FoodHACCP Newsletter

Food Safety Job Openings

08/10. Supply Chain QC Assoc - White Plains, NY
08/10. Food Safety & Brand Std Spec - Annapolis, MD
08/10. Food Safety & QA Supervisor - Carroll, IA
08/07. Food Safety Specialist - Riverview, FL
08/07. Food Safety Specialist - Silver Spring, MD
08/07. Supplier Food Safety Auditor - Green Bay, WI
08/07. Food & Nutrition QA Manager - Fort Myers, FL
08/06. Food Safety & QA Manager - Moosic, PA
08/06. Food Safety Specialist - Issaquah, WA
08/06. QA Regulatory Manager - Vancouver, WA

08/13  2018 ISSUE:821


Rules for Safe Home Canning of Summer Produce
Source :
B Linda Larsen (Aug 9, 2018)
Many people are harvesting produce from their gardens and want to can the fruits and vegetables to preserve them. Canning has a long history in this country, but to make sure the food is safe, there are some rules you must follow.
Extension offices of the universities in your state offer lots of excellent canning and preserving advice. Home canning isn’t difficult as long as you know what you’re doing.
Unfortunately, sometimes produce canned at home can make people very sick. In 2015, home canned potatoes used to make potato salad served at a church potluck in Ohio sickened 27 people with botulism. One woman died.
The extension office at the University of Connecticut offers ten rules for home canning. First, make sure that all of your equipment is in good shape. Only use canning jars that are manufactured for home canning. Jar rings should not be dented or rusty. Always buy new jar lids, since the sealing compound can disintegrate; never reuse old lids. Rubber jar rings can be reused unless they are dry or cracked.
Always follow up to date canning guidelines. Recipes that are older than 1996 should not be followed. The National Center for Home Food Preservation has good recipes and guidelines.
Then, choose the right canner. Water bath canners are best for jellies, jams, relishes, pickles, fruits, apples sauce, peaches, and tomatoes. Those products are acidic, which provide protection against Clostridium botulinum bacteria. Pressure canners should be used for all other vegetables, soups, meats fish, and some tomato products that contain low acid veggies such as celery, peppers, or onions. If you use a pressure canner, make sure the gasket is soft and pliable.
Always use high quality, just ripe produce for canning. Overripe or decayed tomatoes may have a higher pH, which is unsafe.
Always make sure that everything is clean before you start canning. Clean everything well and make sure to wash your hands.
Follow recipes to the letter. If you change an ingredient amount or type, you could make an unsafe product. Always make sure you follow processing times. Processing times for specific foods destroy the bacteria that are an issue for that specific product.
Let your jars cool naturally, right side up, for 12 hours or more before you test the seals. Cool jars away from open windows. And don’t leave screw bands on jars after they are opened. Test the seals and reprocess if necessary.

Why Do We Hear So Much About Food Safety and Recalls?
Source :
By JoAnn Alumbaugh (Aug 9, 2018)
Foodborne illness is a common and costly public health problem, says the Center for Disease Control (CDC), but it is also preventable. The CDC estimates that one in six Americans get sick from contaminated foods or beverages each year, and 3,000 die. The U.S. Department of Agriculture (USDA) estimates that foodborne illnesses cost more than $15.6 billion each year.
These are significant figures. However, when a food safety breach occurs, it seems media outlets quickly jump on food producers, processors, distributors, food service providers or restaurants.
More likely than not, food safety issues are caused by improper handling of uncooked food.
“Bacteria are ubiquitous, says Jacek Jaczynski, professor of food science and muscle food safety in the Davis College of Agriculture, Natural Resources and Design at West Virginia University. “They’re all around. You may see them in dust, soil and water, but if they get into food and grow in numbers that are high enough to cause infection or intoxication, that’s how contamination occurs.
‘Local’ Food May Not be Safer
 It’s popular to buy food at farmers’ markets or roadside stands, because many consumers feel they’re minimizing their carbon footprint by lowering their food miles (which may not be the case, in reality), or buying environmentally friendly products (also not necessarily true).
However, foods that consumers buy from local sources often don’t meet the same strict standards required by large companies. They’re washed, delivered and handled differently.
“To protect ourselves, it’s really simple: Cook your food well and wash your hands for two minutes,” Jaczynski says. “In food safety, we always say, ‘When in doubt, toss it out.’ If you think somehow food seems suspicious to you, just don’t eat it. Don’t treat yourself as a lab experiment. People have done it before and that’s how we learn how dangerous foodborne pathogens can be.”
Could Regulations be a Culprit?
West Virginia University expert Simon Haeder says the massive increases in food recall over the last five years-- 92.7% for the U.S. Food and Drug Administration and 83.4% for the U.S. Department of Agriculture (according to a study by the Stericycle Recall Index)-- could be attributed to alterations in agency regulations, a news release from West Virginia University stated.
Haeder says that based on research on “regulatory politics at the federal level, these numbers are to be expected.” He says the Office of Management and Budget “serves as the ultimate arbiter when it comes to issuing regulations, [and] we found that business interests, including agricultural interests and food producers, overwhelmingly out-lobby public interest groups at OMB. We also found that OMB is more likely to alter agency regulations in their favor.”
Business interests are more likely to look at food safety as a whole, and at processes that may be cumbersome or outdated and need to be revised through regulation. It makes sense, then, that rules from liberal agencies were altered more often than those from moderate or conservative agencies, and that’s what Haeder’s research found. Those findings were evident under both Republican and Democratic presidents, according to Haeder.
Challenges Remain
The CDC believes food safety issues will continue in the future, due to changes in food production and supply; more imported foods; new and emerging bacteria, toxins, and antibiotic resistance; and unexpected sources of foodborne illness, such as flour and meal replacement shake mixes.
To address these potential issues the CDC is working to make food safer. An article on the CDC website says it is accomplishing this task by:
•Building state and local capacity to improve surveillance and investigation of foodborne illnesses through PulseNet, the Integrated Food Safety Centers of Excellence, and other programs.
•Working with local, state, and federal partners to investigate outbreaks, and to implement systems to better detect, stop, and prevent them.
•Using data to evaluate and revise foodborne disease prevention strategies and policies.
•Working with other countries and international agencies to improve surveillance, investigation, and prevention of foodborne infections in the United States and around the world.
Take Responsibility
 It boils down to making good decisions and taking a defensive approach to protect yourself and loved ones, says Jaczynski.
“We need to remember that from farm to table we have several events happening including manufacturing, including transportation, including retail sales, including your own house – and all these events can contribute to foodborne illnesses,” Jaczynski says.


Is Your Smart Phone or Tablet A Food Safety Hazard in the Kitchen?
Source :
B Linda Larsen (Aug 8, 2018)
If you use your phone, tablet, or laptop in the kitchen, is that tool a food safety hazard? Two researchers at the FDA are looking at this issue.
Amy Lando, MPP, and Dr. Michael Bazaco in the Office of Analytics and Outbreak at FDA’s Center for Food Safety and Applied Nutrition analyzed findings from the 2016 Food Safety Survey and related focus groups. Their next step is to find out if there’s any danger of contamination from using these devices during food preparation. The researchers already know that bacteria that can cause human illness can survive on cell phones.
This is the first study to look at how consumers use personal electronic devices in the kitchen. It was published in the February 2018 issue of the Journal of Food Protection. The researchers say that there is no hard evidence that these devices have caused any food poisoning cases, but that’s what they are going to study next.
The FSS study was a telephone interview with 4,000 respondents, conducted from October 2015 through January 2016. Seventy-three of those participants met in eight focus groups with a trained non-FDA moderator.
One of the pieces of information uncovered in the study showed that 49% of consumers use these devices while preparing food, but only 37% of them wash their hands with soap after touching the device. Lando said that most people don’t recognize this as a food safety issue. Consumers are more likely to wash their hands after touching raw meat, chicken, or fish, with 85% reporting this behavior.
This study’s intention was to understand the risks associated with cross-contamoiantion from device surfaces to food. The researchers want to develop advice to help consumers minimize this risk. Voice activation functions may have the potential to allow less manual contact.
The researchers say that it’s best to minimize contact with the phone or table during cooking, and to wash hands regularly during the food preparation process. Both researchers say they do use these devices in the kitchen, but always wash their hands well after handling it.
"The inspections found that a number of food workers at these businesses did not have even a basic knowledge or training in food safety and hygiene, which is a legal requirement."
"There is absolutely no excuse for careless practices. Staff must be properly trained in food safety and hygiene and it is also imperative that an effective pest control system is in place,” she said.
Under the FSAI Act, 1998, a Closure Order is served where it is deemed that there is or there is likely to be a grave and immediate danger to public health at or in the premises or where an Improvement Order is not complied with.
Under the EC (Official Control of Foodstuffs) Regulations, 2010, Closure Orders and Prohibition Orders are served where there is a non-compliance with food legislation.
An Improvement Order may be issued by the District Court if an Improvement Notice is not complied with within a defined period. Further non-compliance can result in a Closure Order also being served.
A Prohibition Order is issued if the activities (handling, processing, disposal, manufacturing, storage, distribution or selling food) involve or are likely to involve a serious risk to public health from a particular product, class, batch or item of food. The effect is to prohibit the sale of the product, either temporarily or permanently.
Further information on the Enforcement Orders is published on the FSAI’s website at




