From: IPERU [iperu@terra.com.pe] Sent: Friday, July 04, 2003 1:51 PM To: fdadockets@oc.fda.gov Cc: ipe Subject: Comments for Establishment and Maintenance of Records from the Peruvian Asparagus Institute Calle Las Dalias 136 (Tel) 001-511-242-1199 / 242-5541 Lima 18 (Fax) 001-511-242-1199 / 242-5541 Perú E-mail: iperu@terra.com.pe. ______________________________________________________________________ IPEC_055/2003 July 4, 2003 Office of Information and Regulatory Affairs Office of Management and Budget New Executive Office Building 725 17th Street, N.W Room 10235 Washington, D.C 20503 Attn: Stuart Shapiro, FDA Desk Officer COMMENTS FOR THE DOCKET No. 02N-0277 SECTION 306 (ESTABLISHMENT AND MAINTENANCE OF RECORDS) INTRODUCTION The Instituto Peruano del Espárrago – IPE ( Peruvian Asparagus Institute ) is a non profitable association established to strengthen the competitive position of the Peruvian asparagus in both, domestic and international markets, through the following services: training, research, technology transfer and information provider, as well as to represent producers and processors in governmental and international organizations. Our members are producers and exporters of fresh, frozen and canned asparagus. If we focus in the fresh presentation, our entity represented 80 % of the total fresh asparagus exports from the last year ( volume ). Our product has an important positioning value in the United States market and the consumers recognize the Peruvian asparagus quality. Last year Peruvian fresh asparagus had a participation of 44 % from the total fresh asparagus imports ( volume) to the USA Source: US Dept of Commerce. The U.S. General Accounting Office issued a report in March 2001 supporting the fact that the importation of fresh asparagus has benefited the market and has not harmed the domestic producers. Not only have imports made asparagus available to the U.S. consumer for the first time on a year-round basis, but also for less. The price has dropped over two dollars per pound over the last few years, stimulating demand. Reports have shown, just like the winter fruit phenomenon, that the availability of asparagus year-round has actually benefited all producers in the industry because consumers know it is available and become more frequent purchasers. U.S. government statistics show per capita consumption of fresh asparagus has increased along with greater off-season availability through imports, from .6 pounds in 1986 to 1.0 pound currently. Peruvian asparagus in the United States not only benefit American producers and consumers as mentioned above, but it is also favorable for other economic activities, such as shipments to the US and local destinations, airlines, specialized storage, sanitary and Customs controls, wholesalers and retailers, etc. For every dollar spent on the Peruvian fresh asparagus produce, 60% stays in U.S. hands. Last year it represented an estimated of $80 million dollars that stay in the U.S. economy. Most retailers in America are supportive of Peruvian asparagus and have used it to build a successful category year-round, again benefiting a large segment of the U.S. The Peruvian growers and their U.S. importers have made a significant level of investment in infrastructure and systems to accommodate the requirements of U.S. retailers, and assure the quality of the product. These developments include Good Agricultural Practices in the farms, HACCP and U.S. third-party independently-audited plants. This business is not one that has come easy to the people involved, both in Peru and in the U.S. The fresh asparagus exports represented an estimated of 75 % of the total Peruvian exports (volume) commercialized by air transportation in the last year. Approximately, 80 % of the total fresh asparagus volume is exported in the period July to December. We represent more than 20 companies who make a living producing and exporting fresh asparagus from our country. This proposal has also the comments of the logistic operators in Peru such as airlines, cargo agents, cold – warehouses, between others. We would like to share some of our comments focus in the Section 306 (Establishment and Maintenance of Records) We are very concern in these issues: 1.The proposal legislation states that the FDA must receive the information they request within 4 hours, if it is made between 8:00 am and 6:00 pm, Monday through Friday, or within 8 hours if the request is made at any other time. Nevertheless, we think this time frame is too short considering the hours difference between countries or any other communication problem that may happen 2. The proposal legislation states that it will be effective after 6 months of its publication in the Federal Register, Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication of the final rule, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from publication of the final rule. The Peruvian Asparagus Institute request more information about what the FDA will consider full and part time employee to make the classification of the companies, specially foreign. PROPOSAL 1. In order to properly consider the time frame stated in the proposal legislation, it is important that the FDA officials will send a formal and written communication ( and also by phone ) to the agent or importer when there is a request of information. We appreciate your consideration of our comments.