligations would vest under the basic importation bond.
    (Comments) Some comments note that there are few options available
in the current penalty structure to assist FDA in enforcing compliance
other then civil and criminal charges. Comments suggest that some form
of monetary consequences, in lieu of civil and criminal charges, should
be available to allow FDA more flexibility in application.
    (Response) Section 1.284 of the final rule provides consequences of
failing to comply with the requirements for submitting prior notice.
These are the primary enforcement options, aside from refusal of the
food, available to FDA under the Federal Food, Drug, and Cosmetic Act.
In addition, CBP can seize goods imported contrary to law, assess civil
monetary penalties or take other enforcement action, including referral
to U.S. Immigration and Customs Enforcement (ICE), as provided for
under its laws in lieu of or in addition to refusal of the food or
other civil and criminal penalties.
    (Comments) Some comments suggest that failure to provide prior
notice in a timely fashion should result in refused entry and the
movement of the food to a secure facility where the prior notice can be
secured. The comments state that failure to enter U.S. commerce should
be considered a sufficient deterrent and that monetary penalties would
be counterproductive. The comments suggest that this arrangement would
avoid instances where businesses find themselves unable to trade or
constantly in situations of being in violation, and consequently
subject to criminal action.
    (Response) FDA does not agree that refusal and movement of the food
to a secure facility will provide a sufficient

deterrent in all cases. CBP may assess civil monetary penalties under
19 U.S.C. 1595a(b) and will, in consultation with FDA, continue to
assess those penalties when warranted. FDA may further use the civil,
criminal, and debarment provisions provided by the Bioterrorism Act.
These statutory penalties are used only when warranted, and to date
have been used relatively infrequently.
    (Comments) One comment notes that importers receive conflicting
information as to the enforcement guidelines at individual crossing
points and/or from individual FDA and CBP enforcement officers. The
comment recommends extension of the full enforcement date, which would
allow FDA and CBP to upgrade their current training efforts with the
officers at all ports of entry to ensure uniform and consistent
enforcement of the IFR.
    (Response) FDA and CBP will continue to coordinate staff training
and industry outreach activities to ensure consistent enforcement of
the final rule. FDA believes that the effective date of 180 days after
publication of the final rule provides sufficient time to communicate
and implement changes to the final rule. As we establish enforcement
policies, these will be made publicly available through our compliance
policy guides. These policies and other information about the final
rule may be found through links on FDA's Web site at http://
www.fda.gov. FDA notes that the communication issues experienced when
the prior notice IFR initially took effect have been addressed and we
generally have found the prior notice process to be proceeding
smoothly.
    (Comments) Some comments state that serious inconsistencies in
interpretation or application of the prior notice requirements at
multiple ports have caused confusion, delayed shipments, and increased
shipment costs. Examples provided by the comments include: the shifting
percentage of shipments that are physically held at the port due to
incomplete or inaccurate prior notice submissions during the initial
phases of enforcement, varying information regarding whether the
carrier must be in possession of the actual prior notice confirmation
number at the time of arrival regardless of whether the submission was
made via an ABI transmission, conflicting information as to whether
submissions of bonded freight will be allowed through the ABI system,
and failure to notify importers of specific errors pertaining to their
submissions. Some comments request that FDA establish a national office
with authority to resolve various field and port interpretations and
actions. Comments note the importance of a timely resolution to
disputes because of the potential financial impact to commerce if food
shipments are detained needlessly.
    (Response) The initial source for resolving all perceived conflicts
is the final rule, and related information, including the responses to
comments in this preamble, the Prior Notice Final Rule CPG, and the
Prior Notice of Imported Food Questions and Answers, which may be found
through links on FDA's Web site at http://www.fda.gov. FDA's PNC, which
directs all prior notice activities, has been operating since the prior
notice IFR took effect on December 12, 2003. The PNC is available 24
hours a day, 7 days a week, and 365 days a year to answer questions and
resolve, as appropriate, operational concerns. The PNC can be reached
at<PHONE_NUMBER> for calls originating in the United States and 703-621-
7728 for calls originating from outside the United States. In addition,
FDA notes that based on the current PNC call/inquiry volume levels as
compared to those experienced during the initial 18 months of
implementation, repetitive prior notice submitters have now been
experiencing fewer difficulties in submitting prior notice.