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6 ways to avoid food-safety problems
Source :
By Aaron Cohen, co-founder, CoInspect (Aug 8, 2018)
Nearly 300 people have gotten ill this summer after eating at a McDonald's in Brevard, North Carolina, in what authorities believe is a case of norovirus passed through human contact.  This is different from the other recent widespread foodborne illness outbreak at McDonald's, where an additional 400 people — across 16 states — got sick after eating the fast food chain's salads, which were unknowingly tainted with the Cyclospora parasite. Around the same time, Chipotle Mexican Grill faced yet another foodborne illness crisis, when nearly 700 people who dined at an Ohio-based Chipotle became ill. That restaurant location temporarily shut its doors to thoroughly clean the facility amid the surrounding investigation. 
Also this summer, a filthyPopeye's restaurant was closed by the Detroit Department of Health. The restaurant was found to have mold in the kitchen, cockroaches and worms crawling around the floors, and unsanitary conditions in their kitchen, bathrooms, and dining area.
Three large, well-known restaurant chains have all faced serious foodborne illness incidents or outbreaks over the span of a week or two.  Then, of course, we've had romaine lettuce contaminated with E.coli that had been shipped, sold and served nationally.  Nearly 200 people became very sick —  and several died — after eating it. Tainted pre-cut fruit, contaminated wraps — it seems like foodborne illness is everywhere.
As reports continue about McSicknesses, another foodborne illness outbreak from a beleaguered burrito chain, and millions of consumers afraid to eat a salad, it's clear that the current food safety process is broken, and needs to be fixed.
There's a growing culture of neglect in the food industry, and we — as an industry — need to find effective solutions that are also affordable, attainable and user-friendly. 
To shift from a culture of neglect to one of food safety, food professionals should:
1. Vary the Work
 Most restaurants and other food businesses ask their employees to fill out long checklists with identical questions the same way, day after day.  And their bored employees eventually just stop doing it.  Face it: long, laborious checklists are boring, tedious and time-consuming.  And when employees have numerous other things to do during any given shift, sometimes they simply skip the checklist.  Therefore, it's important to stop making the work so tedious.  In the same way that people shouldn't do the same physical workout each day, companies should switch up what they're asking of employees. 
2. Offer better checklists. 
 Want an easy fix to long, laborious paper checklists and employees who won't complete them?  Switch to short digital checklists that can rotate and randomize daily safety inspections, keeping employees more engaged and willing to complete the task. These checklists can be as short as a few (targeted, strategic) questions that take employees just a few minutes to complete.  When the task is made easier (and shorter), employees are more likely to comply.
3. Boost accountability through photos/video
 Pencil whipping — or cheating on inspections, audits and other important food safety protocols — is prevalent in the food business.  As much as we'd like to believe otherwise, many food service employees take shortcuts that put our foods and customers at risk.  A big factor in pencil whipping is the monotony of the tasks. Many workers simply don't want to go through the same lengthy, repetitive processes day after day.  Paper and pencil safety checks — which are also the industry norm — make it easy for employees to cheat. Team members can say they checked to make sure all equipment was cleaned, foods were held at proper temperatures, and other safety checks were completed during a specific shift.  But there's no accountability or system to ensure the inspections were done accurately or at all.  Photographic "proof" of inspections — as simple as snapping photos or video on a smartphone or tablet — can help eliminate this dangerous "pencil whipping" practice.
4. Conduct more frequent inspections.  Many restaurants have very infrequent third-party inspections — in some cases — just one to four times per year. In between inspections, some restaurants simply don't worry about meeting safety and cleanliness codes. The Popeye's in Detroit is a perfect example of that. It's wise to invest in third-party inspections more frequently and definitely more than once or twice per year.  Regular checks from an objective expert can help ensure that a facility is operating safely. Equally important, an outside auditor can spot potential problems before they become true liabilities.  While some food companies may balk at the expense, an investment in food safety is critical. 
And just ask Chipotle — inspections are far less expensive than managing a foodborne illness outbreak. Chipotle's profits have taken a huge tumble since their first foodborne illness outbreak in 2015, and they haven't recovered.  Between legal fees/lawsuits, loss of revenue, plummeting stock prices, closed restaurants and more, Chipotle has taken a major financial hit as a result of their multiple, ongoing foodborne illness issues. More frequent third-party inspections combined with elevated self-inspections will go far in keeping food businesses cleaner, healthier and safer.
5. Embrace technology.  Other industries rely on technological innovations to elevate the way they operate, yet food businesses lag behind. Even in the high-tech world we live in, 90% of food businesses still use antiquated paper and pencil systems to manage food safety standards, including inspections, audits and training.  Compounding the problem: humans make errors that can compromise food safety.  Utilizing tech solutions helps various safety checks get done accurately and regularly every day, during every shift. Adding tech tools is a good way to ensure that even "tedious" tasks are done correctly: foods are stored properly, temperatures are checked, refrigerator doors are sealed, etc.   
6. Practice what you preach.  It's not enough to just say you're committed to food safety protocols — it has to be engrained in the company culture.  For example, Chipotle pays employees to stay home if they have the flu or a stomach virus, which is commendable and can theoretically reduce the incidents of norovirus and other issues. But if the organization's management doesn't respect that rule, it becomes technically but not culturally true. And then you get what recently happened in the Ohio Chipotle, where 700 guests became sick after eating at the restaurant.  (Initial reports said that several Chipotle employees were ill during that timeframe, so there may be a connection.) While it's important for the members of the C-suite to promote the importance of food safety, that alone is not enough. That missive has to permeate every level of a food business, and every employee — during every shift — must work to keep the facility, foods, and guests healthy and safe.
The only true food safety culture is a daily food safety culture. As restaurants shift to fresher, more fragile ingredients, food safety must always be top-of-mind. Adopting a culture of food safety doesn't need to be overwhelming, expensive or difficult to implement. There are actionable, manageable steps that food businesses can (and should!) take to move the needle from a culture of neglect to one of food safety.
Aaron Cohen co-founded CoInspect, a  software company that powers food safety, quality assurance, and standards management for restaurants and food manufacturers.

13 food premises closed in July for breaches of food safety legislation
Source :
By irishexaminer.c (Aug 8, 2018)
15 food businesses were issued with Enforcement Orders in July for breaches of food safety legislation.
The Food Safety Authority of Ireland (FSAI) today reported that 13 Closure Orders, 1 Prohibition Order and 1 Improvement Order were issued last month.
Some of the reasons for the closures include: A live rat seen in the rear storage area, a foul smell in the potato chipping room, rodent droppings on food shelf, and evidence of rodent activity in shop floor area.
In other premises, the staff toilet was out of service for over a month, there was evidence of an active mouse infestation, and a significant number of mouse droppings were observed on shelving and baking equipment.
Flies, particularly in the raw meat and deli counter areas, filthy kitchens and no running hot water available at sinks contributed to other orders being issued.
Here are the full list of enforcement orders issued for July:
Four Closure Orders were served under the FSAI Act, 1998 on:•Shannon Heritage at Bunratty Folk Park, trading as Bakery, Bunratty Castle & Folk Park, Bunratty, Clare
•Neree Mbala (retailer), 10a Base Enterprise Centre, Damastown Road, Mulhuddart, Dublin 15 (post Improvement Order)
•Supervalu (Closed area: loose/open food areas – deli, fish counter, butchery counter, bakery, salad bar, shop floor hot counter, fruit & veg), Walkinstown Road, Dublin 12
•Roberto’s (Closed area: food storage and potato peeling area at the rear of the premises) (takeaway), 12 Ranelagh, Dublin 6
Nine Closure Orders were served under the EC (Official Control of Foodstuffs) Regulations, 2010 on:•Ricky’s Fast Food and Indian Takeaway, 1 Abbey Street, Roscrea, Tipperary
•Declan Lavers (wholesaler/distributor), Dromleena, Dunmanway, Cork
•Alchemy by the Lough (restaurant), 1B Valentine Villas, The Lough Road, Cork
•Dragon Inn (takeaway), Unit 4, Ashbourne Town Centre, Ashbourne, Meath
•Glanworth Takeaway, Main Street, Glanworth, Cork
•Grace’s Garden (restaurant), Main Street, Shankill, Co. Dublin
•Clarkes (butcher shop), 24 Fassaugh Avenue, Cabra, Dublin 7
•Anu’s Kitchen (restaurant), Unit 3 Glen Abbey Complex, Belgard Road, Tallaght, Dublin 24
•Totu Douglas (Closed area: raw meat butcher counter and deli counter area) (retailer), 2 Church Road, Douglas West, Douglas, Cork

One Prohibition Order was served under the EC (Official Control of Foodstuffs) Regulations, 2010 on:•Michael Walsh and Sons Butcher Shop, The Square, Athenry, Galway
One Improvement Order was served under the FSAI Act, 1998 on:•Bruree Hut (restaurant), Main Street, Bruree, Limerick
Meanwhile, in recent months and separately to the orders above, there were two prosecutions taken by the Health Service Executive in relation to:•Inishowen Frozen Foods (standalone temperature controlled storage), Culkeeny, Malin, Donegal
•The Loft Bar (public house), Ballyconnell Road, Falcarragh, Donegal. For offences observed on July 27, 2017 and August 31, 2017, convictions were secured against Frank Gallagher and Aaron McGarrigle. They were fined €400 and €500 respectively. The Loft Bar is now under new ownership.
Commenting today, Dr Pamela Byrne, Chief Executive of the FSAI, said the onus is on food businesses to ensure they protect the health of their customers by always strictly following food safety legislative requirements.
“It is somewhat alarming that 15 Enforcement Orders were required to be served on food businesses in the month of July. The legal responsibility for producing food that is safe to eat rests firmly with food businesses.

