Tag Archives: Preventive Controls

First FSMA Deadline Here, Industry Awaits Final Preventive Controls Rule

By Food Safety Tech Staff
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According to an FDA alert, the agency has submitted the final preventive controls rules for human and animal food to the Federal Register. FDA notes it can take several days from the date of submission to final publication.

“The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so.” The agency will be providing more information on the FSMA section of its website.

In the meantime, are you prepared for the Preventive Controls Rules for Human and Animal Food?

And if you’re in the animal feed industry, take these steps to prepare for success.

Is Your Company Prepared to Fight Food Fraud and Product Adulteration?

By Maria Fontanazza
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Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.

Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?

Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.

FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?

Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.

FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?

Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.

Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.

FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?

Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.

In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.

Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:

  • When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
  • Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.

FST: What factors are contributing to under-use of microscopy-based methods?

Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.

FST: What industry partnerships/collaborations are essential in testing and analysis?

Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.

Bug Bytes

Tis the Season for Mosquitoes. Take Preventative Action to Protect Your Facility

By Maria Fontanazza
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With the heat of summer quickly upon us, food processors should take measures to keep their facilities free of pests that can both harm workers and lead to contamination.

Memorial Day is the unofficial start of summer, a time when we can look forward to more relaxing days sitting by the pool, just enjoying life. But the season also welcomes the unwelcome: more bugs and other little critters.  It is during this time of year that food processers should be extra vigilant about inspecting their facilities to ensure that pests do not become a problem.

While small in size, mosquitoes can be big in nuisance. Ron Harrison, Ph.D., director of technical services at Orkin, LLC, offers a few steps that companies should take to prepare for the season to both protect workers from potentially serious disease transmission such as West Nile Virus or chikungunya virus, and keep mosquitoes from contaminating a food processing facility.

1.    Inspection. Conduct a thorough survey of the perimeter or outside of your building. Have your pest control professional or entomologist look for the presence of natural breeding sites and how they can be eliminated. For example, if there is standing water, how can it be drained? Can it be moved as opposed to remain standing? Growth regulators can also be used to inhibit the developing larvae.

2.    Secure your building. Make sure all screens are in place and that your heating and air system is in proper working order. Check the pressure of your building. If you have positive air pressure with a door open, it pushes air out; if you have negative air pressure, it sucks air in, so a mosquito or any type of bug could be sitting on the outside and get sucked inside.

3.    Use residual products. Mosquitos can be blown in from long distances. Using good residual products on vegetation and shrubs on the outside of your building can help reduce the population. In addition, make sure any dense landscaping is pruned to reduce the harboring sites where mosquitoes might live.

Harrison adds that the prevalence of mosquitos tends to be worse based on the location of a facility. This is where making sure your building is tightly sealed, from the cracks to the positive air pressure in entranceways, is important. “The biggest reason we struggle is that the building or processing plant is built in a swampy area, which is a haven for bugs,” he says. Other factors, including the color of the building (light-colored buildings) and the presence of excessive lighting, can attract more insects.
Now is the time for food processing facility managers to take action and inspect their facility. “Mosquitos are just now starting. In another two or three weeks, it’s going to get serious,” says Harrison. “Preventative activity means that later on in the season when they are bad, your processing plant won’t have problems because you took proactive steps.”

Prepare Your Food Safety Plan for the Preventive Controls Rule

By Maria Fontanazza
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As FDA prepares to issue its next final FSMA rule, Preventive Controls for Human Food, companies should already be laying the groundwork for training staff.

With the August 31 deadline for the Preventive Controls for Human Food rule only months away, careful attention must be paid to training, metrics and collaboration between larger and smaller players to prepare for implementation.

Training surrounds all aspects of a food safety plan, from understanding validation and verification to proper recordkeeping. “Regardless of what happens, training is critical and imperative,” said Donna Garren, Ph.D., American Frozen Food Institute, at the Food Safety Summit last week in Baltimore. “FDA is measuring food safety culture in an operation, and training must be ongoing.”  Garren pointed to the FDA-funded Food Safety Preventive Control Alliance (FSPCA), which was established to develop standardized curriculum and help companies, especially those small and mid-sized, with training programs to meet requirements of the preventive controls regulation. The FSPCA curriculum is fairly broad and includes content that addresses an overview of food safety plans and GMPs, preventive controls related to allergens, sanitation, and suppliers, recall plans and record-keeping procedures. FSPCA has planned its pilot sessions for April, May and June of this year, with a train-the-trainer course planned for the fall.

Formed in January, the FSMA training workgroup has been working to develop training curriculum specifically for regulators on how to evaluate a facility against the preventive controls requirements. According to Priya Rathnam, supervisory consumer safety officer, Division of Enforcement/Office of Compliance at CFSAN/FDA, the agency plans to take a staggered approach to training based on deadlines, beginning with larger companies, as it is not practical to train all safety staff at once.

FDA’s Preventive Controls Phase 2 Workgroup is developing a metrics plan to measure progress (specifically measures that directly tie in with public health outcomes) and track trends, making adjustments as necessary. The agency plans to issue a guidance document to help industry and food and feed safety staff identify significant hazards and implement preventive control strategies. An internal technical assistance network is also planned to assist in consistent implementation in the field.

Start the journey now

While many in the industry may suffer from “FSMA fatigue”, discussing the implications of FSMA day in and day out, a lot of education and outreach still remains. Not everyone within an organization is aware of the intricacies of the regulation. “[We] need to make sure others have the same level of insight that we do,” said Tim Jackson, Ph.D., director of food safety at Nestlé North America.  In addition, the bigger industry players need to work with smaller suppliers and manufacturers that don’t have the resources.

When developing an implementation approach, a company should standardize an internal approach now, rather than wait until the rule comes out in August. This begins with establishing a FSMA team. Jackson advises that this specialized team perform a detailed review of the preventive controls rule requirements and conduct a face-to-face workshop to confirm a rollout strategy and action plan. “We’re looking at our own HACCP plan,” Jackson says of Nestle, adding that they are reviewing validation of control measures and the company’s documentation system, challenging whether it’s “good enough,” and enhancing its early warning system.