Posts Tagged ‘FSMA’

Are you ready for FSMA?

July 1st, 2017
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Armed with clipboards, swabs and a keen eye, the Food and Drug Administration (FDA) has slowly begun assessing bakery operations across the country. Under the Food Safety Modernization Act (FSMA), baking facilities will undergo inspections verifying that preventive controls are in place. And while being prepared for an unannounced inspection is at the top of many companies’ agendas, what should they expect when the investigators walk through the door?

Shawn Stevens, FDA consultant and attorney at FoodIndustry Counsel, LLC, said there are five enforcement priorities for the agency. These include critical review of food safety plans and verification records, extensive microbiological sampling, recall requirements for samples that test positive for pathogens exceeding FDA thresholds, comparing pathogens found in the facility against human isolates stored in the Centers for Disease Control’s PulseNet database, and initiating broader investigations — including criminal — of food companies whose products are found to have caused human illness.

With this in mind, bakers must ensure their records are up-to-date, staff is properly trained and preventive controls are established, all before investigators arrive.

For the record

Under FSMA, a company’s food safety plan should have been established in September 2016, but many bakeries are still struggling to develop an effective document that encapsulates its approach to identifying food safety hazards. It’s even harder to establish one that can be updated easily. Many facilities are creating overcomplicated plans, leaving room for questions they may not be able to answer during an inspection.

Len Heflich, former co-chair of the American Bakers Association (ABA)’s Food Technical Regulatory Affairs Committee (FTRAC) and current president of The Center for Food Integrity, witnessed this pattern within the field.

“The industry doesn’t grasp the concept of a food safety plan because FDA doesn’t spell it out — and we don’t want them to,” Mr. Heflich said. “We want to take the lead on this and define it ourselves.”

So, Mr. Heflich developed a model for food safety plans, which he shared with ABA members. The two-page report outlines the policies and programs that a facility should have in place and contains brief information about them. The policy and program specifications are then detailed in a separate document specific to plant processes and products. This model allows baking companies to break down the plan and detail how they manage, control and minimize risk.

Plant operators must also remember to update plans accordingly. In the report, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” the FDA expressed the plan must be reanalyzed at least every three years. This includes when changes are made to systems or equipment, when new information is discovered about potential hazards associated with the food or facility, when there is an unanticipated food safety problem, or when a preventive control, combination of preventive controls — or the plan itself — is ineffective.

“It’s an evergreen document and process,” said Rasma Zvaners, vice-president of regulatory and technical services at the ABA. “If you change something in your operations, revisit your food safety plan and update it accordingly. The food safety plan should not live on the bookshelf collecting dust.”

One of the biggest changes resulting from FSMA is the role recordkeeping will play in day-to-day operations and during inspections. Documentation is required to confirm that actions such as monitoring, verification, validation and more have taken place in the facility.

“In the age of FSMA, your records become the face of your company,” said Elizabeth Fawell, counsel at Hogan Lovells. “It is how you show FDA you are doing a good job, not just when the investigator is in the facility but also day in and day out. That’s why we continually advise people, ‘If it isn’t documented, it didn’t happen. And if it is documented, it happened just that way.’”

To ease the recordkeeping process, it is in a food manufacturer’s best interest to standardize the plan while allowing for specific details. This includes creating a method of documentation with the same format among forms while still recording all the necessary information. An area should also be designated for documents to be stored for easy access. Finally, a system should be in place that verifies documentation is completed clearly, as to avoid any gaps.

Karl Thorson, food safety and sanitation manager, General Mills, Inc., Minneapolis, advised food processors to avoid creating overly complex procedures they will not follow through with.

“Trust but verify,” Mr. Thorson said. “Trust that your employees are doing it correctly but also have a program in place to check on them once in a while to make sure it was getting done right.”

Is your team ready?

 Participating in a mock inspection can be an effective method to determine whether your team is prepared for an unannounced inspection. AIB International’s latest field service, FDA Preparedness Inspection, simulates a FSMA-type investigation and determines if a facility’s regulatory policy is in line with requirements, if employees understand their company’s policy for handling regulatory inspections and if its food safety plan meets requirements.

Alicia Pulings, quality compliance manager at Schaumburg, Ill.-based Gonnella Baking Co., set up one of AIB’s FDA Preparedness Inspection knowing there were minor gaps in the facility’s FSMA compliance process but still confident in her group’s abilities. With the exception of two key decision-makers, the visit was unannounced to its staff, including the plant manager.

“Even though it was a test inspection, I could sense our team’s uneasiness, and it reminded them that we need to be audit-ready at all times,” Ms. Pulings said.

When an AIB inspector began collecting swabs at the Gonnella plant, it was a big reveal for the staff. Ms. Pulings believed this was an eye-opener for employees, especially those who did not attend a FSMA training.

“Knowing FDA could collect swabs is new and important,” Ms. Pulings said. “We needed minor revisions to a few of our existing programs. During the inspection, we learned that FDA has granted an extension to one of our new programs that are in the process of being implemented — without this simulated inspection, we would not have known.”

Making sure an operation’s team also understands how to interact with investigators is crucial, as any of them can be pulled aside at any moment to discuss procedures in detail or to pull records. This may entail taking extra time to train employees on methodologies and educating them on the reasoning behind it.

“If people are going to do their job well, they have to understand why they’re doing it,” Mr. Thorson said. “We’ve got to do better at explaining processes. Whether it’s the employee on the floor operating and cleaning the line or the engineer building the system, everyone has to understand why we have the expectations we do: ‘Why do I need to clean to this level? Why are you swabbing it with that swab?’”

What to expect

Being prepared for an inspection means more than having preventive controls in place. Such preparation includes mapping out a process for when investigators arrive and understanding the actions they will take while conducting the inspection. In his checklist, Mr. Stevens outlined how operators can effectively navigate the process from beginning to end and appropriately respond to any FDA criticisms once the site visit concludes.

Before the inspection begins, Mr. Stevens advised teams determine which members will interact with FDA investigators, revisit where critical documents are stored and organized, and review topics employees can discuss with the agency. To ensure all measures are in place, perform a mock audit that includes all staff performing their specified roles. Undergoing this practice will help employees feel confident when interacting with investigators.

When FDA representatives arrive, they will ask to conduct an entrance meeting to detail how they plan to conduct the inspection, how long they anticipate it will last and the specific tasks they intend to accomplish. These typically include a facility inspection, records review and “swab-a-thon.”

During the inspection, the agent will tour the production, packing, distribution and storage locations searching for physical deficiencies and sanitation violations and conditions that allow bacteria to grow. Throughout the process, the investigator should be accompanied by a designated guide to observe and immediately document and respond to any concerns.

At the time of the records review, the FDA will have wide access to most documents within the organization. However, the agency is not entitled to review or copy any recipes or data pertaining to finances, pricing, research, sales or personnel, other than to ensure that the company’s employees have received training appropriate to their position and responsibilities. If the FDA requests copies of any records the company deems confidential, be sure to mark those records accordingly.

Once investigators enter the plant floor, they will collect approximately 100 to 200 microbiological samples from incoming ingredients, outgoing finished products and various environments within the facility. Staff charged with accompanying the inspection should carefully document the areas where samples are being collected. If any samples are positive, this information will be critical to determine the most appropriate response.

If the FDA collects finished product or processing line samples to test for the presence of Listeria MonocytogenesSalmonella or any other pathogens, that facility should hold back any products made from the same lot or batch until the results come back. If any are positive, and the product has been held, a recall will not be issued.

Once the inspection is complete, the investigator will conduct an exit interview and share the findings. If violations have been identified, the agency personnel will issue a Form 483, which details the specific issues. Although not required by law, a company is generally expected to provide a written response with the appropriate documentation within 15 business days. The FDA will not pursue further regulatory action if the response adequately addresses the agency’s concerns.

In some cases, the investigator may ask the company to consider a recall of certain products. Any recall decisions — and whether to announce it — should be made very carefully and only after consultation with legal counsel. Mr. Stevens noted that many companies have successfully convinced the FDA, based on the availability of supporting facts, forensic analysis and scientific data, that a recall is not needed or that the scope can be significantly limited.

