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1250 I Street, N.W., Suite 1003, Washington, D.C., 20005-3922

July 8, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

**RE: Docket No. 02N-0277**

> **Establishment and Maintenance of Records under the Public Health
> Security**
>
> **and Bioterrorism Preparedness and Response Act of 2002**

The National Grain and Feed Association (NGFA) and the North American
Export Grain Association (NAEGA) submit this joint statement in response
to the Food and Drug Administration's notice of proposed rulemaking that
would require the establishment and maintenance of records by domestic
and certain foreign facilities that manufacture, process, pack, hold or
import food for human or animal consumption in the United States. The
FDA-proposed regulations are intended to implement portions of the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002 \[Bioterrorism-Prevention Act\].

The NGFA, established in 1896, consists of 1,000 member companies from
all sectors of the grain, feed, processing and exporting business that
operate about 5,000 facilities that handle more than two-thirds of all
U.S. grains and oilseeds. The NGFA's membership includes country,
terminal and export elevators; feed manufacturers; cash grain and feed
merchants; end users of grain and grain products, including processors,
flour millers, and livestock and poultry integrators; commodity futures
brokers and commission merchants; and allied industries. The NGFA also
consists of 36 affiliated state and regional grain and feed
associations, as well as two international affiliated associations. The
NGFA also has established strategic alliances with the Pet Food
Institute and the Grain Elevator and Processing Society.

NAEGA, established in 1912, is comprised of private and publicly owned
companies and farmer-owned cooperatives involved in and providing
services to the bulk grain and oilseed exporting industry. NAEGA member
companies ship practically all of the bulk grains and oilseeds exported
each year from the United States. The Association's mission is to
promote and sustain the development of commercial export of grain and
oilseed trade from the United States. NAEGA acts to accomplish this
mission from its office in Washington D.C., and in markets throughout
the world.

The NGFA and NAEGA are committed to enhancing the security of U.S.
agricultural facilities and support reasonable, prudent steps that
enable FDA to better respond promptly and effectively to a threatened or
actual terrorist attack on the U.S. food or feed supply, without
imposing undue burdens or costs on the food and feed system. As a
demonstration of this commitment, the NGFA on November 16, 2001
published an ***Agribusiness Facility and Operations Security*** guide
that outlines security issues and considerations that may need to be
addressed at agribusinesses. The guide includes sections on conducting a
facility vulnerability assessment; improving the general security of the
physical facility and grounds; implementing prudent security operating,
shipping and receiving procedures; and a sample emergency action plan.
The guide has been distributed widely by the NGFA, and is available at
no charge to members and nonmembers alike.

The NGFA and NAEGA join with other sectors of the food and animal feed
chain in believing that substantial sections of FDA's proposed
recordkeeping requirements exceed the mandate of the
Bioterrorism-Prevention Act; transcend what is needed to effectuate an
effective and efficient method for identifying the immediate previous
source and immediate subsequent recipient of food and feed; and in
several respects would be burdensome, costly, and in some respects,
unworkable.

For these reasons, the NGFA and NAEGA strongly urge FDA to make major
modifications to its proposed rules regarding the establishment and
maintenance of records under the Bioterrorism-Prevention Act.
Particularly troubling are provisions concerning:

-   the quantity and specificity of recordkeeping information FDA
    proposes be maintained concerning the immediate preceding source and
    immediate subsequent recipient of food;

-   the ambiguity and subjectivity concerning the specificity of
    information required to be kept for commodities -- like raw and
    processed grains and oilseeds -- that customarily are stored,
    handled and transported on a commingled basis;

-   the excessively narrow definition of "retail facilities" exempted
    under FDA's proposal from maintaining and providing access to
    records for product sold to consumers.

