FoodHACCP Newsletter



Food Safety Job Openings

06/06. QA & Manufacturing Specialist – Dallas, TX
06/06. Regional Food Safety Spec – Frederick, MD
06/06. Quality Assurance Specialist – Stuarts Draft, VA
06/03. Director, QA/Food Safety – Joplin, MO
06/03. Food Safety Coordinator – Van Buren, AR
06/03. Food Safety & Brand Std - San Francisco, CA
06/01. Quality Supervisor - 1st Shift - Caseyville, IL
06/01. Food Safety Superintendent - Columbus, NE
06/01. Director of Food Safety - Millsboro, DE
06/01. QA Supervisor – New Hampton, IA
05/30. Dir QA, Food Safety & Reg – Frontenac, KS
05/30. QA Technician – Colorado Springs, CO
05/30. Quality Assurance Manager – Chaska, MN

06/06 2016 ISSUE:707

Birds: Crowds of crows spread Campylobacter
Source : http://barfblog.com/2016/06/birds-crowds-of-crows-spread-campylobacter/
By Doug Powell (June 6, 2016)
Crows are smart, highly social animals that congregate in flocks of tens of thousands. Such large, highly concentrated populations can easily spread disease — not only amongst their own species, but quite possibly to humans, either via livestock, or directly.
On the campus of the University of California, Davis, during winter, approximately half of the 6,000 American crows that congregated at the study site carried Campylobacter jejuni, which is the leading cause of gastroenteritis in humans in industrialized countries, which could contribute to the spread of disease. The research is published in Applied and Environmental Microbiology.
The investigators posited that the crows’ daily wanderings contributed to C. jejuni’s spread. To track the crows, they trapped a small number of individuals and attached tiny GPS devices to diminutive backpacks. They affixed these to the birds with harnesses that looped around each wing to attach at the breast. The additional weight represented less than one twentieth that of the crows.
The crows’ favored destinations were areas with easy access to food, such as a dairy barn, and a primate research center. “This movement pattern, coupled with high infection rates, suggests that crows could play an important role in transmission from wild birds to domestic animals and, ultimately, to humans,” said first author Conor Taff, PhD.
Crows are also strong flyers, and able to spread contamination far from the roost.
Crows’ social behavior also probably contributes to the pathogen’s spread. Their communal winter roosts can pack thousands of crows into a few trees each night, said Taff, a postdoctoral researcher at Cornell University, Ithaca, NY, who conducted some of the research while he was a postdoctoral fellow at the University of California, Davis. And crowds of crows, opportunistic omnivores, forage together, defecating where they eat. “These things together probably explain why crows have such high prevalence of infection compared to other wild birds,” said Taff.
Crows’ opportunistic foraging frequently leads them to live in proximity to humans, and to livestock, putting us at risk for infection. Among other places, crows forage at livestock feedlots and in fields containing particular crops.
Nonetheless, data is lacking on the prevalence of crow-borne strains of C. Jejuni that have the potential either to infect humans, or to easily mutate to infect humans. (A coauthor on this paper, Allison M. Weis of the School of Veterinary Medicine, Pathogen Genome Project, University of California, Davis, is working on that issue.) Nor is it clear whether Campylobacter sickens crows — another issue which team members are investigating.
“Our study is just a start, but our results suggest that integrative work that combines microbiology, ecology, and behavior is likely to be important in controlling cross-species transmission of Campylobacter,” said Taff. “Since wild birds may be an important source of initial poultry infection, it is important to understand how infection persists in wild birds and how their behavior might contribute to domestic animal infection. Our movement data are particularly interesting in this regard, because we found that crows were making heavy use of some areas with domestic animals.”
“Understanding how both this behavior and infection rates vary across the year might make it possible to devise mitigation strategies that exclude wild animals from interacting with domestic animals in certain places or at certain times of the year,” said Taff.
“Our study is among the first to combine extensive sampling and whole genome sequencing of C. jejuni with relevant information on host ecology, movement, and social behavior,” the investigators write.
“Whether crows represent a major source of domestic animal and, ultimately, human C. jejuni infection remains uncertain, but our study indicates that data on infection prevalence and molecular characteristics of isolates alone will be insufficient for understanding C. jejuni transmission dynamics,” the investigators write. They suggest that more work is needed combining genomics, ecology, and movement and social behavior of the birds. They also note that roost sizes have increased as locations have shifted from rural to increasingly urban over the last 50 years.

FDA’s new food safety partnership with Canada
Source : http://www.foodsafetynews.com/2016/06/fdas-new-food-safety-partnership-with-canada/#.V1YngU7yWUk
By Caroline Smith DeWaal (June 5, 2016)
Opinion
Editor’s note: This was originally published on as part of FDA’s Voice Blog series.
With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.
Systems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.
Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.
With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.
Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.
For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.
Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.
Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.
Note on author: Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition

Summer Food Safety Tips From the USDA
Source : https://foodpoisoningbulletin.com/2016/summer-food-safety-tips-from-the-usda/
By Carla Gillespie (June 4, 2016)
Planning a summer picnic or barbecue? Bacteria multiplies rapidly at warm temperatures, so the U. S. Food and Drug Administration has compiled some food safety tips to help people avoid food poisoning during the summer months.
Consumers need to be aware of the food “Danger Zone” when temperatures are between 40 and 140 F and perishable food spoils rapidly, said Deputy Under Secretary for Food Safety Al Almanza.  “Foods that should be served hot or cold should not spend more than one hour in the Danger Zone when temperatures are above 90 F, and two hours when temperatures are below 90 F.”
Bacteria can double in number in as little as 20 minutes when perishable food is kept at temperatures in the Danger Zone. To reduce risk, keep cold food, at or below 40 °F, in the refrigerator, in coolers, or in containers on ice. Use a thermometer to make sure of the temperature, and limit the time coolers or doors are open. And don’t leave coolers in direct sunlight.
Before cooking and after handling foods, wash hands with soap and warm water for 20 seconds. If you will be away from a kitchen, pack clean cloths and moist towelettes for cleaning surfaces and hands.
Never put cooked food on the same platter that held raw meat or poultry. And refrigerate leftovers as quickly was possible. Any food left in the Danger Zone too long should be thrown out. Finally, advises the USDA, when in doubt, throw it out.

Produce Trends Highlight Food Safety, Unique Cuts, and International Flavors
Source : https://www.fsrmagazine.com/sustainability/produce-trends-highlight-food-safety-unique-cuts-and-international-flavors-0
By Industry Headlines (June 2, 2016)
With prime produce season here, restaurant operators should be thinking about the best ways to incorporate the latest produce trends into their menus.
According to the Florida Fruit and Vegetable Association, fruits and vegetables will become more of a main attraction on restaurant dishes and will be infused with international flavors on plates moving forward. This sentiment of trend was echoed by David Liesenfelt, CEO of Fresh Concepts, a produce procurement company serving the restaurant industry.
"The biggest thing with produce right now is innovation," Liesenfelt says. "This means having unique produce items or serving produce items in unique ways."
For example, operators should now look at serving cauliflower cut like a steak, rather than florets, in addition to using new and interesting spices to keep flavors fresh.
"Ghost peppers are really popular right now and hotter spices are going into vegetables. The trend is about taking traditional produce and making it exciting to eat again," Liesenfelt adds.
Consumers also are looking for the use of any type of fruits and vegetables that carry the banner of being local, sustainable, organic, and heirloom. Heirloom items such as tomatoes and carrots have more colorful varieties that can be used to spruce up plates and give a more artisanal look and feel to menu options.
Of course, food safety is top of mind for restaurant operators today and each should have a food safety program in place. The program needs to begin with every grower and filter into every area of the restaurant.
"The management of a food safety system is critical to mitigating risk and traceability is a practice that restaurant operators should employ," Liesenfelt says. "You can ruin your brand by having food safety issues, especially if you weren’t doing everything you could as a company to mitigate that public risk."
Fresh Concepts' Produce Management Program is available to restaurant operators through a partnership with Consolidated Concepts, a purchasing consultancy for multi-unit restaurant brands.
"We go out and select growers that follow GFSI standards, who have third-party audits and who would be willing to submit to our second-party audits. We also look for distributors who have GFSI food safety programs in place so that from shipper to distributor to restaurant we can trace the product from the field where it was grown to the restaurant where it was served," Liesenfelt says. "By following this process, we can ensure food safety protocols are being followed from field to fork."

