FDA's Proposed Rule on Prevention of Intentional Contamination (Food Defense)

On December 20, 2013, FDA rolled out the proposed rule on food defense – Proposed Rule for Protecting Food against Intentional Adulteration. In this rule, facilities will need to develop and implement a food defense plan. In doing this, they will identify any actionable process steps and implement mitigation strategies that will protect food from intentional contamination.

 

Of the FSMA sections proposed thus far, this is one that should receive sufficient debate. Requiring facilities to have a written food defense plan is one thing, but the sticking points will be on enacting mitigation strategies for actionable steps is where there can be some controversy. Adulteration is a low risk event, so how much resources should a facility commit to putting in control measures. And there can be significant difference of opinions on which steps truly represent a risk, and then which control measures should be used for those steps.

 

For example, a facility may have a bulk mixing tank. People who work in the facility may not see any significant risk due to the fact that it is out in the open and only employees have access. But from the CARVER analysis, this process step was deemed the highest risk area within the facility. The facility management may not think that further mitigation is needed, outside of limiting visitors in the facility. But an inspector may want more control, like a cover (which would making cleaning difficulty), a gate to limit access (not practical if the batch operator has to constantly access the batch area), or hire an extra employee for two batch operators. Maybe all would be suggested.

 

In doing a Food Defense Plan, there are a number of factors that come into play in preventing adulteration in a facility. But a motivated assailant can pose a risk to even the most secure facilities. So in the case of the mix tank, what if a subversive terrorist was hired, what if they paid an employee millions of dollars, what if…..

 

So it is important that facility management and regulatory inspectors understand the true risks associated with intentional adulteration and that resources be judiciously applied. Otherwise, the ‘what ifs’ that can be posed the security of any operation or any process can get way out of hand and pose a significant financial burden to the facility, or create a bigger food safety risk.

 

 

Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

 

Link to the proposed regulation.

http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1425-0002

 

 The Link to the proposed rule website.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#summary

 

Here are a few sections from that summary page:

 

Summary

 

FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Modernization Act, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.

 

The FDA is proposing that the requirements be effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size. The proposed rule was published on December 24, 2013, and comments are due by March 31, 2014. The FDA will hold a public meeting on February 20, 2014, to explain the proposal and provide additional opportunity for input.

 

MMWR case study- Staph enterotoxin outbreak from food served at office party

In the Dec 20th edition of MMWR, a case study of a 2012 incident of staphylococcal enterotoxin poisoning is presented. The outbreak occurred at a military base where 13 individuals were admitted to the hospital after eating contaminated perlo (a chicken, sausage rice dish). According to the report, the 22 individuals became ill 2 to 3 hours after eating at a work lunch party. Symptoms included nausea, vomiting and diarrhea. While there were a number of dishes served, the investigation determined the perlo was the culprit. This item had been prepared the previous day, kept warm in an unheated oven overnight (8 hrs), and then reheated the next day.

Staphylococcus is commonly found on people and can contaminate food when properly handled. However, the key factor in this case was the temperature abuse, in this case, holding the food overnight in the unheated oven. During this time at the elevated temperature, the organism grows and produces the heat stable enterotoxin that is not destroyed during reheating. When the contaminated food is eaten, symptoms are usually seen within a few hours. If the perlo had been properly cooled, the organism would not have grown and would not have formed the toxin.

Keep this story in mind as you attend the various holiday parties this holiday season. It will make you wonder about who cooked each of the dishes and how good their food safety practices are.


 Outbreak of Staphylococcal Food Poisoning from a Military Unit Lunch Party — United States, July 2012
Weeklyhttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm6250a2.htm?s_cid=mm6250a2_e
December 20, 2013 / 62(50);1026-1028


On July 30, 2012, the emergency department at a military hospital was visited by 13 persons seeking care for gastrointestinal illness with onset 2–3 hours after a work lunch party. The hospital responded by opening up temporary evaluation and treatment capacity in primary-care clinics and a progressive-care unit and by diverting one patient to a local civilian hospital. An immediate outbreak investigation was conducted by local military public health personnel with assistance from CDC. Initial epidemiologic analysis implicated "perlo" (a chicken, sausage, and rice dish) and bacterial intoxication as the outbreak mechanism. This enabled public health personnel to 1) recommend no further consumption of perlo and 2) reassure appropriate authorities that no additional ill persons likely would be seeking care and advise that nothing more than supportive care of ill persons likely would be required. After interviewing party attendees, investigators found nine additional persons who met their case definition. Subsequent CDC laboratory analysis of a sample of perlo detected staphylococcal enterotoxin A, supporting the epidemiologic findings. Improper food handling and preparation measures were identified and addressed by the appropriate authorities, who provided additional detailed education on food preparation safety for the persons who prepared the meal.

