From: Mullett, Randy - CNF [Mullett.randy@cnf.com]
Sent: Tuesday, July 08, 2003 4:42 PM
To: 'fdadockets@oc.fda.gov'
Subject: Docket: 02N-0277 

July 8, 2003

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re:  Establishment and Maintenance of Records Under the Public Health
Security and 
Bioterrorism Preparedness and Response Act of 2002; 
Docket No. 02N-0277.

Comments of CNF, Inc.

Dear Sir or Madam:

CNF, Inc. appreciates the opportunity to provide comments on the proposal of
the Food and Drug Administration ("FDA") to implement section 306 of the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002 ("the Bioterrorism Act"), which provides for the establishment and
maintenance of certain records related to the production and distribution of
food for consumption in the United States.

CNF, Inc.

CNF Inc., through its operating subsidiaries, Con-Way Central Express,
Con-Way Southern Express, Con-way Western Express, Con-Way Canada Express,
Con-Way Mexico Express, Con-Way Now, Con-Way Full Load, Con-Way Air, Con-Way
Logistics, Menlo Worldwide Forwarding, Menlo Worldwide Logistics, Menlo
Worldwide Technologies, Menlo Worldwide Expedite!, and Vector SCM, is
involved in practically all facets of the freight transportation industry.
CNF is a $4.8 billion management company that is a leading provider of
global supply chain services for a wide range of manufacturing, industrial,
retail, and government customers.  Effective supply chain management is
increasingly important for businesses worldwide as competition drives them
to reduce inventories and speed up cycle times.  The value of the U.S.
supply chain alone is estimated to be $900 billion, or 10 percent of gross
domestic product. 

With more than 26,000 employees at 1000 locations in over 200 countries, the
CNF companies collectively move 25 billion pounds of freight a year. This
total includes literally thousands of FDA regulated shipments moving via
truck and air each day

General Comments

CNF shares with the FDA the goal of enhancing the security of the food
supply. , CNF supports and, as applicable, participates in the "Known
Shipper" database program, C-TPAT, PAPS, and FAST.  Our evaluation of FDA's
proposals to implement the Bioterrorism Act has been heavily influenced by
the commitment we share with FDA to provide a safe and secure food supply to
the American people.

Purpose

The purpose of the proposed regulations is to improve the security of the
U.S. food supply by enhancing the FDA's ability to oversee and monitor
imported and domestic food shipments and thereby improve the security of the
U.S. food supply.  Although we agree with this objective, we believe that if
implemented as currently written, these regulations will accomplish little
if any real improvement over current regulations and policies.
Additionally, we believe these regulations will cause significant economic
harm to a large number of both large and small companies, as well as,
serious economic damage to the United States.

Section 306 of the Bioterrorism Act provides for access to records under
certain specified circumstances and permits the FDA, by regulation, to
require the establishment and maintenance of limited "chain of distribution"
records.  The proposal that FDA issued deals largely with the establishment
and maintenance of records and only incidentally with the subject of records
access.  In these comments, CNF suggests some changes to the proposed
requirements for the establishment and maintenance of records that will
preserve the value of those records in tracing the movement of food while
reducing the burden on the transportation industry.  We also suggest some
changes to the records access provisions of the proposal that will better
take into account some of the practical considerations in records
maintenance and retrieval.  Finally, we urge FDA to add some provisions to
the regulation that will provide procedural protection when FDA exercises
the records access authority under section 306 of the Bioterrorism Act.

Statutory Authority

 The proposed rule has been issued to implement the provisions of the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002.
Bioterrorism Act, P.L. 107-88, 116 Stat. 662 (June 12, 2002) (hereinafter
"Act").  The Act contains several provisions to enhance the safety and
security of the U.S. food supply.  Throughout the many provisions of the
Act, Congress specifically directs the FDA to issue regulations whereas, in
other sections, it simply leaves the enactment of any regulations to the
agency's own discretion.  Under Section 306 (a), the Secretary of Health and
Human Services may by regulation establish requirements regarding the
establishment and maintenance of records.  Therefore, a literal reading of
this particular statutory language would conclude that the FDA is not
required to issue the regulations at issue herein, but rather has discretion
not to issue regulations or to determine other more appropriate means to
further the purposes of the Act.  This particular section also provides that
FDA consult and coordinate with Other Government Agencies (OGA's) before
issuing any regulations.  Section 306 (a).  It is therefore logical to
assume that Congress intended for FDA to coordinate with other agencies to
determine if such records already exist within OGA's in order to address
credible threats of serious adverse health consequences or death to humans
or animals.  Upon such coordination, FDA should only issue additional
recordkeeping regulations, if absolutely necessary.  CNF respectfully
submits that the information currently provided to FDA, the Bureau of
Customs and Border Protection (CBP) and OGA's is sufficient for the FDA to
further the purposes of the Act.