 

 

 

 

 


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Food safety at weddings
Source : http://www.financialexpress.com/article/fhw/management-fhw/food-safety-at-weddings/271952/
By financialexpress.com (June 2, 2016)
While the wedding invitations, the clothes, the jewellery, the dance and music, décor and venue are all important aspects of a wedding but the biggest takeaway is the food! The multiple functions spanning a minimum of three days require multitudinous menus. Wedding caterers need to offer unique and exquisite cuisine but they also need to keep food safety in mind when preparing foods. The safer the food experience, the higher the demand for the caterer at other celebrations! If you wish to be a wedding caterer par excellence you need to ensure that the food is tasty but also completely safe. Wedding feasts therefore, require a huge amount of planning, right from procuring the best ingredients to handling, storing, preparing, serving and transporting food to preserve its freshness. You also need to consider the number of people you are catering for and the time at which the food is to be served so it does not get a chance to allow bacterial growth. If you also serve cold foods you must know for how long the fresh cut fruit dessert, salads, cold fish, cream, etc., can be safe to eat without refrigeration.
Procurement of raw food and ingredients
Food preparation plays a vital role in keeping away hazards, right from raw material to final dishes. Caterers that follow food preparation norms as laid down in the FSSAI regulations keep consumers safe as well as their own reputation. The first step is to procure raw materials only from licensed vendors as that helps prevent chemical and physical hazards from entering vegetables, pulses, rice, spices, etc. Raw milk must be only supplied by certified vendors because toxins produced by staph bacteria can appear in unpasteurised milk and cheese and these cannot be destroyed by cooking. Similarly, procure meat and chicken only from vendors that have been certified by the veterinary surgeon. Only those colours, additives and flavours must be used that are approved by food regulations as they can infuse foods with toxins. Use only branded packaged oil for cooking. Taking these precautionary steps eliminates hazards from entering food right at the beginning.
Is the venue suitable?
If you are planning to cook food at the venue then it is in your best interest to ensure the cleanliness of the food preparation area. Are the walls, ceilings and floors clean? Is the venue designed to prevent the entry of pests and vermin? Are there sufficient food preparation surfaces to handle vegetarian and non-vegetarian food so there is no cross contamination? Keep in mind that the venue must have enough space to prepare, store and serve food according to the volume of the food prepared. Any food for human consumption cannot be prepared under unhygienic or unsanitary conditions. Doing so could invite a penalty which may extend to one lakh rupees especially if there is an outbreak of food poisoning.
Water is a key ingredient
Keep in mind that the kitchen area in the venue must have a running supply of potable water or the water must be chlorinated or ozone water.
Water is also needed to thoroughly clean vegetables and meats and also to clean and disinfect food preparation surfaces, cooking and serving utensils so the supply should be sufficient and safe as unsafe water can cause a number of water borne diseases. All drinking water, water used for preparing beverages and ice must be potable and stored in a sanitary condition in containers that have taps for withdrawing it.
Right temperature
If there is no kitchen at the venue and you have transported the food from another location then you must ensure that you have the required equipment to keep the food hot. If reheating is required you must have heat sources that ensure that food reaches a temperature of up to 70°C as that temperature is required to destroy and minimise bacteria. Most often transported food is hot held in equipment like Bain-marie, hot holding cart, soup kettle or electrical heating is used.
These must be available with the caterer to keep the temperature at a steady 60°C to 63°C. Food that is in hot holding must not be mixed with food that is already on display as the previously served food might have been on display beyond two hours. It goes without saying that food that is left uncovered will attract flies and contaminants like dust will find their way into food. Besides, properly covered hot served food must also be stirred constantly so that it remains evenly hot. The practice of using higher quantity of oil to keep food hot for longer periods must not be used as excess oil in food is a health hazard.
High risk foods and frozen desserts
Fresh fruit, salads, confectionery items, chutneys, cream, cold platters become easy target for microbial contamination. These are high risk foods and if they are not consumed within two hours of preparation then they must be refrigerated at 5°C or lower as bacteria begin to multiply when the temperature of food is above 5°C. If caterers use their own refrigerated van then it must be parked close to the venue. In case there is no way to refrigerate high risk food at the venue then you must time the delivery in such a way that it is consumed within two hours or change the menu, if food safety is compromised.
Frozen desserts like ice-cream, cakes, ras malai are perishable and subject to microbial contamination if not stored appropriately. If electric freezer is not available then perishable cold desserts must be stored in ice-cream carts or insulated ice-boxes packed with dry ice. High risk foods and desserts also need to be handled with care when serving them as they can get contaminated easily and so gloves should be worn at all times when serving them.
Thawing and cooking temperatures
Caterers who use frozen foods must ensure that they are thawed thoroughly before they are cooked. Meat and chicken might not cook to the centre if they are not thawed fully. Temperature of the food must be maintained at 5°C, so it is best to thaw foods in the refrigerator or a microwave. Do not leave food outside on a surface to thaw. All foods whether vegetarian or non- vegetarian must be cooked so that the internal core temperature is 70°C as that kills all bacteria. In fact meat and poultry must be cooked to a temperature or 74°C to make it completely safe. Caterers use calibrated probe thermometers to check that correct cooking temperatures are reached. Probes are disinfected before and after use. Undercooking foods like meats allow bacteria to survive and cause food poisoning. Slow cooking and slow reheating at temperatures 20°C to 50°C cause bacteria to grow faster.
Equipment must not cause cross contamination
Another important aspect to keep in mind when cooking is to use separate equipment and utensils for vegetarian and non-vegetarian cooking, cooked and uncooked food so as to prevent cross-contamination. Knives, tongs, cutting boards, etc., must be separate for raw and ready-to-eat and they must be cleaned and sanitised between each use. Check to see that cooking equipment is made of steel, brass and not of aluminium or other corrodible material. According to experts cooking utensils must be flat bottomed as that helps to distribute heat evenly so all parts of the food are cooked at the right temperature.
Health and hygiene of staff
Most wedding caterers employ additional temporary staff for cooking and servicing if the catering order is big. Anyone handling food in the kitchen or in the service area must be suitably trained and supervised. Sometimes food can be contaminated by S Aureus bacteria by food service workers who handle food without washing their hands. Maintaining personal hygiene is extremely important and emphasis must be laid to train all staff to follow all hygiene rules like washing hands before handling food and after toilet use, not smoking, coughing, sneezing, scratching, or touching hair or nose when handling food.
It is an FSSAI requirement for all workers, whether permanent or temporary, to undergo a health check if they handle food. If a food handler has any cuts or abrasions, a skin infection or has recently had diarrhoea then he must not handle food in the kitchen, serve food or work as a waiter as the food can be contaminated or infection passed to the wedding guests. As a wedding caterer of repute you must provide clean uniforms, aprons, gloves, caps for the cooking and serving staff. Hair must be tied back neatly. Disposal towels and anti-bacterial soap must be available for washing hands. Food poisoning outbreaks can occur when workers don’t handle, cook or store food properly.
Transportation of cooked food
When transporting food to the wedding venue, caterers must use food grade, easy to clean, and covered containers. Cardboard boxes are hardly suitable for transporting food safely or hygienically. The vehicle must be clean and must not be used to transport other goods so as to avoid the risk of contamination. When transporting the food the temperature needs to be controlled to ensure it is kept hot at above 60°C or cold at below 5°C.
For short journeys insulated boxes with cold packs can also be used while for longer journeys a refrigerated vehicle is ideal. Once it arrives at the venue the temperature must be checked and food must be reheated to the adequate temperature. Food poisoning is the caterer’s biggest nightmare. As a caterer if you have ensured proper handling, storing and transporting of food then there should not be any danger of food poisoning. After the wedding is over you will know all has gone well if you get calls from wedding guests to cater food for them too.

