From: Embassy of Argentina - Economic and Commercial Section - Washington, D.C. [cew.dc@verizon.net] Sent: Tuesday, July 08, 2003 12:21 PM To: fdadockets@oc.fda.gov Subject: Recordkeeping - Docket No. 02N-0277 - Submission by the Goverment of the Argentine Republic II PUBLIC HEALTH AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 REGULATION ISSUES Submission by the Government of the Argentine Republic 1. Regarding the general implementation of the Act, we reinforce the comments that had been introduced in previous submissions (August 2002 and April 2003) in the sense that we recognize the efforts carried out by the United States in its struggle against international terrorism. 2. Since we must continue evaluating the full effects of the Act, it is essential to have answers to the questions raised regarding the contents of several of its sections. - Section 301 "Food Safety and Security Strategy" - Section 305 "Registration of Food Facilities" - Section 307 "Prior Notice of Imported Food Shipments" 3. With regard to the proposed regulations implementing two sections in Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, regarding maintenance and inspection of records for foods (Docket No. 02N-0277) and administrative detention (Docket No. 02N-0275), Argentina would like to receive the following clarifications: 3. Food and Drug Administration 21 CFR Parts 1 and 11 Establishment and Maintenance of Records 3.1.- General Questions Relative to the Legal Consistency with the SPS Agreement 3.1.2.- Provide the scientific evidence that supports the proposed measure. 3.1.3. Clarify if there is a risk assessment, in accordance with article 5 of the SPS Agreement, in which the proposed measure is based on. 3.1.4. In case of a positive answer, precise the relevant components that were taken into account, in conformity with article 5.2. of the SPS. 3.1.5. Does the US consider that the relevant proposed measure is not more trade-restrictive than required to achieve their appropriate level of sanitary and phytosanitary protection? In case of a negative answer, which alternative measure have the US considered and which are the reasons why the US rejected them? 3.1.6. Explain the legal compatibility of art. 1.337 of the proposed measure with the SPS principle on proportionality. 3.2.- General Questions Relative to the Procedure 3.2.1. Identify the list of persons / facilities that are excluded from all or part of the regulation in accordance with art. 1.327(e). 3.2.2. Explain the reasons why, in accordance with art. 1.329, some foods must comply with a double record system. 3.2.3. Clarify the meaning of "reasonably available" of art. 1.337(a). 3.2.4. Confirm if, in the case of non-transporters, they must identify the specific source of each ingredient that was used to make every lot of finished products. 3.2.5. Clarify if the requirements established in art. 1.351 and 1.352 shall be observed by domestic and foreign transporters of food. 3.2.6. Explain the reasons why records shall be retained for 1 or 2 years, depending on the case. 3.2.7. Explain if there is any formal requirement relative to the establishment and maintenance of the records. 3.2.8. Explain which is the meaning of a "reasonable belief that an article of food is adulterated", in accordance with art. 1.361. 3.2.9. Has the US considered any special or differential treatment for the following cases: - positive earlier experiences of trade with a person / facility / country. - low risk products - developing countries 3.2.10. Did the document take into account the costs of implementing such a record system in developing countries regarding article 10.1 of SPS? 3.2.11. Confirm if commodities, such as grains and seeds, are covered by this proposal. Have you considered the difficulties of identifying the different sources or segregating these commodities? 3.2.12. Regarding the availability of the records, is the US considering any special treatment in case of small facilities? 3.2.13. Identify which are the sanctions in case of failure with the compliance of the record system? 3.2.14. It remains unclear how this will be regulated and how long it will take tracing the food back to its source and tracing the food forward to all recipients. 3.2.15. We require more information about the functioning of the Register in order to ensure the right treatment for business proprietary information. 4. Food and Drug Administration 21 CFR Parts 1 and 16 Administrative Detention of Food for Human or Animal Consumption 4.1.- General Questions Relative to the Legal Consistency with the SPS Agreement 4.1.1.- Provide the scientific evidence that supports the proposed measure. 4.1.2.- Clarify if there is a risk assessment, in accordance with article 5 of the SPS Agreement, in which the proposed measure is based on 4.1.3.- In case of a positive answer, precise the relevant components that were taken into account, in conformity with article 5.2. of the SPS. 4.1.4.- Does the US consider that the relevant proposed measure is not more trade-restrictive than required to achieve their appropriate level of sanitary and phytosanitary protection? In case of a negative answer, which alternative measure have the US considered and which are the reasons why the US rejected them? 4.2.- General Questions Relative to the Procedure 4.2.1.- In article 1.378 the US establishes the general criteria for using the administrative detention of food for human or animal consumption. Explain the extent of the concept "credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals". Provide us with some examples. 4.2.2.- Which measures are you planning to implement in order to prevent that this administrative detention won't be applied in a manner which would constitute a disguised restriction on international trade? Is the US considering any limit to avoid abuses from competent agents? 4.2.3.- In article 1.379 the US establishes that a food article shall not be detained for a period longer than 30 working days. Inform us if the US has considered that some food articles could lose their nature or quality between that period of time. Who will support that cost? 4.2.4.- In case that the final analysis on the food articles demonstrates that they are safety for human or animal consumption: - who will support the costs derives from the detention? - who will be responsible in case the exporter fails to comply with the timeframes accorded with the importer? - who will be responsible for the costs/damages that the detention causes on the products, the trade operation and the exporter? - is there any provision relative to confidentiality treatment as far as the final analysis result is obtained? 4.2.5.- Which is the timeframe that the FDA has to respond to a request of limited conditional release? In case this request is approved, is the timeframe established in article 1.379 suspended? In case during this new detention the product is damaged, who will support the costs? 4.2.6.- Explain to us how are you planning to implement the labelling requirements established in article 1.382. Is the label going to be placed on the container or on the products? Are you planning to place a special label for products that were subject to an administrative detention, even though they were finally approved by the FDA? 4.2.7.- Explain to us if you are planning to implement a legal mechanism in order to complain against the administrative detention? 4.2.8. It remains unclear which are the procedures that will be implemented for detaining food -especially for perishable food- and which US federal agencies will be involved. 4.3. Continuing with our previous commentaries on the application of the new legislation on Public Health Security and Bioterrorism and its impact in the market, we would like to ask some questions on certain products of interchange and that in the case of Argentina, are in the scope of control of the National Agri-Food Health and Quality Service (SENASA). They are referred to know if the following products are under the control of the FDA in the application of these new regulations: - No refined sunflower oil in packages of 200 liters - Yeast non conditioned for its direct sale to the public - Tea in bags of 50 kg. - Processed meats - Cheese - Extracts or broths or soups of animal origin in packages of 50 kg. or more - Bovine insides in packages of 50kg. or more - Seafood in packages of 50kg. or more - Fish - Honey in packages of 200 liters - Other apicultural products