National Coalition of Food Importing Associations

##### 3301 Route 66, Suite 205, Building C  Matawan, NJ 07753

**Phone 732-922-3008**  **Fax 732-922-3590**  **E-mail:
afi@afius.org**

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> May 12, 2004

# By Federal Express And Electronic Mail

Dockets Management Branch

U.S. Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

Michael S. Craig

PGA Coordinator

Bureau of Customs and Border Protection

1300 Pennsylvania Avenue, N.W.

Room 52C

Washington, D.C. 20229

> Re: Docket No. 02N-0278 -- Comments On Prior Notice of Imported Food
> Under the Public Health Security and Bioterrorism Preparedness and
> Response Act of 2002 \-- [Reopening Comment Period]{.underline}

The National Coalition of Food Importing Associations (NCFIA) is pleased
to submit comments to the Food and Drug Administration (FDA) on the
Interim Final Rule, Prior Notice of Imported Food Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(Bioterrorism Act), 69 Fed. Reg. 19763 (April 14, 2004) (Prior Notice
Interim Final Rule).

NCFIA is a coalition of trade associations that represent different
segments of the food importing community. Members of NCFIA include the
following associations: American Spice Trade Association, Cheese
Importers Association of America, Association of Food Industries, The
Cocoa Merchants' Association of America, and the National Fisheries
Institute. Companies belonging to NCFIA members annually import over
\$13.5 billion in food products.

NCFIA is encouraged by FDA's efforts since the passage of the
Bioterrorism Act to craft a workable scheme for the provision of notice
prior to importation of food articles. The compromises affected have,
with some notable exceptions, allowed food to continue to flow into the
United States while also arming FDA with the information it needs to
protect the American food supply. We recognize that the agency has
worked especially hard in its outreach and educational efforts. The
graduated enforcement policy, which has emphasized education and
information over enforcement at the outset, has aided in a smoother
implementation of these new requirements.

With the Prior Notice Interim Final Rule now in effect, our members have
had the benefit of several months of working with the new Prior Notice
System (PN System). That experience informs the comment we offer here.
As is to be expected, NCFIA members have experienced "glitches" in the
interface between the Bureau of Customs and Border Protection (CBP)
Automated Broker Interface (ABI) and the FDA PN System. In some
instances, while the effects upon industry have been severe and
disrupting, we believe the solutions are relatively simple operational
"fixes" that must be achieved at the computer interface level. Other
issues our members have confronted are far more substantive or are
reflective of systemic weaknesses in the PN System. We urge FDA to
consider our comments below and incorporate NCFIA's recommendations into
the final prior notice rule.

Among the changes NCFIA would like to see FDA implement in the final
prior notice rule:

-   Exemption for pre-purchase and trade samples imported for
    research/development purposes and laboratory and/or organoleptic
    analysis;

-   Resolution of PN/ABI system problems so that CBP entry and prior
    notice need not be made at the same time. Resolution of this timing
    problem is especially critical because for many foods, prior notice
    must be submitted before entry can be made (e.g., for quota class
    merchandise subject to CBP "live entry" requirements) and current
    system configurations can make it impossible to comply with both CBP
    and prior notice requirements.

-   Resolution of PN/ABI system problems so that CBP entry can be made
    for articles of food that are already in the United States;[^1]

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-   Provision for FDA to communicate refusals and rejections to the
    importer, and to the ultimate consignee, if different, and to the
    electronic filer, if different, as well as the carrier;

-   Establishment of a system for swift resolution of technical and
    operational problems;

-   Establishment of a system that validates data and resolves conflicts
    between CBP and FDA databases;

-   Resolution of the problem of duplicate prior notice filings;

-   Provision for correction of errors in prior notice submissions, so
    long as corrections are made prior to passage of the 2, 4 or 8-hour
    deadline;

-   Improvement of the capacity of the FDA Prior Notice Internet System
    Interface; and

-   Better FDA communication to, and involvement with, the importing
    community.

Before FDA begins enforcing the prior notice requirements, industry
would also wish to learn from FDA now of the mistakes the agency is
observing in filed prior notices. NCFIA suggests that FDA inform the
filer electronically of the nature of any deficiencies in a filed prior
notice. Alternatively, the agency could post on its website a
description of the types of errors most commonly observed in prior
notice filings.

