Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -17

Accepted - Volume 2

Comment Record
Commentor Mr. Alejandro Casiró Date/Time 2002-08-30 15:35:57
Organization Embassy of Argentina
Category International

Comments for FDA General
Questions
1. General Comments As per your request, please find attached some preliminary comments from the Argentine Agriculture Secretariat and the Argentine Trade Secretariat on the dockets concerning the Bioterrorism Preparedness and Response Act of 2002. Stakeholders in Argentina continue to analyze available information and will do so as the regulatory process develops. Therefore, additional comments from Argentine stakeholders may be forwarded when necessary. 1. Comments from the Argentine Agriculture Secretariat: a) The Argentine government understands and shares the United States government concerns about preventing possible terrorists attacks by pollutants in foods, animal and vegetable products, in order to protect the interests of the population's health. Likewise, Argentina also works to improve and to assure the security of its foods and to avoid attacks against the quality of the alimentary chain. b) At the same time, the Argentine government expresses its concern for the recently approved Act, in relation to: - If the measures to be adopted correspond with such objectives of security. If they are consistent with the commitments in the WTO (SPS, TBT) and will not result in a barrier to trade. 1. If the Act would fit into the technical procedures definition or in the framework of sanitary measures, or if it should be considered as a general norm? 2. Which would be the provisions of those agreements that would enable the United States to modify the actual conditions of trade? - Instrumentation of the Act: The current information about the law generates certain doubts about how the instrumentation of the norm will carried out; which methodology will be used and how it will sensibly rebound on the costs that will be assumed when marketing the products, to fulfill the requirements that the measure establishes. c) There are some questions to be consider, among others, that result from a first reading of the text of the Act: Registration of Food Facilities: It is not clear which is the meaning of “agents” of the facilitiesthat export foods to the United States, regarding registration. How will be carried out the evaluation and the analysis of the applications of the exporters to register? The registration will be valid for a year or if it may be for a longer period of time? Prior Notice of Imported Food Shipments: there is a lack of information about the processing of the notifications. Administrative Detention: who will assume the costs related to detention, specially in the case when the merchandise is wrong detained? Which is it the additional level of protection that the registration proposed by this norm grants the United States and that is not achieved by means of the bilateral negotiations of sanitary and fitosanitary requirements, in which the exporter country declares and the importer country verifies the absence of pathogenic or toxins? Regarding the previous question, could it not be considered that the requested demands are not proportional in relation to the pursued objective? 2. Comments from the Argentine Trade Secretariat: · The GOA recognizes the efforts carried out by the United States in its struggle against international terrorism; · The GOA supports the emphasis given by the government of the United States in order to avoid the increase of violent events which would undermine the security levels for the international community as a whole; · The GOA shares the general view of the law with regard to the development of strategies that prevent bioterrorist threats to the food supply, animal and vegetable products, drugs, medicines and medical equipment. However, the GOA is concerned about the possible damaging consequences that could arise from the implementation of the law both to the Argentine market and to the bilateral trade at a moment of critic circumstances for the economy of our country. I. Cost structure Even though it is not possible to account for the exact trade impact due to the fact that the law has not entered into the final regulation stage yet, the cost structure for exports will be noticeably increased. Additional export procedures for exporters as well as modification of domestic regulations and controls will increase the cost burden both for exporters and for the GOA. According to this assumption, the GOA believes that an eventual price distortion might arise in world trade, and that this pattern will affect, sooner or later, our country’s exports. II. Registrations In respect to the contents of the Act under analysis, the implementation of the registrations set forth by the law stands as the most concerning issue regarding the bilateral relationship: Registration of food facilities: this register will require the owner, operator or agent in charge of a foreign facility which manufacture, process, pack or hold food and drugs which will be exported to the United States to register with the Food and Drug Administration (FDA). Besides, the requirements set forth in Section 415 (“Registration of Food Facilities”) indicate the additional requirement for foreign facilities to appoint a US agent, which will be also registered by the US government through the assignment of a registration number. This requirements will set in place strict control mechanisms which could not only affect the existing capacities but could generate additional costs for exporters, due to the fact that they will have the obligation to hire the services of US agents in order to export according to the new law. Registration Safety and Security of Food and Drug Supply: same issue mentioned above. III. WTO Notification Obligation Argentina will like to receive comments from the U.S. Government on how this Act will be presented in the WTO.




EC -17