Safe Food Coalition says safe handling labels need a rewrite
Source : http://www.foodsafetynews.com/2016/06/food-safety-coalition-says-safe-handling-labels-need-a-rewrite/#.V1Yfnk7yWUl
By Dan Flynn (June 2, 2016)
Seven well-known consumer groups acting together as the Safe Food Coalition are petitioning USDA’s Food Safety and inspection Service for a revised safe handling instruction label for meat, poultry and catfish.
The petition calls upon FSIS to continue to require that labels include information about the potential risk of pathogenic contamination in USDA-regulated meat and poultry products while further requiring that labels provide more specific information about safe handling and cooking practices for meat, poultry and catfish products.
The Safe Food Coalition, active since 1993, includes the Center for Foodborne Illness, Research and Prevention, Center for Science in the Public Interest, Consumer Federation of America, Consumers Union, Food and Water Watch, National Consumers League, STOP Foodborne Illness, and the Government Accountability Project.
They describe themselves as representing consumers, public health interests, victims of foodborne illness, and “labor organizations dedicated to reducing the burden of foodborne illnesses in the United States by improving government food inspection programs.”
The current Safe Handing Label text as mandated by the Code of Federal Regulations, Title 9, Parts 317 and 381, has remained the same since 1994. Here’s what those labels say:
Safe Handling Instructions
This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.
•Keep refrigerated or frozen. Thaw in refrigerator or microwave.
•Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry.
•Cook thoroughly.
•Keep hot foods hot. Refrigerate leftovers immediately or discard.
The petition asks for revisions that would require Safe Handling Instruction (SHI) labels to include recommended internal end-point temperatures and rest-time requirements that allow for bacteria to die off after cooking as well as instructions to use a thermometer to verify internal temperatures, among other information.
The petition also requests that USDA require SHI labels for all raw or partially cooked siluriformes fish, including catfish products, which now fall under USDA‘s oversight.
USDA catfish inspection began only on March 1, after years of confusion over whether or not 2008 and 2014 farm bill provisions were going to be implemented by FSIS and FDA. The Senate just voted on May 25 to switch catfish inspection back to FDA from USDA. The resolution is now before the House.
“Many consumers read the current labels and think they know what ‘cook thoroughly‘ means, but the research shows there is a lot of confusion out there,” said Patricia Buck, executive director for the Center for Foodborne Illness Research & Prevention.
“Using a thermometer to verify the internal temperature of meat, poultry and catfish products is one of the most important ways to avoid a foodborne illness, and the labels should reflect that fact.”
The petitioners say their proposed changes are backed up by research on consumer behavior in the kitchen and grocery store in addition to laboratory studies on the survival rates of pathogens at specific end-point temperatures.
Thomas Gremillion, director of Food Policy at Consumer Federation of America, says remaking   the Safe Handling Labels will lead to more informed consumer choices that will benefit public health and the food system as a whole.
While the Safe Handling Label has gone unchanged for 22 years, it’s been the subject of fairly frequent academic research. One 1998 study found the trouble consumers were having with the label was “trouble reading the food labels” because the type was too small for those with poor eyesight uncorrected by eyeglasses. Those researchers found improved underlining of storage temperatures, widespread use of cooking thermometers and larger type would reduce foodborne illness, especially among the elderly living independently.
The petition recognizes those concerns by calling for the “use of easily legible type located away from curved or seamed areas of the packages” and the use of bold or large type for end-point temperatures and “rest-time” instructions.”
As for what they want that larger type to cover, the groups are calling for more specific information on safe handling practices for meat, poultry and catfish products such as:
•An end-point temperature for raw and partially cooked product categories (intact meats, non-intact meats, poultry, catfish), as well as any “rest-time” requirement;
•Instructions to use a thermometer to verify the product has reached the recommended internal temperature;
• Information on safe handling practices to minimize risks associated with improper sanitation, handling, storage, and temperature control for meat, poultry and catfish products;
• The four core “Check your steps” safe food handling graphics featured on the www.foodsafety.gov website, instead of the graphics currently displayed; and
•A web address on the package for additional information on meat, poultry and catfish cooking recommendations.
Correction: The name of the organization sponsoring the petition is the Safe Food Coalition.  It was incorrectly stated in an earlier version of this story.

