comment also has similar concerns regarding the PAPS-program at the
Southern border.
    (Response) While FDA welcomes the additional information provided
by C-TPAT and FAST, these programs would require relatively significant
changes to be useful in helping us carry out the prior notice program.
The purpose of prior notice is to help identify food that potentially
poses a significant health risk to the American public and to deploy
resources to the port of arrival so that inspections can be conducted
before the shipment enters the United States. Information about the
manufacturing facility is used in conducting this risk assessment. The
C-TPAT assessment, however, does not always include the food
manufacturing/processing operations. Even when it does, C-TPAT focuses
on security risks

whereas the prior notice program considers all health and safety risks
to the food, such as unintentional contamination. Moreover, unlike PNC
reviewers, the CBP Supply Chain Specialists who conduct the validation
assessments for C-TPAT are not necessarily trained in assessing the
potential risks associated to food products and neither FDA nor CBP has
the resources to fund the extensive training that would be required to
do so. Because knowing that a firm participates in C-TPAT does not
assist FDA in conducting its food safety review, we have decided not to
provide special treatment in terms of reduced prior notice information
requirements or reduced timeframes based on C-TPAT participation.
    It is important to note that participation in C-TPAT does not
affect the information requirements of CBP's advance electronic
information rules; the same information is required regardless of C-
TPAT participation. However, successful participation in C-TPAT does
affect the frequency of CBP cargo and trade examination. FDA likewise
uses a risk-based approach in selecting foods for examination at the
border for security and food safety reasons. FDA, thus, is continuing
to explore with CBP and industry use of these programs in making
decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions).
    Comments addressing which foreign operators are eligible for
participation in FAST and C-TPAT are outside the scope of this rule.
CBP stated in a document entitled ``Frequently Asked Questions
Regarding Minimum Security Criteria for Importers,'' dated March 25,
2005, (CBP's March 25, 2005, Frequently Asked Questions (FAQ) document)
(available at http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/
security_criteria/criteria_importers/questions.xml (FDA has verified
the Web site address, but FDA is not responsible for any subsequent
changes to the Web site after this document publishes in the Federal
Register)), that ``C-TPAT remains a voluntary, incentive based
partnership. However, once a company commits to the C-TPAT program,
there are specific program requirements that must be adhered to by the
company to qualify for C-TPAT benefits, which are significant. C-TPAT
importers are six times less likely to undergo a security related cargo
examination, and four times less likely to be subject to a trade
related examination, than non-C-TPAT members. These significantly fewer
cargo examinations help save importers time and money, while leading to
a more predictable supply chain. CBP continues to explore additional
benefits, which can be afforded members who meet or exceed the minimum-
security criteria.''
    The document also states that ``CBP employs a risk management
approach in screening and targeting, and such shipments, as well as
those from unknown or less established entities, receive higher
scrutiny from CBP. The agency does not disclose ATS targeting rules.''
    (Comments) Several comments suggest that FDA should not establish a
duplicative program, but should incorporate additional factors or
criteria necessary for prior notice into existing programs.
    (Response) FDA agrees that it is generally preferable not to
establish duplicative programs. Thus, while we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes, we will continue
exploring use of these programs in making decisions regarding which
products to inspect for the purposes of admissibility (801(a)
decisions).
    b. Special programs.
    i. Should food products subject to FDA's prior notice requirements
be eligible for the full expedited processing and information
transmission benefits allowed with C-TPAT and FAST? If so, how should
this be accomplished? (Comments) Numerous comments assert that
businesses that participate in the C-TPAT and FAST programs should be
eligible for processing/transmission benefits. These comments contend
that importers, carriers and drivers who have been approved for C-TPAT
and FAST already have been deemed to be ``low risk'' by CBP. Importers
and carriers have had to demonstrate supply chain security controls,
and drivers have been subjected to rigorous background screening.
Companies have made the security investments and have bolstered their
operations to provide the requisite security and integrity of their
trade transactions. The federal governments of the United States and
Canada have encouraged FAST participation on the grounds that it will
mean expedited border crossings and reduced information requirements.
By allowing food to move through the FAST ``stream'' in the same manner
as other products, FDA would demonstrate the commitment to
harmonization that industry has long encouraged and would provide an
incentive for additional participation in the C-TPAT and FAST programs.
In addition, the comments noted that if the primary benefits of the C-
TPAT program were removed, FDA would create a disincentive for C-TPAT
participation that would ultimately reduce the security of the articles
covered by the Bioterrorism Act. Finally, the comments note that these
benefits are necessary to avoid duplication and inconsistent
application of prior notice requirements for shipments that meet the
stringent FAST criteria.
    (Response) FDA continues to use a risk-based approach for
determining which foods to inspect for the purposes of admissibility.
FDA will continue to work with CBP and acknowledges that the additional
information provided by C-TPAT participation could be helpful in this
risk-based assessment. In CBP's March 25, 2005, FAQ document cited
previously, CBP states that ``[u]nsolicited shipments will
understandably lie outside the capability of the importer to ensure
security. CBP employs a risk management approach in screening and
targeting, and such shipments, as well as those from unknown or less
established entities, receive higher scrutiny from CBP.'' FDA agrees
with this statement.
    (Comments) Numerous comments provide suggestions on how to
accomplish processing/transmission benefits for C-TPAT and FAST
participants. Many of the comments cite a need for better harmonization
and streamlining between FDA and CBP. Suggestions from the comments
include:
     Enhance coordination between CBP and FDA, allowing trained
CBP/FDA officers to process food shipments through the FAST lane, and
allowing FAST importers using a FAST driver and carrier importing food
and/or feed products to submit prior notice to both the CBP and FDA
through the existing CBP/FDA interface.
     Allow for integrated targeting processes, including a
reduction in the risk targeting factors for food shipments, as well as
other product categories, which would translate into expedited
processing, reduced exams and other benefits for food import shipments
under the program.
     Integrate the CBP and FDA data systems to allow for one
filing of the required information. The C-TPAT certification process
delves into the critical aspects of a company's handling and
documentation procedures, and requires a company to demonstrate it has
good process controls in place throughout the supply chain.
     Modify the CBP and FDA systems for the receipt of advance
notice and prior notice to ``flag'' importation under

C-TPAT and FAST. These notices should receive priority attention for
entry and clearance purposes.
     Establish an MOU between FDA and CBP to allow the sharing
of necessary information with the understanding of the program
applicant.
     Implement a shorter prior notice timeframe for C-TPAT
members.
     Reduce data element reporting by virtue of having
successfully passed the C-TPAT validation process. Product information
(HTS code, product code, manufacturer's registration numbers, etc.)
should be part of the pre-filed information profiles under FAST.
    Finally, one comment suggests the following:
    (1) A statement of proof of acceptance (e.g., copy of acceptance
letter from CBP) into the C-TPAT and/or FAST programs;
    (2) A detailed statement/description of policies and procedures in
place for meeting FDA prior notice requirements. This submission should
follow the format of the supply chain questionnaire information
submitted to CBP as part of the C-TPAT application process and should
be considered as an addendum to the original submission; and
    (3) FDA should notify the importer in writing of: (a) its
acceptance/agreement with the importer's FDA prior notice procedures;
or (b) additional questions to be answered or data to be provided to
meet FDA requirements for acceptance into the FDA prior notice ``C-
TPAT/FAST'' program.
    (Response) As we discussed previously, we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes. FDA, however, is
continuing to explore with CBP and industry use of these programs in
making decisions regarding which products to inspect for the purposes
of admissibility (801(a) decisions).
    ii. If the timeframe for submitting prior notice for food arriving
by land via road is reduced to 1 hour consistent with the timeframe in
the advance electronic information rule, would a shorter timeframe be
needed for members of FAST? (Comments) One comment suggests that the
timeframe for submitting prior notice of one hour is fine, even for
express deliveries. Another comment believes that reducing the
timeframes for submission of prior notice would not sufficiently
expedite the clearance of product for participants of FAST. However, an
overwhelming majority of the comments favor reducing the timeframe for
FAST participants to 30 minutes. Under the CBP Advance Electronic
Information Rule, the time element for FAST participants is 30 minutes.
The comments state that to have two different time standards for the
same mode of transportation only serves to create confusion. The
comments believe that any harmonization of FDA and CBP security
programs would assist the orderly flow of trade at the border crossing
points.
    The comments contend that the key premise behind the FAST program
is that low-risk parties should receive expedited treatment at the
border, freeing up enforcement resources to concentrate on parties of
higher or unknown risk, which is why the timeframes CBP adopted are
shorter for FAST than for other shipments. If FDA adopted the 30 minute
timeframe, it would demonstrate a commitment to harmonizing with CBP,
and prevent a situation whereby FAST requirements vary depending on the
type of commodity being transported. Finally, one comment believes that
to ensure consistency with FAST and CBP's Automated Commercial
Environment (ACE),\4\ prior notice should be required and calculated
from the port of entry and not the first point of arrival, as is
currently the case.
---------------------------------------------------------------------------

    \4\ The ACE system will replace the current ABI/ACS, as well as
combine other CBP entry functions and transactions. Prior Notice
submissions will be compatible with ACE.
---------------------------------------------------------------------------

    (Response) Harmonized timeframes could facilitate the orderly flow
of trade traffic at the borders. Advance screening of consistent
information also would aid in reducing the review time. However, as we
discuss later in section II.F of this document (``When must prior
notice be submitted to FDA? (Sec.  1.279)''), we are maintaining the
timeframes that are in the IFR. These timeframes represent the minimum
amount of time FDA needs to meet the statutory responsibility to
receive, review, and respond to prior notice submissions. Our
assessment of the timeframes and review times showed that we would not
be able to reduce the timeframes to correspond to those used by CBP for
land and air shipments.
    iii. Should the security and verification processes in C-TPAT be
modified in any way to handle food and animal feed shipments regulated
by FDA? If so, how? (Comments) Four comments respond that the security/
verification processes of C-TPAT/FAST should be modified for food.
Fourteen comments respond that the process should not be modified for
food. Most comments suggest that the current validation processes are
sufficient and caution that additional FDA inspection would be
redundant. Many of these comments state that C-TPAT is a well-thought-
out program and that with its current security profile requirements and
present followup verification systems, the program is already well
suited to handle human and animal food shipments. The comments suggest
that FDA should rely on CBP's successful programs and avoid
``recreating the wheel'' or imposing new and potentially inconsistent
criteria on food companies. The comments further contend that food
safety and product integrity is already an integral part of the
industry's own internal policies, which have always been concerned and
accountable for the safety and security of their products without
regard to the more recent border security program. Therefore, companies
certified under C-TPAT have made the critical security investments and
have bolstered their operations to provide the requisite security and
integrity of their trade transactions, regardless of the commodities
(food or nonfood products) that are shipped. Another comment stresses
that FDA should not impose additional conditions of participation for
FAST members because the requirements for FAST participation imposed by
CBP provide adequate assurance that expedited clearance is appropriate.
    (Response) FDA agrees with the statement in CBP's March 25, 2005,
FAQ document that says ``For C-TPAT to ensure its continued viability,
effectiveness, and relevance, the program must continue to evolve--as
the terrorist threat and the nature of global trade evolves. The
impetus for strengthening the existing security guidelines is to
provide more detail to the membership on the expectations of the
program, and to assist CBP in defining a more consistent baseline for
minimal program requirements and better-defined C-TPAT benefits.'' The
issue of how to modify the processes is discussed in the next comments
and responses.
    (Comments) Numerous comments provide suggestions on how to modify
the security/verification processes of C-TPAT/FAST. These include:
     FDA should investigate security plans with actual physical
inspections of the facilities prior to allowing participation in the
programs.
     FDA should verify that other countries' regulatory systems
for food production and safety are equivalent to those of the United
States. The agency should also perform on-site audits and inspection of
production facilities