    (Comments) One comment requests that FDA outline what actions will
be taken against a company that is not complying with prior notice
requirements, but has committed the error only by acting on incorrect
advice from an FDA representative. The comment wants to know what
recourse is available to industry when a company faces large fines due
to inaccurate FDA guidance.
    (Response) The PNC is responsible for resolution of these actions,
on a case-by-case basis. The advice that a submitter may have received
from an agency representative is considered when determining whether an
enforcement action is warranted. FDA notes that under the proposed
enforcement policy in the Prior Notice Final Rule Draft CPG, we intend
to take into consideration the circumstances surrounding a violation,
including the seriousness of the violation and flagrant and repeat
violations.
    (Comments) One foreign government agency requests access to the
quantity and identity of the industries that are not complying with the
prior notice IFR so that they could help bring these industries into
compliance. The comment suggests creating a mechanism to notify foreign
governments of any noncompliance related to the Bioterrorism Act to
enable them to provide a faster and more efficient response.
    (Response) FDA has established mechanisms for working cooperatively
with foreign government regulatory authorities on issues of mutual
concern, including matters relating to compliance with the prior notice
regulations. When requested and as resources allow, FDA/PNC personnel
have continued to participate in briefings for foreign governments and
organizations and at industry trade meetings. These have included
presentations to European Community visitors to the United States,
joint FDA-Canadian Food Inspection Agency import meetings, and other
foreign government and industry outreach events widely attended by both
industry and other government agencies, e.g., WESCCON (Western Cargo
Conference). FDA continues to work with foreign governments to develop
more efficient and effective communications. In addition, information
about compliance with prior notice requirements is posted at http://
www.cfsan.fda.gov/~pn/pnsum.html.
    (Comments) Some comments request that FDA provide a sufficient
period of time for implementation of the final rule so that affected
parties can prepare for any changes in the rule.
    (Response) FDA agrees and is providing 180 days after publication
of the final rule, which should be sufficient time for implementing
changes necessary to comply with the final rule.
    (Comments) One comment states that FDA and CBP categorize some
articles of food differently; i.e., some articles that are ``drugs''
for FDA purposes are classified by CBP as ``foods.'' The comment
indicates that such products should not be denied entry or assessed
monetary penalties and suggests that the final rule provide for
immediate release and cancellation of monetary penalties for such
articles that are not ``food,'' as defined by the FDA.
    (Response) FDA does not agree that a change in the final rule would
alleviate the concern expressed by the comment. The scope of the final
rule is stated explicitly in Sec.  1.277. Situations involving
discrepancies between FDA and CBP classification of an imported article
as a food or drug are best resolved on a case-by-case basis as they
arise. However, because FDA and CBP have worked closely to identify and
resolve such issues, the agencies believe that such situations will be
rare. In cases of doubt, the submitter should contact the PNC to
determine whether a product is an article of food subject to prior
notice requirements.

    FDA uses a list of HTS codes to indicate which products FDA
believes prior notice is or may be required under the prior notice
regulations. FDA has provided this list to CBP so that CBP can ``flag''
the HTS codes in its entry systems to screen for foods for which prior
notice to FDA is required and to ensure that, as appropriate, prior
notice has been provided. FDA publishes this list to inform the food
industry which HTS codes have been ``flagged'' in CBP entry systems
with prior notice indicators. Guidance about the HTS flags is posted at
http://www.cfsan.fda.gov/~dms/htsguid3.html.
