<http://www.fda.gov/dockets/ecomments>

Dockets Management Branch (HFA 305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

> **Re:** **Registration of Food Facilities**

**Docket No. 02N-0276**

Sir or Madam:

At Kraft Foods the safety of our products is of paramount importance,
since our well- known brands are found in 99.6% of US households and
sold in 150 countries around the world. Kraft is a \$30 billion global
company, the largest food manufacturer in North America, and the second
largest worldwide. As Kraft celebrates its centennial year, we are
especially aware that the trust we have built over the last 100 years is
priceless and critical to our continued success. We share the
government's goal of protecting the safety of the US food supply.
Furthermore, our interest in this particular proceeding is substantial,
because we will be registering approximately 1000 Kraft facilities under
the regulations the Food and Drug Administration (FDA) is developing.

Kraft commends the dedicated FDA personnel who are diligently attempting
to implement the Bioterrorism Act in record time. We understand the
pressure under which the agency's officials have been operating and the
long hours they have invested and appreciate their service. We too, have
devoted significant effort to improving the safety of our supply chain
and to understand the impact the new regulations will have on our
operations.

From our point of view, however, the stringent time constraints imposed
upon this proceeding only increase the importance of incorporating into
the final rule reasonable recommendations from responsible stakeholders
like Kraft. We offer our practical experience and suggestions for change
to improve the agency's implementation plan and not to criticize the
work that has been done to date. Both government and industry are
investing considerable resources in systems and procedures intended to
reduce bioterrorism risks. Working together, we can assure that our
efforts are as effective as possible.

Kraft recommends that FDA modify two aspects of the proposed
registration rules. First, we suggest that FDA make collection of
"establishment type" data mandatory, rather than voluntary, and forego
collection of "FDA product code" categories for each registered food
"manufacturer/processor" facility. The establishment type would change
only rarely, but facility specific product category information would
need to be updated frequently. Of much greater concern, however, is the
possibility that, having gone to the expense of collecting and
maintaining the product category information, FDA might rely upon the
registration data base to "target communications" related to
bioterrorism threats and, in so doing, fail to communicate with all
affected facilities.

One manufacturer's product is another's ingredient. Ingredients are
spread throughout the food supply and are stored not only at
manufacturing sites but also at warehouses, retail stores and in
consumer's homes. If FDA were to focus communication and investigation
resources only on registered production sites for foods, all those in
the supply chain that use those foods as ingredients would fail to
receive potentially critical information.

Rest assured, we stand ready to answer the agency's questions about what
products are made in a particular facility upon request, with the
specificity necessary to facilitate effective action. However, we cannot
support the proposal to build and maintain a data base by facility of
arbitrarily defined "FDA product code" categories, which bear no
relationship to bioterrorism risk and which could reduce communication
of critical information. Thus, we are compelled to make our best effort
to dissuade the agency from adopting this proposal.

Our second recommendation is related to the mechanics of gathering the
registration data. While we agree that interactive registration over the
Internet is likely to be efficient both for FDA and for companies
registering only a few facilities, we suggest that the agency also
accept transmission of electronic data files in lieu of interactive data
entry. Offering companies registering a large number of facilities the
option to process registration data electronically, but without using
time consuming interactive data entry, will reduce entry errors and
permit both the agency and larger companies to accomplish the massive
registration task as efficiently as possible.

**I. FDA should track Establishment Types, but not FDA Product Code
Categories.**

The Bioterrorism Act gives FDA discretion to gather general food
category data, if the agency determines that such information is
"necessary." The general food categories identified under 21 CFR 170.3
Section 170.3 are to be used, if FDA does determine that product
category information for each facility is "necessary." FDA has correctly
acknowledged the problems associated with use of the outdated,
irrelevant 170.3 categories. Instead, the agency has tentatively decided
to require submission of \"FDA product code\" categories concluding, we
think incorrectly, that tracking FDA product code categories

> "...is necessary for a quick, accurate, and focused response to a
> bioterrorist incident or other food-related emergency, because the
> categories will assist FDA in conducting investigations and
> surveillance operations in response to such an incident. These
> categories will also enable FDA to quickly alert facilities
> potentially affected by such an incident if FDA receives information
> indicating the type of food affected."
>
> 68 Fed. Reg. 5384. The agency's speculation that a potential threat to
> the food supply might be framed in terms of highly technical "FDA
> product code" category definitions is at best unrealistic.