Furthermore, NCFIA recommends that after full enforcement has been in
place for at least six months, that FDA then re-open the comment period
for an additional 60 days. With the benefit of a period of active
FDA/CBP enforcement and surveillance, the food import community will be
better able to offer informed comments to FDA on the PN System. FDA will
also be in a better position to evaluate the degree to which the PN
System is achieving its stated goals and any problems that have arisen.
Only after this period of full enforcement and additional comment would
FDA then issue a final rule covering prior notice of imported food
shipments.

Last, we comment on the specific questions raised in FDA's *Federal
Register* notice announcing the re-opening of the comment period.

**[Exemption for Pre-Purchase and Trade Samples]{.underline} --
Exemption for pre-purchase and trade samples imported for
research/development purposes and laboratory and/or organoleptic
analysis**

As NCFIA has assisted its members with implementation of the Prior
Notice Interim Final Rule, the issue of prior notice for pre-purchase
and trade samples has become a serious problem. Members of the food
industry, routinely receive samples from customers, suppliers, and
affiliates for qualitative testing, organoleptic analysis, research, and
evaluation. Filing prior notices for these pre-purchase and trade
samples imposed significant burdens without improving food security.

There are many reasons for the steady flow of samples into the U.S. In
the case of spices and other agricultural products, for instance, a
supplier may want their U.S. customer to examine a sample of a
particular lot or crop to monitor fluctuations in quality, flavor, or
cleanliness that often occur with these types of raw agricultural
products. In the spice, flavor, and extract businesses, a foreign
customer of a U.S. company may send samples of other commercial products
and ask their U.S. supplier to analyze the sample and offer a
competitive product. In the cheese industry, a supplier may send a
wheel, log or other form to a potential customer for evaluation of
quality, flavor, and other organoleptic testing.

Samples received in this manner are not intended for commercial
distribution and usually are not intended for human or animal
consumption. In some instances, with ingredients such as flavors,
extracts, gums, or food ingredient chemicals, the article could not be
consumed unless it is processed and manufactured into a food. The
amounts provided are too small for commercialization or resale. With
spices, the sample size is usually five pounds or less. In the case of
other foods, such as a wheel of cheese or package of frozen fish sent
for organoleptic testing, the sample is typically only one unit of the
food product and, therefore, too small for commercial distribution. The
analysis conducted often consumes the entire sample. If there is any
leftover material, it is usually discarded.

FDA has already provided exemptions from the prior notice for certain
categories of food it deems to present a very low risk to public health.
Exemptions include food carried by or otherwise accompanying an
individual arriving in the United States for that individual's personal
use, and food that was made by an individual in his/her personal
residence and sent by that individual as a personal gift to an
individual in the United States.

The lack of risk to public health that justifies exempting personal use
and homemade foods from prior notice requirements applies, indeed even
more persuasively, to pre-purchase and trade samples. The sample will
not be in commercial distribution. Unlike the personal and homemade
foods exemptions, frequently, a human or animal will not even consume
imported samples. Where the sample is consumed, such as for organoleptic
sampling, the quantities are very small and sampling is conducted in
highly controlled environments -- often in a company's own laboratory or
test kitchen. For these reasons, FDA should exempt from prior notice
requirements any samples imported for laboratory analysis, organoleptic
evaluation, and research and development purposes.

In the interim final rule, FDA poses that prior notice covers trade
samples because:

> \[T\]rade samples are imported or offered for import to generate
> sales, which is a commercial, not personal, use. Thus, there is a
> "shipper" when these samples are brought to the United States.

68 Fed. Reg. at 58992. However, we note that in the case of pre-purchase
and trade samples sent for laboratory analysis, these samples are not
imported to generate sales. The trade samples are offered for the
purposes of research, testing, and analysis. The results of such testing
may ultimately lead to future sales of further articles, which would, of
course, be subject to prior notice requirements. However, the purpose of
the importation of laboratory samples is not the sale of the sample; the
importation is for analysis of the sample.

We note that the U.S. Department of Agriculture (USDA) has addressed the
issue of samples and defined a class of products that are exempt from
certain tariff-rate quota requirements:

> Licenses are not required if . . . \[t\]he article imported will not
> enter the commerce of the United States and is imported as a sample
> for taking orders, for exhibition, for display or sampling at a trade
> fair, for research, for testing of equipment; or for use by embassies
> of foreign governments.

7 C.F.R. § 6.22(b)(3). In defining the scope of this proposed exemption,
we urge FDA to look to the definition ad exemptions USDA already has in
place.

NCFIA suggests the following parameters for a pre-purchase and trade
sample exemption.

