Tag Archives: contamination

FDA Inspections: Top Five Violations for FY2017

By Food Safety Tech Staff
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FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Among the items on the spreadsheet are food safety hazards, failure to clean, sanitation records, corrective action plan, and lack of sanitation.

“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA

The following are the top five (most frequent) observations.

  • 5. Contamination: Cleaning and sanitizing operations for utensils and equipment not conducted in a manner that protects against contamination of food, food contact surfaces and food packaging materials.
  • 4. Failure to implement HACCP plan procedures.
  • 3. Facility not constructed in a way that enables floors, walls and ceilings to be adequately cleaned; buildings, fixtures and other physical facilities not kept in sanitary condition.
  • 2. Sanitation monitoring: Sanitation conditions and practices not monitored with enough frequency to be in conformance with CGMP.
  • 1. Pests: Lack of effective pest exclusion from processing areas and contamination of foods, and failure to provide adequate screen against pests.
Cara Pahoyo

5 Burning Questions About The Rise In Foodborne Illness

By Cara Pahoyo
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Cara Pahoyo

The food industry has been one of the most celebrated and fastest-growing industries over the last decade or so. Which is no surprise, considering how much food is now being consumed, or posted on Instagram, on a daily basis. Pop-up food carts and hole-in-the-wall food places have been a huge hit too and even inspired a number of Hollywood films about the tough competition and revolutionary marketing tactics that have taken over the food industry (see: Jon Favreau’s Chef and Bradley Cooper’s Burnt). It’s good times, for sure. Well, for the most part, I mean.

When did foodborne illness become a major concern in the US?

Unfortunately, it’s not just the revenue that’s on the rise, because food borne illnesses too are making the headlines as of late. Talk about spoiling (no pun intended) the fun, eh? Well, according to the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, the number of foodborne disease outbreaks resulting from imported foods increased during surveillance years 2005 to 2010.

Where are the numbers coming from?

Dr. L. Hannah Gould, Ph.D., a senior epidemiologist at the CDC, revealed those findings during an oral presentation here at the International Conference on Emerging Infectious Diseases in 2012. According to the CDC, 39 foodborne disease outbreaks were reported in which the implicated food had been imported into the United States. These outbreaks resulted in 2348 illnesses, 434 hospitalizations and 3 deaths.

How many are affected?

Though foodborne illnesses are often never formally reported, about 48 million Americans, or one in six, get sick each year from food, the CDC estimates, with 128,000 hospitalizations and 3,000 deaths. In fact, in 2014, 19,542 cases of infection were traced from 15% of the US population being surveyed by CDC.

Why is it on the rise?

The culprits? Chances are, you’ve been storing them somewhere inside your establishment: packaged caramel-coated apples, frozen ice cream sandwiches, fresh peaches and nectarines, frozen meet, etc. Not exactly the answers you were expecting, perhaps?

According to experts, the growing popularity of packaged foods such as pre-cut fruit and prepared sandwiches has heightened the risk of spreading foodborne illnesses. Furthermore, they have identified that contamination can occur between preparation and packaging, or in high-tech processing plants, after heating to destroy harmful bacteria and before packaging. Which means, somewhere in the last decade, we lost our way (or something like that).

What can we do to stop foodborne disease from spreading?

The whole fiasco regarding foodborne illness is a public safety concern and must be addressed by everyone. However, while adjusting individually may not be a problem for most of us, the same cannot be said for food places and restaurants. Just imagine the public relations horror for restaurant managers if any of their customers get sick while dining at their place?

Restaurants must be more strict and thorough when addressing food safety concerns. The entire crew must be trained when it comes to food handling and a food safety manager must also take charge in overseeing procedures in the kitchen. In fact, proper storage and disposal must also be adequately done at all times. With those safety measures in play, establishments will be able to showcase their commitment to adhere with local food standards and basic food handling procedures. That’s a step in the right direction, for sure.