FDA sued for failing to impose regs about shellfish bacteria
Source : http://www.foodsafetynews.com/2016/06/fda-sued-for-failing-to-impose-regs-about-shellfish-bacteria/#.V1YfDU7yWUl
By Coral Beach (June 1, 2016)
The FDA’s failure to act to protect the public from deadly bacteria in shellfish not only means the agency is in violation of the Food Safety Modernization Act, but it means at least 15 people will likely die unnecessarily every year, according to a lawsuit filed in federal court.
“The U.S. Food and Drug Administration (FDA) should stop dragging its feet and act on a four-year-old petition urging the agency to regulate deadly bacteria in shellfish harvested in Gulf Coast waters and sold for raw consumption,” wrote the legal team for the Center for Science in the Public Interest (CSPI) in a lawsuit filed in late May in U.S. District Court for the District of Columbia.
 “Without this safety standard, in the next year, an estimated 30 people will become seriously ill, and 15 of them will die, after consuming raw shellfish that contain the bacteria, called Vibrio vulnificus (V. vulnificus),” the complaint states, citing statistics from the FDA and Centers for Disease Control and Prevention.
FDA policies prohibit agency staff from commenting on pending litigation. The government has until July 25 to file a response to CSPI’s complaint. The FDA updated its warning to consumers in June 2015 regarding consumption of raw oysters and other shellfish because of V. vulnificus.
The bacteria V. vulnificus is the leading cause of seafood-associated deaths in the United States, based on data in government records.
“The FDA’s failure to adopt a safety standard to control these deadly bacteria is unconscionable,” Julie Murray, the Public Citizen attorney who filed the case against FDA with the CSPI, said in a news release.
“The technology to eliminate or reduce V. vulnificus while preserving the texture and flavor of raw oysters is readily available. What’s missing is the FDA’s resolve to do something meaningful about this public health hazard.”
The federal case contends the FDA’s failure to act “constitutes agency action unlawfully withheld or unreasonably delayed, in violation of the Administrative Procedure Act.” The CSPI wants a federal court order to force the FDA to issue a decision within 30 days on the 4-year-old petition seeking imposition of testing regulations for oysters and other shellfish sold with the intention they will be consumed raw.
Because of the well-documented presence of V. vulnificus, especially during warm weather months when water temperatures are higher, and its high fatality rate, the non-profit watchdog groups Public Citizen and CSPI contend FDA’s inaction also puts it in violation of requirements in the Food Safety Modernization Act (FSMA).
“The FSMA includes a provision entitled ‘Performance standards,’ which requires FDA, ‘not less frequently than every 2 years, [to] review and evaluate relevant health data and other relevant information … to determine the most significant foodborne contaminants.’ ” according to the complaint.
“That provision also mandates … the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations.
“To date, four years after CSPI’s petition and three years after the FSMA’s first deadline for the review and evaluation of significant foodborne contaminants, FDA has neither granted nor denied CSPI’s petition.”
Activists say hundreds have died since FDA learned of this hazard
Vibrio-quote-CSPI-vs-FDAThe CSPI complaint says from 1989 to 2010, at least 300 people died from V. vulnificus-related illnesses, according to the government’s own records. More individuals have died in the years since then.
“The FDA has recognized since the 1980s that V. vulnificus poses a hazard to public health. But in the decades since then, it has repeatedly caved to industry pressure not to adopt a safety standard that would require companies to reduce V. vulnificus to nondetectable levels,” according to the lawsuit.
V. vulnificus is particularly dangerous for people with certain health conditions, including diabetes, liver disease, cancer, iron overload disease (hemochromatosis), hepatitis and HIV/AIDS. These people are at greatest risk of contracting blood poisoning from a V. vulnificus infection, which can result in painful swelling and blistering wounds on the legs.
“Half of all individuals who are infected with V. vulnificus-related blood poisoning die, usually within a matter of days. The fatality rate is 100 percent if individuals delay seeking medical treatment for 72 hours. Many other individuals must have their limbs amputated to survive. Even a single raw oyster may contain a sufficient amount of V. vulnificus bacteria to be lethal,” according to the CSPI complaint against the FDA.

FDA Finalizes Anti-Terrorism Food Safety Rule
Source : http://www.legalreader.com/fda-finales-anti-terrorism-food-safety-rule/
By Eric Needs (June 1, 2016)
FDA finalizes anti-terrorism food safety rule on Thursday that aims to prevent wide-scale harm to public health by requiring domestic and foreign companies to work to prevent intentional tempering with the U.S. food supply.
The rule is the latest of seven major regulation changes that implement the core provisions of the Food Safety Modernization Act, requiring food facilities to complete and maintain a written defense plan that assesses their potential weaknesses in the case of a deliberate attack. The rule, slated for publication of Friday, states the food manufacturers need to comply with the rules within three to five years from its publication, depending on their size.
The FDA estimates that the implementation of the rule will cost companies an average of $280 million to $490 million annually for 10 years, with the first-year cost running between $680 million to $930 million. The cost, counting only domestic firms, will be about $90 million to $150 million annually, with a first-year cost of between $220 to $300 million. The FDA expects the rule to cost between $27,000 to $47,000 per company and between $9,000 and $16,000 per facility annually.
The FDA said the costs and benefits will break even if the rule will prevent 28 to 48 attacks each year that are similar to attacks that have happened previously in the U.S., or prevent one to two attacks yearly that are similar to typical food-related illness outbreaks, or would prevent a catastrophic terrorist attack with thousands of deaths once every 270 to 460 years.
“Today’s rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” Stephen Ostroff, the FDA’s incoming deputy commissioner for foods and veterinary medicine, said in a statement. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”
Food facilities will need to identify and implement mitigation strategies to address their unique weak points, establish food defense monitoring procedures and corrective actions, verify that their system is working, ensure that people assigned to food defense jobs have appropriate training, as well as maintain appropriate records.
Three provisions will be implemented from the Federal Food, Drug and Cosmetic Act, as amended by the FSMA, that relate to intention food attacks. The three provisions in turn relate to facilities that manufacture, process, pack and hold food, and facilities that deal with fruits and vegetables and facilities that handle high-risk foods. The provision of high-risk foods exempt farms from the rule but do not exempt farms that produce milk.
The rule will not apply to small business that include subsidiaries and affiliates that make less that $10 million per year. The rule does not apply to facilities that hold food, unless the food is in liquid storage tanks, facilities that package food if the container holding the food remains intact, facilities handling some alcoholic beverages, and facilities that deal with animal feed.
The rule was first proposed in December of 2013 and takes into consideration more that 200 public comments. The revisions, mostly prompted by comments, include requiring companies to consider the possibility of insider attacks, specifying the elements that should be considered when making a vulnerability assessment: the potential health impact if a contaminant is added to the food, the degree of physical access to a given product, and the ability of an attacker to successfully contaminate the food.

Feds delay poultry testing; expect many operations to fail
Source : http://www.foodsafetynews.com/2016/05/127038/#.V1Yf5E7yWUl
By Coral Beach (May 31, 2016)
Certain poultry producers have a few extra weeks to beef up their pathogen reduction programs, which were scheduled to face new Salmonella and Campylobacter testing beginning in May.
The U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) won’t begin assessing whether poultry operations are meeting new pathogen reduction standards until July 1, according to a recent USDA update. The delay is necessary to allow inspectors additional time to become familiar with new instructions on sampling procedures, the agency reported.
When they do hit the road, the inspectors will be collecting more samples than they did in the past as the FSIS pursues the goal of reducing human illnesses from Salmonella and Campylobacter in “chicken parts and comminuted chicken and turkey products,” according to a Federal Register notice published earlier this year.
Federal officials expect more than half of chicken operations will fail, at least initially.
“FSIS estimates that approximately 63 percent of raw chicken parts producing establishments, 62 percent of NRTE (not-ready-to-eat) comminuted chicken producing establishments, and 58 percent of NRTE comminuted turkey producing establishments will not meet the new Salmonella standards,” the agency stated in the Federal Register.
The expectations for reducing Campylobacter are better. However, FSIS still estimates that 46 percent of raw chicken parts producing establishments, 24 percent of NRTE comminuted chicken producing establishments, and 9 percent of NRTE comminuted turkey producing establishments will not meet the new Campylobacter standards.
Chicken parts and the other poultry products are in the crosshairs because they have historically shown much higher pathogen levels than ground beef or pork chops, FSIS reported.
“Recent research supports that poultry represents the largest fraction of Salmonella and Campylobacter illnesses attributed to FSIS-regulated products,” the Federal Register notice states.
“Furthermore, data from the National Antimicrobial Resistance Monitoring System (NARMS) show that the incidence of Salmonella in poultry products is five to 10 times higher than that in ground beef or pork chops.”
Federal officials cited outbreaks in recent years involving the targeted chicken parts and other poultry products, including two Salmonella outbreaks this past year. Public health officials traced the two 2015 outbreaks to raw, frozen, stuffed chicken entrées from two separate establishments.
“In both outbreaks, the establishment involved did not consider implementing effective controls for the source materials or for the production process to know the frequency of contamination of source materials with Salmonella,” FSIS reported.
“Currently, events that cause contamination of raw carcasses cannot be eliminated through the commercial production and slaughter practices employed by the U.S. industry. Contamination can be minimized, however, with the use of proper sanitary dressing procedures and by the application of interventions during slaughter and fabrication of the carcasses into parts and comminuted product.”
Suggested changes will mean cost increases for some operations, but the procedures are not complicated. The FSIS reports that changes made by poultry slaughter establishments could include interventions such as:
•vaccination programs;
•well-timed feed withdrawal;
•clean and dry litter and transportation, and
•supplier contract guarantees of pathogen-free flocks.
During processing, establishments could add additional cleaning procedures, apply chemical antimicrobial agents to parts and source materials for comminuted poultry product, and provide additional sanitation training to employees.
In July, when inspectors begin assessing whether operations are meeting new pathogen reduction goals, the number of testing samples and frequency of sample collections will depend on the size and food safety record of specific facilities. The largest operations can expect to have inspectors collecting samples four or five times a month, roughly once a week, according to the new procedures.
Regardless of an operation’s size, FSIS will post assessment results on its website for public review. The agency will use the following categories and pass/fail designations when posting results:
•Category 1 — Consistent Process Control: Establishments that have achieved 50 percent or less of the Salmonella or Campylobacter maximum allowable percent positive during all completed 52-week moving windows over the last three months.
•Category 2 — Variable Process Control: Establishments that meet the Salmonella or Campylobacter maximum allowable percent positive for all completed 52-week moving windows but have results greater than 50 percent of the maximum allowable percent positive during any completed 52-week moving window over the last three months.
•Category 3 — Highly Variable Process Control: Establishments that have exceeded the Salmonella or Campylobacter maximum allowable percent positive during any completed 52-week moving window over the last three months.
•Passing — Establishments that meet the Campylobacter maximum allowable percent positive for NRTE comminuted chicken or turkey during all completed 52-week moving windows over the last three months.
•Failing — Establishments that have exceeded the Campylobacter maximum allowable percent positive for NRTE comminuted chicken or turkey during any completed 52-week moving window over the last three months.