Back to School Food Safety Tips
Source :
B Linda Larsen (Aug 7, 2018)
It’s almost time for the new school year to begin. As parents start to prepare, it’s important to consider back to school food safety if you pack lunches or snacks for your child. The government is offering tips on keeping your children safe from foodborne illness.
It’s important that you always use an insulated carrier to pack the food your child takes to school. If the lunch or snack contains a perishable food such as meat, eggs, cheese, or yogurt, always use at least two cold sources in the insulated carrier. You can use commercial freezer packs, frozen juice boxes, or frozen water containers. The last two will thaw in time for lunch while it keeps the temperature in the carrier below 40°F.
Never use a paper bag to pack lunches or snacks for your child. Perishable cold foods can become unsafe to eat if held above 40°F for two hours. That safe time period shrinks to 1 hour if the ambient air temperature is 90°F or above.
Back to school food safety is also true with hot foods. Any soup, chili, stew, or casserole should be placed in an insulated container to keep it above 140°F. Fill the container with boiling water, let it stand for a few minutes, empty it, then add the food that is at least 160°F.
You can pack a lunch or snack that contains cold food the night before, but don’t put it into the insulated lunch box until that morning. The meal or snack will stay cold longer because everything will be well child when it’s put into the lunch box. You can pack the food into the insulated container the night before, but leave the container open so cold air can circulate around the food.
If you are packing snacks for a team, scout troop or group, keep perishable foods in a cooler with cold packs or ice until it’s time to eat. Pack snacks in individual bags or containers. Don’t have the children share food from one serving dish, because pathogenic bacteria can bee transferred person-to-person.
Finally, pack disposable wipes for washing hands before and after eating. And tell your child to discard all leftover food, paper bags, and used food packaging after the lunch or snack is eaten.

New Demands for Data Require Paperless Approach
Source :
By Agrian (Aug 7, 2018)
New Demands for Data Require Paperless Approach
It’s a challenging time to be a food processor. New pressures—driven by food safety concerns, sustainability programs, and issues surrounding exporting like constantly changing maximum residue levels (MRLs)—are creating demands on processors like never before. Demands to produce and manage require something else: data.
Food processors today are faced with the reality that they need to have reliable, accurate, and documented data from their growers available at the drop of a hat to protect their brand and standing in the market. Electronic data collection, management, and sharing can help everyone along the food chain to trace commodity inputs from field to fork. With more than 200,000 users, Agrian is the food processing industry's premier choice for recording, tracking, and sharing information. Quite literally, if it’s grown and goes into the food stream, Agrian can help.
Food chain traceability sounds simple enough to the consumer, but for those of us in the industry, we know that it is a complex issue. It requires consistent standards and advanced technology in a rapidly expanding world of data. In addition, food processors often work with hundreds of growers, their crop consultants, and crop input applicators. Agrian provides simplification to this complex challenge: a centralized system that streamlines communication among all constituents—allowing everyone to push their information into a single repository.
This central hub, Agrian’s Documented Processor Account, has become an indispensable tool for grower management by many food processors’ field departments. It enables a food processor to track cultural practices during the growing season ito dynamically and securely share field-level crop data among growers, processors, and government-reporting agencies with pinpoint accuracy.
“Agrian has received considerable adoption from both field-level users and processors, making sharing growing practices and answering, ‘What happened in the field?’, as easy as pressing a button,” says Richard Machado, president, Agrian Inc. “We call it the ‘network effect.’ Growers, crop consultants, and applicators can simply log into Agrian’s web-based service and share product use reports (PURs) directly with food processors. These electronic submissions eliminate the need for repetitive data entry and painful paperwork. Processors can also generate detailed reports in their account, or easily integrate the data into their own ERP [enterprise resource management] system for more flexibility.”
Good Field Data = Risk Mitigation
An Agrian Documented Processor Account also helps mitigate risk, as it helps manage the data needed for compliance  reporting. Growers and processors can know exactly which crop protection products were used, the dates applied, and other essential application details. Data are easily queried to render the preharvest interval (PHI) to clear a field for harvest. Within an account, users can even customize a list of crop protection products to check against during the season or at harvest, and the list can be updated in real-time.
In addition, customized crop forecasting formulas can be created using the Agrian system. A detailed geographical information system and global positioning system mapping of all growing sites allow for the identification of potential hazards from surrounding crops or other sources.
“The Agrian system really does help us meet food retailers’ demands for grower-specific information,” says Donald Drake, a food safety/field services specialist for Stemilt’s cherry processing operation in California. “About 75–80 percent of our growers use Agrian’s reports, because the Agrian system makes it easy to convert recommendations into PURs. Since every retailer is asking for traceability assessments, and each one has their own database, data input can be very time-consuming. Having a central repository for the data needed for reporting saves considerable time.”
Drake also notes using the Agrian platform as a helpful tool in forecasting or determining the tonnage coming into the warehouse, as well as a means to access weather data to study trends and help predict incoming volumes.
“One of the results of the Food Safety Modernization Act is an increase in the number of food safety audits being conducted,” says Machado. “Collecting field data is more onerous—and important—than ever before for food processors. Ensuring that field activities meet compliance requirements hugely impacts processors’ bottom lines. For example, if MRLs are exceeded in production, the market for an export crop could be dramatically limited. So not only tracking and sharing data, but also having a reliable source for chemical and pesticide use guidelines and restrictions are critical up and down the food production chain.”
With more than 11,000 indexed labels, the Agrian database is the largest manufacturer-indemnified database in the world. The label database features crop-specific rates, re-entry, and PHl timelines, and it is a valuable tool to check against any standards or controls established internally.
Special Capabilities Designed for Food Processors
For the food processor, Agrian’s web-based, subscription-based service means no expensive new software and efficient implementation. An Agrian Documented Processor Account offers several clear benefits:
Grower Management
Agrian takes communications among food processors, growers, crop consultants, and applicators and allows everyone to use one system to push their information into a single place. It's an easy, flexible solution—an Agrian Processor Account can be linked with any grower, crop consultant, or applicator that uses the system. Processors pay only to communicate with those who use the Agrian solution.
For processors, harvest time means a flurry of activity—and a blizzard of paperwork. Agrian streamlines the electronic transmission of data and provides a robust electronic compliance check on all the data submitted at harvest and throughout the season. The Agrian solution reduces risk by removing the human element in checking to make sure that label instructions, government regulations, and cultural practices were correctly followed.
Agrian Mobile (available via iPhone or iPad app) allows grower reps to develop customized record-keeping and/or cultural practices programs that are easily accessible by growers, crop consultants, and applicators in the office and directly in the field. From their mobile device, users can access Agrian’s label database and field data—map, track, and record notes on each visit to the growing site during the season.
“Data is—and will remain—central to our business,” says Drake. “Putting numbers behind management decisions is key. At Stemilt for example, we are adding more weather stations at the field level to make decisions on spray timings. We are adding soil moisture monitors to make better irrigation decisions. And while we are still a few years away from an ‘as applied’ approach here in our California cherry orchards, the industry is heading that way. It’s critical we stay up-to-date with the tools needed to keep pace.”
To learn more about Agrian and its capabilities, contact or visit

Wrapping Food Packaging Law into Bite-Size Pieces
Source :
By Kate Malvetti (Aug 7, 2018)
Wrapping Food Packaging Law into Bite-Size Pieces
Federal laws, third-party food safety certifying agencies, and customer regulations all play key roles in what knowledge you have today regarding food contact packaging rules. Let’s start with some facts and unravel some common misconceptions. Table 1 provides an overview of commonly used materials for food contact packaging and some key information about each.
Fact or Fiction? FSMA applies to food packaging manufacturers
Fiction: Food Safety Modernization act (FSMA) rules do not apply to the manufacturers of food contact materials (bottles, food service containers, cans, etc.).
While packaging does not fall under the umbrella of FSMA, it does fall under a different set of U.S. Food and Drug Administration (FDA) regulations located in Title 21 of the Code of Federal Regulations (C.F.R.) in parts 174–179 and 186. This is where the regulations for indirect food additives, including food contact packaging, are found. The category of indirect food additives also includes adhesives and components of coatings, paper and paperboard components, polymers, adjuvants, production aids, sanitizers, and irradiation processes.
What are food contact packaging manufacturers required to do per federal law? First, comply with Good Manufacturing Practices (GMPs), although, not the GMPs with which food manufacturers are familiar. GMPs are summed up in the following sentences about food contact packaging materials: Ingredients must be suitable for their intended purpose and chemicals within packaging/from the process cannot exceed levels defined as safe by FDA (these levels are specified in the above referenced sections of the C.F.R. for various materials).
At a minimum, food packaging manufacturers must comply with the federal regulations outlined above. Building on the basic premise posed in the law, third-party agencies—both Global Food Safety Initiative (GFSI)-benchmarked and not—came up with their own standards of rules and best practices that food contact materials must comply with to attain and maintain their certification. The commonly used GFSI schemes all have a food packaging standard to which companies can become certified to provide more of a facility-focused inspection and certificate of compliance. Third-party food safety audits are technically optional, but it may be required of a packaging company to have some type of certification per customer requirements. This may be obtained either via a third-party audit or customers may prefer to directly audit their suppliers themselves and issue their own standards for compliance. The variation here boils down to who is buying the packaging materials and what is required.
Today, there isn’t much meat in the regulations for food contact packaging manufacturers in terms of the basic food GMPs and Hazard Analysis and Critical Control Points principles that are second nature to food manufacturers. Striving for increased food safety and the security of the U.S. supply chain is a trend that isn’t going to waver in the years ahead. To get ahead of regulations, training everyone, from front-line workers to management, on basic food safety principles at food contact packaging companies is highly recommended, as packaging is key to consumer safety and the maintenance of a high quality, consistent product.

