Draft

9/27/02

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The National Association for the Specialty Food Trade, Inc. (NASFT)
welcomes the opportunity to comment on Title III (Protecting safety and
Security of Food and Drug Supply) of Public Law 107-188, the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002.
(Bioterrorism Act). The Food and Drug Administration has requested
public comments regarding the four provisions in Title III that require
implementing regulations on an expedited basis.

NASFT understands that the provisions about which comment is sought are
included in the Bioterrorism Act, which is law and is designed to
protect the United States food supply. However, the new requirements in
the law impose heavy administrative and financial burdens on the food
industry. NASFT urges FDA to develop the least burdensome implementation
rules and, when the existing administrative structure is sufficient, to
rely on that structure instead of new rules. NASFT also urges FDA to
study very carefully the small business impact of the proposed
regulations on small businesses at a time when the U.S. economy is
somewhat weak and faced with uncertainty. This will require an
examination of the economic impact, as required by law. It also will
require an understanding of business practices, since the methods by
which small companies do business may be different from the
administrative practices of large companies. A rule that applies the
same obligations on large and small companies might be unfair to the
latter. Finally, the information, notice and other requirements should
impose only realistic burdens on companies -- realistic in the sense
that they are built around current practices that conform to law and
existing systems like the Automated Broker Interface.

NASFT is the trade association for approximately 2,400 companies in the
specialty foods industry. Manufacturing members are located throughout
the United States. Among the principal specialty food products are
confectionery, bakery products, snack foods, sauces and condiments, jams
and preserves, bottled water and juices. These are high-value, processed
foods. The vast majority of NASFT member companies are small businesses.
Specialty food retailers -- usually small businesses that feature unique
and upscale products -- participate through a special membership
category, as do importers, distributors and brokers of specialty foods.

NASFT will submit more extensive comments when FDA publishes its
proposed rules. Meanwhile, it offers the following comments.

**Administrative Detention (Section 303)**

Section 303(a) expands the enforcement authority of the FDA and provides
for the administrative detention of foods. NASFT is concerned about the
impact detentions and lengthy periods of detention on small businesses
and on those who handle perishable products. The period of detention
must be limited. FDA must quickly make its determinations.

NASFT urges FDA in particular to interpret carefully language in the law
that could justify detention based on very vague "information"
discovered by a person who might not be a regular FDA employee.
Regarding the basis for the order of detention, the law refers to
"credible evidence or information". This need not be interpreted as a
weak threshold. NASFT also suggests that the "qualified employees"
referred to in the Bioterrorism Act be given a limited meaning. Only
persons who, in their day to day job responsibilities, conduct food
inspections, examinations or investigations should be considered
"qualified". Likewise, the official whom the Secretary designates to
order detentions should be the highest ranking person in the District.

The regulations must provide that the period of detention shall be as
brief as possible. The Bioterrorism Act speaks only of "not to exceed"
time limits. It permits shorter periods for action than the delays
specifically noted in the law's text. FDA should impose on itself the
obligation to act as quickly as possible, particularly when dealing with
perishable ingredients used by U.S. specialty food manufacturers, and
should only in exceptional circumstances order that the article be
removed to a "secure facility" Staff shortages should not be a
justification for failures to act quickly.

[Finally, FDA should not be able to cause harm by an unjustified
detention, then just say "Sorry". The impact of such a mistake on a
small business can be catastrophic. FDA should consider seriously the
minimum evidence required to justify a detention and should consider how
the wronged businesses can be compensated.]{.underline}

**Registration of Food Facilities (Section 305)**

Registration is a burden on U.S. agencies and on foreign firms.
Experience with the low acid canned food filing system illustrates
recent problems and delays with even a limited mandatory registration
system. This burden should not begin until a working, simple, electronic
registration system is in place. Moreover, there should be allowances
for small foreign suppliers, who might not have electronic capability.

**Establishment and Maintenance of Records (Section 306)**

Recordkeeping can be particularly burdensome on small businesses. FDA
should rely on existing recordkeeping rules whenever possible and should
base any new requirements on the documents created during the normal
course of business, such as invoices, purchase orders and bills of
lading. This approach will be particularly helpful to small businesses.
A company should be able to delete business confidential information and
trade secrets from any record supplied to FDA.

**Prior Notice of Imported Food Shipments (Section 307)**

#  Any prior notice requirement will involve more recordkeeping and some delays, creating another burden that will affect small companies disproportionately. Consequently, the requirements should be as streamlined as possible and should be linked to existing electronic messaging and information systems, such as the Automated Broker Interface.