**DATE:** 8 July 2003![](media/image1.wmf){width="7.1in"
height="0.9236111111111112in"}

**TO:** Dockets Management Branch (HFA--305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

www.fda.gov/dockets/ecomments

fdadockets@oc.fda.gov.

**FROM:** Jim Gorny, Ph.D., V.P. Technology & Regulatory Affairs, IFPA

**RE:** \[Docket No. 02N-0277\] Establishment and Maintenance of Records
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002

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Dear Food and Drug Administration,

The International Fresh-cut Produce Association\'s (IFPA) mission is to
advance the industry by supporting its members with technical
information, representation and knowledge to provide convenient, safe
and wholesome food. Our association membership is comprised of fresh-cut
produce processors, produce grower/shippers, food service companies,
retailers and those who provide goods and services to the fresh-cut
produce industry.

As per the Federal Register Notice (68 FR 25188) of May 9, 2003 \[Docket
No. 02N--0277\] Establishment and Maintenance of Records Under the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002, the IFPA is submitting the following attached comments.

If you have any questions or you would like to discuss this matter
further please feel free to contact me at 530.756.8900.

Best Regards,

![](media/image2.png){width="2.0118055555555556in"
height="0.8041666666666667in"}

James R. Gorny, Ph.D.

VP Technology & Regulatory Affairs

International Fresh-cut Produce Association

The International Fresh-cut Produce Association represents and provides
technical expertise to commercial suppliers of fresh-cut produce, as
well as companies affiliated with the fresh-cut produce industry,
including equipment manufacturers, retailers and food service operators.
We represent over 400 corporate members who are actively involved in the
\$10 billion plus fresh-cut business. The International Fresh-cut
Produce Association, which has as members both suppliers and buyers of
fresh-cut produce, defines fresh-cut produce as any fresh-cut fruit or
vegetable or any combination thereof that has been physically altered
but remains in the fresh state. These products are items such as bagged
salads, baby cut carrots and broccoli florets.

The IFPA is a strong advocate for consumers and diligently works with
our membership to assure consumer safety and security in the produce
industry. After careful review of the proposed regulations regarding
\[Docket No. 02N-0277\] Establishment and Maintenance of Records Under
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, the International Fresh-cut Produce Association \"IFPA\"
would like to assert the following which would make the proposed rules
less burdensome, but still effective in protecting the U.S. food supply.

***General Comments***

The fresh-cut produce industry takes the issues of potential terrorist
acts against the food supply and food security very seriously.
Implementation of food security measures is incremental in nature and
every gain in security awareness and practices contributes to the total
security of an individual company, organization and the nation. The
currently proposed recordkeeping requirements would require substantial
and significant alterations in current business practices for compliance
and will substantially impact food costs, while only marginally
enhancing food security. The currently proposed regulations regarding
establishment and maintenance of records of food for human and animal
consumption fail to take under consideration the following:

***1) Burden of Requirements***

**[Issue]{.underline}:** The recordkeeping requirement as proposed would
incur a tremendous burden to the food industry. The proposed
recordkeeping requirements would significantly alter the content of
records currently being kept, how records are being maintained and the
length of time that the records must be archived.

**[Recommendation]{.underline}:** Food manufacturers\' core business
focus is not data collection and analysis. While the proposed
recordkeeping requirements making access to data may be beneficial to
the Agency, is all of the data that is being requested to be archived
and retrievable absolutely essential? It is recommended that the FDA
assess each proposed rule regarding recordkeeping and compare the
purpose of each proposed activity with its security benefit. This will
help determine if the cost of each practice correlates proportionally
with the effectiveness and usefulness of such actions. The two-year
record keeping requirement is

redundant with other regulatory provisions such as PACA and should be
harmonized with PACA. It is recommended that the currently proposed
recordkeeping requirements be appropriately scaled to reflect the
inherent business practices of specific industries such as for
perishables.

**2) *Statutory Requirement for Recordkeeping***

**[Issue]{.underline}:** The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 does not require or mandate that
the FDA must promulgate a recordkeeping regulation.

**[Recommendation]{.underline}:** The proposed regulations regarding
recordkeeping should not be expanded beyond what has been set forth in
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002.

