these codes are often not sufficient to specifically identify a product
for FDA decisionmaking. For example, in many cases, the tariff code
does not describe how the product was processed (e.g., commercially
sterile or shelf-stable) or how the product is packaged. Thus, several
products that FDA considers different from each other (because these
differences affect the potential safety of the food) may be combined
under one HTS code. (See 68 FR 58974 at 59004.) Moreover, the HTS code
has never been sufficient for FDA admissibility decisions; at entry,
the FDA product code has been required on FDA-regulated products.
Therefore, the FDA product code should be familiar to most submitters
of prior notice. Prior notice requires that we now get this information
before arrival of the article of food into the United States.
    (Comments) One comment asserts that FDA has issued an interim final
regulation that requires prior notice needlessly. The comment provides
an example of a container containing red wine, under 14 percent alcohol
and in multiple varietals and sizes from the same manufacturing
facility and asserts that multiple prior notice submissions should not
be required.
    (Response) FDA disagrees. For prior notice to accomplish its
intended purpose and help FDA protect American consumers, a prior
notice must be submitted for each article of food. If the food is
identified by a single FDA product code, size, and manufacturer, then
only one prior notice is required. Currently there are only seven FDA
product code designations covering wine: White/still, red/still, rose/
still, naturally carbonated sparkling, artificially carbonated
sparkling, Champagne, and wine coolers. The identity of the size of the
article of food is covered under the requirement to submit the
estimated quantity of the article of food (see Sec.  1.281(a)(5)(iii),
(b)(4)(iii), and (c)(5)(iii)). In the previous example, although the
shipment contains only red wine from the same manufacturer, there are
different sizes of bottles within the container and each package size
requires a separate prior notice. The reason is that a problem in
sealing one size bottle of wine, but not the other size bottles, may
result in serious adverse health consequences. As we explained in the
preamble to the IFR, FDA believes that package size is necessary and
part of product identity. Moreover, the base unit of measure is a
characteristic of product identity and is thus necessary for effective
review of the prior notice information. Base unit is critical to
processing safety requirements and is particularly important when
evaluating the safety of low-acid canned foods (68 FR 58974 at 59005).
    (Comments) One comment requests that a single prior notice should
cover one commodity and alternately suggests that a single prior notice
be required for each FDA Product Code. As an example, the comment
suggests that a separate prior notice is required for each size of
apples in a load with 10 sizes of apples representing one FDA Product
Code.

Another comment suggests that all products covered by the same FDA
product code should require a single prior notice entry.
    (Response) A separate prior notice is required for each article of
food represented in a shipment or a load. In the example of different
sizes of apples, because apples are identified by one FDA Product Code,
and assuming that all the apples represent the same grower, if known,
and the remainder of the required information is the same for all the
apples, then one prior notice would be sufficient. However, if the
articles of food represent the same FDA product code but contain
different package sizes, then these are different articles of food and
a separate prior notice is required for each.
    (Comments) One comment states that prior notice would need to be
submitted for each brand, and then each bottle size and format.
    (Response) In response to comments to the proposed rule, FDA
determined that the brand is not critical for risk-based screening and
the IFR did not require identification of the brand of the article of
food. This determination has been retained in the final rule.
Identification of the size of the article of food is covered under the
requirement to submit the estimated quantity of the article of food
(see Sec.  1.281(a)(5)(iii), (b)(4)(iii), and (c)(5)(iii)).
    a. The complete FDA product code. FDA's product code is a unique
numeric code currently used by FDA and customs brokers and self-filers
to describe food products, as well as other products regulated by FDA.
The IFR requires in Sec.  1.281(a)(5)(i), (b)(4)(i), and (c)(5)(i), the
complete FDA Product Code be submitted.
    (Comments) Several comments ask for clarification about the
appropriate FDA product code to use for specific products and for
guidance concerning specific types of products. Several comments
request that the FDA Product Code Builder be translated into various
foreign languages. Two comments request clarification regarding the
appropriate product code for gift packs. One comment requests that
submitters be advised of the correct product code for foods subject to
prior notice requirements.
    (Response) The final rule does not attempt to clarify appropriate
coding for specific products. The FDA product codes are frequently
updated, revised and changed. The active codes are available in the FDA
Product Code Builder at http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/
PCB.HTM. The FDA Product Code Builder also contains many synonyms for
foods covered by the same product code designations; e.g., Rice Flour
(FDA Product Code 02C-01) has the synonyms of Bot Gao (Vietnamese rice
flour), Harina De Arroz (Latin American rice flour), and Joshinko
(Japanese fine, white rice flour, used to make taffy-like sweets). At
this time due to resource constraints, FDA does not plan to translate
the FDA Product Code Builder into foreign languages. A product code
builder tutorial is available at http://www.cfsan.fda.gov/~pn/pcb-
tut.html.
    As stated previously (see the discussion on the identity of the
article of food being imported or offered for import), a gift pack is
not a single article of food, but multiple articles of food packed
together. Each article of food in a gift pack must be covered by a
separate prior notice with an FDA product code for each article.
However, FDA is proposing an enforcement policy whereby FDA should
typically not take regulatory action if a single prior notice is
submitted for a gift pack. More details about this proposed enforcement
policy are described in the Prior Notice Final Rule Draft CPG,
published elsewhere in this issue of the Federal Register.
    b. The common or usual or market name. The IFR in Sec.
1.281(a)(5)(ii), (b)(4)(ii), and (c)(5)(ii) requires the submission of
the common or usual name or market name of the article of food as an
element of the identity of the article of food. (See 21 CFR 102.5 for
additional information about common or usual names.)
    (Comments) Several comments ask for clarification about the
appropriate common, usual, or market name to use for specific products
and for guidance concerning specific types of products. One comment
asks if a sufficient common, usual, or market name would be the name or
names of products listed in the FDA Product Code Builder.
    (Response) The final rule does not attempt to clarify appropriate
common, usual, or market names for specific products. The FDA Product
Code Builder contains many synonyms, which are common, usual, or market
names, for foods covered by the same product code designations; e.g.,
FDA Product Code 16A--4 Ocean Perch is also known as Pacific Perch, Red
Perch, Red Rockfish, and Rosefish. Therefore, anyone needing
information about the appropriate common, usual or market name to use
should consult the FDA Product Code Builder, which is accessible at
http://www.cfsan.fda.gov/~pn/pcb-tut.html.
    c. The estimated quantity of food. The IFR in Sec.
1.281(a)(5)(iii) and (b)(4)(iii) requires the estimated quantity of
food that will be shipped, described from largest container to smallest
package size and for articles of food that have been refused under
section 801(m) of the act in Sec.  1.281(c)(5)(iii), the quantity of
food that was shipped, described from largest container to smallest
package size.
    (Comments) Several comments recommend elimination of the submission
of quantity for each article of food, and recommend that such
situations involving various sizes and quantities of similar articles
of food (e.g., same FDA product code and same manufacturer) be covered
by one prior notice submission.
    (Response) FDA disagrees. FDA continues to believe that quantity is
a necessary component of product identity. FDA also believes that
package size is a necessary part of product identity. The base unit of
measure is a critical characteristic of product identity and is thus
necessary for effective review of the prior notice information. Base
unit also is critical to processing safety requirements and is
particularly important when evaluating the safety of low-acid canned
foods. Both base unit and total quantity (which includes knowing the
smallest ``package size'') are necessary for response (examination) and
communication with FDA and CBP staff at the port. As noted in FDA's
``Food Security Preventive Measures Guidance for Importers''
(``Guidance for Industry, Importers and Filers, Food Security
Preventive Measures Guidance,'' March 2003), these elements are also
critical for food security examinations to determine if the amount
ordered is the amount received. For example, if more was received than
was ordered, the guidance recommends an investigation to determine the
cause of the discrepancy, as additional and unwanted articles may have
been added to intentionally contaminate the shipment. If less is
received than ordered or than shipped, some of the food may have been
intentionally diverted. Both base unit and total quantity are currently
data elements that can be submitted via ABI/ACS to OASIS.
    (Comments) One comment asks for clarification as to the
requirements in Sec.  1.281(a)(5)(iii) and (b)(4)(iii) for estimated
quantity and the requirement in Sec.  1.281(c)(5)(iii) for the actual
quantity.
    (Response) The requirement for providing estimated quantity in
Sec.  1.281(a)(5)(iii) and (b)(4)(iii) apply to those prior notices
provided in accordance with the requirements in the final rule; i.e.,
those submitted before the food arrives at the port of arrival in

the United States as required in Sec.  1.279. The requirement for
providing the actual quantity in Sec.  1.281(c)(5)(iii) applies only to
those articles of food refused under section 801(m) of the act, i.e.,
prior notices submitted after the article of food has arrived at the
port of arrival without adequate prior notice and has been refused. In
this case, since the article of food already has arrived, the quantity
is set and the actual quantity can be determined and submitted in the
post-refusal prior notice.
    (Comments) One comment asserts that a slide entitled ``Article of
Food vs. Shipment of Food'' in an FDA presentation about the IFR
provides a conflict of interpretation about the requirement to provide
the estimated quantity. The comment asserts that the illustration
suggests a separate prior notice is required for each and asks that FDA
clarify this presentation.
    (Response) The illustration in question (see http://
www.cfsan.fda.gov/~dms/fsbtac17/sld014.htm) provides the following
example:

         Table 1A.--``Article of Food'' vs. Shipment of Food\1\
Tuna           24/12 oz. cans      2,000 cases        Company 1
------------------------------------------------------------------------
Tuna           48/6 oz. cans       1,000 cases        Company 1
------------------------------------------------------------------------
Tuna           24/12 oz. cans      300 cases          Company 2
------------------------------------------------------------------------
Tuna           6/66 oz. cans       2,400 cases        Company 3
------------------------------------------------------------------------
\1\ One shipment; 4 different products; 4 prior notices

