Norovirus 2013 - Sydney Strain

Jeff Mullhollem, Penn State Live 2/1/13
http://live.psu.edu/story/64019
UNIVERSITY PARK, Pa. -- A new strain of norovirus, known as GII.4 Sydney 2012, is making the rounds this winter, causing a significant number of acute outbreaks. According to the U.S. Centers for Disease Control and Prevention, it has become the dominant strain, causing more than 140 reported outbreaks in the United States so far this year.

People should try to limit their exposure to norovirus and try to minimize its spread, advised an expert in Penn State's College of Agricultural Sciences.
"There are some important reasons that lead to so many people becoming ill from norovirus," said Martin Bucknavage, extension food safety specialist.

"One is this virus's low infectious dose. It is estimated that it may take less than 20 viral particles to make someone ill. Then, there is the ability of the virus to survive on dry surfaces for two weeks or more and in water for months."

The virus can be spread in contaminated food or water, from contaminated surfaces, directly from a sick person or from the intake of aerosolized droplets of vomitus. Norovirus is not related to the flu (or influenza), which is a respiratory illness caused by a different virus, and flu shots do not protect against it.

The main symptom of norovirus infection is another factor in its spread -- acute-onset vomiting.

"This prevents people from becoming sick in a secure location," Bucknavage said. "Rather, rapid onset can occur at a dinner table, in a meeting or on the bus. People usually become ill within 12 to 24 hours of exposure, although longer incubation periods do occur."

Once someone is sick, they can experience symptoms for 24 to 72 hours and can remain contagious for up to three days, Bucknavage noted.

"Because of this short incubation time, low infectious dose and ease of spread, one can see why it spreads through a school or a cruise ship so quickly," he said. "While rarely fatal, people who become ill need to be sure to consume liquids so they don't become dehydrated."

The key to preventing infection is frequent, but correct, hand washing -- scrubbing hands with soap and warm water. In addition, it is important for people to stay home when ill, especially when they may have been exposed to someone who has had the illness.

"They also should stay home for at least 48 hours after symptoms have subsided," Bucknavage said. "Contaminated surfaces must be cleaned using a strong chlorine bleach solution, one cup of bleach to one gallon of water. Cooking also will destroy the organism."

To learn more about norovirus, visit the Centers for Disease Control and Prevention website at http://www.cdc.gov/ncidod/dvrd/revb/gastro/norovirus.htm.

 

Salmonella from Hedgehogs and Other Pets

The poor hedgehog took a beating from the media as the poor critter was linked to 20 cases of Salmonellosis.
Hedgehog - http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6204a3.htm?s_cid=mm6204a3_w

 Hedgehogs are not the only pets that have been responsible for outbreaks. Many reptiles and amphibians have had past history of being a source of salmonella outbreaks.
Reptiles and amphibians - http://www.cdc.gov/Features/SalmonellaFrogTurtle/

 Turtles have caused a number of Salmonella outbreaks over time including last year.
Turtles - http://www.cdc.gov/salmonella/small-turtles-03-12/

Along with turtles, we have frogs, lizards, and snakes.
Frogs - http://www.cdc.gov/salmonella/water-frogs-0411/
Lizards - http://www.cdc.gov/mmwr/preview/mmwrhtml/00017445.htm
Snakes - http://wwwnc.cdc.gov/eid/article/12/2/pdfs/05-0692.pdf

Birds are another group of animals that also get flagged for causing Salmonella outbreaks. Both chicks and ducklings that are given as pets top the list.
Chicks - http://www.cdc.gov/mmwr/preview/mmwrhtml/00046940.htm
Ducklings - http://www.cdc.gov/mmwr/preview/mmwrhtml/00016299.htm

But there is also a link with the exotic birds, such as parrots and macaws. (My Dad had a macaw and that was one messy bird with regard to its watery poop).
Exotic birds - http://vdi.sagepub.com/content/7/2/270.full.pdf