    (Comments) One comment suggests that FDA consider the importer's
circumstances when denying entry or assessing penalties. The comment
states that, although it is reasonable to expect a company whose
principal business is importing food to abide by regulations applicable
to food imports, companies that rarely import food products will likely
have greater difficulty in complying with the requirements. The comment
further states that although these companies should be required to
comply before their entries are released, blanket denials of entry or
assessments of monetary penalties are not appropriate.
    (Response) Elsewhere in this issue of the Federal Register, we are
announcing our Prior Notice Final Rule Draft CPG which describes our
policies for enforcing prior notice. Under the CPG, we are proposing to
take into consideration the circumstances surrounding a violation,
including the seriousness of the violation and flagrant and repeat
violations.
    (Final rule) Section 1.284 of the final rule states that 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 and sets out the civil, criminal, and
debarment actions that the United States may bring against persons who
are responsible for the commission of a prohibited act.

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

    Section 1.285 of the IFR outlines the consequences for food
arriving at the port of arrival from facilities that are not registered
as required under section 415 of the act and 21 CFR part 1, subpart H.
These are similar to provisions in the IFR for handling food that is
refused for inadequate prior notice. The IFR states that if an article
of food from a foreign manufacturer that is not registered as required
under section 415 of the act and subpart H is imported or offered for
import into the United States, the food is subject to being held at the
port under section 801(l) of the act and refusal under section 801(m)
of the act and Sec.  1.283 for failure to provide adequate prior
notice. Under the IFR, the failure to provide the correct registration
number of the foreign manufacturer, if registration is required under
section 415 of the act and 21 CFR part 1, subpart H, renders the
identity of that facility incomplete for purposes of prior notice.
    (Comments) Several comments state that FDA should increase
inspections of imported food when they arrive at the port, rather than
denying admission based on lack of the manufacturer's registration
number.
    (Response) If the prior notice does not include a registration
number, it can instead include the full address of the manufacturer and
the reason why the registration number is not provided. In this
situation, the article of food will not be refused admission solely
because of the lack of the manufacturer's registration number. We agree
with the comments it is appropriate to consider the fact that the
registration number is not provided in determining whether FDA should
inspect the food, either upon arrival or as part of the admissions
process.
    While an article of food will not be refused admission solely
because of the lack of the manufacturer's registration number, the food
is nonetheless subject to being held under section 801(l) of the act if
the manufacturer has not registered under section 415 of the act. It
may take FDA more time to determine the registration status of the
manufacturer if the name and full address, but not the registration
number, is provided as part of prior notice. Thus, if the registration
number is not provided, this may delay the food at the border until
this verification is completed.
    (Comments) Some comments state that, although the prior notice
regulations clearly indicate that the manufacturer's registration
number is required on the prior notice, even for U.S. Goods Returned,
they do not expressly indicate that refusal will result when the
registration number is not provided. Rather, according to the comments,
Sec.  1.285(a) of the regulations only indicates that articles of food
arriving from an unregistered foreign facility will be subject to
refusal, as will articles of food arriving with an inaccurate
registration number in the prior notice. In more general terms, under
Sec.  1.283(a)(1)(ii), articles of food arriving with an ``inaccurate''
prior notice are subject to the same possibility of refusal upon
arrival. The comments state that the language of the regulations does
not guarantee refusal, but provides for flexibility and discretionary
enforcement. Comments suggest that FDA should not refuse entries for
which the importer does not know and cannot determine the registration
number.
    (Response) As discussed in the previous response, if the prior
notice does not include a registration number, it can instead include
the full address of the manufacturer and the reason why the
registration number is not provided. In this situation, the article of
food will not be refused admission solely because of the lack of the
manufacturer's registration number, although the food is nonetheless
subject to being held under section 801(l) of the act if the
manufacturer has not registered under section 415 of the act.
    Because this is a change from the IFR, in the final rule we have
deleted the text in ' 1.285(a) that states that failure to provide the
manufacturer's registration number renders the identity of the facility
incomplete for purposes of prior notice. We have also clarified the
text in ' 1.285(b) by removing the phrase ``imported or offered for
import from a foreign facility that is not registered as required under
section 415 of the act'' because it is redundant.