    FDA reiterates that the previously shown chart illustrates a
situation with four different articles of food, each requiring a
separate prior notice. The example provides three different
manufacturers of the canned tuna; thus, canned tuna from each of these
manufacturers requires a separate prior notice submission. Further, the
12 ounce (oz) cans and the 6 oz cans manufactured by Company 1 are
different sizes and thus are different articles of food. Accordingly,
each requires a separate prior notice submission.
    The final rule continues to require submission of the estimated
quantity of food that will be shipped, described from largest container
to smallest package size. A prior notice will not be inadequate if the
estimated quantity changes between the confirmation of prior notice and
the time of arrival. Similar to the IFR, the final rule does not
require that a prior notice be cancelled and resubmitted if the
estimated quantity changes after confirmation.
    d. The lot or code numbers or other identifier. The IFR in Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) requires the submission of
the lot or code numbers or other identifier of the food if required by
the act or FDA regulations; e.g., low-acid canned foods, at Sec.
113.60(c); acidified foods, at Sec.  114.80(b); and infant formula, at
Sec.  106.90.
    (Comments) One comment requests clarification concerning when a lot
or code number or other identifier is required for an article of food.
    (Response) The lot or code numbers are the identification numbers
or code of a production lot, which can more specifically identify a
product for screening and examination purposes and for communication
within FDA and with CBP and the manufacturer, etc. For example, recalls
involving serious health risks are often associated with a specific
production lot, such as counterfeit infant formula or under-processed
canned food. FDA screening can target these food products for
examination based on information of public health emergencies or
recalls in foreign countries.
    FDA regulations require lot/code identifiers for certain foods.
Currently, low acid canned foods, acidified foods, and infant formula
are required to bear lot codes or other identifiers (see Sec.
113.60(c) (low-acid canned foods); Sec.  114.80(b) (acidified foods);
and Sec.  106.90 (infant formula low-acid canned foods)). The interim
final and final rules require lot/code or other identifiers only for
these kinds of articles of foods. Many other foods may have lot or code
identifiers that are not required by FDA regulation; submission of
these identifiers is optional under the final rule.
    Submission of the required lot/code identifier is accommodated by
ABI/ACS as an affirmation of compliance or through PNSI as a production
identifier. ACS currently allows for submission of more than one
affirmation of compliance per article of food. PNSI also accepts more
than one lot identifier per article of food.
    (Final rule) The final rule requires in Sec.  1.281(a)(5)(i),
(b)(4)(i), and (c)(5)(i) the complete FDA product code. The final rule
in Sec.  1.281(a)(5)(ii), (b)(4)(ii), and (c)(5)(ii) requires the
submission of the common or usual name or market name of the article of
food as an element of the identity of the article of food. The final
rule in Sec.  1.281(a)(5)(iii) and (b)(4)(iii) requires the estimated
quantity described from the largest container to the smallest package
size. For articles of food that have been refused under section 801(m)
of the act, the final rule in Sec.  1.281(c)(5)(iii) requires
submission of the quantity of food that was shipped, described from
largest container to smallest package size. The final rule in Sec.
1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) requires the submission of
lot or code numbers or other identifiers for articles of food if
required to bear such numbers by the act or by FDA regulations.
7. Identity of the Manufacturer
    Section 801(m)(1) of the act states that a prior notice must
contain the identity of the manufacturer of the article of food being
imported or offered for import. Section 1.281(a)(6), (b)(5), and (c)(6)
of the IFR requires that prior notice for an article of food that is no
longer in its natural state include the name and address of the
manufacturer and the registration number assigned to the facility that
is associated with the article of food. The IFR further states that a
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage, and export, or further manipulation and export.
The IFR also provides that if the article of food is sent by an
individual as a personal gift (i.e., for nonbusiness reasons) to an
individual in the United States, he or she may provide the name and
address of the firm that appears on the label under 21 CFR 101.5
instead of the name, address, and registration number of the
manufacturer. If a registration number is provided, city and country
may be provided instead of the full address.
    FDA received many comments on the requirement to provide the name,
address and registration number, when applicable, as the identity of
the manufacturer. For ease in discussing these comments, we are
presenting the issues they raise into the following general categories:
     Does ``the manufacturer'' in section 801(m) of the act
mean the place where the food was actually manufactured or can it
include other entities? What if more than one entity was involved in
the manufacture of the article of food?
     Does FDA have the authority to require the registration
number of the manufacturer of the article of food being imported or
offered for import as a data element in prior notice?
     Assuming FDA can require the manufacturer's registration
number in a prior notice submission, should FDA continue to do so in
the final rule and/or should FDA provide an alternative means for
submitters to provide the identity of the manufacturer? and

     Questions Seeking Clarification.
    a. Does ``the manufacturer'' in section 801(m) of the act mean the
place where the food was actually manufactured or can it include other
entities? What if more than one entity was involved in the manufacture
of the article of food? (Comments) Section 1.281(a)(6) of the IFR
requires the submission of the identity of the manufacturer of each
article of food no longer in its natural state. Several comments
recommend that the final rule define ``the manufacturer.'' Some
comments note that for ``gray market'' or ``parallel market''
importations (food purchased outside the manufacturer's distribution
chain and imported to the United States), the only identifiable product
information is that which is on the product itself. The comments
suggest that in lieu of the name, address, and registration number of
the manufacturer of the food, the prior notice submission should
include the name and address of the entity that appears on the label on
the food. A comment notes that while this information is not as
detailed as that required for other imports, it relieves importers of
``gray market'' foods from having to provide information that in most
instances would never be available to them. Other comments suggest that
shipments of gifts to individuals but with a commercial purpose, such
as business gifts to generate goodwill among colleagues, should be
permitted to reference the manufacturer's name and address as shown on
the label in lieu of the registration number of the manufacturer.
    Several comments request that FDA provide guidance regarding how to
complete prior notice for imported food from multiple manufacturing
facilities. One comment suggests that the final rule should define the
manufacturer as the last entity to conduct a processing operation;
e.g., including bottling, but excluding labeling. Another comment
provides an example of wine that is produced and bottled at winery
``X'' and sent to winery ``B'' for labeling, which sends the wine to
another facility for storage, which then transfers the wine to the
freight forwarder ``F'' who stores and consolidates the wine with other
wines for shipment to the United States. Another comment provides an
example of fresh fruit that is processed in one facility in a foreign
country and then is transported to one or several other facilities that
re-palletize the fruit, resulting in a finished pallet containing boxes
that have been packaged at several packing facilities.
    (Response) These comments address, directly or indirectly, the
meaning of ``the manufacturer'' in section 801(m) of the act. In
construing the prior notice provision of the Bioterrorism Act, FDA is
confronted with the question of whether Congress has directly spoken to
the precise question presented (``Chevron step one''). Chevron, U.S.A.,
Inc. v. NRDC, Inc., 467 U.S. 837, 842 (1984). To find no ambiguity,
Congress must have clearly manifested its intention with respect to the
particular issue. Young v. Community Nutrition Institute, 476 U.S. 974,
980 (1986). If Congress has spoken directly and plainly, the agency
must implement Congress's unambiguously expressed intent. Chevron, 467
U.S. at 842-843. If, however, the Bioterrorism Act is silent or
ambiguous as to the meaning of ``the manufacturer,'' FDA may define
this term in a reasonable fashion (``Chevron step two''). Chevron, 467
U.S. at 842-843; FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
132 (2000).
    We have determined that in enacting section 801(m) of the act,
Congress did not clearly manifest its intention with respect to the
meaning of ``the manufacturer.'' When an article of food is made from
one or more raw ingredients, there could be several entities involved
in its manufacture. For example, boxed macaroni and cheese might
involve preparing the dried macaroni, preparing the dried cheese,
combining these materials, and packaging and labeling the finished
product. Where multiple steps are carried out by multiple entities, the
act does not directly and plainly set forth which entity or entities
Congress intended as the manufacturer to be submitted as part of the
prior notice. Another question regarding ``the manufacturer'' whose
answer is not clearly manifested in the act is whether the manufacturer
means the specific facility where the article is manufactured or the
entity that owns, or contracts with, the manufacturing facility.
Additionally, Congress did not plainly address whether the entity
listed on a product's label could be considered the manufacturer. The
entity listed on a product's label can be, as provided by 21 CFR 101.5,
the packer or distributor. Additionally, under that regulation, the
label may state the principal place of business of the manufacturer,
packer, or distributor in lieu of the actual place where the food was
manufactured or packed or is to be distributed, unless the statement
would be misleading.
    For the reasons given in the following paragraphs, we have
determined that, for purposes of section 801(m) of the act, the phrase,
``the identity of the manufacturer,'' should be interpreted to mean the
place where the food was actually manufactured/processed (i.e., the
site-specific manufacturing facility). We believe that this
interpretation is reasonable and consistent with the goals of the
Bioterrorism Act.
    In considering whether it is reasonable to interpret the
manufacturer as being the actual place where the food was manufactured,
we considered the language and purpose of the prior notice provision,
as well as the other provisions of the Bioterrorism Act. The 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'' (Public Law 107-188). The prior notice provision
contributes to this goal by providing the agency with the information
it needs to determine whether, due to significant concerns about an
article of imported food, it should inspect the food upon arrival in
the United States. Having the identity of the actual place where the
food was manufactured (i.e., the site-specific manufacturing facility)
will inform these risk-based decisions much better than having the
identity of the packer or distributor or even the name and address of
the manufacturer's principal place of business.
    Information about the manufacturer contributes to FDA's inspection
decisions under prior notice in two principal ways. One way is that
when FDA receives intelligence regarding potential areas of concern
about food shipments, this intelligence is often linked to a site-
specific manufacturing facility. For example, FDA received intelligence
regarding alleged contamination with a harmful chemical substance of
certain imported food products from a certain specific foreign
manufacturing facility. FDA flagged shipments from this facility for
further PNC review, and subsequently recommended the examination and
sampling of several shipments from the site specific facility due to
the significant public health threat posed by the articles of food.
Because the identity of the site-specific manufacturing facility was
included in the prior notices, FDA was able to match the intelligence
with the relevant food shipments, without affecting the importation of
similar products from other manufacturers. If prior notice only
included the name and address listed on the label, FDA could not have
confidence that it could flag shipments of the food manufactured at the
specific facility, either for further PNC review or for inspection.
Matching a third-party distributor or packer with the actual
manufacturer that FDA wants to flag

based on intelligence would be very difficult and time consuming, and
may even be impossible to do with the information available to the
agency. If prior notice included the principal place of business of the
manufacturer (e.g., the corporate headquarters location) instead of the
site-specific manufacturing facility, FDA's ability to correctly target
shipments would not be much better. More often than not, when FDA
receives intelligence regarding a manufacturer, it is specific to the
site-specific manufacturing facility and not just the manufacturer's
corporate identity. In these situations, if the prior notice that has
been submitted contains only corporate-level information, FDA would
have to target every relevant shipment from every plant the firm owns
or contracts with, which could be dozens, or even hundreds. As a
result, much time would be spent unnecessarily reviewing many shipments
that may not be of interest but whose risk could not be discounted
based on the supplied manufacturer information.
    The other way information about the manufacturer contributes to
FDA's inspection decisions under prior notice is the agency's use of
this information during its manual review of a prior notice. Regardless
of the reason a shipment is flagged for manual review by the PNC, the
identity of the manufacturer is one of the key elements FDA relies on
in further assessing the potential risk a shipment poses to the United
States. FDA does this by using the identity of manufacturer, as
provided in prior notice, to gather additional information from a
variety of sources, such as FDA's and other government agencies'
databases and research using publicly available information. For
example, FDA will often try to determine whether the article of food
being imported is consistent with the type or types of food the
facility usually makes and ships to the United States, whether the
facility's owners, agents, or workers have potential ties to security
concerns, and whether FDA has found problems with prior shipments from
the facility. The more closely that this information is tied with the
site-specific manufacturing facility, the more reliable the risk
assessment will be. If prior notice could include the name and address
of the firm on the label (in lieu of the site specific manufacturer),
and this firm is the product's distributor, then FDA would be able to
gather additional information about the distributor but not the
manufacturer. A risk assessment based on information concerning the
distributor would be much less meaningful than one based on the actual
manufacturer because the actual manufacturer has much more control over
the product's quality and security than the product's distributor.
    For example, when researching the site-specific manufacturer listed
in a prior notice to investigate potential security concerns, FDA found
information in a government database suggesting the facility had ties
to terrorism. Based on this and other information, FDA decided to
examine the product covered by the prior notice. If the name and
address of a different firm, such as the distributor, had been provided
in the prior notice instead, it is unlikely that FDA's research would
have turned up this association and unlikely that this shipment would
have been flagged for inspection. In its experience under the IFR, when
prior notice has not included the identity of the actual manufacturer,
FDA has had to attempt to determine the site-specific manufacturer by
using alternative means such as inspection, contacting the submitter,
and/or contacting the firm listed on the label, a process that in some
cases has taken days and even weeks. The only other way to be sure that
the subject article of food is not a threat is to have the food stopped
and examined at the port of arrival to determine if it is a threat.
Stopping shipments while FDA conducts additional research or an
inspection would require significant agency resources and could create
inefficiencies for the agency, CBP, industry, and consumers as food
shipments back-up at the border.
    Similarly, if the prior notice included the principal place of
business of the manufacturer rather than the specific manufacturing
facility, this information is likely to be too broad to be helpful,
particularly if it is a large company. Each manufacturing facility is
different, in terms of its employees, the food it manufactures for the
United States, its manufacturing processes, and its security standards
and procedures. One location of a company may have a higher standard
for the security of its employees and manufacturing processes than
another location. In those cases where the parent company owns or
contracts with multiple manufacturing facilities, FDA would have to
determine the risk associated with each of these facilities to ensure
our review is adequate. Because FDA is under strict timeframes to
review, assess risk, and respond to the prior notices, conducting such
wide-ranging research is not practical. Not only would this be
prohibitively time-consuming (which would have a detrimental impact on
trade), in many situations FDA may not be able to ascertain the
identity of each of the firm's manufacturing facilities. Alternatively,
FDA could attach a risk to the headquarters location, but doing so
would result in a less meaningful prior notice risk assessment and may
result in articles of food being assigned a lower or higher risk than
they should have based on the specific manufacturing facility.
    Our interpretation of ``the manufacturer'' to mean the actual place
where the food was manufactured also furthers the purposes of the
Bioterrorism Act by helping to ensure that imported food is from
registered facilities. Under section 801(l) of the act, food that is
imported or offered for import is subject to being held if it ``is from
a foreign facility for which a registration has not been submitted to
[FDA] under section 415'' of the act. FDA checks the information about
the site-specific manufacturing facility provided in prior notice to
verify that facility's registration status. If the prior notice
provided only the name and address listed on the label of the food
rather than the actual manufacturing facility, FDA would have no
practicable means to readily determine whether the manufacturing
facility is registered. As explained previously, the name and address
on the label could be, for example, the distributor or the parent
company of the facility.
    Collecting information regarding the manufacturing facility of an
imported product and its registration status goes back to well before
prior notice. As part of the admissibility review process for the
various types of imported goods it regulates, FDA collects, among other
information, the ``FDA Manufacturer'' and applicable registration
numbers. (See, for example, 70 FR 69576, November 16, 2005.)
    The Bioterrorism Act expanded the registration requirement with
respect to food facilities. New section 415 of the act requires
domestic and foreign facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United States to be
registered with FDA, unless the facility is exempted. Under new section
801(1) of the act, food from a foreign facility that has not registered
under section 415 of the act is subject to being held until the foreign
facility has registered. It could be argued that FDA should make its
determination about the food manufacturing facility's registration
status as part of the entry and admissions process. The reason it is
necessary to make this determination at the time FDA is reviewing prior
notice