Food Prep & Food Safety Go Hand-in-Hand in the Kitchen
Source : http://nrn.com/back-office-solutions/food-prep-food-safety-go-hand-hand-kitchen
By nrn.com (May 31, 2016)
Food preparation and food safety go hand-in-hand.  Nothing is more important to your business than preparing, storing and serving food that meets your high standards.
With that in mind, CrunchTime is excited to release the new KitchenSync food prep workstation in partnership with Transact Technologies.  KitchenSync is a hybrid product that combines a kitchen-tough, Wi-Fi and Bluetooth-enabled food safety terminal with integrated label printers by Transact Technologies, with cutting-edge Android 5.0 food prep and production application software by CrunchTime.
KitchenSync was designed to work in seamless connection with CrunchTime’s back office system to:
1.    Eliminate food expiration date errors
2.    Make food prep fast
3.    Integrate with operations
CrunchTime’s KitchenSync makes the AccuDate XL a fully integrated prep planning and recipe display station that connects kitchen prep functions with CrunchTime’s enterprise back-office system.  KitchenSync delivers powerful features that incorporates sales forecasts, intra-day POS transactions, and historical consumption patterns to provide the restaurant team with the ability to review the day’s prep plan, perform prep as required by the flow of the business and print prep labels using the AccuDate XL.
KitchenSync seamlessly connects the prep staff’s activities directly to the CrunchTime back office system, immediately updating inventory levels that can trigger prep and purchasing alerts.  KitchenSync displays recipe information, production instructions, plating instructions, recipe pictures, video, cost information, and nutritional and allergen information.
Read the press release here.
If you would like more information about how CrunchTime can improve your back office operations, reach out to us here for a demo.

Raw Flour Can Be a Health Hazard Just Like Raw Meat
Source : https://foodpoisoningbulletin.com/2016/raw-flour-can-be-a-health-hazard-just-like-raw-meat/
By News Desk (May 31, 2016)
Most people don’t know that raw flour can be a health hazard just like raw meat. In 2009, a multistate E. coli O157:H7 outbreak linked to raw Nestle cookie dough sickened at least 77 people in 30 states. Since pasteurized eggs were used to make that product, the flour was singled out as a possible culprit after months of investigation. The other ingredients used to make the cookie dough, including molasses, sugar, baking soda, chocolate, vanilla, and margarine, underwent pathogen kill steps during processing and were considered less likely sources of contamination in a study published in Clinical Infectious Diseases in 2011.
Investigators never found E. coli bacteria at the plant that produced the cookie dough, or at the flour mills that supplied the flour for the product. No conclusive evidence was found in that outbreak investigation or in the resulting study that definitely labeled a culprit, but “contaminated flour remains a prime suspect for introducing the pathogen to the product,” according to the discussion in the study. Epidemiological evidence linked the outbreak to the product.
Several cookie dough manufacturers started using heat-treated flour for their ready-to-bake food items after that outbreak. And consumers and food manufacturers were warned that foods containing raw flour should be “considered as possible vehicles of infection of future outbreaks of STEC or Salmonella infections.”
Now, another E. coli outbreak has been associated with raw flour. At least 38 people in 20 states are sick with E. coli O121 infections; half of them made something homemade with raw flour and some ate raw cookie dough before they got sick. As a result of this outbreak, General Mills has recalled more than 10,000,000 pounds of its flour that was marketed in several forms and under several brand names.
Ryan Osterholm, an attorney who represented several people in the Nestle E. coli outbreak, said, “This outbreak is significant and widespread. We likely won’t know just how large it is, and how many people were sickened for quite some time.”
The recall notice on the General Mills web page states that Gold Medal Flour, Wondra flour, and Signature Kitchens flour is being recalled. No E. coli O121 has been found in any General Mills flour products or in the flour manufacturing facility. But half of those sickened reporting making something homemade with flour before they got sick, and some used General Mills flour.
Raw flour is just like any other raw ingredient; it has risks of pathogen contamination. When in the field, the wheat can come into contact with bird or animal feces, or contaminated irrigation water. It can also become contaminated during transport or processing. But because it seems so innocuous and is so dry, people don’t usually associate it with pathogenic bacteria.
When working with raw flour, consumers should take steps to protect themselves. Watch out for cross-contamination, which happens very easily with flour, since it can hover in the air and land on other foods that will not be cooked before they are eaten. Wash your hands well with soap and water after handling flour, and clean work surfaces and utensils thoroughly with soap and water after they come into contact with flour.
Most importantly, do not prepare any recipe that calls for raw flour and doesn’t use any type of heat, whether it’s cooking on the stovetop, in the oven, in the microwave, or on the grill. Many published recipes, from truffles to no-bake cookies, use raw flour. Be especially cautious if anyone in your family is in a high risk group, i.e. very young, the elderly, pregnant women, or anyone with a chronic illness or compromised immune system. Never serve them anything made with raw flour.
If you have experienced the symptoms of an E. coli infection, especially after you have eaten something made with raw flour, see your doctor. These symptoms include severe and painful abdominal  cramps, nausea, mild fever, fatigue, and severe watery and/or bloody diarrhea. Symptoms begin three to four days after exposure to the bacteria, but can begin as early as one day or as late as seven days.
If an E. coli infection is improperly treated with antibiotics, it can develop into hemolytic uremic syndrome (HUS), which is a serious and potentially deadly complication. Young children are especially at risk for developing HUS. If anyone who has been experiencing E. coli symptoms starts having the symptoms of HUS, which include little or no urine output, fatigue, lethargy, a skin rash, pale skin, easy bruising, or jaundice, take them to a doctor immediately.