    As part of our effort to develop policies for enforcing prior
notice and section 801(l) of the act, we are publishing the Prior
Notice Final Rule Draft CPG, announced elsewhere in this issue of the
Federal Register.
    (Final rule) Section 1.285 of the final rule describes the
consequences and processes for food imported or offered for import in
the United States that is from a facility that is not registered under
section 415 of the act and 21 CFR part 1, subpart H. The food is
subject to being held and cannot be delivered to any importer, owner,
or consignee.
    FDA also made other minor changes in this section.
     We revised the requirement in Sec.  1.285(c)(2) to notify
FDA of the location where the food has been or will be moved from
within 24 hours of refusal to before the food is moved to the hold
location. FDA needs this information before the food is moved to verify
that the facility where the food is to be held is a secure facility.
Moreover, because refused food shall not be delivered to the importer,
owner, or ultimate consignee, before the food is moved, FDA needs to
verify that the

hold location is not owned by any of these parties. In addition, Sec.
1.285(c)(2) of the IFR states that food under hold must be moved under
appropriate custodial bond. We have revised this paragraph in the final
rule to state that the refused food must be moved under appropriate
custodial bond, unless immediately exported under CBP supervision. The
final rule also clarifies that the refused food may be held at the port
of entry or at a secure facility.
     We revised Sec.  1.285(g) for clarity by adding the word,
``number,'' after the word, ``registration.'' We also changed the last
phrase of Sec.  1.285(g) from ``* * * except that the article may only
be sold for export or destroyed as agreed to by CBP and FDA'' to ``* *
* except that, unless otherwise agreed to by CBP and FDA, the article
may only be sold for export or destroyed.'' Similar to Sec.
1.283(a)(6), this change was needed because concurrence from CBP and
FDA is not needed whenever an article of food placed under hold under
section 801(l) of the act is sold for export or destroyed, and no
registration number or request for FDA review is submitted. We are
adding the phrase ``unless otherwise agreed to by CBP and FDA'' to
allow for the improbable (but not impossible) scenario when such a
shipment would need to be transferred to another agency for examination
or investigation; in these cases, we would want concurrence from both
FDA and CBP.
     In Sec.  1.285(h), we added the phrase, ``is not for
personal use,'' after the phrase, ``food carried by or otherwise
accompanying an individual arriving in the United States,'' because if
it is for personal use, then it is not subject to prior notice as
provided by Sec.  1.277(b)(1).
     We deleted references and provisions in Sec.  1.285(i) and
(l) relating to refusals, because the process for resolving a prior
notice submission for an article of food from a facility that is not
registered as required is based on holds under section 801(l) of the
act and not refusals under section 801(m) (see discussion above for
Sec.  1.285(a)). Under Sec.  1.285(i)(2), we are allowing submission of
the notification resolving the hold by fax and e-mail only, and
deleting the option to submit the notification by mail and express
courier. We also made other minor revisions to this Sec.  1.285 to
simplify the text.
     We revised Sec.  1.285(j)(2) of the final rule to allow
the carrier to submit a request for review after hold. Under Sec.
1.285(j)(3), we revised the final rule to allow submission of the
request for review after hold by fax and e-mail only, and deleted the
option to submit the notification by mail and express courier.

M. Outreach and Enforcement

    As discussed in the IFR, FDA directed outreach to both domestic and
international stakeholders after publication of the IFR (68 FR 58974).
