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**Re: Notice of Proposed Rulemaking Under the Public Health Security\
and Bioterrorism Preparedness Act of 2002**

-   **Docket No. 02N-0275 (Section 303**---**Administrative Detention)**

-   **Docket No. 02N-0277 (Section 306**---**Maintenance of Records)**

**Comments of the Federation of German Food and Drink Industries (BVE)**

Dear Sir or Madam:

The Federation of German Food and Drink Industries (BVE) again welcomes
the opportunity to provide comments on the FDA proposed rulemakings to
implement the Public Health Security and Bioterrorism Act of 2002. With
this document we wish to comment on the proposed rulemaking to implement
Sections 303 and 306 of the Bioterrorism Act.

As already pointed out in our previous comments on FDA's proposals
concerning "registration" and "prior notice", BVE is the leading
association of the food and drink industry in the Federal Republic of
Germany, for the area of economic and trade policy. It represents the
interests of Germany\'s fourth-largest industrial sector, an industry
that comprises an especially large number of small and medium-sized
companies and that produces a broad range of wholesome, high-quality
products. We would like to reiterate that to the German food and drink
industry the US is its largest single overseas export market, with an
export volume of roughly US-\$ 800 mn or 3.2% of total German food and
drink exports. Over the last years, trade has developed very
favourably---in 2002 alone, the volume of German food and drinks
exported to the US rose by 7.4%. At the same time, imports originating
in the US rose by 7.7% to almost US-\$ 700 mn.

However, we fear that this positive trend is at risk of being disrupted
by the proposed rulemaking of FDA to implement the Bioterrorism Act
2002. BVE is concerned about the impact the proposed measures may have
on trade, especially as the proposals on administrative detention and
maintenance of records are likely to increase uncertainty and costs for
exporters. Small and medium sized companies in particular may be
prevented from continuing to export to the US for these reasons. The
cost estimates of FDA for cases of administrative detention are a case
in point; however, FDA seems to have significantly underestimated the
costs and difficulties of setting up the required systems for the
maintenance of records in small an mediums sized companies.

It is also questionable if the US or FDA have the right to impose
requirements on the way of operating a business abroad, i.e. its way and
scope of storing records. We will however, not dwell on this legal
consideration but wish to express our concerns regarding the technical
problems of implementing the proposed rules and their commercial
consequences.

BVE---as a member of the Confederation of EU food and drink industries
(CIAA)---fully endorses the CIAA's comments on the proposed rulemaking
which was sent to FDA recently. In addition to that, we ask you to
consider the following remarks that are of particular importance to the
German food and drink industry.

**[Section 306: Establishment and Maintenance of Records]{.smallcaps}**

**[Docket No. 02N-0277]{.smallcaps}**

**1) Data elements**

For BVE it is of particular importance that no *new records* will be
required by FDA. The proposed rule states that existing records can be
used if they contain the information required.

It is usual business practise that purchase and / or shipping records,
e.g. bills of lading, include the following information that FDA
requires to be kept in records:

-   Name of firm and responsible individual, address, phone number, and,
    usually, if available, fax number and email address of the
    nontransporter immediate previous source or recipient (whether
    domestic or foreign)

-   Adequate description of the type of food received or shipped,
    including brand name and specific variety

-   Quantity and how the food is packaged

-   Date of receipt or shipment

Concerning these data elements it should therefore suffice to maintain
the appropriate records (e.g. bills of lading).

However, it is not at all general pracise to include all of the
following required information in the very documents mentioned above:

-   Name of the firm and responsible individual, address, phone number,
    and, if available, fax number and email address of the transporter
    who delivered the food to the nontransporter or transported the food
    to another nontransporter

Rather, seperate order papers are usualy established by the ordering
party instructing the trasporter to transport the food in question.
Usually some sort of reference, e.g. an invoice date or a lot number
stated on theses order papers can serve as a link between these papers
and the corresponding purchase / shipping documents. Hence, it should be
sufficient in order to comply with the proposed rule, insofar as these
data elements are concerned, to maintain these transport ordering
papers. Put differently, it should not be required to merge the
information on the two sets of records into a new form of document which
would have to be introduced at great cost.