Food irradiation: What is it and is it safe?
Source : http://www.ctvnews.ca/health/food-irradiation-what-is-it-and-is-it-safe-1.2923309
By Angela Mulholland (May 30, 2016)
Studied and used for more than 50 years now, irradiation is nothing new, but then neither is the debate about it.
Irradiation has been used to sterilize medical and hospital supplies, food packaging materials and cosmetics ingredients for years, but it hasn’t been used widely in food
The World Health Organization says more than 30 countries have granted approval for the irradiation of dozens of foods, but the industry has been slow to expand its use because of fears of consumer backlash.
Here’s a closer look at this controversial food preservation method.
What is irradiation?
Irradiation involves passing foods are through a machine that sends out low doses of ionizing radiation, typically gamma rays, to kill off unwanted organisms. The rays pass through food like microwaves in a microwave oven, but do not heat the food significantly. The process is enough though to disrupt the DNA and kill insects and bacteria that can make people ill.
Like food heated in a microwave, irradiation energy disappears from the food immediately. The food does not become radioactive in any way.
What are its benefits?
Irradiation can significantly reduce bacteria levels on food and kill off parasites. In fact, the Canadian Cattlemen's Association has been calling for the approval of irradiation in ground beef, saying that, when combined with other food safety interventions, "irradiation could essentially eliminate E.coli-related illness" from ground beef.
Irradiation can also help slow spoilage by destroying moulds and yeast that cause food to spoil. As well, it can slow the ripening of fresh fruits, and prevent sprouting in root vegetables, allowing for longer shelf life.
The World Health Organization says irradiation offers a residue-free alternative to pesticides for preventing the importation of harmful insects on tropical fruits and foods, saying the process can even kill the weevils that lodge inside mango seeds.
How much energy is used?
The amount of radiation energy absorbed by a food is measured in Grays (named after 20th century British physicist Louis Harold Gray) The World Health Organization has determined that irradiation up to 10 kilograys (kGy) "introduces no special nutritional or microbiological problems."
Ten kGy is the amount of heat required to raise the temperature of water by 2.4 degrees Celsius. The amount of irradiation used to delay sprouting of vegetables and fruit ripening is less than 2 kGy, while the amount used to kill off pathogens ranges from 1 to 7 kGy.
High dose irradiation over 10 kGy can completely sterilize a food, but is only used for products intended for those with severely compromised immune systems.
In Canada, Food and Drug Regulations place upper limits on the energy levels that can be used on foods.
Are irradiated foods free of all pathogens?
Irradiation doesn’t sterilize a food, so the process does not guarantee food safety. But it does significantly reduce the levels of microorganisms that may be present on or in food, such as E.coli, Salmonella and Campylobacter bacteria.
The foods must still be handled safely after they are irradiated, says Health Canada. Consumers must refrigerate irradiated foods and cook them well, to fully destroy organisms.
Does it change the food?
Food irradiation kills off living cells and organisms, but Health Canada says it does not diminish the nutritional value of the food.
The WHO says irradiation can lower the content of some vitamins, but “storing food at room temperature for a few hours after harvesting does the same thing.”
Irradiation has little effect on the flavour of most fruits and vegetables but can change the flavour of some foods. Milk and dairy products have an odd flavour after irradiation, for example, and leaner cuts of meat can also have a different flavour, says the WHO.
Is irradiation safe?
The WHO, the UN’s Food and Agricultural Organization, and the International Atomic Energy Agency have reviewed about 50 years of research and conclude the process is safe.
They found that irradiated foods are as safe as food preserved with other techniques, such as canning, pasteurizing and fermenting.
“Studies in animals, many of which continued for periods of years, have not disclosed any reason to be concerned about long-term health effects of irradiated food or about risks from eating such food,” the WHO says. “These studies have been conducted in many different countries and by reputable international organizations.”
The WHO says irradiation is a cost-effective way of controlling harmful organisms and extending shelf-life, particularly in tropical countries, where foods can spoil quickly.
Which foods are irradiated in Canada?
Health Canada says so far, the main use of irradiation in Canada has been on spices, but onions, potatoes, wheat, white and whole wheat flour have all been approved for irradiation and sale in Canada. It’s not clear how much of those foods are currently regularly irradiated.
Health Canada has completed the scientific review of four proposed new uses of the food irradiation: mangoes, poultry, shrimp and ground beef. Reports suggest Health Canada will propose changes next month to allow the sale of irradiated ground beef in Canada.

