Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Reference:

FDA Docket No. 02N-0277, Section 306 Recordkeeping

Under the

Public Health Security and Bioterrorism Preparedness and Response Act of
2002

Food trade is a major component of Chile's exports. In the case of the
United States of America, Chilean food exports totaled as much as
\$1,664 million dollars in 2002. This represents almost 47% of the total
value of our shipments to the U.S.

Introducing, developing and maintaining the highest quality, hygiene and
safety standards in the production and exportation of food have always
been a national priority. It is in Chile's best interest to continue
strengthening these features of our food industry, since these high
standards have made our country one of the largest fruit, sea food and
wine exporters of the Southern Hemisphere.

The norms proposed by the FDA under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 ("*Rekordkeeping" and
"Administrative Detention*") seek to guarantee the safety of food supply
--both from domestic and imported origins--- in the United States. The
discussion and implementation of these regulations are a renewed
opportunity for strengthening the long established and close bilateral
cooperation on these issues.

The collaboration and joint activities carried out throughout the years
with the U.S. Department of Agriculture, the Food and Drug
Administration (Department of Health and Human Services) and the Bureau
of Alcohol, Tobacco and Firearms (Department of the Treasury), have
facilitated trade flows while at the same time safeguarded SPS standards
and protected public health.

All this has been possible through close cooperation, amongst other
activities, in:

\(1\) the massive preclearance program run jointly by the Animal and
Plant Health Inspection Service (APHIS) of the USDA and Servicio
Agrícola y Ganadero (SAG), Chile's official inspection service. This
program has been in place since 1982.

\(2\) numerous training programs addressed at improving different
aspects of food safety and Good Agricultural Practices (GAPs) which have
been jointly run by the FDA and Chile's Ministry of Agriculture and SAG;
and

\(3\) joint activities between ATF and SAG in issues relating to
labeling and commercialization of Chilean wines in the U.S. market.

The implementation period of the new rules is of particular concern to
Chile's commercial interests since it overlaps with the beginning of our
main fresh fruit export season. Chile intends to comply in a timely
manner with the new rules once they are finally approved. Nevertheless,
their implementation may prove to be a major barrier to foreign
shipments due to the additional strains and demands upon communication
systems, port and airport facilities, and on the inspection
infrastructure.

Given the long established bilateral relationship addressing food safety
issues, as well as the effectiveness and security of the system
currently in place in our country, Chile urges the FDA to rely upon the
proven registration, control, reporting and traceback mechanisms used in
Chile to guarantee the security of our food supply and food exports.

[General Comments]{.underline}:

The comments that follows below are relevant both to Section 303
(*"Administrative Detention*") *and to Section 306* ("*Recordkeeping"*)
of the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002:

\(1\) The distribution of legal text, supporting documents and relevant
background information should be accompanied by official translations
(to Spanish in the case of most Latin American countries) to facilitate
comprehension and proper use.

\(2\) Additionally, effective and timely implementation of recordkeeping
would require focused and intensive training at all levels, including
firm managers, establishment supervisors and floor operators. This could
be accomplished through a combination of workshops for local trainers,
slide and video presentations, on line training manuals, and explanatory
leaflets focusing on recordkeeping and security control. All this should
be done in several languages and on a continuing basis until smooth
implementation of new rules is achieved.

\(3\) There is a general opinion in the industry, that managers and
plant operators need a clearer definition of various concepts used in
the proposed regulations, in particular the idea of "*de minimis*
activity". In other words, clearer definitions should be provided in the
rules, in order to have simple but efficient recordkeeping in place.

Regarding timeframes, rules should be clear and transparent, defined
with precision but at the same time with sufficient flexibility to allow
for the specifics of the various types of food that enter into
international trade flows. For instance, clearly distinguishing highly
perishable produce and processed food that could be stored for many
years.

Agricultural Office

Embassy of Chile