Furthermore, concerning this information, it should be made explicitely
clear that only the party ordering the transport is obliged to maintain
the records containing it. In a usual transportation process it is
either the sender or the recipient of the food who orders the
transportation. The information required about the transporter is only
reasonably available to the ordering party. Proposed § 1.337 (6)
specifies that the "name of the \[\...\] transporters who transported
the food *to* you" should be recorded. Proposed § 1.345 (6) likewise
specifies to record the "name \[\...\] of the transporters who
transported the food *from* you". Both rules should be altered to read
"name \[\...\] of the transporters who transported the food *for* you".

Concerning the recording of a lot or code number or other identifier, if
it exists, it should be emphasized that there is no obligation to create
such an identifier. Where such an identifier exists it must be
sufficient to record it on any one (but not necessarily all) business
documents mentioned above or any other separate document.

**2) Tracing of inputs in final products**

According to the draft rule, the records must include all information
reasonably available to the food manufacturer to identify the specific
source of each ingredient that is used to make every lot of finished
products. FDA acknowledged that the industry relies on several sources
of ingredients to make foodstuffs. For all but the largest producers it
would be a tremendous effort to implement systems that enable them to
trace the use of each and every ingredient in each and every finished
product.

This was acknowledged in the European Union Regulation (EC) No. 178/2002
of the European Parliament and of the Council of 28 January 2002 laying
down the general principles and requirements of food law, establishing
the European Food Safety Authority and laying down procedures in matters
of food safety (Official Journal L 031, 01/02/2002, pages 1 - 24). This
regulation provides for the establishment of records of the immediate
sources or recipients of food (i.e. "one up, one down") without
requiring a tracing of ingredients in finished products (Article 18).
Such tracing systems may however be implemented on a voluntary basis.
BVE would therefore strongly argue for the adaption of a similar system
in the US.

Having said that, BVE would like to stress that it is not against the
disclosure of ingredient tracing information where it is available in a
documented form in the producing companies. Thus, BVE asks FDA to state
more precisely what "reasonably available" means. We would like to
reiterate, it is BVE's view that it should not mean to require the
creation of new records. Indeed, for most companies it appears to be
possible only to require information on possible sources of ingredients
of certain batches of final products, and only in cases of crises that
require this action by FDA to be taken.

**3) Definition of recipes**

BVE is concerned by the potential disclosure of confidential ingredient
formulation and would like to know how the confidentiality of sensitive
business information will be ensured in case of application of the
records access authority.

**4) Records availability requirements**

Under the proposed rule, records must be available for inspection and
copying by FDA in short time limit (4 or 8 hours). It is questionable
how this will be managed in practice if non-US companies are involved.
Firstly, outside the USA FDA should not have the legal right to
undertake inspections. Secondly, there is the question of different time
zones that must be taken into consideration. BVE would therefore ask FDA
to reconsider and spell out explicitly the time periods and procedures
for inspection of maintained records for non-US firms.

**[Section 303: Administrative Detention]{.smallcaps}**

**[Docket No. 02N-0275]{.smallcaps}**

FDA issued a proposal to implement Section 303 of the Bioterrorism Act
according to which an officer of FDA may order detention of food if
credible evidence or information that the food presents a threat of
serious adverse health consequences or death to humans or animals.

**1) Definitions used**

FDA does not give any clarifications concerning the meaning of "serious
adverse health consequences or death to humans or animals". Indications
should be given in order to limit the scope of implementation of the
regulation. Specifically, some sort of reference to a risk to a large
part of the population---as opposed to merely few individuals---should
be included. If a risk associated with a food product only affected a
very limited group of people, detention would not be the appropriate
action to take. Also, the health consequences must really be severe to
average-type people in order to justify a detention. It must not be the
case that, for example, only a risk of a limited effect on the
well-being of elderly people triggers a detention.