is that if the article of food is held under section 801(l) of the act,
it may not be delivered to the importer, owner, or consignee and cannot
be moved under bond under section 801(b) of the act. Operationally, the
only way to implement these movement restrictions is to conduct the
registration status review before entry is filed, which is when the
prior notice review is conducted.
    The comments recommending that the prior notice rule be expanded to
allow the identity of the entity shown on the product label in lieu of
the identity of the manufacturer are generally based on the argument
that information about the manufacturer, especially its registration
number, is not always available to the submitter, such as when food is
purchased outside the manufacturer's distribution chain. The statute
indicates that Congress considered the issue of whether it would be
difficult or impossible to provide the identity of the manufacturer but
chose to require it nonetheless. Among the data required by prior
notice are the identity of the manufacturer and, for food in its
natural state, the identity of the grower, if known. Section 801(m) of
the act expressly provides that the identity of the grower does not
need to be submitted if it is not known within the prior notice
timeframes; however, the act does not include this exemption for the
identity of the manufacturer. This indicates that this information
about the manufacturer must be submitted regardless of any potential
difficulties in obtaining it. With respect to the comments that were
concerned about situations where the person submitting prior notice
does not know the registration number of the manufacturer, as discussed
elsewhere in this preamble, FDA and CBP are modifying the final rule
such that the identity of the manufacturer can be submitted as the name
of the manufacturer and either the registration number, city, and
country of the manufacturer, or both the full address of the
manufacturer and the reason the registration number is not provided.
    Regarding situations where multiple steps are carried out by
multiple entities, we have determined that ``the manufacturer'' can
reasonably be interpreted to mean the last facility that manufactured/
processed the article. A facility is the last facility that
manufactured/processed the food if the food does not undergo further
manufacturing/processing, other than the addition of labeling or any
similar activity of a de minimis nature. This interpretation is based
on the definition of a foreign manufacturer under the food facility
registration provision, section 415(b)(3) of the act, and our
implementing rule, 21 CFR part 1, subpart H (see specifically
Sec. Sec.  1.227(b)(2) and 1.226(a)). It also is consistent with the
definition of FDA manufacturer collected as part of the entry and
admissibility process, which states that if more than one party
processed the article, then the manufacturer is the last party who
substantially transformed the product. (See, for example, 70 FR 69576,
November 16, 2005.)
    Applying this definition to the example pertaining to wine in the
comments, the manufacturer for purposes of prior notice would be winery
``X'' since this is the facility that produced and bottled the wine.
The other facilities involved in this example perform either
manufacturing activities of a de minimis nature, such as labeling, or
other activities not related to manufacturing, such as storing and
consolidating the wine. Thus, although some of these facilities might
have to register with FDA as required by 21 CFR part 1, subpart H as
holders or packers of food intended for consumption in the United
States, the facilities in the example other than winery ``X'' are not
considered the last facility under the prior notice final rule's
definition of ``manufacturer.'' Regarding the comment on fresh fruit,
FDA assumes that the comment is using the term ``processed'' to mean an
activity (such as treatment against pests or polishing) that leaves the
food still in its natural state, as explained in the definition of ``no
longer in its natural state'' under Sec.  1.276(b)(10). Although
subsequent facilities palletize the fruit, these would not be
manufacturers because they only pack the food and packing is not
considered manufacturing/processing. Under this scenario, no
information for any manufacturers would be required for the prior
notice. Instead, under Sec.  1.281(a)(7) of the final rule, the prior
notice would require the name and address of the grower, if known.
    Consistent with the interpretation that the identity of the
manufacturer requires site-specific information, we are removing the
provision in the IFR stating that if the article of food is sent by an
individual as a personal gift to an individual in the United States,
then the name and address of the firm that appears on the label could
be submitted instead of the identity of the facility that manufactured
the food. We note, however, that under the enforcement policy
contemplated in the Prior Notice Final Rule Draft CPG, FDA and CBP
would typically consider not taking regulatory action when no prior
notice is submitted with respect to gifts that are shipped by an
individual to an individual.
    Given the importance of having the site-specific manufacturer, we
are also proposing a change to the CPG regarding the identity of the
manufacturer. The Prior Notice Interim Final Rule CPG had a policy that
covered situations where, after a good faith effort, the person
submitting prior notice did not know the name and address of the
facility that manufactured the food. It stated that if the submitter
provided certain alternative information, such as the identity of the
facility's headquarters, FDA and CBP should typically consider not
taking any regulatory action despite this noncompliance with the prior
notice requirements. The Prior Notice Final Rule Draft CPG does not
continue this policy because, as described above, FDA and CBP believe
that knowing the identity of the facility involved in the food's
production is critical to ensuring that FDA can effectively target food
for inspection at the border upon arrival and can effectively determine
whether food should be held because it is from an unregistered
manufacturing facility.
    Accordingly, section 1.276(b)(9) of the final rule defines
manufacturer for the purpose of prior notice submission as the last
facility, as that word is defined in Sec.  1.227(b)(2), that
manufactured/processed the food. A facility is considered the last
facility even if the food undergoes further manufacturing/processing
that consists of adding labeling or any similar activity of a de
minimis nature. If the food undergoes further manufacturing/processing
that exceeds an activity of a de minimis nature, then the subsequent
facility that performed the additional manufacturing/processing is
considered the manufacturer. We have removed in the final rule the
option that was in the IFR to provide the label information in Sec.
101.5 instead of the name, address, and registration number of the
manufacturer for food sent by an individual as a personal gift (i.e.,
for nonbusiness reasons) to an individual in the United States. Unless
excepted elsewhere in the regulation, the identity of the manufacturer
must be submitted for an article of food that is no longer in its
natural state.
    b. Does FDA have the authority to require the registration number
of the manufacturer of the article of food being imported or offered
for import as a data element in prior notice? (Comments) Many comments
state that the Bioterrorism Act does not require registration numbers
to be submitted in prior notice. Some comments further assert that the
statute clearly states that the ``identity of the manufacturer'' must

be included for prior notice but it does not allude to nor require the
registration number. Another comment explains that if Congress intended
FDA to require the registration number, it would have specifically
articulated this requirement as it did in section 321 of the
Bioterrorism Act for drug and device imports. The comment concludes
that the failure of the Congress to include registration numbers in the
enumerated statutory elements of prior notice is powerful evidence that
Congress did not intend for FDA to require it. Another comment states
that the act does not prescribe how the identity of the manufacturer
must be provided, and therefore Congress has not spoken to this issue.
Accordingly, FDA is entitled to deference in crafting a permissible
construction of the statutory requirements.
    One comment notes that all wineries producing wine for consumption
in the United States are required under section 415 of the Bioterrorism
Act to provide to FDA their name, the street addresses of their
facilities and the trade names under which they do business. It further
states that as long as the importer provides the name and address of
the manufacturer of the wine, this will be sufficient for FDA to
identify whether the manufacturer is registered with the FDA, and that
additionally requiring the importer to furnish a registration number is
unnecessary to implement the Bioterrorism Act.
    Another comment asserts that the obligation to verify that the
manufacturer of a food article imported or offered for import into the
United States is registered, or is required to do so, is an obligation
imposed upon the FDA by Congress under the Bioterrorism Act, not upon
the importer. The comment further asserts that for FDA to shift its
burden to importers who are not related to the facilities required to
be registered is, at the very least, unjust and certainly was not the
intent of Congress. The comment further states that FDA has the ability
and access to the information necessary to verify registration status
of manufacturers; unaffiliated importers do not. Another comment
asserts that FDA's overly broad interpretation of the prior notice
provision of the Bioterrorism Act results in an anticompetitive
business environment that is contrary to the spirit of the Bioterrorism
Act. Another comment emphasizes that to enforce the registration
requirement through the means of prior notice requirements, which
affect persons that are completely unrelated to the party responsible
for registering the facility, is inappropriate.
    Another comment states that the U.S. Congress placed the burden
upon the FDA to ensure that a facility's owner, operator or agent in
charge complies with the registration requirements established under
the Bioterrorism Act and while it is reasonable for the FDA to request
that importers assist them in this task by asking for facility
registration numbers on prior notice submissions, the agency must not
condition lawful entry on the provision of this number that may, for a
variety of reasons, be unavailable to the importer.
    Another comment claims that FDA has no jurisdiction to enforce the
registration requirements upon the affected foreign facilities. Another
comment asserts that domestic food manufacturers are not faced with
this dilemma because they are already within the United States, and
there are no equivalent requirements to verify that domestic foods are
produced at facilities that are properly registered with FDA.
    (Response) FDA's position remains that it has the authority to
require the registration of the manufacturer as a data element in prior
notice. Under section 801(m) of the act, prior notice must include the
identity of the manufacturer. The manufacturer's registration number is
an identifier, just as, for example, Employer Identification numbers,
Social Security numbers, and driver's license numbers are regularly
used to help identify establishments and individuals. Such numerical
identifiers are much better for matching than name and address
information alone. For example, names and addresses often do not have
standardize formats, there can be alternative spellings and
abbreviations, and misspellings are not uncommon. In addition, many
facilities have similar names, even facilities in the same country or
city. Unique identifiers are all the more important given the high
volume of prior notices that FDA needs to process, FDA's goal of
processing them expeditiously, and the need to ensure that FDA can
accurately flag shipments of potential concern.
    As contemplated by the Registration of Food Facilities rule, Sec.
1.241(c), FDA also uses the identity of the manufacturer collected as
part of prior notice to ensure that imported food is from registered
facilities. Section 801(l) of the act, which was enacted as part of the
Bioterrorism Act, states that if an article of food is being imported
or offered for import into the United States, and such article is from
a foreign facility for which a registration has not been submitted
under section 415 of the act, such article shall be held at the port of
entry for the article, and may not be delivered to the importer, owner,
or consignee of the article, until the foreign facility is so
registered. In the preamble to the IFR, we described how we would use
registration in concert with prior notice to carry out our
responsibilities under section 801(l) of the act ``Registration is
designed to work in concert with prior notice at the border, as
reflected in new section 801(l) of the FD&C Act, which provides that
food from facilities that must register may not be admitted into
distribution for consumption in the United States unless the relevant
facilities have been registered. To enforce section 801(l) of the FD&C
Act as intended by Congress, FDA has determined that it must review
registration status of manufacturers and shippers as part of prior
notice. The information provided by registration will allow FDA to
check prior notice submissions against registration data to confirm the
identity. Moreover, the information provided by prior notice
submissions can serve as a crosscheck as to whether these facilities
are registered as required and have provided the necessary updates * *
*. FDA does not agree that it should confirm registration without
requiring that the number be submitted. Each registered facility will
be assigned a unique registration number by FDA. Thus, the registration
number will help identify the manufacturer. Without a registration
number, it may be difficult to determine exactly which registered
facility to associate with the article: Different firms may have the
same or similar names and more than one firm may operate from a
particular location.'' (68 FR 58974 at 59001). FDA continues to believe
that it should use the information in prior notice to verify the
manufacturer's registration status, and that the registration number is
the simplest and fastest way for us to do this. FDA further notes that
it verifies the registration status of both domestic and foreign
facilities. FDA's procedures for enforcing the registration
requirements for domestic facilities are explained in FDA's
``Compliance Policy Guide--Guidance for FDA Staff, Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002.'' See http://www.cfsan.fda.gov/
~furls/cpgreg2.html.
    c. Assuming FDA can require the manufacturer's registration number
in a prior notice submission, should FDA continue to do so in the final
rule and/or should FDA provide an alternative means for submitters to
provide the identity of the manufacturer other than

