Monday, August 29, 2016

Improving Knowledge of Antibiotic Resistance - What You Should Know

This month's Food Protection Trends has an article by a group of experts on the topic of antibiotic resistance and the impact on human and animal health.  The goal was to provide knowledge to professionals in an way to counter the many misstatements being made in the news media by uninformed 'professionals.'

First, there are four main themes that should highlight communications:

Saturday, August 27, 2016

Packages of Cut Fresh Vegetables Recalled Due to Listeria Positive Sample

A Texas firm is recalling various fresh diced and sliced vegetables after the Georgia Department of Agriculture sampled product and found it was positive for Listeria monocytogenes.  The date range for production lots recalled is about two weeks with use by dates from 8/7 to 8/19/16. At this point, no illnesses have been reported.

The reason for the broad range of items is that there must be concern for cross contamination in the facility.  Being that there are sliced and diced vegetables, the equipment used for processing, the cutting equipment, the flume lines for transferring, and the packaging equipment can be areas for cross contamination or even be a harborage site for the organism if it was not properly cleaned.

FDA Recall Notice
Country Fresh Recalls Product Because Of Possible Health Risk
For Immediate Release
August 26, 2016

Friday, August 26, 2016

FSMA Compliance Date Schedule - September 18th for General Compliance

FDA's FSMA compliance dates are nearing.  Take a few minutes to review to see if you are where you need to be.

Source - GMA website

*Farms have an additional 2 years to comply with certain water-related requirements. Separate compliance date applicable to sprouts.

**PC Human: Supply Chain Program general compliance is (1) 3-17-17 (9-18-17 for small business) OR (2) six months after a supplier is required to comply with the applicable rule. PC Animal: Supply Chain Program general compliance is (1) 9-18-17 (9-17-18 for small business) OR (2) six months after a supplier is required to comply with the applicable rule.

†All importers must comply with FSVP requirements by 5-30-17 OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later. “Very small importers” and “importers of food from very small foreign suppliers” are subject to modified requirements.

‡ 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA.

EpiPen Price Hike Impacts People with Food Allergies

EpiPens, those self-given injection needles to prevent allergic reactions, have gone up in price to over $600 for a set of pens..  Even with insurance, the price can be as much as $200 to $300 per set.   And considering these pens have a limited shelf-life of a year, this is a reoccurring cost.

EpiPens deliver epinephrine, a drug that slows the symptons of the immune response such as swelling.  In those people that are highly allergic to an allergenc such as peanuts or crustacean shellfish,  swelling of body tissue including the throat can be life threatening.  So these folks need to carry EpiPens.

NY Times
EpiPen Price Rise Sparks Concern for Allergy Sufferers
By Tara Parker-Pope and Rachel Rabkin Peachman August 22, 2016 6:05 pm August 22, 2016 6:05

A steep increase in the price of the EpiPen, a lifesaving injection device for people with severe allergies, has sparked outrage among consumers and lawmakers who worry that parents won’t be able to afford the pens for children heading back to school.

Frozen Chicken Entrees Recalled Due to Foreign Material

Another recall due to consumer complaints on foreign objects in product.   In this case, a GA company is recalling chicken entrees with glass or hard plastic.

FSIS Recall Notice
Sentry Foods Recalls Frozen Chicken Entrées due To Possible Foreign Matter Contamination
Class II Recall 074-2016

Thursday, August 25, 2016

Warning Letter Issued to Facility with Recurring Strain of Listeria

Jeni's Splended Ice Cream was issued a warning letter by FDA.  Basically FDA inspected the firm in January, and during that inspection, they found 2 of 75 swabs positive for Listeria.  Both positives were from the floor - non-food contact surfaces.  They also found two GMP issues - 1) "our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored." and 2) observed an employee in the prep room placing  “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers.

Now, it is important to point out that an inspection had been done the previous year and that the 2 GMP violations were previously noted.  More impactful however, is that during that 2015 inspection, FDA had found 20 samples positive for Listeria.  It is also important to note that this audit had been done as a result of a state laboratory finding Listeria in a product sample.

Further, the Listeria was the same strain in all samples "Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015".  (Associated Recall)

So while the firm conducted corrective actions  (conducted a voluntary recall of ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers in 2015, made changes in the production flow including no longer manufacturing finished ice cream, frozen yogurt, or sorbet on-site (instead just manufacturing frozen flavor bases that are shipped to co-manufacturers, and conducted training for employees), the same organism is still in the facility.
"The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism."
A few things to note:
1) This is a reason for facilities to consider using Whole Genome Sequencing (WGS) when they find Listeria in their facility.  Too often the assumption is that it is reentering the facility, but it may be worth determining if there is a resident strain.

2) Although this firm went to great lengths to escape the problem, including changing the products they make, they did not solve the fundamental issue of systematic contamination in the facility.  Although the facility findings were not huge or overly impactful, that issue still existed and resulted in further scrutiny .  WGS had an impact on how FDA evaluated this facility, and making marginal issues bigger than they should have been.  Including finding 2 samples of Listeria in the facility.