A reflective approach

As inspections come and go, they create opportunities for the industry to unite and learn from one another’s triumphs and mistakes. Mr. Heflich noted that food safety should not be a competitive process. Fostering discussions amongst companies builds confidence within the field and may provide insights the FDA can use to modify guidelines and protocols.

Industry groups already have expressed interest in creating guidance documents on FSMA requirements with two goals in mind: providing a valuable resource for their members and developing industry standards that can become part of FDA guidance in the future. The agency laid out steps for industry associations interested in developing food guidance documents and stated it would provide technical advice and check for potential conflicts with federal regulations.

“FDA has listened to a lot of what we asked for,” Mr. Heflich said. “We asked to keep it simple, not prescriptive; tell us what we need to do but not how to do it. The industry needs the flexibility and the ownership.”

With that in mind, he urged bakers to get involved with industry associations and discuss issues with peers and competitors to ensure that the industry can guide and define regulations and protocols set forth by the FDA.



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Food safety insecurity used as a hook against regulatory reform

April 15th, 2017
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Each side has just the congressional recess left to practice its hyperbole for the coming Senate fight over how regulations will be used across government. It’s going to get nasty. And confusing. The practice of giving the other side’s bill a dirty name is now a common tactic.

Since the Regulatory Accountability Act passed the House by a vote of 238-to-183 in January, the collection of consumer and environmental groups opposing the bill have taken to calling it the “Filthy Food Act.”

It’s far from certain, however, that the new Regulatory Accountability Act would translate  into  weakened federal food safety standards.  It is, after all, about how new regulations might be imposed, not about changes to any of the 47,661 rules put in place since 2001, including 1,062 “major new rules” that each cost the economy $100 million or more each year.

Since the 1970s, agencies have had to keep track of the costs and benefits of regulations and Government Accountability Office dutifully keeps track of all the data, which is a said to impose $2 trillion a year on the economy.

The new Regulatory Accounting Act would  put agencies through more hoops in the regulatory process.  More were added the 1980s, but it’s hard to say that slowed the process.   Congress likes leaving the details to the agencies.

The new Regulatory Accounting Act calls for more attention to the economic impact on small business, and calls for indirect and cumulative impacts of new regulation to be taken into account when new regulations are being proposed.

Agencies promulgating rules would be required to come up with alternatives to proposed rules to minimize any adverse economic impact or maximize any beneficially significant economic impact on small entities. The Bureau of Land Management (BLM) and the U.S. Forest Service, the agency landlords for most of the 640 million acres owned by the U.S. government,  are required to generate business –friendly alternatives in their own planning.

Current food safety rules were adopted after bipartisan approval of the Food Safety Modernization Act and a 5-year rule making process that FDA conducted with stakeholders, sometimes reversing directions to maintain consensus. Opponents of the Regulatory Accountability Act says the current food safety rules would not have survived “never-ending reviews and layers upon layers of wasteful Congressional and judicial red tape.”

However, there was Congressional involvement and judicial review, especially over deadline dates for the various rules.

Several consumer/environmental groups that are often involved in food safety issues have written several companies also often involved in food safety to persuade them to oppose the Regulatory Accountability Act when it comes to the Senate in May.

The “open letter” went out to Campbell Soup Company, Cargill, Coca-Cola, CVS Health, Domino’s Pizza, General Mills, PepsiCo, Target, Walmart, and Yum! Bands. “Food safety rules help reduce the risks posed by pathogens, additives, and pesticides,” says the letter. “But the “Filthy Food Act” passed by the House would create an unprecedented regulatory gauntlet through which no food safety rule or guidance could pass.”

Signing the letter were representatives of Food Policy Action, Food & Water Watch, Environmental Working Group, Consumers Union, Consumer Federation of America, and Center for Science in the Public Interest.

Putting aside whether the new law would truly be a “regulatory gauntlet” for regulations, some significant elements are included.  One would repeal the so-called “Chevron” doctrine, so named for a 1984 Supreme Court case of Chevron USA v. Natural Resources Defense Council Inc. that gave deference to agency legal interpretations when their decisions are challenged.

Also billion dollar rules would not take effect until timely filed litigation challenging their promulgation is resolved.  It also beefs up the existing prohibition on federal agency lobbying for their own rules.

The consumer/environmental groups claim the new Regulatory Accountability Act “would require officials at the U.S. Department of Agriculture, the Food and Drug Administration, and other agencies to seek out the least costly, and not the most beneficial, regulatory approach to food safety problems…”

“Manufacturers, retailers, and restaurants generally take food safety serious, which is why they should not stand by while their trade associations dismantle the food safety system,” said CSPI president Michael F. Jacobson. “Extremists like (White House chief strategist) Steve Bannon may sneer at what he calls the ‘administrative state,” but that’s generally what’s keeping E. coli, Salmonella, and Listeria out of our food supply.”

Jacobson is inviting the food companies “to work cooperatively with us to defeat this reckless and irresponsible piece of legislation.”



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Improving the sanitary design of packaging machinery

April 8th, 2017
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Once upon a time, an outbreak occurred, and the game was never the same. There probably isn’t a member of the baking industry who doesn’t remember the salmonella outbreak at Peanut Corp. of America. And Bill Kehrli, vice-president, sales and marketing, Cavanna Packaging Group, will never forget: Cavanna supplied around 30 packaging lines to a major North American bakery plant that received a tainted shipment of peanut butter.

“The plant shut down and basically tore apart the entire factory trying to clean it. Our equipment was in pieces,” Mr. Kehrli recalled. It took more than a dozen technicians to reassemble the equipment, and from that moment, the idea of “clean” for Cavanna — along with nearly every food production facility and equipment manufacturer in the country — changed forever.

“We partnered with our customers and attended seminars put on by the American Meat Institute about what it means to be clean and how to build equipment that’s sanitary design,” Mr. Kehrli said. “Today, we’re preaching the ‘Gospel of Sanitary Design.’ ”

In this Food Safety Modernization Act (FSMA) era, sanitary design is a top priority for the baking industry. “Food safety not only affects brand awareness and the health of end users, but it also influences overall equipment effectiveness,” said Kelly Meer, product manager, Bosch Packaging Technology. “In order to achieve higher production efficiency, reduce cleaning time and prevent product contamination, it is essential for bakers to invest in a hygienically designed packaging solution.”

The meaning of clean

There’s no disputing that every facet of bakery production has to be clean. But words such as clean and sanitary, while vital pieces of a baker’s lexicon, can often mean different things to different people. To make sure that packaging equipment meets sanitary design standards for both the baker and supplier, communication is crucial, and that should start at the training level.

“The same diligence a bakery puts into training staff to make the product should go into cleaning equipment and preparing it to run the next day,” said Dennis Gunnell, vice-president, sales and marketing, Formost Fuji. “Identifying standards and understanding what ‘clean’ means is critical because ‘clean’ to one person might not mean the same thing to someone else.”

Mr. Kehrli echoed that sentiment. “Someone else’s definition of clean might not be my definition,” he said. “My definition of clean is that it’s spotless. You can swab it anywhere, and all the bacteria are killed. It goes beyond wiping something down with a damp rag or blowing with compressed air.”

Visibility is often the key to identifying a standard of clean. Remember the adage, “If you can’t see it, you can’t clean it” — the same goes for confirming that it’s clean. “We design our equipment with guides that come off quickly without tools and decks that pivot out of the way so you can see underneath,” Mr. Gunnell said. “Not only do these features make the equipment easier to clean, but it also helps an operator see it’s clean as well. For example, if you don’t allow a deck to be removed, or at least pulled out of the way, an operator might think it’s clean, when in fact, there could be bacteria growing underneath.”

For food safety purposes, Bosch designs its packaging equipment so that stationary parts are below the process belt. “This ensures that products cannot become contaminated by dust and other residue, and it prevents parts from falling down and jeopardizing products or consumer health,” Mr. Meer observed. That said, Bosch’s packaging equipment’s observation windows, transparent casings and other accessibility features allow operators to inspect or clean it at any time.