the registration number? (Comments) Several comments recommend
elimination of the registration number as a requirement for identifying
the manufacturer of a food no longer in its natural state. One comment
suggests that inclusion of a food facility registration number does not
ensure the legitimacy of the shipment and that a black market for
certain foods could result if registration numbers continue to be
required for prior notice. Many others comments recommend elimination
of the requirement for the manufacturer's registration number in
various situations:
     The food facility is not required to register because
ingredients or finished goods manufactured by it are not consumed in
the United States, and thus it has no registration number;
     The manufacturer that has gone out of business and does
not have a facility registration number;
     Samples for:
    Any reason/any type of sample;
    Any product samples not intended for public consumption or for
retail sale;
    Quality control;
    Research;
    Analytical samples that are not intended for human or animal
consumption;
    Quality assurance samples that will be used for taste testing or
quality control that includes human consumption;
     Fine wines;
     Registration numbers of the parties in possession of the
wine over the past 2 years;
     All wines and distilled spirits, when a registration
number is not available;
     Wine produced more than 5 years prior to the date of its
import (the year of production is typically indicated on the bottle's
label, and label approvals are required under U.S. Tax and Trade Bureau
regulations);
     All food produced prior to December 12, 2003;
     All food sent into the country for the personal
consumption of the recipient and not for business use or
redistribution;
     Gifts arriving in the United States from one individual to
another in a business setting; and
     Consumer-to-consumer shipments.
    Some comments state that the requirement to provide the
manufacturer's registration number in the prior notice is overly
burdensome and unreasonable for some segments of the food industry. The
comments suggest that there are numerous legitimate reasons that food
companies may seek to import food products from manufacturers whose
registration number is unknown or which are not required to register
with FDA.
    Other comments recommend alternatives to the requirement to submit
the manufacturer's registration number. The most commonly recommended
alternative to submission of the manufacturer's registration number is
to allow submitters to identify the manufacturer by providing the name
and address of the facility with an accompanying reason as to why the
registration number was not submitted. One comment specifically
recommends a drop-down menu that allows the submitter to explain the
reason for the lack of a registration number, such as ``product was not
obtained from the manufacturer.'' The comment reasons that this
optional approach allows FDA to continue to require registration
numbers, but does not per se invalidate a prior notice based on the
absence of this single piece of information. Another comment suggests
that the submitter affirm that it believes, to the best of its
knowledge, that the manufacturer is registered with FDA. One comment
recommends that only the manufacturer's name for a ``gray market'' food
should be sufficient for the prior notice when the submitter does not
know the manufacturer's registration number.
    Another comment asserts that FDA must consider alternative means
for ensuring that all facilities subject to the Registration of Food
Facilities Rule (21 CFR part 1, subpart H) have an updated registration
on file with FDA that has been verified. The comment further suggests
that taking such action will allow the FDA to ensure that the
regulations are not implemented in a manner that prevents the lawful
import of safe and healthy food products based solely upon the
unavailability of the confidential facility registration number.
Several comments assert that confirmation that a facility is registered
can be made without obtaining the registration number of the facility.
    One comment states that, though FDA has indicated that it wants the
new facility registration requirement to be enforced through the prior
notice regime, enforcement can be accomplished without requiring that
the facility registration numbers be included in the prior notice. With
the name and address of the manufacturer included, FDA can look up the
manufacturer in its database of registered manufacturers. If the
manufacturer has not registered, then the FDA could deny entry to the
articles of food in question. The manufacturers therefore already have
a strong incentive to register with the FDA, since that is the only way
their products can gain entry into the United States.
    Other comments suggest inspection of a food shipment to ensure its
safety when the prior notice submission lacks the required registration
number, rather than refusal of that food as an acceptable alternative.
The comments state that this approach will avoid situations where
shipments are rejected while still preserving FDA's regulatory
discretion. Another comment states that importers who obtain food from
parties other than the original food manufacturers are willing to bear
the burden of increased inspections when they do not provide a
manufacturer's registration number in the prior notice. Other comments
agree that the manufacturer's registration number should be required in
prior notice submissions, but that the prior notice should not be
deemed inadequate (i.e., the food should not be refused under 801(m) of
the act) if the manufacturer is identified by name and address of the
facility and a reason for lack of submission of the manufacturer's
registration number is provided.
    Another comment suggests that the final rule should be amended to
provide that the prior notice only need to include such information
about the manufacturers of older vintage wines that is readily
available to the importer, together with registration numbers for all
persons who have owned the wine and all facilities that have stored the
wine over the preceding 2 years.
    One comment suggests that FDA permit the importation of quality
assurance samples that will be used for taste testing or quality
control that includes human consumption without the facility
registration number of the foreign manufacturer or processor. The
comment further suggests that in lieu of the registration number, the
prior notice should include the manufacturer's name and location along
with the identification of the person sending the samples.
    While most comments state that the name and address of the
manufacturer could be submitted in prior notice, one comment states
that re-sellers will not normally supply the name of their supplier or
the name of the manufacturer of a particular product to their
customers. The comment asserts that supplying the name of the
manufacturer would allow that customer to circumvent the re-seller and
attempt to make direct contact with the supplier or manufacturer, thus
taking business away from the re-seller. Another comment states that if
only the

name of the manufacturer is submitted in a prior notice, the prior
notice should not be considered inadequate.
    Other comments support requiring the registration number of the
original processor on prior notice submissions, particularly when a
third-party is exporting the product to the United States. One comment
further recommends that FDA should revise its rules regarding the use
of registration numbers in general, and in the prior notice rule in
particular, to protect legitimate buyers and distributors from
unauthorized ``gray market'' imports. Several comments suggest that the
manufacturer's registration number should be required and that only the
registration number be submitted, not the name and country.
Additionally, some comments suggest that if manufacturer and facility
registration numbers are provided and the numbers provided are specific
to a particular facility location, the requirement to complete the
address information should be removed to avoid duplication of
information.
    (Response) To effectively implement the prior notice and
registration provisions in the Bioterrorism Act, the final rule
requires the registration number of the manufacturer or, if the
registration number is not provided, the facility's full address and
reason the registration is not provided. Reasons for not providing a
registration number include, for example, the manufacturing facility is
out of business; the manufacturing facility is a private residence and
thus is not a ``facility'' for the purposes of the registration
requirements; and the submitter is unable to determine the registration
number of the manufacturing facility.
    Matching of facilities is vital for making an initial assessment on
the accuracy of the prior notice; assessing the risk of the associated
article of food based on the associated manufacturing facility, its
operations, and history of importations; and verifying registration
status. Without the registration number, PNC reviewers have to conduct
this matching using the name and address submitted in a prior notice.
Due to the potential for human error during data input or deviations in
the spelling or format of a facility's name, address or city, FDA may
incorrectly think it has found a match between the facility described
in the prior notice and a facility in the registration database.
Similarly, the facility described in the prior notice may be close, but
not exact, to several facilities listed in the registration database,
causing uncertainty as to which, if any, is the correct match. This is
complicated by the fact that the manufacturing facility submitted as
part of prior notice might not be registered. At best this matching
process may take significantly longer (depending on the number of
manufacturers, products, and other factors involved), impeding FDA's
ability to complete its review within the prior notice timeframes. At
worst, a facility mismatch will result in FDA conducting its risk
assessment based on incorrect information.
    The information provided in a registration thus enables FDA to
better assess risk of the product itself, as it gives the PNC more
information upon which to base its assessment. PNC reviewers use the
registration information to verify whether the articles of food in the
shipment match the food product categories that the owner, operator, or
agent-in-charge of the facility listed in the site-specific facility's
registration with FDA. The registration information also provides
alternate names for a facility, lists the parent company and
subsidiaries of the facility, verifies addresses, and provides the
identity of the officers of the facility and/or their U.S. Agents. This
additional information may identify potential terrorist threats (e.g.,
a facility and/or facility official has ties with a terrorist
organization). Not providing the registration number in a prior notice
leads to prolonged or incomplete searches, which in turn could lead to
additional cargo delays or examinations at the port of arrival as the
PNC completes its intensive review (see earlier discussion under
timeframes). We also note that registered facilities generally do not
make their registration numbers public, so they generally have to be
obtained directly from the manufacturer or its designee during the
importation process as part of completing a prior notice. Thus it is
harder to falsify registration information than the facility's name and
address, deterring the submission of false manufacturer identification
information.
    In some cases, the registration number of the manufacturer is not
available to the submitter, and therefore, we have revised the rule to
provide an alternate means for satisfying the requirement to provide
the identity of the site-specific manufacturer in prior notices. For
purposes of the prior notice final rule, the identity of the
manufacturer is the name of the manufacturer and either: (1) The
registration number, city, and country of the manufacturer or (2) both
the full address of the manufacturer and the reason the registration
number is not provided (see Sec.  1.281(a)(6), (b)(5), (c)(6)). One of
the following reasons may be submitted when no manufacturer
registration number is provided:
     Situations where the facility is out of business, as
stated in Sec.  1.235(a);
     Private residence, as stated in Sec.  1.227(b)(2);
     The facility is a restaurant, as defined in Sec.
1.227(b)(10), and qualifies for the restaurant exemption in Sec.
1.226(d);
     The facility is a retail food establishment, as defined in
Sec.  1.227(b)(11), and qualifies for the retail food establishment
exemption in Sec.  1.226(c);
     The facility is a nonprocessing fishing vessel, as stated
in Sec.  1.226(f);
     Nonbottled drinking water collection and distribution
establishment, as stated in Sec.  1.227(b)(2);
     The manufacturer satisfies the definition of ``farm'' in
Sec.  1.227(b)(3), and qualifies for the farm exemption in Sec.
1.226(b); or
     The submitter is unable to determine the registration
number of the manufacturer. The full address of the manufacturer has
been provided by the submitter.
    The Prior Notice Final Rule Draft CPG that is announced elsewhere
in this issue of the Federal Register lists these reasons to use when
the registration number is not provided and describes our proposed
enforcement policies.
    As discussed previously, without the registration number, it will
be more difficult and/or may take more time for us to verify the
identity of the manufacturing facility and its registration status and
to determine whether the article of food is subject to being held under
section 801(l) of the act. Thus, it is in the interest of the parties
involved in the import to provide the manufacturer's name and
registration number, and not simply the manufacturer's name and full
address, because the registration number will help us process the
shipment more expeditiously. The submitter should exercise a reasonable
amount of effort to obtain and provide the registration number before
using the reason ``the submitter is unable to determine the
registration number of the manufacturer.''
    FDA does not agree with the comments asserting that the
registration number is sufficient by itself to ``identify'' a facility
in a prior notice submission. The additional information is needed to
verify that the registration number, which is comprised of eleven
digits, is accurate. Without additional information, there is a
significant possibility of typographical errors, leading to
misidentification of facilities, which could lead to foods being
stopped