Summing up, foodborne illness is definitely a manageable concern and will likely not become a factor that will hinder the overall growth of the food industry. However, the fact that it can be controlled and yet still recurring means that there’s still a fair amount of work needed to be done to improve the industry in other aspects—and that isn’t necessarily a bad thing (at least not yet).

Randy Fields, Repositrak
FST Soapbox

Technology’s Role In The Future Of Food Safety

By Randy Fields
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Randy Fields, Repositrak

As we have all read in the media, when a food safety emergency occurs, a company’s reputation stands to take a significant hit that may be unrecoverable. This phenomenon isn’t going away soon, nor are compliance requirements that pose a threat to the personal freedom of executives. If these aren’t enough reasons to get busy automating your food safety programs, read on.

Randy Fields will be speaking as part of a panel of experts during the Food Safety: Past, Present & Future Plenary Session during the Food Safety Consortium, November 29th at 4:00pm.

The trends toward social and health-related product claims, like organic, the ‘free-froms’ and locally-grown, have had the impact of adding dozens if not hundreds of new suppliers to a retailer’s procurement list. And, it’s important to note, that these generally smaller suppliers are just now approaching their compliance deadlines for FSMA, and if they are very small, still have another year. New trends appear every year, and they will compound the challenge for retailers and wholesalers of knowing exactly who all of their suppliers are, which in turn will worsen compliance issues.

Our studies show that at least 12% of documents that certify organic, ‘free-froms’ and other product label claims have some level of discrepancy or inaccuracy making them invalid, and rendering the systems that rely on vendor self-disclosure near useless. With sales expected to skyrocket within these categories during the next few years, companies need to leverage technology to protect the supply chain, and consider having the system hold purchase orders generated for vendors who are not compliant with requirements.

An alternative is to have the system add a compliance fee to the purchase order that escalates over time or swiftly replace suppliers if they are not willing or not able to comply. That also speeds compliance as news travels quickly if there is a hard-hitting consequence for non-compliance. Either way, it’s important to be able to substantiate any claims to the consumer, since if those assertions are deemed unreliable, retailers and their suppliers risk a breach in consumer confidence and will suffer economically when shoppers turn away from them at the shelf.

And while retailers and wholesalers have begun to turn the Titanic on regulatory and business compliance, they need to continue to diligently find the risks in their supply chain, working even more aggressively to automate their current food safety and quality programs using new technology and procedures. Otherwise, their reputation and their existence are in jeopardy.

Cloud-based compliance management solutions that help retailers, wholesalers and suppliers meet the new food safety requirements can be configured to manage documentation requirements by supplier type vs. requiring the same documents from all suppliers. These systems also go beyond just storing digital copies of documents, and actually manage any form of compliance by reading inside the document to confirm it meets requirements. The benefits of these compliance management tools extend to streamlining new vendor approvals, which can save time and enable the redeployment of resources to more productive business-building activities.

Make no mistake: business and regulatory compliance will continue to be a focal point in the future. This includes addressing potential safety, certification and quality challenges throughout the extended supply chain as nearly one-third of all recalls are due to ingredient suppliers. We believe that in less than three years, retailers will require supply chain visibility from the shelf all the way back to “dirt”. It’s been proven too risky not to have that kind of visibility for ultimately everyone’s customer – the consumer. And now technology companies are on the hook to deliver it.

Results: FSMA IQ Test on Intentional Adulteration Rule

By Food Safety Tech Staff
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The results are in for this year’s final FSMA IQ test on the intentional adulteration rule. If you didn’t take the test yet, follow this link. Find out how you fared below.