Collaborative effort

After defining clean and identifying standards, the next critical issue is mapping out a plan. “Whether it’s processing or packaging equipment, the first question I always ask is, ‘What is our reason to clean?’” said Karl Thorson, food safety and sanitation manager for Minneapolis-based General Mills. “There has to be a reason to clean, and sometimes a better way to think of it is, ‘What would happen if I didn’t clean? What’s the impact to the system, the environment, the product?’ ”

It doesn’t matter if it’s a food safety or allergen issue. When bakers understand why a piece of packaging equipment needs to be cleaned, it’s much easier to move forward with design, an area where many bakeries are becoming more involved much earlier in the process. “Once I understand the ‘why,’ I can address it by marrying up the right design with the appropriate cleaning method,” Mr. Thorson said.

Mr. Gunnell encouraged bakers to take a more active role in the design process, something he’s seen trending in the past few years. “It’s been prevalent in the frozen food and meat industries, but we are now seeing more bakers asking to see the design of the conveyor and have a conversation about how it’s being built,” he said.

Increased collaboration is also happening at BluePrint Automation, according to Alan Beehler, director of applications. “Food safety professionals are getting more and more involved in the equipment design,” he said. “Every year, food safety concerns are becoming more elevated, and more of our customers are taking their involvement a step further.”

The sooner a bakery can start a sanitary design dialogue, the better. “Bakers should think about it up front — not after the new equipment is installed — right from the first stage,” Mr. Gunnell suggested. “Always ask the question, ‘How is this going to help me not only in production but also in sanitation?’ ”

Angela McDaniel, Formost Fuji sales and marketing coordinator, agreed. “It’s important for bakers to weigh the assessment of sanitary design from the beginning,” she said. “Trying to change it after the equipment has been built is not as cost-effective as going with sanitary design from the beginning.”

Matching method to need

It goes beyond just identifying what the standards are, especially in the packaging area where it might not be so black-and-white. Depending on the product and its specific characteristics, sanitary design for packaging equipment can range from wipe down to full washdown.

“It really depends on what ‘soil’ is going to be run on that system, and what concerns go along with that,” Mr. Thorson said. “What are the anticipated issues going forward? In packaging, if you anticipate having jam-ups, unsealed liners or major spillage or contamination of the line — which is a huge risk — then maybe you’ve got to design differently and go to the extreme of wet washdown.”

For Mr. Kehrli, washdown is more than the gold standard; it’s the standard. “If you’re going to clean the primary packaging equipment, then really clean it. The only way to fully do that is get in there and hit it with hoses and the right chemicals,” he said.

Washdown is also a core capability for BluePrint Automation, and Mr. Beehler pointed out its importance, especially for systems that have exposed product entering the packaging area. “We offer full washdown capable equipment using caustic foams and sanitizing solution that is corrosion resistant,” he said. The company’s sanitary design also minimizes nooks and crannies where crumbs, inclusions and other sanitary threats might hide. “All these areas are mechanically cleanable and also visible, and the equipment is constructed in a way that caustic foams and sanitizing solutions can be applied without damaging the equipment,” he said.

But — there’s always that “but” — some operations are not conducive to washdown packaging equipment, or they simply don’t need it. Mr. Thorson always considers the food safety need, wear on the equipment and also the cost of installation. He suggested a packaging line that only experiences minor spills might not require fully washdown capable equipment. He also emphasized the importance of planning ahead. “You have to think about what kind of flexibility you want for the future,” he said. “Will you possibly be running formulas in the future that would be more challenging to clean?”

Another important consideration for washdown is the environment itself. Oftentimes, the packaging area of an existing facility is not washdown-friendly. “It’s not just the equipment that needs to be sanitary design; the building needs to withstand washdown with drains in the floor,” Mr. Kehrli observed.

In a legacy building that’s been operating for decades, installing a washdown capable piece of equipment in an area that’s not conducive to it is counter-productive, especially for neighboring equipment that isn’t designed with the same capability. “In that case, when you spray the water, and the chemicals get in the air, it’s almost like raining inside the building, and that can potentially harm the other equipment,” Mr. Kehrli said.

Burford Corp. takes this into consideration with its tyers. Although its equipment does not come in contact with product, it’s compatible with other machines that are washdown-capable. “For a wet environment, we’ve made modifications to ensure that, while our machine isn’t washdown, it can be removed so that operators can wash in that area,” said Mitch Lindsey, technical sales, Burford. “All they have to do is roll our equipment off the line so the components that are in contact with product can be washed down.”

If not opting for washdown, there are still plenty of options. “Bakers are looking for sanitary design, even if not necessarily complete washdown,” Ms. McDaniel said. “As long as equipment meets the standards for sanitation, then removal of all the parts for proper cleaning becomes most important.” Formost’s sanitary design enables its packaging equipment to transform from a full machine into bare bones for complete sanitation.

When cleaning equipment, bakers understand that time is money … and downtime costs. To shorten downtime, redundancy helps. “Maybe I’ve got a belt for one product or another, or at least a clean set that can easily follow quick changeover principles and get into the next product run as soon as possible,” Mr. Thorson said. “Then I can do a detailed spot cleaning on the framework and things like that without doing a full-flood washdown.”

Bosch offers a second format set with its format parts carriage, according to Mr. Meer, allowing one set to be cleaned while the other is in use. “In a four-leg system, four operators just need two hours to change over the format parts and clean the entire system while critical parts are cleaned out of place,” he said, explaining that this helps bakers quickly resume production without the risk of allergen residues.

The allergen issue

Allergens are hard to control. It’s an issue that transcends individual areas of processing, and packaging can’t be discounted, either. When it comes to allergens, a proactive defense is best.

“It’s not unheard of on a packaging line to take many hours to pass an allergen clean,” Mr. Kehrli said. “For example, on a flowwrapping system for bars, operators can clean all the belts. Then, they go around with a swab and touch the different areas of equipment; if they find allergens on it, they can’t start up the line.”

When running products with very different formulas, Mr. Thorson advised bakers to consider everything with packaging design, especially when running products with allergens and non-allergens. “At minimum, you need to ensure that you can clean the product zone to the visibly clean standard,” he said. “If appropriate, you can follow up with analytical allergen testing (protein specific) of the surfaces and/or product.”

In areas such as secondary packaging where sanitary design is not as crucial, some bakeries rely on layout to address the allergen issue. “What we’ve done with certain customers is wall off processing and primary packaging and then have wrapped product go through a wall into secondary and tertiary packaging,” Mr. Kehrli said. “That creates an internal room that can handle washdown and an external room that does not require it.”

In the end, sanitary design should permeate every stage of bakery operations in some way. In a post-peanut-crisis, FSMA-driven world, it’s the new normal. “This should be the standard, not the goal,” Ms. McDaniel said.



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FDA Issues Final Food Defense Regulation Under Food Safety Modernization Act

May 28th, 2016
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The US Food and Drug Administration have finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

The FDA is committed to working with both industry and its state, local and tribal partners to ensure effective implementation of this new rule. Implementation of the Intentional Adulteration rule and all FSMA final rules will require partnership, education, and training. The FDA and others will provide industry with valuable tools to make compliance with the final rules easier, such as guidances, training courses and a technical assistance center.

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.

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

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

In a statement from The Grocery Manufacturers Association, (GMA) Pamela G. Bailey, president and CEO said: “We welcome the release by FDA of its final rule on prevention of intentional product adulteration, the last of the seven major foundational rules for FSMA. FSMA ensures that prevention is the cornerstone of our nation’s food safety strategy. It places new responsibilities on food and beverage manufacturers and provides the FDA with the resources and authorities it needs to further strengthen our nation’s food safety net.”

“GMA will continue its work to support the effective implementation of FSMA and will maintain a leadership role on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, both in the US and the entire global supply chain,” she said.



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Food Safety Modernization Act

February 20th, 2016
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fda-fsma-logoAt the recent American Bakers Association (ABA) Food Technical Regulatory Affairs Committee (FTRAC) meeting in Washington DC several topics were presented that might be of interest to retail bakeries. Among these is the implementation by the
Food and Drug Administration (FDA) of the Food Safety Modernization Act (FSMA).  FSMA will provide some bakeries with challenges that will need to be addressed.  In addition, changes in state law in Vermont
will affect wholesalers whose products will potential be sold there.

