MessageFrom: Andrade Castro Maria Jose [mjandrade@jvalle.com.mx]
Sent: Tuesday, July 08, 2003 8:55 AM
To: fdadockets@oc.fda.gov
Subject: ATTN: Docket No. 02N-0275

Dockets Management Branch (HFA-305)
Food and Drug Administration


ATTN: Docket No. 02N-0275
Administrative Detention of Food for Human or Animal Consumption Under 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002.

  a.. The FDA will investigate, examine, and inspect the food product that have to enter to the EU, nevertheless if they have a credible evidence or information that indicates them that the food presents a threat for the health of the consumers, so we propose to define a criteria to consider an evidence to be “credible”. 
  a.. The inspection, examination or investigation will be realized when the food products having entered or in later moments, when the products are already on the market, so the proposed rule should have to consider that about the last case, the responsibility of a threat in a product can belong to a third party not included in the importation and distribution of a product within the north American commerce. 
  a.. The period of detention will not have to exceed 20 or 30 days, according to the type of food, but we propose that the term should be reduced to 15 calendar days to reduce the cost of the process. 
 


  a.. The proposed rule should have to consider a secure investigation when FDA has a threat of serious adverse health consequences or death to get the real responsible parties. 

  a.. In case that FDA exceeds the referred terms in the proposed rule about the administrative detention, FDA must become responsible for the damages and prejudices caused to the firm, if it really had not any responsibility.
 

  a.. The proposed rule should have to establish if the person who has faculties to appeal an administrative detention and to claim the food products must have specific characteristics, and if can be considered as such the agent of the establishment that should reside in United States.

  a.. We desire to explain us if the current procedure of import will be still in force, and if it must be followed together with the FDA’s proposed rules, or these rules will substitute the above mentioned current procedure.
  a.. If food products have an administrative detention, we propose that FDA defines if the following products will be able to import it without any problem, and if facilities can continue with their exports while they have a process or investigation of an administrative detention.
  a.. FDA is proposing that the food product with an administrative detention will not be able to be removed and they will have to be stored in secure places, but if we consider the high costs of the stores, we propose that the procedure of a detention should be since nowadays it follows under the conditions to not commercialize it, or in the case, FDA has to establish the costs and the authorized stores.

  a.. The proposed rule should have to define if mistakes which an importer incurs on the current procedure of import, they will reverberate, or if they will be considered mistakes to the requirements of the Bioterrorism Act.

Jugos del Valle, S.A. de C.V, appreciate the opportunity to submit these comments regarding the Food and Drug Administration’s  proposals to the development of new regulations required for implementation of the Public Health Security and Bioterrorism Preparedness and Response Act.

Respectfully submitted,

María José Andrade
ph. (5255)25816500 ext. 6357
e-mail. mjandrade@jvalle.com.mx