July 8, 2003

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

**Re: Establishment and Maintenance of Records under the Public Health
Security & Bioterrorism Preparedness and Response Act of 2002; Docket
No. 02N-0277; 68 Fed. Reg. 25188 (May 9, 2003)**

Dear Sir or Madam:

The Flexible Packaging Association (FPA) appreciates this opportunity to
provide comments regarding the Food and Drug Administration's (FDA)
proposed rule to implement section 306 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism
Act"). Pursuant to section 306 of the Bioterrorism Act, FDA has
published a proposal in the May 9, 2003 *Federal Register* requiring the
establishment and maintenance of records.

FPA is the national trade association representing all segments of the
flexible packaging industry. Flexible packaging, which combines the best
qualities of paper, plastic film, foil, and other packaging materials,
is used in packaging food, drugs, and cosmetics, among other consumer
products, and also is used in agricultural, industrial, and
institutional packaging applications. FPA's members include companies
engaged in the manufacture of flexible packaging materials for sale to
the users or distributors of such packaging for the production of
finished packaging for foods and other consumer products, as well as a
host of other products. FPA membership is also open to any operations
engaged in the manufacture of materials, equipment, or supplies related
to the flexible packaging industry. FPA member companies account for
more than half of the 20 billion dollars of flexible packaging produced
in the United States each year.

FDA is to be commended for its commitment to food security and its
ongoing efforts to implement the Bioterrorism Act. FPA recognizes, in
particular, that regulations to implement the Act must be promulgated in
a relatively short timeframe, and that this task presents numerous
challenges. FPA appreciates this opportunity to provide input and offers
the following comments concerning the May 9, 2003 recordkeeping
proposal.

#### Recognition of the Functional Barrier Concept

FPA believes strongly that "packaging" is not "food" for purposes of the
Bioterrorism Act. Even if FDA disagrees, the Agency is urged to exclude
from the recordkeeping obligation all materials that are separated from
edible food by a "functional barrier." In other words, FPA believes
that, at a minimum, any materials that are separated from edible food by
a functional barrier should be regarded as a type of "outer packaging"
for which recordkeeping is not required.

The FDA has long recognized the use of a functional barrier in
determining what types of materials can be used in a packaging product.
If a functional barrier (such as aluminum foil) is present in a
packaging laminate, there is no expectation of migration of any material
through the functional barrier. Therefore, FPA strongly requests that
any materials on the exterior side of a functional barrier be excluded
from the recordkeeping regulation. Because there is no expectation of
migration of any material through a functional barrier, the likelihood
that such materials could be used to adulterate food is extremely
remote.

**[Traceability]{.underline}**

Under § 1.337 (a) of the proposal, it is stated that a nontransporter
must establish and maintain records to include information reasonably
available to identify the specific source of each ingredient that was
used to make every lot of finished product. However, in the preamble the
FDA recognizes the common practice in food industry to commingle
ingredients from different sources prior to incorporating them into a
finished product, thus eliminating the ability to identify the specific
source of each ingredient used to make finished product. Manufacturers
of packaging face the same issues. For instance, during the manufacture
of multiple-layer packaging products, it is common to use multiple lots
of raw material within a master roll of semi-finished or finished
product.  An example of this condition would be a paper/foil lamination
where one roll of foil and three to four rolls of paper are used in the
same production run.  In this situation, the lot numbers of the raw
materials and the lot numbers of the finished products may be known, but
it cannot be determined with precision which lot of the input materials
is in an individual roll of finished product. 

Another example would be the use of inks and coatings.  These materials
are mixed in batches for the manufacturing process.  During the process,
sumps are replenished with material from sequential batches of inks and
coatings.  Batches of inks and coatings cannot be separated during the
manufacturing process.  Hence it cannot be determined with certainty
exactly which raw material was used on a particular roll of finished
product.

Silos are also used in the manufacture of packaging. For example,
extrusion resin may be purchased and held in silos until processed into
product.  The manufacturing processes ensure that materials in the silos
are not contaminated through the introduction of foreign material, but
do not require that the silo be emptied between each batch of finished
product or receipt of additional raw material.  Although it may be
possible to track the lot numbers and date of receipt of raw material,
and infer which lots of incoming raw material are associated with a lot
of finished product, it cannot be determined with absolute certainty
which exact lots of material are in the finished packaging product.

In light of these industry realities, FPA requests that the Agency in
the final rule make clear that, in many instances, it will be impossible
to identify the specific source of a material that is held in bulk and
that multiple sourcing information in recordkeeping is to be anticipated
for raw materials that are held in bulk form.

# [Records Maintenance in Foreign Facilities]{.underline}

According to § 1.326 of the proposal, foreign facilities that
manufacture/process, pack, or hold food for human or animal consumption
in the United States are subject to recordkeeping requirements, unless
the food is further processed (in more than a de minimis manner) in
another facility prior to exportation. Many manufacturers of packaging
materials, however, may not know the ultimate destination of their
products. For example, a facility may supply a primary packaging
material to an agent or distributor, who in turn sells the material to
another converter for further processing. The converter who further
processes the material may export the material to the United States,
without the knowledge of the original supplier; if the further
processing is of a "de minimis" nature, however, the proposed rule could
be interpreted to require the original supplier to maintain records. To
address this scenario, FPA asks that foreign facilities be subject to
recordkeeping, if at all, only if the facility knows or has reason to
know that it is manufacturing/processing, packing, or holding product
that is destined for the United States.

FPA also seeks clarification as to the types of activities that will be
deemed de minimis. For example, a parent roll of film produced by a
foreign facility may be supplied to a foreign distributor/converter who
slits and rewinds this roll into small rolls for shipment to food
packer/filler in the United States. FPA seeks guidance as to whether
this type of slitting/rewinding operation would be considered to be de
minimis.

**[Records Availability ]{.underline}**

Under the record availability requirement in § 1.361 of the proposal, it
states that records and other information must be made available within
8 hours if the request is made at any time other than between 8 am and 6
pm, Monday to Friday. On this basis, for example, the regulation might
be interpreted to require records requested at 8 pm to be made available
by 4 am. Such an expectation would create an unreasonable burden on
facilities, because employees working normal office hours (9 am -- 5 pm)
typically manage the records. It would be more reasonable and practical
to require records to be supplied in such a circumstance without
unjustified delay, but no later than the close of next business day.

# [Compliance Dates]{.underline}

In proposed § 1.368, additional time is provided for "small and very
small businesses" to come into compliance with the regulation. FPA seeks
clarification as to whether the size of the "businesses" that may
qualify for additional compliance time is based upon the size of the
entire corporation or the number of employees at a single manufacturing
facility.

\*\*\*\*\*

FPA looks forward to working cooperatively with the Agency on this
proposal and other food security proposals and initiatives. Please call
me at (410) 694-0823 if you have any questions or need additional
information.

Sincerely,

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Ram K Singhal

Director, Regulatory & Government Relations.