at the port for inadequate prior notice and registration. There also is
the possibility of someone entering data in an attempt to ``guess'' at
a registration number. Having identifying information in addition to
the registration number helps prevent such guessing. Having this
confirmatory information also allows us to notify submitters of a
mismatch before the prior notice is accepted and confirmed for review,
which allows them to correct any inadvertent errors before the food
arrives at the port, where it otherwise may be subject to refusal for
an inadequate (inaccurate) prior notice.
    If the prior notice does not contain either the manufacturer's
registration number or the reason and name and full address, the food
is subject to refusal of admission under section 801(m)(1) of the act
for failure to provide adequate prior notice, as the identity of the
manufacturer is incomplete. The food also may be subject to a hold
under section 801(l) of the act if the food is from a foreign
manufacturer that is not registered under section 415 of the act.
    In response to comments from those who are importing food from a
facility that is not registered because food manufactured by it is not
intended to be consumed in the United States, FDA notes that these
shipments are subject to hold under 801(l) of the act. Under section
801(l) of the act, food is subject to being held if it is imported or
offered for import into the United States and it is from a foreign
facility that has not registered. This provision applies regardless of
whether the food was intended for consumption in the United States at
the time it was manufactured, for example where an article of food is
made in Country X for consumption in Country X, but is purchased by a
third party who re-labels the product for import and resale in the
United States.
    (Comments) One comment recommends that inter-company gifts be
exempt from the requirement to provide the manufacturer's registration
number on the prior notice because these items have no commercial value
and are sent as business gifts. The comment suggests that FDA use the
same approach for business and nonbusiness gifts, by allowing a listing
of the manufacturer's name and address as it appears on the product's
label.
    (Response) The provisions in the final rule regarding the
registration number are being revised, and these revised provisions
apply to both business and nonbusiness shipments. The final rule no
longer allows for submission of the name and address as it appears on
the label in any situation. However, the rule also is being changed
such that the submitter may submit either the manufacturer's
registration number, city, and country or both the manufacturer's full
address and the reason why the registration number is not provided.
    d. Questions seeking clarification.
    i. Designation of grower. (Comments) Two comments state that they
are exempt from the registration requirements because they are farms;
however, they want guidance regarding the steps these farms should
follow to ensure that their products move through the prior notice
system without delays at the port.
    (Response) If the article of food is no longer in its natural
state, such that the identity of the manufacturer is required, the
submitter can submit a reason for why the registration number was not
provided; i.e., facility is a grower, meets farm exemption. These
reasons also are listed in the Prior Notice Final Rule Draft CPG
announced elsewhere in this issue of the Federal Register. If the
article of food is in its natural state, the identity of the
manufacturer is not required and the systems will know that they do not
need to verify the manufacturing facility's registration status.
    ii. Manufacturer cancels registration. (Comments) A comment asks
what designation is appropriate for the scenario where at the time of
production the manufacturing/processing facility was legitimately
registered with the FDA, but cancelled its registration prior to the
importer submitting prior notice.
    (Response) If the manufacturing facility still is operational, but
chooses to cancel its registration with FDA, then the food from this
facility is subject to refusal under 801(l) of the act. As stated
therein, ``If an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to [FDA], such
article shall be held at the port of entry for the article, and may not
be delivered to the importer, owner, or consignee of the article, until
the foreign facility is so registered.'' If the facility has canceled
its registration because it has gone out of business, then this reason
may be entered on the prior notice.
    iii. Identity of manufacturer for samples. (Comments) One comment
states that there are some circumstances involving market survey and
consumer complaint samples where the manufacturing facility is unknown
to the submitter of prior notice and the manufacturing facility may not
have a registration number because it does not do business in the
United States. One comment provides the example of when shoppers are
hired to collect company trademark products, package these according to
company-established protocol, enclose purchase information and ship
these to designated laboratories in the United States. and the shoppers
often have no way of knowing the identity of the specific manufacturing
facility. One comment states that it is not likely that a
manufacturer's registration number would be available for competitive
product samples and for finished product samples used for evaluation
purposes, as well as for articles used for research and development
purposes. The comment states that the registration number does not fall
under the Freedom of Information Act and in some cases, the
manufacturer's facility may not be required to register since the
article of food was not intended for consumption in the United States.
Another comment provides the example of when a consumer expresses a
concern about either the quality or safety of a purchased food, and the
consumer is instructed to ship that product to the U.S.-based franchise
company laboratory for a timely analytical assessment.
    (Response) We have revised the final rule such that the identity of
the manufacturer must include the name of the manufacturer and either
the registration number, city, and country of the manufacturer or both
the full address of the manufacturer and the reason the registration
number is not provided. Relevant to these comments, one of the reasons
for not providing the registration number is that the submitter is
unable to determine it. However, as described above, if the article of
food is from an unregistered facility, it is subject to being held
under section 801(l) of the act. Moreover, without the registration
number, it will be more difficult and/or may take more time for FDA to
verify the identity of the manufacturing facility and its registration
status. As a result, the food may be delayed until the verification is
completed.
    While the final rule requires prior notice, including the identity
of the manufacturer, for shipments of samples, under the enforcement
policy proposed in the Prior Notice Final Rule Draft CPG, FDA and CBP
should typically consider not taking any regulatory action with respect
to prior notice violations when an article of food is imported or
offered for import for quality assurance, research or analysis purposes
only, not for human or animal consumption without prior notice.
    iv. U.S. manufacturer of product being imported. (Comments) Two

comments express concern that FDA would reject a prior notice for
imported food that contains a U.S. manufacturing facility and that
facility's registration number.
    (Response) Both ABI/ACS and PNSI accept the identity of a
manufacturing facility from any internationally recognized country
designation, including the United States. FDA recognizes that some food
imported into the U.S. is manufactured in the U.S., exported, and then
re-imported. Prior notice applies to these articles of food and
identification of the U.S. facility as the manufacturer is correct.
    v. Require manufacturer to reveal or conceal the registration
number. (Comments) Two comments recommend that FDA compel manufacturers
to divulge their food facility registration numbers upon inquiry.
Another comment requests that FDA issue guidance stating that: FDA does
not require the registration number on commercial documents; the
inclusion of a registration number on commercial documents will not
facilitate clearance by CBP or FDA of the shipment; and FDA recommends
that companies reveal this confidential information once only in a
formal letter and ensure by all possible means that their customer
(e.g., distributor, importer, or customs broker) also respect the
confidentiality of this information. One comment cautions about
reported abusive and misleading declaration of a registration number in
a prior notice for shipments that are unconnected with the food
facility that actually owns that registration number. Another comment
suggests that FDA should revise both the prior notice and registration
rules to clarify that those doing business with the owner of a facility
should not and have no reason to demand the facility registration
number.
    Several comments suggest that FDA provide a means for importers and
others to verify a facility's registration, even if such verification
does not disclose any information beyond affirmation or denial. One
comment suggests that FDA compare Manufacturer Identity (MID) data
submitted through ABI/ACS to the FDA Food Facility Registration
database and notify the transmitter of a MID mismatch while keeping
actual registration information secure. The comment reasons that this
process would give the submitter and transmitter of a prior notice a
noncompliance alert and also would alert the agency of possible
additional intensive review requirements even before the prior notice
submission has been completed. Another comment encourages the agency to
allow American importers to query a database that would do nothing more
than confirm whether the details provided are accurate. Another comment
suggests that FDA make the registration database available to
authorized customs brokers only.
    (Response) FDA does not intend to direct registered food facilities
to divulge their registration numbers on documents or upon request.
However, FDA does agree that guidance regarding divulging registration
numbers and prior notice submissions may help to clarify the process,
and provided this guidance in our ``Guidance for Industry, Questions
and Answers Regarding Registration of Food Facilities Final Guidance''
available at http://www.cfsan.fda.gov/~dms/ffregui4.html.
    vi. Exporting facility. (Comments) One comment requests that FDA
accommodate the importation of previously manufactured food products
that were purchased at retail outlets outside the United States and
recommends that FDA require only the registration number of the
exporting facility and information identifying the company responsible
for the product. The comment reasons that this information, along with
other identity information required by prior notice, should be
sufficient for FDA and CBP to make risk decisions about a particular
import.
    (Response) FDA disagrees. The Bioterrorism Act requires the
identity of the manufacturer as well as the shipper. The identity of
the shipper or the exporting facility alone is not sufficient to
satisfy the requirements of the statute. The facility that manufactured
the food must be identified.
    vii. Food imported or offered for import for transshipment,
storage, and export, or further manipulation and export. In the IFR, a
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage, and export, or further manipulation and export.
We have removed this exception in the final rule because we have
determined that section 801(m) of the act requires the identity of the
manufacturer for food imported or offered for import into the United
States, regardless of whether that food will be consumed in the United
States. Likewise, under section 801(l) of the act, food is subject to
being held if it is imported or offered for import into the United
States and it is from a foreign facility that has not registered. This
provision applies even if the food is not for consumption in the United
States. As noted previously, if the submitter is unable to determine
the registration number of the manufacturer, the submitter may provide
a reason along with the name and full address of the manufacturer.
    (Final rule) Section 1.281(a)(6), (b)(5), and (c)(6) of the final
rule requires for an article of food that is no longer in its natural
state, the identity of the manufacturer, as follows: the name of the
manufacturer; and either the registration number, city, and country of
the manufacturer or both the full address of the manufacturer and the
reason the registration number is not provided.
8. The Grower, if Known
    The Bioterrorism Act requires the submission of the identity of the
grower of the article, if that identity is known within the specified
period of time that notice is required to be provided. Section
1.281(a)(7), (b)(6), and (c)(7) of the IFR requires for an article of
food that is in its natural state, submission of the name and growing
location address of the grower, if known. If the submitter does not
know the identity of the grower or, if the article has been
consolidated, and the submitter does not know the identity of any of
the growers, the submitter may provide the name and address of the firm
that has consolidated the articles of food from different growers or
different growing locations.
    (Comments) One comment asks that the requirement to identify the
grower not be mandatory in the final rule and suggests exempting the
growers and providing the information of growers on a voluntary basis.
Another comment asserts that it is virtually impossible to identify
each grower once grain is commingled at the country elevator.
    (Response) The Bioterrorism Act requires the identity of the
grower, if known, in the submission of prior notice. Therefore, we
cannot eliminate the requirement to provide the identity of the grower
in all cases, as suggested by the comment. If the identity of the
grower is not known at the time of submission of the prior notice, and
the food has been consolidated, then the submitter may, but is not
required to, provide the name and address of the consolidator (Sec.
1.281(a)(7), (b)(6), and (c)(7)).
    (Comments) Another comment states that a single shipment of fresh
fruit may represent hundreds of growers, all of whom are known by the
submitter of the prior notice. The comment asserts that requiring
submission of an individual prior notice for each article represented
by a single grower seems unnecessarily burdensome. The comment suggests
that in lieu of requiring identification of all