-   the extremely short time frame that FDA proposes that records be
    made available;

-   the lack of clarity concerning when records would be required to be
    kept (i.e., intra-company versus inter-company transfers);

-   the seeming redundancy of records required to be kept by
    non-transporters and transporters of food and feed; and

-   FDA's attempt to exercise regulatory authority over the records
    maintained by foreign facilities that manufacture, process, pack or
    hold food for human or animal consumption in the United States. As
    previously noted in our statement filed in response to FDA's
    proposed regulations concerning prior notice of imported food, we
    are concerned that attempting to impose specific recordkeeping
    requirements on foreign facilities could make the United States
    vulnerable to challenges under the World Trade Organization and
    could set a troubling precedent that might be replicated by other
    countries against firms exporting U.S. agricultural commodities. We
    cannot stress this latter point enough. FDA's final rules very
    likely will become the template for practices that could be adopted
    by foreign countries and applied with equal force and vigor against
    U.S. exports of bulk and processed agricultural commodities, feed
    and feed ingredients, meat products and other agricultural exports.

The NGFA and NAEGA offer the following comments concerning specific
sections of FDA's proposed rules for registration of domestic and
foreign facilities that manufacture, process, pack or hold food for
human or animal consumption:

-   **Section 1.326 (a) -- Scope:** The NGFA and NAEGA urge FDA to
    clarify in this section of its proposed regulations that the
    recordkeeping requirements apply only when articles of food change
    possession between firms. We do not believe that firms should be
    required to maintain internal records above and beyond what they
    normally require for their own internal operations, provided that
    such information is sufficient to identify the immediate preceding
    source(s) and immediate subsequent recipient once the food or feed
    changes possession to a different company, firm or person.

FDA also proposes to require that foreign facilities establish and
maintain records as prescribed if they manufacture/process, pack or hold
food for human or animal consumption in the United States -- the same
requirement that would trigger a foreign facility to register with FDA
under the agency's previous proposal. The NGFA and NAEGA believe that
this is an inappropriate reading of the Bioterrorism-Prevention Act.
Section 305 of the statute contains express language requiring foreign
facilities to **[register]{.underline}** with the agency. But Section
414 of the statute, which governs maintenance and inspection of records,
does not mandate recordkeeping by such foreign facilities. Instead, this
section of the Bioterrorism-Prevention Act refers to the maintenance and
inspection of records related to the "manufacture, processing, packing,
distribution, receipt, holding or **[importation]{.underline}** of such
articles...." *\[Emphasis added.\]* Thus, the NGFA and NAEGA believe
that the statutory intent is to require the agent importing food into
the United States to maintain such records, but not the foreign facility
itself.

Further, as stated previously, we have real concerns that attempts by
FDA to expand requirements on facilities operating within the borders of
sovereign states may well encourage or outright trigger an equivalent or
more onerous reciprocal move by foreign governments against U.S. firms
exporting agricultural commodities and products, thereby disrupting
two-way trade. As an alternative, we encourage FDA to examine other
mechanisms, such as sharing of information and joint investigations with
the foreign governments if and when a foreign country is implicated in a
credible bioterrorism threat against the U.S. food supply that meets the
statutory threshold -- that is, poses a threat of serious adverse health
consequences or death to humans or animals.

Further, the NGFA and NAEGA believe that FDA should modify this section
of its proposed rules to clarify that domestic grain-handling, feed
manufacturing/ingredient or processing facilities dedicated solely to
exporting bulk or processed agricultural commodities to other countries
should be **[exempt]{.underline}** from the recordkeeping requirement
unless the commodities, products or byproducts they handle are
introduced into U.S. commerce. This clarification would be consistent
with the statutory language and FDA's proposed regulations that the
recordkeeping requirement applies only to domestic and foreign
facilities that manufacture, process, pack or hold food for human or
animal consumption in the United States.

