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**German Agricultural**

**Marketing Board**

Home Office: 42 Lehigh Lane

Hicksville, NY 11801

TEL: (516) 433-4864

FAX: (516) 433-0637

North American Office: 1800 Diagonal Road

Suite 210

Alexandria, VA 22314

TEL: (703) 739-8900

FAX: (703) 739-8910

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# April 1, 2005 

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## Prior Notice of Imported Food

**Docket No. 2002N-0278**

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The German Agricultural Marketing Board -- CMA, the official government
trade and marketing organization representing foods and beverages from
Germany, previously submitted comment on May 14, 2004 and would like to
follow up on those comments with the following remarks.

The Interim Final Rule concerning the Prior Notice of Imported Food
under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 has been in effect since December 12, 2003 and as a
result, has given the industry an opportunity to use the new system and
to find out where confusion and problems exist. It also has given them a
chance to get through the very busy Christmas season 2004, which is a
time when imports from Germany to the US increase, especially for
seasonal items.

We have been extremely active in assisting the German food and beverage
industry in complying with the new requirements. However, in our own
personal experiences as well as those of the individual companies, many
problems seem to continue to occur.

Most of our German manufacturers are small to middle-sized companies.
Their US importers and potential clients, for the most part, expect them
to fulfill the Prior Notice requirements and offer no assistance in
complying. This leaves these companies to "fend for themselves" with an
outcome, that is often -- but not always -- predictable.

We sent an email blast to German manufacturers and exporters asking them
to inform us of their experiences with the new regulations. Below please
find the responses from this segment of the industry:

The overriding problems remain accessibility to the website, cost and
time of the filing procedure, language barriers and complexity of the
information requested.

Below are some examples of these issues and possible suggestions for
their resolution, while still fulfilling the requirements of the Act. In
many cases, the problem and possible solution remains the same as in our
former submission. However, additional problems have also arisen, which
will also be mentioned.

***[PROBLEM #1:]{.underline}*** **Problems Accessing FDA's Website**

When completing the online Prior Notice submission, many companies have
been thrown off the website or the form would constantly "recycle" so
that the submitter could not proceed. They would try to go back to where
they left off, after sometimes completing countless points, only to find
that they had to start all over again. This problem was mentioned by 95%
of the companies responding to our survey.

In some instances, the manufacturer could not even access the website.
The main cause for this appears to be demand / traffic on the website.
Many companies noticed, that if they filed during the night (US time --
Germany is 6 hours ahead), the problems were not as severe and/or did
not occur as often.

However, once US businesses were open, the problems often became
insurmountable. The obvious solution would be for companies to file
during these off hours. However, that is not always possible, since
shipments are often only completed late in the business day and as a
result, would become "victim" to the "website traffic".

***[SUGGESTION:]{.underline}*** Make sure that FDA's server is able to
handle the huge amount of traffic that confronts it each day. Possibly
look into why so many companies are being "thrown off" the site and
having to restart the process, which is frustrating and time-consuming.
When considering that registrations take place at the same website, the
number of hits from all over the world at any given time must be
astronomical.

*PROBLEM #2:* Prior Notice Still Too Cumbersome for Mail Order

> Companies

The biggest problem still seems to be for mail order companies, who
sometimes mail thousands of packages at one time. When you consider,
that each individual package needs a prior notice, the workload becomes
unbearable. Since these companies cannot afford to hire additional staff
and in addition, the sheer volume of the type of information required,
makes this a very overwhelming task. We appreciate that the FDA has
reduced the paperwork for shipments of food sent by international mail.
However, it is still a cumbersome and time-consuming project, even with
the changes.

A specific example from a small manufacturer, who does almost all of his
sales to the US as mail order: "From September to December we had
approx. 850 web entries and for each at least 1 -- 10 Prior Notices!!
With a gift shipment of 10 different items for one recipient, we spent
at least 30 minutes completing the necessary paperwork, eventhough the
entries had become "routine". The total amount of time spent during the
September to December time frame was between 200 -- 250 hours!!" For any
company, especially a small business, this is extreme and very costly!

Regular customers of this company also stated that shipments took on
average

2 -- 3 weeks longer to reach them than in past years. It was everyone's
opinion that this was not what was supposed to happen with the new
regulations.

*SUGGESTION:* Would it be possible for the manufacturers to only submit
their company information and product information for similar items once
and then add the different recipients' addresses at the end? At
completion, either the manufacturer could receive one number for all of
the shipments sent at the same time or possibly the FDA computer could
generate all required separate numbers at once. This seems more cost and
time efficient for all concerned.

It would also seem to us, that it would be much more efficient if one
prior notice could be submitted for each shipment rather than for each
item. Considering that the US consumer often orders many different types
of items, this would require the manufacturer to submit countless prior
notices for one consumer (as was stated in the example above). The task
remains daunting. If a manufacturer has a "packing list" where all items
in one shipment are listed (such as a proforma invoice), it would allow
the manufacturer to submit one prior notice and yet the FDA would still
be able to track what was in the shipment since all items would have
that shipment number. The tracking for Customs and FDA would, in our
opinion, be much easier and more streamlined.