FDA, however, takes a different reading of the Act.  FDA is relying on
Section 306 (d) of the Act that directs the agency to promulgate proposed
and final regulations no later than December 12, 2003.  116 Stat. 670, 306
(d).   FDA recognizes that the use of term "may" in one section and "shall"
in another section creates ambiguity and specifically invites comments on
such ambiguity.  68 Fed. Reg. 25189.  CNF submits that Section 306 (d) and
its deadline of December 12, 2003, would apply only if FDA elects to issue
regulations and FDA's clear discretionary authority to issue recordkeeping
regulations in the first place remains unchanged by Section 306 (d).

One Size Does Not Fit All 

Many of the movements of food by truck into and within the United States are
not done on a rigidly scheduled basis.  Rather, these movements are done on
demand, often on an expedited basis. This is also the case with many
airfreight shipments. For ocean and rail, this scenario is somewhat
different because they tend to adhere to rigid schedules. In addition, the
way goods are shipped - whether they are foodstuffs or widgets or clothing -
varies according to the transport mode used.   In order to accommodate the
operational differences among the transportation modes, and the different
types of operations within each mode, CNF suggests that the FDA avoid
implementing a "one size fits all" rule. Rather, we suggest, as is currently
being done by CBP for the Trade Act of 2002 requirements, that the agency
look at the operational capabilities and realities of the different modes to
formulate mode-specific rules for record keeping.  We also suggest that the
agency work closely with OGA's to ensure that the recordkeeping rules for
food do not in any way conflict with existing or planned CBP or DOT
requirements.

Unfair Competitive Advantage

We are concerned that these proposed rules apply only to domestic, for-hire
transporters.  Foreign transporters that enter the United States as well as
domestic private transporters are not covered.  We believe these
record-keeping rules should apply uniformly to all transporters: domestic
and foreign; for-hire and private, to insure that no group has an unfair
competitive advantage.  Accordingly, Section 1.326 should be modified to
list private and foreign transporters as subject to the records requirement.

Detention

CNF is extremely concerned with the uncertainty surrounding "detention" of a
food shipment by FDA.  While in the control of transporters, food shipments
will be "moving targets" that will be in another location by the time a FDA
request to detain is received.  In many instances, unrelated shipments being
transported in the same unit (truck, trailer, plane, etc.) will be impacted
by any effort on the part of FDA to detain a shipment of foodstuffs.  The
proposed regulations do not provide sufficient means to obtain quick
resolution when this issue occurs.  FDA has also not sufficiently addressed
liability issues that will result from incidents involving detention.  We
suggest that, rather than the proposed appeal protocols, FDA initiate
proposals that provide an opportunity for emergency redress to be handled
outside the court system.
 
Establishment and Maintenance of Records

a.	 Lot and Code Numbers

Under the proposal, nontransporters (food manufacturers) and transporters
would be required to maintain records of the movement of food that include
the lot or code numbers of the food products produced and distributed.  This
requirement is neither feasible nor necessary and should be deleted from the
final regulation.  

Under the proposal, FDA would appear to have determined that the modest
grant of authority under the Bioterrorism Act to allow the maintenance of
limited distribution records, should result in a "cradle to grave" record
keeping system that would trace every package of food distributed in the
United States literally to the very shelf in a specific retail establishment
in which it is sold.  FDA fails to appreciate that it is not possible to
know this information without major adjustments in the way the food
industry, transportation industry and retailers work.  Moreover, FDA does
not make the case that protecting the public from food products that present
serious risks to the public health necessitates the maintenance of records
with lot or production code information captured at every step of the
process of producing and distributing food.

Lot by lot tracking throughout the entire chain of food distribution is not
possible.  It is now commonly the practice within the food industry to track
product from production to a warehouse by lot number.  It is typically not
the case, however, for the lot numbers to be tracked once the product leaves
a warehouse and enters the retail environment.  (We explain below why it is
not necessary to have this information.)  In some instances, products are
delivered to the retail store directly by representatives of the food
manufacturer.  In the so-called "direct store delivery" situation, the
transporter who picks up say, snack products, from the food manufacturer's
warehouse, delivers the products directly to retailers and stocks the
shelves.  The supplier of the product and the transporter (who is a
representative of the supplier) will be able to trace the movement of the
product, with lot numbers, from the warehouse to the transportation vehicle.
Neither of them, nor the retailer, however, will have the ability to
determine the lot number of each bag of chips that are placed on the shelf
of each retail establishment that the transporter visits with each load of
product in his or her vehicle.