Even feeding birds has its risk. Bird seed has been recalled because of Salmonella contamination.
Bird seed - http://www.fda.gov/Safety/Recalls/ucm325609.htm

And of course, wild birds can carry Salmonella. This is why it is important to maintain clean bird feeders.
Wild birds (including songbirds) - http://vetmed.tamu.edu/common/docs/public/schubot/SalmonellosisinWildBirds.pdf.
http://www.wildcarebayarea.org/site/PageServer?pagename=TakeAction_Salmonella_Outbreak

Pet rodents have been a issue, but in most cases, the animal will be ill from the Salmonella infection. That is, they are not as good as carriers when compared to reptiles.
Rodent pets such as guinea pigs - http://www.webmd.com/news/20050505/cdc-pet-rodents-can-carry-salmonella

Dogs and cats are generally not an issue unless it comes via their food.
Pet food - http://www.cdc.gov/salmonella/dog-food-05-12/vet-info.html
http://www.nwhc.usgs.gov/disease_information/other_diseases/salmonellosis.jsp
Regular pets - http://www.cdc.gov/salmonella/typhimurium/salmonella_pets.html

Petting zoos have a history of causing illness via cross contamination of Salmonella and STEC E. coli.
Petting zoos - http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5450a1.htm

Handwashing is among one of the many control steps for petting zoos.
Preventing disease in animal settings - http://www.cdc.gov/mmwr/pdf/rr/rr6004.pdf

Finally, we have this from CDC on reducing risk of Salmonella from animals.
Pets - http://www.cdc.gov/healthypets/diseases/salmonellosis.htm

CDC Report on Ciguatera Fish Poisoning in NY - 2010 to 2011

Wen discussing chemicals hazards in food, we often mention ciquatoxin, a natural toxin found in tropical predator fish such as grouper and barracuda. CDC’s MMWR (Feb 1, 2013), Ciguatera Fish Poisoning - New York, 2010-2011, is a case study that looks at 28 cases of ciguatera fish poisoning (CFP) in 28 individuals that occurred in a one year period, from August, 2010 to July 2011. 13 people became ill after eating barracuda, and 15 after eating grouper.

 

The toxin originates as a precursor in dinoflagellates (microalgae) which live in coral reef areas. These algae are eaten by smaller fish and the precursor toxin is converted to the toxic form. Predator fish such as barracuda, grouper, snapper, amberjack and surgeonfish eat these small fish, and over time, this toxin accumulates in the larger fish’s body. People eat these larger fish and then suffer the symptoms of CFP. “CFP is characterized by various gastrointestinal, cardiovascular, and neurologic symptoms. A prolonged period of acute illness can result, and the neurologic symptoms can last months, with variable asymptomatic and symptomatic periods.” Typical symptoms include diarrhea, abdominal cramps, dizziness, headache, faintness, nausea, vomiting and tingling in the extremities (fingers and toes).

Two interesting points made in this report:

• “CFP is considered a highly underreported illness, with only an estimated 10% of cases reported to health authorities (7). Increasing awareness among health-care providers might improve reporting and investigation. However, CFP prevention is complicated by difficulty in identifying high-risk fishing grounds and inadequate industry knowledge and compliance with the FDA seafood Hazard Analysis and Critical Control Point (HACCP) regulations.† Premarket testing of fish for CTX is not feasible because of the lack of rapid field methods and the sporadic distribution of toxic fish, even in endemic areas. Coordinated tracebacks of implicated fish by federal and state agencies to specific fishing grounds remains the primary strategy for managing CFP.”

• “This investigation demonstrates the value of CFP-implicated fish traceback along with updated information on emerging CFP risks, including new harvest areas and species. Prevention through education alone might be limited by seafood mislabeling.”

