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  • CFR 20 Part 133: Pass the Cheese, Please

    Before concluding our month-long conversation on dairy, we must take a moment to acknowledge the unrivaled versatility, variety (over 2000!), and vitality of cheese. Without cheese, there would be no pizza. Without cheese, there would be no enchiladas. And without cheese, there would be no grilled cheese sandwiches!

    It would be preposterous to consider hosting a wine and cheese party featuring fruit and crackers only (imagine what the French would say). Additionally, it's very challenging to imagine the classic American cookout consisting of just hotdogs and plain hamburgers (how unpatriotic). Indeed, cheese is omnipresent and omnipotent!

    So, just how much of this soft gold does humanity actually devour? Well, according to the International Dairy Foods Association, in 2011 the U.S. consumed cheese in the following manner:

    U.S. per capita consumption of natural cheese increased by 0.36 pounds over the 2010 amount, reaching a level of 33.50 pounds, the second highest amount on record.

    The largest consumption increase in 2011 was for Italian-type cheeses, which were up 0.36 pounds per person to 14.80 pounds, setting a record for the second straight year. American-type cheese consumption decreased slightly, dropping by 0.14 pounds to 13.18 pounds per person. Consumption of other than Italian or American cheeses increased by 0.14 pounds to 5.52 pounds per person.

    The most consumed types of cheese in the U.S. are mozzarella and cheddar. Mozzarella cheese per capita consumption reached a new record high of 11.43 pounds in 2011; the previous record was 11.25 pounds per person set in 2010. Consumption of cheddar cheese declined for the second straight year; down 0.29 pounds or 2.8%.

    Volume sales of natural cheese in U.S. Food and Drug Stores reached approximately 2.272 billion pounds in 2011, with a value of over $11 billion dollars. The top three cheese types that accounted for the largest volume sales were Cheddar (36.7%), Mozzarella (20.9%) and Colby Jack (9.3%). Together, these three account for two-thirds (66.9%) of the volume sales of natural cheese. The top three also account for almost $7 billion dollars (62.5%) of the $11 billion dollars in sales.

    Even with such strong numbers in terms of volume and value, America's per capita cheese consumption in 2009 didn't even crack the top-five global standings according to this chart from the Wisconsin Milk Marketing Board:

    International Cheese Consumption

    With domestic and international demand robust with growth, the production of all types of cheese must maintain an equal or greater escalation or the potential for a, dare I write, cheese shortage could emerge. According to the United States Department of agriculture, the EU currently leads all regions of the world regarding output, but the U.S. is the number one individually producing country.

    Though some farms or companies specialize in one or two varieties, putting all their milk in one vat so to speak, other, large-scale manufacturers may churn out (pun intended) over twenty! Regardless of size, however, the federal government maintains guidelines on the production, labeling, and distribution of cheese under CFR 20 Part 133. This section of our much referred to document not only provides general temperature thresholds for pasteurization, shown in the table below, but specific ingredients, process steps, and labeling terminology on over seventy-five varieties like asiago, colby, gouda, gruyere, muenster, provolone, and swiss. Additionally, the pasteurization requirements for processed cheese similar to what is found inside a compressed can or plastic container, or amongst other processed food items like fruits, vegetables, or meats.

    Compliance with rules respective to specific cheeses ensures safety and quality for consumers and is enforced by federal inspectors. If violations are found, timely warnings can be disseminated to the public and, based upon the degree of the error, penalties issued to the liable firm. The latest validation of these guidelines and oversights involves a March 2014 recall of Hispanic-style cheeses after the CDC confirmed eight reports of listeriosis, and a subsequent FDA inspection discovered related bacterial strains at an inadequate Delaware production facility.

    Avoiding a similar catastrophe involves maintaining the structural integrity of the plant in use, imploring employees to keep themselves and their workstations sanitary, and monitoring the environmental conditions of individual process stages, like pasteurization and storage. Temperature and humidity requirements vary by cheese type, which means recording and storing data for twenty varieties or more can be quite the daunting task if done manually.

    Temp/Time Requirements for Pasteurization

    Temperature Time
    145 deg. F 30 min.
    161 deg. F 15 s.
    191 deg. F 1 s.
    204 deg. F 0.05 s.
    212 deg. F 0.01 s.

    But what if your chances of a violation could be greatly reduced, level of asset protection impressively increased, and operations budget responsibly left intact? A proprietary, cloud-based monitoring system with features like wireless nodes and phone alerts, automated reports, and audit trails through an independent Sensor Cloud service not only answers all three hypotheticals, it is an investment worth its weight in, you guessed it, cheese.

