Friday, April 25, 2014

FDA releases Food Code Reference System

FDA has released the Food Code Reference System, (FCRS) a search tool for providing additional information on questions posed to FDA on various provisions in the Food Code. It can be used when looking for specific issues that may come up. For example:
Can a wait staffer or server not involved in food prep have artificial nails? ? Short answer from what was posted – no.
What is the maximum strength allowed for a chlorine hand dip? ? Short answer from what was posted – there is no maximum, only a minimum of 100 mg/L of chlorine?
Are eggs that have been pasteurized in the shell shelf stable? Short answer – no, but they are free from Salmonella.
So this may be a useful site when you have a specific question and are looking for support documentation. However the amount of items in the database is limited and you may not find what you need. And I found that the answers could be somewhat basic. For example, a question on allergens and cooking oil is pretty simplistic in its response. It gets to the fact that allergens from food can be transferred by oils, but does not get to a question that is often posed, ant that is, what is defined as a refined oil.  

Possible reason is that the database has answers that were posted over a 8 or so year range, and so these questions/answers may not provide sufficient depth to some of the more complex questions that arise today. Perhaps as time goes, these questions will be posed to FDA and then this information will become searchable on the database.

Overall, I find that the information listed in the Annex section of the 2013 Food Code (the section that supports the 2013 Food Code) to be a better source for supporting documentation, however, for more specific questions you may come across, the FCRS can be a tool to find that answer.   

One other issue….the FDA website is sooooo slooowwwww.

FDA Constituent Update
FDA Releases Searchable Database - Food Code Reference System
Latest effort to strengthen understanding and application of the FDA Model Food Code
April 21, 2014

The U.S. Food and Drug Administration (FDA) has created the Food Code Reference System1 as part of an effort to promote consistent understanding and application of the FDA’s Food Code.

The FDA Food Code -- a model that has been widely adopted by state, local, tribal and territorial regulatory agencies -- provides FDA’s best advice for a uniform system of provisions to address the safety and protection of food offered at retail and in food service. The food code assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.

The new Food Code Reference System, a searchable database that answers questions users may have about the Food Code and the application of its model regulations, will help to promote nationwide consistency and increase transparency about the Food Code.

Federal, state, local, tribal, and territorial government agencies; consumers, and stakeholders from academia and industry will benefit from this database as they promote compliance with their respective food safety requirements throughout the United States.

The Food Code Reference System contains entries derived from responses to Food Code-related questions posed to FDA.

Initially, users of the FCRS will find more than 20 entries that clarify many issues including:

The storage of foods that require temperature control for safety.
The design of food establishments and the cleaning of food equipment.
Bare-hand contact with ready-to-eat foods
Preventing contamination of food through proper hand hygiene and employee attire 

The FDA intends to add entries it believes are important to the uniform application of the Food Code and that may have implications across all jurisdictions that regulate food establishments. These entries will reflect questions previously answered by FDA as well as responses to future inquires that FDA receives.

The Food Code Reference Systems contains a User Manual and a Frequently Asked Questions (FAQs) page, both accessible from the log-in page. After an initial registration, system users can search the database using dropdown menus, keyword search, date fields, or a combination of these options. Users can also retrieve, view, and save documents to a local computer system. The materials contained in the Food Code Reference System are developed and issued by the Retail Food Protection Team in FDA’s Center for Food Safety and Applied Nutrition.

More information on FDA’s Food Code Reference System is available at Questions about the use of FDA’s Food Code Reference System can also be sent by email to:

Friday, April 11, 2014

Spices and Herbs recalled due to postive Salmonella tests

Two different products, one a spice and the other herb (dried sweet basil), are being recalled after testing indicated the presence of Salmonella.
There has been increasing attention on herbs and spices with regard to Salmonella.  FDA recently  issued a report on the risks associated with spices.   And most of the recent issues, including the recent issue with black peppercorn  and an organic fresh basil product, have been small producers that have been found to contain Salmonella through testing, often completed by the FDA.

FDA Recall Notice
Lisy Corporation Issues Recall on: Lisy Sweet Basil (Albahaca) 6 Oz., Item 1132 Lot #'s A013 0518 & A014 0518
Consumer:  1-305-836-6001 ext. 233

Media:  Henry Rosen  305-836-6001

FOR IMMEDIATE RELEASE - April 9, 2014 - Lisy Corporation of Miami, FL is voluntarily recalling Lisy Sweet Basil (Albahaca), 6 oz jar, Item #1132, Lot #'s A013 0518 & A014 0518, because it has the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

No illnesses have been reported to date in connection with this recall.