-   Only pre-purchase and trade samples intended for research and
    development and/or laboratory or organoleptic analysis would be
    exempt from the prior notice requirement.

-   The sample must be plainly marked: SAMPLE -- FOR ANALYSIS AND
    EVALUATION PURPOSES ONLY -- RESALE PROHIBITED."

-   The paperwork accompanying the shipment should include a reference
    to the final prior notice regulation as the authority for the
    exemption from prior notice.

-   FDA should create an exemption code \-- a separate affirmation of
    compliance code -- to be affixed to documentation and entered into
    the PN System, to plainly signal that the sample is exempt from
    prior notice requirements.

NCFIA urges FDA to exempt pre-purchase and trade samples imported for
laboratory analysis, organoleptic evaluation, and research/development
purposes from the prior notice requirements. Public health will not be
endangered by the creation of this narrow exemption.

### Timing and Coordination of Entries -- Resolution of PN/ABI system problems so that CBP entry and prior notice need not be made at the same time 

In the final prior notice rule, FDA should work with CBP to cure serious
timing issues and better coordinate the PN System with CBP entry
requirements. The problems arise because CBP entry of certain foods
cannot be made until after the prior notice deadline has passed. This
dilemma is particularly acute with CBP "live" entry requirements for
quota class merchandise (i.e., most dairy products, sugar,
sugar-containing products and peanuts). For quota class merchandise, CBP
entry cannot be made until the goods arrive at port. In addition, for
articles of food arriving by air, CBP entry may not be made until
"wheels up." From points within the Americas, flight time will often be
less than four hours in duration. Thus, with foods such as quota class
merchandise and articles arriving via a flight of less than four hours
in duration, *prior notice must be made before CBP entry can be made or
the article will be refused*.

However, numerous problems have arisen for filers using the ABI when
they try to file prior notice for an article of food for which they
cannot yet make entry. Most fundamentally, the ABI does not allow the
filer to file the prior notice, and concurrently, generate, but not
make, CBP entry. The ABI requires the two filings be made concurrently
and the filer receives an error message if it attempts to either file
prior notice without entry, or file entry without prior notice.

Filers have attempted to resolve the problem by filing prior notices for
all quota class merchandise and articles arriving via a flight of less
than four hours through the FDA's own Prior Notice Internet System
Interface (FDA PNSI), rather than via the ABI. However, the FDA PNSI
does not have the capacity to handle so many prior notice filings and
the process is very burdensome and time-consuming for the filing
brokers. Moreover, even if the prior notice is completed through the
PNSI, significant problems have arisen when the broker has tried to make
CBP entry later. The experience of our members has shown that if the
filer first makes the prior notice submission through the FDA PNSI, and
then later attempts to make CBP entry through the ABI, the CBP system
rejects the prior notice.

Brokers face a system that makes legal compliance impossible. The ABI/PN
systems as currently configured are creating perverse incentives and
encouraging inappropriate conduct. Filers could wait until the
merchandise arrives at port and then file the prior notice at the same
time entry is made. However, this approach assures refusal of the food
and delays while FDA processes the now untimely prior notice. This
approach also invites FDA to bring an enforcement action -- an outcome
every responsible importer wishes to avoid.

For these instances, where prior notice must be made before entry can be
made, CBP and FDA need a procedure in the ABI that allows the CBP entry
to be generated, but not filed, at the time prior notice is submitted.
Several technology and computer-interface solutions are possible,
including unlinking the two systems or allowing information to be
submitted at the same time to CBP and to FDA, even if some of that
information (as in the case of live entries, for instance) is processed
later.

Similarly, NCFIA asks that FDA consider allowing the submission of prior
notice through the ABI even when that prior notice will not be timely.
This would avoid brokers having to use the very difficult and slow PNSI,
thereby, potentially, delaying late-filed prior notices even further. As
the accepted for review message the filing broker receives is plainly
not affirmation that a filed notice is timely or adequate, it does not
seem that there is any prejudice to, or problems for, FDA and CBP if the
ABI can used for filing untimely prior notices.