Epidemiologic and Environmental Investigation

Consumer Reports Chicken Report - Fear your chicken or Cook your chicken

Consumer Reports has just released a report on the safety of chicken, “The High Cost of Cheap Chicken”. This report is bound to get a lot of airplay.

There is little dispute over the fact that chicken can contain pathogenic bacteria…in fact, USDA on-going testing shows similar numbers. And while this report deals out some harsh treatment of your common grocery store chickens, it is important to note that even small farmed raised chicken can have pathogenic bacteria. In the Penn State study by Dr. Cutter and Josh Scheinberg where farmers’ market chicken were found to have a high prevalence of pathogens .

The CR report does point out good information: 1) no type/brand of chicken tested was really any better than any other in terms of the prevalence of pathogenic bacteria, and 2) that it is important for people to properly handle and prepare their poultry. This includes cleaning of surfaces that may have come in contact with raw poultry or their juices and that poultry be properly cooked to a temperature of 165ºF or higher.

But in this report, as well as in the mass media reports that followed, there is there over-the-top titles or commentary that will cause confusion among consumers. In the Chicago Tribune, there is “Superbug bacteria widespread in U.S. chicken: consumer group” and in Huffington Post, “Half of Supermarket Chicken Harbors Superbugs, Consumer Reports Finds”. Superbugs in my chicken…OMG!. The term ‘superbug’ is a loosely used term that generally is applied to organisms that are resistant to multi-antibiotics. The biggest concern for multi-antibiotic resistance organisms is in hospitals, where they can cause severe infections especially during surgery. But many of these species have not been shown to be a concern in food, outside of Salmonella. Antibiotic resistance is nothing new….it has been found in microorganisms that have never been exposed to antibiotics, so superbug status could have been applied to organisms long before antibiotics were used by people. And just having resistance to a few antibiotics is not as important as to which antibiotics the organisms are resistant. So the study, which is not a scientifically peer reviewed research (as far as we can tell), does not provide detail on these particulars, but rather throws out a generalized number that is latched on by the media without providing any qualifiers. So this nebulous term ‘superbug’ used in these reports does not advance the understanding of the general public, but rather serves to grab headlines through fear.

This is not to say that antibiotics should be used judiciously for animals. In fact the FDA is looking to put tougher restrictions on antibiotic use in food producing animals. As many farmers will point out however, antibiotic use is a lot lower than portrayed in the news media.






So yes, chicken can contain pathogenic bacteria. That is why it is important to properly handle it as well as cook it.

Deer hunters, be sure downed animal was healthy before eating venison

November 22, 2013

 
UNIVERSITY PARK, Pa. -- Food-safety specialists with Penn State's College of Agricultural Sciences annually issue warnings to deer hunters to keep food safety in mind if they are fortunate enough to get a buck or a doe, and this fall is no exception.

However, this year because of the discovery of chronic wasting disease in wild Pennsylvania deer, they are cautioning hunters to be sure their animal appears healthy.

Chronic wasting disease -- often called CWD -- is a chronic, degenerative neurological disease affecting the central nervous system of animals such as deer and elk. The disease has been moving east in recent decades.

"In the past year, three free-ranging deer harvested by hunters in Blair and Bedford counties were found to have the disease," said Martin Bucknavage, senior food safety extension associate in the college's Department of Food Science. "While there is no evidence that supports CWD being linked to human illness, the U.S. Centers for Disease Control and Prevention does recommend against eating meat from deer infected with the disease."

Bucknavage noted that it is best to take precautions, such as making sure the deer you killed appears to have been healthy, and to follow best practices for handling and processing deer, such as wearing rubber gloves and minimizing contact with brain and spinal cord material.

"While the risk of CWD is very low, hunters need to focus on the overall safety of the meat. This starts from the time the deer is downed until it is processed and cooked for eating," he said.