before a food manufacturer or carrier can be certified.
     It should be mandatory for food manufacturers to provide
notice concerning any changes in the manufacturing processes or
supplies, as well as those that may affect physical and personnel
security. In addition, the current requirements that manufacturers
periodically review the security commitment of their service providers
to detect weakness or potential weaknesses in security should be
altered to require that: (1) The review is conducted on an annual basis
and (2) a certification that the review has been conducted.
     FDA and CBP should work together, along with the trade
community, to identify potential areas where the C-TPAT security and
verification processes can or should be modified. CBP and FDA should
coordinate these processes to address the additional concerns of the
FDA in order to allow C-TPAT/FAST members expedited processing of food
and feed shipments in addition to CBP shipments.
     C-TPAT requirements should encompass any industry and food
specific security measures into C-TPAT's checklist.
     These processes must be more comprehensive. There are no
questions on the Supply Chain Security Profile Questionnaire to specify
the type of freight being hauled. In addition, there are no
opportunities in the questionnaire to indicate different locations to
which a company is shipping regularly, or insurance a company has to
cover those states.
    (Response) FDA notes that CBP has continued to expand the C-TPAT
program, which now includes minimum security criteria for importers who
participate in C-TPAT. FDA also notes that as of July 10, 2006, CBP has
received over 11,000 C-TPAT applications of which 6,089 have been
certified and 2,973 have been validated (certified members provide a
complete security profile that is screened by CBP, while validated
members also undergo a complete validation of their security profile
that includes an on-site visit to the company to review the submitted
security profile, followed by a physical verification of security
measures). There are limited resources at this time to add new
significant program requirements to meet FDA's needs under the
Bioterrorism Act and verify that those procedures have been
incorporated. The two agencies will continue to explore the feasibility
of the approaches recommended in the comments in the future.
    c. Flexible alternatives. In the Federal Register document to
reopen the comment period, FDA and CBP also requested comment on the
following questions regarding flexible alternatives (69 FR 19763 at
19764):
     If timeframes are reduced in FDA's prior notice final
rule, would other flexible alternatives for participants in FAST or for
food imported by other agencies be needed?
     In considering flexible alternatives for food imported by
other government agencies, what factors or criteria should FDA consider
when examining alternatives? Should participation be voluntary? If so,
should FDA consider inspection of companies in the supply chain from
the manufacturer to those who may hold the product, including reviews
of their security plans to determine what procedures are in place to
prevent infiltration of their facilities as a condition of
participation?
     In considering flexible alternatives for submission of
prior notice, should FDA consider additional means of ensuring that all
companies subject to the Registration of Food Facilities Interim Final
Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
     Are there conditions of participation that FDA should
consider; e.g., inspections of companies in the supply chain from the
manufacturer to those who may hold the product, or reviews of their
security plans to determine what procedures are in place to prevent
infiltration of their facilities?
     Should the food product category be considered as a
criteria or element of expedited prior notice processing or other
flexible alternatives? If so, should certain foods be excluded from
expedited prior notice processing? If so, what should be the basis for
determining which foods should be excluded?
     If FDA adopts reduced timeframes in the prior notice final
rule, should FDA phase in the shorter timeframes as CBP phases in the
advance electronic information rule?
     Should FDA offer a prior notice submission training
program for submitters and transmitters, including brokers, to ensure
the accuracy of the data being submitted?
    This section will address the comments to each of those questions
introduced in the Federal Register of April 14, 2004, beginning with
general comments.
    (Comments) One comment said that if the final rule is refined, then
it is not necessary to offer additional flexible alternatives. Several
comments state that any flexible alternatives should be incorporated
into existing programs because the duplication of security programs and
division of limited resources are not in the best interest of our
security goals and the protection of public health.
    (Response) FDA believes that additional flexible alternatives
should be incorporated into existing programs when appropriate and
feasible. FDA will continue to work with CBP and acknowledges that the
additional information provided by other programs such as C-TPAT could
be helpful for purposes of admissibility decisions.
    i. If timeframes are reduced in FDA's prior notice final rule,
would other flexible alternatives for participants in FAST or for food
imported by other agencies be needed? (Comments) Several comments
encourage incorporation of prior notice requirements into the C-TPAT
and FAST programs. Most comments caution that additional requirements
should not be added as separate programs, but that FDA should recognize
participants in the existing programs for expedited review and
processing of prior notice. One comment further suggests that
participation in C-TPAT and FAST should also ensure expedited 801(a)
admissibility processing. Another comment suggests that CBP be solely
responsible for administering both the FDA and CBP requirements of C-
TPAT and FAST.
    (Response) As we discussed previously, we have determined not to
provide C-TPAT members with special treatment in terms of reduced prior
notice information requirements or reduced timeframes. FDA, however, is
continuing to explore with CBP and industry use of these programs in
making decisions regarding which products to inspect for the purposes
of admissibility (801(a) decisions).
    FDA disagrees with the comment's suggestion that CBP be solely
responsible for administering both the FDA and CBP requirements for
these programs, as the expertise related to food safety and possible
additional participation requirements that address food safety resides
in FDA. Accordingly, FDA and CBP will continue to consider how to
administer FAST and C-TPAT programs so that they could apply to FDA
regulated products.
    ii. In considering flexible alternatives for food imported by other
government agencies, what factors or criteria should FDA consider when
examining alternatives? Should participation be voluntary? If so,
should FDA consider

inspection of companies in the supply chain from the manufacturer to
those who may hold the product, including reviews of their security
plans to determine what procedures are in place to prevent infiltration
of their facilities as a condition of participation? (Comments/
Response) There were no comments addressing flexible alternatives for
food imported by other government agencies. However, FDA has considered
imported shipments of foods for official U.S. federal government use
and our draft policy for enforcing prior notice in these situations is
contained in the Prior Notice Final Rule Draft CPG that is announced
elsewhere in this issue of the Federal Register. Under the draft
policy, FDA and CBP should typically consider not taking any regulatory
action when an article of food is imported or offered for import for an
official government purpose, provided that a Federal Government agency
is the importer of record.
    (Comments) Many comments advise that voluntary participation
enhances the success of these programs.
    (Response) C-TPAT is a voluntary, incentive based partnership. As
we continue exploring use of the C-TPAT and FAST programs in making
decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions), it will be based on the assumption
that participation should remain voluntary.
    iii. In considering flexible alternatives for submission of prior
notice, should FDA consider additional means of ensuring that all
companies subject to the Registration of Food Facilities Interim Final
Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
(Comments) Several comments reiterate that it is not necessary for FDA
to provide flexible alternatives that exceed or augment CBP's existing
programs, including a requirement to have an updated and verified
registration on file with FDA. However, another comment believes that
companies eligible to participate in low-risk programs should have an
updated registration and that verification of that registration would
be useful in determining low-risk status. Another comment assumes that
verification of registration with FDA should have been conducted under
CBP's current validation aspect of the C-TPAT program.
    (Response) FDA agrees that participants designated as low risk
should have an updated and verified registration of all facilities
subject to 21 CFR part 1, subpart H. FDA also agrees it would be
efficient to conduct the verification as part of the C-TPAT validation
process, but neither FDA nor CBP has the resources to do so at this
time.
    iv. Are there conditions of participation that FDA should consider;
e.g., inspections of companies in the supply chain from the
manufacturer to those who may hold the product, or reviews of their
security plans to determine what procedures are in place to prevent
infiltration of their facilities? (Comments) Most comments suggest that
other conditions, such as inspection of other companies in the supply
chain would be unnecessary and a repetition of effort with little
return on investment. Another comment states that to begin a process of
examining the security plans and procedures of foreign food facilities
would be tremendously expensive, call into question the validity of the
prior notice and registration requirements already in place, and the
efficacy of the targeting tools FDA employs.
    (Response) We agree that adding conditions for C-TPAT participation
and validating them to meet the purpose of the Bioterrorism Act would
be extremely expensive and potentially only benefit a small number of
those entities subject to this rule. We do not believe that this is the
best use of our limited resources at this time, particularly as we have
not experienced significant impacts on the flow of trade as a result of
the timeframes in the rule since the IFR took effect on December 12,
2003.
    v. Should the food product category be considered as a criteria or
element of expedited prior notice processing or other flexible
alternatives? If so, should certain foods be excluded from expedited
prior notice processing? If so, what should be the basis for
determining which foods should be excluded? (Comments) While one
comment asserts that the food product category be considered an
important element of expedited processing, most other comments state
that no product category distinctions should be made. One comment
states that to allow items imported under food product categories to
qualify for expedited prior notice could easily lead to abuse of the
system intended to protect us from terrorist attack. Other comments
suggest that all food products be treated in the same manner and be
subject to the same regulations. Most comments state that no product
should be specifically included or excluded from participation, but
that the criteria for participation should be focused solely on
attributes of the company and a company's ability to meet the program
standards set by the particular government agency.
    (Response) FDA agrees in part that no product category distinctions
should be made. However, FDA acknowledges that some foods are more
susceptible to terrorism and food safety problems than others,
regardless of the processes within the supply chain. But if we were to
make product category distinctions, such actions could be disruptive to
transportation (e.g., we may need to segregate products) and may make
such products targets for terrorism since such products may be eligible
for special (e.g., expedited) treatment.
    vi. If FDA adopts reduced timeframes in the prior notice final
rule, should FDA phase in the shorter timeframes as CBP phases in the
advance electronic information rule? (Comments/Response) Comments
addressing phase-in of timeframes are found under the discussion of
Sec.  1.279 ``When must prior notice be submitted to FDA.''
    vii. Should FDA offer a prior notice submission training program
for submitters and transmitters, including brokers, to ensure the
accuracy of the data being submitted? (Comments/Response) Most comments
support additional training for submitters and transmitters. Additional
discussion of training is found under section III. M (Outreach and
Enforcement) of this document.
7. Additional Exclusions Requested--Samples
    (Comments) Numerous comments request an exclusion from the
requirements of prior notice for samples used in trade fairs, market
research, market testing, and laboratory analyses (i.e., quality
analysis/quality control (QA/QC) samples, scientific research,
compositional analyses, research and development, standard of identity
confirmation testing or quality comparison testing). The comments state
that QA/QC samples are clearly not destined for consumption and will
never enter the food chain or be consumed by the general public,
thereby placing samples in a low-risk category. In addition, the
comments note that these samples are often imported in very small
quantities for a specific purpose. Samples used for organoleptic
analyses will be consumed in very small quantities as part of the
analytic procedures in a laboratory setting. In the case of trade
samples, the comments contend that although the food will be consumed,
the consumption is minor and is contained within a controlled
environment, such as a test kitchen or trade booth.