FSMA Issues

Food Facilities

Under FSMA some bakeries will need to register with the FDA as food facilities regardless of size.  The key is the percentage of wholesale sales of the business.  If the percentage of wholesale is greater than retail sales, that business most register with the FDA under FSMA as a food facility.  There are different deadlines for compliance based on whether it is a small business (less than 500 fulltime equivalent employees) or a very small business (less than $1 million in sales of human food).  Please look at the FDA website for further information.
Under FSMA, if your bakery or business imports food items for resale, if not already, you will need to register your business with the FDA and have a Food Safety Verification Plan (FSVP) for each product imported.  Under FSMA “an importer must, for each food that it imports, implement an FSVP for each foreign supplier before importing a food into the United States as necessary to provide assurance that hazards in food requiring a control are significantly minimized or prevented.”

The FSVP must include:

* a written hazard analysis;
* an evaluation of the risks posed by a food and the foreign
* supplier’s performance;
* supplier verification activities to allow the importer to
* approve the foreign supplier, and
* corrective action procedures.

Please look at the FDA website for further information and guidelines.

GE Product Labeling in Vermont

This new law applies to any food containing Genetically Engineered (GE) ingredients sold in Vermont after July of this year.  While this may not apply to many RBA members, it doesn’t involve any product sold over the internet, it is something to be aware of.  It applies to any product that contains any more than .9% GE material.  These products need to be labelled as such.  The law is much more complicated than what is laid out in this paragraph and the penalties can be onerous.  If you are involved in wholesaling and your products are shipped across state lines, potentially you are subject to the Vermont law.  Please check with your distributor regarding compliance the Vermont law.

ABA’s FTRAC meets in person three times annually. It conducts conference calls and with ABA staff has subcommittees work on topics that impact the baking industry.  In conjunction with ABA staff it issues reports and bulletins as issues develop that impact the industry.  RBA has been a member of the committee since 2014 and provides a voice for the retail bakery industry at these meetings.  It also gains valuable insights into the issue and problems facing the baking industry through our participation.

Dennis Stanton
RBA Board of Directors
Swedish Bakery

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GMPs, FSMA and GFSI: Making the Right Connections

August 29th, 2014
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haccp_logoGood manufacturing practices play an obvious role in both FSMA and GFSI schemes, but in reality, you won’t pass FSMA muster or obtain a GFSI certification if you haven’t done your GMP homework.

As FDA regulations spell out in 21 CFR Part 110, good manufacturing practices (GMPs) or current good manufacturing practices (cGMPs) are the basics you need to know and perform to keep the food products you make free of adulteration—whether from bacteria or chemicals. It doesn’t take long after you start reading 21 CFR Part 110 for you to realize these rules and regulations are simply based on common sense. After all, you take the same precautions when you prepare a meal for your family, whether from fresh or processed ingredients.

In fact, cGMPs are a basic part of FSMA and any GFSI scheme, along with HACCP (also found in Codex Alimentarius) and prerequisite programs (PRPs). All GFSI schemes approach food safety differently, but the outcome is the same: A certification from SQF, BRC or FSSC 22000 should be satisfactory for your customer, showing you have a documented HACCP plan(s) and risk-based preventive controls in place (HARPC)—and your staff and plant live and breathe food safety cGMPs.

As much as cGMPs are the building blocks of FSMA and GFSI schemes, the latter two not only have a mutual interrelationship, they both reflect back on and modulate cGMPs. You might say the three are contributing to each other’s growth and interconnectedness as we progress along the path toward food safety refinements with the help of technology.

cGMPs: Evolving with the times

For those interested in reminiscing, GMPs were actually started in the mid-1960s and first published in 1968, according to Jack Payne, Aptean vice president of solution consulting.  A lot has changed since the Ozzie & Harriet days of the ‘50s and the turbulent ‘60s when not that much attention was paid to food safety. With the evolution from local to national and international supply chains, interest in food safety has picked up, and cGMPs have evolved to match today’s needs, adds Payne.

“Both FSMA and GFSI are changing or have changed cGMPs,” says Jim Cook, SGS food scientific and regulatory affairs manager. Revised in June 1986, cGMPs have changed little since they were amended in April 1996 and November 2001, according to Cook. “While what was listed was a common sense approach, the use of ‘shall’ and ‘should’ in the guidelines resulted in some manufacturers adhering to the ‘shall’ requirements but ignoring the ‘should’ requirements, thereby creating gaps in their systems,” adds Cook. It’s these gaps that often show up later on as processors prepare for FSMA or GFSI audits.

According to Cook, GFSI has taken these “should” requirements, made them “shall” requirements and expanded or clarified those areas. FSMA will remove most of the “should” requirements and convert some of them to “shall” requirements. For example: When it comes to Toilet Facilities and Handwashing, both FSMA and cGMPs state this is a requirement. However, they go on to state, “this may be accomplished by” and provide a list of how it may be done. In addition, GFSI requirements have turned “may be” requirements into “shall” requirements and have modified some, such as (d)(4): “providing doors that do not open into areas where food is exposed to airborne contamination, except …” where these exceptions have been removed. Validation of these exceptions would need to be accomplished by the facility for any of them to be utilized based on GFSI requirements.

“FSMA and GFSI platforms ensure a facility maintains and implements a robust cGMP program,” says Warren Gilbert, FSS Corp. food safety specialist. “They are specific regarding employee hygiene and awareness for product handling.”

While cGMPs provide the foundation for a food safety system, it is imperative to have a strong foundation of prerequisite programs in place to control basic food safety issues, says Jeff Chilton, principal of the Chilton Consulting Group. “This foundation also prevents certain hazards from becoming reasonably likely to occur, therefore reducing the number of CCPs required in HACCP plans.” Prerequisite programs include, for example, GMPs, sanitation, microbial control, pest control, allergen control, foreign material control, maintenance, training, calibrations, supplier approval, potable water, waste disposal, and storage and transport. “Effective PRP development [and] implementation are crucial to the success of the food safety system. Most failures in food safety systems that cause recalls for reasons such as allergen labeling or pathogen contamination are due to failures within these PRPs rather that a CCP failure,” adds Chilton.

“GFSI standards have definitely added more substance to the cGMPs,” Chilton continues. “All the GFSI schemes require verification and validation of these PRPs at least annually.” When done properly, this verification and validation process includes a review of the written programs, plant inspections to verify compliance, reviews to ensure effective implementation and analytical report reviews to ensure effective validation. These verification and validations ensure the programs are effective and identify opportunities for continuous improvement. FSMA will add more substance, too, once the final rules are published with anticipated additional requirements coming with the cGMP regulations, according to Chilton.

“The goal of FSMA is to shift the focus of federal regulators from responding to contamination to preventing it,” says Jennifer Wondergem, SSOE Group chemical engineer. “This places significant responsibility on farmers and food processors to prevent contamination. cGMPs are the main tool food processors have to monitor and control food safety within their processes. FSMA [Section 101] gives FDA access to all plant records, including industry food safety plans and the records firms will be required to keep to document implementation of their plans.”

Getting started

While writing this article I received an email from an American consultant who is helping processors in Central and South America. A major seminar was recently held on FSMA in Brazil by the Brazilian agency ANVISA, which controls food regulations. This consultant reports  most Brazilian producers/processors, except the large international processors that are starting plants in South America, are just beginning to get on board with FSMA.

Unfortunately, getting on board with FSMA, GMPs and GFSI can be tough for smaller operations. “We see this a lot with smaller startup companies,” says Gilbert. “People just don’t know what they don’t know. It’s a learning process for them, and sometimes, they don’t know where to look for information.”

“This happens mainly with small manufacturers that have been providing an item to specialty retailers or their domestic market, and now, that item is being sold, or they desire it to be sold, to large retailers and/or the international market,” says SGS’s Cook. “GFSI identified this issue and developed a Basic cGMP audit program and accompanying requirements. Many GFSI schemes offer gap assessments, training and/or consultants to help companies achieve the desired compliance goals. An SQF Level 1 audit mainly involves a cGMP audit program and compliance.”

Even processors that think they’re prepared for FSMA or GFSI audits may be in for a surprise. “We receive calls every week from companies needing to become GFSI certified to meet customer requirements,” says Chilton. “It is common for companies to think they have good cGMPs in place, but when they are audited, numerous nonconformances are often identified that expose serious vulnerabilities in their food safety and quality systems.”