"Each year we hear stories of people who get sick a day or two after getting a deer, most often from cross contamination, the result of not handling the raw meat properly."

Bucknavage urges hunters to do the following:

-- Carry a pair of rubber gloves with you when hunting and then be sure to wear them when field dressing the deer.

Deer carry pathogenic bacteria, and so precautions are needed to prevent cross contamination, he pointed out. "Whether you get blood on your hands or clothes or not, be sure to wash thoroughly in soap and water after handling the carcass or the meat."

-- Eviscerate the animal as soon as possible. This helps the carcass dissipate heat and removes internal organs where spoilage can occur more quickly.

Be sure to avoid cutting into the internal organs, especially the intestines. There are large numbers of bacteria -- including pathogenic bacteria -- in the intestines. "Tie off the anus," he said. "This can be done with a string or rubber band."

-- Evaluate the internal organs of the deer during field dressing. If any of the internal organs smell unusually offensive, or if there is a greenish discharge, black blood or blood clots in the muscle, do not consume the meat.

"If you kill a deer and question the safety and quality of the meat, immediately contact the Pennsylvania Game Commission," Bucknavage said. "The agency has policies for authorizing an additional kill."

-- The brain, spinal cord, spinal column and lymph nodes of deer are considered high risk for CWD, so avoid cutting into those tissue when butchering. If possible, hang deer by hind legs with head down when aging or butchering.

"Most cattle and livestock processed in this country are hung with the head down," Bucknavage said. "That prevents brain and spinal fluids from contacting the meat."

-- Remove all visible hair, dirt, feces and bloodshot areas from the internal cavity. Wipe the inside of the body cavity with a dry cloth or paper towel. If you rinse the cavity, be sure to dry thoroughly. Excess moisture will encourage bacterial growth.

-- Be sure to clean residues from knives and equipment, then sanitize with a chlorine bleach solution. It is wise to carry sanitary wipes with you to clean knives in the field.

If the outside temperature is greater than 40 Fahrenheit (F), you can help to chill the carcass by inserting plastic bags of ice or snow into the body cavity. Once out of the field, get the carcass into a cooler or refrigerator as soon as you can. If the temperature is below 40 F, prop open the cavity with sticks to promote cooling.

Don't tie the deer to the hood of your car. This will serve only to heat the carcass.

Because of the possibility of pathogens on the meat, such as E. coli O157:H7 and Salmonella, it is important to properly cook the meat to a minimum internal temperature of 160 degrees F or higher before eating.

The USDA guidelines are available online through Penn State's Food Safety website. The Department of Food Science offers hunters a wealth of information on the preparation of wild game from the field to the table.

The Field Dressing Deer Pocket Guide explains how to field-dress a deer safely. Extensively illustrated in full color, it explains the process of field dressing and also covers important food-safety information for hunters. See it online.

http://news.psu.edu/story/296308/2013/11/22/deer-hunters-be-sure-downed-animal-was-healthy-eating-venison

Updates on Sliced Apple Recall, Jensen Brother Lawsuit against Auditors, and Foster Farm Salmonella Outbreak

Here are some quick updates of food safety issues of ongoing food safety issues.

Sliced Apple Recall Due to Listeria - As reported by the Packer (link/story below) FDA did not find any deficiencies at the sliced apple facility that produced the pack of apple slices that tested positive for Listeria. Further, samples taken by FDA and the state were all negative. This indicated either a very low level contamination on the product. Or, should it be considered that there was the potential for lab error at the state lab?
Jenson brothers and Lawsuit Against Auditing Firm – The Packer (link/story below) is reporting that the Jensen’s have signed over a lawsuit they filed against Primus Labs to the victims. It is probably easier for the victims to extract money from the auditing firm that it is for the convicted brothers.

Foster Farms outbreak of Salmonella – CDC is reporting (link/story below) that as of November 15, 2013, a total of 389 persons infected with seven outbreak strains of Salmonella Heidelberg have been reported from 23 states and Puerto Rico. USDA did not push for the company to conduct a recall.

Don't overlook safe turkey-handling practices for a happy holiday

Penn State News - November 20, 2013
http://news.psu.edu/story/295976/2013/11/20/dont-overlook-safe-turkey-handling-practices-happy-holiday

 UNIVERSITY PARK, Pa. -- Thanksgiving is a time for sharing: good food, family time, friendship and memories. But one thing you don't want to share, warns a food-safety expert in Penn State's College of Agricultural Sciences, is pathogenic bacteria.

