Tag Archives: FSMA

Tim Curran, Sample6
FST Soapbox

Putting FSMA Into Practice

By Tim Curran
1 Comment
Tim Curran, Sample6

High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.

Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?

FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.

Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:

  • Preventive controls
  • Inspection and compliance
  • Imported food safety
  • Response
  • Enhanced partnerships

I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.

Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.

Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.

Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.

Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.

Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.

The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.

Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.

Patrick Embwaga, The Hershey Company
FST Soapbox

Open Letter to FDA on Adoption of Systems Approach to FSMA

By Patrick Embwaga
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Patrick Embwaga, The Hershey Company

The new FSMA regulations are primarily intended to enhance the protection of public health through promotion of adopting a modern, preventive and risk-based approach to food safety regulation. The general consensus industry-wide is that the new regulations will increase the capacity of firms in the industry to develop effective food safety management system at facility levels that will be effective in preventing distribution of food-related hazards to the general public, which may result in foodborne illness.

There is widespread consensus that the development and implementation of a food safety system whose primary purpose is to prevent the distribution of hazardous product to the general public and hence prevent or reduce foodborne illness is a much more effective and practical approach towards this end. This is especially the case when compared to past approaches, among which many programs were quality control based and focused on end-product testing given the highly fluid and dynamic complexity in the food industry, which is being fueled by technological advancements that occur at the speed of light.

Having stated consumer safety as the primary stakeholder of a facility’s food safety system, there are other secondary stakeholders whose requirements are subservient to the consumer’s health requirements, but they play key roles in determining the architectural structure of the food safety system:

  • Regulatory requirements. Primarily serve the public and act on its behalf in ensuring that all food products distributed in the market are safe for consumption. However, the regulatory requirements have their own innate requirements (i.e., the uniformity of the structure of a food safety system) at the most basic level for the purposes of compliance, which enables a harmonized structure that conveniently lends itself to a uniform approach in the inspection of facilities by FDA agents.
  • Organizational requirements. There are existential risks to an organization should a facility ship out contaminated product, as can be seen from the recent cases widely reported by the media. These range from market share reductions to rattled shareholders, and to employees, it becomes a job security issue. In fact, this is one of the key points I always bring out during trainings: The consumer is the ultimate boss, and if the consumer complains, it’s bad for our jobs as food manufacturers. If they are outright sickened/angry/mad by our job performance, we should expect the pink slips (I’m sure a number of employees at the Blue Bell Creameries will support this opinion).

From a regulatory requirement perspective, uniformity is a key aspect of the requirements, as can be inferred from regulatory text on the preventive rules, which describe the fundamental elements that must be implemented by a facility in order for it to be compliant with FDA registration. The lifecycle of regulatory requirements are long term—the last time comprehensive changes were conducted on cGMPs was in the mid-1980s. And hence the analytical/reductionist approach of focusing on food safety at the facility level is complementary to its enforcement strategy (i.e., facility-based registration and inspection).

From the organizational perspective, given that the food safety system serves an existential purpose to the business, organizations are leveraging the best available resources to endure its proper design and implementation, including employing the use of the latest available technologies. From the organizational perspective, the organizational requirements are highly dynamic and often tied to consumer and market trends. And as such in most corporate organizations, the food safety system adopts a holistic approach, whereby plant facility food safety systems are often nested within larger hierarchical corporate food safety systems. One of the fundamental reasons for this holistic set up is to enhance efficiency of these programs, especially given their key functional roles in mitigating or preventing organizational risks that may be presented through distribution of contaminated product.

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Stephen Ostroff, FDA

FDA Commissioner Reflects on Food Safety Progress in 2015

By Food Safety Tech Staff
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Stephen Ostroff, FDA

Stephen Ostroff, M.D., acting commissioner for food and drugs at FDA, released his final blog on 2015 FDA achievements earlier this week, highlighting the strides made in food safety. As expected, Ostroff pointed to FSMA and how it will help industry take stronger steps in preventing contamination, improving safety in growing produce and holding importers accountable. He offered a few agency high points in food safety for 2015:

FST Soapbox

Technology Can Help Food Manufacturers Navigate FSMA in 2016

By Jack Payne
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It’s safe to say that 2015 has been one of the worst years in recent history when it comes to food contamination. Everyone from global food manufacturers to major restaurant chains and grocery stores perpetuated or experienced outbreaks of foodborne illnesses like E. coli, Listeria, Salmonella and Norovirus. From farm to fork, the food industry needs to evalutate and improve its processes to deliver the utmost health and safety to consumers.