Evaluating the “gap” or the unknown

It’s the gap analysis that reveals the unknown—the surprise(s) where there’s some small detail missing from a processor’s GMPs that could spell trouble down the road. Better to find out now what remedies are needed to achieve a GFSI certification rather than wonder why a recall was needed for a product that never had problems before. “A [gap audit] is a good start for any processor,” suggests Gilbert. “Depending on the gap format chosen, it will give the facility good initial direction that will help with a timeline and budget for implementation.”

A gap audit performed by a technically competent internal or external auditor is essential to determine any areas that need to be addressed, says SGS’s Cook. This assessment is needed before any regulatory, customer or certification audit takes place. After a gap assessment, it is also essential that someone equally technically competent performs a root cause analysis and implements both corrective and preventative actions to address any found nonconformances. Unfortunately, in many small businesses, a person with this level of competency is not on staff, and they must obtain a consultant or third party to complete these tasks, adds Cook.

“Upon completion of the gap audit, a gap analysis will provide the processor with a clear summary of where gaps exist between its documentation and the standards,” says SSOE’s Wondergem. The analysis will also result in a list of corresponding actions that should be taken to close those gaps. This analysis can be done by a third party or internally, if the processor has the resources.

For processors thinking GFSI, a gap analysis is indispensable. “The gap analysis assesses the effectiveness of [a processor’s] existing programs, records and facility,” adds Chilton. “The gap analysis also compares all the GFSI standard requirements to identify what must be done to comply with the standard to achieve certification. With our consulting process, we also create action registers to formulate a strategy to correct the gaps to bring the client into compliance with the GFSI standard.”

Updating 21 CFR Part 110 to reflect the times

Soon, GFSI and FSMA will influence 21 CFR Part 110 in the areas of documentation and PRPs. “FDA’s 21 CFR Part 110 regulations on cGMPs already provide the foundation for a sound food safety program,” says Wondergem. “To accommodate requirements for FSMA and/or GFSI certifications, I could see them being expanded to include more guidance for controls and documentation since [they are] a major component of any certification program.”

“FDA’s GMP regulations are expected to be updated when the FSMA final rules are published,” says Chilton. “The GMPs will be strengthened and expanded to include additional items such as all the PRPs identified in the GFSI standards. In addition, the scope will be expanded beyond [human] food processing and will also apply to animal food and feed. Last, it will raise the bar for international companies exporting to the US, requiring them to meet the same standards.”

The updated GMPs also will show the shift from a HACCP environment to preventive controls, that is Hazard Analysis and Risk-Based Preventive Controls (HARPC). “cGMPs are being updated by FDA to create a link between them and the HARPC requirements,” explains Cook. “Probably the greatest area of change between the old cGMPs and the new will be in allergen management. This is being done because a large percentage of recalls are attributed to undeclared allergens. GFSI programs are addressing this issue.”

Tools to pull the loose ends together

Processors can get help with cGMPs, GFSI and/or FSMA from a variety of free or fee-based sources. “FDA’s 21 CFR Part 110 is a good starting point for a facility wanting to get FSMA or GFSI certification,” offers SSOE’s Wondergem. On its website, FDA provides HACCP Principles and Application Guidelines, which outline how a processor can develop, implement and maintain a HACCP plan. FSMA and GFSI offer guidance documents and other resources that demonstrate the requirements to become certified. Third-party auditors such as SQF provide information including audit checklists that can help prepare a facility for an audit.

SGS provides training programs for cGMP, HACCP and HARPC. Additionally, there are programs to help processors decide which GFSI scheme is appropriate for a particular business, with further training available in a specific GFSI scheme. Further training and information for each GFSI program also can be obtained through the scheme owner. For FSMA, SGS offers information through webinars, white papers and other specific training. In addition, FDA offers videos, webinars and training for food defense. USDA’s DSIS offers webinars and training on food defense.

Consultants like Chilton Consulting Group, FSS Corp. and SGS offer several services. For example, FSS Corp. offers classes for HACCP and internal auditor, SQF and BRC training. Chilton Consulting Group has partnered with SafetyChain Software to help clients automate, streamline and improve their food safety and quality assurance systems.

Problem is, some of today’s processors are still operating in the pre-computer era. Aptean’s Payne describes a typical scenario he’s seen at many processor locations. “They may have a very good food safety plan, a good HACCP plan and all the procedures in place, but how many are ensuring these procedures are followed every day and every shift? In most cases, they have a notebook where they write down that they have checked the temperature in the cooler, the cook temperature or whatever parts of their HACCP plan they followed.” But do they remember to put these entries into the manual, and are they alerted or reminded to make the entries automatically? And, if a food safety event occurs, how can they correlate the information and show what happened—much less provide the information to an auditor on a timely basis? “We need some type of formal, auditable software system that provides the ability to notify or alert operators when they need to take readings and advise management when prescribed actions weren’t taken,” states Payne.

At a recent conference I attended, a couple of food processors asked if software tools were readily available to help them prepare for an FSMA audit or a GFSI certification. To get some answers, I posed this question to a few software suppliers. From the responses I received, there are two main types of software.

There are static forms (often based on Microsoft Word, Excel or Access templates), and there are other, more automated systems that demand user participation. “Rather than filling out a standalone static document, processors can look into filling out actionable documents, where key data is extracted and put into a centralized database,” explains Gary Nowacki, TraceGains CEO. These tools can be used to alert operators when it is time to inspect or maintain a machine or gather fresh information from ingredient suppliers. “Once the actionable database is in place, processors can respond quickly to internal audits, GFSI readiness and third-party auditors,” says Nowacki.

“One of the things we provide is a utility, which we call an event management framework, that records specific events or actions that typically define part of a food safety plan,” says Aptean’s Payne. This utility is an application that prevents operators from moving to new tasks if the present ones haven’t been completed and signed off. “It prevents operators from getting ‘too busy.’” Also, quality (a software module) should be part of an enterprise system where information is recorded as ingredients come in the door, are processed and go out the door as finished product. All parts of a food safety plan should be recorded by the software, making track and trace possible at any step in the supply chain and at the processor’s facility, says Payne.

One tool constructed by SafetyChain Software allows food and beverage companies to assess risks and food safety gaps while putting HACCP, HARPC, GMP/cGMP and GFSI programs in place. According to Barbara Levin, SafetyChain senior vice president, marketing, the software provides processors with the ability “to say what they do, do what they say, make sure it works and make sure it’s documented. That’s what a food safety chain management system does.”

But is that how yours works? You may be doing all the right things in your process  in all the critical stages, have several PRPs in place and work with equipment suppliers to find sanitary designs and with architectural and engineering firms to determine what may need to be done to bring your plant up to date. But if you haven’t been documenting it all, the amount of work that needs to be done to satisfy FSMA or a GFSI audit could be overwhelming. Before your customer asks you for a GFSI certification, why not get prepared now?

What are PRPs?

According to the ISO 22000 food safety certification, prerequisite programs (PRPs) are defined as “specified procedure(s) or instruction(s), specific to the nature and size of the operation, that enhance and/or maintain operational conditions to enable more effective control of food safety hazards, and/or that control the likelihood of introducing food safety hazards to—and their contamination or proliferation in—the products(s) and product processing environment.”

In an ISO 22000 food safety management system (FSMS), PRPs basically focus on the production environment—or in other words, people and facility—which will affect food safety and the validation of a processor’s ISO 22000 FSMS. Maintaining PRPs is essential to food safety operations and obtaining ISO and GFSI certification.

For more information on PRPs and ISO 22000, see ISO 22000: The General Prerequisite Program Requirements of ISO 22000, ISO 22000 Resource Center.