*PROBLEM #3:* Express / Courier Shipment Problems and Delays

Express shipment companies, such as FedEx, UPS, DHL previously filled
out the Prior Notice forms for manufacturers sending samples and
products to the US. Some of them, such as FedEx, then sent an invoice to
the shipment recipient (usually in the amount of \$20.21 or thereabout)
requesting payment of this amount for "FDA paperwork submission".
Usually the manufacturer was not even aware this was going on.

Now, all express companies have stopped submitting Prior Notice forms
for the shipper. Reason given: they have received too many penalties
from FDA for incorrect PN submissions. Now the small companies are left
"high and dry" and must struggle with the form for express shipments,
often without having sufficient arrival information. Add to the mix,
that these small manufacturers often have a limited knowledge of
English, and the difficult PN Form becomes a daunting task. Very often,
the company gives up and no longer sells to the US.

*SUGGESTION:* A shortened, easy-to-use form for express shipments. It
would still provide the necessary information yet not in such great
detail. Similar to our suggestion for Mail Shipments.

*PROBLEM #4:* FDA Product Code Confusion and Problems

The establishment of an FDA Product Code has created many problems for
companies. It is cumbersome and often difficult to understand. Also, it
is not as complete as it should be -- which would make it even more
complicated. There is also no way for the manufacturer to know that he
has chosen the correct Product Code. Case in point: A German
manufacturer of Red Cabbage in a jar and Sauerkraut in a jar, wanted to
establish a Product Code for his products. However, there was no such
subdivision and the closest was cabbage. When the shipment arrived, the
FDA Inspector argued that the sauerkraut was not cabbage and would not
be permit entry of the product into the US since the PN was incorrect.
It took weeks -- and tremendous storage costs -- for this problem to
finally be resolved. Now they are still arguing as to who is responsible
for the error and should cover the additional costs: the manufacturer,
broker, importer, maybe even the FDA???

*SUGGESTION:* Permit use of the HTSUS if a company does not know or does
not have an FDA Product Code. The HTSUS is very detailed and would once
again, provide sufficient information for the FDA in the event of an
emergency.

*PROBLEM #5:* Problems Completing and Submitting Prior Notice from
Computers Other Than The Computer That Registered The Company

As stated above, an additional huge problem encountered by our companies
(and also by us when trying to assist the companies): Either we could
not gain access to the website for hours on end and/or it could only be
accessed on the computer that had done the initial company registration.
It had been our belief that the Prior Notice could be done by anyone
regardless of who submitted the company registration. And yet, when
trying to gain access to the website, only the actual computer used for
the registration worked. This posed problems when other departments of a
company needed to submit a Prior Notice since the person who was at that
particular computer had to finalize all paperwork for everyone else. In
all of these scenarios, it is again time costly and inefficient. The
companies also received notices saying that the Registration and PIN
Numbers were invalid when they were permitted access on the registering
computer.

Often the companies had to resort to re-registering, obtaining a new
registration, PIN and ID Number and then trying to submit a Prior Notice
again. Sometimes that worked, but we are sure that is not FDA's
intention. This will have the result, that the FDA has a company
registered many times with several different numbers creating total
confusion and no oversight for anyone!

*SUGGESTION:* Allow a fax option for any company that is having problems
gaining access to the website. We are certain that in underdeveloped
countries, the problem of accessing a computer is even more difficult
than for, as in this case, a developed country (who is having a hard
time!).

Another possibility would be to establish a form that can be filled in
offline and submitted by fax or email. It would allow the companies to
spend less time online and make sure that they have all information. As
with other forms, companies become used to completing them and then the
time needed to complete is reduced. A printable form is also much easier
to understand and often much shorter than the one currently being used.

One of our manufacturers stated that he had established such a form,
which he preprinted with the constantly repetitive information. He fills
out the remaining portions and submits it to FDA. He has received a PN
number each time without any problem. This type of solution seems to us
to be time and cost effective both for the shipper and the FDA and yet
still complies with the Act.

It seems that prior to ceasing to offer the submission service, an
express shipper had established a form that was one page long and was
sent to the manufacturer in pdf format as a fax form. This was one form
for all products NOT dozens of forms! The form was completed, submitted
and an hour later, the manufacturer had a PN number. No excessive time,
costs or manpower was involved!

*PROBLEM #6:* Too Many Registration Requirements for Some Companies!

Many of our manufacturers are already registered with the FDA because of
Low Acid Canned Food Registrations, etc. Now this additional
registration.

*SUGGESTION:* Since most of the information that is required is readily
available to the FDA, wouldn't it suffice to have these companies list
their FCE and SID Numbers, which are already mandatory to be included in
the paperwork? This information is always checked at the time of import
and would make Prior Notice "redundant".

*PROBLEM #7:* Sample Shipment Prior Notice Problems and Difficulties

Filling out Prior Notice Forms is the same for a sample shipment as it
is for a container load. It is time consuming and costly, especially
when a manufacturer is sending components for testing and the like. The
same is true for samples carried by a person on a plane for business
purposes.