Updated Food Safety Training, Solution for Upcoming FSMA Challenges
Source :
By Mehrdad Tajkarimi, D.V.M., M.P.V.M., Ph.D. (Aug 7, 2018)
Updated Food Safety Training, Solution for Upcoming FSMA Challenges
The demand for increasing awareness of the Food Safety Modernization Act (FSMA) has never been greater, and with this demand comes an increasing requirement for training to facilitate a proper food safety management system. To meet these demands, the industry needs to see dramatic improvements in the quality and quantity of food safety trainings. While the cost of training is high, it is negligible compared to overall costs of a product recall or possible food safety-related health issue raised from consuming an unsafe food product.
There are several challenges ahead for proper food safety training at all levels and job descriptions; these challenges include, but are not limited to, numbers of training hours, type, content, and facilitation procedures. Applications of customized base training, mass custom training, and tools such as e-leaning could have dramatic impacts on food safety management systems, improvements in FSMA compliance, and employee productivity.
Successful training programs are based on the following three steps for the development of a customized base training (Figure 1):
Step 1: Develop a list of specific company knowledge and skill requirements based on employee hierarchy (the company input)
Step 2: Develop clear educational objective(s) specific to the required knowledge and skills including, but not limited to, employee level, content, time, quantity, and training goals (trainer input)
Step 3: Develop a detailed course curriculum verified by company human resources and management, incorporate their recommendations, and then proceed (both trainer and the company)
Training Tools for Improving FSMA Compliance
There are several tools to improve an effective food safety program. The most productive food safety training program requires a matrix-based educational system addressing FSMA priorities. Examples of food safety educational improvement objectives could be awareness about food temperature, safer handling of utensils and products, proper cleaning/sanitizing, and general food safety principles. The training content could be designed based on two main learning categories: constructive and authentic.
The constructive content learning method assumes students have a prior education related to the topic (in this case, food safety) and will construct additional learning based on previous information. This approach enables the connection of new information to prior knowledge using variety of educational tools.
The authentic content learning method assumes that student do not have prior education related to food safety and will learn the content for the first time.
Either method could be developed to encompass five distinct food safety training levels:
Level 1: Entry
Both Constructive and Authentic: All learning is received through the instructor with little room for interpretation as most tasks involve memorization.
Level 2: Adoption
Constructive: Educational and technology learning tools (such as graphic organizers) are used to build on prior knowledge and construct meaning.
Authentic: Technology tools are incorporated to develop some content specific activity.
Level 3: Adaptation
Constructive: Educational and technology tools are used independently to learn and build related knowledge.
Authentic: Educational tools and technology are used to develop activities that are beyond the instructional setting.
Level 4: Infusion
Constructive: Technology tools are used in a way that makes for an improved version of understanding.
Authentic: Technology tools are used to achieve goals beyond instructional setting.
Level 5: Transformation
Both Constructive and Authentic: Educational tools and technology allow exploration and extension in projects that may have been impossible without.
In the examples below, we use the above definition to develop a personal hygiene training course in a facility:
Personal hygiene operation: Constructive Learning (Entry)
Course Description: This professional development course gives an overview of basics of personal hygiene and its effects on food safety, which helps familiarize students with general personal hygiene practices as a food safety management system requirement. This characteristic is concerned with the flexible use of technology to build knowledge in the modality that is most effective for each student.
Course Goals: This class aims to teach the basic principles of personal hygiene, so that students will be able to utilize best personal hygiene practices to build on prior knowledge and construct meaning.
Target Audience: This course is designed for staff involved in receiving, processing, storage, and shipping, retailers and suppliers, dairy plant managers, corporate office staff, as well as those who require retraining, as defined by the customer.
Course Resources: Will be determined
This course will include 2 hours of a better food hygiene practice and methods of transmitting pathogenic microorganisms plus 1 hour of proper documentation and weekly incentives for a better personal hygiene.
Personal hygiene operation: Authentic Learning (Entry)
Course Description: This professional development course gives an overview of basics of personal hygiene and its effects on final product food safety, and familiarizes students with general personal hygiene practice as a food safety management system requirement. This characteristic is concerned with the flexible use of technology to build knowledge in the modality that is most effective for each student.
Course Goals: This class aims to teach the basic principles of personal hygiene, so that students will be able to utilize best personal hygiene practices, placing learning into a meaningful personal hygiene context while increasing personal hygiene relevance to the learner, tapping into students’ intrinsic motivation.
Target Audience: This course is designed for staff involved in receiving, processing, storage, and shipping, retailers and suppliers, dairy plant managers, and corporate office staff who are new hires or require instruction pending employment.
In conclusion, developing a written educational strategy that identifies the target audience(s), skills, and knowledge, and conducting an effective implementation program is critical for building an effective food safety management system for FSMA compliance. Given several examples of failures in food safety programs resulting in foodborne outbreaks, it is clear that prevention, through a productive and comprehensive food safety education and written program, is essential. The overall cost of these types of advanced educational programs is minimal when one considers the benefits to product quality and safety, and the significant expense of product destruction, lost utility, and market withdrawal.
Critical to implementation of an effective employee training program is the incorporation of cutting edge technology, subject matter experts developing the training material, use of modern video technology, and a positively reinforced testing/training accountability program. Creating dynamic and informative training is difficult, particularly when considering multiple levels of prior knowledge, experiences, and variations in job descriptions. Use of an outside expert who is well-versed in review and improvements to food safety training programs will enable more confidence in the food safety management system’s effectiveness and resulting FSMA compliance.
Mehrdad Tajkarimi, D.V.M., M.P.V.M., Ph.D., is an expert in national and international food safety regulations, warehouse and wholesale manufacturing, and the dairy, grain, poultry, and retail industries. He assists clients with organic requirements, FSMA, and natural food preservatives and packaging, foodborne pathogenic and spoilage microorganisms characteristics, and shelf life studies. He is an independent consultant to the EAS Consulting Group.

Deadly Romaine Lettuce E. coli O157:H7 Outbreak May Be Linked to Cow Feces
Source :
By News Desk (Aug 7, 2018)
The FDA just updated their investigation into the deadly Romaine lettuce E. coli O157:H7 outbreak this summer that sickened 210 people in 36 states and killed 5. Ninety-six people were hospitalized, including 27 who developed hemolytic uremic syndrome (HUS), a type of kidney failure. It seems that canal water in the Yuma Arizona growing region is close to a Concentrated Animal Feeding Operation (CAFO).
In other words, it’s likely that cow feces contaminated with the pathogenic bacteria got into the canal water that irrigated the romaine lettuce fields in that area.
CAFOs are huge cattle operations that can hold more than 100,000 head of cattle at any one time. There is a cluster of romaine lettuce farms nearby. The Environmental Assessment report the FDA is working on will be made publicly available when it is complete.
Cows and other ruminant animals can carry E. coli O157:H7 bacteria in their guts. The bacteria does not make the animals sick. But the pathogens are released in the animals’ feces, where it can contaminate the environment the cows live in. The feces can then wash downstream to streams and canals and that water will be contaminated.
Government officials declared that the deadly E. coli O157:H7 romaine lettuce outbreak is over as of June 27, 2018. The illnesses in the outbreak can’t be explained by a single grower, harvester, processor, or distributor. But CDC analysis of canal water in the region found the outbreak strain of E. coli O157:H7 bacteria. More strains of E. coli were found in water and oil samples in the area.
Food safety attorney Fred Pritzker, who has represented many clients sickened with E coli O157:H7 infections and HUS, said, “It doesn’t take a genius to recognize the danger of having a 100,000 head of cattle in close proximity to irrigation canals that service a huge swath of prime produce growing fields. More importantly, it also points to the need to carefully monitor and test irrigation water in real time. ‘Too big to fail’ is not a valid food safety system, especially when the food product is not exposed to a kill step.”
This outbreak may be larger than officials suspect. Some people may not have heard of the outbreak, or haven’t been to a doctor for a diagnosis. If you ate precut romaine lettuce this summer and have been ill with symptoms of bloody diarrhea, severe abdominal cramps, and nausea, you may be part of this deadly romaine lettuce E. coli O157:H7 outbreak. See your doctor for a diagnosis.

Equipment, manpower deficit hobbles Valley’s Food Safety on Wheels program
Source :
By ZEHRU NISSA (Aug 7, 2018)
The food safety vans, which are meant to provide instant and mobile food testing service in J&K to ensure quality of commodities in market, are not being put to use since March 2018, due to lack of proper equipment and manpower shortage.
A report by Food Safety and Standards Association of India (FSSAI) has revealed, no monthly progress report (MPR) has been sent by the DFCO to FSSAI, the central regulatory authority, in past six months as mandated under food safety laws.
The progress report of states uploaded by FSSAI on 25 July, latest one available, states “MPR pending for May and June 2018” for J&K. In May, the FSSAI report stated “MPR pending for March, 2018”.
When contacted Commissioner food safety J&K, Dr Abdul Kabir Dar agreed that work output of food safety on wheels was low. “There was some problem with technical staff as well as drivers,” he said, adding that the issue had been “sorted out recently”.
He said the department had sourced technical staff from health department to run the mobile labs and to “fill the gaps”.
“We have roped in an agency to train the staff and the vans will become fully functional in a month,” the commissioner said.
Currently, he said the vans were being used for “transportation of samples, do basic testing and create awareness, especially in peripheral areas”.
A source in the department said the reports were not being sent on a regular basis because of “inadequate output” of these testing labs.
“These are merely vehicles without requisite equipment and manpower for testing. That is a big hurdle,” the source said.
Sharing details he said the equipment that has been fitted in the van for milk testing was able to give a report only on whether water has been added to it or not.
Moreover, the machine is not fit to test processed milk available in market, local and from other states. “It can only test solid fat and non solid fat in raw cow’s milk,” he said. He said other types of milk, toned, pasteurized, packaged, was out of the ambit of testing due to lack of facility.
 Similarly, for testing edible oil, the equipments fitted in the vans have provision to give only refractive index of oil. It cannot detect impurities and adulteration. The same is case with water testing.
An official of the department said that manpower engaged to run the equipment in mobile vans was also not “adequately trained”.
This has also been corroborated by FSSAI, which in its May status report stated that in J&K “Training and awareness programs (for mobile testing vans) are also not being undertaken”.
The program, which cost state Rs 2.4 crore, was flagged off in J&K in March 2017 to improve infrastructure for food testing in state.
While Rs 1.75 crore had been allocated by the state government for procurement of five testing vans, Rs 60 lakh was given by FSSAI for two of the mobile labs fitted with “high tech” equipment to detect adulteration and quality of food samples on the move in market and food business operators.