With FSMA and tougher industry standards in place, there will be much more emphasis on preventative measures—especially for food manufacturers. FSMA establishes a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.

FSMA
Not surprisingly, most food manufacturers say they are being impacted by FSMA

Even though most of the regulations affiliated with the FSMA have just gone into effect, or will go into effect in 2016, food manufacturers are already feeling the heat. A recent survey found that the majority (81%) of food manufacturers are experiencing some level of impact from current and impending regulations. Processes pertaining to traceability, supplier and facility audits, HACCP and product recalls are causing the most concern. While most food manufacturers support FSMA’s mission to put prevention at the forefront, the reality is that many aren’t equipped to handle growing compliance demands.

There are still a sizeable number of food manufacturers that manually record their processes for identifying, evaluating and controlling food safety hazards. In fact, more than 30% of food manufacturers document their HACCP plan in this manner.

FSMA Infographic
58% of manufacturers surveyed are using an in-house system for recording issues as part of their HACCP plan

With FSMA, there isn’t any room for human error. Although technology with track and trace capabilities has been available long before FSMA came into play, obstacles such as complicated interfaces, lack of interoperability and resources deterred wide-spread adoption among food manufacturers. The tide is changing here. Advanced enterprise resource planning (ERP) solutions have built in track and trace functionality that is more intuitive and integrates seamlessly with vital manufacturing execution systems (MES).

FSMA and traceability
Manufacturing execution solutions play a key in helping companies achieve traceability. All figures courtesy of Aptean. View full infographic

Although the FDA does not have the legal authority to require companies to use computerized traceability solutions, implementing track and trace technology is one of the most effective measures a food manufacturer can take when it comes to FSMA compliance. It can help create a more systematic and reliable account throughout the lifecycle of a food product, and also establish preventative measures, including automated product checkpoints and quality tests throughout the supply chain. Ultimately, this gives food manufacturers the opportunity to identify and prevent issues before they become epidemics.

In addition to taking strong measures to prevent contamination, under FSMA the FDA now has authority to initiate mandatory recalls. Although mandatory recalls are anticipated to be rare, food manufacturers should use track and trace technology to make recall preparation routine. When used properly, these tools can pinpoint specifics about a product in real time, streamline quality reporting, and launch mock recalls.

Of course, technology is not only the vessel for improvement—to actually see change, food manufacturers need to take a critical look at their processes and make adjustments. Automating poor processes will only accelerate poor results, therefore approaching FSMA compliance and implementing track and trace technology requires time and strategy.

Ultimately, your company’s reputation is on the line as well as the safety of consumers. Dedicating necessary resources toward compliance planning and technology implementation is always well worth the investment. Many of the companies and suppliers that were in this year’s spotlight for contamination will look back on 2015 with regret because safety wasn’t at the forefront. Let’s learn from the hard lessons they provided and make 2016 the year that food manufacturers win back consumer trust and focus on quality.

FSMA Raises Pressure on Pest Management

By Maria Fontanazza
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As with many areas in food safety, the future of pest management will place more emphasis on implementing a scientific approach and leveraging digital technologies. Food manufacturers and processors will rely more heavily on their pest management providers to be their eyes and ears to find issues within a facility that may have otherwise gone undetected and could lead to potential deadly outbreaks. “The pest control industry is always trying to control pests. But now the manufacturers are realizing that this [regulation] is pretty serious and people [could] go to jail,” says Ron Harrison, director of technical services at Orkin, LLC. “I think you’re going to find a much more scientific approach to pest control in food processing.” In a discussion with Food Safety Tech, Harrison shares insights on the changes (for the better) that FSMA is having on the relationship between pest management professionals and food manufacturers and processors.