3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..

4) This points out the long term impact of finding product in the field positive for Listeria.  It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.

5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage.  Below is an article in the Wall Street Journal countered by an article in Columbus Business First.

Supermarket's Communication on Food Recalls Varies

A report published by CSPI shows that supermarket chain procedures for handling recall communications varies from chain to chain.  By regulation, stores are supposed to post information in a conspicuous spot for 14 days after the recall.  Not everyone is doing it the way they are supposed to be doing it according to this report.

Center for Science in the Public Interest
Supermarkets Do Uneven Job Notifying Consumers of Recalls

Acorns.......the New Old Superfood?

More people are looking for that food or pill that will improve health.  Well, instead of a cache of pills or some over processed beverage drink, let's consider eating what squirrels and bears eat....acorns.

In an review article in Comprehensive Reviews in Food Science and Food Safety, researchers found that the lowly acorn is chock full of healthful stuff.  In addition to a whole host of phytochemicals, acorns are a good source of fiber, protein, and vitamins A and E, and unsaturated fatty acids.

Wednesday, August 24, 2016

FDA Releases Draft Guidance on GMPs for Animal Feed

 FDA issued Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals "to help facilities that manufacture, process, pack or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks posed by some animal foods."

This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food and provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping.

FDA Issues Draft Guidance for Facilities Sending By-Products for Use in Animal Feed

FDA issued a draft guidance for food processing facilities that send their by-products for animal feed. For example, a company sending peels or rinds after processing produce, or a company sending over baked cookies to a hog farmer.  The following is the important sections from this draft guidance.

FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.
  • certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
  • for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
  • for certain facilities that color RACs.  
  • for facilities solely engaged in the ginning of cotton. 
  • for importation of food contact substances. 
  • for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.
The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.

Monday, August 22, 2016

Hepatitis A Outbreak Link to Frozen Strawberries from Egypt

The VA Department of Health issued a health warning about a cluster of hepatitis A cases and has identified a potential association with frozen strawberries used in smoothies from Tropical Smoothie Cafe restaurants in Virginia.  The frozen strawberries came from Egypt.

This is not the first time that frozen fruit sourced from the Middle East has been a problem for Hepatitis A.   In 2013, frozen pomegranate seeds were linked to a Hepatitis A outbreak  where over 150 were infected.  Smoothies are an issue because there is no elimination step such as heating.  Any contamination on the fruit gets blended into the drink.

Virginia Department of Health News Release
Health Officials Warn of Increased Hepatitis A Risk
August 19, 2016

Frozen Corn Recalled Due to Positive Listeria Results

A Lancaster, PA frozen food distributor is recalling frozen cut corn after the North Carolina Department of Agriculture tested samples of the corn and found them positive or Listeria.  The recall affects Laura Lynn, Key Food, and Better Valu brands.

No illness have been reported to date.

FDA Recall Notice
Cambridge Farms, LLC Recalls Three Brands Of Frozen Cut Corn Because Of Possible Health Risk
For Immediate Release
August 19, 2016

Friday, August 19, 2016

Curry Spice Recalled for Elevated Levels of Lead

A Miami, FL company is recalling approximately 377,000 lbs. of spice blends containing curry powder after testing found elevated levels of lead.  The testing was completed by the NY Health Department.
Two weeks back, turmeric was recalled because of elevated lead levels, also discovered by the NY Health Department laboratory.  Companies selling spices may want review their supply chain to see where there may be spices that are subject to high lead levels.
FDA Recall Notice
Oriental Packing Co. Inc. Issues Alert On Lead In Curry Powder
For Immediate Release
August 18, 2016

Wednesday, August 17, 2016

Hepatitis Outbreak in Hawaii Linked to Raw Scallops

Raw sea scallops served at a sushi restaurant in Hawaii are being blamed for over 200 cases of Hepatitis A.  This is one of the largest Hepatitis A cases in the US in the last 20 years.

While sushi grade seafood must be frozen in order to kill parasites, this freezing process will not eliminate bacteria and viruses. 

The scallops are reported to have been sourced from the Philippines.

Hawaii Dept of Health
DOH NEWS RELEASE: Hawaii Department of Health orders embargo of frozen imported scallops and closure of Genki Sushi restaurants on Oahu and Kauai

Thursday, August 11, 2016

Texas Firm Recalls Ground Meat Due to Complaint of Metal in Product

A Texas firm is recalling 60, 350 lbs of ground meat after a complaint was made from someone who found a piece of metal.  Unfortunately, the FSIS news release does not say what conditions, in addition to one complaint, were present to necessitate such a huge recall.  Were there more complaints logged in the companies consumer complain file, was there a non-conformance on metal detectors checks or grinder plate checks, or was there a noticeable metal issue in the facility?

Good reminder to have proper checks in place for metal.