Lisy Sweet Basil- 6oz, bottle, UPC Code 0 96786 30032 8 began distribution on 01/15/2014 in retail stores in the states of New Jersey, New York, Rhode Island, and Maryland.

The voluntary recall was initiated by Lisy after a routine sampling by the FDA revealed the presence of Salmonella in the Lisy Sweet Basil (Albahaca), 6 oz., Lot #'s A013 0518 & A014 0518.

Any consumers that have purchased Lisy Sweet Basil (Albahaca), 6 oz., from Jan 15, 2014 to present are urged not to eat the product, and dispose of it or return product to the place of purchase for a replacement or for a full refund. Consumers with questions may contact the company at 1-305-836-6001 ext. 233.

Consumers with questions may contact Henry Rosen at 305-836-6001 ext. 233 from 8:00 am – 5:00 pm EST, Monday through Friday.

FDA Recall Notice
Fernandez Chile Company Inc. Recalls 4oz Chile Molido Puro and 6oz Chile Rojo Potential Salmonella Contamination

Contact: Consumer: Blair Fernandez 719-589-6043

FOR IMMEDIATE RELEASE - April 10, 2014 - Fernandez Chile Company Inc of Alamosa, Colorado is recalling 4oz Chile Molido Puro UPC code 77601-10011 and 6oz Chile Rojo UPC code 77601-10053 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis.

The recalled 4oz Chile Molido Puro UPC code 77601-10011 and 6oz Chile Rojo UPC code 77601-10053 was distributed in Colorado, New Mexico, Wyoming, Utah, Arizona, and California. King Soopers, Safeway, City Market and various independent grocers received these products.

The 4oz Chile Molido Puro UPC code 77601-10011 comes in a clear plastic bag marked with an expiration of 01 2017 on the back. The 6oz Chile Rojo UPC code 77601-10053 comes in a clear plastic bag marked with an expiration 02 2017 on the back.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing by an independent lab revealed the presence of Salmonella in some of the 4oz Chile Molido Puro and 6oz Chile Rojo.

These products are being recalled and taken out of production while the company and the FDA continue their investigation into the source of the contamination.

Consumers who have purchased these products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Blair Fernandez at Fernandez Chile Company Inc. at 719-589-6043 Monday - Thursday 8:00am - 5:00pm MDT

Pizza worker diagnosed with Hepatitis A potentially exposes thousands to the virus

A North Carolina Papa John's foodservice worker was diagnosed with Hepatitis A, this after he worked for about 2 weeks.  During that time, some 2,400 orders were placed (at 4 people per pie, and each order was at least one pie, that could potentially mean about 10,000 people have been exposed).

There is a long delay from the time someone who is exposed with Hepatitis A until they see symptoms.  And in this case, it took even longer from the time he had symptoms until the time he was diagnosed.

This worker had traveled overseas and probably contracted the disease during that trip.

It is important for those who have been exposed to get vaccinated, especially those who are more susceptible.

A few interesting notes form the CDC website.
  • Hepatitis A is a contagious liver disease that results from infection with the Hepatitis A virus. It can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. Hepatitis A is usually spread when a person ingests fecal matter — even in microscopic amounts — from contact with objects, food, or drinks contaminated by the feces, or stool, of an infected person.
  • If you were recently exposed to Hepatitis A virus and have not been vaccinated against Hepatitis A, you might benefit from an injection of either immune globulin or Hepatitis A vaccine. However, the vaccine or immune globulin must be given within the first 2 weeks after exposure to be effective.
  • The Hepatitis A virus is extremely hearty. It is able to survive the body’s highly acidic digestive tract and can live outside the body for months. High temperatures, such as boiling or cooking food or liquids for at least 1 minute at 185°F (85°C), kill the virus, although freezing temperatures do not.
  • Some people get Hepatitis A and have no symptoms of the disease. Adults are more likely to have symptoms than children.   If symptoms occur, they usually appear anywhere from 2 to 6 weeks after exposure.  Symptoms usually develop over a period of several days. Symptoms usually last less than 2 months, although some people can be ill for as long as 6 months.
  • Almost all people who get Hepatitis A recover completely and do not have any lasting liver damage, although they may feel sick for months. Hepatitis A can sometimes cause liver failure and death, although this is rare and occurs more commonly in persons 50 years of age or older and persons with other liver diseases, such as Hepatitis B or C.
  • There are no special treatments for Hepatitis A. Most people with Hepatitis A will feel sick for a few months before they begin to feel better. A few people will need to be hospitalized. During this time, doctors usually recommend rest, adequate nutrition, and fluids.  Alcohol [unfortunately] should be avoided.
  • Anyone traveling to or working in countries with high rates of Hepatitis A should talk to a health professional about getting vaccinated. Hepatitis A vaccine is highly effective in preventing Hepatitis A virus infection. Protection begins approximately 2 to 4 weeks after the first injection. A second injection results in long-term protection.
Charlotte Observer

