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Part III: FSMA IQ Test

By Food Safety Tech Staff
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Here are the results of Part II’s FSMA IQ Test. If you haven’t taken Part II yet, follow this link. Under the results is Part III of the IQ test, results of which will be posted next week.

  1. Written supply chain plans are not included in FSMA food safety plans. FALSE
    • 92% answered correctly
  2. Mandatory recalls are provided under FSMA as a new requirement. TRUE
    • 82% got this right
  3. Under FSMA, FDA cannot unilaterally issue administrative detention and must work through a court order. FALSE
    • 93% answered correctly
  4. Under FSMA verification and validation, a thermometer challenge and calibration for use is an acceptable example of an established validation program and controls. TRUE
    • 85% said “true”
  5. Dogs may be allowed into some areas of the plant under FSMA. TRUE
    • ONLY 27% answered this correctly!
  6. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA. FALSE
    • 92% answered correctly

Create your own user feedback survey

New Report Gives Failing Grade to Many Food Retailers on Pesticide Use

By Food Safety Tech Staff
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A recent report released by Friends of the Earth revealed that very few of the nation’s biggest food retailers have what it considers satisfactory policies and practices in pollinator protection, pesticide reduction and organic offerings. The organization graded 20 of largest retailers in the report, “Swarming the Aisles: Rating Top Retailers on Bee Friendly and Organic Food”.

In the category of publicly available policies on reducing or eliminating pesticides in order to protect pollinators, only Aldi, Costco and Whole Foods received passing grades.

“U.S. food retailers must take responsibility for how the products they sell are contributing to the bee crisis,” said Tiffany Finck-Haynes, food futures campaigner with Friends of the Earth, in a press release. “The majority of the food sold at top U.S. food retailers is produced with pollinator-toxic pesticides. According to Friends of the Earth, neonicotinoids (insecticides) are a leading cause of pollinator declines, while glyphosate (the most widely used herbicide) has been tied to monarch butterfly declines.

“To protect pollinators, we must eliminate pollinator-toxic pesticides from our farming systems and expand pollinator-friendly organic agriculture,” said Dr. Kendra Klein, staff scientist at FOE. “Organic farms support 50% more pollinator species than conventional farms. This is a huge opportunity for American farmers. Less than one percent of total U.S. farmland is in organic production — farmers need the support of food retailers to help them transition dramatically more acreage to organic.”

In conducting the report, FOE mainly used publicly available information sources such as company websites and annual reports, SEC filings, corporate social responsibility and sustainability reports, press coverage, and other forms of industry analysis.

FSMA

FDA Addresses Hazards Requiring Control in New Draft Guidance

By Food Safety Tech Staff
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FSMA

Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.

“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.

The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).

MediaBox Sterile Liquids, EZ-Flow Gravimetric Diluter Automate Sample Prep

MediaBox broths and buffers are sterile, easy-to-use and come in a convenient stackable storage box with a long shelf life. Significantly reduce staff workload by removing weighing, measuring, mixing, autoclaving and cleaning glassware. MediaBox is supplied ready-to-use and is far easier to use than dry bags, which are difficult to fill, often leak and are not consistent from one bag to the next.

MediaBox directly connects to the EZ-Flow gravimetric diluter creating an automated system for weighing and diluting your samples. EZ-Flow automatically weighs samples and provides diluent from MediaBox for the correct dilution factor. Your lab will love the convenience and increased efficiency. Microbiology International offers a wide range of dosing systems to pair with your MediaBox of choice.

All MediaBox products pass strict quality control protocols and include Certificate of Analysis documentation. MediaBox sterile liquids come in 5L, 10L and 20L boxes.

Available types include Buffered Peptone Water, Modified UVM, mTSB, Demi-Fraser Broth Base, Phosphate Buffer, Butterfields, Lactose Broth, Sterile Water, LB Broth, PBS, and more. Custom formulations are available.

Part II: FSMA IQ Test

By Food Safety Tech Staff
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More than 400 people took Part I of the FSMA IQ Test. Read on for the results, and then take Part II of the FSMA IQ test (results of which will be posted next week).