    In addition, the comments suggest some ways in which the burdens
for submitting prior notice for samples could be less cumbersome. These
recommendations include:
     Exempt all samples or some subset of samples, e.g.,
analytical, research, consumer complaint;
     Set a limit of the quantity of samples in each shipment
and do not require prior notice for quantities below this limit;
     Exempt samples from the requirement to provide the
manufacturer's registration number;
     Include a field in the prior notice in which a filer can
indicate that the item(s) is a sample, and eliminate certain data
elements if this field is flagged (i.e., registration number);
     Allow a single prior notice without registration numbers
for commingled shipments of many small sample items falling under the
same or similar FDA product codes;
     Allow shippers to provide a pre-approved list of customers
who may receive samples in a particular month, on a monthly basis in
lieu of filing individual prior notices;
     Specify procedures in the final rule for clearly
identifying samples, such as the inclusion of a statement on the airway
bill of lading that says: ``Quality Evaluation and Research and
Development Use Only--Resale Prohibited;'' and
     Provide a limited exemption for intra-corporate (within
the same company) samples.
    One comment requests that FDA exempt foods for exhibit at trade
shows and food samples. The comment reasons that these foods are not
intended for consumption in the United States, but are imported for
``show'' and sampling at the trade shows, not for later general
consumption. The comment further reasons that the quantity involved
with each shipment is minuscule, usually no more than five hundred
consumer units, which is too small a quantity to pose a potential
national security threat.
    Another comment states that there should be a de minimus provision
for samples from known shippers/importers that is ``cross-referenced''
by shipper facility registration, manufacturer facility registration,
importer facility registration, low value, and low weight.
    (Response) Many samples of food, including those for test
marketing, are ``articles of food imported or offered for import,'' as
stated in section 801(m) of the act. If, however, the samples are items
that are in such early stages of research and development that they
cannot yet be considered food under Sec.  1.276(b)(5) of the final
rule, they would not be subject to prior notice requirements. In
addition, if the sample is in a form that is not an article of food,
such as a slurry of lettuce for pesticide analysis, then prior notice
requirements would not apply. But where a sample is food, as defined
under prior notice, the sample is not excluded from the final rule even
if it is imported or offered for import for quality assurance, research
or analysis purposes only, not for human or animal consumption and not
for resale. However, as outlined in the Prior Notice Final Rule Draft
CPG, FDA's and CBP's enforcement discretion policy would apply to these
foods, under which FDA and CBP should typically consider not taking any
regulatory action when there is no prior notice and the food is a
sample not intended for human or animal consumption.
    Samples of food are considered to be for quality assurance,
research or analysis purposes, rather than human or animal consumption,
when they are in small quantities (i.e., quantities consistent with the
quality assurance, research, or analysis purposes) and the entire
sample is used up by the analysis, destroyed after analysis, or
destroyed following a reasonable retention period after analysis. The
analysis may include sensory examination, such as organoleptic
examination for determining tea quality or detecting the presence of
histamines. Evidence that an article of food is for quality assurance,
research, or analysis purposes only might include, among other
evidence, markings on the food and shipping documents.
    FDA disagrees with the comments that suggest that prior notice
should only be required for food, including samples, that is intended
for consumption. In the preamble to the IFR, FDA discussed extensively
its rationale for not limiting the prior notice requirements to food
for consumption in the United States. (See 68 FR 58974 at 58990 and
58991.) This rationale still holds. FDA also disagrees with the
comments that state samples should be exempted from prior notice if the
consumption of the samples is minor and is contained within a
controlled environment, such as a test kitchen or trade booth, or the
quantity involved with each shipment is minuscule, such that it ``is
too small a quantity to pose a potential national security threat.''
The purpose of the Bioterrorism Act is not limited to terrorist
activity or other national security threats; its purpose is ``[t]o
improve the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health emergencies'' [emphasis
added]. (Public Law 107-188.) Moreover, we have had incidents where
small quantities of samples that had been consumed caused serious
illness or death. For example, in the preamble to the IFR, FDA noted
that ``in the summer of 2003, FDA received a report from a poison
control center in country T concerning the acute poisoning of 9 men
(one died) from ingestion of an herbal fermented wine. Symptoms
occurred within minutes. Reports indicated that this product may have
been exported to the United States in small quantities for test
marketing in restaurants. This underscores the importance of FDA
receiving prior notice of all food imported or offered for import.''
(68 FR 58974 at 58993.)
8. Additional Exclusions Requested--Mail
    (Comments) One comment sought better information regarding the
sending of food products as international packages or bringing food
products into the United States personally in their baggage.
    (Response) Information on the sending of food through international
mail can be found at: http://www.cfsan.fda.gov/~pn/pnmail.html. Food
products for personal use brought into the United States that
accompanies an individual are not subject to the requirements of prior
notice (Sec.  1.277(b)(1)).
    (Comment) One comment questions whether express couriers, such as
EMS, FEDERAL EXPRESS, DHL, and TNT, are considered ``international
mail.''
    (Response) Section 1.276(b)(8) of the final rule defines
international mail to mean foreign national mail services and further
states that international mail does not include express consignment
operators or carriers or other private delivery services unless such
service is operating under contract as an agent or extension of a
foreign mail service. Therefore, if food items are shipped through one
of these services and the food items are not otherwise excluded from
prior notice requirements, prior notice is required.
    (Comments) One comment questions if the rule applies to the
military postal service, which is a subsidiary of the United States
Postal Service that operates overseas.
    (Response) If the military post offices are located outside of the
United States, as defined for the purposes of prior notice, articles of
food would be subject to the requirements of prior notice (Sec.
1.277(a)).
    (Comments) One comment states that the costs and resource
implications of FDA applying this type of approach to single-piece,
person-to-person,

international mailings of manufactured food products may outweigh any
perceived benefits. FDA's current approach to prior notice forces the
U.S. Postal Service (USPS), FDA, and CBP to dedicate substantial
resources simply to attempt effective implementation of these
regulations. The comment asks that FDA: (1) Exempt these single-piece,
personal use mailings from prior notice; (2) allow CBP to continue
using its time-tested strategies for screening and selections of items
from mail shipments arriving at the first port of entry; (3) allow the
delivery of mail items containing food, even if the contents are not
accompanied by prior notice confirmation numbers to the U.S. address,
as long as the U.S. authorities find no problem with the contents at
border inspection; and (4) work in close coordination with CBP and USPS
to promote more clarity of understanding on the procedures for packages
where the majority of the contents are not food items. The comment
states that these policies will need to be uniformly applied, and also
must ensure that proper accountability is provided to the mailers and
recipients whose mailed items might have been refused, seized, or
destroyed.
    Another comment requests an exemption for manufactured food
products that are sent via international mail for noncommercial
purposes. Some comments complain that the required data are very
complex for the average customer and the system is not very customer-
friendly, entries take a long time, and each single item has to have a
separate prior notice.
    A few comments state that most of the required information, such as
the manufacturer's registration number, is not available to private
persons, and therefore, not available to international mail and mail by
express carriers. The comments note that this is particularly
problematic, since FDA does not provide information on registration of
facilities to private parties. The comments further note that a
business relationship between the buyer of the goods (e.g., a private
person), the mail service and the manufacturer will in general not be
present. In addition, the comments state that to file prior notice,
Internet access and knowledge of the English language is required. The
comments contend that mail users will have to bear unreasonable
disadvantages and unequal treatment. The comments argue that this seems
disproportionate because most shipments are of low value. Therefore,
the comments suggest that FDA simplify the prior notice requirements
through FDA's PNSI for mail users.
    In addition, the comments suggest that: (1) Private persons should
be excluded from prior notice; (2) the requested information should be
limited to some key-information, such as the submitter and the type of
food; (3) all mail services, including express carriers, should fall
under the definition of ``international mail;'' and (4) FDA should
provide on their Web site dedicated information for companies and
consumers about international mail, in different languages.
    (Response) The act does not exempt noncommercial shipments with a
noncommercial shipper. FDA explained this position in the preamble to
the IFR (See 68 FR 58992) and believes that this rationale is still
valid. However, under the Prior Notice Final Rule Draft CPG, when food
is purchased or otherwise acquired by an individual for nonbusiness
purposes and sent to an individual with a noncommercial shipper, FDA
and CBP would typically consider not taking regulatory action if prior
notice is not submitted. This proposed enforcement discretion policy
would be continued from the Prior Notice Interim Final Rule CPG.
    Express consignment operators or carriers or other private delivery
services, unless such service is operating under contract as an agent
or extension of a foreign mail service, are not considered
international mail. (See Sec.  1.276(b)(8) of the final rule). The IFR
created a category for international mail because the rule imposed
slightly different requirements for such imports. For example, given
the nature of international mail imports, prior notice required the
planned date of mail instead of the anticipated arrival information; it
required the identification of the recipient instead of the importer,
owner, and consignee; and it did not require the mode of
transportation, carrier, planned shipment information, and hold
information. In addition, for international mail the prior notice must
be submitted before the article of food has been sent in order to allow
the prior notice confirmation number to accompany the package. We do
not believe these changes are relevant for shipments arriving by
express consignment operators or carriers or other private delivery
services. For example, if the express carrier submits the prior notice,
it will be able to include the mode of transportation, carrier, and
other data elements not included in the international mail category. In
situations where the submitter and/or transmitter is not the express
consignment operator or carrier, the final rule now allows the
submission of the express consignment operator or carrier tracking
number in lieu of anticipated arrival and certain planned shipment
information. Thus, we do not believe the final rule should be revised
to expand the definition of international mail to include express
consignment operators or carriers or other private delivery services.
    FDA also does not agree the prior notice requirements should not
apply to low-value shipments, as neither the Bioterrorism Act nor
experience with samples support this approach. See FDA's responses to
comments previously under section III.D.7 of this document ``Additional
Exclusions Requested--Samples'' for further discussion on this point.
    (Comments) A few comments suggest that FDA modify the existing
procedures for commercial shipments arriving by international mail. The
comments state that complying with the requirements of FDA's prior
notification procedure results in an unbearable workload for mail order
companies, which sometimes mail thousands of packages at one time, with
each package requiring a prior notice. The comments suggest that
manufacturers submit their company information and product information
for similar items once and then add the different recipients' addresses
at the end.
    (Response) FDA's PNSI has been designed to accommodate repetitive
information so that the basic prior notice can be created and saved,
and each U.S. recipient can be added at the end of each subsequent
prior notice. A separate prior notice confirmation number is generated
for each article of food (and recipient). Similarly, a number of the
software programs that customs brokers use to file prior notice and
entry submissions with ABI/ACS do allow for repetitive information to
be saved on the filer's computer and used for future shipments, as
appropriate.
9. Additional Exclusions Requested--Gifts
    (Comments) Several comments recommend that FDA expand the exemption
already provided for homemade food products sent as gifts (Sec.
1.277(b)(2)) or food items carried in for ``personal consumption''
(Sec.  1.277(b)(1)) to include all gifts, regardless of mode of
transportation, that are intended for personal use. Another comment
asks for clarification regarding food articles sent as gifts to persons
in the United States for personal consumption. This comment believes
that prior notice is only required for food articles that will be