**[Timing and Coordination of Entries]{.underline} -- Resolution of
PN/ABI system problems so that CBP entry can be made for articles of
food that are already in the United States**

Brokers have learned that currently the ABI cannot accept a new entry if
the article of food has already arrived in the United States. The
situation arises persistently with imports where important CBP
information and entry requirements can rapidly change, even from the
time that prior notice and entry are filed. For instance, with quota
class merchandise, by the time the food arrives in the United States,
the importer may have exceeded its tariff rate quota (TRQ) license
allotment or in the case of TRQs administered by CBP on a first-come,
first-served basis, the shipment may exceed the remaining TRQ quantity.
In these circumstances, the ABI will reject the entry and the importer
must quickly locate and identify another importer to purchase and then
enter the food. Or, in the case of non-licensed TRQs, the importer will
need to make a new consumption entry for the opened amount and make an
in-bond entry for the balance. However, when the importer seeks to make
the new, corrected CBP entry, the ABI system rejects the entry for lack
of prior notice, even though the food had already arrived in the United
States and was already subject to an adequate and timely prior notice.

Brokers have sought to resolve this problem by filing a new prior notice
for food already in the United States that was already subject to a
previously filed prior notice. Plainly, this is not an adequate
solution. These types of rejections and re-filings of CBP entries are
common in the imported food industry. Importers run the risk of FDA
enforcement if it appears that they are repeatedly disregarding prior
notice requirements. Moreover, the food must sit at the port until FDA
reviews the re-filed prior notice and, eventually, releases the food.

NCFIA urges FDA and CBP to address this issue. Where an article of
imported food was already subject to an adequate and timely prior
notice, there should be no requirement that the filer submit a second
notice. The notice prior to importation applies to foods that are not
yet in the U.S. In the case where the foods are already in the U.S., but
the CBP entry has had to be cancelled and re-submitted, it should not be
necessary to repeat the prior notice filing; filing entry should be
sufficient. It will be necessary for FDA and CBP to accommodate this
situation by modifying the interface between the two computer systems.
Ideally, when the second entry is made, CBP will allow for submission of
the previous PN number the system generated.

**[Communication of Rejections of Prior Notice Filings and Refusals of
Articles of Food]{.underline} -- Provision for FDA to communicate
rejections and refusals to the importer, ultimate consignee, and filer,
if different, as well as the carrier**

The Prior Notice Interim Final Rule provides that the carrier is the
point of contact if an article of food is refused. The problem with this
requirement is that the carrier is not in a position to resolve the
problem with the article of food refused. Burdening truck drivers,
railway operators, airlines, and other cargo shippers with a duty to
report a product refusal to the importer or other concerned party is, in
our view, likely to lead to delays, confusion, and ports clogged with
refused food.

The Prior Notice Interim Final Rule provides communication of refusal to
a party without the resources or incentive to resolve the refusal. In
the case of a rejected notice, the importer or ultimate consignee, if
different, and the filer, if different, are the persons in the best
position to address the agency's concerns regarding the refused articles
and to correct any prior notice deficiencies or other problems. In the
case of refused food, the carrier merely has temporary possession of the
article; the importer or ultimate consignee, if different, has an
ownership interest in the refused food and a strong economic incentive
to resolve the refusal swiftly. The importer, the ultimate consignee,
and the filer are also in the best position to export or destroy the
refused food if the prior notice defects cannot be corrected. Delaying
the notification to the importer, ultimate consignee, and filer, unduly
hinders resolution and increases the likelihood of crowding ports of
entry with refused food.

Involvement of the importer in prior notice refusals will result in an
important benefit to FDA in terms of its improving risk assessment
capabilities, which, in turn, will improve enforcement. Years of
experience has taught NCFIA that unscrupulous importers who are
potentially trafficking in unlawful food most often disappear when FDA
notifies them of a refusal under Section 801(a) of the Act. In contrast,
a responsive importer who cooperates with FDA could demonstrate itself
to pose less risk to food security concerns. Being able to judge the
importer's response will prove to be very valuable to the agency in
targeting unlawful activity and assessing the risk an importer poses.
The importer's response, or lack thereof, allows the agency to refine
its risk assessment tools and analysis.

For these reasons, NCFIA strongly urges FDA to include the importer, or
the ultimate consignee, if different, and the filer, if different, in
the notification chain. Effecting this change will not cause any
additional burden since FDA knows from the prior notice filing the
importer's identity and contact information. Thus, the agency has the
ability to swiftly communicate with the importer via email.

**[Technical Assistance from FDA]{.underline} -- Establishment of a
system for swift resolution of technical and operational problems**

FDA has been of tremendous assistance to industry members with the
implementation of the PN System. Industry is grateful to FDA for its
educational outreach. FDA has undertaken sincere and extensive efforts
to explain the legal and regulatory requirements of the Prior Notice
Interim Final Rule.