The proposed categories bear no relationship to potential bioterrorism
risks; thus, collecting information about the categories associated with
each facility would not be useful in reducing threats to the food
supply. As a practical matter, the categories are hard to work with,
even for the import specialists at brokerage firms who must deal with
them every day. Some categories overlap each other, yet many foods fall
into gaps among the categories, so deciding which category FDA would
deem correct can be quite difficult. Determining the proper category
also is a struggle because the categorization scheme is in many respects
counter-intuitive. Therefore, manufacturers are likely to classify
similar products differently or make mistakes in reporting category
classification.

Examples may help to explain the difficulty we see with the use of the
"FDA product code" categories.

-   If Kraft had not had prior experience importing ready to eat
    chocolate pudding from Canada, we would not have been familiar
    enough with the "FDA product codes" to know that this type of
    pudding is classified in the category "*bakery products, dough
    mixes, or icings*." We probably would have placed the product in the
    category described on the form as "*gelatin, rennet, pudding mixes,
    or pie fillings*," even though the pudding is not in mix form; or
    perhaps we might have selected the category described as "*chocolate
    and cocoa products*." Both choices would have been incorrect under
    the agency's product code builder scheme, for which there is a
    tutorial on the
    [fda.gov](http://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/tutorial.cfm)
    web site.

-   There are virtually no products on the market today labeled
    "imitation," yet FDA proposes "*imitation dairy products*" as a
    product category that must be tracked to avert risk of bioterrorism.
    In fact, the "imitation" designation always was solely economic\--to
    protect consumers from spending money on products that are not
    "true" dairy products\--and unrelated to safety or even to
    commonality of product composition.

-   The single category 170.3(n) (3) (beverages and beverage bases) is
    referenced after 4 different "FDA product code" categories on the
    proposed registration form. We fail to see the benefit of attempting
    to distinguish facilities that make beverage bases, from those that
    make soft drinks and water, cocoa drinks, or coffee and tea. Into
    which category should we place a mocha coffee beverage base?

-   Similarly, why does a registration need to tell FDA whether candy is
    made with or without chocolate? Does "without chocolate" mean
    without chocolate liquor or without chocolate and cocoa products?

-   Why should facilities making dressings and condiments be
    distinguished from those making gravies and sauces? The distinction
    between sauces and dressings is unquestionably arbitrary and easily
    subject to varying interpretations.

-   Likewise, is a fruit sauce a "*fruit product*" or a "*sauce*"?
    Banana sauce belongs in the "FDA product code" category for
    "*multiple food dinners, gravies, sauces, and specialties*," yet
    banana topping and syrup are classified in the category "*fruits and
    fruit products*."

Thus, under the FDA proposal, for each product (stock keeping unit or
"SKU") a company makes, the company must take the time and spend the
money to determine the accurate "FDA product code", and then from that
detail determine the "FDA product code" category. Alternatively, the
company could guess the correct category based upon the agency's
descriptions on the form. The latter, more expedient, approach
inevitably would lead to classification inconsistency, if not to a
database full of useless information. Incidentally, Kraft alone makes
over 19,000 SKUs. In short, the "FDA product code" categories simply are
no more workable or useful in fostering the agency's mission of
maintaining the safety of the food supply than would be the 170.3
categories FDA properly rejected.

Moreover, company officials are required to certify that all
registration information is "true and accurate." The preamble tells us
that FDA will consider false information to be "a materially false,
fictitious, or fraudulent statement to the US government under 18 USC
1001, which subjects the person \[submitting the information\] to
criminal penalties." 68 Fed. Reg. 5385. No one should even potentially
be subject to criminal penalties for failing to discern the
idiosyncrasies of the "FDA product code" system.