    Cheese Monitoring

    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • Food Companies: Not All Press is Good Press

    One of the most recent and highly profiled U.S. dairy incidents occurred during the fall of 2013 and involved a New York-based Greek yogurt company. Hundreds of consumers fell sick after they had purchased and eaten yogurt tainted by mold. While no one became seriously ill, and the mold discovered was not of a foodborne pathogen variety (salmonella, E. coli etc.), reports of gastrointestinal ailments among consumers prompted the company to remove and destroy all questionable inventory. Besides costing money, the mishap took a toll on the firm’s previously admired and trusted brand and manufacturing processes, respectively, as many consumers took to Twitter and Facebook to express their concern and disapproval.

    The mold that tainted this company’s products is one commonly found around foods like fruits, vegetables, and dairy, Mocur circinelloids, and can be a culprit in spoilage when not immediately identified and removed. Some folks questioned whether or not it was actually Mocur circinelloids that caused people to fall ill, but the subsequently filled FDA report stated that no other bacterial culprit was found inside the Idaho facility.

    Regardless of whether or not another organism was at the core of the contamination, the entire ordeal stands as another reminder of how fiercely rapid a gap in a company’s manufacturing process can lead to public fury and governmental scrutiny, especially in today’s world of digitally instantaneous, consumer blowback. But this latest example is perhaps even more disconcerting than most because it involved the molding of yogurt, a product that is inherently, well, moldy.

    Crudely speaking, yogurt is created by adding bacteria to heated milk, and the entire process, whether undertaken within a factory or household kitchen, requires precision both in terms of combining the ingredients and monitoring the mixture’s temperature during heating and cooling stages. The FDA, consistent in its dedication to oversee the application of Good Manufacturing Practices (GMP), provides 21 CFR Part 131 as a blueprint for producing all types of milk, cream, and yogurt. The document, which contains guidelines on general pasteurization procedures and the production and labeling of specific varieties of aforementioned dairy products, begins its section on non-fat, low-fat, and regular yogurt by defining core expectations for the base product:

    Yogurt, before the addition of bulky flavors, contains not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.9 percent, expressed as lactic acid. The food may be homogenized and shall be pasteurized or ultra-pasteurized prior to the addition of the bacterial culture. Flavoring ingredients may be added after pasteurization or ultra-pasteurization. To extend the shelf life of the food, yogurt may be heat treated after culturing is completed, to destroy viable microorganisms.

    Beyond listing the required milkfat parameters and acidity level for regular yogurt, this excerpt mentions two activities predicated on proper environmental monitoring. Temperature plays a critical role in heating and cooling, and any increase in humidity can act as a bellwether for deteriorating ambient conditions and possible bacterial growth. Monitoring these variables can prevent production failures, and customizable, cloud-based monitoring systems like Temperature@lert’s Cellular Edition with Sensor Cloud are more than just technical instruments; they’re autonomous, comprehensive solutions to problems that once seemed unavoidable.

    free Temperature@lert eBook

    Even without being presumptuous about a yogurt company’s past oversight, one can deduce that dangerous windows of exposure exist during dairy manufacturing processes, and deploying preventative safeguards to ensure a product’s quality and condition isn’t just operationally and financially prudent, it’s also organizationally principled.

    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • GMPs Don’t Sour, But Dairy Does

    Last week I started a series on Good Manufacturing Practices (GMPs) within the dairy industry, specifically ice cream. Beyond the regulations outlined in CFR 21 Part 110, producers of dairy products must also adhere to the guidelines of Part 11, the expectations for collecting, storing, and maintaining electronic records.

    CFR 21 Part 11 was implemented in 1997, but as a response to various concerns of the business community, it has been in a period of reexamination since 2003. Regardless of what may occur or change in the near future, the components of Part 11 are still relevant and enforced, and its five core requirements are validation, audit trails, legacy systems, copies of records, and record retention.

    Validation: We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures.

    Audit Trails: Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date, time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.

    Legacy Systems: The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11.

    Copies of Records: You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules.

    Record Retention: The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period.

    The fundamental purpose of part 11 plays an active role throughout the dairy production and distribution process. From pumping tubes to storage tanks to assembly lines to shipping containers to store shelves, dairy, whether frozen or not, passes through numerous stages of preparation and various pieces of equipment before reaching consumers’ hands, and one example of this highly involved supply chain is the procedure of pasteurization.

    Pasteurization, named after scientist Louis Pasteur, is a process that removes pathogens by way of extremely intense heat, and though there are several levels of it, the range of applied temperatures is 145-280°F with exposure times starting at fractions of a second and ending at several minutes. Too often dairy products are subjected to poor pasteurization practices or compromised environments, and when such happens, like in these historic and recent cases, consumers fall ill, companies lose money, and FDA investigators start, well, doing their job.