 

Ciguatera Fish Poisoning — New York City, 2010–2011

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6204a1.htm?s_cid=mm6204a1_x

Weekly

February 1, 2013 / 62(04);61-65

During August 2010–July 2011, the New York City Department of Health and Mental Hygiene (DOHMH) received reports of six outbreaks and one single case of ciguatera fish poisoning (CFP), involving a total of 28 persons. CFP results from consumption of certain large, predatory, tropical reef fish that have bioaccumulated ciguatoxins (CTX). CFP is characterized by various gastrointestinal, cardiovascular, and neurologic symptoms. A prolonged period of acute illness can result, and the neurologic symptoms can last months, with variable asymptomatic and symptomatic periods. The first two outbreaks and the single case, involving 13 persons, were reported during August 6–September 13, 2010. DOHMH distributed a health alert in November 2010 requesting health-care providers be alert for CFP signs and symptoms. The health alert resulted in identification of 11 more cases that month and an additional two outbreaks involving four persons in July 2011. In comparison, only four CFP outbreaks, involving 21 persons total, had been reported in New York City (NYC) during the preceding 10 years (2000–2009). DOHMH's investigation revealed that 13 persons became ill after eating barracuda, and 15 became ill after eating grouper. Although specific and highly sensitive laboratory analyses can detect and confirm CTX in fish, no practical field tests are available for fish monitoring programs. CFP prevention depends on educating the public, seafood suppliers, and distributors about known CFP endemic areas and high-risk fish species. Traceback investigations of fish associated with outbreaks provide valuable information regarding fishing areas associated with CFP. Not all fish from CFP endemic areas are ciguatoxic, but persons who eat fish from endemic regions are at higher risk for CFP. If an illness is suspected to be CFP, public health authorities should be notified and informed of the case history for possible investigation and intervention measures.

Ground Beef Recalled after Salmonella Infects Those Who Ate Meat Raw

Ground meat from Michigan is being recalled after 16 individuals became infected with Salmonella Typhimurium. It is important to point out that at least 7 of those people ate the meat raw as part of an middle eastern dish. (Perhaps there were a few others who ate it raw, but have not admitted it.)

There has been a growing trend of eating raw meat. There are even raw meat diets. On Livestrong.com (the Lance Armstrong related group), they suggest using organic as a way to supply your raw meat needs....right, like that will work.(http://www.livestrong.com/article/541420-is-it-bad-to-eat-raw-meat/).

So if a small processor sells some meat to a person, and this person makes a raw meat dish for his/her band of raw-meat-diet groupies, and all 12 of them come down with a Salmonella infection, will that processor be forced to recall that lot of meat, even though the rest of the customers who bought that same meat were smart enough to cook it?

And do you think the people who ate the raw meat will file a lawsuit? You bet they will. http://www.marlerblog.com/legal-cases/marler-clark-retained-in-raw-ground-beef-salmonella-kibbeh-cases-in-michigan/

Multistate Outbreak of Salmonella Typhimurium Infections Linked to Ground Beef
CDC Release - Posted January 25, 2013 05:30 PM ET

http://www.cdc.gov/salmonella/typhimurium-01-13/index.html

Highlights
· A total of 16 persons infected with the outbreak strain of Salmonella Typhimurium have been reported from 5 states.
The number of ill persons identified in each state is as follows: Arizona (1), Illinois (2), Iowa (1), Michigan (9), and Wisconsin (3).
53% of ill persons have been hospitalized, and no deaths have been reported.

· Collaborative investigative efforts of state, local, and federal public health and regulatory agencies indicated that ground beef produced by Jouni Meats, Inc. and Gab Halal Foods are likely sources of this outbreak.
Seven of the ill persons reported eating a raw ground beef dish at the same restaurant before becoming ill. The restaurant served raw beef to customers and had acquired the raw beef from two retailers.
On January 24, 2013, JouniMeats, Inc. recalled approximately 500 pounds of ground beef products .
On January 25, 2013, Gab Halal Foods recalled approximately 550 pounds of ground beef products.