Specific Example: A manufacturer of snacks sends samples of flavorings
to the US for testing. He does not have all the necessary information
for the Prior Notice and must contact the supplier several times for
additional information -- all for a sample shipment meant for testing!!

*SUGGESTION:* Wouldn't it be easier for all parties to allow the Customs
declaration to also serve as the Prior Notice for Sample Shipments?
Also, exempt all samples carried by a person whether for business or
private purposes.

*PROBLEM #8:* Express Shipment Refusals

Sample shipments entering via DHL, UPS and/or FedEx were refused entry
for PN errors and returned to the shipper. We assume that is why these
couriers have ceased offering this service. (see above)

*SUGGESTION:* As mentioned previously, allow ALL sample shipments, no
matter what mode of transportation is used, an easier, shorter format to
expedite and facilitate entry. Or, as stated above, exempt all sample
shipments from registering requirements and accept a detailed Customs
declaration with a proforma invoice.

*PROBLEM #9:* Entry / Clearance Delays because of Prior Notice

As a result of the Prior Notice requirements, clearance of shipments is
taking 10 -- 14 days longer than before the new regulations. The Customs
brokers tell our manufacturers, that this is due to the increased
inspection by FDA, but also because of the additional paperwork.

*SUGGESTION:* We can appreciate that FDA has the authority and
obligation to inspect shipments at the time of import. However, if a
foreign company has established a clean "track record" of Prior Notice
Filings, to allow them expedited entry. We feel that the increased
delays in processing and clearing shipments is no longer fair or
reasonable and results is high storage costs that must be carried by the
foreign and US companies.

*PROBLEM #10:* Excessive Expenses for Small Businesses due to Prior

> Notice

One of our mid-sized companies gave us an estimate of the costs of the
Prior Notice: If the system runs without problems, and the submitter is
not "thrown out", the individual positions take about 10 minutes each to
complete. Add to that an additional 4 -- 5 minutes for supplementary
information and you have a time factor of approximately 15 minutes for a
5 g sample shipment. Total annual costs are estimated to be about Euro
15,000 (approx. \$35,000!!). Quite a lot for a midsized company!

*SUGGESTION:* As mentioned above, simplify and shorten the process in
order to make compliance easier.

*PROBLEM #11:* Limitations for Listing Container and Shipment Sizes on
Prior Notice Form and Problems that Causes

It is not possible to enter several container sizes at once. As a
result, a second part has to be opened and the information recorded,
eventhough it is going to the same person. For example a shipment has
the same product destined for the same recipient packed as follows: 280
kg are packed in 11 x 25 kg + 1 x 5 kg containers. Two entries have to
be made for the same product and same recipient!!

*SUGGESTION:* Allow more container size possibilities as had been the
case at the start of the Prior Notice process.

*PROBLEM #12:* Repetitve Information Requirements

Some information requested is repetitive. For example: A manufacturer
gives the "Production Identifier" and later on has to mark off again
that it is the same production number. Same applies to "Shipper" and
"Manufacturer": eventhough they mark off that these two are one in the
same, yet at the end of the form, the information has to be given again.

*SUGGESTION:* In order to save time and frustration, reduce the amount
of repetitive questions. Once a question has been checked off, do not
require that information again any way later on.

*PROBLEM 13:* Language Difficulties and Simplification of Form

We translated the Food Facility Registration Form as well as the
instructions into German to facilitate compliance for our companies. We
still find the Prior Notice impossible to do, in first order, because we
are not able to obtain a workable copy (the tutorial does not lend
itself to it) and there seem to be constant changes to the system.

*SUGGESTION:* Provide Foreign Governments and Trade Organizations (such
as ours) with a detailed outline of the Prior Notice Form with
explanations of the individual requirements etc. so that they can be
translated into the respective languages and sent out to the affected
companies. The FDA would also need to keep these government agencies and
groups apprised of any changes and updates as they are made. It would be
a partnership towards achieving compliance for all involved. Preferably
a shorter form would be ideal and make it so much easier for all
concerned!

Conclusions

We truly believe that the new regulations to some extent continue to
deter the innocent from entering the market and the small and mid-size
companies from keeping their market share, and we are sure that is not
anyone's intention.

We appreciate your taking the time to consider our comments, suggestions
and concerns and applaud the FDA for their continued openness and
willingness to listen. We hope that the Agency will look into these
issues before publishing the Final Rules.

We are available should you have any additional questions.

On behalf of the German Agricultural Marketing Board -- CMA and small
and medium-sized German food and beverage manufacturers and their US
importers, I remain

Very truly yours,

German Agricultural Marketing

Board - CMA

Margaret Eckert

Director of Trade Relations

**P.S. I can be reached at:**

**\
**Tel: (516) 433-4864

Fax: (516) 433-0637

Email: <Eckert@germanfoods.org>

Cc: Martina May, CMA Bonn, Germany

Arnim von Friedeburg, CMA North America

Julia Lueb, CMA Bonn, Germany

Axel Wildner, CMA Bonn, Germany

Michael Deckwitz, German Ministry

Friedrich Wacker, German Embassy