Part I

  1. FSMA requires all records for the reevaluation of cGMPs every three years. FALSE
    • Only 31.8% got it right
  2. Implementation records are required for every FSMA requirement. TRUE
    • 77% answered correctly
  3. Plant borders not under the operator’s controls are not included within cGMPs. FALSE
    • 81% answered FALSE
  4. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required. TRUE
    • 85% got it right
  5. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product. FALSE
    • Results were almost split: 48% answered TRUE; 52% answered FALSE
  6. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan. TRUE
    • 95% answered correctly.

Part II

Create your own user feedback survey

Joann Givens, FDA

What to Expect Now that the First Big FSMA Compliance Dates Are Here

Joann Givens, FDA

The first major compliance dates have arrived for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016. That’s the date when larger businesses must comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)

Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

What happens next in terms of FDA enforcement of these new standards?
We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.

This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)

Does the focus on education mean that companies won’t really be held to these standards yet?
No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.

What is the best thing covered food facilities can be doing now?
The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.

In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.

If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?

Where can companies go wrong?
A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements.

And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.

What is the ultimate goal?
The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.

The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.

We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.

This article has been republished with permission from FDA. The original version can be viewed on FDA’s website.

Meritech Helps Companies Improve Employee Hygiene GMPs

Meritech, manufacturer of the world’s only fully-automated, touch-free handwashing systems will be exhibiting at the 2016 Food Safety Consortium in Schaumburg, Illinois — with one of its automated handwashers onsite for attendees to experience the technology-based approach to employee hand hygiene. Meritech offers a full line of automated handwashing and footwear sanitizing systems, designed to meet increasingly stringent food safety standards and regulations.

All CleanTech automated handwashing systems deliver a consistent 12-second wash and rinse cycle, removing 99.98% of dangerous pathogens from hands. Meritech products use 75% less water, require less soap/sanitizer, and reduce discharge waste, compared to equivalent manual handwashing.

Listeria and Salmonella outbreaks are some of the biggest fears throughout the food industry. Effective employee hygiene at critical control points is necessary and Meritech offers the best guaranteed preventative measures through its automated systems.  Effective, efficient footwear sanitizing, especially when  combined with simultaneous handwashing, can reduce or eliminate the spread of these and other pathogens. Meritech’s automated handwasher with an optional footwear sanitizing pan guarantees clean hands and sanitized shoes in 12 seconds.

Meritech helps companies in a wide variety of markets, including food production, food service, theme parks, cruise lines and hospitals. All Meritech products are designed and manufactured in Golden, Colorado. The company ensures that your equipment is always effective by delivering best-in-class, proprietary chemicals and providing no charge, onsite scheduled calibration by its team of Service Engineers. Visit www.meritech.com to learn more.

Robert Ferguson, Strategic Consulting

Contract Food Labs Gain Traction

By Maria Fontanazza
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Robert Ferguson, Strategic Consulting

Last month Food Safety Tech and Bob Ferguson, managing director at Strategic Consulting, discussed changes that are affecting the contract lab industry, from processor concerns in keeping pathogens out of their facility to operational challenges. In part II of our interview, Ferguson reviews how these factors are increasing competition among food contract laboratories.

Food Safety Tech:  Since we published your article “Changing Landscape for Selecting a Food Contract Laboratory” you’ve mentioned that you have been getting quite a few questions about the piece, your study and your findings. What is the most common question you have received?

Robert Ferguson: It’s been interesting! I have received questions directly via email and many over various social media. People have been very interested in the overall impact that these changes will have on the market. As more and more companies outsource their food diagnostic testing, and as food contact labs companies capture a greater share of the testing market and also grow through consolidation of the market, testing labs will have greater market power. It is a common purchasing practice, of course, for buyers to commoditize services such as laboratory analysis to the extent that they can and then force the labs to sell on price. This has clearly been the case in the food lab market. But as more companies outsource, and the larger labs grow and consume greater share, the balance of bargaining power between the larger labs and processors will change.

FST:  Is it just the relative size of the labs that is having the major impact?