-   **Section 1.327 -- Exemptions:** Consistent with the definition of
    "food" contained in Section 201(f) of the Federal Food, Drug and
    Cosmetic Act \[which states, in relevant part, *"...articles used
    for food or drink for man or other animals...,"\]* as well as the
    definition of "food" being proposed by FDA in Section 1.328 of its
    proposed regulations \[which includes *"animal feed, including pet
    food, food and feed ingredients and additives"*\], the NGFA and
    NAEGA believe **[FDA should interpret the exemption from maintaining
    records for immediate subsequent recipients of food to expressly
    include retail farm supply and feed stores that sell finished
    product directly to consumers and final purchasers.]{.underline}**
    For instance, many small rural feed manufacturers also have a retail
    outlet in their facilities that sell bagged feed, pet food and feed
    ingredients/additives over the counter directly to consumers and to
    final purchasers for use in their own animals. These products are
    **[not resold]{.underline}** by the purchaser-customer. Maintaining
    records of these sales is not common practice today; would represent
    a costly burden to such enterprises, many of which are small
    businesses; and would not demonstrably enhance human or animal
    protection from bioterrorism-related threats.

> We believe that this concern can be addressed most effectively by
> amending the definition of "retail facility" in Section 1.328.

-   **Section 1.328 -- Definitions:**

    -   **Definition of Farm:** Under the Bioterrorism-Prevention Act,
        "farms" are exempt from the recordkeeping requirement. FDA
        proposes to define farm as a "...facility in one general
        physical location devoted to the growing of crops for food, the
        **[raising of animals for food]{.underline}** (including
        seafood), or both...." *\[Emphasis added.\]* The NGFA and NAEGA
        believe FDA's definition of the "farm" exemption should be
        size-neutral, and apply equally to integrated livestock and
        poultry facilities, so long as the activities engaged in at such
        locations are limited to "growing or raising" farm animals for
        human food but do not extend to further processing of
        food-producing animals into meat, milk or eggs (such as occurs
        at food processing and packing plants and rendering facilities)
        for subsequent commercial sale to humans or animals.

    -   **Definition of Retail Facility:** For the reasons cited in
        Section 1.327 (concerning the exemption from the requirement for
        maintaining records of the immediate subsequent recipients of
        food) for retail farm supply and feed stores that sell finished
        product directly to consumers and final purchasers, we urge FDA
        to amend the definition of "retail facility" to read as follows
        *\[new language boldfaced and underscored; deleted language
        stricken through\]*:

"Section 1.328. Retail facility means a facility that sells food
products directly to consumers **[or final purchasers]{.underline}**
only**[, and which is not for further sale]{.underline}**. The term
includes, but is not limited to, grocery and convenience stores, vending
machine locations, ~~and~~ commissaries **[and farm supply and feed
stores that manufacture and sell feed, pet food or feed ingredients
directly to consumers for use with their own animals, and which are not
used in the further manufacture of feed]{.underline}**."

-   **Section 1.330 -- Existing Records:** We commend FDA for including
    this section in its proposed regulations, and for recognizing that
    existing records maintained by covered firms and persons will
    suffice if they contain the information required under the final
    regulations.

-   **Section 1.337 -- Records Required for Non-Transporters and
    Transporters Concerning Immediate Previous Source of All Food:** The
    NGFA and NAEGA believe FDA's proposal would require non-transporters
    and transporters to collect and maintain records that exceed what is
    required to meet the statutory requirement of the
    Bioterrorism-Prevention Act.