Food GMP development timeline

Date  Milestone
1906 1906 Pure Food and Drugs Act prohibits interested commerce in misbranded and adulterated foods, drinks and drugs
1933 FDA recommends revising 1906 act
1938 FDA passes 1938 Federal Foods, Drugs and Cosmetics Act, which provides identity and quality standards for food
Mid ’60s FDA decides to clarify FDCA through GMP regulations
1968 FDA proposes GMP regulations
1969 FDA finalizes GMP regulations
Early ’70s FDA considers promulgating industry-specific regulations
Late ’70s FDA decides to revise general GMPs rather than adopting industry-specific GMPs
1986 FDA publishes revised food GMPs
2002 FDA forms Food GMP Modernization Working Group
2004 FDA announces effort to modernize food GMPs
2007 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements (Final Rule) June 25, 2007
2011 FDA passes FSMA, which is enacted into law

Source: Food engineering magazine


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Food Safety Summit 2014 focuses on FSMA

May 10th, 2014
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More than 1,500 food safety professionals gathered at BNP Media’s 16th Annual Food Safety Summit (FSS) last month in Baltimore, MD to learn about the latest FSMA updates and how they will affect their companies’ businesses. They also heard the latest on food fraud and learned about traceability, prerequisite programs to manage food safety and quality, agricultural water issues, ways of preparing and responding to natural disasters, regulatory affairs and more. On the exhibit floor, where 178 vendors displayed their products and services, attendees found tools for functions such as managing food safety and track-and-trace systems, rapidly analyzing products for contamination and providing sanitation.

Speakers at FSS presented key information about FSMA updates and changes, which emphasize preventing any occurrences that could result in food contamination, rather than “putting out fires” as or after they occur. Sessions included “Enforcing FSMA Requirements Through an Integrated Food Safety System,” “Food Safety Hazards Revisited” and “Food Fraud/Economically Motivated Adulteration.”

In the Food Fraud presentation, Douglas Moyer, instructor at the Food Fraud Institute at Michigan State University, noted 11 mentions of “intentional adulteration” in FSMA. Moyer pointed out that the public comment period for Section 106 on Intentional Adulteration has been extended. He also encouraged food safety professionals to participate in rulemaking, emphasizing that in addition to considering terrorism of our food and water supplies as part of food defense, “food fraud should have a place at the table under the food protection umbrella.” Moyer added, “So if that’s the direction we’re going to take, we need to reopen preventive controls and talk about food fraud with respect to HACCP.” According to one change to FSMA, “catastrophic events” (traditionally food defense), adulteration by disgruntled employees and economically motivated adulteration are now placed under Preventive Controls.

While food processors do their best to maintain food safety and quality in their plants, problems can and do happen in transportation. A session entitled, “Storage and Distribution: The Forgotten Food Safety Link,” addressed these issues and included presenters from Dawn Foods, US Foods, The Acheson Group, Feeding America and Avendra. Dawn Food Products has a comprehensive set of global policies on preventive controls and system management aspects that are consistent with manufacturing and food safety standards such as IFS and FSMA. The company also has GFSI accreditations. Stephen Thome, vice president, global quality and food safety at Dawn Foods, asked why there shouldn’t be food safety systems in food logistics. “Between 2 and 12 percent of all food in the farm-to-fork cycle is lost. Reasons for losses include improper handling, temperature problems and products sitting too long on loading docks. If you look at this list, these are very solvable, common problems.” Thome added, “Issues like cross-contamination, spoiled product and pest infestation provide an economic incentive for all of us to improve [this situation].” Thome suggested that, with the creation of food safety management systems applied to logistics, much of this loss could be prevented.

Ed Lonergan, Chiquita Brands CEO, and Don Zietlow, CEO of Kwik Trip, Inc., shared their passion for food safety in the opening keynote. After the keynote, BNP Media’s Scott Wolters presented a donation on behalf of Chiquita Brands and Kwik Trip to Mitzi Baum, director of food safety for Feeding America. The nation’s largest domestic hunger-relief charity, Feeding America supplies food to more than 25 million Americans each year.

The FSS 13th Annual Food Quality and Safety Award was presented to Backyard Farms of Madison, ME for its contributions to food safety and consumer satisfaction with a positive impact on business results. The event began with a presentation by Sara Mortimore, vice president of product safety, quality assurance and regulatory affairs, Land O’Lakes.

Gina Nicholson, NSF Global client director of retail food services, presented the 11th Annual Food Safety Leadership Awards. The 2014 NSF Food Safety Leadership Lifetime Achievement Award was presented posthumously to William Keene, Ph.D., senior epidemiologist, acute & communicable disease prevention, Oregon Public Health Division. The 2014 NSF Food Safety Leadership Awards for Training and Education were presented to Jason Bashura, RS senior food defense analyst, FDA Center for Food Safety and Applied Nutrition (now working at PepsiCo), and Brian Nummer, extension food safety specialist, Utah State University.

Source: Food Engineering Magazine


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FSMA Update: Staying ahead of the curve

February 15th, 2014
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fda-logoComments are in for proposed Produce Safety Rule and Preventive Controls, but final rules have not been issued, leaving processors time to explore audit and certification alternatives.

If you’re going through the motions of obtaining a GFSI certification (e.g., SQF, BRC, FSSC 22000), you may be in pretty good shape if FDA were to run an FSMA audit at your facility. Or, if you’re a farm-based producer following good agricultural practices, you may be set for an FDA visit. But whether you’re ready for FSMA may depend on the final rules developed from the input received during comment periods.

For example, foreign suppliers—especially importers—that have, by their own volition, had little to do with food safety in the past may find themselves ill-prepared to comply with FSMA,  which means they will have to meet the same regulations as American processors. Producers of animal feed will have to operate at a higher standard as well.

This article provides a snapshot of FSMA rule-making progress, looks at the potential impact to processors and producers, and uncovers what consultants and suppliers believe are the appropriate actions to take to keep on producing safe, high-quality food—and pass FSMA audits.

State of the rules

Passed in January 2011, FSMA is still a work in progress, with FDA seeking input from the public, research organizations and processors/producers—before turning all the proposed rules into final rules, which then become law. As Michael R. Taylor, FDA deputy commissioner for foods, said in his November 26, 2013 blog, “The comment period for the proposed produce safety rule closed on Friday, November 22, but this is far from the end of FDA’s collaboration on produce safety with growers, the food industry and consumers. FDA will continue to engage stakeholders, and we are committed to engagement through a final rule’s ultimate implementation.”

The comments period for both the Preventive Controls for Human Food and Produce Safety rules closed on November 22, 2013. Comments for the Notice to Determine Scope for the Environmental Impact Statement on the Produce Safety Rule may be submitted until March 15, 2014. In addition, the comments period for Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/Certification Bodies was extended and now will close on January 27, 2014. Finally, the call for comments for Preventive Controls for Animal Feed, which would require facilities that manufacture, process, pack or hold food for animals to adhere to current good manufacturing practices and implement hazard analysis and risk-based preventive controls, has been extended until February 26, 2014. FDA will hold three public meetings on this proposed rule.

So, what’s it to me?

In many cases, your customers and their demands are way ahead of FSMA’s final regulations. Consider QTrade, for example. Its new state-of-the-art facility blends up to 40,000 pounds of tea a day, packs 100,000-plus iced tea bags and inventories more than two million pounds of teas and herbs. “My background is in biopharmaceuticals,” says Ronald Eng, vice president, quality assurance. “I’ve seen how higher regulation costs via industry fees can lead to faster product reviews and approvals. It’s not clear to me what the final cost of [FSMA] implementation will be, but the cost of not having control over food quality, coupled with the potential damage to our clients’ brands, necessitates greater investments on improved policies, procedures, equipment and capabilities.”

Waiting for the government to get its act together isn’t a prudent business decision, according to Eng. “A couple of years ago, our choice was whether to invest and try to stay ahead of the curve, or wait until the government more fully regulates how we manage quality. In our minds, our clients have already answered that question by monitoring our performance on certified third-party audits.”

The problem is, according to John Surak, principal at Surak and Associates, until FDA officially releases its final rulings on paper, a lot of details will remain imprecise. However, processors that have submitted to a GFSI certification to meet their customers’ requirements should be ahead of the game when finally they have to go through an FSMA audit, adds Surak.

FSMA requires owners and operators of registered facilities to conduct a hazard analysis and develop and implement a written control procedure to ensure safe, quality food, according to Michael Vetter, SSOE Group senior project manager. “The written procedure typically includes a hazard analysis of the process, preventive control measures, process monitoring, verification of the process, corrective action plans (when necessary) and recordkeeping.”