FDA’s Foreign Supplier rule has an especially ambitious agenda
Source : http://www.foodsafetynews.com/2016/05/126975/#.V1YkT07yWUl
By Cathy Siegner (May 30, 2016)
Of the seven rules the U.S. Food and Drug Administration (FDA) has issued under the 2011 Food Safety Modernization Act (FSMA), the one regarding Foreign Supplier Verification Programs (FSVP) is particularly ambitious. It attempts a number of things never done before with respect to the U.S. food safety system.
As FDA describes it, FSVP requires importers of food products into the U.S. which are destined for either humans or animals to take responsibility for the safety of the food they import by performing certain risk-based activities. The goal is to make sure that the imported food has been “produced in a manner that provides the same level of public health protection as that required of domestic food processors and produce farms and is not adulterated or misbranded with respect to allergen labeling.”
It’s hard to miss all the imported food items on grocery store shelves these days. According to FDA, the U.S. trades in food products with more than 200 countries and territories and imports food products through more than 300 U.S. ports. In addition, the agency states that food imports to the U.S. more than doubled from 2003-2013.
“This active international trade has allowed U.S. consumers to enjoy a wide variety of foods year-round, and U.S. consumers expect that all foods sold in U.S. markets will be safe for themselves and their families,” FDA notes.
What does the FSVP rule require?
Importers who come under the authority of the new rule will need to conduct hazard analyses for the food they produce and also for food products supplied to them by others. Specifically, they will need to:
1.Anticipate known or foreseeable hazards associated with particular types of food.
2.Evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance. The particular food risks, as well as the foreign supplier’s performance, must be reevaluated every three years, or when new information comes to light.
3.Use the data to approve foreign suppliers and design appropriate methods of supplier verification. The importer is free to tailor the verification processes to the unique characteristics of a food or a supplier’s situation.
4.Conduct corrective actions to maintain the integrity of their supply chain.
For food items entirely manufactured outside the U.S., the rule requires the importer of the finished product to make sure that appropriate safety controls are in place. If the food items are made in this country, the domestic facility must do so.
As noted by attorney Kathy Hardee in a December 2015 article for Food Safety magazine, the FSVP rule first looks to the importer, which is the U.S. owner or consignee of a food offered for import into the U.S.
“If the importer is a food manufacturer otherwise subject to the preventive controls rules, no FSVP program is necessary because the hazard is identified and managed under their preventive controls processes,” Hardee wrote. “If the importer is not a U.S. manufacturer subject to the preventive controls rules and does not meet one of the other enumerated exceptions, the importer must create and implement an FSVP.
“An FSVP requires the importer to vouch for the foreign supplier of an article of food. The foreign supplier is generally the foreign entity that manufacturers and processes the food being exported to the United States. If a foreign food passes through an intermediary packer, holder or re-labeler, the original manufacturer is still deemed to be the foreign supplier,” she stated.
FDA’s outreach efforts
While FDA is working on guidance for all food importers on how to comply with the FSVP rule, the agency has reached out to affected parties by previously soliciting public comments (now closed) and will be holding three public meetings next month to help ease the way.
The first meeting will be June 7 in Costa Mesa, CA, the second will be June 15 in Rutherford, NJ, and the third will be June 21 in Detroit, MI.
According to Liz Freedman, a health communications specialist with FDA, these meetings have two major goals:
“The purpose of the regional outreach public meetings is to continue the dialogue with the importer community on FSMA and elicit ideas that will help to inform the FDA and our stakeholders on how to continue to work together to endure the industry successfully complies with FSVP and other FSMA regulations.”
Charles Breen plans to attend these meetings in order to better advise his clients on complying with the FSVP. The food safety consultant, who retired in 2013 as FDA’s district director in Seattle, said he has been conducting assessments with food importers about the rule.
“What I hear is, ‘What does FDA expect?'” he told Food Safety News. “The rule provides a lot of different ways for suppliers to verify, and it’s baffling for those who do not read government documents on a regular basis.”
Timelines for compliance
Common sources of confusion are the effective compliance dates for the rule and who will actually need to comply with it and to what degree.
FDA set up one entire web page to outline the effective compliance dates. It shows that the first one is May 30, 2017, for any FSVP importer whose foreign supplier is not subject to FDA’s FSMA PC or produce safety rules. (“PC” refers to Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, while “produce safety rules” means Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”)
At the outside, certain “very small businesses” could have until July 27, 2020, to comply with provisions of the FSVP rule. FDA defines that category of importer the same way as in the agency’s preventive controls rule, Freedman noted, or “a sales ceiling of $1 million for human food and $2.5 million for animal food.”
“Modified FSVP requirements are established for very small importers and importers of food from certain small foreign suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses. They must verify their foreign supplier by obtaining written assurance of compliance from the supplier.),” she stated in an email to Food Safety News.
Additionally, importers of food from certain “small foreign suppliers” are subject to modified FSVP requirements, Freedman noted. These small suppliers include:
•Facilities subject to modified requirements under the preventive controls rules because they are qualified facilities,
•Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption, and,
•Shell egg producers with fewer than 3,000 laying hens.
“There are modified FSVP requirements for certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the United States’ system,” she pointed out.
The only countries meeting the criteria to date are New Zealand and Canada, Breen said.
“Canada was officially recognized as having a food safety system sufficient to comply with requirements. The first was New Zealand,” he said, adding, “The rumor I’ve heard is that Australia and then the European community are next in line.”
Breen called the idea of the entire European community being recognized as equivalent “a challenge” because food safety systems in Spain or Greece may be different than, for example, those in Germany or France.
When a foreign country applies to the U.S. for food safety equivalency status, FDA uses what’s called an ICAT (International Comparability Assessment Tool) to evaluate the application.
Exemptions from the FSVP rule
Freedman stated that the following foods are exempt from the FSVP rule:
•Fish and Fishery Products (in compliance with FDA’s seafood HACCP regulations) or certain ingredients used in such products in compliance with the seafood HACCP regulations;
•Juice (in compliance with FDA’s juice HACCP regulations) or certain ingredients used in juice products in compliance with the juice HACCP regulations;
•Food for research or evaluation;
•Certain alcoholic beverages or certain ingredients used in such beverages;
•Certain meat, poultry, and egg products regulated by the USDA;
•Food imported for personal consumption;
•Food that is transshipped [transferred from a ship or other form of transport to another form of transport];
•Food that is imported for processing and export, and,
•U.S. food that is exported and returned without further manufacturing/processing in a foreign country.
More information about who and what is subject to the FSVP rule can be found here.
The question of enforcement
Due to its ambitious agenda, it’s assumed that the FSVP rule will require a strong enforcement presence. However, FDA has limited resources for that function, particularly overseas, and can only do so much with its current budget and staffing levels.
Asked how the agency plans to enforce the rule, Freedman responded this way:
“First, we plan to provide educational materials to industry (e.g. public meetings, webpages). After the compliance dates, the FDA will begin reviewing the records of importers to determine compliance with the FSVP regulation. If the FDA determines, based on the review, that the importer is not in compliance with the applicable FSVP requirements, the agency may pursue regulatory action (e.g., Warning Letter, placing the importer on Import Alert).”
Breen said FDA knows that the agency will need to work with staff on state, tribal and other levels to help with the enforcement piece of the puzzle. That’s why FDA is contracting with states (37 at last count) to get this done, he said.
Breen also said that he expects FDA to use a “risk-based approach” to enforcing the FSVP rule, meaning that it will “focus its traditional activities to better target firms and foods that prevent the highest potential risk,” as the agency puts it.
“I don’t think FDA will be enforcing for some time,” Breen said. “Paraphrasing from [FDA Deputy Commissioner for Foods and Veterinary Medicine] Mike Taylor, it will more be doing education before enforcement. Even though he’s leaving next month, I think that FDA knows that it will need to be educating for some time.” (Taylor has announced that he plans to depart FDA on June 1.)
According to the agency’s Office of Regulatory Affairs, FDA has approximately 2,000 investigators to handle an increasing number of imports, and there is ongoing concern about how they will be able to complete the additional foreign inspections called for under the FSVP rule.
“The question of what is enough has long been an issue,” Breen said. “I do know that one aspect of FSMA is that FDA has told Congress that it does not have the resources to do foreign inspections. By next year, there are supposed to be 9,000 foreign inspections. The agency has told Congress it will able to do between 1,200-1,300 of those inspections without additional resources.”
Like the other six FSMA rules FDA is responsible for implementing, the Foreign Supplier Verification Programs rule is ambitious, challenging and maybe even a bit scary for those who face changing the way they do business in order to meet its requirements.
However, Breen indicated that taking a longer and more collective view of these new regulations could be the best strategy, and he had the following advice for those who will need to comply with the FSVP rule:
 “Everybody who is going to be subject to this rule should not forget to breathe,” he said. “FDA is going to make sure that this rule works. This is my personal opinion that the success of FSMA in general is as crucial to FDA as it is to the food industry. This has to work for both.”