First, we believe that FDA's proposal that records include information
that is *"**[reasonably available]{.underline}**...to identify the
specific source of each ingredient that was used to make every lot of
finished product \[emphasis added\]"* is unreasonably broad and open to
misinterpretation, and is inappropriate for industries like the raw
grain handling, processing, animal feed manufacturing and pet food
industries that store, handle and transport commodities, ingredients and
finished lots on a commingled basis. Our concerns are not allayed -- but
in fact are reinforced -- by the narrative contained in the agency's
description of the proposed regulations, in which it states, *"\[w\]hat
is 'reasonably available' may vary from case to case."* FDA goes on to
state that its intent is *"not...to require the reconfiguration of each
manufacturing plant. These proposed regulations, however, would require
you to capture the information available to you to connect finished
products with the immediate previous source of each of the food products
used to make that finished product. FDA understands that in some
multiple sourcing contexts this information only may allow for a
reduction in the number of potential sources for a specific food
product, but may not necessarily identify one specific source of the
food product...."* FDA in its description of the proposed rules cites
the example of a bakery that may source flour from five different
companies and store the flour "in one common silo" prior to being used
in the manufacture of cookies. *"In this scenario," the agency states,
"the information is not reasonably available to determine a single
source of the flour used in a particular lot of cookies. In this case,
the information reasonably available...would be the identity of all of
the potential sources of the flour for each finished lot of cookies.
Conversely, if the manufacturer did have dedicated silos for each
supplier of flour, then the information would be reasonably available to
the manufacturer to specify the specific source of the flour for each
finished product."*

In this narrative, FDA obviously recognizes that it would be infeasible,
unreasonable, burdensome and prohibitively costly for industry sectors
-- like the grain, feed manufacturing and grain processing industry --
that source commodities and ingredients from multiple sources to be
required to segregate or identity-preserve such "food" for purposes of
this rule. Typical grain-handling facilities and commercial feed mills
frequently source raw commodities and ingredients from hundreds of
farmers and ingredient suppliers. Thus, this section of the proposed
rule is of major concern for entities that store, handle and ship
commodities and ingredients on a commingled basis, and we believe
additional clarity is needed. Therefore, the NGFA and NAEGA strongly
urge FDA to expressly incorporate its stated intent into the
regulations, rather than subjecting the regulated industry to
case-by-case determinations by FDA district offices of what may or may
not constitute "reasonably available" information concerning the
specific source of commodities or ingredients used in each and every
food product. To effectuate this recommendation, we propose that FDA
consider the following revision to this section of its proposed
regulations *\[new language boldfaced and underscored; deleted language
stricken through\]*:

*"Section 1.337(a) If you are a nontransporter, you must establish and
maintain the following records for all food you receive. Your records
must include information reasonably available to you to identify the
specific source of each ingredient that was used to make every lot of
finished product; **[this requirement to identify the specific source of
each ingredient shall not apply to nontransporters that originate food
from multiple sources and manufacture, process, pack, or hold food as a
commingled mass, unless such food is generally segregated or
identity-preserved for commercial purposes.]{.underline}**"*

Second, FDA's proposed language contained in Section 1.337(a)(2) -- by
requiring that records identify the "brand name and specific variety" of
food -- is more appropriate to the finished food and feed industry than
to covered facilities that store, handle and/or ship raw agricultural
commodities and processed bulk ingredients. We believe this type of
descriptive information (e.g., brand name) would be more appropriate if
it were relocated to the description section preceding the proposed
rule, as well as contained in guidance documents the agency subsequently
issues to further amplify the intent of its final regulations.
Therefore, we encourage FDA to consider amending this section of its
proposed rule to read as follows *\[new language boldfaced and
underscored; deleted language stricken through\]*:

*"Section 1.337(a)(2) An adequate description of the
**[specific]{.underline}** type **[and variety]{.underline}** of food
received~~, to include brand name and specific variety (e.g., brand x
and cheddar cheese, not just cheese; or romaine lettuce, not just
lettuce.)~~."*

Third, we believe that FDA should limit the scope of information it
proposes under Section 1.337(a)(1) to require non-transporters to
identify **[either]{.underline}** the firm name or individual that
represents the immediate previous source of the "food" (e.g., commodity
or ingredient), but not both. We also believe it is unreasonable for FDA
to require the non-transporter that receives a food to determine the
"responsible" individual from the source company, and note that FDA
fails to define this term in its proposed rules. Therefore, it is
recommended that this section be amended to read as follows *\[new
language boldfaced and underscored; deleted language stricken
through\]*:

*"Section 1337(a)(1) The name of the firm ~~and responsible~~
**[or]{.underline}** individual, address, phone number and, if
available, the fax number and e-mail address of the nontransporter
immediate preceding source, whether foreign or domestic."*

Fourth, the NGFA and NAEGA wish to note that raw grain, manufactured
feed and processed commodities typically are not labeled with a lot or
code number that identifies the specific shipment. We note that Section
1.337(a)(4) of FDA's proposed rule recognizes this, by stating that the
*"lot or code number or other identifier of the food (to the extent this
information exists)."*

-   **Section 1.345 -- Records Required for Non-Transporters and
    Transporters Concerning Immediate Subsequent Recipient of All
    Food:** Consistent with our aforementioned comments with respect to
    Section 1.337(a)(1), the NGFA and NAEGA recommend that FDA limit the
    scope of information it proposes under Section 1.345(a)(1) to
    require non-transporters to identify **[either]{.underline}** the
    firm name or individual that constitutes the immediate subsequent
    recipient of the "food" (e.g., commodity or ingredient), but not
    both. We also believe it is unreasonable for FDA to require the
    non-transporter that receives a food to determine the "responsible"
    individual from the source company, and note that FDA fails to
    define this term in its proposed rules. Therefore, it is recommended
    that this section be amended to read as follows *\[new language
    boldfaced and underscored; deleted language stricken through\]*:

*"Section 1345(a)(1) The name of the firm ~~and responsible~~
**[or]{.underline}** individual, address, phone number and, if
available, the fax number and e-mail address of the nontransporter
immediate preceding source, whether foreign or domestic."*

Similarly, consistent with our previous comments with respect to the
proposed language contained in Section 1.337(a)(2), we encourage FDA to
consider amending this section of its proposed rule to read as follows
*\[new language boldfaced and underscored; deleted language stricken
through\]*:

*"Section 1.345(a)(2) An adequate description of the
**[specific]{.underline}** type **[and variety]{.underline}** of food
received~~, to include brand name and specific variety (e.g., brand x
and cheddar cheese, not just cheese; or romaine lettuce, not just
lettuce.)~~."*

-   **Sections 1.351 and 1.352 -- Transportation Records:** In Section
    1.351, FDA proposes to require that domestic transporters of food
    and feed be required to maintain records containing information on
    the immediately preceding source and immediate subsequent recipient
    of food and feed. In Section 1.352, the agency lists the
    recordkeeping information that transporters would be required to
    establish and maintain.

The scope of the records that FDA proposes transporters to keep exceeds
the information traditionally provided in truck and rail bills of lading
(see attached exhibits), as well as the information necessary to
effectuate the purposes of the Bioterrorism-Prevention Act. For example,
the bill of lading does not typically list the name of the responsible
individual, the phone number, fax number or specific brand name and
variety of food being hauled.

Consistent with our aforementioned comments with respect to Sections
1.337(a)(1) 1345(a)(1), the NGFA and NAEGA recommend that FDA limit the
scope of information it proposes under Section 1.352(a)(1) and (a)(2) to
require transporters to identify **[either]{.underline}** the firm name
or individual that constitutes the immediate previous source and
immediate subsequent recipient of the "food" (e.g., commodity or
ingredient), but not both. We also believe it is unreasonable for FDA to
require the transporter that receives a food to determine the
"responsible" individual from the source company, and note that FDA
fails to define this term in its proposed rules. In addition, for
intra-company shipments, the records reflect a chain of custody that is
not necessarily related to the name of a specific individual. Truck
drivers, warehouse employees and others engaged in intra-company
transfers generally will not have access to the detail needed to require
FDA's proposed recordkeeping requirements. For these reasons, it is
recommended that these sections be amended to read as follows *\[new
language boldfaced and underscored; deleted language stricken
through\]*:

*"Section 1352(a)(1) The name of the firm ~~and responsible~~
**[or]{.underline}** individual, address, phone number and, if
available, the fax number and e-mail address of the person who had the
food immediately before you, and the date you received it from that
person;"*

*"Section 1352(a)(2) The name of the firm ~~and responsible~~
**[or]{.underline}** individual, address, phone number and, if
available, the fax number and e-mail address of the person who had the
food immediately after you, and the date you delivered it to that
person;"*

Similarly, consistent with our previous comments with respect to the
proposed language contained in Sections 1.337(a)(2) and 1.345(a)(2), we
encourage FDA to consider amending Section 1.352(a)(3) of its proposed
rule to delete the reference to brand name. In addition, for purposes of
the records transporters are required to keep, we recommend that
reference to the specific variety also be deleted from this subsection,
since this information is redundant and already will have been recorded
by the immediate previous source and immediate subsequent recipient of
the food. Thus, it is suggested that this provision be rewritten as
follows *\[new language boldfaced and underscored; deleted language
stricken through\]*:

*"Section 1.352(a)(3) An adequate description of the
**[specific]{.underline}** type of food received~~, to include brand
name and specific variety (e.g., brand x and cheddar cheese, not just
cheese; or romaine lettuce, not just lettuce.)~~."*

-   **Section 1.360 -- Record-Retention Requirements:** We commend FDA
    for proposing to adopt the existing one-year record-retention
    requirement that applies to medicated feed under the agency's
    Current Good Manufacturing Practices to pet food, all other animal
    feed, and perishable foods not intended for further processing into
    non-perishable foods. For simplicity's sake, we encourage FDA to
    consider imposing an identical one-year record-retention requirement
    on raw grains, oilseeds and all other foods.

-   **Section 1.361 -- Record-Availability Requirements:** The NGFA and
    NAEGA believe FDA's proposed rule contains inappropriate,
    unrealistic and unworkable deadlines for making records available.
    Reflecting Section 404(a) of the Bioterrorism-Prevention Act, FDA
    proposes that records be made available if it has a "reasonable
    belief that an article of food is adulterated and presents a threat
    of serious adverse health consequences or death to humans or
    animals" and that access to records be limited to those "relating to
    the manufacture, processing, packaging, distribution, receipt,
    holding or importation of such articles...."

But we believe FDA then departs from congressional intent by proposing
hard-and-fast deadlines by which time records are to be provided.
Specifically, the agency proposes that such records "and other
information" be made available within four hours if FDA requests it
between 8 a.m. and 6 p.m. on weekdays, and within eight hours if the
request is made "at any other time." This, we believe, is not consistent
with the tenor of the statute itself, which states that facilities and
persons covered by the recordkeeping requirements are to **[grant
access]{.underline}** to such records to FDA *"upon presentation of
appropriate credentials and a written notice..., **[at reasonable times
and within reasonable limits and in a reasonable
manner]{.underline}**,...."* *\[Emphasis added.\]* The statute contains
no deadlines by which time all such records are to be provided, and we
believe it is inappropriate and unwise for FDA to propose arbitrary
deadlines in regulation given that the scope, volume and complexity of
the products and associated records to which the agency may seek access
may vary dramatically from one instance to the next. The infeasibility
of FDA's proposed deadlines is further exacerbated the fact that records
may be stored offsite from the location where FDA seeks access.