Food Safety Tech: What are the biggest areas of concern surrounding FSMA and pest management? Are companies in the food industry prepared for compliance?

Ron Harrison: The big part about FSMA is that everything is now suspect in reference to food safety—from deliveries to storage to transportation on the backend; there’s a much more holistic approach. It has had a major impact on us—we’re doing more inspections on the front end, when the trucks [deliver] the raw ingredients, and we look for possible pests on the truck, rather than [inspecting] an isolated building.

The elevation has been that owners and managers realize that they’re going to be held responsible for potential food safety issues, and so they’re holding their pest professional at a much higher level to help be their eyes and spot potential problems to ensure compliance with safety issues. For example, take two situations that have come up in the last five years—the Peanut Corporation of America [Salmonella outbreak] and Blue Bell Ice Cream [Listeria outbreak]. In neither one of those cases were pests responsible for the problems. But questions came back to pest control professionals about why they weren’t making [the manufacturers] aware of leaking coming from the ceiling, etc. I think they’re looking for us to support their programs of food safety, not just ‘kill some cockroaches’ or prevent rodents from coming into [a facility]. Manufacturers are asking us to tell them what they’re doing wrong rather than us going back to them. I think there’s a better partnership moving forward.

The industry went from pulling out equipment and spraying [to control pests] to [the present] where it’s not uncommon for a microbiologist to take samples to find out not just if there’s a cockroach, but did it leave anything behind. I think you’re going to find the approach to pest control to be much more scientific.

FST: What digital technologies should food companies leverage as part of a proactive pest management plan?

Harrison: I think this is where the big future is. It’s how do we monitor just in time to provide service based upon that monitor. That’s futuristic looking. For bigger animals, we’re already moving in that direction: A relay goes off when the animal crosses a threshold, and a picture is taken that can be determined by movement and heat. But for the smaller creatures, like rodents and cockroaches, why isn’t there some type of monitoring system as well? From a monitoring and detection standpoint, we’re going to see a lot more technology that helps us very quickly assess what’s going on, which therefore will limit some of the robotic routine services that we do. That’s happening in Europe—it’s not uncommon to have monitors in place and as soon as something happens, you’re out there getting rid of [the pest] rather than putting traditional baits every 25 feet. If you think about it, wouldn’t it be much better that when the mouse is caught in the glue board that immediately a signal goes out and it’s removed rather than sitting there for five days until the pest control professional goes back and checks the device?

The person in charge of pest control wants to come into work and know exactly what’s going on: What pests were seen, what treatments were made, what the local manager is doing, etc. All of it needs to roll up into easy, accessible data. The data collection and reaction would be immediately downloaded every morning or evening when the shift is over. The demand is very clear for what the expectation is.

I’d say within the next year or two you’ll have a variety of companies providing these monitoring systems (inside and outside) to food processing plants.

Food Safety Tech

Most Popular Stories of 2015

By Food Safety Tech Staff
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Food Safety Tech
Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry.

5: FSMA’s FSVP: Clearing the Confusion of Importing Rules

Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

4: When Someone Dies, It’s Not Business as Usual

“His actions resulted in technically more deaths than that of Charles Manson,” said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness.

3: Marijuana Edibles: Update on a Rapidly Developing Market

Marijuana has catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry

Steward Parnell, PCA, salmonella outbreak
Stewart Parnell sentenced to 28 years in prison.

2: Food Safety Culture: Measure What You Treasure

A renewed recognition of the importance of individual employee behavior within food processing and manufacturing organizations is shining a spotlight on awareness and accountability, but a standardized measure of food safety culture must be defined.

1: PCA Executives Sentenced: Stewart Parnell Gets Virtually Life in Prison

The landmark case sets a precedent for the food safety industry.