distributed or traded in the United States.
    (Response) If the food was made by an individual in his/her
personal residence and sent by that individual as a personal gift
(i.e., for nonbusiness reasons) to an individual in the United States,
prior notice is not required (Sec.  1.277(b)(2)). Other food products
sent by an individual and imported for noncommercial purposes with a
noncommercial shipper are not excluded from prior notice requirements.
FDA explained this position in the preamble to the IFR (See 68 FR
58992) and believes that this rationale is still valid. However, under
the Prior Notice Final Rule Draft CPG, when gifts are shipped by an
individual for nonbusiness reasons to an individual without prior
notice, FDA and CBP should typically consider not taking regulatory
action. This proposed policy would apply regardless of the mode of
transportation.
10. Additional Exclusions Requested--Low-Value
    (Comments) Many comments request a de minimis exemption from prior
notice for all low value shipments (less than $200). The comments
assert that the prior notice requirements can be quite onerous for
small shipments and that low value shipments of prepared food sent from
and to individuals for their personal use are of little risk to the
U.S. food supply, especially relative to the individual size and large
number of commercial shipments entering the country. One comment states
that a low value exemption from prior notice for shipments under $200,
whether for personal or commercial use, would be consistent with CBP's
de minimis exemption. In addition, one comment states that foreign
individuals shipping low value gifts to the United States will not know
the Bioterrorism Act's requirements and will not be able to obtain the
manufacturer's phone and registration numbers. The comment states that
these numbers are not readily available to the consumer when products
are purchased in small quantities. One comment requests an exemption
for small dollar value mail-order sales to U.S. customers ($100 or
less) since the prior notice system is difficult and costly to
implement for this type of business.
    (Response) FDA disagrees. Low-value shipments are clearly subject
to the terms of section 801(m) of the act as they are ``articles of
food imported or offered for import.'' Moreover, low-value articles of
food can pose the same threat level to the U.S. food supply as do
articles of food that cost more, as we explained in the IFR (68 FR
58974 at 58993). However, under the proposed enforcement discretion
policy, described in the Prior Notice Final Rule Draft CPG, when food
is sent by an individual for noncommercial purposes with a
noncommercial shipper without prior notice, regardless of the article's
value, FDA and CBP should typically consider not taking any regulatory
action.
    (Comments) Two comments recommend that FDA consider incorporating
into the final rule a limited exemption for very small quantities of
food. One of those comments considers a small quantity to be under 80
pounds or less than 100 bottles.
    (Response) FDA disagrees and will not place a weight or quantity
restriction on the requirements for prior notice. ``Small quantity''
shipments are clearly subject to the terms of section 801(m) of the act
as they are ``articles of food imported or offered for import.''
Similar to low-value articles of food, small quantity shipments can
pose the same threat level to the U.S. food supply as do articles of
food that arrive in larger quantities. If we were to exempt small
quantity food shipments, small quantities of poisoned food (with the
potential to do a high level of damage) could be imported into the
United States without prior notice, thereby negating the purpose of the
Bioterrorism Act.
11. Additional Exclusions Requested--Couriers
    (Comments) One comment reports that many of the express couriers
refuse to do the necessary paperwork for shipments being sent via their
services. Therefore, the manufacturers are required to submit prior
notice. However, the manufacturer does not have the necessary
information needed to complete the form, such as flight number,
departure and arrival time, etc. The comment suggests that express
courier shipments should be treated in the same manner as mail
shipments.
    (Response) FDA disagrees but has modified the rule to address the
underlying concern. Food imported or offered for import via these
private delivery services are subject to prior notice, which must be
submitted within the timeframe of the applicable mode of
transportation--water, air, or land (Sec.  1.279). In the prior notice
CPG published in November 2004 (November 9, 2004; 69 FR 64959), FDA and
CBP stated that they generally would consider not taking regulatory
action if the prior notice is inadequate because it does not include
the required anticipated arrival information and/or planned shipment
information and if, among other criteria, the prior notice includes the
shipment's tracking number in lieu of the required anticipated arrival
information and/or planned shipment information. A person shipping food
into the United States via an express courier will have access to the
tracking number to use in lieu of the flight number or other planned
shipment information. FDA has incorporated this policy in Sec.  1.281
of the final rule, which allows the submitter and/or transmitter to
submit the express consignment operator or carrier tracking number in
lieu of anticipated arrival and certain planned shipment information as
long as neither the submitter nor transmitter is the express
consignment operator or carrier and prior notice is submitted via PNSI.
12. Additional Exclusion Requested--Gift Packs
    (Comments) One comment requests clarification of the interpretation
pertaining to gift baskets. The comment states it is unclear whether
prior notice is based upon the description of the entire gift basket as
an entity, which is currently the case for CBP entry processing, or on
the individual items within the basket. One comment asks FDA to exempt
gift baskets because they are ``no-risk.''
    (Response) Under the final rule, a gift pack is not considered a
single article of food (e.g., a gift pack consisting of four articles
of food would require four prior notice submissions). This is because a
gift pack is not manufactured/processed as a single product, but is
packed by consolidating a variety of articles of food into a unit, with
or without other nonfood articles. However, FDA and CBP are proposing
to continue their enforcement discretion policy for gift packs, which
the agencies first announced in their March 2005 CPG (March 4, 2005; 70
FR 10657). Under that policy, ``FDA and Customs Border Protection (CBP)
staff should typically consider not taking regulatory action if there
is a prior notice violation because a single prior notice is submitted
for a gift pack and the identity of the facility that packed the gift
pack is submitted in lieu of the identity of the manufacturer(s),
provided that the gift pack is purchased or otherwise acquired by an
individual and imported or offered for import for nonbusiness
purposes.''
    There is no CBP rule or regulation, nor is there a General Rule of
Interpretation (GRI) under which gift packs are classified. In the case
of ``gift packs'' that contain multiple products,

CBP tries to classify the gift pack using the concept of a set. That
is, if the products included in a gift pack are part of a common
activity, the gift pack may be classified under the HTS code that is
most applicable. However, CBP does not consider eating to be a common
activity, even when all items in a gift pack are to be consumed.
Therefore, unless there has been an applicable CBP ruling, entries of
gift packs should be declared to CBP using the HTS code for each item
included within the gift pack. This principle applies even when there
are food and nonfood items in the pack (e.g., a soup mug and a can of
soup) as well as for make-your-own gift packs (e.g., if you created a
gift pack by personally selecting individual items from a list of
available products).
13. Additional Exclusions Requested--Household Goods and Unaccompanied
Baggage
    (Comments) Many comments suggest that the final rule exempt
unaccompanied food that is included in a shipment of personal household
goods, if the food is owned by and intended to be consumed by the
shipper of the household goods, their family or friends, and if the
food is not to be offered for sale or distribution. In addition,
several comments suggest that food contained in unaccompanied baggage
should be exempt from the requirements of prior notice. The comments
state that the owner of the food never changes, and that there is no
sale or transfer of the goods. The comments believe that shipping food
items contained in household goods or unaccompanied baggage to the
United States is equivalent to carrying the items in baggage for
personal use. The comments further state that household goods are even
more personal than food accompanying a traveler because although it
travels from one personal residence to another, it remains part of the
same household or home. The comments suggest that FDA not require as
many data elements for these types of shipments, and allow a minimum
amount of food/consumables to be imported without prior notice. The
comments believe that it will be unnecessarily tedious and exhaustive
for individuals to input the required information into the FDA PNSI,
and that it is unreasonable to ask individuals to destroy or leave
behind hundreds of dollars of canned goods.
    Additionally, one comment suggests that persons on duty in the
United States as members of the armed forces of a North Atlantic Treaty
Organization (NATO) or Partnership for Peace or civilian component
attached to or employed by NATO Headquarters, Supreme Allied Commander
Transformation Atlantic and their immediate families be granted an
exemption from prior notice. The comment contends that these
individuals have undergone an intense screening process prior to being
selected for a NATO position. One comment requests that FDA exempt
Department of Defense active duty military and civilian personnel
unaccompanied baggage and household good shipments.
    (Response) Section 801(m) of the act does not authorize an
exclusion from prior notice for food imported as part of unaccompanied
baggage or food included as part of a shipment of personal household
goods. Therefore, food contained in household goods and accompanied
baggage are subject to prior notice requirements.
    However, a proposed enforcement discretion policy in the Prior
Notice Final Rule Draft CPG would apply to most or all of the household
goods and unaccompanied baggage shipments described in the comments.
Under the proposed policy, FDA and CBP should typically consider not
taking any regulatory action when an article of food is imported or
offered for import for noncommercial purposes with a noncommercial
shipper without prior notice. We consider food in household goods,
including military and civilian transfers, to be food imported or
offered for import for a noncommercial purpose. This enforcement
discretion policy would be a continuation of the policy in effect since
FDA issued the June 2004 Prior Notice Interim Final Rule CPG (June 29,
2004, 69 FR 38906).
14. Additional Exclusions Requested--Noncommercial Use
    (Comments) One comment asserts that shipments for personal
consignment when sent from a business are, by definition,
noncommercial, due to the fact they are purchased for personal use and
not for resale. The comment suggests that FDA define noncommercial
shipments to include any consignment to an individual for personal,
noncommercial use, as exempt from the requirements of prior notice,
regardless of whether the shipper is a business entity or an
individual.
    (Response) FDA disagrees. As we described in the IFR, there is no
basis in the statute for an exemption based on shipments that are for
personal use, regardless of whether the shipper is a commercial or
noncommercial (i.e., an individual) entity (68 FR 58974 at 58992).
However, we are proposing an enforcement discretion policy in the Prior
Notice Final Rule Draft CPG for food imported or offered for import for
noncommercial purposes with a noncommercial shipper without prior
notice, irrespective of the type of carrier. Under the proposed policy,
FDA and CBP should typically consider not taking any regulatory action
when an article of food is imported or offered for import for
noncommercial purposes with a noncommercial shipper without prior
notice. The noncommercial shipper, under this policy, would be an
individual (e.g., the individual delivers the food to a post office or
common carrier for delivery to self, family member, or friend for
nonbusiness purposes).
    When a business ships a food, it is for a commercial or business
purpose. The situation as described in this comment, therefore, would
not meet the criteria covered by the enforcement discretion policy
since the shipper is a business.
    (Comments) One comment requests that private persons should be
excluded from the requirements of prior notice. The comment states that
commercially-produced food imported for the personal use of an
individual, even if included in a shipment of personal effects, should
not require prior notice.
    (Response) Section 801(m) of the act does not authorize a broad
exclusion from prior notice for food imported or offered for import by
private persons. Therefore, food that is commercially produced that is
imported for the personal use of an individual, as described in the
comment, would be subject to this final rule.
    However, we are proposing an enforcement discretion policy in the
Prior Notice Final Rule Draft CPG for food imported or offered for
import for noncommercial purposes with a noncommercial shipper,
irrespective of the type of carrier without prior notice. Under the
proposed policy, FDA and CBP should typically consider not taking any
regulatory action when an article of food is imported or offered for
import for noncommercial purposes with a noncommercial shipper without
prior notice. This policy would cover the food described in the
comment, commercially produced food imported for the personal use of an
individual, as long as the shipper is noncommercial. This enforcement
policy would continue the policy initially announced in our June 2004
Prior Notice Interim Final Rule CPG. The draft CPG describes a
noncommercial purpose as one where the food is purchased or otherwise
acquired by an individual for nonbusiness purposes, and a noncommercial
shipper is one where the shipper is an individual (e.g., the individual
delivers the food to a post