Robert Ferguson, Strategic Consulting
Robert Ferguson, managing director, Strategic Consulting, Inc., will discuss the results of the survey at the 2016 Food Safety Consortium in December | LEARN MORE

Ferguson:  Larger lab companies will certainly have economies of scale, operating efficiencies and bargaining power with their suppliers that the smaller labs will not that they will use to their advantage. But there is more to it than that. Close to 70% of the processors in our survey say that they outsource their pathogen samples to labs within 100 miles of their plant. Many of these processors are multi-site operations and will look to outsource their work with the fewest number of laboratory contracts. With growth and consolidation in the market, fewer and fewer lab companies will have laboratories in the right places to meet this 100-mile requirement. Fewer labs will qualify for the bidding process, and this will reduce competition.

FST:  Will this change pricing?

Ferguson: Probably, especially over time. The other thing we heard from processors is that economics is not the main criteria in their decision to outsource. Traditionally, processors would “do the math” and those with fewer samples would outsource, as it would not be economical to maintain their own lab operation, while those with high sample volumes would run their own plant lab or a consolidated corporate lab. But what we hear from processors is a greater focus on food safety and a desire to get any work with pathogens out of their plant. We also hear more reluctance from processors to be “in the lab business.” Their core competence is food production, not maintaining lab accreditations, keeping up to date on more sophisticated analytical techniques, and everything else it takes to maintain an efficient lab operation. Neither of these goals is economic, and we are seeing more companies outsource their samples at a higher cost per sample than what it was costing at their in-plant lab. Less competition and more focus on qualitative goals and not just pricing will create longer-term increases in contract lab prices.

Read part I of the Q&A with Ferguson, “Increased Testing for Pathogens and More Complex Tests Means More Outsourcing”FST:  That sounds positive for food contract laboratories. What is the risk?

Ferguson: These changes will be a significant opportunity for some food contract lab companies and a significant risk for others. Those who can create the best lab network will qualify for the most outsourcing contracts and will likely be far more competitive. Single location labs, however, will find it harder to be competitive, and many will likely be acquired while others will fail. We will certainly see a continued high level of M&A activity in this market.
Some of the other questions people have asked are about the impact on lab companies’ strategies, outside of M&A. We have heard from processors that while the larger labs with the better networks are better outsourcing partners, they are also finding that these larger lab companies are more “industrialized” and have far less emphasis on customer service. This seems to introduce an opportunity for a laboratory company with a strong network that can also maintain a high level of customer service to gain a competitive advantage.  We see some indication that this is already happening as more lab companies offer services such as auditing, onsite inspections and testing, and program development. In fact, our data shows that services, while still a small proportion of most food contact lab’s revenue, is nonetheless the fastest growing component, overall growing at nearly 15%. This seems to be a clear opportunity for food contract labs to differentiate themselves and stay competitive.

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Test Your FSMA IQ Smarts

By Food Safety Tech Staff
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FSMA Preventive Controls: Are You Prepared? Use this self-diagnostic assessment tool to help determine your current state of planning for FSMA.With so many factors and new requirements to consider, have you and your team thought about how well you really know FSMA and all that the new regulations entail? Here at Food Safety Tech, we’ve heard from sources in the industry that many elements of FSMA are not fully understood.

Working with Bill Bremer, principal of food safety compliance at Kestrel Management, LLC, Food Safety Tech is introducing a six-part FSMA IQ test. Results will be posted each week in our Food Safety Consortium newsletter leading up to the 2016 event.

Take part I of the FSMA IQ Test.

Find out how you did on Part I, and then take Part II here.

Part III

Part IV

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Inspection and Recovery Services

FlexXray will be exhibiting at the 2016 Food Safety Consortium in Schaumburg, IL. At the booth representing FlexXray will be CEO Kevin Fritzmeyer and Project Manager John Hower. They will be discussing their food inspection process and capabilities of foreign material detection.

FlexXray is the leader in Inspection & Recovery Services dedicated to serving food companies. The company X-rays food products for various types of foreign material and contaminants, which it can see down to 0.8 mm or even smaller.  Metal, plastic, gasket material, glass, stones and bone are a few of the items our customers ask us to inspect for.

FlexXray provides quick turn IN/OUT service, your truckload of product is inspected, contaminants removed and returned in only 8-12 hours. The company has introduced a new audit program for our customers to conform to the new HACCP and FSMA regulations. It is meant to help catch and prevent problems before recalls occur.

Our goal is to work with food companies to inspect their finished product for foreign material versus their other option, throwing it away. We strive to provide your company a cost-effective option in the event that you have an incident.

For more information, visit the FlexXray website.