Phages to Fight Food Pathogen

The FDA issued an amendment to the food-additive regulations authorizing the safe use of a bacteriophage preparation on ready-to-eat (RTE) meat and poultry products as an antimicrobial agent against Listeria monocytogenes, in response to a petition filed by Intralytix, Inc., Baltimore. This approval is effective Aug. 18, 2006.

L. monocytogenes has been found in a variety of foods including uncooked meats and vegetables, as well as processed foods contaminated after processing, such as soft cheeses and cold cuts. The bacterium causes listeriosis, a serious food-borne infection that primarily strikes pregnant women, newborns and adults with weakened immune systems. Symptoms generally mimic a mild, flu-like illness; however, in pregnant women it might lead to miscarriage or stillbirth, premature delivery or infection of the newborn. Authorities at the Centers for Disease Control and Prevention estimate that, in the United States, 2,500 persons per year become seriously ill with listeriosis, and of these, 500 die.

The additive as described consists of a mixture of equal proportions of six different purified phages. Each phage is specific against various L. monocytogenes strains, and the inclusion of multiple phages should minimize the possibility that the bacteria develop a resistance to the additive. The phage preparation is intended for direct spray on the products' surface at a level of approximately 1 mL per 500 cm² of surface area just prior to packaging. Because phages are ubiquitous in the environment and only act on bacteria, not animal or plant cells, FDA concluded that the food additive does not present a toxicological concern for use in food as proposed.

The final rule can be found in the Federal Register, Aug. 18, 2006 (Vol. 71, No. 160, Pg. 47729-47732), or online at http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13621.htm.