"As you prepare your Thanksgiving dinner, it is important to remember some key food-safety rules when it comes to cooking and serving turkey," said Martin Bucknavage, extension food-safety specialist. "We don't want to spread pathogenic bacteria, such as Salmonella and Campylobacter."
He offers some advice to keep cooks, helpers and guests safe when preparing a turkey:

--There is no need to wash the outside of your turkey. Proper cooking will take care of any pathogenic bacteria that may be present.

"The only thing you will achieve by washing the outside of the turkey is spreading bacteria in your kitchen. This can occur as the water splashes or drips across your kitchen counter, potentially carrying bacteria with it," Bucknavage said.

--Clean as you go when handling raw turkey.

"As people move the raw turkey around in the kitchen, they treat it more like a football than a raw piece of meat, in that it touches a lot of surfaces including the hands," he said. "Because of this, there is the potential to get pathogenic bacteria on our hands, on the counter and on the cutting board. Therefore, clean these surfaces immediately after coming in contact with the raw bird."

-- Cook it to the right temperature. UDSA suggests that the bird gets to at least 165 F, (best if over 172 F for chewing). So Bucknavage recommends the use of a thermometer to monitor the temperature.

"Check the temperature of the bird in a number of spots, including the breast meat and the thickest part of the thigh," he said. "Allow time for further cooking if the temperature is not met."

-- Cook your stuffing separately. If you stuff the bird, the temperature of the stuffing must also get to 165 F.

"In order to get the stuffing to the right temperature, the bird will reach much higher temperatures, often over 185 F, making it very dry. Too often, people will stop cooking once the bird is at the right temperature, but unfortunately, they end up having undercooked stuffing," Bucknavage said.

"Because this stuffing was inside the raw bird, it absorbed turkey juice potentially carrying pathogenic bacteria such as Salmonella and Campylobacter. Undercooking the stuffing lets those bacteria survive. It is much better, and safer, to cook them separately. You will get the right temperature in the turkey without having to overcook it, and you'll get the right temperature in the stuffing."

If you want the look of a stuffed turkey on your table, stuff it before serving, after both have been properly cooked, he advised.

-- Handle leftovers immediately after dinner. Do not allow the turkey to sit on the table for hours after everyone is done eating.

"Bacteria such as Staphylococcus aureus can grow on meat items if left out for a long period of time," Bucknavage said. "To prevent that from occurring, it is important to handle leftovers right away. Cut up the turkey, put it in a container or sealable bag, and then refrigerate or freeze."

Sliced Apples Recalled Due to Potential for Listeria After State Lab Finds Positive Sample

A Washington state company is recalling sliced apples due to the potential for Listeria contamination. The contamination was discovered by testing conducted by Minnesota Health Department. A sample tested was found to be positive for Listeria monocytogenes.

There have been no know Listeria outbreaks associated with sliced apples, however sliced apple product had been recalled in the 2012. Perhaps this is why MN Dept. of Health decided to pull this sample…perhaps it was just somebody pulling samples. Was the level of contamination significant? Studies have shown that Listeria can survive on apples and that it has grown on sliced apples when that product was temperature abused.

How we view risk of an item may not be constant over time.  This was the case with cantaloupes, where Listeria was probably not on the radar of those conducting a risk analysis, until the Jensen related outbreak in 2011. And so now for companies packing fresh apple slice, they too will need to include Listeria as part of their hazard analysis, and with this, they will need to implement environmental control measures in the processing environment.


The Packer
Crunch Pak recalls apple slices
http://www.thepacker.com/fruit-vegetable-news/Crunch-Pak-recalls-apple-slices-232066161.html

 11/15/2013 10:10:00 AM  Coral Beach

Possible listeria contamination spurred Crunch Pak, Cashmere, Wash., to voluntarily recall almost 5,500 cases of apple slices that had been distributed nationwide.

A random sample of a 14-ounce package of Crunch Pak brand Tart Apple Slices that was collected by the Minnesota Department of Agriculture tested positive for listeria monocytogenes, according to Crunch Pak spokeswoman Amy Philpott.