Unfortunately, the experience among some industry members with FDA
responsiveness to technical and operational problems has been uneven.
Questions directed to the Help Desk, to the general email address, and
even to FDA District Office personnel have not been answered in a timely
way. When some members have received responses, in many cases, the
answers have been, on further study, simply incorrect. Or, the Help Desk
refers the caller to the regulations, and then when the regulations do
not provide the answer (as, for example with the timing/interface
problem discussed above), the Help Desk refers callers to CBP. Questions
to CBP are directed back to FDA, leaving the caller in a limbo of
uncertainty. Urgent requests to FDA headquarters for assistance with
severely disrupting operational problems have gone unanswered, even
after repeated but polite queries.

We recognize that some "growing pains" are to be expected. Prior notice
is a new and complex requirement. Promulgation of all the Bioterrorism
Act rules has been a very, very large undertaking for FDA and resources
are stretched thin.

Yet, to make this system as error-free as possible, there needs to be a
more systematic method for addressing technical and operational
problems, such as the timing issues we described above. We note that
these are not legal or regulatory questions. Rather, these are specific
problems that are preventing smooth implementation of the PN System.
While perhaps of relatively minor importance to the agency, in that
these particular problems may only affect one company or a group of
companies, a particular product, or a particular transaction, for the
participants to the transaction the problem is severe with serious
economic consequences and business disruption. The Help Desk, and other
methods now established for resolution of these operational issues
simply are not yielding a workable "fix" to the "kinks" in the new
PN/ABI system.

We suggest the following to specifically address operational (as opposed
to legal or regulatory) issues, such as computer interface, data entry,
coding, database, and other technical problems:

-   Establishment of a CBP and FDA agency-industry working group;

-   Creation of an exclusive Help Line staffed with individuals with the
    requisite technical expertise and the ability to resolve operational
    problems as they arise; and

-   Creation of dedicated email boxes within FDA to whom specific
    questions can be addressed, such as timing problems, code rejection,
    transmission problems, and other categories of problems. Email
    capability would also allow industry and FDA to create and document
    an audit trail of potential systemic, technical problems.

We understand that FDA has now established a continuously staffed toll
free number solely for the resolution of technical issues. If this call
center is operational and has staff with the knowledge and authority to
resolve problems such as ABI/PN System interface problems, we believe
this will be a valuable resource. We thank FDA for taking such
constructive measures.

Looking to these types of solutions, FDA can monitor where problems are
arising in the PN System. We believe that dedicating resources
specifically to deal with the interface/system aspects of the Prior
Notice/CBP systems will be of immeasurable use to industry, the
government, and to the smooth flow of safe and lawful food into the
United States.

**[Communication to Trade]{.underline} -- FDA Provision of feedback to
industry regarding errors in filed prior notices**

NCFIA members have been concerned with the lack of information so far
from FDA regarding whether the agency is observing prior notice problems
and deficiencies. Currently, a filer is receiving only the FDA/CBP
confirmation that the transmission was received and that the fields have
data. No error message is sent if data is incomplete or inaccurate.
While reassuring, filers do not know if what they are doing is
substantively correct; they are ignorant of problems with their filings,
or indeed, if there are any problems. As a consequence, industry filers
are looking with concern toward the future when FDA begins enforcing
prior notice requirements because they do not yet know what errors they
are making, and they may not know until FDA refuses an article of food.

We note with concern that the April 2, 2004 Compliance Summary
Information FDA published indicates that 50% of prior notices filed were
incomplete or inaccurate. For brokers, importers, and other filers
working very hard with FDA to establish a viable and efficient PN
System, this compliance rate is disheartening and disquieting. Members
of the import community are eager to know whether they, individually,
are complying.

NCFIA recommends that FDA establish a notification system to alert the
transmitter and submitter when there are errors in a filing. We urge FDA
to do this before the "grace period" of the enforcement policy elapses.
That notification could be in the form of individual responses to filers
describing deficiencies in a prior notice. We also request that FDA
publish deficiency information on its website that lists the most common
problems seen in submitted prior notices. In this way, filers can
correct errors they are now making unknowingly, and articles of food can
continue to be imported lawfully and without interruption. Such an
exercise would be useful for FDA as well, to identify systemic problems
in the PN System and where further educational outreach is needed.

