FDA finalizes FSMA rules on human, animal food safety steps

The US Food and Drug Administration (FDA) today finalized the first two of seven major rules for implementing the 2011 Food Safety Modernization Act (FSMA)—those covering prevention steps for both human and animal food.

The two "preventive controls" rules require human and animal food facilities to establish written food safety plans that outline potential food safety problems and how to minimize the risk. They also need to verify that their plans work. The FDA will assess the plans to help prevent outbreaks before they occur and be better able to respond to foodborne diseases should they occur, the agency said in a news release.

The rules focus on employing manufacturers' "best practices" for food safety.

"Today's action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities," the FDA said in the release, referring to the two rules plus those yet to be finalized.

All seven rules are slated to be completed by the end of next year. The rules for produce safety, foreign supplier verification, and third-party accreditation must be finalized by Oct 31.
Sep 10 FDA news release
FDA final rule on human food safety
FDA final rule on animal food safety

DoD lab may have mishandled plague, encephalitis pathogens

Add the bacterium that causes plague and equine encephalitis viruses to the dangerous pathogens that high-containment Department of Defense (DoD) labs might have improperly handled and shipped, USA Today reported today.

Potential mislabeling, improper storage, and shipping of possibly infectious Yersinia pestis, which causes plague, and Venezuelan equine encephalitis virus and Eastern equine encephalitis virus played a role in Army Secretary John McHugh ordering a research moratorium at nine DoD labs last week, the story said. The Centers for Disease Control and Prevention (CDC) noted the practices—as well as those involving the anthrax bacterium, Bacillus anthracis—after inspections last month at an Army lab in Maryland.

In May officials revealed that the Army's Dugway Proving Ground in Utah has for years been mistakenly shipping live B anthracis samples to multiple labs, with the number of affected US labs now at 194 in all 50 states, plus labs in the District of Columbia, 3 US territories, and 9 foreign countries. Those lapses triggered a CDC investigation that led to the most recent findings.

Although McHugh when announcing the moratorium last week cited only the Dugway failings regarding B anthracis, Army spokesman Dov Schwartz said in today's story that the CDC's concerns over the newly identified pathogens contributed to the decision.

An anonymous senior DoD official said there is no danger to the public or to scientists who worked with the plague and encephalitis pathogens. Final test results from the Maryland lab are expected by the end of the month, the story said.
Sep 10 USA Todayreport
DoD laboratory review home page

Study: Immunocompromised carry heavy pneumococcal burden

Immunocompromised people have a burden of pneumococcal disease about 12 times higher than those with healthy immune systems, according to Toronto researchers writing yesterday in Clinical Infectious Diseases.

The study, which was conducted to establish baseline levels before the introduction of the 13-strain pneumococcal conjugate vaccine (PCV13) in 2012-13, also demonstrated protective effects of both adult and child PCVs.

The investigators analyzed population-based surveillance data in the city from 1995 through 2012. They found that 2,115 of 7,604 episodes of invasive pneumococcal disease (IPD), or 28%, occurred in immunocompromised patients, a rate 12 times higher than in immunocompetent patients. Also, the use of immunosuppressive medications was associated with a 2.1- to 2.7-fold increase in IPD incidence.

They also found that, 5 years after the introduction of 23-strain polysaccharide pneumococcal vaccine in 1995, IPD incidence had declined 43% in immunocompromised adults. And 10 years after pediatric seven-strain PCV (PCV7) was authorized in 2001, IPD caused by PCV7 serotypes had decreased by 90% in immunocompromised children and adults.

The authors conclude, "PCV13 vaccination of immunocompromised adults may substantially reduce the residual burden until herd immunity from pediatric PCV13 is fully established."
Sep 9 Clin Infect Dis abstract