Tag Archives: Focus Article

Tim Curran, Sample6
FST Soapbox

Putting FSMA Into Practice

By Tim Curran
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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.

USDA Logo

Pesticide Residues Not a Food Safety Risk, Says Federal Government

By Food Safety Tech Staff
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USDA Logo

After publishing data from its 2014 Pesticide Data Program (PDP) earlier this week, the USDA has stated that it is not concerned with the level of pesticide chemical residues in the U.S. food supply. More than 99% of products sampled through the USDA’s Pesticide Data Program had residues below EPA tolerances (residues exceeding the tolerance were detected in 0.36% of samples).

“The PDP plays an essential role in ensuring the safety of the U.S. food supply. Under the Federal Food, Drug, and Cosmetic Act, the FDA has authority to take enforcement action when a food bears or contains unlawful pesticide chemical residues,” said Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition in a press release. “By providing an accurate assessment of pesticide levels in the most commonly consumed commodities in America, the PDP generally confirms the U.S. food supply is safe with respect to pesticide chemical residues.”

Among the foods tested were fresh and processed fruits and vegetables, oats, rice, and salmon. The findings from the PDP annual summary can be accessed via the USDA’s website.

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:

Jeff Mitchell, Gina Kramer, Listeria

The Increase in Listeria Recalls and What You Can Do About It

By Food Safety Tech Staff
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Jeff Mitchell, Gina Kramer, Listeria

Why has the food industry been seeing more Listeria outbreaks in recent years? What is the reason behind it? According to Jeff Mitchell, vice president of food safety at Chemstar, the prevalence in Listeria-related recalls may have more to do with the fact that industry is collecting more meaningful data. During a Q&A with Gina Kramer, founder and executive director of Savour Food Safety International, Inc., Mitchell discusses the methods through which industry is collecting data and how food companies should be using a sanitation program to rid facilities of resident Listeria at the 2015 Food Safety Consortium.

Listeria

Fast Facts About Listeria

By Maria Fontanazza
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Listeria

Attend the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREAccording to the CDC’s Foodborne Outbreak Online Database (FOOD Tool), there were 29 Listeria outbreaks between 2010 and 2014, resulting in 325 illnesses and 68 deaths (nearly a 21% fatality rate). In light of the recent reports that the U.S. Department of Justice is looking into Blue Bell Creameries following the Listeria outbreak in its facilities that killed three people, food companies need to have a strong mitigation and control program before it’s too late. The government is placing is a higher level of accountability on employees at all levels within food organizations and no one, including company executives, are immune to it.

“It’s extremely important that we understand how deadly Listeria is,” said Gina Nicholson-Kramer, founder and executive director at Savour Food Safety International, Inc. during a Listeria workshop at the 2015 Food Safety Consortium. “We’re put here to protect our consumer.”

Containing what may be growing (and rapidly spreading) within the nooks and crannies of a facility is a challenge. To learn more about how to prevent product contamination within all areas of food production, read the column by Nicholson-Kramer and Jeff Mitchell, vice president of food safety at Chemstar, Activate Your Listeria Mitigation and Control Program.

 Fast Listeria Facts

Types of Infections

 Non-invasive gastroenteritis: Self-limiting, diarrhea, fever, fatigue

Invasive gastroenteritis: Headache, stiff neck, loss of balance

At-Risk Populations

 Pregnant women, neonates, elderly, immune-compromised

Where It’s Found

 Soil, water, silage, manure, sewage, processing plants

How It Spreads in Facilities

 Foot traffic, wheels, forklifts, pallets, boxes, bins

Average Fatality Rate

 Up to 25%

Other Traits

 Psychrophilic bacteria (grows well in cold temperatures)

Adheres to surfaces and creates biofilms on equipment that is difficult to remove (Preventing transient Listeria from becoming resident Listeria is critical)
Department of Justice seal

Department of Justice Reportedly Investigating Blue Bell Creameries Over Listeria Outbreak

By Maria Fontanazza
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Department of Justice seal

Several news outlets have reported that the U.S. Department of Justice (DOJ) is investigating Blue Bell Creameries following the Listeria outbreak that resulted in three deaths in Kansas and 10 illnesses in Arizona, Kansas, Oklahoma and Texas between January 2010 and January 2015.

According to The Wall Street Journal, the DOJ is mainly interested in the involvement of company executives—did they know about the Listeria contamination? If so, what did they do about it?

Last April Blue Bell recalled all of its products over concerns of Listeria contamination and shut down the production line where the products were manufactured.