known growers in the prior notice, the rule should require the
submitter of the prior notice to retain a complete list of growers and
to make this list available to FDA for inspection and copying upon
request.
    (Response) We do not agree. Periodic access, inspection, and
copying of a complete listing of all growers of an article of food does
not satisfy the requirement to identify the grower of the article of
food, if known, within the specified period of time that notice is
required to be provided. FDA responded to a similar comment in the
prior notice IFR and explained that FDA does not agree that a list
would satisfy the statutory requirement, as it would not tell FDA which
grower was associated with the particular article of food as envisioned
by the statute (68 FR 58974 at 59006). We affirm the view here.
    (Comments) One comment requests that FDA reconsider the requirement
to submit the names of multiple growers, if known, in the prior notice.
The comment notes that submitters of prior notices must provide
separate notices for each grower in the case of consolidated shipments
(if the growers are known), which it asserts is onerous and costly for
exporters of consolidated shipments of horticulture products. The
comment believes that the proposed recordkeeping rules will cause the
names of the growers to be recorded and available and the prior notice
information is a duplication of effort. The comment asks that, for
consolidated shipments, FDA permit the submission of one prior notice
providing the name of the consolidator or one notice with the names of
all the growers.
    (Response) FDA disagrees. Adding the capability to accept a list of
growers would add considerable complexity to both the data entry
software (PNSI and/or ABI) and the screening programs. FDA responded to
a similar comment in the prior notice IFR and explained that FDA does
not agree that a list would satisfy the statutory requirement, as it
would not tell FDA which grower was associated with the particular
article of food as envisioned by the statute (68 FR 58974 at 59006).
And as we explained in the previous response, periodic access,
inspection, and copying of a complete listing of all growers of an
article of food does not satisfy the requirement to identify the grower
of the article of food, if known, within the specified period of time
that notice is required to be provided. FDA notes that users of PNSI
can create a prior notice for one grower, copy that prior notice, and
edit just the grower information and the quantity and packaging
information, assuming the imports for each grower are distinctly
packaged.
    (Final rule) Section 1.281(a)(7), (b)(6), and (c)(7) of the final
rule requires for an article of food that is in its natural state, the
submission of the name and growing location address of the grower, if
known. If the submitter does not know the identity of the grower or, if
the article has been consolidated and the submitter does not know the
identity of any of the growers, the name and address of the firm that
has consolidated the articles of food from different growers or
different growing locations may be submitted.
9. FDA Country of Production
    The Bioterrorism Act requires the submission of the identity of the
country from which the article originates. The IFR in Sec.
1.281(a)(8), (b)(7) and (c)(8), requires that a prior notice contain
the FDA Country of Production of the article of food being imported or
offered for import into the United States. As set out in the IFR
definition at Sec.  1.276(b)(4), the FDA Country of Production is, for
an article of food in its natural state, the country where the article
of food was grown, including harvested or collected and readied for
shipment to the United States. If, however, an article of food is wild
fish, including seafood, that was caught or harvested outside the
waters of the United States by a vessel that is not registered in the
United States, the FDA Country of Production is the country in which
the vessel is registered. For a food that is no longer in its natural
state, the FDA Country of Production is the country where the article
of food was made. However, if an article of food is made from wild
fish, including seafood, that was made aboard a vessel, the FDA Country
of Production is the country in which the vessel is registered. The IFR
also provides that the FDA Country of Production of food grown and
harvested or collected or made in a U.S. Territory is the United
States.
    (Comments) One comment asks what is required as the country of
production in a case where spirits are exported in bulk to a third-
country for local bottling and subsequent export from that third-
country for consumption in the United States.
    (Response) For a food that is no longer in its natural state (e.g.
spirits), the FDA Country of Production is the country where the
article of food was made (e.g. bottled). For an article of food that
undergoes multiple manufacturing steps, as in this comment, the FDA
Country of Production would be country where the last facility performs
a manufacturing/processing step that exceeds an activity of a de
minimis nature.
    (Final rule) The final rule retains without change the provisions
in Sec.  1.281(a)(8), (b)(7), and (c)(8) of the IFR.
10. Shipper
    The Bioterrorism Act requires the submission of the identity of the
shipper of the article. The IFR at Sec.  1.281(a)(9), (b)(8), and
(c)(9) requires that the shipper be included in a prior notice. The IFR
defines shipper (Sec.  1.277(b)(12)) as the owner or exporter who
consigns and ships the article of food from a foreign country or the
person who sends an article of food in international mail to the United
States.
    (Comments) One comment states that the FDA has augmented section
307 of the Bioterrorism Act to require not only supply chain party
identification but also the registration number of the shipper. The
comment further states that the requirement to submit the shipper's
registration number is easily met. There were no other comments
received on this issue.
    (Response) We revised certain sections pertaining to the identity
of the shipper. The IFR required the registration number of the
shipper, if the shipper is required to be registered. The final rule
requires the identity of the shipper only if the shipper is different
from the manufacturer. Moreover, the final rule eliminates the
requirement to submit the registration number of the shipper, if the
shipper is required to be registered, and made the submission of the
registration number optional. The identity of the shipper in the final
rule is satisfied by submission of the name and full address of the
shipper.
    (Final rule) The final rule in Sec.  1.281(a)(9), (b)(8), and
(c)(9) requires the name and full address of the shipper, if the
shipper is different from the manufacturer. If the address of the
shipper is a registered facility, the submitter may submit the
registration number of the shipper's registered facility.
    FDA revised this requirement to require the shipper's information
only when the shipper is different from the manufacturer in order to
eliminate duplicative requirements. Moreover, we eliminated the
requirement to provide the registration number of the shipper, if the
shipper is required to be registered, and made the submission of the
registration number optional.
    In the IFR, the shipper's registration number is not required for a
facility associated with an article of food if the article is imported
or offered for import for transshipment, storage, and export,

or further manipulation and export. We have removed this exception in
the final rule since the shipper's registration number is now optional.
11. The Country From Which the Article is Shipped
    The Bioterrorism Act requires the submission of the identity of the
country from which the article is shipped. The IFR requires in Sec.
1.281(a)(10) and (c)(10) submission of the identity of the country from
which the article is shipped. In Sec.  1.281(b)(9), the IFR requires
submission of the identity of the country from which the article is
shipped (i.e., mailed).
    (Comments) There were no comments received on this issue.
    (Final Rule) The final rule retains without change the provisions
in Sec.  1.281(a)(10), (b)(9), and (c)(10) of the IFR.
12. Anticipated Arrival Information
    Section 1.281(a)(11) of the IFR requires the submission of
anticipated arrival information to include the anticipated port of
arrival and anticipated border crossing; the anticipated date on which
the article of food will arrive at the anticipated port of arrival; and
the anticipated time of that arrival. In Sec.  1.281(c)(11), the IFR
requires the submission of the actual port of arrival. Anticipated
arrival information is not required for food arriving by international
mail.
    A prior notice will not be inadequate if the anticipated port of
arrival, the anticipated date of arrival, or the anticipated time of
arrival changes between the time of confirmation of prior notice and
the time of arrival, as provided by Sec.  1.282(a) of the IFR.
    The anticipated arrival information must specify the anticipated
port of arrival and, if there is more than one border crossing location
within that port, the specific anticipated border crossing where the
food will be brought into the United States.
    (Comments) One comment suggests the elimination of the anticipated
arrival information as a data element. Another comment suggests that in
light of the MOU between FDA and CBP, arrival data are no longer
important, as CBP can provide the personnel to conduct the necessary
inspections.
    (Response) Section 801(m) of the act requires the submission of the
identity of the anticipated port of entry for the article of food,
therefore, this data element cannot be eliminated. The anticipated time
and date of arrival are needed for planning resources because it
relates to when the food will first become available for examination at
the border. The coordination procedures between FDA and CBP should not
be construed to mean that arrival information is no longer important
nor that we will not, whenever possible, conduct necessary inspections
at the port. Moreover, FDA's working with CBP personnel does not negate
our need for anticipated time and date of arrival since headquarters
and field staff still need to know when articles of food plan to
arrive.
    (Comments) One comment states that the arrival information should
be linked to the ABI entry filing at the port of entry because the FDA
prior notice requirement is inconsistent with the existing entry
clearance processes of CBP. The comment contends that requiring prior
notice at the port of arrival will result in severe disruption to
flight schedules, with the possible consequence of aircraft offload for
any affected food shipment for which prior notice was not submitted.
    (Response) FDA disagrees. The Bioterrorism Act requires
notification about articles of food prior to arrival in the United
States. Although prior notice and entry information can be submitted
together through ABI/ACS, prior notice cannot be substituted by the
entry process, which legally can occur well after the food has arrived
in the United States. Since implementation of the IFR, FDA and CBP have
noted no severe disruptions, including to flight schedules due to lack
of prior notice of some articles of food within an aircraft, truck, or
vessel load. FDA points out that in December 2003, CBP issued and began
implementation of the Advance Electronic Cargo Information rule, which
also requires information about cargo before it arrives in the United
States and allows for prohibition of landing authorization if such
information is not provided in advance of arrival. (See 19 CFR
122.12(c) (international airports), 19 CFR 122.14(d)(4) (landing rights
airports); and 19 CFR 122.15(a) (user fee airports).)
    (Comments) One comment recommends that FDA ask CBP to change their
ABI system to provide for port diversion functionality. The comment
acknowledges that, although the FDA prior notice system is designed to
allow a shipment to be diverted to a port other than the intended port
of entry reported in the prior notice, CBP's ABI system precludes the
CBP entry from being accepted at other than the reported port of entry.
Another comment requests that when a prior notice is transmitted via
either the Cargo or Border Cargo Selectivity application, the data
should be moved from ACS to OASIS regardless of the estimated time of
arrival date.
    (Response) Such changes to the ABI system are not feasible at this
time given resource constraints, and the development of CBP's new
Automated Commercial Environment. Moreover, CBP transfers information
to FDA at 8 p.m. on the day before arrival for truck shipments and 9
p.m. on the day before arrival for air shipment. Information is
transferred to FDA on the same day if that information is submitted the
same day as anticipated arrival of the shipment. CBP and FDA believe
that this is sufficient for meeting the timeframes for receipt, review,
and response to prior notice submission.
    (Comments) Two comments address the difficulty of obtaining exact
arrival information, including a specific time of arrival for air
shipments, because many airlines are often closed at night. The comment
also states that including a specific date and time for arrivals by
ocean vessel is difficult.
    (Response) FDA disagrees. From FDA's standpoint, ``time of
arrival'' relates to when the food will first become available for
examination at the port. For vessels, this would be when the vessel
docks in the port. For planes, this would be when the plane lands. For
land vehicles, such as trucks, buses, and trains, this would be when
they cross the border. FDA believes that someone involved in importing
or offering for import an article of food has an indication of
anticipated arrival into the United States of that food and can inform
the submitter and/or transmitter of the prior notice. FDA also
emphasizes that the information being requested is ``anticipated''
information, not ``exact'' or ``specific'' information as the comment
incorrectly describes.
    (Final rule) FDA and CBP have determined that for the purposes of
communication, the identity of the border crossing within the port of
arrival is no longer necessary. Therefore, that information is not
required in the final rule. The final rule requires in Sec.
1.281(a)(11) the anticipated arrival information, including the
anticipated port of arrival, the anticipated date on which the article
of food will arrive at the anticipated port of arrival, and the
anticipated time of that arrival. If the article of food is arriving by
express consignment operator or carrier, and neither the submitter nor
transmitter is the express consignment operator or carrier, and the
prior notice is submitted via PNSI, the express consignment operator or
carrier tracking number may be submitted in lieu of the anticipated
arrival information. This revision is being made because anticipated
arrival