Our outreach activities included many methods of communication:
     Dissemination of materials to guide affected domestic and
international food facilities through the new processes established to
implement prior notice requirements;
     Numerous domestic and international outreach meetings to
the food industry, trade organizations, and State and foreign
government regulators;
     A series of videoconferences and a satellite downlink
video broadcast to more than 1,000 sites around the world;
     Materials provided for and events targeted to the media;
     Presentations by FDA officials and exhibits at
professional and trade conferences and meetings to inform industry and
State and local government representatives of the new requirements;
     Presentations by USDA's Foreign Agricultural Service (FAS)
and U.S. embassy officials who disseminated materials and answered
questions in various countries;
     Cooperative arrangements with CBP and other Federal
agencies to ensure that information on the interim final regulations
and their requirements is disseminated to affected companies and
individuals; and
     Issuance of several guidance documents (all available on
the Internet) that explain the prior notice requirements, including,
``Prior Notice of Imported Food: Questions and Answers,'' ``What You
Need to Know About Prior Notice of Imported Food Shipments,'' and
numerous Web-based tutorials for PNSI. Many of these guidance documents
are available in foreign languages; e.g., Arabic, French, Hindi,
Japanese, Malay, Portuguese, and Spanish.
    Specifics regarding each of these activities are included on FDA's
Web site. In addition, FDA also provided training in new or revised
procedures for its field personnel, as well as CBP field personnel. FDA
included an initial transition period in the December 2003 prior notice
CPG for more than 8 months, during which the agencies emphasized
education to achieve compliance, rather than refusal of articles of
food with inadequate prior notice.
    Shortly after publication of the IFR, FDA began disseminating at
U.S. ports flyers and posters summarizing the new requirements and
informing representatives of affected entities how to provide prior
notice to FDA. We also provided (and continue to provide) online
assistance and the FDA Help Desk to deal with technical issues
involving PNSI after the IFR became effective.
    When FDA reopened the comment period on the IFR in the Federal
Register of April 14, 2004, under discussion of Flexible Alternatives
in question 7, we asked: ``Should FDA offer a prior notice submission
training program for submitters and transmitters, including brokers, to
ensure the accuracy of the data being submitted?'' Many comments
address various issues concerning outreach and enforcement. Discussion
of these issues by subject follows, proceeded by a discussion of
general issues.
1. General Outreach and Enforcement Issues
    (Comments) Several comments acknowledge that the outreach
activities conducted by FDA and CBP were of tremendous assistance to
affected persons with the implementation of the PNSI and encourage
continued communication between the trade community and FDA and CBP.
Several other comments state that FDA and CBP's outreach efforts were
ineffective and encourage continued efforts toward education and
outreach.
    (Response) FDA received praise from the Small Business
Administration for our efforts to address regulatory flexibility and
the impact on small business of the interim final rule. FDA and CBP
will continue outreach efforts to affected industry and other
governments, as resources allow. These efforts will focus on changes to
and implementation of the final rule. The PNC also will continue to
answer questions and provide technical assistance upon request, and FDA
and CBP will issue and update guidance as policies change or need
clarification.
2. Prior Notice Submission Training Program From Flexible Alternative
Question 7
    (Comments) Many comments believe that a training program will
improve the accuracy of the data being submitted under the regulations
and that a training program would resolve many of the other problems
being encountered with the present rules. One comment suggests that,
following a detailed analysis of compliance issues, FDA should target
its training to specific problems and their solutions, and to entities
new to the process. One comment suggests that FDA offer a training
program for brokers and other transmitters and submitters. Other

comments recommend that specific outreach and training should be
conducted for each mode of transportation. Another comment cautions
that the FDA and CBP should have resources to implement an educational
campaign before initiating another training and outreach program.
    (Response) FDA and CBP will conduct training focused on changes
between the final rule and the IFR. Depending on resources, the
education and outreach may take the form of public meetings, Web-based
interactive training, or posting on our Web sites of guidance and other
outreach materials. As resources permit, we also may translate our
guidance and other outreach materials into other languages.