Who knows their bugs?
Source :
 By Nichola Murphy (Aug 7, 2018)
Outbreaks of food poisoning have resulted in product recalls, illnesses and even deaths. So are we educated enough about food poisoning and do we truly understand the importance of food safety? Research from the UK and New Zealand suggests there is still more to be done in this area.
The seriousness of food safety is made apparent by the number of foodborne outbreaks worldwide. 21 people became ill with Salmonella Havana linked to alfafa sprouts in South Australia, at least 183 South Africans have died after eating Listeria-contaminated polony and nine deaths have been caused by an outbreak of Listeria from frozen vegetables in Europe.
The Food Standard Agency’s (FSA) recent biannual public attitudes tracker surveyed 2000 consumers in England, Wales and Northern Ireland to understand attitudes towards food-related issues and the FSA.
Surprisingly, food poisoning was not the highest food safety concern (28%). Instead, the survey found 33% of consumers were concerned about food hygiene when eating out, 30% about chemicals from the environment such as lead in food and 29% about food additives.
It found that Salmonella and E. coli are the most known types of food poisoning, capturing the awareness of 91% and 85% of consumers respectively. Norovirus (56%), Listeria (51%) and botulism (46%) also featured near the top of the list, but despite being the most common cause of food poisoning in the UK, only 24% of respondents were aware of Campylobacter.
Respondents perceived raw chicken or turkey to be the most likely source of food poisoning (79%), followed by shellfish (55%), reheated takeaway food (46%) and eggs (37%).
Bacteria doesn’t change the appearance or smell of food, but there are a number of ways to reduce the risk of food poisoning. Consumers believed that the best way was cooking food thoroughly, but the survey found that awareness of hygiene standards when eating outside the home is 82%, which is a 4% decrease since May 2017. Just under half of respondents were concerned about food safety in UK restaurants, pubs, cafes, takeaways, shops and supermarkets.
According to the survey, consumers trust accurate food labels, food producers and the FDA to uphold safety standards. Of the 79% of respondents aware of the FSA, 69% trusted it to do its job and 72% trusted it to provide truthful information.
Similar research was also recently conducted in New Zealand, focusing on food safety from the business’s perspective.
Research commissioned by the Food Safety Assurance and Advisory Council (FSAAC) and the Ministry for Primary Industries (MPI) analysed how New Zealand food businesses were implementing and maintaining food safety cultures.
Drawing on a telephone survey with 900 business decision-makers, an online survey with 193 food safety staff and 20 qualitative interviews with business decision-makers, the research looked at six dimensions of food safety culture. These were: leadership; managers demonstrating visible commitment; accountability; sharing practice and knowledge; following best practice and understanding; and confidence.
“Food safety must be treated as a way of doing business and not just something that is discussed at a weekly meeting,” said the Chair of the FSAAC, Michael Ahie. “This initial research provides a baseline that will be valuable for tracking improvements over time.”
The research revealed that 95% of businesses said they had policies in place to identify and deal with food safety risks, but only 69% had specific food safety goals and key performance indicators.
Customer safety was also a top priority, and three quarters of employees said there was good leadership which visibly showed support for food safety.
However, the research found that there needs to be more shared responsibility across the supply chain, better communication from managers and more reward programs. Only 3% of food businesses reported data on their food safety performance back to their employees and 13% had a formal reward system for staff who identified problems.
New Zealand Food Safety’s Director of Food Regulation, Paul Dansted, said most food businesses “have an inherent sense of pride in what they are doing and are motivated to build and maintain a good reputation for their business”.
While there is an overall strong commitment to food safety, he said the research helps identify potential areas for improvement. New Zealand Food Safety plans to release a food safety guide this month aimed at boards, directors, chief executives and business owners.
Whether the responsibility falls on the business or the consumer, these pieces of research highlight there is room for improvement in regard to upholding food safety and minimising the risk of illnesses.