**[Validation System]{.underline} -- Establishment of a system that
validates data and resolves conflicts between CBP and FDA databases**

NCFIA has previously raised its concern that the PN System provides for
little validation of data transmitted. In particular, NCFIA members are
reporting problems with the lack of interface between two separate
databases of information -- the FDA database of manufacturer facility
registration numbers and the CBP Manufacturer ID (MID) database. Filers
use the MID database for information such as the manufacturer's name and
address when they complete the prior notice. Unfortunately, the MID
database is over 15-years old and has become corrupted with erroneous
information that CBP has provided no means to correct. When the
transmitter/submitter files the prior notice, there is no way to compare
the manufacturer's information from the MID database to the facility
information for the same manufacturer on file with FDA in the PN System.
Additionally, the system used to construct the CBP MID codes has
generated multiple manufacturers with the same code. These kinds of
mismatches are causing rejection of the prior notice.

NCFIA suggests that there be an interface between the MID codes and the
facility registration numbers on file with FDA. In this way, when a
broker completes the prior notice and enters the manufacturer's facility
number, and the city and country it obtains from the MID, there will be
a notification to the filer if the information from the MID does not
match the facility registration information on file with FDA. This will
give the broker the opportunity to correct the likely incorrect MID
information. NCFIA urges FDA to coordinate an interface with CBP that
allows for validation and coordination of data between these two
systems.

##### [Duplicate Entries]{.underline} -- Resolution of the problem of duplicate entries

##### 

##### Among importers, a significant operational problem that has arisen does not concern the failure to file prior notice. Rather, brokers are finding that a single article of food is being subject to multiple prior notices! Several parties within the importing chain are all trying to file prior notice for a single article of food. It would be useful if the PN System, in its validation processes, could include a check to see if other notices are already on file for the same article.

**[Correction of Errors]{.underline} -- Provision for correction of
errors in prior notice filings up to time of the 2,4, or 8-hour
deadline**

The PN System does not allow for any corrections once the notice is
filed. Either changed information does not need to be corrected (i.e.,
arrival time, quantity), or the prior notice must be cancelled and
resubmitted. The PN System locks the filer out, even though the required
period for prior notice has not yet elapsed. We urge FDA to allow in the
final rule for filers to re-enter the PN System to correct errors, so
long as changes are made before the applicable 8-hour, 4-hour or 2-hour
prior notice deadline has elapsed.

Flexibility to correct errors is particularly important because the
system requires so many alphanumeric entries. Innocent errors, such as
transposing of numbers, are and will be constantly occurring. In the
case of processed foods, it is not uncommon that the identity of the
plant where an article was produced is initially inaccurately reported
to the filer and, consequently, must be corrected. FDA must be cognizant
of the fact that in developed countries the production of food products
involves a vast and highly complex supply, production and distribution
network. Therefore, errors concerning such important information as
identification of the production facility are not uncommon.

The efficiency, indeed the efficacy, of the FDA PN System is not served
if filers must cancel and refile notices for simple errors and changes
in information. Canceling and refiling notices is also costly and
time-consuming for importers and their Customs brokers. The PN System
should be flexible enough to allow filers to correct these mistakes, so
long as the changes are made before the prior notice deadline (2, 4, or
8 hours prior to arrival, depending on mode of transportation).

### Accessing the FDA PNSI -- Improvement of the capacity of the FDA PNSI 

NCFIA members report tremendous difficulty in accessing the FDA's PNSI
during normal business hours. Access is slow and uncertain; the portal
cannot handle the data submitted. The lags and problems are, of course,
particularly critical for prior notices submitted for articles of food
arriving by truck, rail, and air. The web portal was not designed to
handle the data demands filers are placing upon the system. FDA must
make more capacity available if it is to handle the prior notice
submissions it is receiving through its Internet Interface.

In addition, the Customs brokers report that inputting information
through the PNSI website is overly and unnecessarily time-consuming. On
average, it is taking thirty minutes to input all of the required prior
notice information. We, therefore, urge FDA to develop and implement a
simplified format that facilitates faster input. For example, the
requirement of supplying the address of a registered food facility is
unnecessary and a waste of valuable manpower.

##### [Involving Industry]{.underline} -- FDA should more actively engage the importing community

A theme recurs in many of the issues we raise above -- better
communication between FDA and the importing community. Most
fundamentally, food importers wish to work with FDA to assure the flow
of safe, wholesome, lawful food into the United States. We share in
FDA's desire to protect American consumers and to identify and apprehend
those who would do our nation harm. Consumers are jeopardized and the
entire importing community injured if a single unscrupulous importer
succeeds. NCFIA members wish to have a productive and useful partnership
with the agency.