office or common carrier for delivery to self, family member, or friend
for nonbusiness purposes, i.e., not for sale, resale, barter, business
use, or commercial use). Examples of foods imported or offered for
import that may be covered by this noncommercial category are: (1) Food
in household goods, including military and civilian transfers; (2) food
purchased by a traveler and mailed or shipped to the traveler's U.S.
address by the traveler, not the commercial establishment; and (3)
gifts purchased at a commercial establishment and shipped by the
purchaser, not the commercial establishment.
    (Comments) One comment suggests that older wines already owned by a
U.S. individual and imported solely for personal consumption be exempt
from prior notice. Another comment provides an example of an individual
who owns a wine cellar overseas and arranges for cases of wine to be
sent to him/herself in the United States for personal consumption.
    (Response) As discussed previously, there is no basis in section
801(m) of the act to exclude food imported or offered for import for
personal use. Although this importation is subject to the provisions of
this final rule, if the wine is imported or offered for import by an
individual for noncommercial purposes and shipped by himself to himself
using a noncommercial shipper without prior notice, the proposed
enforcement discretion policy in the Prior Notice Final Rule Draft CPG
would apply. Under the proposed policy, FDA and CBP generally should
typically consider not taking regulatory action when an article of food
is imported or offered for import for noncommercial purposes with a
noncommercial shipper without prior notice.
    (Comments) One comment suggests that small shipments of nominal
value for personal, noncommercial use should be exempted from the
requirements of prior notice. The comment states that the express
industry handles many of these shipments now, which include purchases
from a growing number of Internet-based sellers. The comment asserts
that these small shipments for personal use do not qualify as a risk to
the domestic food supply, and should be exempt from prior notice.
    (Response) As we discussed previously, section 801(m) of the act
does not authorize an exclusion for small quantity or low-value
shipments. FDA notes that under the Prior Notice Final Rule Draft CPG,
FDA and CBP should typically consider not taking regulatory action when
an article of food is imported or offered for import for noncommercial
purposes, such as small shipments for personal use, with a
noncommercial shipper without prior notice. However, this proposed
enforcement discretion policy would not extend to situations where the
shipper is a commercial entity (e.g., a retail store, an Internet
company, etc.).
15. Additional Exclusions Requested--U.S. Goods Returned
    (Comments) A few comments request exemptions for unadulterated U.S.
goods being returned. The comments state that these items do not pose
an adequate threat to the nation's food supply. In addition, these
comments indicate that it is not possible to provide the manufacturer's
registration number for merchandise that was manufactured in the United
States and then exported overseas, where the merchandise can be
purchased and then shipped back to the United States. The comments
state that the original manufacturer in the United States will not
provide their registration number in these scenarios.
    (Response) FDA disagrees. As discussed in the IFR, FDA believes
that, for the purpose of section 801(m) of the act, the phrase
``imported or offered for import into the United States'' applies to
articles of food of U.S. origin that are ``reimported'' back into the
United States (68 FR 58974 at 58990). FDA believes that this
interpretation, and the underlying rationale for it, are still valid.
We also believe, as explained in the IFR, that section 801(m) of the
act does not authorize us to exclude ``low-risk'' food shipments from
prior notice requirements (68 FR 58974 at 58993).
    The inability to submit the manufacturing facility's registration
number is not a valid reason for excluding such a shipment from prior
notice requirements. However, we are revising Sec.  1.281(a)(6) of the
final rule to provide flexibility in submitting the identity of the
manufacturer. In addition to the name of the manufacturer, the
submitter may submit either the registration number, city, and country
of the manufacturer, or both the full address of the manufacturer and
the reason why the registration number is not provided.
    (Comments) One comment requests that FDA provide clear direction
whether prior notice is required for food shipments of U.S. products
that are returned to the United States after refusal by a foreign
government.
    (Response) FDA requires prior notice for an article of food that
has been exported from the U.S. and is being ``reimported'' back into
the U.S., as we consider such a shipment as being ``imported or offered
for import into the United States'' (Sec.  1.277(a)), regardless of
whether it was initially a U.S. export that was refused by a foreign
government. We would require prior notice for these shipments even if
entry is not required by CBP. In these cases, we recommend that prior
notice be submitted via PNSI.
16. Additional Exclusions Requested--In-Transit Shipments
    (Comments) Several comments request that in-transit shipments be
excluded from the prior notice requirements. The comments express
concern that submitting prior notice for such shipments presents a
tremendous burden on industry. Companies may seek to avoid the
potential cost and disruption by diverting freight to other routes
rather than use transshipment facilities through U.S. territory for
destinations in Mexico and Canada.
    The comments note that requiring prior notice for shipments not
intended for consumption in the United States appears to be beyond the
statutory authority provided by the Bioterrorism Act. The comments
reason that in-transit shipments are under strict CBP regulations and
control by the carrier with respect to movement and are secured by a
bond, and thus, the food cannot be diverted to enter the U.S. food
supply.
    (Response) FDA disagrees. The IFR contains FDA's rationale and
legal support for determining that for the purpose of section 801(m) of
the act, the phrase, ``imported or offered for import into the United
States,'' applies to articles of food of U.S. origin that are
``reimported'' back into the United States, as well as to food that
transits the United States (See 68 FR 58974 at 58990). FDA continues to
believe this determination is correct and is not convinced it should be
revised. Moreover, the comment implies that these shipments should be
exempt from prior notice requirements since the shipments are under
strict CBP control and are secured by a bond, i.e., that these
shipments are low-risk. However, section 801(m) of the act does not
authorize an exemption for articles of food that are ``low risk'' or
covered by programs of other agencies, such as CBP or foreign
government regulatory authorities.
    (Comments) One comment requests that the final rule exempt foreign-
to-foreign transit mail; i.e., mail shipments that simply transit the
United States for delivery in a third country. The comment reasons that
these items are not intended for U.S. consumption (i.e., not intended
for a U.S. recipient); represent the transfer of universal

service obligation mail between sovereign governmental entities; and
are items from foreign mailers who would not know when to submit the
required prior notice data as they do not always know whether their
mail dispatches will be transiting the United States.
    (Response) As we explained in the IFR and elsewhere in this notice,
food that is not intended for U.S. consumption is still within the
scope of ``imported or offered for import'' (68 FR 58974 at 58991) and
is subject to prior notice requirements. However, we understand that in
the case of foreign-to-foreign mail, the sender does not have control
over the transportation route that the foreign-to-foreign shipment will
transit. Therefore, we are proposing an enforcement discretion policy
in the Prior Notice Final Rule Draft CPG that would address this
situation. Under that policy, FDA and CBP should typically consider not
taking any regulatory action when an article of food is imported or
offered for import via international mail without prior notice and
there is no U.S. recipient.
    (Comments) Comments filed by express carriers request that FDA
exempt all non-U.S. destination shipments from the requirement to
provide prior notice. The comments note that the shipment is in the
custody of the express carrier at all times and the risk of diversion
from the highly-controlled environment in which express shipments move,
particularly in-bond shipments, is low. The comments also reason that
foreign shippers and foreign consignees do not submit the required
prior notice data because they are, by design, not aware that their
shipments will transit the United States on their way to a third
country because express carriers do not disclose flight routes of
packages either to shippers or consignees due to security concerns. If
prior notice must be submitted, express carriers will be required to
make the customers aware of routes, nullifying this simple but
effective security precaution.
    (Response) As described in the previous comment, prior notice
applies to food imported or offered for import notwithstanding that the
food is not intended for U.S. consumption. However, we recognize that,
when shipping via express carrier or other private delivery service,
the sender does not have control over the transportation route that the
foreign-to-foreign shipment will transit. For example, a person in
Europe intends to mail an article of food to South America via an
express carrier. This person has no control over the package entering
the United States if the express carrier, for example, chooses to
consolidate shipments going to South America in Florida. The proposed
enforcement discretion policy in the Prior Notice Final Rule Draft CPG
states that FDA and CBP should typically consider not taking any
regulatory action when an article of food is imported or offered for
import and the carrier is an express consignment operator or carrier;
neither the submitter nor transmitter is the express consignment
operator or carrier; and the importer, owner, or recipient/consignee is
not located in the United States.
    (Comments) Several comments request that FDA exempt shipments of
food that move from Canada to Canada under bond by rail through
Northern Maine. These comments note that such shipments moving by rail
in bond cannot be delivered to points within the United States, must
move from Canada to Canada, and that the food products in trailers on
rail cars cannot be diverted to enter the U.S. food supply. The
comments state that having to submit prior notice puts the U.S. rail
carriers at a competitive disadvantage when competing for Canadian rail
business. Other comments request that FDA exempt shipments of food that
move from Canada to Canada by marine and trucking companies. The
comments reason that their Canada to Canada in-transit shipments move
in sealed containers and that providing detailed information for
products that are never going to enter the U.S. food supply is a
hardship to U.S. businesses.
    (Response) FDA disagrees. The Bioterrorism Act does not create any
exemptions for this situation and therefore, there is no basis for
excluding such business operations from prior notice requirements. The
preamble to the IFR provides our rationale for determining that food
that transits the United States falls under the scope of this rule (68
FR 58974 at 58990) and we continue to hold this view. Moreover, the
comment implies that these shipments should be exempt from prior notice
requirements because they pose a relatively low risk by moving by rail,
in bond, and/or under seal. Even if such food shipments are a low risk,
as discussed elsewhere in this notice, section 801(m) of the act does
not authorize a ``low risk'' exemption. However, the proposed guidance
in the Prior Notice Final Rule Draft CPG (which would continue the
policy established in the March 2005 revision to the Prior Notice
Interim Final Rule CPG) addresses imported food arriving from and
exiting to the same country. It describes the situations and conditions
under which FDA and CBP should typically consider not taking regulatory
action when prior notice is not submitted.
    (Comments) Another comment suggests that the FDA work cooperatively
with CBP such that transshipments that follow the CBP transshipment
procedures are not required to enter additional information for FDA
prior notice purposes, and that shipments that may pose a risk are
identified through the CBP process. The comment also states that the
current requirements in the agreement for secure in-transit procedures
could be modified to meet the objective of the prior notice IFR to
prevent the entry of products that have been intentionally adulterated.
Shipments that follow the proposed secure in-transit procedures would
not be distributed in the United States and would be of minimal risk to
human or animal security and safety. The comment also suggests that FDA
can achieve certainty of safety of overseas shipments that are
transiting to the United States through Canada by conducting
examinations at the first point of arrival in North America and through
the expansion of existing bilateral harmonized risk screening and
lockout sharing systems to accommodate additional high-risk
commodities.
    (Response) CBP's secure in transit procedures cannot substitute for
the submission of prior notice for in transit shipments because they do
not meet the requirements of the Bioterrorism Act, such as providing
FDA with certain specified information. The information in a prior
notice is necessary for FDA to determine whether it should examine the
food at the U.S. port of arrival. In addition, section 801(m) of the
act does not authorize an exemption for articles of food that are
covered by programs of other agencies, such as CBP, even if those
programs would ``prevent the entry of products that have been
intentionally adulterated.''
    (Comments) One comment notes that there are many ocean containers
crossing into the United States for transshipment purposes and prior
notice is not being submitted. The comment asks how to ensure that
ocean containers that arrive in Canada or Mexico and cross into the
United States by rail have prior notice submitted in a timely fashion,
or submitted at all, when shippers are not always aware of when the
containers are due to cross or on which train.
    (Response) FDA addressed this issue in the IFR when it allowed any
person with knowledge of the required information to submit prior
notice. In

Sec.  1.285 of the proposed prior notice rule (68 FR 5428, February 3,
2003), FDA provided that a purchaser or importer of an article of food
who resides or maintains a place of business in the United States or an
agent thereof was authorized to submit prior notice. FDA further
proposed that if the article of food is imported for in-bond movement
through the United States for export, the prior notice must be
submitted by the arriving carrier or, if known, the carrier making the
in-bond entry. Many comments to the proposed rule objected to the
limitation that only a person who resides or maintains a place of
business in the United States can submit the prior notice. In addition,
comments pointed out that under some circumstances, the U.S. importer
or purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice.
    In response, FDA modified this provision in the IFR and removed the
restriction on who can submit prior notice. Accordingly, Sec.  1.278 of
the IFR provides that any person with knowledge of the required
information may submit prior notice to FDA. FDA has retained this
provision in the final rule.
17. Additional Exclusions Requested--Diplomatic Pouch
    We have determined that prior notice does not apply to food in
diplomatic pouches because Art. 27(3) of The Vienna Convention on
Diplomatic Relations (1961) states that: ``The diplomatic bag shall not
be opened or detained.''
    (Final Rule) Section 1.277(b)(7) of the final rule adds a new
exclusion to the rule: ``Articles of food subject to Art. 27(3) of The
Vienna Convention on Diplomatic Relations (1961), i.e., shipped as
baggage or cargo constituting the diplomatic bag.''
18. Additional Exclusions Requested--Seeds for Planting
    (Comments) One comment requests that FDA exempt imported seed that
is destined solely for planting purposes, even if small amounts found
unsuitable for planting will end up in the food supply. The comment
also requests that the FD3 flags be removed from HTS codes that cover
seed for sowing or planting or, alternatively, to clarify that FD3
flagged HTS codes may be ``disclaimed'' at entry.
    (Response) Whether seeds are subject to prior notice depends on
whether the seeds meet the definition of food. Some seeds, such as
sesame seeds for baking or as a garnish, are food for which prior
notice must be submitted to FDA before the seed is imported or offered
for import into the United States. Some seeds are capable of both food
and nonfood uses, such as seeds that are sometimes processed into
cooking oil and other times processed into industrial-use oil. As
discussed elsewhere in this document, FDA considers such seed to be
food for the purpose of prior notice if the seed is reasonably likely
to be directed to a food use. Even when seed is for a nonfood use, such
as seeds for growing flowers, if a small portion of that seed is
reasonably likely to be directed for use in animal feed, prior notice
would be required. Because seeds, including seeds for planting, may be
subject to prior notice under section 801(m) of the act, we believe
they are properly flagged as FD3.
    Nonetheless, we note that the draft Prior Notice Final Rule CPG,
announced elsewhere in this issue of the Federal Register, proposes an
enforcement policy regarding seeds for planting. Under the draft
policy, FDA and CBP should typically consider not taking any regulatory
action regarding seeds that will be used for cultivation if they are
imported or offered for import without prior notice. The policy would
apply when no more than a small portion of that seed is diverted from
cultivation to animal feed or other food use. It would not apply,
however, where the seed is used for the production of edible sprouts,
such as alfalfa seeds for the production of alfalfa sprouts.