Current State of Intentional Adulteration
Source :
By The Food Protection and Defense Institute
Current State of Intentional Adulteration
The last century has seen significant changes in our food production and consumption. The early 1900s were met with global challenges in world wars, economic depression, and food rationing. Rapid production and technology growth in the second half of the twentieth century introduced advanced capabilities in food production including advances in preservation and packaging. These changes, along with advances in transportation, moved consumption patterns of food from local to global sourcing. Today, our global food system is a complex, integrated system of systems. While we will need to produce a lot more food to feed an estimated 9 billion people by 2050, we can’t ignore the threats to our food supply from adulteration.
With the terror attacks of 9/11 seventeen years in our rearview mirror, response structures have evolved and funding scenarios have changed. The limited economic environment at all levels of government presents new challenges for maintaining and protecting critical infrastructures, including food and agriculture. In the food and agriculture sector, a multitude of factors complicates the task of protecting and maintaining critical infrastructure. Food is produced, harvested, processed, formulated, packaged, and transported through an interconnected network from farm to fork, with challenges presented through global production, just-in-time delivery, and evolving consumer demands.
Whether at a restaurant or processing facility, intentional adulteration perpetrated by disgruntled employees, terrorists, or those motivated by money can happen at any time. No doubt you’ve seen past headlines:
“Factory worker sentenced for lacing seafood with malathion”[1]
“Woman draws jail sentence for contaminating chicken in 2016”[2]
“Michigan Man Charged With Sprinkling Poison on Food at Stores”[3]
“Extortionist seeking millions by poisoning supermarket food: German police”[4]
Intentional adulteration of food did not diminish in 2017. Adulteration cases of spices with undeclared ingredients to extend the product or boost color were documented.[5] Terrorists’ plans and food adulteration tests were uncovered and publicized.[6] As evidenced by the headline above, a German man threatened to put antifreeze in the nation’s baby food supply chain. Disgruntled employees continued to adulterate food to get revenge on their employer or coworkers.[6]
We hear about terror attacks or foiled terror attacks involving explosives with increasing frequency. However, a 2017 incident in the UK is one of the first we’ve seen where an intelligent adversary met all three conditions of the food defense triangle to present a threat—motivation, capability, and insider access to vulnerable food production.[7] In this case, two people were found guilty of preparing for a terrorist attack, including ties to a terrorist organization and the manufacture of ricin. One of the two was employed by a major food manufacturer. Inside attackers with legitimate access to our food systems exist, and even though we may not be able to influence their motivation and capability, we can certainly mitigate the vulnerabilities to the resource we depend on for life.
Given the complexity of our food system and limited transparency of supply chains from farm to fork, those willing and able to adulterate will continue to do so in 2018. Certain trends or issues like consumer demands, global supply chains, and disasters create new opportunities and motivations for adulteration or increase vulnerabilities in the food system. However, we can all work together to decrease the vulnerabilities and risks of intentional adulteration through continued research and outreach, conferences and networking, and employee and public education, and training.
Consumer Demand
We speak with our dollars spent. And food companies listen. Food production is driven by consumer purchasing, whether it is a flavor trend—sriracha-flavored almonds—or a perceived health benefit—Golden Milk (juice with turmeric). Look at your local grocery aisles and you will find an ever-increasing section of “freedom foods.” These are foods that claim to be free of something, whether it be gluten, lactose, pesticides, or genetically modified ingredients.
With increasing frequency, consumers are also asking questions about the sustainability and agriculture practices of the food they buy: How have the oceans been fished? Are my eggs from cage-free chickens? Does the food I buy protect the environment? Based on current trends, consumers will continue to spend their food dollars on flavor trends, organic, “free of,” and sustainably produced food. Consumers are willing to pay the additional costs for these items, making it a lucrative business for both legitimate food companies and fraudsters.
This means food defense needs to have a keen eye on where those with intent to adulterate could enter the market with products representing these food trends. Such opportunities may come from an evolution in technology or policy where regulation or inspection has not caught up or from the sheer demand of a trendy food product.
Cascading Events of Supply Chain Failure
Today, the food system from farm to fork is a global, highly integrated, and complex system of systems. Failure in one place has ripple effects downstream. When these infrastructure failures stack on top of each other, there are cascading effects that leave the companies without product for the market and consumers without food. For example, a sign was posted in our local grocery not long ago that read:
Sorry for the inconvenience we are currently out of bananas
The causes of the current shortages are many and complex:
•    Typical low winter production from the tropics, exasperated by both flooding and colder than normal temps in Costa Rica.
•    Abnormal Heavy seas causing vessel delays both in delivery to the US and return vessels to reload in the tropics.
•    The same weather front causing heavy seas bringing heavy rains in Guatemala.
•    Political upheaval in Honduras. In addition to unseasonable heavy rains, Honduras has been under political unrest for two months after their election. Now there are major strikes going on causing a very small amount of bananas to leave the country.
The sign single-handedly demonstrates our point. The “banana shortage” is a result of disruptions, including weather events, political unrest, and civil strikes. These precipitated a series of cascading infrastructure and supply chain failures. Extreme weather (flooding and temperature) led to low production. Choppy seas disrupted transportation of product. Political instability in one region of the world resulted in labor challenges. All these factors contribute to significant supply chain disruption. Obviously, the disruption in banana supply affects consumers, but how does it impact protecting our food from intentional adulteration?
Another recent example illustrates how easily intentional adulteration, economically motivated adulteration in this case, may occur with supply chain disruption. A major fast-food chain experienced catastrophic failure in their supply chain as they transitioned to a new transportation company. The fast-food chain has been forced to temporarily close more than 80 percent of their stores in one of their significant markets.[8] This in itself is significant, but when paired with headlines like “Workers filmed smuggling chicken through the backdoor,” damage to the brand grows even more due to the mistrust sown in the consumer mindset about the quality of product in the restaurants.[9]
Intelligent adversaries constantly look for new vulnerabilities to exploit in the food system, whether to make money (economically motivated adulteration, EMA) or cause harm to humans, animals, or brands. A significant shift in supply and demand offers an opportunity for adulteration when there is less product available in the marketplace. It is imperative that we start integrating our information and make sense of what it is telling us to make evidence-based decisions. While the banana shortage case is one example among many (e.g., transshipment of product, species substitution of meat and fish), it is a great example of predictable surprise. The concept articulated by Bazerman and Watkins[10] defines these circumstances as “an event or set of events that take an individual or group by surprise, despite prior awareness of all of the information necessary to anticipate the events and their consequences.” With data and computing power available, we can, and need to, identify these cascading infrastructure failures sooner. We can prevent and mitigate catastrophic consequences of adulterated food. This critical work of “sense making,” or putting disparate information pieces together to share a complete picture of potential or actual disruption, is the focus of projects like the Food Protection and Defense Institute (FPDI) Focused Integration of Early Signals.[11]
Current State of Food Defense
“Food defense” is the sum of actions and activities related to prevention, protection, mitigation, response, and recovery of the food system from intentional acts of adulteration. We have seen global expansion of food defense activities to counter all motivations of intentional adulteration (terrorism, sabotage, and EMA). Typically, there has been some intentional adulteration threat or event that has led countries around the world to change their food defense posture. In the UK, the 2013 horse meat scandal created reform to address this issue, which led to EU funding for food integrity.[12] New Zealand initiated its reform in 2015 after a blackmail case where the perpetrator threatened to lace infant formula with a pesticide. Some countries have added policies under their food safety laws and others have labeled this work as food protection.
In the U.S., the Food Safety Modernization Act (FSMA) initiated the largest food policy reform in decades. Two of the published U.S. Food and Drug Administration (FDA) rules relate to food defense activities. EMA must be addressed under the Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food rule. EMA is considered a hazard that is reasonably foreseeable, and companies must develop preventive controls to address the risk. The second rule related to intentional adulteration is the Mitigation Strategies to Protect Food Against Intentional Adulteration rule, which requires, for the first time in the United States, that food companies develop a plan to defend and protect the food system from terrorism and acts by insiders with legitimate access that may cause wide-scale public health harm.
The Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration, also known as the Intentional Adulteration or “IA” rule, requires FDA-registered food facilities to identify specific vulnerabilities in their facilities that could allow someone with bad intentions to deliberately introduce an adulterant. This vulnerability is named an actionable process step by the IA rule. Food companies must also create a food defense plan to prevent or mitigate those vulnerabilities at the actionable process steps. The IA rule also requires that employees who work at actionable process steps in food facilities must have:
•    Education, training, and necessary experience to perform their responsibilities
•    Knowledge of the mitigation strategies at the actionable process step
•    Training in food defense awareness
Any employee who is responsible for an identified actionable process step in a food facility—and the supervisors of those employees—must complete food defense awareness training. Furthermore, any employees responsible for writing the parts of a food defense plan (e.g., vulnerability assessment, assignment of mitigation strategies, plan reanalysis) will also have to complete appropriate topical training to perform the task according to regulation and guidance.
What Can Food Companies Do Now?
Compliance with the IA rule for many food companies will be required in July 2019. To prepare, companies should take time in the next 12 months to strategize and initiate activities that will be required for compliance. One approach is to start small by taking a single food product and considering the following:
Assess: How much information is already available through past food safety and food defense planning? Identify and document where action may be needed.
Understand Hazards: Select a food product and document the hazards that may affect this product. Think outside the typical safety hazards. What could cause harm beyond the normal concerns you have? Consult incident reports, published literature, and known cases. Have you considered introduction of pesticides, undeclared allergens, or cleaning and sanitizing agents?
Assess the Supply Chain: Map the supply chain of the food product including the supply chain of ingredients. Where is the product coming from? Indicate how it travels and where there are inspection points. Can you document all the way back to “farm”?
Plan: Do you have a food defense plan? If yes, evaluate to see that it meets the requirements of the IA rule. Does it consider all hazards identified above the transportation network? Determine the last time the plan was challenged or exercised; was it more than a year ago? If no, find a resource to aid your planning (e.g., FDA Food Defense Plan Builder, U.S. Department of Agriculture, FPDI). Determine who within the food company can initiate a food defense plan and start identifying and prioritizing where vulnerabilities need to be mitigated first. Create a timeline for development and review.
Conduct Vulnerability Assessments: Evaluate the production of the food product to determine where it may be susceptible to intentional adulteration.
Determine Actionable Process Steps: From the vulnerability assessment, identify the processes during food production where mitigation strategies can be applied and are essential to substantially minimize or prevent the significant vulnerability.
Mitigate: Identify mitigation strategies for each actionable process step based on your assessment. FDA has a database of mitigation strategies13 that may be helpful. Next, determine the cost of those strategies and prioritize what strategies should be implemented first. Finally, initiate a plan to implement selected strategies.
Educate and Train: Different team members need various levels of training or awareness. Identify who will have a role in food defense and align the appropriate training. There are many training opportunities already available at the FDA Food Defense website. In addition, FPDI offers a variety of in-person food defense trainings14 as well as a food defense awareness online training15 for those looking to be trained from the comfort of their home.
The Food Protection and Defense Institute
In 2004, the Department of Homeland Security (DHS) created the FPDI. The institute was formerly known as the National Center for Food Protection and Defense. It was one DHS Center of Excellence established to evaluate and research the terrorist threat to the homeland. Over the past decade, the work at FPDI has evolved to consider food system disruption regardless of motivation. Today, FPDI operates with a mission of “Providing the highest impact innovation, education, and outreach to defend the global food supply.” By taking a comprehensive farm-to-table view of the food system, encompassing all aspects from primary production through transportation and food processing to retail and foodservice, FPDI’s work addresses both the vulnerabilities requiring assessment by the IA rule and vulnerabilities throughout the food system.
FPDI’s research and education programs aim to reduce the potential for contamination at any point along the food supply chain as well as the mitigation of potentially catastrophic public health and economic effects of such attacks. FPDI’s programs incorporate cutting-edge research across a wide range of disciplines, including supply chain management, logistics, epidemiology, risk assessment, economics, molecular biology, food microbiology, biomedical engineering, toxicology, information sharing, supply chain security, cyber security, and risk analysis.
FPDI education professionals and subject matter experts have extensive experience in designing, developing, and delivering a continuum of food defense training. FPDI also offers in-person programs developed to address food defense needs at all levels within an organization—entry level to C-suite—and across a variety of disciplines: national to local government, law enforcement, food manufacturing and retail, supply chain and logistics, and foodservice, catering, and restaurants.
In addition, a variety of training opportunities and course offerings are available that address FSMA IA training requirements, FSMA Preventive Controls requirements regarding EMA, increasing awareness of food defense on a global scale, understanding and applying food defense principles, identifying food defense vulnerabilities, creating tailored food defense plans, and challenging preparedness and response planning. FPDI’s programming supports industry, government agencies (law enforcement, emergency responders), nongovernmental organizations, international partners, undergraduate and graduate students, and educators. FPDI strives to provide strategies for prevention, mitigation, response, and recovery from potentially catastrophic public health and economic effects of attacks on our food supply.
Food defense is a critical aspect of ensuring the availability of safe, nutritious food on a global scale. Our food systems are a global, complex, interconnected system of systems. Defending this system, the integrity of the food produced by it, and the health of the public it feeds, from malevolent actors—both terrorist and criminal—requires engaged collaboration from all stakeholders, including domestic and international food producers, academic researchers, nongovernmental organizations, and many government agencies. This collaboration must include sharing information and robust discussion about 1) the latest scientific advances in detection, risk and vulnerability assessment, and prevention and response methods; 2) analysis of emerging threats and important evolutions in long-standing ones; and 3) emerging regulatory and policy issues. These activities, accomplished through work initiated at FPDI, are critical for advancing food defense knowledge and achieving the coordination of effort required to successfully protect the food supply and public health.   
The Food Protection and Defense Institute (FPDI), formerly known as the National Center for Food Protection and Defense, was officially launched as a Department of Homeland Security Center of Excellence in July 2004 at the University of Minnesota. Developed as a multidisciplinary and action-oriented research consortium, FPDI addresses the vulnerability of the nation’s food system. FPDI takes a comprehensive, farm-to-table view of the food system, encompassing all aspects from primary production through transportation and food processing to retail and foodservice.