Officials: Mecklenburg Papa John’s worker contracted hepatitis A
By Karen Garloch The Charlotte Observer
Posted: Thursday, Apr. 10, 2014
Modified: Thursday, Apr. 10, 2014

Mecklenburg County health officials are urging customers who ate food from a Papa John’s restaurant in the northeast part of the county from March 28 to April 7 to get a hepatitis A vaccine.

A worker at the restaurant, at 8016 Cambridge Commons Drive, became ill March 24 but wasn’t diagnosed until April 7 after he was hospitalized. The Health Department learned of his illness Wednesday, according to Health Director Dr. Marcus Plescia.

Monday, April 7, 2014

Whole Genome Sequencing - A Food Safety Game Changer

A new tool is going to have a huge impact on food safety - whole genome sequencing.  Whole genome sequencing is a laboratory process that determines the complete DNA sequence of an organism's genome at a single time.

Using this tool, investigators can tell whether an organism found in a food is the same organism that caused the illness.  In the past, investigators looked a fragmentation patterns on a gel (PFGE) or looked for certain genetic markers.  But with whole genome sequencing (WGS), they can tell, whether an organism is the same, down to a DNA base pair comparison in the whole genome, which for bacteria, is in the range of 4 million base pairs

This tool has already been used in determination that cheese was responsible for a Listeria outbreak.
Twenty years ago, sequencing the whole genome of a living organism was a monumental undertaking, but within the last 10 years, the development and commercialization of the process, has dramatically improved the price and drastically decreased the time needed.  Now, this tool is available for investigators to definitely determine the bacteria involved in outbreaks.
Experts decode germ’s DNA to fight food poisoningBy LAURAN NEERGAARD / AP Medical Writer / April 7, 2014

WASHINGTON — Chances are you’ve heard of mapping genes to diagnose rare diseases, predict your risk of cancer and tell your ancestry. But to uncover food poisonings?

The nation’s disease detectives are beginning a program to try to outsmart outbreaks by routinely decoding the DNA of potentially deadly bacteria and viruses.

The initial target is listeria, the third-leading cause of death from food poisoning and bacteria that are especially dangerous to pregnant women. Already, the government credits the technology with helping to solve a listeria outbreak that killed one person in California and sickened seven others in Maryland.

“This really is a new way to find and fight infections,” said Dr Tom Frieden, director of the Centers for Disease Control and Prevention. “One way to think of it is identifying a suspect by a lineup or by a fingerprint?”

Whole genome sequencing, or mapping all of an organism’s DNA, has become a staple of medical research. But in public health, it has been used more selectively, to investigate particularly vexing outbreaks or emerging pathogens, such as a worrisome new strain of bird flu.

Black Peppercorns Recalled Due to Potential Salmonella Contamination

Sprout Farmers Markets and Frontier Organic Spices are recalling containers of black peppercorns after random testing completed by FDA came up positive for Salmonella.  The pepper was reportedly treated (steam pasteurization) and then tested before use by Frontier.  No illnesses have been reported.
So what questions could be asked?
  • Did the steam pasteurization step perform to the level needed to eliminate Salmonella?  One could at microbial test results for other indicators such as generic E. coli, coliforms, and even APC?  Also, it is important to conduct large sample testing of the peppercorns from this and other lots.
  • Was the product potentially contaminated after the processing, perhaps during handling and repackaging?  Are potential sources of contamination also handled within the peppercorn processing environment?  Is environmental testing done, and hopefully if so, did those results indicate any issues?  It will be important for the facility to conduct extensive testing of the processing environment including preoperational and in-process testing looking for Salmonella as well as indicators (coliforms and/or Enterobacteriaceae).
  • Did the laboratory complete the verification testing correctly? 
  As we know, Salmonella can survive in dry environments (and products) for long periods of time.