    Maintaining and monitoring imperative pasteurization thresholds and times is vital to the integrity of dairy products and dairy companies, and as noted, GMP regulations (CFR 21 Part 11) are in place to verify production processes and historical data. However, firms need not obsess over product and governmental mandates with the existence of proprietary and automated, cloud-based systems like Temperature@lert’s Cellular Edition and Sensor Cloud.

    Meeting or even exceeding GMPs and the standards of CFR 21 Part 11 is easier than ever with features like backup battery power, actionable email, phone, or text alerts, six-year data storage, and, should anything require attention, corrective action and audit trails. Temperature@alert’s solutions are more than just sensors and software; they are reliable and autonomous partners in asset protection and regulation compliance, and there’s nothing sour about that.

    Temperature@lert Food Service Monitoring Guide

    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • 2014 FDA Food Safety Predictions and the Role of Temperature Monitoring

    Steps to automate temperature recording and reporting help meet key food safety concerns.

    A recent blog on the Food Safety Tech website featured predictions by former Chief Medical Officer at the US FDA Food Safety and Inspection Service Dr. David Acheson. The piece presents five prediction for 2014 Food Safety.  Link to Blog With his insight into the workings of the FDA, Dr, Acheson offers a first look at likely FDA actions in 2014.  These include:

         1. FSMA Final & Proposed Rules will be pushed for completion

         2. Poultry Modernization Act Pressure to reduce high levels of bacteria on raw chicken

         3. More Recalls

         4. More calls for GMO & Nano labeling

         5 Other - expanded focus on front of package labeling and more stringent requirements on heavy metals (lead, cadmium), especially in imported foods.

    Due to the publicity that food safety problems garner, many of the issues above are key in the minds of consumers, and therefore need to be considered seriously.  For example, an October 2013 Los Angeles Times editorial titled Keeping Salmonella out of Chicken made headlines when the piece pointed out that Sweden has virtually eliminated salmonella in store bought chicken and that a 2010 Consumers Union study found no salmonella in the organic store-brands chicken tested (Link to Editorial). The editorial's note that one particular outbreak was from antibiotic resistant strains and led to a call for tighter regulation and reduced antibiotic use.   The industry’s response that thorough cooking will kill the bacteria does little to stem the adverse publicity and potential liability from such outbreaks.  Dr. Acheson ties such events to his prediction for more recalls in 2014.

    December 2013 CDC Salmonella Heidelberg Contaminated Chicken Case Count (CDC Link)

    Certainly producers of chicken as well as other meat, fish, dairy and produce can improve their operations to reduce such outbreaks.  The question is whether or not they will take the initiative to show proactive approaches to reducing bacterial contamination or weather another storm of headlines accompanied by a drop in consumer purchases of suspect problems and the resultant lawsuits that always follow.  The FDA is looking at this issue closely and proactive measures can help in arriving at practices and regulations that meet both consumer and producer needs.

    One such proactive approach for the poultry industry is to monitor breeding area temperatures to insure the animals are kept at temperatures that promote health and reduce bacterial growth.  Temperature@lert’s WiFi and Cellular Edition devices have been deployed in numerous breeding houses with good results.  While temperature controls take care of cooling and heating needs they are not infallible; these systems can and do fail.  And if temperatures climb too high on hot, humid days, all the fans in the world will not be enough to keep the poultry safe.  Temperature@lert’s devices alert growers to the dangers before they cause serious harm by sending email, text and voice messages to managers when problems arise.


    Chicken Farm (Link to National Geographic); Processing Plant (Link to Pine Manor Farms)

    Quick responses can be the difference between sick or injured birds and healthy ones at medium and  large commercial chicken grower sites.  Keeping temperatures from reaching extremes can help prevent rapid bacterial growth.  Likewise, processing plants are at risk of contamination when temperatures rise promoting the growth of bacteria.  This is why major chicken growers have deployed Temperature@lert’s Cellular Edition alerting devices coupled with secure cloud based data collection, storage and alert reporting offers a fault tolerant solution for times when site power or HVAC systems are malfunctioning.  Temperature@lert’s proprietary Sensor Cloud can send text, voice and phone alerts to insure responsible personnel are aware of problems when they occur, day or night, holidays or weekends, and growers can get a good nights sleep because they know their chickens are safe.

    Temperature@lert ZPoint Cellular DeviceTemperature@lert ZPoint Wireless Sensor

    Cellular Edition (Left) and optional ZPoint Wireless Network Sensor Module (Right)

    Temperature@ert’s WiFi, Cellular and ZPoint product offerings linked to the company’s Sensor Cloud platform provides a cost effective solution for organizations of all sizes. The products and services can help bring a laboratory or medical practice into compliance with minimum training or effort. For information about Temperature@lert’s Cellular and SensorCloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.