“FSMA is ensuring all processors maintain excellent recordkeeping, which is essential in the event of a recall,” says Joe Scioscia, VAI vice president of sales and marketing. These records, which can be requested by FDA during a recall, can pertain to the manufacturing, processing and packaging of any suspect product. Further, proper labeling can enhance the tracking and tracing of raw materials used in finished-goods production.

“Because FSMA has so much yet to be clarified, it’s important for my engineering design team to take into account existing FDA, HACCP and USDA guidelines as we design new food manufacturing plants and systems,” says Justin Hamilton, engineering product manager, food and consumer products group, Burns & McDonnell Engineering. “In general, if we incorporate existing standards and strive to move our clients closer to full compliance, it’s very likely we will be helping them comply with future FSMA requirements as well.”

“FSMA has a strong focus on prevention,” says Dag Heggelund, Trace Register executive vice president and chief technology officer. “The food industry, like any other industry, must operate at a consistent, high-quality level. Food safety issues are just one category of ‘product defects.’” Other industries have adopted Six Sigma tools to address and solve quality problems, but Heggelund sees his company’s role as an enhanced traceability provider to put traceability data to work to prevent problems—rather than just provide recordkeeping functions to meet government regulations.

Large integrated processors are well on their way to compliance, says Robert Schlegel, Athena Controls president. “Most have significant investments in quality and whole plant systems that accommodate these new regulations. Our role is to help the mid-sized and small processors focus limited capital on critical areas, such as process control upgrades and independent data validation.”

“There is no requirement to capture these data in any automated or electronic fashion,” says Jennifer McEntire, The Acheson Group vice president and chief science officer. “That said, now that these records will be used to show regulators the food safety plan is being followed, and facilities need to respond when data shows a trend toward a loss of control, there is a lot of interest in transitioning to more automated systems that provide for trending, reports, alerts, etc.”

“When needing to validate the internal temperature of thousands of pieces per minute, you have to work from verifying the process temperature,” says Evan Miller, Hertzler Systems president. “You can’t rely on manual inspection, and you can’t depend on paper-based systems. Statistical sampling using automated systems is the only reliable and meaningful way to meet the requirement.” The electronic recordkeeping makes sense because of the value of a fast response when evaluating a risk situation. When an incident occurs, digging through paper files creates an unacceptable delay compared to obtaining the information from a computer.

Beyond process issues

Another issue needing clarification and affecting all processors and producers is security. Much of what has been implemented to date has dealt with administrative topics, with which many companies already comply, says R.J. Hope, department manager—global security services, Burns & McDonnell Engineering. “Very little has come in firm direction or expectations as it relates to security. Companies are looking at the effect increased security expectations may have on new facilities, but many are hesitant to make significant change without clear guidance.” Hope notes that for existing and new facilities, the importance of food defense—especially the accidental or intentional introduction of foreign matter—will change some thinking on how facilities will operate in the future to minimize threats from within.

“Because FSMA requires manufacturers to minimize the use of chemical pesticides, we’re using design standards and equipment selection to help plants take more of a non-chemical approach to issues such as insect control,” says Joe Bove, Stellar vice president of design. “We’re installing tighter fitting doors, better filters on exterior openings such as exhaust fans and louvers, using lighting that repels insects and adding improved sealants at wall and roof/floor junctures to minimize intrusion.”

One of the most common causes of food safety problems is a flaw in the sanitary design of food processing equipment, explains Bove. Consequently, education on the process of actually cleaning the equipment is critical. Older equipment may not have been specifically designed for frequent or complete sanitation. But process equipment sanitation design will always be progressive and never complete. Hence, today’s focus is on material selection and reducing hidden harborage points. However, even the most creative equipment design will fail if the sanitation procedure is inadequate, adds Bove.


Analyze risk

 FDA is becoming more enforcement and inspection oriented than ever before, according to Sonal Sinha, MetricStream vice president of industry solutions. “The FDA has been conducting more in-depth audits and inspections, specifically targeting high-risk categories, broadening the items within the high-risk category, conducting environmental testing and identifying GMP violations,” states Sinha.

Risk simply cannot be mitigated until it is measured and understood, says Chris Prather, EtQ senior solutions engineer. “We find that many of our clients are implementing an enterprise-wide [suppliers included] risk register to document areas of potential risk and control plans to mitigate said risks. Furthermore, they are establishing risk matrices to assess both identified and unidentified risk in all operational areas of the business. They utilize software tools such as EtQ’s Reliance platform to monitor the efficiency of control plans, identify trends and take a more proactive approach in risk mitigation. The goal is to standardize how employees and suppliers identify and measure risk, allowing for a holistic approach and view to risk in the enterprise.”

“FSMA has caused a philosophical shift from reactive to proactive,” says Stellar’s Bove. An inward look to minimizing risks is a big step. When planning an upgrade or renovation, plants should start with an internal audit of the existing facility and prepare a risk matrix based on the likelihood of a food safety breach, including potential timing and costs, suggests Bove. Plants can then prioritize projects based on this risk matrix. It’s also important to determine root causes of potential violations in risk areas and address them in their entirety since Band-Aid approaches don’t work. “For example, changing air filters due to bacteria, mold spores or allergens will not ‘fix’ the problem. You must look at the root cause of the problem, which may include equipment such as hygienic air units and other potential causes of airborne contaminants,” adds Bove.

Produce safety creates a stir

Along with meat, produce has had its fair share of recalls in the last five years: spinach, lettuce, sprouts, cantaloupes, peppers, and the list goes on. In response, FDA has implemented some rules that small farmers and producers say single them out with difficult-to-meet demands on the use of organic fertilizer and irrigation techniques.

An article published by Agri News (11-17-2013), entitled “Comment now on proposed changes to food safety rules,” suggested that farmers must wait nine months to harvest a crop that was fertilized with organic (raw manure) fertilizer. This wait would make it impossible to harvest a crop in the same year the field was fertilized and is, therefore, unfair to small, organic farms that don’t use chemical fertilizers. The article suggested the proposed FDA rule is in conflict with USDA organic standards, which allow a four-month waiting period after a field has been fertilized with raw manure.

Another issue concerns the use and testing of irrigation water or agricultural water. FDA says the “basic requirement is that all agricultural water must be safe and of adequate quality for its intended use.” Agricultural water is defined as water used in activities on produce where it is intended to, or is likely to, contact either the produce itself or surfaces that come into contact with the produce. This definition does not include indirect water application methods where the water is not likely to contact produce, e.g., furrow irrigation of fruit-bearing trees.

Farmers using public water systems or other water supplies under certain specified conditions, or  those who treat their water in accordance with the proposed rule’s treatment provisions, would not be required to test their water. Critics of the proposed rules suggest that small farmers may have to test their water on a monthly basis, which is not only time consuming but an extra expense that is more easily handled by large farms.

According to Mark Kastel, cofounder of the Cornucopia Institute, although FSMA exempts small farms (under $500,000) through the Tester-Hagan amendment, the regulations allow FDA to revoke the exemption based on its determination a farm may not have been perfectly following GAPs as defined by FDA. Kastel claims even most small farms have gross revenues larger than $500,000, and the additional, rigorous recordkeeping protocols and water testing standards place an unfair burden on the management of a small family farm selling to its community.

FDA’s Taylor noted in his blog that he has spoken with small producers, especially about irrigation water and the use of manure to fertilize corps, and will take these issues into consideration. Taylor also noted these farmers and producers “told us about parts of the rule with which they fully agree and want to see stay in place.”

Getting control of suppliers

FSMA and GFSI certifications will simplify finding trustworthy or quality suppliers. But maybe not for the same reasons. “We view these as separate objectives by different organizations,” says QTrade’s Eng. “FSMA is a very significant shift in government authority and assigns greater responsibility for food safety to importers and producers. I think this is very good for the food industry and for the consumer. As regulations continue to evolve, I think it is our responsibility as food import professionals to provide practical insights during FDA’s comment periods. Furthermore, we are not only pressured by changing regulations, but also by the quality standards we set for ourselves along with those expectations set by our clients. Certainly, our clients are very keen on our obtaining SQF certification.”

