FDA finalizes FMSA rule on preventing intentional food adulteration
The seventh and last major rule of the US Food and Drug Administration's (FDA's) Food Safety Modernization Act (FSMA), this one focusing on preventing intentional adulteration of the food supply and its consequences, is now final and will be published tomorrow in the Federal Register.
The rule includes the first-time requirement that both domestic and foreign food facilities "complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm," says an FDA press release.
The FDA goes on to say, " Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records."
The newly finalized rule applies mainly to large companies, covering 3,400 firms that operate 9,800 food facilities. Small companies are exempted, as are farms unless they produce milk, says an FDA fact sheet on the new rule.
Until now there have been no requirements for food facilities to implement strategies or measures against intentional contamination of food. A webinar is being offered Jun 21 by the FDA to outline provisions of the new requirements.
The landmark, bipartisan FMSA was passed in 2011 to address the complex public health issue of foodborne disease. The FDA estimates that about 48 million (1 in 6 Americans) become ill from foodborne disease each year, with 128,000 of them hospitalized and 3,000 dying.
May 26 FDA press release
May 26 FDA fact sheet
FDA FMSA docket folder (final rule will appear May 27)
May 26 FDA announcement of Jun 21 webinar
FAQ on FMSA (updated May 26)
China reports human H7N9 case in Guangdong province
Chinese officials today reported another human case of H7N9 avian influenza, according to updates from the Hong Kong Centre for Health Protection (CHP) and Xinhua, China's state news agency.
The case involves a 63-year-old man from Meizhou city in Guangdong province, the CHP said. No additional information on his condition was given. The number of H7N9 cases in the province is down by 83% compared with the same period last year, Xinhua said.
Maternal streptococcal colonization varies by geography, serotype
The average global prevalence of rectovaginal group B streptococcal colonization in pregnant women is about 18% and varies widely according to region and serotype, according to findings yesterday in The Lancet Infectious Diseases.
A research team led by GlaxoSmithKline Vaccines and South Africa's University of the Witwatersrand conducted a meta-analysis of 78 studies representing 73,791 pregnant women from 37 countries between January 1997 and March 2015. Group B Streptococcus is transmitted to about half of babies born to colonized women, and 1% to 2% of those babies develop severe disease, the authors said.
Globally, the average colonization prevalence was 17.9%, or 13,100 women. Prevalence was highest in Africa (22.4%, or 619 of 2,735 women), followed by the Americas (19.7%, or 4,360 of 23,163) and Europe (19%, or 6,113 of 31,642), and lowest in southeast Asia (11.1%, or 389 of 3,749). Variation in prevalence was significant across regions and could not be ascribed to differences in culture methods, time of specimen collection, or study sample size, the authors said.
Among the 17 studies that identified a Group B Streptococcus serotype, the proportions of types Ia, Ib, or III were highest in the western Pacific (76.5%) and Africa (69.2%) and lowest in the Americas (55%) and Europe (58.3%) because of higher serotype II prevalence in the latter two regions, the authors said.
Considering the significant geographic heterogeneity in maternal streptococcal colonization and its implications for disparities in neonatal disease incidence, further research should determine whether sociodemographic factors or population immunity contribute to this variation, the authors said.
May 25 Lancet Infect Dis study
New-found phage may help preserve utility of old antibiotics
A bacteriophage recently isolated from a Connecticut pond can attack Pseudomonas aeruginosa and force the bacterium to fight back in ways that make it susceptible to traditional antibiotics, according to a study today in Scientific Reports.
Phage therapy, in which a virus is used to combat a bacterial infection, is viewed as a potential alternative to antibiotic use for multidrug-resistant (MDR) bacteria like P aeruginosa. Researchers led by Yale University used the new bacteriophage to prompt a bacterium-phage battle that lowered P aeruginosa's antibiotic-fighting ability.
The phage, dubbed OMKO1 (outer-membrane-porin M knockout dependent phage #1), is from the Myoviridae family and was initially isolated from Dodge Pond in East Lyme, Conn., then mutated through 20 passages in an MDR P aeruginosa strain.
OMKO1 was able to attack the bacterium's multidrug efflux pumps, which remove antibiotics from bacterial cells and are an important contributor to drug resistance. Phage therapy has typically had limited effects in treating bacterial illness, because bacteria readily develop resistance to phages, according to the report.
In this instance, however, OMKO1 targeted a site on the bacterium's surface that forced P aeruginosa to change its efflux pump mechanism to fight the phage, thus decreasing its ability to resist antibiotic treatment.
Phage resistance in P aeruginosa caused increases in sensitivity to ciprofloxacin, tetracycline, ceftazidime, and erythromycin in two MDR strains. The authors also said that all bacterial strains from environmental, laboratory, and clinical settings showed a general ability to make the observed genetic trade-off: resisting the phage at the cost of lowered ability to expel antibiotics.
Phage therapy shows promise in situations in which antibiotics must be preserved or in which immunocompromised people require tailored treatment for bacterial infections, the report says. "Furthermore, our approach suggests that antibiotics not typically used during treatment of P. aeruginosa infections due to intrinsic resistance could be used with phage OMKO1," the authors added.
May 26 Sci Rep study