| 2002N-0278 - Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food; Availability|
|FDA Comment Number :||EC412|
|Submitter :||Mr. Luis Acuna||Date & Time:||05/17/2004 06:05:32|
|Organization :||CF Fresh|
| FOOD AND DRUG ADMINISTRATION
DOCKETS MANAGEMENT BRANCH (HFA-305)
5630 Fishers Lane - Room 1061
Rockville, MD 20852
RE: Comments on Proposed Notice of Rulemaking: Docket No. 2002N-0278.
VIA: Electronic Comment
To Whom It May Concern:
In accordance with volume 69, Number 72 of the Federal Register, we are submitting our comments on the FDA Bioterrorism Act (BTA), specifically Section 307 of the Interim Final Rule (IFR) which pertains to Prior Notice. Our comments are limited to the issues discussed in the publication that directly affect our business.
CF Fresh is a small firm based in Sedro-Woolley, Washington, specializing in the importation of organic produce. We have been in business since 1993.
We would like to request that produce be exempt from the requirement of prior notice. It is already carefully monitored by The Bureau of Customs and Border Protection. Since produce is placed on automatic quarantine for a mandatory inspection, it meets the requirement of the BTA. For instance:
1. The purpose of the prior notification to FDA is to provide FDA with the information necessary to make a decision (prior to arrival) for apossible physical inspection
2. Fresh produce already is subject to mandatory quarantine at the first port of arrival by USDA/CBP.
3. The CBP Agriculture Specialist performs the physical inspection (or reviews original documentation that confirms 'pre-inspection').
Therefore, we firmly believe that importations of fresh produce are already meeting the requirements of the FDA BTA.
Security is of the utmost concern to those of us involved in the international food industry. Our livelihood depends upon the free flow of legitimate trade. We want to comply and cooperate fully with all programs that promote border security and food safety. However, we also believe
| that the government (CBP, USDA, FDA) should be able to consolidate this process and share information.
Luis H. Acuna
Director, International Operations
922 Third Street
Sedro-Woolley, WA 98284
Phone (360)855-0566 - Fax (360)855-2430