It would require substantial technological innovation and reworking of this
delivery system for it to be possible to capture the lot number of each
product as it was delivered to each retail location.  Moreover, the
difficulty does not exist merely in the direct store delivery situation.  In
other situations, food manufacturers may use independent delivery persons
who will pick up product from several manufacturers for delivery to
retailers within a certain geographical area.  There may well be as many as
75-100 different products on each truck.  In this case, there will be a
record that shows what lots of product were picked up by the independent
delivery person and that delivery person will have a record of what retail
establishments were visited during the course of a working day, but the
delivery person has no capability to capture the lot numbers of the products
of several different manufacturers whose products are being delivered.

It is important for FDA to appreciate that the problem with the proposed
requirement for lot by lot tracking is not merely the
difficulty/impossibility of capturing the information with current
technology and distribution systems and practices.  The problem with the
proposal is that while companies know that the information is not reasonably
needed by it to address any public health event involving food products, FDA
thinks it might need the information.  This is an assumption that will
result in a bureaucratic nightmare for food companies and transporters

Even without the lot information down to the retail level, it is still
possible to determine where particular lots of product that left warehouses
are likely to be.  When the food manufacturer knows that certain lots were
in warehouse "x" on a specific date, it is possible to identify the specific
retailers that received one of several lots of food.  This is important
because the manufacturer can then be said to have a record that identifies
the immediate subsequent recipient of the food.

To briefly summarize:  (1) the food industry and transportation industry
cannot now capture lot information to the retail level; (2) neither the food
industry nor FDA needs the lot information to the retail level; and (3) the
requirements of the Bioterrorism Act are met even without the lot
information.

	b.	Responsible Individual

Under the proposal, FDA would require that in every transaction involving
the movement of food through the entire chain of distribution, records be
maintained which contain the identity of the "responsible individual."  It
is not clear from the proposal whether the "responsible individual" is the
same as the "emergency contact person" for purposes of facility
registration, sometimes the same, or never the same.  It is equally unclear
whether the term refers to the person who loaded a pallet of product onto a
loading dock, the person who loaded it onto a truck, the driver of the truck
and so forth.   For transporters, it should be sufficient to require that
the transporter designate a "responsible individual" and that a
nontransporter who uses a specific transporter be able to identify that
transporter.  There is no demonstrated need for the record of each
commercial transaction involving the distribution of food to contain the
name of each individual involved in the manufacture, sale, and distribution
of a food product whomever FDA intends for that person to be.

	c.	Product Descriptions

Under the proposal, records would be required to contain an "adequate
description" of the food, including the brand name, specific variety, and
how packaged (proposed 1.337, 1.345, and 1.352).  Typically, this
information is maintained now by the use of company-specific codes and
abbreviations.  It is unclear whether FDA intends to permit the use of codes
and abbreviations to satisfy the proposed requirement.  We strongly urge
that FDA make clear in the final regulation that currently used descriptions
are acceptable to identify the food with the specificity that FDA expects
(that is brand, variety, how packaged) and to consider the large impact on
the transportation community if they must make substantial changes in
standard shipping documents (commercial bills of lading) to accommodate
FDA's request.  In short, there would be a large financial burden associated
with eliminating the use of established procedures on existing commercial
documents without commensurate benefit.  

	d.	Time Periods for Records Maintenance

Under section 1.360, FDA proposes a one-year record retention period for
records related to perishable foods not intended for conversion into
nonperishable foods and two years for all other human foods.  There are
several problems with the proposed requirement.

First, for transporters, the two primary documents involved in any shipment
are the bill of lading and the delivery receipt.  The Department of
Transportation (DOT) has already established retention periods for these
documents.  FDA should consult with DOT to insure compatible requirements
that do not require expensive creation of additional document management IT
systems by the transportation industry.

Second, the definition of perishable food is too narrow and limiting.  There
are many foods with a limited period of shelf life, but which are not
strictly speaking "perishable."  For example, a bag of chips is not
perishable under the proposed FDA definition, but it will not remain on a
store shelf for as long as canned soup.  FDA should revisit the
perishable/nonperishable distinction and provide clarity.  It is
unreasonable to assume that transporters are qualified to make such
determinations.

Third, under the proposal, records for perishable foods would have to be
maintained for one year, unless the perishable foods were intended to be
made into non-perishable foods.  This requirement would thus impose an
obligation on the person distributing perishable foods to determine the
ultimate intended use of the foods.  This is not feasible or routinely
possible and places undue responsibility on the transporter if required to
make such a determination. How is someone who distributes fresh produce in a
position to know what every buyer (direct and indirect) intends to do with
the produce purchased?  The produce distributor may not even know what the
persons who buy directly from him intend to do with the product, much less
what persons several transactions away intend do to.  Thus, as proposed,
persons would have to assume that perishable foods were or might be made
into non-perishable foods.  They would have no choice but to apply the
non-perishable record retention period.  