  1. The Intentional Adulteration program that must be developed can rely on food security issues addressed by Preventive Control programs.
    • FALSE
    • 39.51% answered correctly
  2. In developing your Intentional Adulteration Plan, you must determine vulnerabilities to your food product risks.
    • TRUE
    • 98.81% answered correctly
  3. Your written program is called a Food Security Plan.
    • FALSE
    • 62.65% answered correctly
  4. There is no reanalysis provision for Intentional Adulteration programs and Food Defense Plans under the rule.
    • FALSE
    • 89.29% answered correctly
  5. The Intentional Adulteration compliance plan must include the monitoring of certain key areas.
    • TRUE
    • 95.18% answered correctly
  6. Only large food companies over a certain size need to develop and establish a Food Defense Plan under the FSMA Intentional Adulteration rule.
    • TRUE
    • 6.02% answered correctly
  7. There is now risk assessment associated with the Intentional Adulteration rule requirements.
    • FALSE
    • 10.84% answered correctly
  8. Mitigation strategies within the Food Defense Plan are key components to a compliant program.
    • TRUE
    • 96.43% answered correctly
  9. Each point, step, or procedure in the facility’s process must be included in the Intentional Adulteration vulnerability assessment process.
    • TRUE
    • 80.72% answered correctly
  10. Economic adulteration is a key component of the FSMA Intentional Adulteration rule?
    • FALSE
    • 23.81% answered correctly
magnifying glass

Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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magnifying glass

Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

Dollar

Pathogens Drive More Than Half of $12 Billion Global Food Safety Testing Market

By Maria Fontanazza
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Dollar

The importance of food safety testing technologies continues to grow, as companies are increasingly testing their products for GMOs and pesticides, and pathogens and contamination. Last year the global food safety testing market had an estimated value of $12 billion, according to a recent report by Esticast Research & Consulting. Driven by pathogen testing technologies, the global food safety testing market is expected to experience a 7.4% CAGR from 2017–2024, hitting $21.4 billion in revenue in 2024, said Vishal Rawat, research analyst with Esticast.

With a CAGR of 9.3% from 2017–2024, rapid testing technologies are anticipated to lead the market. Testing methods responsible for this growth include immunoassays (ELISA), latex agglutination, impedance microbiology, immune-magnetic separation, and luminescence and gene probes linked to the polymerase chain reaction, said Rawat, who shared further insights about the firm’s market projections with Food Safety Tech.

Food Safety Tech: With the GMO food product testing market expected to experience the highest growth in the upcoming future, can you estimate the projected growth?

Vishal Rawat: The GMO food product testing market is estimated to generate a revenue of approximately $5.2 billion in 2016. The market segment is expected to witness a compound annual growth rate of 8.3% during the forecast period of 2017–2024. This is a global market estimation.

FST: What innovations are occurring in product testing?

Rawat: Nanomaterials and nanobased technologies are attracting interest for rapid pathogen testing. Sustainable technologies such as edible coatings or edible pathogen detection composition can attain a trend in the near future. Also, new rapid allergen testing kits are now emerging out as the latest food testing technology in the market, which are portable and easy to use.

FST: Which rapid pathogen detection testing technologies will experience the most growth from 2017–2024?

Rawat: New and emerging optical, nano-technological, spectroscopic and electrochemical technologies for pathogen detection, including label-free and high-throughput methods would experience the highest growth.

FST: What pathogen testing technologies are leading the way for meat and poultry in the United States?

Rawat: The presence of a microbial hazard, such as pathogenic bacteria or a microbial toxin, in ready-to-eat (RTE) meat or poultry products is one basis on which these products may be found adulterated. The FSIS is especially concerned with the presence of Listeria monocytogenes, Salmonella, Escherichia coli O157: H7, and staphylococcal enterotoxins in RTE meat and poultry products. Rapid pathogen testing for E. coli O157:H7 and Salmonella, for ground beef, steak and pork sausages is going to lead the U.S. market.

An overview of the report, “Food Safety Testing Market By Contaminant Tested (Pathogens, GMOs, Pesticides, Toxins), By Technology (Conventional, Rapid), Industry Trends, Estimation & Forecast, 2015– 2024” is available on Esticast’s website.

FSMA

FDA Releases Chapter 6 of Draft Guidance for PC Rule

By Food Safety Tech Staff
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FSMA

Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.

Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.

FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).