3. Requests for Additional Outreach
    (Comments) There were many comments that request additional
outreach and training, as well as some comments that suggest specific
outreach programs, such as:
     Providing an expanded program that would educate and train
all stakeholders, including substantially more and varied educational
programs before the full enforcement of the IFR, and escalating
training efforts in the area of shipper and carrier education and
compliance;
     Establishing an effective mechanism for disseminating
answers to specific questions to affected persons;
     Providing enforcement guidance that addresses specific
enforcement issues, such as enforcement of the food facility
registration requirements at the time of prior notice submission and
describing enforcement procedures in detail;
     Providing guidelines on the procedures to submit prior
notice either via FDA's PNSI or CBP's ABI, such as instructions on
cancellation or change of a prior notice and descriptions on what is
meant by identifying goods by the common, usual or market name;
     Explaining procedures of the rule in foreign languages and
establishing point of contacts in foreign countries;
     Publicizing the rule to individual Americans who will
travel abroad, and making compliance with it a simple, practicable, and
straight forward process;
     Providing a Web-based tutorial;
     Using CBP's ABI Administrative Messages to announce
changes in PNSI;
     Establishing an FDA and CBP agency-industry working group
and/or a more formal advisory committee with representatives of various
industry groups;
     Improving staffing on the ``hotline'' and/or creation of
an exclusive Help Line staffed with individuals with the requisite
technical expertise and the ability to resolve operational problems as
they arise;
     Creating dedicated e-mail addresses within FDA to which
specific questions can be addressed and/or specific e-mail addresses
for different technical and operations areas;
     Providing prompt information to submitters regarding
inadequacies or inaccuracies in prior notice, including shipment level
feedback to the filer; and
     Holding public meetings before the final rule takes effect
to ensure that all affected parties understand the rule and can be
heard.
    (Response) We will provide outreach and training on the final rule
as resources permit. At a minimum, we will provide guidance and
instructions on the process for filing prior notice on our Web site.
This guidance, along with detailed instructions on the use of PNSI,
including step-by-step help, is available at http://www.cfsan.fda.gov/
~furls/helpf.html.
    We agree with the recommendation to establish an effective
mechanism for disseminating answers to specific questions to industry,
and have issued guidance documents for each of the rules we have issued
to implement the authorities in the Bioterrorism Act that provide our
response to the frequently asked questions (FAQs), including the prior
notice IFR. We anticipate doing the same for this final rule. These
guidance documents are designed to help affected parties comply with
the legal requirements established by the various rules. We intend to
issue additional guidance as new questions arise and as resources
permit.
    In terms of providing enforcement guidance, in December 2003, FDA
and CBP issued a CPG that stated that, until August 12, 2004, the two
agencies generally would utilize communication and education strategies
with escalating imposition of civil monetary penalties rather than
refusal of shipments. The two agencies revised the CPG in June 2004,
August 2004 (August 16, 2004, 69 FR 50389), November 2004, March 2005,
and November 2005 (November 14, 2005, 70 FR 69160), as our enforcement
policies changed and evolved. Published elsewhere in this issue of the
Federal Register is a notice of availability for the Prior Notice Final
Rule Draft CPG, which describes FDA's and CBP's proposed policies for
enforcing this final rule. A copy of the CPG may be found at http://
www.fda.gov/ora under ``Compliance References.''
    Generally, FDA enforcement procedures regarding imports are
provided in FDA's Regulatory Procedures Manual, Chapter 9. This
guidance is posted at http://www.fda.gov/ora/compliance_ref/rpm_new2/
ch9/default.htm.
    FDA agrees, in part, with the recommendation about providing user
guidelines and has provided guidance and instructions on the process
for filing prior notice. This guidance, along with detailed
instructions on the use of the PNSI, including step-by-step help, is
available at http://www.cfsan.fda.gov/~furls/helpf.html. Instructions
for contacting FDA with questions about prior notice are also available
at that Web site.
    FDA cannot provide specific instructions on the use of ABI software
to file prior notice, as that software is developed and made available
through private vendors. Users should contact their vendor for specific
instructions on the use of their ABI software. CBP does regularly issue
to filers ABI Administrative Messages which provide instruction and
guidance regarding submission of prior notice through ABI/ACS.