Fontanazza and Fields

Food Companies: Know Your Suppliers

By Food Safety Tech Staff
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Fontanazza and Fields

Read the Q&A with Randy Fields, “Senior Execs in for a Rude Awakening Regarding Supply Chain Compliance”Both accountability and liability will play a role in how food companies work with their suppliers moving forward. “The global food supply chain has really been based on trust for the last 70 years,” said Randy Fields, chairman and CEO of Park City Group and Repositrak. In a video interview with Food Safety Tech at the 2015 Food Safety Consortium, Fields explains how companies must go beyond simply “trusting” their suppliers to having a keen awareness of their suppliers’ activities from a compliance perspective.

 

FSMA

Are You Ready for the Produce Rule? You Just Might Be

By Marsha Madrigal
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FSMA

At last the new Produce Rule is out, issued on November 13, 2015.  For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.  The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.

The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act.  It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.

The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.

Food Safety Consortium
During the FDA Town Hall, an audience member asks about the Produce Rule and the work being done with Mexico. Watch the video

For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along.  For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).

This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.

The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.

However, some key requirements of the new rule not noted in existing third-party standards include:

  • Water testing of untreated water, sample collection and survey creation for agricultural water.
  • Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
  • The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
  • The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.

This rule does not apply to:

  • Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
  • Produce for personal or on-the farm consumption
  • If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
  • A food grain such as wheat or oats

The rule provides also for exemptions:

  • Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
  • Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.

Under certain conditions the FDA may withdraw a farm’s qualified exemption.

The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.

This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.

FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.

The compliance dates for the new rule are staggered and based on business size.

Resources

  1. Produce Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  2. FSMA Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
Food Safety Consortium

Moving Produce Rule Forward, United States and Mexico Partnership Critical

By Food Safety Tech Staff
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Food Safety Consortium

During an FDA Town Hall at the 2015 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Watch video of Taylor’s speech: Part I and Part IIMedicine Michael Taylor was asked about implementation of the produce rule from the perspective of Mexico. Taylor touched on the partnership, announced about a year ago, between the United States and Mexico in recognition of the fact that working together will be the only way to move forward in verifying compliance with the new rule. “Our work with Mexico on produce safety is one of the most important things we’re doing right now in implementing FSMA,” said Taylor.

Jill Bender, SafetyChain

GFSI in the Age of FSMA Series Helps Companies Prepare for FSMA Compliance

By Jill Bender
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Jill Bender, SafetyChain

The “GFSI in the Age of FSMA” three-part series wrapped up in early December, providing the food safety community insight on how leading GFSI schemes align with, and help prepare for, compliance with FSMA.  The series was presented by SafetyChain with media partner FoodSafetyTech.

Each GFSI scheme leader from SQF, BRC and FSSC 22000 discussed how their schemes align with FSMA in several key areas, including Supply Chain Controls, migrating Food Safety Plans from HACCP to HARPC, and audit readiness. While each scheme leader provided insights and details on how their scheme aligns with FSMA, common key themes across all three sessions included: 

  • FSMA’s focus on prevention vs. reaction is similar and aligns with GFSI’s objectives; Scheme certifications and ongoing compliance is centered around continuously assessing risks and putting preventive measures in place to mitigate those risks
  • GFSI’s global approach surrounding a company’s food safety program—to ensure better supply chain controls internally, upstream and downstream prepares companies to manage FSMA’s increased focus on both domestic and foreign supplier compliance
  • GFSI stringent documentation and recordkeeping requirements—along with unannounced audit protocols—are a strong foundation to help food and beverage companies prepare for FSMA’s “if it isn’t documented you didn’t do it” mantra

The GFSI scheme leaders also spoke about the importance and opportunity companies have to leverage technology tools to help more effectively manage the complexities and requirements of GFSI and FSMA compliance.  Series participants were able to see an example of how these automation tools work and the impact they can have on managing a robust food safety program via a post session demo of SafetyChain Software.

Archived recordings of all three sessions—SQF in the Age of FSMA, featuring Robert Garfield, Senior VP, SQF; BRC in the Age of FSMA, featuring John Kukoly, Director, BRC Americas; and FSSC 22000 in the Age of FSMA, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000—are available and can be accessed here.