Thomas Tarantelli
In the Food Lab

Lead Found in Recalled Ground Cumin

By Thomas Tarantelli
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Thomas Tarantelli

Laboratory reports recently acquired by the Freedom of Information Law from the New York State Department of Agriculture and Markets show the Sol Andino brand ground cumin to contain 1090 ppm lead as well as 259 ppm chromium. The spice was also analyzed by IS:2446, 1980 method, “Detection of Lead Chromate in Chillies, Curry Powder and Turmeric by diphenyl carbizide.” A positive result was given, indicating the presence of hexavalent chromium, which is a component of lead chromate. Lead chromate is a yellow pigment, not allowed in food anywhere in the world as it is toxic, containing both lead and hexavalent chromium. The New York State Department of Agriculture and Markets posted a Class I recall of the Sol Andino ground cumin on July 10, 2017, without mention of the extremely high concentration of lead in the product.

Sol Andino, ground cumin
Sol Andino ground cumin recalled

The author could find no record of an FDA recall for the Sol Andino brand cumin powder containing excessive lead.

Some of us remember the four FDA Class I recalls of Pran brand turmeric for excessive lead in October 2013. These recalls were initiated by the New York State Health Department due to an illness complaint—most likely a child with high blood lead levels. The recalled Pran brand turmeric contained 28–53 ppm lead.

Also worthy of mention is the FDA/Illinois Class I recall of Nabelsi brand Thyme (actually a spice mix containing Thyme) on March 17, 2017.

“There have been two cases of high blood levels of lead associated with this product to date. Both cases have been reported through the Illinois Department of Public Health, Environmental Health Protection.”

According to the recall, the “Thyme” was found to contain 422 ppm lead.

Wondering if the 422 ppm lead was caused by adulteration of the “Thyme” with lead chromate or another lead pigment, a food chemist at the New York State Food Laboratory (a Division of NYS Dept. of Agriculture and Markets) requested from Illinois a sub-sample of the “Thyme” for analysis. Lab analysis of the spice found 323 ppm lead, 109 ppm chromium and a positive result for the chromate test. Thus, this recalled “Thyme” contains lead chromate.

In both cases, Pran turmeric and Nabelsi Thyme, illness complaints led to the recall of lead adulterated spices.

The New York State Department of Agriculture and Markets has a proactive program. Random samples of spices are sampled from retail markets and subsequently analyzed for unallowed colorants, undeclared allergens and heavy metals. In 2016 this resulted in the Oriental Packing Class I recall of 377,000 lb. of turmeric containing spices for excessive lead. (A typo in the FDA recall attributes the recall to the New York State Health Department, instead of the New York State Dept. of Agriculture and Markets.)

Still, it’s even better to analyze spices being imported into the country at receiving warehouses before the product reaches retail markets. Lead concentrations above 10 ppm can be determined instantaneously with a handheld XRF analyzer.

Adulteration with Sudan Dye Has Triggered Several Spice Recalls

Sprouts

FDA Releases Sampling Report on Sprout Contamination

By Food Safety Tech Staff
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Sprouts

In an effort to determine the prevalence of Salmonella, Listeria and E. coli O157:H7 in sprouts, FDA conducted a large sampling study of sprouts, the results of which were released last week.

The agency collected 825 samples from 37 states, Puerto Rico and the District of Columbia and found 14 positive samples at eight of the 94 growers (10 samples came from four growers). Samples were collected from three production process points: Seeds, finished product and spent irrigation water, and tested for contamination. FDA found the following contamination:

  • Salmonella on 2.35% of seed samples, 0.21% in finished sprouts and 0.53% in spent irrigation water
  • Listeria monocytogenes on 1.28% of finished sprouts
  • No positive E. coli O157:H7 results in finished sprout or spent irrigation. Due to limitations of the test method, FDA didn’t test seed samples.

“Sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States linked to sprouts. These outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths.” – CFSAN

In the event that contaminated sprout samples were uncovered, FDA worked with the firms that own or released the affect sprouts to conduct voluntary recalls or destroy them. FDA inspections also followed.

The full report, FY 2014 – 2016 Microbiological Sampling Assignment, is available on FDA’s website.