    As part of our outreach efforts for the prior notice IFR, we issued
a number of documents explaining the requirements of the IFR and/or
PNSI and provided them on our Web site in English and one or more other
languages, including:
     FDA Industry Systems, Index of Help Pages at http://
www.cfsan.fda.gov/~furls/helpol.html) (also available in Spanish);
     HELP: Getting Started: Create New Account Quick Start
Guide) (also available in Spanish);
     OUTREACH: Overview of Prior Notice Interim Final Rule
(Slide Presentation) (also available in Arabic, French, Malay and
Spanish);
     Booklet: What You Need to Know About Prior Notice of
Imported Food Shipments (also available in French and Spanish); and
     Fact Sheet on the Interim Final Rule--Prior Notice of
Imported Food Shipments (also available in French, Malay, Polish,
Portuguese, Spanish, Arabic, Chinese, Hindi, and Japanese).
    We also have an ``FDA Food and Cosmetic International/Foreign
Language Documents and Videos,'' which is a list of all food (and
cosmetic) documents that have been translated and the languages in
which they are available on our Web site at http://www.cfsan.fda.gov/
~mow/internat.html. Many of the documents describing prior notice
requirements and guidance have been translated into foreign languages.
    FDA does not currently maintain staff in foreign countries.
However, FDA has

developed the Beyond our Borders initiative, which includes plans to
build an on-the-ground presence for FDA in Asia, Europe, Latin America,
and the Middle East. In March of 2008, we received approval from the
U.S. Department of State to establish eight full time permanent FDA
positions at U.S. diplomatic posts in the People's Republic of China,
pending authorization from the Chinese government. Furthermore, CBP,
U.S. Department of State, and USDA Food Agricultural Service staff are
located at U.S. Embassies in many foreign countries. These U.S.
government entities frequently provided assistance to foreign
stakeholders, including foreign government officials and private
companies, in understanding the requirements of various U.S.
regulations, including those provided in our Bioterrorism Act
regulations. We will routinely update these U.S. officials abroad about
changes to and implementation of this prior notice final rule.
    As resources permit, we also will continue to translate guidance
documents and system instructions into other languages.
    FDA agrees with the comment requesting publicizing the rule to
individual Americans who will travel abroad, and making compliance with
it a simple, practicable, and straight forward process. CBP Publication
 0000-0512, revised January 13, 2005, Know Before You Go--
Regulations for U.S. Residents, is posted at http://www.cbp.gov/xp/
cgov/travel/vacation/kbyg/. This publication is the primary CBP
guidance document concerning import regulations targeted to travelers
and contains information about the prior notice final rule's
requirements for importation of food. In addition to providing
information about prior notice requirements, the publication also
provides a link to FDA's Web site at http://www.fda.gov/oc/
bioterrorism/bioact.html.
    FDA also agrees with the comment that requests us to provide a Web-
based tutorial. Since October 2003, FDA has provided a PNSI tutorial in
the form of step-by-step help on its Web site (http://
www.cfsan.fda.gov/~furls/helpf.html). FDA welcomes any additional
comments or suggestions on how to improve the help information; these
can be submitted to the PNC using the phone number or e-mail provided
on that Web page.
    FDA and CBP agree that operational issues impacting ABI filers
should be announced using Administrative Messages, and intend to
continue to use that system, as we have routinely done since December
2003. When appropriate, information about the PNSI system will also be
announced both on the FDA Web site and through CBP's Administrative
Messages.
    CBP also has established avenues of communication with trade
working groups and ensures FDA's participation when the subject for
discussion is prior notice. FDA does not plan to establish a formal
advisory committee to address prior notice.
    FDA agrees with the comment to improve help desk staffing, as
resources permit. Our Web site contains a tutorial on how to submit a
registration for a facility subject to the requirements at 21 CFR part
1, subpart H. In addition, the PNC staff can answer questions about how
to submit prior notice. Questions regarding clarification of the rule
that are not addressed in this preamble or existing publications should
be submitted to FDA at<EMAIL_ADDRESS>We will generally not
provide an individual response to these questions, but will answer them
in Question and Answer Guidance Documents so the information will be
broadly available.
