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Federal Register/Vol. 64, No. 207/Wednesday, October 27, 1999

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Federal Register/Vol. 64, No. 207/Wednesday, October 27, 1999 Federal Register / Vol. 64, No. 207 / Wednesday, October 27, 1999 / Notices 57893 clarity of the information to be They will also be asked if they have the best of the manufacturer's collected; and (4) ways to minimize the contingency plans. The survey will also knowledge. The information will be burden of the collection of information ask if they have tested, verified, and used for possible FDA inspectional on respondents, including through the certified their systems. The request will followup, if it indicates potential unsafe use of automated collection techniques, also ask for a single point of contact at food manufacturing situations, as well when appropriate, and other forms of the manufacturer to discuss as in the preparation of industry and information technology. information. consumer directed material addressing Title: Survey of Food Manufacturing The manufacturer will provide paper Year 2000 concerns. Facilities for Year 2000 Compliance copy of the information to FDA. The Respondents: Food manufacturers. Facilities will be asked to provide a provision of information will signify FDA estimates the burden of this status on their Year 2000 readiness. that the information provided is true to collection of information as follows: TABLE 1.ÐESTIMATED ANNUAL REPORTING BURDEN 1 Annual No. of Respondents Frequency per Total Annual Hours per Total Hours Response Responses Response 250 1 250 1 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA establishment inventory lists Drug Administration, 200 C St. SW., ACTION: Notice. were used to determine the number of Washington, DC 20204, 202±418±3091. firms who would be subject to this SUPPLEMENTARY INFORMATION: In a notice SUMMARY: The Food and Drug collection. FDA estimates that it will published in the Federal Register of Administration (FDA) is publishing two take firms an average of 2 hours to August 3, 1995 (60 FR 39753), FDA related guidance documents entitled collect, prepare, and submit the announced that a food additive petition ``Guidance for Industry: Reducing requested information. (FAP 5B4467) had been filed by Ciba- Microbial Food Safety Hazards for Dated: October 20, 1999. Geigy Corp., Seven Skyline Dr., Sprouted Seeds'' and ``Guidance for William K. Hubbard, Hawthorne, NY 10532. The petition Industry: Sampling and Microbial Testing of Spent Irrigation Water During Senior Associate Commissioner for Policy, proposed to amend the food additive Planning and Legislation. regulations in § 178.2010 Antioxidants Sprout Production.'' These guidances are intended to provide [FR Doc. 99±27977 Filed 10±26±99; 8:45 am] and/or stabilizers for polymers (21 CFR 178.2010) to provide for the safe use of recommendations to suppliers of seed BILLING CODE 4160±01±F poly[[6-[(1,1,3,3- for sprouting and sprout producers tetramethylbutyl)amino]-s-triazine-2,4- about how to reduce microbial food DEPARTMENT OF HEALTH AND diyl] [2,2,6,6-tetramethyl-4- safety hazards common to the HUMAN SERVICES piperidyl)imino] production of raw sprouts to ensure that hexamethylene[(2,2,6,6-tetramethyl-4- sprouts are not a cause of foodborne Food and Drug Administration piperidyl)imino]], as a light stabilizer in illness and to ensure that they comply polymers used as an indirect food with the food safety provisions of the [Docket No. 95F±0187] additive. Ciba Specialty Chemicals Federal Food, Drug, and Cosmetic Act Corp., has now withdrawn the petition (the act). The first guidance is based Ciba Specialty Chemicals Corp.; without prejudice to a future filing (21 largely on recommendations from the Withdrawal of Food Additive Petition CFR 171.7). National Advisory Committee for Dated: October 12, 1999. Microbiological Criteria for Food's AGENCY: Food and Drug Administration, report entitled ``Microbial Safety Alan M. Rulis, HHS. Evaluations and Recommendations on Director, Office of Premarket Approval, ACTION: Notice. Sprouted Seeds'' (the 1999 NACMCF Center for Food Safety and Applied Nutrion. report) (Ref.1). The second guidance is SUMMARY: The Food and Drug [FR Doc. 99±27976 Filed 10±26±99; 8:45 am] intended to assist sprouters in Administration (FDA) is announcing the BILLING CODE 4160±01±F implementing one of the principle withdrawal, without prejudice to a recommendations (i.e., microbial future filing, of a food additive petition testing) in the broader sprout guidance. (FAP 5B4467) (filed by Ciba Specialty DEPARTMENT OF HEALTH AND Chemicals Corp.; formerly named Ciba- HUMAN SERVICES DATES: Written comments may be Geigy Corp.) proposing that the food submitted at any time, however, additive regulations be amended to Food and Drug Administration comments should be submitted by provide for the safe use of poly[[6- [Docket Nos. 99D±4488 and 99D±4489] December 13, 1999, to ensure adequate [(1,1,3,3-tetramethylbutyl)amino]-s- consideration in preparation of revised triazine-2,4-diyl] [2,2,6,6-tetramethyl-4- Guidance for Industry: Reducing documents, if warranted. Microbial Food