In the FDA training video on the proposed registration regulations,
agency personnel talk about the importance of using product category
information for "targeted communication," a concept that appears to be
based on the faulty premise that only facilities making one or a few of
the identified FDA categories would need to know about a potential
threat. 68 Fed. Reg. 5384-5385. In fact, all food manufacturers need to
know about potential security issues, just as all learn from recall
information. Information about potential security issues helps companies
understand the mechanisms underlying various threats and prepare
accordingly.

Furthermore, it is important to recognize that one food manufacturer's
product is another's ingredient. Most of the proposed FDA categories are
for foods that are virtually ubiquitous throughout the food supply, like
cheese, dried milk products, flours, and vegetable oils. "Targeted
communication" would address only primary ingredient manufacturers, not
processors throughout the system that use those ingredients in other
food products. Improperly targeted communication based upon the "FDA
product code" categories could hinder, rather than foster, effective
response to a potential threat as well as the associated FDA
investigations and surveillance operations.

The agency's "targeted communication" concept also presumes that a
serious threat would not need to be public. If that presumption were
correct, public media would not be needed routinely in Class I recall
situations.

Instead of collecting data on FDA product code categories, Kraft urges
FDA to make mandatory submission of information on establishment types
and type of storage for warehouses (see section 9 of the proposed
registration form). This information would not change frequently, as
would product categories, and might well be useful to FDA in targeting
some types of communications and allocating agency inspection resources.
For example, the establishment type information would make it possible
for FDA to segregate manufacturing facilities from all the other types
of facilities required to register. FDA also could identify easily
manufacturers of higher risk products such as acidified/low acid food
processors or mollusk shellfish establishments. Incidentally, FDA is
unlikely to get voluntary compliance with the request for establishment
and storage type information, when penalties would be imposed if this
optional information were inaccurate when submitted initially or became
out of date. Therefore, we suggest that establishment type data and type
of storage for warehouses should be made mandatory.

Additionally, the proposed rules appropriately require submission of the
emergency contact information FDA unquestionably needs for "a quick,
accurate, and focused response to a bioterrorist incident or other
food-related emergency." Kraft recommends that the agency expand that
section of the form, so that food companies can provide several back-ups
to the identified primary emergency contact person. At our company, for
example, the main security telephone number always can be used to reach
the people on the Special Situations Management Team. We would like to
provide that phone number in addition to all the contact information for
our primary emergency contact, just in case unforeseen circumstances
make back up necessary.

During investigations, FDA will not need to rely upon the establishment
type and emergency contact information alone, however, for the agency
also will be adopting regulations for tracking movement of food
ingredients and finished products. Thus, there is no need for the agency
to stretch the registration rules to cover product category tracking
information. Other provisions of the Bioterrorism Act will enable FDA to
get records that would be much more useful during any investigation.

In summary, collection of "FDA product code" category data is not
required by the Bioterrorism Act, is unnecessary for the accomplishment
of the agency's mission, and is not useful as a practical matter.
Tracking "FDA product code" categories for each facility would not
improve the agency's capacity to protect the public health, but would
increase the cost of the registration system and would divert resources
that should be focused elsewhere. With the emergency contact information
provided as part of the company's registration, FDA will have the best
possible means of reaching key decision makers quickly, so proper
actions can be taken immediately by people who are familiar with their
company's products, systems, and distribution practices.

II\. The agency\'s cost estimates are understated.

The agency's cost estimates are understated and based on assumptions
that do not reflect typical operating practices. To research and
understand the rules, any company would need far more than the one-hour
FDA factored into the economic impact assessment. The proposal is 40
pages of fine print in the Federal Register. The agency's video takes
another hour to watch. No time was allocated for the task of evaluating
the implications of the proposed rules for current business systems or
for preparing comments. When the final rules are published, assuring
compliance will involve reading and understanding the final Federal
Register document as well as any accompanying question and answer
documents or videos. The "FDA product code" is not used by industry, so
companies first will need to learn the agency's system and then will
need to classify products by facility. FDA proposes to require
management certification that the submission is accurate, but does not
appear to have factored the time the manager needs to learn the agency's
requirements into the economic analysis. No systems development costs
were included. Furthermore, the actual average wage rate at Kraft for
the type of personnel who would be responsible for registration
activities is \$75 hourly (including benefits), far more than the \$33
per hour weighted average wage rate used by FDA (\$25.10 per hour for ¾
hour for an administrative worker plus \$56.74 per hour for ¼ hour for
management personnel yields a weighted average wage rate of \$33 per
hour).