E. Who is Authorized to Submit Prior Notice? (Sec.  1.278)

    Section 1.278 of the IFR states that prior notice may be submitted
by any person with knowledge of the required information and identifies
this person as the submitter. The IFR also states that the submitter
also may use another person to transmit the required information on
his/her behalf and identifies the person who transmits the information
as the transmitter. The IFR also states that the submitter and
transmitter may be the same person.
    (Comments) Several comments note that carriers often do not have
access to the information required to classify articles in the FDA
system (the commercial invoice and packing list) because it is
proprietary information that the owners of the goods will not want to
give to intermediaries in the transportation chain. Also, there is
confusion regarding who is responsible for submitting prior notice.
This causes particular problems for carriers of in-bond cargo
transiting the United States. The comment suggests that exempting in-
bond shipments from prior notice would allow carriers to move the
shipment without having to submit prior notice and permit the broker at
the port of entry, who does get the necessary documents, to properly
submit the prior notice. (Response) FDA disagrees that there is
confusion regarding who is responsible for submitting prior notice. The
IFR and this final rule expressly state in Sec.  1.278 that any person
with knowledge of the required information may submit the prior notice.
FDA provided this flexibility as to who could submit prior notice in
response to comments that FDA received on the proposed rule, which
urged FDA not to limit who could file prior notice to either a
purchaser or importer of an article of food who resides or maintains a
place of business in the United States or an agent thereof, or to the
arriving carrier or the carrier making the in-bond entry if the article
of food is imported for in-bond movement through the United States for
export. (See 68 FR 58974 at 58994.) Comments to the proposed rule also
pointed out that under some circumstances, the U.S. importer or
purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice. In response, FDA modified
this provision in the IFR and removed the limitation on who can submit
prior notice.
    (Response) FDA disagrees that there is confusion regarding who is
responsible for submitting prior notice. The IFR and this final rule
expressly state in Sec.  1.278 that any person with knowledge of the
required information may submit the prior notice. FDA provided this
flexibility as to who could submit prior notice in response to comments
that FDA received on the proposed rule, which urged FDA not to limit
who could file prior notice to either a purchaser or importer of an
article of food who resides or maintains a place of business in the
United States or an agent thereof, or to the arriving carrier or the
carrier making the in-bond entry if the article of food is imported for
in-bond movement through the United States for export. (See 68 FR 58974
at 58994.) Comments to the proposed rule

also pointed out that under some circumstances, the U.S. importer or
purchaser or carrier would not have all the information required by
prior notice, but that other entities, e.g., the foreign manufacturer/
processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice. In response, FDA modified
this provision in the IFR and removed the limitation on who can submit
prior notice.
    Accordingly, Sec.  1.278 of the IFR provides that any person with
knowledge of the required information may submit prior notice to FDA.
FDA noted in the preamble to the IFR that any person may now take
responsibility for submitting prior notice for a particular article of
food, as long as that person can provide all the required information.
This person is referred to as the submitter in the IFR. The IFR also
states that the submitter may use another person to transmit the
required information to FDA. For ease of reference, the person who
transmits the prior notice is referred to as the transmitter in the
IFR. FDA has retained these provisions in the final rule. FDA further
notes that to the extent that there is confusion, the parties to the
transaction may want to consider a means for identifying which party is
responsible for submitting prior notice as part of their business
arrangements (e.g., within their contract).
    (Comments) Several comments note that problems arise because the
IFR creates no particular obligation on any particular party within the
distribution system to submit prior notice. One comment states that
because prior notice can be submitted by any person who has the
information, there are many cases of duplicate prior notices filed by
different parties for the same shipment. Another comment suggests that
FDA select one party to be responsible, suggesting the appropriate
party would be either the exporter or the importer-broker.
    (Response) Please see the response to the previous comments. FDA's
proposed rule did specify a limited class of individuals who could
provide prior notice and this limitation received significant adverse
comment. Accordingly, both the IFR and this final rule provide that any
person with knowledge of the required information may submit the prior
notice (Sec.  1.278). FDA notes that the parties to a transaction can
elect to take steps among them to identify which party should submit
the prior notice and ensure that the party submitting prior notice has
the appropriate and correct information.
    (Comments) One comment suggests that it is improper for a carrier
to require the shipper to submit prior notice when the shipper is not
shipping goods into the United States, but the carrier unilaterally
moves the goods through their hub in the United States, thereby causing
the shipment to enter the United States. Another comment notes that the
data elements required in a prior notice are not available to the
shipper, inferring that it is not possible for a shipper to submit
prior notice.
    (Response) Neither the IFR nor this final rule specifies who must
file prior notice. Rather, the rule provides that any person with
knowledge of the required information may submit prior notice to FDA.
Accordingly, it is not for FDA to say whether it is proper for a
carrier to require a shipper to submit prior notice as a condition of
shipment, as that is a matter between two contracting parties. We 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.
    (Comments) One comment asks whether there are any prior notice
obligations to fulfill if the exporter is not required to register with
the FDA under the Bioterrorism Act (21 CFR part 1, subpart H).
    (Response) Prior notice and registration are separate obligations
under different regulations and with differing applicability. For
example, registration applies to facilities that manufacture, process,
pack or hold food that will be consumed by humans or animals in the
United States. By comparison, prior notice generally applies to FDA-
regulated food being imported or offered for import into the United
States, regardless of whether it will be consumed in the United States
and regardless of whether the exporter must register.
    (Comments) One comment asks for clarification of the legal
responsibility of the submitter.
    (Response) Among the requirements of the final rule, the prior
notice information must be accurate and timely. As described in Sec.
1.283, if an article of food is imported or offered for import and the
notice is inaccurate or untimely, the food is subject to refusal of
admission. Other consequences under the act for those who fail to
comply with the prior notice requirements, such as by submitting
inaccurate or untimely notice, are described in Sec.  1.284.
    (Final rule) Section 1.278 of the final rule states that prior
notice may be submitted by any person with knowledge of the required
information and identifies this person as the submitter. The final rule
also states that the submitter may use another person to transmit the
required information on his/her behalf and identifies the person who
transmits the information as the transmitter. The final rule also
states that the submitter and transmitter may be the same person.

F. When Must Prior Notice Be Submitted to FDA? (Sec.  1.279)

    Section 801(m)(2)(A) of the act states that FDA shall by regulation
prescribe the time of submission of the notification in advance of
importation or the offering of the food for import, which period shall
be no less than the minimum amount of time necessary for the Secretary
to receive, review, and appropriately respond to such notification, and
any timeframe FDA adopts in the final rule must be justified under this
standard. Section 1.279(a) of the IFR requires FDA to receive prior
notice and confirm it for review no less than 2 hours before arriving
at the port of arrival by land via road, no less than 4 hours before
arriving at the port of arrival by air and land via rail, and no less
than 8 hours before arriving at the port of arrival by water. We
explained in the preamble to the IFR that the ``interim final rule
provides for greatly reduced timeframes for foods [from what we had
proposed] based on mode of transportation. These timeframes are what
FDA has determined are the minimum timeframes necessary to allow it to
satisfy the statutory mandate that the timeframes give the agency the
time it needs to `receive, review, and respond' to prior notices.'' (68
FR 58974 at 58995)
    Under Sec.  1.279(b) of the IFR, prior notice may not be submitted
more than 5 calendar days before arrival, except in the case of food
imported or offered for import by international mail. Under Sec.
1.279(c) of the IFR, if the article of food is arriving by
international mail, the prior notice must be submitted before the food
is sent to the United States.
    Section 1.279(d) of the IFR provides that the time of submission is
fixed and the prior notice time will start for purposes of determining
if prior notice is timely when the prior notice submission is confirmed
by FDA for

review. FDA will confirm a prior notice once all required information
has been submitted and confirmed as facially complete. For example, if
the information submitted failed to include an FDA Product Code, the
system will not provide a confirmation for that prior notice. The
transmitter has an opportunity to correct the rejected information.
When the information is corrected, transmitted, and determined to be
facially valid, the system will then notify the transmitter and provide
the prior notice confirmation number.
    Under Sec.  1.279(e) of the IFR, the prior notice confirmation
number must accompany any article of food arriving by international
mail. Under Sec.  1.279(f), a copy of the confirmation (with the prior
notice confirmation number) must accompany any article of food carried
by or otherwise accompanying an individual (unless excluded under Sec.
1.277(b)(1)), and be provided to CBP or FDA upon arrival. Additionally,
under Sec.  1.279(g) the prior notice confirmation number must
accompany any article of food for which the prior notice was submitted
through the FDA PNSI when arriving in the United States and must be
provided to CBP and FDA upon arrival.
    We further stated in the IFR's preamble that we also were
interested in exploring flexible alternatives for submission of prior
notice for foods or firms covered by programs of other agencies, such
as C-TPAT, or imported by other agencies. We explained that FDA and CBP
would publish a plan, including an implementation schedule, to achieve
the goal of a uniform, integrated system, and to coordinate timeframes
for import prior notice information while fulfilling the Bioterrorism
Act mandates for air and truck modes of transportation with timeframes
finalized by CBP when they finalize their rule entitled ``Required
Advance Electronic Presentation of Cargo Information'' (the Advance
Electronic Information Rule) (68 FR 58995). On December 5, 2003, CBP
issued the Advance Electronic Information Rule (68 FR 68140), which
requires CBP to receive, by way of a CBP-approved electronic data
interchange system, information pertaining to cargo before the cargo is
either brought into or sent from the United States by any mode of
commercial transportation (water, air, rail, or truck). The cargo
information required is that which is reasonably necessary to enable
high-risk shipments to be identified for purposes of ensuring cargo
safety and security and preventing smuggling under the laws enforced
and administered by CBP. The Advance Electronic Information Rule
implements the provisions of section 343(a) of the Trade Act of 2002,
as amended by the Maritime Transportation Security Act of 2002. The
relevant timeframes provided in the Advance Electronic Information Rule
are as follows:
     For arrival by land via road at ports that are fully
equipped to accommodate CBP's Advance Electronic Information Rule, no
later than 1 hour prior to the arrival of the truck at the border, or
for Free and Secure Trade (FAST) participants, 30 minutes;
     For arrival by land via rail at ports that are fully
equipped to accommodate CBP's Advance Electronic Information Rule, no
later than 2 hours prior to the arrival of the train at the border; For
arrival by air, no later than the departure time (``wheels up'') of the
aircraft from any foreign port or place in North America, including
locations in Mexico, Central America, South America (from north of the
Equator only), the Caribbean, and Bermuda, and from other areas into
ports that are fully equipped to accommodate CBP's Advance Electronic
Information Rule no later than 4 hours prior to the arrival of the
aircraft in the United States.
    On April 14, 2004, FDA and CBP announced their ``Joint FDA-CBP Plan
for Increasing Integration and Assessing the Coordination of Prior
Notice Timeframes'' (69 FR 19765), which the agencies amended in August
2004 (http://www.cfsan.fda.gov/~pn/pnplan2.html). As stated in the plan
regarding the agencies' assessment of reduced timeframes ``FDA and CBP
continuously are assessing the completeness of prior notice submissions
received as well as the amount of time necessary to receive, review,
and respond to those submissions requiring a human review. However,
that process is not yet complete, as we are currently operating under
the enforcement policies outlined in the Prior Notice Compliance Policy
Guide (CPG). See Compliance Policy Guide Sec. 110.310--Prior Notice of
Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. (Issued December 15, 2003, and
revised June and August 2004; http://www.fda.gov/ora under Compliance
References.) We currently do not receive prior notice for all
shipments.''
    In our plan, we also stated that we would assess existing
procedures and staffing needed to receive, review, and respond to the
prior notices submitted in accordance with the Prior Notice IFR;
identify what changes to work practices and staffing would be necessary
to determine if FDA could continue to receive, review, and respond to
all prior notice submissions with reduced timeframes for land and air
consistent with CBP's rule; and implement necessary changes and make
appropriate adjustments to ensure we could receive, review, and respond
to all prior notice submissions with reduced timeframes before issuing
the final rule, consistent with our obligation to ensure that any
timeframe selected is sufficient to receive, review, and respond to
prior notice submissions, as set out in section 801(m)(2)(A) of the
act. We also emphasized that ``the evaluation of whether to reduce the
timeframes for prior notice review will depend on the level of
compliance industry achieves during the assessment. If we are unable to
make such an assessment, our intended timeframe for issuing a prior
notice final rule may be delayed.''
    Comments received on the prior notice IFR addressed the timeframes
required in the IFR, as well as integration of those timeframes with
the timeframes covered by CBP's advance electronic information rule.
Comments also covered the IFR's requirement that prior notice must be
submitted at least 5 days prior to arrival. We respond to the issue of
timeframes for submitting prior notice here, and respond to the other
questions raised in our Joint Implementation Plan and April 14, 2004,
reopening of the comment period later in this preamble.
1. IFR Timeframes (2, 4, and 8 hours)
    (Comments) One comment asks FDA to permit prior notice to be
submitted at the port of entry, instead of at the port of arrival, in
order to align the prior notice process with long-standing, existing
CBP clearance processes and infrastructures at the port of entry. The
comment reasons that since according to FDA's own estimates, 80 to 90
percent of prior notice data will be filed by the ABI filer, it is
logical that prior notice should be filed at the same port where
clearance entry is filed. The comment also suggests that FDA may want
to consider a two-step process for submitting prior notice, under which
the CBP ``ACI data'' is accepted as the first step, filed at port of
arrival as part of the ``ACI data,'' followed by complete prior notice
in its current form, filed as a second step at the port of entry, i.e.,
concurrent with the clearance entry. Another comment suggests that to
ensure consistency with ACE, the prior notice should be required and
calculated from the port of entry and not the first point of arrival,
as is currently the case.