Brokers and importers are now using the PN System thousands of times a
day. They are in a position to offer feedback to the agency on the
technical and operational problems. Where FDA is contemplating changes
and improvements, it is imperative that the agency follow the excellent
example set by CBP and engage regulated industry early and frequently.
Importers need time to reconfigure operations and computer systems to
respond to FDA changes. If there is an active and ongoing dialogue,
importers and brokers can bring their observations to the agency as
problems arise, which, in turn, fosters FDA's ability to develop and
implement corrective measures.

NCFIA notes that these operational and technical issues do not relate to
the requirements of the regulations. These are not concerns raised by
those looking for clarification as to the scope of the regulations or
advice on what information must be in a prior notice. The parties who
wish to engage FDA more actively are those who are actually making the
prior notice filings daily on a very fundamental, operational level.
These individuals and entities very much share the same goals as FDA --
they want the PN System to operate seamlessly and efficiently and they
profoundly want to do their utmost to insure the safety of our nation's
food supply. NCFIA looks forward to participating in an ongoing
conversation with FDA about the PN System.

**[Reopen Comment Period]{.underline} -- FDA should reopen the comment
period after a period of full enforcement before issuing the final
rule**

As mentioned above, NCFIA recommends that FDA reopen the prior notice
rule comment period for an additional 60 days after full enforcement has
been in place for at least six months. Both the government and industry
need the benefit of experience with active and full enforcement before
fine- tuning the prior notice regulations for the final time. The food
import community and FDA will be able to offer more informed comments
with the benefit of a period of real-world enforcement to evaluate.
NCFIA recommends that FDA issue a final prior notice rule only after
there has been a period of full enforcement and additional comment.

### Questions FDA Poses In the Federal Register Notice

FDA asks a series of questions regarding the PN System, timeframes for
the submission of prior notice, importations by government agencies
(such as the Department of Defense), and consistency with other CBP
programs, including Required Advance Electronic Presentation of Cargo
Information, the Customs-Trade Partnership Against Terrorism (C-TPAT),
and the Free and Secure Trade (FAST) program. Generally, it is our view
that participants in C-TPAT and FAST programs are not the types of
imports on which FDA should be expending its scarce inspection
resources. The point of these programs is, in part, to aid the U.S.
government's inspection mission and risk assessment. We encourage FDA to
look to any program another government agency has undertaken where doing
so may aid FDA in better identifying risks to the food supply and better
deployment of its inspection resources.

We address the questions FDA poses in turn.

# C-TPAT/FAST questions

1\. Should food products subject to FDA's prior notice requirements be
eligible for the full expedited processing and information transmission
benefits allowed with C-TPAT and FAST? If so, how should this be
accomplished?

NCFIA believes that C-TPAT and FAST participants should be eligible for
the expedited processing and information transmission benefits of these
programs. In the view of NCFIA, it would be useful for purposes of risk
assessment if FDA knew from the PN Notice if any of the parties to the
import transaction are participants in C-TPAT and/or FAST. Participants
in these programs, as FDA knows, have had to undergo auditing and supply
chain assessment. If FDA were aware of which articles of food C-TPAT
participants were importing and which were using FAST drivers, the
agency would be able to focus its scarce resources on imports likely to
pose a higher risk.

2\. If the timeframe for submitting prior notice for food arriving by
land via road is reduced to 1 hour consistent with the timeframe in the
advance electronic information rule, would a shorter timeframe be needed
for members of FAST?

NCFIA would support FAST participants being eligible for shorter prior
notice periods. As stated above, FAST participants must demonstrate
control over their supply chain and delivery systems. Streamlining and
harmonizing requirements between FDA and CBP will allow FDA to
concentrate its needed risk assessment and inspection resources where
they are most needed.

3\. Should the security and verification processes in C-TPAT be modified
in any way to handle food and animal feed shipments regulated by FDA? If
so, how?

NCFIA believes that the C-TPAT processes are more than adequate to
handle human and animal food imports and need not be modified.

# Flexible Alternative Questions

1\. If timeframes are reduced in FDA's prior notice final rule, would
other flexible alternatives for participants in FAST or for food
imported by other agencies be needed?