For these reasons, we believe that FDA should revise this section to
reflect that covered non-transporters and transporters are to make
good-faith efforts at providing FDA access to such records within a
specified time frame. As such, we recommend that Section 1.361 be
revised as follows *\[new language boldfaced and underscored; deleted
language stricken through.\]*

*"Section1.361 When FDA has a reasonable belief that an article of food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals, any records and other
information accessible to FDA under section 414**[(a)]{.underline}** or
704(a) of the act must be readily available for inspection and
photocopying ~~or other means of reproduction~~. **[Access to
s]{.underline}**~~S~~uch records and other information must be ~~made~~
provided within 4 **[8]{.underline}** hours of a request if the request
is made between 8 a.m. and 6 p.m., Monday through Friday, or within 8
**[24]{.underline}** hours of a request if made at any other time, by an
officer or employee duly designated by the Secretary who presents
appropriate credentials and a written notice. If records and other
information are stored offsite, the records must be retrieved and
provided onsite within the specified time period. Electronic records are
considered to be onsite if they are accessible from an onsite
location."*

-   **Section 1.363 -- Penalties for Non-Compliance:** Under the
    Bioterrorism-Prevention Act and this section of FDA's proposed
    regulations, failure to establish and maintain records is a
    prohibited act and subjects the offending party to civil and
    criminal penalties, as well as debarment. We encourage FDA not to
    use incidental infractions of its final recordkeeping regulations to
    as a pretext for bringing additional enforcement for alleged
    violations of other agency regulations that are outside the scope of
    the Bioterrorism-Prevention Act.

**Conclusion**

The NGFA and NAEGA appreciate this opportunity to provide our collective
input on FDA's proposed regulations to implement the recordkeeping
requirements of the Bioterrorism-Prevention Act. We believe our proposed
changes will contribute to implementing the law in the most efficient
manner possible, while minimizing the regulatory burdens and costs that
could disrupt efficient business operations by companies engaged in
providing an abundant and affordable food supply to U.S. and world
consumers.

In summary, the following are the major concerns that we believe FDA
should rectify in its recordkeeping proposal:

1.  FDA should amend the proposed rules to explicitly exempt facilities
    that handle commodities on a commingled basis from the requirement
    to identify the specific source of each ingredient, unless such
    commodities are stored, handled and shipped as a segregated or
    identity-preserved lot for commercial purposes. *\[See pages 5-6\]*

2.  FDA should amend the definition of "retail facility" to include feed
    and farm supply stores that sell finished product (feed, pet food
    and feed ingredients) directly to consumers and final purchasers for
    use with their own animals. *\[See pages 4-5\]*

3.  FDA should not attempt to expand recordkeeping requirements imposed
    on foreign facilities, and be cognizant of the backlash and
    reciprocity that such actions may well trigger from foreign
    governments against U.S. firms exporting agricultural products.
    *\[See pages 3-4\]*

4.  FDA should clarify that its recordkeeping requirements apply only
    when food articles change possession between firms, not to
    intra-company records. *\[See page 3\]*

5.  FDA should revamp its proposed deadlines by which time access to
    records is to be provided to reflect that companies would be deemed
    to be in compliance if they have made good-faith efforts to begin
    the process of providing FDA with access to such records within 8
    hours on weekdays, and within 24 hours at any other time. *\[See
    pages 10-11\]*

6.  FDA should eliminate its proposed requirement that records identify
    the "responsible" individual from the companies that constitute the
    "immediate preceding source" and "immediate subsequent recipient" of
    a commodity, food or feed. *\[See pages 7, 8 and 9\]*

7.  FDA should eliminate its proposed requirement that records identify
    the "brand name" of a food, since that is inappropriate for the
    breadth of commodities the agency is proposing to regulate under the
    recordkeeping requirement. *\[See pages 7, 8 and 9\]*

8.  Records should be required to be kept for only one year for all
    food, consistent with FDA\'s proposal to require that records for
    animal feed, pet food and perishable commodities be kept for only
    one year. *\[See page 9\]*

We pledge our continued proactive efforts to work with our industry
sectors and with government to further enhance the safety and security
of the nation's food and feed supply.

Sincerely,

![](media/image3.jpeg){width="2.290277777777778in"
height="1.4048611111111111in"}![](media/image4.png){width="2.9611111111111112in"
height="1.1958333333333333in"}

Kendell W. Keith Gary C. Martin

President President

National Grain and Feed Association North American Export Grain
Association