Thursday, May 21, 2015

The Blue Bell Situation and the Impact of FSMA

In his piece, Blue Bell and the Very Real Impact of the Food Safety Modernization Act,  FDA’s Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, discusses how FSMA will help prevent (not eliminate) foodborne outbreaks such as those associated with ice cream sold by Blue Bell.

The coming change with an implemented FSMA regulation that can be taken from this article is that companies will need 'real' controls in place for hazards that have been determined for their product and operation.  Real controls are ones that are well planned, implemented and verifiable.  This not only covers process-related controls, but those that had been considered as part of the prerequisite programs...sanitation for example.

In the Blue Bell case, Listeria monitoring was in place, but all their program was really able to do was show that Listeria was showing up, but beyond that, questions could be easily raised - was it in product, was it on food contact surfaces, what was the source and was anything done to eliminate that source.  In the FDA's 2008 draft guidance document,  Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, recommendations for environmental and product sampling are made.  However, FSMA differs in that it will ask....'how do you know?'.  So instead of recommending testing, the question is 'how do you know you are controlling Listeria?'.  It is now on the that processor to be able to provide proof of control...which in this case, is most likely testing of the environment  as well as product.  Along with that, verification, documentation, and corrective action.

So in the build-up to FSMA, challenge the controls by asking 'how do you really know' whether the controls you have identified are working.  How do you know whether the corrective actions taken eliminated the hazard from occurring and prevented suspect product from reaching the consumer.
 

FDA Voice
 http://blogs.fda.gov/fdavoice/index.php/2015/05/blue-bell-and-the-very-real-impact-of-the-food-safety-modernization-act/
Blue Bell and the Very Real Impact of the Food Safety Modernization Act
Posted on May 20, 2015 by FDA Voice

By: Michael R. Taylor

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.

Above all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.

But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.

Friday, May 15, 2015

USDA Develops Program for Certifying Food as GMO Free

USDA has developed a new program for certifying that a food is GMO free.   There is a similar program in place for organic foods that would cover GMO free as well, but not for just GMO free.

The verification process would be paid by the companies, not the government.


Huffington Post
http://www.huffingtonpost.com/2015/05/14/usda-gmo-label_n_7284544.html
USDA Develops New GMO-Free Certification And Label For Foods
| By MARY CLARE JALONICK
Posted: 05/14/2015 12:47 pm EDT Updated: 05/14/2015 12:59 pm EDT 

WASHINGTON (AP) — The U.S. Agriculture Department has developed a new government certification and labeling for foods that are free of genetically modified ingredients.

USDA's move comes as some consumer groups push for mandatory labeling of the genetically modified organisms, or GMOs.

The certification is the first of its kind and would be voluntary — and companies would have to pay for it. If approved, the foods would be able to carry a "USDA Process Verified" label along with a claim that they are free of GMOs.

Thursday, May 14, 2015

USDA Issues Rule on Labeling of Mechanically Tenderized Beef Products

Mechanically tenderized meat (aka injected meat, blade tenderized meat, chopped steak) will have to be labeled as such and also have proper cooking instructions.  This type of meat has a higher risk in that the process of sticking needles in the meat, or cutting the meat, can force harmful bacteria into the internal portions of the meat.  Because of this, it needs to be cooked more, just like hamburger (no rare or medium rare).  Unlike hamburger, it is not obvious that it needs to be cooked more in that the meat cuts look the same as whole 'intact' cuts of beef.

This is a good rule.  People are normally unaware of the difference of tenderized cuts of meat and intact cuts of meat and the fact that you need to cook it more.  Labeling these cuts will help. 

The rule does not go into effect until May, 2016.

USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2015/nr-051315-01
USDA Finalizes Rule to Require Labeling of Mechanically Tenderized Beef Products
New labels and cooking instructions will give consumers information they need to safely enjoy these products

WASHINGTON, May 13, 2015 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) today announced new labeling requirements for raw or partially cooked beef products that have been mechanically tenderized. Consumers, restaurants, and other food service facilities will now have more information about the products they are buying, as well as useful cooking instructions so they know how to safely prepare them.

“Labeling mechanically tenderized beef products and including cooking instructions on the package are important steps in helping consumers to safely prepare these products,” said Deputy Under Secretary Al Almanza. “This common sense change will lead to safer meals and fewer foodborne illnesses.”

Woman Contracts Botulism Poisoning from Improperly Canned Carrots

A North Carolinian woman contracted botulism poisoning after almost eating an improperly processed carrot.   Instead of pressure canning the jars of carrots, she used the hot water bath canning technique (which is only appropriate for high acid foods).  After putting the carrot in her mouth, she realized it was 'off' and spit it out.  However, she ingested enough toxin to get the illness with just putting that carrot in her mouth.

