News Scan for Apr 24, 2015

News brief

FDA presents schedule for implementing Food Safety Modernization Act

The US Food and Drug Administration (FDA) at a conference yesterday presented a plan and schedule for implementing the Food Safety Modernization Act (FSMA), signed in 2011, according to Food Safety News.

At its "FSMA Kickoff Meeting," FDA officials gave food industry representatives an update on main components of the new law, declaring 2015 "the year of FSMA," the story said. Plans call for completing all of the rules within a year and requiring nearly all food makers to comply within 5 years.

Aug 30 is the deadline for the final rule on Preventive Controls for Human Food, which sets safety requirements for facilities that process, package, and store food, according to the story. Compliance deadlines are 1, 2, or 3 years after publication of the rule, depending on the size of the firm. The deadlines are the same for the Preventive Controls for Animal Food.

The deadline for completion of the Produce Safety Rule, which sets standards for growing, harvesting, packing, and holding produce, is Oct 31. Depending on company size, compliance deadlines are 2, 3, or 4 years after publication of the rule. It exempts farms that sell less than $25,000 worth of produce annually.

The deadlines for completion of other rules under the law are as follows:

Foreign Supplier Verification Program, Oct 31, 2015
Third-Party Certification of Auditors for Foreign Suppliers, Oct 31, 2015
Sanitary Transportation Rule, Mar 31, 2016
Intentional Adulteration Rule, Mar 31, 2016

Yesterday's meeting included listening sessions at which FDA officials heard concerns from many stakeholders, the story said. For example, domestic food manufacturers wanted to know how the FDA's new inspection system will affect them and how the agency will keep it consistent for all businesses.
Apr 24 Food Safety News story

Ohio ice cream company recalls products over Listeria detection

An ice cream maker in Columbus, Ohio, has recalled all its products after a sample tested positive for Listeria monocytogenes, thus becoming the second US ice cream company in recent months to recall products because of Listeria.

Jeni's Splendid Ice Creams recalled all its ice creams, frozen yogurts, sorbets, and ice cream sandwiches yesterday after Listeria was found in a sample collected by the Nebraska Department of Agriculture. In a press release, the company said it was of aware of no related illnesses but decided to recall the products to ensure consumer safety.

A company official said experts have been called in to help find the cause of the contamination and pledged that production will not be restarted until the safety of the products is ensured. The recalled products were distributed to retail outlets in the United States.

The action comes 4 days after Blue Bell Creameries recalled all of its products because of a Listeria outbreak involving 10 cases, including 3 deaths, in Kansas, Texas, Arizona, and Oklahoma.

An FDA spokesman said the agency had no evidence of any connection between the Listeria found in Jeni's ice cream and that found in Blue Bell ice cream, the Associated Press (AP) reported today.
Apr 23 Jeni's recall statement
Apr 24 AP story

Company barred from selling sprouts after 2014 listeriosis outbreak

The discovery of Listeria last year in sprouts from a Chicago company has led to a consent decree that permanently bars the firm from selling mung bean and soybean sprouts, the FDA announced yesterday.

US District Court for the Northern District of Illinois issued the decree of permanent injunction Apr 22 against Wholesome Soybean Products, the FDA said.

Listeria was first found in the firm's products in August 2014, leading to a recall and production stoppage, the FDA said. In September, five listeriosis cases involving the strains found in the company's products were reported. Further testing by the FDA revealed Listeria in nine samples of company sprouts.

The FDA concluded that the firm couldn't safely produce sprouts in its facility, and in November the company agreed to shut down, the agency said.
Apr 23 FDA statement
Related Nov 10, 2014, CIDRAP News item

Flu Scan for Apr 24, 2015

News brief

US flu season continues to decline, but hospitalizations up again

Influenza activity continues to drop in the United States even as rates of hospitalization for flu continue to climb, the Centers for Disease Control and Prevention (CDC) said today in its weekly update. The CDC also reported three flu-related deaths in kids.

Almost all key markers for flu activity dropped again in the week that ended Apr 18, the CDC said, indicating a waning season. The percentage of respiratory specimens that tested positive for influenza dropped substantially nationwide, to 7.6%, down from 9.6% the week before. The percentage varied widely by region, however, reaching as high as 16.9% in the Midwest.

The estimated proportion of outpatient visits for flulike illness was 1.4%, down from 1.8% and well below the 2.0% baseline level for the third straight week.

Flu activity was geographically widespread in the same three states as the week before: New York, Massachusetts, and Connecticut. Ten states reported regional activity, down from 14 the week before. All 50 states reported minimal flu activity, compared with 44 the week before.

The CDC reported 3 new flu-related pediatric deaths after none the previous week, bringing the total for the season to 128. The proportion of deaths from pneumonia and flu climbed a bit, to 6.7%, up from 6.5% but still below the epidemic threshold of 7.0%.

The cumulative hospitalization rate, however, climbed for yet another week, from 62.4 per 100,000 population to 63.6 per 100,000. And the rate in those 65 and older set yet another record since the CDC began recording that data in 2005-06. It rose from 308.0 to 313.8 per 100,000.

Influenza B continued its typical late-season surge, accounting for 88.2% of influenza viruses typed, up from 87.1% the week before.
Apr 24 CDC FluView update
Apr 24 CDC flu situation report

Trial shows Vietnam-made H5N1 vaccine safe, immunogenic

A Vietnam-made H5N1 influenza pandemic vaccine candidate proved safe and immunogenic in a phase 1 trial, Viet Nam News (VNS) reported today.

Of 75 people participating in the trial, 32 received a 15-microgram (mcg) dose of the vaccine, , 31 received a 7.5-mcg dose, and 12 received a placebo. The vaccine was produced by the Institute of Vaccines and Medical Biologicals of Viet Nam (IVAC).

The higher dose of the vaccine, called IVACFLU-H5N1, was shown to be immunogenic "according to standard testing methods," the story said. No serious local or systemic adverse events were noted in any of the volunteers.

"We confirm the readiness of IVACFLU-H5N1 to progress into phase 2 and 3 clinical trials," said Dr. Le Van Be, IVAC director.

The study was conducted by the HCM City Pasteur Institute. It was funded by the World Health Organization with a grant through the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services.
Apr 24 VNS story