The importance of a GFSI certification like SQF can’t be underestimated. “SQF requires a stringent documentation process on how you make your product and everything you do,” says SSOE’s Vetter. “It helps ensure things are done the same way every time, and it is documented.” If a processor undergoes an FSMA audit, it should have good examples to give FDA from its SQF certification. The certification also should give the FSMA auditor a better sense of how the process is done at the facility being audited, according to Vetter.

“Being certified to a GFSI scheme certainly puts a facility in a better position to prepare for FSMA, especially when it comes to preventive controls, than a facility with nothing,” says The Acheson Group’s McEntire. “We have evaluated several of the schemes against the proposed preventive controls rule. There are differences between the schemes themselves, and there are some different terms FDA uses, compared to the GFSI schemes. Those that hold a GFSI certificate will still need to make sure they are crossing the t’s and dotting the i’s for the FDA food safety plan, but they should have most of the story already written.”

How does FSMA affect the choice of a supplier—whether US or foreign? Food and beverage manufacturers understand the need for better electronic recordkeeping, especially as it pertains to raw materials and receiving and storage, says Katie Moore, GE Intelligent Platforms global industry manager—food & beverage. “Being able to understand fully the impact of variances in the quality of every raw material and how it affects each step of the manufacturing process will enable manufacturers to hold their suppliers more accountable. But if the manufacturer does not have the tools and automation in place to fully understand its process, how can it know what quality levels to hold its supplier to? Suppliers and processors will need to have food safety plans in place as a minimum requirement of FSMA. But leveraging technology to continually improve supplier quality and make real-time manufacturing process adjustments to accommodate normal, accepted variations will be easily possible in the future, Moore states.

According to Trace Register’s Heggelund, the industry has already started to use traceability in new ways to achieve the objectives FSMA has defined. For example, in the past, traceability has been reactive rather than proactive. With a proactive environment, tainted food such as the horsemeat in Northern Europe can be more quickly traced. “In seafood supply chains, species substitution is a common problem, as are other abuses like unapproved product treatments,” adds Heggelund. “Enhanced traceability has a key concept of critical tracking events, which are similar to the critical control points of HACCP. As improved internal traceability becomes more and more common, we see a merging of CTE and CCP, with both of these forming the basis for Lean Six Sigma continuous improvement processes.”

In any case, suppliers can expect new and updated agreements requiring documented compliance to FSMA, says Burns & McDonnell’s Hope. “In addition, many [of our] clients are anticipating auditing suppliers, especially those outside the US, through the use of internal or subcontracted resources. The damage that can be done to a brand far outweighs the cost of confirming compliance to FSMA.”

“In theory, the FSMA should make manufacturers more confident in sourcing materials offshore, assuming they have met the requirements outlined by the Foreign Supplier Verification Program section of the law,” says Infor’s Mike Edgett, industry & solution strategy director, process manufacturing. “But given FDA is just rolling out the actual rules for this, it is unclear how well this self-regulation of importers is going to work. Under the law, the expectation from manufacturers doesn’t really change, as they will expect their suppliers to meet the specifications as outlined, just as they always have.”
FSMA Moving Forward

FDA is required to submit annual reports to Congress on the progress of implementing FSMA. The 2013 Annual Report on Food Facilities, Food Imports and FDA Foreign Offices Provisions of the FDA Food Safety Modernization Act was submitted in November 2013. This represents the third annual report in response to this mandate since FSMA was signed into law.

In 2009, President Obama created the multiagency President’s Food Safety Working Group, which is tasked with implementing FSMA. FSWG’s recommendation for a new public health-focused approach to food safety was based on three core principles: prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery.

  • FDA works with several agencies—and in many cases—has memoranda of understanding and interagency agreements to delineate how FDA and other agencies will coordinate their respective responsibilities. Some of these include:
  • CDC: Conducts surveillance; investigates outbreaks of foodborne illness; develops standards, protocols and guidelines; conducts studies and risk assessments; and educates the public, consumer groups, public health partners, industry and other stakeholders on food safety. FDA partners with CDC and FSIS on the biennial update of the Food Code, a model ordinance developed in 1993 through the Conference for Food Protection.
  • USDA/FSIS: FDA covers all domestic and imported food except meat, poultry and processed eggs, which are the responsibility of FSIS. Under a 2012 MOU, FDA and several USDA agencies share information related to food safety, public health and associated regulatory, marketing, trade and research activities affecting public health.
  • USDA/AMS/FAS/FNS: FDA works with all these USDA agencies with respect to shell eggs and poultry farms, imports from foreign countries and domestic nutrition programs.
  • EPA: FDA, FSIS and EPA coordinate activities on establishing priorities and addressing other issues related to residues of animal drugs and pesticides in food animals, detecting illegal residues and taking regulatory actions against violators.
  • US DHS: FDA works closely with Department of Homeland Security’s US Customs and Border Protection regarding the import of FDA-regulated products.

    National Marine Fisheries Service: Conducts a voluntary seafood inspection and grading program that focuses on the marketing and quality attributes of US fish and shellfish.

Other agencies with which FDA partners include the Department of Defense, Department of Labor, OSHA and the Federal Trade Commission.

The report also notes approximately $198.5 million of FY 2012 appropriations were used to inspect facilities. Of this amount, $145.2 million was used for FDA inspection of domestic facilities and $34.7 million for FDA inspection of foreign facilities. The average inspection cost of an FDA-identified FSMA high-risk food facility was $15,500; for a non-high-risk facility, it was $9,200.

Prior to October 22, 2012, there were 172,969 active, registered domestic food and feed facilities and 285,977 active, registered foreign food and feed facilities, for a total of 458,946. In FY 2012, FDA, and the states under contract with the agency, inspected (or attempted to inspect) 24,462 domestic food facilities; FDA inspected 1,342 foreign food facilities.

For more information on this report, including food imports and FDA foreign offices, visit

Source: Refrigerated frozen food


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FDA to modify FSMA

December 20th, 2013
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fda-logoFood and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, released a statement on Dec. 19 announcing that the FDA will propose modified rule language and open up an additional comment period on two of the rules under the Food Safety Modernization Act (FSMA).

“FDA appreciates and takes very seriously the extensive input we have received from produce farmers and others in the agricultural sector on the proposed FDA FSMA rules on produce safety and preventive controls for human food, which we published in January 2013,” Taylor said. “We have made every effort to solicit input on the proposed rules, not only through the standard rulemaking process, but also by participating in more than 150 meetings and by travelling to numerous farms of varying types and sizes from Maine to California. To ensure broad input and facilitate constructive dialogue with the produce community, FDA has extended the comment periods on the proposed rules three times.

“Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement.”

The two rules include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. “We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.”

Joel G. Newman, president and chief executive officer, American Feed Industry Association, reacted positively to the announcement. “The American Feed Industry Association is pleased with the U.S. Food and Drug Administration’s decision to release changes, derived by the industry, to the proposed Food Safety Modernization Act’s preventive controls rules. FDA’s decision shows the agency’s recognition of the rules’ complexity and their willingness to take the extra step to ensure the final rules will be as practical as possible for implementation by the industry.

“No rule is perfect, but AFIA acknowledges FDA’s intent to make these rules well suited for everyone involved in various industry segments. This is a positive sign for the future of FSMA. AFIA will continue to work hand-in-hand with FDA as we move forward in this process.”

Source: World Grain


Food Safety ,

Bakers oppose food import fee

October 11th, 2013
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ABA logoThe American Bakers Association (ABA), a Washington trade group representing commercial bakers, is opposing the proposed food import user fee, proposed as a way to partially fund the Food Safety Modernization Act (FSMA).

“We believe the user fees are unwarranted and will pose an unjustified burden on industry and consumers,” ABA CEO Robb Mackie wrote in a letter to FDA.

Mackie said the organization also believes that the fee is inconsistent with lawmakers’ intent, noting that Congress has repeatedly rejected proposals to fund food safety activities through user fees. At issue are two fees, including a “food import fee” that would be imposed on specific food entries into the US. The second is a “Food Facility Registration Fee,” imposed on individual food facilities.

“ABA believes that these fee programs are neither necessary nor appropriate,” Mackie wrote in the letter.

The fees are intended to fund implementation of FSMA, which greatly expanded FDA’s role in the food safety system. Mackie says FDA has already implemented many aspects of the new law without any funding challenges.

Source: Food Engineering


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