FSIS Recall Notice
Sam Kane Beef Processors, LLC Recalls Ground Beef Products Due To Possible Foreign Material Contamination
Class II Recall 071-2016
Health Risk: Low Aug 10, 2016

Sunday, August 7, 2016

Alfalfa Sprouts Recalled After Linked to Salmonella Outbreak

Alfalfa sprouts from a Denver, CO facility have been liked to 30 cases of Salmonella infection spread over 9 states.  The company has issued a recall.

CDC Outbreak Notice
Multistate Outbreak of Salmonella Reading and Salmonella Abony Infections Linked to Alfalfa Sprouts
August 5, 2015

Friday, August 5, 2016

Cyclosporiasis Outbreak Reported in Texas

Texas is facing another outbreak of cyclosporiasis with 66 cases now reported across the state.  In 2013, a nationwide outbreak of cyclosporiasis resulted in over 600 becoming ill.  In 2015, cyclospora contaminated cilantro resulted in over 450 becoming ill.

The parasitic agent, cyclospora, contaminates produce through the use of contaminated water.  Symptoms last about a week or so and symptoms include watery diarrhea, with frequent, sometimes explosive, stools, and in general, just feeling like heck (tired, bloated, slight fever, etc).  It can be a much bigger issue for those with compromised immune systems.

NBC 5  Dallas Fort Worth, TX
Source: Cyclospora Found in North Texas Counties Likely Food Borne | NBC 5 Dallas-Fort Worth
Cyclospora Found in North Texas Counties Likely Food Borne By Frank Heinz

PA Distributor Recalls Frozen Green Beans Due to Listeria

A Pennsylvania distributor of frozen foods is recalling frozen green beans for Listeria.  The recall was issued after their customer, a manufacturing company, tested and found Listeria in the product. It appears that JBL is just a distributor, so there may be a bigger supply chain involved going back to the company that produced and/or packaged the product.  It appears from the expiration date that this product was packed last year, so could be linked to the CRF recall?

FDA Recall Notice
JML Ingredients Recalls IQF Cut Green Beans Because Of Possible Health Risk
For Immediate Release
July 22, 2016

Thursday, August 4, 2016

Warning Letter Issued to WA State Frozen Food Processor Responsible for Listeria Related Recall

FDA issued a warning letter in response to Oregon Food Company correction of inspection items as part of the Listeria recall of frozen produce.  A few things to note 1) the number of the issues the facility had in the inspection and the fact that they had a pretty big Listeria issue, and 2) their responses were rejected because while the facility addressed items they had to fix, they did not show that the fixes actually worked and that they implemented procedures for ongoing verification.  This is a good lesson in the issues that the plant faced, but also in how to, or how not to, respond to a FDA 483 report.
First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer).  These samples were linked via Whole Genome Sequencing to clinical isolates.  While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions."  So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.
On GMP issues, the facility was found to be not as clean as it should have been.  While the plant indicated it trained the employees, FDA found the response lacking.  ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."
The facility had many condensation issues, which is not good from controlling Listeria.  While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment."
The facility had poorly made food contact surfaces that would provide harborage.  While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "
In addition, there were steam ventilation issues and general facility issues.  Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.
FDA Warning Letter
Oregon Potato Company 7/15/16

Organic Cheese Products Recalled After Linked to E. Coli Outbreak

Grassfield Cheese Company is recalling organic cheese products sold in Whole Foods and its own store in MI after the product was linked to an E. coli STEC outbreak where 7 people become ill.  Product was shipped into the Southeast and Midwest.

FDA Recall Notice
Grassfields Cheese Recall Affects Select Whole Foods Market Locations; Grocer Recalls Product from Cheese Departments

Contamination Rates on Cucumbers, Hot Peppers, and Raw Milk Cheese from FDA Sampling

FDA released testing results for 3 commodity items they have been testing - Cheese made from raw milk and aged for 60 days, cucumbers, and hot peppers.

While the testing is still ongoing, the results they have to date:
Aged raw milk cheese - 1606 samples in 2014 and 2015, less than a one percent contamination rate for Salmonella, Listeria monocytogenes, E. coli O157:H7 and Shiga toxin-producing E. coli., and the overall contamination rate for generic E. coli was 5.4 percent.  (See chart below)

Hot peppers -  452 samples taken with 13 of those samples positive for Salmonella (2.8% ) and no samples were positive for STEC E. coli.

Cucumbers - 352 samples  taken with 3 of those samples positive for Salmonella (0.8%) and no samples were positive for STEC E. coli

Surprising...not so much for the produce.  Hot peppers and cucumbers grow near or on the soil and are subject to contamination from soil and animals such as birds.  Hopefully, and this is a good reminder, these items should be washed before consumption in order to reduce the risk. Peeling and other processing steps will also reduce or eliminate the contamination.  And it is also important to remember that just because the organism is there, it doesn't mean someone will get sick. Something the contamination is sufficiently low that a person's immune system will handle it, or the specific species found may not be overly virulent.

 As for cheese, this is going to be eaten as is, so this may be a bit more concerning.  Here, you are relying on the producing company to have good practices in place.  So raw milk cheese can be a risk, although low.

FDA News Release
FDA Shares Completed Survey and Data from Ongoing Sampling Program