Records Access

The proposal fails to include provisions necessary to ensure that the
exercise of the records access authority under the Bioterrorism Act is
Constitutional and otherwise in accordance with law.  Moreover, there are
several provisions of the proposal in which records access is addressed
(time period for access in proposed 1.361), which are neither feasible nor
needed.  We address these issues in this section of these comments.

		a.	A request for access to records must be accompanied
by an explanation of the basis for the request. 

The proposal should be revised to provide that, whenever FDA exercises the
records access authority under sections 414 or 704(a), it will provide a
written statement which contains a summary of the evidence on which FDA
relied in concluding that the standard for records access ("reasonable
belief that an article of food is adulterated and presents a serious risk of
adverse health consequences or death to humans or animals") has been met to
the person from whom the records are sought.  Without such a written
statement, persons from whom records are sought will have no basis to assess
the bona fides of the request itself or to determine whether the requested
records are reasonably related to the risk that led the FDA to conclude that
the high standard for records access had been met.

Under the Bioterrorism Act, access to records requires that FDA possess a
"reasonable belief."  If FDA does not provide to the person whose records
are sought an explanation of the evidence that provided the "reasonable
belief," there will be no practical way for anyone to provide a check on the
exercise of discretion by the FDA.  How will anyone ever determine whether
FDA had a "reasonable belief" as opposed to merely a belief or even an
unreasonable one?  On the other hand, if FDA provides such a statement to
persons whose records are sought, there is the ability of such a person to
assess the legitimacy of the request and, if not persuaded, decline to
provide the requested access or, alternatively, seek judicial intervention
to nullify the request.  Without a statement, persons whose records are
sought have to choose between: (1) providing the records merely because the
agency asked for them; or (2) declining to provide access in order to
determine whether the basis for the request is a "reasonable belief" (under
the theory that the agency will seek judicial intervention to enforce its
access rights).  It is only when the agency has a "reasonable belief" that
the exercise of its access authority is lawful; providing the suggested
statement will thus help to ensure - FDA and the regulated industry - that
the authority is being used responsibly.

	b.	The Time to Provide Records Must Be Reasonable

FDA has proposed entirely unreasonable time periods for providing access to
records (proposed 1.361).   CNF, and many other transporters, are not open
twenty-four hours a day, seven days a week.  If not clearly stipulated,
FDA's proposed regulations will require the expense of adding additional
staff "just in case" the FDA makes an off-hours request for information.

Under that section, companies would have only four hours to provide records
if the request is made between 8 a.m. and 6 p.m., Monday through Friday.
The notion that companies should always be in a position to respond fully to
a request for records within four hours has no foundation in either FDA's
regulatory needs nor the practices and procedures of other regulatory
agencies.  It should be pretty obvious that the time that will be required
to respond fully to a request for records is very much a function of the
scope of the request and the timing of the request.  There is a difference,
for example, between a request made early in the day where the person who
maintains the requested records has the bulk of the normal business day to
respond and a request made at 5 p.m. (technically within the proposed 4-hour
time to respond, but barely in the normal business day).

CNF recognizes FDA's desire for a simple and straightforward rule on records
availability.  We suggest, however, that such a rule can be adopted only by
ignoring the variety of circumstances in which records may be sought and the
vast differences in the time required to produce say, three months worth of
records and three days worth.  

We suggest that proposed section 1.361 be revised to delete the 4-hour and
8-hour time periods for making records available.  Alternatively, FDA could
revise that section to provide that the 4 and 8 hour time periods are
illustrative only and acknowledge that the actual time to make records
available will depend on a variety of things, including the scope of the
request.  It would certainly be reasonable to provide that persons must
begin the process of making records available within 4 hours of a request
made during the normal business day.

Conclusion

CNF recognizes the pressures on FDA from multiple directions to implement
regulations that will insure the security of the U.S. food supply.
Americans are more aware of security issues than at any time in recent
memory, and a sense of urgency surrounds the issues.  The transportation
industry, however, faces pressure from those same consumers to deliver
affordable products expeditiously.  As the economy continues to struggle,
additional strains place upon the supply chain will severely hamper any such
efforts.  The costs of complying with the proposed record keeping and
recording requirements in their current form will be enormous.  Even if the
time and administrative cost of a single shipment is modest, the large
numbers involved will, cumulatively, be a great administrative and financial
burden for CNF. The large amount of data that must be accumulated, stored,
and managed on all FDA regulated shipments will require development and
implementation of new IT systems and the addition of support personnel. U.S.
businesses simply cannot maintain viability if strapped with arduous and
inefficient regulations.  

In closing, CNF applauds the FDA for a thorough and transparent process that
included all effected parties.  Thank you for the opportunity to present our
views today.  We look forward to working with you on this important policy
decision.

Respectfully submitted,

C. Randal Mullett
Director, Government Relations
CNF, Inc.
3240 Hillview Ave.
Palo Alto, CA  94303