CDC Releases Report on Commodities Responsible for Foodborne Illness

The CDC released a study that attributes foodborne illness to food commodities. "CDC developed a comprehensive set of estimates using data from more than a decade of foodborne disease outbreaks and previously published estimates on how many illnesses can be attributed to each food category." Of course, every news outlet has issued a relase listing a highlight or two from this CDC report.
With any report of this nature, there is a lot of extrapolation. One of the biggest is the fact that many foods involved in outbreaks were classified as complex foods - foods with more than one commodity involved. And the number of reported illnesses is small considering it is over a ten year period (270,000 illnesses compared to an estimated 460,000,000 cases that would have estimated to occur 46 million X 10 years OR less than 1%).
And it cannot be overlooked that the data is now 5 years old.
There is some information we can glean from the report. Produce and meat/poultry are important commodities when it comes to foodborne illness. Norovirus is the leading cause of illness, Some excerpts are listed below. Beyond that, it makes for press releases keeping food safety in the news.

For full report: http://wwwnc.cdc.gov/eid/article/19/3/11-1866_article.htm

 

Attribution of Foodborne Illnesses, Hospitalizations, and Deaths to Food Commodities by using Outbreak Data, United States, 1998–2008

Painter JA, Hoekstra RM, Ayers T, Tauxe RV, Braden CR, Angulo FJ, et al. Attribution of foodborne illnesses, hospitalizations, and deaths to food commodities by using outbreak data, United States, 1998–2008. Emerg Infect Dis [Internet]. 2013 Mar [date cited]. http://dx.doi.org/10.3201/eid1903.111866

• During 1998–2008, a total of 13,352 foodborne disease outbreaks, causing 271,974 illnesses, were reported in the United States (Technical Appendix 1 Table 1 [PDF - 723 KB - 8 pages]). Of those outbreaks, 4,887 (37%), causing 128,269 (47%) illnesses, had an implicated food vehicle and a single etiology; 300 of those outbreaks were excluded because information about the vehicle was insufficient to categorize the ingredients. We also did not include the 3% of outbreaks that had multiple etiologies reported.
• Norovirus caused the most outbreaks (1,419) and outbreak-associated illnesses (41,257), far above the median for all agents (29 outbreaks, 1,208 illnesses).
• Produce commodities (fruits-nuts and the 5 vegetable commodities) accounted for 46% of illnesses; meat-poultry commodities (beef, game, pork, and poultry) accounted for 22%. Among the 17 commodities, more illnesses were associated with leafy vegetables (2.1 million [23%]) than any other commodity. The high estimate for illnesses attributable to leafy vegetables was many times higher than the low estimate (Figure 2, panel A), which indicates that leafy vegetables were frequently found in complex foods. After leafy vegetables, the commodities linked to the most illnesses were dairy (1.3 million [14%]), fruits-nuts (1.2 million [12%]), and poultry (900,000 [10%]). Norovirus comprised 57% of all illnesses.
• Most bacterial illnesses were attributed to dairy (18%), poultry (18%), and beef (13%) commodities (Table 1). Most chemical illnesses were attributed to fish (60%, most caused by the marine biotoxin ciguatoxin).
• Most viral illnesses were attributed to leafy vegetables (35%), fruits-nuts (15%), and dairy (12%). Of the 20 outbreaks associated with simple foods and caused by norovirus transmitted by dairy, 14 (70%) were transmitted by cheese products.

Two recalls the result of metal fragment contamination

There were two recalls announced today that were both related to metal fragment contamination. One recall was packaged bagels and it was discovered due to the presence of metal fragments found in two different packages. The other was frozen pizza product. Here, small metal fragments were found in the flour. It was an ingredient issue in that the flour used to make the product had been contaminated – the third party flour mill had a faulty metal mesh screen. The fragments were reported to be too small to be detected by conventional metal detectors that were being used.

For many products, metal control is important. Too often, poorly operating metal detectors are all that stand in line for protection. Unfortunately companies may not be willing to allocate sufficient resources to buy well-built detectors or to provide proper maintenance including yearly equipment-supplier calibration. It is important that metal detectors must are properly spec’d for the type of product and process. Another important part of metal control is preventive maintenance, with a regular inspection and scheduled replacement of parts subject to operational fatigue. The cost of these recalls goes a long way against the cost of properly operating equipment.