Navajo food taboos and food safety
Source : http://www.foodsafetynews.com/2016/05/navajo-food-taboos-and-food-safety/#.V1Yk7k7yWUl
By Dave Nezzie (May 30, 2016)
Opinion
As a consumer, I’ve purchased food without ever considering whether it is contaminated with pathogens. I’ve made the assumption that the food is safe. If the label included a small emblem noting that it is “certified,” “inspected” or “organic,” I felt reassured. But after a course on food safety litigation, I am more reluctant to believe that our food is completely safe, especially since there is pushback from the industry and hesitation from regulating authorities. As a result, I’ve recently turned to Navajo teachings and begun analyzing traditional stories for their messages about food safety. I’ve come to the conclusion that Navajo food taboos are stricter than current food laws, thereby offering better protection against pathogens on certain foods. However, like the current laws in place, they are not a guarantee against all types of food adulterants.
Traditional teachings influence my daily thought process about safe and edible foods. Toward the end of the food safety course, I began to think more deeply about the messages from the various stories among my people. I am Diné, or Navajo Indian, from the southwest region of the United States. Navajos have many rules governing their lifestyle. Lately, however, certain rules are dismissed as irrelevant in the modern era, notably the rules relating to food. Traditional Navajo teachings promote a mostly vegetarian diet. Small game animals were common meals when I was a child. But as globalization continues to connect a variety of cultures into one conglomerate society, Navajo foods are being replaced with foreign foods. In addition to the displacement of indigenous ingredients is a shift in attitude about food taboos. Many Navajos disregard the rules and choose to eat whatever and however they want.
In the Navajo language, yiiyah, bahadzid, or dóójiiyaada are phrases often used when speaking about foods that should be avoided. Each of these words carries an underlying message that invokes fear. Yiiyah, or its shorter version, yii, translates as “scary.” Bahadzid refers to something that is “dangerous,” and doojiiyaada simply means “don’t eat it.” If an elder knows of another person eating a tabooed food, a lecture will ensue, followed by a story to reinforce the reasoning for its prohibition.
According to our traditional teachings, there are foods in this world that we, as Navajo people, are not supposed to consume. If a Navajo consumes a tabooed food, then the resulting consequence is illness. The illness, it is said, may not take immediate effect but would rather impact the individual at a later time. As my elders explained to me, “Certain foods weren’t meant for us to eat it. It might be OK for other Natives or other people to eat, but for us Navajo it wasn’t given to us.” One of the best examples to illustrate the concept of a foreign food to the Navajo diet is portrayed in an oral story about a gambler.
The Gambler’s story speaks of a powerful and manipulative person who challenged many people throughout the land. Each challenger bet their life and lost. The Gambler enslaved the losers and forced them to build a great city, known today as Chaco Canyon. Toward the end of the story, a hero emerges and challenges the Gambler. The Gambler loses everything and those once enslaved were freed. The Gambler was exiled; he was shot into the sky with a large bow and arrow. The Gambler landed at the home of the Moon-Bearer, poor and helpless. The Moon-Bearer felt sorry for the Gambler and gifted him with domesticated animals, which included cattle, pigs, and chickens. It was foretold that the Gambler would return with these animals and would attempt to regain power and control over others. For this reason, we were warned not to consume these animals.
The restriction against eating domesticated animals is merely the beginning. As a Navajo, I must also avoid various types of exotic meats and a variety of plants. For example, consuming reptiles is absolutely forbidden. Through experience I’ve discovered that avoiding the prohibited food itself is more complex than it seems. One evening I was invited to dinner as a work function. The management thought a fun dinner at an old Western town would provide a unique experience, particularly because the menu offered deep-fried rattlesnake. Upon informing the server that I had a cultural allergy to the “bites,” he instructed that I not consume anything that was fried because it shared the same frying oil. It was from that dining experience that I realized I needed to avoid not just the meats themselves, but also all the other items in a kitchen which may have cross-contaminated with the product. I find this analogous to pathogens in contaminated meats which cross-contaminate with other foods.
While reptiles are rarely offered as food and can be easily avoided, there are other foods that are not easily avoidable because of their wide acceptance from the general public. Those examples include any form of seafood, okra, and blue agave syrup. The list of foods to avoid goes on and on. Aside from specific restrictions on food, there are also taboos related to how to eat food. For example, I’m not allowed to stab food with a knife, or use a knife like a fork. A knife should be used only to cut. Perhaps the greatest food taboo that specifically relates to food safety is not to consume meat that is raw or undercooked because eating the blood causes illness. However, transforming blood into a sausage is acceptable. In fact, sheep’s blood sausage is a delicacy. As long as the food is thoroughly cooked, it is accepted.
While these food taboos apply only to Navajos, I think they offer a cultural law that is stricter than current food laws. In many respects, these taboos offer a consumer better protection from certain pathogens. Consider the Gambler’s story, where the underlying message is to avoid eating beef, pork, and chicken. I’ve consistently examined the story’s reasons to avoid those meats, other than the fear of a monopoly or capitalism, and determined that the Gambler’s message also correlates to food safety and health. In theory, if one adheres to the Gambler’s strict lessons and does not consume domesticated animal meat products, then that individual avoids E. coli and Salmonella outbreaks related to those meats altogether. This theory, however, has two immediate drawbacks. First, simply avoiding contaminated meats does not entirely shield one from other types of contamination found in vegetables or fruit. Second, the exclusion of meats from an accustomed eating pattern is not practical for many and is extremely dogmatic.
Admitting that these drawbacks are difficult to overcome, I still believe that, in the aggregate, certain contaminants could be avoided. Imagine if domesticated livestock were dramatically reduced because the rate of meat consumption paralleled the reduction. The resulting outcome is less livestock raised near fields that grow other types of foods, and the risk of animal fecal matter contaminating vegetables or fruits is greatly reduced. Following a second food taboo, which prohibits eating rare meats, offers a compromise to the second drawback. The alternative of eating meat well-prepared is a safe guideline already in existence and currently promoted under food safety policies.
I am not advocating that everyone, or even Navajos themselves, should follow Navajo food beliefs. Rather I find that the traditional knowledge embedded in these stories becomes more real for me and provides a sense of strength and understanding that’s deeper than statutes or regulations.
Following food taboos is not a bright-line rule to end all food-related sicknesses, but it’s a reliable foundation to build upon. Food taboos emerged within a society for a reason, and that reason is to avoid illnesses. While it is difficult for me to adhere to many of the Navajo rules that govern eating patterns, it’s important that I remember that these rules were adopted with the intention to keeping me safe, healthy, and in harmony with the universe. The food rules that come from origin stories or by an ancestor’s trial and error were developed over time and should continue to evolve within our society. Therefore, I believe that food taboos shouldn’t be easily dismissed and that is the reason why I’ve strongly reconsidered them relevant in my diet in this modern era.
Editor’s note on author: Dave Nezzie is a candidate in the LL.M. Program in Agriculture & Food Law at the University of Arkansas School of Law. He received a J.D. from the University of New Mexico School of Law with program certificates in Federal Indian Law and Natural Resources & Environmental Law. Nezzie attended Arizona State University as an undergraduate, earning concurrent degrees in Anthropology and American Indian Studies. Nezzie is a tribal member from the Navajo Nation and resides near Albuquerque, New Mexico, with his wife and three children.

FDA Publishes Final FSMA Rule: Intentional Adulteration
Source : http://www.qualityassurancemag.com/article/fda-publishes-final-fsma-rule-intentional-adulteration/
By qualityassurancemag.com (May 27, 2016)
With its publication of the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration, FDA has now finalized all seven major rules that implement the core of FSMA.
With its publication of the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration, FDA has now finalized all seven major rules that implement the core of FSMA. The Intentional Adulteration rule is intended to help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.
Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.
“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., FDA's incoming deputy commissioner for foods and veterinary medicine. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”
The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.
The FDA says it is committed to working with both industry and its state, local and tribal partners to ensure effective implementation of this new rule. Implementation of the Intentional Adulteration rule and all FSMA final rules will require partnership, education, and training. FDA and others will provide industry with valuable tools to make compliance with the final rules easier, such as guidances, training courses and a technical assistance center.
Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business. A webinar is planned for June 21, 2016 to present key pieces of the final rule.

The Intentional Adulteration final rule builds on FSMA's Preventive Controls rules for human food and animal food, the Produce Safety rule, Foreign Supplier Verification Program rule, Accreditation of Third-Party Certification rule and the rule on Sanitary Transportation of Human and Animal Food. These seven rules will work together to systemically strengthen the food safety system and better protect public health.

 

 

 

 

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