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    Dave Ruede, Well-Versed Wordsmith

    Dave Ruede, a dyed in the wool Connecticut Yankee, has been involved with high tech companies for the past three decades. His background in chemistry and experience in a multitude of industries such as industrial chemicals and systems, pulp and paper, semiconductor fabrication, data centers, and test and assembly facilities informs his work daily. Well-versed in sales, marketing, management, and business development, Dave brings real world experience to Temperature@lert. When not crafting new Temperature@lert projects, Dave enjoys spending time with his young granddaughter, who keeps him grounded to the simple joys in life. Such joys for this wordsmith include reading prize winning fiction and non-fiction. Although a Connecticut Yankee, living for a decade in coastal California’s not too hot, not too cold climate epitomizes Dave’s favorite temperature, 75°F.

    Temperature@lert Dave Ruede

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  • The Evolution of U.S. Food Regulations & Compliance

    Previously we had discussed why high quality foods demand close monitoring of food temperatures during transportation and cooling practices, and how to meet the FDA recommendations for food temperature control. A brief review on the evolution of the FDA shows how food regulations in the U.S. have been developed over time and how it now demands food suppliers to conduct stricter monitoring to enhance food quality.

    At the beginning of 20th century, it was commonly believed that it was the consumers’ responsibility to inspect their food prior to consumption. This was before the government stepped in to intervene with food regulations.

    The early development of food regulations began at a relatively slow pace; mainly regulating food adulteration and deceptive commercials. Congress passed the original Food and Drugs Act in 1906 to prohibit interstate commerce in adulterated food and drug. The Meat Inspection Act was passed the same year as an action was brought against the “shocking disclosures of unsanitary conditions in meat-packaging plants.” 17 years later in response to the U.S. v. 95 Barrels Alleged Apple Cider Vinegar case, the Food and Drugs Act condemns “every statement, design, or device on a product’s label that may mislead or deceive, even if technically true.” Another six years passed until McNary-Mapes Amendment (1930) authorized the creation of FDA standards for the overall quality of canned food, excluding meat and dairy products.

    Since the 1950s, the food industry grew prosperously thanks to new food processing technology and advanced refrigeration equipment. Accordingly, it called for a more complete food regulation system. In 1952, groups of FDA consumer consultants were assigned to conduct field research in order to maintain close connections with customers as well as to ensure that the FDA truly reflects the needs and problems of the food market.

    Soon, amendments regulating food additives, color additives, fair packaging, and labeling were enforced. In 1969, FDA started to administer sanitation programs for perishable foods, food services, and interstate traveling facilities to prevent food borne illness and food poisoning. The responsibilities of food safety monitoring were transferred from other Public Health Service departments to the FDA.

    Temperature@lert Free Monitoring Guide on Food Refrigeration

    In recent decades, the U.S. food regulation system has become more developed with an emphasis shift from controlling food adulterations to enhancing food quality. There are now multiple compliances regulating product ingredients as well as manufacturing procedures, elevating the importance of temperature and humidity monitoring during food processing and storage.

    In 1990, the Nutrition Labeling and Education Act created a requirement for all packaged foods to mark its ingredients and health claims on their labels. In 2002, the current Good Manufacturing Practice (cGMP) focused on the risk of public health during manufacturing procedures. In 2003, the FDA made a substantive change to the nutrition facts panel: trans fat content is now required to appear on nutrition panels. In that same year, the National Academy of Sciences announced the Scientific Criteria to Ensure Safe Food, buttressing the Hazardous Analysis and Critical Control Point (HACCP) approach. In 2004, the Food Allergy Labeling and Consumer Protection Act was passed to ensure proper labeling of foods that contain proteins that account for food allergies.

    A quick look at the evolution of the FDA suggests that in the future, it will take food suppliers more effort to meet the growing government regulations on food. In March, we will transition into a series on the FDA and drug monitoring processes.

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    U.S. Food and Drug Administration, “Significant Dates in U.S. Food and Drug Law History”. http://www.fda.gov/aboutfda/whatwedo/history/milestones/ucm128305.htm

    Written by:

    Ivory Wu, Sharp Semantic Scribe

    Traveling from Beijing to Massachusetts, Ivory recently graduated with a BA from Wellesley College in Sociology and Economics. Scholastic Ivory has also studied at NYU Stern School of Business as well as MIT. She joins Temperature@lert as the Sharp Semantic Scribe, where she creates weekly blog posts and assists with marketing team projects. When Ivory is not working on her posts and her studies, she enjoys cooking and eating sweets, traveling and couch surfing (12 countries and counting), and fencing (She was the Women's Foil Champion in Beijing at 15!). For this active blogger, Ivory's favorite temperature is 72°F because it's the perfect temperature for outdoor jogging.