Voluntary Regional Recall Of Thomas', Sara Lee, Publix, And Weight Watchers Bagels
http://www.fda.gov/Safety/Recalls/ucm336565.htm?source=govdelivery

FOR IMMEDIATE RELEASE - January 16, 2013 - BBU, Inc., the parent of the Bimbo Bakeries companies, has initiated a voluntary recall due to possible presence of fragments of metal caused by a faulty manufacturing part. Recalled products are the following fresh bagels with "Best Buy" dates (month and day) "JAN 18" to and including "JAN 27"found on the lock tab bag closures in the following states:

Thomas' Everything Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Blueberry Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Onion Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Plain Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Cinnamon Raisin Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Hearty Grains 100% Whole Wheat Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Cinnamon Swirl Bagels 1 lb 4 oz AL, FL, GA, TN
Thomas' Honey Wheat Bagels 1 lb 4 oz AL, FL, GA, TN
Sara Lee Deluxe Bagels Honey Wheat 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Plain 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Blueberry 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Sara Lee Deluxe Bagels Cinnamon Raisin 20 oz AL, FL, GA, LA, MS, NC, SC, TN
Publix Premium Original Bagels 20 oz AL, FL, GA., SC, TN
Publix Premium Multi-Grain Bagels 20 oz AL, FL, GA., SC, TN
Publix Premium Cinnamon Raisin Swirl Bagels 20 oz AL, FL, GA., SC, TN
Weight Watchers 6 Original Bagels 15 oz AL, FL, GA, NC, SC, TN 

The company announced the recall after discovering metal fragments in two packages. No consumer reports have been received. There are no reports of injury.
All recalled products are being removed from store shelves. No other THOMAS', SARA LEE, PUBLIX or WEIGHT WATCHERS products are affected.

 Consumers who have purchased the product can return the product to its place of purchase for a full refund. Consumers with questions may contact the company at 1-800-984-0989 at any time 24 hours a day.



California Firm Recalls Frozen Pizzas Due To Possible Foreign Matter Contamination
http://www.fsis.usda.gov/News_&_Events/Recall_006_2013_Release/index.asp


CLASS II RECALL
HEALTH RISK: LOW

FSIS-RC-006-2013
January 23, 2013

Congressional and Public Affairs
(202) 720-9113
Richard J. McIntire

WASHINGTON, Jan. 23, 2013 – - Annie's Homegrown Inc., a Berkeley, Calif. establishment, is recalling an undetermined amount of frozen pizzas that may be contaminated with extraneous materials and are the subject of a Food and Drug Administration (FDA) recall, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

All varieties of "Annie's Homegrown RISING CRUST FROZEN PIZZA" with a "Best By" date including and between "09Jan13" and "14Sep13" are affected.

The following products are subject to USDA recall: [View Label]

23.6-oz. Organic Pepperoni Pizza, UPC code 0 13562 20000 9

25.4-oz. Organic Supreme Pizza, UPC code 0 13562 20002 3

22.6-oz. Pepperoni Pizza, UPC code 0 13562 20006 1

23.1-oz. BBQ Recipe Chicken Pizza, UPC code 0 13562 20009 2

Each product package above has an establishment number of "EST. 5699", "EST. 15815B", "P-5699" or "P-15815B" ink jetted on the upper flap of carton's side panel.
In addition, the following products are subject to FDA recall: 
23.5-oz. Organic Four Cheese Pizza, UPC code 0 13562 20001 6 
22.5-oz. Four Cheese Pizza, UPC code 0 13562 20007 8 
25-oz. Organic Spinach and Mushroom Pizza, UPC code 0 13562 20005 4

The products were manufactured at two facilities from May 9, 2012 to Jan. 17, 2013, and shipped to retail establishments across the United States.