As discussed above, NCFIA believes there are sound practical reasons for
streamlining and shortening the prior notice required for FAST and
C-TPAT participants. Shortening the prior notice timeframes and allowing
expedited processing are appropriate allowances for companies who have
demonstrated supply and delivery chain integrity. NCFIA does not believe
further accommodation is necessary. The system of import surveillance
and inspection benefits if the FDA and CBP requirements are harmonized
to the greatest extent possible. FDA should be consistent with CBP
requirements and timeframes wherever possible; FDA need not exceed CBP.

Accommodation can and should be made for those who have demonstrated
supply and delivery chain integrity through C-TPAT and FAST. Creating an
additional system of flexible alternatives on top of those already in
existence is not warranted. In NCFIA's view, creation of additional
exemptions and certifications could undermine the integrity of the prior
notice and CBP entry system.

2\. In considering flexible alternatives for food imported by other
government agencies, what factors or criteria should FDA consider when
examining alternatives? Should participation be voluntary? If so, should
FDA consider inspection of companies in the supply chain from the
manufacturer to those who may hold the product, including reviews of
their security plans to determine what procedures are in place to
prevent infiltration of their facilities as a condition of

participation?

As stated above, NCFIA does not believe it is desirable or necessary for
FDA to provide flexible alternatives that exceed what CBP is already
implementing. Consistency of requirements between the two agencies is
very useful to NCFIA members. NCFIA firmly believes, moreover, that it
is not an efficient use of FDA's scarce inspection resources to
duplicate the security audit and screening CBP has already undertaken as
part of its C-TPAT and FAST programs.

3\. In considering flexible alternatives for submission of prior notice,
should FDA consider additional means of ensuring that all companies
subject to the registration of food facilities interim final rule ((68
FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have an updated
registration on file with FDA that has been verified?

As discussed, NCFIA does not believe it is desirable or necessary for
FDA to provide flexible alternatives that exceed or augment CBP's
existing programs. Insofar as registration specifically is concerned,
the statute and regulations require that all food facilities register
and update that registration as appropriate; prior notice must contain
accurate registration information, where required. We believe nothing
further need be required. NCFIA would prefer to see FDA's resources
devoted to a sound, risk-based assessment of the prior notices
submitted.

4\. Are there conditions of participation that FDA should consider,
e.g., inspections of companies in the supply chain from the manufacturer
to those who may hold the product, reviews of their security plans to
determine what procedures are in place to prevent infiltration of their
facilities?

As discussed, NCFIA does not believe FDA needs to provide alternatives
that are more flexible even than those CBP's C-TPAT and FAST programs
afford. If FDA believes that it must implement alternatives, NCFIA does
not believe that FDA should seek to repeat the inspection and auditing
CBP has already undertaken. FDA would duplicate the work CBP has already
done if it undertakes the considerable task of inspecting companies in
an importer's supply chain and evaluating other security measures.
Either FDA can rely upon the auditing undertaken in the CBP
anti-terrorist programs, or it cannot. Second-guessing another agency's
determinations and duplicating another agency's efforts is not an
efficient use of FDA's recourses.

5\. Should the food product category be considered as a criteria or
element of expedited prior notice processing or other flexible
alternatives? If so, should certain foods be excluded from expedited
prior notice processing? If so, what should be the basis for determining
which foods should be excluded?

NCFIA does not believe such distinctions are warranted. As stated above,
creating further distinctions and exceptions risks opening holes in the
food security net.

6\. If FDA adopts reduced timeframes in the prior notice final rule,
should FDA phase in the shorter timeframes as CBP phases in the advance
electronic information rule?

NCFIA believes the import system is strengthened by consistency between
FDA and CBP. It is more cost efficient and comprehensible to minimize
the number of changes to existing import practices. A coordinated
phase-in of CBP and FDA requirements means an easier and smoother
implementation for import businesses.

7\. Should FDA offer a prior notice submission training program for
submitters and transmitters, including brokers, to ensure the accuracy
of the data being submitted?

NCIFA strongly supports such training for the import community.

\* \* \*

To conclude, NCFIA sincerely thanks FDA for its efforts to create a
workable Prior Notice System that balances food security needs and
commercial realities. The final rule needs refinement to make it an
effective enforcement tool that still allows for the smooth and rapid
importation of lawful articles of food. We are available to meet with
you to discuss our hopes for the final rule and our anticipated
resolution of these issues.

Very truly yours,

Richard H. Koby Coalition Coordinator

[^1]: We note that with several of the timing issues cited above, the
    issue arises because once Customs entry is made, the filer is locked
    out of the system altogether. De-linking these two systems so that
    Customs entry is no longer so closely tied to the prior notice may
    ease these problems.