information is often not available to people who ship food using an
express consignment operator or courier (see also the discussion in
section III.E of this document describing the shipper as it relates to
who is authorized to submit prior notice). For food that has been
refused under section 801(m) of the act, Sec.  1.281(c)(11) of the
final rule requires the port of arrival. We revised this provision in
the final rule to require the actual date on which the article of food
arrived at the port of arrival. This information is important for
shipments where no previous prior notice was filed so that FDA knows
how long it has been since the refused food shipment arrived in the
United States. For shipments where a previously refused prior notice
was filed, the actual arrival date will help FDA to connect the refused
prior notice to the post-refusal prior notice submission. Anticipated
arrival information is not required for food arriving by international
mail.
13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient
    In Sec.  1.281(a)(12) and (c)(12), the IFR requires the name and
address of the importer. In Sec.  1.281(a)(13) and (c)(13), the IFR
requires the name and address of the owner if different from the
importer or ultimate consignee. In Sec.  1.281(a)(14) and (c)(14), the
IFR requires the name and address of the ultimate consignee. However,
the identity of the importer, owner, and ultimate consignee are not
required for an article of food that is imported or offered for import
for transshipment through the United States under a T&E entry.
    The identity of the importer, owner, or ultimate consignee is not
required for an article of food that is imported or offered for import
via international mail. Instead, Sec.  1.281(b)(11) of the IFR requires
the name and address of the U.S. recipient.
    a. Importer. (Comments) There were no comments received on this
issue.
    (Final rule) The final rule in Sec.  1.281(a)(12) and (c)(12)
requires the name and full address of the importer. FDA continues to
require the identity of the importer so that FDA can take steps to
ensure that food refused admission under section 801(m) of the act is
not delivered to the importer illegally. FDA is inserting the word
``full'' in front of ``address'' in the final rule to make clear that
the complete address is required. Consequently, FDA also is revising
the subsequent sentence of this paragraph to state that if the business
address of the importer is a registered facility, then the facility's
registration number also may be provided in addition to the facility's
full address. Providing the registration number will facilitate FDA's
review. The identity of the importer is not required for an article of
food that is imported or offered for import for transshipment through
the United States under a T&E entry.
    b. Owner. (Comments) One comment asks that FDA clarify what it
means by owner and provide examples.
    (Response) In the preamble to the IFR, in response to a comment, we
explained that the ``owner'' is the entity who owns the article of food
at the time of arrival (68 FR 58974 at 59011). However, if a prior
notice is given after the article is refused under section 801(m)(1) of
the act, then the owner is the entity who owns the article of food at
the time the prior notice is submitted (Id.).
    (Final rule) The final rule in Sec.  1.281(a)(13) and (c)(13)
requires the name and full address of the owner if different from the
importer or ultimate consignee. FDA is continuing to require the
identity of the owner so that FDA can take steps to ensure that food
refused admission under section 801(m) of the act is not delivered to
the owner illegally. FDA is inserting the word ``full'' in front of
``address'' in the final rule to make clear that the complete address
is required. Consequently, FDA is revising the subsequent sentence to
state that if the business address of the owner is a registered
facility, then the facility's registration number may be provided in
addition to the owner's full address. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a T&E entry.
    c. Ultimate consignee. (Comments) One comment states that the
ultimate consignee, as defined by CBP (Customs Directive No. 3550-
079A), is not necessarily the party to whom the merchandise is
delivered and asks who is the ultimate consignee for purposes of this
rule. Another comment notes that there are a number of manufacturers in
Canada who ship their product to public warehouses in the United States
to have product available on a just-in-time basis for their customers.
The comment states that at the time the product crosses the border, it
is still the property of the manufacturer and it does not have a
specific customer (consignee) in the United States other than the
manufacturer because the consignee is still to be determined. The
comment asks for guidance as to how to comply and fill out the prior
notice for these types of shipments.
    (Response) FDA intends to interpret the ``ultimate consignee''
consistent with CBP's use of that term in regards to the entry of
merchandise. In a case where a customer or consignee has not been
identified, as described in the previous comment, the public storage
warehouse where the merchandise will be delivered and stored should be
identified as the ultimate consignee in the prior notice submission.
    (Final rule) Section 1.281(a)(14) and (c)(14) of the final rule
requires the name and full address of the ultimate consignee. FDA is
continuing to require the identity of the ultimate consignee so that
FDA can take steps to ensure that food refused admission under section
801(m) of the act is not delivered to the ultimate consignee illegally.
FDA is inserting the word ``full'' in front of ``address'' in the final
rule to make clear that the complete address is required. Consequently,
FDA is revising the subsequent sentence to state that if the business
address of the ultimate consignee is a registered facility, then the
facility's registration number also may be provided in addition to the
facility's full address. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a T&E entry.
    d. U.S. recipient. (Comments) There were no comments received on
this issue.
    (Final rule) The identity of the importer, owner, or ultimate
consignee is not required for an article of food that is imported or
offered for import via international mail. Instead, the final rule
requires in Sec.  1.281(b)(11) the name and address of the U.S.
recipient. FDA is continuing to require the identity of the U.S.
recipient so that FDA can take steps to ensure that food refused
admission under section 801(m) of the act is not delivered to the U.S.
recipient illegally.
14. Mode of Transportation
    Section 1.281(a)(15) and (c)(15) of the IFR requires submission of
the identity of the mode of transportation.
    (Comments) There were no comments received on this issue.
    (Final rule) The final rule retains without change the provisions
in Sec.  1.281(a)(15) and (c)(15) of the IFR. The mode of
transportation data element is necessary to calculate whether prior
notice is timely, as well as for identification of the article of food
at the time of arrival for the purposes of planning examinations and
communicating with CBP for enforcement and examination.

15. Carrier
    Section 1.281(a)(16) and (c)(16) of the IFR requires the SCAC or
IATA code of the carrier which is, or will be, carrying the article of
food from the country from which the article is shipped to the United
States, or if codes are not applicable, then the name and country of
the carrier.
    (Comments) Several comments ask for clarification of identification
of the carrier and provide examples of when the article of food is
transferred from one carrier to another both prior to arrival in the
United States and after arrival in the United States.
    (Response) In the prior notice proposed rule, we had proposed to
require the identity of each carrier or transporter firm that
transports the article of food from the country from which the article
was shipped into the United States. We agree with the comments we
received to the proposed rule that asked FDA to eliminate the
requirement to identify multiple carriers, and revised the proposed
provisions to require in the IFR the submission of the identity of the
carrier that is or will be carrying the article of food from the
country from which the article is shipped to the United States. In
doing so, FDA acknowledged the suggestion that the only pertinent
carrier is the one arriving at the U.S. port. The final rule clarifies
that the carrier is the carrier which is, or will be, carrying the
article of food from the country from which the article is shipped to
the United States to the port of arrival.
    (Final rule) FDA and CBP have determined that identity of the
country of the carrier is not necessary when the SCAC or IATA codes are
not provided; the name alone of the carrier is sufficient for
communication between the two agencies. However, FDA and CBP have
determined that the license plate number of a privately owned vehicle
as well as the State or Province that issued the license plate number
is necessary for such communication.
    While identity of the license plate number and State or Province
that issued the license is needed to identify the carrier of the food
at the port of arrival, it is more properly categorized as part of the
identity of the carrier than as part of the identity of the planned
shipment information. Therefore, the requirement for the submission of
the license plate number (and State or Province that issued the
license) for food arriving by privately owned vehicle has been moved to
Sec.  1.281(a)(16) and (c)(16). FDA has found that the identification
of the privately owned vehicle as the carrier, when applicable, is such
a critical factor in the identification of the article of food for
examination and communication, that we have included this information
in Sec.  1.281(a)(16) and (c)(16) of the final rule.
    Section 1.281(a)(16) and (c)(16) of the final rule requires the
identity of the carrier by submission of the SCAC or IATA code of the
carrier which is, or will be, carrying the article of food from the
country from which the article is shipped to the United States to the
port of arrival, or if these codes are not applicable, then the name of
the carrier. If the carrier is a privately owned vehicle, the final
rule requires the submission of the license plate number of the vehicle
and the State or Province that issued the license plate number.
Identification of the carrier is not required for an article of food
that is imported or offered for import via international mail.
    Identification of the carrier is necessary to enable FDA and CBP to
identify the appropriate article of food for inspection or holding when
the food arrives in the United States. FDA notes that a carrier
typically is a different firm than the shipper. The broker or self-
filer currently submits carrier information to ABI/ACS when entry is
made, and it later is transmitted to OASIS.
16. Planned Shipment Information
    In Sec.  1.281(a)(17) and (c)(17), the IFR requires submission of
planned shipment information as it exists when the prior notice is
submitted. FDA recognized that some of this information may change
after the prior notice has been submitted and addressed this in the IFR
in Sec.  1.282(a), which specifies when changes require resubmission to
FDA.
    Many comments addressed the planned shipment information. These
comments are discussed in order of appearance of the specific data
elements in the IFR and preceded by a discussion of general comments.
    a. General comments. (Comments) One comment suggests that a
complete list of ABI mandatory and optional data elements be
immediately published via the CBP Administrative Message system. The
comment asserted that some planned shipment information, such as the
vessel carrier flag, is not necessary when the carrier code is
submitted.
    (Response) The ``vessel carrier flag'' is not part of the planned
shipment information. For food arriving by ocean vessel, the vessel
name and voyage number are part of the planned shipment information.
The preamble to the final rule contains a table of information required
at the end of this section (table 2 of this document). Each information
requirement listed in the table 2 of this document is annotated to
indicate when that information is required.
    (Comments) One comment suggests an additional requirement for
planned shipment information. The comment suggests that a number
assigned through CBP's PAPS be required and that the PAPS number could
be added after the prior notice is submitted, but before the truck
arrives at the border. The comment asserts that this amendment of a
confirmed prior notice, would greatly decrease a truck's waiting time
at the border and aid in quickly clearing trucks through CBP.
    (Response) PAPS is a CBP border cargo release mechanism that
utilizes barcode technology to expedite the release of commercial
shipments. FDA at this time has no plans to utilize PAPS in reviewing
prior notices or otherwise administering the prior notice program, and
therefore, FDA is not adding the PAPS number as an additional data
element.
    (Comments) One comment requests clarification as to whether the
additional requirement for planned shipment information, as applicable
(carrier, vessel name, voyage flight numbers and bill of lading
number), will require a resubmission of prior notice when those details
change due to transportation arrangements outside of the control of the
supplier.
    (Response) When we issued the IFR, we recognized that some of this
information may change after the prior notice has been submitted, and
addressed this in Sec.  1.282(a) of the IFR, which specifies when
changes require resubmission to FDA. If planned shipment information
required in Sec.  1.281(a)(17) changes after you receive notice that
FDA has confirmed your prior notice submission for review, you are not
required by the IFR to resubmit prior notice. The final rule retains
this provision.
    b. Airway bill number(s) and bill of lading number(s)--Sec.
1.281(a)(17)(i) and (c)(17)(i). (Comments) One comment stated that FDA
should simplify the data requirements and make the requirements more
manageable. The comment states that one data element should link all
information secured by prior notice, which would be beneficial for
locating shipments in the event of a possible crisis. The comment
suggests that the waybill/bill of lading number be utilized as a single
reference point because all shipments that are moved are repeatedly
covered by this number.