The problem was discovered when metal fragments were visually detected in the flour and pizza dough at a third-party crust production facility. The problem was traced back to a defective metal mesh screen at a third party flour mill. Some wire fragments are too small to be detected by standard industry metal detectors, so it may be possible for fragments to become lodged in a finished pizza. FSIS, FDA and the company have received no reports of injury associated with consumption of these products.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers with questions about the recall should contact the Annie's Homegrown Pizza hotline at (888) 825-6720. Media with questions about the recall should contact Donald C. Cutler, of Kekst & Company acting on behalf of Annie's, at (415) 852-3903.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. “Ask Karen” live chat services are available Monday through Friday from 10 a.m. to 4 p.m. ET. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: www.fsis.usda.gov

Listeria Recalls - Could This Be the Story of Jason?

Within the week, there were two recalls, both involving Listeria contamination of cooked meat products that were discovered through testing. So luckily, no illnesses were reported. One is an FDA recall involving chicken salad sandwiches sold at retail. The other is a USDA recall involving meat strips that were sold in bulk to be used as ingredients.  

The process for both products would have entail post -process handling, so both would be at risk for Listeria contamination. The difference is that the sandwiches would be shipped refrigerated, allowing some time for growth to occur, although there is a limited shelf-life on the product. The other is a frozen product, so during the time that product is frozen, Listeria would not grow. The risk associated with this product would be impacted on how the further manufacturer used that product. Of course, if they further cook the product, perhaps as part of a BBQ meat product, it would eliminate the Listeria risk. However, if they made it into chicken salad and shipped it in a refrigerated state to retail stores, it would be similar to the FDA recalled product.

Once an operation has found they have a Listeria contamination issue, it is important that those companies do extensive cleaning and sanitizing that is verified by heavy monitoring. Too often, companies jump back into production without eliminating the true source of contamination. In some cases, they don’t find it in testing completed on non-production swabs and think they are good to go. However, once product starts to roll through the process, Listeria reemerges. The source of Listeria was hidden well within the bowls of the equipment, and only once product is flowing through for hours or even days, does the Listeria make its way back out onto the food contact surfaces and ultimately the product.  

Listeria is sort of like Jason, the scary dude in the hockey mask featured in in those horror movies. In this movie, after the screaming girl shoots him a zillion times and he falls off the two-story roof, the distraught girl, laying there for what seems to be an eternity, finally gets the nerve to look. However, looking down, she realizes Jason is not there on the ground. Slowly turning around, she screeches as she sees that Jason was standing right behind her with a machete in his hand. As you are watching the flick, you wonder, why did she not verify that he was dead sooner.  So yeah, Jason is like Listeria, you are just never able to kill it and he continues to scare the heck out of you. So don’t be the screaming girl, use a rocket-launcher instead of a handgun and check well and often that he is not standing behind you. And never assume he is really dead.

KNOTT'S FINE FOODS RECALLS CHICKEN SALAD SANDWICHES BECAUSE OF POSSIBLE HEALTH RISK
http://www.fda.gov/Safety/Recalls/ucm336282.htm?source=govdelivery

FOR IMMEDIATE RELEASE - January 21, 2013 - Knott's Fine Foods, Inc. of Paris, TN, is voluntarily recalling its 3 ounce Chicken Salad Sandwiches with an expiration date of 1/29/13 and earlier because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

New Food Safety Regulations Proposed for Fresh Produce Growers

Dr. LaBorde produced a very nice write-up on FSMA's proposed rule for produce safety.

 

New Food Safety Regulations Proposed for Fresh Produce Growers

 

Dr. Luke LaBorde, Department of Food Science, Penn State University 1/16/13

 

On January 4, 2013, the U.S. Food and Drug Administration (FDA) released a draft Produce Safety Rule as required under the Food Safety Modernization Act (FSMA) of 2011. This proposed regulation would establish mandatory practices that farmers must take to prevent microbial contamination of fresh produce. Below are highlights of requirements FDA would issue in the final regulation:

 

Worker Health and Hygiene - Farm and packing house workers who harvest or handle fresh produce, and their supervisors, must receive training on personnel hygiene and health conditions that can increase the risk for food contamination. Growers are required to show proof of training by keeping written records. Toilet facilities have to be readily accessible, kept reasonably clean, and supplied with toilet paper. Hand-washing stations must be close to toilet facilities and supplied with potable running water, hand soap, and clean single use towels.