Safety Hazards for piperidyl)imino] hexamethylene ADDRESSES: Submit written requests for [(2,2,6,6-tetramethyl-4-piperidyl)imino]] Sprouted Seeds and Guidance for Industry: Sampling and Microbial single copies of the guidance entitled as a light stabilizer in polymers used as ``Guidance for Industry: Reducing indirect food additives. Testing of Spent Irrigation Water During Sprout Production Microbial Food Safety Hazards for FOR FURTHER INFORMATION CONTACT: Sprouted Seeds'' and/or the guidance Julius Smith, Center for Food Safety and AGENCY: Food and Drug Administration, entitled `Guidance for Industry: Applied Nutrition (HFS±215), Food and HHS. Sampling and Microbial Testing of VerDate 12-OCT-99 16:47 Oct 26, 1999 Jkt 190000 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.XXX pfrm04 PsN: 27OCN1 57894 Federal Register / Vol. 64, No. 207 / Wednesday, October 27, 1999 / Notices Spent Irrigation Water During Sprout and have led to a significantly better disinfection treatments (such as 20,000 Production'' to the Office of Plant and understanding of the microbial ecology parts per million of calcium Dairy Foods and Beverages (HFS±306), of sprout-associated foodborne illness, hypochlorite in water) is likely to Center for Food Safety and Applied not all industry segments have been reduce the level of contamination if Nutrition, Food and Drug reached. Traceback investigations reveal present in or on seeds and, in turn, Administration, 200 C St. SW., that most of the firms associated with reduce the risk of foodborne illness from Washington, DC 20204, 202±205±4200. recent outbreaks were not using the consumption of sprouted seed. Send one self-adhesive label to assist approved seed disinfection treatments, However, current approved treatments that office in processing your request. or were not using them consistently, do not guarantee total elimination of The guidances are attached to this and were not testing for microbial pathogens. If even a few pathogens notice as appendixes 1 and 2 and are contamination during sprout survive a seed disinfection treatment, also accessible via the FDA home page production. Although currently they can grow to high levels during on the Internet: http://www.fda.gov. approved treatments can significantly sprouting and contaminate the entire Submit written comments on the final reduce pathogen levels in or on seeds, batch. Therefore, although seed guidance(s) to the Dockets Management they have not been shown to completely disinfection treatment is recommended, Branch (HFA±305), 5630 Fishers Lane, eliminate pathogens (Ref. 1). microbial testing of spent irrigation rm. 1061, Rockville, MD 20852. Consequently, outbreaks continue to water from each batch or production lot FOR FURTHER INFORMATION CONTACT: occur. of sprouts should also be conducted to Michelle A. Smith, Center for Food On July 9, 1999, FDA issued a prevent contaminated product from Safety and Applied Nutrition (HFS± consumer advisory advising all entering the food supply. 306), Food and Drug Administration, consumers to be aware of the risks In addition, FDA is issuing ``Guidance 200 C St. SW., Washington, DC 20204, associated with eating any variety of to Industry: Sampling and Microbial 202±205±2975, FAX: 202±205±4422, e- raw sprouts, and advising persons at Testing of Spent Irrigation Water During mail: [email protected]. high risk of developing serious illness Sprout Production'' (the microbial SUPPLEMENTARY INFORMATION: due to foodborne disease (children, the testing guidance). This guidance is elderly, and persons with weakened designed to assist sprouters in designing I. Background immune systems) not to eat raw sprouts a microbial testing program to ensure Since 1995, raw sprouts have been (Ref. 3). This advisory is updated from adulterated product does not enter increasingly implicated in foodborne a previous advisory issued August 31, commerce. Specifically, this guidance outbreaks. Between January 1995 and 1998 (Ref. 4), and was prompted by recommends testing spent irrigation May 1999, there were 11 reported information from clover and alfalfa water from each individual batch or outbreaks in the United States sprout-associated salmonellosis production lot of sprouts for two associated with sprouts from outbreaks that occurred from January pathogens, E. coli O157:H7 and commercial growers, 9 of which were 1999 through May 1999. Salmonella. The microbial testing due to various Salmonella serotypes and guidance also provides instructions for II. Guidance 2 to Escherichia coli O157. The number the sampling and testing of sprouts for of culture-confirmed cases in each of In 1997, FDA asked the National those instances when it is not possible these outbreaks ranged from 8 to more Advisory Committee for Microbiological to test spent irrigation water. However, than 500, and more than 1,300 cases Criteria for Food (NACMCF) to : (1) sprouts should not be tested in lieu of have been reported overall (Ref. 1). Review the current literature on sprout- irrigation water when spent irrigation Alfalfa and clover sprouts have been associated outbreaks, (2) identify the water is available.
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