    Another comment recommends that to fully achieve the FDA-CBP goal
of coordinating timeframes, FDA should adopt the ``point of entry,''
rather than the ``point of arrival'' in the United States to measure
the timeliness of the prior notice filing. CBP's ``point of entry'' is
well known to importers and its use for purposes of the Bioterrorism
Act not only will alleviate unnecessary confusion, but also will
facilitate the stream of U.S. commerce without compromising food
safety.
    The comment also states that with the growing partnership between
FDA and CBP, FDA's concern regarding limited personnel should no longer
be an issue now that FDA and CBP collectively are using their
respective enforcement officials for this joint endeavor.
    (Response) FDA discussed the ``port of entry/port of arrival''
issue extensively in the preamble to the IFR and is not persuaded by
the comments that its initial position should be changed (See 68 FR
58974 at 58988). The Bioterrorism Act established that prior notice be
provided by a specified period of time in advance of the time of the
importation of the article of food involved or the offering of the food
for import, which period shall be no less than the minimum amount of
time necessary for the Secretary to receive, review, and appropriately
respond to such notification, but may not exceed 5 days. That means
that prior notice must be submitted before the article of food arrives
in the United States. Moreover, we explained in the IFR that the
overall purpose of the Bioterrorism Act is to improve the ability of
the United States to prevent, prepare for, and respond to bioterrorism
and other public health emergencies, thereby making essential the
ability to examine or hold a suspect article of food when it first
arrives at a port of entry in the United States, rather than later at
the port where CBP will process the entry. Thus, the final rule uses
the term ``port of arrival'' rather than ``port of entry'' as the food
may not arrive at the port of entry until long after it has arrived in
the United States. In addition, CBP's advance electronic information
rule also requires notice in advance of ``arrival'' in the United
States, and not at ``entry.''
    The IFR and final rule define ``port of arrival'' and ``port of
entry.'' Neither, however, use the terms ``point of arrival'' or
``point of entry.'' FDA could not find reference to ``point of entry''
in CBP rules or regulations.
    FDA does agree that FDA's staffing at certain U.S. ports is much
less of an issue. Under an MOU between FDA and CBP signed by the
respective commissioners of both agencies on December 3, 2003, FDA has
commissioned thousands of CBP officers in ports and other locations to
conduct, on FDA's behalf, investigations and examinations of imported
foods. This unprecedented FDA-CBP collaboration significantly
strengthens the implementation of the Bioterrorism Act to ensure the
security of imported foods, particularly with respect to implementing
the prior notice rule. Building on FDA's and CBP's long history of
close cooperation, the MOU upgrades the two agencies' teamwork in
training, day-to-day operations, and information sharing. As part of
the MOU, FDA and CBP have provided specialized training for the
commissioned CBP employees who carry out this work, and both agencies
have expanded their existing cooperative arrangements to directly share
information affecting the safety and security of imported foods,
including co-locating FDA's PNC with CBP staff. Although the FDA and
CBP partnership benefits the prior notice process in many ways, this
partnership does not mean that the PNC no longer would have staffing
concerns such that the prior notice timeframes could be reduced, as the
comment implies. Please see the discussion later in this document
regarding ``Integration of FDA and CBP timeframes'' for further
discussion on reducing timeframes.
    (Comments) One comment noted that the time difference between their
country and the United States makes it difficult for the agent to start
submitting prior notice immediately upon the receipt of necessary
information. Therefore, some food transported by air, as well as by
water, has actually missed the appointed timeframe. The comment
requests that prior notice be accepted until immediately before the
arrival of the food.
    (Response) FDA disagrees. FDA's PNSI is available 24 hours a day to
submit prior notice. The timeframes established in the final rule are
the minimum amount of time that FDA needs to receive, review, and
respond to prior notice submissions.
2. Integration of FDA and CBP Timeframes
    (Comments) One comment states that ``no shorter timeframes should
be allowed.'' However, the remainder of the comments addressing
consistency of timeframes between FDA and CBP recommend that FDA
timeframes for imported food arriving by air and land be reduced and be
consistent with those set forth by CBP in their advanced electronic
information rule. No comments recommend aligning the prior notice
timeframe for imported food arriving by water with the CBP advanced
electronic information rule timeframe of 24 hours prior to loading on
the vessel. The reasons for recommending that prior notice timeframes
be the same as CBP's advanced electronic information timeframes for
food arriving by air and land are that it would minimize the complexity
of the process by presenting a more streamlined flow of information and
avoid unnecessary duplication, result in fewer errors, provide better
compliance rates, allow for fewer disruptions at the border,
significantly reduce the burden on the trade community without creating
additional security risks, and allow operators at close border points
to load and verify truck loads and travel routes prior to submitting
notice. One comment suggested that there is no basis for concluding
that more time is needed for food shipments than for other shipments.
Another comment states that utilizing one system and one set of
timelines should provide adequate notice to FDA and improve compliance
with the prior notice requirements.
    (Response) The timeframes established in the final rule represent
the minimum amount of time FDA needs to meet our statutory
responsibility to receive, review, and respond to prior notice
submissions. In accordance with our Joint Implementation Plan, we
evaluated the feasibility of conducting prior notice reviews in a
reduced time period in an effort to more closely harmonize the
submissions with CBP timeframes. As part of our assessment, we analyzed
data regarding prior notices we received in the first 9.75 months of
fiscal year (FY) 2005--specifically from prior notices received and
responded to by the PNC between October 1, 2004, and July 23, 2005.
Based on the results of our assessment, in the final rule we have
maintained the timeframes that are in the IFR:
     If the article of food is arriving by land by road, no
less than 2 hours before arriving at the port of arrival;
     If the article of food is arriving by land by rail, no
less than 4 hours before arriving at the port of arrival;
     If the article of food is arriving by air, no less than 4
hours before arriving at the port of arrival; and
     If the article of food is arriving by water, no less than
8 hours before arriving at the port of arrival.
    FDA and CBP established these timeframes for the IFR based on the
information available at the time. By necessity, though, these
decisions regarding timeframes were not informed

by actual experience in operating the prior notice program. We now have
that experience, and the information gained during our assessment shows
that the minimum timeframes for submitting prior notices contained in
the IFR closely match the minimum time necessary for FDA to receive,
review, and respond to the prior notices. During the assessment period,
FDA was able to receive, review, and respond to almost all notices
within the established timeframes. In a relatively small number of
situations, FDA was not able to make a decision regarding whether to
inspect the food at the port of arrival by the end of the timeframe. In
these situations, when the food arrived at the port of arrival, it was
delayed while FDA completed its review. The number of such shipments,
however, has been relatively low, and the resulting impact on
government resources and the flow of traffic at ports has not been
significant. Thus, we do not believe we should increase the timeframes
to account for this relatively small number of outliers whose review
takes longer than the IFR's timeframes.
    Our assessment also shows that, because the IFR's timeframes
closely match the minimum time necessary for FDA to receive, review,
and respond to the prior notices, those timeframes could not be
significantly reduced. If we were to change the timeframes to be
consistent with those of CBP's advance electronic information rule, not
only would this go against the statutory standard for setting the
timeframes, but it would also significantly increase the number of
shipments where FDA would not be able to decide whether it should
examine the food at the port of arrival by the end of the timeframe.
Based on current and projected staffing levels in the PNC, such
shipments would be delayed at the port of arrival until FDA has either
completed its review or decided to examine or not examine the food at
the port of arrival without the benefit of a complete review. FDA could
expend additional resources to increase capacity to review and reduce
the timeframe, but it would be at considerable cost to assist a small
number of shipments that have difficultly meeting these timeframes. In
the nearly 4 years since the end of the transition enforcement period
for the interim final rule, very few shipments have arrived without
prior notice and as such, the timeframes are both reasonable, and
economically efficient. The prior notice review process, information
from our assessment, and the consequences of reducing the timeframes
for conducting the prior notice review are discussed in more detail
below.
    To implement the Prior Notice IFR, FDA established the PNC that
operates 24 hours a day, 7 days a week, all days of the year to
receive, review, and adequately responds to these notices as they are
submitted. PNC staff is also responsible for responding in real-time
(by e-mail, fax, or telephone) to inquiries they receive from affected
parties about pending prior notices and/or operational issues.
    The purpose of prior notice is to help identify food that
potentially poses a significant health risk to the American public and
to deploy resources to the port of arrival so that inspections can be
conducted before the shipment ever enters the United States. Regardless
of whether a prior notice is submitted electronically to FDA through
CBP's ABI/ACS or FDA's PNSI, the prior notice information undergoes a
validation process and is then screened against food safety and
security criteria.
    If the results of our initial validation indicate that the prior
notice requirements have been met and the results of our screening
indicate that the shipment does not appear to be a potential
bioterrorism or significant public health threat, the submission is
considered to have satisfied prior notice requirements and the
associated article of food is allowed to proceed for further
processing, including FDA admissibility review under section 801(a) of
the act. Alternatively, if the results of the initial screening of the
prior notice information indicate there is a potential bioterrorism or
other significant public health threat, the prior notice undergoes
additional intensive review by the PNC using other databases and
sources of information to determine whether the article of food should
be held at the port of arrival for examination or should be allowed to
proceed into 801(a) status for admissibility review. PNC personnel make
this determination using their experience with imported foods and the
expertise within FDA's CFSAN for human food or FDA's CVM for animal
feed, the inspectional information obtained by FDA's ORA, and the
expertise of CBP. FDA's goal is to complete its review within the 2, 4,
or 8 hour timeframe for submitting prior notice so that the review is
complete before the shipment arrives at the port of arrival. If the
intensive review takes longer than the timeframe and the shipment
arrives at the port of arrival, then FDA may delay the shipment at the
port of arrival until its review is completed. FDA could increase
staffing at the PNC in order to decrease timeframes, but the effect has
diminishing returns. When a shipment must undergo intensive review, PNC
staff members are reviewing databases and sorting through information
to determine whether the shipment poses a potential threat. Reviewing
one source of information leads to other sources of information to
investigate. It would not necessarily be effective to expend, for
example, five staff members on one intensive review at the start
because not all sources of information for review are known at the
beginning of an intensive review. Doubling or tripling staff, as
discussed in Option 2B of the Final Regulatory Impact Analysis of this
document, also would result in a significant amount of unused office
space and equipment during the slowest time periods. Staffing at
increased levels at all times would result in wasteful unproductive
staff waiting for shipments to arrive.
    Moreover, the constant unpredictability of the submission times for
high risk prior notices requiring the shortest timeframe review (2
hours for food arriving by land via road) is a significant issue. The
exact busiest times are variable, and are very difficult to predict on
a daily basis. In addition, PNC targeting for high risk shipments also
varies based on contemporaneous targeting intelligence and changing
risk assessment strategies. Having constant two to three times the
number of staff to cover those short bursts of time when the highest
volume of high risk shipments, with the lowest timeframes are at their
peak would be inefficient and wasteful.
    In addition, it has been suggested that the PNC reduce their time
frames and hold only those shipments it needs more time to review.
There are two very significant reasons why this would be impractical.
First, from a security perspective, doing so would result in holding
only potential high risk shipments at the border and would make PNC
targeting strategies widely visible and predictable to both those
involved in legitimate trade, and those with nefarious pursuits looking
to exploit weaknesses in U.S. food cargo security. Second, the holding
of high risk shipments at the port would cause logistical challenges
for port operators, and would almost certainly have a negative impact
on all food and nonfood shipments processed through those ports. In
contrast, with the current PN timeframes which have been in place for
more than 4[frac1s2] years, these logistical challenges have been
almost nonexistent, and PNC targeting strategies are virtually
transparent to the import trade.

