November 14, 2023

# Via Email to fdadockets@oc.fda.gov

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Notice of Proposed Rulemaking

> May 9, 2003
>
> Establishment and Maintenance of Records
>
> Under the Public Health Security and Bioterrorism Preparedness
>
> and Response Act of 2002
>
> Docket #02N-0277

Werner Enterprises, Inc. is one of the five largest truckload motor
carriers in the United States and regularly transports food and food
grade products for various shippers between points in the U.S., Canada
and Mexico. As such, Werner Enterprises would be classified as a
"transporter" and subject to the regulations regarding establishment and
maintenance of records proposed in the Docket Number 02N-0277. For that
reason, the following comments are hereby submitted in response to the
Health and Human Services' Food and Drug Administration's ("FDA") Notice
of Proposed Rulemaking referenced above.

**[Responsible Individuals - Sections 1.352(a)(1) and
1.352(a)(2)]{.underline}**

These proposed sections would require the name of the firm and
[responsible individual]{.underline}, address, phone number and, if
available, the fax number and email address of the persons who had
possession, custody or control of the food immediately prior to and
following possession by the motor carrier transporting the shipment. All
shipments are transported under a bill of lading which details the name
and address of the consignee (who is normally the person taking
possession upon delivery shipment), however, that document does not
necessarily identify a "responsible individual" for the shipment. In
addition, there does not appear to be a definition of the term
"responsible individual" anywhere in the proposed rules, and it is not
clear as to whether that terms would refer to an individual with overall
management responsibility, or if it refers to the last dock worker or
fork truck driver who physically loaded the food on the trailer for
shipment. We suggest that (1) the term "responsible individual" be
stricken from the final rules, or (2) that the term is clearly defined
in the final rules.

**[Identification of Food - Sections 1.352(a)(3), 1.352(a)(4) and
1.352(a)(5)]{.underline}**

These proposed sections would require the carrier to obtain very
detailed information regarding each shipment of food, which would
include brand names, specific variety (e.g., specific name and type of
produce), lot codes or other identifiers, carton or package quantities
and type of packaging. The legal document utilized by shippers and
carriers in the transportation of commodities is a bill of lading or
shipping manifest, which describes the commodities shipped in a general
manner, but does not provide the level of detail required by the
proposed rules. As a practical matter the shipper almost always prepares
the bill of lading or shipping manifest, and since the shipper is the
most likely party to have intimate and specific knowledge regarding the
food being tendered for shipment, the burden of accurately describing
the commodities should lie with the shipper and not the carrier. In
addition, the carrier's driver cannot reasonable be expected to be an
"expert" in the proper identification of the commodities, and in many
instances, trailers are preloaded and sealed by the shipper prior to the
carrier's arrival precluding any opportunity to confirm the identity or
quantity of the commodities described on the bill of lading. While we
understand the need for specific information to assist the FDA in
identifying the source of any food which is suspected to have been
contaminated, the carrier is dependent upon the accuracy of the
commodity descriptions provided by the persons tendering the shipment.
Therefore, we suggest that the final rules should be amended so that (1)
the burden for accurately describing the commodities tendered is placed
on the shipper or person tendering the shipment, and (2) the carrier's
retention of the bill of lading or shipping receipt issued by the
shipper fulfills the carrier's obligations under proposed Section 1.352.

## Record Availability -- Section 1.361

Proposed § 1.361 would require that all records be made available to the
FDA within four (4) hours of a request made between the hours of 8 a.m.
and 6 p.m. Most carriers will probably be capable of complying with such
requests in a timely manner depending on whether the information request
is for information residing in an electronic format, or if the request
involves copies of physical documents containing the information
specified in §1.352. General information is maintained in most carriers'
computer systems such as the names of the parties tendering and
accepting deliveries of shipments, dates of shipment and delivery, the
names of individual drivers, geographic points, times and dates of
transfer or reassignment to new drivers and equipment, and
identification of equipment utilized. However, carriers will be forced
to rely on the physical bill of lading or shipping manifest prepared by
the shipper for the specific descriptions and other information required
by §1.352. Once a shipment is delivered, the carrier's driver generally
forwards the bill of lading to the carriers offices by U.S. mail. As
such, there will be a period of ten days to two weeks where the physical
bill of lading and information specific contained therein will not be
available from the carrier. Therefore, we suggest there needs to be a
greater degree of flexibility in the final rules regarding time limits
for production of records to reflect the practical realities faced by
carriers in physically collecting bills of lading following delivery.

In summary, Werner Enterprises asks the FDA to give consideration to the
following issues when drafting the final rules.

-   Amend § 1.352(a)(1) and § 1.352(a)(2) by striking the term
    "responsible individual", or in the alternative, clearly define that
    term.

-   Amend § 1.352 so as to make it clear that the burden of accurately
    describing food commodities tendered for transportation is placed on
    the shipper or individual tendering the shipment, and that the
    carrier's retention of the bill of lading provided by the shipper
    will fulfill the carrier's obligations under this proposed section.

-   Amend the time limit in § 1.361 for response to FDA requests for
    record availability by incorporating some degree of flexibility
    allowing for the real-world practicalities of collecting bills of
    lading following delivery of shipments.

Should you have any questions regarding the comments contained herein,
please feel free to contact the undersigned at 402-895-6640, extension
2994.

Respectfully submitted,

![](media/image2.png){width="2.4993055555555554in"
height="0.5763888888888888in"}

Foster L. Kent

Sr. Director, Contract Administration