Erin Mann, Food Protection and Defense Institute
FST Soapbox

Targeting Agent Detection with Horizon Scanning of Food System Disruptions

By Erin Mann, MPH
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Erin Mann, Food Protection and Defense Institute

Agent detection to identify contamination of food products is required in food safety and defense programs. Detection typically involves laboratory methods or technologies, such as biosensors, that are used in close physical contact with food products. While the field of food protection has benefited from the development of novel agent detection methods in recent years, the challenge of determining which food products to test remains. The sheer volume of food produced within and traded across U.S. borders makes agent detection a daunting, time-consuming and expensive task. The decision of when to utilize detection methods depends on the risk of a particular product being contaminated. Contamination may be unintentional or intentional, including economically motivated adulteration (EMA).

The risk of contamination fluctuates over time and is a function of several factors. Risk depends on the biochemical makeup of the product, supply chain characteristics such as complexity and transport distance, and a wide range of natural or manmade events that may disrupt supply and potentially incentivize intentional adulteration. This is particularly true in the case of EMA. Events include but are not limited to natural disasters that destroy or reduce the usual supply of an ingredient, political instability that disrupts usual trade patterns, interruptions of routine food safety inspections, and market fluctuations that impact global prices. While data exists to monitor these risk factors of contamination, optimal use of this information by government and private industry is hindered by several challenges. For example, valuable data often exists across multiple data systems with data across systems appearing in inconsistent formats. In addition, the amount of data that must be reviewed to find a signal within the noise is frequently overwhelming.

Erin Mann, Food Protection and Defense Institute
Read our recent Q&A with Erin Mann, “As Food Fraud Grows, More Comprehensive Tools Emerge”

To address finding signals within vast quantities of data sources and systems, the Food Protection and Defense Institute (FPDI) developed technology to curate and help make sense of this data. With support from both the FDA and the Department of Homeland Security, FPDI developed FIDES or Focused Integration of Data for Early Signals to perform “horizon scanning” of food system disruptions in support of food protection efforts, including agent detection. FIDES was designed to help users forecast, monitor and identify food system risk factors and adverse food events. The FIDES web application fuses multiple streams of data from disparate sources and displays information in the form of an online dashboard where users browse, search and layer both dynamic and reference data sets related to food system disruption events. Examples of data currently included in FIDES are import refusals, global disasters, animal health alerts, food defense incidents, historical food safety incidents, import data, price alerts and reference data on food production worldwide.

Events in recent years illustrate the value of gathering intelligence and utilizing data related to food system risks to inform decisions regarding product targeting. Tsunamis, crop failures and disease outbreaks in humans and animals around the globe have threatened supply of products such as shrimp, spices, cocoa and eggs. When supply is disrupted, companies are often forced to quickly identify new and sometimes previously unvetted suppliers, including spot market purchasing. Likewise, supply disruptions often lead to price increases. As prices increase in the absence of adequate supply, concerns about EMA also increase. In both of these instances, the risk of product contamination—both unintentional and intentional—may rise and an increase in product screening or a change in agent detection methods may be appropriate.

For example, the 2014–2016 Ebola outbreak had a significant impact on West Africa, the primary production region for the world’s cocoa supply. Disruptions from the outbreak, including border closures and other trade interference, led to uncertainty about supply availability and prices. This raised concern for EMA, particularly given that many cocoa products are sold as powders, butters and liquors— forms that are more vulnerable to EMA than raw ingredients. As a test case, FPDI reviewed FIDES data streams during the peak of the outbreak. Real-time data on the outbreak was layered with data on global cocoa production and import patterns. Import refusal data from multiple global systems was assessed to identify any concerning patterns. Historical food defense and food safety incidents were also reviewed to determine which cocoa products had been previously contaminated. A similar approach could be used by the food and agriculture sector to guide decisions about targeted inspections—which product(s) and region(s) to monitor, which method(s) to use and which contaminant(s) to test. FIDES could support targeted screening and enhanced awareness of product risk profile that would allow the food industry to assure continued supply of authentic and quality products.