    FDA has included features in PNSI to inform submitters of many
types of inadequacies in the information provided, such as missing
required fields. FDA also has coordinated with CBP to provide prompt
messaging back to users when Prior Notice is filed through ACS. FDA
notes that certain inaccuracies cannot be identified electronically,
but could be detected in an intensive prior notice review (e.g., the
packaging of an actual shipment (12 oz cans of tuna fish) does not
match the prior notice data submitted for that shipment (e.g., 6 oz
cans of tuna fish)).
    With respect to holding public meetings to provide an opportunity
for parties to voice their opinions on the IFR, FDA and CBP published
the IFR on October 10, 2003, and opened the comment period through
December 24, 2003. We reopened the comment period from April 14, 2004,
through July 13, 2004. We reviewed 320 timely comments that raised
multiple issues, and have considered those comments as we developed
this final rule. We also held numerous outreach meetings both
domestically and abroad--in person and by video conferencing--to
explain the requirements of the IFR to affected parties and answer
questions of clarification to ensure all were able to provide
meaningful comment to FDA and CBP. The comment period was the time for
all parties to be heard on the provisions of the IFR. While the
agencies welcome discussion and wanted to ensure that all stakeholders
understand their obligations under the statute and the IFR, the comment
period ended July 13, 2004, and the agencies did not consider comments
submitted outside of the open comment periods.
    (Comments) Several comments recommend that FDA provide feedback to
the industry detailing areas of noncompliance and compliance. One
foreign government stated its willingness to work with FDA to increase
the level of industry compliance within their country through outreach
and education activities. It requests that FDA provide it on a timely
basis detailed information concerning noncompliance by their industry.
Another comment suggests that FDA could post on its Web site a
description of the types of errors most commonly observed in filed
prior notices.
    (Response) We agree, and have been posting on our Web site summary
information about submission of prior notice, including data on the
types of errors. See http://www.cfsan.fda.gov/~pn/pnsum.html. We stated
that this information will also be analyzed to help FDA take
appropriate enforcement action when necessary. FDA presented the
Summary Information in two categories: (1) General interest--
Information about the number and types of prior notices that are being
submitted, and which systems are being used to submit them; and (2)
Specific requirements--Information about submission of the required
information. We provided an initial posting of the summary information
and two subsequent updates. The August 2004 update included some
summary information from December 2003 through April 2004 and some
snapshots of activity in July 2004, along with information on specific
information requirements such as registration number and carrier
information.
    We also posted information summarizing the number of facilities
registered pursuant to 21 CFR part 1, subpart H at: http://
www.cfsan.fda.gov/~furls/ffregsum.html. This summary includes a
breakdown of the number of registered facilities by country and U.S.
State.
4. Enforcement Timeframe
    (Comments) Many comments state that because FDA and CBP have not
informed prior notice submitters of specific deficiencies in their
submissions, FDA must extend the enforcement date of the rule to allow
more time to communicate errors and allow adequate time to fix them.
One comment suggests that the agencies should develop and implement a
notice-

specific informational system that provides detailed feedback to
submitters when a prior notice is deemed to be noncompliant. Another
comment states that exporters should be advised of noncompliant
shipments in order to take corrective action prior to the shift to full
enforcement. One comment believes that part of the phase-in period
should include a feedback program to let brokers know which importers
and corresponding transactions are handled with inadequate or no prior
notice. The comment states that this program should be developed in
conjunction with the industry to define measurements (history profile
and/or transactional), and determine what the notification process
should be. One comment encourages FDA to expeditiously publish a notice
that it intends to continue outreach and delay enforcement of the
regulation so that the business community may have a greater
opportunity for education, training, and continued dialogue with the
agencies. Other comments recommend a delay in the final phase of
enforcement until all systems are fully operational.