2002N-0276 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period
FDA Comment Number : EC372
Submitter : Ms. ANA PINEDA Date & Time: 05/19/2004 09:05:10
Organization : COFEPRIS
Federal Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
FEDERAL COMISSION FOR PROTECTION
FROM SANITARY RISKS

Comments on dockets 02N-0276, 02N-0278. Registration of Food Facilities and Prior Notice of Imported Food Under the Public Health Security Bioterrorism Preparedness and Response Act of 2002; Interim Final Rules.

With the entry into force of the dispositions for registration of food facilities and prior notice of food import of the Bioterrorism Act and specially the implementation of the educational period prior to their application, the Mexican government has detected some problems with their compliance. In order to solve these problems the support of your agency is required in the following aspects:

1. There is an important under registry which we have to deal with immediately. To do so, we would really appreciate if you could issue a report every two weeks about the quantity and the type of facilities registered. With this valuable information we will be able to strengthen those sectors that have more non-compliance problems.

2. A very important reason leading to non-compliance is the lack of English language of the Mexican exporters. Therefore, we have translated the registration templates as well as those for the prior notice and we would like to share them with you in order to include them in your webpage, so they can be used (CD enclosed).

3. On December 2003 a Compliance Policy Guide was issued by FDA and we have two main questions about it:

1. Monetary penalties have not been defined nor the mechanism or criteria for its application

2. The Policy refers to provide industry and the public with summary information about the level of compliance with the prior notice requirements, including data on the types of errors in submitted prior notices, however it is not clear if the same information will be issued regarding registration of food facilities.

4. If possible, we would like to have access to the quantity and identity of the industries that are not complying with any of the two dispositions (registration and prior notice), in order to help each other to bring these industries into compliance.

5. We would like to propose to create a mechanism that will allow the Mexican Government to be notified about any non-compliance related to the Bioterrorism Act. This proposal will result in a faster and more efficient response of the Mexican Agencies.