    The other factor to consider is the tremendous growth of imported
foods year to year (approximately 14 percent growth over the past 4
years), which far exceeds what FDA projected in the IFR. FDA has been
able to maintain the existing timeframes without adversely impacting
trade. Given that we continue to expect imports to increase in volume,
FDA does not believe that reducing timeframes is warranted. For all the
above reasons, FDA believes that its current and projected staffing
levels are sufficient and appropriate, and the timeframes are both
reasonable, and economically efficient.
    FDA receives approximately 167,000 prior notices each week. The
distribution of prior notices by mode of transportation during our
assessment that were flagged by the initial screening and that received
an intensive prior notice review by the PNC is as follows:

 Table 1.--Proportion of Prior Notices Flagged at the Initial Screening,
                        by Mode of Transportation
Truck                                27.6%
------------------------------------------------------------------------
Car                                  2.9%
------------------------------------------------------------------------
Air                                  17.6%
------------------------------------------------------------------------
Rail                                 0.8%
------------------------------------------------------------------------
Sea                                  39.2%
------------------------------------------------------------------------
Mail                                 11.1%
------------------------------------------------------------------------
Other                                0.8%
------------------------------------------------------------------------

    As indicated, a significant portion (approximately 31 percent) of
the prior notices reviewed by the PNC on a daily basis are land/road
border entries, which under the IFR are subject to submission
timeframes of at least 2 hours before arrival. On average, during the
assessment period, the PNC conducted intensive security reviews on 225
to 250 prior notices per day from all modes of transportation, which
means that, on average, the PNC conducted intensive security reviews on
about 77 prior notices (31 percent of 250) each day that are subject to
the 2-hour timeframe. Moreover, the prior notices are not evenly
distributed over an 8 hour shift or 24-hour day. The actual dispersal
pattern of the prior notice submissions is not uniform; an overwhelming
majority of prior notice submissions arrive between a certain 12-hour
period.
    The amount of time the PNC has needed for its intensive review has
ranged from 20 minutes to 315 minutes (5 hours and 25 minutes) from
when FDA received the prior notice and confirmed it for review. Using
data collected on articles of food arriving by land via truck and car
during our assessment period, the PNC expended an average of 61 minutes
to receive, review, and make a decision on whether or not a shipment
should be refused or held for examination under section 801(m) of the
act, or allowed to proceed into 801(a) status for admissibility review.
The PNC completed about 99 percent of its intensive reviews of prior
notices submitted for land/road border arrivals within 120 minutes of
receiving and confirming the prior notice for review. Only about 57
percent of the intensive reviews were completed within 1 hour. Reviews
for the remaining 43 percent (8,900 prior notices for the assessment
period, or more than 10,000 for FY 2005) took longer. If the timeframe
were set at 1 hour for these articles of food instead of the IFR's 2
hours, the PNC would have had to either delay the food at the port of
arrival until it completed its review or decide whether to examine the
food at the port or arrival without the benefit of a complete review,
based on current and projected staffing levels in the PNC.
    FDA does not have data to accurately analyze the impact of changing
the timeframe to 30 minutes for FAST participants because FAST
membership is not one of the data elements that we currently require in
a prior notice submission. FDA instead did the analysis based on the
total number of prior notices submitted that the PNC could review based
on a timeframe of 30 minutes. The PNC completed less than 10 percent of
its intensive reviews of prior notices submitted for land/road border
arrivals within 30 minutes of receiving and confirming the prior notice
for review. If the timeframe for all articles of food arriving by land
by truck and car during our assessment period had been 30 minutes
(i.e., the timeframes for FAST participants) instead of 2 hours, the
PNC would not have completed approximately 68 percent of its intensive
reviews (over 14,000 during the assessment period, which equates to
approximately 16,000 for FY 2005 of the land/road border prior notices)
within the applicable timeframe. As a result, the PNC would have had to
either delay the food at the port of arrival until it completed its
review or decide whether to examine the food at the port of arrival
without the benefit of a complete review, based on current and
projected staffing levels in the PNC. This assessment is an
overestimate of the number of articles of food that would be eligible
for FAST timeframes, as we do not know how many articles of food
arriving in the United States subject to the prior notice requirements
are from FAST and C-TPAT participants. Moreover, there are other
impediments to integrating prior notice with the C-TPAT and FAST
programs. These are discussed in section III.D.6 of this document
(``Additional Exclusions Requested--Special Programs (C-TPAT/FAST) and
Flexible Alternatives'').
    We also conducted a similar assessment on prior notices submitted
for articles of food arriving by air between October 1, 2004, and July
23, 2005. The IFR requires prior notices for these shipments to be
submitted and confirmed for review at least 4 hours before the food
arrives at the U.S. port of arrival. If the timeframes for articles of
food arriving by air during our assessment period had been reduced to
``wheels up,'' the PNC would not have completed approximately 21
percent of the intensive prior notice reviews for articles of food with
flight times less than 3 hours. These articles of food (2,700 for our
assessment period, or an estimated 3,230 for FY 2005) also would have
been subject to cargo delays and/or increased cargo examinations, based
on current and projected staffing levels in the PNC.
    Neither FDA nor CBP have sufficient personnel or resources to
accommodate the number of additional cargo delays and/or food shipment
examinations that would result under either 60- or 30-minute timeframes
for articles of food arriving by land by road. This would include the
significant additional personnel and resources needed to track,
facilitate, and coordinate the evaluation and/or examination of the
delayed cargo. Coordination of the handling of delayed shipments is a
resource intensive process that can last for multiple days per
shipment, and includes communicating with both FDA and CBP personnel at
the border, and the brokers/filers and importers involved in the
shipment.
    To handle the extra work, the PNC would need to shift its personnel
based on current and projected staffing levels in the PNC, resulting in
fewer staff being available to review prior notices for all categories
of shipments including shipments arriving by water. The PNC's current
approximate average time for the PNC intensive review for shipments
arriving by water is 5 hours, which is within the 8 hour submission
timeframe. We would expect, based on our assessment, that the time
taken away from prior notice review work for the increase in
coordination due to the increase in delays and examinations for

land and air shipments would increase the time needed to complete
intensive review of prior notices for shipments arriving by water by 25
percent at the minimum. As a result, over 7,000 shipments by water
during our assessment period (estimated as 7,370 for FY 2005) would
have been delayed at the port of arrival while the PNC completed its
intensive review and determined whether the shipment in fact presented
a significant health threat, based on current and projected staffing
levels in the PNC.
    In setting the timeframes, the act provides that we may consider,
among other considerations, the effect on commerce (section
801(m)(2)(A) of the act). Assuming current and projected PNC resources,
lowering the timeframes to 60 or 30 minutes would likely result in
delays at the border, not only for those shipments delayed for
intensive review longer than the timeframe, but also for other
shipments passing through the port, especially at the busiest land
border ports where traffic lanes, parking, and inspection facilities
are extremely limited. In some ports, the lack of holding facilities
could result in an increase in trucks being turned around at the
border. As we have mentioned above, there have been a relatively small
number of situations where FDA was not able to make a decision
regarding whether to inspect the food at the port of arrival by the end
of the timeframe, causing a small number of shipments to be delayed
when it arrived at the port of arrival. Since the impact of these small
number of delays on trade has not been significant, continuing to
maintain that the current IFR timeframes is the most efficient use of
resources.
    Thus, based on current and projected resources and other high-
priority activities FDA is addressing, reducing the timeframes would
lead to an increase in delays at the ports of arrival, causing FDA to
shift some resources away from conducting intensive reviews of prior
notices so they can conduct the coordination and other activities
necessary for these delayed shipments. The shift in resources away from
conducting intensive reviews would, in turn, further increase the
number of shipments that are delayed because FDA has not been able to
finish its intensive review within the applicable submission timeframe.
This ultimately would cause a delay in getting cargo to its final
destination, which would have an adverse impact on trade.
    Moreover, the number of prior notices identified for intensive
review has increased over time, as intelligence and other risks are
identified. We expect the number of intensive reviews to continue to
increase relative to the assessment period, resulting in even more food
shipments that would be delayed or held for examination under shortened
timeframes.
    We did not get any comments asking us to coordinate the timeframes
for articles of food arriving by water in our prior notice rule (8
hours before arrival) with those in CBP's rule (24 hours before
arrival). We received one comment asking us to reduce the time for
articles arriving by water. We stated in the preamble to the IFR ``In
determining the actual timeframes for submission of prior notice for
each mode of transportation, FDA considered the need to provide
sufficient time for the agency to review and respond to the information
submitted, as well as the current ability of the food industry to
provide the information required within the stated timeframe given the
differences in lead time before arrival among different modes of
transportation. We determined that information for shipments whose
transport time is measured in days or weeks (e.g., ocean shipments) is
available further in advance of arrival than shipments whose transport
time is measured in hours (e.g., land and air shipments.) Staggered
prior notice submission timeframes will allow FDA reviewers to direct
additional resources to shipments with short transport times and to
defer review of shipments with longer transport times. Based on these
considerations, FDA established the prior notice timeframes in the
interim final rule to associate with the mode of transportation.'' (69
FR at 58995). We continue to hold this view for shipments arriving by
water in light of our assessment for articles of food arriving by land
and air.
    For all of the previously stated reasons, we did not reduce the
timeframes for submitting prior notice in the final rule for any mode
of transportation, as these timeframes still are the minimum amount of
time FDA needs to fulfill its statutory obligation to receive, review
and respond to prior notices while having the minimal impact on trade.
    (Comments) One comment suggests that it would be preferable for FDA
to harmonize the prior notice timelines to the future ACE transmission
timelines, ensuring consistency and compliance of the trade community
and efficiencies in both agency and industry workforces.
    (Response) FDA agrees that timeframes for submission of prior
notice may be further evaluated in light of new trade programs such as
ACE, when it is implemented and in effect. CBP is planning to bring its
ACE system on line in the next few years, which will accommodate prior
notice submissions and eliminate or change ABI/ACS and PNSI prior
notice submissions. FDA will continue to assess and pursue the
integration of timeframes as policies, processes, and strategic IT
systems are improved. FDA believes that the most opportune time for
coordinating timeframes will coincide with the startup of CBP's ACE. We
will determine at that time or after ACE is operational whether the
prior notice timeframes should and can be reduced further. Until that