These inaccuracies in the economic analysis are not nearly as
significant as the cost of collecting the highly questionable "FDA
product code" data. Of all the information FDA proposes to collect, only
the product category information would change constantly, as
manufacturers move product lines to achieve optimum use of their
facilities and introduce new products. At Kraft, we would need to update
our registrations monthly, so tracking FDA product categories would not
only be difficult initially, as the technically correct categories for
19,000 products would need to be determined, but would require a
significant ongoing investment.

FDA estimated that deleting product categories would save 15 minutes or
\$8.25 per facility (using the weighted average wage rate of \$33 per
hour), without considering the cost of keeping the registration data up
to date after the information is first gathered. We estimated the
ongoing cost of maintaining registrations for facilities making products
for Kraft as follows:

-   Approximately 400 facilities make products distributed by Kraft.

-   Some change requiring review is likely to go on at 100 of the 400
    facilities each month.

-   We estimate it would take about 1-½ hours per facility to identify
    changes, evaluate implications, and, if necessary, update the
    registrations (in the 1-½ hours, we counted ½ hour of plant time and
    1 hour of headquarters time).

-   Therefore, 150 hours per month or 1800 hours per year could be
    needed to keep the FDA product category database up to date.

-   Applying the typical industry wage rate of \$75 per hour, estimated
    ongoing yearly costs for submitting updated product category data
    would be around \$135,000 each year.

Even given the rough nature of these estimates, adding product
categories to the required registration data would result in ongoing
investments for industry and FDA together totaling millions of dollars
over a few years, if not in the first year alone. If this investment
would increase safety, the cost would be justified; but FDA has not
identified a safety benefit nor have we been able to identify one.
Moreover, processing constant minor registration changes related to
changing food categories would not be a good use of FDA or industry
resources. From our point of view, sound policy requires that these
resources be used for more focused and productive security measures.

**III. FDA should accept electronic data files as well as registration
data entered interactively.**

FDA could reduce the burden of collecting the information, if
multi-facility registrants were able to send a single transmission
containing all of the requisite data, in lieu of entering the data
interactively over the Internet. The interactive Internet data entry
approach is probably excellent for many small manufacturers, but is too
time consuming for companies, like Kraft, that must register hundreds of
facilities. Assuming the 1 hour FDA data entry estimate were correct,
Kraft would need 1000 hours to enter data for our facilities. At 40 hrs
per week, the task would take 25 weeks, far more than the 8 weeks
provided, if only one person could be entering data interactively for a
single company at a time. Thus, we suggest that the final rule include a
format for submitting electronic data files, such as XML documents,
Microsoft Excel documents, or standard flat files. Additionally, we
recommend that the agency make provisions for a single registrant to
stop entering data and begin again another day as well as for a single
registrant to enter data simultaneously from more than one desktop.

**[Conclusion]{.underline}**

Americans depend upon both industry and government to assure the safety
of the food supply. Deploying government and industry resources as
effectively and efficiently as possible is essential. Adjusting the
information collection requirements and the data transmission methods
proposed for FDA facility registrations as we have suggested will enable
industry and FDA to comply with Congressional directives without
unnecessarily misdirecting resources that could be better used for more
focused security measures.

Kraft always is ready to work with the government to protect the safety
of the food supply. Please do not hesitate to contact me at (847)
646-6125, if we can provide additional information that might be
helpful.

Sincerely,

![](media/image1.png){width="1.7513888888888889in"
height="0.5784722222222223in"}

Jean E. Spence

Senior Vice President

Worldwide Quality, Scientific Affairs and Compliance