§172.785 李斯特菌特异性噬菌体制剂(Listeria -specific bacteriophage preparation)

　　�� 172.785 Listeria -specific bacteriophage preparation.

　　The additive may be safely used as an antimicrobial agent specific for Listeria monocytogenes � L. monocytogenes � in accordance with the following conditions:

　　（a� Identity . �?� The additive consists of a mixture of equal proportions of six different individually purified lytic-type （lacking lysogenic activity� bacteriophages （phages� specific against L. monocytogenes .

　　�?� Each phage is deposited at, and assigned an identifying code by, a scientifically-recognized culture collection center, and is made available to FDA upon request.

　　�?� The additive is produced from one or more cell cultures of L. monocytogenes in a safe and suitable nutrient medium.

　　（b� Specifications .�?� The additive achieves a positive lytic result （OD600�� 0.06� when tested against any of the following L. monocytogenes isolates available from American Type Culture Collection （ATCC（� ATCC 35152 （serogroup 1/2a�? ATCC 19118 （serogroup 4b�? and ATCC 15313 （serogroup 1/2b�? The analytical method for determining the potency of the additive entitled ��Determination of Potency of LMP�C102TM ,�� dated October 9, 2003, and printed by Intralytix, Inc., is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552（a� and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety （HFS�C200�? Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration （NARA�? For information on the availability of this material at NARA, call 202�C741�C6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

　　�?� The mean phage titer of each monophage in the additive is 1 �� 109 plaque forming units （PFU�?ml. The analytical method for determining phage titer entitled ��Method to Determine Lytic Activity/Phage Titer,�� dated November 6, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph （b）（1� of this section.

　　�?� The phages present in the preparation must not contain a functional portion of any of the toxin-encoding sequences described in 40 CFR 725.421（d�? No sequences derived from genes encoding bacterial 16S ribosomal RNA are present in the complete genomic sequence of the phages.

　　�?� L. monocytogenes toxin, listeriolysin O （LLO�? is not greater than 5 hemolytic units （HU�?ml. The analytical method for determining LLO entitled ��Quantitation of Listeriolysin O Levels in LMP�C102TM ,�� dated September 27, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph （b）（1� of this section.

　　�?� The additive is negative for L. monocytogenes . The modified version of the U.S. Department of Agriculture's method for determining L. monocytogenes entitled ��LMP�C102TM Listeria monocytogenes Sterility Testing,�� dated May 24, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph （b）（1� of this section.

　　�?� The additive is negative for gram-positive and gram-negative bacteria capable of growing in commonly used microbiological media （e.g., Luria-Bertani （LB� medium�? including Escherichia coli , Salmonella species and coagulase-positive Staphylococci , as determined by the ��Method to Determine Microbial Contamination,�� dated July 11, 2003, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph （b）（1� of this section.

　　�?� Total organic carbon （TOC� is less than or equal to 36 mg/kg. The analytical method for determining TOC entitled ��Determination of Total Organic Carbon by Automated Analyzer,�� dated March 30, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph （b）（1� of this section.

　　（c� Conditions of use . The additive is used in accordance with current good manufacturing practice to control L. monocytogenes by direct application to meat and poultry products that comply with the ready-to-eat definition in 9 CFR 430.1. Current good manufacturing practice is consistent with direct spray application of the additive at a rate of approximately 1 mL of the additive per 500 cm2 product surface area.

　　[71 FR 47731, Aug. 18, 2006]

　　更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规，请点击美国FDA 21 CFR �?72部分已批准的直接用于人类食品的添加剂种类汇怺�/a>