MessageFrom: Andrade Castro Maria Jose [mjandrade@jvalle.com.mx]
Sent: Tuesday, July 08, 2003 8:56 AM
To: fdadockets@oc.fda.gov
Subject: ATTN: Docket No. 02N-0277

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

ATTN: Docket No. 02N-0277
Establishment and Maintenance of Records Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002; 
Proposed Rule

  a.. Under the proposed rule, manufacturers, processors, packers, distributors, receivers, holders and importers of food would be required to sep records, but the rule would have to specify to whom FDA will realize the requirement, and the form in which such person will receive the requirement. 

  a.. If a person do not execute these sections, it will considered to be a prohibited act, nevertheless it has not been specified if it will be in accordance to the degree of breach.

  a.. La FDA requires that facilities keep the information of non-perishable foods for two years after the date they were created, but we suggest that it would have to be retained for one year considering the expiration date of the food. 

  a.. The information could be kept in the form that the companies prefer, so it may be kept in paper or electronic format, if they contain the required information, but we consider that is necessary to specify the forms and formats, because the “hazard” information is not accepted in electronic formats. 

  a.. If an article of food is reasonably believed to be adulterated and presenting a threat of serious adverse health consequence or death to humans or animals firms would be required to provide these and other records to FDA within four hours during certain business hours, or eight hours at other times; about it, the rule could to specify the place where has to be present the information, if any person can deliver the required information. It should consider some factor as the difference of time, the business hours of other countries, so we propose that the time could be extended even up to 72 hours.

  a.. If the required information is not delivered at time, it is not clear if it will be considered as a prohibit act, so which will be the penalty about it? 

  a.. The proposed rule pretends to identify the immediate previous source and the specific source of each ingredient that was used to make every lot of finished food product, if this information is reasonably available, so we propose that FDA could provide a format to include here each information of each source, and at final, the receiver of the food articles keeps the information. So with this process, we consider that the information could be getting so easy. 

  a.. During the process to transport the food products, the persons have to register the quantity of the product that were delivered and received, so it permits to FDA to identify the quantity specified with the quantity that is received, but should be considered if the quantity of products is not the same, but it is caused for any accident, and in these cases, FDA does not consider it a cause to a detention of the food products. 
 
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