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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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# May l4, 2004 

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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, appreciates the opportunity to comment on the Interim Final
Rule concerning the Prior Notice of Imported Food under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002.
We recognize the need to protect public health, however, not through a
disruption of trade.

The Interim Final Rule 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.

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,
massive problems seem to have constantly occurred.

Many of our US importers are small businesses dealing with small to
middle-sized German manufacturers and the following topics come from
these segments of the industry.

The overriding problems seem to be 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.

*PROBLEM:* The biggest problem 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.

*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.

*PROBLEM:* 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.

*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!).

*PROBLEM:* Companies were not able to access the website for days and,
as a result, not in a timely manner. One manufacturer tells of a case,
where all day Friday, access was denied and that a fax submission was
not possible. The shipment arrived on Sunday and no Prior Notice had
been filed. The products were detained by Customs as a result and
finally after much discussion, the shipment was released (cost \$180 !!)

*SUGGESTION:* As stated above, fax transmission if computer access is
not possible.

*PROBLEM:* Several companies told us that in order to complete the
forms, several security settings on the respective computers had to be
disabled. In this age of computer hackers and viruses, this action is
not welcome by the companies and creates great uneasiness.

*QUESTION:* Would an easier solution without taking these steps be
possible?

*PROBLEM:* Below is an accurate example of the problems encountered by
one of the above-mentioned mail order companies when trying to fulfill
the Prior Notice Requirements:

"In January and February, which is a rather calm business period for us,
it took at least 20 minutes from the start of a web entry till finishing
the Prior Notice !

Frequently occurring breakdowns of your website make us afraid of our
main season in the months before Christmas and let us fear the worst
case !

"Considering the fact that in this period we send up to 1.000 mail
parcels [per day]{.underline} to the US, a mere sticking to the current
procedure is -- already out of reasons of time -- unthinkable.

***[THEIR SUGGESTION]{.underline}***: "To ensure the continuation of our
renowned mail order service we propose that US-Customs give us a defined
quantity of registration numbers at our disposal, which we will print in
ascending order onto our dispatch labels.

"During this fully automated process, a file including all data relevant
for Prior Notice would be created. This file then would be transmitted
electronically to CBP resp. FDA by a FTP-server.

"If requested by them, we even could print a barcode on the dispatch
labels.

"Regarding the quantities of mail parcels to be sent by us to the US,
you surely understand that the current procedure of a manual input of
all details is just impossible to handle. This fact would persist, even
if the operation time for the manual input could be halved.

"The continuation of our mail order service to the US can only be
assured, if the procedure is done electronically as described above.

*PROBLEM:* What can a submitter do that consistently receives the web
notice "WE'RE SORRY! -- We are sorry for the inconvenience. Due to
technical difficulties, FDA Industry Systems cannot be used at this
time. We request that you revisit this web site later. We expect that
the problem will be resolved shortly". However, the problem is not
resolved shortly but at times, days later.\
\
*SUGGESTION:* Allow for fax submission or the information to be
submitted after arrival in the US (if time is short before arrival as
was the case in the example cited above)

*PROBLEM:* In many cases, the smaller US Importers cannot afford the
additional costs charged by a broker to submit the FDA information via
the ABI system. It seems that larger companies are charged \$10 - \$15,
up to \$25 per entry, depending on the volume. The cost is negotiable
based on the volume. This is a situation that does not come in to play
for small companies because they do not have the huge quantities and as
a result, do not have the "negotiating clout" that the larger companies
do. As a result, they are telling their foreign supplier to submit the
prior notice. Some small companies estimate, that when including website
disruptions, 80 packages would take 40 -- 80 hours just for Prior
Notice, they are exasperated. This is totally unmanageable.

*SUGGESTION:* One time entries of manufacturer and product information
as explained above.

*PROBLEM:* Language barriers are another issue, especially when trying
to establish the FDA Product Code. The tutorials do not assist the
foreign companies; if anything, they confuse them further. The needed
information is not clear: for instance, what is "NEC-Y" under "Process
Applied". The "type of packaging (ex. "commercially sterile")" etc. is
confusing to say the least. We contacted the FDA support staff for
clarification on behalf of several manufacturers, who just could not get
through this section. It took us DAYS to help them even though the FDA
Help Desk responded quickly.

Since we were only able to go to the tutorial and could not actually
"walk them through it", this part of the Prior Notice became an
incredibly daunting and difficult task. As an American, I found the
system quite difficult and complicated to maneuver through.

*SUGGESTION:* Use the Customs Numbers the companies must use from the
Harmonized Tariff Schedule of the United States. Without these numbers,
Customs does not allow products to enter the US and we feel, they
provide all the information that the FDA would need.

*PROBLEM:* If small and mid-sized companies are spending 40 minutes per
entry for a shipment, how will "Grandmother" be able to do this when
sending food as gifts to the US? What happens if Granny does not have
access to a computer, which is often the case? In addition, odds are
great that she also does not speak any English.

Most US consumers are still not aware of the new requirements, how can
FDA expect that foreigners will know about them?

*SUGGESTION:* Provide a form to all Post Offices worldwide (in the
native language) that could be filled out onsite and attached to the
product, similar to the Customs Declaration. It would at least provide
the FDA with important tracking information, should that become
necessary. Keep the form short and simple (the current required
information is much too cumbersome for the average consumer).

*PROBLEM:* Many of the express couriers refuse to do the necessary
paperwork for shipments being sent via their services. This means that
the manufacturers are required to submit the Prior Notice (the
regulations also do not stipulate who must fill out the form). The
problem is, that the manufacturer does not have any of the necessary
information needed to complete the form, such as flight number,
departure and arrival, etc. It becomes a "catch 22".

*SUGGESTION:* Treat Express Couriers (DHL, FedEx etc) the same as mail
shipments to simplify the filing requirements for the submitter.

*PROBLEM:* We translated the Food Facility Registration Form as well as
the instructions into German to facilitate compliance for our companies.
We 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 ourselves) 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.

Conclusions

We truly believe that the new regulations 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 the opportunity to submit our comments, suggestions and
concerns and applaud the FDA for their openness and willingness to
listen. The fact that the Agency issued Interim Final Rules rather than
Final Rules and the FDA's reopening of the comment period, to allow for
actual trade experiences, is to be commended.

We thank you for your attention to our comments and 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

Michael Deckwitz, German Ministry

Friedrich Wacker, German Embassy