    Chris Monaco Temperature@lert

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  • Building a GMP Sundae

    Ice cream has long been an emotionally critical component of my diet. During high school, and regardless of the season, I would eat an entire pint of Vermont-sourced, peanut butter cup heaven every Monday afternoon. Mondays were quite often rest days for my sports teams, and there was nothing like both icing a nagging injury and fulfilling an insuppressible craving with a healthy serving of frozen dairy—two needs; one pint.

    peanut butter ice cream picture

    Though my teenage metabolism has since slowed, I still indulge in a now-and-then, waffle-coned scoop of the good stuff during summer months. How can one not succumb to the serendipitous sensory experience that is ice cream? It’s a vehicle for retrospection, rumination, and satisfaction, and, in my opinion, vital to the sustainment of an invigorating life.

    Ice cream plays such an integral and positive role in the lives of people from all backgrounds and locales that it’s difficult to envision not having any due to poor manufacturing or contamination; thus, the duty of maintaining trust between person and product rests with the crystalized confection’s producers. Luckily, for those who carry this heavy yet rewarding burden of crafting and distributing the sweet sacrament, a set of helpful and detailed guidelines exist, the FDA’s Good Manufacturing Practices.

    Initially conceptualized and introduced through the Pure Food and Drug Act of 1904, GMPs were officially formulated by the FDA in the late 1960s and modernized during the mid-to-late 2000s; they encompass the production, storage, and distribution of food, drugs, cosmetics, and other consumer-centric products.

    The portion that deals with human provisions is covered in detail by the Code of Federal Regulations (CFR) 21 Part 110, and some private dairy organizations have produced industry-specific manuals based on the lengthy government document. In general, GMPs cover employee practices, facility conditions, operational controls, and corrective actions, and each subsection highlights the expectations for training, audits, and documentation.

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    Employee practices include direction and details on dress, glove use, disease control, and contamination prevention, and facilities should have adequate ventilation and lighting, no pest issues, proper sewer and water systems, and be sanitized regularly. Operational controls are in essence the preventative steps taken to reduce food contamination during production and distribution processes. These steps include the storage and movement of raw materials, equipment sanitization, and environmental monitoring.

    Understanding that human error is often the cause of contamination, the FDA requires that employees be properly educated and trained in GMP, audits of facilities, equipment, and processes be conducted by the agency, and documentation of incidents and corrective actions taken be collected, stored, and made accessible to audit teams.

    With so many microbiological variables and external elements threatening the sanitation and integrity of dairy products, it’s important for all producers of ice cream to operate with vigilance and diligence, employing a system of check and balances that monitors environmental conditions and worker behavior. And because their offering is one that inherently generates happiness and facilitates inter/intrapersonal engagement, creameries have a responsibility to keep one of the world’s few remaining examples of eatable idealism as preserved and untainted as possible.

    Moving forward, this series will look at a few particular points of note from CFR 21 Part 110, connecting each to challenges and incidents within the ice cream world, and share how companies, with the help of technology, are fulfilling their GMP compliance obligations.

    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • Temperature Control of Potentially Hazardous Foods

    Some categories of food are more likely to have microbial reproduction due to intrinsic and extrinsic factors. According to the FDA Food Code, potentially hazardous food refers to natural or synthetic foods that require temperature control because they tend to have:

         1) rapid and progressive growth of infectious or toxigenix microorganisms

         2) growth and toxin production of Clostridium botulinum

         3) growth of Salmonella Enteritidis (in shell eggs)

    Foods that fall into this description include meat, poultry, seafood, eggs, cooked rice, raw seed sprouts, cut melons, garlic and oil mixtures, etc.

    Due to their varied natures and components, different kinds of food need to be kept in specific environments. The FDA demands constant temperature monitoring to ensure that foods are stored within the safe zone.

    Food suppliers should also be aware that food processing also influences the microbial level in the foods. Washing fruits and vegetables with chlorinated water would lower the bacteria levels but would not necessarily eliminate pathogens. Freezing practices can slow down the microbial reproductions, but do not affect the pathogen level. Cooking, fermenting, and smoking can restrict the majority of bacterial flora, and the low pH level in pickled products inhibits the growth of most bacteria. Meanwhile, improper handling and packaging may introduce microorganisms into the food during the handling process.

    Temperature@lert Food Storage

    Meat and Poultry

    Raw meat and poultry usually have a higher water activity level and a neutral pH level—the optimum combination for bacterial growth. When meat is cooked or processed followed by refrigeration, the bacteria level in meat and poultry greatly reduces, yet environmental post-processing pathogen contamination might still occur.