    (Response) FDA does not agree that the waybill/Bill of Lading can
be used as a single reference point for all shipments instead of the
prior notice confirmation number. A Bill of Lading number is not always
assigned to a shipment at the time of prior notice submission. For
certain shipments, such as those sent by international mail, no Bill of
Lading may exist. Thus, FDA has determined that it is better to use a
unique confirmation number provided by the FDA system to transmitters.
    (Final rule) The Airway Bill number(s) or Bill of Lading number(s)
have been valuable information for identification, examination and
communication; however, this information is generally not available to
an individual submitter of an article of food that is arriving via
express consignment operator or carrier. The express consignment
operator or carrier tracking number is available to those individuals
who send an article of food via express courier. Therefore, we have
amended the final rule to allow the submission of the express
consignment operator or carrier tracking number in lieu of the Airway
Bill or Bill of Lading numbers when the article of food is arriving by
express consignment operator or carrier and the submitter is not the
express consignment operator or carrier.
    Section 1.281(a)(17)(i) and (c)(17)(i) of the final rule requires
submission of the Bill of Lading number(s) or the Airway Bill
number(s), as applicable to the mode of transportation and when it
exists. This information is not required for an article of food that is
imported or offered for import via international mail or when carried
by or otherwise accompanying an individual when entering the United
States. For food arriving by express consignment operator or carrier
when the submitter is not the express consignment operator or carrier,
the tracking number may be submitted in lieu of the Bill of Lading or
Airway Bill number.
    c. Vessel name and voyage number--Sec.  1.281(a)(17)(ii) and
(c)(17)(ii). (Comments) One comment asks the purpose of this
requirement because the vessel name and voyage number are provided to
other U.S. agencies, such as CBP and U.S. Coast Guard, at an even
earlier stage than required for the prior notice.
    (Response) The planned shipment information is necessary to ensure
the effective enforcement of section 801(m) of the act. Submission of
the vessel name and voyage number in prior notice associates that
information with the article of food and enables FDA to effectively
communicate with CBP regarding examination of that article of food
prior to arrival of that food. It is one of the means that FDA and CBP
use to match the prior notice review to the food when it arrives at the
port; e.g., what conveyance is carrying the article of food. The final
rule will continue to require the vessel name and voyage number for
food arriving by ocean vessel. As we discussed in the preamble to the
IFR, while we are dedicated to increasing information sharing
capabilities with other agencies, it is generally difficult to have the
required information readily accessible if we need to coordinate with
other agencies or governments to obtain from them the information
necessary to respond to bioterrorism incidents or other food-related
emergencies (68 FR 58974 at 58992).
    (Final rule) Section 1.281(a)(17)(ii) and (c)(17)(ii) of the final
rule requires submission of the vessel name and voyage number for food
arriving by ocean vessel, when they exist.
    d. Flight number--Sec.  1.281(a)(17)(iii) and (c)(17)(iii).
(Comments) There were no comments received on this issue.
    (Final rule) The final rule requires the flight number for food
arriving by air carrier. The flight number has been valuable
information for identification, examination and communication; however,
this information is generally not available to an individual submitter
of an article of food that is arriving via express consignment operator
or carrier. The express consignment operator or carrier tracking number
is available to those individuals who send an article of food via
express consignment operator or carrier. Therefore, Sec.
1.281(a)(17)(iii) and (c)(17)(iii) of the IFR have been amended to
allow the submission of the express consignment operator or carrier
tracking number in lieu of the flight number when the article of food
is arriving by express consignment operator or carrier and the
submitter is not the express consignment operator or carrier.
    e. Trip number--Sec.  1.281(a)(17)(iv) and (c)(17)(iv). (Comments)
Several comments request clarification of the definition of trip
numbers. One comment reasons that the load tender numbers or manifest
numbers should be used as trip numbers for food arriving by truck
because loads are tendered to carriers with these numbers, and the
carrier uses the numbers for billing reference. Another comment reasons
that trip number appears to refer to a number that relates to the
particular trip or journey rather than the vehicle. Another comment
asserts that the trip number should identify the conveyance, everything
onboard a trailer or container entering the United States. One comment
recommends elimination of the mandatory requirement for trip number.
    (Response) FDA disagrees. Land carriers use the ``Trip'' number to
signify a train number, bus route number, and/or a truck route number.
This number normally designates a repetitive route between two
locations (e.g., Washington, DC to New York, NY) and may signify the
specific truck, bus, or train route (e.g., Train  138 or Bus
 4411). This information is necessary for communication
between FDA and CBP, and thus, the final rule continues to require a
trip number for food arriving by truck, bus, or rail.
    (Final rule) Section 1.281(a)(17)(iv) and (c)(17)(iv) of the final
rule requires submission of the trip number for food arriving by truck,
bus, or rail, as applicable to the mode of transportation and when it
exists. This information is not required for an article of food that is
imported or offered for import via international mail.
    f. Container number(s)--Sec.  1.281(a)(17)(v) and (c)(17)(v).
(Comments) One comment suggests that FDA should allow for multiple
container submissions on one prior notice.
    (Response) Multiple container numbers can be submitted for one
prior notice on screen via PNSI submission or through use of multiple
qualifiers for the Affirmation of Compliance code for container number
via ABI/ACS submission.
    (Final rule) Section 1.281(a)(17)(v) and (c)(17)(v) of the final
rule requires the identification of container numbers for food arriving
as containerized cargo by water, air, or land, as applicable to the
mode of transportation and when it exists. This information is not
required for an article of food that is imported or offered for import
via international mail or when carried by or otherwise accompanying an
individual when entering the United States.
    g. Car number--Sec.  1.281(a)(17)(vi) and (c)(17)(vi). (Comments)
No comments were received on this issue.
    (Final rule) The final rule retains the provisions of the IFR and
requires submission of the identity of the car number for food arriving
by rail, when it exists. This information is not required for an
article of food that is imported or offered for import via
international mail or when carried by or otherwise accompanying an
individual when entering the United States.
    h. License plate number and State or Province--Sec.
1.281(a)(17)(vii) and (c)(17)(vii). (Comments) No comments were
received on this issue.

    (Final rule) FDA has determined that while identity of the license
plate number and State or Province that issued the license is needed to
identify the carrier of the food at the port of arrival, it is more
properly categorized as part of the identity of the carrier than as
part of the identity of the planned shipment information. Therefore,
the requirement for the submission of the license plate number (and
State or Province that issued the license) for food arriving by
privately owned vehicle has been moved to Sec.  1.281(a)(16) and
(c)(16). The final rule requires the submission of the license plate
number of the vehicle and the State or Province that issued the license
plate number, if the carrier is a privately owned vehicle. By including
the identification of the privately owned vehicle as a carrier
information requirement, when applicable, you must resubmit the prior
notice in accordance with this subpart (see Sec.  1.282) if the
privately owned vehicle information changes after the prior notice has
been confirmed by FDA for review. Identification of the license plate
number and State or Province that issued the license is not required
for an article of food that is imported or offered for import via
international mail.
    i. Harmonized tariff schedule (HTS) codes--Sec.  1.281(a)(17)(viii)
and (c)(17)(viii). (Comments) One comment suggests the use of the HTS
codes in lieu of FDA product codes and asserts that the HTS codes
provide all the information that the FDA would need for prior notice.
    (Response) The HTS codes often are not sufficient to specifically
identify a product for FDA decisionmaking. For example, in many cases,
the tariff code does not describe how the product was processed (e.g.,
commercially sterile or shelf-stable) or how the product is packaged,
which is indicated in the Process Indicator Code (PIC) element of FDA's
product code. Several products that FDA considers different from each
other (because these differences affect the potential safety of the
food) may be combined under one HTS code. Therefore, the HTS codes do
not provide all the information that is required to identify the food.
    Additionally, at the time that FDA and CBP issued the IFR, we
believed that the HTS code was needed for communication between FDA and
CBP and that the identification of the HTS would assist CBP in the
efficient processing of prior notice through ACS. We also thought that,
for prior notices submitted through the FDA's PNSI, the HTS numbers
were needed to ensure that the data collected from the CBP entry when
it is transmitted through ABI/ACS could be matched to prior notice. We
have found that the HTS code is neither critical for communication with
CBP nor for identification of the food for examination purposes.
Accordingly, we have removed the requirement to submit the HTS code as
a part of prior notice planned shipment information.
    (Comments) One comment suggests that FDA and CBP upgrade the flags
associated with HTS numbers. The comment also states that prior notice
cannot be submitted through ABI/ACS if the HTS code does not have a FDA
flag. One comment states that FDA should not rely solely upon HTS flags
to implement the prior notice requirements.
    (Response) FDA agrees and monitors and updates the HTS flags.
Guidance about the HTS flags is posted at http://www.cfsan.fda.gov/
~dms/htsguid3.html. Prior notice can be submitted on any product
because of intended use, regardless of the HTS flag. Not having a FDA
flag associated with the HTS code does not prevent submission of prior
notice via ABI/ACS or PNSI.
    (Final rule) Section 1.281(a)(17) and (c)(17) of the final rule
requires submission of the following planned shipment information, as
applicable, based on the mode of transportation:
     Bill of lading number(s), Airway bill number(s), or
express consignment operator or carrier tracking number when the
article of food is arriving by express consignment operator or carrier
and the submitter is not the express consignment operator or carrier
(not applicable to food carried by or otherwise accompanying an
individual);
     For food arriving by ocean vessel, vessel name and voyage
number;
     For food arriving by air carrier, flight number or the
express consignment operator or carrier tracking number when the
article of food is arriving by express consignment operator or carrier
and the submitter is not the express operator or carrier;
     For food arriving by truck, bus, or rail, the trip number;
     For food arriving as containerized cargo by water, air, or
land, the container number(s) (not applicable to food carried by or
otherwise accompanying an individual); and
     For food arriving by rail, car number (not applicable to
food carried by or otherwise accompanying an individual).
    We also added the phrase ``to the mode of transportation and when
it exists'' after ``as applicable'' in the opening sentence of Sec.
1.281(a)(17) and (c)(17) to clarify that the data elements under
planned shipment information are applicable by mode of transportation
and when the data element exists. For example, rail car number,
container number, and train trip number may be applicable for rail
shipments, and vessel name, voyage number, and container number may be
applicable for food arriving by ocean vessel.
    The final rule does not require that prior notice be cancelled and
resubmitted if this planned shipment information changes after FDA has
confirmed the prior notice for review. A prior notice will not be
inadequate if any of the planned shipment information changes between
the confirmation of prior notice and the time of arrival.
    j. Refused articles. (Comments) One comment requests clarification
of the process for resubmission if a prior notice is refused for
reasons other than failure to satisfy prior notice requirements. The
comment asks once the failure is rectified, should companies use the
PNSI or ABI/ACS to resubmit the load for clearance?
    (Response) A food may be refused under 801(m) of the act only if it
is imported or offered for import with inadequate prior notice; i.e.,
no prior notice, untimely prior notice, or inaccurate prior notice. To
resolve a refusal, prior notice or a revised prior notice must be
submitted via PNSI until such time as ACS or its successor system can
accommodate such transactions.
    The following table 2 summarizes the information required under
Sec.  1.281(a), (b), and (c):

                             Table 2.--Prior Notice Information Required by Category
----------------------------------------------------------------------------------------------------------------
   Information      Transshipment     Carried By or    Food Not in      Food in          Mail      After Section
------------------------------------ Accompanying an  Natural State  Natural State --------------- 801(m) of the
                                        Individual   ------------------------------                 Act Refusal
  Sec.   1.281                      -----------------
  paragraph(s)       (a) and (c)                           (a)            (a)            (b)      --------------
                                           (a)                                                          (c)
----------------------------------------------------------------------------------------------------------------
Submitter         Y                  Y                Y              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Transmitter       Y                  Y                Y              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Entry type        Y                  Y                Y              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Entry identifier  Y                  Y                Y              Y              N              Y
----------------------------------------------------------------------------------------------------------------
FDA product code  Y                  Y                Y              Y              Y              Y
----------------------------------------------------------------------------------------------------------------
Common, usual,    Y                  Y                Y              Y              Y              Y
 or market name
----------------------------------------------------------------------------------------------------------------
Estimated         Y                  Y                Y              Y              Y              Actual
 quantity
----------------------------------------------------------------------------------------------------------------
Lot/Code
----------------------------------------------------------------------------------------------------------------