FDA also explicitly rejects to define "credible evidence or information"
indicating such article presents a threat. Rather it points out such
vague definition is common practice in US law making. Nevertheless we
are very concerned that this vague definition offers FDA too much
discretion when deciding to order a detention. This is aggravated by the
fact that FDA may order a detention on the basis of confidential /
classified information. Given that the potential damages to a company of
a wrongly ordered detention will usually be enormous, it is our view
that FDA\'s ability to detain food shipments must be limited more
strictly by a more precise definition.

**2) Appeal process**

Even though FDA has elaborated at length the process of ordering a
detention, giving notice to the holder / owner of the food, inviting and
conducting a hearing and releasing products from detention, some
"question marks" still remain.

First, the detention rules proposed are modeled after the existing
detention rules for medical devices. It can be questioned whether these
rules are a model for food, given the usually short "best before" dates
of foods.

Second, the proposed rule states that the owner, operator or agent in
charge of the place where the article of food is located shall be issued
a copy of the detention order. Also, as will be typical for food imports
to the US, the owner of the food shall receive a copy if he can be
determined "readily". We would wish that FDA stated more clearly what
"readily" meant in these circumstances. Clearly, in any case of
detention it is absolutely vital that the European sending company gets
knowledge of the detention immediately. Given the registration
requirement of Section 305 of the Bioterrorism Act, it must be possible
to find out the identity of the sending company, the buying company and
all intermediaries of the food detained *at once*. At least one or them
will typically be the owner, so it would be no harm to inform all of
them of a detention order. In fact, this is the only way to give the
owner a realistic chance to file an appeal.

Third, the reasons for a detention should be stated more clearly than
foreseen in the draft regulation. Otherwise the filing of an appeal will
be made unduly difficult.

Fourth, the proposed rulemaking only foresees a requirement to give
notice of the opportunity for a hearing. In other words, the agency
believes that it has the discretion to grant or deny requests for
hearings. BVE believes that a right for a hearing as well as a written
appeal must be given to the owner of the food *in any case*.

**3) Detention period**

FDA foresees a detention period of 20 calendar days which may be
extended to 30 days. BVE would like to call into question if 20 days are
reasonable for perishable foods that FDA itself defines as being
marketable only for 7 days.

In our view FDA should be required to limit---in each and every
case---the detention period to that period which is absolutely minimally
necessary to undertake the necessary investigations into the possible
threat that underlies the detention order. Thus, it must be made clear
that a detention will typically vary in length from case to case, up to
a maximum of---regularly---20 days. For perishable food it should be
considered to limit the maximum detention period to 7 days. Considering
the possible extension to 30 days it must be made clear that this is not
an extension by a "block" of 10 days but rather a possible extension by
up to 10 extra days.

**4) Erroneous detention orders**

For food companies, erroneous orders of administrative detention will
constitute a very costly and unnecessary economic burden to EU
exporters. The cost of administrative detention may include
transportation, storage, marking and labeling, loss of product, loss of
product value and appeal. According to its impact analysis, FDA
estimates that up to 48% of the food that is administratively detained
may be held up erroneously. FDA calculates the costs of a detention to
at least 20.000 US-\$, up to 330.000 US-\$ for SMEs, and even larger
sums for bigger companies. So the potential economic impact may be
substantial. With these considerations in mind, BVE requests that the US
foresee a reimbursement of companies with erroneously detained food
shipments.

**5) Detention of partial shipments**

If a lot is detained because it is considered as potentially dangerous,
the whole container may be detained. FDA should develop this possibility
further and propose rules that would regulate that only the "risky" food
is detained while the rest can proceed into commerce as usual.

We thank you for taking our concerns into consideration.

Yours sincerely,

(original signed by:)

**Christoph Freitag**

Manager