FDA Recall Notice
Frontier Natural Products Co-op Initiates Voluntary Class 1 Recall Due to Possible Health Risk from Organic Black Peppercorns
FOR IMMEDIATE RELEASE - April 4, 2014 - Frontier Natural Products Co-op is voluntarily recalling several of its products manufactured with organic black peppercorns that were sold under its Frontier and Simply Organic brands, Whole Foods Market 365 Everyday Value, and others due to potential Salmonella contamination. To date, no illnesses have been associated with these products.

Chicken Nuggets Recalled Due to the Potential for Contamination by Small Pieces of Plastic

Tyson is recalling 75,000 lbs of chicken nuggets due to the potential to have small pieces of plastic.  It came to light after the company received numerous complaints.  It is believed the plastic pieces were the result of  a scraper inside of a blending machine.

To prevent such issues, it is important to have a good preventive maintenance program and good quality inspection program.

Tyson Foods recalls chicken nugget products for possible plastic pieces

Small pieces of plastic found in the chicken products resulted in some minor oral injuries.
By Alex Cukan | April 6, 2014 at 3:35 PM

SEDALIA, Mo., April 6 (UPI) -- Tyson Foods Inc. recalled more than 75,000 pounds of chicken nugget products that may be contaminated with small pieces of plastic and other extraneous materials.

The food company said it received consumer complaints that small pieces of plastic were found in the chicken products resulting in minor oral injury. The problem was traced to a product scraper inside a blending machine in the Sedalia, Mo., facility.

The recalled fully cooked chicken nuggets include:

Friday, April 4, 2014

Maintenance of Records Finalized in FSMA Regulation

The Establishment and Maintenance Rule become final for those companies in the U.S. who manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or animals, and foreign persons who transport food in the U.S.  Here is a simplified version of the FDA guidance to help you identify what you need to know about records needed for food operations.

Of course, this should already be in place, much having been required as part of the Bioterrorism Act of 2002.

What are the record availability requirements?

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, will cause serious adverse health consequences or death to humans or animals, any records or other information accessible to FDA must be made readily available for inspection and photocopying or other means of reproduction. These records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. 
The records may be kept in any format, paper or electronic, provided they contain all the required information.
The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.

Food Producers Push Back on FSMA's Feed Rule

A number of food producers, impacted by FSMA Animal Feed Regulation, have commented to FDA about the impositions that the regulation will make.

Many of the waste products generated by food processing plants, including grains generated by distillers, will be subject to the feed regulation because these products are fed to animals.  The concern is that the producers will have to absorb additional costs to implement additional food safety controls over their waste streams.  And in reality, there have been really no issues to support the need for this level of control.
For many, it may come to the point where it is more cost effective to dump rather then use these items for feed.  From a sustainability standpoint, this is not the way to go.  The regulation needs to written that makes it easy, yet safe, for producers to continue to use their waste streams, when appropriate, as a source of animal feed.

The Safety of Nutritional Supplements

An article in the New England Journal of Medicine warns about the dangers of nutritional supplements.  There is an increasing market of supplements, and unfortunately, the system for ensuring the safety of those supplements is inadequate.

These supplements are marketed to people looking to loose weight, to be more energetic, or to be less depressed, however, there have been instances where these supplements have been deadly or caused severe damage including liver failure.  Many of us buy into the notion that a pill can fix our issues.

We also overuse many of our normal vitamins and supplements often without the scientific evidence to support such claims.  In some cases, overuse can do more harm than good.

In a related case, there are parents who look to improve the health of their children through 'juicing'.  An article in Medical Daily shows there is a trend for children to take 'detox juice blends".  What works in adults may not be as good for children.

New England Journal of Medicine
Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements

Pieter A. Cohen, M.D.

N Engl J Med 2014; 370:1277-1280April 3, 2014DOI: 10.1056/NEJMp1315559

Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA's ability to detect dangerous supplements.

The 2007 Peanut Butter Salmonella Outbreak - Criminal Investigation Still Ongoing

The Peter Pan Peanut Butter Salmonella Outbreak is a great case study in how Salmonella can contaminate a low moisture, ready-to-eat food.  In this case, CDC reported indicated over 400 cases  linked to peanut butter that had become contaminated due to "inadvertent moisture got into the production process", or a leaky roof.

Although this case is seven years old, it is not over yet for the parent company, ConAgra.  According to a story in the Atlantic Business Chronicle, the plant underwent an investigation in 2011by the Justice Department for criminal wrongdoing.  The company and the US Attorney's office are still in negotiations regarding the investigation, where it is possible that this "will likely involve a misdemeanor criminal disposition under the Food, Drug & Cosmetics Act."