    FDA recommendations on time/temperature control:

    “Unless the specific product parameters referenced in the previous section are met, meat and poultry products must be considered as requiring time/temperature control. Raw meat and poultry products currently require safe-handling instruction labeling that includes a time/temperature control provision. For ready-to-eat foods, product parameters and processing schedules are needed to ascertain whether temperature control for safety is required. Post-processing contamination is also an important consideration and should not be overlooked. Because meat offers a rich nutrient media for microbial growth, products that incorporate meat and poultry as ingredients, such as meat salads and meat pastries, also must be considered as requiring time/temperature control.”

    Fish and Seafood Products

    The high level of soluble nitrogen compounds found in seafood makes it more perishable than other high-protein products. Since seafood is usually harvested from the wild, it’s also exposed to environmental contaminants and pathogens. Mishandling during or after processing is a main cause of foodborne illness from seafood.

    FDA recommendations on time/temperature control:

    “Most seafood, including cooked seafood and sushi, requires time/temperature control. Only fully retorted or fully dried and salted products are considered shelf stable. Most smoked seafood products require time/temperature control because of the concern with C. botulinum growth and toxin production, in addition to their being highly perishable. Heavily smoked products with low water activities are spoiled primarily by molds.”

    Fruits and Vegetables

    With fruits, the initial bacteria level is usually comparatively low. Fruits and vegetables do not have as many issues with pathogens, but yeasts and molds are more prevalent due to fruits’ low pH level. There is a lot of concern with fresh-cut products: the process breaks the natural protective barriers, causing increased pathogen multiplication, adequate moisture, abusive temperature, and sufficient time will allow bacteria population to increase exponentially.

    FDA recommendations on time/temperature control:

    “Strategies to reduce microbial hazards in produce include the implementation of Good Agricultural Practices on farms, and Good Manufacturing Practices (GMP) in packing, handling, and storage. Due to their highly perishable nature, most fresh fruits and vegetables need time/temperature control to extend their shelf life. In any case, attention should be paid to storage times and temperatures since pathogens, if present, are able to grow- particularly in the case of fresh-cut produce or where internalization is possible. Storage temperature and time management are important in reducing the risks of foodborne illness, and become critical parameters for any fresh-cut produce. However, as mentioned above, the time/temperature for seed sprouts will not reduce the risk of presence of high levels of pathogens. While, traditional processing methods such as freezing, canning, dehydration, fermentation, and acidification are used to improve the stability of fruits and vegetables, and time/temperature control may not be a requirement for these processed products.”

    Egg and Egg Products

    Despite their natural antimicrobial barriers, eggs can still be contaminated by trans-shell and trans-ovarian infections. Heat treatment does not guarantee the products to be shelf-stable or safe.

    FDA recommendations on time/temperature control:

    “Eggs and egg products will easily support the growth of spoilage and pathogenic microorganisms and clearly require time/temperature control to assure safety. Control methods require an integrated approach that begins at the egg production facility, and carries through to processing and further processing operations as well as to retail and food service facilities. Temperature control of shell eggs, followed by thorough cooking and proper handling, are essential in assuring safety. As mentioned above, heat treatments used for liquid eggs do not produce shelf-stable products, so they should be kept refrigerated or frozen. These products should be safely handled to reduce the likelihood of post-process and/or cross contamination.”

    Milk and Milk Products

    Milk provides adequate nutrients for microbes, has a neutral pH level, and is high in moisture. Subject to microbial spoilage, it will quickly become unacceptable for human consumption if sanitary practices and temperature control during handling are not conducted properly.

    FDA recommendations on time/temperature control:

    “During handling, basic sanitary practices and temperature control are required to maintain acceptable sensory qualities of milk and milk products. Similarly, most milk and milk products are sold refrigerated to prevent spoilage. Exceptions include canned milks, dried milk, ice cream, aseptically processed and packaged products, and thermally processed products that are packaged hot in conjunction with specific product formulations. These milk products do not require refrigeration because of the combination of moisture content, salts, and pH that control the growth of microbes.”

    Overall, the following categories of food require close temperature control to prevent spoilage and to extend their shelf life: meat and poultry, most seafood (including cooked seafood and sushi), eggs, and most fresh fruits and vegetables. Dairy goods and cooked egg products need to be refrigerated before consumption. Fully salted and dried seafood products, as well as acidified fruits and vegetables are shelf stable thus not requiring stringent temperature monitoring.

    Free Temperature@lert Food Service Monitoring Guide

    For more details on the varied requirements for foods from processing to storage, please visit the FDA report, “Evaluation & Definition of Potentially Hazardous Foods.” Please email info@temperaturealert.com to learn more about our monitoring solutions for potentially hazardous foods.