 

Agricultural Water - Growers must be able to demonstrate that the water they use for irrigation, pesticide preparation, cooling and washing, etc. is safe for its intended use. Maximum average E. coli levels of 126 cells per 100 milliliters have been proposed for irrigation water that can contact the edible part of the crop. Water used for post harvest operations face more stringent standards; no detectable levels of E. coli are allowed.

 

FSMA Preventive Control Proposed Rule – Key Points for Food Processors

Official Title - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

 There has been a lot of press regarding the FDA’s proposed rule on preventive controls. It has been hailed by many as a needed step for a safer food supply. If anything, it certainly helps to bring most every processor up to the same level in terms of HACCP based preventive measures.

The rule requires that FDA registered firms have a written food safety plan which is based upon HACCP principles.

For the food processor who has a HACCP plan in place and has undergone third party audits, there is nothing overwhelming within this rule. The challenge will be for those companies that do not have a HACCP system in place yet, (or a good plan in place). All companies who have registered their facility with the FDA, including those that do not ship out of state, may be subject to the FSMA preventive control rule. However, there are exemptions from the requirements for a Food Safety Plan for firms based upon size and whether they can be considered ‘on-farm’.

For firms with an active, functioning HACCP plan, the biggest thing to revise will be in the hazard analysis and the need to identify preventive controls. Preventive controls, as defined, can be CCPs or certain prerequisite programs that are needed to control potential hazards. Also, in addition to biological, chemical and physical hazards, we now include radiological hazards.

In current HACCP, the focus is on hazards controlled within the process by CCPs. In this, we acknowledge that prerequisite programs as making certain ‘hazards not likely to occur’. In the FSMA rule, all potential hazards must be addressed, and then for any considered reasonably likely to occur, the preventive control must be identified that renders the product safe (non-adulterated), whether that be a CCP or other program. In doing the hazard analysis, it will be important to include an assessment the severity of the illness or injury associated with the hazards.

Similar to what is done with CCPs, all preventive controls must have documented procedures. There must be monitoring, verification, and record keeping. However, unlike a CCP, there may not be a measurable parameter (critical limit). Validation for the preventive controls may not be needed (for sanitation and allergen control).

For example, one would need to identify sanitation as a preventive control for Listeria with a RTE food item when there is exposure of that product to the environment before packaging. They would need procedures for cleaning, verification that cleaning was done, and documentation to show this.

Facilities are required to have a written Recall Plan. At this time, there are no requirements for an environmental monitoring program, finished product testing, or supplier verification, although there is this with regard to process control (Proposed § 117.80(a)(5) would require that chemical, microbial, or extraneous-material testing procedures be used where necessary to identify sanitation failures or possible cross-contact and food contamination). FDA does ask for comments regarding the need of these being addressed. 

Food defense / intentional contamination will not be addressed in this rule.

Overall, FDA takes a less prescriptive approach with regard to the preventive control rule. While this gives processors opportunity to use a number of different methods to meet standard, it can be an issue when being inspected when that inspector doesn’t agree with that method. (We see that now with USDA inspectors with regard to validation…..’how do you know that process works’).

It is important to remember that this is just the proposed rule. This is the comment period and this closes on May 16th. At that time FDA will review and then reissue the rule, which then becomes implemented 60 days after being issued. Large firms will have one year to implement, small firms will have 2 years, and very small firms will have 3 years.

For more detailed summaries (prepared by lawyers) see http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm or http://leavittpartners.com/wp-content/uploads/2013/01/Proposed-Rule-On-Preventive-Controls-Key-Provisions.pdf

Other points to note – (Items I found interesting):