The Chronicle reports that the company has spent $25 million in connection to the investigation.  This is in addition to the 10's of millions spent on upgrading the plant and the 50 to 60 million for the recall itself.  And of course there is the loss in sales over that time period.

Atlantic Business Chronicle
2007 peanut butter recall hanging over ConAgra

David Allison
Editor- Atlanta Business Chronicle
Apr 1, 2014

Seven years after a recall of peanut butter made at a Georgia plant, federal investigations are still hanging over the head of ConAgra Foods Inc.

Thursday, April 3, 2014

British Study Shows Organic Unlikely to Reduce Risk for Cancer

The British Journal of Cancer published an scientific study that indicates women who eat organic foods do not reduce the risk to develop cancer when compared to women who eat a more conventional diet.

British Journal of Cancer
Organic food consumption and the incidence of cancer in a large prospective study of women in the United Kingdom

K E Bradbury1, A Balkwill1, E A Spencer2, A W Roddam3, G K Reeves1, J Green1, T J Key1, V Beral1 and K Pirie1 The Million Women Study Collaborators4

1Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK
2Department of Primary Care and Health Sciences, University of Oxford, Oxford OX2 6GG, UK
3Worldwide Epidemiology, GSK, Uxbridge UB11 1BT, UK
Correspondence: Dr KE Bradbury, E-mail:
4Members of the Million Women Study Collaborators are listed before References.
Received 3 December 2013; Revised 24 February 2014; Accepted 26 February 2014
Advance online publication 27 March 2014
Top of page


Organically produced foods are less likely than conventionally produced foods to contain pesticide residues.


We examined the hypothesis that eating organic food may reduce the risk of soft tissue sarcoma, breast cancer, non-Hodgkin lymphoma and other common cancers in a large prospective study of 623 080 middle-aged UK women. Women reported their consumption of organic food and were followed for cancer incidence over the next 9.3 years. Cox regression models were used to estimate adjusted relative risks for cancer incidence by the reported frequency of consumption of organic foods.


At baseline, 30%, 63% and 7% of women reported never, sometimes, or usually/always eating organic food, respectively. Consumption of organic food was not associated with a reduction in the incidence of all cancer (n=53 769 cases in total) (RR for usually/always vs never=1.03, 95% confidence interval (CI): 0.99–1.07), soft tissue sarcoma (RR=1.37, 95% CI: 0.82–2.27), or breast cancer (RR=1.09, 95% CI: 1.02–1.15), but was associated for non-Hodgkin lymphoma (RR=0.79, 95% CI: 0.65–0.96).


In this large prospective study there was little or no decrease in the incidence of cancer associated with consumption of organic food, except possibly for non-Hodgkin lymphoma.


organic food; cancer; cohort; women

Tuesday, April 1, 2014

Changing an Establishment's Name Does Not Rid a Facility of Listeria

A Brooklyn fish processing plant was ordered to shut down due to Listeria....Listeria that never seemed to go away, even after the established changed ownership.  However, according to this report, the new and old ownership failed to take sufficient corrective actions.

We have seen in numerous cases, that once Listeria gains a foothold in a facility, the best you can do is control it...and that takes a lot of work.  According to a prominent lawyer website report, FDA had found Listeria in the facility 48 times over a 6 year period...presumably the same strain.

Even used equipment can harbor Listeria for years.  To rid used equipment of Listeria,  intense detail cleaning is needed.  For a plant, detailed cleaning to the point of pathogen free can be a bit more difficult (drains, cracks in floors, etc).

Listeria is not the only pathogen that can be a problematic environmental pathogen.   In 2008, Mars Pet Food closed a facility after a restart failed after two recalls due to Salmonella.  It will be interesting to see if after the Sunland Food plant purchase, whether that facility will have ongoing issues.

Daily News
Judge shuts down Brooklyn fish processing plant
A federal judge has ordered the shutdown of Brooklyn fish processing plant New York City Fish, which has been plagued for years by life-threatening Listeria bacteria.
BY John Marzulli 


Monday, March 31, 2014, 1:10 PM

A federal judge has ordered the shutdown of a Brooklyn fish processing plant that has been plagued for years by life-threatening Listeria bacteria.

Judge Roslynn Mauskopf stuck a harpoon in New York City fish, granting the government's request for a permanent injunction against the plant located on Chester St. in Brownsville, which distributes smoked salmon, mackerel and herring.