FDA Issues 2013 Food Code

The FDA issued the new 2013 Food Code, the model for handling and preparation of food offered to consumers. This model establishes the most up-to-date food safety practices based on current scientific thinking The Food Code applies to retail and foodservice operations and the agencies who inspect those facilities. The food code is adopted in full or in part the states and local jurisdictions in developing their own regulations. Pennsylvania adopts the entire Food Code as it is updated. The Food Code is also used by the food processing industry in that it provides support documentation for practices used within FDA food operations (cooking, cooling, etc). Click here for summary of changes.

There are only a few significant changes from the 2009 version, however there are many minor changes that update the language of the previous version.

• Language changes include:

o PHF or Potentially Hazardous Food is now Temperature Control for Safety Food (TCS), and the Potentially Hazardous Foods is completely eliminated.

o Defines Shiga Toxin Producing E. coli (STEC) to include all E. coli that are capable of producing Shiga toxin. 

• One of the biggest changes is the inclusion of non-typhoidal Salmonella in the list of reportable illnesses. In the past versions, from all the Salmonella species, only the highly contagious Salmonella typhi was considered in the list. So now all species of Salmonella that cause illness are reportable, and thus require to be addressed in employee health controls (exclusion from the operation, return to work requirements, etc). (In Annex 3 – Table 2-20112 provides a table on exclusion and return to work for this and the other reportable pathogens).
• A section was added to provide provisions for refilling containers brought from home from refill. (Of course, this would cover the refilling of growlers).
• Section 3-501.11 requires that frozen fish package in ROP packaging be removed from that packaging PRIOR to starting the thawing process.
• With regard to ROP packaging - All TCS foods packaged in ROP packaging require a HACCP plan, but only TCS food that is ROP packaged that do not control for growth of and toxin formation by C. botulinum and growth of Listeria monocytogenes needs a variance. Note that ROP packed non-TCS foods are not included (so if one is vacuum packing hard candy or dried beans, no requirement for a HACCP plan...outside of FSMA).
• More on ROP Packaging - Section 3-502-12 Reduced Oxygen Packaging without a Variance – Criteria - this whole section discusses ROP packaging and should be referenced by anyone who is planning to vacuum pack product. Additional support information is provided in Annex 3 - Section 3-502-12 . Along with 3-502-12, section 8-201.14 requires the permit holder to submit a properly prepared HACCP plan before engaging in processing Reduced Oxygen Packaging foods.

In FDA's Constituent Update, there post some additional changes.
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm374979.htm
These include

• Restaurants and food stores must post signs notifying their customers that inspection information is available for review.
• Revisions to the minimum cooking temperatures associated with procedures such as non-continuous cooking and circumstances under which bare-hand contact with ready-to-eat foods is permitted.
• Stronger requirements for cleaning and sanitizing equipment used in preparing raw foods that are major food allergens.

Baby Food Pouches Recalled Due to Spoilage Issues

Plum Organics, a California company, is recalling its baby food pouch products due to the spoilage issues. The reason for the spoilage was blamed on a manufacturing issue and resulted in swollen pouches. The product has national distribution including distribution through outlets such as Target. 

While this is not claimed to be a pathogen issue, eating spoiled product can still result in gastrointestinal distress (diarrhea, stomach pain, etc), which can be especially troublesome in infants and preschool-aged children. 

Looking at the variety of products in pouches, there may be some difficulty in determining which pouches are affected. Click here for a listing / pictures of the affected products.

The company also issued a recall in 2009 when it was determined the proper acidity was not achieved thus resulting in a Clostridium botulinum risk. 

Plum organics is a subsidiary of Campbell Soup Company.


FDA News Release
Plum Organics Voluntarily Recalls a Range of Pouch Products
http://www.fda.gov/Safety/Recalls/ucm374393.htm

Contact:
Consumer:
Plum Organics Consumer Hotline:
866-495-3774

Media:
Kara Flynn
Plum Organics
202-821-3888
press@plumorganics.com

 FOR IMMEDIATE RELEASE —November 8, 2013 – Plum Organics is voluntarily recalling pouch products within its Baby Stage 2, Tots Mish Mash and Kids lines after discovering a manufacturing defect that may cause spoilage in some pouches. Recalled products can be identified by the “Best By” dates ranging from 08/05/14 to 12/08/14 and the letters “AT.” Consumers can find a list of affected products at www.plumorganics.com/Nov13Recall.pdf1.