The Foreign Supplier Verification Program: Boon or Bane?
Source :
By Dr. Ramakrishnan Nara
As the population of the U.S. becomes ethnically more diverse and their appetite for a variety of foods becomes insatiable, there is a growing need to import a greater variety of food products. The U.S. imports food products from more than 90 countries. More than 20 percent of the total food supply in the U.S. is imported (70% of seafood and 35% of fresh produce available in the U.S. are from other countries). Of these importers, 70 percent are small business entities. The data in Tables 1 and 2[1] provide information about the value of imports from the top 10 importing countries and the value of food product categories coming through U.S. ports, respectively.  
High-profile food safety incidents from 2000 to 2010 prompted Congress to implement a series of regulations in 2011—the Food Safety Modernization Act (FSMA)—to protect the food supply chain in the country. Details of the seven rules of FSMA were published widely. According to U.S. Centers for Disease Control and Prevention statistics, foodborne illness strikes 48 million Americans each year, requiring hospitalization for more than 120,000 people and resulting in approximately 3,000 fatalities, particularly for vulnerable groups. The intent of the seven rules of FSMA is to comprehensively and proactively prevent food safety incidents in the U.S. supply chain.
FSMA represents a sea change for food safety, not only in the U.S. but also globally. The focus is on prevention. It will have a dramatic and progressive effect on the safety of the food supply in the U.S. The most important regulation for food importers is the Foreign Supplier Verification Program (FSVP), published on November 27, 2015, with an initial compliance date of May 30, 2017. It contains a new set of requirements for importers.
This article is about the impact of the FSVP on the food production and processing entities in the domestic and foreign arenas, and the challenges that importers face.
What Are the Key Requirements of the FSVP?
The details of the FSVP have been widely published in the print media. However, in the opinion of the author, there is a big gap in understanding, particularly in the food importer community. Therefore, a review of the requirements will be appropriate here. According to the rule, importers are responsible for ensuring the safety of food products they bring into the U.S. for distribution and sale for consumption by the public. The FSVP rule requires importers to perform risk-based activities to verify that food imported into the United States is not adulterated [Section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938] or misbranded with respect to allergen labeling (Section 403 of the FD&C Act) and has been produced in a manner that meets applicable U.S. product safety standards. The rule is flexible in the sense that importers have the flexibility to determine the appropriate verification measures for the foods they import based on food and supplier risks.
The FSVP applies only to importers of food products in the U.S. By definition, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.
The specific responsibilities of importers with respect to food safety include:
•    Determining known or reasonably foreseeable hazards with each food
•    Evaluating the risk posed by a food, based on the Hazard Analysis, and the foreign supplier’s performance
•    Approving suppliers and determining appropriate supplier verification activities based on the risks posed by an imported food and the supplier’s performance
•    Conducting supplier verification activities and taking corrective actions for deviations and discrepancies
It is a requirement that importers import foods only from approved foreign suppliers based on an evaluation of the risk posed by the imported food and the supplier’s performance. However, it does not mean that importers cannot import food products from unapproved suppliers on a temporary basis, as long as these products are subjected to adequate verification activities before importation. Per the FSVP, importers are required to develop, maintain, and follow an FSVP for each food brought into the U.S. from each foreign supplier of that food. This implies that if an importer imports a certain food from a few different suppliers, a separate FSVP would be required for each supplier. Similarly, if an importer imports many different foods from a single supplier, a separate FSVP would be required for each food.
It is also likely that certain importers are also manufacturers/processors. The question is: What is the applicability of the FSVP in such cases? These entities will be in compliance if: 
•    the importer/manufacturer complies with the supply chain program requirements of the preventive controls rules; or
•    the importer/manufacturer implements preventive controls for the hazards in the food as per the requirements of preventive controls rules; or
•    the importer/manufacturer is not required to implement preventive controls under specified circumstances, such as when the type of food could not be consumed without application of a preventive control or when the customer of the importer-manufacturer will minimize or prevent the identified hazards.
Importers must evaluate the risk posed by the imported food and the supplier’s performance every 3 years and keep records of reviews. Evaluation of the identified risks is also mandated when new information emerges about a potential hazard or the foreign supplier’s performance. If the importer receives adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable FSMA rule requirements, then reevaluation of product risks and supplier performance is not required.
To proactively mitigate or eliminate the hazards in imported foods, an importer is required to identify and evaluate the known or reasonably foreseeable hazards for each type of food to determine whether there are any hazards requiring control and document them. The importer is also required to assess the vulnerability of materials/products to food fraud. Importers will have to produce such documentation when required during an inspection by the U.S. Food and Drug Administration (FDA).
Another important requirement of the FSVP rule is that importers must evaluate the performance of their foreign suppliers periodically. It should include foreign manufacturers’ Hazard Analyses, entities responsible for controlling hazards (foreign manufacturer or their suppliers), their food safety procedures, processes, and practices, their compliance with the applicable regulations, and food safety history. It is also possible for the importer to rely on another entity (other than the foreign supplier) to perform an evaluation of risk, so long as the importer reviews and assesses the relevant documentation.
It is again the responsibility of the importer to verify their foreign supplier on a regular basis. You may want to know what type of verification activities would comply with the FSVP requirements. The FSVP rule provides adequate flexibility for importers to meet the requirements that are unique to the products and supplier characteristics. Some of the accepted verification activities are annual on-site audits of the supplier’s facility, sampling and testing, review of the supplier’s relevant food safety records, etc. Annual on-site audits of the supplier’s facility are required when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (a SAHCODHA hazard). However, the importer can also choose other means of verification, provided the alternate choice will ensure that the foreign supplier is producing the food in accordance with applicable U.S. safety standards. An importer can also rely on another entity to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.
Taking appropriate corrective action by importers is the last piece of the puzzle in meeting the FSVP requirements. At times, an importer’s verification activities may provide evidence that a foreign supplier has not provided the same level of public health protection as required under the Produce Safety and Preventive Controls rules. This should promptly trigger corrective actions at the importer’s end. The appropriate corrective measure will depend on the circumstances and may include discontinuing the use of the foreign supplier.
The FSVP rule requires importers to provide the name, email address, and unique facility identifier (UFI) for each line entry of food product offered for importation into the United States. FDA has recognized the data universal numbering system (DUNS) number as an acceptable UFI for the FSVP. If the importer is temporarily unable to obtain the DUNS number, FDA intends to temporarily allow filers to transmit the value “UNK” (“unknown”) in the UFI field. This option began May 30, 2017, so that food offered for import could be processed through the Customs and Border Patrol automated commercial environment system, even if the importer has not yet provided a DUNS number.
Are There Exemptions from FSVP Rules?
Importers of the following categories of food products do not have to comply with the FSVP rule:
•    Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Points (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations
•    Food for research or evaluation
•    Food for personal consumption
•    Alcoholic beverages and certain ingredients for use in alcoholic beverages
•    Food that is imported for processing and future export
•    Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards)
•    Certain meat, poultry, and egg products regulated by the U.S. Department of Agriculture (USDA) at the time of importation
Who Is Eligible for Modified FSVP Requirements?
In certain cases, importers need not comply with all the FSVP requirements. The criteria for modified FSVP requirements are listed below.
Dietary supplement importers: Importers complying with the requirements of 21 C.F.R. Part 111 (Current Good Manufacturing Practices) regulation will be required to comply with the modified requirements. Importers of other dietary supplements would be required to comply with the standard FSVP requirements (except the Hazard Analysis requirement).
Very small importers and importers of food from certain small suppliers: The definition of “very small importer” is annual sales of $1 million for human food and $2.5 million for animal food (averaged over a 3-year period) combined with the U.S. market value of food that is imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee). In this case, importers would not have to conduct Hazard Analyses and would be able to verify their foreign suppliers by obtaining written assurances from their suppliers.
Importers of certain small foreign suppliers are subject to modified FSVP requirements: Those small suppliers are:
•    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
•    Shell egg producers with fewer than 3,000 laying hens
•    Products from countries whose food safety system has been recognized as comparable or determined to be the equivalent of the U.S. system (e.g., Canada, New Zealand, Australia)
Please verify the applicability of the FSVP rule to you using the flowchart in Figure 1.
How to Develop and Implement a Robust FSVP?
Although FDA had been working on the FSVP rule for quite some time, the requirements caught many an importer off guard, specifically, those pertaining to developing food safety plans to control the safety of products they import. Many importers simply do not have the technical expertise or resources.
Traditional FDA inspections are production-centric. FSVP inspections, on the other hand, will be based on review of records, according to Sharon Mayl, senior adviser for policy in the Office of Foods and Veterinary Medicine at FDA. Further, while most of the FSVP inspections will be at the importer’s place of business, FDA may also request importers to provide FSVP records electronically, or by other means, to get them promptly. During the initial stages of FSVP implementation, FDA inspectors may review records and provide importers opportunities to correct them to support compliance. However, this approach will not be applicable to problems that pose a danger to health or reflect intentional disregard for legal responsibilities, according to Mayl.
A six-step approach to implementing an effective FSVP is shown below.   
Step 1: Determine type of food/food categories to be included in the FSVP
The first step is to determine what food or food categories are to be included in the FSVP. FSVP requirements are risk based and depend on the type of food, type of hazard, and performance of suppliers. Per the FSVP rule, an importer is required to prepare an FSVP for each imported food or food category from each facility and each country. This is because the potential hazards requiring preventive controls may be specific to the type of food or food category from each facility and from each country. It may be possible to combine products and include them all under one FSVP, provided the hazards are the same or similar. However, you are still expected to prepare different FSVPs for the various facilities and various countries from which you import these products. If this is not clearly understood, you may get into issues with FDA.   
Step 2: Assign responsibilities
As an importer, you must clearly understand the roles and responsibilities of the various entities, such as the importer, foreign supplier, and qualified individual (QI). Assigning responsibility does not absolve you from ensuring that the food you import is equivalent with respect to the safety of the products manufactured in the U.S. and will not pose any public health issues in the U.S. Your foreign suppliers may not be knowledgeable about the applicable Preventive Controls rules (human food or animal food), Produce Safety rule, or other relevant product-specific regulations. It is your responsibility to provide the relevant information to them.
You may request the foreign supplier or foreign manufacturer to assist you in preparing your FSVP by providing relevant information regarding the potential hazards and the control or mitigation strategies related to their products.
It is certainly a difficult task, at least for small importers, to meet such technical requirements of the FSVP rule without the help of a QI. If you can afford it, you may hire a full-time QI. Alternatively, you may seek an external resource to help you with the responsibilities. It is a requirement of the FSVP rule that certain activities must be carried out only by a QI.   
Step 3: Implement QI responsibilities
A QI has the following responsibilities:
•    Document and implement the Hazard Analysis
•    Conduct performance evaluation of foreign suppliers
•    Approve suppliers
•    Document and implement verification activities
•    Document and implement corrective actions
•    Reevaluate FSVP and document reevaluation
•    Maintain records
By definition, a food hazard is something that could cause illness or injury to humans or animals that eat the food. The first step in the FSVP is to evaluate known or reasonably foreseeable hazards for the food that is being imported to determine whether each of the potential hazards requires control.
Hazards can be biological, chemical, physical, unintentionally introduced, or intentionally introduced for economic gain (economic fraud).
The importer must use a QI to evaluate the hazards. It is quite acceptable for an importer to rely on someone else’s Hazard Analysis of the foreign supplier’s food so long as the importer’s qualified individual has reviewed the Hazard Analysis document and approved it. An importer’s Hazard Analysis is more than just accepting a Hazard Analysis of your foreign supplier.
It is your responsibility again to monitor the performance of your foreign suppliers. This process consists of examining their food safety procedures, processes, and practices. It should also include your verification of their compliance history with FDA food safety regulations and their food safety history. Further, your QI should document in the FSVP plan the entity that will be significantly minimizing or preventing the hazards identified by the Hazard Analysis, such as the foreign supplier or the supplier’s raw material or ingredient supplier, or perhaps a customer located in the U.S.
It is a requirement of the FSVP rule that importers approve their foreign suppliers before importing food from them. Again, you may use unapproved suppliers on a temporary basis, but only after ensuring the food is subjected to adequate verification activities before importation. You need to consider evaluation of the risk posed by the food, who is controlling the hazards, evaluation of foreign supplier performance, and other relevant factors in approving your foreign suppliers. Your QI will have to be responsible for this activity.
As an importer, you must monitor the food safety performance of your foreign suppliers. You have the flexibility to determine the type of verification activity for your foreign suppliers based on the risk posed by the products imported. FDA has identified the following supplier verification activities: on-site auditing, sampling and testing, review of supplier records, and other appropriate measures. Annual on-site audits of the supplier’s facility are required only when there is a reasonable probability that exposure to a food hazard controlled by the foreign supplier will result in a SAHCODHA hazard. However, the importer may choose other means of comparable verification to confirm the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
As a result of the verification activities conducted by your QI, you may discover that your foreign supplier is not properly controlling the identified hazards. Should this happen, you are required to take action to correct the deficiency. The QI may be required to reevaluate the FSVP for the specific food and foreign supplier, depending on the deviations, and document them.
Reevaluation of your FSVP by your QI is required every 3 years or anytime you become aware of new information that may affect your prior evaluations.
FDA is going to rely heavily on records during inspections to determine your compliance with FSVP requirements. Therefore, ensure that your record maintenance procedures are robust. Failure to keep adequate records is a violation of the FSVP rule and the FD&C Act. FDA can take enforcement action in such cases. The list of records to be maintained includes the Hazard Analysis, the foreign supplier performance evaluation, procedures for approving foreign suppliers, foreign supplier approvals, procedures to ensure use of only approved foreign suppliers, determination  and frequency of verification activities, performance of verification activities, corrective actions, and reevaluations of your FSVP. Records can be kept as original records, true copies, or electronic records. 
Step 4: Determine applicability of other food safety requirements
Your foreign supplier may not be aware of the applicable U.S. food safety regulations. Your QI should determine whether other U.S. regulations apply to products that are imported. You should communicate such requirements to your foreign supplier so that the foreign supplier is in a position to comply with these requirements before the product reaches the U.S. port.   
Step 5: Communicate effectively
The importance of communicating with your stakeholders cannot be overlooked. You must ensure effective communication at all levels in the supply chain, including your foreign suppliers, your clients/customers, and regulatory bodies. A good communication plan is all that is needed for effective communication.
Step 6: Be “FDA inspection ready”
This is the last step of the six-step approach to implementing a robust FSVP. It will automatically fall into place once you have taken care of the five previous steps.
Implementation of FSVP Rules and FDA Inspections
The Office of Regulatory Affairs of FDA releases inspectional observational summaries every year, providing information about the number of Form 483s issued to companies producing drugs, foods, veterinary medicines, biologics, medical devices, etc. A total of 5,045 Form 483s were issued from October 1, 2016, to September 30, 2017, out of which 2,662 were issued to food companies. One hundred eight Form 483s were issued against 21 C.F.R. 1.502(a) to importers for not developing an FSVP plan. It is already one of the top 20 violations in the food sector. Although the first compliance date for implementing the FSVP was May 30, 2017, it is interesting to note that FDA inspectors have already issued 108 Form 483s to importers out of a total of some 300 importers inspected in 6 months. It is quite likely that FDA in 2018 will ramp up the inspections of importers three to four times that of last year.
The second compliance date was March 19, 2018, for “small businesses” (foreign suppliers with < 500 full-time employees) and March 18, 2019, for “qualified facilities” and “very small businesses” (foreign suppliers with < $1 million in average annual sales). The compliance dates for importers whose foreign suppliers are subject only to the Produce Safety rule are July 29, 2019, for small business and July 27, 2020, for very small businesses. All other businesses must comply starting July 26, 2018. FSVP compliance dates are based on the size of the foreign supplier and not on the size of the U.S. importer.
Recent FDA FSVP Guidance Documents
Recently, FDA has released the following FSVP draft guidance documents:
Application of the FSVP Regulation to the Importation of Live Animals: Guidance for Industry, March 2018
This guidance document provides clarification regarding the applicability of the FSVP rule for the importation of live animals. The food resulting from the slaughter and processing of certain live animals cannot be consumed without slaughter and processing at establishments subject to USDA-administered HACCP requirements (or equivalent state programs). FDA has clarified that FSVP importers of live animals that are slaughtered and processed at USDA-inspected establishments subject to USDA-administered HACCP requirements (or state-inspected establishments subject to equivalent requirements) do not have to meet any of the FSVP requirements.
Application of the FSVP Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry, January 2018
Many raw agricultural commodities (RACs) that are not fruits or vegetables, including grains, are imported into the United States. The importation of grain RACs into the United States is subject to certain supplier verification requirements established in FSMA. FSMA amended the FD&C Act to add, among other food safety requirements, provisions requiring the verification of the safety of food imported from foreign suppliers of that food.
To better align the FSVP regulation with the exemption from preventive controls requirements for facilities solely engaged in the storage of nonproduce RACs, and because of the nature of the hazards associated with grain RACs and how they are generally addressed in the distribution chain, FDA intends to exercise enforcement discretion for importers of grain RACs that are solely engaged in the storage of grain intended for further distribution or processing [in accordance with 21 C.F.R. 117.5(j) or 507.5(g)] with respect to the FSVP regulation. This means that FDA will not expect the FSVP importers of grain RACs (i.e., grain elevators and other facilities solely engaged in the storage of grain RACs intended for further distribution or processing) to meet any of the FSVP requirements. However, these grain RAC importers remain subject to the statutory prohibition against the introduction or delivery for introduction into interstate commerce of adulterated food {Section 301(a) of the FD&C Act [21 U.S.C. 331(a)]}.
FSVPs for Importers of Food for Humans and Animals: Guidance for Industry, January 2018
FDA issued the final FSVP regulation for importers of food for humans and animals on November 27, 2015 (80 C.F.R. 74225). The FSVP regulation, codified in 21 C.F.R. 1.500 through 1.514, specifies the foods and importers to which the FSVP regulation applies and establishes requirements relating to:
•    Use of qualified individuals to conduct FSVP activities
•    Hazard Analysis
•    Food and supplier evaluation
•    Foreign supplier verification
•    Corrective actions
•    Record keeping
This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.
Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry, January 2018
This guidance describes FDA’s current thinking on considerations for determining whether a measure or procedure used in lieu of an FDA requirement in 21 C.F.R. Part 112, 117, or 507 provides the same level of public health protection as the corresponding FDA requirement.
Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or FSVPs: Guidance for Industry, January 2018
The purpose of this document is to state the intent of FDA not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. This includes enforcement policy for importation of food contact substances under the FSVP regulation, enforcement policy for certain human food by-products for use as animal food that is further manufactured/processed, etc.        
Further, FDA recently posted a document on its website that lists all importers that have been identified at entry in connection with the FSVP regulation. This posting is a statutory requirement under FSMA. The list provides all of the FSVP importer names that have been declared at entry.
Blockchain Technology and FSVP
Blockchain is a new technology tool for storing and sharing of information in open virtual network space. It has wide-ranging applications from finance to the food industry. It is certain that the technology will make the food supply chain more transparent than ever before by allowing users to look at the information associated with that food simultaneously. Further, it can greatly improve product traceability in the supply chain. Realizing the huge potential of this technology, big food corporations and retailers such as Nestlé, Unilever, and Walmart, and IT corporations such as IBM have invested huge resources to tap the full potential in the field of food safety. In addition to enhancing food product/ingredient traceability, it can reduce food waste by helping organizations target and withdraw only the specific batches of affected products during recalls.
Another potential application of blockchain technology is its use in food fraud. Food fraud is quite prevalent in many countries with the sole objective of economic gain. Unlike the common contaminants in ingredients, raw materials, and other food products that are known to occur, food fraud is difficult to detect. A well-known example of food fraud is the melamine incident in milk powders and pet foods that happened in 2008–2009. The need to enhance traceability and transparency in the food supply chain is overdue.
The FSVP rule requires importers to ensure their products are safe and ensure the integrity of the supply chain. The global food supply chain is complex, loaded with several unknown factors that an importer in the U.S cannot easily detect and control. While the regulatory requirements to ensure the integrity of the supply chain are clear, importers do not have effective tools to achieve these objectives. Blockchain technology is the best solution for this. Blockchain is nothing but a chain of blocks (records) arranged in a chronological order. Therefore, the possibility of altering records is greatly reduced. 
Currently, the technology is in its infancy particularly as it applies to food safety. Nevertheless, it offers enormous potential for improved product traceability in the supply chain. Importers will be able to trace the full history of the products they are importing. It will be much easier to protect the integrity of the food supply chain and consequently prevent major foodborne illness as this new technology matures.
Challenges Ahead for FSVP Implementation
It is going to be a tough task for at least the very small importers to comply with the requirements within the specified timeline, knowing their limited technical capabilities and financial constraints. Implementation of the requirements of the FSVP rule is not a simple task. It requires a good understanding of the hazards associated with food products and their control measures. Although FDA has published guidance documents, importers are not yet fully prepared. The other major hurdle for very small importers is maintaining proper documentation and records. The food importer community needs to be more disciplined in this respect.
On the other hand, FDA may also face some challenges in enforcing the FSVP rule. The agency has to make sure the importer community understands the requirements of the rule; otherwise, there will be repeat failures on the part of importers. Kudos to FDA for making it clear that the initial phase of implementation of the rule is going to be an opportunity for importers to crawl before walking. 
Dr. Ramakrishnan Nara is a technical adviser/consultant for the food, pharma, and dietary supplements industries. He can be contacted at




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