Unfortunately, too many people still process jars of low acid foods (carrots, peas, beans) in boiling water rather than using the pressure canner.  No doubt this woman would have fought against using the pressure canner..its too dangerous, the carrots are not firm, etc.  After 11 weeks in the hospital, maybe she can be a warning to others.

North Carolina Health News
http://www.northcarolinahealthnews.org/2015/05/12/botulism-case-highlights-need-to-follow-canning-directions/
Botulism Case Highlights Need to Follow Canning Directions
May 12, 2015

 An Ashe County woman learned the hard way her food-preservation techniques were wrong.
By Rose Hoban

It only took one bite.

Five days later, an Ashe County woman lay in the hospital, on a ventilator, unable to breathe.

The woman, who’s name has not been released, told health officials she didn’t even swallow the carrot. She opened the home-canned jar of carrots, tasted one, decided it looked and tasted off, and spit it out.

But that was enough to give her botulism, sending her to the hospital for an 11-week stay.

Norovirus Infection from Swimming in Lake (2014) - CDC Report

Last summer, approximately 70 people contracted Norovirus infection after swimming in a lake.  The lake, located close to Portland OR was shut down for 10 days following the outbreak which occurred on July 12, 2014.

It is always nice to be reminded of these swimming related outbreaks now that summer approaches.  I have always preferred pools with a dash of chlorine and plenty of sunlight to that of some oversized pond with imported sand and plenty of stuff floating in the water.  I will gladly accept chlorine induced red eyes over the possibility of swallowing some viral or bacterial pathogen, or even worse, a parasite such as Giardia or Cryptosporidium.  But even chlorine has limitations.  CDC has a publication on recreational water (below).

CDC - Morbidity and Mortality Weekly Report (MMWR)
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6418a2.htm?s_cid=mm6418a2_e
Norovirus Outbreak Associated with a Natural Lake Used for Recreation — Oregon, 2014
Weekly

May 15, 2015 / 64(18);485-490
Amy Zlot, MPH1, Maayan Simckes, MPH1,2, Jennifer Vines, MD1, Laura Reynolds, MPH1, Amy Sullivan PhD1, Magdalena Kendall Scott, MPH3, J. Michael McLuckie1, Dan Kromer, MPA4, Vincent R. Hill, PhD5, Jonathan S. Yoder, MPH5, Michele C. Hlavsa, MPH5 (Author affiliations at end of text)
In July 2014, Multnomah County public health officials investigated a norovirus outbreak among persons visiting Blue Lake Regional Park in Oregon. During the weekend of the reported illnesses (Friday, July 11–Sunday, July 13) approximately 15,400 persons visited the park. The investigation identified 65 probable and five laboratory-confirmed cases of norovirus infection (70 total cases). No hospitalizations or deaths were reported. Analyses from a retrospective cohort study revealed that swimming at Blue Lake during July 12–13 was significantly associated with illness during July 13–14 (adjusted relative risk = 2.3; 95% confidence interval [CI] = 1.1–64.9). Persons who swam were more than twice as likely to become ill compared with those who did not swim in the lake. To control the outbreak, Blue Lake was closed for 10 days to prevent further illness. This investigation underscores the need for guidance for determining when to reopen untreated recreational water venues (e.g., lakes) associated with outbreaks, and communication tools to inform the public about the risks associated with swimming in untreated recreational water venues and measures that can prevent illness.

Thursday, May 7, 2015

FDA Inspectional Reports From Blue Bell Production Facilities

FDA published the inspectional observations from the Blue Bell production facilities in their three plants.  This comes after their product was linked to Listeria illnesses and product recalls.
Here is a list of finding, primarily the OK facility, but many of the same issue were identified in all three facilities.  It is important to remember that these facilities are producing a ready-to-eat product, and should be maintaining a high hygiene environment.  However these findings would not suggest high hygiene zones (or high care zones).

Thursday, April 30, 2015

Canadian Firm Recalled Sliced Apples Due to Listeria

A Canadian firm is recalling sliced apples after someone reported getting ill and CFIA test results.  The apples were distributed in Canada.



Canadian Food Inspection Agency
http://www.inspection.gc.ca/about-the-cfia/newsroom/food-recall-warnings/complete-listing/20150429b/eng/1430375161334/1430375167258
Food Recall Warning - Sliced apples and products containing sliced apples recalled due to Listeria monocytogenes

Recall date:April 29, 2015
Reason for recall: Microbiological - Listeria
Hazard classification:Class 1
Company / Firm:Sun Rich Fresh Foods Inc.
Distribution:Possibly National
Extent of the distribution: Retail
   
Recall details

Ottawa, April 29, 2015 - Sun Rich Fresh Foods Inc. is recalling sliced apples and products containing sliced apples produced in its Brampton, Ontario facility from the marketplace due to possible Listeria monocytogenes contamination. Consumers should not consume and distributors, retailers and food service establishments such as hotels, restaurants, cafeterias, hospitals and nursing homes should not sell or use the recalled products described below.