***3) FDA Intrastate Jurisdiction***

**[Issue]{.underline}:** The FDA is proposing that \"domestic persons\"
who manufacture, process or pack, transport, distribute, receive, or
hold food intended for human or animal consumption in the United States
must maintain appropriate records as stipulate by the proposed
regulations regardless of whether their food enters interstate commerce.

**[Recommendation]{.underline}:** Appropriate state, local and municipal
regulatory bodies have authority to regulate domestic persons who
manufacture, process or pack, transport, distribute, receive, or hold
food intended for human or animal consumption, when intended solely for
intrastate commerce in the United States. The proposed regulations
regarding recordkeeping should not be expanded beyond what has been set
forth in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.

***4) Producers of Food Products and Ingredients/Additives Intended for
Export***

**[Issue]{.underline}:** The proposed regulations regarding
recordkeeping do not address whether firms producing finished food
products or food additives and ingredients intended for export must
comply with the recordkeeping requirements.

**[Recommendation]{.underline}:** It is recommended that producers of
products intended for export should be exempt from the proposed
recordkeeping requirements.

***5) Reasonable Belief of Credible Evidence or Information Standard***

**[Issue:]{.underline}** The reasonable belief standard in the
recordkeeping proposal is similar to the administrative detention
provision's requirement. Specifically \"if the Secretary 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, each person who manufactures, process, packs, distributes,
receives, holds, or imports such article shall, at the request of an
officer or employee duly designated by the Secretary . . . permit access
to and copy all records relating to such article that are needed to
assist the Secretary in determining whether the food is adulterated and
presents a threat of serious adverse health consequences or death to
humans or animals." The term "reasonable belief" is vague and open to
interpretation.

**[Recommendation]{.underline}:** Specific guidelines should be
developed to clearly define what \"reasonable belief \" is and assure
that it clearly presents a threat. Specifically the FDA should make
clear that it will be relying on evidence such as laboratory analysis
confirming the presence of an adulterant and/or affidavits sworn to
under penalty of perjury. "Reasonable belief" should be similar to a
"probable cause" standard and more than mere speculation or an anonymous
telephone tip.

***6) Notification of the Agency\'s Request to Review Records***

**[Issue]{.underline}:** In the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the FDA has been given expanded
authority to access and review food manufacturer records if there is
\"reasonable belief that an article of food is adulterated and presents
a threat of serious adverse health consequences or death to humans or
animals.\" This is a significant expansion of the FDA\'s authority and
powers.

**[Recommendation]{.underline}:** It is recommended that written notice
should be provided by the inspector delineating which records are being
requested and the written notice should also contain an explanation of
how the \"reasonable belief\" standard is being met. This would be
similar to the procedure followed under the low acid canned foods
statute.

**[Issue]{.underline}:** The FDA does not propose a definition for
"responsible individual" at the firm that was the immediate prior
source, the transporter, or the immediate subsequent recipient

**[Recommendation]{.underline}:** This term \"responsible individual\"
should be clarified to ensure that sufficient procedural safeguards are
in place when the FDA wishes to exercise its record review authority.

***7) Access to Proprietary and Confidential Information***

**[Issue]{.underline}:** The proposed regulations regarding
recordkeeping give the FDA authority to access recipes so as to identify
the ingredients and additives that are used in a finished food product.
The very identity of some ingredients may in some cases be a trade
secret.

**[Recommendation]{.underline}:** It is recommended that the FDA
implement a system to adequately safeguard against the inadvertent
release of proprietary and confidential information.

***8) Scope of Records Available***

**[Issue]{.underline}:** The proposed regulations regarding
recordkeeping do not address whether processing aids and incidental
additives are exempt from disclosure.

**[Recommendation]{.underline}:** It is recommended that the FDA clarify
whether or not processing aids and incidental additives are exempt from
disclosure.

We would like to thank the FDA for the opportunity to offer comments.
Feel free to contact IFPA at 530.756.8900 if you have any questions or
for additional information or clarification on any of the topics
mentioned above.

Sincerely,

Dr. James Gorny, VP Technology & Regulatory Affairs, IFPA