    The Institute of Food Technologists. “Evaluation & Definition of Potentially Hazardous Foods: A Report of the Institute of Food Technologists for the Food and Drug Administration of the U.S. Department of Health and Human Services”. December 31, 2001 http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094147.htm

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  • Monitoring Food Cooling Processes in Restaurants

    Last week we briefly introduced how Temperature@lert could help the food suppliers remotely monitor food temperature during transportation, and this week we’d like to share some crucial knowledge on the topic of temperature monitoring during food cooling—a process wherein the majority of the restaurants in the U.S. fail to meet the FDA recommendations.

    The notion that improper cooling processes of hot food will very likely lead to foodborne illness is a well known fact—between 1998 and 2008, inadequate food cooling processes in restaurants led to 504 outbreaks in the United States alone. The shocking nature of that statistic exposes the critical improvements needed to be made to the sectors within food preparation, along with the necessary implementation of stricter monitoring procedures during the cooling process.

    The FDA’s Food Code provides detailed guidelines for food service establishments to reduce pathogen proliferation during the cooling processes. The FDA explicitly states that for potentially hazardous food, time-temperature control is necessary to keep food safe before consumption. The food has to be cooled “rapidly” in order to minimize the amount of time that the food temperature is within the danger zone (40°-140°F). For instance, the food temperature has to drop from 135° to 70°F within 2 hours, and from 70° to 41°F in no less than 4 additional hours.

    Cooling processes (a critical step in food preparation) should be tested, verified, and monitored. The FDA Food Code recommends temperature monitoring on an ongoing basis, and the obtained temperature data should be recorded for future verification.

    In a research project conducted by Brown et al, 420 restaurant managers were interviewed on the food cooling practices in their working site. Only 20% of them admitted that the food cooling regulations in their jurisdiction were consistent with the FDA’s recommendations. 60% of the managers said the food cooling practices were monitored on a routine basis—half of those calibrated the thermometers weekly. But 6% of the restaurants had never calibrated their thermometers. In 79% of the observations, the food was not cooled to the required temperature on time. Given the information, it won’t surprise anyone to learn that 85.5% of the managers reported cooling processes that did not meet all FDA recommended components.

    In order to prevent customer exposure to food borne illness, restaurants must follow FDA’s recommended guidelines in all the steps of food preparation. We suggest that restaurants implement rapid cooling as well as temperature monitoring in order to keep food out of the danger zone. Temperature@lert products can help you efficiently monitor the temperature during the food cooling process as well as in storage. Please feel free to contact info@temperaturealert.com for solution recommendations.

    Temperature@lert Food Service Refrigeration Monitoring Guide


    Brown, L,G, Ripley, D, Blade,H, Reimann, D, Everstine, K, Nicholas, D, Egan, J, Koktavy, N, Quilliam, D,N, EHS-NET Working Group. “Restaurant Food Cooling Practices”. Journal of Food Protection, (75:12), 2012, 2172-2178.

    U.S. Food and Drug Administration. “Limitation of growth of organisms of public health concern”. Food Code. 2009. Available at: http://www.fda.gov/Food/FoodSafety/Retail FoodProtection/FoodCode/FoodCode2009/ucm186451.htm#part3-5. Accessed 24 April 2012.

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  • Pathogenic Bacteria Growth and Temperature: Tied at the Hip

    We know from our previous posts that HACCP compliance, specific to seafood, specifically highlights temperature control as a critical preventative method against pathogenic growth and toxin formation. In short, these methods of temperature control are designed to protect both food establishments (in maintaining safe practices) and consumers (in preventing foodborne illnesses). This FDA list outlines pathogens that are common in seafood and thereby represent the biggest threats to consumer safety.

         - Listeria monocytogenes (L. monocytogenes)

         - Vibrio vulniicus (V. vulniicus)

         - Vibrio parahaemolyticus (V. parahaemolyticus)

         - Vibrio cholera (V. cholera)

         - Escherichia coli (E. coli)

         - Salmonella spp.

         - Shigella spp.

         - Staphylococcus aureus (S. aureus) j,

         - Clostridium perfringens (C. perfringens)

         - Bacillus cereus (B. cereus)

         - Campylobacter jejuni (C. jejuni)

         - Yersinia enterocolitica (Y. enterocolitica)


    And yet, the list of common pathogens isn’t enough. There are several “process points” by which these pathogens can become an issue, and these include unsanitary utensils and equipments, cross-contamination between raw and cooked foods, as well as several others. The overall goal is to maintain temperatures that prevent the growth of pathogenic bacteria, as in the examples listed above. One must consider the types of bacteria that may be present, their growth rates within the food, and the initial expectation for pathogenic presence. Capping the growth rates of these pathogens with temperature control is the biggest obstacle to overcome, as a “0%” pathogen presence is nearly impossible. To this, the FDA offers this advice:

    “In other words, product temperatures should be maintained below the minimum growth temperature for the pathogen or should not be allowed to exceed that temperature for longer than the lag growth phase (i.e., the slow growth phase during which a pathogenic bacteria acclimates to its environment before proceeding to rapid growth) of the pathogenic bacteria at the exposure temperature.”

