Dec 30, 2011
FSIS actions seek to strengthen Listeria testing of food producers
The US Department of Agriculture's Food Safety and Inspection Service (FSIS) issued a notice Dec 28 of new actions aimed at circumventing the practice of some food producers of temporarily altering routine production practices during FSIS sampling. The involved FSIS testing protocols, which are designed to gain information on sanitary conditions during production in food establishments, are Routine Risk-Based Listeria monocytogenes (RLm) Sampling, done once every 4 years in ready-to-eat production facilities, and Intensified Verification Testing (IVT), done as needed in response to identification of food safety issues at an establishment. The new actions lay out instructions for Enforcement, Investigations, and Analysis Officers (EIAOs) regarding notification of food producers of impending sampling, protocols for the producer to advise the officer of any production changes planned during the sampling process, and actions for EIAOs and their superiors to follow if the protocols are not followed. Data on experience with the new procedures will be analyzed quarterly to determine whether new policy or guidance is needed.
Dec 28 FSIS notice
FDA approves Prevnar 13 vaccine in adults 50 and older
The Food and Drug Administration (FDA), through its accelerated approval process, today approved the pneumococcal 13-valent conjugate vaccine Prevnar 13 for people 50 years of age and older. The vaccine, already in use in children, protects against pneumonia and invasive disease caused by Streptococcus pneumoniae. In randomized, multicenter studies in the United States and Europe, adults 50 and older received either Prevnar 13 or Pneumovax 23, another pneumococcal vaccine already licensed for use in adults. Prevnar induced antibody levels comparable to or higher than those induced by Pneumovax, and adverse reactions were similar for the two vaccines. It is estimated that 300,000 people 50 and older are hospitalized each year with pneumococcal pneumonia.
Dec 30 FDA news release