Blue Bell started a limited-release of its ice cream products last August. The company has not yet issued a response to the reports about the DOJ investigation, but last week it announced that it would begin a “bonus phase” of product re-entry in El Paso, Texas, Little Rock, Arkansas, and Memphis, Tennessee. This is scheduled to be followed by phase five of market re-entry in parts of Tennessee, Alabama, Georgia, Kentucky, North Carolina, South Carolina, and Virginia the week of January 18, and then shipment into all of Florida, southern Georgia and southern South Carolina the week of January 25.

The company stated in a press release that after phase five is completed, all of Blue Bell’s furloughed employees will have returned to work.

Following the landmark sentencing of Peanut Corporation of America executives last fall, industry will be watching the outcome of the investigation very closely.

FDA Town Hall, 2015 Food Safety Consortium

Working Smarter with Foreign Regulatory Bodies on Imports

By Food Safety Tech Staff
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FDA Town Hall, 2015 Food Safety Consortium

With FDA’s limited resources, it’s important for the agency to work smarter, not necessarily harder, when it comes to implementing FSMA. During an FDA Town Hall at the Food Safety Consortium last fall, Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, briefly touched on the agency’s strategy for working with foreign parties to ensure compliance related to importing foods into the United States, including the Food Safety Systems Recognition Agreement with New Zealand.

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

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

Top 10 Tips for Creating a Sustained Food Safety Culture

By Holly Mockus
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After much anticipation, FDA has finally published the FSMA final rules. If you’ve had time to dig into the details, you most likely noted the new initiative that requires companies to measure food safety culture. The industry is also seeing SQF, BRC and other GFSI audit schemes ramping up discussions around measuring food safety culture. However, FDA and GFSI audits aside, how do you create a culture for sustained compliance with this initiative? Follow these 10 tips to ensure your food safety culture is constant and in line with the new requirements

Photo credit: Dennis Burnett for Alchemy Systems
Set clear expectations for employees across the board. Photo credit: Dennis Burnett for Alchemy Systems

1: Create a solid foundation of programs, procedures and policies

Have a preset annual schedule for review and update of all programs, procedures and policies. Don’t let the schedule slide because there are competing priorities. A small pebble is all it takes to start ripple effect in the company, making it difficult to recover.

2: Set clear expectations, driven from the top down

Everyone should follow the rules and guidelines—from visitors to the CEO to the plant manager to the hourly employee. A “no exceptions” policy will drive a culture that is sustainable and drive a “this-is-just-how-we-do-things” mindset.

3: Use record keeping to ensure that food safety culture is well documented and data-driven

Collect the data that is measureable and non-subjective to help drive continuous improvement. If you collect it, you must do something with it. Good documentation is imperative to proving you did what you said you were going to do, especially in the event of an audit. Be stringent in training, and review all documentation before it hits the file cabinet to ensure it is accurate and appropriate.

4: Implement a robust continuous improvement process

Forward momentum through a continuous improvement process cannot be achieved unless management nurtures the program. If you are not continuously improving, you are falling behind.

5: Have a 360-degree approach to employee engagement with 24/7 awareness and communication

Top-down communication is critical to highlighting the priorities and needs of an organization and will not be effective unless an organized program is in place. Organizations that are not making the necessary pivots to communicate with the multiple generations within their workplace today will struggle to sustain change.

6: Foster an atmosphere of mutual respect

Treat people as you would like to be treated, turn the other cheek, etc. There may be lots of adages you quote, but which one best describes your facility and the relationships with management and peers on a daily basis?

7: Be sure employees have consumer awareness for the products they produce

Do your employees know who the end consumer is of the product that they are producing every day?  Does your culture include a review of consumer complaints and customer complaints with your frontline workers?  Listening in to a call center is a very powerful way to help employees understand what affects consumers and how their job is critical to avoiding a food safety or quality issue.

8: Create accountability across the board

Hold folks who do not support the culture in which you are striving to develop or maintain accountable, regardless of their position or stature.

9: Provide positive reinforcement. It’s the best motivator

Work to catch people doing things right and make a big fuss when you do. Positive reinforcement for a job well done is the most powerful motivator. It helps keep every team member on board with food safety commitments.

10: Celebrate often

We spend too much time at work not to celebrate all the good things that are accomplished. Whether it’s a cake and recognition for those that served in the armed forces on Veterans Day or a successful launch of a new product—celebrations are a great way to recognize and reinforce your employees’ hard work. Identifying and correcting mistakes should also be celebrated; they are fertile ground for making changes and provide great nutrients for continuous improvement.