    Further, the strategies for control of pathogenic bacteria in seafood are clearly outlined by the FDA in the same document. Control of moisture and temperature are the most important factors within these respective strategies. This is an abridged list of the FDA’s strategic suggestions, and for more information on FDA best practices and suggestions, visit the link at the footer of this post.

         1. Management of Time/Temperature: Manage the time by which seafood is exposed to temperatures that encourage      rapid bacterial growth.

         2. Retroactive Revitalization: Kill pathogens and other bacteria with methods such as re-cooking, pasteurization, and/or      retortion.

         3. Moisture Control: Use drying and safe holding practices to control the amount of moisture that is available for growth.

         4. Salt Control: Observe, document, and adjust the amount of preservatives like sodium nitrite in the food.

         5. Acid Control: Observe, document, and adjust the pH levels in the food.

    Free Temperature@lert Monitoring Guide for Food Service

    FDA.Gov: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, April 2011

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  • Remote Temperature Monitoring during Food Transportation

    As the food market becomes increasingly globalized, our neighborhood supermarkets are shelved with well-traveled products from every nook and cranny of the planet. Fresh Wellfleet oysters from Massachusetts are shipped to the finest restaurants in Las Vegas; cod from Norway is processed into filets in China and then shipped to Scandinavia for sale; coffee beans travel across continents, from crops to cups, to meet the demands of the coffee connoisseurs who desire exotic and original tastes of nature. In the United States, the average distance that food travels to reach a consumer is 1,300 miles. Given this, our “movable feast” requires safe food transportation, and it is critical to store the food within the temperature safe zone before consumption. Improper processes can and will lead to food spoilage and food poisoning.

    global food picture

    To prevent economic loss and public health risk, the FDA Food Code requires all hot foods be maintained at 135°F or above and all cold food below 41°F to reduce bacteria growth. Food temperature should be monitored and recorded throughout the transportation process, and immediate corrective action should be taken if the temperature falls out of the required safety zone. Below are some detailed requirements from the National Food Service Management Institute’s Food Safety Fact Sheet on food temperature during transportation.

    Monitor transporting process:

         - Check the temperature of all food carriers with a calibrated thermometer before loading with food

         - Check cold carriers in the warmest part

         - Check hot carriers in the coolest part

         - Check food temperatures with a clean, sanitized, and calibrated thermometer before placing it in the food carrier

         - Check food temperatures with a clean, sanitized, and calibrated thermometer when it arrives at the satellite site

         - Record the temperatures and the times of when temperatures were checked

    Take corrective action if appropriate holding temperature of the food is not met during transporting:

         - Continue heating or chilling food carrier if it is not at the appropriate temperature

         - Reheat food to 165 °F for 15 seconds if the temperature is found to be below 135 °F and the last temperature      measurement was 135 °F or higher and taken within the last 2 hours

         - Cool food to 41 °F or below using a proper cooling procedures if internal temperature of cold food is greater than 41 °F.

         - Repair or reset equipment before returning the food to the unit if temperatures are not maintained.

         - Discard food that has been held in the temperature danger zone of 41 °F–135 °F for more than 4 hours

         - Record corrective actions taken

    Next week we will investigate on temperature monitoring during food cooling process in restaurants.

    Temperature@lert Free Food Service Monitoring Guide

    Temperature@lert products and services help you remotely monitor food temperatures on the road. Once the temperature falls out of your preset threshold, Sensor Cloud will immediately alert you through phone calls, e-mails, and text alerts to take corrective actions. For added peace of mind, the data and reports are logged and stored in our Sensor Cloud platform for future analysis and health department reporting.


    Rosenthal, E. “Environmental Cost of Shipping Groceries Around the World”. New York Times. April 26, 2008. http://www.nytimes.com/2008/04/26/business/worldbusiness/26food.html?pagewanted=all&_r=0.

    National Food Service Management Institute, The University of Mississippi. “Food Safety Fact Sheet: Transporting Foods”. 2013. http://nfsmi-web01.nfsmi.olemiss.edu/documentlibraryfiles/PDF/20130806033715.pdf.

    Food Facts http://www.sustainablelafayette.org/?page_id=1015.

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