+--------+-------------------------------------------------------------+
| ![]    | Ministry of Fisheries of the Socialist Republic of Vietnam  |
| (media |                                                             |
| /image | **National Fisheries Inspection and Quality Assurance       |
| 1.png) | Centre( NAFIQACEN)**                                        |
|        |                                                             |
|        | *Add: 10 Nguyen Cong Hoan, Ba Dinh, Hanoi, Vietnam*         |
|        |                                                             |
|        | *Tel: 84.4.8354966; 8310983 Fax: 84.4.8317221 E-mail:       |
|        | [nafiqacen@mofi.gov.vn](mailto:nafiaqacen@mofi.gov.vn)*     |
+--------+-------------------------------------------------------------+

Ref.N^0^: **CL/TH** *Hanoi, August 2003*

**To: The United States Food and Drug Administration (FDA)**

The National Fisheries Inspection and Quality Assurance Centre
(NAFIQACEN) -- the national Competent Authority in fisheries quality and
safety controls of the Ministry of Fisheries of the Socialist Republic
of Vietnam would like to present its compliments to the U.S. Food Drug
Administration and has the honor to inform you some issues relating to
your official letter dated May 5^th^, 2003 as follows:

1\. Comments concerning the proposed record-keeping regulations

According to the final proposed regulations:\" If an article of food is
reasonably believed to adulterated and presenting a threat of serious
adverse health consequence or death to humans or animals, firms would be
required to provide the records and other concerning information to FDA
within four hours during certain business hours, or eight hours at other
times\". This thing is hard to be done due to the following reason:

At the time being, in Vietnam, there are many processers acting as
exporters, but there are also many exporters who just do export
services. If an article of food is suspected by FDA and FDA require the
exporter to provide with concerned records, the exporter then has to
trace back the processers who had sold these products, and these
products may be collected from many processers, so the time set for the
tracing back and providing concerned records activity required by FDA is
not feasible. We would like to propose FDA to expand the timeframe, in
the short term we could consider this period is a transition stage in
order to adjust and supplement before officially coming into force.

2\. Concerning the proposed detention regulations

According to the final proposed regulations :\" there is credible
evidence that the article poses a threat of serious adverse health
consequences or death\", we think that this is not clear enough. It is
necessary to define \"credible evidence\" by criteria, and so FDA should
draw up specific standards, procedures for each kind of product by
defining concepts and specifying responsibilities of concerned parties.

3\. Concerning the time set for establishments to register.

According to the 305 of the proposed registering regulation of the
Bioterrorism Act (registering for food processing conditions), all food
processing firms and enterprises must register with FDA before 31^st^
December, 2003. So if a firm wants to export its products to the US but
registers after the above-mentioned deadline, or if there are some new
products that only be additionally registered after 31^st^ December,
2003, will FDA accept it? If so, there should be an article on it.

The above-mentioned comments base on current state in Vietnam, it would
be highly appreciated if you take these into consideration.

Seizing this opportunity, I would like to renew to you the assurance of
my highest consideration.

Yours sincerely,

> **Nguyen Tu Cuong**

**Director of NAFIQACEN**